nctId
stringlengths 11
11
| briefTitle
stringlengths 7
300
| briefSummary
stringlengths 2
5.11k
| detailedDescription
stringlengths 0
32.3k
| eligibilityCriteria
stringlengths 0
20.1k
| embedding
listlengths 256
256
|
|---|---|---|---|---|---|
NCT04725084
|
Comparison of Non-invasive Oxygenation Strategies in Patients Admitted for Covid-19 Acute Respiratory Distress Syndrome
|
Acute Respiratory Distress Syndrome (ARDS) is the main clinical presentation of SARS-CoV-2 (Covid-19) infected patients admitted in Intensive Care Unit (ICU).
During the first phase of the outbreak (between February and May 2020), the use of invasive Mechanical Ventilation (MV) was largely required with 63% of ICU patients intubated in the first 24 hours after admission and up to 80% of patients during the overall ICU stay. Mortality was especially higher when using MV in the first 24 hours. In contrast, the use of non-invasive oxygenation strategies in the first 24 hours was only 19% for High Flow Nasal Cannula oxygen therapy (HFNC) and 6% for Non-Invasive Ventilation (NIV).
Several non-invasive oxygenation strategies were proposed in order to delay or avoid MV in ICU patients suffering from Covid-19 ARDS. The use of HFNC became the recommended oxygenation strategy, based in particular on publications prior to the outbreak. The use of NIV or Continuous Positive Airway Pressure (CPAP) combined with HFNC have also been proposed. Although these non-invasive oxygenation strategies seem widely used in the second phase of the outbreak, they have not yet confirmed their clinical impact on MV requirement and patient's outcome. Moreover, no comparison has been made between these different non-invasive oxygenation strategies.
The aim of this study is to compare different non-invasive oxygenation strategies (HFNC, NIV, CPAP) on MV requirement and outcome in ICU patients treated for ARDS related to Covid-19.
|
Retrospective multicenter observational registry in French intensive care unit including all consecutive patients admitted for acute respiratory distress syndrome related to SARS-CoV-2 pneumonia between1st July and 31th December 2020.
Patients characteristics, ICU treatments and outcome will be recorded.
|
Inclusion Criteria:
* patients admitted in intensive care unit because of a SARS-CoV-2 infection confirmed by PCR wherever was collected the analyzed sample
* acute respiratory distress syndrome according to Berlin criteria
* age superior or equal to 18 years old
Exclusion Criteria:
* patient opposition to participate in the study
* patients under judicial protection measures
|
[
0.3230280876159668,
2.4822587966918945,
-0.823891818523407,
-2.123058319091797,
0.6090457439422607,
0.27498650550842285,
0.47482189536094666,
0.22232821583747864,
-0.231149360537529,
0.923891544342041,
-1.2790940999984741,
1.0442448854446411,
-0.6852580308914185,
1.145653247833252,
-0.791015625,
1.417927861213684,
0.08252675831317902,
0.40984097123146057,
0.6180293560028076,
-1.2225135564804077,
0.5213057398796082,
0.5255678296089172,
-0.7721253633499146,
0.26504966616630554,
0.7379931211471558,
-0.2968238890171051,
-0.6817539930343628,
-1.1148518323898315,
-0.0274183452129364,
0.7422764301300049,
0.5878269672393799,
-1.4874807596206665,
0.17985732853412628,
0.912609875202179,
0.5758627653121948,
-0.2736443281173706,
-0.05545082688331604,
1.0945156812667847,
-0.3649729788303375,
-0.8412016034126282,
0.8078761100769043,
0.6808250546455383,
-0.44846946001052856,
-0.6013498902320862,
0.7033377289772034,
0.4654126763343811,
0.19495142996311188,
0.06692448258399963,
1.0804795026779175,
-0.13182002305984497,
-1.383848786354065,
0.42789435386657715,
-0.46201077103614807,
0.006226988043636084,
1.6453092098236084,
0.3068408966064453,
-0.11144088953733444,
0.6803102493286133,
0.7230699062347412,
0.5057412981987,
0.028919044882059097,
0.06360889226198196,
0.5025293827056885,
0.0007948389975354075,
-1.096579670906067,
-0.42382073402404785,
-0.547248363494873,
0.13927000761032104,
-0.628835141658783,
-0.10098249465227127,
-0.22985348105430603,
-0.6022893190383911,
0.25882893800735474,
0.09639465063810349,
0.08870361000299454,
0.5209495425224304,
-0.6308891177177429,
0.5801953673362732,
-0.3160250782966614,
0.1742156744003296,
-0.9508891701698303,
-0.016392815858125687,
-0.2941938042640686,
-0.48967427015304565,
0.367053747177124,
0.19972144067287445,
-1.2359508275985718,
-0.44711071252822876,
0.38911598920822144,
-0.6338856220245361,
0.08121542632579803,
-0.7100004553794861,
-1.004906415939331,
-0.10306013375520706,
-0.15647603571414948,
0.49410074949264526,
-0.02837628498673439,
-0.3851914405822754,
-0.27388501167297363,
-0.4893924593925476,
0.47696858644485474,
-0.3203846216201782,
-0.4234555661678314,
0.32175225019454956,
-0.39503803849220276,
0.3981665372848511,
0.22723932564258575,
-0.596059262752533,
-0.1406230628490448,
-0.5914478898048401,
0.2433619201183319,
-0.018093271180987358,
-0.13435006141662598,
-0.48410600423812866,
0.1994132250547409,
0.2939639389514923,
0.6913766264915466,
0.11553104221820831,
0.5376479625701904,
-1.0171538591384888,
-0.5658265352249146,
0.11283174157142639,
0.6216527223587036,
0.21514953672885895,
-1.0103495121002197,
-0.10788299888372421,
-0.8786712288856506,
0.6721946001052856,
-0.16716939210891724,
-0.24791978299617767,
-0.6581828594207764,
0.24132713675498962,
0.6891651153564453,
-0.5693734288215637,
-0.1263512820005417,
-0.3737168610095978,
0.5411720275878906,
0.8758999705314636,
-0.1428067833185196,
-0.4720439314842224,
0.015667537227272987,
0.15201839804649353,
0.6776556372642517,
-0.7660112380981445,
-0.6573144793510437,
-0.510703980922699,
-0.27991196513175964,
0.2717241644859314,
-0.7902991771697998,
-0.009239680133759975,
-0.5332669615745544,
0.2779275178909302,
-0.03426962345838547,
0.7504159808158875,
0.5320216417312622,
0.6182347536087036,
0.20144087076187134,
0.19664300978183746,
-0.051882293075323105,
-0.10362395644187927,
0.16805851459503174,
0.07388848811388016,
0.10456901043653488,
-0.45178455114364624,
0.5527340173721313,
-0.3318478465080261,
-0.3410480320453644,
0.4473652243614197,
0.0934562087059021,
-0.04006605222821236,
-0.3604905307292938,
0.0987824872136116,
0.013627753593027592,
-0.39667007327079773,
-0.3555101752281189,
0.04106477275490761,
-0.3119554817676544,
0.465855211019516,
0.3281450867652893,
-0.2726897895336151,
0.3041953146457672,
-0.33305850625038147,
-0.2474672943353653,
0.3099270164966583,
-0.05357411131262779,
-0.060975052416324615,
0.11167457699775696,
-0.1767149567604065,
-0.21662724018096924,
0.04278969764709473,
-0.25314030051231384,
0.1724025011062622,
-0.2887611389160156,
0.2914057672023773,
0.19853222370147705,
0.26904958486557007,
-0.6430296897888184,
-0.3841697573661804,
0.27710679173469543,
-0.054955173283815384,
0.2464800924062729,
0.051842398941516876,
0.10868635773658752,
0.7112686038017273,
0.5373720526695251,
-0.503128707408905,
-0.07062080502510071,
-0.22556012868881226,
0.05309022590517998,
0.6324268579483032,
0.2996409833431244,
0.3823060393333435,
-0.12756524980068207,
-0.07957717031240463,
0.11750377714633942,
0.010082057677209377,
0.29256847500801086,
0.47687453031539917,
-0.9434625506401062,
0.2896292209625244,
0.10268642008304596,
-0.26869767904281616,
0.10501698404550552,
0.24328729510307312,
-0.11060528457164764,
0.06605150550603867,
0.24323417246341705,
0.42877060174942017,
0.09709983319044113,
-0.11249919980764389,
-0.2622266411781311,
-0.02490820549428463,
-0.0768827274441719,
0.3013041019439697,
-0.192724347114563,
-0.17287249863147736,
0.21690239012241364,
0.2040604054927826,
0.22684775292873383,
0.42068350315093994,
0.536483645439148,
-0.21916039288043976,
-0.18775218725204468,
-0.3325471580028534,
0.07346455007791519,
0.04805191233754158,
-0.12680961191654205,
0.04687735065817833,
-0.057284172624349594,
-0.16262120008468628,
0.2821404039859772,
-0.24907436966896057,
0.4160332679748535,
0.09462101757526398,
-0.4721021354198456,
-0.0625438243150711
] |
NCT03126916
|
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
|
This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.
|
PRIMARY OBJECTIVES:
I. To determine in the context of a randomized trial whether the event-free survival (EFS) of patients with newly diagnosed high-risk neuroblastoma (NBL) is improved with the addition of iobenguane I-131 (131I-MIBG) during induction, prior to tandem autologous stem cell transplantation (ASCT).
II. To determine whether the addition of lorlatinib to intensive multimodality therapy for patients with high-risk NBL whose tumors harbor activating point mutations in the ALK gene with a variant allele frequency (VAF) \>= 5% results in superior EFS compared to a contemporaneously treated cohort of patients with tumors without documented ALK activating mutations.
SECONDARY OBJECTIVES:
I. To describe the toxicities associated with treatment for high-risk NBL with and without the addition of 131I-MIBG or ALK inhibitor therapy.
II. To estimate EFS and describe toxicity in patients with newly diagnosed high-risk NBL randomized to treatment with an 131I-MIBG-containing induction prior to busulfan/melphalan (BuMel) ASCT.
III. To describe the overall survival (OS) and response rates (evaluated per International Neuroblastoma Response Criteria \[INRC\] criteria prior to ASCT and prior to post-consolidation therapy) for patients with high-risk neuroblastoma treated with or without 131I-MIBG or ALK inhibitor therapy.
IV. To prospectively evaluate the relationship of response rate per revised International Neuroblastoma Response Criteria (INRC) to EFS and OS in patients with high-risk NBL treated with and without the addition of 131I-MIBG or ALK inhibitor therapy.
EXPLORATORY OBJECTIVES:
I. To evaluate whole body radiation dose, tumor factors, and host factors as potential predictors of efficacy and/or toxicity associated with 131I-MIBG therapy and transplant conditioning.
II. To describe end-Induction response, EFS, and OS according to specific ALK mutations, VAF, ALK amplification, the presence of additional genomic findings, or the ALK inhibitor administered.
III. To characterize changes in tumor markers (circulating tumor deoxyribonucleic acid \[DNA\], including ALK and other tumor specific genetic aberrations, and circulating GD2) over time in response to protocol therapy.
IV. To correlate results of tumor and host profiling with end-induction response and EFS.
V. To prospectively evaluate EFS for patients with MIBG non-avid high-risk NBL compared to patients with MIBG-avid high-risk NBL who are randomized to treatment without 131I-MIBG.
VI. To correlate Curie scores calculated from 131I-MIBG post-treatment scans with end-induction response, EFS and OS.
VII. To describe changes in image defined risk factors (IDRFs) over the course of induction therapy, with correlation to surgical outcomes and local failure rates following primary tumor resection.
VIII. To define patterns of failure at time of first relapse or progression in patients with high-risk NBL.
IX. To determine the feasibility of prospectively monitoring adverse events using electronic health records.
X. To compare local, central, and computer assisted Curie score assignment at baseline and during therapy in patients with MIBG-avid high-risk NBL.
XI. To compare late toxicities (including impaired organ function and secondary tumor occurrence) in patients treated with 131I-MIBG or ALK inhibitor therapy to late toxicities in patients who have not received these therapies.
XII. To determine the association between household material hardship (HMH) and clinical outcomes, including event free and overall survival, and 131I-MIBG receipt.
XIII. To compare the outcomes (EFS, OS, and toxicity) of patients treated with post-consolidation therapy that does not contain aldesleukin to historical outcome data for patients treated with similar induction and consolidation regimens followed by post-consolidation therapy that contained aldesleukin.
XIV. To characterize and describe longitudinal neuropsychological and behavioral effects of high-risk neuroblastoma therapy.
XV. To evaluate change in neurobehavioral outcomes over time in patients with neuroblastoma treated with high-risk neuroblastoma therapy plus lorlatinib compared to high-risk therapy alone using parent- or self-report measures of adaptive, executive, and psychosocial functioning.
XVI. To characterize the pharmacokinetics and pharmaceutical properties of lorlatinib in children with high-risk neuroblastoma.
OUTLINE: Patients are randomized or assigned to 1 of 5 arms.
All patients receive cyclophosphamide intravenously (IV) over 15-30 minutes and topotecan hydrochloride IV over 30 minutes on days 1-5 during cycle 1 of induction therapy in the absence of disease progression or unacceptable toxicity. Patients not assigned to an Arm by the end of cycle 1 may receive an addition cycle of cyclophosphamide and topotecan.
ARM A:
INDUCTION THERAPY: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan hydrochloride IV over 30 minutes on days 1-5 of cycle 2 and cisplatin IV over 4 hours and etoposide phosphate IV over 2 hours on days 1-3 of cycles 3 and 5. Patients also receive vincristine sulfate IV over 1 minute on day 1 and dexrazoxane hydrochloride IV over 5-15 minutes, doxorubicin hydrochloride IV over 1-15 minutes, and cyclophosphamide IV over 1-6 hours on days 1-2 of cycle 4 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY:
HSCT#1: Patients receive thiotepa IV over 2 hours on days -7 to -5 and cyclophosphamide IV over 1 hour on days -5 to -2 in the absence of disease progression or unacceptable toxicity.
HSCT#2: Patients receive melphalan hydrochloride IV over 30 minutes on days -7 to -5, and etoposide phosphate IV over 24 hours and carboplatin IV over 24 hours on days -7 to -4 in the absence of disease progression or unacceptable toxicity.
POST-CONSOLIDATION THERAPY: Patients receive sargramostim subcutaneously (SC) on days 1-14, dinutuximab IV over 10 hours on days 4-7 of cycles 1-5, and isotretinoin orally (PO) twice daily (BID) on days 11-24 of cycles 1-5, and days 15-28 during cycle 6 in the absence of disease progression or unacceptable toxicity.
Patients undergo echocardiography or multigated acquisition (MUGA) scan, magnetic resonance imaging (MRI) or computed tomography (CT) scan, receive 123I-MIBG and undergo MIBG imaging, bone marrow aspiration and biopsy and blood sample collection throughout the study.
ARM B:
INDUCTION THERAPY: Patients receive cyclophosphamide, topotecan hydrochloride, cisplatin, and etoposide phosphate as in Arm A, iobenguane I-131 IV over 1.5-2 hours on day 1 beginning 3 weeks after the start of cycle 3, and vincristine sulfate, dexrazoxane hydrochloride, doxorubicin hydrochloride, and cyclophosphamide as in Arm A beginning no sooner than 35 days after the infusion of iobenguane I-131.
CONSOLIDATION THERAPY:
HSCT#1: Patients receive thiotepa and cyclophosphamide as in Arm A.
HSCT#2: Patients receive melphalan, etoposide phosphate, and carboplatin as in Arm A.
POST-CONSOLIDATION THERAPY: Patients receive sargramostim, dinutuximab, and isotretinoin as in Arm A-D.
Patients undergo echocardiography or MUGA scan, MRI or CT scan, receive 123I-MIGB and undergo MIBG imaging, bone marrow aspiration and biopsy and blood sample collection throughout the study.
ARM C (CLOSED TO ACCRUAL AS OF DECEMBER 17, 2020):
INDUCTION THERAPY: Patients receive cyclophosphamide, topotecan hydrochloride, cisplatin, etoposide phosphate, iobenguane I-131, vincristine sulfate, dexrazoxane hydrochloride, doxorubicin hydrochloride, and cyclophosphamide as in Arm B.
CONSOLIDATION THERAPY: Patients receive busulfan IV over 3 hours on days -6 to -3 and melphalan hydrochloride IV over 30 minutes on day -1 in the absence of disease progression or unacceptable toxicity.
POST-CONSOLIDATION THERAPY: Patients receive sargramostim, dinutuximab, and isotretinoin as in Arm A.
Patients undergo echocardiography or MUGA scan, MRI or CT scan, receive 123I-MIGB and undergo MIBG imaging, bone marrow aspiration and biopsy and blood sample collection throughout the study.
ARM D: Patients receive treatment identical to Arm A.
Patients undergo echocardiography or MUGA scan, MRI or CT scan, receive 123I-MIGB and undergo MIBG imaging, bone marrow aspiration and biopsy and blood sample collection throughout the study and may undergo fludeoxyglucose- positron emission tomography (PET) scan on study.
ARM E:
INDUCTION THERAPY: Patients receive cyclophosphamide, topotecan hydrochloride, cisplatin, etoposide phosphate, vincristine sulfate, dexrazoxane hydrochloride, doxorubicin hydrochloride, and cyclophosphamide as in Arm A. Patients also receive lorlatinib PO once daily (QD) starting cycle 2 prior to HSCT #1 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY:
HSCT#1: Patients receive thiotepa and cyclophosphamide as in Arm A. Patients also receive lorlatinib PO QD until day -8 of HSCT#2 in the absence of disease progression or unacceptable toxicity.
HSCT#2: Patients receive melphalan hydrochloride, etoposide phosphate, carboplatin as in Arm A. Lorlatinib is restarted when patient has reached at least day +14 post-HSCT#2 and is able to tolerate enteral medications, provided there is no evidence of disease progression or unacceptable toxicity.
RADIATION THERAPY: Patients receive lorlatinib PO QD concurrently with radiation therapy in the absence of disease progression or unacceptable toxicity.
POST-CONSOLIDATION THERAPY: Patients receive sargramostim and dinutuximab as in Arm A-D. Patients also receive isotretinoin PO BID on days 11-24 of cycles 1-5 and days 15-28 of cycle 6, and lorlatinib PO QD on days 15-28 of cycles 2-5 and days 1-28 of cycle 6 in the absence of disease progression or unacceptable toxicity.
CONTINUATION THERAPY: Patients receive lorlatinib PO QD on days 1-28. Cycles repeat every 28 days for 18 months in the absence of disease progression or unacceptable toxicity.
Patients undergo echocardiography or MUGA scan, MRI or CT scan, receive 123I-MIGB and undergo MIBG imaging, bone marrow aspiration and biopsy and blood sample collection throughout the study and may undergo MRI and PET scan on study.
After completion of study therapy, patients in Arms A-D are followed up every 3 months for 18 months, and then every 6 months for 42 months; patients in Arm E are followed up every 3 months for 6 months, and then every 6 months for 42 months.
|
Inclusion Criteria:
* Patients must be enrolled on ANBL00B1 (NCT00904241) or APEC14B1 (NCT02402244) prior to enrollment on ANBL1531 (NCT03126916)
* Patient must be \>= 365 days and =\< 30 years of age at diagnosis
* Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; the following disease groups are eligible:
* Patients with International Neuroblastoma Risk Group (INRG) stage M disease are eligible if found to have either of the following features:
* MYCN amplification (\> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR
* Age \> 547 days regardless of biologic features
* Patients with INRG stage MS disease with MYCN amplification
* Patients with INRG stage L2 disease with MYCN amplification
* Patients \> 547 days of age initially diagnosed with INRG stage L1, L2 or MS disease who progressed to stage M without prior chemotherapy may enroll within 4 weeks of progression to stage M
* Patients \>= 365 days of age initially diagnosed with MYCN amplified INRG stage L1 disease who progress to stage M without systemic therapy may enroll within 4 weeks of progression to stage M
* Patients initially recognized to have high-risk disease must have had no prior systemic therapy (other than topotecan/cyclophosphamide initiated on an emergent basis and within allowed timing); patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high risk disease but subsequently found to meet the criteria will also be eligible; patients who receive localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis will be eligible
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/sex as follows:
* 1 to \< 2 years: male = 0.6; female = 0.6
* 2 to \< 6 years: male = 0.8; female = 0.8
* 6 to \< 10 years: male = 1; female = 1
* 10 to \< 13 years: male = 1.2; female = 1.2
* 13 to \< 16 years: male = 1.5; female = 1.4
* \>= 16 years: male = 1.7; female = 1.4
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age, and
* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 10 x ULN; for the purposes of this study, ULN for SGPT (ALT) is 45
* Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \> 50% by echocardiogram or radionuclide angiogram
* No known contraindication to peripheral blood stem cell (PBSC) collection; examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure
Exclusion Criteria:
* Patients with INRG stage L2 tumors without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial)
* Patients with bone marrow failure syndromes
* Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders
* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
|
[
2.4268531799316406,
-0.6877517104148865,
-0.875711977481842,
-3.389765977859497,
1.057129979133606,
-0.153581902384758,
-0.12063809484243393,
0.9090052247047424,
-1.15374755859375,
-0.7313017845153809,
-0.8836917281150818,
0.40593868494033813,
-1.1415915489196777,
0.43795087933540344,
0.9550631642341614,
0.4054834246635437,
-1.5198222398757935,
-0.32017168402671814,
0.05245338752865791,
-2.8024513721466064,
1.302841305732727,
-0.9244459271430969,
-1.5294965505599976,
-2.0214929580688477,
0.5348775386810303,
0.2643144130706787,
0.2964162826538086,
1.2900480031967163,
0.4211753010749817,
2.3855676651000977,
-0.5450997352600098,
-0.858115017414093,
-0.20904235541820526,
0.15325945615768433,
-0.7568573355674744,
0.26044681668281555,
2.142721176147461,
-0.8172922134399414,
-1.4184807538986206,
-0.18834930658340454,
-0.08353515714406967,
0.17897649109363556,
0.3870888650417328,
-0.013758658431470394,
-1.684340476989746,
-0.15030121803283691,
-0.7400122284889221,
0.6033521294593811,
0.924419105052948,
0.7717498540878296,
-1.7674553394317627,
2.0112438201904297,
0.4013443887233734,
-0.45578429102897644,
0.7144104242324829,
1.095084309577942,
0.3147698938846588,
-1.2092044353485107,
1.8634229898452759,
-0.40246009826660156,
1.5119279623031616,
-1.1258691549301147,
0.2744125425815582,
0.7962942719459534,
-0.2700492739677429,
-0.6488227248191833,
-0.44897210597991943,
0.04691033437848091,
-0.8791158199310303,
-0.17932981252670288,
-0.42512527108192444,
-0.29450035095214844,
0.2178482860326767,
-0.30779504776000977,
0.8851847648620605,
0.6529860496520996,
-0.45361462235450745,
-0.17095758020877838,
1.131630778312683,
-0.13110341131687164,
-0.15393054485321045,
-2.0094099044799805,
0.26860564947128296,
0.09175381064414978,
-0.16674986481666565,
-0.6478896737098694,
-1.0078765153884888,
-0.6784371733665466,
-0.035976342856884,
-1.399740219116211,
1.2366961240768433,
0.09566344320774078,
-1.5553903579711914,
1.85117769241333,
-1.7217432260513306,
-1.0581787824630737,
0.518756628036499,
-1.0996792316436768,
-1.064936876296997,
0.19807256758213043,
0.4505588412284851,
-0.6190019249916077,
-0.8022326827049255,
-0.725408136844635,
-0.1286272257566452,
-0.1187068447470665,
0.5255053043365479,
-0.7202594876289368,
-0.4719313383102417,
-1.4380394220352173,
0.7736110687255859,
-1.4610271453857422,
-0.9219563007354736,
-0.09411302953958511,
0.9663194417953491,
1.225854754447937,
1.0886669158935547,
-0.6413028240203857,
-0.31025445461273193,
-0.6923952102661133,
-0.17704083025455475,
0.6580842733383179,
-0.5404366254806519,
0.07902946323156357,
0.3493708670139313,
-0.23776580393314362,
0.6937605142593384,
-0.31669631600379944,
-1.0714819431304932,
-1.7727388143539429,
-0.27443012595176697,
1.2643576860427856,
-0.30754128098487854,
0.2739478051662445,
-0.33553290367126465,
-0.560221254825592,
0.12315835058689117,
0.8122404217720032,
0.5843365788459778,
-0.42426231503486633,
0.47191759943962097,
0.18044547736644745,
-0.10025013238191605,
-0.42290499806404114,
-1.3643078804016113,
-0.2836964726448059,
0.2975580394268036,
1.235404372215271,
-0.6081291437149048,
-0.34013867378234863,
0.4881551265716553,
0.43090149760246277,
-0.5607960820198059,
0.2364712506532669,
-0.0010562412207946181,
0.904334545135498,
0.8580014109611511,
-0.4379725754261017,
-0.14852555096149445,
-0.19405631721019745,
-1.4093725681304932,
0.39233556389808655,
0.41897016763687134,
0.20979049801826477,
1.3139442205429077,
-1.0493850708007812,
-0.22840535640716553,
-0.775307834148407,
-0.17872364819049835,
0.6733388304710388,
-0.7143223285675049,
-0.3326663076877594,
0.04656754806637764,
-0.4234064817428589,
0.2926274240016937,
-0.12477263063192368,
0.8318325281143188,
0.12772908806800842,
0.13249459862709045,
-0.4533424377441406,
-0.5740995407104492,
-0.46864888072013855,
0.8820555210113525,
-0.519078254699707,
0.426423579454422,
-0.23458537459373474,
0.14915598928928375,
0.407487690448761,
-0.2893604338169098,
0.1585788130760193,
0.8716222047805786,
0.32018792629241943,
0.04089449718594551,
0.2303609699010849,
0.6013732552528381,
-0.7928479909896851,
-0.1443638950586319,
-0.009439927525818348,
0.7436395883560181,
-0.16407260298728943,
-0.045337971299886703,
0.7028799653053284,
0.13481299579143524,
0.8798660039901733,
0.728245198726654,
0.07116712629795074,
0.5040441155433655,
0.24053579568862915,
-0.6274904012680054,
0.5327445268630981,
0.10637884587049484,
0.2187797874212265,
0.6264349818229675,
0.2529139816761017,
0.5433399677276611,
-0.3480413556098938,
-0.08584176003932953,
0.6150033473968506,
-0.9070535898208618,
-0.13072098791599274,
-0.3279406726360321,
-0.44968873262405396,
-0.03737945109605789,
-0.45532625913619995,
0.23811253905296326,
0.11796800047159195,
0.25897377729415894,
-0.03395352140069008,
-0.2191150039434433,
-0.7810021042823792,
-0.28959351778030396,
0.03005961887538433,
-0.30160224437713623,
-0.5686329007148743,
-0.30800583958625793,
-0.6221333146095276,
0.10301034897565842,
-0.011697866022586823,
-0.6237760186195374,
0.38178080320358276,
-0.042534321546554565,
0.024472152814269066,
-0.1736869066953659,
-0.18487679958343506,
-1.3156216144561768,
-0.5751288533210754,
-0.4630475342273712,
-0.48378974199295044,
-0.4267136752605438,
0.2025860995054245,
-0.43683263659477234,
0.10557717829942703,
0.47068163752555847,
0.45367196202278137,
-0.45495864748954773,
-0.4701573848724365
] |
NCT01264107
|
An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine
|
An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine.
|
Inclusion Criteria:
1. Patients is currently clevudine treatment.
2. Patients with HBV DNA \< 300 cpoies/mL and ALT normal Showing Muscle-related Symptom Who received Clevudine
3. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion Criteria:
1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
2. Patient is pregnant or breast-feeding.
3. Patient has a significant gastrointestinal, renal, decompensated liver, bronchopulmonary, neurological, cardiac, oncologic(except HCC)or allergic disease.
4. Patient, in the opinion of the investigator, unsuitable for the study.
5. Showing Muscle-related Symptom who any other evidence.
|
[
-0.03971809893846512,
2.5802998542785645,
-2.8509578704833984,
-2.301337480545044,
-0.14665532112121582,
0.009263032115995884,
0.40932658314704895,
1.5103965997695923,
-1.600095272064209,
-0.021323783323168755,
0.2285853624343872,
2.139708995819092,
-2.886787176132202,
2.9949934482574463,
0.4735534191131592,
0.4433743953704834,
-2.3503575325012207,
-0.658422589302063,
3.2688119411468506,
-1.3902615308761597,
-0.4699831008911133,
0.8230992555618286,
-1.6923280954360962,
-0.27222976088523865,
-0.2641977071762085,
-1.1578549146652222,
-3.052528142929077,
1.5413628816604614,
-0.7650150060653687,
0.6656864881515503,
1.4445314407348633,
-0.9000839591026306,
-0.4102802872657776,
1.5496952533721924,
0.4415914714336395,
-1.602858543395996,
1.0411596298217773,
1.0229856967926025,
-1.711358904838562,
-0.9917641878128052,
-0.21929197013378143,
1.0123300552368164,
-1.237037181854248,
0.5303817391395569,
0.8316744565963745,
0.9798991084098816,
0.30744075775146484,
2.008984327316284,
0.44982555508613586,
1.221901297569275,
-0.8975618481636047,
0.6411504149436951,
-1.6478238105773926,
0.6799710392951965,
1.7536802291870117,
1.2020033597946167,
1.7916343212127686,
1.009648323059082,
0.7650668025016785,
1.2040702104568481,
1.9232269525527954,
-0.5170784592628479,
0.04441119357943535,
0.9732179045677185,
-1.3001059293746948,
1.3934506177902222,
-0.9949949979782104,
-1.4046125411987305,
-0.9295214414596558,
0.5193500518798828,
0.005625545978546143,
0.4287821352481842,
0.11649523675441742,
-0.2736194431781769,
0.34659528732299805,
-0.15141236782073975,
-1.447031021118164,
1.2275443077087402,
-0.22971665859222412,
-0.1624630093574524,
-0.3961271643638611,
-1.521193265914917,
-2.640745162963867,
0.6128685474395752,
-0.8279604911804199,
-1.6986474990844727,
-1.4744523763656616,
0.5215844511985779,
0.13571198284626007,
-0.967363715171814,
0.2781783938407898,
-2.6435887813568115,
-0.23040403425693512,
-0.49114295840263367,
-0.43680310249328613,
1.1357091665267944,
-0.2477770447731018,
-1.4694839715957642,
-0.8375535607337952,
-1.0129073858261108,
0.2053716480731964,
0.02589854784309864,
1.2672748565673828,
-1.532685399055481,
0.5163795351982117,
-0.7392138242721558,
-0.6408647894859314,
-0.8144596219062805,
0.2004195898771286,
-0.13162776827812195,
-0.2648867666721344,
-0.2829771339893341,
1.050357699394226,
-1.2556226253509521,
-0.36757132411003113,
0.6966181397438049,
0.4585651755332947,
0.5532374382019043,
0.006388192065060139,
-0.01841418258845806,
-0.181150421500206,
1.229216456413269,
-0.4755985736846924,
0.48202240467071533,
-2.0292580127716064,
-1.0619524717330933,
-0.4587946832180023,
-0.4283345937728882,
-0.6572498679161072,
-0.8564465045928955,
-0.545464038848877,
-1.3202991485595703,
1.202143669128418,
-1.0794943571090698,
-1.9489142894744873,
-0.452301025390625,
-0.5996618866920471,
1.317468523979187,
0.1589292287826538,
0.0429026335477829,
0.25366371870040894,
0.8973113298416138,
-0.5245484709739685,
0.5425745248794556,
-1.3382989168167114,
0.9035698771476746,
0.3522569239139557,
-0.38234493136405945,
-0.34839197993278503,
0.0846003070473671,
0.9068385362625122,
1.5146379470825195,
0.9388883113861084,
0.6052374839782715,
-0.24883724749088287,
0.12580257654190063,
-0.020870551466941833,
-1.0559850931167603,
0.7666317820549011,
-0.23476147651672363,
1.0531542301177979,
-1.0887690782546997,
-0.1893727034330368,
-1.491308569908142,
0.6052905321121216,
0.331137090921402,
0.09285604953765869,
0.08140771090984344,
1.1439074277877808,
-0.1949974149465561,
-0.917438805103302,
-0.4011606276035309,
0.7531493902206421,
1.3225456476211548,
-0.5803467035293579,
0.7433202862739563,
0.7984763383865356,
1.2886316776275635,
0.4293622374534607,
-0.2185734212398529,
-0.42335569858551025,
-0.4096648395061493,
-0.3630293905735016,
0.10022024810314178,
0.6996611952781677,
0.888707160949707,
0.037927597761154175,
0.3135371804237366,
-0.5472638010978699,
0.12248548120260239,
-0.7810829877853394,
-0.16393573582172394,
0.602973222732544,
0.4751529097557068,
0.6070339679718018,
0.15701939165592194,
-0.4681873619556427,
-1.2961184978485107,
0.753759503364563,
0.12008938938379288,
0.1956656128168106,
0.10873667150735855,
-0.8012814521789551,
1.3554177284240723,
-0.7422478199005127,
-0.27299797534942627,
-0.37214601039886475,
0.5391231775283813,
-0.23071245849132538,
0.7984340190887451,
0.24973978102207184,
-0.12057501822710037,
0.45068812370300293,
0.8824398517608643,
-0.28830620646476746,
-0.7660165429115295,
0.3477732241153717,
0.0008718556491658092,
0.25784313678741455,
0.03638321906328201,
-0.6046618819236755,
0.16436168551445007,
0.6778931617736816,
-0.22541628777980804,
-0.3787683844566345,
-0.6056743860244751,
0.17195568978786469,
0.4004211127758026,
0.5521615743637085,
0.6744984984397888,
0.26816868782043457,
-0.32066279649734497,
0.09676085412502289,
-0.3661636710166931,
0.20796959102153778,
0.7901368141174316,
-0.04803512990474701,
-0.5860554575920105,
0.29538533091545105,
0.7749499082565308,
-0.26176175475120544,
-0.14904780685901642,
0.20461134612560272,
0.4522361755371094,
-0.6023275256156921,
0.27640748023986816,
0.46559953689575195,
-0.7175136208534241,
0.15344832837581635,
0.13035927712917328,
-0.991867184638977,
0.3724757730960846,
-0.2647680640220642,
-0.10949063301086426,
0.09804534167051315,
0.09591267257928848
] |
|
NCT02609958
|
ASLAN001 in Patients With Advanced or Metastatic Cholangiocarcinoma Who Progressed on at Least 1 Line of Systemic Therapy
|
This is a single arm, multicentre, Phase 2 study to assess efficacy and safety of ASLAN001 in patients with advanced or metastatic cholangiocarcinoma who progressed on at least 1 line of systemic therapy.
25 evaluable patients will be enrolled in the study. After evaluation of initial response in the first 10 evaluable patients, Sponsor will make a decision on recruitment of an additional 15 evaluable patients. If no response is observed, the study will stop.
The primary objective is to assess efficacy of varlitinib (also known as ASLAN001) as measured by ORR (based on RECIST v1.1). The secondary objectives are to (1) evaluate the efficacy of varlitinib, as measured by DoR, PFS, OS and DCR, (2) assess ORR, DoR, PFS, DCR and OS by tumor EGFR/HER2 status, (3) assess safety and tolerability of ASLAN001 monotherapy. Exploratory objectives are to explore possible relationships between response to ASLAN001 and the protein expression levels and gene mutational status of the proteins and genes via IHC and PCR/Sequencing.
|
Cholangiocarcinoma (CCA) is a malignancy arising from the biliary epithelium characterized by poor prognosis and poor response to current treatments. Emerging at any portion of the biliary tree, it includes a group of tumours with epidemiologic, morphologic, biologic, and clinical heterogeneity. Despite recent medical advances, the long-term outcomes and recurrence rates for CCA are poor. The 5-year survival rate following surgical resection is 11-40%. Tumour recurrence rates are as high as 50-65%, with a median time to recurrence between 12-43 months.
In the United States, the incidence and mortality of CCA have increased over the last 30 years without clear underlying etiological reasons. The only curative therapy is surgical; however this is not an option for many patients given the stage of the disease at presentation and metastasis. While improvements in diagnostic modalities and neoadjuvant chemotherapy have allowed for detection at earlier stages and greater survival rates, the prognosis is still unfavorable. Therapies that can decrease tumour growth, improve resection outcomes, increase survival rates, and decrease recurrence would make a great impact on the quality of life of CCA patients and are urgently needed.
Currently, the Food and Drug Administration (FDA)-approved agents used in unresectable CCA include gemcitabine, capecitabine, cisplatin, oxaliplatin, fluoropyrimidines (including 5-fluorouracil), or a combination of these. However, none are FDA-approved primarily for use in CCA specifically. Gemcitabine and cisplatin combination therapy, along with fluoropyrimidine-based or other gemcitabine-based regimens are part of the guidelines for unresectable cancer per the National Comprehensive Cancer Network. To date, the most effective chemotherapy regimen is administration of gemcitabine with cisplatin or oxaliplatin, which have now become the standard of care for systemic therapy. Even this most efficacious treatment has been found to only modestly increase overall survival (11.7 months vs 8.3 months for patients receiving gemcitabine alone) and progression-free survival (8.4 vs 6.5 months). Standard treatment as second-line chemotherapy for CCA is unclear as there is no significant evidence for specific therapy which indicates that further chemotherapy beyond progression on first-line chemotherapy improves survival.
CCA involves mutations in members of the ErbB family, including EGFR and HER2 mutations. EGFR is overexpressed in both intrahepatic and extrahepatic CCA (30.8% and 20.9%, respectively) and is an independent prognostic factor in intrahepatic cases, per Yang et al 2014. While this study found overexpression of HER2 exclusively in extrahepatic samples (and only in 4.5% of these), previous studies have implicated this protein in both extra- and intrahepatic tumours. Settakorn et al (2005) showed HER2 expression is correlated with high histological grade in intrahepatic CCA. Kim et al. (2007) found HER2 (gene and protein levels) are overexpressed in approximately 30% of extrahepatic CCA patients and is a prognostic factor for survival in those with lymph node metastasis.
EGFR, HER2, and HER4 are single-pass transmembrane glycoprotein receptors, members of the type I receptor tyrosine kinase family. Upon ligand binding, their activation induces the homo- or heterodimerization and subsequent phosphorylation of intracellular tyrosines, which lead to both cell proliferation and survival and therefore cancer development and progression. EGFR and HER2 inhibitors have both demonstrated clinical efficacy in cancer treatment. The simultaneous inhibition of both represents a new therapeutic approach for broadly targeting different tumour types that may be more effective than selective inhibition of each receptor.
Varlitinib, also known as ASLAN001 is a potent, orally active inhibitor of the receptor tyrosine kinases epidermal growth factor (EGFR) and human epidermal growth factor receptors 2 and 4 (HER2, HER4). In cell-based assays, varlitinib has been shown to potently inhibit the phosphorylation of EGFR, HER2, and HER4 in a dose-dependent manner. In cell lines overexpressing HER2, varlitinib also inhibited the phosphorylation of the HER2 downstream effector AKT.
ASLAN hypothesises that varlitinib will inhibit EGFR, HER2, HER4 as their mutations results in CCA, thus in turn inhibiting the growth of cancerous cells and development/progression. ASLAN believes that varlitinib is a compound that may be beneficial to patients with cancer by simultaneous inhibition of these receptors.
|
Inclusion Criteria:
* Patient must have advanced (unresectable) or metastatic, intra or extra hepatic adenocarcinoma originated from bile duct. Histologically-confirmed diagnosis is required for the first 10 evaluable patients. The following patients could be confirmed histologically or cytologically.
* Patients must have disease progression after failing at least 1 line of systemic drug regimen for advanced cholangiocarcinoma due to disease progression or intolerance.
* Presence of radiographically measurable disease based on RECIST v1.1.
* No evidence of biliary duct obstruction, unless obstruction is controlled by local treatment or, in whom the biliary tree can be decompressed by endoscopic or percutaneous stenting with subsequent reduction in bilirubin to below 1.5 x upper level of normal (ULN).
* Patients of respective country's legal age or older at the time of written informed consent.
* Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Patient must be able to understand and willing to sign the informed consent form and donate tumour tissue (archival or fresh) for evaluation of relevant exploratory endpoints. The first 10 evaluable patients need to have adequate archival tissues for exploratory objectives.
* Patient with adequate organ and hematological function:
* Hematological function, as follows:
* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
* Platelet count ≥ 100 x 10\^9/L
* Renal functions, as follows:
---Serum creatinine ≤ 1.5x ULN or eGFR \> 60 mL/min/1.73m\^2
* Hepatic function, as follows:
* Total bilirubin ≤ 1.5 x ULN
* AST and ALT ≤ 5 x ULN
Exclusion Criteria:
* Patient with radiation or local treatment within the past 6 weeks for the target lesion(s).
* Patients with major surgical procedures within 21 days prior to study entry.
* Patient with brain lesion, known brain metastases (unless previously treated and well controlled for a period of at least 3 months).
* Patient with malabsorption syndrome, diseases significantly affecting gastrointestinal function, resection of the stomach or small bowel, or difficulty in swallowing and retaining oral medications.
* Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, diabetes, hypertension, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients with any history of other malignancy unless in remission for more than 1 year. (Nonmelanoma skin carcinoma and carcinoma-in-site of uterine cervix treated with curative intent is not exclusionary).
* Female patients who are pregnant or breast feeding.
* Patients who were previously treated with Varlitinib.
* Patients who have received any investigational drug (or have used an investigational device) within the last 14 days before receiving the first dose of study medication.
* Patient with unresolved or unstable serious toxicity ( ≥ CTCAE 4.03 Grade 2) from prior administration of another investigational drug and/or prior cancer treatment.
* Patients with a known history of HIV, decompensated cirrhosis, chronic hepatitis B with HBV DNA \> 2000 IU/ml or persistent abnormal ALT in the past 6 months, chronic hepatitis C with persistent abnormal ALT in the past 6 months.
* Known History of drug addiction within last 1 year.
* Patients who need continuous treatment with proton pump inhibitors during the study period.
* Any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease or any other condition which in the opinion of the Investigator could jeopardize the safety of the patient or the validity of the study results.
For additional information regarding investigative sites for this trial, pls contact ASLAN at [email protected]
|
[
0.6382784843444824,
2.4171676635742188,
-2.715320587158203,
-1.480043649673462,
1.1256400346755981,
0.9562232494354248,
-0.6046512722969055,
-0.08637963980436325,
-0.3830925226211548,
-0.24217994511127472,
-0.773224949836731,
0.9981133341789246,
-2.074215888977051,
0.6721023917198181,
0.968428909778595,
1.496658205986023,
-0.24967792630195618,
0.02934904210269451,
-0.17082174122333527,
-2.1115224361419678,
0.246712788939476,
-0.5923764109611511,
0.6070457696914673,
0.09905241429805756,
0.33929669857025146,
-0.4083075225353241,
-0.24489034712314606,
0.3734664022922516,
-0.18318705260753632,
1.1083626747131348,
0.005883410107344389,
0.484380841255188,
0.45283812284469604,
0.29753226041793823,
0.47244516015052795,
-0.32579508423805237,
-0.03129827603697777,
0.055561065673828125,
-1.1446295976638794,
0.237925186753273,
0.042883310467004776,
-0.19886496663093567,
-0.026627181097865105,
-0.4588286876678467,
0.9477748870849609,
-0.6894845962524414,
-1.0858174562454224,
0.645973265171051,
0.7743729948997498,
0.3549300730228424,
-0.33380550146102905,
0.23560769855976105,
-0.6838662028312683,
0.3284589648246765,
0.26052412390708923,
0.4621441662311554,
0.13769882917404175,
0.3071887791156769,
0.9138312935829163,
0.553812563419342,
0.018314620479941368,
-0.32778194546699524,
0.39865610003471375,
0.33391180634498596,
-0.3866472840309143,
-0.318236768245697,
-0.06354767084121704,
-0.35271623730659485,
-0.706843912601471,
0.5187960863113403,
0.08381225913763046,
-0.23708319664001465,
0.6494752168655396,
0.22938789427280426,
-0.30210059881210327,
0.4053606688976288,
0.3138098120689392,
0.5476169586181641,
0.2461603879928589,
0.6795232892036438,
-0.473450243473053,
-0.9096349477767944,
-0.3566516935825348,
-0.20089656114578247,
0.7524850964546204,
-0.38826727867126465,
-0.7977461814880371,
-1.0630019903182983,
0.435787558555603,
-0.5961178541183472,
-0.11520544439554214,
-0.320334792137146,
-1.1557003259658813,
0.29074952006340027,
-0.6721358299255371,
-0.07401309162378311,
0.16972683370113373,
0.05285405367612839,
-0.9489896893501282,
0.17750757932662964,
-0.10278051346540451,
-0.2272138148546219,
0.07611910253763199,
-0.0721527636051178,
-0.46135976910591125,
-0.5875929594039917,
0.05848352611064911,
-0.2773611843585968,
-0.658035397529602,
-0.8318595886230469,
0.43654024600982666,
-0.63730788230896,
-0.3090662360191345,
-0.4302521049976349,
0.25602322816848755,
-0.06345085054636002,
0.2825174629688263,
0.5630714297294617,
0.40957239270210266,
0.09178037941455841,
0.06643419712781906,
0.08360563963651657,
-0.00689722690731287,
0.578820526599884,
-0.600471556186676,
-0.5898048877716064,
0.02100282907485962,
-0.20934420824050903,
-0.5204340219497681,
-0.4599915146827698,
-0.7275383472442627,
-0.6621862649917603,
-0.0842181071639061,
0.3186888098716736,
-0.512092649936676,
0.09615139663219452,
-0.18112275004386902,
0.8956791162490845,
0.479762464761734,
-0.5302634835243225,
-0.14227381348609924,
0.7772002220153809,
0.1366279572248459,
0.378614217042923,
-1.4231679439544678,
0.5182346105575562,
-0.3900561034679413,
0.2528185546398163,
-0.14865224063396454,
0.04886893555521965,
-0.6491754055023193,
0.1767367422580719,
0.03176194056868553,
-0.12125087529420853,
0.1132296472787857,
0.10432137548923492,
0.48431161046028137,
-0.6472243666648865,
0.12771031260490417,
0.001787049463018775,
-0.18141226470470428,
-0.08334352821111679,
-0.22065255045890808,
-0.5416100025177002,
0.5399003028869629,
0.1612812578678131,
-0.31777647137641907,
0.10266291350126266,
-0.45364120602607727,
0.1986778974533081,
-0.7420720458030701,
0.011153751984238625,
0.2582031786441803,
0.28731971979141235,
0.30697935819625854,
0.009802826680243015,
0.2935403287410736,
0.3199501633644104,
0.273981511592865,
0.031220681965351105,
-0.19659051299095154,
0.21746721863746643,
0.20610252022743225,
0.17589181661605835,
-0.0783039927482605,
0.2350442260503769,
-0.1534203290939331,
-0.22825206816196442,
-0.10075308382511139,
0.26510241627693176,
0.2043187916278839,
-0.07295738905668259,
0.5296639204025269,
0.4712914228439331,
0.06465844810009003,
-0.530059278011322,
-0.3544887900352478,
0.03185746446251869,
0.2137683480978012,
-0.1799083948135376,
0.36347535252571106,
0.2847719192504883,
0.27657896280288696,
0.3043668270111084,
0.6426200270652771,
-0.26626139879226685,
-0.35778576135635376,
0.2159673571586609,
0.23001785576343536,
-0.10254564136266708,
-0.10093486309051514,
-0.0593123733997345,
-0.2659233510494232,
-0.029203742742538452,
0.5583047866821289,
0.30302128195762634,
-0.33575841784477234,
0.2717874050140381,
-0.6394500136375427,
-0.03920667618513107,
-0.35231804847717285,
-0.17090100049972534,
0.1361144483089447,
0.5550827383995056,
0.11737406998872757,
-0.47030922770500183,
-0.2373245358467102,
-0.018773281946778297,
-0.07909902185201645,
-0.21829476952552795,
-0.28633105754852295,
-0.20963627099990845,
-0.21509969234466553,
-0.2537689805030823,
-0.11692353338003159,
0.15785785019397736,
0.41141194105148315,
-0.23231931030750275,
-0.1152922585606575,
0.592002272605896,
0.33106693625450134,
-0.03568735346198082,
0.19107088446617126,
-0.18845179677009583,
0.050457458943128586,
0.018555670976638794,
-0.11666670441627502,
0.07259407639503479,
-0.3191365599632263,
-0.055377159267663956,
-0.19801944494247437,
-0.2513729929924011,
0.1801058053970337,
0.4475938379764557,
0.2735699415206909,
-0.041779763996601105
] |
NCT00316251
|
Application of Specific Frequencies to Stimulate the Spinocerebellar Tract in Subjects With Unilateral Dysafferentation
|
The purpose of this study is to determine the effects of Power Plate vibration therapy on balance as measured by the NeuroCom Balance Master.
|
Acute and chronic equilibrium disorders result in over five million patient visits per year in the United States with unknown additional individuals not seeking care. Symptoms of dizziness, vertigo, and lack of balance are among the most common symptoms reported to physicians. Equilibrium disorders not exclusively due to visual or vestibular conditions are typically due to problems in proprioception. Proprioception is the specialized sensory modality that informs the body as to movement, position, and spatial orientation through mechanisms that track sensations accompanying joint movement and position. Mechanoreceptors in joints, along with vestibular, visual, muscle spindle, Golgi tendon organ, ligament and tendon sensory receptors, comprise the propriosensory system, which conveys information to the motor system to maintain equilibrium on a reflexive, automatic basis. Alterations in somatosensory input from mechanoreceptors have been identified as causing aberrant muscle firing patterns.
The NeuroCom Balance Master is an FDA approved device designed to both measure and treat balance problems and evaluate the neuromuscular control by quantifying the ability to maintain dynamic postural stability. The NeuroCom Unit is a microprocessor controlled balance unit that provides quantitative data regarding the patient's ability to control the platform. This unit is widely used throughout the country in both university and clinical settings to help patients restore their balance.
|
Inclusion Criteria:
* Logan student, staff, or faculty with no history of ankle injury
* Ages 18 - 60 years old
* Logan student, staff, or faculty with no history of ankle surgery
* No visual or vestibular condition that would affect balance
Exclusion Criteria:
* Systemic illnesses that have an adverse effect on balance
* Local infection, injury, or other malignancy affecting the lower extremity
* Any unstable joints of the lower extremity
* Any spinal manipulation within 48 hours
* Prescription or herbal muscle stimulants, relaxants, etc. that could affect balance
* Pregnancy
|
[
-0.8464722633361816,
4.178600311279297,
-2.003615140914917,
-4.0161824226379395,
1.2756303548812866,
0.36686646938323975,
-1.034864902496338,
-0.7107718586921692,
-0.6359183192253113,
1.3130652904510498,
0.9032354950904846,
2.334360361099243,
-0.07313978672027588,
-1.0353196859359741,
-1.0377042293548584,
1.6038243770599365,
-0.6223514080047607,
-0.8772225975990295,
0.5434633493423462,
-2.1180126667022705,
1.3264557123184204,
-2.216374158859253,
0.07557425647974014,
-1.1440908908843994,
1.1532224416732788,
0.4090343713760376,
1.9788973331451416,
2.944819450378418,
1.4279342889785767,
-0.20462468266487122,
1.0037354230880737,
-0.9395655393600464,
0.8755962252616882,
0.28037095069885254,
0.8134266138076782,
-1.6374473571777344,
-0.027589961886405945,
1.391718864440918,
-0.8950215578079224,
0.9099140167236328,
1.4845210313796997,
-0.09639713168144226,
0.7921537756919861,
2.453043222427368,
-0.8642523288726807,
1.349251627922058,
-2.2548062801361084,
0.8994467854499817,
0.2746120095252991,
-2.9968533515930176,
1.292195200920105,
0.5176958441734314,
-1.546750783920288,
-0.5145208835601807,
1.68381667137146,
-1.3074440956115723,
1.3695504665374756,
-1.9835810661315918,
-0.6420755982398987,
1.4126007556915283,
-0.03132626414299011,
0.6411744356155396,
0.32173818349838257,
2.589946985244751,
-0.6362731456756592,
0.955765426158905,
-0.22213658690452576,
-1.8257282972335815,
-1.5878039598464966,
2.0812718868255615,
0.025486843660473824,
1.1301116943359375,
0.35356956720352173,
-0.48399224877357483,
1.0000942945480347,
-2.029836654663086,
-0.2099475860595703,
0.5467842817306519,
1.3274661302566528,
0.03959238901734352,
0.21849022805690765,
-0.2117847055196762,
-1.8875608444213867,
-0.46169808506965637,
1.6986135244369507,
0.45113030076026917,
0.16666942834854126,
-0.18001310527324677,
1.1886769533157349,
-0.681766927242279,
-0.42779526114463806,
0.34792304039001465,
-0.2937001883983612,
-0.34816601872444153,
-1.5453946590423584,
-0.47779324650764465,
1.3585875034332275,
0.4692343473434448,
-0.6171854734420776,
-1.0659232139587402,
-0.8839541673660278,
1.0409015417099,
-0.5771782398223877,
-0.18670402467250824,
-0.4710429012775421,
-0.03279365226626396,
-1.2994643449783325,
-0.43404120206832886,
-0.205276221036911,
-0.8520476222038269,
0.6251347661018372,
-0.2837288975715637,
-0.289206326007843,
-1.0043978691101074,
-0.184264674782753,
0.06302224844694138,
0.19778721034526825,
0.9702208042144775,
-0.0909489169716835,
1.6233693361282349,
1.8509905338287354,
0.617278516292572,
0.07165516912937164,
0.6654743552207947,
-1.0304712057113647,
-0.8574205040931702,
-0.04431423917412758,
-0.9090335965156555,
-1.1570897102355957,
-0.562081515789032,
0.562964141368866,
0.26903489232063293,
0.7407544255256653,
0.039175841957330704,
-0.5533433556556702,
-0.31571725010871887,
0.6333765387535095,
0.6511068940162659,
-0.6369075179100037,
-1.416810154914856,
-0.3304947018623352,
0.7791869640350342,
-0.9565356373786926,
-0.8115630149841309,
-0.8170228600502014,
-0.871492862701416,
0.017243094742298126,
0.6662147641181946,
-0.12135182321071625,
-0.829728364944458,
0.415557861328125,
-0.31021958589553833,
1.0964604616165161,
-0.1546664535999298,
-0.33505767583847046,
-0.81558758020401,
-0.8096876740455627,
-0.5874390006065369,
0.020720604807138443,
0.03494732454419136,
-0.6750108003616333,
-0.05475889891386032,
-1.0099412202835083,
0.4153285324573517,
0.9061742424964905,
-0.014854584820568562,
-0.8237988352775574,
-0.9327334761619568,
0.43735748529434204,
-0.031293872743844986,
0.1420164704322815,
-0.12853099405765533,
0.25469374656677246,
-0.16775399446487427,
0.21166811883449554,
0.29293906688690186,
0.36166444420814514,
0.6457847356796265,
0.10332226753234863,
-0.1858353465795517,
-0.7259616255760193,
0.1531306356191635,
0.5469518303871155,
0.07338064908981323,
0.43978479504585266,
-0.3951452970504761,
-0.5856536030769348,
-0.058888908475637436,
0.049557026475667953,
-0.6838228702545166,
0.3479421138763428,
0.31306394934654236,
0.17446859180927277,
-0.5427280068397522,
0.15475568175315857,
0.229786679148674,
-1.2429479360580444,
-0.8214156627655029,
0.8416527509689331,
-0.5769940614700317,
-0.26547595858573914,
1.0838483572006226,
-0.6605220437049866,
0.559044599533081,
0.12810580432415009,
-0.40918517112731934,
0.4073294401168823,
-0.04587504640221596,
0.8142853379249573,
0.7854481935501099,
0.19489450752735138,
0.3001020550727844,
-0.5081703066825867,
0.42488378286361694,
0.02344300039112568,
-0.24693149328231812,
-0.525331437587738,
0.00335089024156332,
-1.023346185684204,
-0.8132647275924683,
-0.8123194575309753,
-0.11719327419996262,
-0.18545325100421906,
-0.43369776010513306,
-0.14049579203128815,
-0.6292039155960083,
-0.06067416071891785,
0.2229757159948349,
-0.30096423625946045,
-0.14222535490989685,
-0.1859898716211319,
0.09574219584465027,
0.8501288890838623,
-0.10047221183776855,
-0.8686218857765198,
0.429800808429718,
0.45344701409339905,
0.763092041015625,
-0.3922353982925415,
0.04490727558732033,
0.4377305209636688,
-0.6163024306297302,
-0.14852549135684967,
0.506381094455719,
-1.4898186922073364,
-0.24571457505226135,
0.1610739380121231,
0.4532333314418793,
0.05677889287471771,
0.19801169633865356,
-0.5003058314323425,
-0.18733415007591248,
-0.9999722242355347,
0.20323078334331512,
0.2033207267522812,
-0.5371946096420288
] |
NCT06601959
|
Energy Needs and Nutritional Status of Adolescent Girls
|
The purpose of this study is to investigate the energy needs and nutritional status of adolescent girls in Abia State, Nigeria
|
Adolescents in low and middle-income countries encounter numerous nutritional challenges, including undernutrition, micronutrient deficiencies, poor dietary habits, and food insecurity. These issues significantly impact their growth, development, and long-term health. Despite their increased vulnerability, this demographic is often overlooked in nutritional program planning and implementation. This neglect is due to a lack of accurate data, inadequate delivery platforms for interventions, and underdeveloped policies and programs.
The Nutrition and Adolescence in Rural Nigeria (NARN'ia) study aims to address this gap through a comprehensive assessment of energy requirements in adolescent girls (N=50; ages 10 - 19 years) in Nigeria. NARN'ia will integrate dietary assessments using the 24-hour recall method (INDDEX24 app); physical activity levels using accelerometry; anthropometric evaluations of body composition, and the doubly labeled water method for assessing both body composition and total daily energy expenditure.
This study will provide evidence-based data essential for formulating appropriate nutritional guidelines for adolescent girls in Nigeria. Furthermore, this research initiative will establish a foundational framework for future studies on energy requirements in Nigeria and other low and middle-income countries.
|
Inclusion Criteria:
* female students
* 10 and 19 years old
* provides verbal assent and has parental consent
Exclusion Criteria:
* physical disabilities
* illnesses during the study period
* students attending boarding schools
|
[
1.8359901905059814,
2.271883487701416,
-2.0093328952789307,
-0.1632772982120514,
-0.809693455696106,
0.19639740884304047,
-1.7424190044403076,
-1.7140207290649414,
-1.2721478939056396,
-0.9438156485557556,
0.9214810729026794,
2.2329039573669434,
-1.530380129814148,
0.9443151950836182,
-0.666353702545166,
0.44246938824653625,
-0.19391170144081116,
2.2910845279693604,
1.4335914850234985,
-0.32174256443977356,
0.5331810116767883,
0.4923989176750183,
0.5764317512512207,
-2.0409963130950928,
1.5409566164016724,
0.8926841020584106,
-2.1128170490264893,
-0.26254987716674805,
-0.004815485328435898,
1.2549909353256226,
1.1391723155975342,
-0.9659962058067322,
-1.532364010810852,
1.3507529497146606,
2.0134599208831787,
1.7246699333190918,
1.735148549079895,
0.9998227953910828,
-2.7724997997283936,
0.45761629939079285,
-0.39623019099235535,
1.7024471759796143,
-0.42043569684028625,
0.37682226300239563,
1.1241899728775024,
-0.5745092630386353,
0.014824369922280312,
0.16241289675235748,
-0.6767798662185669,
0.5575099587440491,
-0.6819543242454529,
1.1111067533493042,
-1.796512246131897,
-0.9516807198524475,
1.7861915826797485,
-0.6038548350334167,
2.3611016273498535,
-0.7512819170951843,
0.44835981726646423,
0.1843157410621643,
-0.5434880256652832,
-1.3182966709136963,
0.20741525292396545,
1.35752272605896,
-0.9149892330169678,
-0.9525582790374756,
0.6371316313743591,
0.2529352307319641,
-2.6360387802124023,
1.4883431196212769,
0.9491974115371704,
0.49587252736091614,
2.361943483352661,
-1.8024563789367676,
-0.5452024936676025,
-0.4161154329776764,
0.3146953284740448,
-0.044166065752506256,
0.6352872252464294,
0.7480225563049316,
0.8381562232971191,
-0.9480661153793335,
-1.8633825778961182,
0.22463655471801758,
0.4037398397922516,
2.0209174156188965,
-1.527677297592163,
-0.320173054933548,
1.933447241783142,
0.39848780632019043,
-0.6304193735122681,
1.3063048124313354,
-1.0107183456420898,
-0.31790611147880554,
-0.45053568482398987,
1.3137702941894531,
0.7423637509346008,
-1.0233945846557617,
-0.8857194781303406,
-1.3733434677124023,
-0.9475994110107422,
-0.29807889461517334,
-0.11656341701745987,
1.156398892402649,
0.037161704152822495,
-0.1014607772231102,
-0.6602678298950195,
2.027752161026001,
0.9679812788963318,
1.2192671298980713,
-0.45639684796333313,
-1.6645902395248413,
-0.8842578530311584,
-1.3096404075622559,
1.2503505945205688,
1.0442413091659546,
1.4010916948318481,
0.8986927270889282,
-0.3363763988018036,
0.12324804067611694,
1.5581026077270508,
0.6654807329177856,
-1.4204106330871582,
0.3819406032562256,
-0.6295983791351318,
-0.6657829284667969,
0.3684147000312805,
-1.8985611200332642,
-0.09356226772069931,
-0.8638202548027039,
0.6753203272819519,
-1.0959315299987793,
0.6500358581542969,
0.675265908241272,
1.6742024421691895,
0.0848054438829422,
1.9143590927124023,
0.21845945715904236,
-1.1778432130813599,
-1.1031917333602905,
-0.22733035683631897,
0.7217547297477722,
0.04521407186985016,
-1.7072944641113281,
-1.5397882461547852,
0.9678488373756409,
1.1938774585723877,
-0.7581362724304199,
0.11384561657905579,
-0.4746372699737549,
0.08497349172830582,
0.9790207147598267,
0.053940147161483765,
0.24612893164157867,
-0.17436832189559937,
0.6068307161331177,
-0.47389158606529236,
-0.26239821314811707,
0.3995169401168823,
-0.0987892597913742,
0.3647722899913788,
0.3256587088108063,
-1.244631052017212,
0.10563945025205612,
-0.26313918828964233,
-1.911513328552246,
0.002331518568098545,
0.9241213798522949,
-0.7477449178695679,
-0.008613990619778633,
0.9698849320411682,
-0.06613138318061829,
-0.3340892195701599,
-0.25884678959846497,
-1.127118706703186,
0.8725609183311462,
0.08218364417552948,
-0.09639371186494827,
-0.6147722005844116,
0.13754935562610626,
-0.4284224808216095,
1.8492534160614014,
-0.847878634929657,
1.088903784751892,
-1.0711826086044312,
-0.45895829796791077,
-0.31181660294532776,
0.9895399212837219,
-0.2889260947704315,
0.4486115574836731,
0.6012161374092102,
-0.034295227378606796,
-0.6134711503982544,
0.0748857781291008,
-0.10651845484972,
-0.4117624759674072,
-0.7318677306175232,
0.08478239178657532,
-0.3132079243659973,
-0.16944710910320282,
0.6225197911262512,
-0.30416953563690186,
-0.8938088417053223,
-0.2580416202545166,
-0.2061384916305542,
-0.009716277942061424,
-0.7286390066146851,
1.055538535118103,
-0.5200821161270142,
0.3978766202926636,
-0.29286834597587585,
0.6023600697517395,
-1.5860671997070312,
-0.5306803584098816,
0.5710979104042053,
0.36146748065948486,
0.0012184248771518469,
-0.9560317993164062,
-1.0862866640090942,
-1.33037531375885,
-0.8189687132835388,
-0.3157920837402344,
0.2976827025413513,
0.14046384394168854,
-0.4279370903968811,
0.8276470303535461,
-0.993344783782959,
-0.7167744636535645,
0.03675513714551926,
0.07667625695466995,
0.4591318666934967,
0.26382213830947876,
-0.6526308059692383,
0.13823926448822021,
-0.107976995408535,
-0.15790434181690216,
0.29080313444137573,
0.026051800698041916,
0.18942010402679443,
0.18799923360347748,
0.34229543805122375,
-0.6417123079299927,
0.44734710454940796,
-0.2526823878288269,
-0.23302598297595978,
0.44708451628685,
-0.008783879689872265,
-0.3693721294403076,
-0.3793826699256897,
0.20767784118652344,
-0.037198252975940704,
0.05149046704173088,
0.10905914008617401,
0.5568503737449646,
0.025016391649842262,
-0.8681690096855164
] |
NCT06129968
|
Transforming Ovarian Cancer Diagnostic Pathways
|
The goal of this observational cohort study is to compare the diagnostic accuracy and cost effectiveness of Risk of Malignancy Algorithm (ROMA) compared with CA125 in the diagnosis of ovarian cancer in patients attending their general practitioner (GP) with symptoms that sometimes might indicate ovarian cancer. The main questions it aims to answer are: • what is the accuracy of the ROMA algorithm which uses the blood tests CA125 and Human epididymis protein 4 (HE4) compared to CA125 in diagnosing ovarian cancer, particularly early-stage ovarian cancer, in women tested for suspected ovarian cancer from primary care? • What is the cost-effectiveness of ROMA versus CA125 testing in primary care to diagnose ovarian cancer? When a participant's GP orders a CA125 blood test, the blood will also be tested for HE4 and the ROMA algorithm calculated. The diagnostic accuracy of ROMA and CA125 will be compared to see if ROMA would be a better diagnostic test for ovarian cancer when used in the primary care setting.
|
A woman's chances of surviving 5 years after Ovarian Cancer (OC) diagnosis drops from 90% if diagnosed at Stage 1 to 15% at Stage 4. Currently, GPs use a blood test called CA125 and ultrasound scan to decide whether to refer a woman to hospital for suspected OC. CA125 misses 50% of early-stage cancers (Stage 1 and 2); both tests cause unnecessary referrals. Recently, a blood test called Human epididymis protein 4 (HE4) in combination with CA125 in a formula called ROMA (Risk of Malignancy Algorithm) has been developed. ROMA is used by doctors in the US and Europe to guide referrals and recommended by the American College of Obstetrics and Gynaecology. A large Cochrane systematic review of 30,000+ patients across 50 papers shows ROMA detects more cancers at earlier stage than a combination of CA125 and ultrasound. All included studies were conducted in hospital where OC rates are high, however a model at 3% OC rate shows that ROMA is superior. Before the test can be introduced in NHS, it is necessary to confirm this evidence in a large primary care study and establish cost effectiveness. The wider NHS cancer programme funded SONATA project evaluates an integrated pathway from community to cancer specialists using ROMA. It includes National Health Service (NHS) pilots in primary and secondary care to establish how practice can be supported to change, evaluates facilitators and barriers to change as well as a community campaign to promote OC awareness. This study is one component of the SONATA project. In it, two large NHS labs will additionally test 41,000 blood samples from women whose GPs requested CA125 testing for suspected OC with ROMA to accurately identify the number of patients who can be detected earlier. This will enable the investigators to establish cost effectiveness of ROMA and definitive data on accuracy in primary care.
|
Inclusion Criteria:
* Women presenting to primary care with suspected ovarian cancer who are tested for the biomarker CA125 according to current standards of care for investigation of CA125 in the primary care setting.
Exclusion Criteria:
* Patients presenting to primary care who do not have potential symptoms of ovarian cancer.
* Women with symptoms sometimes associated with ovarian cancer not tested for ovarian cancer.
|
[
2.326890707015991,
2.104078531265259,
-2.3484179973602295,
-0.9686993360519409,
0.1430140882730484,
0.43970873951911926,
-0.6751132011413574,
-0.22921708226203918,
-0.20579631626605988,
-0.3175402879714966,
0.9689052104949951,
1.2033298015594482,
-1.5794068574905396,
0.16720660030841827,
-0.6673606634140015,
0.780165433883667,
-0.5626248717308044,
-0.6193443536758423,
1.5185421705245972,
-1.8022114038467407,
-0.23344825208187103,
0.18071220815181732,
-0.2672923803329468,
1.871942400932312,
-0.6249676942825317,
-0.2974127233028412,
-0.002490463200956583,
0.0033621538896113634,
-0.40279778838157654,
1.4825586080551147,
1.2132411003112793,
0.6719719767570496,
0.10057299584150314,
1.1167597770690918,
0.5121841430664062,
-1.220033884048462,
0.6191199421882629,
0.3894956111907959,
-0.9648246169090271,
-0.03585555776953697,
1.3154957294464111,
0.10656972229480743,
0.9337710738182068,
-1.7839252948760986,
1.2457489967346191,
-0.2736613154411316,
0.06537198275327682,
0.48789289593696594,
0.5477229952812195,
0.8728691339492798,
-1.159390926361084,
-0.14853164553642273,
-2.200979709625244,
0.5046812891960144,
1.2177022695541382,
0.3047003448009491,
0.24007229506969452,
0.7933040261268616,
2.154097318649292,
0.5196665525436401,
0.7007486820220947,
-0.3413447141647339,
0.8750820159912109,
-0.5358946323394775,
-1.3184072971343994,
-0.009088383987545967,
-0.7321611046791077,
-1.5423288345336914,
-0.2050018161535263,
0.44482314586639404,
0.3962976038455963,
1.5993990898132324,
0.7546442747116089,
-0.7082562446594238,
0.4836251139640808,
0.6234947443008423,
0.6480032801628113,
0.6977079510688782,
0.4732968509197235,
0.6951627731323242,
-0.7672808766365051,
0.029357783496379852,
-0.6574991345405579,
0.2620180547237396,
0.8849342465400696,
-0.8208500742912292,
-0.7893540859222412,
-0.23463252186775208,
1.2084870338439941,
-1.377537488937378,
0.06850583106279373,
0.4895256459712982,
0.6623921990394592,
0.11251470446586609,
-0.9377285838127136,
0.7972526550292969,
0.22963902354240417,
-0.5744441151618958,
-0.07497148960828781,
0.09193416684865952,
-0.7729151844978333,
-1.115608811378479,
0.1332055926322937,
0.3544667959213257,
-1.5171111822128296,
-0.2685871124267578,
-0.25998854637145996,
-0.28971484303474426,
-0.7093580365180969,
-0.453762024641037,
1.1264092922210693,
0.08684606105089188,
-1.0000821352005005,
0.2884441018104553,
-0.3145461976528168,
-0.42531895637512207,
0.7708775401115417,
0.9009814262390137,
0.22329799830913544,
-0.679364800453186,
0.19662994146347046,
0.7438762187957764,
-0.2842419147491455,
0.14529217779636383,
0.21818223595619202,
0.07738760858774185,
0.15958625078201294,
-0.23324887454509735,
-0.2884455919265747,
-0.9403054714202881,
0.07110264152288437,
0.4510268568992615,
0.17945589125156403,
0.15242241322994232,
-0.31982219219207764,
-0.2549724578857422,
0.01583942584693432,
0.7572758197784424,
0.1344688981771469,
-0.17025981843471527,
-0.1919039636850357,
0.5780776143074036,
-0.42794761061668396,
0.5423221588134766,
-0.42690739035606384,
0.17245589196681976,
-0.43471235036849976,
-0.19567254185676575,
-0.5467884540557861,
-0.21778354048728943,
-0.6768244504928589,
0.37929385900497437,
1.305389642715454,
-0.12478664517402649,
-0.29137125611305237,
0.4091033339500427,
-0.4064768850803375,
0.3652041554450989,
-0.07346000522375107,
1.1506329774856567,
-0.3286230266094208,
0.462835431098938,
-0.18963946402072906,
-0.24172146618366241,
0.6860690712928772,
-0.7565736770629883,
-0.38936299085617065,
-0.3082524836063385,
0.0744316503405571,
0.055645901709795,
-0.10769298672676086,
-0.05051129311323166,
0.7840571999549866,
0.5011797547340393,
0.5591294169425964,
0.48026153445243835,
0.20523256063461304,
1.0882611274719238,
0.15863145887851715,
-0.24226818978786469,
-0.16944852471351624,
0.6261757016181946,
0.500273585319519,
-0.012943838723003864,
-0.010288635268807411,
-0.2896607220172882,
-0.7681052088737488,
-0.6696375608444214,
-0.2665262222290039,
-0.1306801587343216,
0.28260108828544617,
-0.23640652000904083,
0.2716502249240875,
-0.09748917818069458,
0.107436902821064,
-0.6203815340995789,
-0.18461298942565918,
0.22521261870861053,
0.156509667634964,
-0.006500329356640577,
0.11917494237422943,
-0.30761393904685974,
-0.28455281257629395,
0.23996968567371368,
0.15017133951187134,
-0.3268199563026428,
-0.8271129727363586,
-0.16366660594940186,
-0.8439802527427673,
-0.0967596247792244,
-0.4332279562950134,
0.32638490200042725,
0.1832883208990097,
-0.4267117381095886,
0.25152140855789185,
0.3417113721370697,
0.11995203047990799,
-0.5129213929176331,
-0.35239851474761963,
-0.3657444715499878,
-0.16024264693260193,
0.2323189675807953,
-0.27398917078971863,
0.45539388060569763,
-0.1564817577600479,
0.16600647568702698,
-0.3711111843585968,
0.27386271953582764,
0.1951059252023697,
0.13915181159973145,
0.0500347875058651,
-0.46732938289642334,
0.010898064821958542,
0.0268640648573637,
-0.6752396821975708,
-0.18919962644577026,
0.0967070460319519,
-0.04045729711651802,
-0.3942174017429352,
0.6356363296508789,
0.7680754065513611,
0.40658897161483765,
0.03331194818019867,
0.0812523141503334,
-0.6710922122001648,
0.41735514998435974,
-0.27733147144317627,
-0.5257106423377991,
0.11070448160171509,
0.12347812205553055,
-0.12680819630622864,
-0.1181010976433754,
-0.09573577344417572,
0.42209261655807495,
0.4772966206073761,
-0.3969217538833618
] |
NCT03031236
|
Reduce Childhood Maltreatment and Promote Development
|
Background (brief):
1. Burden: The uniqueness of each child is tremendously influenced by interaction between nature and nurture during critical period of brain development that promotes foundation of brain architecture through neuronal connections.
2. Knowledge gap: Young children in Bangladesh are prone to multiple physiological and psycho-social risk factors e.g. poverty, maltreatment, malnutrition, disease, parental illiteracy, maternal depression and lack of stimulation, all of which are preventable. Little is reported about any comprehensive package of development that addresses most of these early childhood risks and promotes optimum early childhood development (ECD).
3. Relevance: The aim of this study is to develop and evaluate an integrated, low cost, and feasible center based approach that focuses on positive parenting of children during early life that will promote early stimulation, minimize childhood maltreatment, boost up of maternal self-esteem and healthy thinking and improve health and nutritional (HN) status of children.
Hypothesis (if any):
This integrated intervention will promote maternal child-care practices and mental health that will finally improve their children's growth, micro-nutrient status, early brain development compared to control group.
Objectives:
To see the effect of an integrated intervention (ECD + HN) on growth, micro-nutrient status, child development along with effect on maternal child-care practices and mental health.
Methods:
Randomly selected 2 groups will be identified as intervention and control (150 mothers' from15 clusters in each group). Mothers of 8-23 months old children living in slums and practice harsh child-disciplining will be identified as study population. The mothers of intervention (ECD+HN) group will receive fortnightly group sessions for 11 months that will include combined messages on a) psycho-social stimulation, b) positive parenting to prevent child maltreatment and c) cognitive behavioral therapy (CBT) for positive thinking, d) health and nutrition messages and e) 15 micro-nutrient sprinkle supplement.(90 sachets of over 6 month-period). The control group will only receive the usual health messages provided by the government.
Outcome measures/variables:
* Children's cognitive, motor, language and socio-emotional development; anthropometry; hemoglobin and micro-nutrient status (serum vitamin B12, iron and folic acid)
* Mother s' parenting practices, depressive symptoms, self-esteem and child-maltreatment.
|
Hypothesis to be tested:
This integrated intervention will a) improve children's growth, hemoglobin, micro-nutrient status (vitamin B12 and folic acid), cognitive, motor, language and social-emotional development, b) minimize maltreatment of children by parents, c) improve positive parenting and d) reduce mothers' stress and depressive symptoms compared to control group.
Objectives:
Primary: This integrated intervention will
* Improve cognitive, motor, language and social-emotional development of children
* Minimize maltreatment of children by the caregivers
Secondary: This integrated intervention will bring following benefits in intervention group compared to control group- On children-
* Improve height, weight and head circumference
* Improve hemoglobin, vitamin B12 and folic acid status, On mothers (primary caregivers)
* Reduce mothers' stress and depressive symptoms
* Improve positive parenting practices
Background of the Project including Preliminary Observations:
The rate of global acute malnutrition is 16% while the rate of stunting in Bangladesh is as high as 41% in \<five yrs children. Moreover, the children in Bangladesh are either deficient in different micro-nutrients like iron 10.7% and iodine 34% or have inadequate micro-nutrients in their diets like vitamin B12 and folate which is less than 50%. Many children in developing countries fail to reach their developmental potential due to lack of cognitive stimulation and Bangladeshi children have limited access to play materials and activities.
According to Walker and colleagues 300 million children are exposed to violence globally. Our unpublished data show that 32% of children \<2 years are subjected to maltreatment and harsh punishment in Bangladesh.
Depression is one of the leading causes of disease burden for women and children of these mothers may suffer from behavioral problems.. Depression is reported as a leading cause of disease burden for women aged 15-44 years in all countries. The South Asia has the least woman-friendly societies in the world. Maternal depression is becoming a major public health problem in these societies, partly due to gender roles and practices and partly to poverty. Depression indicates state of mind that causes symptoms like crying spells, sleeping problems, depressed mood, irritability, fatigue, anxiety, poor concentration and interpersonal hypersensitivity, and these can range from mild to severe in nature. Maternal depression not only affects mothers' health, evidenced by poorer nutrition, higher suicide attempts and self harm but also results in poor health and developmental outcomes of their children.
In Bangladesh prevalence of anxiety and depressive symptoms are as high as 18-33% and we found a significant association with child maltreatment in an urban community on). Rahman et al. tested an innovative model of community-based management of depression using Cognitive Behavioral Therapy (CBT) in Pakistan and reported improvement in maternal depression 6 months postpartum. Considering similar family structure, religion and culture between Bangladesh and Pakistan, it is likely that the program will work in Bangladesh too.
Despite prevalent child maltreatment in Bangladesh, there are very few interventions to reduce maltreatment and those for children under 5 yrs of age are even rarer. Similarly, though attention has been diverted to ECD for several years now, very few of those programs address children under 3 yrs of age. Study design would probably be the 1st intervention using a robust research method to test the efficacy of an integrated method to address ECD, child maltreatment as well as health and nutrition of young children. Investigators will modify existing curriculum to further focus on child maltreatment. Investigators have targeted poor families from urban slums who are deprived of such services but face most of the risk factors and hope to improve their families' condition using low-cost intervention. Researchers have targeted the mothers as study participants who also primary caregiver of a child especially at younger age and have a major role in the child development. Mothers are also more vulnerable for depression than the fathers in Bangladeshi culture.
In addition, there is no culturally appropriate tool to assess child maltreatment in Bangladesh. In this project researchers attempt to modify or adapt existing instruments or if needed develop new tools suitable for use in Bangladesh.
Research Design and Methods
Population and sample size:
This study will be conducted in the semi-urban area (preferably in Kamalapur) of Dhaka, Bangladesh. Total sample is 10 mother-child duos in randomly selected 30 clusters ( n=300), half of which (n=150) will be beneficiaries from the intervention.
Plan of work: The intervention package will be piloted in the non study community for its feasibility and will be modified accordingly. The selected mother-child duos will be invited to field office for baseline assessments. Intervention group will be invited to join the center-based group sessions fortnightly for one year, the control group will receive existing government health messages. Both the groups will receive free health service from study medical officer for acute illnesses. After a year, final assessments will be done in both the groups. At baseline and end line mother-child interaction will be observed in a sub-sample of the population.
Procedures:
It will be a cluster-randomized trial. Clusters will be formed based on number of household members (those using the same cooking pot) as well as geographical boundary. On average there will be 150-200 households in each cluster, but there may be some variation in household numbers per cluster and per stratum.Total sample will be 10 mother-child duos in randomly selected 30 clusters (n=300), half of which (n=150) will be beneficiaries from the intervention.
Plan of work: The intervention package will be piloted in the non study community for its feasibility and will be modified accordingly. The selected mother-child duos will be invited to field office for baseline assessments. Intervention group will be invited to join the center-based group sessions fortnightly for 1 year, the control group will receive existing government health messages. Both the groups will receive free health service from study medical officer for acute illnesses. After a year, final assessments will be done in both the groups. At baseline and end line mother-child interaction will be observed in a sub-sample of the population. At the beginning of the study, 4 Focus group discussions of (8-10 non-study mothers) will be conducted in the community to know about the mothers' parenting practices. At the middle of the study qualitative information (case report and 30 In-Depth Interviews) will be collected form the intervened mothers about the intervention package they are receiving. Intervened mothers will be interviewed at their home according to their time availability. Key Informant's Interview (KII) will be conducted after a year from 2 play leaders (who will deliver the intervention) and 2 supervisors (who will train the play leaders and monitored them). Interviews will be taken and tape recorded with consent of the participants.
1. Preparatory works: At the first phase researchers will select the site and also complete the process of 'Ethical Review' of the project.
Screening and enrollment: After taking the consent, screening of mothers of 8 to 23 months old children, who practice harsh discipline will be conducted in 30 identified clusters by trained health workers using ISPCAN Child Abuse Screening Tool-Parent Version (ICAST-P). Researchers have already used the modified version of these tools in Bangladesh. According to primary investigation there are 10% mothers having 8 to 23 months old children in study field site. With this estimation to get 10 eligible mothers from each cluster researcher group have to screen 100 mothers. Mothers who will fulfill the study enrollment criteria will be offered to join the study and will be invited to the test centers for baseline assessments.
At the same time research group will start developing the study materials:
For intervention: Development and piloting of following manuals, that already exist and needs further simplification and adaptations
* Psycho-social stimulation for individual visits
* Cognitive behavioral therapy For assessments: Cultural adaptation, Standard Operating Procedures (SOPs) preparation and field testing of following tools
* Bayley Scale of Infant and Toddler Development (Already adapted, we have to take permission from Pearson's to use it)
* Field testing and adaptation of ISPCAN Child Abuse Screening Tool -Parent Version (ICAST-P)
* Qualitative questionnaires
* Observational tools
Tools that are adapted, tested and ready to use
* Parenting questionnaire
* Home observation for measurement of environment (HOME)
* Rosenberg Self Esteem Scale
* CES-D to measure depressive symptoms
* Socio-economic status (SES) questionnaire
* Wolke's Behavior Rating scale
* Anthropometric measurements
2. Baseline assessment:
On children:
Bayley Scales of Infant and Toddler Development (Bayley-III) will be used to assess cognitive, language and motor development of the children. The test has been used in many developing countries, and has been the instrument of choice for much nutrition and child development research at this age in other countries like Indonesia and Brazil. The Bayley has often been sensitive to changes following interventions. Because the Bayley has not been standardized in Bangladesh, researcher will not compare these children's scores with the test norms or children of other countries. Study aim is only to compare the development of groups of children within the same community. Bayley usually takes about an hour to test the children.
The children's behavior during the Bayley tests will be rated on five 9-point scales using a modified version of the scales developed by Wolke (1990). These ratings include infants' activity (very still=1 to overactive=9), emotional tone (unhappy=1 to radiates happiness=9), approach or responsiveness to examiner in the first 10 minutes (avoiding=1to friendly and inviting=9), cooperation with test procedure (resists all suggestions=1to always complies=9), and vocalization (very quiet=1to constant vocalization=9). The scale has been used in several studies in Bangladesh and was sensitive to intervention effects .
Anthropometry: Mother and child's anthropometric measurements (height and weight of mothers; length/height, weight, MUAC and head circumference of children) will be assessed at using standard procedures.
On mothers':
Maternal self esteem: This will be assessed using adapted version of the Rosenberg Self Esteem Scale, the most widely used measure of self esteem for research purposes. It has been used previously in Bangladesh by this research team and by others as a valid instrument.
Information on child maltreatment and neglect: The International Society for the Prevention of Child Abuse and Neglect (ISPCAN) has developed ISPCAN Child Abuse Screening Tool- Parent Version (ICAST-P) that has been widely used in developing countries, like India and Jamaica. This research group already used modified version of this tool in Bangladesh on hospital mothers.
Measurement of maternal depressive symptoms will be done using Center for Epidemiologic Studies Depression Scale (CES-D). This tool has been used in Bangladesh and South-East Asian countries.
Quality of stimulation at home was assessed using Caldwell's Home Observation for Measurement of Environment (HOME) which was modified for Bangladesh and was used in other studies by the same research team.
Other measurements: These following measures will be collected as covariates - Socioeconomic status: On enrollment information will be collected on the family's assets (furniture e.g. bed/tables/chairs, electrical household equipment's e.g. radio/TV/fan, farm animals, vehicles e.g. rickshaw/boat/bicycle/motorbike, etc.), housing condition (type of roof, floor and walls), access to water and sanitation, electricity, crowding condition, and parental education and occupation. An asset quintile will be created from all available assets available at household level.
Observational tools: Structured observation checklist will be used to see mother-child interaction Qualitative assessments will be used to conduct focus group discussion, in depth interviews and case reports.
3. Intervention:
It will be a low cost intervention focusing on building awareness among population at risk through hands on training delivered by trained health workers with minimum educational level and low salary. Our previous experience shows that it is possible to train paraprofessionals to provide intervention of this intensity. We have also shown that psycho-social stimulation provided for 10 or 12 months can improve the development and behavior of children significantly. Two weeks training and one week's field practice will be required to train these staff. We will train the play leaders regarding the whole intervention package including stimulation, Cognitive Behavioral Therapy, health and nutrition messages that include infant and young child feeding practices, good hygiene practice, and positive parenting messages (stimulation, learning through play, love and affection). There will be one-hour sessions fortnightly for 11 months. Attending 2 sessions per month is feasible for the mothers. This intervention will address the major risk factors e.g. negative parenting, lack of stimulation, child maltreatment, malnutrition, maternal stress/depressive symptoms, faulty care-seeking practices due to knowledge gap, etc. using a combined package.
There will be a combination of 3 types of interventions:
(i) Early stimulation and prevention of maltreatment through positive parenting, boosting up of maternal self-esteem and stress management (ECD): Psycho-social stimulation intervention will follow a set of culturally appropriate, semi-structured, child's age appropriate curriculum. This integrated approach will be given in groups of mothers and child. During the session the field-workers will show the mothers how to play with home-made toys and books and interact with their children in a way to promote their development. Along with the stimulation program, the field workers will also provide some advice regarding positive parenting and boosting up maternal self esteem and stress management. Care will be taken to appreciate mothers for their activities and positive reinforcement will be strongly encouraged. The developmental activities will be conducted in a playful manner and not as a work-oriented activity. The activities in the curriculum will be ordered by difficulty level and the health workers will be trained to choose the level for each child according to their ability to do the activities.
(ii) Health education and sprinkles supplementation (HN): The participants will receive health and nutrition messages to improve children's health. In addition children will receive multiple micro-nutrient powder (Vitamin A 400 µg, vitamin D 5 µg, vitamin E 5 mg, vitamin C 30 mg, thiamine 0.5 mg, riboflavin 0.5 mg, niacin 6 mg, pyridoxine 0.5 mg, vitamin B12 0.9 mg, folate 150 µg, iron 10 mg, zinc 4.1 mg, copper 0.56 mg, selenium 17.0 µg and iodine 90 µg) supplementation at household level (90 sachets of over 6 month-period).
(iii) Cognitive Behavioral Therapy: Intervention to help mothers change their negative behaviour and to improve self care, child care, income generation activities, will follow the "Thinking Healthy Program" model of Rahman and colleague using cognitive behavior therapy (CBT). CBT will improve maternal behaviour leading to "positive parenting" and prevention of maltreatment. Cognitive Behavioral Therapy is an "evidence-based and structured form of talking therapy that aims to alter the cycle of unhelpful or unhealthy thinking (cognition) and the resulting undesirable actions (behavior)." Cognitive Behavioral Therapy specifically focused on "changing thinking style toward positive" and not associated with any medication. CBT found to be effective in managing or treating not only depression, also a variety of other conditions-e.g. mood, personality, stress, eating habit, tic etc.This approach with rural mothers of similar context showed positive impact on child outcome in Pakistan, which is culturally and economically similar to Bangladesh.
CBT is aimed to alter the cycle of negative thinking of people to positive direction. The cycle of negative thoughts usually breaks in two ways by using Cognitive and Behavioral aspect of the therapy -
* Cognitive aspect of CBT: This focuses on altering ways of thinking of a person (mother) that includes thoughts, beliefs, ideas, attitudes, assumptions, mental imagery, and ways of directing her attention.
* Behavioral aspect of CBT: This focuses on helping the mother to face the challenges and the opportunities that facilitates child-raising with a sound and clear mind- and then to take necessary actions that are likely to have desired outcomes.
This model is proven to be an effective approach in breaking the cycle of depression and improving confidence, coping strategies and assertiveness in poor community with low resource setting. The cycle is broken through two ways of CBT- cognitive aspect (directing attention to positive direction) and behavioral aspect (helping to meet challenges).
d) Final assessment, data entry and data analysis: After 11 months of intervention, the participants will be invited again in the centre for end line assessment. The same assessment tools will be used as in the base line. Simultaneous data entry will continue in SPSS software. After data cleaning, preliminary analysis will be done according to following plan.
All the baseline variables will be used to compare between lost and tested groups as well as the intervention and control groups. The two time-point assessment will also provide information about within group changes. Some variables e.g. HOME, mother-child interaction, parenting, childcare etc. will be used either as mediator or as outcome in separate analyses
Outcome Variables:
On Mothers-
1. Maternal stress and depressive symptoms using CES-D at baseline and at the end.
2. Self Esteem assessment using Rosenberg Self Esteem Scale at baseline and at the end in test centre
3. Information about child maltreatment by parents will be collected at baseline during screening at home and at the end.
4. Home observation for measurement of environment (HOME) at household level, twice (at baseline and at the end)
On Children-
1. Child's cognitive, motor and language assessment using Bayley-III and behavioral assessment during test using Wolke's Behavior Rating Scale, at baseline and at the end in test centre. Children will accompany their mothers to the centre. (45 min)
2. Children's Micronutrient status (vitamin B12 and folic acid) at baseline and at the end in test centre
3. Children's Hemoglobin status
4. Children's height, weight, MUAC, head circumference at baseline and at the end
Covariates-
1. Socio-economic variables (asset index/ quintile)
2. Demographic variables (housing/ sanitation)
3. Maternal nutritional status (BMI)
4. Child's age and sex
5. Compliance on micro-nutrients and dietary recall
6. Morbidity Sample Size Calculation and Outcome (Primary and Secondary) Variable(s)
Considering 5% level of significance, 80% power, an improvement of 0.4 SD in children's developmental outcome based on our previous experiences, an ICC of 0.01 and 30% drop outs, we need to enroll 150 mother-child duos in each group as per equation below- 2(SD)2 n = ---------------- X f (αβ) (M1-M2) 2
n: sample required, SD: 16 (based on previous data of Bayley Score) α: 5% level of significance β: 80% power f= α\*β M1-M2 = Difference = 6.4 points (based on previous studies) So the calculated n=100
Considering the clustering we need to adjust this sample size by multiplying the above value (100) by the design effect.
Design Effect = 1 + \[(m-1) \* ICC m corresponds to the average number of infants per cluster. Assuming there are on average 10 mother-child duos/cluster.
Using ICC = 0.01, the design effect = 1 + \[(10-1) \* ICC = 1 + 0.9 = 1.09 Therefore new sample size = 100\*1.09= 109 per group , considering 30% drop-out the sample size per group is around 150 infants in stimulation group and 150 infants in control group.
Data Analysis
icddr,b scientists and co-investigators of this research project will analyze the data using Stata/SPSS. All data will be checked for normality. Log transformation will be done if not normally distributed. Indices will be created where it is required (eg: SES index, housing index etc). Pearson's correlations will be conducted to examine the association between age of the child and each developmental measure. A comparison will be done between the socio-demographic characteristics of the intervened and control groups using t-test for continuous variables and χ2 for categorical variables. Partial correlation will be used controlling age and sex to examine association of different covariates with developmental scores.
Finally, multi-level regression analyses will be done. In each regression analysis, the outcome will be the final developmental score, with age at enrollment, the relevant initial scores, and intervention as predictors. Again, comparison will be done between the treatment effect in intervention and control groups. All variables that will be different between intervention and control groups at baseline and will correlate with the developmental outcomes and will address high co-linearity among the covariates in all analyses.
The main outcomes are children's cognitive, language and motor development measured on Bayley Scales of Infant and Toddler Development. In addition it is expected that an improvement in growth, home stimulation and mother's positive parenting. It is also expected that improvement of the hemoglobin and micro-nutrient status (vitamin B12 and folic acid) over 150 children in the intervention group by the end of the project. At the same time it is expected of a reduction on mothers' stress and depressive symptom and rate of maltreatment of children by parents. A cost analysis will be conducted based on the success indicators, cost per successful outcome will be calculated from total cost of intervention program.
Data Safety Monitoring Plan (DSMP)
Researcher group do not expect the low risk activities of this study to put the study population at increased risk of adverse outcomes, however any human activity can have unforeseen untoward consequences. researchers will actively monitor the impact of the intervention on the population. The primary objective of these evaluations is to understand practices, knowledge, and attitudes towards the interventions. researchers will include questions in the evaluations that ask if they have noted any adverse outcomes.
If the field team learns of any adverse outcomes they will be trained to report them to the study team the same day they learn of them.
Ethical Assurance for Protection of Human rights
The project will have to be approved by the Institutional Review Board of icddr,b. Investigator group will collect written informed consent in Bengali from the parents before starting data collection. Research group will ensure confidentiality when collecting data on sensitive issues like maternal depression. Hard copies of the data will be kept in a locked cabinet only accessible to the investigators. The electronic data will not have the name and other identifiable information. Clinically depressed mothers will be referred to counsellors or psychiatrists as needed. Children with mental retardation or developmental disabilities will be referred to proper places for treatment.
|
Inclusion Criteria:
* Mothers of 8 to 23 months old children, who practice maltreatment or harsh child-discipline (screened by a previously used tool), will be included.
* Children 8-23 months old with weight-for-length ≥-3 z score, MUAC ≥ 115 mm
* Mothers are the primary caregivers and consented to participate.
Exclusion Criteria:
* severe malnutrition nutritional edema, known developmental disability, chronic illness, haemoglobin level \<8 gm/L (at enrolment). They will be referred to the nearby health facilities for necessary clinical management
|
[
-0.41560831665992737,
2.0723719596862793,
-2.2529845237731934,
-2.204059362411499,
0.02104930952191353,
-0.16560609638690948,
-0.9314961433410645,
-0.7059409022331238,
-0.9677610397338867,
-0.37091970443725586,
0.14375039935112,
1.496944785118103,
-0.7909181714057922,
-0.02672259323298931,
-0.8251269459724426,
0.5166082978248596,
-0.10786571353673935,
0.1685945689678192,
0.7271014451980591,
-0.6093210577964783,
0.5772024393081665,
-0.6078978776931763,
0.35578569769859314,
-1.4836890697479248,
0.029948098585009575,
0.5083998441696167,
-1.004333734512329,
2.0670530796051025,
-0.24026641249656677,
0.649836003780365,
0.715678334236145,
-0.45346057415008545,
-0.05803733319044113,
0.1260870397090912,
0.47746676206588745,
-0.3553524315357208,
0.8542787432670593,
-0.029327942058444023,
-0.35038354992866516,
0.725226104259491,
-0.009603036567568779,
0.2566215991973877,
0.21683861315250397,
0.9232836365699768,
0.4842455983161926,
0.7883061170578003,
-0.07174854725599289,
0.28630372881889343,
-1.024793267250061,
0.863278329372406,
-0.24690456688404083,
1.1137155294418335,
-0.37226369976997375,
-0.6309419274330139,
1.456214189529419,
-0.04335108771920204,
-0.248674213886261,
0.2555317282676697,
1.4150655269622803,
-0.34679409861564636,
0.6441368460655212,
-0.3562364876270294,
0.44494807720184326,
0.153004452586174,
-0.7934226393699646,
-1.0663543939590454,
0.47275444865226746,
-0.0762767493724823,
-1.0344970226287842,
0.4872859716415405,
0.4224745035171509,
-0.005056391004472971,
0.7918723821640015,
-0.5516229271888733,
-0.08465911448001862,
0.1514817476272583,
-0.3289811909198761,
1.4206441640853882,
0.21081149578094482,
0.6549939513206482,
-0.11071126163005829,
0.0035315537825226784,
0.3483290672302246,
-0.6577504277229309,
1.1637179851531982,
0.021523727104067802,
-0.7256368398666382,
0.2782202661037445,
1.0804133415222168,
-0.36860665678977966,
0.37228959798812866,
-0.17918342351913452,
-1.1685291528701782,
0.23694364726543427,
0.21318723261356354,
1.1434588432312012,
0.07601431757211685,
0.005303835961967707,
-0.42499035596847534,
0.0023508297745138407,
0.1609942615032196,
-0.300526887178421,
-0.5647231936454773,
0.11361222714185715,
-0.9591773152351379,
0.09958469122648239,
0.21082913875579834,
0.02874687872827053,
-0.13757769763469696,
0.5199211835861206,
-0.6290276646614075,
-0.4640761613845825,
-0.06522046774625778,
-0.4258345365524292,
0.08278313279151917,
0.5142558813095093,
0.07708681374788284,
-0.06263741850852966,
-0.19807107746601105,
-0.7240251302719116,
0.08139220625162125,
0.6881661415100098,
-0.12108036130666733,
0.3255150020122528,
-0.7495899796485901,
-0.3384389281272888,
0.42032718658447266,
0.11781300604343414,
-0.3279308080673218,
-0.08220114558935165,
-0.9783608913421631,
0.9053572416305542,
0.5262140035629272,
-0.3623350262641907,
-0.6444104909896851,
0.16665883362293243,
0.44014447927474976,
0.13401933014392853,
-0.008443818427622318,
-0.7180639505386353,
-0.6262091994285583,
0.03896806389093399,
-0.4648183286190033,
-0.5427272319793701,
-0.8868586421012878,
-0.41811472177505493,
0.5954163670539856,
0.0012517868308350444,
-0.8412514328956604,
-0.1059529036283493,
-0.11584226042032242,
0.32426339387893677,
0.15051250159740448,
0.143683061003685,
-0.04067336022853851,
0.45180630683898926,
0.18354007601737976,
-0.3409568667411804,
0.15424120426177979,
-0.3714763820171356,
0.8179491758346558,
-0.2004324346780777,
-0.264981210231781,
-0.20605167746543884,
-0.5236185789108276,
0.1501733660697937,
0.3699980676174164,
0.13463012874126434,
-0.042051371186971664,
-0.000024702787413843907,
0.13372434675693512,
-0.05974644050002098,
-1.0304515361785889,
0.044311050325632095,
-0.06238031014800072,
0.27845847606658936,
0.6619726419448853,
-0.20926357805728912,
0.26600417494773865,
-0.1534193903207779,
-0.20191197097301483,
0.283248633146286,
0.06831935048103333,
-0.24228762090206146,
-0.13717295229434967,
-0.15079063177108765,
-0.6973747611045837,
-0.3138871490955353,
-0.6443675756454468,
0.12328964471817017,
0.031558673828840256,
0.19368977844715118,
0.08798560500144958,
-0.18244442343711853,
-0.40425920486450195,
-0.12187902629375458,
-0.28253498673439026,
-0.3008342385292053,
0.35791102051734924,
-0.193463996052742,
0.3784210681915283,
0.3047265112400055,
-0.20064090192317963,
-0.040746938437223434,
0.14972341060638428,
0.3837636113166809,
-0.0765053927898407,
0.26466700434684753,
0.029729673638939857,
-0.2136150449514389,
0.14625295996665955,
0.6553606390953064,
-0.10589532554149628,
0.1758168637752533,
0.2449277937412262,
-0.23356527090072632,
0.05492974817752838,
0.11110053956508636,
-0.313708633184433,
-0.19927699863910675,
0.027881832793354988,
-0.27103057503700256,
-0.11812105029821396,
-0.21432296931743622,
0.1082797572016716,
-0.004733521491289139,
-0.2012059986591339,
0.1856456995010376,
-0.0796414390206337,
-0.22648681700229645,
-0.11825758963823318,
-0.15508200228214264,
-0.10562620311975479,
0.24788397550582886,
-0.34816011786460876,
-0.3593708276748657,
-0.16689704358577728,
0.06536943465471268,
0.07364348322153091,
-0.01914241537451744,
0.36877837777137756,
-0.17761221528053284,
0.18520162999629974,
0.019160807132720947,
-0.19445063173770905,
-0.5012748837471008,
-0.247320756316185,
0.5215691924095154,
-0.2059132605791092,
-0.25277525186538696,
0.21571286022663116,
0.23868568241596222,
0.04763340950012207,
-0.5425687432289124,
0.7521312236785889,
0.008257159031927586
] |
NCT00275665
|
The Study is Being Done to See if Taking the Drug Valganciclovir Can Prevent CMV Infection.
|
This study is being done in stem cell transplant recipients to see if taking the drug valganciclovir can prevent or reduce serious cytomegalovirus (CMV) infections that can occur 100 days or later after transplant.
|
This study is a phase III, randomized, double-blind, palacebo-controlled, multicenter study of the drug valganciclovir. This study is to see if taking prophylactic doses of valganciclovir starting 100 days after stem cell transplantation can prevent late CMV from occurring.
Participants will be randomized (like a flip of a coin) into one of two groups. Neither the participant nor the doctor will know which group the participant is in. One group will receive the drug valganciclovir. The other group will receive a pill that looks like valganciclovir, but does not contain any active medicine (a placebo).
Participants enrolled in the study will take the drug by mouth daily starting at day 100 post stem cell transplant. Participants will also have blood samples taken along with their routine blood weekly, until day 270. Participants will also be required to return to their routine clinic visits.
Participants' acquiring an active CMV bloodstream infection at the time of the study will receive ganciclovir by the vein twice a day or a high dose of valganciclovir. Participants will be instructed to stop taking the study drug during the treatment time. After active CMV infection can no longer be detected, the treatment will be stopped. Patients will start taking the study drug and will be monitored for a CMV bloodstream infection until 270 days after transplant. Participants developing symptoms that look like CMV disease (pneumonia, infection of the intestines, eye infection) while on the study drug, will have an examination and lab tests to diagnose the organism. Participants that are hospitalized for CMV disease or for any other reason are asked to notify study personnel.
Participants will need to record study medicine taken in a daily study drug diary. Questionnaires will be filled out by the participant throughout the study, they will also be called monthly to see how they are doing and feeling overall.
After 270 days, participants will complete the study drug phrase. They will receive follow up phone calls on days 400, 520, and 640 days after transplant to see how they are doing.
|
Participants who are undergoing allogeneic peripheral blood stem cell, cord blood, or marrow transplantation that are 18 years of age or older, may be eligible to participate in this study.
|
[
-0.09242405742406845,
1.7362473011016846,
-0.3602169156074524,
-2.344308614730835,
-0.1620384156703949,
1.3472164869308472,
-1.6866189241409302,
0.9494719505310059,
-1.8595902919769287,
0.16794171929359436,
-1.1298972368240356,
2.751128911972046,
-0.11154808104038239,
1.4647338390350342,
0.3786933720111847,
-1.2220152616500854,
-1.4253500699996948,
0.8018178343772888,
1.187474012374878,
-1.300887942314148,
0.870029628276825,
0.7135218977928162,
0.38942474126815796,
-0.3011305332183838,
0.7917202115058899,
-1.331977367401123,
0.13696610927581787,
0.9504303336143494,
0.1636471301317215,
2.228862762451172,
-0.006114557851105928,
-3.4709763526916504,
1.537667989730835,
2.1272454261779785,
-1.0344825983047485,
-0.9206220507621765,
2.346679449081421,
1.4085311889648438,
2.1693897247314453,
0.5101982355117798,
0.5435999631881714,
-0.17432451248168945,
-0.016005270183086395,
-0.25499361753463745,
-0.06529393047094345,
0.03547264263033867,
3.0044164657592773,
0.8993734121322632,
1.1214687824249268,
1.1644012928009033,
-1.2414354085922241,
0.4189468324184418,
-0.07740132510662079,
2.1969025135040283,
0.6299300193786621,
-0.35823342204093933,
-0.8409653306007385,
2.463359832763672,
2.7752671241760254,
-0.22892624139785767,
1.462842345237732,
-0.19517533481121063,
-0.7110191583633423,
-1.3897671699523926,
-2.4760477542877197,
0.6411238312721252,
-0.07430049777030945,
-0.976871132850647,
-0.6361298561096191,
1.4962972402572632,
1.316299557685852,
0.2811419367790222,
0.9631333351135254,
1.1483654975891113,
-0.8987578749656677,
1.6188769340515137,
-0.21277344226837158,
1.3055554628372192,
0.837553858757019,
-0.11593792587518692,
-0.1006673127412796,
-2.0424764156341553,
-0.8784198760986328,
1.046735167503357,
-0.27213919162750244,
-1.0681099891662598,
-0.49295946955680847,
0.5173093676567078,
0.7861418724060059,
-1.4917587041854858,
0.017825333401560783,
-0.7402803301811218,
0.22393374145030975,
-0.08068639039993286,
-0.9930259585380554,
0.33295363187789917,
0.13139307498931885,
0.2194579839706421,
-1.0277312994003296,
0.41034573316574097,
0.6742580533027649,
-0.1537613719701767,
-0.7386931777000427,
0.0015178666217252612,
-0.11886397749185562,
-0.7636100053787231,
-1.5179122686386108,
-0.20344913005828857,
-1.4337661266326904,
-1.606183648109436,
0.01806030422449112,
-0.23792776465415955,
-0.1614261120557785,
-0.4667239785194397,
-0.9705270528793335,
-0.33814364671707153,
0.9933386445045471,
-0.14121687412261963,
-1.5530335903167725,
0.3801799714565277,
0.7835124731063843,
-1.0120673179626465,
0.18252630531787872,
0.1761883795261383,
-0.5020273923873901,
-0.38071098923683167,
-1.0060080289840698,
-0.20486629009246826,
0.4596542716026306,
-0.6080573797225952,
0.419374018907547,
0.636618435382843,
0.4081886410713196,
-1.3194537162780762,
-1.205223560333252,
-0.5762174725532532,
0.8771862983703613,
0.43773332238197327,
-0.37729838490486145,
-0.5878685116767883,
1.3967605829238892,
0.2264234870672226,
0.39325225353240967,
0.061718858778476715,
-2.3204848766326904,
-0.44507598876953125,
0.3211756944656372,
0.9758530259132385,
-0.24788960814476013,
-0.3707551956176758,
0.08845379948616028,
0.5442179441452026,
-0.0479743592441082,
0.6681583523750305,
-0.1934288740158081,
0.6795439720153809,
-0.16710713505744934,
-1.0556094646453857,
0.18541644513607025,
-1.1436738967895508,
-0.7590659856796265,
-0.5411102771759033,
0.46641457080841064,
-0.5827878713607788,
0.22321996092796326,
-1.57675302028656,
-0.7718644142150879,
-0.10559055954217911,
-0.011509597301483154,
-0.11883926391601562,
-0.23945043981075287,
-0.6092296242713928,
-0.18306966125965118,
-0.4243829548358917,
-0.776644766330719,
-0.5950480103492737,
0.0646442249417305,
1.3193538188934326,
0.36271148920059204,
-0.6952751874923706,
0.20552530884742737,
-0.6003207564353943,
-0.6836926341056824,
0.26330557465553284,
0.6722769141197205,
0.44365042448043823,
-0.7011245489120483,
-0.3557588756084442,
-0.3035387098789215,
0.20592144131660461,
-0.054794784635305405,
0.8083095550537109,
0.4066944420337677,
-0.14040890336036682,
0.8930617570877075,
-0.5225718021392822,
0.6241836547851562,
-0.32835862040519714,
0.28288188576698303,
0.09857061505317688,
0.7509359121322632,
0.16894672811031342,
-0.1822524070739746,
0.5666013956069946,
-0.5437599420547485,
-0.1969383955001831,
0.1257394254207611,
0.7454982995986938,
1.1397178173065186,
-1.305638313293457,
0.16867604851722717,
-0.006065064575523138,
-0.5670565962791443,
0.670208215713501,
-0.3714650571346283,
-0.31887078285217285,
0.5646964907646179,
-0.507203221321106,
-0.4861227571964264,
0.003653379622846842,
0.14662867784500122,
-0.8175324201583862,
0.21968969702720642,
-0.12418791651725769,
-0.24831676483154297,
-0.1510915756225586,
0.46605032682418823,
-0.07676619291305542,
-0.13117757439613342,
-0.6453114151954651,
-0.34169802069664,
0.6294129490852356,
-0.5542494058609009,
-0.21664412319660187,
-0.10855338722467422,
0.08106130361557007,
0.18282254040241241,
0.21499617397785187,
0.5821045637130737,
-0.3364414870738983,
0.2909089922904968,
-0.5101875066757202,
0.06382352113723755,
-0.44845303893089294,
0.05078057572245598,
-0.493054062128067,
0.4979228079319,
-0.2078734040260315,
-0.04509436711668968,
0.14768032729625702,
-0.5587494373321533,
-0.7417927384376526,
-0.6373594403266907,
-0.6732439398765564,
0.589168906211853,
-0.2868849039077759
] |
NCT06409286
|
Assessment of Flow in Cerebrospinal Fluid Shunts with a Second Generation Wireless Thermal Anisotropy Measurement Device
|
This study evaluates the performance of a thermal anisotropy measurement device for non-invasively assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction who require shunt revision surgery will be evaluated with the study device to assess flow in CSF shunts as confirmed by surgical outcomes at 7 days. If successful, this study will show that the study device accurately distinguishes between functioning (flowing) and non-functioning (non-flowing) shunts.
|
Inclusion Criteria:
1. Existing ventriculoperitoneal CSF shunt on which the subject is dependent
2. At least one symptom of shunt malfunction as determined by the investigator, such as but not limited to seizure, fever, headache, vision problems, dizziness, disorientation, confusion, vomiting, lethargy, irritability, difficulty waking or staying awake, swelling along shunt tract, enlargement of head, loss of balance, gait disturbance, and loss of sensory or motor function
3. Exhibit shunt malfunction symptom(s) requiring surgical shunt revision per standard of care assessment without use of device data
4. Region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
5. Available for follow-up for up to seven days
6. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol)
Exclusion Criteria:
1. Presence of more than one distal shunt catheter in the study device measurement region
2. Presence of an interfering open wound or edema in the study device measurement area
3. Subject-reported history of adverse skin reactions to adhesives
4. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
5. Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject
6. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
7. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
|
[
-1.3508501052856445,
3.4560680389404297,
-3.9586093425750732,
-3.1891250610351562,
0.16302748024463654,
0.3335353434085846,
0.1371813863515854,
0.2066028118133545,
-2.134700059890747,
0.9819403886795044,
0.28033313155174255,
0.45594850182533264,
-1.8674061298370361,
0.5285614728927612,
-0.3640056848526001,
0.8310917019844055,
0.695734441280365,
1.0045890808105469,
0.4783080518245697,
0.16698065400123596,
0.5603914260864258,
1.0876410007476807,
0.497184157371521,
-0.09353874623775482,
1.489846110343933,
0.4406724274158478,
0.30081287026405334,
-0.20713885128498077,
0.24983002245426178,
0.40088242292404175,
1.6573046445846558,
-1.4227650165557861,
-0.20834378898143768,
1.6305192708969116,
0.9642630219459534,
-1.2812024354934692,
0.7656446099281311,
0.8943134546279907,
0.696008026599884,
-0.0013744635507464409,
1.4448144435882568,
0.6859403252601624,
-0.5178077220916748,
1.0412278175354004,
0.7623280882835388,
-0.7491256594657898,
0.7602212429046631,
1.2778637409210205,
-0.4380011260509491,
-0.30487626791000366,
-0.1427047848701477,
-0.5002164244651794,
-0.3573680520057678,
-0.3989246189594269,
1.6256858110427856,
1.08314847946167,
1.5973848104476929,
1.0105623006820679,
0.925081729888916,
0.36468976736068726,
1.1429389715194702,
0.10471577942371368,
0.22249621152877808,
0.6988184452056885,
-0.880246639251709,
0.5983835458755493,
1.0733011960983276,
-0.39366868138313293,
-1.6765018701553345,
-0.33464038372039795,
0.6302997469902039,
-1.48563551902771,
0.5502974987030029,
1.1124403476715088,
1.0019432306289673,
-0.16700224578380585,
-1.0620640516281128,
0.15521922707557678,
0.7532338500022888,
0.2514037489891052,
0.6724287867546082,
-1.1774157285690308,
-1.542851448059082,
0.8760076761245728,
0.5598531365394592,
0.010503710247576237,
0.08396296203136444,
-0.14219887554645538,
1.6892951726913452,
-1.3878775835037231,
-0.7500343918800354,
0.1906423717737198,
-0.4634999632835388,
-0.9920220971107483,
-0.11191608011722565,
0.9513615965843201,
0.5839225053787231,
-0.624057412147522,
-0.42492279410362244,
0.6737807989120483,
-1.360929012298584,
-1.125549554824829,
-0.725253701210022,
-0.10571583360433578,
0.5525089502334595,
-0.7054373025894165,
0.17964987456798553,
-0.4820988178253174,
0.057397786527872086,
-2.1109414100646973,
0.9538115859031677,
-0.741186797618866,
0.5914278626441956,
-1.6653764247894287,
-0.701460063457489,
0.47796955704689026,
0.35860228538513184,
1.8644285202026367,
1.148769497871399,
0.9207357168197632,
0.18584084510803223,
0.5741551518440247,
0.8213322758674622,
1.256173014640808,
-1.0748958587646484,
0.819595456123352,
-0.07941242307424545,
0.7751456499099731,
-1.414940595626831,
-0.19801117479801178,
-1.1014364957809448,
-0.2580534517765045,
-0.33121252059936523,
0.26228055357933044,
0.16159068048000336,
-1.2312438488006592,
0.7470070719718933,
0.6874865889549255,
-0.8096243739128113,
-0.624588131904602,
-0.26133641600608826,
0.6290565133094788,
0.0831875205039978,
0.15005750954151154,
-1.8812098503112793,
-0.2640135586261749,
-0.05685458704829216,
-0.2581026256084442,
0.6511964797973633,
0.09344232082366943,
-0.02546299248933792,
0.24472936987876892,
-0.31562089920043945,
0.3131808042526245,
-0.5829172730445862,
0.6366766095161438,
0.8982656598091125,
-0.4922562837600708,
1.0865683555603027,
1.015583872795105,
-0.7372481822967529,
0.09603924304246902,
-0.08240599930286407,
-0.9633052945137024,
1.1408424377441406,
-0.4900088608264923,
0.0220378115773201,
0.3838868737220764,
-0.7845430374145508,
-1.1006064414978027,
-0.8938770294189453,
0.44448575377464294,
0.7057895064353943,
-0.2941897213459015,
-0.9560760855674744,
0.009756628423929214,
0.4384322762489319,
1.0273517370224,
-0.13686077296733856,
0.21309533715248108,
0.617609441280365,
0.4949418902397156,
-0.15893524885177612,
0.589176595211029,
-0.03226430341601372,
0.22971215844154358,
-0.3912425637245178,
-1.0585625171661377,
-0.36171388626098633,
0.863041341304779,
-0.3264574706554413,
-0.042302072048187256,
0.3144095242023468,
0.12095203995704651,
-0.09682869166135788,
0.01003420539200306,
-0.9895777106285095,
-1.369105339050293,
-0.08431639522314072,
-0.05208669602870941,
0.31831470131874084,
0.307117223739624,
0.1151728555560112,
0.42316141724586487,
0.5332171320915222,
-0.6732361316680908,
-0.1510435789823532,
-0.1913093626499176,
0.05102577432990074,
1.0046288967132568,
0.4328239858150482,
0.241861030459404,
-0.30550286173820496,
-0.4393661320209503,
0.2560734748840332,
0.6146834492683411,
-0.6716133952140808,
0.06227754056453705,
-0.42786380648612976,
0.6501736640930176,
-0.1611967235803604,
-0.4799189567565918,
0.47153520584106445,
-0.3292212188243866,
-0.5036630034446716,
-0.7300272583961487,
-0.48953142762184143,
0.5631706118583679,
0.033652015030384064,
-0.19853508472442627,
0.2707383334636688,
0.2718223035335541,
-0.704582154750824,
0.2935342490673065,
-0.6319326162338257,
0.795137882232666,
-0.27783286571502686,
0.45476672053337097,
0.11884478479623795,
-0.08086682111024857,
0.14848250150680542,
-0.2783575654029846,
0.3156268000602722,
0.2208896428346634,
-0.8576540946960449,
-0.45779988169670105,
0.576267659664154,
-0.33882859349250793,
0.4582091271877289,
0.14374928176403046,
-0.5229915380477905,
-0.9548128247261047,
-0.2135736048221588,
0.687238872051239,
0.2963079810142517,
-0.15792831778526306
] |
|
NCT06156384
|
Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail
|
This study is a prospective observational non-interventional multi-centre cohort study of patients, 12 years or older, initiating a lower limb lengthening procedure with FITBONE and who have a length discrepancy of 30mm or more between the limbs.
The following parameters will be assessed for up to 24 months.
* Pain using the Visual Analog Scale (VAS), Patient Global Assessment (PGA) and Clinical Observer Global Assessment (COGA)
* Patient satisfaction using the Patient Global Impression of change (PGI-C) scale
* QoL using the 36-Item Short Form Survey/Paediatric Quality of Life Inventory (SF-36/PedsQL)
|
The study period is 24 months post-surgery. Each patient's demographic data, medical history, any relevant concomitant medication, physical examination, range of motion data will be recorded using a standardized case record form after informed consent is provided and the healthcare provider completes a physical examination regarding the patient's conditions and record determination as to whether FITBONE is recommended. The decision to treat, observe, and to include in this observation study is at the discretion of the healthcare provider. This is an observational study and therefore, the participating healthcare provider will manage patients according to the usual clinical practice.
Surgery will be performed according to the standard surgical procedure described previously. Study of Investigational Product(s). Five to ten days after the lengthening nail placement, the lengthening mechanism is operated by transmitting energy necessary for the lengthening from the outside. This period is referred to as the distraction period. The rhythm of lengthening and strict protocol for an individual patient, indicating the daily lengths of lengthening to be applied, are decided by the healthcare provider taking into account all influencing factors. Therefore, the end of the distraction period, bone healing, implant removal, and 6 months post-implant removal may differ by individual. In the event the distraction period is extended by the healthcare provider, the new distraction period will determine the end of the distraction time point. All patients will be followed until the end of the scheduled study period regardless of any change in their treatment or other conditions.
Six visits are planned:
1. Surgery (baseline)
2. End of the distraction phase
3. End of bone healing
4. Implant removal
5. 6-month post-removal
6. 24-month post-surgery The satisfaction will be assessed at implant removal, 6 months post implant removal, and 24 months post-surgery.
The QoL will be assessed at baseline, at 6 months post implant removal, and 24 months post-surgery.
Pain will be assessed at all timepoints. Measurement of pain at the end of the distraction phase, the patient will be requested to report the pain experienced in the past week, at the moment, and during or immediately after the distraction period. At other time points, pain for only at the moment will be captured.
Range of motion (ROM) will be measured at the end of bone healing, and at the 24 months post-surgery.
Lengthening achieved will be measured at the end of bone healing. Any incidence of adverse events will be recorded at any point during the 24-month follow-up period.
|
Inclusion Criteria:
* Patients aged ≥12 years old, with congenital or acquired lower limb discrepancy greater than 30mm, undergoing femoral or tibia bone lengthening with FITBONE
* Patients with a regular indication for a surgical intervention with FITBONE according to manufacturer IFU
* The patient (or his/her legally acceptable representative) is capable of understanding the content of the Informed Consent Form (ICF)
* The informed consent form is correctly obtained
Exclusion Criteria:
* Patients with a medical condition that is contraindicated according to the FITBONE instruction for use.
* Patients with any conditions that, in the Investigator's opinion, may interfere with the study execution, including those likely to be lost to follow-up.
* Patients who have any conditions or medical condition that, in the investigator's opinion, may interfere with the study's execution or in which the patient should not participate for safety reasons.
* Patients requiring the application of or have already in-situ concomitant devices that cannot be safely removed (except for permitted concomitant devices).
* Patients participating in other clinical or have taken part in any clinical study in the last 3 months.
|
[
0.7278321981430054,
3.1161818504333496,
-2.8527817726135254,
-1.902114987373352,
-0.38214823603630066,
0.05052540451288223,
0.916492223739624,
-0.518222451210022,
-0.34497225284576416,
-0.43251708149909973,
0.3120449483394623,
0.5348168015480042,
0.04636799171566963,
0.2784962058067322,
-0.34372174739837646,
1.0914602279663086,
-0.08213889598846436,
-0.329213410615921,
-0.5051787495613098,
-0.505594789981842,
0.14943960309028625,
0.27196019887924194,
0.12493192404508591,
-0.6584224104881287,
0.26394709944725037,
0.3054676949977875,
-0.5147854685783386,
1.402585744857788,
-0.10519099980592728,
1.2250174283981323,
0.9921361207962036,
-0.3992108106613159,
0.5092389583587646,
1.379123330116272,
0.01476161926984787,
-0.29350218176841736,
0.5300995111465454,
-0.33243656158447266,
-0.3909187614917755,
0.5062615871429443,
0.7913006544113159,
0.527683675289154,
-0.3831675052642822,
-0.8812659382820129,
1.1922880411148071,
0.22283484041690826,
-0.7288627624511719,
0.04364238306879997,
-0.24114185571670532,
-0.6231496930122375,
0.19608837366104126,
-0.12549051642417908,
-1.6364585161209106,
0.053983934223651886,
0.7387192845344543,
0.6471130847930908,
0.6535537242889404,
0.6669089198112488,
0.900836706161499,
0.5855550169944763,
-0.37863487005233765,
0.7617908716201782,
0.49878543615341187,
0.06483004242181778,
0.34886497259140015,
0.0510425940155983,
-1.122104287147522,
0.6257155537605286,
-0.6266809105873108,
0.24450673162937164,
0.4192602038383484,
0.12582798302173615,
1.1708931922912598,
-0.22391152381896973,
-0.19322028756141663,
0.07028648257255554,
-0.4320789575576782,
0.9154221415519714,
0.052275240421295166,
0.9195756912231445,
0.18250857293605804,
0.034175384789705276,
-0.2495698183774948,
0.4724383056163788,
0.5119112133979797,
0.10431422293186188,
-1.243858814239502,
0.4616161286830902,
-0.10226291418075562,
-0.6484094858169556,
0.8066969513893127,
-0.7519994378089905,
-1.0950160026550293,
0.08039837330579758,
-1.3452402353286743,
0.7217716574668884,
-0.14449232816696167,
-0.4041413366794586,
-1.2891020774841309,
0.0067067532800138,
-0.5740208625793457,
-1.1645324230194092,
1.700084924697876,
0.06647956371307373,
-0.832552969455719,
0.08107107877731323,
-0.44519415497779846,
-0.018781505525112152,
-0.6254855990409851,
-0.5364692807197571,
0.47598448395729065,
-0.976744532585144,
-0.06443110853433609,
-0.4384923577308655,
-0.31545814871788025,
0.14786390960216522,
-0.014519298449158669,
-0.21685779094696045,
0.23624706268310547,
-0.8224528431892395,
-0.399168998003006,
0.37056881189346313,
0.10773948580026627,
0.0390281155705452,
-0.08370555937290192,
-0.18902544677257538,
0.30237922072410583,
0.45219945907592773,
0.1132153645157814,
-0.6524338126182556,
-1.3990707397460938,
-0.1522037386894226,
0.40585386753082275,
0.04327155649662018,
0.17216302454471588,
0.062418341636657715,
0.00961584784090519,
0.3164544403553009,
-0.1335725337266922,
-0.30339139699935913,
0.09416355192661285,
-0.10885842889547348,
-0.3247276842594147,
0.38501712679862976,
-0.42337602376937866,
-0.028952598571777344,
-0.5215745568275452,
0.27751967310905457,
-0.7183066010475159,
-0.4969753623008728,
-0.34533634781837463,
0.07089311629533768,
0.0961240828037262,
0.8005728721618652,
0.32948657870292664,
0.19368459284305573,
0.42783206701278687,
0.1563957929611206,
0.2931596338748932,
-0.573766827583313,
0.2774237394332886,
-1.0924686193466187,
-0.15124379098415375,
-0.2613198757171631,
0.7250739336013794,
0.1799239218235016,
-0.1652849018573761,
-0.34432756900787354,
0.5618568658828735,
0.6001169085502625,
-0.6348744630813599,
0.22881828248500824,
0.5443200469017029,
0.3441506624221802,
-0.09761067479848862,
-0.016518425196409225,
0.37227779626846313,
0.018796447664499283,
0.22239457070827484,
0.047322895377874374,
-0.06041322275996208,
-0.5045148134231567,
0.4115624725818634,
-0.07499700784683228,
-0.19804255664348602,
-0.3396304249763489,
0.005188062321394682,
-0.6694700121879578,
-0.48453399538993835,
0.6110678315162659,
0.5634062886238098,
-0.09838343411684036,
-0.04334452375769615,
0.14940010011196136,
0.4871057868003845,
0.04601871967315674,
-0.5875940918922424,
-0.21959643065929413,
0.1921635866165161,
-0.10339510440826416,
0.34182897210121155,
0.27664390206336975,
-0.16565345227718353,
0.8472989797592163,
0.06534901261329651,
0.09484776854515076,
-0.4445780813694,
-0.30969637632369995,
0.09806008636951447,
-0.2305407077074051,
0.5501760840415955,
0.16990341246128082,
-0.4111226797103882,
0.08452571928501129,
0.0016227086307480931,
0.019955312833189964,
0.07970727235078812,
-0.05902305617928505,
-0.12799327075481415,
-0.34892651438713074,
-0.4112563729286194,
-0.3382663130760193,
-0.06348123401403427,
-0.03799712285399437,
0.13754962384700775,
-0.2840031087398529,
-0.5419356822967529,
0.3919779658317566,
-0.09926450997591019,
-0.1731053739786148,
-0.25390076637268066,
-0.07991443574428558,
0.3965599536895752,
0.07316014915704727,
0.030433181673288345,
0.10232873260974884,
0.06793106347322464,
0.02560468576848507,
-0.020257309079170227,
0.5331108570098877,
0.01240371074527502,
-0.21782313287258148,
0.20399215817451477,
-0.13086313009262085,
-0.029288198798894882,
0.5294421315193176,
-0.3490614593029022,
0.005130907520651817,
-0.4058198034763336,
0.15244294703006744,
-0.050098344683647156,
-0.23076964914798737,
-0.22024942934513092,
0.30331769585609436,
0.09778382629156113,
-0.2951503098011017
] |
NCT01783678
|
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults
|
This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.
|
Inclusion Criteria:
* Age ≥ 18 years with HIV-1 and chronic HCV genotype 1, 2, 3, or 4 co-infection
* HCV RNA \> 10,000 IU/mL at screening
* HCV treatment history:
* Treatment-naive for HCV genotypes 1, 2, 3, or 4, or
* Treatment-experienced for HCV genotypes 2 or 3
* HIV antiretroviral (ARV) criteria:
* On a stable, protocol-approved, HIV ARV regimen with undetectable HIV RNA for \> 8 weeks prior to screening, or
* ARV untreated for ≥ 8 weeks prior to screening, with a CD4 T-cell count \> 500 cells/mm\^3
* Presence or absence of cirrhosis; a liver biopsy may be required
* Healthy according to medical history and physical examination with the exception of HCV and HIV diagnosis
* Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
Exclusion Criteria:
* HCV genotype 1 or 4 with previous HCV treatment
* Poor control with HIV ARV regimen requiring a possible dose modification of therapy within 4 weeks of study medication dosing
* A new AIDS-defining condition diagnosed within 30 days prior to screening
* Prior use of any other inhibitor of the HCV NS5B polymerase
* History of any other clinically significant chronic liver disease
* Evidence of or history of decompensated liver disease
* Chronic hepatitis B virus (HBV) infection
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of immunosuppressive agents or immunomodulatory agents
* Clinically relevant drug or alcohol abuse within 12 months of screening
* History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study or not be in the best interest of the participant in the opinion of the investigator
|
[
0.7312454581260681,
0.2275482416152954,
-1.3841747045516968,
-1.1201891899108887,
-0.5210363268852234,
0.33222493529319763,
-1.0693731307983398,
-1.248496174812317,
0.21888431906700134,
-0.16797101497650146,
-0.6927186846733093,
1.4469850063323975,
-0.2735650837421417,
1.437127709388733,
-0.45038270950317383,
-0.119047150015831,
-1.0775172710418701,
-1.3545643091201782,
0.6808723211288452,
-0.1958736926317215,
-0.7449983358383179,
0.45882198214530945,
-0.9853485822677612,
0.4154522716999054,
1.099843978881836,
-0.18759490549564362,
-1.1982486248016357,
0.09563658386468887,
-2.099729537963867,
0.3485042154788971,
0.6361289024353027,
-1.1521369218826294,
0.2549112141132355,
0.34351783990859985,
-0.6010233163833618,
-0.04624298959970474,
1.3096708059310913,
1.7546318769454956,
-0.48059988021850586,
0.7882970571517944,
0.043016813695430756,
0.4627830982208252,
-0.5492303371429443,
-1.8302479982376099,
0.2476014643907547,
-0.04899080842733383,
0.36755725741386414,
-0.2929672300815582,
0.25525954365730286,
0.8779818415641785,
-1.1488258838653564,
1.346502661705017,
-0.7943354249000549,
1.635666012763977,
2.679562568664551,
0.5004770159721375,
-0.3463933765888214,
2.5580074787139893,
1.1966739892959595,
-0.3171052634716034,
0.9683117270469666,
-1.229387640953064,
-0.08326084166765213,
-0.7624346613883972,
-1.2957361936569214,
0.4481951594352722,
-0.7601461410522461,
-0.29657575488090515,
-0.8172619342803955,
0.24533620476722717,
-1.552347183227539,
0.32482966780662537,
0.5118739604949951,
0.03303743526339531,
-0.9062738418579102,
1.2879924774169922,
-1.5934215784072876,
0.853839099407196,
0.06043816730380058,
0.672488272190094,
-1.1265753507614136,
-0.4894133508205414,
-0.23039348423480988,
0.13572010397911072,
0.25134190917015076,
-0.6121534109115601,
-0.9570707082748413,
-0.21091940999031067,
-0.4581759572029114,
-1.3596731424331665,
0.7933183908462524,
-1.383023977279663,
0.3602661192417145,
-0.17094282805919647,
-0.3759947717189789,
0.9254595041275024,
-0.48089393973350525,
-0.18903464078903198,
-1.0910109281539917,
-0.733153760433197,
-0.07837692648172379,
-1.2940961122512817,
0.2216322124004364,
-1.8323681354522705,
-0.9668529629707336,
-0.40184879302978516,
0.1925176978111267,
0.03502405434846878,
-1.444684624671936,
-0.020079534500837326,
-0.18901774287223816,
-0.5485128164291382,
-0.4878595173358917,
-0.25674140453338623,
0.49082472920417786,
-1.7612606287002563,
0.4325289726257324,
-0.060895778238773346,
0.29920145869255066,
-0.6771118640899658,
-0.2871290147304535,
0.5783863663673401,
-0.08212006092071533,
-0.17031744122505188,
-0.13395752012729645,
-0.7939713597297668,
0.286709725856781,
0.5632636547088623,
0.4241163432598114,
0.21323193609714508,
0.10340484231710434,
-0.6981192231178284,
0.8374835252761841,
0.18217186629772186,
-0.6697888970375061,
-0.2817375063896179,
0.620231032371521,
0.1533263623714447,
0.007385457865893841,
-0.4747387170791626,
0.7476080656051636,
-0.3377726674079895,
0.6208806037902832,
-0.5100525617599487,
-2.417680501937866,
1.0996383428573608,
-0.12042941153049469,
0.04069065675139427,
0.16033124923706055,
-0.5925441384315491,
-0.5778852105140686,
0.15618224442005157,
-0.46866390109062195,
0.02969476580619812,
-0.16026248037815094,
0.47267675399780273,
-0.39110085368156433,
-0.07932855933904648,
0.1396082043647766,
0.6194630861282349,
0.014742862433195114,
0.6709227561950684,
0.501003086566925,
0.10348665714263916,
0.8171170353889465,
-0.20554432272911072,
0.21435515582561493,
-0.48263633251190186,
0.3937431275844574,
0.20133566856384277,
0.19361357390880585,
-0.2782573103904724,
0.7677708268165588,
-0.805629551410675,
-0.11455056816339493,
-0.32647210359573364,
0.254635214805603,
1.044737696647644,
0.13012346625328064,
-0.6543393135070801,
0.23734569549560547,
0.1625511646270752,
-0.4618739187717438,
0.40766388177871704,
0.4454255998134613,
0.39947310090065,
0.3777911067008972,
0.4338057339191437,
-0.6084836721420288,
-0.3032998740673065,
-0.2872781753540039,
0.6727902889251709,
-0.07070093601942062,
0.21870259940624237,
0.4738726317882538,
0.6965204477310181,
-0.23320087790489197,
0.5255753397941589,
-0.12265884876251221,
-0.6186409592628479,
0.6003953814506531,
0.14823603630065918,
0.805668830871582,
1.0286710262298584,
-0.10530286282300949,
0.38081949949264526,
-0.24619631469249725,
0.6880137324333191,
0.05259985476732254,
-0.1316251903772354,
-0.17979659140110016,
-0.0219728983938694,
-0.17861436307430267,
0.08259688317775726,
0.23319053649902344,
0.17604012787342072,
0.1425306648015976,
-0.19241943955421448,
-0.40982785820961,
-0.19612771272659302,
0.22768966853618622,
0.06181168556213379,
-0.03271179646253586,
-0.10588490962982178,
0.17444172501564026,
-0.5263863205909729,
0.29904690384864807,
0.15432968735694885,
0.15728706121444702,
-0.4524230360984802,
-0.018013345077633858,
0.514975368976593,
-0.28702762722969055,
0.031063595786690712,
-0.08599452674388885,
0.04195113480091095,
0.03311231732368469,
0.1345837116241455,
-0.1896325647830963,
0.5428503155708313,
0.8595946431159973,
0.06316502392292023,
-0.5759784579277039,
-0.529015064239502,
0.35837870836257935,
-0.4877007007598877,
0.5127946138381958,
0.4496784806251526,
0.06396572291851044,
-0.1795966923236847,
-0.26034265756607056,
0.24570779502391815,
0.02048778161406517,
0.03204215690493584,
-0.18436425924301147,
-0.5923568606376648
] |
|
NCT06364527
|
Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma
|
The United Kingdom has a high prevalence of asthma (over 12%) and some of the worst health outcomes in Europe. The management of respiratory disease and associated patient outcomes has long been an area of focus and improvement for the National Health Service. With the advancement of digital health technology, there is the potential to transform patient care and improve outcomes.
The Aptar Digital Health respiratory disease management platform, a digital therapeutic will be utilized to determine its value and how it supports: i) asthma patient engagement and facilitates communication between patients and providers to accelerate medication adherence; ii) asthma control through the use of the Asthma Control Questionnaire-5. In addition, spirometry and fractioned exhaled nitric oxide will be utilized during the study to validate and enhance current National Institute for Health and Care Excellence guidelines.
|
This is an open-label, single comparative study that will accrue a total of 118 participants and compare pre and post study results. Group # 1 will consist of 59 participants with a fractioned exhaled nitric oxide ≥ 45 ppb and ≥ 3 exacerbations / year (biologic eligible). Group # 2 will consist of 59 participants with a fractioned exhaled nitric oxide ≥ 45 ppb and \< 3 exacerbations / year (non-biologic eligible). At the baseline visit, clinic appointment # 1, health care providers will review the participants' medical records to determine clinical outcomes in the past year, including number of exacerbations, medication pharmacy refill percentage, and fractioned exhaled nitric oxide score. At the baseline visit, participants will also complete the Asthma Control Questionnaire-5 and the Mini-Asthma Quality of Life Questionnaire. The past year clinical evaluation and Asthma Control Questionnaire-5 and Mini-Asthma Quality of Life Questionnaire will be considered baseline results.
Patients will be screened for study appropriateness at the Guy's Hospital Severe Asthma Clinic. During the initial visit, which will be considered the study baseline visit, patients will be provided with the Aptar Digital Health respiratory disease management platform and trained to use the platform. Participants will be scheduled for in person follow-up visits at 1-2 months and then 6-months post-baseline; patients will be scheduled for virtual visits at 3-months post-baseline.
Patients will then be trained by Guy's Hospital team members; Aptar Digital Health staff will provide extensive training to the Guy's Hospital team prior to the study to ensure the team is fully knowledgeable about the product, its features, and can successfully onboard participants onto the Aptar Digital Health respiratory disease management platform. Once participants are trained, they will utilize the BreatheSmart mobile application by downloading it through either the Apple Store™ or Google Play™.
The BreatheSmart mobile application records, stores, and transmits usage events to the HeroTracker sensors, or via manual user entry, to a remote storage system. Participants may self-enter their medication schedule either with or without the help of their health care providers. Through the BreatheSmart mobile application, they can review information collected from the HeroTracker Sense metered dose inhaler and FindAir ONE dry powder inhaler sensors, report and review their adherence and self-reported symptoms, and answer validated questionnaires.
Participants can share the data entered through the BreatheSmart mobile application with caregivers and health care providers. Health care providers are then able to utilize BreatheSmart Connect, a web application, to obtain an overview of all participants utilizing the Aptar Digital Health respiratory disease management platform including detailed views of individual participant information. Health care providers can view real-time adherence, medication list, participants within and outside of risk zones (depending on adherence), rescue medication usage, symptoms, and triggers. Based on the information gleaned from the BreatheSmart Connect platform, clinicians will schedule follow-up participant appointments with either a junior or senior pharmacist at the Guy's Hospital Severe Asthma Clinic.
Participants will use the Aptar Digital Health respiratory disease management platform for 6 months and will be required to return the device upon study completion.
|
Inclusion Criteria:
* Age ≥ 16 years
* Utilization of asthma controller therapy: inhaled corticosteroids (ICS), long-acting β2-agonists (LABAs) and/or fixed combination therapies of LABA and ICS (medium to high-dose ICS/LABA therapy)
* Use of metered dose inhaler (MDI) and / or dry powder dose inhaler (DPI) list of compatible medications is noted in section 9.2.
* FeNO ≥ 45 ppb
* Primary respiratory diagnosis of asthma
* Patients with uncontrolled, moderate-to-severe asthma
* Non-smoker
* Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in consent form and protocol.
* Subject understands and is willing, able, and likely to comply with study procedures and restrictions
* Willingness to participate in this study and to use the Aptar Digital Health technology
* Willingness to share information / data with Aptar Digital Health (through informed consent)
Access to technology
* Access to a smartphone (requirements Android ≥13 and iOS ≥16
* Ability to use smartphone (smartphone usability assessment to be provided by Aptar Digital Health)
* Access to a current email account
* Access to data / Wi-Fi
Exclusion Criteria:
* Age \< 16 years
* FeNO \< 45 ppb
* Known or suspected alcohol or drug abuse which in opinion of investigator could interfere with subject's proper completion of the protocol requirement
* History of life-threatening asthma: Defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within last 6 months
* A lower respiratory tract infection within 7 days of the screening visit
* Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other respiratory disorders including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
* History of hypersensitivity/intolerance to any components of the study inhalers (example, lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation will also be excluded.
* Ever received treatment with biological based therapy example, omalizumab, mepolizumab, for asthma.
* Received an investigational drug and/or medical device within 30 days of entry into this study (Screening), or within five drug half-lives of the investigational drug, whichever is longer
* An immediate family member of the participating investigator, sub-investigator, study coordinator, employee of the participating investigator, or any family member of a Aptar Pharma, Aptar Digital Health, Voluntis, or Cohero employee.
|
[
0.32555487751960754,
4.297457695007324,
-2.0653958320617676,
-2.518500804901123,
0.4748566746711731,
0.5620562434196472,
-0.0781356543302536,
0.9328708648681641,
-0.6239067316055298,
0.30762141942977905,
0.5842143297195435,
2.3067586421966553,
-1.3384853601455688,
0.2098756730556488,
-0.8227249383926392,
0.8636101484298706,
0.6756517887115479,
0.8610250353813171,
1.363715410232544,
-1.0210731029510498,
0.9246433973312378,
-0.9431748390197754,
1.1024998426437378,
-0.07637571543455124,
1.1403437852859497,
0.658867359161377,
-0.17774155735969543,
1.4242727756500244,
0.06656242907047272,
0.6274408102035522,
0.12579980492591858,
-1.1196484565734863,
0.11254160106182098,
0.7244144678115845,
-0.18179652094841003,
0.43036141991615295,
1.1648868322372437,
0.5131664276123047,
-1.1810959577560425,
0.2974770963191986,
1.003873348236084,
0.6710980534553528,
-0.07653207331895828,
-1.1274794340133667,
1.1951993703842163,
-0.04953097552061081,
-0.45595136284828186,
0.06453995406627655,
-0.05945096164941788,
0.15068252384662628,
0.2830527424812317,
1.4747827053070068,
-0.6727391481399536,
-0.06775323301553726,
2.8061749935150146,
-0.5621715784072876,
0.5554567575454712,
0.5960713028907776,
1.0507344007492065,
0.7957233190536499,
-0.42790111899375916,
0.3778518736362457,
0.04370427504181862,
1.381291151046753,
-1.2990915775299072,
-0.19468100368976593,
0.1970282942056656,
1.2005715370178223,
-0.18673475086688995,
0.5416246652603149,
-0.6386324167251587,
-0.6076668500900269,
0.07641421258449554,
-0.16126395761966705,
0.3724319636821747,
0.5708038210868835,
-0.8748833537101746,
0.8843404054641724,
0.5054888725280762,
0.14011751115322113,
-0.3710392117500305,
-0.07459043711423874,
-0.9820985794067383,
-0.7337392568588257,
0.3900042176246643,
-0.1716463565826416,
-1.5503058433532715,
-0.0564606711268425,
0.2726175785064697,
-1.519751787185669,
0.4510294497013092,
-1.1562299728393555,
0.41367077827453613,
0.6228240728378296,
-0.8560749888420105,
0.37549740076065063,
0.3145524561405182,
-0.2953951954841614,
-1.843801736831665,
-0.819083034992218,
-0.04955026134848595,
-0.7717553973197937,
0.27706652879714966,
-0.038371555507183075,
-0.5208104252815247,
0.5197774171829224,
-0.0785830169916153,
-0.07373140007257462,
-0.4334378242492676,
-0.16723251342773438,
0.42161688208580017,
-1.1617234945297241,
0.9010473489761353,
0.3454524874687195,
0.7215096354484558,
-0.059180110692977905,
0.7365344762802124,
0.33638983964920044,
0.11714176088571548,
0.4294564127922058,
0.5604912042617798,
0.4351941645145416,
0.11609729379415512,
0.22382643818855286,
-0.4356585443019867,
-0.9245408177375793,
-0.662835955619812,
0.2290128916501999,
-0.5894571542739868,
-0.46349406242370605,
-0.26948145031929016,
0.19896364212036133,
0.4059616029262543,
0.13695982098579407,
-0.6374667882919312,
0.1266818642616272,
0.33207541704177856,
1.1334173679351807,
0.3789528012275696,
-0.2521466612815857,
-0.15543845295906067,
0.35488346219062805,
0.17122434079647064,
0.0903981626033783,
-0.09058014303445816,
-0.3942505717277527,
-0.25309687852859497,
-0.10905654728412628,
-1.0536476373672485,
-0.9039323925971985,
-0.20012176036834717,
0.7425573468208313,
-0.20481941103935242,
0.5599950551986694,
-0.17125645279884338,
0.4279358983039856,
0.8110113143920898,
-0.7432506084442139,
0.09536770731210709,
0.09604103118181229,
0.5710656642913818,
-0.0003452827804721892,
-0.5080721974372864,
-1.0082800388336182,
0.0665249451994896,
-0.4469662606716156,
0.809216320514679,
-0.040598176419734955,
0.03318992629647255,
0.09314510971307755,
0.22341695427894592,
0.059292037039995193,
-0.7788760662078857,
-0.4787403643131256,
-0.30920442938804626,
-0.28340569138526917,
0.5733143091201782,
0.012334673665463924,
0.4164143204689026,
-0.13098669052124023,
0.39189988374710083,
0.4477468430995941,
0.17289479076862335,
-0.034050993621349335,
-0.15637829899787903,
-0.23531877994537354,
-0.24291157722473145,
-0.5189104080200195,
-0.23552148044109344,
0.1443561166524887,
-0.20674355328083038,
-0.6808063387870789,
-0.11998270452022552,
0.9124666452407837,
0.3454095125198364,
-0.011813635006546974,
-0.8190226554870605,
-0.6965746283531189,
0.451968252658844,
0.37891730666160583,
0.4813958704471588,
-0.021843936294317245,
0.0925283282995224,
0.3692423701286316,
0.4162198603153229,
0.14461952447891235,
0.07618052512407303,
-0.4734732508659363,
-0.09038852900266647,
0.3759029805660248,
0.2583542466163635,
0.1827017217874527,
-0.15915639698505402,
-0.7932065725326538,
-0.17945486307144165,
0.013264241628348827,
0.06884260475635529,
0.26543793082237244,
-0.12282045185565948,
-0.23337146639823914,
-0.28663119673728943,
0.10729236900806427,
0.11108453571796417,
0.3996675908565521,
-0.4702073633670807,
0.11135423183441162,
0.1824062168598175,
0.3983007073402405,
0.5356454253196716,
-0.17530491948127747,
0.09284590184688568,
0.5330484509468079,
0.37734267115592957,
-0.1466679871082306,
-0.02181542105972767,
-0.05844505503773689,
0.26753807067871094,
0.343284010887146,
0.015467748045921326,
0.4592699408531189,
0.10027517378330231,
0.01783551461994648,
0.07702828198671341,
-0.22849062085151672,
-0.20036041736602783,
0.20121335983276367,
-0.3078400194644928,
-0.2295607030391693,
-0.1792634278535843,
-0.07180243730545044,
-0.4054466784000397,
-0.6688944101333618,
-0.26514068245887756,
0.020289303734898567,
-0.21400757133960724,
-0.5155876874923706
] |
NCT04543565
|
Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Phase3 Study
|
This is a phase three study to evaluate the safety and efficacy of Pradefovir treatment in chronic hepatitis B patients. Subject will be randomized to Pradefovir group and TDF group at a ratio of 2:1. Treatment duration will be 96w in randomization and followed by 48w in open. The interim analysis will be conducted when all subject completed the first 48-week treatment.
|
this is a randomized, double-blind, positive drug parallel control, multicenter, phase 3 study .Eligible HBeAg-positive or HBeAg-negative chronic hepatitis B patients will be stratified by historical antiviral treatment (untreated or treated) at the time of screening, and then randomly assigned to Pradefovir mesylate tablet group or tenofovir disoproxil fumarate tablet group at a ratio of 2:1. The proportion of subject with compensatory stage of cirrhosis is no more than 20 percentage. Patients will receive a total of 144 weeks of antiviral treatments, and after 96 weeks of double-blind treatment, all subjects will switch to open mesylate Pradefovir tablets for additional 48 weeks. The first 48 weeks are the core period and the followed 96 weeks are the extension period. Statistical analysis was conducted on the efficacy and safety of the whole trial. (After the completion of 48-week visit of the last one subject, the interim analysis will be conducted. The analysts will be unblinded, while the remaining participants will still be blind.
|
Inclusion Criteria:
* Age from 18 to 65 years old, male or female.
* Meets the diagnosis and treatment standards of chronic hepatitis B( HBsAg or HBV DNA positive over 6 months, or diagnosed by liver biopsy.
* For HBeAg positive, HBV DNA equal or over 20000 IU/ml; for HBeAg negative ,HBV DNA equal or over 2000 IU/ml.
* ALT level between 1.2 ULN to 10 UNL.
* Treatment naive or experienced when any nucleos(t)ide analogs or interferons stopped over 6 months.
* Use of effective contraceptive measures if procreative potential exists.
* Written informed consent.
Exclusion Criteria:
* Allergic to study drug,metabolite product or excipient.
* Evidence of hepatic decompensation such as Child-Pugh B or C, with previous gastroesophageal variceal haemorrhage, hepatic encephalopathy, ascites
* Suspected or confirmed hepatocellular carcinoma, or AFP\>50μg/L.
* Other liver diseases (such as Chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease).
* Resistant to antiviral drugs (adefovir or tenofovir).
* Concommitant disease of severe heart, blood, respiratory and central nervous system diseases.
* Chronic kidney diseases, or Ccr\<60ml/min at screening.
* Abnormal hematological and biochemical parameters at screening: White blood cell count less than 3.0×109/L，or neutrophil count less than 1.5×109/L，or platelet count less than 80×109/L，or total bilirubin more than 2ULN，or the prolong of PT more than 3s.
* Positive-HCV or positive-HIV.
* Severe bone disease (such as osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, rickets) or multiple fractures.
* History of pancreatitis or malignancy within 5 years (excluding cervical epithelial carcinoma, squamous epithelial carcinoma, or basal cell carcinoma of the skin that was clinically cured within 5 years of diagnosis).
* Plan to receive or have already had an organ transplant.
* Subject with disabilities as prescribed by law (blindness, deafness, deafness, deafness, mental disorders, etc.).
* History of alcohol or drug abuse within the last 1 year.
* Pregnant or lactating women.
* Participated in any clinical trial or taken any IMP (investigational medical product) within 3 months prior to the trial.
* Other cases that could not be enrolled in the judgement of the investigators.
|
[
0.028687085956335068,
3.6445281505584717,
-1.056077003479004,
-1.8269386291503906,
0.4014532268047333,
1.220598816871643,
0.09354218095541,
0.43867453932762146,
-1.5110987424850464,
-0.6119159460067749,
-0.5699805021286011,
1.3112448453903198,
-1.1351759433746338,
1.5814459323883057,
-0.5598952174186707,
0.04140948876738548,
-1.1770908832550049,
0.9840308427810669,
1.8916664123535156,
-1.5740691423416138,
0.11004573106765747,
0.35245832800865173,
-0.47096073627471924,
1.2206307649612427,
-0.4773605167865753,
-0.3821602761745453,
-1.9977635145187378,
0.784940242767334,
-0.7001628279685974,
1.6128274202346802,
0.27795934677124023,
-0.07625347375869751,
0.6622934937477112,
0.8612740635871887,
1.3955121040344238,
-0.27510130405426025,
1.2667086124420166,
0.6859933137893677,
-0.5650671720504761,
0.5643582940101624,
-0.28331291675567627,
0.8496972322463989,
-0.24034497141838074,
-0.5688271522521973,
2.1762137413024902,
0.7781162261962891,
-0.34006068110466003,
0.4544616639614105,
-0.3460225760936737,
1.2409980297088623,
-0.2881026268005371,
1.586071252822876,
-1.588866114616394,
-0.41575121879577637,
1.4605315923690796,
-0.0035521259997040033,
-0.3768317997455597,
0.46314889192581177,
0.9674764275550842,
-0.1896638572216034,
0.10116898268461227,
-0.6203756332397461,
-0.03908134251832962,
-0.18063385784626007,
-0.510662317276001,
0.1048717126250267,
0.33848172426223755,
0.35655269026756287,
-0.7620038986206055,
0.6942453980445862,
-0.20665346086025238,
0.3542841672897339,
1.2529985904693604,
-0.06393271684646606,
0.5633183717727661,
0.5068525075912476,
-1.0366255044937134,
0.04227060079574585,
0.15602093935012817,
0.01675296761095524,
-0.3810502886772156,
-0.17428629100322723,
0.4115179479122162,
-0.9682196378707886,
-0.5098752379417419,
-0.8187826871871948,
-0.14155299961566925,
-0.3084421157836914,
0.2564440071582794,
-0.5855870842933655,
0.8487990498542786,
0.1031111478805542,
-0.8461064696311951,
-0.47433316707611084,
-0.26384517550468445,
-0.3210420608520508,
-0.13974885642528534,
0.018347272649407387,
-0.2262437790632248,
0.4525226652622223,
-0.07704433053731918,
0.0801040455698967,
-0.007296497467905283,
-0.1966978907585144,
-1.3663443326950073,
-0.4256259799003601,
0.18784335255622864,
-0.49853116273880005,
-0.1000504419207573,
-0.7096425294876099,
-0.2383539229631424,
0.07544080168008804,
-0.13885100185871124,
-0.6419005990028381,
0.7201327085494995,
-0.0713508129119873,
0.44552507996559143,
0.03373691067099571,
0.3071950376033783,
-0.5187784433364868,
0.6385163068771362,
-0.3159634470939636,
0.9908064603805542,
-0.47717761993408203,
-1.1284770965576172,
0.22680680453777313,
0.515169084072113,
0.44434234499931335,
-0.23353885114192963,
-0.6146296858787537,
-0.6411466002464294,
-0.22889426350593567,
-0.30505669116973877,
-0.09533946216106415,
-1.3949371576309204,
-1.5540342330932617,
-0.38706716895103455,
1.2261933088302612,
0.27705660462379456,
-0.9239610433578491,
-0.5212233662605286,
-0.2162708044052124,
0.22827358543872833,
0.05056088790297508,
-0.9891381859779358,
-0.4331536591053009,
-0.2847217917442322,
-0.3672289550304413,
-0.3228929936885834,
-0.33307957649230957,
0.16571193933486938,
0.20157204568386078,
-0.35600823163986206,
0.3841698169708252,
0.2868548631668091,
0.3701220750808716,
0.3642997741699219,
-0.097199946641922,
0.6389334797859192,
-0.977242648601532,
-0.026176730170845985,
-0.43506312370300293,
0.33770644664764404,
-0.9519039392471313,
0.5011667013168335,
0.3237272799015045,
-0.709182858467102,
-0.12295609712600708,
0.5047889351844788,
0.14959242939949036,
-0.4570402503013611,
0.47858673334121704,
0.7835137844085693,
0.25742894411087036,
-0.4929160475730896,
-0.03835421800613403,
1.1572015285491943,
0.43864285945892334,
0.4594385027885437,
-0.2339017391204834,
-0.10972876846790314,
-0.2004248946905136,
-0.7756692171096802,
0.09747368097305298,
-0.07112055271863937,
-0.9289586544036865,
-0.15590651333332062,
0.015063569881021976,
0.1609528362751007,
0.2313804179430008,
1.0366244316101074,
0.01051330752670765,
0.35585498809814453,
0.2586240768432617,
0.333116352558136,
-0.5216593146324158,
0.12985661625862122,
-0.37482208013534546,
0.6903643608093262,
-0.2645131051540375,
0.061700932681560516,
0.3010357618331909,
0.19800348579883575,
0.7912384867668152,
0.10681633651256561,
-0.05511856824159622,
-0.39280325174331665,
0.41908273100852966,
-0.2420174926519394,
0.5316881537437439,
0.07837533205747604,
0.23921260237693787,
-0.39122137427330017,
-0.08421577513217926,
-0.28049811720848083,
-0.014583859592676163,
0.20555326342582703,
0.7022585272789001,
0.04138471931219101,
-0.06477858126163483,
0.04301309213042259,
-0.256061315536499,
0.06401904672384262,
0.5136489868164062,
0.030538061633706093,
-0.17366379499435425,
-0.10894075036048889,
-0.07213522493839264,
-0.16591498255729675,
0.42161399126052856,
-0.1354023814201355,
0.28277522325515747,
-0.062073756009340286,
0.12770144641399384,
-0.06074639409780502,
0.28354203701019287,
0.21023587882518768,
-0.012914285063743591,
-0.3679765462875366,
0.5545204281806946,
0.5927017331123352,
-0.8823513388633728,
-0.3625018000602722,
-0.645104169845581,
0.05193955823779106,
-0.8305211663246155,
-0.07592650502920151,
0.8549984693527222,
0.03021751530468464,
-0.0761716291308403,
-0.32475635409355164,
-0.3161441385746002,
-0.1091560646891594,
-0.05615701898932457,
0.011418752372264862,
-0.48182159662246704
] |
NCT04607512
|
Study to Evaluate the ECG Effects of Telaglenastat in Healthy Adult Subjects
|
This study is designed to evaluate the effects of telaglenastat on cardiac repolarization (relative to placebo) in healthy adult subjects.
|
This is a multiple-dose, randomized, double-blind (with respect to telaglenastat and placebo), placebo- and positive controlled, 3 way crossover thorough QT (TQT) study in healthy adult subjects.
On Day 1 of Period 1, subjects will be randomized to 1 of 6 treatment sequences.
In Treatments A and B, subjects will receive the assigned treatment on Day 1 through the morning of Day 4. In Treatment C, subjects will receive a single-dose administration of moxifloxacin in the morning of Day 4. Cardiodynamic readings will be collected for 24 hours on Days 1 and 4. Plasma PK samples will be collected prior to dosing (for Treatments A and B or Hour 0 for Treatment C) and up to 24 hours on Days 1 and 4 of all treatments.
|
Inclusion Criteria:
1. Healthy, adult, male or female (of non childbearing potential only), 18-45 years of age, inclusive, at the screening visit.
2. Continuous non smoker who has not used nicotine containing products (chewed or smoked) or replacement products, including electronic cigarettes, for at least 3 months prior to the first dosing and throughout the study, and have a negative cotinine test result at the screening and check-in visits.
3. Body mass index (BMI) ≥ 18 and ≤ 28.0 kg/m2 at the screening visit.
4. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
5. A female of non childbearing potential has undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
* hysteroscopic sterilization;
* bilateral salpingectomy;
* hysterectomy;
* bilateral oophorectomy. or be postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status.
6. A non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after the last dosing. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to the first dosing. A male who has been vasectomized less than 4 months prior to study first dosing must follow the same restrictions as a non vasectomized male).
7. If male, must agree not to donate sperm from the first dosing until 90 days after the last dosing.
8. Able and willing to swallow whole tablets without breaking, cutting or chewing.
9. Understands the study procedures in the informed consent form (ICF) and is willing and able to comply with the protocol.
Exclusion Criteria:
1. History or presence of diseases which, as judged by the investigator, may affect the outcome of this study, including but not limited to significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.
2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
3. History of hospitalization for a major illness or procedure in the last 3 months. Subjects with preplanned and elective surgery or a procedure that requires inpatient hospitalization throughout the duration of the study are excluded from the study.
4. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the subject by their participation in the study.
5. Any condition that may interfere with the absorption, metabolism, or elimination of telaglenastat.
6. Clinically significant laboratory values that would place the subject at undue risk in the opinion of the PI or designee, including but not limited to serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) \> 1.2 × upper limit of normal at the screening visit.
7. History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
8. History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds.
9. History of tendon disease/disorder related to quinolone treatment.
10. Female subjects with a positive pregnancy test at the screening visit or first check in or who are lactating.
11. Positive urine drug or alcohol results at the screening visit or first check in.
12. Regular use of alcohol within 6 months prior to the screening visit (more than 21 units of alcohol per week for men, or 14 units of alcohol per week for women \[1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol\]).
13. Use of recreational drugs (such as marijuana) within three months prior to the screening visit or illicit drugs (such as cocaine or methamphetamine) within one year prior to the screening visit.
14. Positive results at the screening visit for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
15. Family history of QTc prolongation or of unexplainable sudden death at \< 50 years of age.
16. History or presence of:
1. Risk factors for Torsade de Pointes (eg, heart failure, cardiomyopathy, or family history of Long QT Syndrome or Brugada Syndrome) 2. Sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF, or clinically significant conduction abnormalities 3. History of angina, myocardial ischemia, arrythmia, heart failure or stroke 4. Clinically significant cardiac history or presence of ECG findings as judged by the PI or designee at screening or first check in, including the presence of abnormal sinus rhythm (HR \< 50 or \> 100 bpm; measurement may be repeated once at the discretion of the PI or designee) 17. Resting supine blood pressure is less than 90/50 mmHg or greater than 140/90 mmHg at the screening visit (may be repeated twice at the discretion of the PI or designee).
18. Unable to refrain from or anticipates the use of:
* Any drug, including prescription and non prescription medications (including gastric acid reducing \[PPIs, histamine-2 receptor antagonists\] or buffering agents \[eg Tums\]), herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing and throughout the study. Medication listed as part of acceptable birth control methods will be allowed (refer to Section 11.1). After randomization/dosing, paracetamol (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee.
* Any drugs known to be substrates of CYP2C9 (eg, warfarin) within 14 days prior to Day 1 and throughout the study. Appropriate sources (eg, Flockhart TableTM) will be consulted to confirm lack of PK/PD interaction with study drug.
* Food and beverages containing xanthines/caffeine (including energy drinks) for 24 hours prior to Day 1 of Period 1;
* Food and beverages containing alcohol for 48 hours prior to Day 1 of Period 1.
* Food and beverages containing grapefruit/Seville orange for 14 days prior to Day 1 of Period 1.
19. Has been on a diet incompatible with the on study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing and throughout the study.
20. Is lactose intolerant or has any significant food allergy, in the opinion of the PI or designee.
21. Donation of blood or plasma, or significant blood loss within 90 days prior to the first dosing.
22. Donation of bone marrow within the last 6 months prior to the first dosing. 23. Participation in another clinical study within 90 days prior to the first dosing. The 90 day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.
|
[
1.0743335485458374,
3.285022735595703,
-2.824770212173462,
-2.7592544555664062,
0.3563486337661743,
-0.004208086524158716,
-0.20234960317611694,
0.3099275529384613,
-2.4777538776397705,
-1.1220285892486572,
1.1523985862731934,
2.1104977130889893,
-0.19619597494602203,
0.10569334030151367,
-0.008508237078785896,
0.47123509645462036,
-0.028087807819247246,
-0.21869269013404846,
0.3638857305049896,
-3.086578845977783,
0.48632967472076416,
-1.7214810848236084,
-0.25127676129341125,
-1.0284289121627808,
-0.15748688578605652,
0.14624296128749847,
0.49973249435424805,
0.6363620162010193,
-1.0750024318695068,
1.3508769273757935,
0.9456338882446289,
-1.627119779586792,
0.32270950078964233,
0.16698169708251953,
1.0978318452835083,
-0.3189429044723511,
0.43375128507614136,
-0.7962068915367126,
-0.8338412046432495,
0.9930416941642761,
0.8100863695144653,
0.4069601893424988,
-0.7441824674606323,
0.20564140379428864,
0.25176185369491577,
0.8655901551246643,
-0.28678712248802185,
0.9266597628593445,
-0.06798078119754791,
-1.7936567068099976,
-1.0699175596237183,
0.6724662184715271,
0.6819579005241394,
0.393466055393219,
1.1158125400543213,
1.6484986543655396,
-0.036124683916568756,
0.8755514621734619,
1.8780224323272705,
-0.04386613517999649,
-0.3364834189414978,
-1.2583039999008179,
1.6162523031234741,
1.070397973060608,
-0.030813300982117653,
0.6930002570152283,
0.905143141746521,
-0.27497589588165283,
-0.4474700093269348,
-0.06119661405682564,
0.8881067633628845,
0.6973477602005005,
1.6313986778259277,
0.19578292965888977,
0.5512236952781677,
0.06815546005964279,
-1.3612183332443237,
0.06191933527588844,
0.19355954229831696,
-0.07707488536834717,
1.0139248371124268,
-0.012551925145089626,
-0.22467480599880219,
-0.5439484715461731,
0.9856736063957214,
-1.6287683248519897,
-1.9259997606277466,
-0.6698161959648132,
0.6596137881278992,
-0.6635682582855225,
-0.4466942548751831,
-0.5278194546699524,
-1.8179967403411865,
0.8926253914833069,
-1.111883521080017,
0.3317309319972992,
-0.15233547985553741,
-1.088201642036438,
-1.2756894826889038,
-0.4225466847419739,
0.7252609729766846,
0.09215424209833145,
-0.08925552666187286,
0.41803038120269775,
0.5924919247627258,
-0.4271220862865448,
-0.9347229599952698,
-0.4714617431163788,
-0.16987089812755585,
-0.05183609575033188,
0.4112280309200287,
-1.726553201675415,
0.42251551151275635,
-0.5324342250823975,
0.6376817226409912,
1.1911166906356812,
1.3574421405792236,
1.6691397428512573,
-0.8274757862091064,
-0.7762945890426636,
-0.7652139067649841,
1.5834187269210815,
0.9373207092285156,
-0.7031572461128235,
0.2723236382007599,
-0.253745436668396,
0.13106468319892883,
0.08796645700931549,
-0.7818074822425842,
-0.6796313524246216,
0.06770502775907516,
0.6377056241035461,
0.6148358583450317,
0.3370093107223511,
-1.9987635612487793,
-0.2837677597999573,
0.13121488690376282,
0.10885985195636749,
-0.044058408588171005,
-0.4362017810344696,
-0.48081883788108826,
0.24473892152309418,
0.7906178832054138,
-0.6350941061973572,
-1.2058322429656982,
0.41382625699043274,
0.28027698397636414,
0.6990944743156433,
0.3790697753429413,
-0.6584455966949463,
-0.5614116787910461,
0.8357632160186768,
0.2787427008152008,
-0.7276334762573242,
-0.7414502501487732,
-0.5453605055809021,
0.4246765673160553,
0.013708341866731644,
-0.4959452748298645,
0.637282133102417,
0.023573976010084152,
0.08848819136619568,
-0.27448397874832153,
0.12773483991622925,
0.7516334056854248,
-0.14316758513450623,
0.3167601227760315,
-0.8109597563743591,
0.40005937218666077,
-0.10495221614837646,
-0.7972862720489502,
0.18869908154010773,
0.08214940130710602,
-0.49223604798316956,
-0.17956103384494781,
-0.28881415724754333,
0.4318616986274719,
0.2769491374492645,
0.08837459236383438,
0.29977139830589294,
-0.5613947510719299,
1.273371934890747,
-0.5026109218597412,
1.0830326080322266,
0.11904221028089523,
-0.3860853314399719,
-0.2628995478153229,
-0.03731274604797363,
-0.1754814237356186,
0.3703371584415436,
-0.18091389536857605,
0.13190151751041412,
-0.02987699583172798,
-0.4928806722164154,
0.6913923621177673,
-0.4089619219303131,
-0.1309058964252472,
-0.8341435194015503,
0.044174421578645706,
-0.2134677916765213,
-0.458856463432312,
0.8307161927223206,
0.13575230538845062,
0.8034181594848633,
-0.13892439007759094,
0.028484314680099487,
-0.6974154114723206,
0.29190748929977417,
-0.1372806280851364,
0.36463090777397156,
0.014658620581030846,
0.16079606115818024,
0.00778011092916131,
0.24951215088367462,
0.9851723909378052,
0.011999043636023998,
-0.838265061378479,
-0.30732297897338867,
0.5526924133300781,
0.020704997703433037,
0.17804203927516937,
-0.5130536556243896,
-0.5326921939849854,
-0.6140700578689575,
0.14215244352817535,
-0.22948536276817322,
-0.06433316320180893,
0.027212079614400864,
-0.12909020483493805,
-0.6590247750282288,
-0.24522627890110016,
0.26174265146255493,
-0.3976627588272095,
-0.3817577362060547,
0.5526265501976013,
-0.17176610231399536,
-0.06344450265169144,
0.006415885873138905,
0.6347754001617432,
-0.47223344445228577,
-0.10105415433645248,
-0.598239004611969,
0.3329733908176422,
0.18687370419502258,
0.024296801537275314,
-0.019662952050566673,
0.05372181162238121,
0.3520452678203583,
0.2839350998401642,
0.005389025900512934,
-0.6901622414588928,
-0.36661261320114136,
-0.7156978249549866,
-0.6424446105957031,
0.6369104981422424,
-0.18361593782901764
] |
NCT04288557
|
Sleep Measurement Study
|
Sleep behaviour has critical importance to health and wellbeing. A large body of evidence has implicated poor sleep in all-cause mortality, and in cardiovascular and cardiometabolic risk factors. Given the importance of sleep to health, the importance of accurately monitoring sleep duration and quality is becoming more evident. Polysomnography (PSG) is considered the gold standard for sleep assessment. Nevertheless, PSG is impractical, expensive and labour-intensive. Another method to quantify indices of sleep is based on actigraphic measures. Wrist worn actigraphy devices provide an indirect measure of sleep parameters e.g. total sleep time, sleep onset latency and waking time. However, the data is in the form of manufacturer-specific activity 'counts', making it difficult to compare the data with different accelerometer brands. Recently wrist-worn accelerometers have become increasingly used for objective measurement of physical activity in large population studies where participants are often asked to wear them for 24 hours continuously. These devices therefore collect data that could be used to estimate sleep parameters, and now there is a sleep algorithm that can be applied to raw data from accelerometers. The three widely used raw-data accelerometer brands are the Axivity, ActiGraph and GENEActiv and ActivPAL which is a thigh-worn accelerometer that provides a measure of posture. Studies that examined accuracy of estimating sleep parameters from different brands of accelerometers compared to PSG have reported conflicting results which could be due to the use of different sleep algorithms and accelerometer placement (dominant vs. non-dominant wrist vs. hip). Therefore this study will aim to validate automated sleep algorithms for research grade accelerometers against PSG in a clinical and healthy adult population.
|
Sleep behaviour has critical importance to health and wellbeing. Insufficient sleep duration and poor sleep quality are independent contributors to high blood pressure and cardiovascular disease, depression, obesity and diabetes. Given the importance of sleep duration and quality to health, the importance of accurately monitoring sleep duration and quality in everyday clinical practice is becoming more evident.
The 'gold standard' physiological measure of sleep is sleep polysomnography (PSG). PSG is used to quantify measures of sleep, including length of sleep, time taken to fall asleep, sleep efficiency. The disadvantages of sleep PSG include the need to attend a laboratory, use of expensive equipment, specialised staff to administer PSG, and to score and interpret the PSG outputs, which limit its use in larger, or free-living studies.
Another method to quantify indices of sleep is based on actigraphy, demonstrating 90% agreement with polysomnography. Wrist actigraphy allows sleep assessment over several days and measures daily sleep-wake cycles. However, the data is in the form of manufacturer-specific activity 'counts' over a specific time window, making it difficult to compare the data with different accelerometer brands. Recently wrist-worn accelerometers have become increasingly used for objective measurement of physical activity in large population studies where participants are often asked to wear them for 24 hours continuously, to maximise compliance. These devices therefore collect data that could be used to estimate sleep parameters, however to be able to use, pool or compare these data there is a need for sleep algorithms that can be applied to datasets from different accelerometer brands. The latest generation of accelerometers measure acceleration in universal units improving comparability among different brands of accelerometers and allowing more control in the data processing. Moreover, now there is a sleep detection algorithm that can applied to data from different raw-data accelerometer brands and is freely available as a part of GGIR package in R (software environment for statistical computing and graphics). The three widely used raw-data accelerometer brands are the Axivity, ActiGraph and GENEActiv and ActivPAL which is a thigh-worn accelerometer that provides a measure of posture using proprietary algorithms; however, raw data are now available.
Studies that have validated the accelerometers with the PSG produced mixed results which can be attributed to use of manufacturer specific sleep algorithms and different accelerometer placement (dominant vs. non-dominant wrist vs. hip). Therefore validation of a sleep algorithm that can be applied to different accelerometer brands against PSG warrants investigation.
|
Inclusion Criteria:
Clinical population:
1. Participants willing and able to give informed consent for participation in the study
2. Male or Female
3. Aged 18-65 years inclusive
4. Patients on the waiting list for overnight PSG recording at Leicester General Hospital Healthy volunteers
1. Participants willing and able to give informed consent for participation in the study 2. Male or Female 3. Aged 18-65 years inclusive 4. No known sleep disorder (This will be self-reported by the participants)
Exclusion Criteria:
1. Participant is unwilling or unable to give informed consent
2. Anyone without a good command of the English language
3. Anyone \<18 years of age and \>65 years of age
4. Patients suspected of having a movement disorder in sleep (e.g. Periodic Limb Movement in Sleep or REM-Sleep Behaviour Disorder).
|
[
-0.19459785521030426,
2.645977735519409,
-2.9778616428375244,
-3.0299339294433594,
0.728399932384491,
-0.02419021911919117,
0.13417929410934448,
-0.9960757493972778,
-0.5812610983848572,
-0.11558913439512253,
1.9743670225143433,
1.6129432916641235,
-0.7553537487983704,
-0.9844038486480713,
0.24221408367156982,
1.1867929697036743,
0.676078736782074,
-0.5831348896026611,
0.6753366589546204,
-1.074156641960144,
0.29073604941368103,
-0.39674967527389526,
-0.7875710129737854,
0.17611387372016907,
0.8458340764045715,
0.04990279674530029,
-0.18021073937416077,
1.119739055633545,
-0.1983935385942459,
1.3601489067077637,
0.11593525111675262,
-1.8274952173233032,
0.20938998460769653,
1.074418067932129,
-0.9277053475379944,
-1.2664638757705688,
0.3192741274833679,
-0.5919259190559387,
-1.277401089668274,
0.34625422954559326,
-0.6446133852005005,
0.7267351150512695,
0.16581010818481445,
-0.2952686846256256,
1.5136688947677612,
-0.5889641046524048,
-0.5370566248893738,
0.8582338094711304,
0.021884802728891373,
-0.30185991525650024,
-0.6066433191299438,
0.3421601355075836,
-1.3852359056472778,
0.24928469955921173,
1.7048531770706177,
0.10323406010866165,
0.04855275899171829,
-0.7032537460327148,
0.7395619750022888,
-0.4647219181060791,
0.4067577123641968,
-0.3688969910144806,
1.0455083847045898,
1.1065266132354736,
-0.6082056164741516,
0.511906087398529,
-0.15033158659934998,
0.7912928462028503,
-0.49441197514533997,
0.5836424827575684,
-0.29563063383102417,
0.6113733649253845,
0.1969195455312729,
0.27183640003204346,
-0.13904748857021332,
0.06931181997060776,
0.12925812602043152,
-0.14185036718845367,
0.3706232011318207,
0.33992210030555725,
-0.3769642114639282,
0.009287238121032715,
-0.6977025866508484,
0.6876077651977539,
-0.15996453166007996,
0.5527049899101257,
0.10994290560483932,
-1.2553741931915283,
1.402479648590088,
-0.709277868270874,
-0.6261247992515564,
0.23221518099308014,
-0.4101196229457855,
-0.08680165559053421,
-0.720394492149353,
0.29850342869758606,
0.35936298966407776,
-0.8722450733184814,
-1.3375681638717651,
-0.4985309839248657,
-0.10787206888198853,
-0.5238084197044373,
-0.7272820472717285,
0.3278845548629761,
0.8077132105827332,
-0.10723228752613068,
-0.7533025741577148,
0.3409753739833832,
-0.20024508237838745,
0.3363289535045624,
0.7740949392318726,
-0.6952940821647644,
-0.10795684903860092,
-0.4506726562976837,
-0.30903345346450806,
0.7008609175682068,
0.7560599446296692,
0.7248419523239136,
-0.15452469885349274,
-0.35702383518218994,
0.13205967843532562,
0.7113927602767944,
0.3046970069408417,
0.5938279032707214,
0.10502194613218307,
0.45621246099472046,
-0.29698559641838074,
-0.7040790319442749,
-0.1930651068687439,
-0.323640912771225,
-0.7843958735466003,
-0.2982730567455292,
-0.7462992668151855,
-0.8567956686019897,
0.1374671757221222,
0.13764597475528717,
-0.016681235283613205,
0.4319310784339905,
-0.28981271386146545,
-0.735849142074585,
-0.29212486743927,
-0.1540592908859253,
-0.6112194657325745,
0.061791982501745224,
-0.2510613203048706,
-0.41515985131263733,
0.09881830960512161,
-0.06271986663341522,
-0.08593732118606567,
-0.01067187450826168,
-0.3033440113067627,
0.8008562922477722,
-0.34658899903297424,
0.1729147881269455,
-0.2268872857093811,
-0.056270986795425415,
-0.11184666305780411,
-0.19098356366157532,
-0.24111101031303406,
0.12889604270458221,
0.182397723197937,
-0.7255459427833557,
-0.07131095230579376,
0.5793367028236389,
0.28379201889038086,
0.11440201103687286,
0.583406388759613,
-0.15118730068206787,
0.07279005646705627,
0.5135520696640015,
0.06209297105669975,
-0.23041774332523346,
0.12282323837280273,
0.7098548412322998,
-0.6588724255561829,
0.050717055797576904,
0.1274886280298233,
0.5192170143127441,
-0.17773783206939697,
-0.08482678234577179,
0.01731167919933796,
-0.1501333862543106,
-0.006735202856361866,
0.4131210744380951,
-0.0018378060776740313,
-0.5260359644889832,
0.13159967958927155,
-0.30615124106407166,
0.3297663629055023,
0.0077370828948915005,
-0.05029521510004997,
-0.22607192397117615,
0.6608771085739136,
0.05171031504869461,
-0.9785990715026855,
0.18998190760612488,
-0.3201906681060791,
-0.14294101297855377,
0.15017955005168915,
0.14224794507026672,
0.004726124927401543,
0.22058583796024323,
-0.41309475898742676,
0.16724886000156403,
0.12293123453855515,
-0.10451345890760422,
-0.636109471321106,
0.25589707493782043,
0.1419091671705246,
-0.4058220386505127,
0.3583439588546753,
0.6768628358840942,
-0.41936081647872925,
-0.3802585005760193,
-0.06463964283466339,
0.5534378886222839,
-0.47317108511924744,
0.12032713741064072,
-0.4145548641681671,
-0.2771017849445343,
-0.3200724422931671,
0.06868631392717361,
-0.24715198576450348,
0.16053572297096252,
-0.15630459785461426,
-0.07920626550912857,
0.39081552624702454,
0.45232489705085754,
-0.1582430601119995,
0.3219146430492401,
-0.3737829625606537,
0.07422608137130737,
-0.20818506181240082,
-0.0512879304587841,
0.30960261821746826,
0.19579550623893738,
-0.16272175312042236,
0.0006133055430836976,
0.10061442106962204,
0.16950929164886475,
0.15878646075725555,
0.0023495934437960386,
-0.20049063861370087,
0.062169089913368225,
0.13709062337875366,
-0.36776667833328247,
0.21072937548160553,
0.12839891016483307,
-0.30947497487068176,
0.20399895310401917,
0.3601512312889099,
-0.4603063762187958,
0.07281012833118439,
0.5088353753089905,
-0.3878336250782013,
-0.7352699041366577
] |
NCT01160705
|
Biomarkers of Response to Taxotere in HRPC. ICORG 08-08, V2
|
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This clinical trial is studying blood samples in predicting how patients with prostate cancer will respond to treatment with docetaxel.
|
OBJECTIVES:
Primary
* To determine if mRNA present in circulating tumor cells will help predict response in patients with hormone-refractory prostate cancer treated with docetaxel.
* In parallel with this, based on discoveries made since our protocol was initially submitted to ICORG, here we also propose to analyse serum specimens from these consenting patients for the presence of EC miRNA, mRNA and protein predictive of response to Taxotere.
Secondary
* To develop a predictive model based on the most accurate and sensitive combination of these biomarkers.
OUTLINE: This is a multicenter study.
Treatment Plan:
All patients will be treated with Docetaxel on a weekly, biweekly or three weekly schedule, dose and schedule at the discretion of the treating physician.
Blood samples are collected for biomarker laboratory studies at baseline, every 3-4 weeks during study, and at disease progression or every 12 weeks after completion of study. Samples are analyzed for mRNA via RT-PCR.
|
Inclusion Criteria:
Patients must satisfy the following criteria:
1. Patients must, in the opinion of the Investigator, be suitable for treatment with Docetaxel on a weekly, biweekly or three weekly schedule.
2. Patients must be aged 18 years or over.
3. Patients must have histologically or cytologically proven adenocarcinoma of the prostate gland.
4. Patients must have evidence of locally advanced or metastatic disease (e.g. bone, pelvic mass, lymph node, liver or lung metastases).
5. Patients must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (LHRH-agonist etc.) with evidence of treatment failure.
6. Patients must not have received prior treatment with chemotherapy.
7. Patients must be able to give written informed consent.
8. Prior radiotherapy is allowed.
9. Concomitant use of bisphosphonates is allowed.
Exclusion Criteria:
1. Patients who have received previous cytotoxic therapy for prostate cancer are ineligible.
2. Patients who in the judgement of their treating physician will not be able to receive therapy and follow-up according to the protocol guidelines will be ineligible.
3. Presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient by participating in this trial.
4. History of other primary cancer, unless:
* Curatively resected non-melanomatous skin cancer
* Other primary solid tumour curatively treated with no known active disease present and no curative treatment for the last year.
|
[
1.5314607620239258,
3.854776382446289,
-1.362425446510315,
0.09448220580816269,
-0.2938857078552246,
-0.33476996421813965,
-1.5289428234100342,
-0.9769249558448792,
-2.3597114086151123,
-0.40708112716674805,
2.0682990550994873,
2.1615517139434814,
0.3878996968269348,
2.1433866024017334,
-0.27755144238471985,
0.6777228713035583,
0.048102058470249176,
0.2965553104877472,
0.6144385933876038,
-0.9180965423583984,
0.8440970778465271,
-0.7268539071083069,
-0.47950121760368347,
-0.08734526485204697,
-0.7415401935577393,
0.38291093707084656,
-0.7879296541213989,
2.968017101287842,
0.42812952399253845,
2.0960278511047363,
0.7010250091552734,
1.2355756759643555,
-0.49528247117996216,
-0.666468620300293,
-0.9415134787559509,
-0.7105581760406494,
1.5657380819320679,
1.1999694108963013,
-2.638728618621826,
0.5838764905929565,
1.0902115106582642,
0.4256887435913086,
-0.6608028411865234,
-0.05912143364548683,
0.6288899183273315,
0.5920547842979431,
0.33383676409721375,
0.5588997006416321,
0.46534818410873413,
-0.03932156786322594,
-0.8886011242866516,
3.4226675033569336,
-1.7510875463485718,
0.7160311937332153,
2.063009738922119,
-0.015270453877747059,
0.6651592254638672,
0.23788341879844666,
2.5482983589172363,
1.49944007396698,
0.20215028524398804,
-0.4873451292514801,
1.3748935461044312,
0.8351742029190063,
-1.8612163066864014,
-0.9687672257423401,
-0.7504261136054993,
-0.7489359378814697,
0.2631285786628723,
0.20538610219955444,
-0.4445580244064331,
0.7120283246040344,
0.7229892015457153,
0.21946091949939728,
1.0165377855300903,
0.4166843593120575,
0.10761761665344238,
0.22280457615852356,
0.19559015333652496,
-0.6919011473655701,
-1.403368592262268,
-1.0094932317733765,
-1.1116042137145996,
0.34885188937187195,
0.515002965927124,
-1.4541758298873901,
-1.2577056884765625,
-0.7343624234199524,
0.6109938025474548,
-2.6704061031341553,
0.999474823474884,
0.3488243818283081,
0.6405505537986755,
1.9001343250274658,
-0.3516729772090912,
0.3757771849632263,
0.6576192378997803,
-0.6236615180969238,
-0.7117821574211121,
0.11130364239215851,
-0.4091505706310272,
1.0091946125030518,
0.09784892201423645,
-0.8211197257041931,
-0.8889473676681519,
-0.746530294418335,
0.051013197749853134,
-0.9252563714981079,
-0.5942564606666565,
-0.22768069803714752,
2.048550844192505,
-1.4022796154022217,
-0.03227038308978081,
0.4754415452480316,
-0.14847496151924133,
-0.7603918313980103,
0.661605954170227,
0.3504365086555481,
0.6943759322166443,
0.5238274931907654,
-0.28461727499961853,
0.6008362174034119,
-0.020749781280755997,
-0.9227924942970276,
0.4074002802371979,
-0.8969482183456421,
-0.39163079857826233,
-1.364063024520874,
-0.41557613015174866,
-1.0040948390960693,
-0.6042819023132324,
-0.3268105983734131,
0.1228717491030693,
-0.7308717966079712,
-0.6628695130348206,
-0.5271973013877869,
0.34831804037094116,
1.7088872194290161,
0.7095659971237183,
-1.0900721549987793,
1.0262845754623413,
-0.0774758905172348,
1.4876357316970825,
1.6666209697723389,
-1.1697686910629272,
-0.21321675181388855,
0.00045934529043734074,
0.3503718674182892,
0.11244458705186844,
-1.1318196058273315,
-0.03138342127203941,
0.16704007983207703,
0.602845311164856,
-0.4873146116733551,
0.027743659913539886,
0.4326157569885254,
-0.9263788461685181,
-0.6344709992408752,
-0.8231927156448364,
-0.2415856122970581,
-0.028407452628016472,
-0.8605855703353882,
0.5182198882102966,
-0.7087612152099609,
0.8878180980682373,
-0.19317999482154846,
0.022306550294160843,
0.014125149697065353,
0.6820570826530457,
0.76304692029953,
-0.19335076212882996,
0.34983623027801514,
0.4912687838077545,
1.5378782749176025,
-0.08904103189706802,
-0.18184654414653778,
0.8895348310470581,
0.4894547164440155,
0.5824875831604004,
0.20881886780261993,
0.009080443531274796,
-0.11134499311447144,
0.3192291259765625,
-0.9283501505851746,
0.36219438910484314,
0.611575722694397,
0.4307198226451874,
-0.07099452614784241,
0.13733845949172974,
-0.4036562740802765,
0.3271777927875519,
0.015011132694780827,
0.5345529913902283,
1.2205994129180908,
0.6492684483528137,
-0.19616740942001343,
-0.3169533312320709,
-0.3277908265590668,
0.22947995364665985,
0.4657304286956787,
0.7425305843353271,
0.6163181066513062,
-0.2278038114309311,
1.7565268278121948,
0.3349297344684601,
-0.31599104404449463,
-0.32207393646240234,
-0.5796425938606262,
0.4186480939388275,
0.6157471537590027,
0.22086666524410248,
0.020697640255093575,
0.48884546756744385,
-0.1589675098657608,
-0.14123202860355377,
0.3237544000148773,
0.6378816366195679,
-0.5581889748573303,
-0.6547806262969971,
-0.6260564923286438,
-0.21341021358966827,
-0.40665602684020996,
0.4363898038864136,
0.04140741378068924,
-0.6218088865280151,
0.1818433403968811,
0.0075959148816764355,
0.9764543175697327,
0.016010472550988197,
0.08047614991664886,
-0.16120828688144684,
-0.04594022408127785,
0.31290403008461,
-0.16441571712493896,
-0.22258612513542175,
0.2088535726070404,
0.42987024784088135,
0.927490770816803,
0.09872239083051682,
0.8658323287963867,
-0.408896267414093,
0.142230823636055,
0.5243109464645386,
-0.7608625888824463,
-1.0050032138824463,
0.5147143006324768,
0.06602977216243744,
-0.3179622292518616,
0.15618981420993805,
0.6837087869644165,
-0.32117655873298645,
-0.1529303938150406,
0.546384334564209,
-0.07509777694940567,
0.07152703404426575,
-0.9977572560310364
] |
NCT03027895
|
Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)
|
The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis (WON), mainly to observe the efficacy and safety of LAMS for WON.
|
Patient with pancreatic walled-off necrosis (WON) would be treated randomized with lumen-apposing metal stent (LAMS) or double pigtail plastic stents (DPPSs) under the guidance of Endoscopic Ultrasonography. The investigators compare the effect of the two stents, including technical success, clinical success, adverse event, recurrence, and so on.
|
Inclusion Criteria:
1. Subject with ages from 18-80 years old
2. Subject with pancreatic pseudocysts confirmed by CT
3. Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months
4. The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall
5. Subject has the symptoms related with the pseudocyst
6. The consent form has been signed
Exclusion Criteria:
1. Subject is younger than 18 years or older than 80 years
2. Pancreatic pseudocyst communicate with the main pancreatic duct
3. Subject can't accept the endoscopic procedure
4. Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess
5. The distance between gastric and the wall of the pseudocyst is more than 1 cm
6. Subject with 2 or more than 2 cysts
7. Subject has blood coagulation dysfunction
8. Pregnant or subject has mental disorders
|
[
0.17535485327243805,
1.2663145065307617,
-1.0883069038391113,
-3.719369649887085,
0.277071475982666,
-0.7741777896881104,
-0.01476630475372076,
0.2731648087501526,
-2.3432178497314453,
0.4922236204147339,
1.084347128868103,
-0.3856813907623291,
0.9153099656105042,
0.14034083485603333,
1.340147614479065,
-0.3117506802082062,
-0.9533615112304688,
0.8695176243782043,
0.5787984132766724,
-1.7625828981399536,
0.23019300401210785,
0.14476852118968964,
-0.2674022614955902,
-0.5607216358184814,
2.067692995071411,
-0.22528879344463348,
0.5370088815689087,
0.2595970928668976,
-1.6115565299987793,
1.705260157585144,
-0.0991894081234932,
-0.0020076350774616003,
-0.44695037603378296,
0.6079533100128174,
0.020619897171854973,
-0.16511769592761993,
0.3304196000099182,
-0.6545102000236511,
0.6561880707740784,
0.6238405704498291,
-0.26031583547592163,
0.7536358833312988,
0.8865187168121338,
0.42012307047843933,
0.08337732404470444,
0.045412156730890274,
0.2523413300514221,
0.5111045837402344,
-0.06140884757041931,
1.4476360082626343,
-0.7802748084068298,
-1.128737211227417,
-0.5704966187477112,
-0.05605966970324516,
0.6249650716781616,
0.6158491969108582,
-0.18702974915504456,
0.1082778349518776,
-0.03859984129667282,
0.17428569495677948,
0.45815783739089966,
-1.0611286163330078,
0.029166726395487785,
1.0396455526351929,
-0.0951637253165245,
-0.10659167170524597,
0.43597814440727234,
-0.07410618662834167,
-1.5259146690368652,
0.08763513714075089,
0.5072386860847473,
-1.2054318189620972,
-0.007959417067468166,
-0.3547520041465759,
0.372734397649765,
-0.8038515448570251,
0.7427710890769958,
1.1144773960113525,
0.7419487833976746,
0.9177958965301514,
0.8300228118896484,
0.9169204831123352,
-1.3222745656967163,
0.03981645777821541,
-0.06186407059431076,
-0.25783249735832214,
-0.37405097484588623,
-0.43351343274116516,
0.5751259326934814,
-1.2402677536010742,
1.484765648841858,
-0.19267109036445618,
-1.6396543979644775,
-0.19568082690238953,
1.2210958003997803,
0.07629498094320297,
-0.5748003721237183,
-0.14821745455265045,
-0.4438341557979584,
0.8043168783187866,
-0.04199288785457611,
-0.1757524162530899,
-0.8481132984161377,
0.5889894962310791,
0.6648576855659485,
-0.3804919421672821,
-1.1805698871612549,
-1.1241549253463745,
0.4067894220352173,
-1.362274408340454,
0.01812041737139225,
-0.47958043217658997,
1.0875587463378906,
-0.8684998154640198,
-1.3788866996765137,
0.024255046620965004,
1.2677143812179565,
0.8615598678588867,
-0.5468747019767761,
0.4990224540233612,
-0.582230806350708,
0.8752140402793884,
-0.02400655671954155,
1.7241274118423462,
-0.08419734984636307,
-0.2658129632472992,
-0.09558677673339844,
0.6957168579101562,
-0.10779672116041183,
-0.11866617947816849,
0.1727527678012848,
0.8450513482093811,
-1.00636625289917,
-1.546677589416504,
-0.8476977348327637,
0.010774063877761364,
0.7574847340583801,
0.3057727813720703,
0.29789090156555176,
0.5026286244392395,
-0.018267447128891945,
1.0936951637268066,
-0.6741964221000671,
0.2846698760986328,
-1.3540163040161133,
-0.9991522431373596,
-0.07586652040481567,
0.04037143662571907,
-0.37775611877441406,
-0.47315728664398193,
-0.03240397199988365,
0.6073484420776367,
0.6420638561248779,
0.2975705862045288,
0.30633944272994995,
-0.4896865785121918,
0.6352273225784302,
-0.19326139986515045,
0.8699794411659241,
0.3450986444950104,
0.16157081723213196,
-0.2211415320634842,
0.28114745020866394,
-0.45525869727134705,
0.1821480095386505,
0.04796355590224266,
-0.8966348767280579,
-0.396932452917099,
-0.3127502202987671,
-0.3108358681201935,
-0.782156229019165,
0.1420772224664688,
-0.02615547925233841,
0.1735660433769226,
0.1728689968585968,
0.3542095124721527,
-0.12187137454748154,
0.021349409595131874,
-0.2938816249370575,
0.10240594297647476,
0.26867449283599854,
0.14788377285003662,
-0.000922200852073729,
-0.1756884604692459,
0.6029253602027893,
0.1053830236196518,
0.09129360318183899,
-0.6819478273391724,
0.13876648247241974,
0.6839300990104675,
-0.3071815073490143,
-0.36156412959098816,
0.3193850517272949,
-0.16101637482643127,
0.0009418060071766376,
0.487432062625885,
-0.47625672817230225,
-0.1285594403743744,
0.23276783525943756,
-0.3397621214389801,
0.31627723574638367,
0.7221636176109314,
-0.044546276330947876,
0.30964070558547974,
0.09006816148757935,
-0.23657506704330444,
-0.2740093767642975,
0.5655289888381958,
-0.1773591786623001,
0.6598594784736633,
0.2151390165090561,
-0.9540694355964661,
0.08233017474412918,
0.03918313980102539,
-0.00397261418402195,
0.4175099730491638,
0.09738397598266602,
0.4684002101421356,
-0.20856529474258423,
0.21864387392997742,
-0.15738974511623383,
-0.4590234160423279,
-0.39469826221466064,
-0.33995354175567627,
0.14237438142299652,
-0.14773206412792206,
-0.7694664001464844,
-0.6363425254821777,
0.10348118841648102,
0.020970983430743217,
0.1927652806043625,
-0.10416124016046524,
-0.18767403066158295,
-0.6593008041381836,
-0.6490190029144287,
0.1766195446252823,
0.4158528745174408,
0.024392208084464073,
0.3829180598258972,
0.17681773006916046,
0.3239295482635498,
-0.5879835486412048,
0.005201935302466154,
-0.16764508187770844,
-0.2940432131290436,
-0.2064855545759201,
-0.1836235523223877,
-0.3157669007778168,
0.21527455747127533,
0.04411153495311737,
-0.09312008321285248,
0.0590200200676918,
0.025266500189900398,
0.0736074149608612,
-0.016310404986143112,
-0.6677259802818298
] |
NCT04133649
|
Evaluation of Safety and Tolerability of Libella Gene Therapy for the Treatment of Aging: AAV- hTERT
|
Using gene therapy to express active telomerase (hTERT) in humans has the potential to treat many of the age related diseases, including Aging itself.
This study will entail treating subjects with hTERT delivered via transduction using AAV. The goal is to extend the telomeres to prevent, delay, or even reverse Aging.
|
Subjects willing to participate who meet with the inclusion - exclusion criteria, will be treated with a single dose of LGT delivered intravascularly (IV).
Baseline will be performed within 8 weeks of beginning the treatment regimen. The treatment regimen will begin with IV delivery of AAV-hTERT, defined as "Day 0." Safety and efficacy analyses will be conducted at Weeks 1, 4, 13, 26, 39, and 52 post-treatment.
Study objectives
Primary: Safety and Tolerability
1. Investigate the safety and tolerability of AAV-hTERT by intravenous (IV) administration.
Secondary: Provisional Efficacy
1. To determine changes from baseline in hTERT expression, telomerase activity, and telomere length in cells after treatment with AAV-hTERT.
2. To determine changes from baseline in health and aging-related biomarkers after treatment with AAV-hTERT.
3. To determine changes from baseline in the immune system after treatment with AAV-hTERT.
4. To determine changes from baseline in physical function measures after treatment with AAV-hTERT
|
Inclusion Criteria:
Subjects must meet the following inclusion criteria at the screening visit.
1. Age of 45 years or older.
2. Subjects, or their authorized representatives, must be adequately informed and understand the nature and risks of the study and must be able to provide a signature and date in the Informed Consent Form (ICF).
3. Women must undergo a negative serum pregnancy test at the screening assessment.
4. Subjects, or their representatives, must be able to communicate effectively with the study staff.
5. Subjects, or their authorized representatives, must certify that they are able and willing to follow all protocol requirements and study restrictions.
Exclusion Criteria:
Subjects are not eligible for the study if they meet any of the following criteria at the screening visit, unless otherwise specified.
1. Subjects who have a history of allergy, hypersensitivity, or intolerance to any medications, components, or excipients of the investigational product, which cannot be resolved by the staff conducting the study.
2. Female subjects who are pregnant, expected to become pregnant, or lactating/nursing.
3. Subjects who are sexually active and who are unwilling or unable to use a method of effective contraception (e.g., hormonal and/or barrier) during their participation in the study.
4. Subjects who are intolerant of, or do not wish to receive, IV or IT injections.
5. Subjects who are currently alcoholics and/or use psychoactive substances.
6. Subjects who cannot tolerate venipuncture and/or venous access.
7. Subjects who have donated or had a significant loss of whole blood (480 ml or more) within 30 days, or donated plasma or platelets within 14 days prior to screening.
8. Subjects who have received blood or blood products within 30 days prior to screening.
9. Subjects who have been treated with another research product 30 days prior to the screening assessment, or plan to participate in another clinical trial, while in this study if in the opinion of the principal investigator, may place the subject at risk due to participation in the study, or may influence the results of the study or the subject's ability to complete the study. If more than 30 days have passed since participation in another clinical trial, the study staff must ensure that the subject has recovered from any adverse event (AE) associated with the research product used.
10. Subjects who have a history or evidence of active infection or febrile illness within 7 days prior to the screening assessment.
11. Subjects who have a history of any other clinically significant disease or disorder that, in the opinion of the principal investigator, may place the subject at risk due to participation in the study, or may influence the results of the study or the subject's ability to complete the study.
-
|
[
-1.168440580368042,
2.7433502674102783,
-3.0745716094970703,
-2.545773506164551,
-1.117438793182373,
0.24179603159427643,
0.7774770855903625,
0.6056051254272461,
-2.6496331691741943,
-0.09285999089479446,
0.8131104707717896,
0.34148091077804565,
-0.19409018754959106,
-0.49214500188827515,
1.7982326745986938,
1.400205135345459,
0.21413320302963257,
0.1998780071735382,
0.25453805923461914,
-1.6217812299728394,
0.24719156324863434,
-0.19148588180541992,
1.0525380373001099,
-0.48810669779777527,
0.15232230722904205,
1.0349127054214478,
-0.04762366786599159,
1.2825205326080322,
-0.33782440423965454,
1.2426995038986206,
-1.1648718118667603,
-0.43669381737709045,
2.362208604812622,
0.7608374357223511,
-0.8408713340759277,
-0.0026689562946558,
2.869699001312256,
0.37354934215545654,
-1.025255799293518,
0.5139181613922119,
-0.4644899070262909,
0.3397763967514038,
0.4651974141597748,
0.7273929119110107,
0.5287047028541565,
1.1686373949050903,
0.6300214529037476,
-0.49359065294265747,
0.7513964772224426,
-0.580184817314148,
0.3505263328552246,
0.40912526845932007,
-0.4959626793861389,
0.3462686240673065,
1.5227653980255127,
1.4855073690414429,
-1.2449750900268555,
-0.9226945042610168,
0.2441314458847046,
0.3676297068595886,
1.2311346530914307,
-0.6085656881332397,
-0.11216571927070618,
-0.28353187441825867,
-1.5496336221694946,
-0.8266926407814026,
1.3654042482376099,
0.3978775441646576,
-0.7123944163322449,
0.419944703578949,
0.36291608214378357,
0.3559947609901428,
0.6707310676574707,
-1.1938657760620117,
-0.9116175770759583,
0.14746370911598206,
0.1993781328201294,
0.1109456717967987,
1.2587358951568604,
-1.6259649991989136,
-1.651005744934082,
0.19813387095928192,
0.06747592240571976,
-0.26210448145866394,
0.787807285785675,
-1.0821609497070312,
-0.8632237315177917,
-0.9094445705413818,
0.01619156263768673,
-1.2791293859481812,
1.0424506664276123,
-1.279381275177002,
-0.8721486926078796,
0.43964073061943054,
-0.5445051193237305,
0.709375262260437,
0.05284030735492706,
-1.2594127655029297,
-0.17582213878631592,
-0.4866461753845215,
0.7028042078018188,
0.07607920467853546,
-0.6556444764137268,
-0.08143046498298645,
-0.6744434237480164,
0.015592525713145733,
-1.6048336029052734,
-0.08313093334436417,
-0.6754815578460693,
-0.5644546151161194,
0.7371701002120972,
-1.5794366598129272,
0.16950759291648865,
0.15839719772338867,
0.7709169387817383,
-0.16228385269641876,
0.2464384138584137,
0.2901708781719208,
-0.21844422817230225,
0.744130551815033,
-0.2585452198982239,
0.23339958488941193,
0.10533072799444199,
-0.5171347856521606,
-1.1301950216293335,
0.06304384768009186,
0.10679816454648972,
0.6097683310508728,
0.3768327832221985,
-0.63559490442276,
0.9331788420677185,
0.2720984220504761,
1.032633900642395,
-0.027325047180056572,
-0.8692646026611328,
-0.7413474321365356,
1.029420018196106,
0.31530630588531494,
0.18084250390529633,
0.7282741665840149,
-0.43141093850135803,
0.5614813566207886,
0.4337173402309418,
0.16436469554901123,
-0.9649115204811096,
-0.011033480055630207,
0.13823091983795166,
1.1125658750534058,
-0.15075775980949402,
-1.128105640411377,
0.10161745548248291,
-0.06488277018070221,
-0.21397390961647034,
0.21221333742141724,
-0.41324666142463684,
0.4964982569217682,
-0.4020295739173889,
-0.34372812509536743,
0.591286301612854,
0.3165411949157715,
-0.1496027559041977,
0.09051617234945297,
-0.10843208432197571,
-0.09135888516902924,
0.6366417407989502,
-0.7218530774116516,
0.8108398914337158,
1.0997891426086426,
0.005039520561695099,
-0.014941125176846981,
-0.0944167971611023,
-0.23495493829250336,
-0.9181466102600098,
0.1879345178604126,
-0.1368933469057083,
-0.06566926836967468,
0.49425238370895386,
0.863703727722168,
0.23727650940418243,
0.60470050573349,
-0.09102737903594971,
0.04030567407608032,
-0.3625391125679016,
0.5997341871261597,
-0.24227534234523773,
0.31840071082115173,
-0.48155441880226135,
0.5059988498687744,
-0.2660978138446808,
0.30426663160324097,
0.27535679936408997,
0.050772424787282944,
-0.3884298503398895,
-0.25530004501342773,
0.05836058408021927,
-0.2765609323978424,
0.6888479590415955,
-0.3151320517063141,
0.7886019945144653,
0.3298066258430481,
0.24878071248531342,
0.07681965827941895,
-0.0333557091653347,
0.3174915313720703,
0.048436008393764496,
-0.23928827047348022,
-0.132127583026886,
0.11602763831615448,
0.11779379099607468,
0.6923084259033203,
0.19313307106494904,
0.08067413419485092,
0.08950786292552948,
-0.08190158754587173,
0.48691678047180176,
0.1756751388311386,
-0.5946892499923706,
0.08554809540510178,
-1.5818003416061401,
-0.21768055856227875,
0.2352348119020462,
0.5811331868171692,
0.1101706326007843,
0.1505778282880783,
-0.007494188845157623,
0.14728878438472748,
0.18569791316986084,
0.16637718677520752,
0.467294305562973,
0.3876366913318634,
-0.4932204782962799,
0.44948235154151917,
-0.3728470206260681,
0.30567169189453125,
-0.3209950029850006,
-0.10659399628639221,
0.021604225039482117,
-0.18513703346252441,
-0.0009739441447891295,
-0.45322322845458984,
-0.4877990186214447,
0.12324541807174683,
0.4818553924560547,
-0.546364963054657,
0.16034038364887238,
0.3309553265571594,
-0.2536807954311371,
0.11265196651220322,
0.4168368875980377,
0.16280174255371094,
0.11995731294155121,
-0.0761159285902977,
-0.14896486699581146,
-0.4012584090232849,
0.33674293756484985,
-0.41051703691482544
] |
NCT00033319
|
Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
|
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of aspirin and/or folic acid may be effective in preventing recurrent polyps in patients who have had polyps removed previously.
PURPOSE: Randomized clinical trial to determine the effectiveness of aspirin and/or folic acid in preventing the recurrence of colorectal polyps.
|
OBJECTIVES:
* Determine whether aspirin and/or folic acid prevents recurrence of colorectal adenomas in patients who have had colorectal adenomas removed.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 4 treatment arms.
* Arm I: Patients receive oral aspirin and oral folic acid daily.
* Arm II: Patients receive oral aspirin and oral placebo daily.
* Arm III: Patients receive oral placebo and oral folic acid daily.
* Arm IV: Patients receive 2 oral placebos daily. In all arms, treatment continues for 3 years in the absence of unacceptable toxicity.
After completion of the 3-year intervention, all patients undergo a surveillance colonoscopy.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1,300 patients will be accrued for this study.
|
DISEASE CHARACTERISTICS:
* Histologically confirmed colorectal adenoma removed within the past 6 months
* Greater than 0.5 cm after fixation or greater than 0.7 cm at time of removal
* OR
* Any size with a history of prior colorectal adenoma removal(s)
* Removed via colonoscopy, flexi-sigmoidoscopy (provided barium enema has been performed), or transanal endoscopic microsurgery
* Removal must be considered complete with follow-up to be done within 6 months
* No prior resection of large bowel (e.g., hemi-colectomy or greater, anterior resection, or subtotal colectomy)
PATIENT CHARACTERISTICS:
Age:
* 75 and under
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* No active bleeding disorders
Hepatic:
* Not specified
Renal:
* Not specified
Cardiovascular:
* No unstable heart conditions
Pulmonary:
* No unstable asthma
Other:
* Not pregnant and no potential to become pregnant within the next 3 years
* No unstable diabetes
* No active upper gastrointestinal ulceration
* No known aspirin intolerance or sensitivity
* No other serious medical conditions that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* See Disease Characteristics
Other:
* No other concurrent folic acid
* No concurrent anticoagulants
* No other prior or concurrent non-steroidal anti-inflammatory drugs, prescribed or self-medicated (more than 3 tablets per week)
|
[
-0.1274529993534088,
3.366990804672241,
-2.1696102619171143,
-3.3212478160858154,
0.17049533128738403,
-1.1052113771438599,
-0.28385719656944275,
-0.2038124054670334,
-1.9219257831573486,
-1.2539279460906982,
-1.0159859657287598,
0.9234899282455444,
-1.0105667114257812,
1.0281816720962524,
2.201915979385376,
-0.9527202844619751,
-0.2147238403558731,
0.21207787096500397,
0.9916018843650818,
-1.1222585439682007,
1.3904520273208618,
-0.33766061067581177,
0.15661445260047913,
0.4402579963207245,
-1.5373014211654663,
-0.5564821362495422,
-1.9554672241210938,
1.497379183769226,
1.2554429769515991,
2.09661602973938,
0.1348036825656891,
0.2740898132324219,
-0.639987051486969,
-0.05219443514943123,
-1.3611994981765747,
-1.0924409627914429,
0.36404120922088623,
-0.6978865265846252,
-1.101595401763916,
1.3905293941497803,
-0.42468398809432983,
0.20916953682899475,
-0.26095932722091675,
-0.07810458540916443,
2.1095757484436035,
0.18709030747413635,
0.052638664841651917,
0.704947292804718,
1.1377673149108887,
-0.8415512442588806,
-1.0094349384307861,
1.2370479106903076,
-1.4364959001541138,
-0.1137290969491005,
0.32038283348083496,
-0.28761565685272217,
-0.047855060547590256,
2.169196128845215,
0.3495575785636902,
-0.22121089696884155,
0.2712515890598297,
-0.07301695644855499,
-0.8438137173652649,
-0.14811040461063385,
-1.0303292274475098,
-0.8465622663497925,
0.7204810976982117,
-0.24968189001083374,
0.15012593567371368,
1.0050475597381592,
0.8609394431114197,
0.6532183289527893,
0.8075900673866272,
0.7318360805511475,
1.0874015092849731,
1.0322686433792114,
0.09248759597539902,
1.2249523401260376,
1.1403177976608276,
0.7342906594276428,
-0.8299115896224976,
-0.13263210654258728,
-1.134822964668274,
-0.5605968832969666,
-0.3651278018951416,
-0.25354963541030884,
0.45603659749031067,
-0.7097958922386169,
1.3661729097366333,
-0.5272310376167297,
0.3515694737434387,
-0.27367833256721497,
-1.7665340900421143,
1.3879508972167969,
0.10343657433986664,
-0.15326720476150513,
0.059528984129428864,
0.7396363615989685,
-0.18507756292819977,
0.1358642280101776,
0.7278501391410828,
-0.20998156070709229,
-1.2144317626953125,
0.638463020324707,
-1.1358535289764404,
-0.02219250239431858,
-0.7058951258659363,
-0.17245236039161682,
0.279415488243103,
-0.32002755999565125,
0.732242226600647,
-1.139785885810852,
-0.011832061223685741,
0.18545928597450256,
0.4540834426879883,
0.3652077913284302,
0.033310580998659134,
0.36435094475746155,
-1.0543859004974365,
0.4679346978664398,
-0.31044769287109375,
1.3229314088821411,
1.0606849193572998,
0.47903159260749817,
-0.5272803902626038,
0.017933350056409836,
-0.15638108551502228,
0.05401536077260971,
-0.032496821135282516,
-0.5786089897155762,
-0.4694117605686188,
0.12200156599283218,
-0.1353113353252411,
0.05198413506150246,
-0.4724064767360687,
-0.580572783946991,
-0.01454249583184719,
1.076217770576477,
-0.1251816302537918,
-0.12707997858524323,
-0.13249991834163666,
0.9161993265151978,
-0.2629353702068329,
0.5873976349830627,
-1.8810945749282837,
-0.9067541360855103,
-0.7135414481163025,
0.13211609423160553,
-0.3991962969303131,
0.15887272357940674,
0.01638798601925373,
0.6479198336601257,
0.6947359442710876,
0.09985547512769699,
0.49103567004203796,
0.28854507207870483,
0.062394317239522934,
-1.0642082691192627,
0.0029419553466141224,
0.6234272122383118,
0.18663296103477478,
-0.21630938351154327,
-0.155450239777565,
-0.13167496025562286,
-0.39015209674835205,
-0.773884654045105,
-0.29869797825813293,
0.4843812882900238,
0.5217744708061218,
-0.45090919733047485,
-0.08767615258693695,
-0.26021718978881836,
-0.0893687978386879,
0.24648644030094147,
-0.6842788457870483,
-0.3687805235385895,
0.09390328079462051,
-0.30224987864494324,
0.5547853112220764,
-0.06800003349781036,
-0.6438978314399719,
-0.07111817598342896,
0.003766421927139163,
-0.5556820034980774,
0.3100604712963104,
0.1694425493478775,
-0.07990919798612595,
-0.6270706653594971,
-0.569461464881897,
0.710594654083252,
0.6975386142730713,
-0.09225545823574066,
0.005895492620766163,
-0.05548260360956192,
0.11722917854785919,
0.01130642183125019,
-0.09360895305871964,
-0.35609784722328186,
0.37137314677238464,
-0.40837594866752625,
0.5345918536186218,
0.4796968102455139,
0.21258270740509033,
0.39147883653640747,
0.5583602786064148,
0.4455033540725708,
-0.015226337127387524,
0.11348629742860794,
0.4551717936992645,
0.5340332984924316,
0.4612787365913391,
-0.022768430411815643,
0.6446308493614197,
0.2504275441169739,
-0.11557073146104813,
0.350388765335083,
-0.042034126818180084,
0.007988983765244484,
-0.5392639636993408,
0.007546211592853069,
0.06375126540660858,
0.18496699631214142,
-0.27186042070388794,
0.08308713138103485,
0.2648027539253235,
0.01177051942795515,
0.14031536877155304,
0.28543221950531006,
-0.23499974608421326,
0.0010053945006802678,
0.2134464979171753,
0.2587060034275055,
0.1352473497390747,
-0.1889002025127411,
0.2177293598651886,
0.1899409145116806,
0.20661331713199615,
-0.21261946856975555,
0.4404955208301544,
0.4635827839374542,
0.5792859792709351,
-0.19855037331581116,
-0.26272016763687134,
0.4496353268623352,
-0.5304319262504578,
-0.32934683561325073,
0.04220619052648544,
0.3222348690032959,
-0.7428777813911438,
0.09030625969171524,
-0.3261150121688843,
-0.3606453239917755,
0.21381017565727234,
-0.36726653575897217,
0.2910752594470978,
-0.14862968027591705
] |
NCT04465422
|
Development and Validation of the Client Centered Occupational Therapy Service Model
|
The purpose of the study is to develop and validate Client-centered Occupational Therapy Service at Taipei City Psychiatric Center (OT@tcpc) service model to assist clinicians to provide and integrate comprehensive OT services.
|
Occupational Therapy (OT) is one of the mental health services. The service phase includes acute/chronic hospitalization, daycare centers (adolescents, adults, and the elderly), community mental rehabilitation institutions, psychiatric nursing home, and outpatient assessment/treatments. OT provides holistic and continuous mental rehabilitation services at each stage of mental health care. During the acute hospitalization and based on the Model of Human Occupation (MOHO) model, the occupational therapist provides daily activities to assist acute patients with mental illness to develop occupation adaptation to enable and prepare for discharge.
However, the lack of a client-centered OT service model limits the interpretation of the treatment effect and the process of change. This will seriously affect the integrity and continuity of OT services and will limit the development of OT professions. Thus, the purpose of the study is to develop and validate Client-centered Occupational Therapy Service at Taipei City Psychiatric Center (OT@tcpc) service model to assist clinicians to provide and integrate comprehensive OT services.
This project consists of 2 stages. First, based on the MOHO model we use 5 stages with 6 weeks program to develop the OT@tcpc service model. Second, validate the to indicate the occupation identity and competence to validate the OT@tcpc service model. We will recruit 70 inpatients with schizophrenia and divided into intervention group, based on MOHO theory, and control group.
|
Inclusion Criteria:
1. Patients diagnosed with schizophrenia according to DSM-5 diagnostic criteria.
2. Over 20 years old.
3. Agree to participate in the study
Exclusion Criteria:
* 1. Diagnosis of intellectual developmental disorders 2. History of severe brain injury 3. Cannot complete the study due to poor cognitive, vision or hand function
|
[
1.7737010717391968,
5.925815582275391,
-2.462559223175049,
-2.0370335578918457,
-0.753130316734314,
-0.06106167286634445,
-0.03258536010980606,
2.3537793159484863,
-1.7764836549758911,
2.2370684146881104,
-0.03741894289851189,
0.33807551860809326,
-0.034382112324237823,
0.4246988892555237,
-1.9909213781356812,
0.045740753412246704,
2.116288185119629,
3.380199909210205,
0.400697261095047,
0.43888238072395325,
-0.18481619656085968,
-0.9179185032844543,
0.03493938967585564,
-2.120938539505005,
1.46836519241333,
1.692596435546875,
-0.2591119706630707,
3.09718656539917,
-0.2510544955730438,
0.17901577055454254,
-0.8720762133598328,
-1.5567686557769775,
0.29563263058662415,
1.6537045240402222,
-0.16624656319618225,
1.0625267028808594,
1.4556266069412231,
1.5673588514328003,
-1.8233146667480469,
1.7003717422485352,
0.7141197919845581,
-0.05437807738780975,
-2.821951389312744,
-0.5719426870346069,
-0.5334078669548035,
0.4074956476688385,
-0.1594134122133255,
-0.7441025376319885,
0.913336455821991,
-1.3995318412780762,
-1.0912328958511353,
-0.05243145301938057,
-0.7482394576072693,
0.2892357409000397,
1.2217411994934082,
1.728806972503662,
1.4284310340881348,
0.3700704574584961,
-0.4659723937511444,
0.01253503281623125,
1.1012787818908691,
0.4130709171295166,
-0.2481660544872284,
0.8822370171546936,
-1.990963339805603,
0.19862496852874756,
0.2506711781024933,
-0.9721795320510864,
0.31382185220718384,
-0.3582557141780853,
0.5265107750892639,
0.8844143748283386,
1.695312738418579,
0.8683865070343018,
-1.1100355386734009,
-0.7292920351028442,
0.1508147418498993,
0.48048558831214905,
-0.6026409864425659,
0.4610399901866913,
0.5844062566757202,
0.3011811673641205,
-1.5745035409927368,
-0.5321023464202881,
2.3624064922332764,
-0.7159584760665894,
-2.240417718887329,
-1.0791079998016357,
1.2048128843307495,
-0.11443823575973511,
1.0556074380874634,
0.4786582291126251,
-0.4755690097808838,
0.7225274443626404,
0.5696033835411072,
-0.20696933567523956,
0.15929849445819855,
-0.11922546476125717,
0.2527952790260315,
1.0922807455062866,
-0.4331528842449188,
-0.42116209864616394,
0.4962858557701111,
-1.0923513174057007,
-1.0021882057189941,
-0.08923935145139694,
-0.979894757270813,
0.009376469999551773,
-1.6970276832580566,
-1.4518632888793945,
-0.30217859148979187,
-1.4350602626800537,
1.17629075050354,
-0.008809839375317097,
-0.044265229254961014,
-0.9498550891876221,
0.40121129155158997,
-0.011678002774715424,
-1.1454824209213257,
1.04563570022583,
0.8029599785804749,
0.6306400895118713,
1.0108981132507324,
-0.6695238351821899,
-0.6562979817390442,
-0.26785826683044434,
-1.381091833114624,
-0.5721327662467957,
-0.9799059629440308,
-0.2764401137828827,
0.9710849523544312,
-0.7864121794700623,
0.6498623490333557,
1.2774587869644165,
-1.0138262510299683,
-1.029836893081665,
-0.1968565732240677,
0.03192697465419769,
-1.3073495626449585,
-0.14105477929115295,
-0.22752992808818817,
-0.22408559918403625,
-0.11932890862226486,
-1.0770180225372314,
-0.1757241189479828,
-0.5495136976242065,
-0.10937540978193283,
0.5859559178352356,
-0.37190479040145874,
-0.5310486555099487,
-0.07310289144515991,
0.6332507729530334,
0.1948544681072235,
0.4971739947795868,
0.31762051582336426,
0.22001893818378448,
-0.4761992394924164,
-0.7038266658782959,
0.912216067314148,
-0.9370852112770081,
-0.3128082752227783,
-0.4666282534599304,
0.5473477244377136,
0.22061266005039215,
0.936644971370697,
-1.333929419517517,
0.190712571144104,
0.4857572317123413,
-0.20086844265460968,
0.37659892439842224,
-0.7105782628059387,
0.6302266716957092,
-1.0841916799545288,
-0.31318414211273193,
0.1388922482728958,
1.028870701789856,
0.4254651367664337,
-0.24427469074726105,
1.3015460968017578,
-0.40986859798431396,
0.5554888844490051,
0.6676074266433716,
-1.1456124782562256,
0.3012746274471283,
0.09270499646663666,
0.17703258991241455,
-0.7882979512214661,
1.229646921157837,
-0.035216838121414185,
-0.057239457964897156,
-0.12873223423957825,
-0.4417177736759186,
-0.9351215362548828,
0.6198753118515015,
-0.8177266716957092,
-0.7790581583976746,
-0.11983241140842438,
-0.32910314202308655,
-0.07418469339609146,
-0.45150429010391235,
0.8193522691726685,
1.0024585723876953,
0.6172718405723572,
-0.46773919463157654,
-0.6321085691452026,
0.22841349244117737,
0.35924237966537476,
-1.0427684783935547,
0.3991704285144806,
0.1945818066596985,
0.6960427761077881,
1.0317069292068481,
-0.8921378254890442,
-0.6785278916358948,
0.873916506767273,
0.5997104644775391,
-0.6103290319442749,
0.5974002480506897,
-0.8811038136482239,
-0.5507721900939941,
-0.3698487877845764,
0.7179962396621704,
-0.1826561838388443,
-0.5590251088142395,
-0.09531142562627792,
0.09235762804746628,
-0.27504900097846985,
0.25419381260871887,
0.6668849587440491,
0.2483295202255249,
-0.1736803948879242,
1.375584363937378,
-0.2762342393398285,
0.36131206154823303,
-0.21636217832565308,
-0.27685829997062683,
-0.22779686748981476,
-0.20874235033988953,
-0.9058173298835754,
-0.10707072913646698,
1.134502649307251,
1.4592840671539307,
0.08076778054237366,
-0.4713834524154663,
-0.9326760172843933,
0.066414974629879,
0.16644003987312317,
0.48455509543418884,
-0.7850565910339355,
0.4468570947647095,
-0.8985064625740051,
-0.31481313705444336,
-0.37062546610832214,
0.9331227540969849,
0.6510003209114075,
-0.2920789420604706
] |
NCT04631939
|
Metacognitive Training as a Serious Game
|
The project aims to evaluate the efficacy of a therapeutic video game that incorporates elements from metacognitive training on delusions and jumping-to-conclusions in patients with psychotic disorders.
|
The study is an international, multicenter study and is being conducted in Switzerland (University of Basel) as well as in Germany (University of Lübeck). A total of 36 participants will be included. The estimated duration of the study is 15 months. All participants play a video game from the genre "Third Person Adventure". A character is navigated through a fantasy world using a keyboard and mouse. In the fantasy world, "stations" in the form of glowing gems are sought where players have to solve different tasks.
Participants are randomized to receive either the therapeutic video game with metacognitive training content or another video game with attention and memory tasks ("control intervention"). The control intervention does not include metacognitive tasks. Metacognitive training is an approach for the treatment of psychotic disorders, particularly delusions. The focus of metacognitive training is on thought distortions (so-called "cognitive biases") that are more pronounced in people with psychosis. The control intervention includes easily understandable, playful tasks. The intervention will take 4 appointments within 2 weeks.
|
Inclusion Criteria:
* aged between 18 and 40
* diagnosis of a psychotic disorder and current delusions or a history of delusions
Exclusion Criteria:
* Language skills insufficient for assessments
* IQ \< 70
* Secondary psychotic disorders that are clearly induced by general medical conditions or substance use.
* Previous participation in meta-cognitive training for psychosis
|
[
-0.602712094783783,
2.9464049339294434,
-2.896329641342163,
-2.8966481685638428,
-1.398996353149414,
-3.094210624694824,
-2.523142099380493,
-0.26475048065185547,
-1.2168781757354736,
1.944730520248413,
0.5114600658416748,
2.997814655303955,
-1.1071441173553467,
1.2320441007614136,
-1.542588710784912,
0.8337342739105225,
-0.5073726177215576,
0.06530746817588806,
1.4774224758148193,
-0.6627591252326965,
-0.2581852674484253,
0.8073737025260925,
0.49496209621429443,
0.043175891041755676,
-0.3140968978404999,
0.4187678098678589,
-0.7528306245803833,
2.001103162765503,
-0.22323544323444366,
0.40475860238075256,
-0.4567587673664093,
-1.3673075437545776,
0.42070144414901733,
-1.0550740957260132,
1.1796150207519531,
0.035166963934898376,
-0.7342596650123596,
0.0865476205945015,
-2.092782974243164,
0.20362147688865662,
0.9268090724945068,
1.4237269163131714,
0.16088813543319702,
1.794360876083374,
-0.1722351759672165,
1.880614161491394,
-0.6873009204864502,
0.9829667210578918,
-1.5261083841323853,
0.2814335525035858,
0.261633962392807,
0.7308617830276489,
-1.263735055923462,
0.6694936752319336,
1.8699111938476562,
0.07169553637504578,
1.1580045223236084,
-0.005214518867433071,
0.8603619337081909,
0.8719298839569092,
0.46156221628189087,
-0.055544860661029816,
0.4120751619338989,
1.2116681337356567,
-0.3856067955493927,
-0.0241220835596323,
0.23201070725917816,
0.11915413290262222,
-1.2031620740890503,
-0.2593160569667816,
-0.6102092862129211,
0.5702996253967285,
1.0672240257263184,
0.9930648803710938,
1.2317782640457153,
0.41606688499450684,
1.2194113731384277,
0.5632374286651611,
0.10251852124929428,
1.1151671409606934,
1.1245108842849731,
-0.5247019529342651,
-0.4942737817764282,
0.06009797379374504,
-0.3086118698120117,
-0.9885556101799011,
-1.6159363985061646,
-0.17506517469882965,
1.0074124336242676,
-0.5764981508255005,
-0.05506694316864014,
0.1098765879869461,
-0.9056013822555542,
0.29429876804351807,
-0.7900377511978149,
-0.07873260974884033,
-1.2170028686523438,
0.00955574307590723,
-0.47879350185394287,
0.21973817050457,
0.8436989188194275,
-0.22258199751377106,
-0.9628798365592957,
0.5281640291213989,
-1.953014612197876,
-0.16141140460968018,
-0.3616333305835724,
-1.0637625455856323,
-0.4782652258872986,
1.2462044954299927,
0.16954392194747925,
0.2732449173927307,
1.0934336185455322,
-0.4444138705730438,
0.6420826315879822,
0.3953687250614166,
0.4847601354122162,
0.09834083169698715,
-0.25143757462501526,
1.4206300973892212,
0.9994585514068604,
1.2011255025863647,
-0.4883385896682739,
-0.6298727989196777,
-0.5706281661987305,
-0.3464425802230835,
-1.2693113088607788,
-0.3207983672618866,
-0.6626620888710022,
-1.6324552297592163,
-1.268743872642517,
0.20074361562728882,
0.616497278213501,
0.6887115240097046,
-0.1576400250196457,
-0.17442254722118378,
0.42261239886283875,
1.5604199171066284,
-0.9115613102912903,
-0.25083619356155396,
-0.3607931137084961,
0.7029057741165161,
0.6045181155204773,
0.7422768473625183,
-0.9174792766571045,
-0.3826429545879364,
0.24301481246948242,
-0.14436893165111542,
-0.7856610417366028,
-1.6300702095031738,
0.07345782965421677,
-0.35713136196136475,
-0.09877986460924149,
-0.45732033252716064,
0.37625396251678467,
-0.18866103887557983,
0.3062991201877594,
-0.5799448490142822,
0.08528105914592743,
-0.8446679711341858,
-0.6439340710639954,
-1.1108145713806152,
0.3342914283275604,
-2.3487043380737305,
-0.07014810293912888,
-0.3464621603488922,
-0.4927469491958618,
0.05083135515451431,
0.7031980156898499,
-0.2717571556568146,
-1.1753102540969849,
-0.12024659663438797,
-0.7005652189254761,
-0.31960782408714294,
-1.1345030069351196,
0.6906696557998657,
0.14631201326847076,
0.32317498326301575,
0.26570913195610046,
0.5619817972183228,
-0.28037703037261963,
0.16095849871635437,
-0.1863044798374176,
-0.08316072821617126,
-0.22982239723205566,
0.9874781370162964,
-1.0075443983078003,
0.2578943967819214,
-0.027380479499697685,
-0.04603695869445801,
-0.32579004764556885,
-0.4915755093097687,
0.18094488978385925,
-0.05204692482948303,
-0.40602391958236694,
-0.37969842553138733,
-0.26454803347587585,
-0.24220871925354004,
0.008692506700754166,
-0.6590210795402527,
0.38356178998947144,
0.5244610905647278,
-0.49889320135116577,
0.5492475628852844,
-0.21322451531887054,
-0.1304481476545334,
-0.1635911464691162,
-0.18399077653884888,
0.020853277295827866,
0.12558962404727936,
0.4065116345882416,
1.047168254852295,
-0.1213294118642807,
0.11082752794027328,
0.11085650324821472,
0.33874472975730896,
0.13216954469680786,
0.48194825649261475,
-0.7877578139305115,
0.32979777455329895,
-0.8981472849845886,
-0.2700161635875702,
0.007224495988339186,
0.6591727137565613,
0.08496106415987015,
-0.34695884585380554,
-0.3242107629776001,
0.1462143063545227,
-0.07413356751203537,
0.08306074887514114,
-0.30618947744369507,
0.14872236549854279,
-0.013639536686241627,
-0.3244014084339142,
0.4260674715042114,
0.10975285619497299,
0.44690343737602234,
-0.2994733452796936,
-0.056673772633075714,
0.14110857248306274,
0.0430837906897068,
-0.13274763524532318,
0.07492408156394958,
0.25724804401397705,
0.382722944021225,
-0.12430974841117859,
-0.37511587142944336,
-0.7162168622016907,
0.3496896028518677,
0.8948862552642822,
-0.17247366905212402,
-0.2692565321922302,
0.21816620230674744,
-0.5077965259552002,
-0.051432207226753235,
-0.39565563201904297
] |
NCT01410916
|
Safety and Efficacy Study of Eculizumab in Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
|
This protocol is designed to collect safety and efficacy data on patients that have been or will be treated with eculizumab for STEC-HUS, in the context of the 2011 STEC-HUS epidemic in Germany.
|
Inclusion Criteria:
1. Patient must be willing and able to give written informed consent/Assent.
2. Adults, adolescents, or pediatric (≥2 months and ≥5kg) patients
3. Patient has been diagnosed with Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
Exclusion Criteria:
1. Known complement regulatory mutation or family history of complement regulatory mutation
2. Unresolved systemic meningococcal disease
3. 3. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
|
[
1.3383960723876953,
1.7842037677764893,
-0.15598127245903015,
-1.191726565361023,
0.7764473557472229,
-0.6583143472671509,
0.4145669639110565,
1.5836213827133179,
-0.11080960184335709,
0.6785508394241333,
1.2811365127563477,
2.158816337585449,
-0.0559987872838974,
1.6794742345809937,
0.9605227708816528,
1.0137885808944702,
0.2466699779033661,
1.4959359169006348,
-0.011995102278888226,
-0.6138585209846497,
0.007022624835371971,
-0.6638471484184265,
-0.5381610989570618,
-0.07677818089723587,
1.62310791015625,
-1.598495364189148,
0.6142858862876892,
-0.5894864201545715,
0.004146766383200884,
1.6356079578399658,
-0.6322965621948242,
0.6104605793952942,
1.0451977252960205,
-0.14225590229034424,
-0.2941707670688629,
-0.22360794246196747,
-0.005169272422790527,
1.1622742414474487,
-0.8960181474685669,
0.3104513883590698,
-1.1634587049484253,
0.23895469307899475,
0.8583881258964539,
-0.2367137372493744,
0.01038018986582756,
-0.8860642313957214,
0.42378848791122437,
-0.6719408631324768,
-0.6827028393745422,
0.2884339988231659,
-1.6249237060546875,
1.3121169805526733,
-0.8297737836837769,
1.247944951057434,
1.9289470911026,
0.6100224852561951,
-1.7360787391662598,
0.7511143684387207,
2.971435546875,
0.5021277666091919,
1.7488206624984741,
0.6315404772758484,
-0.19399240612983704,
0.9006522297859192,
-1.1743900775909424,
-0.9314634203910828,
0.4699099659919739,
0.7749490737915039,
-1.1853361129760742,
-0.3579096794128418,
0.5564935803413391,
-0.6391622424125671,
-0.02912227064371109,
0.024633778259158134,
0.19554108381271362,
-0.9710671305656433,
-0.2605806291103363,
0.40943315625190735,
0.24105443060398102,
0.16025573015213013,
0.6421507000923157,
0.3498259484767914,
-0.4517858028411865,
-0.38237014412879944,
0.022187555208802223,
-1.3759616613388062,
-1.24891197681427,
-0.6295225024223328,
1.0021498203277588,
-0.8392383456230164,
0.9135066270828247,
-0.43774181604385376,
-0.2649453282356262,
-0.5860958099365234,
-0.5941920280456543,
0.14763382077217102,
-1.7423763275146484,
-0.7499852180480957,
0.47577330470085144,
-0.1128552183508873,
-0.2261967957019806,
-0.6489894390106201,
-0.29939842224121094,
-0.5442070960998535,
-1.2233353853225708,
0.2894224226474762,
-0.9030008316040039,
0.1856260746717453,
0.7339937686920166,
-0.768775224685669,
-0.03874697908759117,
-0.25678205490112305,
0.03517383709549904,
-0.5010533928871155,
-0.5106057524681091,
-0.013349849730730057,
0.626237154006958,
0.8193100690841675,
-0.372763454914093,
-0.4541778564453125,
-0.02502901293337345,
1.5247461795806885,
0.10299453139305115,
0.4948383569717407,
-0.45158854126930237,
-0.5509344339370728,
1.0009652376174927,
0.9538233280181885,
-0.7985184788703918,
0.2863233685493469,
-1.459004282951355,
0.3836476802825928,
-1.56793212890625,
0.38476070761680603,
-0.42886433005332947,
0.22676561772823334,
1.147139072418213,
1.0717167854309082,
0.3192131221294403,
-0.2339259684085846,
0.8427624106407166,
0.35237595438957214,
0.43165573477745056,
-0.24984748661518097,
-0.9253270626068115,
-0.6793842911720276,
-0.7455917000770569,
0.7009071111679077,
-1.006611943244934,
-1.3626344203948975,
0.38825371861457825,
0.35708755254745483,
-0.10493595153093338,
-0.1171455979347229,
0.10637199133634567,
-0.4426310658454895,
0.5357237458229065,
0.19187875092029572,
-0.10389254987239838,
0.12183608114719391,
-0.28916966915130615,
-0.6719195246696472,
0.6591740250587463,
0.21684448421001434,
0.42870286107063293,
0.3926548361778259,
-0.16809748113155365,
-0.08668423444032669,
0.5172774791717529,
0.5376063585281372,
-0.645038902759552,
-0.6495605111122131,
-0.21727310121059418,
0.05992567166686058,
-0.16746047139167786,
0.31496089696884155,
0.5445245504379272,
-0.3528522849082947,
0.48439180850982666,
0.2492038905620575,
0.11266612261533737,
-0.44544142484664917,
0.43316739797592163,
0.5243921279907227,
-0.16439665853977203,
-0.04564591497182846,
-0.2527654469013214,
-0.15725363790988922,
0.6415114998817444,
0.7976181507110596,
-0.20944544672966003,
-0.8087425827980042,
0.1230880543589592,
0.052537593990564346,
0.6994454264640808,
-0.4285929203033447,
-0.5799248218536377,
-0.5410860776901245,
0.9067520499229431,
0.3375609815120697,
0.5041167736053467,
0.06552393734455109,
-0.19324463605880737,
0.17025870084762573,
0.23703935742378235,
0.2787579596042633,
0.6134993433952332,
-0.1470743864774704,
0.5839300155639648,
1.2019786834716797,
0.3725256323814392,
-0.6301824450492859,
0.44906705617904663,
-0.18824335932731628,
0.011712383478879929,
0.699388325214386,
-0.012288366444408894,
0.08789104968309402,
-0.3644636869430542,
0.14236421883106232,
-0.43542611598968506,
-0.6718811392784119,
-0.425409734249115,
0.0435531847178936,
0.43111342191696167,
-0.05690860375761986,
-0.1631198674440384,
-0.2553522288799286,
-0.4395766258239746,
0.328199177980423,
-0.3370157480239868,
-0.2901838421821594,
0.00019067070388700813,
-0.14132367074489594,
-0.4812580347061157,
-0.3275509774684906,
-0.09329551458358765,
0.5840497612953186,
0.475614994764328,
0.051513396203517914,
0.1671537607908249,
-0.8427699208259583,
-0.3137133717536926,
-0.6625135540962219,
0.26658132672309875,
0.03224192187190056,
0.3313591182231903,
-0.21976791322231293,
0.15526339411735535,
0.10075736790895462,
-1.0625373125076294,
-0.4774470925331116,
-0.48540598154067993,
-0.0756826251745224,
0.5238603353500366,
-0.2934695780277252
] |
|
NCT04845919
|
Sonodynamic Therapy with ExAblate System in Glioblastoma Patients
|
The goal of this prospective, non-randomized, single-arm study is to evaluate the safety and feasibility of sonodynamic therapy with 5-aminolevulinic acid in patients with newly diagnosed cerebral glioblastomas using the ExAblate Model 4000 Type-2 "Neuro-System".
Patients will be consented, screened, and will undergo study SDT treatment with 5-ALA using the ExAblate Model 4000 Type-2 "Neuro-System". After SDT treatment, patients will perform a strict neuro-radiological follow-up (minimum of 2 MRI) and undergo tumor resection 15-21 days after SDT, according to the clinical and radiological status.
The main goal of the present study is to investigate the safety and feasibility of SDT in patients affected by GBMs attained with low-frequency FUS.
In particular:
Safety will be evaluated by patient examination and MRI images during the treatment, and by follow-up MRI and clinical and neurological visits.
To evaluate feasibility, the extent of the sonicated area will be calculated at the end of the procedure in order to evaluate the targeted area.
Secondary objective of the trial is to assess the efficacy of the SDT procedure in terms of tumor regression and/or cell apoptosis and necrosis.
|
Despite progress made in many cancer treatments, High-Grade Gliomas (HGG) remain an extraordinary challenge. Their aggressive and infiltrative nature, the limited efficacy and inherent risk of surgical resection combined with radiotherapy, and the difficulty in delivering anticancer drugs to the brain, make the prognosis for patients with gliomas grim. Therefore, new and less-invasive alternatives to existing procedures are needed.
Sono-Dynamic Therapy (SDT) represents an emerging approach that offers the possibility of noninvasively eradicating solid tumors in a site-directed manner. It involves the delivery of a non-toxic chemical agent that selectively accumulates into target areas and the subsequent exposure of the targeted tissue to relatively low-intensity ultrasound. These procedures (sensitization and ultrasound exposure) are both per se harmless, but, when combined, result in activation of the chemical agent and subsequent cytotoxic events limited to the target tissue volume. SDT offers significant advantages because ultrasound energy can be tightly focused and delivered through the intact skull to deep areas of the brain, depending on the frequency. SDT is achieved by focusing low-intensity and lowfrequency ultrasound, which, as opposite to high-intensity ultrasonic beams, can be focused effectively within the whole intracranial space with the currently available device ExAblate 4000, Insightec, Haifa, Israel). This would enable to target also tumors in the peripheral area of the intracranial space. 5-ALA is a PpIX (Protoporphyrin IX) precursor that selectively accumulates in HGGs because of an enhanced uptake and metabolism from tumor cells. It is used for intra-operative guidance in surgery as tumoral tissues shows an exceeding fluorescence under certain light conditions due to PpIX accumulation, as compared to the normal surrounding parenchyma. It is therefore a good candidate for SDT. 5-ALA can exert sono-dynamic effects against HGGs, as it has been shown in several preclinical studies. Pre-clinical data on a safety experiment conducted at the University of Virginia showed that SDT with 5-ALA was not exerting a toxic effect to the normal brain \[Raspagliesi L. et al. 2021\].
The idea of the present study is to investigate the antitumor effects of SDT in patients affected by HGGs attained with low-frequency Focused Ultrasound. Focused Ultrasound under MRI-guidance can be safely delivered through an intact human skull to perform SDT in combination with 5-ALA with a low risk of transient adverse effects, and will be evaluated during follow-up visits, postprocedural serial MRI, and histology.
The main goal of this prospective, non-randomized, single-arm study is to evaluate the safety and feasibility of SDT in patients with newly diagnosed cerebral glioblastomas using the ExAblate Model 4000 Type-2 "Neuro-System". The ExAblate Model 4000 Type-2 "Neuro-System" is intended for use as a tool to induce targeted tumor's inhibition of growth and cell destruction in patients with cerebral lobar glioblastomas.
Patients harboring newly diagnosed lobar glioblastoma according to RANO criteria will provide informed consent, will be screened, and will undergo study SDT treatment using the ExAblate Model 4000 Type-2 "Neuro-System". After SDT treatment, patients will perform a strict neuro-radiological follow-up (minimum of 2 MRI) and undergo tumor resection about 15-21 days after SDT, according to the clinical and radiological status.
The main purpose of this study is to evaluate the safety and feasibility of SDT. In particular, safety will be evaluated by patient examination and MRI during the treatment, and by follow-up by daily clinical visits and MRI every 5 (± 2) days according to clinical and radiologic findings. Safety data will be assessed during each visit through a combination of MRI evaluations, clinical assessments, and neurological examinations, according to the clinical findings assessed until the decision to proceed with surgical resection. Feasibility will be evaluated performing 4 MRI (Day 1, 5, 10, 15) after SDT treatment evaluating tumor size, morphology and perilesional edema until tumor resection.
A secondary objective of the present study is to assess the efficacy of the treatment; in particular, to investigate the antitumor effects of SDT in patients affected by HGGs attained with low-frequency
Focused Ultrasound, the following data will be collected:
* Tumor volume changes after SDT according to sonicated tumors volumes (by imaging).
* Histology after tumor resection, comprising assessment of apoptosis and necrosis.
Despite all current treatment modalities, glioblastoma patient's prognosis remains dismal. By proving that procedure is safe and feasible this study will establish the SDT treatment modality as a possible alternative or a synergistic tool to current treatment modalities. It will also pave the way to the application of SDT in other forms of brain tumors, both intra- and extra-axial, and to the development of tumor specific sono-sensitizers.
|
Inclusion Criteria:
1. Men or women, age between 18 and 75 years, inclusive.
2. Suspected primary lobar Glioblastoma clearly measurable on the basis of Response Assessment in Neuro-Oncology (RANO) criteria
3. Newly diagnosed brain glioblastomas located in a surgically accessible brain region for resection
4. The targeted tumor resection volume measures between 1 cm and 6 cm in diameter.
5. Karnofsky rating 70-100.
6. ASA score 1-3.
7. Able to attend all study visits.
8. No previous brain surgery.
9. No previous radiation treatment.
10. No previous systemic treatment for the tumor.
11. Able and willing to give Informed Consent.
12. No contraindication to MRI.
13. No contraindication to brain surgery.
14. Contraceptive use by both male and female subjects consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Male participants: Male participants must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception. The participants must agree to use the contraception during the whole period of the study and for 12 weeks after the study intervention injection.
* Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: (i) is a woman of nonchildbearing potential (WONCBP) as defined in Appendix C Contraception and Barrier Guidance OR (ii) is a WOCBP and using an acceptable contraceptive method as described in Appendix C: Contraceptive and Barrier Guidance during the study intervention period (at a minimum until after the last dose of study intervention).
Exclusion Criteria:
1. Brain glioblastoma presenting with the following characteristics:
* Brain edema and/or mass effect that causes midline shift of more than 15 mm
* Evidence of recent intracranial hemorrhage within the targeted tumor volume
* Calcifications in the focused ultrasound sonication path (system tools may not tailor the treatment around these calcifications)
2. The sonication pathway to the tumor involves either:
* more than 30% of the skull area traversed by scars, scalp disorders (e.g., eczema), or atrophy of the scalp
* Clips, shunts, or other metallic implanted objects in the skull or the brain
3. Cardiac disease or unstable hemodynamic status including:
* Documented myocardial infarction within six months of enrolment
* Unstable angina on medication
* Congestive heart failure
* Left ventricular ejection fraction \< 50%
* Right-to-left, bidirectional, or transient right-to-left cardiac shunts
* History of a hemodynamically unstable cardiac arrhythmia
* Cardiac pacemaker
4. Severe hypertension
5. Anti-coagulant therapy or medications known to increase risk of hemorrhage within washout period prior to treatment
6. History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage
7. Abnormal level of platelets (\<100000) or INR \>1.3
8. Cerebral or systemic vasculopathy
9. Known allergy sensitivity or contraindications to gadolinium
10. Contraindications to MRI such as non-MRI-compatible implanted devices
11. Subjects not fitting comfortably into the MRI scanner
12. Difficulty lying supine and still for up to 4 hours in the MRI unit or claustrophobia
13. Positive pregnancy test (for pre-menopausal women) (see Appendix C)
14. Severely impaired renal function with estimated glomerular filtration rate \<30mL/min/1.73m2 and/or on dialysis
15. Respiratory: chronic pulmonary disorders (e.g., severe emphysema, COPD, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area).
16. Other contraindications to 5-ALA, including chronic or acute porfiria, and hypersensibility to 5-ALA or porfirins
17. Any illness or medical condition that in the investigator's opinion precludes participation in this study
18. Patients unable to sign an Informed Consent
|
[
0.06376112252473831,
2.7580602169036865,
-1.8385403156280518,
-2.2646522521972656,
0.5496041774749756,
0.48509839177131653,
-0.15640947222709656,
-0.420462429523468,
-1.736473560333252,
0.24276408553123474,
-0.6657689213752747,
1.0698435306549072,
-0.9944620132446289,
0.7028076648712158,
0.14494018256664276,
1.2626261711120605,
0.10746505856513977,
0.4340980350971222,
0.5760616064071655,
-1.0870007276535034,
1.0298144817352295,
-0.5346019268035889,
-0.16576118767261505,
0.40510526299476624,
0.322543740272522,
-0.8069761991500854,
-0.7941353917121887,
1.7075369358062744,
0.4714334011077881,
0.7398622632026672,
-0.740410327911377,
-0.7281669974327087,
-0.07071898877620697,
0.9291066527366638,
1.0180567502975464,
0.4288385212421417,
0.774919867515564,
0.38196808099746704,
-1.0620728731155396,
-0.09838100522756577,
0.5476617813110352,
0.6356602311134338,
-0.4014478921890259,
-0.4276058077812195,
0.6091926097869873,
0.7730661630630493,
-0.026456143707036972,
-0.029791807755827904,
0.11224088072776794,
-0.4517876207828522,
-0.07464738935232162,
0.5049280524253845,
-1.4506726264953613,
0.12242811918258667,
1.2454338073730469,
0.35180503129959106,
0.7517449855804443,
-0.2738061547279358,
2.0501794815063477,
0.26567012071609497,
0.4513704776763916,
0.08888445794582367,
0.3756440281867981,
0.33835694193840027,
-0.38611406087875366,
-0.3925459384918213,
-0.6799079179763794,
0.16080598533153534,
-0.6786734461784363,
-0.7941347360610962,
1.1374858617782593,
-0.017970334738492966,
0.576954185962677,
-0.16938148438930511,
-0.13635103404521942,
0.6836423873901367,
0.051530443131923676,
0.16342438757419586,
0.8411461710929871,
0.09201331436634064,
0.04729628190398216,
-0.7905936241149902,
-0.6175901889801025,
0.3218448758125305,
0.6765698194503784,
-0.2336420714855194,
-0.9797403812408447,
0.11079806089401245,
0.5489189624786377,
-0.36477357149124146,
0.4032021164894104,
-0.014601544477045536,
-0.8501284122467041,
0.8155307769775391,
-0.9061961770057678,
0.5935138463973999,
0.23657330870628357,
-0.7355268001556396,
-1.172603964805603,
-0.5881255269050598,
-0.3511015474796295,
-0.14260289072990417,
-0.4123055040836334,
-0.01330303680151701,
-0.7583032250404358,
-0.05679842457175255,
0.3591914176940918,
-0.6588453650474548,
0.012763477861881256,
-1.0116174221038818,
0.7588725686073303,
-0.9339064955711365,
-0.011149168014526367,
-0.6899935007095337,
-0.04754982888698578,
0.14053598046302795,
0.572833240032196,
0.15777331590652466,
0.31704840064048767,
-0.05833754315972328,
0.3605150580406189,
0.18514923751354218,
-0.1711922287940979,
0.2882117033004761,
-0.7369997501373291,
-0.15729545056819916,
0.004091999493539333,
-0.037187609821558,
-0.3568810224533081,
-1.0949126482009888,
-0.6950010061264038,
0.00972847267985344,
-0.007388127967715263,
0.2581373453140259,
-0.5367260575294495,
0.017039446160197258,
0.26783081889152527,
0.3599925637245178,
-0.2940690517425537,
-0.5717613101005554,
0.47295302152633667,
0.4869968593120575,
0.280119925737381,
0.31088629364967346,
-1.1744874715805054,
-0.24119529128074646,
-0.3906579613685608,
0.2647407650947571,
-0.6324111223220825,
-0.2535113990306854,
-0.0036145702470093966,
0.3180530369281769,
-0.07205358892679214,
0.08680801838636398,
0.020281951874494553,
0.3839890956878662,
0.2164868712425232,
-0.2347010374069214,
0.10695359110832214,
-0.5402200818061829,
-0.22362081706523895,
-0.5460793972015381,
0.20737168192863464,
-1.2364734411239624,
0.7073538303375244,
0.16656357049942017,
-0.6013144254684448,
-0.49713394045829773,
0.22227081656455994,
0.2925918400287628,
-0.03963937982916832,
0.16031907498836517,
0.2802431583404541,
0.39416995644569397,
-0.10602381825447083,
-0.08772291988134384,
0.4872440993785858,
-0.04621685668826103,
0.2985455095767975,
0.06209950894117355,
-0.204703226685524,
0.2189318984746933,
0.161803737282753,
-0.5708351135253906,
0.07584655284881592,
-0.07870318740606308,
-0.1059759259223938,
-0.001019695308059454,
0.12214595824480057,
-0.24837589263916016,
0.3101324737071991,
-0.07944592833518982,
0.21533474326133728,
0.1718108355998993,
0.3943917155265808,
-0.2992091178894043,
-0.5298244953155518,
-0.5510916709899902,
0.30843889713287354,
-0.3128657639026642,
0.5803226828575134,
0.49378836154937744,
-0.2552565038204193,
0.1858680546283722,
0.36614111065864563,
-0.011812249198555946,
0.07172398269176483,
0.24910417199134827,
-0.3752162456512451,
0.25443166494369507,
-0.13566339015960693,
0.02649553120136261,
-0.4295049011707306,
0.10463790595531464,
0.1039731428027153,
-0.2043105810880661,
0.302333265542984,
0.33800533413887024,
-0.860729455947876,
0.15547937154769897,
0.06958744674921036,
-0.4572668969631195,
0.2247847616672516,
0.32058584690093994,
-0.1449066549539566,
-0.32460036873817444,
-0.08582652360200882,
-0.011723066680133343,
0.09730883687734604,
-0.17399519681930542,
-0.1349194049835205,
0.2350451797246933,
0.3286110758781433,
-0.006779387127608061,
-0.24945004284381866,
0.08657385408878326,
0.15274560451507568,
0.4452798068523407,
-0.10416723042726517,
0.46332457661628723,
0.26642799377441406,
-0.37609583139419556,
0.25465142726898193,
-0.05365371331572533,
0.04407089203596115,
-0.14662808179855347,
-0.059904638677835464,
-0.393493115901947,
0.08177907764911652,
0.2290651500225067,
-0.1335042417049408,
-0.5372855067253113,
0.3352251350879669,
0.08691111207008362,
0.015692390501499176,
-0.1234784945845604
] |
NCT05936346
|
Evaluation of Safety and Tolerability of Salvia Haenkei Extract As a Dietary Supplement Ingredient
|
Evalution of the safety and tolerability of the oral administration of Salvia haenkei in a healthy population.
|
The aim of the study is to assess the safety and tolerability of the oral administration of Salvia haenkei in a healthy population. Furthermore, Salvia haenkei has been identified as a potential anti-senescence agent and may counteract aging and aging-associated disorders. In this scenario, the current study aims also at exploring the effects of this supplementation on muscular and other organ functions (kidney, liver, heart, etc.) and on systemic inflammation and metabolism.
|
Inclusion Criteria:
* Informed consent as documented by signature
* Male or female
* Age 55-65 years, inclusive
* In good general health as evidenced by medical history and current health status
* Willingness to maintain dietary and sports habits as of baseline
* Willingness and ability to comply with the requirements of the study
Exclusion Criteria:
* Body Mass Index \< 18.5 or ≥ 30
* Difficulty in swallowing (dysphagia)
* Known allergy or sensitivity to any ingredient of the study intervention
* Any medical condition or clinically significant abnormalities in laboratory values (hematology, blood chemistry, urinalysis) at screening which in the judgment of the Investigator makes the subject unsuitable for the study
* Planned or anticipated major surgical procedure during the subject's participation in this study
* Inability or contraindications to undergo the study intervention
* Inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, dementia, etc.)
* Use of any new vitamins, herbal or dietary supplements, functional foods and sports drink, of any kind, liable or presented as liable to enhance physical performances within one month prior to the start and during the study
|
[
0.9191750288009644,
0.5516330599784851,
-3.080601453781128,
-1.3604497909545898,
0.48649391531944275,
0.49008476734161377,
0.18280382454395294,
1.2301585674285889,
-0.7727236151695251,
-2.1529924869537354,
0.8056685924530029,
2.3106911182403564,
-0.920000433921814,
0.1490667462348938,
2.7169313430786133,
1.6755385398864746,
1.5443530082702637,
2.0899274349212646,
0.5480778217315674,
-3.0641748905181885,
3.1102206707000732,
1.597249150276184,
-0.4910462498664856,
0.5423285961151123,
0.6106783747673035,
-1.3446005582809448,
-0.4523409307003021,
-2.178917407989502,
-0.25365495681762695,
2.386829137802124,
0.23782411217689514,
-2.355283737182617,
-1.0671902894973755,
-0.30235058069229126,
1.1738137006759644,
0.00018059760623145849,
0.018176550045609474,
0.07658591866493225,
-0.8339505195617676,
0.06988027691841125,
-0.3835069239139557,
-0.6888834238052368,
1.0699597597122192,
-0.5124619603157043,
0.5904971361160278,
0.33778733015060425,
0.6593753099441528,
-0.04236328974366188,
0.8635017275810242,
1.5808193683624268,
-0.47979581356048584,
-0.023645080626010895,
-0.5737515091896057,
0.053767550736665726,
3.2876503467559814,
-0.3580677807331085,
-0.25418081879615784,
-2.124329090118408,
1.9029940366744995,
0.3468096852302551,
0.5543237924575806,
-1.2649059295654297,
-0.12157055735588074,
-0.15152238309383392,
-3.1605091094970703,
0.20057332515716553,
0.8185392022132874,
0.7874698042869568,
-1.348564624786377,
0.44086116552352905,
-1.166449785232544,
-0.8594117164611816,
0.5555241107940674,
-1.6059134006500244,
-0.763359785079956,
-0.6146194934844971,
1.170183539390564,
-0.3621985912322998,
0.6829884052276611,
-1.0630546808242798,
-0.3198488652706146,
-0.07736002653837204,
-1.2928239107131958,
0.6087619662284851,
1.8950140476226807,
-0.7504535913467407,
-0.8299646973609924,
-1.10117769241333,
1.605961561203003,
0.4771912693977356,
0.2691701650619507,
-0.7517076134681702,
-2.4542975425720215,
-0.748024046421051,
-0.654619574546814,
-1.699987769126892,
-0.6609353423118591,
-0.9434068202972412,
0.20104457437992096,
-1.271772027015686,
-0.8963576555252075,
0.8519824743270874,
0.9702910780906677,
-0.7625070810317993,
-0.5387141108512878,
0.8511621952056885,
-0.6784632205963135,
0.10622435808181763,
-0.46811816096305847,
0.4058973789215088,
-0.31693992018699646,
0.0768178179860115,
-0.6809451580047607,
-0.19798965752124786,
0.8018653988838196,
-1.0212482213974,
0.4357336461544037,
-0.5345505475997925,
-0.5128647089004517,
-1.0557750463485718,
-0.46130087971687317,
0.15456463396549225,
0.31225839257240295,
-0.38421130180358887,
-0.4710793197154999,
0.049056269228458405,
0.4717685580253601,
-0.26509833335876465,
0.4304121732711792,
0.9365190267562866,
-0.8374306559562683,
0.3264644742012024,
-1.4363597631454468,
0.12920460104942322,
-0.1706477701663971,
-0.05296621844172478,
0.313513845205307,
-0.4648922383785248,
1.2867798805236816,
0.35007867217063904,
-1.9009976387023926,
0.761443018913269,
-0.24109956622123718,
-0.9053710699081421,
-0.9743784070014954,
0.11421319842338562,
0.051872123032808304,
-0.09244342148303986,
0.044102706015110016,
-0.10993974655866623,
-0.1966378539800644,
0.7765647768974304,
0.19367389380931854,
-1.2574976682662964,
0.2189544439315796,
1.1961532831192017,
1.7608609199523926,
-0.5532209277153015,
0.9144831895828247,
0.1458524912595749,
-0.6301553249359131,
1.2352865934371948,
-1.3646867275238037,
-0.4158213138580322,
-1.4843475818634033,
-0.21111896634101868,
1.0737440586090088,
-0.7741998434066772,
-0.6300901174545288,
0.6134613156318665,
0.07100031524896622,
-0.655805766582489,
-0.270636647939682,
-0.19667284190654755,
0.7495646476745605,
-0.18470847606658936,
1.2228162288665771,
0.07139153778553009,
-0.22088243067264557,
0.9180858731269836,
-0.38869738578796387,
-0.3977130055427551,
-0.0220391433686018,
0.30829936265945435,
-0.4653882086277008,
-0.5543198585510254,
0.6425465941429138,
-1.0757986307144165,
0.4456750452518463,
0.13421820104122162,
-0.9148243069648743,
0.14874492585659027,
-0.8226781487464905,
0.6095373630523682,
-0.2536422908306122,
-0.279541939496994,
-0.6324403285980225,
-0.4719100892543793,
0.4055686891078949,
0.03039512224495411,
-0.6127447485923767,
-0.4582999050617218,
-0.16854767501354218,
-0.7275594472885132,
0.33728477358818054,
0.9268826246261597,
-0.9990004897117615,
0.1886136382818222,
0.16572600603103638,
-0.614783525466919,
0.2818976938724518,
-0.5725322961807251,
0.048275791108608246,
-0.9045947194099426,
1.357503056526184,
0.3051374554634094,
0.20136116445064545,
0.3802964389324188,
-0.1926637440919876,
0.8981914520263672,
0.02154141664505005,
-0.2733299732208252,
-0.8035342693328857,
0.14641669392585754,
-0.6434577107429504,
-0.04870755597949028,
-0.7139378190040588,
-0.3294340968132019,
0.14928779006004333,
-0.4520432949066162,
-0.7106505036354065,
-0.35417279601097107,
-0.41928309202194214,
0.10059502720832825,
-0.6393182277679443,
0.250180184841156,
-0.1998831033706665,
0.5189680457115173,
0.29227548837661743,
0.17168264091014862,
0.10521524399518967,
-0.5035765171051025,
0.26728734374046326,
-0.1146048754453659,
0.5251070261001587,
-0.7717819213867188,
-0.18170279264450073,
0.43264007568359375,
-0.623420774936676,
-0.6550657153129578,
-0.24653510749340057,
0.4521394371986389,
-1.0506963729858398,
-0.6121425032615662,
-0.028286544606089592,
-0.2873688042163849
] |
NCT05189678
|
Correlation Between Modified Weakness Index and Postoperative Delirium in Elderly Patients
|
1. To study whether there is a correlation between weakness and postoperative delusions in elderly non-cardiac surgery patients
2. Can the improved debilitating index predict the delusion after non-cardiac surgery
3. Which of the debilitating index are independent risk factors associated with postoperative delusions
|
Early identification of frailty patients is of great clinical significance for preoperative decision making and prognosis assessment. To date, the incidence of postoperative delirium in elderly patients undergoing noncardiac surgery has not been assessed. This study aimed to investigate the relationship between preoperative frailty assessment and the incidence of postoperative delirium after noncardiac surgery.
1. To study whether there is a correlation between weakness and postoperative delusions in elderly non-cardiac surgery patients
2. Can the improved debilitating index predict the delusion after non-cardiac surgery
3. Which of the debilitating index are independent risk factors associated with postoperative delusions
|
Inclusion Criteria:
1. Age ≥ 70 years old;
2. ASA: Grade Ⅰ～Ⅳ;
3. Signed informed consent；
4. Scheduled non-cardiac surgery.
Exclusion Criteria:
1. Refuse to participate;
2. Expected length of stay \<3 days;
3. The same patient can only be included once, regardless of whether the reason for the second operation is related to the first cause;
4. Emergency surgery patients;
5. Inability to communicate due to illiteracy, language impairment, severe hearing or visual impairment;
6. Central nervous system diseases, including various types of dementia and depression
7. Severe renal insufficiency (requiring dialysis treatment);
8. Severe liver dysfunction (Child-Pugh score ≥10);
9. Patients who have participated in other relevant clinical studies within 3 months MMSE examination has confirmed the existence of cognitive dysfunction: illiteracy ≤17 points, primary school degree ≤20 points, middle school degree (including technical secondary school) ≤22 points, university degree (including junior college) ≤23 points
|
[
-0.27556151151657104,
3.422163486480713,
-2.7750136852264404,
-1.7906253337860107,
0.7240294218063354,
-0.9858359098434448,
-0.1015968918800354,
-0.40495651960372925,
-1.9434962272644043,
1.705053448677063,
1.4165794849395752,
1.4895117282867432,
-0.9446461200714111,
1.6390300989151,
-1.7614954710006714,
0.9645156860351562,
-0.07668036967515945,
-1.5923950672149658,
1.1031850576400757,
-1.0815775394439697,
-0.10267450660467148,
1.1010257005691528,
0.8997990489006042,
-0.75217205286026,
0.22125616669654846,
-0.6377047896385193,
1.463879108428955,
0.5580875277519226,
-0.39225637912750244,
-0.45412561297416687,
-0.7320386171340942,
-1.8613018989562988,
-0.20634642243385315,
1.9697619676589966,
0.6308289766311646,
0.05132570117712021,
-1.8340582847595215,
-1.4557744264602661,
-2.440965414047241,
0.06601095199584961,
1.7749583721160889,
1.3270801305770874,
-0.4013543426990509,
0.7884756326675415,
1.1656850576400757,
1.2844932079315186,
-0.05125623196363449,
1.2995260953903198,
-0.7765756249427795,
-0.48145943880081177,
-1.8655539751052856,
0.9936432242393494,
-0.8899682760238647,
-0.11365624517202377,
0.719135046005249,
1.432969331741333,
1.6920477151870728,
-0.2570406496524811,
0.2357010841369629,
-0.25667059421539307,
0.6236108541488647,
-0.5849226713180542,
-0.1670941263437271,
1.6314274072647095,
-1.933383584022522,
-1.2626657485961914,
-0.1659330576658249,
0.03484845161437988,
-1.636512279510498,
-0.6106157898902893,
-0.0037608761340379715,
-0.21434499323368073,
-0.015461287461221218,
-0.24861229956150055,
0.9679034948348999,
-0.2710689306259155,
-0.6343036890029907,
1.3342863321304321,
1.1889210939407349,
0.4151034951210022,
-0.5271512866020203,
-0.34811046719551086,
-1.179362177848816,
0.02137676253914833,
-0.7473765015602112,
-0.5005175471305847,
-1.1197013854980469,
-1.26405668258667,
0.9691833257675171,
-0.6895341277122498,
-0.16747084259986877,
0.7057323455810547,
-1.2649813890457153,
1.0480986833572388,
-0.6246451139450073,
-0.33802446722984314,
-0.4008462429046631,
-0.2715318500995636,
-1.9501700401306152,
-1.749196171760559,
0.23535405099391937,
-0.21443501114845276,
-0.5718284845352173,
0.6079912781715393,
0.07882245630025864,
-0.3797608017921448,
0.4771096408367157,
-1.4700722694396973,
-0.49644750356674194,
0.0905703529715538,
1.046133279800415,
-1.1666451692581177,
0.40451979637145996,
-0.08752826601266861,
-0.322843998670578,
0.8958327174186707,
0.2641623914241791,
0.15143783390522003,
0.7270954251289368,
-0.7039659023284912,
-0.6026308536529541,
0.5156804323196411,
-0.7527880668640137,
0.6640991568565369,
-1.0842784643173218,
0.1642899066209793,
-0.43679484724998474,
1.4233064651489258,
-0.07275393605232239,
0.4931718707084656,
-0.36659112572669983,
0.5064635276794434,
0.1436135470867157,
-0.05949601158499718,
-1.8986825942993164,
1.4346133470535278,
-0.16031403839588165,
-0.7707669734954834,
-0.2353833168745041,
-0.7224580645561218,
-0.1414114087820053,
-0.5978924036026001,
-0.5448201298713684,
0.9418164491653442,
-0.09832821041345596,
-0.18720075488090515,
0.05705588683485985,
0.48030999302864075,
-0.5236658453941345,
0.08771377801895142,
-0.02776525542140007,
-0.24567829072475433,
-0.21721169352531433,
-0.09870795160531998,
0.7866936326026917,
0.19768331944942474,
0.09108060598373413,
0.2780131995677948,
0.18950530886650085,
-0.36340606212615967,
-0.806243896484375,
0.7423518896102905,
-0.05330963805317879,
-1.4651930332183838,
0.09347206354141235,
-0.6934892535209656,
0.42952731251716614,
-0.18101434409618378,
0.1992906779050827,
0.12372714281082153,
-1.1152544021606445,
0.38787832856178284,
-0.03892134875059128,
0.2333502173423767,
-1.1553281545639038,
0.9792101383209229,
-0.3213961124420166,
0.3800589144229889,
-0.3317674994468689,
-0.07072404026985168,
0.4204511344432831,
-0.9867806434631348,
-0.14830024540424347,
0.29026588797569275,
0.3543596863746643,
0.897293210029602,
0.49396857619285583,
-1.338297963142395,
-0.7537658214569092,
0.6357665657997131,
-0.8116421103477478,
0.23783357441425323,
-0.7371028661727905,
-0.6714476943016052,
0.6770964860916138,
0.5129365921020508,
-0.9355950951576233,
0.03325863182544708,
-0.1432192027568817,
-0.3939576745033264,
0.003324443707242608,
1.2741408348083496,
-1.0403109788894653,
0.3676479458808899,
0.22093649208545685,
-0.356578528881073,
-0.10488637536764145,
-0.5273707509040833,
-0.48688188195228577,
-0.34652143716812134,
-0.5550392866134644,
0.6024532914161682,
-0.08391036838293076,
0.4118535816669464,
-0.705297589302063,
0.16569583117961884,
-0.6872363090515137,
-0.35937950015068054,
-1.3255573511123657,
0.7178727984428406,
0.42150232195854187,
-0.31908342242240906,
0.3583679497241974,
0.45675021409988403,
-0.0018827299354597926,
-0.5511726140975952,
0.4304927885532379,
-0.7011610269546509,
0.8372835516929626,
0.031776633113622665,
-0.7507719397544861,
-0.16168613731861115,
-0.24976269900798798,
-0.8055851459503174,
0.7050755023956299,
0.20103000104427338,
0.6617286205291748,
-0.06208477541804314,
0.3552032709121704,
1.0248178243637085,
-0.45175567269325256,
0.14301811158657074,
-0.386258989572525,
-0.13071584701538086,
-0.11534472554922104,
-0.2914332449436188,
-0.09561587870121002,
-0.7236136794090271,
-0.059670478105545044,
-0.04098973795771599,
0.4283498227596283,
-0.01517139095813036,
0.6515744924545288,
-0.02426525391638279,
-0.9428458213806152,
0.2906719744205475
] |
NCT02027597
|
Improving Oral Health With Serious Games
|
This study investigated if computer games can be effective at changing the way children take care of their teeth. We a museum exhibit with 3D virtual reality games called "Attack of the S. Mutans!" Our hypothesis was that children who played the games and visited the exhibit would show improved attitudes about oral health, which would translate into improved brushing and self-care habits.
In this randomized controlled study with school children aged 8-12, we compared the outcomes for three groups: Group 1) Visited Attack of the S. Mutans!; Group 2) Experienced a hands-on classroom presentation about virtual reality being used for healthcare; Group 3) Received no-treatment.
|
Inclusion Criteria:
For participation in the study, enrollment criteria are as follows: 1) a dentist's diagnosis of tooth decay, or restorative dental work in the previous year; and 2) Parents or guardians provide usable baseline data, including contact information for follow-up questionnaires.
Exclusion Criteria:
None
|
[
-0.6281530857086182,
2.8613874912261963,
-1.0574549436569214,
-0.5203243494033813,
-0.6419568061828613,
0.7186667919158936,
-1.1659867763519287,
-1.5283584594726562,
-0.7843714952468872,
0.3313852846622467,
0.2533246874809265,
1.1915029287338257,
-0.3758649528026581,
0.3181340992450714,
-0.3766176700592041,
1.052940011024475,
1.1707468032836914,
-0.19740472733974457,
0.35773617029190063,
-0.18849153816699982,
0.07719311863183975,
0.09837792068719864,
-0.7101340889930725,
-0.7855633497238159,
-0.2702333629131317,
0.7739205360412598,
-1.6144226789474487,
0.3531755805015564,
-0.2070762813091278,
1.4599231481552124,
-0.24317295849323273,
-0.4882466793060303,
0.28248220682144165,
0.23245911300182343,
0.4749075472354889,
0.6944727897644043,
0.34255751967430115,
0.32028278708457947,
0.07295446842908859,
0.5743653178215027,
1.0378979444503784,
0.7430417537689209,
0.5405080318450928,
0.4204460680484772,
-0.2379976511001587,
1.6688638925552368,
1.5666213035583496,
0.4110168218612671,
0.22473584115505219,
-0.06818696856498718,
0.5301069617271423,
0.25510329008102417,
0.42494115233421326,
0.024754097685217857,
1.5721365213394165,
0.1025216355919838,
-1.1500003337860107,
0.1944328397512436,
0.8952522277832031,
-0.23915576934814453,
-0.23606109619140625,
0.00941401720046997,
1.0707638263702393,
0.48243433237075806,
-0.8029658794403076,
-0.18912863731384277,
-0.12102565914392471,
-0.1407380998134613,
-0.5597776174545288,
0.7062267065048218,
0.8425005078315735,
-0.0450407937169075,
0.6911048293113708,
-0.20123840868473053,
0.6217961311340332,
-0.46011289954185486,
0.14890913665294647,
-0.5137627720832825,
0.734865128993988,
0.5608153343200684,
-0.46614792943000793,
-0.31067463755607605,
-0.17147769033908844,
-0.31228142976760864,
0.31880977749824524,
-0.22218917310237885,
-1.2933954000473022,
0.10283223539590836,
0.4854534864425659,
-0.8937072157859802,
0.5206121206283569,
-0.35757002234458923,
-0.9968453645706177,
0.35285359621047974,
-0.5562314391136169,
0.4279225766658783,
0.5789026021957397,
-0.8298217058181763,
-0.6024293899536133,
0.7484564781188965,
0.6251413822174072,
-0.8261340260505676,
0.21999116241931915,
-0.5439279675483704,
-1.138688087463379,
0.09780701249837875,
-0.8809016346931458,
-0.038681164383888245,
-0.42723575234413147,
0.42970967292785645,
-0.2539435029029846,
-0.6360979676246643,
0.3959603011608124,
0.5275359153747559,
0.39338916540145874,
-0.6205717325210571,
0.9757989048957825,
0.44932109117507935,
-0.4993528425693512,
-0.3229612112045288,
0.0005751146818511188,
0.7073901295661926,
0.10547180473804474,
0.26457348465919495,
-1.1637179851531982,
0.6872565150260925,
0.07917875051498413,
0.02169250138103962,
-0.4704129695892334,
-0.7504602074623108,
-0.27110520005226135,
-0.12916573882102966,
0.2161617875099182,
-0.2306906282901764,
-0.39212727546691895,
-0.03515918552875519,
0.41161757707595825,
0.6813991665840149,
0.05082530900835991,
0.17515811324119568,
0.01928241178393364,
0.14920157194137573,
-0.36484554409980774,
0.15337322652339935,
-0.7957441210746765,
-0.31262287497520447,
0.06658011674880981,
-0.3075259327888489,
-0.7719131112098694,
0.16074080765247345,
-0.5781674385070801,
0.42670801281929016,
-0.5028721690177917,
-0.3043649196624756,
-0.6185719966888428,
0.3198149502277374,
0.3542802631855011,
-0.45388340950012207,
0.5699625611305237,
0.5028370022773743,
0.8634709715843201,
-0.09010143578052521,
-0.3265116214752197,
0.027001794427633286,
-0.254013329744339,
0.07341849058866501,
0.29675495624542236,
0.24396082758903503,
0.18384695053100586,
0.5981169939041138,
-0.17682771384716034,
0.7959365844726562,
0.2647329866886139,
0.060775917023420334,
0.14518190920352936,
0.19476401805877686,
0.8079814910888672,
-0.10889310389757156,
0.29843199253082275,
-0.1242009773850441,
0.1461661010980606,
-0.23694054782390594,
0.32281288504600525,
0.3099040985107422,
0.25368258357048035,
-0.39247775077819824,
-0.2820901572704315,
-0.5587623119354248,
0.19935649633407593,
0.09996853023767471,
-0.06088408827781677,
0.0371570885181427,
0.698013186454773,
0.21787633001804352,
0.3244856894016266,
-0.2944472134113312,
-0.49092164635658264,
0.07058893889188766,
0.24364300072193146,
-0.469367116689682,
0.5250873565673828,
0.01405723113566637,
-0.3608684837818146,
0.06265415996313095,
-0.3076555132865906,
-0.15253545343875885,
-0.1288093775510788,
-0.01156424731016159,
0.09399161487817764,
0.30037814378738403,
0.17552030086517334,
-0.06000823900103569,
0.4252293109893799,
0.14774221181869507,
0.06960543245077133,
-0.18058465421199799,
0.230773463845253,
0.10655463486909866,
-0.004092876799404621,
-0.09816772490739822,
-0.21377907693386078,
-0.13315795361995697,
0.10381630063056946,
0.27750036120414734,
-0.24680249392986298,
0.04573581740260124,
0.05257254093885422,
0.05835553631186485,
-0.21627114713191986,
0.2202683687210083,
0.17860263586044312,
-0.06955056637525558,
-0.06612765789031982,
0.10767676681280136,
0.05225757881999016,
0.48612093925476074,
-0.1228671669960022,
-0.042018890380859375,
-0.37516334652900696,
-0.06089043617248535,
0.07351476699113846,
-0.17315037548542023,
0.1395273655653,
-0.5785431265830994,
-0.2100750207901001,
-0.2435704469680786,
-0.38324159383773804,
0.2539951801300049,
0.05541616678237915,
-0.05744006857275963,
0.09241203963756561,
-0.12990809977054596,
0.16350769996643066,
-0.011096282862126827,
0.3047138750553131,
-0.48315930366516113
] |
|
NCT02971982
|
PCD Versus RCD for the Treatment of Patients With Waldenstrom's Macroglobulinemia
|
Patients will receive RCD or PCD combination as induction treatment followed by rituximab or velcade maintenance therapy, as the investigators try to compare the, very good partial remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR + partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
|
This is an open-label, single-centre, randomised study, looking at a series of 40 patients up to the age of 75 with newly diagnosed Waldenstrom's macroglobulinemia (WM) not previously treated. Patients will receive RCD or PCD combination as induction treatment followed by rituximab or velcade maintenance therapy, as the investigators try to compare the, very good partial remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR + partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
|
Inclusion Criteria:
* Recently diagnosed WM according to the second 2002 WM international working group
* Not previously treated, apart from not regularly received by Chlorambucil
* Aged from 18 to 75 years, both male and female
* Ability to give signed informed consent
* Negative pregnancy test at inclusion (if necessary)
* ECOG from 0 to 2
Exclusion Criteria:
* Known hypersensitivity to rituximab or velcade or cyclophosphamide
* Uncontrolled infection including bacteria, virus and fungus, including active HBV infection
* Organic dysfunction: Bilirubin \> 1.5 x normal above, Renal failure requiring dialysis, glutamic pyruvic transaminase (ALT) and Glutamic-Oxaloacetic Aminotransferase (AST) \> 2.5 x normal above
* Positive HIV serology
* Serious psychiatric item in the history
|
[
0.5372112989425659,
4.6597819328308105,
-1.1934260129928589,
-1.6424760818481445,
2.068906784057617,
1.4045422077178955,
1.4414854049682617,
1.448032259941101,
-1.2817803621292114,
-0.03644193336367607,
-0.7884583473205566,
0.837965190410614,
-1.6783595085144043,
0.589036762714386,
1.740150809288025,
0.1344863623380661,
-0.1560305953025818,
0.2563331127166748,
0.32416731119155884,
-0.5687737464904785,
-0.41535457968711853,
-0.7860784530639648,
-0.16177868843078613,
1.3519378900527954,
-1.2476383447647095,
-1.0712820291519165,
-2.2317147254943848,
2.2655935287475586,
0.6677329540252686,
2.013291835784912,
0.190731480717659,
1.1515036821365356,
-0.08677869290113449,
0.8759559988975525,
0.49159014225006104,
-0.9307999610900879,
0.44112908840179443,
-1.0833994150161743,
0.871097981929779,
-0.7875015735626221,
-0.3114551901817322,
-0.9934933185577393,
0.4005923867225647,
-0.2431626170873642,
0.8373402953147888,
1.3719590902328491,
-1.3640984296798706,
0.01149716041982174,
1.1182907819747925,
-0.6152113080024719,
-0.11170679330825806,
-0.26983848214149475,
-0.891411542892456,
1.273432731628418,
0.3414011597633362,
2.4645769596099854,
0.22861996293067932,
0.8482358455657959,
1.1635948419570923,
-0.5561527609825134,
0.7631269097328186,
0.6275212168693542,
0.1696891337633133,
-0.046468380838632584,
-0.5050040483474731,
0.094271719455719,
0.19118086993694305,
-1.0107970237731934,
-0.05460293963551521,
1.2792720794677734,
-0.044997211545705795,
0.7260574698448181,
1.4707227945327759,
1.4179394245147705,
-0.17764875292778015,
0.7853026390075684,
-1.6253172159194946,
1.3376834392547607,
0.4841215908527374,
0.5372052192687988,
-0.29523301124572754,
-0.07622417062520981,
-0.19053274393081665,
-0.27606675028800964,
-0.47443071007728577,
-0.8663238883018494,
-0.9665997624397278,
-1.9034656286239624,
0.32821837067604065,
-0.8661384582519531,
0.6351833939552307,
-1.2161906957626343,
-0.5637422800064087,
0.878514289855957,
-0.38001176714897156,
0.7160524129867554,
0.5376864671707153,
0.15169930458068848,
0.045910026878118515,
0.3221648633480072,
0.6598269939422607,
-0.39533731341362,
-0.16514943540096283,
-0.5799682140350342,
-0.7128362059593201,
-0.24144017696380615,
-0.6024026274681091,
-1.1522581577301025,
0.2318730652332306,
0.2582828402519226,
0.12647248804569244,
-1.0981483459472656,
-0.2821040153503418,
-1.2483502626419067,
0.3005465865135193,
0.7110498547554016,
0.07575994729995728,
-0.04657917097210884,
-0.08020353317260742,
0.9601089954376221,
-0.015405469574034214,
-0.297270804643631,
-0.48318853974342346,
0.423200398683548,
-0.37972649931907654,
-0.4483988285064697,
-0.1661701798439026,
0.1004863753914833,
-0.05146797001361847,
-0.004948743619024754,
-0.3170901834964752,
-0.0980365127325058,
-0.13027364015579224,
-0.1900855153799057,
-0.6857349872589111,
0.5958520770072937,
-0.3130345344543457,
1.0925434827804565,
0.7360868453979492,
0.20025400817394257,
0.32530203461647034,
-0.47574129700660706,
0.6315070986747742,
-0.6119728684425354,
-0.8689306378364563,
0.26998454332351685,
0.11883331835269928,
0.804987370967865,
0.05700425058603287,
0.8108894228935242,
-0.02925986237823963,
0.13938860595226288,
0.2508662939071655,
0.8464571237564087,
0.543887197971344,
1.1435606479644775,
1.1552680730819702,
0.39817187190055847,
0.026204071938991547,
-0.3191520869731903,
-0.4058115780353546,
-0.5324302911758423,
0.34532976150512695,
-0.4851730763912201,
1.2697068452835083,
0.07310008257627487,
-0.4781263768672943,
0.2874208092689514,
0.09884665906429291,
0.2714545726776123,
-0.40650635957717896,
0.06796357035636902,
0.23389220237731934,
-0.06528141349554062,
-0.14615190029144287,
0.5093744397163391,
0.03244533762335777,
0.5138746500015259,
0.9779858589172363,
0.1947522908449173,
0.541306734085083,
-0.0942404642701149,
-0.4096805453300476,
-0.43403446674346924,
-0.2392062395811081,
-0.09608358144760132,
0.6722536087036133,
-0.6756892800331116,
0.262301504611969,
-0.10263080894947052,
0.33352723717689514,
-0.33476608991622925,
0.11236909031867981,
0.03576419875025749,
0.2964039742946625,
-0.058696430176496506,
0.2208588868379593,
-0.3880329430103302,
-0.054940130561590195,
0.05257285758852959,
-0.13644415140151978,
0.0711992159485817,
0.23651716113090515,
0.29716798663139343,
-0.7603716850280762,
-0.04650307074189186,
0.014644710347056389,
-0.4123658537864685,
-1.3670316934585571,
0.827048659324646,
0.9282200336456299,
0.22062911093235016,
-0.5054740905761719,
0.018209602683782578,
0.33512991666793823,
0.45467454195022583,
0.34982365369796753,
0.2753604054450989,
-0.39554286003112793,
0.6065261960029602,
-0.0931236520409584,
-0.659003496170044,
-0.8203056454658508,
0.36724230647087097,
0.13266679644584656,
-0.48262643814086914,
0.45432010293006897,
-0.2748236656188965,
0.006402964703738689,
-0.2647078335285187,
0.13732708990573883,
0.12039763480424881,
0.019567862153053284,
-0.5937461256980896,
0.35044392943382263,
-0.6759437322616577,
-0.1892610490322113,
-0.3717533051967621,
-0.3379751741886139,
-0.18939058482646942,
0.7002759575843811,
-0.5462265610694885,
0.012618998996913433,
0.8616614937782288,
0.5706521272659302,
-0.3394356071949005,
0.1920618861913681,
-0.03886023908853531,
-0.3579119145870209,
-0.053802739828825,
0.23737727105617523,
0.5296767950057983,
0.434885174036026,
0.3451063930988312,
0.5057330131530762,
-0.1753649264574051
] |
NCT05199142
|
A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive Decline
|
This is a multi-center, double-blind, randomized, placebo-controlled study to determine the safety, tolerability, and pharmacodynamics of SDI-118 in a once daily (QD) dosing regimen on elderly male and female study participants with cognitive decline at screening.
|
Inclusion Criteria:
* Male and female study participants between 65 and 85 years of age (inclusive) at screening, with cognitive decline, defined as:
* \>25 on the MMSE;
* \<11 on the GDS; and
* IQCODE score of ≥52.
* Participants with delayed recall of ≤6 words from the ISLT 15 minutes after the presentation of the word list;
* Must be in good health for their age as determined by medical history, physical examinations, 12-lead ECGs, vital signs, and clinical laboratory assessments (serum chemistry, serum hematology, and urinalysis) performed at the Screening Visit;
* Must have an informant (eg, spouse, family member, caregiver, or other close contact) who has known the study participant for at least 10 years to provide data on the study participant;
* Negative serology tests for HIV antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies at screening;
* Have a body mass index of 18 to 36 kg/m2 inclusive;
* Agree not to use herbal medications (including herbal tea, St. John's Wort), within 14 days prior to study drug administration to the Safety Follow-Up Visit (Visit 7);
* Agree not to use previously prescribed medications that are expected to interfere with the absorption, distribution, metabolism, and/or excretion (ie, strong cytochrome P450 3A4 or 2C19 inhibitors or inducers, LEV, and brivaracetam) or safety/tolerability evaluation of SDI-118 or that could interfere with the objectives of the study (ie, medications with CNS activity);
* Participants must have signed an informed consent document indicating that the participants understand the purpose of, and procedures required for the study, and are willing to participate in the study;
* Smokers are allowed if their average daily consumption does not exceed 5 cigarettes per day (or maximum equivalent of 5 cigarettes per day);
* Non-vasectomized male participants with a female partner of childbearing potential must agree to use a condom from first dosing up to 90 days after the last dose. Additionally, the female partner must be willing to use a highly effective method of contraception;
* Female participants must have confirmed menopause;
* The participant, in the opinion of the Investigator, is willing and able to adhere to the study visit schedule and other requirements, prohibitions, and restrictions of the study.
Exclusion Criteria:
* Are left-handed;
* Have, or have a history within the last 12 months of, drug or alcohol dependency or positive urine drug screen or alcohol breath test at Screening or Assessment Visits;
* History, or presence upon clinical examination, of cardiac, ophthalmologic, pulmonary, endocrine (uncontrolled diabetes), cancer, blood disease, gastrointestinal, hepatic, renal disease, or other condition that, in the opinion of the Investigator, could interfere with the test procedures;
* History or presence of significant neurological or psychiatric conditions such as stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, or blackouts requiring hospitalization;
* History of, or current condition of, migraine headaches;
* Have undergone operations to the brain;
* Have significant visual impairment including color blindness, history of ocular treatment including corrective laser eye surgery, or ongoing condition that, in the opinion of the Investigator, may interfere with the performance of the cognitive test battery;
* Participants who consume large amounts of caffeinated drinks (more than 8 cups of standard caffeinated drinks \[eg, tea, instant coffee\] or 6 cups of stronger coffee or other drinks containing methylxanthines such as soda or energy drinks per day);
* Have received an experimental drug and/or used an experimental medical device within 30 days of the Screening Visit or within 5 half-lives, whichever is longer;
* Are unable to comply with MRI Patient Declaration;
* Have a resting pulse \<45 bpm or \>100 bpm at Screening or on Day 1;
* Participants with any of the following findings in the resting ECG:
* Fridericia-corrected QT interval \>450 ms (males); \>470 ms (females); or \<300 ms at Screening or on Day 1; or
* Wolff-Parkinson-White syndrome, complete left bundle branch block (LBBB).
* Family history of congenital long QT syndrome or sudden death;
* Poorly controlled diabetes (hemoglobin A1c \>8.5%);
* Poorly controlled hypertension (systolic blood pressure \>155 mmHg and diastolic blood pressure \>95 mmHg);
* Diagnosed with anemia (defined as hemoglobin \<12 g/dL);
* Have reduced renal function defined as having an estimated glomerular filtration rate (eGFR) of \<59 mL/min/1.73 m²;
* Have physical, language, or other impairments of such severity as to adversely affect the validity of the data derived from the cognitive tasks as judged by the Investigator;
* Any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 3 months prior to screening or at Screening or Baseline Visits;
* Unable to comply with MRI or blood draw procedures (suffers from claustrophobia or needle phobia);
* Known clinically relevant structural brain abnormality as determined by previous MRI or persistent MRI imaging artefact which is judged to produce extensive imaging distortions (eg, extensive dental work) as determined at the Imaging Baseline Visit (Visit 2, Day 0); or
* With a disease or take any medication that, in the Investigator's and/or Sponsor's opinion, could interfere with the assessments of safety, tolerability, or pharmacodynamics as well as the conduct or interpretation of the study.
|
[
0.5062271356582642,
1.5317316055297852,
-2.055690050125122,
-2.2771759033203125,
0.8025311231613159,
0.09287027269601822,
-0.10557670891284943,
-0.8294399380683899,
0.3283870220184326,
0.26940420269966125,
-0.8292974829673767,
1.580902099609375,
-1.069411039352417,
0.8584129214286804,
0.7354084849357605,
0.8701737523078918,
0.3202388882637024,
0.4061119854450226,
0.6979427933692932,
-2.0575857162475586,
-0.20882558822631836,
1.1120240688323975,
-0.3312036097049713,
-0.16541555523872375,
-0.5295688509941101,
-0.048640526831150055,
0.16249379515647888,
0.15124094486236572,
0.5386768579483032,
1.198994755744934,
-0.3453138768672943,
-0.4028434455394745,
0.5593498349189758,
1.258509874343872,
0.9917653203010559,
0.6124347448348999,
-0.19561436772346497,
-0.8114303946495056,
0.16725188493728638,
0.05178375542163849,
0.20028381049633026,
0.37005069851875305,
-1.077288269996643,
-0.686831533908844,
0.796442449092865,
1.286915898323059,
0.29792267084121704,
0.4659118950366974,
-1.0632953643798828,
-0.40751758217811584,
-0.4937301576137543,
1.251132845878601,
-0.5682166814804077,
-0.16801999509334564,
1.658561110496521,
0.2733253240585327,
0.6077675223350525,
0.027339652180671692,
1.4179893732070923,
-0.5113202929496765,
0.1243266612291336,
0.28647512197494507,
0.7088169455528259,
0.8463183641433716,
-1.0360225439071655,
-0.08254577219486237,
-0.5102444887161255,
0.05995679646730423,
-0.9116944074630737,
0.33568668365478516,
-0.7991889715194702,
0.8426221013069153,
-0.26792973279953003,
0.09233605116605759,
0.5792527198791504,
-0.36563917994499207,
0.03728706017136574,
0.8074241876602173,
0.6020752191543579,
-0.09048420190811157,
-0.3541126847267151,
0.14308132231235504,
-0.28703752160072327,
0.5918622016906738,
1.078320026397705,
-0.18086788058280945,
-0.6543958783149719,
0.48065948486328125,
0.5432674288749695,
-0.1691666841506958,
0.9004460573196411,
0.2359418123960495,
-0.8126856088638306,
-0.5008397102355957,
-0.0011872408213093877,
0.27604445815086365,
-0.037646785378456116,
-0.8774043917655945,
-0.2458571046590805,
0.10685873031616211,
-0.09403509646654129,
-0.2410254329442978,
-0.04856507107615471,
0.2455974519252777,
-1.1863739490509033,
-0.37020498514175415,
0.043603189289569855,
-0.6410226225852966,
-0.04819518327713013,
-0.4151521921157837,
0.4099894165992737,
-0.4056558609008789,
-0.10199190676212311,
0.616733968257904,
0.8706333041191101,
0.2363768219947815,
0.8603578805923462,
0.33087825775146484,
0.04254218190908432,
-0.28571224212646484,
0.13975630700588226,
0.7301180958747864,
0.54308021068573,
0.6786569952964783,
-0.6940317749977112,
0.21258728206157684,
0.03234754875302315,
0.19371674954891205,
-0.2562781274318695,
-0.12480039149522781,
-0.6318312287330627,
-0.3724662661552429,
0.23447191715240479,
-0.31385883688926697,
-1.1181155443191528,
-0.2830430269241333,
0.3926927149295807,
0.4872001111507416,
0.139328733086586,
-0.6089497804641724,
-0.7454111576080322,
-0.09876745939254761,
-0.1846899390220642,
-0.12083467096090317,
-1.2719802856445312,
-0.20846527814865112,
-0.26811090111732483,
0.5820516347885132,
0.4117143750190735,
-0.8444712162017822,
-0.6346986293792725,
0.53968346118927,
-0.048709988594055176,
-0.2929486036300659,
0.03599260747432709,
-0.006663117557764053,
0.43596458435058594,
-0.04284119978547096,
0.08436309546232224,
-0.24223443865776062,
0.12106805294752121,
-0.16448649764060974,
-0.2139277458190918,
0.27095556259155273,
-0.14806129038333893,
0.22752195596694946,
0.2493799328804016,
0.38946571946144104,
0.014656838960945606,
0.30688735842704773,
-0.06947975605726242,
0.06144235283136368,
0.3199690878391266,
0.8507329225540161,
-0.38798514008522034,
-0.34187424182891846,
-0.20387843251228333,
-0.01797451451420784,
0.11202652007341385,
0.6907339096069336,
-0.21627652645111084,
0.4319145083427429,
-0.484283447265625,
-0.2785487473011017,
0.27102014422416687,
-0.8342880010604858,
0.333472341299057,
-0.38445690274238586,
-0.22929969429969788,
0.3306106925010681,
0.12456116080284119,
0.05186927318572998,
0.030500095337629318,
0.5919896364212036,
0.1130366325378418,
-0.5322389006614685,
-0.12937864661216736,
0.02036488987505436,
0.34367606043815613,
-0.46284735202789307,
0.19267886877059937,
0.6580942273139954,
-0.07530587166547775,
-0.3811783492565155,
0.37768951058387756,
0.11041499674320221,
0.10723460465669632,
-0.3043709397315979,
-0.278899610042572,
-0.5409554243087769,
0.6641066670417786,
-0.3691379427909851,
-0.5597328543663025,
0.17249681055545807,
0.5647321939468384,
0.14720836281776428,
-0.6134641170501709,
0.7399908304214478,
-0.22267046570777893,
0.06400471925735474,
-0.4573972225189209,
0.0005189605290070176,
-0.5614836812019348,
-0.19463613629341125,
-0.22739706933498383,
0.3825300931930542,
-0.29269301891326904,
-0.11067414283752441,
-0.032890547066926956,
-0.33799615502357483,
-0.1690382957458496,
0.06438777595758438,
-0.18217839300632477,
0.12227533012628555,
-0.03476282209157944,
0.06743412464857101,
-0.3399885296821594,
0.7443351745605469,
0.021758776158094406,
0.2746615409851074,
0.13400058448314667,
-0.7634057402610779,
0.012228730134665966,
-0.30483850836753845,
-0.1421336978673935,
0.08735159039497375,
-0.5009244680404663,
0.211401104927063,
0.27969634532928467,
0.14017491042613983,
-0.2692464292049408,
-0.31510117650032043,
0.09405827522277832,
0.38793885707855225,
-0.1411089301109314,
-0.19466520845890045
] |
|
NCT02493790
|
Cognitive Dysfunction in COPD Patients : Role in the Performance of Cognitive-motor Dual Task Situation?
|
Chronic Obstructive Pulmonary Disease (COPD) is a respiratory disease starting point characterized by multiple systemic effects as cognitive dysfunction. This one seems to have an impact in activity daily living, considered mainly as a cognitive-motor dual task situations. Yet to date, no study has specifically focused in the cognitive-motor performance in patients with COPD or on the effects during a rehabilitation program. The main objective of this work was to evaluate the impact of cognitive dysfunction in COPD, comparing performance between COPD patients and healthy subjects in a single and dual task cognitive-motor situation. The secondary objective was to assess the impact of a rehabilitation program on these performances.
|
Inclusion Criteria:
* Male or female about 40 to 80 years old
* COPD patient (Tiffeneau \<70%); stage moderate to severe (Stage 2,3 and 4) with or without oxygen therapy (\>15h/day)
* Written and informed consent of the subject
* Authorization to physical activity referring doctor in the clinic
* Comorbidities no dominating
Exclusion Criteria:
* Subject with neurological pathology, cognitive or psychiatric
* Subject with pain and / or plantar injuries
* Subject has a prosthetic knee and / or hip.
* Subject requiring walking aid (cane, walker, etc.)
|
[
-1.0067633390426636,
3.496309995651245,
-2.1068475246429443,
-2.2703378200531006,
1.5616660118103027,
-1.011720061302185,
-1.1496491432189941,
-1.0470575094223022,
-0.5278332233428955,
1.453494906425476,
-0.0073304204270243645,
1.5627278089523315,
-0.7648290991783142,
1.1339788436889648,
-0.6403964757919312,
1.4158871173858643,
0.3918490707874298,
0.014362744987010956,
0.1776508092880249,
-0.668672502040863,
-1.1502902507781982,
-0.14844632148742676,
-0.3968355059623718,
0.12990321218967438,
0.5942351818084717,
-0.059422191232442856,
0.0021060865838080645,
1.055323839187622,
-1.2990649938583374,
1.2821729183197021,
0.11250627040863037,
-1.118216872215271,
-0.29759466648101807,
1.3914155960083008,
0.40346476435661316,
-0.30357369780540466,
-0.4694156348705292,
0.18538498878479004,
-1.801194190979004,
0.6817938089370728,
0.9120461940765381,
1.195595383644104,
-0.3132272958755493,
-0.4667116701602936,
1.011549711227417,
1.452247142791748,
-0.7623079419136047,
0.6959596872329712,
-2.1904330253601074,
-0.2440280318260193,
1.4525643587112427,
0.6151438355445862,
-1.337122917175293,
0.06487740576267242,
1.6307964324951172,
-0.15945076942443848,
1.0056989192962646,
-0.16371819376945496,
0.3876931071281433,
-0.14842401444911957,
0.09825467318296432,
-0.5613689422607422,
0.5057500004768372,
0.37336307764053345,
-0.9701665043830872,
-0.5430465936660767,
-0.32167479395866394,
-0.5686361789703369,
-1.5531481504440308,
0.039053045213222504,
0.5425401926040649,
0.1548747569322586,
0.504237174987793,
-0.3107873201370239,
0.5261364579200745,
0.29185062646865845,
-0.8652028441429138,
1.60101318359375,
1.4379373788833618,
-0.6531652808189392,
-0.049974288791418076,
-0.1221047192811966,
-1.0732299089431763,
-0.6534205079078674,
0.3864540159702301,
0.15957526862621307,
-1.135128140449524,
0.36146116256713867,
1.0338209867477417,
0.33469158411026,
-0.3714226186275482,
0.3274846076965332,
-1.4804770946502686,
0.6085824966430664,
-0.038370709866285324,
0.30600500106811523,
-0.1678636372089386,
-0.16372406482696533,
-0.5968587398529053,
-0.7991963624954224,
0.39921560883522034,
-0.25065651535987854,
0.12230826914310455,
-0.11555974185466766,
-1.496431589126587,
0.5305668711662292,
0.3355551064014435,
-0.05810348317027092,
-0.4031398296356201,
0.5702964067459106,
0.8085999488830566,
-0.38362494111061096,
0.497119277715683,
-0.6311625242233276,
1.3845499753952026,
0.3463059067726135,
1.1321123838424683,
1.202742099761963,
0.3444844186306,
0.010404663160443306,
0.6253728270530701,
0.5764004588127136,
-0.08124465495347977,
-0.09622815251350403,
-1.08644700050354,
-0.6871349811553955,
-0.904278576374054,
0.6196929812431335,
-0.28431233763694763,
0.27675020694732666,
-0.005696323700249195,
-0.5026711225509644,
0.6280728578567505,
-0.8686532974243164,
-1.148880124092102,
0.03952346369624138,
0.7053631544113159,
0.919460117816925,
-0.600207507610321,
-0.27865058183670044,
-0.3458276093006134,
-0.05013662576675415,
0.2682863473892212,
-0.6203353404998779,
-0.37455031275749207,
-0.34373605251312256,
0.21670304238796234,
0.34662577509880066,
-0.10162770003080368,
-1.0852127075195312,
0.09537279605865479,
-0.4276730418205261,
0.3185685873031616,
0.2741025984287262,
-0.15881673991680145,
0.5775558352470398,
0.13738656044006348,
-0.06255099922418594,
0.43058136105537415,
0.10303982347249985,
0.3694981038570404,
-0.1184961125254631,
0.1477441042661667,
-0.037458598613739014,
0.2777629792690277,
-0.22112199664115906,
0.6895228028297424,
0.01568068377673626,
-0.5630941390991211,
-0.19603708386421204,
-0.1862790733575821,
-0.16424819827079773,
0.47194474935531616,
-0.22532743215560913,
-0.43055903911590576,
0.48971644043922424,
0.5213726162910461,
0.005018975120037794,
0.6462491750717163,
-0.3548744320869446,
0.2063310742378235,
0.029361167922616005,
0.0012840278213843703,
0.10697051137685776,
0.46087950468063354,
0.4259723722934723,
-0.42447659373283386,
-0.566192090511322,
-0.4982830882072449,
-0.17318058013916016,
-0.9101780652999878,
-0.2549765110015869,
0.32868731021881104,
0.1495669037103653,
0.7730583548545837,
-0.19291038811206818,
-1.0022977590560913,
-0.49851614236831665,
0.9562623500823975,
-0.47252193093299866,
0.40852853655815125,
0.31929418444633484,
0.20942933857440948,
0.0746830478310585,
-0.44446608424186707,
-0.01013079471886158,
-0.7925713658332825,
-0.09277693182229996,
-0.0007094715838320553,
0.5058751106262207,
0.7392755150794983,
0.14373677968978882,
-1.017988681793213,
0.05639795586466789,
0.6678916215896606,
0.643983006477356,
-0.012260135263204575,
0.11497567594051361,
-0.4307767450809479,
0.398476779460907,
-0.26017194986343384,
0.1224639043211937,
-0.11629749089479446,
-0.005059351213276386,
-0.21319566667079926,
-0.6048064827919006,
-0.3680586516857147,
0.14763088524341583,
-0.18479453027248383,
-0.7496011853218079,
-0.44806215167045593,
-0.7916975021362305,
-0.38580194115638733,
-0.03862234950065613,
-0.462177038192749,
0.7459668517112732,
0.18465837836265564,
-0.40762394666671753,
0.09869257360696793,
-0.09266598522663116,
0.4604896903038025,
-0.26723891496658325,
-0.2638137638568878,
-0.3080311417579651,
0.32415691018104553,
-0.26696473360061646,
-0.2057342380285263,
0.3022778034210205,
-0.06880538165569305,
0.190384641289711,
-0.08705783635377884,
-0.5176059007644653,
0.08212149888277054,
0.16580817103385925,
0.3223271667957306,
-0.28969648480415344
] |
|
NCT01326884
|
Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study
|
A prospective study conducted in Japan to collect confirmatory peri-operative and 30-day information on use of the Zenith LP AAA Graft.
|
Inclusion Criteria:
* Abdominal aortic, aorto-iliac, and iliac aneurysms of appropriate size
* Vessels suitable for endovascular access and aneurysm repair
Exclusion Criteria:
* Less than 20 years of age
* Inability or refusal to give informed consent
* Disease considerations that would compromise patient safety or study outcomes
* Unsuitable arterial anatomy
|
[
0.4555008113384247,
3.0433242321014404,
-2.696974039077759,
-1.1257688999176025,
-0.7518437504768372,
0.9529953002929688,
-0.2907569110393524,
2.1206705570220947,
-0.8722079992294312,
1.368074655532837,
1.298210859298706,
-1.6720592975616455,
-1.0769538879394531,
2.0869972705841064,
-0.6461747884750366,
-0.1101127564907074,
0.5956624150276184,
1.6579155921936035,
-1.0358068943023682,
-0.44489550590515137,
0.1814722865819931,
0.09760943800210953,
-0.054117437452077866,
0.034501273185014725,
1.684599757194519,
-0.5904471278190613,
-1.1681592464447021,
0.2569490075111389,
-0.2508784532546997,
0.5357422232627869,
1.225803256034851,
-0.38237571716308594,
-0.26576998829841614,
-0.8758848309516907,
-0.12381212413311005,
0.8215223550796509,
1.904063105583191,
-1.0413990020751953,
-0.5434444546699524,
-0.3460955321788788,
1.6279020309448242,
0.4126223623752594,
-0.22129644453525543,
-1.187667965888977,
2.433135509490967,
1.0024878978729248,
-0.2672521770000458,
0.35702866315841675,
0.47698473930358887,
-1.2913892269134521,
-1.654184103012085,
-0.4201548993587494,
-0.6108930706977844,
0.05173514038324356,
-0.7899383902549744,
1.274172067642212,
-0.4625310003757477,
-0.8309260606765747,
0.053960226476192474,
-0.3062043786048889,
-0.11211980134248734,
0.17794080078601837,
1.3199453353881836,
-0.7247669696807861,
-1.1340798139572144,
1.4029301404953003,
-0.9662265777587891,
0.27617645263671875,
-1.265496850013733,
0.0640740692615509,
0.9422004818916321,
-0.604803740978241,
1.1740390062332153,
-0.14237040281295776,
0.24984899163246155,
0.5883508324623108,
0.4197765290737152,
-0.45374515652656555,
-0.7766290903091431,
0.6330520510673523,
-0.29539087414741516,
-0.4966147243976593,
0.47606098651885986,
-0.7108756899833679,
0.5693220496177673,
-0.1754947304725647,
0.1819528490304947,
-0.47441962361335754,
-0.6736670732498169,
-0.20190276205539703,
0.007236949633806944,
-0.1718863546848297,
-1.0100734233856201,
0.35994866490364075,
-1.1161134243011475,
0.6016253232955933,
0.06266339868307114,
0.7650100588798523,
-0.7913444638252258,
-0.1098225936293602,
-0.22515344619750977,
-0.32923781871795654,
0.6886375546455383,
-0.2409956306219101,
-1.0615053176879883,
-0.652127742767334,
-0.830405592918396,
0.348180890083313,
0.21869303286075592,
-0.7742652893066406,
0.6005712151527405,
-0.794195294380188,
-0.5989536046981812,
0.3856813907623291,
-0.15960244834423065,
-0.090861976146698,
1.3472845554351807,
0.21409112215042114,
0.35814929008483887,
-0.37833455204963684,
0.8285702466964722,
-0.06688357144594193,
-0.49485844373703003,
1.068243145942688,
-1.3685674667358398,
0.010044068098068237,
0.979880154132843,
0.11809135228395462,
0.21519705653190613,
-0.3563012182712555,
0.05980966240167618,
0.974511444568634,
-2.0021703243255615,
-0.7424219846725464,
0.5788642764091492,
0.9506229758262634,
-0.4334605932235718,
-0.7714409232139587,
-0.5739347338676453,
-1.515233039855957,
0.22141775488853455,
-0.24183402955532074,
-0.9832726716995239,
0.06419685482978821,
-1.477088212966919,
0.7295902371406555,
-1.1045215129852295,
1.1763018369674683,
-0.4753071069717407,
-0.7408167719841003,
-0.34595543146133423,
0.22447814047336578,
0.12078950554132462,
0.7682950496673584,
0.4974762201309204,
-0.13201197981834412,
0.720780074596405,
-0.007157513406127691,
0.39396774768829346,
-0.7604184150695801,
-0.08439707010984421,
-0.9129197597503662,
-0.06903458386659622,
-0.31632107496261597,
0.07195509225130081,
0.16595062613487244,
0.11165307462215424,
0.8486992120742798,
0.9232121706008911,
0.26765531301498413,
-0.07641515135765076,
0.3261268138885498,
-0.25625845789909363,
-0.0683145821094513,
-0.4091433882713318,
-0.18360036611557007,
-0.35984325408935547,
-0.13066434860229492,
-0.18609246611595154,
0.5505279302597046,
0.6568300724029541,
0.6165465712547302,
-0.41324084997177124,
-0.1858861893415451,
0.25072503089904785,
0.34784892201423645,
0.879026472568512,
-0.10419613122940063,
0.6374212503433228,
0.009686163626611233,
0.1987113505601883,
-0.15497061610221863,
-0.432464599609375,
-0.3086129128932953,
0.8234401941299438,
0.3922824263572693,
-1.029476284980774,
-0.6901545524597168,
0.2905697524547577,
-0.4354749917984009,
0.6400415897369385,
0.5663413405418396,
-0.5145447254180908,
1.0236060619354248,
0.017725763842463493,
-0.24401192367076874,
-0.24189545214176178,
0.4033399820327759,
-0.4110390841960907,
-0.22891639173030853,
0.13659316301345825,
-0.6912205815315247,
-0.7788295745849609,
-0.022775735706090927,
-0.12567220628261566,
0.2239159196615219,
0.5494783520698547,
-0.3310137987136841,
-1.0349712371826172,
0.10664080828428268,
-0.1854390650987625,
-0.7273808717727661,
-0.23274646699428558,
-0.43113622069358826,
-0.07105880975723267,
-0.286895751953125,
-0.5621784925460815,
-0.03651738911867142,
0.7368660569190979,
-0.3671007454395294,
-0.21437813341617584,
0.05941171199083328,
0.36197108030319214,
0.04606309533119202,
-0.28780150413513184,
0.6171751618385315,
0.8757125735282898,
0.49319231510162354,
-0.363373726606369,
-0.4872381091117859,
0.015701789408922195,
-1.3176077604293823,
-0.009589514695107937,
-0.19883885979652405,
0.6533984541893005,
-0.5197790265083313,
-0.1579611599445343,
-0.23894335329532623,
-0.5447856187820435,
0.7612603306770325,
0.44287359714508057,
-0.9195039868354797,
0.39732882380485535,
0.37674909830093384,
0.19006647169589996,
-0.27056485414505005
] |
|
NCT03946917
|
JS001 Combined With Regorafenib in Patients With Advanced Colorectal Cancer
|
Colorectal cancer is one of the most common malignancies in China. Regorafenib is the standard multi-kinase inhibitor for refractory advanced colorectal cancer. In mice, regorafenib combined with anti-PD-1 was shown superior to regorafenib, which has not yet been verified in humans. JS001 is the Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma. This study is the first multi-center, open-label, phase I/II clinical trial to evaluate tolerability, safety and efficacy of JS001 in combination with regorafenib tablet in patients with MSS/MSI-L/pMMR, relapsed or metastatic colorectal cancer who have failed or can not tolerate fluorouracil, oxaliplatin and irinotecan based systemic treatment. The phase I clinical trial is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of regorafenib tablet in this regimen, and select an acceptable safe dose for the phase II clinical trial to further determine safety and efficacy of this combination regimen in patients with metastatic colorectal cancer.
|
Colorectal cancer is one of the most common malignancies in China, with incidence and mortality ranking the 3rd and 4th among malignancies in China. Regorafenib is the standard multi-kinase inhibitor for refractory metastatic colorectal cancer, with multiple anti-tumor effects by inhibiting targets related to tumor cell proliferation, tumor metastasis, tumor angiogenesis and tumor immune escape, howerver, its efficacy is limited. Immunotherapy has become standard treatment for mCRC patients with MSI-H/dMMR. Combination of anti-angiogenesis treatment and immunotherapy may have a better anti-tumor effect. In mice, regorafenib combined with anti-PD-1 was shown superior to regorafenib, which has not yet been verified in humans. JS001 is the Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma. This study is the first multi-center, open-label, phase I/II clinical trial to evaluate tolerability, safety and efficacy of JS001 in combination with regorafenib tablet in patients with MSS/MSI-L/pMMR, relapsed or metastatic colorectal cancer who have failed or can not tolerate fluorouracil, oxaliplatin and irinotecan based systemic treatment. The phase I clinical trial is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of regorafenib tablet in this regimen, and select an acceptable safe dose for the phase II clinical trial to further determine safety and efficacy of this combination regimen in patients with metastatic colorectal cancer.
|
Inclusion Criteria:
1. Males and females aged ≥18 years;
2. Histologically or cytologically confirmed colon or rectal adenocarcinoma, with unresectable relapsed or metastatic disease;
3. Microsatellite stability (MSS) or microsatellite instability-low (MSI-L), or proficient expression of DNA mismatch repair gene (pMMR);
4. Patients who have failed, or can not tolerate after previous systemic treatment for relapsed or metastatic colorectal cancer, with no more than 3 months for disease progression after the last systemic treatment. The systemic treatment must contain fluorouracil, oxaliplatin and irinotecan, with or without targeted therapy (bevacizumab, cetuximab, and so on);
5. With at least 1 measurable lesion according to RECIST 1.1 criteria; 1) Non-nodal lesions with the maximum diameter ≥10mm, or nodal lesions with the short axis ≥15mm; 2) For lesions previously treated locally with radiotherapy or ablation, if there is definite progression according to RECIST 1.1, and the maximum diameter ≥10mm, these can also be considered as measurable target lesions.
6. ECOG score 0-1;
7. Expected survival ≥3 months;
8. Good organ function (without blood transfusion, use of hematopoietic stimulating factors, or transfusion of albumin or blood products within 14 days prior to examination):
1) Platelet (PLT) count ≥100,000 /mm3; 2) Neutrophil count (ANC) ≥1,500 /mm3; 3) Hemoglobin (Hb) level ≥9.0 g/dl; 4) International normalized ratio (INR) ≤1.5; 5) Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN; 6) Glycosylated hemoglobin (HbA1c) \<7.5%; 7) Total bilirubin (TBIL) level ≤1.5×ULN; 8) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) level ≤2.5×ULN (≤5×ULN in case of liver metastasis); 9) Alkaline phosphatase level ≤2.5×ULN (≤5×ULN in case of liver metastasis); 10) Serum creatinine (Cr) level ≤1.5×ULN and creatinine clearance ≥60 ml/min; 11) Thyroid stimulating hormone (TSH) ≤ULN; 12) Normal serum free thyroid hormone (T4); 13) Normal serum free triiodothyronine (T3); 14) Serum amylase ≤1.5×ULN; 15) Lipase ≤1.5×ULN. 9. Females of child bearing age must have a negative pregnancy test, and have to take contraception measures and avoid breast feeding during the study and for 3 months after the last dose; male subjects must agree to taken contraception measures during the study and for 3 months after the last dose.
10. Able to understand and willing to sign written informed consent form.
Exclusion Criteria:
1. Diagnosis of any other malignancy at different primary site or of different histological type from colorectal cancer within 5 years prior to initiation of study treatment, except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of cervix;
2. Microsatellite instability-high (MSI-H) or deficient expression of DNA mismatch repair gene (dMMR);
3. Previous treatment with regorafenib, PD-1/PD-L1/PD-L2 antibody or any other antibody that acts on T cell costimulatory or checkpoint pathways;
4. Known allergy to study drug or excipients, or allergy to similar drugs;
5. Have received other anti-tumor treatment within 4 weeks prior to initiation of study treatment, or no more than 5 half lives from the last dose;
6. Have participated in other clinical study and received drug within 4 weeks prior to initiation of study treatment;
7. Have undergone major surgery or open biopsy, or have massive trauma within 4 weeks prior to initiation of study treatment;
8. Have received immunosuppressants (excluding inhaled corticosteroids or ≤10 mg/day prednisone or other systemic steroids at equivalent pharmaphysiological dose) within 2 weeks prior to initiation of study treatment;
9. Have vaccination with attenuated live vaccines within 4 weeks prior to initiation of the study treatment or plan to vaccinate during the study;
10. CYP3A4 inducers or inhibitors should not be stopped within 1 week prior to initiation of study treatment and during the study;
11. Known metastasis to central nervous system;
12. Present or history of any autoimmune disease;
13. Human immunodeficiency virus (HIV) infection (HIV antibody positive), or active hepatitis C virus (HCV) infection (HCV antibody positive), or active hepatitis B virus (HBV) infection (HBsAg or HBcAb positive, and HBV-DNA ≥2000 IU/ml (copies/ml)), or other severe infection requiring systemic antibiotic treatment, or unexplained body temperature \>38.5℃ during screening period/before study treatment;
14. Presence of pleural effusion, peritoneal effusion, or pericardial effusion;
15. Development of the following diseases within 6 months prior to initiation of study treatment: myocardial infarction, severe/unstable angina, congestive heart failure above NYHA grade 2, poorly controlled arrhythmia;
16. Poorly controlled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
17. With bleeding tendency, or evident hemoptysis or other hemorrhagic events (e.g. gastrointestinal hemorrhage, hemorrhagic gastric ulcer) within 2 months prior to initiation of study treatment, or presence of hereditary or acquired bleeding or thrombotic tendency (e.g. hemophilia, coagulopathy, thrombocytopenia, etc.), or current/long-term thrombolytic or anticoagulant therapy (except aspirin ≤100 mg/day);
18. Development of arterial/venous thrombotic events, e.g. cerebrovascular accident (transient ischemic attack, cerebral hemorrhage, cerebral infarction etc.), deep venous thrombosis, vasculitis, etc. within 6 months prior to initiation of study treatment;
19. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
20. Seizure requiring drug (e.g. steroids or antiepileptic drugs) treatment;
21. Presence of malabsorption disorder;
22. Unable to swallow study drug;
23. Presence of toxicities (except alopecia) of grade 2 and above (CTCAE V5.0) due to previous anti-tumor treatment or surgical procedure;
24. History of drug abuse, illegal drug use or alcohol dependence;
25. Patients with other severe acute or chronic conditions that may increase the risk of participation in the study and study treatment, or may interfere with interpretation of study results, and judged by the investigator as not suitable for participation in this clinical trial.
|
[
1.338139533996582,
1.1650381088256836,
-2.627182960510254,
-2.6157078742980957,
1.7760136127471924,
-0.00552320946007967,
0.15599927306175232,
1.3442234992980957,
-0.44603925943374634,
-0.638011634349823,
0.1762181967496872,
0.887703001499176,
-2.1976430416107178,
-0.08306034654378891,
1.5268751382827759,
0.5020217895507812,
-1.422149419784546,
0.49820348620414734,
1.0889853239059448,
-2.399599075317383,
0.3093031048774719,
-0.9558621644973755,
-1.042611002922058,
0.6234377026557922,
0.3051481544971466,
-1.1567150354385376,
-1.030971884727478,
1.586208462715149,
0.8161818981170654,
1.5328727960586548,
-0.7110968828201294,
-0.11660772562026978,
-0.3398575186729431,
0.9387415051460266,
-0.09786386042833328,
-0.5045958161354065,
0.19420304894447327,
-0.06854599714279175,
-1.6585081815719604,
-0.2038104236125946,
0.6419290900230408,
-0.6366985440254211,
0.5655156970024109,
-0.5485395193099976,
0.37844255566596985,
0.30231973528862,
-0.33719372749328613,
-0.9374868869781494,
0.8575951457023621,
0.11968410760164261,
-1.5543320178985596,
1.348770022392273,
-0.5858452916145325,
-0.5580490827560425,
1.3332957029342651,
0.05346521735191345,
0.41865527629852295,
1.0287827253341675,
1.1711992025375366,
0.061968859285116196,
-0.5812341570854187,
-0.14682510495185852,
0.23063987493515015,
0.6293269991874695,
-0.4108041226863861,
-0.09032320976257324,
-1.2692292928695679,
-0.014060268178582191,
0.5075393319129944,
1.0831021070480347,
-0.000572851684410125,
-0.13859353959560394,
1.0293457508087158,
0.5915675163269043,
0.16839289665222168,
0.334868460893631,
0.22226226329803467,
0.5118027329444885,
0.3666059970855713,
0.36630183458328247,
-0.05270969495177269,
-0.6663029789924622,
-0.25275933742523193,
-0.37113070487976074,
0.06375908106565475,
-0.8553910851478577,
-0.2583881914615631,
-0.6089144349098206,
0.24424037337303162,
-1.0305136442184448,
0.9113829731941223,
-0.5268498659133911,
-0.5238916873931885,
1.2558029890060425,
-0.08084622025489807,
0.17499083280563354,
-0.6887185573577881,
-0.3768676221370697,
-0.3840976059436798,
0.3726191222667694,
0.028606554493308067,
-0.5349686145782471,
-0.3093564212322235,
-0.14076732099056244,
-0.44640088081359863,
0.09091328829526901,
0.0446493923664093,
-0.8434938192367554,
-0.30636805295944214,
-1.746138334274292,
0.5276370048522949,
-0.8373623490333557,
-0.3484489917755127,
0.3595829904079437,
0.7558043599128723,
0.8312057256698608,
0.5842218399047852,
0.15377360582351685,
-0.05188159644603729,
0.2076936811208725,
-0.18785490095615387,
0.8290438652038574,
0.5545192360877991,
0.3651432693004608,
0.20111410319805145,
0.7672721743583679,
0.3390837013721466,
-0.4988785684108734,
-0.237354576587677,
-1.138430118560791,
-1.0380059480667114,
0.38877370953559875,
0.09637297689914703,
0.019557315856218338,
-0.6871042847633362,
-0.5860826373100281,
0.16105221211910248,
1.5152559280395508,
0.6551008820533752,
-0.2852430045604706,
-0.1455625295639038,
0.8728881478309631,
0.3465214967727661,
0.25959211587905884,
-1.4211353063583374,
0.4071559011936188,
0.501022219657898,
1.1587212085723877,
-0.008256467059254646,
-0.20173825323581696,
-0.10247069597244263,
0.23795221745967865,
-0.11380687355995178,
0.04272661730647087,
0.342081218957901,
0.8312788009643555,
0.6942023038864136,
-0.2702692151069641,
0.04066753387451172,
0.24748356640338898,
-0.7289157509803772,
-0.08239904791116714,
0.0833316370844841,
-0.3893839120864868,
0.908318281173706,
0.479047030210495,
-0.22361335158348083,
-0.17439541220664978,
0.35243847966194153,
0.2614082098007202,
-0.7983319759368896,
0.0002110293135046959,
0.12143309414386749,
0.5697895288467407,
0.24129576981067657,
-0.43045541644096375,
0.23776628077030182,
-0.2517358064651489,
0.2135259062051773,
-0.06482063233852386,
-0.39011844992637634,
0.24512018263339996,
0.5062667727470398,
-0.4283706545829773,
0.0861406996846199,
-0.1839342564344406,
0.4018590450286865,
0.266056627035141,
0.039411094039678574,
0.6814992427825928,
0.6096361875534058,
-0.2426549643278122,
-0.33896493911743164,
0.6768777966499329,
-0.11135318875312805,
-0.29755061864852905,
-0.014238277450203896,
0.2962539494037628,
0.5559446811676025,
-0.016298282891511917,
0.3773690462112427,
0.3622380793094635,
0.2686885893344879,
0.28933051228523254,
0.378644198179245,
0.27050289511680603,
0.19042779505252838,
-0.01877504028379917,
0.06573542952537537,
-0.34631630778312683,
0.22689342498779297,
-0.2006310224533081,
0.21991124749183655,
-0.1268100142478943,
0.21996109187602997,
0.42383071780204773,
-0.055789295583963394,
0.6715249419212341,
-0.4541052579879761,
0.21027612686157227,
-0.2067136913537979,
0.33802616596221924,
-0.013549869880080223,
0.2222854048013687,
0.06444665789604187,
0.047029826790094376,
-0.2910573482513428,
-0.1370057761669159,
-0.6682851910591125,
-0.6299115419387817,
-0.34490182995796204,
0.22300869226455688,
-0.08899637311697006,
0.18823756277561188,
0.004782308358699083,
-0.42436766624450684,
0.12314485013484955,
0.27353760600090027,
-0.1754947155714035,
0.37578636407852173,
0.6523696184158325,
-0.6549785733222961,
-0.5606215596199036,
-0.14920660853385925,
0.060109782963991165,
-0.21929064393043518,
-0.06004847213625908,
0.12849652767181396,
-0.26326805353164673,
-0.025167379528284073,
-0.4540341794490814,
-0.17800357937812805,
0.38387539982795715,
0.09762600809335709,
-0.23429928719997406,
-0.31006601452827454
] |
NCT04592835
|
To Evaluate the Safety, Tolerability and Pharmacokinetic Properties of DWRX2003
|
This study is designed to assess the safety, tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) in healthy volunteers.
|
Inclusion Criteria:
1. Healthy males and females, between 18 and 65 years of age, inclusive, at time of signing the Informed Consent Form (ICF).
2. Body mass index between 18.0 lesser than or equal to Body Mass Index (BMI) lesser than or equal to 32 at Screening, with a minimum weight of 50 kg (inclusive).
3. Willing to sign ICF on a voluntary basis and to voluntarily participate in the study, after being fully informed of and completely understanding this study, prior to any Screening procedure being undertaken
Exclusion Criteria:
1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note participants with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee).
3. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee)
|
[
0.9885475039482117,
2.267146348953247,
-2.119137763977051,
-5.12660551071167,
0.7379863858222961,
1.4466396570205688,
0.2854944169521332,
0.7922358512878418,
-0.227216899394989,
1.5102343559265137,
-1.9282608032226562,
3.5177512168884277,
-0.698868453502655,
1.0261683464050293,
2.194524049758911,
-0.5060941576957703,
0.3215741217136383,
0.8715208768844604,
0.5651492476463318,
-2.636718511581421,
0.4905472695827484,
1.0128309726715088,
1.808025598526001,
1.2551363706588745,
0.41971832513809204,
-0.02633473090827465,
-1.3152238130569458,
-0.06773796677589417,
0.8316128849983215,
1.2058072090148926,
-0.620725154876709,
-0.8780035972595215,
-0.2749100923538208,
2.0378856658935547,
-0.10296499729156494,
0.42028769850730896,
-0.7068822979927063,
0.402425080537796,
-0.3316177725791931,
0.47306308150291443,
1.0323185920715332,
0.0012858167756348848,
-0.7176237106323242,
-1.3156760931015015,
0.822765052318573,
-0.015671800822019577,
-0.24690675735473633,
0.12909024953842163,
-0.5576605200767517,
-1.1451102495193481,
-0.486888587474823,
0.8802808523178101,
-1.0678296089172363,
0.45353251695632935,
1.2734876871109009,
-0.5216435194015503,
1.934110164642334,
-1.3016175031661987,
1.2208797931671143,
0.7094041109085083,
0.04469054937362671,
-0.5015087723731995,
1.2498112916946411,
1.0638686418533325,
-0.5372236967086792,
0.5894602537155151,
0.6711037755012512,
0.28670230507850647,
0.3690907061100006,
1.0564936399459839,
-1.9018443822860718,
1.4172430038452148,
-0.6802164912223816,
1.321339726448059,
0.9645611643791199,
-0.65058833360672,
1.3967434167861938,
1.0782157182693481,
-0.17255569994449615,
0.48029085993766785,
-0.19512677192687988,
-0.8192667961120605,
-0.5651857256889343,
0.7804659008979797,
-0.09408344328403473,
0.7066124081611633,
-0.895428478717804,
-0.4781465530395508,
0.46102654933929443,
-0.6419050693511963,
0.7149041295051575,
-0.04280099272727966,
-0.7120408415794373,
0.22773413360118866,
0.03239330276846886,
0.11860933899879456,
0.5797715187072754,
0.29593726992607117,
-1.2789373397827148,
-1.4792391061782837,
0.4760134816169739,
-0.9786158204078674,
-0.824721097946167,
-0.42953357100486755,
-0.4273574650287628,
0.40218791365623474,
-1.5697338581085205,
-0.3672521710395813,
-0.620872437953949,
0.15559996664524078,
-0.636954128742218,
0.21153366565704346,
-0.0011021906975656748,
0.39222002029418945,
0.9879211783409119,
1.105258822441101,
-0.13450855016708374,
0.779190182685852,
0.3311852812767029,
0.16000989079475403,
0.047905582934617996,
1.0797600746154785,
0.7490480542182922,
-0.2567012310028076,
0.543910801410675,
-0.26890531182289124,
0.16195689141750336,
-0.09162300825119019,
-0.39161166548728943,
-1.0325440168380737,
-1.3488975763320923,
0.001064486219547689,
0.5833943486213684,
0.2245779037475586,
-0.1906082034111023,
0.2880931794643402,
0.3523726463317871,
0.2197965830564499,
0.23366135358810425,
-0.6770126819610596,
-0.11073457449674606,
0.28436142206192017,
-0.00641112495213747,
-0.10021506994962692,
-1.174780249595642,
-0.13417145609855652,
-0.5627630352973938,
-0.48859545588493347,
0.9783104062080383,
-0.8108835816383362,
-0.44314825534820557,
1.0889806747436523,
0.02468685247004032,
0.09306620806455612,
0.8677161335945129,
0.18204578757286072,
1.620400071144104,
-1.4181222915649414,
0.1850915253162384,
0.1002325490117073,
-0.5693432688713074,
0.10722659528255463,
-0.7993130087852478,
0.35416412353515625,
-0.5944452881813049,
0.35908666253089905,
0.8335757255554199,
-0.44352632761001587,
0.1634110063314438,
-0.514562726020813,
-0.737530529499054,
0.4326964318752289,
-0.13755708932876587,
-0.11001509428024292,
-0.2205306887626648,
-0.278799831867218,
-0.14962777495384216,
-0.5605905652046204,
-0.7755767703056335,
0.46035677194595337,
-0.665624737739563,
0.3553212583065033,
0.348168283700943,
0.16291989386081696,
-0.2610848546028137,
-0.37849798798561096,
-0.11743661016225815,
-0.579393208026886,
-0.6033974289894104,
-0.4261035919189453,
-0.42455437779426575,
-0.01546629797667265,
-0.09770714491605759,
-0.13513270020484924,
0.07782299071550369,
-0.28442883491516113,
-0.25998133420944214,
-0.513611912727356,
0.5478520393371582,
-0.42818883061408997,
0.7748464941978455,
0.15441656112670898,
0.12186376750469208,
-0.05673951283097267,
0.36281800270080566,
0.17047162353992462,
-1.0268796682357788,
-0.35153353214263916,
0.14200763404369354,
-0.2103360891342163,
-0.2036782056093216,
-0.6839004755020142,
-0.9050866961479187,
-0.40214765071868896,
0.12898893654346466,
-0.25622454285621643,
-0.6369861364364624,
0.2934145927429199,
0.09705056995153427,
0.6090663075447083,
-0.5515424609184265,
-0.24638371169567108,
-0.3162688612937927,
0.0032018725760281086,
-0.04909699782729149,
-0.5058286190032959,
-0.44422683119773865,
-0.48077845573425293,
-0.29197657108306885,
0.0036554106045514345,
-0.8416900634765625,
0.458635538816452,
-0.7469990253448486,
-0.06992395967245102,
0.006783532444387674,
-0.18029816448688507,
-0.29791897535324097,
0.20514102280139923,
0.4287974238395691,
0.2520628869533539,
-0.40623340010643005,
-0.7272347211837769,
0.30068033933639526,
-1.0097731351852417,
-0.4925762414932251,
-0.1313730925321579,
-0.07462874054908752,
0.3157433569431305,
-0.2231045961380005,
0.17826800048351288,
-0.09019789099693298,
-0.4003370404243469,
-0.31026995182037354,
0.5954100489616394,
-0.636885404586792,
-0.37223684787750244
] |
|
NCT02964871
|
Rapid Assessment of and Prophylaxis for Influenza in Dwellers of Long-term Care Facilities
|
RAPID-LTCF is a stratified, block-randomized controlled trial to assess the effectiveness of a simple ARI case definition, rapid influenza diagnostic test (RIDT) with wireless transmission of results, and provision of infection control guidance when influenza is detected. Because of the nature of the intervention, blinding is not possible. Sites will be initially recruited for a study of "respiratory infections within LTCFs." After acceptance into the study, sites will be matched in terms of bed capacity, location, and other features prior to randomization.
|
Project Overview: The primary goal of RAPID-LTCF is to conduct a randomized, controlled clinical trial (RCT) to assess the effect of on-site, rapid influenza detection at long-term care facilities (LTCFs) on influenza-related hospitalizations, deaths, and healthcare-associated costs.
The basic research question in PICO format is:
Population: for residents of LTCFs across Wisconsin
Intervention: does early detection of influenza coupled with infection control guidance
Comparator: compared to usual care
Outcomes: result in:
1. increase early detection and reporting of influenza outbreaks?
2. increased early antiviral treatment of influenza?
3. increased use of antiviral prophylaxis for other at-risk residents?
4. fewer hospitalizations during the influenza season?
5. reduced mortality during the influenza season?
6. lower healthcare associated costs during the influenza season?
Building on two highly successful pilot QI projects-undertaken during the last two influenza seasons-that confirmed the feasibility and desirability of this approach, existing, CLIA-waived, low-complexity rapid influenza diagnostic test (RIDT) with high sensitivity and high specificity in this population as the diagnostic platform will be used. RIDT analyzers will be configured for wireless transmission of anonymous test results to a cloud-based server for real-time access by public health. Detection of influenza at a LTCF and its transmission to public health in real time will trigger communication and advice on appropriate infection control measures to reduce in-facility transmission. This approach has high potential for limiting influenza's effect at LTCFs.
Residents of LTCFs are at high risk for influenza infection due to reduced efficacy of influenza vaccines in elders, close quartering, presence of co-morbid medical conditions, and delayed response times. Consequently, outbreaks of influenza and other significant respiratory viruses easily spread within LTCFs and cause substantial morbidity and mortality in these populations. Results from this RCT will provide highly generalizable approaches using low-cost, low-complexity and easily-adapted tools and protocols for extremely early influenza detection and response. It is anticipated that early outbreak recognition and control in LTCFs will substantially reduce morbidity, mortality and healthcare associated costs in this vulnerable population.
Background: At present, 1.8 million individuals live in this nation's 16,000 nursing homes and an additional 900,000 live in assisted living facilities. Significant healthcare disparities exist for these individuals; a recent study found that the largest for-profit nursing homes delivered significantly lower quality of care. Part of this disparity is reflected in the fate of those infected with influenza. Influenza and pneumonia combine to form the 8th leading cause of death in the United States. Outbreaks of influenza and other respiratory viruses are common in LTCFs and result in significant morbidity and mortality among residents. This increased morbidity and mortality is due to a combination of close quartering, residents with co-morbid medical conditions, and delays in medical response. Because of this high risk, influenza vaccination has long been recommended for all residents and health care workers in these settings. Influenza vaccines, however, can have very low efficacy in older individuals; vaccine efficacy for protection from the predominant influenza strain in 2014-2015 was estimated to be only 14% for individuals aged 50 years and older. Accordingly, elders (aged 65+) accounted for 72.4% of Wisconsin's influenza-related hospitalizations during the 2014-2015 influenza season and 63% of influenza-related ICU admissions. Moreover, across the country, the rate of attributable influenza hospitalization was 313 per 100,000 for individuals aged 65 year and older.
The current practice for identifying and responding to influenza outbreaks in LTCFs is reactive and delayed. Of 41 known influenza outbreaks in LTCFs during the 2010-2011 season in New York, most were identified retrospectively through reporting of influenza hospitalizations and well before the LTCFs submitted reports to the Department of Health. The availability of CLIA-waived, low-complexity, sensitive and specific rapid influenza detection tests (RIDTs) can facilitate on-site diagnosis and early detection of an outbreak. Coupling RIDTs with wireless transmission of anonymous results directly to public health officials provides the means for extremely early and proactive outbreak recognition and intervention.
Program Goal: A randomized, controlled clinical trial to assess the effect of on-site RIDTs at LTCFs on subsequent influenza-related hospitalizations, deaths, and healthcare-associated costs is proposed. LTCF nursing staff will use RIDT technology to screen residents with acute respiratory infections (ARI). The proposed RIDT is a CLIA-waved, low-complexity test that uses a benign nasal swab specimen. It is configured to send test results via wireless transmission to a cloud platform. From there, data can be accessed in real-time by public health partners.
Methods: Starting in January 2013, extensive experience with the Quidel SOFIA Influenza A+B system at 20 clinical sites and 7 LCTFs where the testing platform transmits influenza test results immediately to a cloud-based system with public health access has been acquired. True "real-time" availability of surveillance results are achievable. Since initiation, this highly innovative system has been working flawlessly. A plan to conduct RAPID-LTCF over three sequential influenza seasons to adapt to the uncertainties of influenza epidemiology has been proposed. Twenty LTCFs across Wisconsin will be recruited for participation and randomized, following stratification, to intervention (RIDT) or control (usual care) arms. Waived consent for on-site specimen collection from residents at the RIDT sites with acute respiratory infections has been approved by the IRB. Nasal swabs will be tested by nursing personnel at each intervention site using SOFIA. Anonymous results will be sent, via wireless transmission, for daily review by the study team and public health personnel. A positive influenza detection will trigger direct communication with LTCF personnel with advice on antiviral treatment, antiviral prophylaxis, and appropriate infection control practices. Data will be collected from each site regarding the number of courses of influenza antiviral medication provided for influenza treatment and for influenza prophylaxis, number of hospitalizations, number of deaths, and associated healthcare costs during annual, dynamic, 4-month risk windows, based on Wisconsin surveillance of influenza patterns. An independent data monitoring and safety board will continuously review outcomes and halt the study should significant differences between the two arms emerge. Outcomes will be assessed using standard statistical methods.
Significance: This program reflects the full intent of the Wisconsin Partnership Program and the Wisconsin Idea by identifying high-risk populations, and combining research, education and public health practice to reduce the disparities of care experienced by these populations. The application of cutting-edge, inexpensive, high-performing and reliable technology into a population of traditionally under-served, high-risk individuals would provide a translatable model for very early and proactive detection of, and response to influenza in LTCFs, thus allowing for appropriate medical (antiviral) and public health (in-room quarantining, enhanced personal protection equipment, prophylaxis of other residents) interventions.
|
Inclusion Criteria:
* Any resident of one of the 10 LTCF intervention facilities with two acute respiratory infection symptoms (rhinorrhea/runny nose, nasal congestion, sore throat, cough or fever).
Exclusion Criteria:
* None
|
[
-1.0018415451049805,
3.2758030891418457,
-1.2361176013946533,
-3.039957284927368,
0.26097434759140015,
0.5356321334838867,
-0.7856278419494629,
0.206370547413826,
-0.9427075982093811,
0.202307790517807,
0.0848689079284668,
1.5865676403045654,
-2.0524673461914062,
-0.14680589735507965,
-0.27518904209136963,
-0.5190330743789673,
-0.4158940017223358,
0.15160086750984192,
2.075488805770874,
-0.40626075863838196,
-0.3883887529373169,
0.3353569507598877,
-0.909654438495636,
0.8480532765388489,
0.08348019421100616,
1.2075141668319702,
-0.6118277907371521,
0.3421034812927246,
0.3370802104473114,
0.9131068587303162,
-0.3423318564891815,
-0.7725578546524048,
0.4407183527946472,
-0.2617095708847046,
1.0275121927261353,
0.20397566258907318,
0.7192145586013794,
0.8564037084579468,
-0.45199230313301086,
0.015725471079349518,
-0.0933605507016182,
0.420852392911911,
-0.4401227533817291,
0.03539774939417839,
1.5891908407211304,
-0.30918580293655396,
0.2023942768573761,
-1.1339470148086548,
0.2749940752983093,
0.13318027555942535,
-0.3189893960952759,
1.2383403778076172,
-0.25037136673927307,
0.14531467854976654,
0.31070226430892944,
-0.65385901927948,
-0.17058375477790833,
0.1485213190317154,
1.8487015962600708,
-0.3720547556877136,
1.1297630071640015,
-0.6140568256378174,
0.45720750093460083,
-0.5350174903869629,
-1.0064482688903809,
-0.02896963246166706,
-0.15033650398254395,
0.30621957778930664,
-0.16407139599323273,
-0.1945987194776535,
0.5853040814399719,
-0.8710687160491943,
0.9339693188667297,
1.585903525352478,
-0.2705617845058441,
-0.45396700501441956,
-0.8244229555130005,
-0.06897123157978058,
0.3791402578353882,
0.49843594431877136,
-0.39288970828056335,
-0.40425699949264526,
-0.08892416208982468,
-0.5593097805976868,
0.21640513837337494,
-1.0552058219909668,
-0.07368939369916916,
0.2585875988006592,
0.3627551198005676,
-0.42894062399864197,
0.1588558852672577,
-0.013353154994547367,
0.6080151200294495,
0.4330465793609619,
-0.4906559884548187,
0.3961319029331207,
-0.02224009856581688,
-0.4531032145023346,
-0.09357413649559021,
-0.43205881118774414,
0.38222017884254456,
-1.3223038911819458,
-0.34725216031074524,
0.059092603623867035,
-0.5438725352287292,
-0.8974888324737549,
0.5770773887634277,
-0.186115562915802,
-0.2582848370075226,
-0.4606339633464813,
0.5187753438949585,
-0.5108316540718079,
-0.33432742953300476,
-0.1714102327823639,
-0.23443077504634857,
0.12875401973724365,
0.37374159693717957,
1.0501821041107178,
0.04166541248559952,
-0.14743943512439728,
0.14557108283042908,
0.884129524230957,
0.6999158263206482,
-0.016777513548731804,
-0.45329853892326355,
-0.19923493266105652,
0.1724749505519867,
0.4389733076095581,
-0.7169654965400696,
-0.6411780118942261,
0.20394884049892426,
-0.4027422368526459,
0.45987752079963684,
0.17699284851551056,
-0.5701414346694946,
-0.8444451093673706,
-0.364005982875824,
0.8257204294204712,
1.2225745916366577,
-0.6833248734474182,
0.10789431631565094,
-0.08422370254993439,
0.45488888025283813,
0.24842312932014465,
-0.7849541902542114,
-0.7704209685325623,
-0.2926955223083496,
0.4717511236667633,
-0.3486773669719696,
-0.19064292311668396,
-0.6329194903373718,
0.8671887516975403,
0.2913306951522827,
-0.016041837632656097,
0.5698695182800293,
0.2814599573612213,
-0.1840507984161377,
-0.029926778748631477,
0.1073719784617424,
-0.2397116720676422,
0.6597643494606018,
-0.31874996423721313,
-0.09063450992107391,
-0.6862069368362427,
0.6857350468635559,
0.16367846727371216,
-0.2255953848361969,
0.4060714840888977,
-0.1495072990655899,
-0.08912257105112076,
0.2500663995742798,
0.22949610650539398,
0.2693585753440857,
-0.124242402613163,
-0.16519682109355927,
-0.05340494588017464,
0.004362461622804403,
-0.12932001054286957,
0.5503847002983093,
0.09318839758634567,
-0.04026578739285469,
-0.20948302745819092,
-0.23904946446418762,
0.0005012249457649887,
0.011351022869348526,
-0.2800329625606537,
-0.012482874095439911,
-0.5186378359794617,
-0.11271795630455017,
-0.2686540186405182,
0.4290667772293091,
0.39301419258117676,
-0.06889183074235916,
0.3463134169578552,
-0.0679360181093216,
-0.2712656855583191,
-0.28952881693840027,
-0.15794408321380615,
0.08297375589609146,
0.31504520773887634,
0.4253222644329071,
0.5139814615249634,
0.17069394886493683,
0.25910869240760803,
0.0932207852602005,
-0.05693323537707329,
0.2214013934135437,
-0.1319160759449005,
-0.2039610743522644,
0.2565455138683319,
-0.4273008108139038,
0.36517924070358276,
-0.6281886696815491,
-0.07630140334367752,
-0.3357541263103485,
-0.06902974098920822,
0.32538896799087524,
-0.2927602231502533,
-0.6676263809204102,
-0.025707948952913284,
-0.15323810279369354,
-0.17224587500095367,
-0.4145439565181732,
-0.14854726195335388,
0.03241927549242973,
0.155060276389122,
-0.04326788708567619,
0.15575185418128967,
0.5925498008728027,
-0.22411492466926575,
0.12022770196199417,
0.29158514738082886,
-0.5692265033721924,
-0.10846365243196487,
-0.21440677344799042,
-0.4228040874004364,
0.17362819612026215,
0.4833051562309265,
-0.27078697085380554,
0.1037285253405571,
0.6986932754516602,
-0.21174265444278717,
0.30777987837791443,
0.10811041295528412,
-0.3245643675327301,
0.10515855997800827,
-0.017368707805871964,
0.11707621812820435,
0.3321588337421417,
-0.008385403081774712,
0.06294786930084229,
-0.3701184093952179,
-0.06509415805339813,
0.11376664787530899,
0.12652087211608887,
0.05600949376821518
] |
NCT03568149
|
Pelvic Congestion Syndrome and Endometriosis
|
The pelvic congestion syndrome (PCS) is a complex and multifactorial condition associated with inflammatory and hormonal etiophatogenesis similar to the endometriosis.
Furthermore, both pathologies share same clinical symptoms as chronic pelvic pain and dyspareunia.
Our hypothesis is that PCS prevalence is higher in patients with endometriosis than in those without clinical or ultrasound signs of endometriosis.
|
Patients undergoing routine gynecological examinations are included in the study.
Patients are divided into 2 groups:
* Group A: with endometriosis
* Group B: without clinical or ultrasound signs of endometriosis This is an observational, monocentric, prospective, exploratory study. The aim is to assess PCS incidence, associated symptoms and ultrasound characteristics in patients with endometriosis and to compare those findings to those of patients who do not present clinical or ultrasound signs of endometriosis.
The study also evaluates the correlation between:
* Type of pain symptoms (dysmenorrhea, chronic pelvic pain, ovulation pain, dyspareunia, dysuria, dyschezia) and PCS
* Pain severity (assessed according to VAS scale from 0= no pain to 10= unbearable pain) and PCS
* Symptoms and ongoing medical treatments
* History of pelvic surgery and PCS.
Ultrasound parameters of pelvic vascular insufficiency are:
* Ovarian vein diameter \<4mm
* Slow ovarian blood flow (\<3cm/sec)
* Retrograde blood flow
* Dilated arcuate veins communicating with pelvic varices
* The presence of pelvic varices is evaluated qualitatively as normal, moderate and serious
This evaluation includes the study of uterine and ovarian vessels, using different techniques:
* Standard 2D study: it allows to measure vessels diameter
* Vascular doppler study: it allows to evaluate flow direction and blood speed
* 3D color study: it allows a three- dimensional reconstruction of vessels and a more accurate qualitative assessment of the congestion degree.
* Ultrasound images are evaluated independently by two operators.
|
Inclusion Criteria (Group A):
* Obtaining Informed Consent
* Nulliparity
* Clinical or ultrasounds signs of endometriosis
Inclusion Criteria (Group B):
* Obtaining Informed Consent
* Nulliparity
Exclusion Criteria:
* Menopause
* Actual or previous pregnancy
|
[
2.4068403244018555,
0.03547375649213791,
-5.443262100219727,
-2.3417751789093018,
0.0458395890891552,
-1.4460774660110474,
1.27675199508667,
-1.516682505607605,
-2.268343210220337,
1.4131672382354736,
0.8898354172706604,
1.3930050134658813,
0.2620053291320801,
-0.2320486605167389,
0.42616793513298035,
1.2095052003860474,
0.578538715839386,
0.04400954395532608,
1.7927753925323486,
-1.9895268678665161,
1.0990679264068604,
-0.4515722990036011,
0.18956677615642548,
-1.072759985923767,
1.97159743309021,
-0.6004341244697571,
-0.7349373698234558,
1.5115454196929932,
0.08991135656833649,
1.3664525747299194,
-0.26919275522232056,
-1.6197471618652344,
0.2046651989221573,
1.5569015741348267,
-1.3610615730285645,
-1.7651268243789673,
0.947737455368042,
1.150194525718689,
-2.4139461517333984,
0.27295148372650146,
0.013397633098065853,
0.8165144920349121,
-0.567541778087616,
-0.8983948230743408,
0.15983431041240692,
0.04347352683544159,
-1.0245060920715332,
-0.5016030669212341,
1.3816981315612793,
0.06414403766393661,
-1.6157512664794922,
1.236502766609192,
-2.9510390758514404,
0.9640549421310425,
1.833052158355713,
0.29101619124412537,
0.7363787889480591,
1.8480886220932007,
0.7577714323997498,
-0.1972000002861023,
0.14472827315330505,
-0.6897760629653931,
-1.5710352659225464,
-0.4295831322669983,
0.7716747522354126,
-0.7082670331001282,
-0.08026155084371567,
0.4012516736984253,
0.06607218086719513,
-0.5395715236663818,
-0.37219616770744324,
0.6119011640548706,
0.15930825471878052,
-0.5893542766571045,
0.7656320929527283,
-0.12466120719909668,
-1.245979905128479,
0.6120294332504272,
0.8518398404121399,
-0.09037817269563675,
-0.7175474762916565,
-0.4762091338634491,
-1.587571620941162,
1.5179438591003418,
-1.4888685941696167,
-0.1427912414073944,
-2.567711591720581,
-0.003704105969518423,
0.39046546816825867,
-1.2792285680770874,
1.4028422832489014,
-0.16623081266880035,
-0.5804625153541565,
1.0577787160873413,
-0.007889334112405777,
0.4077189564704895,
-1.107211709022522,
0.2692481279373169,
-1.5134446620941162,
0.4236775040626526,
0.2562059760093689,
0.18640416860580444,
-1.7667537927627563,
-0.63323575258255,
0.0819348618388176,
-0.32670316100120544,
0.20551852881908417,
-0.17030316591262817,
-1.3321952819824219,
-0.48603031039237976,
0.9367536902427673,
1.0571589469909668,
-0.011739605106413364,
0.2871357202529907,
0.6681137681007385,
0.9328161478042603,
0.17968949675559998,
-0.7686153650283813,
0.30861222743988037,
-0.2898325026035309,
-0.7660939693450928,
1.35545814037323,
0.2386014461517334,
0.5748319029808044,
-0.7648836374282837,
0.015728173777461052,
-0.30406975746154785,
1.2203174829483032,
0.12115123122930527,
-1.3950649499893188,
-0.5898252725601196,
0.613956093788147,
1.2614119052886963,
0.03342937305569649,
-0.5727552175521851,
0.2584390342235565,
0.13202150166034698,
1.1806018352508545,
0.5242941975593567,
-0.5506320595741272,
0.07903773337602615,
-0.0113291647285223,
-0.04012155905365944,
0.44740843772888184,
-0.9118813276290894,
-0.3000265061855316,
-0.8012816309928894,
0.5589421391487122,
-0.8554730415344238,
-0.6276363730430603,
0.33202439546585083,
0.6064104437828064,
1.6522161960601807,
0.10538744181394577,
0.7066414952278137,
0.7029421925544739,
0.23031874001026154,
0.4518800377845764,
1.2491531372070312,
0.4250434637069702,
-0.0792899802327156,
-0.10282069444656372,
0.15933331847190857,
0.497084379196167,
0.6157212257385254,
0.05992359668016434,
0.12175916880369186,
-0.028577277436852455,
0.7024580240249634,
-0.11213822662830353,
0.2848399877548218,
-0.551118791103363,
-0.0979808121919632,
0.12140699476003647,
-0.791955828666687,
0.32358866930007935,
0.42319735884666443,
0.6767356395721436,
0.6774609088897705,
-0.5187917351722717,
0.22029812633991241,
-0.7225441336631775,
0.20463331043720245,
0.24466079473495483,
0.45121586322784424,
-0.1383749097585678,
-0.03830966353416443,
0.16592571139335632,
-1.5528682470321655,
0.11438452452421188,
-0.10386195033788681,
-0.32887065410614014,
-0.4758719205856323,
0.12204769253730774,
-0.06072429195046425,
0.32894986867904663,
0.27249783277511597,
0.2869761288166046,
0.17723630368709564,
0.09723649173974991,
-0.0849294662475586,
-0.014395896345376968,
-0.009174413979053497,
0.2639697194099426,
-0.4317995011806488,
-0.19520173966884613,
0.42895177006721497,
0.1620768904685974,
0.27003708481788635,
-0.5467743277549744,
0.36202365159988403,
-0.26276126503944397,
0.4465639293193817,
0.119118832051754,
0.2306293100118637,
0.6910614967346191,
-0.004872565157711506,
-0.16874590516090393,
-0.9043740034103394,
-0.5135698318481445,
-0.1902768909931183,
0.28844502568244934,
-0.05538242310285568,
0.03181981295347214,
-0.1823440045118332,
-0.2992863953113556,
0.42480432987213135,
0.45974957942962646,
0.4142495393753052,
-0.2259226143360138,
-0.9942613840103149,
0.25667569041252136,
-0.06180577352643013,
-0.012022461742162704,
-0.5012940764427185,
-0.541800320148468,
0.4509076774120331,
-0.012666039168834686,
0.4594951868057251,
0.7973200082778931,
-0.46924710273742676,
-0.18044477701187134,
-0.1044655367732048,
0.01060517132282257,
-0.15689678490161896,
-0.17096637189388275,
0.3539973795413971,
-0.45686763525009155,
-0.2672975957393646,
-0.40945035219192505,
-0.7575815320014954,
-0.05622516945004463,
1.0971977710723877,
-0.34552428126335144,
0.4629662334918976,
-0.0974203571677208
] |
NCT00000602
|
Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG)
|
To determine whether hydroxyurea prevents the onset of chronic end organ damage in young children with sickle cell anemia.
|
BACKGROUND:
Sickle cell anemia is a complex syndrome with multiple organ system disturbances brought about by the interplay of genetic, humoral, vascular and environmental factors. The clinical course can be one of abrupt and insidious exacerbations and remissions, often migratory and repetitive. These events may result in impairment of function, permanently damaged organs, and ultimately death. Although there is wide variability in the clinical expression of sickle cell disease, this complex set of clinical manifestations is experienced by most patients. In addition, there is no evidence that the primary disease process is different in children when compared with adults with regard to painful episodes. However, children have a higher incidence of respiratory viral infections, and are susceptible to pneumococcal septicemia. With the successful completion of the Multicenter Study of Hydroxyurea (MSH) Trial in adults, attention has now been focused on the use of this agent in children.
The Cooperative Study of Sickle Cell Disease (CSSCD) has demonstrated that sickle cell anemia patients with increased painful episode rates die at a younger age. In addition, increased levels of fetal hemoglobin are associated with improved survival, and is probably a reliable childhood forecaster of adult life expectancy. The beneficial effect produced by hydroxyurea is thought to occur because it increases fetal hemoglobin levels. Therefore, if chronic end organ damage can be prevented in early childhood by hydroxyurea administration, and if the crisis rate can be decreased by hydroxyurea use early in life, sickle cell anemia patients may experience increased longevity and an improved quality of life.
DESIGN NARRATIVE:
The Phase I-Phase II study, HUG-KIDS, examined the safety of hydroxyurea. Children with sickle cell anemia, age 5 to 15 years, were eligible for this multicenter Phase I/II trial. Hydroxyurea was started at 15 mg/kg/d and escalated to 30 mg/kg/d unless the patient experienced laboratory toxicity. Patients were monitored by 2-week visits to assess compliance, toxicity, clinical adverse events, growth parameters, and laboratory efficacy associated with hydroxyurea treatment. Eighty-four children were enrolled between December 1994 and March 1996. Sixty-eight children reached maximum tolerated dose (MTD) and 52 were treated at MTD for 1 year. The study was conducted at four Comprehensive Sickle Cell Centers by the following investigators: Thomas R. Kinney at Duke University Medical Center, Durham, North Carolina; Kwaku Ohene-Frempong at Children's Hospital of Philadelphia; Orah S. Platt at Children's Hospital in Boston; and Elliot Vichinsky at Children's Hospital in Oakland, California. The complete study lasted three years.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
|
Children with sickle cell disease and between the ages of five and eighteen years.
|
[
-1.4230579137802124,
-1.0236995220184326,
-1.1943706274032593,
-2.5858206748962402,
-0.5880255699157715,
0.8928819298744202,
0.877754271030426,
-0.8168948292732239,
-2.3959479331970215,
0.14508166909217834,
0.8449275493621826,
4.297456741333008,
0.7707604765892029,
2.352078914642334,
-0.3010370433330536,
0.027902204543352127,
-1.1652880907058716,
-0.02657066285610199,
1.938590407371521,
-3.287875175476074,
-0.0078087979927659035,
0.369989275932312,
0.138278529047966,
-1.4426536560058594,
2.3022348880767822,
0.4605437219142914,
0.032420702278614044,
0.1613805890083313,
0.22402963042259216,
-0.12593470513820648,
0.9130001068115234,
-0.848633348941803,
-0.5740182399749756,
-0.023549165576696396,
-0.9908339977264404,
-0.2204388678073883,
1.1940009593963623,
0.6074660420417786,
-0.7411566972732544,
0.499678373336792,
0.3596257269382477,
0.7886458039283752,
-0.9605911374092102,
-1.9275445938110352,
0.06849396228790283,
-0.6572900414466858,
-0.24523603916168213,
-0.2811311185359955,
-0.46838364005088806,
1.3068565130233765,
1.4073708057403564,
3.2614002227783203,
-1.8472354412078857,
0.7731584310531616,
2.419145345687866,
0.06597501784563065,
1.3835006952285767,
1.6853854656219482,
0.9200746417045593,
1.0009418725967407,
0.685717761516571,
-0.06074338033795357,
-0.49261313676834106,
-1.3582576513290405,
-3.1682894229888916,
-1.045934796333313,
0.21040046215057373,
-1.4814914464950562,
-1.3139541149139404,
0.47839996218681335,
0.3789186477661133,
0.9015259742736816,
0.5356199741363525,
-0.49898430705070496,
-0.45723116397857666,
0.8208350539207458,
-1.606499433517456,
0.5153181552886963,
1.3828179836273193,
-0.9109055399894714,
-2.087390661239624,
-1.5841962099075317,
-1.328860878944397,
-0.06259085237979889,
-0.724148690700531,
0.8927574157714844,
-1.4060570001602173,
-0.5697599649429321,
1.9640250205993652,
-2.3331286907196045,
0.2918778657913208,
0.03137108311057091,
-1.2992777824401855,
3.243345022201538,
-0.9864863753318787,
1.2525484561920166,
-0.8188694715499878,
0.053999099880456924,
-1.5303248167037964,
-1.6908040046691895,
0.3387150466442108,
0.21404537558555603,
-0.927543044090271,
-0.43090900778770447,
1.3758511543273926,
0.813671350479126,
-0.5629996657371521,
-0.11255225539207458,
-1.2187371253967285,
-0.538748562335968,
-0.07973716408014297,
-2.3609790802001953,
0.3625311255455017,
0.05161821469664574,
-0.4607654809951782,
-1.2154405117034912,
1.3115789890289307,
-0.26579177379608154,
-0.1991562843322754,
-0.43951132893562317,
-0.8358906507492065,
1.3198655843734741,
0.161174476146698,
0.42986294627189636,
-0.299454927444458,
-0.39545315504074097,
0.439605176448822,
-1.0985817909240723,
-1.4487004280090332,
1.2279192209243774,
-0.18590524792671204,
-0.4142571687698364,
-0.03789440542459488,
-0.7991586923599243,
0.3142181932926178,
-0.03537246584892273,
1.155428409576416,
0.44336777925491333,
0.7698497772216797,
-0.3983789086341858,
1.0806491374969482,
0.35405176877975464,
-1.120619535446167,
-0.08741020411252975,
-1.3051573038101196,
0.5278639793395996,
0.030785255134105682,
0.12314239144325256,
-0.10089430958032608,
-0.9690747261047363,
0.9614328145980835,
0.46580401062965393,
0.11737264692783356,
0.10974857956171036,
0.6734022498130798,
1.5491093397140503,
-0.9841412305831909,
0.5664380192756653,
0.34160834550857544,
1.1443086862564087,
0.4800340235233307,
-0.5644866824150085,
0.5413764715194702,
-0.7154254913330078,
0.19832979142665863,
0.5493155121803284,
-0.2562170922756195,
-0.3128301501274109,
0.30046772956848145,
-0.3122929334640503,
0.7519606947898865,
-0.4875539541244507,
-0.46393248438835144,
0.3158608675003052,
-0.5422422885894775,
-1.1677073240280151,
0.3343518376350403,
-0.026154592633247375,
-0.9306766390800476,
-0.14795757830142975,
-0.11478700488805771,
0.19942496716976166,
0.0991993248462677,
0.22160156071186066,
0.8693171143531799,
-0.413289338350296,
-0.8698102831840515,
-0.12697894871234894,
-1.439215064048767,
0.4943542182445526,
0.06822676956653595,
1.3578301668167114,
0.5485506057739258,
0.09603722393512726,
0.016369668766856194,
0.28243422508239746,
-0.10379920154809952,
-0.1141824945807457,
1.396740436553955,
0.2281605303287506,
1.0646227598190308,
0.2417142540216446,
0.04809748753905296,
0.48475563526153564,
-0.2066200226545334,
0.047871969640254974,
0.2162969410419464,
0.44601771235466003,
0.40076392889022827,
-0.15035945177078247,
-0.8085585236549377,
0.2155480980873108,
-0.34604600071907043,
-0.6094078421592712,
-0.1723717451095581,
-0.1903580278158188,
0.42161667346954346,
-0.28633272647857666,
-0.31464844942092896,
-0.6628924012184143,
-0.24234174191951752,
0.10969564318656921,
0.7867821455001831,
-1.1981416940689087,
0.08180058747529984,
-0.3338366448879242,
-0.16352014243602753,
0.7172325253486633,
-0.45758315920829773,
0.18665096163749695,
-0.44540295004844666,
-0.15773028135299683,
-0.6026284694671631,
0.09876775741577148,
-0.23007720708847046,
0.1105625331401825,
0.4654228687286377,
-0.18109287321567535,
0.6351681351661682,
0.06718092411756516,
-0.19241087138652802,
-0.11433380842208862,
0.5346454381942749,
-0.8583467602729797,
-0.5789428949356079,
-1.2160147428512573,
0.04594705253839493,
-0.05854496359825134,
0.45341044664382935,
0.34460780024528503,
-0.45878517627716064,
-0.17938438057899475,
0.43962061405181885,
-0.859557569026947,
0.8519899845123291,
-0.16048116981983185
] |
NCT04871893
|
Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy
|
Objective of the study is to assess the safety and efficacy of CO2 removal by the multiECCO2R (CO2 Removal System) on the multiFiltrate/multiFiltrate Pro in veno-venous extracorporeal circulation during continuous renal replacement therapy (CRRT) in patients presenting with hypercapnia due to acute lung failure and acute kidney injury.
|
Inclusion Criteria:
* Informed consent signed and dated by the investigator; and:
1. if patient is able to give consent: by the study patient
2. if patient is unable to give consent: by the legal representative or
3. if an emergency situation is determined: by an independent consultant physician
* Minimum age of 18 years
Study-specific:
* Body weight greater than 40 kg
* Acute Kidney Injury (AKI) with clinical indication for CRRT
* Hypercapnia with indication for ECCO2R:
(paCO2 ≥ 55 mmHg at given best possible protective ventilation parameters: Guiding parameters: tidal volume = 6 ml/kg PBW, PEEP to be adjusted according to the FiO2 1, driving pressure \< 15 cmH2O, max. inspiratory pressure \< 30 cmH2O or TV\<=5 ml/kg when max. inspiratory pressure\< 30 cmH2O cannot be held)
* Vascular access and Shaldon catheter allowing blood flow of 100 ml/min to 500 ml/min
* Arterial line in place, allowing blood sampling
* Estimated life expectancy greater than 3 days
Exclusion Criteria:
* In case of female patients: pregnancy or lactation period (if patient is ≥ 55 years old or have been surgically sterilized, a negative pregnancy test is not required)
* Participation in an interventional clinical study during the preceding 72 hours
* Previous participation in the same study
Study-specific
* Severe ARDS (Berlin definition): PaO2/FiO2 \< 100 mmHg
* Intracerebral haemorrhage
* Intracranial hypertension
* Acute myocardial infarction
* Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT Type II), if heparin is used as anticoagulant
* severe liver insufficiency or fulminant hepatic failure
* Uncontrolled bleeding and coagulation disorders, thrombocytopenia \< 75000µL
* Liver cirrhosis CHILD Pugh Classification \> A
* BMI \> 40 kg/m²
* Decision to limit therapeutic interventions
|
[
0.9926905632019043,
3.690253257751465,
-1.4612523317337036,
-4.027557373046875,
1.4284337759017944,
0.3392082452774048,
-0.4351128041744232,
1.2168848514556885,
-1.7768964767456055,
1.6349741220474243,
0.06587237864732742,
1.686617136001587,
-0.5034195184707642,
0.44395917654037476,
0.6290134191513062,
0.29029566049575806,
-0.7010740637779236,
1.6825767755508423,
0.20122244954109192,
-2.210214138031006,
0.6302391886711121,
-0.3749735653400421,
0.2067384272813797,
2.0543477535247803,
1.5564138889312744,
-0.7941756248474121,
0.6863552331924438,
0.1370951235294342,
-0.6156342029571533,
1.62690269947052,
0.20265762507915497,
-1.8815335035324097,
-0.29493096470832825,
1.0552730560302734,
-0.3236623704433441,
-1.2165424823760986,
1.9298033714294434,
1.23771071434021,
-0.6978609561920166,
0.1823819875717163,
1.3202078342437744,
0.3541101813316345,
-0.7701448798179626,
-0.06451611965894699,
1.5641355514526367,
0.7862425446510315,
-0.45037510991096497,
-0.7931578159332275,
0.901799201965332,
-0.7525991201400757,
-0.4463057518005371,
-0.2724355161190033,
-0.9578697085380554,
-0.5205331444740295,
1.0177712440490723,
1.0186645984649658,
-0.6205645203590393,
0.545198917388916,
0.20791910588741302,
0.7106902599334717,
0.935420036315918,
0.5352230072021484,
-0.2140379250049591,
0.9423806071281433,
-1.0006930828094482,
0.03967510908842087,
1.0410248041152954,
-0.6666507124900818,
-1.5891679525375366,
-0.095468670129776,
-1.551439881324768,
0.775102972984314,
0.8931710124015808,
0.8832436800003052,
0.2885260283946991,
0.7584216594696045,
-0.2772533595561981,
0.3218276798725128,
-0.027521898970007896,
0.06305785477161407,
-0.45503002405166626,
0.620682418346405,
-2.1148548126220703,
-0.30549269914627075,
0.7291460633277893,
-0.3655664324760437,
-1.2530986070632935,
-1.2796968221664429,
1.2737348079681396,
-0.8855345845222473,
0.02708062343299389,
0.26886865496635437,
-1.2507833242416382,
0.1705142855644226,
-0.29328247904777527,
-0.18473994731903076,
-0.7497014403343201,
-0.7831380367279053,
-0.897854208946228,
0.06840868294239044,
0.4852214753627777,
-0.21458695828914642,
0.05357150733470917,
0.13467168807983398,
-0.47514232993125916,
0.26090317964553833,
1.087550401687622,
-0.26738283038139343,
-0.27061864733695984,
-0.5913128852844238,
0.33019697666168213,
-0.8111897706985474,
1.0737284421920776,
-0.6445803046226501,
-0.17610275745391846,
1.0502769947052002,
0.18941077589988708,
-0.23144283890724182,
-0.529777467250824,
-0.21287988126277924,
-0.5359926223754883,
0.9127097129821777,
-0.07760867476463318,
0.5653403997421265,
0.5566021203994751,
0.4911513328552246,
0.21838213503360748,
1.1270296573638916,
0.2599388062953949,
-0.09400102496147156,
-1.1102510690689087,
-0.20197565853595734,
0.25136110186576843,
-0.46728670597076416,
-0.3032013177871704,
0.2596665918827057,
-0.04712090641260147,
1.1913912296295166,
0.018094632774591446,
-0.06129816547036171,
0.14200915396213531,
0.697050929069519,
0.2862353026866913,
0.1436259001493454,
-0.39657506346702576,
-0.340655654668808,
-0.36570772528648376,
0.34044286608695984,
-0.12057845294475555,
0.04181772097945213,
-0.4439641833305359,
-0.11859246343374252,
0.8824406266212463,
0.3360533118247986,
0.6348031759262085,
-0.06842334568500519,
0.6186096668243408,
-0.8561623096466064,
0.10374005138874054,
0.20096006989479065,
0.27930667996406555,
-0.38486021757125854,
0.08040089160203934,
-0.5650056004524231,
0.09306414425373077,
-0.4480748772621155,
-0.07858136296272278,
-0.0014252642868086696,
0.03381533920764923,
0.09883328527212143,
-1.444596767425537,
-0.08510968834161758,
0.03925812244415283,
0.06386321038007736,
-0.25852975249290466,
-1.0060460567474365,
0.2044776827096939,
0.21973760426044464,
0.6001723408699036,
-0.40959805250167847,
0.12479394674301147,
-0.31643202900886536,
-0.6724889874458313,
-0.24155032634735107,
0.060740675777196884,
0.491152286529541,
0.13391055166721344,
-0.5743823051452637,
-0.09494492411613464,
0.1860373169183731,
0.2219042330980301,
-0.03602691367268562,
0.4867513179779053,
-0.22048482298851013,
-0.44614508748054504,
0.2909679710865021,
-0.4646100699901581,
-0.14531362056732178,
0.26952341198921204,
-0.41899168491363525,
0.47154146432876587,
0.14983664453029633,
0.293063759803772,
0.8518825173377991,
0.3733440637588501,
-0.1113353818655014,
-0.23553122580051422,
-0.021389923989772797,
-0.22233623266220093,
0.7056463360786438,
0.49461355805397034,
0.12233439087867737,
0.036658719182014465,
0.3607776463031769,
0.7310311198234558,
0.29282495379447937,
0.3021174967288971,
-0.24375881254673004,
0.11912160366773605,
0.2306661754846573,
0.12851835787296295,
-0.13052573800086975,
0.1154300644993782,
0.3610764145851135,
0.11878221482038498,
0.5045697689056396,
-0.059397269040346146,
0.4027617573738098,
-0.4385177791118622,
-1.1634384393692017,
-0.060188163071870804,
-0.40685757994651794,
-0.15338489413261414,
-0.10882186889648438,
-0.5233114957809448,
0.03161118924617767,
0.43011772632598877,
-0.16247378289699554,
-0.4042171835899353,
0.32498645782470703,
0.31146273016929626,
-0.3232695162296295,
-0.3768473267555237,
0.4239872992038727,
0.541739284992218,
-0.4934673011302948,
-0.13182100653648376,
-0.9378212094306946,
-0.7512335777282715,
0.18476071953773499,
-0.2726917564868927,
0.26553696393966675,
0.39700427651405334,
0.2963162958621979,
0.536396324634552,
-0.016034981235861778
] |
|
NCT02876887
|
Cocoa to Improve Walking Performance in Peripheral Artery Disease
|
The COCOA-PAD trial will determine whether epicatechin-rich cocoa daily for six months improves walking performance in individuals with peripheral artery disease compared to placebo.
|
Therapeutic properties that target pathophysiologic impairments in PAD. These therapeutic properties include improved skeletal muscle mitochondrial function, increased skeletal muscle capillary density, and favorable changes in skeletal muscle levels of myostatin and follistatin that increase muscle mass and strength. Cocoa also protects against ischemia-reperfusion injury, improves endothelial function, and reduces oxidative stress. In summary, epicatechin-rich cocoa targets and reverses several pathophysiologic processes that are common in PAD and that are associated with functional impairment and functional decline in PAD. However, the effect of chronic daily cocoa consumption on functional decline has not been studied in older people with PAD.
The COCOA-PAD trial is a pilot study of 44 PAD participants age 60 and older: a double-blind, randomized controlled pilot clinical trial to provide preliminary data to address the hypothesis that chronic daily epicatechin-rich cocoa improves lower extremity functioning in older people with PAD by improving mitochondrial oxidative metabolism, increasing calf muscle capillary density, promoting calf skeletal muscle mitochondrial biogenesis, and improving endothelial function.
In the primary aim, the investigators will determine whether PAD participants randomized to an epicatechin-rich cocoa beverage have greater increases or smaller declines in six-minute walk performance at 6-month follow-up, compared to those randomized to an identical appearing placebo drink with comparable caloric composition. In the secondary aims, the investigators will determine whether PAD participants randomized to cocoa have improved treadmill walking performance, improved brachial artery flow-mediated dilation, favorable changes in calf muscle biopsy measures of mitochondrial function, mitochondrial biogenesis, follistatin, myostatin, and capillary density, increased calf skeletal muscle regeneration and reduced oxidative stress, and increased MRI-measured calf muscle perfusion. Outcome measures will be carefully timed relative to the last intervention dose to distinguish between the acute vs. chronic effects of cocoa-epicatechin.
If the hypotheses are correct, results will be used to design a large, definitive randomized controlled trial of epicatechin-rich cocoa to improve lower extremity functioning and prevent mobility loss in the large and growing number of older people who are disabled by PAD.
|
Inclusion Criteria:
1. All participants will be age 60 and older.
2. All participants will have PAD. PAD will be defined as follows. First, an ABI \< 0.90 at baseline is an inclusion criterion for PAD. Second, potential participants with an ABI \> 0.90 who have vascular lab evidence of PAD or angiographic evidence of PAD will be eligible.
Exclusion Criteria:
1. Above- or below-knee amputation.
2. Critical limb ischemia.
3. Wheelchair-bound or requiring a cane or walker to ambulate.
4. Walking is limited by a symptom other than PAD.
5. Baseline six-minute walk value of \<500 feet or \>1,600 feet
6. Lower extremity revascularization, major orthopedic surgery, cardiovascular event, or coronary revascularization in the previous three months.
7. Planned revascularization or major surgery during the next six months.
8. Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. \[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who require oxygen only at night may still qualify.\]
9. Mini-Mental Status Examination (MMSE) score \< 23 or dementia.
10. Unwilling to attend three visits in one week for final outcome measures.
11. Allergy to chocolate.
12. Unwilling or unable to consume products manufactured on the same equipment that processes peanuts, tree nuts, egg, wheat, soy, and milk.
13. Use of cocoa-containing dietary supplements.
14. Unwilling to give up major dietary sources of epicatechin during the study.
15. Symptoms of heart failure or angina that limit walking activity more than ischemic leg symptoms, increase in angina, or angia at rest (i.e. unstable angina).
16. Participation in or completion of a clinical trial in the previous three months. \[NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.\]
17. Non-English speaking, a visual impairment that limits walking ability.
18. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.
|
[
1.1568363904953003,
1.9047843217849731,
-1.3172919750213623,
-1.872413158416748,
0.21044504642486572,
2.446039915084839,
-1.6937236785888672,
-0.7184564471244812,
0.9912391304969788,
0.06673533469438553,
1.5366016626358032,
1.6609070301055908,
2.9385504722595215,
-1.3968052864074707,
-0.6875796914100647,
2.094179153442383,
0.0773991197347641,
-0.433027446269989,
-0.06272187829017639,
-1.026119351387024,
0.9958070516586304,
-1.9810936450958252,
1.2137922048568726,
-0.7396007180213928,
0.16147710382938385,
-0.9982481002807617,
0.31546375155448914,
-0.32161980867385864,
0.2031310349702835,
1.7166157960891724,
-1.5949419736862183,
0.1057039424777031,
0.4943048059940338,
0.06479218602180481,
-1.935651421546936,
1.3413755893707275,
1.571783423423767,
-0.46903592348098755,
-1.1015313863754272,
-0.04794106259942055,
1.432826280593872,
-0.791123628616333,
-0.36235955357551575,
1.7834439277648926,
1.0605367422103882,
0.21321308612823486,
-1.0875986814498901,
1.2681117057800293,
-1.4319758415222168,
0.2812533676624298,
2.2905759811401367,
0.6537724733352661,
-0.033036570996046066,
-0.5918940305709839,
1.4930094480514526,
-0.3971914052963257,
0.5914257168769836,
1.722881555557251,
0.7894929051399231,
-0.7904249429702759,
-0.780898928642273,
-0.6678193211555481,
-1.0201538801193237,
1.1695592403411865,
-0.7737385630607605,
-1.1306816339492798,
-2.174830913543701,
0.030832773074507713,
-0.5028331279754639,
-0.6898664236068726,
1.1595478057861328,
0.05841412395238876,
-0.3519873023033142,
0.17223678529262543,
-0.11808085441589355,
-0.2364417314529419,
-0.724860668182373,
1.2518028020858765,
0.4103746712207794,
0.5168096423149109,
-2.021714210510254,
0.869760274887085,
0.43607741594314575,
-0.9517146348953247,
0.2591053247451782,
0.8681385517120361,
-1.2551847696304321,
-1.677504062652588,
2.4508883953094482,
-2.115831136703491,
-0.6707603335380554,
-0.002172687090933323,
-0.9283760190010071,
0.3997177481651306,
-0.30963876843452454,
-2.1364378929138184,
-2.0061473846435547,
0.2256309539079666,
-0.9081775546073914,
-0.7433702945709229,
-0.9935981035232544,
-0.49637386202812195,
-1.5122413635253906,
-0.14244696497917175,
0.7023872137069702,
0.5542012453079224,
0.3927329182624817,
0.02603631652891636,
-0.6430532336235046,
-1.1111137866973877,
0.07158555835485458,
-0.8318597674369812,
0.4119004011154175,
0.35232067108154297,
0.07488194108009338,
1.045649528503418,
1.0303945541381836,
2.0973246097564697,
-0.9238683581352234,
-0.8056881427764893,
-0.0002272165147587657,
0.5516829490661621,
1.133545160293579,
0.30556169152259827,
0.5359578728675842,
-0.032304536551237106,
-0.09699930250644684,
0.35952746868133545,
-1.1727368831634521,
-1.0478079319000244,
0.4907093048095703,
1.3677414655685425,
0.08669458329677582,
-0.5346658825874329,
0.28537270426750183,
-1.2413344383239746,
-0.5550602674484253,
0.764909565448761,
-1.137090802192688,
-0.7384026646614075,
-1.220763921737671,
-0.7723476886749268,
-0.8458206653594971,
0.9820308685302734,
-1.0843523740768433,
0.3137219548225403,
-0.8642512559890747,
0.23306557536125183,
-0.17250888049602509,
0.2915921211242676,
0.3070412874221802,
2.2001047134399414,
0.44508522748947144,
0.33282288908958435,
0.2812631130218506,
1.0621479749679565,
0.6572976112365723,
-1.1355397701263428,
1.2994736433029175,
0.8024283647537231,
-0.07600563764572144,
-0.5940356850624084,
-0.3788890838623047,
-1.1426255702972412,
1.5463900566101074,
0.32985684275627136,
-0.4308081865310669,
-0.20207689702510834,
0.4023453891277313,
-0.01582307554781437,
-1.4646652936935425,
0.8956219553947449,
0.311566561460495,
0.2434033900499344,
-0.38414546847343445,
0.6110889315605164,
1.4749692678451538,
-0.1990763545036316,
0.49787747859954834,
-0.38329529762268066,
0.3754175007343292,
0.6025108695030212,
-0.9445103406906128,
-0.07379434257745743,
0.3930790424346924,
-0.9357067942619324,
0.2714633345603943,
-0.12430572509765625,
0.36363476514816284,
0.8020540475845337,
0.025107087567448616,
0.03971288725733757,
0.3009369671344757,
1.4927010536193848,
0.982797384262085,
0.49126169085502625,
-0.05563739687204361,
-0.9162967205047607,
0.7465875744819641,
-0.9081948399543762,
0.9651743769645691,
0.1187368631362915,
-0.582804262638092,
0.9900345206260681,
-0.5927742123603821,
1.0279467105865479,
-1.0984493494033813,
-1.069105863571167,
-0.5832292437553406,
0.5393320918083191,
-0.12107453495264053,
0.08765029907226562,
-0.6373381614685059,
-0.47901132702827454,
0.03768488019704819,
0.26723048090934753,
-1.1011484861373901,
-0.24614077806472778,
0.63135826587677,
-1.0181571245193481,
-0.3700864017009735,
-0.31721118092536926,
-0.09159241616725922,
-0.8892499804496765,
-0.23926061391830444,
-0.818803608417511,
0.5981327295303345,
1.1331565380096436,
-0.0057529485784471035,
-0.7604788541793823,
-0.4252711534500122,
-0.14955788850784302,
0.5165672302246094,
-0.17242257297039032,
-0.6130737066268921,
0.34244269132614136,
0.8341286182403564,
0.6076844334602356,
0.28094443678855896,
0.6135914921760559,
0.8453852534294128,
-0.48308736085891724,
0.5067380666732788,
-0.5841302871704102,
-0.7114261388778687,
0.046483851969242096,
-0.09040083736181259,
0.5786193013191223,
0.3492809534072876,
0.16977041959762573,
0.5250821709632874,
-0.5088123083114624,
0.02770344726741314,
-0.20175641775131226,
0.05865447223186493,
-0.5398368239402771
] |
NCT04481425
|
Evaluation of the Efficacy of Non-drug Therapy (SMS Intervention) for Adolescents With NSSI
|
In this proposed study, Text messages are used to intervene in the NSSI behavior of adolescents, and the efficacy of this intervention method is evaluated, as well as the internal mechanism of adolescents' NSSI behavior is discussed.
|
In this proposed study, the investigators will evaluate the effect of text message intervention on Nonsuicidal self-injury behavior in adolescents. The study will recruit 110 adolescents with Nonsuicidal self-injury behavior in outpatient and ward, then all the participants will be randomized to the intervention group (55 cases) or the control group 55 cases) for an 8-week clinic trial. Clinical efficacy and safety assessment will be done at baseline, the fourth week, and the eighth week. The specific aims are to evaluate the effect of text message intervention on NSSI in adolescents are on 1) Tendency and frequency of Nonsuicidal self-injury behavior; 2) Level of negative emotion such as depression, anxiety, and hopelessness 3) The use of emotion regulation strategies and coping styles. A semi-structured quantitative interview will be conducted among adolescents from the SMS group to get the attitude and experiences feedback about the text message.
|
Inclusion Criteria:
1. Adolescents aged 10-19 years old.
2. Meet the diagnostic criteria of NSSI behavior recommended by DSM-5.
3. The adolescents who have mobile phone, and have the ability to send or receive text messages.
4. Adolescents and guardians agreed to participate and signed the informed consent form
Exclusion Criteria:
1. Adolescents with severe somatic diseases who cannot complete the study.
2. Adolescents with cognitive impairment, neurodevelopmental disorder, mental retardation, visual impairment who cannot complete the study.
3. The adolescents who do not have a mobile phone.
|
[
-1.205703854560852,
4.761913776397705,
-2.827719211578369,
-1.9626187086105347,
0.7349488735198975,
-3.012296199798584,
-1.0870099067687988,
-0.5255193114280701,
0.4893435537815094,
-0.6493930816650391,
-1.3949859142303467,
1.8779140710830688,
-1.5932708978652954,
2.3227953910827637,
-0.16511709988117218,
2.0718791484832764,
0.8135672211647034,
0.5080960392951965,
3.173112392425537,
-1.563750147819519,
0.7989693284034729,
0.649718701839447,
0.9810852408409119,
-1.669445514678955,
1.1961857080459595,
0.27273237705230713,
-2.588914632797241,
-0.3273414373397827,
0.7565146088600159,
2.292140007019043,
-0.33754825592041016,
-1.282161831855774,
1.4558930397033691,
1.650961995124817,
1.105521321296692,
-0.6261529922485352,
1.057571530342102,
0.2220245748758316,
-0.4644765853881836,
0.7118263244628906,
-0.7689964175224304,
0.10002739727497101,
-0.24504375457763672,
0.4404201805591583,
0.6191505789756775,
-0.7450357675552368,
0.7326228618621826,
1.1737353801727295,
-0.9646245837211609,
0.12219056487083435,
-0.25838229060173035,
1.916776180267334,
0.8904834985733032,
-0.4497211277484894,
2.4203317165374756,
-0.10206586867570877,
0.5937313437461853,
-1.5713921785354614,
2.3603007793426514,
-1.1971694231033325,
0.10153653472661972,
-0.039799246937036514,
0.6731802225112915,
-0.5889905095100403,
-0.7162205576896667,
-0.8460838794708252,
1.4775317907333374,
0.8902917504310608,
-0.44751426577568054,
-1.6339508295059204,
1.9295287132263184,
0.37857887148857117,
1.115186333656311,
-0.40078604221343994,
-0.0934070274233818,
-1.7034027576446533,
-0.11407546699047089,
-0.16121286153793335,
0.8367758393287659,
1.4790748357772827,
-0.7541898488998413,
0.6839821338653564,
0.288225382566452,
0.3232429325580597,
0.899212121963501,
-1.2313454151153564,
0.18965719640254974,
0.5506442189216614,
0.036909326910972595,
-0.3464144468307495,
-0.3497549593448639,
0.030225791037082672,
-1.9753180742263794,
-0.4445771276950836,
0.5666152238845825,
1.1052136421203613,
-0.03067203238606453,
-0.6885523200035095,
0.6710919737815857,
-0.6577559113502502,
-0.35440316796302795,
-1.6864594221115112,
-0.3004433810710907,
0.3857993185520172,
0.16754432022571564,
0.6566104292869568,
-0.523247480392456,
0.04786287248134613,
0.06799336522817612,
0.6092005372047424,
-0.050676677376031876,
-0.205122709274292,
0.9492325186729431,
-0.44338110089302063,
1.667422890663147,
0.0005440300446934998,
0.41587626934051514,
0.4008311927318573,
-0.28397005796432495,
0.44373753666877747,
1.038909912109375,
0.6213712096214294,
-0.692272961139679,
0.3431597352027893,
-0.9346908926963806,
-0.7875112891197205,
0.008585113100707531,
-0.5578157901763916,
-1.5445080995559692,
-0.7829784750938416,
-0.29000309109687805,
1.1509997844696045,
0.19976167380809784,
1.0240463018417358,
0.07952562719583511,
-0.45865219831466675,
0.29495999217033386,
0.9832172393798828,
-0.13660170137882233,
-0.849865198135376,
-0.43782150745391846,
0.6852062344551086,
0.8779163956642151,
-0.7646189332008362,
-1.3403265476226807,
-0.8588629364967346,
0.5218621492385864,
0.7359047532081604,
-1.08755362033844,
-0.8827978372573853,
-0.6616277694702148,
0.6584839224815369,
-0.24215397238731384,
0.2509719133377075,
-0.9128425717353821,
-0.44460204243659973,
0.9394432306289673,
-1.560146450996399,
-0.6476161479949951,
-0.24639032781124115,
2.249159812927246,
-0.44282495975494385,
0.13985870778560638,
0.02770904451608658,
-0.4996204674243927,
-0.6148808002471924,
-1.140259861946106,
0.9651355743408203,
0.3093039095401764,
-0.00938151404261589,
-0.23661628365516663,
0.3688777685165405,
-0.7066314220428467,
0.42182084918022156,
-1.5619622468948364,
0.3809727728366852,
0.548225462436676,
-1.331561803817749,
-1.0385067462921143,
0.5263293981552124,
-0.10205673426389694,
-0.5802236199378967,
0.19137606024742126,
0.8596281409263611,
0.45251381397247314,
-0.8577274084091187,
-0.9897712469100952,
0.6658116579055786,
-0.012600475922226906,
0.4518029987812042,
-0.43915653228759766,
-0.2501382529735565,
0.48990270495414734,
0.0171111561357975,
-0.30690816044807434,
-0.37511682510375977,
-0.3433605432510376,
-1.3394801616668701,
-0.1105625182390213,
0.31195175647735596,
0.5050745606422424,
-0.00963862519711256,
-1.1982935667037964,
-0.9154512882232666,
-0.25488123297691345,
-0.8103786110877991,
-0.15215875208377838,
0.024898957461118698,
-0.519529402256012,
1.1514099836349487,
-0.04136564955115318,
0.07215382158756256,
-0.10129913687705994,
-0.513714611530304,
-0.3515249490737915,
-0.28022634983062744,
-0.3045828342437744,
0.2004590928554535,
0.04004430025815964,
-0.15602844953536987,
-0.26778700947761536,
-1.011144757270813,
0.3730962574481964,
0.6401249170303345,
0.0028166496194899082,
-0.06708845496177673,
0.15951158106327057,
-0.4597682058811188,
-0.3739685118198395,
0.720855176448822,
0.007882554084062576,
0.7073755264282227,
-0.3079988658428192,
0.6417190432548523,
0.4774199426174164,
-0.37183678150177,
0.33980074524879456,
-0.011229180730879307,
-0.31465473771095276,
0.6720290184020996,
0.7393922209739685,
0.0018458073027431965,
-0.6569376587867737,
0.3020820915699005,
0.11151354759931564,
-0.09738330543041229,
-0.06689012795686722,
0.04835515096783638,
0.4491427540779114,
0.4833257496356964,
0.19891910254955292,
-0.3000708818435669,
0.17025960981845856,
0.6605384349822998,
0.16830353438854218,
-0.45933496952056885
] |
NCT03584802
|
Therapeutic Plasma Exchange, Rituximab and IV Ig for Severe Acute Exacerbation of IPF Admitted in ICU
|
Idiopathic pulmonary fibrosis (IPF) is a fibroproliferative, irreversible disease of unknown cause, occurring mainly in patients older than 50. IPF is a rare but fatal lung disease, with an estimated prevalence of 14 to 28/100000 and a median survival time of 3 years. Acute exacerbation of IPF (AE-IPF) is a major event of IPF, as it is responsible for the death of 30-50 % of IPF patients; its annual incidence varies between 5 and 10%. The current literature indicates that IPF is associated with the development of an auto-immunity process targeting epithelial and endothelial lung cells. Autoantibodies have been associated with a poorer prognosis. A study by DONAHOE et al. (Plos One, 2015) indicates that the combination of corticosteroids, plasma exchanges, rituximab and immunoglobulins may improve the prognosis of the most severe forms of AE-IPF. In that study, the observed survival rate in patients receiving this combination of treatment was 70% as compared with 20% in historical controls. This therapeutic combination approach is designed both to eliminate and inhibit the production of circulating antibodies targeting the lungs. Considering the high mortality rate of an AE-IPF episode and the potential benefit of such an original approach, a well-conducted randomized controlled trial is critical.
|
Idiopathic pulmonary fibrosis (IPF) is a fibroproliferative, irreversible disease of unknown cause, occurring mainly in patients older than 50. IPF is a rare but fatal lung disease, with an estimated prevalence of 14 to 28/100000 and a median survival time of 3 years. Acute exacerbation of IPF (AE-IPF) is a major event of IPF, as it is responsible for the death of 30-50 % of IPF patients; its annual incidence varies between 5 and 10%. The current literature indicates that IPF is associated with the development of an auto-immunity process targeting epithelial and endothelial lung cells. Autoantibodies have been associated with a poorer prognosis. A study by DONAHOE et al. (Plos One, 2015) indicates that the combination of corticosteroids, plasma exchanges, rituximab and immunoglobulins may improve the prognosis of the most severe forms of AE-IPF. In that study, the observed survival rate in patients receiving this combination of treatment was 70% as compared with 20% in historical controls. This therapeutic combination approach is designed both to eliminate and inhibit the production of circulating antibodies targeting the lungs. Considering the high mortality rate of an AE-IPF episode and the potential benefit of such an original approach, a well-conducted randomized controlled trial is critical.
The main objective is to evaluate the impact on overall mortality at day 28 of plasma exchanges, rituximab, intravenous immunoglobulins (IVIg), and corticosteroid administration versus standard corticosteroid therapy in hypoxemic patients admitted in ICU for severe acute exacerbation of idiopathic pulmonary fibrosis.
The primary assessment criterion will be overall mortality at day 28 after initiation of therapy (Day 1).
Secondary objectives are the following:
1. Efficacy:
1.1. To compare the overall mortality at day 90, at 6 months and at 12 months after the initiation of therapy 1.2. To compare the exposition to mechanical ventilation 1.3. To compare the length of ICU and hospital-stay 1.4. To compare the evolution of Sequential Organ Failure Assessment (SOFA) score 1.5. To compare the radiological evolution 1.6. To compare the evolution of lung injury biomarkers in plasma 1.7. To compare the changes in circulating autoantibodies levels before and after therapy 1.8. To compare the evolution of blood fibrocytes proportion 1.9. To evaluate respiratory functional at 3 months and compare data previously available.
1.10. To assess quality of life (SF36), autonomy (ADL) and muscle strength scores (MRC) at 3 months of inclusion (Cf annexe)
2. Safety:
2.1. To compare the occurrence of healthcare-associated infection 2.2. To describe the specific complications associated to the experimental treatment
Secondary assessment criteria are the following:
3. Efficacy:
3.1. Overall mortality at day 90, at 6 months and at 12 months 3.2. Number of days alive without mechanical ventilation between inclusion and day 28 3.3. Length of ICU-stay and hospital-stay 3.4. Changes in SOFA score from D1 to D3, D7, D16, D21, D28 or discharge-day from ICU as appropriate 3.5. Variation of global extent of High Resolution Computed Tomography (HRCT) infiltrates between initial HRCT and D90 3.6. Changes in lung injury plasmatic biomarkers (KL-6, SP-D) from D1 to D16, D21, D28 and D90 3.7. Changes in circulating antibodies levels (anti-periplakin, anti-HSP70 and anti-vimentin antibodies) from D1 to D28 and D90 3.8. Changes in the proportion of blood fibrocytes from D1 to D16, D28 and D90
4. Safety:
4.1. Proportion of patients with at least one episode of any healthcare-associated infection between inclusion and D28 4.2. The following complications in the experimental group will be described: 4.2.1. Proportion of catheter-linked complications between inclusion and D16 4.2.2. Number of blood units transfused between inclusion and day 28. 4.2.3. Proportion of major bleeding according to the International Society On Thrombosis And Haemostasis 4.2.4. Proportion of patients with occurrence of an acute renal failure at D28, according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines 4.2.5. Proportion of patients with anaphylactic reaction at day 28
The experimental design is multicenter, randomized, controlled, open-label superiority trial in parallel groups. The population involved is ICU patients with a Partial pressure of oxygen/ Fraction inspired by oxygen (PaO2/FIO2) ratio \< 200 and a diagnosis of acute exacerbation of idiopathic pulmonary fibrosis.
The experimental group will receive a combination of:
1. Methylprednisolone bolus of 1g i.v. day 1, then 20 mg/day (or oral prednisone equivalent) for 21 days;
2. Nine therapeutic plasma exchanges of 1.5x the estimated plasma volumes using albumin:saline (3:1) or fresh frozen plasma in case of an International Normalised Ratio (INR) superior to 1.5, on days 1,2,3,5,7,9,11,13,15; followed by administration of low dose of intravenous immunoglobulin (100 mg/kg)
3. Rituximab 1 g i.v. on days 7 and 15 (after therapeutic plasma exchange and premedication);
4. Intravenous immunoglobulin 0.5 g/kg/d on days 16 to 19.
The reference group will receive:
Intravenous methylprednisolone bolus of 10 mg/kg (max. 1g) on day 1, 2 and 3, then 1 mg/kg/d for 1 week, and 0.75 mg/kg/d for 1 week, then 0.5 mg/kg/d for 1 week, and 0.25 mg/kg/d for 1 week, and 0.125 mg/kg/d until day 90. Shift to oral prednisone as soon as the oral route is available.
Other procedures added by the research:
Blood sampling for serial serum lung injury biomarkers, fibrocytes determination and circulating antibodies measurements
Risks added by the research: C Number of subjects chosen: 40 Number of centres : 17
Research period:
Inclusion period: 36months Length of participation: one year
* Maximum period between selection and inclusion: 3 days
* Treatment period: 90 days
* Follow up period: 1 year +/- 2 weeks
* Total research period: 48 months
|
Inclusion Criteria:
1. Patient ≥ 18 years of age
2. Admitted to ICU in the last 72 h
3. Definite or probable IPF diagnosis defined on 2018 ATS/ERS/JRS/ALAT guidelines or a possible usual interstitial pneumonia pattern on HRCT without etiology.
4. Definite AE-IPF according to the 2018 revised criteria :
1. Previous or concurrent diagnosis of idiopathic pulmonary fibrosis (if the diagnosis of IPF is not previously established, this criterion can be met by the presence of radiologic and or histopathologic changes consistent with usual interstitial pneumonia (UIP) pattern on the current evaluation);
2. Acute worsening or development of dyspnea typically of less than one-month duration;
3. Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with a UIP pattern (if no previous computed tomography is available, the qualifier "new" can be dropped);
4. Deterioration not fully explained by cardiac failure or fluid overload.
5. PaO2/FiO2 ratio \< 200 measured on FiO2 1
Exclusion Criteria:
1. Known hypersensitivity intravenous immunoglobulins or rituximab
2. Severe heart failure
3. Active and uncontrolled bacterial fungal or parasitic infection ruled out by at least one of these two conditions
1. Procalcitonin value at inclusion \< 0.25 ng/mL OR
2. Adapted antimicrobial therapy for at least 48 hours at inclusion
4. Positive multiplex PCR for Influenzae A and B, or VRS
5. Deep Veinous Thrombosis or Pulmonary embolism in the last six months
6. Prior exposures to human-murine chimeric antibodies
7. Ongoing treatment with a cellular immunosuppressant (e.g., cyclophosphamide, methotrexate, mycophenolate, azathioprine, calcineurin inhibitors, etc.)
8. Subject treated with more than 2 boluses of methylprednisolone (total dose \> 500mg of methylprednisolone) or one dose \> 10mg/kg in the last 72 hours
9. Uncorrectable coagulopathies or thrombocytopenia \< 30000/mm3
10. Active cancer (other than basal cell carcinoma of the skin)
11. Other source of immunosuppression (i.e. HIV infection, solid organ transplant, lymphoma or leukemia)
12. Pregnancy
13. Patient listed for lung transplantation
14. Patient on ECMO
15. Patient with a do-not-intubate order at inclusion
16. Concurrent participation in other experimental trials
17. Not Affiliation to the French social security
18. Not Written informed consent from the patient or a legal representative if appropriate
19. Hypersensitivity to corticosteroids, cotrimoxazole / atovaquone
20. Patients with severe renal insufficiency (creatine clearance \<15ml / min)
|
[
0.9701913595199585,
2.1193175315856934,
-1.9965879917144775,
-2.6930885314941406,
0.6685507297515869,
-0.7605768442153931,
0.46765708923339844,
-0.15795457363128662,
-0.13930624723434448,
0.5697839260101318,
0.3366979956626892,
1.803175687789917,
-1.118735909461975,
0.5687119960784912,
-0.3747275173664093,
0.7901157140731812,
-0.7652262449264526,
0.8262079358100891,
0.9554486870765686,
-2.384262800216675,
0.18157121539115906,
0.4348042905330658,
0.32099592685699463,
0.1899806559085846,
0.8684104681015015,
-0.29346907138824463,
-0.6290884017944336,
-0.672812819480896,
-0.5577055811882019,
0.7443773746490479,
0.7800291180610657,
-0.6043897867202759,
0.4735766351222992,
0.5476861000061035,
0.15639114379882812,
-0.5621156692504883,
1.4174537658691406,
0.9270803332328796,
-1.0782949924468994,
-0.37401294708251953,
0.1661868393421173,
0.8580293655395508,
0.30755114555358887,
0.01615261100232601,
1.3459452390670776,
-0.4463396370410919,
-0.2812972068786621,
0.19171054661273956,
-0.22909729182720184,
0.14685873687267303,
-0.7435610294342041,
1.4155046939849854,
-0.685809850692749,
0.4240347743034363,
1.0856126546859741,
-0.2713724672794342,
-0.24985192716121674,
0.7100828289985657,
0.03455890342593193,
0.3301618695259094,
-0.02536701411008835,
-0.6205753684043884,
-0.2562919855117798,
-0.9053556323051453,
-0.10265853255987167,
-0.3424402177333832,
-0.7416329979896545,
0.16682183742523193,
-0.7201398611068726,
0.03065503016114235,
-0.13698749244213104,
-0.09368019551038742,
0.1988847255706787,
0.2854617238044739,
-0.2561101019382477,
-0.23965199291706085,
-0.3142867088317871,
0.3569304347038269,
0.42310354113578796,
0.33828267455101013,
-0.3311314582824707,
-0.7396644353866577,
-0.5044223666191101,
-0.5127507448196411,
0.4779480993747711,
-0.698944628238678,
-0.5992390513420105,
-1.2290232181549072,
0.013057717122137547,
-1.017912745475769,
0.7376323938369751,
-0.6234548687934875,
-0.45013540983200073,
0.9354896545410156,
-0.41397491097450256,
-0.6303964853286743,
-0.8480039238929749,
0.38363587856292725,
-1.5402802228927612,
-0.2634020149707794,
-0.21846280992031097,
-0.2587744891643524,
-0.5341979265213013,
0.004360021557658911,
-0.42508241534233093,
0.3424588739871979,
0.4369589686393738,
-1.0607448816299438,
0.3843672275543213,
-1.2695015668869019,
0.3397355377674103,
-0.1139417216181755,
0.17570827901363373,
-0.014400696381926537,
0.05761081352829933,
0.15472441911697388,
0.6462511420249939,
-0.15813826024532318,
0.4960198700428009,
-0.3476828634738922,
-0.26339587569236755,
0.7622467279434204,
0.03459121286869049,
0.51539146900177,
-0.3634431064128876,
-0.4918295443058014,
-0.09605865180492401,
1.0439693927764893,
-0.17446395754814148,
0.03574986755847931,
-0.5499090552330017,
0.40540453791618347,
0.4966057538986206,
-0.2415734827518463,
-0.6344950795173645,
-0.1403747797012329,
-0.08579295873641968,
1.2699975967407227,
0.2629186809062958,
-0.18172143399715424,
-0.5360618233680725,
-0.06936037540435791,
-0.05085748806595802,
0.0492422990500927,
-0.7915992736816406,
0.32708731293678284,
0.2051326185464859,
0.7476993203163147,
-0.6535730957984924,
-0.49199095368385315,
0.2875872552394867,
0.5530081391334534,
0.2719704508781433,
0.23098164796829224,
0.207822784781456,
0.7630950212478638,
0.12011300027370453,
0.14398686587810516,
-0.2645939886569977,
0.2823949158191681,
-0.27500462532043457,
0.16138875484466553,
-0.1849386841058731,
-0.6030236482620239,
0.6707479357719421,
0.17096863687038422,
0.26975521445274353,
-0.0005147902993485332,
-0.10370227694511414,
0.39276570081710815,
-0.44426098465919495,
-0.09740322083234787,
-0.003572363406419754,
-0.5346503257751465,
-0.39590051770210266,
-0.20951005816459656,
0.6330123543739319,
0.4949917793273926,
-0.01990009844303131,
0.23122543096542358,
0.11460202187299728,
-0.30757492780685425,
-0.17423425614833832,
-0.214047372341156,
0.22994190454483032,
-0.049413252621889114,
-0.007586359977722168,
0.12286490201950073,
-0.3045760989189148,
-0.13746331632137299,
-0.03910569101572037,
0.15504665672779083,
0.13052640855312347,
0.43842872977256775,
0.22740721702575684,
0.11962459236383438,
-0.10782895982265472,
-0.13222800195217133,
0.47264474630355835,
0.03465498983860016,
0.03948623314499855,
0.04470280185341835,
0.1978885382413864,
0.47814270853996277,
0.00018029172497335821,
-0.3185916841030121,
0.41001826524734497,
-0.018567800521850586,
0.0632266104221344,
0.4884141981601715,
0.06892668455839157,
0.15014798939228058,
0.09237297624349594,
-0.4570913016796112,
0.27195942401885986,
0.2842894494533539,
-0.3156147301197052,
0.09719797223806381,
-0.583451509475708,
-0.459439754486084,
-0.04045805335044861,
-0.3171587884426117,
0.13489863276481628,
0.15858985483646393,
-0.16639423370361328,
-0.3021617531776428,
0.31431612372398376,
0.32602986693382263,
0.4896310865879059,
-0.47622624039649963,
-0.3696894645690918,
-0.055751968175172806,
-0.19474655389785767,
0.09681104868650436,
0.16918215155601501,
0.03260846436023712,
0.2626095414161682,
-0.05946817994117737,
-0.04706684872508049,
0.057895172387361526,
0.15742453932762146,
-0.38602954149246216,
-0.06543809920549393,
0.11862447112798691,
0.41171029210090637,
-0.45877739787101746,
0.0797632485628128,
-0.12726111710071564,
0.04558243602514267,
0.08765096962451935,
0.12831246852874756,
-0.0606616772711277,
-0.07104115188121796,
0.2687995731830597,
0.45221540331840515,
-0.1992536038160324
] |
NCT02604342
|
Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib
|
This randomized active-controlled multicenter Phase III open-label study will evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy and crizotinib, as measured by investigator-assessed progression-free survival (PFS) and to evaluate and compare between treatment groups the central nervous system (CNS) objective response rate (C-ORR) in participants with measurable CNS metastases at baseline, as assessed by an Independent Review Committee (IRC).
|
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive. ALK positivity must have been determined by a validated fluorescence in situ hybridization (FISH) test (recommended probe, Vysis ALK Break-Apart Probe) or a validated immunohistochemistry (IHC) test (recommended antibody, clone D5F3)
* Participant had received two prior systemic lines of therapy, which must have included one line of platinum-based chemotherapy and one line of crizotinib
* Prior CNS or leptomeningeal metastases allowed if asymptomatic
* Participants with symptomatic CNS metastases for whom radiotherapy is not an option will be allowed to participate in this study
* Measurable disease by RECIST Version 1.1 prior to the administration of study treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* For all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment
Exclusion Criteria:
* Participants with a previous malignancy within the past 3 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal \[GI\] cancer by endoscopic resection or in situ carcinoma of the cervix)
* Participants who have received any previous ALK inhibitor other than crizotinib
* Any GI disorder that may affect absorption of oral medications
|
[
0.8150653839111328,
3.7632558345794678,
-2.341310739517212,
-2.574021816253662,
1.693228006362915,
0.07345077395439148,
-1.4543827772140503,
-0.2599765360355377,
-0.04082112014293671,
-0.18645092844963074,
-1.0926966667175293,
1.8157012462615967,
-1.914874792098999,
0.09768358618021011,
-0.8830008506774902,
1.192491054534912,
0.02440912462770939,
0.20748500525951385,
0.9152789115905762,
-1.2470619678497314,
-0.3809937834739685,
-0.49437546730041504,
-0.5074775815010071,
0.8599139451980591,
0.12165968120098114,
-0.19252625107765198,
-0.22117741405963898,
1.5248943567276,
-0.005957808345556259,
0.6841855645179749,
-0.6083683371543884,
0.2818061113357544,
0.44243237376213074,
-0.9166377782821655,
0.3724074959754944,
-0.7805264592170715,
0.46663063764572144,
0.10097110271453857,
-0.10859689861536026,
0.4020559787750244,
0.6125706434249878,
0.4795285165309906,
-0.3594488203525543,
-0.3682320713996887,
0.7643941044807434,
0.23901057243347168,
-0.1904270201921463,
0.5397254824638367,
0.4652596414089203,
0.18990592658519745,
-0.4665314555168152,
0.7873689532279968,
0.019900457933545113,
0.1928289234638214,
0.8300584554672241,
0.3219248056411743,
-0.5991600751876831,
1.2242940664291382,
2.117553472518921,
-0.4802890121936798,
0.5506506562232971,
-0.31685495376586914,
-0.3660348951816559,
-0.06416135281324387,
-0.38127124309539795,
0.6131184697151184,
0.13996627926826477,
-0.9915444850921631,
-0.06601085513830185,
0.48852041363716125,
0.2968234717845917,
-0.012063170783221722,
1.001934289932251,
-0.07383846491575241,
0.3109453618526459,
-0.5074966549873352,
-0.6540901064872742,
0.12031331658363342,
-0.22795841097831726,
1.1453752517700195,
-0.450409859418869,
-0.18393342196941376,
-0.09209469705820084,
-0.5652318596839905,
0.3379426598548889,
0.06102083623409271,
-1.1715439558029175,
-1.0327693223953247,
0.5705649256706238,
-1.2054481506347656,
-0.39576005935668945,
-0.5151757001876831,
-1.6036043167114258,
0.5063692927360535,
-0.4581049084663391,
0.5610678791999817,
-0.7387208342552185,
-0.33190274238586426,
-0.22612835466861725,
0.14124801754951477,
-0.3485257029533386,
-1.4561280012130737,
-0.1206812933087349,
0.6029489636421204,
-0.6945489048957825,
-0.8055405616760254,
-0.4962601065635681,
-1.5823009014129639,
0.22449296712875366,
-0.6637901663780212,
-0.37780359387397766,
-0.7967065572738647,
0.16742673516273499,
-1.266789436340332,
0.830230712890625,
1.1098774671554565,
0.8187748193740845,
0.7697268724441528,
0.2215287983417511,
0.021879546344280243,
-0.21054856479167938,
0.7185200452804565,
0.28229501843452454,
0.4676811099052429,
-0.4148179292678833,
-0.04973824694752693,
0.334518700838089,
-0.8557584881782532,
-0.9261820316314697,
-1.1417196989059448,
-1.062047004699707,
-0.12831318378448486,
0.5092130899429321,
0.7335250973701477,
-1.0980597734451294,
-0.09468894451856613,
-0.29351064562797546,
1.5183006525039673,
-0.04979801923036575,
-0.61790531873703,
-0.24803799390792847,
0.41855302453041077,
0.007077368907630444,
-0.07905658334493637,
-0.9035452008247375,
-0.39748722314834595,
-0.15377280116081238,
0.36649587750434875,
-0.27231982350349426,
0.1992456316947937,
-1.1209018230438232,
-0.06555017083883286,
0.24631497263908386,
0.4870971739292145,
-0.4950292110443115,
0.48683759570121765,
0.34717535972595215,
-0.5575909614562988,
-0.039674460887908936,
0.5204834342002869,
-0.9467396140098572,
0.03016078658401966,
-0.1663225293159485,
-0.6293672323226929,
0.19736319780349731,
-0.31037527322769165,
-1.2088592052459717,
0.16380968689918518,
-0.010875237174332142,
0.1769760102033615,
-1.1454957723617554,
0.3600728511810303,
1.097786545753479,
0.01556360349059105,
-0.3791270852088928,
0.12984034419059753,
0.41053152084350586,
0.27511242032051086,
0.15718072652816772,
-0.513703465461731,
0.17969341576099396,
0.6617088913917542,
0.7429158091545105,
-0.31230705976486206,
-0.057926714420318604,
-0.36651313304901123,
-0.49826809763908386,
-0.2874433398246765,
-0.0019578207284212112,
-0.20474335551261902,
0.4843514561653137,
-0.09176997095346451,
0.8192155361175537,
0.8070908188819885,
0.14124487340450287,
-0.5410432815551758,
-0.44044429063796997,
-0.7870741486549377,
0.24267801642417908,
-0.3109676241874695,
0.2770896553993225,
0.39218640327453613,
-0.2531370520591736,
0.07032550871372223,
0.02032378688454628,
-0.5993906259536743,
-0.17054332792758942,
-0.5753366947174072,
-0.4595538377761841,
0.23192866146564484,
0.10876769572496414,
-0.0446259006857872,
-0.2546480894088745,
-0.16313166916370392,
0.3823794424533844,
0.1614113450050354,
-0.0945090502500534,
0.7658059000968933,
-0.5312758684158325,
0.4467379152774811,
-0.42661306262016296,
-0.630706250667572,
0.011762114241719246,
0.7593662738800049,
0.16482411324977875,
-0.193743035197258,
-0.06039753556251526,
0.2921946048736572,
-0.25059419870376587,
-0.19924332201480865,
-0.14142833650112152,
-0.05800295248627663,
-0.20471574366092682,
-0.3618755638599396,
0.015602007508277893,
-0.05728064104914665,
0.19059503078460693,
-0.23697587847709656,
-0.004761805757880211,
-0.04180169478058815,
0.59293532371521,
-0.353499174118042,
0.015616164542734623,
-0.026384662836790085,
0.44794678688049316,
-0.8064410090446472,
-0.11562324315309525,
0.2691408693790436,
0.34009164571762085,
0.3634771406650543,
-0.43062591552734375,
-0.03521864116191864,
0.04012080281972885,
0.6500056385993958,
-0.1647825390100479,
-0.5637236833572388
] |
|
NCT06287164
|
Management of Heart Failure in Italian Outpatients Clinics: Observational Study
|
OPTIMA-HF is an observational, cross-sectional, multicenter, real-life study conducted in two different clinical settings: HF outpatients' clinics of Italian University Hospitals and territorial Cardiology outpatients' services.
Aim of the Optimization of Therapy in the Italian Management of Heart Failure \[OpTIMa-HF\] Registry is to collect data on HF patients followed in different Italian outpatients' settings to describe the current Italian population of HF patients, in terms of demographic characteristics and disease features, with a specific focus on guideline-directed medical therapy (GDMT) prescription, assessing its improvement after educational activities. In the present analysis we report the baseline data on the general enrolled population with a specific focus on HFrEF treatment adherence and prescription rates, according to the most recent European Guidelines.
|
Inclusion Criteria: age \>18 years, post-menopausal, permanent sterile, or childbearing potential on highly effective contraceptive methods women, stable clinical conditions (NYHA class I-III), outpatients setting, capability to understand the study procedures and sign the informed consent form.
Exclusion Criteria: any clinical condition that would have jeopardized patient safety while participating in this study.
|
[
2.0764122009277344,
3.35970401763916,
-2.306868076324463,
-1.5992772579193115,
0.024778680875897408,
-0.17210130393505096,
0.34354427456855774,
-0.4492258131504059,
-0.15687856078147888,
0.7483806014060974,
0.7343061566352844,
1.6492120027542114,
-1.4445089101791382,
0.7973722219467163,
-0.12241929024457932,
0.9637835621833801,
0.02951078489422798,
0.6872566342353821,
0.7108016610145569,
-0.6525011658668518,
-0.14267343282699585,
-0.20591646432876587,
0.19738727807998657,
0.18138940632343292,
0.7598206996917725,
-0.21826334297657013,
-0.6706249117851257,
1.661361813545227,
-0.19295038282871246,
1.1063838005065918,
0.49547281861305237,
-2.556442975997925,
0.5812327265739441,
0.3067058026790619,
1.7333639860153198,
-0.21788856387138367,
0.4198637306690216,
0.08853569626808167,
-1.6344571113586426,
-0.0066756196320056915,
0.3252815902233124,
0.3799373209476471,
-0.6033722758293152,
-0.5992253422737122,
0.800839364528656,
0.8581715226173401,
-0.3527769446372986,
-0.9991998672485352,
-0.4528442323207855,
0.2753278911113739,
-0.5044383406639099,
1.485390543937683,
-1.5469895601272583,
-0.6015283465385437,
1.4811427593231201,
0.6395668387413025,
0.07485160231590271,
0.5886074900627136,
0.345240980386734,
1.0728687047958374,
0.7682217359542847,
-0.19544893503189087,
0.08704973757266998,
0.6086310148239136,
-0.8680358529090881,
-0.19507190585136414,
-0.43234217166900635,
0.22868162393569946,
-0.43835681676864624,
0.8374646902084351,
-0.45031264424324036,
-0.06359300017356873,
1.0281791687011719,
1.2397050857543945,
-0.05387623608112335,
0.26970821619033813,
-0.5763608813285828,
1.0023761987686157,
0.6397162675857544,
-0.031877998262643814,
-0.1383531093597412,
-0.494013249874115,
-0.4220433831214905,
-0.8151650428771973,
0.543499231338501,
-0.5834194421768188,
-1.2333950996398926,
-0.2817343473434448,
0.4728339612483978,
-0.11193966865539551,
0.18704311549663544,
-0.3942317068576813,
0.26618146896362305,
0.8866344094276428,
-1.030622959136963,
0.9183725118637085,
0.48150742053985596,
-0.6464495062828064,
-1.0449522733688354,
-0.13293159008026123,
-0.5415031313896179,
-0.5249395370483398,
-0.21627309918403625,
-0.32254156470298767,
-0.5703438520431519,
-0.2819128632545471,
0.2991352677345276,
-0.056443486362695694,
-0.4045655131340027,
-0.22988666594028473,
0.1277858167886734,
-0.48209652304649353,
0.5359196662902832,
0.052527278661727905,
0.13816218078136444,
-0.12108887732028961,
0.5921767354011536,
0.03407299518585205,
0.04103008657693863,
-0.40472447872161865,
-0.18357478082180023,
0.6776076555252075,
0.4727606177330017,
0.2009846419095993,
-1.3732120990753174,
-0.4659740626811981,
-0.02136383391916752,
-0.18351410329341888,
-0.5703702569007874,
0.0019860819447785616,
-0.6927222013473511,
-0.5238938927650452,
0.04468969255685806,
0.2473306506872177,
-0.9567391276359558,
0.33588820695877075,
-0.5604946613311768,
0.6723985075950623,
0.14834263920783997,
-0.5152135491371155,
0.22339969873428345,
-0.2655126452445984,
0.2938700020313263,
-0.13754718005657196,
-0.6530304551124573,
-0.016169020906090736,
-0.30970555543899536,
-0.17573393881320953,
-1.6020737886428833,
-0.5591832399368286,
-0.2511766254901886,
0.2553146481513977,
0.14837020635604858,
0.43527448177337646,
0.14439766108989716,
0.44083425402641296,
0.6181726455688477,
0.004037190228700638,
-0.30966880917549133,
0.21584853529930115,
-0.0987241119146347,
-0.3797267973423004,
0.22694343328475952,
0.1579749584197998,
0.7411987781524658,
-0.38048651814460754,
-0.3429621756076813,
0.17063647508621216,
0.7173660397529602,
0.04491506889462471,
0.17628709971904755,
0.29855653643608093,
-0.3356114327907562,
0.07042177766561508,
-0.6534242630004883,
-0.5052993893623352,
0.566483199596405,
0.2573944330215454,
0.773874819278717,
0.23329289257526398,
0.17588485777378082,
-0.6523289084434509,
0.2752959430217743,
0.009751939214766026,
0.123174287378788,
0.399198442697525,
0.23938602209091187,
-0.3765072822570801,
-0.2642368972301483,
-0.11931587755680084,
-0.5203472375869751,
-0.7597616314888,
0.2276865839958191,
0.705568253993988,
0.8812171816825867,
-0.5461413264274597,
-0.4574492573738098,
-0.540284276008606,
0.2801373600959778,
0.09787997603416443,
0.2654338479042053,
0.38797008991241455,
0.05646480992436409,
0.7614874839782715,
0.13715524971485138,
-0.3749764859676361,
0.19976335763931274,
-0.2881397604942322,
-0.6728777289390564,
0.647032618522644,
0.33438533544540405,
0.3418625295162201,
-0.09889977425336838,
-0.9235996603965759,
-0.20396912097930908,
0.43109452724456787,
0.5195404291152954,
0.1703495979309082,
-0.5930342078208923,
-0.35603490471839905,
0.07382932305335999,
0.013180219568312168,
0.24561923742294312,
0.5512269735336304,
-0.5437414646148682,
-0.3848842680454254,
0.015695534646511078,
-0.03250450640916824,
-0.005990632809698582,
-0.17242752015590668,
-0.47720131278038025,
-0.21036873757839203,
0.277601420879364,
-0.12431259453296661,
-0.011430946178734303,
-0.3262145221233368,
-0.25991591811180115,
0.13307470083236694,
-0.214408278465271,
0.258142352104187,
0.266851007938385,
-0.14967095851898193,
-0.2950375974178314,
-0.18734928965568542,
0.1581145077943802,
0.03626936301589012,
0.07345803081989288,
-0.4864862859249115,
0.11512713134288788,
0.018319599330425262,
-0.3448137938976288,
-0.1184423565864563,
0.19321630895137787,
0.06612613052129745,
0.07893522083759308,
-0.3002381920814514
] |
|
NCT01600898
|
Screening of Pulmonary Arterial Hypertension in BMPR2 Mutation Carriers
|
In this prospective study, the investigators will implement a systematic screening program and 3-year follow-up in a cohort of asymptomatic BMPR2 mutation carriers. This study is designed to:
* determine predictive factors (biological, functional, radiological and hemodynamic) of development of PAH
* monitor these subjects' clinical, functional, biological, echocardiographic and hemodynamic characteristics
* assess the risk of occurrence of PAH
* screen patients with PAH at an early stage of disease and offer them an early management
* constitute a collection of biological samples (0, 12, 24 months follow-up) of asymptomatic BMPR2 mutation carriers.
|
Introduction:
Pulmonary arterial hypertension is characterized by remodeling of small pulmonary arteries leading to a progressive increase in pulmonary vascular resistance resulting to right heart failure and ultimately death. The disease is diagnosed when symptomatic, demonstrating the existence of an already advanced form of the disease. Indeed, there is no simple tool allowing an early diagnosis of PAH and the disease is usually diagnosed in advanced stages. Diagnostic confirmation of PAH is based on the elevation of mean pulmonary arterial pressures measured during right heart catheterization. Despite the development of specific treatment in recent years, PAH remains a disease with poor prognosis, for which no cure is possible, apart from lung transplantation in selected cases. However recent studies have shown that specific drug therapy in early disease stages could improve the prognosis of this life threatening disease. This is why it seems important to establish early diagnosis of PAH, especially in high-risk populations such as asymptomatic carriers of BMPR2 (Bone Morphogenetic Protein Receptor 2) mutations. PAH due to BMPR2 mutations is an autosomal dominant disease with incomplete penetrance. Even if there are no accurate data in the literature, it is estimated that 20% of patients with BMPR2 mutations develop PAH in the course of their life. The implementation of a genetic counseling in the National Reference Center for Severe Pulmonary Hypertension (BICETRE Hospital) allowed us to propose systematic assessment of BMPR2 mutations in patients with idiopathic or familial PAH. In 2012 we identified 130 PAH patients carriers of a BMPR2 mutation. This approach has enabled the detection of families at risk for PAH and to offer genetic counseling to the asymptomatic relatives with BMPR2 mutation. However, data on the evolution of asymptomatic carriers of BMPR2 mutation are lacking. Furthermore, there is no available consensus or guideline on how to follow this population. To date, it is not possible to differentiate asymptomatic subjects carrying BMPR2 mutations that will develop PAH from those who will never develop this disease. However, given the high risk of these subjects to develop PAH (risk of 20% against 25/million in the general population), and the limited knowledge of characteristics of this population, it seems essential to offer a prospective follow-up to this population at risk.
Aim and objective:
The main objective of this study to is follow prospectively for 3 years a cohort of asymptomatic carriers of BMPR2 mutation to:
* determine predictive factors (biological, functional, radiological and hemodynamic) of development of PAH
* monitor these subjects' clinical, functional, biological, echocardiographic and hemodynamic characteristics
* assess the risk of occurrence of PAH
* screen patients with PAH at an early stage of disease and offer them an early management
* constitute a collection of biological samples (0, 12, 24 months follow-up) of asymptomatic BMPR2 mutation carriers.
Methodology :
Evaluation of subjects at inclusion after informed consent (Ethics Committee approval obtained since 2011):
* Clinical evaluation: dyspnea assessed by NYHA functional class (I-IV), signs of right heart failure
* Chest radiograph, electrocardiogram
* Right heart catheterization (in a subset of volunteers): measurement of mean pulmonary artery pressure, pulmonary artery occlusion pressure (PAOP) and cardiac output (CO) at rest and during exercise
* Echocardiography: measurement of the velocity of tricuspid regurgitation (VIT), measurement of TAPSE and Tei index, pericardial effusion, dilatation and hypertrophy of the right ventricle
* Stress Test: VO2 peak and VO2 specific, VE minute ventilation, VD / VT dead space, ventilatory reserve, alveolar-arterial gradient, pulse oxygen, PaO2
* Lung function tests: measurement of DLCO and DLNO
* Magnetic resonance imaging (MRI) measuring end systolic diastolic volumes of the right ventricle, right ventricular mass, septal curvature, diameter of the pulmonary arteries, surface of the right atrium
* Biology: Determination of plasma NT-proBNP, uric acid, serum sodium, creatinine, PDGF, ET-1, ET-3, CRPus, IL-6, soluble c-kit, CXCL12, progenitors and circulating fibrocytes
Subjects will be evaluated as outpatients scheduled to the National Reference Center for Severe Pulmonary Hypertension 12, 24 and 36 months after inclusion or if symptoms appear (dyspnoea, right heart failure, malaise or syncope).
During these consultations, the assessment will include: clinical evaluation, chest radiograph, electrocardiogram, echocardiogram, stress testing, pulmonary function tests, magnetic resonance imaging, and biology.
To confirm the suspicion of PAH and assess their severity, right heart catheterization at rest and during exercise will be offered according to a decision algorithm.
Right heart catheterization will be performed if one of the following abnormalities is found:
* Dyspnea, malaise or unexplained syncope
* Tricuspid regurgitation velocity ≥ 2.8 m / s
* Decrease of the specific peak VO2 ≥ 20% as compared to the gold standard
If diagnosis of PAH is confirmed, patients will be treated according to the recently updated recommendations of the European Respiratory Society and European Society of Cardiology.
|
Inclusion Criteria:
* men and women over 18 years old,
* carriers of a BMPR2 mutation without known PAH,
* having given his informed consent
Exclusion Criteria:
* men and women under 18 years old,
* patients with a known PAH,
* pregnant women,
* adults protected,
* detainees,
* people in emergencies,
* people refusing or unable to give informed consent,
* no affiliation to a regime of social security.
|
[
0.5946812033653259,
1.759359359741211,
-2.9450531005859375,
-2.0864195823669434,
0.6100196838378906,
-0.6087889075279236,
-0.31582382321357727,
-1.461525559425354,
-0.6849212646484375,
0.7138397693634033,
0.04462005943059921,
0.8814527988433838,
0.014737571589648724,
-0.40785765647888184,
0.24557195603847504,
1.133819818496704,
-1.2881783246994019,
0.3626624643802643,
1.2128677368164062,
-0.8311115503311157,
0.06349390000104904,
-1.9866219758987427,
0.24246160686016083,
-0.9813435673713684,
-0.05651969090104103,
-0.3053743243217468,
-1.231877326965332,
1.6528747081756592,
-0.6381874084472656,
0.3550940454006195,
1.0269365310668945,
0.12492695450782776,
0.4583793878555298,
0.25390946865081787,
0.007822804152965546,
-0.6072950959205627,
1.8438152074813843,
0.9153206944465637,
-0.5866998434066772,
0.3752525746822357,
-0.6712949275970459,
0.16967365145683289,
-0.8055170774459839,
0.2022446244955063,
0.30345556139945984,
0.34259065985679626,
-0.17806224524974823,
0.15945275127887726,
0.7892791032791138,
0.6321342587471008,
-1.065727949142456,
0.45529407262802124,
-1.5095363855361938,
-0.11283640563488007,
1.822029709815979,
0.6720759272575378,
0.6901880502700806,
0.40251076221466064,
1.5491185188293457,
0.480413019657135,
0.698526918888092,
-1.4086763858795166,
1.1040499210357666,
0.2682725787162781,
-0.8535141944885254,
0.016344742849469185,
-0.5602936148643494,
0.4041401743888855,
-1.2236740589141846,
-0.24203422665596008,
0.39046579599380493,
0.40533575415611267,
0.7159178853034973,
0.009919724427163601,
-0.662238359451294,
1.0292422771453857,
-0.4700663685798645,
1.1962461471557617,
-0.005492866970598698,
0.4169505834579468,
0.093254454433918,
-0.8957664966583252,
-1.3857251405715942,
-0.012678788043558598,
-0.1896643340587616,
-0.29582101106643677,
-1.0551596879959106,
0.17718549072742462,
1.4143438339233398,
-0.46382415294647217,
-0.16688711941242218,
0.030653107911348343,
-0.21731294691562653,
1.1498645544052124,
-0.4624958336353302,
0.8624466061592102,
-0.19440467655658722,
-0.2270638346672058,
-0.7800625562667847,
-0.3073003888130188,
-0.22678904235363007,
-0.06401528418064117,
-0.5407959222793579,
0.03149610385298729,
-0.8939940333366394,
-0.20947778224945068,
0.45052215456962585,
-0.44349876046180725,
-0.423828125,
-0.7943277955055237,
0.7945373058319092,
-0.3959659934043884,
-0.13417930901050568,
-0.15110720694065094,
0.2844293713569641,
-0.31842494010925293,
0.6148840188980103,
0.6935255527496338,
0.23602154850959778,
0.044769953936338425,
-0.05982336401939392,
0.8231327533721924,
0.46444833278656006,
0.09320136159658432,
0.2814193665981293,
-0.6871892213821411,
0.032750993967056274,
-0.6943872570991516,
0.7141479253768921,
-0.6758201718330383,
-0.9042898416519165,
-0.014666114933788776,
0.11865902692079544,
-0.46088799834251404,
-0.5414572358131409,
-0.48814213275909424,
0.2302279770374298,
0.4580687880516052,
0.34465131163597107,
0.041592102497816086,
0.6300237774848938,
0.20078283548355103,
0.05243636667728424,
0.34879183769226074,
-1.099683165550232,
-1.0050504207611084,
-0.172623872756958,
-0.026841498911380768,
-0.18676939606666565,
0.06720945984125137,
-0.2526465356349945,
0.4148045480251312,
0.7502838373184204,
0.3052992820739746,
0.3948659896850586,
-0.16422760486602783,
0.03385457769036293,
-0.10856014490127563,
0.05374237149953842,
0.41889581084251404,
-0.15509042143821716,
-0.9207537174224854,
-0.6214609146118164,
0.2763141393661499,
0.3165012300014496,
0.40615400671958923,
0.15910828113555908,
-0.1839061677455902,
0.39868515729904175,
0.2465583086013794,
-0.1728886067867279,
-0.151993528008461,
-0.3497729003429413,
-0.15096624195575714,
-0.7970405220985413,
-0.4245991110801697,
0.4311538338661194,
0.15801222622394562,
-0.3041940927505493,
0.25636178255081177,
-0.3253111243247986,
0.030917707830667496,
0.3239970803260803,
0.38264286518096924,
0.36337077617645264,
0.2872784435749054,
-0.09825272858142853,
-0.22244805097579956,
-0.16392216086387634,
0.029700910672545433,
-0.22778017818927765,
0.11200849711894989,
-0.6073575615882874,
-0.20106451213359833,
0.10396433621644974,
0.24500295519828796,
-0.31489095091819763,
0.1343832015991211,
0.5296615362167358,
-0.08782131969928741,
0.5225717425346375,
0.1315990388393402,
0.5755573511123657,
0.35270386934280396,
0.20709840953350067,
0.17560994625091553,
-0.25415945053100586,
0.16825708746910095,
-0.005191865377128124,
0.0969347208738327,
-0.11223920434713364,
0.09676937013864517,
-0.38914570212364197,
-0.27279651165008545,
0.11213689297437668,
-0.2679918706417084,
0.37913423776626587,
-0.11962676048278809,
-0.5209402441978455,
0.17808948457241058,
0.16469095647335052,
-0.20005396008491516,
0.3158133029937744,
0.08614447712898254,
-0.2747776508331299,
0.06589558720588684,
-0.3217296898365021,
-0.06631401181221008,
0.27252376079559326,
-0.03773786872625351,
-0.0952150821685791,
0.3624461591243744,
-0.22344394028186798,
-0.23242124915122986,
-0.1869838386774063,
0.0519387312233448,
0.22366277873516083,
0.04526474326848984,
0.023120051249861717,
0.38071537017822266,
0.24477626383304596,
-0.18209315836429596,
0.13903029263019562,
0.0592261403799057,
-0.1632367968559265,
-0.35980477929115295,
0.12574456632137299,
-0.46016213297843933,
0.0911751240491867,
0.3373611271381378,
0.21779021620750427,
-0.4023090898990631,
0.018874039873480797,
0.48429298400878906,
0.18881863355636597,
-0.21541163325309753
] |
NCT00932529
|
Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting
|
Despite different pharmacological properties, the scientific evidence is inconclusive regarding which of the first-line second generation antipsychotics (SGAs) should be preferred for the individual patient suffering from psychosis. The limitations of the evidence base may be related to the highly selected samples, short duration, and rigid experimental designs of most randomized clinical trials of efficacy. Moreover a high proportion of the clinical trials are drug company sponsored which could introduce funding bias. The purpose of this non-commercially funded study is to investigate whether effectiveness differences exist among the first-line SGAs olanzapine, quetiapine, risperidone, and ziprasidone when the drugs are used in a representative clinical setting. Eligible patients are those admitted to hospital for acute psychosis and candidates for oral antipsychotic treatment. The investigators hypothesise that in the naturalistic setting of every-day clinical practice and in a diverse sample representative of most patients admitted for symptoms of acute psychosis, differential effectiveness among the SGAs could be disclosed when the patients are followed for up to 2 years. This could deliver valuable information regarding which SGA should be the starting antipsychotic drug in order to facilitate the most beneficial outcome.
|
Inclusion Criteria:
* Psychosis
* Must be able to use oral antipsychotic drugs
Exclusion Criteria:
* Mania
* Unable to cooperate with the assessments
* Unable to understand Norwegian language
* Candidates for electroconvulsive therapy
* Use of Clozapine at admittance
|
[
0.3245275914669037,
2.779285430908203,
-2.9272620677948,
-1.047200083732605,
-0.6588044166564941,
-1.3125604391098022,
-1.2030847072601318,
-0.7537490129470825,
-0.6835030317306519,
-0.5057633519172668,
0.4484604299068451,
2.8034558296203613,
-0.5848006010055542,
0.761635422706604,
0.21458642184734344,
0.5907508134841919,
0.4738604724407196,
0.4429444670677185,
1.1741704940795898,
-0.7851529121398926,
0.7185107469558716,
0.9796527624130249,
-0.8958860039710999,
0.4919721186161041,
-1.0324128866195679,
-0.5397164225578308,
-1.007393717765808,
2.5918593406677246,
0.7451601028442383,
1.075430154800415,
1.070751428604126,
-0.40027791261672974,
0.3531552851200104,
-0.3445427417755127,
0.74101322889328,
-0.33794155716896057,
0.25402283668518066,
0.7867083549499512,
-0.9119327664375305,
-0.8265964984893799,
0.1600772738456726,
1.193932056427002,
-0.46514564752578735,
-0.1302039474248886,
1.3899182081222534,
1.146817922592163,
-0.5623520016670227,
0.3788010776042938,
0.20305947959423065,
-0.5891024470329285,
-0.9281145930290222,
0.935905396938324,
-1.4427330493927002,
0.41619250178337097,
1.8183435201644897,
0.39312252402305603,
1.0676883459091187,
0.6463689208030701,
1.3283807039260864,
0.3662835359573364,
0.04025707021355629,
0.2424263060092926,
-0.07229726016521454,
0.010623249225318432,
-0.21761606633663177,
0.3734431862831116,
-0.32494959235191345,
0.7459466457366943,
-0.7214462161064148,
-0.2520439922809601,
-0.145904541015625,
0.4457343816757202,
0.082117460668087,
0.10236313194036484,
0.10809361189603806,
-0.32772064208984375,
0.3703855276107788,
0.6131976842880249,
0.18639150261878967,
0.38805150985717773,
-0.02812149003148079,
0.01603442244231701,
-0.30403634905815125,
-0.027396850287914276,
-0.13640989363193512,
-0.10438944399356842,
-1.2062816619873047,
-0.7140989899635315,
0.1221073642373085,
-0.7148396372795105,
0.401254802942276,
-0.23328882455825806,
-0.05111433193087578,
0.14437483251094818,
0.1640845090150833,
-0.3695296347141266,
-0.4192959666252136,
-0.15024086833000183,
-0.9547019004821777,
-0.21964606642723083,
0.1474086046218872,
-0.21847304701805115,
-0.5631439089775085,
0.05948717147111893,
-0.9971917271614075,
-0.23259133100509644,
0.3228485882282257,
0.14769349992275238,
-0.47246214747428894,
-0.39346587657928467,
0.662786602973938,
-0.6559475064277649,
-0.030866403132677078,
0.4025604724884033,
0.5569146871566772,
-0.13872739672660828,
0.45245328545570374,
-0.15956926345825195,
0.108831487596035,
-0.24999019503593445,
-0.1365218460559845,
0.808434009552002,
0.4068272113800049,
0.0770886167883873,
-0.9336047172546387,
-0.2227494865655899,
-0.2940569519996643,
0.019091453403234482,
-0.5203570127487183,
-0.5482628345489502,
-0.35904747247695923,
0.7916118502616882,
-0.12461217492818832,
-0.3036448359489441,
-0.6332629323005676,
-0.890924870967865,
0.5528047680854797,
1.0816463232040405,
0.13731950521469116,
-1.0940642356872559,
0.2703574299812317,
0.5638836026191711,
0.5783408284187317,
0.2523283362388611,
-0.7438403964042664,
-0.22127394378185272,
-0.10744646191596985,
0.42666175961494446,
-0.4541672468185425,
-0.5520508885383606,
0.3383150100708008,
0.8856382966041565,
0.5151585936546326,
0.09064338356256485,
0.424894243478775,
0.458808034658432,
-0.08621629327535629,
-0.3419390618801117,
0.14363962411880493,
0.3101711571216583,
0.037716299295425415,
-0.5397945046424866,
0.4228672385215759,
-0.5263081192970276,
0.5931790471076965,
0.32501494884490967,
-0.4139502942562103,
0.13322670757770538,
0.7856094241142273,
-0.15900026261806488,
-0.5675463676452637,
-0.026832355186343193,
-0.25306272506713867,
1.0121990442276,
-0.1310548186302185,
-0.09450660645961761,
0.9751220345497131,
0.019047051668167114,
0.5836114883422852,
-0.22551171481609344,
-0.4423295557498932,
0.02135295979678631,
-0.092643141746521,
-0.33647823333740234,
0.3938855230808258,
-0.19207429885864258,
-0.49080783128738403,
-0.08861751854419708,
-0.2656572759151459,
0.24686038494110107,
-0.3390684723854065,
0.12183921784162521,
-0.14312206208705902,
-0.004227165598422289,
0.23224377632141113,
-0.09923490136861801,
-0.1292630434036255,
-0.13479948043823242,
0.532783567905426,
-0.4128243625164032,
0.5694393515586853,
0.5199838876724243,
-0.30347949266433716,
0.10543938726186752,
-0.1609002947807312,
-0.4806616008281708,
-0.48248133063316345,
0.4766917824745178,
-0.12504221498966217,
0.03919996693730354,
0.31640544533729553,
0.004339062143117189,
-0.036988042294979095,
-0.3977743685245514,
0.1310068815946579,
0.3052227795124054,
0.20241446793079376,
0.2064540982246399,
-0.5016342997550964,
-0.32789313793182373,
-0.49089357256889343,
-0.1441926211118698,
-0.22542567551136017,
0.0015708873979747295,
-0.31374743580818176,
0.21228374540805817,
0.11555486172437668,
0.6163048148155212,
0.13690747320652008,
0.1374770551919937,
-0.3472687602043152,
0.30737200379371643,
-0.03617003932595253,
0.1329585462808609,
-0.31629759073257446,
0.1257864236831665,
0.28559187054634094,
0.17668458819389343,
-0.42688506841659546,
0.1277342587709427,
0.4879508316516876,
-0.36946943402290344,
-0.2970832884311676,
-0.21145516633987427,
-0.19280487298965454,
-0.208745077252388,
-0.30644306540489197,
-0.10418973863124847,
-0.061013028025627136,
0.3427579998970032,
-0.27664124965667725,
-0.4504699409008026,
0.15407225489616394,
0.0026994284708052874,
-0.03192390874028206,
-0.450708270072937
] |
|
NCT02119728
|
Photodynamic Therapy With HPPH in Treating Patients With Squamous Cell Carcinoma of the Oral Cavity
|
This randomized phase II trial studies how well photodynamic therapy with HPPH works in treating patients with squamous cell carcinoma of the oral cavity. Photodynamic therapy uses HPPH that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against squamous cell carcinoma of the oral cavity.
|
PRIMARY OBJECTIVES:
I. To test the non-inferiority of photodynamic therapy (PDT) to standard of care surgery.
SECONDARY OBJECTIVES:
I. To determine improvement in quality of life (QoL) using the University of Washington Quality of life questionnaire version 4.
II. To assess the toxicity using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0).
III. To explore progression-free survival in this patient population treated with HPPH mediated PDT.
TERTIARY OBJECTIVES:
I. Immune markers (T cells). II. To investigate the correlation of the tri-modal optical spectroscopy with tumor response to PDT.
OUTLINE: Patients are randomized to 1 of 2 treatments arms.
ARM I: Patients undergo standard of care surgery on day 1.
ARM II: Patients receive HPPH intravenously (IV) over 1 hour on day 0. Approximately 24 hours later, patients undergo photodynamic therapy on day 1.
After completion of study treatment, patients are followed up 3-4 months for 1 year, 3-6 months for 1 year, 4-8 months for 1 year, and once a year for 2 years.
|
Inclusion Criteria:
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
* Patients with Tl/T2 squamous cell carcinoma of the oral cavity with or without extension to the oropharynx
* Histologically confirmed squamous cell carcinoma of the target tumor(s)
* Tumor thickness is 4 mm or less (in the judgment of the physician)
* Computed tomography (CT) of the neck to confirm staging
* Tumor accessible for unrestricted illumination for photodynamic therapy (PDT) (accessibility as determined by the physician)
* Life expectancy of at least 12 months in the judgment of the physician
* Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* Patient or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
* Patients who have had chemotherapy or radiotherapy or targeted agents within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Patients with known brain metastases should be excluded from this clinical trial
* Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds
* White blood cells (WBC) \< 4,000
* Total serum bilirubin \> 2 mg/dL
* Serum creatinine \> 2 mg/dL
* Alkaline phosphatase (hepatic) \> 3 times the upper normal limit
* Serum glutamic oxaloacetic transaminase (SGOT) \> 3 times the upper normal limit
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Nodal disease as detected by clinical exam or CT
* Pregnant or nursing female patients
* Unwilling or unable to follow protocol requirements
* Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug
* Received an investigational agent within 30 days prior to enrollment
|
[
0.39216893911361694,
0.2679046094417572,
-1.5436546802520752,
-1.8573881387710571,
-1.603869080543518,
0.7685368061065674,
0.24925239384174347,
-1.5254369974136353,
-0.9231029748916626,
-0.31583264470100403,
0.25294384360313416,
2.11567759513855,
-0.3234797418117523,
0.8622344732284546,
-0.6296822428703308,
-0.04064119979739189,
0.4126099944114685,
2.2778472900390625,
2.0375864505767822,
-1.597553014755249,
0.13632556796073914,
-1.8599897623062134,
0.3037762939929962,
0.776710033416748,
0.5244172215461731,
-0.5654214024543762,
-0.14421780407428741,
0.3740266263484955,
1.7088216543197632,
1.6325045824050903,
-0.6037116050720215,
0.6672895550727844,
-1.5630983114242554,
0.5309117436408997,
-1.027152419090271,
1.2438137531280518,
2.0598461627960205,
1.171412467956543,
-0.6370328664779663,
0.6904011368751526,
-0.3177494406700134,
-0.9386964440345764,
-0.19549009203910828,
-0.8312786817550659,
-0.8079344630241394,
1.2526060342788696,
0.3665945529937744,
-0.002316288650035858,
1.1634492874145508,
0.018690381199121475,
-1.4464666843414307,
1.675675868988037,
-0.6219692230224609,
0.23939141631126404,
2.643507242202759,
0.5961238145828247,
-0.6381946802139282,
0.8486966490745544,
0.33622631430625916,
-0.32623714208602905,
-0.30878186225891113,
-0.08489307016134262,
0.17942523956298828,
-0.3220018148422241,
-1.2132738828659058,
0.3716237545013428,
-0.72030109167099,
-0.28387683629989624,
-0.3043445646762848,
0.06274234503507614,
0.6697765588760376,
0.6470062136650085,
-0.9350093603134155,
-0.17370934784412384,
0.5849101543426514,
0.44233590364456177,
0.118350550532341,
0.13018861413002014,
1.2853279113769531,
-1.4511314630508423,
-0.9986183643341064,
-0.9893555641174316,
-0.25837936997413635,
0.16513286530971527,
-0.04571264237165451,
-0.7428428530693054,
0.3131602704524994,
-0.026423152536153793,
0.9631666541099548,
-1.6748918294906616,
0.8008280992507935,
0.2563145160675049,
-1.4517048597335815,
0.2576463222503662,
-1.0478630065917969,
-0.3356199860572815,
0.20033743977546692,
-1.252813458442688,
0.21641981601715088,
-0.7300350666046143,
0.2030663788318634,
0.2159578651189804,
-1.1245163679122925,
-1.2588869333267212,
-1.1029071807861328,
-0.4337995648384094,
0.15366899967193604,
-0.9086806774139404,
-0.9120616912841797,
-0.9148449897766113,
0.4605681896209717,
-1.3704191446304321,
-1.152417540550232,
-0.28558358550071716,
0.8848671913146973,
-0.571038544178009,
1.4061635732650757,
0.040814608335494995,
-1.5242646932601929,
-0.3047850430011749,
-0.6750322580337524,
1.0389995574951172,
-0.6615867018699646,
1.0211044549942017,
-0.8234227299690247,
-0.5500312447547913,
-0.3286868929862976,
0.23944400250911713,
0.244352787733078,
-0.4605846405029297,
-0.08810301125049591,
-0.3931308388710022,
0.15603509545326233,
-0.23318174481391907,
-0.3747413158416748,
-1.127250075340271,
0.20328180491924286,
1.7150688171386719,
0.41623029112815857,
0.33134889602661133,
-0.03961511328816414,
0.22230513393878937,
1.2397685050964355,
0.2684149146080017,
-0.322345495223999,
-0.7909448742866516,
0.7813113331794739,
1.1698373556137085,
-0.1354604959487915,
-0.0005999058485031128,
-0.5042887926101685,
-0.034242380410432816,
-0.0859362930059433,
0.3519051671028137,
0.05785774439573288,
1.2837387323379517,
-0.004348133224993944,
-0.06451241672039032,
-0.3224532902240753,
-0.24469730257987976,
-0.31196027994155884,
-0.3086933493614197,
-0.213528111577034,
0.1612645387649536,
0.9621610045433044,
0.21280956268310547,
-0.3376372158527374,
-0.4297425448894501,
-0.18137870728969574,
0.06738504022359848,
-0.5748608112335205,
-0.30568525195121765,
-0.019605865702033043,
0.03222958371043205,
-1.2560205459594727,
0.02676353231072426,
0.7877814769744873,
-0.5509505867958069,
0.890302836894989,
-0.5496697425842285,
-0.808830976486206,
0.4804275929927826,
0.6692605018615723,
-0.43716272711753845,
0.49408096075057983,
-0.949988067150116,
-0.16848193109035492,
-0.1522819846868515,
-0.011766942217946053,
0.06895799934864044,
0.30919378995895386,
0.3014186918735504,
-0.3088511824607849,
0.5698692798614502,
-0.05703447014093399,
-0.31304898858070374,
-0.6839163899421692,
0.7168889045715332,
1.4688137769699097,
-0.47470900416374207,
0.8698012232780457,
0.7341413497924805,
0.05306639522314072,
0.13771799206733704,
0.014506513252854347,
-1.0887682437896729,
-0.1888865828514099,
-0.230412557721138,
0.04889535903930664,
0.978746235370636,
-0.6438375115394592,
0.11701161414384842,
0.2547266185283661,
-0.6544358134269714,
0.07276806235313416,
-0.025862114503979683,
0.3230340778827667,
0.4151036739349365,
-0.969323456287384,
-0.7998778223991394,
-0.9798836708068848,
-0.2738374173641205,
-0.8993781208992004,
0.6989476084709167,
0.07899417728185654,
0.37045061588287354,
0.08782186359167099,
0.054865773767232895,
0.1740349382162094,
0.062447719275951385,
0.2244347631931305,
0.0169652309268713,
-0.1841338872909546,
-0.18215312063694,
0.5043860673904419,
0.20301610231399536,
-0.062412865459918976,
0.792130708694458,
0.34362518787384033,
0.3863871991634369,
0.5828555226325989,
0.23715057969093323,
0.019826827570796013,
-0.2544936239719391,
-0.33435168862342834,
-0.8012065887451172,
-0.000032130807085195556,
0.3399922847747803,
0.298666387796402,
0.24692924320697784,
-0.5238537788391113,
-0.2502240538597107,
-0.04739854484796524,
0.14183609187602997,
-0.3049715459346771,
-0.36879652738571167
] |
NCT03297034
|
Swiss Childhood Cancer Survivor Study
|
The SCCSS is designed to investigate which long-term effects childhood cancer and its treatment have on survivors, and includes those who were under 20 years when they were diagnosed. The SCCSS explores childhood cancer survivors' quality of life, the health care received by childhood cancer survivors during follow-up care, the effects of medication, somatic and psychosocial health issues, how childhood cancer survivors take care of their own health, and also collects demographic details like family background, education and profession. To learn more about these topics, the investigators send questionnaires to childhood or adolescent cancer survivors. The investigators use the results to inform physicians and patients, and to improve treatment of childhood cancer and follow-up.
|
Background: Therapies have improved so much in the past decades that more than 80% of children and adolescents now survive cancer. This means that the population of long-term childhood cancer survivors is growing. Since cancer and its treatments may later have adverse effects, it is important to track and improve survivor health and quality of life. Comprehensive data on the burden of late effects of childhood cancer or risk factors for late effects was not available, and so Switzerland set up the SCCSS to increase knowledge and improve the quality of care and follow-up.
Objectives: The SCCSS investigates long-term outcomes of survivors of childhood and adolescent cancer, and the incidence and spectrum of various somatic and psychosocial outcomes including late mortality, second primary malignancies, somatic health and medication, mental health, educational achievements, health-related quality of life, and the association of these outcomes with risk factors like tumor, treatment modalities, and demographic characteristics. The SCCSS also investigates how health-care is provided, and how long-term childhood cancer survivors take care of their health.
Methods: All Swiss residents who were diagnosed with cancer at age \<20 years, have survived at least 5 years since cancer diagnosis, received a detailed questionnaire. The investigators added data from general practitioners and hospital records. To compare survivors with the general population, they also send the questionnaire to the siblings of childhood cancer survivors.
Rationale and significance: The data collected by the SCCSS allows the investigators to study long-term outcomes of Swiss childhood cancer survivors. The SCCSS helps to learn more about the incidence of late effects and their risk factors. It also allows to summarize the current state of care in Switzerland. Since early diagnosis can prevent or mitigate many late effects, tracking them will help to improve the health of current and future childhood cancer survivors.
Current status of the project: From 2008-2023, the investigators have contacted 5949 childhood cancer survivors diagnosed between 1976-2015 and 2062 of their siblings. The investigators contact new 5-year childhood cancer survivors at regular intervals, and continuously analyse and publish data and findings. By 2022, the investigators have contacted 3443 childhood cancer survivors for a follow-up questionnaire and will continue with this at regular intervals.
Funding: Swiss Cancer League/ Swiss Cancer Research (Grant No: KLS/KFS-4825-01-2019), Stiftung für krebskranke Kinder (Regio basiliensis) and Kinderkrebshilfe Schweiz.
|
Inclusion Criteria:
* Who were diagnosed with cancer at age \<20 years
* Who have survived at least 5 years after cancer diagnosis
* Who were Swiss residents when they were diagnosed, and
* Who gave informed consent
|
[
0.8438240885734558,
2.25962233543396,
0.06906960159540176,
0.9959912896156311,
-1.140116810798645,
0.22179283201694489,
-1.782191514968872,
-1.7771759033203125,
-0.5672269463539124,
0.033735740929841995,
0.30507075786590576,
3.5836002826690674,
-0.19684098660945892,
0.9725737571716309,
-0.2212575376033783,
1.7237294912338257,
0.9509429931640625,
0.9725731015205383,
0.695938229560852,
-0.512373149394989,
0.15565848350524902,
-0.6854812502861023,
0.6628398299217224,
-0.6762910485267639,
-0.25091445446014404,
0.37070775032043457,
-0.21439214050769806,
2.1160597801208496,
-0.010274994187057018,
1.6150087118148804,
-0.18553021550178528,
0.5775164365768433,
0.4316582679748535,
-0.780988335609436,
-0.3382779061794281,
-0.540856122970581,
0.5147737860679626,
1.0971041917800903,
-1.7899476289749146,
0.4553621709346771,
-0.3906712234020233,
0.7378773093223572,
-0.4716108739376068,
-0.4414035975933075,
-0.711646318435669,
0.12698322534561157,
0.5385984182357788,
0.8334977030754089,
-0.19930578768253326,
0.34639880061149597,
-1.269294261932373,
1.459281325340271,
0.18110015988349915,
0.21143537759780884,
1.1713693141937256,
0.13415396213531494,
-0.4442191421985626,
0.5542022585868835,
1.4087152481079102,
-0.1895056664943695,
1.1203237771987915,
-0.6680834293365479,
0.3697589039802551,
-0.20655958354473114,
-0.894414484500885,
-0.3048095703125,
-0.23169755935668945,
-0.8618360161781311,
0.7003160119056702,
0.9688915014266968,
0.7393806576728821,
0.7049424052238464,
1.008561134338379,
0.01225618552416563,
0.08887868374586105,
-0.4143740236759186,
0.024877524003386497,
1.0287359952926636,
0.703337550163269,
-0.49893006682395935,
-0.0769505426287651,
-0.5861691832542419,
-0.9873051047325134,
0.08984605222940445,
0.7117581367492676,
-0.7190083265304565,
-2.1747708320617676,
-0.5723599791526794,
1.31938898563385,
-1.5588910579681396,
0.052331313490867615,
-0.624381422996521,
-1.7627300024032593,
1.172593116760254,
-0.6268712282180786,
0.9616186022758484,
0.20025604963302612,
-0.2615549862384796,
-2.130026340484619,
-0.05977141857147217,
0.40618616342544556,
-0.27504128217697144,
-0.43616482615470886,
-0.27336880564689636,
-1.2961612939834595,
-0.34935450553894043,
-0.39405006170272827,
-0.6801050305366516,
0.35668107867240906,
0.3018929660320282,
-0.23297159373760223,
-1.2321367263793945,
0.9758939146995544,
-0.09847970306873322,
0.30355581641197205,
-0.4655628800392151,
1.1533002853393555,
0.038434941321611404,
-0.046536657959222794,
-0.06285252422094345,
-0.4066201448440552,
0.5056464076042175,
-0.3356332778930664,
0.46992141008377075,
-0.6397469639778137,
-0.12931127846240997,
-0.5464314818382263,
-0.2899499535560608,
-0.715783417224884,
-0.7980117797851562,
-1.053542137145996,
0.055299583822488785,
0.06985297054052353,
-0.2984836995601654,
-0.4559727907180786,
-0.4006847143173218,
0.1924116164445877,
0.1789410561323166,
0.17816700041294098,
-1.2619242668151855,
0.17202797532081604,
-0.09369650483131409,
-0.6807237267494202,
0.05049031600356102,
-1.19625985622406,
0.6225906014442444,
1.1752079725265503,
0.06616882234811783,
-1.0575789213180542,
-1.2491087913513184,
0.707085132598877,
0.38754698634147644,
-0.1341131627559662,
0.19156481325626373,
0.06224951148033142,
0.4227076768875122,
-0.46989041566848755,
-0.3288445770740509,
-0.3502836525440216,
0.39019688963890076,
0.6831827163696289,
-0.15498217940330505,
-0.4474666118621826,
-0.32934507727622986,
0.6501728892326355,
-0.38900846242904663,
0.203791543841362,
-0.17777633666992188,
-0.28177711367607117,
0.16241435706615448,
0.16749539971351624,
-0.3468703329563141,
-0.05838268622756004,
0.6102365255355835,
-0.23276807367801666,
0.4376692771911621,
0.6254472136497498,
0.5057098865509033,
0.8546284437179565,
-0.5904962420463562,
-0.04292865842580795,
0.07201550900936127,
0.6302269101142883,
-0.3687048852443695,
-0.2621975243091583,
-0.08338041603565216,
-0.6123514771461487,
-0.0970103070139885,
-0.34559202194213867,
0.14572960138320923,
-0.021585633978247643,
-0.49403825402259827,
0.6269482970237732,
0.34637516736984253,
0.7234053015708923,
-0.35631754994392395,
-0.005140336230397224,
-0.5098101496696472,
0.1289447695016861,
0.13892599940299988,
0.3416423797607422,
-0.25342339277267456,
-0.1308233141899109,
0.4536017179489136,
-0.08617343753576279,
-0.22534459829330444,
0.10896763205528259,
-0.08150513470172882,
-0.01783004216849804,
0.14019571244716644,
0.33574172854423523,
-0.06662888824939728,
-0.07155901938676834,
-0.2415713369846344,
-0.28159406781196594,
-0.06897895783185959,
0.3426794707775116,
-0.03283168002963066,
-0.027655605226755142,
0.17103621363639832,
-0.9211825728416443,
-0.03947107866406441,
0.352517306804657,
-0.17190000414848328,
-0.39771926403045654,
-0.13213947415351868,
-0.4549616575241089,
-0.20191144943237305,
0.08526231348514557,
0.03475766256451607,
-0.00003787372406804934,
-0.12591400742530823,
0.3954443037509918,
-0.17630872130393982,
0.07047436386346817,
-0.06916647404432297,
-0.17339786887168884,
0.5113650560379028,
-0.015083844773471355,
0.43845483660697937,
0.4146134555339813,
0.15582673251628876,
0.22770629823207855,
-0.7336732745170593,
-0.44781574606895447,
-0.029015617445111275,
-0.41132062673568726,
0.016042985022068024,
0.25365152955055237,
0.8873965740203857,
0.11999902874231339,
-0.25924450159072876,
0.06442961096763611,
0.43448933959007263,
0.2943052649497986,
-0.2521574795246124
] |
NCT02223130
|
Addressing Discrimination and Mistrust Among Black Men: Phase III
|
The purpose of this research study is to test a group program aimed at improving the quality of life of HIV+ Black men who have sex with men. The group will address ways to cope with discrimination and will help men examine mistrust that they may have about healthcare, including doctors and other healthcare providers and HIV medications. The aim is to provide a supportive community for HIV+ Black men.
|
The aim of the study is to examine whether the pilot intervention can reduce mistrust and improve coping responses to discrimination among HIV positive Black men who have sex with men (MSM). We will conduct a small randomized pilot trial to test the feasibility of evaluation methods. All participants will attend a baseline, a first follow-up visit, and a final follow-up visit (each 3 months apart) at which they will take computer assessments. Participants who are assigned to the intervention will attend 9 weekly intervention sessions after baseline and before the first follow-up. Using a wait-list control design, control group participants from the first two cohorts will be offered the intervention after they complete the final follow-up visit. Control group participants from the third cohort will be offered the intervention after they complete the first final-up visit and before they complete their final follow-up due to timing and budgetary restraints. We will hold three consecutive groups for our small randomized control trial. This means that we will be recruiting continuously; once we finish recruiting for the first group, we will start recruiting for the second group, and so on. Each group has about 12 or 13 intervention and 7-11 control participants.
|
Inclusion Criteria:
* 18 years-old or older
* Biologically male at birth
* Currently self-identifies as male
* Self-identifies as Black or African American (mixed-race individuals will be eligible if they primarily identify as Black or African American)
* HIV-positive
* Reported having sex with men in lifetime
* Able and willing to provide informed consent
Exclusion Criteria:
* Does not meet all of the inclusion criteria (e.g., if they are unable to provide proof of their HIV-positive status)
* Unable to provide informed consent
* Reports or presents evidence of severe mental health problems that require immediate treatment (e.g., psychotic symptoms, active suicidality at time of enrollment) or diagnosed mental disorder that would limit the ability to participate (e.g., dementia)
* Reports or presents evidence of cognitive impairments that limit the ability to comprehend the informed consent or to fully participate in the various parts of the study (assessments, intervention, homework).
|
[
0.338472843170166,
3.226705551147461,
-0.7812648415565491,
-0.42029836773872375,
0.49453046917915344,
0.5038717985153198,
-0.7216150164604187,
-0.12574772536754608,
-1.114140272140503,
-1.7616268396377563,
0.15237891674041748,
1.8932160139083862,
0.22905971109867096,
0.2544986605644226,
-0.1470140814781189,
0.7055650949478149,
0.4497383236885071,
0.6856176853179932,
0.33576589822769165,
0.7481973767280579,
0.21468722820281982,
1.8203600645065308,
-0.2780410349369049,
-1.1398154497146606,
1.198348045349121,
1.4440027475357056,
-0.5948721766471863,
1.384575366973877,
-0.4366414546966553,
0.45715776085853577,
0.07059858739376068,
-1.2092629671096802,
0.27680158615112305,
0.39274173974990845,
0.5058243274688721,
-0.5601595640182495,
1.3473447561264038,
1.7812496423721313,
-1.2944062948226929,
1.0627275705337524,
-0.032121460884809494,
1.2046788930892944,
-0.3979225754737854,
0.23380985856056213,
1.37706458568573,
0.36496502161026,
0.08570617437362671,
-0.2336781620979309,
-0.4457736313343048,
1.21950364112854,
-0.7948445081710815,
1.3864680528640747,
-0.11832107603549957,
0.8202708959579468,
2.909184217453003,
-0.1785650998353958,
0.23166348040103912,
1.1579439640045166,
0.5783416628837585,
0.10269255191087723,
1.077272891998291,
-0.9723040461540222,
0.3333416283130646,
1.327344298362732,
-1.032918095588684,
0.3951587378978729,
-0.4281564950942993,
-0.7931533455848694,
0.26758065819740295,
0.8627740144729614,
-1.2346988916397095,
0.15459853410720825,
1.348517894744873,
0.08766615390777588,
0.9931493997573853,
0.9343155026435852,
-0.732711672782898,
0.7773318886756897,
1.2611310482025146,
0.10597837716341019,
-0.6535972952842712,
0.3825351893901825,
0.48953691124916077,
-0.6203143000602722,
1.1147674322128296,
-0.4712083637714386,
-0.20344458520412445,
-0.5803870558738708,
-0.14196385443210602,
-1.7154589891433716,
1.586997628211975,
0.29159805178642273,
0.98001629114151,
0.6219497323036194,
0.054536305367946625,
0.9298447966575623,
0.6403887271881104,
-0.6926647424697876,
-1.3817380666732788,
-0.26410797238349915,
-0.7642003297805786,
0.43879881501197815,
-0.31943580508232117,
-1.3247779607772827,
-0.6824199557304382,
-0.21388618648052216,
-1.2319226264953613,
-0.062071267515420914,
-0.7100532054901123,
0.3747505247592926,
0.9131761193275452,
-0.8268173336982727,
-0.037369344383478165,
0.27951887249946594,
0.14163129031658173,
-0.06427138298749924,
0.7621003985404968,
0.3389567732810974,
0.23098553717136383,
0.43492448329925537,
0.29097896814346313,
0.7064892649650574,
0.2743041217327118,
-0.7798090577125549,
-0.6085637807846069,
0.1435144692659378,
-0.1514376401901245,
-0.6800426840782166,
0.9502542018890381,
0.21488197147846222,
-0.2550230622291565,
0.38145822286605835,
0.3629607558250427,
-0.07861213386058807,
-0.6774057745933533,
-0.13013453781604767,
0.059099722653627396,
0.6782618165016174,
-0.1324319839477539,
0.0530911460518837,
0.772659957408905,
0.18530268967151642,
0.8928778171539307,
-0.35482075810432434,
-1.6160906553268433,
-0.022106114774942398,
0.347594678401947,
-0.42655569314956665,
-0.9980209469795227,
-1.1116021871566772,
-0.250587522983551,
1.0662012100219727,
0.8712910413742065,
0.4681532084941864,
-0.6146948337554932,
0.38393527269363403,
-1.2146120071411133,
-1.0507978200912476,
0.10750474780797958,
0.4576762616634369,
-0.42886924743652344,
-0.17542710900306702,
-0.34030336141586304,
-1.0198601484298706,
0.4207753539085388,
0.05376000329852104,
0.00839877501130104,
-0.32801353931427,
0.19132795929908752,
0.1213468685746193,
0.21663783490657806,
0.07377125322818756,
-0.29537084698677063,
0.41444578766822815,
0.6359009742736816,
0.21472690999507904,
0.7245102524757385,
-0.04442466050386429,
-0.20454221963882446,
-0.6847075819969177,
-0.216007798910141,
0.44870561361312866,
-0.14501573145389557,
0.1443053036928177,
0.2529345154762268,
-0.46753790974617004,
-0.3186793327331543,
-0.9250404238700867,
0.2610509693622589,
0.31130972504615784,
0.4439735412597656,
-0.7313209176063538,
0.12589213252067566,
0.46483176946640015,
0.20835307240486145,
0.009918862022459507,
0.06018975377082825,
0.06689684092998505,
-0.5618563890457153,
-0.1677425354719162,
0.26544713973999023,
0.089447021484375,
-0.24570420384407043,
0.7664992213249207,
-0.002888182643800974,
-0.2909436523914337,
-0.5159057378768921,
-0.48502930998802185,
0.3438325822353363,
-0.18202662467956543,
0.3786796033382416,
-0.21291153132915497,
0.19551226496696472,
-0.2824915647506714,
-0.08002550899982452,
0.1571972370147705,
-0.12634822726249695,
0.12982167303562164,
0.1797114759683609,
0.12100504338741302,
-0.10938245803117752,
0.07442189753055573,
-0.42733925580978394,
-0.6555489301681519,
-0.3626789152622223,
0.039014194160699844,
-0.42083245515823364,
0.09421619027853012,
0.11651313304901123,
0.4645509421825409,
0.17636969685554504,
0.27054932713508606,
0.05746549367904663,
0.04035449028015137,
-0.39576783776283264,
-0.25536829233169556,
-0.015941178426146507,
0.7027767300605774,
-0.9451897740364075,
0.2697046995162964,
0.5895029306411743,
0.3297900855541229,
0.33760690689086914,
-0.8304380774497986,
-0.18048611283302307,
0.6886305809020996,
-0.262982577085495,
0.625777542591095,
0.55745530128479,
0.0885954350233078,
-0.09765506535768509,
-0.1670389026403427,
-0.07387962192296982,
-0.593693733215332,
0.15139402449131012,
-0.6428890824317932
] |
NCT03656120
|
A Study of Thienorphine Hydrochloride Tablets in Relapse Prevention Treatment of Opioid Dependence
|
Opioid addiction is common worldwide. Thienorphine hydrochloride is a newly partial opioid receptor agonist drugs. It's affinity with opioid receptors was much higher than opioids, which could effectively prevents opioid dependence by stop opioids competition for opioid receptors and causing opioid dependence. The aim of this research was to determine whether thienorphine hydrochloride would reduce opioid use and better preventing relapse among opioid addicts.
|
Opioids dependence is a chronic brain disease, with a much higher rate of relapse rate. Relapse prevention is important for opioid dependence treatment. Thienorphine hydrochloride, derivatives of buprenorphine, is one of the receptor partial agonists. Previous research indicated that, it may be a safe and effective treatment for the prevention of opioid dependent patients after detoxification. In this multicenter, randomized, double-blind, placebo-controlled, phase Ⅱb clinical trial, we are aimed to evaluate the efficacy of thienorphine hydrochloride tablets for anti-relapse therapy after opioid dependence detoxification treatment, determining the optimal dose of thienorphine hydrochloride tablets, and further evaluate the safety of thienorphine hydrochloride for patients with opioid dependence. 180 eligible patients are going to be recruited and randomly assigned to 0.2mg/day group, 0.5mg/day group and placebo control group after they provided their consent forms. Subjects in each group would receive assigned treatment for 12 weeks. Primary outcome measure was retention time of each participants during these 12 weeks. Urine test for opioids, changing of withdrawal score and craving, self-reported euphoria after using heroin, subjects and researchers' overall evaluation of treatment efficacy are secondary outcome measures.
|
Inclusion Criteria:
1. Currently meets the diagnostic criteria for DSM-IV opioid dependence, with a history of opioids using more than 1 year; having relapsed for opioids for at least twice, and meets one of the following criterion:
1.1 Opioid dependent patients (including heroin dependent patients or patients undergoing methadone maintenance treatment) treated with buprenorphine and meeting the following criteria: 1.1.1 Taking buprenorphine 2 mg per day for at least 3 consecutive days; 1.1.2 Clinical Opioid Withdrawal Symptom Scale (COWS) score ≤ 4; 1.1.3 Negative urine test results for morphine and methadone; 1.2 Having been stopped to using opioids. Negative urine test results for morphine, methadone and buprenorphine. As well as negative result for naloxone-precipitated tests ((including patients returning to the community from drug rehabilitation agencies).
2. Age 18 to 60 years old, male and female
3. Weight 40 \~ 95kg
4. Able to communicate with researchers, willing to receive anti-relapse therapy, and provide signed consent forms.
Exclusion Criteria:
1. Substance dependence other than nicotine;
2. Severe psychiatric disorders;
3. Severe physical illnesses, including severe digestive, cardiovascular, respiratory, and endocrine systems problems;
4. Patients with severe chronic pain;
5. Women in pregnancy or lactation
6. Patients who do not have effective contraception methods
7. Systolic/diastolic pressure is higher than 150/100mmHg or lower than 85/60mmHg
8. Heart rate \<50 beats / min;
9. Severe liver or kidney dysfunction or severe abnormalities confirmed by laboratory test (liver function indicators ALT, AST are more than 3 times higher than the upper limit of normal values; any of the renal function indicators BUN, Cr that is higher than the upper limit of normal 1.5 times and above);
10. Allergic to buprenorphine or other similar drugs;
11. Patients with dysuria or urinary retention symptoms;
12. People with severe habitual constipation;
13. Those with HIV infection;
14. Poor adherence;
15. Participants enrolled in other clinical trials within 4 weeks prior to enrollment.
|
[
-0.6332571506500244,
0.01380366925150156,
-4.074034214019775,
-3.8171396255493164,
1.9151554107666016,
-2.147390604019165,
0.7681121826171875,
1.956315040588379,
-0.35190868377685547,
2.4792771339416504,
-0.32894352078437805,
0.7800597548484802,
0.7422692775726318,
1.2550100088119507,
2.7652170658111572,
0.04118908941745758,
-0.16150641441345215,
1.2970867156982422,
0.5660257339477539,
-1.6911931037902832,
2.084456205368042,
0.3469114303588867,
1.5731704235076904,
-0.9848307967185974,
2.239332914352417,
-1.382739782333374,
-1.7993898391723633,
0.026025377213954926,
0.3056366741657257,
1.0488156080245972,
-0.2646728456020355,
-0.5872554779052734,
-0.13489511609077454,
0.97733473777771,
0.7592738270759583,
-1.0000499486923218,
2.3938395977020264,
-2.012592315673828,
-1.9569685459136963,
1.1387195587158203,
0.7984081506729126,
0.2598188519477844,
-0.5668079257011414,
-2.1757090091705322,
3.815537452697754,
0.1273413747549057,
-0.7036382555961609,
1.608745813369751,
0.931795060634613,
-0.05081842094659805,
-0.958775520324707,
2.477696180343628,
0.23787762224674225,
-0.08332861959934235,
1.838160753250122,
-0.07305130362510681,
2.8807246685028076,
0.7150000929832458,
-1.018903374671936,
-2.2953953742980957,
-1.4179631471633911,
1.4479379653930664,
-0.6103968620300293,
-0.22212812304496765,
-0.8835461139678955,
-0.5721536874771118,
-0.6386812329292297,
-0.4782049357891083,
0.15990108251571655,
2.1587777137756348,
-2.737647533416748,
1.5902775526046753,
-0.7954378724098206,
-0.4354814887046814,
1.428432822227478,
0.519705593585968,
-1.5266550779342651,
1.792352557182312,
0.25605395436286926,
1.49506676197052,
-1.2508450746536255,
-2.0824029445648193,
0.3335433006286621,
-0.3949134051799774,
-1.1579232215881348,
-0.4858737885951996,
-0.45572295784950256,
-0.0856141448020935,
0.8152205348014832,
-1.8834211826324463,
2.792086601257324,
-0.3065077066421509,
-0.571121096611023,
1.6142252683639526,
-0.007365325465798378,
0.28006795048713684,
-0.6680987477302551,
-0.3776080906391144,
-2.5295748710632324,
-0.35181814432144165,
0.6873621940612793,
-1.4673115015029907,
0.797173023223877,
-0.07462406903505325,
-0.7729189991950989,
-0.37779664993286133,
-0.4582650065422058,
0.0226768646389246,
-1.036503553390503,
-1.160123348236084,
0.47700148820877075,
-0.4771125018596649,
0.35362690687179565,
-0.6235162615776062,
1.0457762479782104,
-0.3303985595703125,
1.4571021795272827,
1.0432921648025513,
-0.03650866076350212,
-2.449061393737793,
0.6047075390815735,
0.9965387582778931,
-0.4893497824668884,
1.6637870073318481,
-1.9845393896102905,
-0.8985866904258728,
0.32308632135391235,
-1.0559520721435547,
-0.24790288507938385,
1.2311246395111084,
0.1381327211856842,
0.23027899861335754,
-0.7897497415542603,
-0.8687105178833008,
-0.7647920846939087,
-0.0036551521625369787,
0.7385787963867188,
1.5948609113693237,
-0.6459575295448303,
-0.27334240078926086,
0.10918167978525162,
-0.09062349051237106,
-1.0012452602386475,
-0.272699773311615,
0.07741191238164902,
-0.5530719757080078,
-0.0242311991751194,
0.6644986867904663,
-0.7956210970878601,
-0.022698398679494858,
-0.5511666536331177,
1.8131206035614014,
0.10375064611434937,
0.7285029292106628,
0.8838136792182922,
0.7695754766464233,
-1.4631284475326538,
0.7008445262908936,
0.4056675136089325,
0.8120757341384888,
-0.9608780145645142,
0.792309582233429,
0.5393052101135254,
2.528244972229004,
-0.37678834795951843,
-0.43549585342407227,
0.9580695033073425,
1.5008670091629028,
0.9266069531440735,
-1.6428791284561157,
-0.8228185176849365,
0.33414945006370544,
-1.0087448358535767,
0.0934433862566948,
-0.5756197571754456,
0.9093121886253357,
-0.5510821342468262,
0.2671002447605133,
0.6771936416625977,
0.5808244347572327,
-0.4031602442264557,
0.30224665999412537,
0.16454759240150452,
-0.026417676359415054,
1.1590039730072021,
-0.8635936379432678,
-0.4040449261665344,
-0.4651954770088196,
-0.775015652179718,
0.8110256791114807,
0.6377586126327515,
-0.08959105610847473,
-0.14250987768173218,
-0.7842124104499817,
-0.15045222640037537,
-0.19155721366405487,
-0.478276789188385,
-0.7933457493782043,
0.9236393570899963,
-0.8269935250282288,
-0.6425422430038452,
1.0835562944412231,
0.022771621122956276,
0.9755369424819946,
-0.3052941560745239,
-0.034642014652490616,
-0.1301838457584381,
0.8052200675010681,
-0.11936470121145248,
-0.2978622317314148,
0.1592225432395935,
-0.41242602467536926,
0.7695404291152954,
0.11498361825942993,
1.0330547094345093,
0.9192409515380859,
-0.26435577869415283,
0.024524087086319923,
-0.8263267874717712,
0.3165155351161957,
-0.34034159779548645,
0.054301124066114426,
-0.22877037525177002,
0.02149583026766777,
-0.3915941119194031,
0.17059971392154694,
-0.29854243993759155,
0.20944839715957642,
0.1283559501171112,
0.13434940576553345,
-0.6878291964530945,
0.6854158043861389,
0.3048090934753418,
0.21206870675086975,
0.1955396682024002,
-0.04807910695672035,
0.1268651932477951,
-0.5871106386184692,
0.3834046423435211,
-0.8899478912353516,
0.7902446985244751,
0.04593116044998169,
-0.8150086998939514,
0.11133741587400436,
-0.32898658514022827,
-0.43062373995780945,
-0.24108804762363434,
0.44662511348724365,
0.06641488522291183,
0.5206632614135742,
-0.4018087387084961,
0.10840801149606705,
-0.07167959958314896,
-0.2847289443016052,
0.12345371395349503,
-0.0069264317862689495
] |
NCT02368860
|
OXIRI [Oxaliplatin (O), Xeloda (X) and Irinotecan (I)] in Pancreatic Adenocarcinoma
|
This is an exploratory Phase I study is to assess the safety and tolerability of the OXIRI regimen \[oxaliplatin (O), xeloda (X) and irinotecan (I)\] and to evaluate for preliminary evidence of efficacy, in patients with advanced and/or metastatic pancreatic adenocarcinoma. The investigators hypothesize that 2 of 3 weekly doses of oxaliplatin and genotype directed-dosing of irinotecan in combination with chronomodulated capecitabine (xeloda) administered continuously will be more tolerable than the FOLFIRINOX regimen (folinic acid, fluorouracil, irinotecan and oxaliplatin) while maintaining anti-tumour activity.
|
This study comprises a dose escalation phase using 3+3 design to determine the safety, tolerability and pharmacokinetics of the OXIRI regimen and an expansion phase to further evaluate the MTD and to determine early signs of efficacy.
Eligible patients will receive a novel chemotherapeutic regimen (OXIRI regimen) with xeloda being administered in a chronomodulated fashion and the dose of irinotecan being guided by the UGT1A1\*28 and UGT1A1\*6 genotype status of the patient.
|
Inclusion Criteria:
1. Patients between 21 to 75 years of age
2. A histopathologically or cytological confirmed diagnosis of locally advanced and/or metastatic PDAC that is unresectable
3. Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) ver 1.1 criteria
4. Life expectancy of at least 12 weeks
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
6. Adequate hematologic function (neutrophils count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L)
7. Adequate hepatic function (total bilirubin ≤ 1.5 x the upper limits of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN
8. Adequate renal function (calculated creatinine clearance \> 50 mL/min)
9. Able to give informed consent
10. Toxicity related to previous radiotherapy or chemotherapy resolved to ≤ Grade 1
Exclusion Criteria:
1. History of prior malignancy except non-melanoma skin cancer within the last 5yrs
2. Uncontrolled central nervous system (CNS) metastases or carcinomatous meningitis
3. Uncontrolled concomitant medical illnesses (e.g. hypertension, myocardial infarct, heart failure, ventricular arrhythmia, diabetes, severe infection)
4. Major surgery within four weeks prior to study treatment
5. Patients on chronic immunosuppressive therapy
6. Pregnant or breast-feeding female patients
7. On anticoagulant therapy with vitamin K antagonists.
8. Dose-escalation cohort:
* Patients homozygous for uridine diphosphate glucuronosyltransferase (UGT)1A1\*6/\*6 or UGT1A1\*28/\*28
* Previous oxaliplatin or irinotecan chemotherapy
* Treatment with any of the following anti-cancer therapies prior to the first dose of OXIRI within the stated timeframes
* Cyclical chemotherapy within a period of time that is shorter than the cycle length used for that treatment. Exception for weekly chemotherapy regimens, where a minimum of 2 week washout from the last dose is required.
* Biological therapy (e.g., antibodies) within a period of time that is ≤ 5 t1/2 or ≤ 4 weeks, whichever is shorter, prior to starting study drug
* Continuous or intermittent small molecule therapeutics within a period of time that is ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug
* Any other investigational agents within a period of time that is ≤ 5 t1/2 or less than the cycle length used for that treatment or ≤ 4 weeks (whichever is shortest) prior to starting study drug
* Wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug
9. Dose-expansion cohort:
* Previous chemotherapy or radiotherapy
|
[
2.5474741458892822,
-0.458528608083725,
-3.6282670497894287,
-3.696399450302124,
1.4733068943023682,
-0.6150155663490295,
0.17225141823291779,
0.4550309181213379,
-1.980026125907898,
1.1355254650115967,
0.07367640733718872,
1.5947883129119873,
-1.3637815713882446,
0.16141901910305023,
1.953359603881836,
0.6167224645614624,
-0.6545584201812744,
-0.4848926365375519,
-0.48741859197616577,
-2.0297422409057617,
1.6036041975021362,
-1.162994146347046,
-0.6712646484375,
1.0647841691970825,
0.8795505166053772,
0.020665910094976425,
-0.837200939655304,
0.6386417746543884,
1.0158957242965698,
1.7770648002624512,
0.8219602704048157,
-0.2791173458099365,
-0.09493046253919601,
-0.29970866441726685,
-0.9529028534889221,
0.45736125111579895,
-0.2581176459789276,
0.16674169898033142,
-1.3296576738357544,
0.5793103575706482,
1.1516368389129639,
-0.8124037384986877,
0.6347309947013855,
-0.604741096496582,
1.9891681671142578,
-0.18919073045253754,
-0.543138861656189,
0.5300525426864624,
1.593000054359436,
-0.13334423303604126,
-2.1771724224090576,
1.424882173538208,
-0.46878504753112793,
-0.6531307101249695,
-1.202016830444336,
0.4720268249511719,
0.008119462989270687,
0.3846348226070404,
0.5892735123634338,
0.1343844085931778,
0.3643408715724945,
0.23428399860858917,
-0.5793164968490601,
0.8771582245826721,
-0.6999059915542603,
0.3466989994049072,
0.0406106635928154,
-0.8508808016777039,
-0.5356910824775696,
0.23944713175296783,
-0.11965513974428177,
1.1120303869247437,
-0.3434361219406128,
0.46360543370246887,
0.3507949709892273,
1.1590769290924072,
0.5893049240112305,
1.1674689054489136,
0.3415348529815674,
0.29710930585861206,
-0.6071314811706543,
0.05427044630050659,
0.04636673256754875,
-0.09656719863414764,
0.6912496089935303,
-0.20594820380210876,
-0.2149779051542282,
-1.1690514087677002,
0.45394137501716614,
-1.1562151908874512,
-0.26289960741996765,
-0.5085340142250061,
-1.7477715015411377,
1.495412826538086,
-0.8541485071182251,
-0.6487986445426941,
-0.08075501024723053,
-0.167218416929245,
-0.3789452314376831,
0.3228283226490021,
0.5190732479095459,
-1.1617132425308228,
-0.18740643560886383,
0.44060423970222473,
-0.456577330827713,
-0.45757803320884705,
0.1573360115289688,
-0.7023987174034119,
0.12840235233306885,
-1.3933372497558594,
0.029332829639315605,
-0.48516619205474854,
-0.538230836391449,
-0.20819492638111115,
0.23592707514762878,
0.7101408243179321,
0.3515777885913849,
0.5242866277694702,
-0.41005173325538635,
-0.2461933046579361,
-0.2227742224931717,
0.38913220167160034,
0.29907241463661194,
1.413520097732544,
-0.381007581949234,
0.16637754440307617,
0.2488580346107483,
-0.6153868436813354,
0.14139629900455475,
-0.862388014793396,
-0.5586666464805603,
0.35879915952682495,
-0.16443181037902832,
-0.5758799910545349,
-1.0927307605743408,
-0.21800726652145386,
-0.05997588858008385,
1.7121455669403076,
0.4172460436820984,
0.059072185307741165,
-0.38907817006111145,
0.7636085152626038,
-0.3311033844947815,
-0.4054023325443268,
-1.3537681102752686,
-0.08969686180353165,
0.0477508008480072,
0.120074562728405,
-0.11866395175457001,
-0.2372865080833435,
-0.6258432865142822,
0.4307768940925598,
0.11586864292621613,
0.485437273979187,
-0.015451132319867611,
0.12758339941501617,
0.8603718876838684,
-0.6178799271583557,
0.5688571333885193,
-0.24634003639221191,
-0.691862165927887,
-0.11978492885828018,
-0.03822553530335426,
0.1769128143787384,
0.2683466076850891,
-0.38978311419487,
0.07299650460481644,
-0.176998570561409,
-0.27161210775375366,
-0.16689158976078033,
-0.8305825591087341,
0.285054087638855,
-0.23769423365592957,
-0.025608671829104424,
-0.14340358972549438,
0.2968381345272064,
-0.05842801555991173,
0.19386282563209534,
0.030871709808707237,
0.3756216764450073,
-0.35566529631614685,
0.4163126051425934,
0.004553304985165596,
-0.30095815658569336,
0.1643688976764679,
-0.08977802842855453,
-0.17257267236709595,
-0.19393140077590942,
0.3015177547931671,
0.36404848098754883,
0.9750342965126038,
-0.31550708413124084,
-0.3932587504386902,
0.7883074283599854,
-0.2222084254026413,
-0.7568674087524414,
0.1710568070411682,
0.27599313855171204,
0.23783083260059357,
0.13906662166118622,
-0.2787282466888428,
0.49673283100128174,
0.2096834033727646,
0.19313731789588928,
0.38660675287246704,
0.10406848043203354,
-0.06891738623380661,
0.3793298006057739,
-0.7179301977157593,
-0.16214370727539062,
0.17294830083847046,
-0.023078976199030876,
0.5524082183837891,
-0.10461995750665665,
0.3621671497821808,
0.00010641835251590237,
-0.5565973520278931,
0.4580821990966797,
-0.44999492168426514,
0.4955652952194214,
-0.2335948497056961,
-0.20975995063781738,
-0.19336864352226257,
-0.2652779817581177,
-0.06753899902105331,
0.19146764278411865,
-0.6278018355369568,
0.031473301351070404,
-0.4552576243877411,
-0.2512300908565521,
0.04587197303771973,
-0.06543517112731934,
-0.37309181690216064,
-0.1495310515165329,
0.10715516656637192,
0.01601792313158512,
0.04796476662158966,
-0.032631002366542816,
-0.1745419204235077,
0.06080237776041031,
0.3612169325351715,
0.041648317128419876,
-0.11201424151659012,
-0.44068607687950134,
0.04800829663872719,
-0.18430031836032867,
-0.19104771316051483,
-0.02562238648533821,
-0.1621619313955307,
0.17805208265781403,
-0.671853244304657,
-0.16391707956790924,
0.12193180620670319,
0.5684338212013245,
0.008288022130727768,
-0.03913825377821922
] |
NCT03770130
|
Dexmedetomidine and Liver Transplantation
|
1.1. Background 1.1.1. Perioperative ischaemia/reperfusion (I/R) injury during liver transplantation is strongly associated with early allograft dysfunction, graft loss, and mortality.
1.1.2. Hepatic I/R injury also causes remote damage to other organs including the renal and pulmonary systems.
1.1.3. Dexmedetomidine, a selective α2-adrenoceptor agonist which is widely used as an adjuvant to general anaesthesia, has been widely shown in preclinical studies to provide organoprotection by ameliorating the effects of I/R injury in a range of tissues (including the liver). However, prospective clinical evidence of any potential benefits in improving outcomes in liver transplantation is lacking.
1.2. Objectives 1.2.1. To investigate the hypothesis that perioperative treatment with dexmedetomidine reduces the incidence of early allograft dysfunction and primary graft non-function in deceased donor liver transplantation.
1.2.2. The impact of dexmedetomidine on postoperative renal and pulmonary function will also be examined.
1.3. Study Design This is a prospective, single-centre, randomised, parallel-group study.
1.4. Setting Departments of Anesthesiology, Renji Hosptial, Shanghai Jiao Tong University School of Medicine, Shanghai, 200127, China.
1.5. Patients 200 patients (18-65 years) scheduled to undergo liver transplantation under general anaesthesia.
1.6 Intervention 1.6.1. For the patients in the treatment group, a loading dose of dexmedetomidine will be given after induction of anaesthesia (1μg/kg over 10 min) followed by a continuous infusion (0.5μg/kg /h) until the end of surgery.
1.6.2. For patients in the placebo group, an equal volume loading dose of 0.9% saline will be given after the induction of anaesthesia followed by an equal volume continuous infusion until the end of surgery.
1.6.3. All other supplements, e.g. opioids, sedatives and muscle relaxant, will be identical in the both arms and administered according to routine clinical practice.
|
Inclusion Criteria:
1. Age 18-65 years
2. Scheduled to undergo allogenic liver transplant(DCD/DBD) surgery under general anaesthesia
3. Patients should meet the UCSF criteria
4. Agree to participate and give written informed consent
Exclusion Criteria:
1. Severe renal dysfunction (undergoing renal replacement therapy before surgery)
2. Severe pulmonary dysfunction (including pneumonia, atelectasis, pleural effusion, acute lung injury or ARDS)
3. Severe circulatory instability (severe coronary artery disease, unstable angina, left ventricular ejection fraction \< 30%, sick sinus syndrome, severe sinus bradycardia \[\< 50 bpm\], second-degree or greater atrioventricular block)
4. Known allergy or intolerance to trial medication
5. Refusal to participate in the study
6. Participation in other clinical trials within 30 days prior to randomisation.
7. Retransplantation
8. Multiple organ transplantation
9. Other reasons that are considered unsuitable for study participation by the responsible surgeon or anaesthetist (reasons must be documented in the case report form \[CRF\])
|
[
0.9222479462623596,
1.5925661325454712,
-2.112071990966797,
-1.5843236446380615,
1.0862483978271484,
0.3085416853427887,
0.6435116529464722,
0.5576361417770386,
-1.4100126028060913,
0.18856218457221985,
0.21391424536705017,
1.9807870388031006,
0.15868718922138214,
1.3756282329559326,
0.21539083123207092,
-0.08186250925064087,
-0.1779334992170334,
0.04168429225683212,
0.2858448028564453,
-1.0491844415664673,
0.38392168283462524,
-0.526666522026062,
-0.07865675538778305,
0.36629804968833923,
0.9506039023399353,
-0.32420265674591064,
0.5455338358879089,
0.8261215090751648,
0.5112343430519104,
0.5769264698028564,
-0.45186156034469604,
-0.9522345066070557,
-0.0008523426949977875,
0.6694368124008179,
0.07685435563325882,
-0.08351422846317291,
0.8318718075752258,
0.3762437403202057,
-0.40315932035446167,
0.175808846950531,
1.1970922946929932,
1.516387939453125,
-0.07738915085792542,
-0.07559607177972794,
1.060530185699463,
-0.24589374661445618,
0.2976878583431244,
0.26987549662590027,
0.8340393900871277,
-0.008078569546341896,
-0.3722783029079437,
0.8023611903190613,
-1.1793354749679565,
-0.11131886392831802,
0.8960354328155518,
-0.02623588591814041,
0.7894927263259888,
0.07698089629411697,
0.6043744683265686,
0.16657662391662598,
0.20414012670516968,
0.04734983295202255,
0.028148138895630836,
0.5772227048873901,
-1.2725279331207275,
-0.9318495988845825,
0.29716795682907104,
0.1608198881149292,
-0.38765081763267517,
0.33270320296287537,
0.27653372287750244,
0.36712655425071716,
0.018979547545313835,
0.32198604941368103,
0.23522765934467316,
1.5679320096969604,
-0.6919928193092346,
0.6909841895103455,
0.3441199064254761,
0.4389176666736603,
-0.3613065779209137,
-0.5659310817718506,
-0.4164107143878937,
0.4342272877693176,
0.1647556573152542,
-0.05655771866440773,
-0.8711063265800476,
-0.2562697231769562,
0.13717465102672577,
-0.7556681632995605,
0.6120373606681824,
0.19518449902534485,
-1.36249840259552,
0.7772592306137085,
-0.6857488751411438,
0.23184864223003387,
-0.49190056324005127,
-0.0866299495100975,
-1.087496042251587,
-0.18139763176441193,
0.33690428733825684,
0.046218447387218475,
-0.2643148899078369,
-0.5318813323974609,
0.2821149230003357,
-0.32604917883872986,
-0.06386812031269073,
-0.6113207340240479,
-0.6096579432487488,
-0.5621592998504639,
0.3095039427280426,
-0.9263057112693787,
0.022695520892739296,
-0.3682737648487091,
-0.10837335139513016,
-0.14092376828193665,
-0.22871889173984528,
-0.017790338024497032,
0.1846088171005249,
-0.488989919424057,
0.09958066046237946,
0.3211669623851776,
0.13799980282783508,
0.38413819670677185,
-0.46044254302978516,
-0.342769056558609,
-0.21006877720355988,
0.23099106550216675,
-0.21594108641147614,
-0.4249632954597473,
-0.772758960723877,
0.46684032678604126,
0.16249214112758636,
-0.5862820148468018,
-0.919883131980896,
-0.6593171954154968,
-0.013613498769700527,
0.21557480096817017,
-0.03341890126466751,
-0.30832067131996155,
0.10720394551753998,
-0.02894696220755577,
-0.17679105699062347,
0.18353405594825745,
-1.0833426713943481,
0.12588220834732056,
-0.22487735748291016,
0.267950177192688,
-0.5841876268386841,
0.014911232516169548,
0.05781541392207146,
0.11188679188489914,
0.35140255093574524,
0.09900721907615662,
0.4245842397212982,
0.43560588359832764,
0.14809034764766693,
0.20447145402431488,
-0.21849483251571655,
-0.053473636507987976,
-0.1952272355556488,
-0.06595341861248016,
0.0590575709939003,
-0.5488384366035461,
0.6766436100006104,
0.048655129969120026,
-0.12245733290910721,
0.016685165464878082,
0.5449188947677612,
0.012826705351471901,
-0.6334462761878967,
0.11840342730283737,
-0.11392248421907425,
0.471757173538208,
-0.5548122525215149,
-0.33755096793174744,
0.43607085943222046,
-0.0850406214594841,
0.05899004638195038,
-0.007996675558388233,
-0.20986336469650269,
-0.010887408629059792,
-0.05221116915345192,
-0.15113705396652222,
-0.13486230373382568,
-0.05418549105525017,
0.2837351858615875,
-0.1902172565460205,
-0.15392917394638062,
0.28494560718536377,
-0.06492006778717041,
-0.006532346364110708,
-0.05435116961598396,
-0.03149528428912163,
0.39386850595474243,
-0.0908893272280693,
-0.2854253053665161,
-0.23069216310977936,
0.3855791687965393,
-0.28076788783073425,
0.09926382452249527,
0.4908950924873352,
-0.2800104320049286,
0.4589255750179291,
0.20969398319721222,
-0.3555930256843567,
-0.01806601695716381,
0.08123022317886353,
-0.2806980013847351,
-0.05867738649249077,
0.09674429148435593,
0.06269098073244095,
-0.13070335984230042,
-0.12128246575593948,
0.0010421279584988952,
0.01110690925270319,
0.051034923642873764,
-0.03754644840955734,
-0.4303804636001587,
0.3658187985420227,
0.19328418374061584,
-0.12385205179452896,
0.19957394897937775,
0.41688865423202515,
-0.14757797122001648,
0.060350753366947174,
-0.08074147254228592,
-0.07807089388370514,
-0.10240517556667328,
-0.3873087167739868,
-0.21008183062076569,
0.12994106113910675,
-0.052391208708286285,
-0.25478866696357727,
0.010189974680542946,
0.045242149382829666,
0.3032752275466919,
0.09346383064985275,
-0.10604608058929443,
0.13915246725082397,
0.04710906744003296,
-0.3065143823623657,
-0.06972275674343109,
-0.02727564424276352,
0.3048751950263977,
0.019937897101044655,
0.062140271067619324,
-0.05151688680052757,
-0.030251111835241318,
-0.007261486258357763,
0.25076866149902344,
-0.20965339243412018,
0.05786266177892685,
0.15048828721046448,
0.10543891787528992,
-0.08870105445384979
] |
|
NCT06780345
|
Role of Vitamin C Infusion in Postoperative Mechanically Ventilated Neonates With Sepsis
|
This study aims to evaluate the effect of intravenous vitamin C infusion on septic mechanically ventilated full-term neonates who underwent surgical interventions regarding mechanical ventilation parameters, time to wean, and the need for inotropic support.
|
Neonatal sepsis is a syndrome featuring non-specific signs and symptoms of systemic infection accompanied by bacteremia in the first 28 days of extrauterine life. This condition is a public health problem that still contributes to mortality and morbidity in neonatal intensive care units (NICUs) in high, as well as low- and middle-income countries.
Vitamins are essential micronutrients with key roles in many biological pathways relevant to sepsis. Some of these relevant biological mechanisms include antioxidant and anti-inflammatory effects, protein and hormone synthesis, energy generation, and regulation of gene transcription.
Vitamin C, ascorbic acid, is a water-soluble essential micronutrient commonly found in plants, especially fruits. When absorbed, it dissociates at physiological pH to form ascorbate, the redox state of the vitamin most commonly found in cells. In addition to being a potent antioxidant, vitamin C is a cofactor for enzymes involved in protein and hormone synthesis, metabolic pathways for energy generation, and regulation of gene transcription.
|
Inclusion Criteria:
* Age more than 37 weeks.
* Both sexes.
* Neonates with sepsis are diagnosed both clinically and serologically after any surgical intervention.
Exclusion Criteria:
* Major congenital anomalies and Chromosomal abnormalities.
* neonate \<37weeks gestation.
* Hypoxic Ischemic Encephalopathy (HIE).
* Neuromuscular diseases.
* Intraventricular hemorrhage (IV Hge).
|
[
-1.0639287233352661,
3.018784761428833,
-3.024428606033325,
-4.922303676605225,
-0.4778729975223541,
-0.6566564440727234,
1.04109787940979,
1.5938369035720825,
-2.97916579246521,
1.114663004875183,
0.3051706552505493,
1.3654851913452148,
-0.6283650994300842,
1.6904996633529663,
-0.8755828738212585,
0.5892572402954102,
-1.7382248640060425,
0.6216623783111572,
0.8869922757148743,
-0.8539209365844727,
0.6186907291412354,
-0.35672131180763245,
0.223414808511734,
1.3300845623016357,
1.6802624464035034,
0.23015925288200378,
-0.7545065879821777,
0.4554116129875183,
0.8772090673446655,
-0.09979911148548126,
0.20194312930107117,
-2.375074625015259,
-0.4849516451358795,
1.7928884029388428,
-0.49055036902427673,
0.05573638156056404,
0.2649843096733093,
1.6136599779129028,
-0.5199888348579407,
0.1895524263381958,
1.1081513166427612,
0.8491390347480774,
0.09408342838287354,
0.03304966166615486,
-0.35820257663726807,
1.1601790189743042,
1.7329868078231812,
-0.022933032363653183,
0.4490491449832916,
0.017548993229866028,
-0.8087283968925476,
0.9012266397476196,
0.06648406386375427,
-0.9312509298324585,
0.49367499351501465,
1.184981346130371,
0.9455658197402954,
0.13131950795650482,
0.4432520866394043,
0.09588512033224106,
0.7361699342727661,
-0.4430595338344574,
0.8467092514038086,
-0.364884614944458,
-0.5754192471504211,
-0.5317085981369019,
0.26766398549079895,
0.7544505000114441,
-1.4919707775115967,
2.0116684436798096,
0.9637051224708557,
0.7350155711174011,
-0.23205161094665527,
0.09368574619293213,
0.21896088123321533,
0.5954008102416992,
-0.17446225881576538,
1.6663028001785278,
-0.5718750357627869,
1.012534737586975,
0.17773136496543884,
-0.02826262079179287,
-0.3189730942249298,
0.6698015332221985,
-0.699445903301239,
-0.1827002465724945,
-0.9958152174949646,
-0.40963292121887207,
1.443731665611267,
-0.7474706172943115,
0.04546373337507248,
-0.7094553709030151,
-1.6878297328948975,
-0.3534700870513916,
-0.8748593926429749,
0.3644859790802002,
0.2922683656215668,
0.018175184726715088,
-1.7774522304534912,
0.09797707945108414,
-0.2579866051673889,
-0.3403736650943756,
0.16755084693431854,
0.6943009495735168,
-0.18351437151432037,
-0.137880340218544,
0.21001330018043518,
-0.15158134698867798,
-0.34999510645866394,
0.07560965418815613,
0.4476509094238281,
-0.531358003616333,
0.8302584886550903,
-0.5658038258552551,
-0.6685683131217957,
0.5306505560874939,
-0.172384113073349,
-0.07600340247154236,
1.1469255685806274,
-0.6168234348297119,
0.9453474283218384,
1.102187156677246,
0.3524430990219116,
0.15482087433338165,
-1.369038462638855,
0.3603861331939697,
-0.4054919481277466,
0.9532955884933472,
0.11421564221382141,
-1.1550101041793823,
-0.009408221580088139,
1.126581072807312,
1.0444468259811401,
-0.46848952770233154,
-1.1807960271835327,
0.47669216990470886,
0.7893598675727844,
-0.7223093509674072,
-0.04550028219819069,
-0.38064661622047424,
0.8580164909362793,
0.5651904344558716,
-0.13549083471298218,
-0.20621757209300995,
-0.9613557457923889,
-0.6272304654121399,
-0.049981921911239624,
0.4002839922904968,
-1.1724052429199219,
-0.3540761172771454,
-0.3876808285713196,
0.4254187345504761,
1.1727120876312256,
0.3103707730770111,
0.0991475060582161,
0.7278692126274109,
0.47537997364997864,
-0.6096781492233276,
-0.09975557774305344,
-0.6899937391281128,
-0.40135660767555237,
0.6042000651359558,
-0.6093491911888123,
-0.5511301159858704,
0.9615873694419861,
-0.40017908811569214,
-0.6927378177642822,
-0.2221849262714386,
0.4378862679004669,
0.5465152859687805,
-0.3615298569202423,
0.7221261858940125,
-0.15648242831230164,
0.1612376570701599,
-0.8681408762931824,
0.14093521237373352,
0.1991717368364334,
-0.9146983623504639,
-0.3102850019931793,
-0.2038007378578186,
0.0527268685400486,
-0.47657129168510437,
0.13909278810024261,
0.583955705165863,
-0.008441464975476265,
0.10336069762706757,
0.6450347304344177,
-0.17758631706237793,
0.3887154459953308,
0.23563356697559357,
0.3248000741004944,
-0.8346623182296753,
-0.5566630363464355,
0.08586160838603973,
-0.05112635716795921,
0.8162909746170044,
-0.5639035105705261,
0.1952996850013733,
0.31258681416511536,
-0.4665549099445343,
0.2230149209499359,
0.6661561727523804,
-0.49798521399497986,
0.050356172025203705,
0.4189053475856781,
0.21288813650608063,
0.26916831731796265,
0.23790383338928223,
-0.69326251745224,
0.5631381273269653,
0.07509104907512665,
-0.6907318830490112,
-0.9272586703300476,
0.434952974319458,
-0.12257640808820724,
0.21602661907672882,
0.11696673184633255,
-0.07588010281324387,
-0.18999268114566803,
-0.18681253492832184,
-0.01922851800918579,
-0.2143876850605011,
0.03441733866930008,
-0.00727746170014143,
-0.058759547770023346,
-0.44591328501701355,
-0.1454259753227234,
0.0019885562360286713,
-0.14188173413276672,
-0.3334944546222687,
0.4557173252105713,
0.22643284499645233,
-0.3602352440357208,
0.4506598114967346,
-0.06542754173278809,
0.2778572142124176,
0.6053141951560974,
0.27232256531715393,
-0.15505914390087128,
-0.0054385000839829445,
0.45860734581947327,
-0.4875936806201935,
0.14575669169425964,
-0.2879248857498169,
-0.45175081491470337,
-0.2027037888765335,
0.13622155785560608,
-0.3819323480129242,
0.3680272698402405,
0.04108922556042671,
0.0525205098092556,
-0.4579659402370453,
0.21333293616771698,
0.19213132560253143,
0.00503698643296957,
-0.5705138444900513
] |
NCT00258128
|
Effect of Salicylate on Glucose Metabolism in Insulin Resistance States
|
Data supports diet induced obesity leads to activation of the IKK/NF-kB inflamatory pathway and that chronic inflammation leads to insulin resistance and diabetes. In rodents, salicylates inhibit IKK/NF-kB and may improve insulin sensitivity. We will study if this is true in people.
|
Please see the following review articles on this topic:
Shoelson SE, Lee J, Goldfine AB. (2006) Inflammation in insulin resistance. J. Clin. Invest. 116, 1793-1801.
Goldfine AB, Fonseca V and Shoelson SE (2010) Therapeutic approaches to target inflammation in type 2 diabetes. Clin Chem. 57, 162-167.
Donath MY and Shoelson SE (2011) Type 2 diabetes as an inflammatory disease. Nat Rev Immunol. 11, 98-107.
Goldfine AB and Shoelson SE (2017) Therapeutic approaches targeting inflammation for diabetes and associated cardiovascular risk. J Clin Invest. 127, 83-93.
|
Inclusion Criteria:
age 18 to 65 years, inclusive; HbA1c \>6.0% (off medication-diabetic) normal hemoglobin and hematocrit, without donation of blood in the previous 2 months; without involvement in any study evaluating an investigational drug or device for the previous 2 months; normal clotting studies; female postmenopausal or surgically sterile, or using barrier or oral contraception and with a negative pregnancy test.
Exclusion Criteria:
pregnant or lactating women; patients with persistent ketonuria or a history of ketoacidosis (suggesting the need for insulin therapy); current of previous use of insulin for glucose control; patients with abnormal liver function defined as elevation of bilirubin, alkaline phosphatase, ALT, AST, or GGTP more than 1.5 times the upper limit of normal; patients with kidney disease (serum creatinine \> 1.5 mg/dL) macroalbuminuria (1+ protein on a standard urine dip-stick, or \> 300 mg urinary albumin/day)- (patients with microalbuminuria will be enrolled); patients with any significant diseases or conditions, including emotional or psychiatric disorders and substance abuse, including history of binge drinking, that, in the opinion of the investigator, are likely to alter the patient's ability to complete the study; patients with metabolic acidosis (abnormal anion gap); history of gastric ulcer, dyspepsia, or upper or lower GI bleed; history of allergy to aspirin, or bleeding diathesis or currently on oral anticoagulants including warfarin, heparin, aspirin or other NSAIDs; patients with major vascular event within 6 months of screening for the study (e.g., myocardial infarction stroke, coronary artery bypass graft (CABG) surgery, angioplasty, peripheral vascular surgery); patients with chronic heart disease, or a history of myocardial infarction or stroke. Symptomatic angina pectoris or cardiac insufficiency as defined by the NYHA; classification as Functional Class III or IV; patients with HbA1C \> 13% (normal range 4-6%); patients who smoke more than one pack of cigarettes daily; patients taking treatment medications known to affect insulin sensitivity (e.g. diuretics, beta-blockers); patients taking warfarin, heparin or NSAID on a chronic basis; patients with inadequately controlled serum lipid levels (total cholesterol ≥ 275 mg/dL and fasting triglycerides ≥ 450 mg/dL); patients with history of cancer within 5 years prior to screening for the study other than basal cell carcinoma; active alcohol or other substance abuse.
|
[
1.178179144859314,
0.42898663878440857,
-2.7355782985687256,
-4.977706432342529,
2.1505162715911865,
-1.439382791519165,
-1.03118896484375,
-0.701513409614563,
1.6116324663162231,
-0.564869225025177,
2.223602294921875,
1.5435874462127686,
-0.6326175928115845,
1.2200324535369873,
1.1608431339263916,
0.15218275785446167,
-0.2886185944080353,
-0.03462783992290497,
1.063356637954712,
-0.10934317111968994,
2.2937769889831543,
1.3123098611831665,
-0.38612619042396545,
0.9934440851211548,
1.932113766670227,
-0.010093677788972855,
-1.850823163986206,
2.42441463470459,
0.20759166777133942,
2.0729176998138428,
-0.7951034307479858,
-2.444211721420288,
0.13228385150432587,
0.1589299440383911,
0.98607337474823,
-1.0492149591445923,
1.539751410484314,
-0.06005113199353218,
-2.4239444732666016,
0.3663645088672638,
1.017923355102539,
0.506773829460144,
0.5659154653549194,
-0.09829792380332947,
0.020621849223971367,
-0.7157261371612549,
2.2236862182617188,
0.1718815565109253,
0.2069009244441986,
1.0524511337280273,
-1.5672574043273926,
2.5992233753204346,
-1.0716488361358643,
-0.6216972470283508,
2.1322338581085205,
0.2824961841106415,
-0.8703094124794006,
0.999025821685791,
0.4510550796985626,
-0.7440052032470703,
-0.3772438168525696,
-0.3694831430912018,
-0.49071091413497925,
0.5610916614532471,
0.37451672554016113,
-2.683061122894287,
0.2963634431362152,
0.5559843182563782,
-0.5567437410354614,
-1.0216447114944458,
-1.2267136573791504,
-1.568223476409912,
0.10909855365753174,
0.3290489614009857,
-0.3370470404624939,
0.18490196764469147,
0.48363009095191956,
0.7055891752243042,
0.1324090212583542,
1.3253296613693237,
-1.4409821033477783,
-0.7130662202835083,
-0.5023701786994934,
0.011403871700167656,
-0.1833714097738266,
-0.32179468870162964,
-0.34614649415016174,
-0.8863188028335571,
0.4389190673828125,
-0.3370862603187561,
1.1903507709503174,
-2.8230252265930176,
-0.25837332010269165,
-0.4736117720603943,
-1.0509624481201172,
0.0029790836852043867,
-0.2472427934408188,
0.9372559785842896,
-0.8927908539772034,
-1.0840007066726685,
-1.2395573854446411,
0.05276556685566902,
-0.5603312253952026,
0.35849037766456604,
1.3754091262817383,
0.8982226252555847,
0.11977450549602509,
-0.23751509189605713,
-0.5010544657707214,
-0.9157735109329224,
0.6371750235557556,
-1.034557819366455,
0.44994494318962097,
0.4772263765335083,
-0.004437514115124941,
0.012351641431450844,
0.3464009761810303,
0.32459765672683716,
0.4600152373313904,
-0.5178818106651306,
-0.3382241129875183,
-0.4283732771873474,
-0.438780814409256,
0.5583855509757996,
-0.029359959065914154,
-0.6733450889587402,
0.39429575204849243,
0.5977688431739807,
-0.7717267870903015,
-0.46294036507606506,
0.6322697401046753,
0.014523478224873543,
0.4887293577194214,
-0.8259901404380798,
-0.2645726203918457,
-0.38890430331230164,
0.023412134498357773,
0.13708165287971497,
-0.035430293530225754,
0.269634872674942,
-0.7404423356056213,
-0.2343529462814331,
-0.23778922855854034,
0.3382840156555176,
-1.3660968542099,
-0.7145302295684814,
0.7111520171165466,
0.0227231215685606,
-0.04201890900731087,
0.3143118619918823,
1.0337679386138916,
0.827336311340332,
1.3353396654129028,
0.15236105024814606,
-0.3492368757724762,
0.09040527045726776,
-0.04815128073096275,
-0.9156776666641235,
-0.4238571226596832,
0.6306708455085754,
-0.02270662784576416,
0.41919538378715515,
-0.6391358971595764,
-0.7624083161354065,
0.6089974641799927,
0.3953312933444977,
-0.04415537789463997,
-0.3227156102657318,
0.1020776703953743,
-0.1896720677614212,
-0.1192435771226883,
0.010692556388676167,
-0.41456136107444763,
0.14426620304584503,
-0.4298746585845947,
0.14862395823001862,
1.059601068496704,
-0.020810376852750778,
0.11531709879636765,
-0.7229056358337402,
-0.17616455256938934,
-0.6299858689308167,
-0.07312168926000595,
-0.7416414618492126,
0.5374703407287598,
0.299896776676178,
-0.5370810627937317,
-0.5675187110900879,
0.2561793923377991,
-0.4894227683544159,
0.41923922300338745,
0.24378351867198944,
-0.5756592750549316,
0.4783366620540619,
0.1729569137096405,
0.24716517329216003,
-0.11944831162691116,
0.11673840880393982,
0.08528171479701996,
-0.09405752271413803,
0.4273700714111328,
0.13353587687015533,
0.09914327412843704,
0.3727771043777466,
-0.1589844524860382,
-0.006002194248139858,
-0.25798913836479187,
0.16461805999279022,
-0.22778256237506866,
0.2066752314567566,
-0.40861669182777405,
0.16156572103500366,
-0.5560399889945984,
-0.13265755772590637,
0.08877990394830704,
-0.528062641620636,
-0.7511875033378601,
0.4301658570766449,
0.4086035192012787,
0.18328963220119476,
-0.08068328350782394,
0.525054395198822,
0.1364452987909317,
-0.667582631111145,
-0.6943055391311646,
-0.19679778814315796,
0.6366929411888123,
0.1122967004776001,
-0.021375594660639763,
0.047015152871608734,
-0.12462902069091797,
-0.10999517142772675,
-0.2971094250679016,
0.21279276907444,
-0.21128806471824646,
-0.25822344422340393,
0.2830389440059662,
-0.04177982732653618,
-0.09129789471626282,
0.27168428897857666,
0.10740813612937927,
-0.9766817092895508,
-0.5875336527824402,
0.6070716381072998,
0.4661213457584381,
-0.7272225022315979,
-0.32874181866645813,
0.10322272032499313,
0.2775225341320038,
0.1992686688899994,
-0.7400463819503784,
-0.3174801170825958,
-0.016412392258644104,
-0.1528184711933136,
0.4547707736492157,
-0.233175590634346
] |
NCT04467905
|
ReVeRA-201: Etripamil in Atrial Fibrillation, Phase 2
|
Many patients with atrial fibrillation (AF) experience persistent tachycardia with episodes of rapid ventricular rate despite chronic treatment to reduce ventricular rate. The objectives of this study were to demonstrate the superiority of a nasal spray of etripamil over placebo in reducing ventricular rate in patients with AF; and to evaluate the safety and efficacy of etripamil nasal spray in participants with AF.
|
This was a multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil nasal spray in participants with AF. This study included Screening, the Treatment Period (Screening and Treatment Period occur on the same day) and safety follow-up procedures.
Each participant received placebo or 70 mg of etripamil intranasally; treatment were randomized in a 1:1 ratio, to yield 50 evaluable participants with AF in 2 groups of 25.
Participants with AF were selected by the Investigator. The screening procedures included obtaining informed consent, a review of inclusion/exclusion criteria, a complete physical examination, and recording of any concomitant medications.
After screening procedures were complete, eligible participants were randomized to receive etripamil or placebo. Heart rate was measured continuously via Holter Electrocardiogram (ECG) from at least 10 minutes prior to dosing to 6 hours after study drug administration. Participants had to exhibit a rapid ventricular rate (≥110 bpm measured during 1 minute) on the Holter report prior to drug administration in order to receive the study drug. Beyond 60 minutes after study drug administration, medical care was offered in accordance with the standard of care and the participant was discharged from the clinic, while still wearing the Holter device.
Participants underwent a safety follow-up assessment and return the Holter device approximately 24 hours post-dose. Participants were contacted by phone 7 days post-dosing for safety follow-up.
|
Inclusion Criteria:
A participant was eligible for study participation if they met all of the following criteria:
1. Aged 18 years and over.
2. Provided written informed consent.
3. Participants with episodes of paroxysmal, persistent or permanent AF, presenting with AF and a ventricular rate ≥110 bpm, measured over 1 minute
4. Participants received appropriate antithrombotic therapy as per the applicable guidelines for atrial fibrillation management (e.g., Canadian Cardiovascular Society (CCS) guidelines / European Society of Cardiology (ESC) guidelines).
1. Etripamil (a calcium channel blocker) was intended for acute rate control only. If rhythm control was desired (outside of the present protocol), anticoagulation as per guidelines could be started after the administration of study drug.
Exclusion Criteria:
A participant was excluded from the study if they met any of the following criteria:
1. Had evidence of atrial flutter (ECG) at presentation.
2. Had a history of stroke, transient ischemic attack (TIA) or peripheral embolism within the last 3 months.
3. Had received by IV route any of the following within one hour before study drug administration: flecainide, procainamide, digoxin, beta-blocker, or calcium channel blocker.
4. Had signs and symptoms of severe congestive heart failure at presentation (e.g. tachypnea, oxygen desaturation \<90% unless due to known pulmonary disease, pulmonary rales, sign of peripheral hypoperfusion).
5. Hemodynamic instability, with systolic blood pressure \<90 mmHg or diastolic blood pressure \<60 mmHg.
6. Known uncorrected severe aortic or mitral stenosis.
7. Hypertrophic cardiomyopathy with outflow tract obstruction.
8. Had a history of second- or third-degree atrioventricular block.
9. Regular rhythm suggesting a complete atrioventricular block.
10. Had a history or evidence of torsades de pointes, sick sinus syndrome, or Brugada syndrome.
11. Evidence of acute coronary syndrome within the last 12 months except if participant was successfully revascularized.
12. Positive pregnancy test result at screening, and females of childbearing potential who did not agree to use adequate method of contraception for the duration of the study.
13. Had evidence of any clinically significant acute or chronic condition of the nasal cavity (e.g., rhinitis or deviated septum) which could have interfered with administration of the study drug in either or both nasal cavities.
14. Had a history of sensitivity to verapamil.
15. Had previously participated in a clinical study for etripamil.
16. Had a history of sensitivity to any components of the investigational product.
17. Had signs of alcohol or drug intoxication at the time of presentation which, in the opinion of the Investigator, would have impacted the validity of study results.
18. Was participating in another drug or device study, or had received an investigational drug or device within 30 days of Screening.
19. Had evidence of clinically significant cardiovascular, endocrine, gastrointestinal, hematologic, hepatic, immunologic, neurologic, oncologic, pulmonary, psychiatric, or renal disease or any other condition which, in the opinion of the Investigator, would have jeopardized the safety of the participant or impacted the validity of study results.
|
[
-0.9351587295532227,
1.8924658298492432,
-0.408581405878067,
-4.541823387145996,
-0.2356654852628708,
-1.256474256515503,
1.3634833097457886,
1.1289992332458496,
-1.906726360321045,
0.3964768648147583,
0.5568219423294067,
1.0359569787979126,
-1.7854349613189697,
0.9497883319854736,
1.1875356435775757,
1.7124977111816406,
-1.8352645635604858,
0.7869004607200623,
2.3238959312438965,
-0.19398233294487,
-0.5740180611610413,
-1.2562718391418457,
0.5122831463813782,
1.339123249053955,
0.7664822936058044,
-0.4274744987487793,
-1.611604928970337,
0.14874941110610962,
0.7944881319999695,
1.2424489259719849,
1.3093205690383911,
-1.5085755586624146,
0.016977202147245407,
0.8954092264175415,
-0.02834226004779339,
-1.0170634984970093,
-0.24053002893924713,
1.501009225845337,
0.046554144471883774,
-1.2898337841033936,
-0.2373119443655014,
-0.004039661958813667,
-0.13158045709133148,
-0.7510237693786621,
1.8500608205795288,
1.423232913017273,
-0.8640502691268921,
-0.49267950654029846,
-0.6129041910171509,
-1.0931941270828247,
-0.5185135006904602,
0.8920547366142273,
0.25465330481529236,
-0.8002258539199829,
1.5883103609085083,
0.19415982067584991,
0.8646700382232666,
1.1880687475204468,
0.4052805006504059,
0.30045053362846375,
0.4150632321834564,
-0.5287214517593384,
-0.8196329474449158,
0.4023789167404175,
-0.6777281165122986,
1.158348560333252,
-0.5154596567153931,
0.25418776273727417,
-0.7660008668899536,
1.0708755254745483,
0.5160048604011536,
1.4608778953552246,
0.2743557393550873,
0.37301701307296753,
-0.40231701731681824,
-0.04826729744672775,
-0.04889167472720146,
1.0065176486968994,
0.28228166699409485,
0.13872942328453064,
-1.3985460996627808,
0.12468533217906952,
0.031237991526722908,
-0.584460973739624,
0.055818185210227966,
-0.8004645705223083,
-0.8225363492965698,
0.2662161886692047,
0.44337669014930725,
-1.092312216758728,
-1.0653156042099,
-1.010900855064392,
-1.3610918521881104,
0.9691729545593262,
-1.0180575847625732,
0.491916686296463,
0.6594582200050354,
-0.4554789662361145,
-1.8052111864089966,
-0.9121545553207397,
-0.012279077433049679,
0.5634979009628296,
0.08972208946943283,
0.1711481511592865,
0.3032868802547455,
0.8867762088775635,
-1.3350435495376587,
-1.417310118675232,
-0.17630210518836975,
-1.0706712007522583,
1.0535457134246826,
-0.89110267162323,
1.3281240463256836,
0.10001299530267715,
0.2784252464771271,
0.14038784801959991,
1.405199408531189,
-0.31518375873565674,
0.03608459606766701,
0.6939906477928162,
-0.9851027727127075,
0.630886435508728,
0.6331502795219421,
0.9607541561126709,
0.5506043434143066,
-0.6665752530097961,
0.5265998244285583,
1.894118070602417,
-0.25609278678894043,
-0.62457674741745,
-0.02451058104634285,
0.33622050285339355,
-0.2004193216562271,
-0.10890331119298935,
-1.6489580869674683,
0.12354296445846558,
0.38960814476013184,
1.171515941619873,
-0.6579992175102234,
-1.2800042629241943,
-0.27377864718437195,
0.7053586840629578,
-0.6359759569168091,
-0.002447697101160884,
-1.0403965711593628,
0.031641483306884766,
-0.7968448400497437,
0.10080078989267349,
-1.9253960847854614,
-0.2533073425292969,
-0.23561635613441467,
-0.07569923251867294,
0.21825635433197021,
0.4123214781284332,
0.037746209651231766,
0.31154122948646545,
0.7773783802986145,
-0.6125052571296692,
0.3413621783256531,
-0.12281759828329086,
-0.2537735402584076,
-0.1390058845281601,
-0.3730855882167816,
-0.2732560634613037,
0.058922022581100464,
-0.6398621797561646,
-0.4674650728702545,
0.2941393256187439,
-0.054537445306777954,
0.4800214171409607,
-0.7948132157325745,
0.46504655480384827,
-0.5824280381202698,
-0.13708046078681946,
-0.707225501537323,
-0.3250514566898346,
0.9285292625427246,
0.17052334547042847,
-0.1015218198299408,
0.3702951669692993,
0.2112153321504593,
-0.03600073605775833,
-0.779029905796051,
1.099693775177002,
-0.6019583344459534,
-0.8094304203987122,
-0.06550723314285278,
0.5877264738082886,
0.6209943890571594,
-0.08437122404575348,
-0.5240657329559326,
-0.19646690785884857,
-0.08544821292161942,
0.21444028615951538,
0.2823706269264221,
-0.004272881429642439,
-0.20423464477062225,
0.21483123302459717,
0.3211357593536377,
-0.43582218885421753,
-0.04146778583526611,
-0.13245359063148499,
0.33499348163604736,
0.19186745584011078,
-0.8040157556533813,
-0.39595717191696167,
0.36729753017425537,
-0.1548183709383011,
-0.9449896812438965,
0.6084797382354736,
0.30638229846954346,
0.052339185029268265,
0.3109060525894165,
-0.39316630363464355,
0.8183099031448364,
0.6067455410957336,
0.14937041699886322,
-0.0847298875451088,
-0.6670028567314148,
-0.10922370851039886,
-0.24125513434410095,
-0.545896053314209,
0.7325111031532288,
0.26169276237487793,
0.17742474377155304,
0.48281294107437134,
-0.0758499726653099,
-0.4434082508087158,
0.640179455280304,
0.14054003357887268,
-0.4155486524105072,
0.45336300134658813,
-0.3990357518196106,
-0.07028615474700928,
0.19359128177165985,
0.25562646985054016,
0.06466231495141983,
0.07693512737751007,
0.012019837275147438,
0.19251590967178345,
0.457319974899292,
-0.4627836048603058,
0.1903049200773239,
-0.11770394444465637,
0.5247530341148376,
-0.5951207280158997,
0.09621882438659668,
0.354470431804657,
-0.1508757472038269,
0.29149129986763,
-0.41035154461860657,
-0.02875305339694023,
0.01793115958571434,
-0.14984744787216187,
0.2591277062892914,
0.02959771454334259
] |
NCT05542940
|
P53 Immunohistochemistry Abnormal Staining in Endometrial Cancer
|
Objective: Calculate the incidence of P53 immunohistochemistry abnormal staining in endometrial cancer and to identify its relation with disease stages, pathological types and grading.
Patients and methods:
100 cases of endometrial cancer will be included in the study, recruited from Alexandria university hospital gyne-oncology unit. Surgical staging, histopathological examination and immunohistochemistry of p53 were done to all cases to calculate the incidence of P53 immunohistochemistry abnormal staining in endometrial cancer and to identify its relation with disease stages, pathological types, grading.
Keywords: P53 immunohistochemistry, endometrial cancer, clinicopathological relation.
|
Inclusion Criteria:
* endometrial cancer patients
Exclusion Criteria:
* patients unfit for surgery
|
[
1.8586230278015137,
0.653931736946106,
-4.316744327545166,
-0.8442603945732117,
-0.8106256723403931,
-2.425999402999878,
0.9373587965965271,
-0.6778462529182434,
-2.6209065914154053,
1.6336798667907715,
-0.10283719003200531,
1.8484790325164795,
1.3559530973434448,
1.0015861988067627,
-0.3593224585056305,
0.3991543650627136,
0.589522659778595,
0.17456960678100586,
1.763842225074768,
-1.663495659828186,
0.4579903185367584,
-2.6212668418884277,
0.4873194098472595,
0.2598658502101898,
0.8432220220565796,
-0.5609604716300964,
-1.0614362955093384,
1.2527841329574585,
-0.33134955167770386,
1.3929378986358643,
-0.8212472796440125,
0.43911218643188477,
-0.1181081160902977,
-0.6486903429031372,
-0.20825175940990448,
0.1788642555475235,
1.1922889947891235,
-1.436496615409851,
-1.5418752431869507,
0.826626718044281,
0.4023432433605194,
0.156488299369812,
-0.06298784911632538,
-1.066449761390686,
-0.5532817840576172,
-0.589641273021698,
-0.4080730378627777,
0.37153998017311096,
0.21875767409801483,
1.7172945737838745,
-1.7126975059509277,
0.5892024040222168,
-2.3455872535705566,
0.06958752870559692,
1.4320886135101318,
1.082228660583496,
-0.13603028655052185,
0.5611585974693298,
1.1135311126708984,
-0.9807594418525696,
0.4101578891277313,
-1.1885446310043335,
0.36076605319976807,
-0.6189339756965637,
-0.8653407692909241,
-0.044621650129556656,
-0.8209637999534607,
0.011942129582166672,
0.5422643423080444,
-0.48537591099739075,
0.8529255986213684,
0.8108353018760681,
0.5345299243927002,
-0.12696094810962677,
1.560336709022522,
2.283783435821533,
-0.8258644342422485,
-0.36980536580085754,
-0.16910657286643982,
0.23927292227745056,
0.13419315218925476,
-1.1718956232070923,
-2.674205780029297,
0.34155455231666565,
0.07142076641321182,
0.034652139991521835,
-1.1756943464279175,
-1.1946438550949097,
-0.18500426411628723,
-1.1633505821228027,
1.0142704248428345,
-0.18200452625751495,
-0.8009541034698486,
1.6322978734970093,
-0.382343053817749,
1.5955945253372192,
0.43777501583099365,
-0.22126136720180511,
-1.522024154663086,
-0.18094341456890106,
-0.4303083121776581,
-0.20688794553279877,
0.08261194825172424,
-0.2121237963438034,
-0.05526150017976761,
-0.9156686663627625,
-0.3575572073459625,
-0.39451855421066284,
-1.343436360359192,
-0.9128462672233582,
1.4368548393249512,
0.06198428198695183,
-0.29049795866012573,
-0.4205157160758972,
-1.163962483406067,
-0.5328071117401123,
0.6035206317901611,
-0.3570114076137543,
0.7686452269554138,
0.3187427818775177,
-0.10372294485569,
1.3888174295425415,
-0.24526529014110565,
0.19336186349391937,
0.1703779548406601,
-0.13770993053913116,
-0.5712422728538513,
-0.24812419712543488,
0.0008082099375315011,
-0.829917848110199,
-0.9485084414482117,
0.7781301736831665,
0.19071456789970398,
0.34845486283302307,
-0.4999780058860779,
-0.8796741962432861,
-0.3709839880466461,
1.5512808561325073,
0.4115833342075348,
0.09583552926778793,
-0.22659443318843842,
-0.430448055267334,
-0.10771416127681732,
0.261524498462677,
-1.1883490085601807,
0.34064674377441406,
-0.6019448041915894,
1.0385323762893677,
0.03561875969171524,
-0.5623506307601929,
0.8696373701095581,
-0.07215908169746399,
0.9577374458312988,
-0.20127977430820465,
0.45449984073638916,
0.256999135017395,
-0.20952728390693665,
-0.034058477729558945,
0.1738177239894867,
0.44109010696411133,
-0.4442495107650757,
0.1904822289943695,
-0.8636665344238281,
0.05124531686306,
0.1888953298330307,
-0.11521763354539871,
-0.054647695273160934,
-0.14316868782043457,
-0.0009511559037491679,
0.6414046287536621,
-0.3289823532104492,
0.1049809530377388,
0.2214578092098236,
0.3488149344921112,
-1.1797651052474976,
0.07856437563896179,
0.23477746546268463,
0.915604829788208,
-0.44928595423698425,
-0.6116185188293457,
-0.0093352310359478,
0.659315824508667,
0.9154935479164124,
-0.07237022370100021,
-0.43032073974609375,
0.6941030621528625,
-0.29034438729286194,
0.09009405970573425,
-0.10326946526765823,
-0.02477809228003025,
0.5075327754020691,
-0.052093256264925,
0.14383137226104736,
0.4456624686717987,
0.15031607449054718,
0.036917176097631454,
0.19148384034633636,
0.0761658102273941,
0.28847524523735046,
0.3429824411869049,
0.20511285960674286,
-0.06152699515223503,
-0.26577866077423096,
0.32429075241088867,
-0.07737557590007782,
-1.0196024179458618,
0.23668421804904938,
0.1816614419221878,
-0.5208583474159241,
0.10332389175891876,
-0.4267873764038086,
-0.4357210099697113,
0.3425442576408386,
0.16380919516086578,
0.19553089141845703,
0.23712532222270966,
0.0831666886806488,
0.07175453007221222,
-1.2424185276031494,
-0.2595142722129822,
0.05762479826807976,
0.014401514083147049,
-0.15660594403743744,
0.2364780753850937,
-0.5461901426315308,
-0.11737325042486191,
-0.14734171330928802,
0.5552394986152649,
0.766278862953186,
-0.26600027084350586,
-0.07574833929538727,
0.5679107308387756,
-0.3034857213497162,
-0.048032402992248535,
0.04304010421037674,
-0.13984787464141846,
0.32426995038986206,
-0.21862651407718658,
0.06794596463441849,
0.22102659940719604,
-0.1716650426387787,
0.09370916336774826,
-0.2980036437511444,
-0.05108245834708214,
-0.26351824402809143,
-0.0978671982884407,
0.11171205341815948,
-0.22075627744197845,
0.39529287815093994,
0.18612942099571228,
-1.0320583581924438,
0.07541099190711975,
0.5941435098648071,
-0.04103786498308182,
-0.024362538009881973,
-0.6522607207298279
] |
|
NCT05837689
|
Minimal Residual Disease Quantification by Next-generation Sequencing in Pediatric B-ALL Children Patients Treated With Blinatumomab Consolidation
|
A retrospective analysis to investigate pediatric B-cell acute lymphoblastic leukemia patients who were treated with blinatumomab for consolidation, and who were detected as minimal residual disease (MRD) positive by next generation sequencing (NGS). The efficacy of blinatumomab clearing MRD detected by NGS will be analyzed, in order to see the potential of using NGS to guide MRD eradication by blinatumomab.
|
Inclusion Criteria:
* Patients diagnosed with B cell precursor acute lymphoblastic leukemia
* Patients who received blinatumomab for consolidation
* Patients who were detected MRD positive by NGS before initiation of blinatumomab treatment
Exclusion Criteria:
* Patients without data of NGS detection after receiving blinatumomab treatment
|
[
0.3726094663143158,
1.1235629320144653,
-1.2048001289367676,
-0.7149810791015625,
1.3653984069824219,
-0.3425575792789459,
-0.6931165456771851,
-0.17603656649589539,
-0.5445414781570435,
-0.02962382324039936,
0.38182348012924194,
0.4323132336139679,
-0.9655817747116089,
0.59909588098526,
0.9314168095588684,
-0.46242907643318176,
-2.814203977584839,
1.6567294597625732,
1.1633903980255127,
-1.7943676710128784,
1.628775954246521,
-3.3301539421081543,
-0.020806679502129555,
-1.079269528388977,
1.1758712530136108,
-0.0957973524928093,
1.568013310432434,
2.436648368835449,
-0.7379277348518372,
0.5910952091217041,
0.5788699388504028,
-0.12065692245960236,
-0.011864222586154938,
-0.366741418838501,
1.040453553199768,
0.5704471468925476,
0.614983081817627,
0.23091626167297363,
-0.9813693761825562,
0.25574663281440735,
-1.9360871315002441,
-0.40601634979248047,
-0.8335436582565308,
1.9687098264694214,
-0.7102655172348022,
-0.34382936358451843,
0.05258616432547569,
0.8210294842720032,
1.8831779956817627,
-0.16854001581668854,
-0.5945549011230469,
1.5592855215072632,
-0.49527835845947266,
-0.5292824506759644,
0.8901435136795044,
0.6962766051292419,
1.2334259748458862,
0.8689990043640137,
1.9452378749847412,
-0.21718434989452362,
0.042782820761203766,
-1.0369436740875244,
0.879663348197937,
-0.800697386264801,
-0.47264665365219116,
-1.7331498861312866,
-1.8972883224487305,
1.2429777383804321,
-0.022162893787026405,
0.01316453330218792,
-0.681541383266449,
-0.6126886606216431,
0.7311999201774597,
-0.6127064228057861,
0.2056206315755844,
1.0867516994476318,
-0.9403784275054932,
0.24643146991729736,
0.9770815372467041,
0.7618851065635681,
0.43998655676841736,
-1.1488683223724365,
-1.12713623046875,
-0.16491428017616272,
-0.31806764006614685,
-0.7057239413261414,
-1.3041030168533325,
0.114096999168396,
-0.4046191871166229,
-1.5299746990203857,
0.2109495848417282,
0.05790169537067413,
-0.6797640919685364,
1.631009817123413,
0.3163626194000244,
0.6701757907867432,
0.10240162909030914,
-0.4304775595664978,
-0.8808956146240234,
-0.7477283477783203,
-0.24901816248893738,
-1.2849454879760742,
-0.4349517524242401,
-0.6198261380195618,
-0.7449513077735901,
0.3196091055870056,
0.5837126970291138,
-1.660887360572815,
0.19195282459259033,
0.22562691569328308,
0.04781694710254669,
-0.7540740966796875,
-0.35504522919654846,
0.11814019829034805,
0.6511812806129456,
0.11645849049091339,
0.09708736091852188,
0.260049045085907,
0.38536885380744934,
0.9725361466407776,
-0.244422048330307,
0.8457754850387573,
0.5191768407821655,
0.6192381381988525,
-0.9268832206726074,
0.2632775604724884,
0.9972504377365112,
-0.4966178834438324,
-0.4490497410297394,
-0.9738330841064453,
0.06751493364572525,
0.16722291707992554,
-0.2452583760023117,
-0.2490328699350357,
-0.9340813755989075,
0.30963632464408875,
-0.32436031103134155,
1.0838772058486938,
0.17103669047355652,
-0.18925687670707703,
0.03130943700671196,
-0.005421201232820749,
-0.20649610459804535,
0.01579829677939415,
-2.0465970039367676,
0.0008598577114753425,
-0.3029949963092804,
0.5350035429000854,
-1.4812496900558472,
-0.3951343297958374,
0.891028881072998,
0.28692737221717834,
-0.42821717262268066,
-0.07344331592321396,
0.40997225046157837,
0.29457297921180725,
0.23748260736465454,
-0.06688100844621658,
-0.12020764499902725,
0.3639816343784332,
-0.10035096108913422,
-0.6109901070594788,
0.8454912900924683,
-0.07219775766134262,
0.12778408825397491,
0.12691964209079742,
-0.7947006225585938,
-0.39050889015197754,
0.31860098242759705,
0.8957916498184204,
0.21940650045871735,
-0.2632366418838501,
0.2288791835308075,
0.4656102657318115,
-0.5887148380279541,
0.049841176718473434,
-0.385821133852005,
0.3884342908859253,
-0.22906719148159027,
-0.21911297738552094,
-0.5401700139045715,
-0.29571157693862915,
0.2709954082965851,
-0.10490112751722336,
0.6173412203788757,
0.3515680730342865,
-0.7937201261520386,
-0.38616853952407837,
0.029705246910452843,
0.4078501760959625,
0.5019620656967163,
0.030581513419747353,
0.07445807754993439,
0.1803514063358307,
0.2778978943824768,
-0.6002521514892578,
-0.34958571195602417,
-0.2068503051996231,
0.4583066701889038,
0.10006523132324219,
0.6247130036354065,
0.19866643846035004,
-0.7476353645324707,
-0.4554995596408844,
0.10176799446344376,
0.17714984714984894,
0.36455196142196655,
-0.031070781871676445,
-0.48911216855049133,
0.35986950993537903,
-0.0022784096654504538,
0.12102392315864563,
-0.4421236217021942,
0.20442132651805878,
0.07653100788593292,
-0.09544049203395844,
0.5534341335296631,
0.14465554058551788,
-0.9660062789916992,
-0.08039390295743942,
0.0320882685482502,
-0.7950001358985901,
0.10635844618082047,
-0.057684868574142456,
-0.05514606460928917,
0.2347794473171234,
0.8723742365837097,
-0.24966219067573547,
0.2697146534919739,
-0.1284627765417099,
-0.4376194477081299,
0.3994865417480469,
0.1133546307682991,
-0.012290303595364094,
0.009220128878951073,
0.31283625960350037,
0.3567925691604614,
0.21427617967128754,
-0.2417779564857483,
-0.18771220743656158,
0.4235990047454834,
-0.5311634540557861,
-0.08416491001844406,
-0.08289637416601181,
0.030599674209952354,
0.21098899841308594,
0.22686676681041718,
-0.627656102180481,
0.14936494827270508,
-0.0730837881565094,
0.31075477600097656,
0.11529752612113953,
0.34860774874687195,
0.37000396847724915,
-0.0735994353890419,
-0.05230138450860977
] |
|
NCT02194049
|
Cisplatin, Etoposide and PI3K Inhibitor BKM120 in Treating Patients With Advanced Solid Tumors or Small Cell Lung Cancer
|
This phase I trial studies the side effects and the best dose of PI3K inhibitor BKM120 when given together with cisplatin and etoposide in treating patients with advanced solid tumors or small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing , or by stopping them from spreading. PI3K inhibitor BKM120 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving PI3K inhibitor BKM120 with cisplatin and etoposide may kill more tumor cells.
|
PRIMARY OBJECTIVES:
I. To determine the safety and feasibility of combining BKM120 (PI3K inhibitor BKM120) with cisplatin and etoposide in advanced solid tumors, with emphasis on small cell lung cancer (SCLC).
SECONDARY OBJECTIVE:
I. To determine the MTD (maximally tolerated dose) of BKM120 in combination with cisplatin/etoposide.
II. To describe the dose limiting toxicities (DLT) and toxicity profile associated with BKM120 in combination with cisplatin/etoposide.
III. To determine the preliminary efficacy of BKM120 in combination with cisplatin/etoposide in an expanded cohort of patients with SCLC.
IV. To characterize the pharmacokinetic (PK) parameters of BKM120 in this combination.
V. To collect blood samples for future exploratory biomarker analysis.
OUTLINE: This is a dose-escalation study of PI3K inhibitor BKM120.
Patients receive PI3K Inhibitor BKM120 orally (PO) once daily (QD) on days 1-21, cisplatin intravenously (IV) over 2 hours on day 1 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of treatment, patients are followed for 30 days.
|
Inclusion Criteria:
* Histological or cytological proven advanced solid tumors
* =\< 3 chemotherapy regimens for metastatic disease; any number of prior targeted or biologic therapies is allowed; (in the expansion cohort, patients must be chemo naïve)
* ECOG performance status =\< 2
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
* Platelets \>= 100 x 10\^9/L
* Hemoglobin (Hb) \> 9 g/dL
* Total calcium (corrected for serum albumin) within normal limits (bisphosphonate use for malignant hypercalcemia control is not allowed)
* Magnesium \>= the lower limit of normal
* Potassium within normal limits for the institution
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within normal range (or =\< 3.0 x upper limit of normal (ULN) if liver metastases are present)
* Serum bilirubin within normal range (or =\< 1.5 x ULN if liver metastases are present; or total bilirubin =\< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)
* Serum creatinine =\< 1.5 x ULN or calculated clearance \>= 60 mL/min
* Serum albumin \>= 3 g/dl
* Serum amylase =\< ULN
* Serum lipase =\< ULN
* Fasting plasma glucose =\< 120 mg/dL (6.7 mmol/L)
* International normalized ratio (INR) =\< 2
* Ability to swallow pills
* Negative serum pregnancy test
Exclusion Criteria:
* Received prior treatment with a P13K inhibitor
* Received \> 300 mg/m\^2 of cisplatin and/or for whom cisplatin would not be beneficial
* Prior treatment with any investigational drug within the preceding 3 weeks
* Known hypersensitivity to BKM120 or to its excipients
* Untreated brain metastases are excluded
* Acute or chronic liver, renal disease or pancreatitis
* Following mood disorders as judged by the Investigator or a psychiatrist, or as a result of patient's mood assessment questionnaire
* Diarrhea \>= CTCAE grade 2
* Active cardiac disease
* History of cardiac dysfunction
* Poorly controlled diabetes mellitus or steroid-induced diabetes mellitus
* Other concurrent severe and/or uncontrolled concomitant medical conditions
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection); patients with unresolved diarrhea will be excluded as previously indicated
* Treated with any hematopoietic colony-stimulating growth factors
* Currently receiving treatment with medication with a known risk to prolong the QT interval or inducing torsades de pointes and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug
* Chronic treatment with steroids or another immunosuppressive agent
* Herbal medications and certain fruits within 7 days prior to starting study drug
* Treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug
* Intravenous chemotherapy or targeted anticancer therapy =\< 4 weeks
* Any continuous or intermittent oral small molecule therapeutics
* Received wide field radiotherapy =\< 4 weeks or limited field radiation for palliation =\< 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
* Undergone major surgery =\< 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
* Currently taking therapeutic doses of warfarin sodium or any other Coumadin-derivative anticoagulant
* Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control
* Known diagnosis of HIV infection
* History of another active malignancy
* Unable or unwilling to abide by the study protocol or cooperate fully with the investigator treatments
|
[
1.330716848373413,
1.0302097797393799,
-1.2195764780044556,
-3.960792064666748,
0.8128380179405212,
-2.2507243156433105,
-0.8943830132484436,
-1.3021082878112793,
-0.6428030133247375,
-0.009422222152352333,
-0.48997119069099426,
0.5005841851234436,
-0.05776244029402733,
-0.2237166464328766,
1.3153841495513916,
0.16141417622566223,
-0.41925206780433655,
0.9234223365783691,
0.7521840333938599,
-1.7735260725021362,
2.114755153656006,
-0.6308035850524902,
-0.3582015335559845,
-0.6256636381149292,
1.5574530363082886,
-1.2058944702148438,
0.18106284737586975,
0.9966506361961365,
2.378588914871216,
1.647655725479126,
-0.19412338733673096,
0.25231364369392395,
0.5587522387504578,
0.6347709894180298,
-0.1595000922679901,
-0.47414296865463257,
1.9167861938476562,
-0.008458903059363365,
0.4433915913105011,
1.28955078125,
0.34719544649124146,
0.779119610786438,
-0.4826076924800873,
-0.8328765034675598,
0.009247553534805775,
-0.7026361227035522,
0.2992208003997803,
0.7492037415504456,
0.745098888874054,
1.1739611625671387,
-2.021733283996582,
2.7627222537994385,
-1.46500563621521,
0.5160889029502869,
0.9359137415885925,
-0.08969482034444809,
-1.3793593645095825,
-0.49102655053138733,
1.806017518043518,
-0.4867500960826874,
-0.46844038367271423,
-0.16012808680534363,
-1.3411731719970703,
-0.1503812074661255,
-1.246910572052002,
-0.9934514164924622,
0.5060433149337769,
-1.569477915763855,
-0.6519150137901306,
-0.7202574610710144,
0.8167327642440796,
0.019972823560237885,
0.7767870426177979,
-0.251400351524353,
0.14577962458133698,
0.7190985083580017,
1.002492904663086,
1.2102959156036377,
1.4557712078094482,
0.9384892582893372,
-0.5344469547271729,
-0.8579246997833252,
0.2226007580757141,
-1.187345266342163,
-0.48836132884025574,
-0.48328155279159546,
-0.41370889544487,
-0.11899112910032272,
-0.032000042498111725,
-3.0819833278656006,
2.1084794998168945,
-0.7944242358207703,
-0.432242214679718,
1.9021222591400146,
-1.31597900390625,
0.6205655932426453,
-0.4361768066883087,
-0.1060890480875969,
0.47592589259147644,
0.16527613997459412,
0.3532991111278534,
0.5675928592681885,
-0.6766078472137451,
0.18539106845855713,
-0.45827510952949524,
-0.06921185553073883,
-0.1846313625574112,
-1.5193519592285156,
-0.1421113908290863,
-1.2081376314163208,
0.9393129944801331,
-0.692840039730072,
0.15137127041816711,
-0.27991214394569397,
0.19585895538330078,
-0.4782960116863251,
1.0200918912887573,
-0.03725286200642586,
0.10440687835216522,
-0.06600474566221237,
-0.5775659084320068,
0.02597585879266262,
-0.7437835335731506,
0.7209030389785767,
0.25099045038223267,
-0.6454236507415771,
-0.6428887248039246,
0.09763041883707047,
0.3196418881416321,
-1.008711338043213,
0.18669568002223969,
0.09498903900384903,
0.4873514175415039,
0.19565145671367645,
-0.22365066409111023,
-0.9225822687149048,
0.46532583236694336,
1.1204150915145874,
0.7686862349510193,
0.12675628066062927,
0.9650800824165344,
0.19000279903411865,
0.8139025568962097,
-0.6006616950035095,
-1.3710006475448608,
-0.49813932180404663,
0.19637271761894226,
0.6771215796470642,
-0.46189969778060913,
0.016018297523260117,
0.3106391727924347,
0.697650134563446,
0.060320205986499786,
0.2329779416322708,
0.09500051289796829,
0.8113551735877991,
-0.31113892793655396,
-0.6730658411979675,
-0.28945252299308777,
-0.11028673499822617,
-1.1289424896240234,
0.45368412137031555,
-0.23728537559509277,
-0.24811674654483795,
1.2005029916763306,
0.6715096235275269,
0.38059568405151367,
-0.3909333050251007,
-0.6188259124755859,
0.17579542100429535,
-1.24850594997406,
-0.4293465316295624,
0.3126418888568878,
0.4686768054962158,
-0.5339906811714172,
-0.5863373279571533,
0.5752462148666382,
0.09723103046417236,
0.19139105081558228,
-0.21852713823318481,
-0.6104521751403809,
0.108620785176754,
1.1284632682800293,
-0.808420717716217,
0.29509589076042175,
0.5148034691810608,
0.1026511862874031,
0.43127745389938354,
0.4178297221660614,
-0.07825756818056107,
1.246903657913208,
0.09758744388818741,
0.10238566994667053,
0.7447476387023926,
-0.030892351642251015,
0.18769028782844543,
0.16493672132492065,
-0.11095257103443146,
1.0794143676757812,
-0.7215733528137207,
-0.03306973725557327,
0.5690434575080872,
0.31560879945755005,
0.6405518054962158,
-0.12506619095802307,
-0.03881332650780678,
0.6770614981651306,
0.4371159076690674,
0.20836347341537476,
0.42710721492767334,
-0.4502458870410919,
-0.024149423465132713,
0.48089537024497986,
0.31709831953048706,
0.17998340725898743,
-0.021582510322332382,
-0.1817973107099533,
-0.048901308327913284,
-0.29045405983924866,
-0.4332939684391022,
-0.07195279747247696,
0.05251086875796318,
-0.5761882066726685,
0.0019003157503902912,
0.43275970220565796,
-0.003416368504986167,
-0.4291289150714874,
-0.13950422406196594,
-0.04890337213873863,
0.19654783606529236,
-0.461799293756485,
-0.46017488837242126,
0.41214221715927124,
-0.13987690210342407,
0.41341260075569153,
-0.4148560166358948,
0.035655681043863297,
0.1194208487868309,
0.2218722254037857,
0.6335237622261047,
-0.05718784034252167,
0.24544565379619598,
-0.7302533388137817,
-1.0655945539474487,
-0.0038423100486397743,
-0.4376669228076935,
0.298462837934494,
-0.12426480650901794,
-0.35562145709991455,
0.24821168184280396,
0.02055760659277439,
0.2533644139766693,
0.30036842823028564,
0.07527574896812439,
0.01737324520945549,
-0.8707859516143799
] |
NCT06774690
|
Intra Artherial Therapies in Treatment of Primary Liver Diseases: an Observational Study
|
The goal of this observational study is to learn what are the best conditions that will give a positive outcome to men and women that receive a intra arterial therapy (IAT) for primary liver cancer.
Intra arterial therapies are radiologic procedures that block liver cancer blood supply.
The researchers will collect the data of participants located in the Radiology department in "IRCCS Azienda Ospedaliera Universitaria" Hospital in Bologna and will study clinic and radiological traits to understand which is the best case scenario for a optimal treatment response.
|
This study is non profit, observational, retrospective, prospective and single institution.
The researchers will do a retrospective and prospective data collection and analyze the results. They will examine the radiological images (CT scan and RM) to assess the type and size of the cancer, track how the disease responds to treatments, identify possible complications.
There are no drugs involved and all the intra arterial therapies are performed within the routine clinical-care path.
* For the retrospective phase the researchers will analyze radiological image of the participants that received a intra arterial therapy from the 1st of January 2009. It's expected to enroll around 2000 participants.
* For the prospective phase the researchers will enroll for 5 years eligible participants that will receive a intra arterial therapy. Participants will go through a follow up every three months for the duration of the whole study. It is expected to enroll around 1300 participants.
|
Inclusion Criteria:
* diagnosis of Hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA) and clinical indication to receive or have already received one of the following treatments:
* Trans-arterial embolization (TAE),
* Transarterial chemoembolization (TACE),
* Transarterial radioembolization (TARE)
* Drug-eluting beads chemoembolization (DEB-TACE)
* Age over 18
* To give informed consent
Exclusion Criteria:
* shunt of gastro intestinal arteries that cannot be embolized
* metastasis spread outside of the liver
* liver failure
|
[
2.738859176635742,
2.912471055984497,
-1.8208287954330444,
-1.2882757186889648,
-0.04302959516644478,
0.09833131730556488,
-0.42207810282707214,
-0.4348525404930115,
-1.8844619989395142,
0.10033216327428818,
0.5589908957481384,
2.1116204261779785,
-1.0654206275939941,
1.162680745124817,
-0.1053447499871254,
1.286737322807312,
0.4651905596256256,
0.6916708946228027,
1.6698436737060547,
-0.38143929839134216,
0.17985105514526367,
-0.7356985807418823,
-0.23137043416500092,
-0.17690716683864594,
0.46624261140823364,
-0.20475630462169647,
-1.6646307706832886,
1.025057315826416,
0.18152309954166412,
1.5254335403442383,
0.5204463601112366,
0.284266859292984,
0.07096558064222336,
0.41507473587989807,
0.796886146068573,
0.14311568439006805,
1.5726317167282104,
0.6262888312339783,
-1.2724926471710205,
1.0776466131210327,
1.2298164367675781,
0.879856526851654,
0.02916497178375721,
-0.5462374687194824,
1.038540244102478,
1.1196863651275635,
-1.0701863765716553,
0.0575481653213501,
0.14196479320526123,
0.9500616788864136,
-1.6524755954742432,
1.5670106410980225,
-1.3925659656524658,
0.2149757593870163,
0.3075132369995117,
0.5048952698707581,
0.6432356238365173,
-0.2642137408256531,
0.8102084994316101,
0.08041410893201828,
0.12668222188949585,
-0.792685866355896,
0.7865968942642212,
0.2613961398601532,
-1.3095815181732178,
0.035996850579977036,
0.3133302330970764,
0.16133227944374084,
-0.7036833167076111,
0.13482455909252167,
0.8366126418113708,
0.44820135831832886,
0.642000138759613,
-0.27149784564971924,
0.4291664659976959,
0.19472937285900116,
-1.0807416439056396,
0.4962681829929352,
-0.04892727732658386,
0.40548595786094666,
-0.4446292519569397,
-1.0177109241485596,
-1.0342371463775635,
0.6354324221611023,
0.866787850856781,
-0.6823983788490295,
-1.0693851709365845,
-0.9103007316589355,
0.5336681604385376,
-0.42147403955459595,
1.0016149282455444,
0.4175175130367279,
-0.8923851847648621,
1.048524260520935,
-1.2660930156707764,
0.4954361021518707,
0.3057441711425781,
-0.46463268995285034,
-0.9410983324050903,
0.14770540595054626,
-0.3743109405040741,
0.3938590884208679,
-0.3995136618614197,
0.2243262678384781,
-0.06128218024969101,
-0.020379425957798958,
-0.15370024740695953,
-0.2818334102630615,
0.04316096752882004,
-0.9131721258163452,
0.2790791392326355,
-1.2257691621780396,
0.14453783631324768,
-0.0426296591758728,
-0.2637755572795868,
-0.0817527323961258,
0.6519585251808167,
0.3565771281719208,
1.0723154544830322,
-0.12854719161987305,
-0.9680995345115662,
1.1174867153167725,
0.1285211741924286,
0.5076453685760498,
-0.16549842059612274,
-0.7154317498207092,
-0.13715462386608124,
0.292248398065567,
-1.0963162183761597,
-0.6961015462875366,
-0.25738707184791565,
-0.2733955383300781,
0.8568835258483887,
0.092107854783535,
-0.643565833568573,
0.24164219200611115,
0.14627182483673096,
0.2363027185201645,
0.438652366399765,
-0.21213693916797638,
0.49769043922424316,
-0.07544515281915665,
0.45996713638305664,
-0.1468750685453415,
-1.0207353830337524,
-0.48554348945617676,
-1.0566856861114502,
0.6566425561904907,
-0.44751879572868347,
-0.7600775957107544,
0.0541047677397728,
-0.11163529008626938,
0.36445334553718567,
0.24577052891254425,
0.18953706324100494,
0.33780595660209656,
-0.020718278363347054,
-0.5272595882415771,
-0.07212309539318085,
-0.7529598474502563,
-0.11163180321455002,
-0.2852286994457245,
0.12092437595129013,
-0.42727532982826233,
1.072786569595337,
-0.7275367379188538,
0.09776178747415543,
0.478078693151474,
0.16691280901432037,
0.11457263678312302,
-0.1466466635465622,
0.38186654448509216,
-0.24126006662845612,
0.6501174569129944,
-0.36280399560928345,
-0.07034317404031754,
0.2705780565738678,
-0.8685367703437805,
0.4560658931732178,
-0.9175332188606262,
0.35335081815719604,
0.593889057636261,
0.10700253397226334,
-0.34202268719673157,
-0.04285358265042305,
0.3535376191139221,
0.2561003863811493,
0.2185659110546112,
0.27118438482284546,
-0.18059800565242767,
0.5168480277061462,
0.12176481634378433,
-0.15889714658260345,
-0.01783670298755169,
0.13039158284664154,
-0.5528481602668762,
0.05650996416807175,
-0.49067211151123047,
0.36356863379478455,
-0.148758664727211,
-0.10671151429414749,
0.3734990060329437,
-0.47072315216064453,
0.8488789200782776,
0.10308535397052765,
-0.005321352742612362,
0.03010377660393715,
0.03741299733519554,
-0.047800567001104355,
-0.1382751315832138,
0.30090516805648804,
-0.1291344314813614,
0.0815957635641098,
0.14649879932403564,
0.4490301311016083,
0.5943464040756226,
0.4111063480377197,
0.022645318880677223,
-0.6043168306350708,
-0.055685512721538544,
-0.013749271631240845,
-0.09670164436101913,
0.15099592506885529,
0.12156516313552856,
-0.042447932064533234,
0.08535677939653397,
-0.16275987029075623,
0.08095644414424896,
0.08585759252309799,
-0.3656921684741974,
0.17666658759117126,
-0.4394184648990631,
0.3511757552623749,
-0.24206556379795074,
-0.1469835489988327,
-0.03393702581524849,
0.5809089541435242,
0.3798355460166931,
-0.49787086248397827,
0.07134706526994705,
0.455348938703537,
-0.14988107979297638,
0.0557585135102272,
-0.6478567719459534,
-0.08819732815027237,
0.4943832755088806,
-0.40036454796791077,
-0.21218986809253693,
-0.05231598764657974,
0.3302513659000397,
-0.30118903517723083,
0.052994657307863235,
-0.28845158219337463,
0.3156096935272217,
0.21734178066253662,
-0.6195084452629089
] |
NCT06309160
|
COMPASS Across Settings (CAST) for Improving Transition Outcomes for Students With ASD
|
Purpose: The purpose of this project is to develop and test the COMPASS \[Collaborative Model for Competence and Success\] Across Settings (CAST) intervention to enhance the goal setting and attainment skills of autistic youth. Despite federal education law mandating transition services as part of the Individualized Education Program (IEP) for ensuring good outcomes for students with disabilities, current educational practices have been unable to demonstrate that autistic students experience positive postsecondary outcomes. There are existing, evidence-based interventions aimed at supporting positive outcomes for these students. However, these interventions have not systematically provided coaching support to the caregivers, students, and employment specialists. To address these issues, CAST will integrate three evidence-based interventions for supporting student transitions while providing this critical coaching support. By doing so, CAST aims to align the priorities and goals of interventions across home, school, and community settings to better support positive postsecondary outcomes for autistic students.
|
Project Activities: The research team will use an iterative approach for integrating the three interventions into CAST, obtaining feedback from focus groups and stakeholder members along the way, and running a field trial after development. The research team will then conduct a randomized controlled trial (RCT) of CAST to examine postsecondary outcomes at both 3 months and 1 year after high school. Social network analysis will be used to understand the integration of services and a cost analysis will be conducted.
Products: This project will result in a fully developed intervention, CAST, for improving IEP and postsecondary outcomes of autistic students. The project will also result in peer-reviewed publications, information on the costs of CAST implementation, an updated intervention manual with fidelity checklists, and other dissemination products aimed at stakeholders.
STRUCTURED ABSTRACT
Setting: This project will take place in public high schools in Indiana.
Sample: Approximately 38 administrators, special education teachers, caregivers, pre-employment transition specialists, and autistic youth will participate in focus groups and interviews in the first year. The field test in year 2 will include five autistic youth and their parents, five classroom special education teachers, and five employment transition specialists. Approximately 140 participants (40 autistic youth and young adults, 40 caregivers, 40 special education teachers, and 20 pre-employment specialists who serve autistic youth) will participate in the pilot RCT in year 3.
Intervention: CAST will integrate three evidence-based interventions- COMPASS, C-HOPE, and COMPASS-T. COMPASS is the original intervention designed for preschool and elementary age students. COMPASS-T is the adaptation of COMPASS for transition-aged youth. Lastly, C-HOPE is based on COMPASS and is a parent-mediated intervention designed to decrease child problem behavior, increase parent competency, and decrease parent stress. CAST will begin with an initial joint session with the student, caregiver, special education teacher, and pre-employment transition specialist that allows for discussion on the student's postsecondary goals, preferences, frustrations, challenges, and strengths related to social skills, adaptive/self-management, communication, problem behaviors, learning skills, and sensory sensitivities and preferences. This discussion will pinpoint critical social, communication, and work behavior/learning goals related to postsecondary goals and inform the intervention plans that are generated for each goal. Following this initial consultation, there will be four additional 1-hour sessions that incorporate evidence-based coaching, provided by the investigators, including performance feedback monitoring and instructional support. Each session is standardized and allows for assessment of student progress and intervention modification/self-reflection on the implementation of the intervention plans.
Research Design and Methods: For the year 1 development activities, the research team will conduct focus groups with administrators, special education teachers, parents, students, and pre-employment transition specialists about how to integrate plans and services across settings. The research team will then conduct a field test of CAST in year 2, making further revisions. In year 3, they will use a mixed methods design using a small RCT and network analysis, oversampling African American students and students from rural areas, to evaluate CAST for improved postsecondary outcomes in employment, training, and education. The secondary aims of the project are to obtain (a) information on how well CAST improves integration and alignment of services across settings and thus student IEP and postsecondary outcomes; (b) information on feasibility, usability, and fidelity; and (c) estimates of costs.
Control Condition: Students in the control condition will receive services as usual.
Key Measures: The primary outcome data will be student goal attainment (GAS) of IEP goals and postsecondary goals. IEP goal attainment is assessed using psychometric equivalence goal attainment scaling (PET-GAS). Postsecondary outcomes will be assessed by parent report of attainment in goals (such as enrolling in a training or college program and living independently). Additional measures completed by all CAST participants (caregivers, students, special education teachers, and pre-employment specialists) include assessment of transition plan quality, organizational connectedness, and fidelity assessments.
Data Analytic Strategy: Focus groups and interviews will be recorded, transcribed, checked for accuracy, and analyzed using a consensual coding technique that will be used to provide a multi-dimensional picture for refining CAST. For the field test, the research team will use a dependent sample t-test to examine whether there is a significant improvement in GAS scores at the end of the year and whether there is a change in students' postsecondary outcomes from end of high school to 3 months out from high school. For the RCT, the research team will use a multilevel model on GAS scores at the end of year and postsecondary outcomes at both post-school time points. Pearson correlations will be used to examine associations in student outcomes and intervention fidelity measures with the CAST participants. Social network analysis will be used to understand integration of services.
Cost Analysis: For the cost analysis, individual ingredients associated with CAST will be identified through a discussion with participants, administrators, and other stakeholders. The costs of each ingredient will then be determined through a review of official records, where possible. Using these various sources, the total cost of implementation will be calculated.
|
Inclusion Criteria:
* Students with verified autism and IEPs that designate services for autism
* Caregivers of students with autism
* Special education teachers of students with autism
* Pre-employment specialists of students with autism
Exclusion Criteria:
* Not planning to move or leave their job over the school year
|
[
-1.1486053466796875,
5.414626121520996,
-2.967975616455078,
-2.023738384246826,
0.18821313977241516,
-0.02761209011077881,
-1.0794018507003784,
1.5384631156921387,
-0.67905592918396,
0.6777443885803223,
-0.501163125038147,
0.5060573220252991,
-0.8247947692871094,
0.38409051299095154,
-1.3566017150878906,
1.631666898727417,
1.1098816394805908,
0.027364913374185562,
1.2035019397735596,
0.7563228011131287,
0.15662603080272675,
1.5759646892547607,
0.4395884573459625,
-0.9890905022621155,
0.09770409762859344,
1.5696264505386353,
-0.7836714386940002,
1.8182116746902466,
-0.0446840338408947,
1.4219669103622437,
0.38980555534362793,
0.08186729997396469,
0.09562615305185318,
0.7236042618751526,
0.2357569932937622,
0.36104312539100647,
-0.8601199388504028,
1.3123854398727417,
-1.1479823589324951,
0.6674785017967224,
-0.1402570754289627,
0.12452713400125504,
0.41579777002334595,
0.3622720539569855,
0.05810564011335373,
0.01400915626436472,
-0.5572717785835266,
0.7503516674041748,
-0.5999277234077454,
1.8179775476455688,
-0.16842558979988098,
0.2831970155239105,
0.3245842158794403,
-1.1407496929168701,
1.0485883951187134,
-0.2676244378089905,
0.05788576230406761,
0.337796151638031,
0.4504466950893402,
0.19592778384685516,
-0.15732289850711823,
0.02033306285738945,
-0.3326857089996338,
0.21589981019496918,
-0.26486822962760925,
-0.6699628829956055,
0.9932501912117004,
-0.07041150331497192,
-0.7004542350769043,
1.2658582925796509,
0.3114595413208008,
0.29589295387268066,
1.2213493585586548,
0.7648342847824097,
-0.7396379709243774,
-0.07144246250391006,
-0.09410285204648972,
0.1802394539117813,
0.12304144352674484,
0.5537351369857788,
0.791629433631897,
0.1893397569656372,
-0.07965315133333206,
-0.9617692232131958,
1.9644060134887695,
-0.39647483825683594,
-1.0117065906524658,
-0.37639927864074707,
0.5928255915641785,
-0.7211403250694275,
0.8933841586112976,
0.13020217418670654,
-0.0010014947038143873,
0.37983453273773193,
-0.3551519513130188,
0.9624414443969727,
-0.6179440021514893,
-0.7893689870834351,
-1.3377656936645508,
0.2692066729068756,
-0.5627051591873169,
-0.6064935326576233,
-0.04840288311243057,
0.2004416286945343,
-0.424218088388443,
0.2260662317276001,
-1.1187126636505127,
-0.06109416112303734,
0.3851228356361389,
0.6536012887954712,
-0.8452271819114685,
-0.7250368595123291,
0.29719558358192444,
-0.20569217205047607,
0.3901703953742981,
-0.1335369199514389,
0.4548228681087494,
0.20647776126861572,
0.5500941872596741,
-0.41753196716308594,
0.763261616230011,
0.5197054147720337,
-0.18441623449325562,
0.061309512704610825,
-0.8981553912162781,
0.35902902483940125,
-0.3489307761192322,
-0.29984480142593384,
-0.17489972710609436,
-0.8464325070381165,
-0.635457456111908,
0.3428477644920349,
0.96639484167099,
0.07249551266431808,
0.01167217269539833,
-0.590880811214447,
0.31576839089393616,
-0.058180246502161026,
-0.31021901965141296,
-0.28450363874435425,
0.10877353698015213,
0.519014298915863,
0.6385728716850281,
0.019612599164247513,
-1.5176408290863037,
0.010853060521185398,
0.6191099286079407,
0.10826648771762848,
-0.56376713514328,
0.23107723891735077,
-0.08280299603939056,
0.5909801125526428,
-0.2457430511713028,
0.946615993976593,
-0.6940417289733887,
-0.4697430729866028,
0.1859518140554428,
-0.7547824382781982,
0.46176931262016296,
-0.2399778515100479,
0.44737133383750916,
0.04196970909833908,
-0.3043077886104584,
-0.9045697450637817,
0.20854945480823517,
-0.8702552914619446,
0.1577506959438324,
0.2961450517177582,
-0.33419471979141235,
-0.537750780582428,
-0.33030998706817627,
-0.16286341845989227,
-1.4600770473480225,
0.1563057154417038,
-0.6484108567237854,
0.3680937588214874,
0.6689667701721191,
-0.35392460227012634,
0.12372516840696335,
-0.1033860594034195,
0.20210956037044525,
-0.23207516968250275,
-0.18787986040115356,
0.5701886415481567,
0.28217607736587524,
-0.3940158188343048,
-0.6093451380729675,
-0.207914337515831,
-0.16790081560611725,
0.3424068093299866,
-0.38185036182403564,
-0.4907354414463043,
-0.04725203290581703,
0.2887917459011078,
0.5215243697166443,
-0.6567965149879456,
-0.6815640330314636,
0.34943675994873047,
0.024551529437303543,
-0.21505308151245117,
-0.5714061260223389,
0.42308729887008667,
-0.4814014136791229,
-0.4451580047607422,
-0.012841780669987202,
-0.5944663286209106,
-0.1521388441324234,
-0.46189063787460327,
0.3304060995578766,
0.20957088470458984,
-0.04444889351725578,
-0.1439158171415329,
-0.032279495149850845,
-0.38024553656578064,
-0.040292300283908844,
0.9274537563323975,
0.637249767780304,
0.26447534561157227,
-0.6568388342857361,
-0.2813534140586853,
-0.15840081870555878,
0.014102642424404621,
0.17372258007526398,
-0.0464002750813961,
-0.6049571633338928,
0.23280951380729675,
-0.14760571718215942,
0.3025783896446228,
-0.17131450772285461,
-0.03284117951989174,
0.04051830992102623,
-0.001748700626194477,
0.11807376146316528,
0.43023765087127686,
-0.33409419655799866,
-0.026469238102436066,
-0.18513408303260803,
0.019893333315849304,
-0.1482221782207489,
0.5851426720619202,
0.4670901298522949,
0.6895221471786499,
-0.27778396010398865,
-0.474763423204422,
0.4755474627017975,
-0.29003795981407166,
-0.09159800410270691,
0.0842539444565773,
0.07976590096950531,
0.065758615732193,
-0.3687979578971863,
-0.20732419192790985,
-0.33307167887687683,
-0.11582700163125992,
0.20692141354084015,
-0.09738443791866302
] |
NCT01631149
|
Effect of Deep BLock on Intraoperative Surgical Conditions
|
Rationale: A deep neuromuscular block is often associated with improved surgical conditions especially in laparoscopic surgery. However, a deep block comes at the expense of a variety of items that may conflict with the use of a deep surgical muscle blockade including a long recovery phase, the need for muscle reversal, postoperative ventilation, impaired postoperative breathing. With the introduction of Sugammadex there is now the possibility to reverse an even deep surgical block. This may overcome most if not all of the issues mentioned.
Objective: To assess whether a deep neuromuscular block provides better surgical conditions than a moderately deep block as derived from a surgical rating score.
Study design: Single center, double-blind randomized controlled trial. Study population: 24 ASA I-III patients scheduled for laparoscopic renal (n=12, GROUP 1) or prostatic surgery (n=12, GROUP 2).
Intervention: In both GROUP 1 and GROUP 2, 6 six patients will receive neuromuscular blockade according to current practice (atracurium (bolus) plus mivacurium (cont. infusion)) aimed at a moderately deep neuromuscular block (1-2 twitches in the Train of Four (TOF) monitor). The other six will receive a bolus plus continuous infusion with rocuronium aimed at a deep neuromuscular block (1-2 twitches post tetanic count (PTC)). All surgical procedures will be performed by one surgeon.
Main study parameters/endpoints: To study the surgical conditions in patients undergoing laparoscopic renal or prostate surgery during deep versus less deep neuromuscular block as assessed by the surgical rating score.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Compared to current practice there will be no additional risk.
|
Surgical conditions in laparoscopic surgery are largely determined by the degree of neuromuscular relaxation during surgery. Especially in procedures which are confined to a narrow working field such as renal and prostatic laparoscopic surgery, deep neuromuscular relaxation may be beneficial. Until recently however, deep neuromuscular block (1-2 twitches post tetanic count) came at the expense of a variety of items that conflicted with its use. Occurrence of postoperative residual neuromuscular blockade after deep neuromuscular block was a common adverse event. Residual neuromuscular block is a risk factor for developing airway obstruction and pulmonary complications such pneumonia and atelectasis. The use of acetylcholinesterase inhibitors, like neostigmine, as a traditional neuromuscular blocking reversal agent, have a slow onset of action. Side effects due to muscarine receptor stimulation are bradycardia, hypersalivation, nausea and vomiting. Coadministration of a muscarine agonist like atropine is often necessary to address the heart rate-related side effects of neostigmine. Atropine, however, in itself may induce other side effects.
Rapid, safe and complete reversal of neuromuscular blockade was not possible until the discovery of Sugammadex. Sugammadex is a modified y-cyclodextrin. It was developed to selectively bind free plasma rocuronium, a non-depolarizing steroidal neuromuscular blocking agent. By binding free rocuronium, less rocuronium becomes available at the neuromuscular junction to bind to the muscarine receptor. Non-depolarizing neuromuscular blocking agents (NMBA's) block the muscarine receptor at the neuromuscular junction, making them unavailable to acetylcholine based signal transmission. Sugammadex has proven to rapidly and safely reverse rocuronium and vecuronium. Even high dose rocuronium (1.2 mg/kg and continuous rocuronium infusion used to achieve deep neuromuscular blockade can safely be reversed by Sugammadex.
Theoretically, the availability of Sugammadex makes it possible to use deep neuromuscular block (DNB) during surgery to improve surgical conditions without the occurrence of the above-mentioned adverse events. The use of DNB to improve surgical conditions, however, has not yet been evaluated. The investigators therefore aim to investigate the use of rocuronium induced-DNB in renal and prostatic laparoscopic surgery. Current anesthesiologic practice during these procedures in the LUMC consists of an intravenous (propofol) or volatile (sevoflurane) anesthetic combined with mivacurium and atracurium to achieve a moderately deep neuromuscular block (0-2 twitches TOF). Reversal of NMB is by the neostigmine atropine combination. In the current study the investigators will assess the effect of a DNB (1-2 twitches post tetanic count) using a continuous rocuronium infusion on surgical conditions. After surgery Sugammadex 4 mg/kg will be used to safely and rapidly reverse the neuromuscular blockade within 5-min.
The main end-point of the study is the effect of the deep block on the surgical conditions. The investigators will study these conditions using two methods. (1) Assessment of the surgical condition by the operating surgeon (all surgeries will be performed by one surgeon), using a 5-point rating surgical rating scale from 1 (= extremely poor surgical condition) to 5 = optimal surgical condition. (2) Video images, used by the surgeon to perform the surgery, will be rated by a team of surgical and non-surgical experts. Apart from the additional scoring data, this approach allows for the validation of the surgical rating scale.
Minor end-points of the study are (1) measurement of hemodynamics during surgery using a non-invasive cardiac output and blood pressure device. Assuming that intra-abdominal pressure will affect the venous return and hence cardiac output during surgery, a deep neuromuscular block might affect the hemodynamic parameters positively; (2) measurement of respiration, pain, and alertness in the recovery room to assess whether reversal with Sugammadex influences these parameters positively compared to neostigmine/atropine reversal.
|
Inclusion Criteria:
* Patients diagnosed with renal or prostatic disease who are will undergo an elective laparoscopic renal surgical procedure or laparoscopic prostatectomy;
* ASA class I-III
* \> 18 years of age;
* Ability to give oral and written informed consent
Exclusion Criteria:
* Known or suspected neuromuscular disorders impairing neuromuscular function;
* Allergies to muscle relaxants, anesthetics or narcotics;
* A (family) history of malignant hyperthermia;
* Patients who have a contraindication for neostigmine administration;
* Women who are or may be pregnant or are currently breast feeding;
* Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output \< 0.5 ml/kg/h for at least 6 h. When available, other indices will be taken into account as well such as glomerular filtration rate \< 60 ml/h and proteinuria (a ratio of 30 mg albumin to 1 g of creatinine).
* Previous retroperitoneal surgery at the site of the current surgery.
* Body mass index \> 35 kg/m2
|
[
0.36163443326950073,
2.550530195236206,
-1.5890494585037231,
-2.2992637157440186,
0.6866292953491211,
0.16169458627700806,
-0.8425584435462952,
-0.24716874957084656,
-2.3619561195373535,
0.7945124506950378,
-0.4356893002986908,
1.2189691066741943,
-1.0742496252059937,
0.2019222229719162,
0.7543895244598389,
1.0434435606002808,
-0.7809089422225952,
-0.644493818283081,
-0.4999600052833557,
-0.2889886796474457,
0.6875453591346741,
0.929706871509552,
-0.6720923185348511,
-0.36476054787635803,
1.4310232400894165,
0.2051970660686493,
0.916289210319519,
-0.2233482003211975,
0.6573460102081299,
-0.06449068337678909,
-0.5278975367546082,
-0.9166954159736633,
0.03831839933991432,
1.509903907775879,
0.13405853509902954,
0.2991137206554413,
-0.02277180552482605,
-0.229694664478302,
-0.30874961614608765,
-0.04688996449112892,
1.700862169265747,
0.8645192980766296,
-0.4607296288013458,
0.05161944031715393,
1.0096302032470703,
1.0518018007278442,
-0.0055118524469435215,
0.4343106746673584,
0.6395887732505798,
-0.33110737800598145,
-0.33553317189216614,
0.5197756886482239,
-0.9153369069099426,
-0.4612228274345398,
0.5944741368293762,
0.6478105783462524,
0.8538021445274353,
0.16562826931476593,
-0.0755099505186081,
-0.29027462005615234,
0.6421732306480408,
0.7047722339630127,
0.284024178981781,
1.3437854051589966,
-0.8535932302474976,
-0.5629144310951233,
-0.9535024762153625,
0.1630219668149948,
-0.35310932993888855,
0.4643833637237549,
0.12766152620315552,
0.5987221002578735,
-0.10448607057332993,
-0.2729543447494507,
1.7065645456314087,
0.262594997882843,
-0.4131586253643036,
-0.06965457648038864,
0.5405615568161011,
0.7482866048812866,
-0.247695192694664,
-0.7738203406333923,
-0.26347458362579346,
-0.9623607993125916,
-0.19405393302440643,
-0.02850315533578396,
-1.349529504776001,
-0.7437034249305725,
0.9675441384315491,
-0.5196478366851807,
0.4888226091861725,
0.1959964483976364,
-0.9392105937004089,
0.21744728088378906,
-0.4075406491756439,
0.3882087767124176,
0.42309778928756714,
-0.9458798766136169,
-0.4471557140350342,
-0.5575268268585205,
-0.44912004470825195,
0.4073539078235626,
-0.23403818905353546,
-0.8594228029251099,
-0.46486225724220276,
0.013594388030469418,
0.02245361916720867,
-0.6197333931922913,
-0.32218149304389954,
-0.8092833757400513,
1.1114338636398315,
-0.8129517436027527,
-0.06695428490638733,
-0.8920196294784546,
-0.22686931490898132,
0.7769473195075989,
0.10161680728197098,
-0.010430327616631985,
0.47467240691185,
-0.4130449891090393,
-0.3139236867427826,
0.4290730953216553,
-0.1429029405117035,
0.21190093457698822,
0.09435966610908508,
-0.14851653575897217,
-0.21074797213077545,
0.6719943284988403,
0.008927523158490658,
-0.166250079870224,
-0.380998820066452,
0.5942705869674683,
-0.06310580670833588,
-0.20812779664993286,
-0.6989500522613525,
-0.09140818566083908,
0.1307474672794342,
0.2740079462528229,
0.03966754674911499,
-0.6321961283683777,
0.46342942118644714,
0.5997002720832825,
-0.49459195137023926,
-0.27481722831726074,
-1.0249115228652954,
-0.3516974151134491,
-0.08240347355604172,
0.7232405543327332,
-1.091179609298706,
0.00825018621981144,
0.29617661237716675,
-0.24803969264030457,
0.31029683351516724,
0.18478775024414062,
-0.04498731344938278,
0.4454014301300049,
0.4317869544029236,
0.0028235577046871185,
0.2233494371175766,
-0.6157307028770447,
-0.48338547348976135,
0.13359278440475464,
0.05117122083902359,
-0.9785218834877014,
0.3661133348941803,
-0.38787537813186646,
-0.46655240654945374,
-0.2516913115978241,
0.17542682588100433,
0.3358752727508545,
-0.25514647364616394,
-0.5748881101608276,
-0.13953004777431488,
0.20148636400699615,
-0.3582009971141815,
0.46052172780036926,
0.5643740892410278,
-0.14044320583343506,
0.31833821535110474,
0.052860431373119354,
0.22224178910255432,
-0.276526540517807,
0.1724528819322586,
0.22630320489406586,
0.06963808089494705,
0.14046531915664673,
0.044793736189603806,
-0.36265403032302856,
-0.49256202578544617,
-0.09925185889005661,
0.03963196650147438,
-0.22858503460884094,
-0.0803157389163971,
-0.08519135415554047,
0.5542668700218201,
0.03629831597208977,
-0.43261149525642395,
-0.20837843418121338,
0.650759756565094,
0.029687317088246346,
0.21076370775699615,
0.17708303034305573,
-0.4376686215400696,
0.1257365643978119,
0.2557057738304138,
-0.3794981837272644,
-0.3886472284793854,
0.001034518238157034,
-0.2347671538591385,
-0.04930613189935684,
0.06091701611876488,
0.23886427283287048,
-0.2249775528907776,
0.08738693594932556,
-0.12731978297233582,
0.013382861390709877,
-0.14750581979751587,
0.1277264505624771,
-0.5583295822143555,
0.07362285256385803,
0.08181637525558472,
0.06736888736486435,
0.24275264143943787,
0.002148495754227042,
-0.06820258498191833,
-0.03246334195137024,
0.052817657589912415,
-0.19864200055599213,
-0.0170451607555151,
-0.3414301872253418,
-0.44709905982017517,
0.10618250072002411,
0.036982856690883636,
-0.13738061487674713,
-0.2800642251968384,
0.021683771163225174,
0.14425985515117645,
0.41449180245399475,
0.13433519005775452,
0.21250353753566742,
-0.14863480627536774,
-0.4360027015209198,
-0.11035618931055069,
-0.06339482218027115,
-0.07200274616479874,
0.1422836035490036,
-0.11373773217201233,
0.08385424315929413,
-0.1742425560951233,
-0.16099616885185242,
0.22329220175743103,
0.0014381535584107041,
0.1404484510421753,
-0.11408008635044098,
-0.06403593719005585,
-0.22576794028282166
] |
NCT06338943
|
Middle-aged Women With Adverse Pregnancy Outcomes and Heart Failure With Preserved Ejection Fraction
|
Due to the steady increase in the burden of HFpEF, especially in women, it is an important task to search for new markers and early predictors associated with the development of this disease. Nowadays, the relationship of adverse pregnancy factors with the development of long-term cardiac pathology, in particular, HFpEF, has not been completely established. One of the most significant issue is studying the younger phenotype of women.
The goal of this observational analytical cross-sectional study is to study the relationship of heart failure with a preserved ejection fraction in middle-aged women with adverse pregnancy outcomes in the history of pregnancy.
Research question: is there an association between adverse pregnancy factors and the development of HF in middle-aged women?
Objectives
1. To assess the frequency of detection of APOs in the history of pregnancy in middle-aged women, depending on the presence or absence of HFpEF.
2. To compare clinical and anamnestic data, morphological and functional parameters of the heart in middle-aged women with the presence and absence of HFpEF.
3. To establish an association between APOs and the development of HFpEF in the long-term period in middle-aged women.
4. To identify mediators between the presence of APOs and the development of HFpEF in middle-aged women.
Study population - 45-60 year-old women with the history of pregnancy (\>20 weeks) in the absence of low left ventricle ejection fraction (\<50%)
Primary endpoint: The prevalence of HFpEF in patients with the history of APOs.
|
Heart failure (HF) occupies a special place in the structure of cardiological pathology. This is largely due to the active modernization of approaches to the diagnosis of HF - every year the possibilities of cardiac imaging increase significantly, which leads to dynamic changes in the criteria for diagnosis. To the greatest extent, these changes affect heart failure with a preserved ejection fraction (HFpEF; left ventricular ejection fraction ≥ 50%), the importance of which is steadily growing with increasing life expectancy, obesity and cardiometabolic disorders. If in the recent past, HF was perceived not as independent disease, which is a complication of the underlying cardiac pathology, today, due to the increasing detectability of HFpEF, the latter can be considered as a separate multifactorial disease. Patients with HFpEF make up about half of the population of patients with HF, which, together with difficulties in understanding the pathophysiological mechanisms of the disease, is a significant problem for clinical practice.
Due to the steady increase in the burden of HFpEF, especially in women, it is an important task to search for new markers and early predictors associated with the development of this disease. This area of scientific activity has become especially popular in recent years in both world and domestic cardiology. The leading causes of the development of HFpEF are old age, obesity, coronary heart disease and pulmonary hypertension. A significant association has also been established with such markers as female gender, diabetes mellitus (DM), chronic kidney disease (CKD), alcohol abuse, arterial hypertension, smoking and others. Important issue now is the study of the association of pregnancy factors and its complications with the development of various forms of HF in both early and long-term periods. It is known that significant changes in a woman's body during pregnancy contribute to the development of important structural and hemodynamic changes in the cardiovascular system, which, in the absence of predisposing adverse factors, are in most cases reversible. Unfortunately, pathology detected during pregnancy is also often a trigger factor for the formation of structural remodeling of the heart and blood vessels, which can lead to the development of HF in the long term after pregnancy.
Despite the presence of large foreign studies reflecting the high incidence of various forms of chronic non-communicable diseases in women with adverse in the gestational period, the relationship of adverse pregnancy outcomes (APOs) with the development of long-term cardiac pathology, in particular, HFpEF, has not been sufficiently studied. Moreover, approaches to the diagnosis of HFpEF vary significantly, there are often no diagnostic protocols in the studies. In such works, a universal approach is more frequently used without dividing patients into phenotypes, depending on age and comorbidity ("one-size-fits-all approach"), which is critically important in assessing such a heterogeneous disease. The above factors make the interpretation of the data and conclusions ambiguous.
To date, the issue of the association of adverse pregnancy factors with the development of HFpEF in the long-term period is unsolved. It is particularly interesting to study the younger phenotype of patients due to the greater detectability of HFpEF in this group of individuals in Russia compared with Western countries. Studying the nature of this relationship will expand understanding of the role of different APOs in the development of structural and functional changes of the heart in a woman's future.
|
Inclusion Criteria:
* All patients who administer to the Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine, who are undergoing echocardiography for medical reasons
* Pregnancy \>20 weeks in the anamnesis
* Signed informed consent to participate in the study
Exclusion Criteria:
* Refusal to sign an informed consent to participate in a clinical trial and to process personal data
* Detection of left ventricle ejection fraction \< 50% according to Echocardiography data
|
[
0.3480106592178345,
2.6121253967285156,
-2.0513224601745605,
-0.6296675801277161,
0.1633557826280594,
-0.0042488230392336845,
0.7195190191268921,
-1.496287226676941,
-0.49268123507499695,
-0.12766212224960327,
0.254825234413147,
0.8556264042854309,
-0.44049960374832153,
0.32303330302238464,
-0.5807439088821411,
0.8176702260971069,
-0.44962042570114136,
-0.4158726632595062,
0.9504223465919495,
-1.689238429069519,
0.65953528881073,
-0.18379025161266327,
1.013635277748108,
-0.3293524384498596,
0.3620505928993225,
0.054203879088163376,
-0.7960748672485352,
0.6064739227294922,
-0.6194208860397339,
0.16086292266845703,
0.4104316830635071,
-0.934310793876648,
0.984031081199646,
0.3014128804206848,
0.2988015115261078,
-0.7663410305976868,
0.7079244256019592,
0.1780811995267868,
-1.1081312894821167,
-0.45679959654808044,
-0.2055058628320694,
0.5240090489387512,
0.12427005171775818,
-0.3757152259349823,
0.5743283629417419,
-0.34300124645233154,
-0.7398145198822021,
-1.1634793281555176,
-1.1423872709274292,
0.6771597862243652,
-0.4806191325187683,
1.2308540344238281,
-1.2672747373580933,
-1.0458502769470215,
0.7665998339653015,
-0.5837724804878235,
-0.6932759881019592,
0.2047257125377655,
0.355206698179245,
0.7438949346542358,
-0.33376288414001465,
-0.4029238224029541,
-0.0440727062523365,
0.17267347872257233,
-0.24354740977287292,
-0.6260499954223633,
-0.24655984342098236,
0.6616791486740112,
-1.3095951080322266,
1.5212918519973755,
0.05425077676773071,
0.3737262487411499,
1.3457309007644653,
-0.23379842936992645,
0.023025134578347206,
0.40874847769737244,
-0.778152585029602,
0.8595466613769531,
0.9853675365447998,
0.4483776092529297,
-0.31442371010780334,
-0.03151589259505272,
-0.8728951215744019,
-0.17458222806453705,
0.33053213357925415,
-0.23173178732395172,
-0.9142588376998901,
-0.5012199878692627,
0.927622377872467,
-0.03281903639435768,
-0.08568336069583893,
0.5817582011222839,
-0.800754725933075,
-0.025670910254120827,
-0.3590279817581177,
1.075860619544983,
0.12073634564876556,
0.000015587391317239963,
-0.9677895307540894,
-0.47817492485046387,
-0.4360368549823761,
-0.0926036387681961,
-0.2508619427680969,
0.35588765144348145,
0.267774760723114,
-0.3971019387245178,
-0.09735232591629028,
-0.2609425485134125,
-0.7072734236717224,
-0.1057620421051979,
0.05053923651576042,
-0.019044920802116394,
-0.26458173990249634,
0.3906242251396179,
0.1348053365945816,
0.4275643527507782,
0.8309563994407654,
-0.08787184208631516,
0.6294540166854858,
-0.9144821763038635,
-0.13921917974948883,
0.5928886532783508,
0.23616543412208557,
0.6330100893974304,
-0.5580418109893799,
-0.1682574301958084,
0.8642902970314026,
0.6142824292182922,
0.20088979601860046,
0.2517070770263672,
-0.8705403804779053,
0.44203615188598633,
-0.02945876307785511,
-0.5119619369506836,
-0.6088520288467407,
0.161840558052063,
-0.32693687081336975,
0.12977632880210876,
-0.13652777671813965,
-0.7283291220664978,
-0.45688527822494507,
-0.09435198456048965,
0.29618510603904724,
0.1956808865070343,
-0.6816287636756897,
-0.02689870446920395,
-0.42550283670425415,
-0.5714954137802124,
-0.2651531398296356,
-0.16584838926792145,
-0.3928750157356262,
0.20858848094940186,
0.22359484434127808,
-0.11670611053705215,
0.2877267599105835,
0.6872622966766357,
0.19157586991786957,
0.13651014864444733,
-0.02542445994913578,
0.5312854647636414,
0.4398631155490875,
-0.5387094020843506,
-0.59213787317276,
0.25297433137893677,
0.16324254870414734,
0.2234581857919693,
0.13018657267093658,
-0.197173610329628,
0.14876984059810638,
-0.47561752796173096,
-0.25503256916999817,
-0.41867727041244507,
0.05975858494639397,
0.18291296064853668,
-0.14908060431480408,
-0.20685012638568878,
0.0985916405916214,
0.4600769877433777,
-0.1408998966217041,
0.14373962581157684,
-0.0005253999261185527,
-0.5420016050338745,
0.396552711725235,
0.2514559328556061,
0.37849852442741394,
-0.4600370526313782,
-0.3948054313659668,
-0.526048481464386,
-0.37846118211746216,
0.36166736483573914,
0.006504494696855545,
-0.17444096505641937,
-0.4556120038032532,
0.08130776137113571,
0.3304564356803894,
0.32436704635620117,
-0.22193282842636108,
0.0375855378806591,
0.4928002655506134,
-0.24111126363277435,
0.43316659331321716,
-0.03770780935883522,
-0.010300304740667343,
0.3455045223236084,
0.11303474754095078,
0.2867037355899811,
-0.2739531695842743,
0.27714142203330994,
0.22990332543849945,
0.0436108261346817,
0.4035476744174957,
0.512437641620636,
-0.27931270003318787,
-0.11156033724546432,
0.02752377837896347,
0.4697892963886261,
-0.41957393288612366,
-0.10561776906251907,
0.00007036694296402857,
0.11208463460206985,
0.07851305603981018,
0.37604856491088867,
-0.09879441559314728,
-0.27851158380508423,
-0.2874363958835602,
-0.20054830610752106,
0.1374547779560089,
0.29774510860443115,
0.3397015631198883,
-0.1606430560350418,
-0.29958462715148926,
0.4818858206272125,
-0.48344096541404724,
0.13618089258670807,
-0.1918543428182602,
-0.1639138013124466,
-0.1457914113998413,
0.0896233543753624,
-0.28435346484184265,
-0.16135986149311066,
0.01948091946542263,
0.014090689830482006,
0.3673904240131378,
-0.10182943940162659,
0.09560106694698334,
0.04199184477329254,
0.07431898266077042,
0.2315906137228012,
0.11840133368968964,
-0.13288693130016327,
-0.12258052080869675,
0.0031511096749454737,
-0.2620849609375,
-0.31531575322151184,
0.14814028143882751,
-0.4247562289237976
] |
NCT01367236
|
Changes in Cerebral Function in Treatment Naive HIV-1 Infected Subjects Commencing Either Boosted Atazanavir With Truvada or Boosted Darunavir With Maraviroc and Kivexa
|
The purpose of this study is to compare two different combination anti-HIV therapies over 48 weeks and to assess if differences in improvement in the function of the brain are observed over this period.
The study will compare anti-HIV therapy combinations which are currently in use.
The patients will not have had any previous treatment for their HIV infection.
|
Impairment in neurocognitive(NC) function in HIV-infected subjects in the current anti-retroviraltreatment (cART) era has been associated with poor compliance with cART, reduced quality-of-life and increased mortality. Reported factors associated with the development of NC function impairment in HIV disease and risks associated with progression of such impairment include degree of immune suppression related to HIV infection, other chronic viral infections (such as chronic hepatitis C co-infection), age and central nervous system (CNS) antiretroviral drug exposure.
One modifiable factor which may be associated with the evolution of NC function impairment is the direct effect of cART on the central-nervous-system (CNS). Certain antiretroviral drugs such as zidovudine, lamivudine, abacavir, nevirapine, efavirenz and indinavir are known to achieve optimal exposure in the cerebro-spinal-fluid (CSF) whereas other drugs, such as the majority of the HIV-1 protease inhibitors penetrate less effectively. Studies to date suggest different cART regimens may have differing effects on NC performance. In the EuroSIDA study, the use of nucleoside-reverse-transcriptase inhibitors was found to specifically protect against the development of HIV related brain disease. More recently, in a small prospective study, ALTAIR, different effect on cerebral function was reported in subjects randomised to commence three different cART regimens.
The investigators propose, in a prospective, randomised study to assess the effects of two different antiretroviral regimens on NC function in HIV infected subjects commencing antiretroviral therapy for the first time.
|
Inclusion Criteria:
* HIV-1 infected males or females
* signed informed consent
* no previous antiretroviral treatment since HIV diagnosis
* screening CD4+ lymphocyte count \<= 350 cells/ųL
* susceptible to all currently licensed (Nucleoside Reverse Transcriptase Inhibitors) NRTIs, (Non-Nucleoside Reverse Transcriptase Inhibitors) NNRTIs and PIs based on HIV-1 genotypic resistance report
* CCR5-tropic HIV based on genotypic resistance testing\*
Exclusion Criteria:
* • existing neurological disease
* hepatitis B or hepatitis C co-infection
* age under 18 years
* screening laboratory parameters \> grade 2 (with the exception of cholesterol and triglycerides)
* current history of major depression or psychosis
* recent head injury (past three months)
* current alcohol abuse or drug dependence
* active opportunistic infection or significant co-morbidities
* patients who are receiving other concomitant medication which are not permitted, as listed in appendix 2
* female patients of child-bearing potential who:
* have a positive serum pregnancy test at screening or during the study
* are breast feeding
* are planning to become pregnant
* all participants unwilling to use a barrier method of contraception
* patients who in the opinion of the investigator are not candidates for inclusion in the study
|
[
-0.32329657673835754,
2.3465206623077393,
-2.225297212600708,
-1.4262224435806274,
0.21906226873397827,
0.3810531497001648,
-0.6108090877532959,
-1.7671682834625244,
-1.6851801872253418,
-0.5976656079292297,
-0.6149880290031433,
2.299837350845337,
-0.5847416520118713,
0.031104039400815964,
-1.148605227470398,
-0.6453924775123596,
-0.10769756138324738,
0.32362017035484314,
1.3921185731887817,
-0.45341625809669495,
-0.2403317391872406,
1.7083284854888916,
-1.4289363622665405,
0.3722456097602844,
0.244388610124588,
0.6400835514068604,
-0.47173431515693665,
1.6568936109542847,
-1.1268779039382935,
1.4411593675613403,
-0.3268852233886719,
-1.24526846408844,
0.3949335813522339,
-0.14480441808700562,
0.11859426647424698,
-0.6543903350830078,
1.0241708755493164,
0.7596524953842163,
-1.3267958164215088,
1.2677135467529297,
1.3060141801834106,
0.37072792649269104,
-0.260658323764801,
-0.2697391211986542,
1.768760323524475,
0.1464199721813202,
-0.3200008273124695,
-0.22108279168605804,
0.27884674072265625,
1.0341005325317383,
-0.19221442937850952,
0.7065668702125549,
-0.11589254438877106,
0.33841755986213684,
2.928956985473633,
0.44875821471214294,
0.07542522996664047,
0.9648999571800232,
0.3418363332748413,
-0.24937808513641357,
0.2972119450569153,
-0.8983197808265686,
-0.3003120720386505,
0.4828284680843353,
-0.9927759766578674,
-0.1867583841085434,
0.2497132569551468,
-0.37864232063293457,
-0.6714684367179871,
0.2169080525636673,
-0.2947468161582947,
0.08639436215162277,
1.5928739309310913,
0.004725067876279354,
0.8326021432876587,
0.8802174925804138,
-0.506072998046875,
1.032321810722351,
1.319534182548523,
0.759830892086029,
-0.34151244163513184,
-1.0203511714935303,
-0.08221199363470078,
-0.7242335081100464,
0.3719024360179901,
0.4144306182861328,
0.5747227668762207,
-0.20007780194282532,
-0.3000291883945465,
-1.5796338319778442,
0.6481088399887085,
0.22409331798553467,
0.2999485433101654,
0.6600701808929443,
-0.3010122776031494,
0.9469389915466309,
0.0991012454032898,
-0.9559972286224365,
-0.5032172203063965,
-0.619248628616333,
-0.4667419493198395,
-0.2193976640701294,
-0.10417689383029938,
0.1283561885356903,
-1.5490531921386719,
-1.3698954582214355,
-0.9524800777435303,
-0.8719145059585571,
-1.0478771924972534,
-0.24742567539215088,
0.45449361205101013,
-0.7179522514343262,
-0.380979061126709,
-0.6490180492401123,
0.3182952404022217,
-0.30695027112960815,
0.2674679160118103,
0.25650909543037415,
-0.15374590456485748,
1.0245332717895508,
1.0659235715866089,
0.485201895236969,
1.5475515127182007,
0.14328868687152863,
-0.7433923482894897,
0.46614325046539307,
-0.14296282827854156,
0.17695312201976776,
-0.7555291056632996,
-0.521093487739563,
-0.032348837703466415,
-0.21740928292274475,
0.38020652532577515,
-0.2766672968864441,
-1.0299725532531738,
-0.8774496912956238,
0.6814204454421997,
1.288830041885376,
-0.7727406024932861,
-0.8406026363372803,
0.38043633103370667,
0.6839452981948853,
0.6705888509750366,
-0.10652467608451843,
-0.9659768342971802,
-0.17963440716266632,
0.30341196060180664,
0.49031010270118713,
-0.9931931495666504,
-0.2635137736797333,
-0.3619319200515747,
0.3730868399143219,
0.8764128684997559,
0.6032066345214844,
-0.26260483264923096,
0.992973804473877,
0.143790140748024,
-0.9450748562812805,
0.2796666622161865,
0.5276017189025879,
0.21936284005641937,
-0.3227781355381012,
0.20509833097457886,
-0.5241006016731262,
0.4876388609409332,
0.2513977885246277,
0.21489772200584412,
0.3542780876159668,
-0.2946927845478058,
0.2605357766151428,
-1.0082703828811646,
0.30371934175491333,
0.9431204199790955,
0.5993817448616028,
-0.542221188545227,
0.11938808858394623,
0.29499363899230957,
1.3595505952835083,
0.5628258585929871,
-0.29436877369880676,
0.25857341289520264,
0.23534654080867767,
0.11639362573623657,
0.5664628744125366,
0.5169422626495361,
-0.9176079630851746,
-0.06324812769889832,
-0.4867798388004303,
0.9143452644348145,
-0.053114600479602814,
-0.24552421271800995,
0.07956694066524506,
0.6974973082542419,
-0.09596122801303864,
0.5577858686447144,
0.46306151151657104,
-0.4033716022968292,
-0.17833146452903748,
0.0904480591416359,
-0.1569133996963501,
0.19240683317184448,
0.17106765508651733,
-0.549892008304596,
1.2494693994522095,
-0.4007205367088318,
-0.13672029972076416,
-0.7331798076629639,
0.24209432303905487,
0.02712979167699814,
0.795107901096344,
0.9032040238380432,
0.18031606078147888,
-0.47355201840400696,
-0.11637929081916809,
-0.2994459271430969,
0.726361870765686,
0.015627562999725342,
0.21832913160324097,
-0.36981919407844543,
-0.7267452478408813,
-0.03175830841064453,
0.4289347231388092,
0.07256802171468735,
-0.11553346365690231,
-0.3356892764568329,
0.09213899075984955,
-0.606837809085846,
-0.1520395427942276,
0.26063182950019836,
-0.37571069598197937,
-0.3817994296550751,
-0.05954675003886223,
-0.23414435982704163,
0.12184242904186249,
-0.5654253959655762,
0.03998580574989319,
0.10832206904888153,
-0.039996787905693054,
0.11235018074512482,
-0.034473370760679245,
0.5862780213356018,
-0.6752749681472778,
0.1435394287109375,
-0.5117477774620056,
-0.3993630111217499,
-0.11001168936491013,
0.49548885226249695,
0.23766453564167023,
0.3730842173099518,
0.03769584372639656,
-0.426989883184433,
-0.4697941839694977,
0.12521259486675262,
0.03843821585178375,
0.018584972247481346,
-1.066634178161621
] |
NCT04276389
|
OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery
|
OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter cohort study aims to assess the efficacy and safety of OCT- versus angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery after lesion preparation with scoring balloon.
|
Inclusion Criteria:
1. 18 to 85 years old
2. Patients have ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of a stenosis of at least 50% in a native coronary artery, including stable angina, unstable angina, or silent ischemia.
3. Reference vessel diameter \>2.5 mm, and \<4.0 mm.
4. Lesion length of \<22 mm
5. Written informed consent
Exclusion Criteria:
1. Myocardial infarction within 4 weeks, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction
2. Cardiogenic shock (systolic arterial pressure \<90mmHg), congestive heart failure (NYHA or Killip≥3)
3. Chronic kidney disease (eGFR \<30 ml/min)
4. Lesion length \>22 mm, or vessel diameters of \<2.5 mm or \>4.0 mm
5. Stents covering a major side branch (\>2 mm)
6. Left main lesion
7. Graft lesion
8. Aortic-coronary ostial lesion
9. In-stent restenotic lesion
10. Chronic total occlusion
11. Severe calcified lesions.
12. Visible angiographic thrombus
13. Severe comorbidities: eg. malignancy (life expectancy \<2 years)
|
[
1.7816942930221558,
2.738554000854492,
-3.333040237426758,
-4.58175802230835,
-0.4886242747306824,
-0.67058265209198,
0.5808324217796326,
1.2059648036956787,
-2.3619155883789062,
-0.10862397402524948,
0.9017540216445923,
-1.9315890073776245,
-0.13257700204849243,
0.18770524859428406,
0.849959671497345,
1.901922345161438,
1.4372832775115967,
1.5120396614074707,
-0.18186092376708984,
-2.7807788848876953,
0.10466384142637253,
0.6702932715415955,
-0.6915414929389954,
1.127883791923523,
1.9152883291244507,
-1.1672084331512451,
0.9714827537536621,
0.5666695833206177,
-0.4053034484386444,
2.100019931793213,
0.9386356472969055,
-1.7280895709991455,
1.9317513704299927,
0.2187536507844925,
-0.021935351192951202,
0.05024488642811775,
-0.6655989289283752,
0.9312278032302856,
-0.25679144263267517,
1.2743141651153564,
-0.09404148161411285,
1.034817099571228,
0.2304951250553131,
0.28069114685058594,
2.34731125831604,
0.15121032297611237,
-1.9077881574630737,
0.5946072340011597,
0.5605902075767517,
-0.3434671461582184,
-2.4538848400115967,
1.4422388076782227,
0.0631423369050026,
-1.0373730659484863,
0.0432710275053978,
-0.15295089781284332,
0.44987067580223083,
0.10306834429502487,
2.0408971309661865,
0.6981058716773987,
-0.43615978956222534,
0.9053316712379456,
-0.13148988783359528,
1.0175471305847168,
-0.9797568917274475,
0.3420547544956207,
0.3202666938304901,
1.4371931552886963,
-0.7672508955001831,
0.3705199360847473,
0.9078150391578674,
0.27015453577041626,
0.6841269731521606,
-0.47457581758499146,
0.15888985991477966,
1.5708216428756714,
0.29234445095062256,
2.9083542823791504,
0.26538923382759094,
0.3266879916191101,
0.04963172972202301,
-0.38574719429016113,
-0.8834319710731506,
-0.47383201122283936,
0.7512074112892151,
-1.0096145868301392,
-1.345208764076233,
-1.3994567394256592,
0.6970461010932922,
-0.7509629726409912,
1.2133198976516724,
0.007747012656182051,
-2.2056448459625244,
1.4356070756912231,
-0.8586723208427429,
0.01698128692805767,
-0.29119718074798584,
-0.7138575911521912,
-1.6588373184204102,
-0.33094123005867004,
0.5010733008384705,
-0.6859903931617737,
-0.6744989156723022,
0.7620166540145874,
-0.5591127872467041,
0.7413539290428162,
-0.5327909588813782,
-0.6089678406715393,
0.18909643590450287,
-0.6647031903266907,
0.6203190088272095,
-1.5487276315689087,
-0.23987369239330292,
-0.8745437264442444,
0.18754726648330688,
0.7022685408592224,
-0.13009195029735565,
1.0889294147491455,
-0.5571171045303345,
0.7152315378189087,
0.1360095590353012,
0.23578369617462158,
-0.05124254897236824,
1.4692823886871338,
0.40661850571632385,
0.7586055994033813,
0.1735362857580185,
0.393675833940506,
0.20501519739627838,
-0.37617093324661255,
-1.9691400527954102,
-0.1692047268152237,
-0.02454947866499424,
-0.2053772211074829,
-1.3888957500457764,
-0.07393135875463486,
-1.8429172039031982,
1.5164433717727661,
-0.9375576376914978,
-0.6451131701469421,
-0.08579575270414352,
0.35524284839630127,
0.3770112097263336,
0.07068686932325363,
-1.3284738063812256,
-0.6247506141662598,
-0.30524593591690063,
-0.39949727058410645,
-0.671395480632782,
0.26024943590164185,
-0.2645779252052307,
0.27608269453048706,
1.2962325811386108,
0.5752783417701721,
0.4241977035999298,
0.8638186454772949,
0.244360089302063,
-0.5319597125053406,
0.04144745320081711,
-0.17867158353328705,
0.0836467370390892,
-0.6267854571342468,
0.00007633176574017853,
-0.6293631196022034,
0.4072129726409912,
-0.6355340480804443,
-0.7954593300819397,
-0.37518173456192017,
0.5137007236480713,
0.33667242527008057,
-1.6880378723144531,
0.7562729120254517,
-0.07903778553009033,
0.17545011639595032,
-0.5897203683853149,
0.030286775901913643,
-0.1993267685174942,
-0.3049885630607605,
-0.47333046793937683,
-0.05237872526049614,
-0.23481206595897675,
0.14652696251869202,
0.7186939120292664,
-0.02056978829205036,
0.34531110525131226,
-0.0909455269575119,
-0.5690283179283142,
-0.6212372779846191,
0.4250865876674652,
0.05791294202208519,
0.14654389023780823,
0.08618278801441193,
0.4332418739795685,
0.17905472218990326,
0.18670861423015594,
-0.6015029549598694,
-0.4182848036289215,
-0.7246084809303284,
0.514786422252655,
0.02764597162604332,
0.3194442093372345,
0.9150881767272949,
-0.10586529970169067,
1.128806471824646,
0.5640257596969604,
-0.49717625975608826,
-0.4487062096595764,
0.728019654750824,
0.07426725327968597,
-0.6849483847618103,
0.1694379299879074,
-0.22162213921546936,
-0.32729992270469666,
-0.23296211659908295,
-0.011496271938085556,
0.6822102069854736,
0.017146501690149307,
0.2545053958892822,
-0.8253260254859924,
0.5003605484962463,
-0.4352917969226837,
-0.011959121562540531,
0.04945525527000427,
-0.5608786940574646,
-0.09682635962963104,
0.1966305375099182,
-0.1352781355381012,
0.3729081451892853,
-0.4222430884838104,
-0.4971865713596344,
-0.06498748809099197,
-0.03857407718896866,
-0.35368624329566956,
0.11697106063365936,
0.11351170390844345,
-0.31757494807243347,
-0.24270310997962952,
0.42892295122146606,
0.027656735852360725,
-0.09260114282369614,
0.1641111522912979,
-0.7424710392951965,
0.42421838641166687,
-0.3059256672859192,
0.32305169105529785,
-0.38991665840148926,
-0.4979785084724426,
-0.3556746244430542,
-0.3768194913864136,
-0.15998566150665283,
0.153562530875206,
-0.5232475996017456,
-0.09831126779317856,
-0.4156060516834259,
0.410757839679718,
0.005302427802234888
] |
|
NCT01488734
|
Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom
|
The purpose of this study is to compare the safety and efficacy of two different amounts of vitamin D2 (600 or 4000 International Units/day) provided by mushrooms added to one of the daily meals versus same doses of vitamin D3 provided as oral supplements sold in any drugstore in reaching adequate or optimal blood levels of 25(OH)D in people with Vitamin D deficiency and pre-diabetes (high blood sugar without full blown diabetes) or the metabolic syndrome. Metabolic syndrome is the name of a group of risk factors that raise the risk for heart disease and other health problems, such as diabetes and stroke as described by the US department of Health and Human Services.
This study will also attempt to demonstrate and compare the effect of the intervention with above two doses of vitamin D on blood levels of tests that show inflammation.
|
Poor vitamin D status is now considered epidemic in North America. In addition to its effects on bone metabolism, Vitamin D has several other important biological effects including modulating the immune system, stimulating the production of insulin and decreasing renin production in the kidney. Furthermore, the active metabolite of vitamin D, 1,25 dihydroxyvitamin D (1,25(OH)2D), is a very potent inhibitor of cellular proliferation and inducer of terminal differentiation and vitamin D deficiency has been associated with higher prevalence of cancer, autoimmune diseases, including multiple sclerosis, rheumatoid arthritis, type 1 diabetes and hypertension.
The current recommendations for dietary vitamin D in North America are much too low to maintain optimal levels of 25(OH)D associated with disease prevention. The majority of circulating 25(0H) D originates from cutaneous synthesis upon exposure to adequate sunlight. However, seasonal changes, living at high latitudes or low polluted altitudes, dark skin pigmentation and aging are among the many factors that can impede this process requiring periodic reliance on dietary sources to supply the precursor to 25(OH)D.
In November of 2010, the Institute of Medicine (IOM) of the National Academy of Science established new DRI values for vitamin: EAR (Estimated Average Requirement) of 400 IU (10 µg; RDA ( Recommended Daily Intake) of 600 IU (15µg) for adults up to 70 years of age, and an UL of 4000 IU (50µg) (21). The IOM also discourages the taking of dietary supplements to achieve the RDA for vitamin D and encourages Americans to achieve their needed vitamin D through food sources.
The proposed study will be to provide meals with one serving of fresh mushroom per day that could have two different levels of vitamin D2 in it (600 IU or 4,000 IU/day, which are the 2011 currently recommended RDA to age 70 AI and UL, respectively) for four months and test both the bioavailability of vitamin D in mushroom, as reflected in blood 25(OH)D levels, as well as the effect of vitamin D on markers of disease (e.g. C-reactive protein (CRP), Hemoglobin A1c, etc). The vitamin D2 amount in mushrooms can easily be manipulated just by adjusting the time and distance of their UVB exposure. Two groups will be compared with controls who will receive the same dose of vitamin D3 in the form of tablets commercially available (600 IU or 4000 IU/day).
|
Inclusion Criteria:
* Adult non-smoking subjects from ages 30 to 90, any race or gender
* Presence of at least two of the following characteristics:
* Waist circumference:
Men: \> 102 cm Women: \> 88 cm
* Blood pressure: \> 130/85 mm Hg (or use of anti-BP medication)
* HDL-cholesterol:
Men: \< 40 mg/dL Women: \< 50 mg/dL
* Triglycerides: \> 150 mg/dL (or use of medications for high triglycerides such as fibrates or nicotinic acid)
* Fasting blood sugar \> 100 mg/dl (or use of metformin), but a HbA1c \< 6.5%
Exclusion Criteria:
* Blood levels of 25(OH)D \> 50 nmol/L
* Regular intake of vitamin D fortified milk exceeding approximately 3 glasses/day
* Lack of the ability to comprehend instructions and/or sign the consent form
* Inability to comply with the potential requirement to eat a daily portion of provided mushroom together with meals
* Inability to comply with the rule of avoiding any beach days during the duration of the study
* Any projected trip to sunny places such as Puerto Rico and the Caribbean during the period of study
* Any attendance to tanning studios during the period of study
* Women who regularly use a veil over their heads
* Any history of kidney stone formation
* Non-traumatic bone fracture over the past 3 years
* Any form of vitamin D supplement intake, including combined calcium and vitamin D products
* Active smoking
|
[
1.2593876123428345,
2.20979642868042,
-1.1050201654434204,
-2.0703165531158447,
0.6647273898124695,
0.29574429988861084,
-0.7024286389350891,
-1.3316559791564941,
-1.3739792108535767,
-0.2241952270269394,
0.5469458699226379,
2.3596787452697754,
0.4083886444568634,
1.1089919805526733,
-0.18428386747837067,
-0.027890237048268318,
-0.790033757686615,
0.6802063584327698,
1.4358408451080322,
-2.024782419204712,
-0.19962099194526672,
0.7486538290977478,
-0.17990854382514954,
-0.6101863384246826,
-0.1356934756040573,
-0.2863515019416809,
-0.5644364356994629,
1.8276344537734985,
0.14532506465911865,
1.1752197742462158,
0.0604202002286911,
-0.6848166584968567,
0.051081087440252304,
-0.25086450576782227,
1.5071395635604858,
1.107664942741394,
1.8567901849746704,
-0.47294187545776367,
-0.1166045218706131,
0.8354086875915527,
1.8814998865127563,
0.6300331354141235,
0.6304045915603638,
0.19906917214393616,
1.3562450408935547,
0.29535800218582153,
1.9400736093521118,
-0.39985576272010803,
-0.27008840441703796,
1.0584616661071777,
0.9838492274284363,
1.500806212425232,
-1.6855385303497314,
-0.22484543919563293,
2.2564640045166016,
-0.12413442879915237,
0.713006854057312,
0.21509669721126556,
0.8257896304130554,
0.08520792424678802,
0.38535916805267334,
-0.10909703373908997,
-0.22847773134708405,
0.04350539296865463,
-0.8191062211990356,
-0.1704779416322708,
0.21485312283039093,
0.2643943727016449,
-1.141389012336731,
0.4086647033691406,
-0.635490357875824,
-0.4697084426879883,
0.10369980335235596,
-0.643669843673706,
1.0480290651321411,
0.5864822268486023,
-0.2196441888809204,
2.20650315284729,
-0.08193002641201019,
0.08004748821258545,
-1.0613839626312256,
-0.00960963312536478,
-0.2675617039203644,
0.18031460046768188,
0.7707037329673767,
0.4607565999031067,
-1.0076439380645752,
-0.20541073381900787,
0.013088662177324295,
-1.6686830520629883,
-0.08808209002017975,
-0.7468000650405884,
-0.7216944694519043,
0.32422205805778503,
-0.8946804404258728,
-0.13479141891002655,
0.32896888256073,
0.33589592576026917,
-0.26371535658836365,
-0.922380805015564,
0.3883683979511261,
1.1016570329666138,
-0.1651955395936966,
-0.24393048882484436,
-0.3702009618282318,
-0.13263261318206787,
0.7936345934867859,
0.33589649200439453,
-1.4851009845733643,
0.40756672620773315,
0.3847140669822693,
-0.47735968232154846,
-0.4553380310535431,
-0.03269290551543236,
0.6091263890266418,
0.26880642771720886,
0.44332295656204224,
-0.31016331911087036,
-0.29108044505119324,
-0.5715077519416809,
0.21127860248088837,
0.6801998019218445,
-0.3622134029865265,
-0.2832905650138855,
-0.4184030592441559,
-0.05608050525188446,
0.30830344557762146,
-0.6493359804153442,
-0.32429707050323486,
-0.31929445266723633,
-0.2664913535118103,
0.2764602303504944,
0.511738121509552,
-0.08218418806791306,
-0.2262873649597168,
-0.041504018008708954,
0.46910929679870605,
0.7632721066474915,
0.2847280502319336,
0.013418118469417095,
-0.31428977847099304,
0.04123297706246376,
-0.6431224942207336,
0.578570544719696,
-1.2389931678771973,
-0.1378776878118515,
0.14051584899425507,
0.1888599991798401,
0.11469757556915283,
-0.4923124313354492,
0.3712124824523926,
0.6082472801208496,
0.5082746148109436,
-0.23024185001850128,
-0.2293548285961151,
-0.2110292613506317,
0.1991739571094513,
-0.18808996677398682,
-0.4060896337032318,
0.36979159712791443,
0.04128231480717659,
-0.07384243607521057,
-0.19309091567993164,
-0.3910643458366394,
0.5517908334732056,
0.32137203216552734,
0.23379942774772644,
-0.15841490030288696,
0.36202991008758545,
0.04314499720931053,
0.17247259616851807,
0.44736918807029724,
-0.44113749265670776,
0.19198940694332123,
0.17986711859703064,
-0.029086103662848473,
0.29231584072113037,
-0.16133403778076172,
0.5331884026527405,
-0.30553969740867615,
-0.2444918155670166,
0.4780922830104828,
-0.07934720069169998,
-0.37122681736946106,
0.09797097742557526,
-0.05874375253915787,
-0.2963719666004181,
-0.48411861062049866,
-0.15210287272930145,
-0.07478662580251694,
-0.2910138666629791,
-0.015945235267281532,
-0.10419826954603195,
-0.02409888431429863,
-0.20618543028831482,
-0.2527869641780853,
-0.03866980969905853,
0.11759675294160843,
0.060190122574567795,
-0.05271568521857262,
0.05791429802775383,
0.024843141436576843,
-0.24373134970664978,
0.4429771900177002,
-0.486830472946167,
-0.23994924128055573,
-0.29796335101127625,
-0.20048466324806213,
0.2636769711971283,
-0.31453633308410645,
0.3305635452270508,
-0.011478562839329243,
-0.29314976930618286,
-0.0645211786031723,
-0.13870203495025635,
0.06844567507505417,
0.1726265847682953,
-0.13733917474746704,
0.2764531373977661,
-0.011353508569300175,
0.03241494297981262,
0.13908027112483978,
-0.10304532200098038,
0.1412191092967987,
-0.30880624055862427,
-0.10863280296325684,
-0.02629244141280651,
-0.01816798746585846,
-0.06338909268379211,
0.10705741494894028,
-0.5495429635047913,
-0.08846983313560486,
-0.012122207321226597,
0.03200487419962883,
-0.2916066646575928,
-0.3239259719848633,
0.22970999777317047,
0.5347762107849121,
-0.29796403646469116,
0.05173345282673836,
0.42533785104751587,
-0.10270341485738754,
-0.1892928183078766,
-0.039163876324892044,
0.10115577280521393,
-0.20444318652153015,
-0.5003824830055237,
-0.08953175693750381,
-0.18655146658420563,
0.24234244227409363,
-0.0480043850839138,
-0.12495091557502747,
0.06921004503965378,
0.4169989824295044,
-0.031971704214811325,
-0.20974385738372803
] |
NCT01518452
|
Computerized Working Memory Training in Very-low-birth-weight Children at Preschool Age
|
The main aim of this prospective interventional study is to compare quantitative EEG findings and cognitive and neuropsychological test results before and after training with the Cogmed JM program in a group of very-low-birth-weight children in preschool age, i.e. ages 5-6 years. The investigators hypothesize that the children in the study may respond positively to the computerized training and improve working memory, but probably to different degrees depending on the underlying neurological condition. The investigators also hypothesize that training may benefit additional executive functions.
|
Children born preterm are at increased risk of neurological disabilities due to perinatal brain damage. During the last ten years an increasing number of especially extremely low birth weight (ELBW: BW ≤ 1000g) children has survived, and one might wonder whether this has lead to increased amount of brain pathology and impairments among survivors. Major impairments including cerebral palsy, mental retardation and impaired vision and hearing are most common in children born extremely preterm (gestational age below 28 weeks). In addition to this, a large part of survivors after preterm birth will experience motor problems, cognitive dysfunctions, psychiatric and behavioural problems of varying severity.
In our previous research we have found significant deficits in working memory in very preterm born children, and this seems to have a strong influence on cognitive functioning. During the last years, several studies have shown that working memory skills can be trained, and training working memory to improve cognition and executive functions is regarded as one of the major steps forward in neuroscience in recent years.
The working memory training program version for preschoolers, Cogmed JM, has recently been launched. Healthy preschoolers trained on working memory improved significantly on trained tasks but also on non-trained tests of spatial and verbal working memory, as well as transfer effects on attention. The preschool version of the program has not yet been administered to preterm born or other neurologic high risk children in this age group.
The main aim of this prospective interventional study is to compare quantitative EEG findings and cognitive and neuropsychological test results before and after training with the Cogmed JM program in a group of very-low-birth-weight children in preschool age, i.e. ages 5-6 years. We hypothesise that the children in the study may respond positively to the computerized training and improve working memory, but probably to different degrees depending on the underlying neurological condition. We also hypothesise that training may benefit additional executive functions.
The children in the study will be divided into two subgroups (15/15 children). Subgroup A will start training, while subgroup B waits during this first training period. Subgroup B will therefore act as a control group. After 8 weeks subgroup B will then start training. This is in agreement with the so-called Stepped Wedge design (Brown and Lilford 2006).
|
Inclusion Criteria:
* VLBW (birth weight ≤ 1500 grams)
* preschool child
* born at St. Olav's University Hospital in Trondheim in 2005 and 2006
Exclusion Criteria:
* birth weight \>1500 grams
* diagnosed genetic syndromes
* severe cerebral palsy with totally impaired bilateral hand function (GMFCS - gross motor function classification scale level V)
* blindness
|
[
0.12273810058832169,
2.7543580532073975,
-3.553328275680542,
-2.111452341079712,
0.30589067935943604,
0.06232696771621704,
-1.64040207862854,
-1.1650261878967285,
-0.2715666890144348,
0.6112655401229858,
1.3864089250564575,
1.9530333280563354,
0.08544804155826569,
0.31688031554222107,
-0.86387038230896,
1.3040143251419067,
0.6438403129577637,
-0.5859962105751038,
-0.20807552337646484,
-1.3104861974716187,
-0.03649422526359558,
0.0969979465007782,
0.31056907773017883,
-1.229943871498108,
0.9193779230117798,
0.8122243881225586,
-0.3123991787433624,
1.6897451877593994,
-0.5591998100280762,
0.7133598327636719,
0.7221542000770569,
0.010275891050696373,
0.36225855350494385,
-0.4727683663368225,
0.42763760685920715,
0.46503958106040955,
0.4666145145893097,
-0.8474916815757751,
-0.5039141178131104,
0.023680536076426506,
0.450463205575943,
0.30295804142951965,
0.38954952359199524,
0.1971403807401657,
0.7756158113479614,
1.4392588138580322,
-0.04450610280036926,
0.9795438051223755,
-0.45491841435432434,
0.6591219902038574,
-0.7448648810386658,
0.03903016075491905,
-0.918120801448822,
-0.2933642268180847,
1.8992605209350586,
-0.3812425136566162,
0.17616230249404907,
-0.2569630444049835,
1.216111183166504,
-0.8262336850166321,
0.8475815057754517,
-0.43965643644332886,
1.5643457174301147,
0.04254917427897453,
-0.28417107462882996,
-0.5905348658561707,
0.11541017144918442,
-0.29855167865753174,
-0.8846734166145325,
0.017863107845187187,
1.318217158317566,
0.1332346498966217,
0.5069432258605957,
0.26709139347076416,
0.28887972235679626,
0.31833508610725403,
-0.0941319391131401,
0.2557142674922943,
1.0002597570419312,
0.4024895131587982,
0.06220664829015732,
-0.07854176312685013,
-0.8995351791381836,
0.3260475695133209,
0.7081673741340637,
-0.5318405628204346,
-0.8816084861755371,
-0.5896759629249573,
1.1814732551574707,
-0.6978746056556702,
-0.6578978896141052,
-0.49903056025505066,
-1.2132134437561035,
0.15356750786304474,
0.7818395495414734,
0.16002555191516876,
-0.32275134325027466,
-0.43853849172592163,
-0.9554269313812256,
0.3969627618789673,
0.26538345217704773,
0.18401791155338287,
-1.0841649770736694,
0.3881486654281616,
-0.697059690952301,
-0.5728039741516113,
0.013408650644123554,
-1.2568974494934082,
-0.5141282677650452,
1.0838168859481812,
-0.2595677971839905,
-1.2096089124679565,
0.16810418665409088,
-0.05917848274111748,
0.24947156012058258,
0.04399542137980461,
1.1365681886672974,
0.5170061588287354,
0.5788173079490662,
-0.7684405446052551,
0.42586877942085266,
0.47575798630714417,
0.277008593082428,
-0.5032330751419067,
0.010545155964791775,
-0.03810810297727585,
0.5535296201705933,
-0.3905014991760254,
-0.5768419504165649,
-0.681007981300354,
-0.38232383131980896,
0.20252680778503418,
0.6101593375205994,
-0.48831772804260254,
-0.24302738904953003,
-0.7341023683547974,
0.857789933681488,
0.3874032497406006,
-0.2624628245830536,
-0.47297531366348267,
-0.16880060732364655,
0.2940928637981415,
-0.280551940202713,
-0.6000648140907288,
-0.8422496318817139,
-0.421377032995224,
0.3092052936553955,
-0.6967740058898926,
-0.6733047366142273,
-0.29631343483924866,
-0.19708222150802612,
-0.14424514770507812,
0.2683691680431366,
0.45641234517097473,
-0.3995165526866913,
0.8317495584487915,
-0.2575666904449463,
-0.3501911163330078,
0.2970830202102661,
-0.3608367443084717,
0.36206841468811035,
-0.9139859080314636,
0.15159237384796143,
-0.08666960895061493,
0.08577678352594376,
-0.5858251452445984,
-0.0806322693824768,
0.3511491119861603,
-0.04137120023369789,
-0.20071318745613098,
-0.7825737595558167,
0.15483145415782928,
0.21885602176189423,
0.4344039261341095,
0.04970496892929077,
0.25350287556648254,
0.6832144260406494,
-0.4862612187862396,
0.08956846594810486,
0.7701327204704285,
0.3110371530056,
0.5207496285438538,
0.2740602195262909,
-0.46683382987976074,
0.14295582473278046,
-0.3968951106071472,
-0.6786990165710449,
-0.09223335981369019,
-0.2886742949485779,
-0.380194753408432,
0.035061683505773544,
-0.3536456823348999,
-0.051897212862968445,
-0.7531821727752686,
0.3897775411605835,
0.25060588121414185,
0.19485481083393097,
-0.3098594844341278,
0.34954383969306946,
-0.30197465419769287,
0.2710629999637604,
0.5217806696891785,
-0.2471872866153717,
0.40658098459243774,
-0.25187063217163086,
-0.0707966759800911,
-0.23276592791080475,
0.13299855589866638,
0.20572589337825775,
-0.18130284547805786,
0.18056006729602814,
0.5680729746818542,
-0.512357234954834,
0.421406626701355,
0.3089200258255005,
0.11056553572416306,
-0.051201026886701584,
-0.27425962686538696,
-0.8458860516548157,
0.3670141398906708,
-0.22250959277153015,
-0.33260273933410645,
0.15562385320663452,
-0.41549280285835266,
-0.2726556360721588,
-0.03058670274913311,
-0.18367056548595428,
0.13258305191993713,
0.46728962659835815,
0.29775187373161316,
-0.26986420154571533,
-0.206524059176445,
-0.1031574159860611,
-0.11928295344114304,
-0.6038284301757812,
-0.12524718046188354,
0.06212753802537918,
0.37333187460899353,
-0.19822748005390167,
-0.25125813484191895,
0.07748319953680038,
-0.3777843713760376,
0.1909296065568924,
-0.42539167404174805,
0.04026387631893158,
-0.5978425145149231,
-0.20170050859451294,
-0.10620024055242538,
-0.5133901834487915,
-0.09719962626695633,
0.38545164465904236,
-0.15577198565006256,
0.14350531995296478,
-0.147133469581604,
0.7548893690109253,
0.0010271284263581038
] |
NCT00478868
|
Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients
|
To assess: a) The prevalence of Modic changes and other findings on lumbar magnetic resonance imaging (MRI), among Spanish adult chronic LBP patients, b) Patient characteristics and radiological findings associated with Modic changes.
|
Ten radiologists from six hospitals across six cities in Spain, consecutively recruited 487 adult patients (263 women and 224 men) in whom lumbar MRI had been prescribed for low back pain lasting ≥ 3 months. Patients' characteristics and imaging findings were assessed through previously validated instruments. A multivariate logistic regression model was developed to assess the features associated with Modic changes.
Outcome measures were: Gender, age, body mass index (BMI), life time smoking exposure, degree of physical activity, and image features (disk degeneration, type and extension of Modic changes, disk contour, annular tears, spinal stenosis and spondylolisthesis).
|
Inclusion Criteria:
* Patients between 35 and 50 years of age having a diagnosis of chronic low back pain (of 3 or more months' duration, and including sciatica and lumbar cytalgia), who get a prescription for an MRI.
Exclusion Criteria:
* Racial characteristics suggesting a non-Spanish origin; central nervous system pathology (with or without treatment);
* Diagnosis or suspicion of systemic disease (inflammatory disease such as rheumatoid arthritis, or infections).
|
[
1.5229421854019165,
3.756711006164551,
-2.6115376949310303,
-2.029883623123169,
0.27627527713775635,
0.3989909887313843,
-0.8952102661132812,
-1.9096649885177612,
-0.8285261392593384,
0.5094240307807922,
1.1959718465805054,
3.7050366401672363,
-2.27585506439209,
0.781928539276123,
0.5592083930969238,
2.123857259750366,
-1.4687199592590332,
-1.1128339767456055,
1.0437943935394287,
-1.1160334348678589,
-0.30257678031921387,
-1.985080599784851,
0.5797277688980103,
-0.5687916278839111,
2.0739336013793945,
-0.9531075358390808,
-1.9152904748916626,
2.0036780834198,
-1.7999337911605835,
0.052510470151901245,
0.9058561325073242,
-1.2683457136154175,
-1.2831358909606934,
2.6333234310150146,
0.7516080737113953,
-1.0158984661102295,
0.3297584354877472,
-0.3227405846118927,
-2.3309593200683594,
-0.04753963649272919,
0.6650041341781616,
-0.8792381286621094,
0.8709504008293152,
0.5604108572006226,
0.15061169862747192,
0.3738252818584442,
-0.36772915720939636,
0.6354950666427612,
-1.4189996719360352,
-1.361693024635315,
-0.35437044501304626,
2.4391930103302,
-0.3627461791038513,
1.5218721628189087,
1.3604685068130493,
1.4568010568618774,
1.277395248413086,
1.2923232316970825,
1.414950966835022,
-0.8973413109779358,
-0.994492769241333,
-0.2375308871269226,
-0.01078715268522501,
2.551971673965454,
1.206210970878601,
0.19960519671440125,
-1.2805581092834473,
0.19921110570430756,
-0.6009948253631592,
0.01700247824192047,
0.5233869552612305,
0.9270214438438416,
0.5180294513702393,
1.176694631576538,
1.1143395900726318,
0.6963379383087158,
-1.5055075883865356,
0.9045525193214417,
-0.3941900432109833,
0.22367851436138153,
0.004801113624125719,
-0.8753058910369873,
-1.5933884382247925,
1.1578316688537598,
0.3040638864040375,
0.17024776339530945,
-1.1093344688415527,
-0.3773678243160248,
0.6666030287742615,
0.7010573744773865,
0.41470715403556824,
-1.108787178993225,
-0.2973213791847229,
0.6579855680465698,
-0.6313334107398987,
0.010632346384227276,
-0.8595786690711975,
-0.6084502339363098,
-2.460585594177246,
-1.1568901538848877,
-1.2948086261749268,
-0.40666648745536804,
-0.7968984842300415,
-1.462785005569458,
0.2858523428440094,
-0.16210700571537018,
-0.33850371837615967,
0.0268414244055748,
0.38332661986351013,
0.6547371745109558,
-0.5494000911712646,
-0.9299175143241882,
-0.29758119583129883,
-1.0985512733459473,
0.4952958822250366,
-0.5516989827156067,
0.8911287188529968,
1.7617661952972412,
0.5866327285766602,
-1.5913742780685425,
0.1364872306585312,
0.8221733570098877,
-0.24863110482692719,
1.2506957054138184,
-0.29441171884536743,
-0.3353588283061981,
-0.3004413843154907,
0.7426789402961731,
-1.303574562072754,
-0.3810264766216278,
0.06354114413261414,
-0.33451664447784424,
0.3690371811389923,
-0.14656561613082886,
0.43242475390434265,
0.9793701171875,
0.21327154338359833,
0.6162482500076294,
0.041292786598205566,
-1.2037941217422485,
0.9150994420051575,
0.5474554300308228,
0.22638501226902008,
0.9753730297088623,
-1.8076701164245605,
-1.480002999305725,
0.33284831047058105,
0.0966094434261322,
-1.496362566947937,
-1.162135124206543,
-0.18403546512126923,
1.1825387477874756,
1.773368000984192,
0.5212122797966003,
-0.3337871730327606,
-0.22827427089214325,
0.5627268552780151,
-0.5314685106277466,
0.8871508836746216,
-0.3052167594432831,
0.788016676902771,
-0.4343738555908203,
-0.4150340259075165,
-0.883867621421814,
0.5388658046722412,
-0.14367270469665527,
0.1462276428937912,
-0.4646936357021332,
0.5170484185218811,
0.2568146586418152,
0.500040590763092,
-0.03292723372578621,
0.6940579414367676,
0.5425420999526978,
-1.3578003644943237,
-0.8873540163040161,
0.6740432381629944,
0.9827867746353149,
1.0996699333190918,
-0.43375763297080994,
0.46073585748672485,
-1.123354434967041,
0.38213708996772766,
0.10645928233861923,
-0.2700221836566925,
0.14770559966564178,
0.06610004603862762,
-0.6141086220741272,
-0.7294542789459229,
-0.15487194061279297,
-0.5132564902305603,
-0.7757554650306702,
-0.13183823227882385,
0.16553501784801483,
0.6376444101333618,
0.21865613758563995,
-0.7477493286132812,
-0.2713601291179657,
0.960636556148529,
0.10573530197143555,
0.1953454166650772,
0.4311550259590149,
-0.2877781093120575,
0.3217012286186218,
0.26937633752822876,
-0.029338596388697624,
-0.593601405620575,
0.08206064254045486,
-0.7413123250007629,
0.361211359500885,
0.016589218750596046,
0.4786061644554138,
0.5843768119812012,
-0.1427958458662033,
-0.054310142993927,
0.1404905468225479,
-0.4404813051223755,
0.4613361060619354,
-0.2800695598125458,
0.07599332183599472,
-0.40792137384414673,
-0.9112335443496704,
0.05795235186815262,
-0.43400588631629944,
-0.9605686664581299,
-0.6160388588905334,
-0.9379494786262512,
0.4093315303325653,
0.7899299263954163,
-0.36460378766059875,
-0.5272315144538879,
-0.344066858291626,
-0.037601277232170105,
-0.33662915229797363,
-0.29154887795448303,
-0.06965509057044983,
0.25033503770828247,
-0.5777264833450317,
-0.3742583692073822,
0.7177140116691589,
0.03641105815768242,
-0.17820343375205994,
-0.02567281574010849,
-0.18082034587860107,
0.2302846908569336,
-0.27289271354675293,
-0.5001190900802612,
-0.30757009983062744,
-0.2473028600215912,
0.05961751565337181,
-0.2736768126487732,
0.22825901210308075,
0.07865576446056366,
0.45359060168266296,
0.2505960464477539,
0.03995376080274582
] |
NCT02745886
|
Metformin Induces a Dietary Restriction-like State in Human
|
The fact that metformin treatment has been associated with reduced risk of cancer and cardiovascular disease raises the possibility of a beneficial role of metformin for other age-related diseases. The actions of metformin resemble the effects of calorie restriction (CR) to some extent, and microarray analyses have shown that metformin induces a gene expression profile that aligns with that of CR in animal. The aim of the study is to investigate whether metformin treatment can induce dietary restriction-like state in human.
Sixty overweight subjects will be included in this study, and participants will be divided 3 groups (20 cases in each group)including metformin group (0.85, twice daily), standard diet group, and CR group. All subjects will be treated 6 months. At the end of this study, blood samples and muscle samples will be obtained.
|
Blood samples will be obtained from all individuals. blood lipids, inflammation markers, insulin, glucose, leptin,adiponectin, ala aminotransferase, asp aminotransferase, creatine phosphokinase,lactate dehydrogenase, alkaline phosphatase,bilirubin, cyclo-oxygenase, citrate synthase, renal function, leukocyte telomere length ratio, and telomerase activity will be measured before and after the treatments.Also, hyperinsulinemic-euglycemic clamp will be performed before and after the treatments. Muscle samples will be obtained by biopsy for 9 individuals (3 cases from each group) at the end of the study. Microarray analysis will be performed for the gene expression profile from the muscle samples. Other protein expressions such asadenosine monophosphate-activated protein kinase (AMPK), peroxisome proliferator-activated receptor coactivator 1a (PGC-1a) activity,will be checked by Western blot.
|
Inclusion Criteria:
* Overweight
* Male
Exclusion Criteria:
* Female
* Obesity
* Using any other drugs
* \< 18 years old
* \> 60 years old
* Mental disorders
* Surgery history for abdomen
|
[
0.5265674591064453,
2.4265615940093994,
-1.9586639404296875,
-1.2647438049316406,
1.1174888610839844,
-0.16507044434547424,
-0.8293021321296692,
-1.028967022895813,
-1.6567593812942505,
-0.8783179521560669,
0.7234742045402527,
1.2447590827941895,
0.02366303838789463,
0.7483675479888916,
0.2682149410247803,
0.020275933668017387,
-0.23727206885814667,
-1.0874205827713013,
1.1161766052246094,
-1.9137033224105835,
-1.0996079444885254,
-0.05269753560423851,
-0.3898540735244751,
-0.5928962230682373,
0.15334607660770416,
0.14229853451251984,
-0.3557341992855072,
1.4996826648712158,
-0.05672614648938179,
0.9379380345344543,
-0.33522430062294006,
-1.1137328147888184,
0.4404357373714447,
0.3595745265483856,
0.2935824692249298,
-0.3040887117385864,
1.3874675035476685,
0.6978684067726135,
-0.5910934209823608,
0.16201551258563995,
-0.1255015730857849,
0.598789632320404,
0.3549923598766327,
0.11011074483394623,
0.4763784110546112,
0.31747570633888245,
0.6256011724472046,
0.22540274262428284,
-0.15004146099090576,
-0.01771320402622223,
-0.255412220954895,
0.8893439769744873,
-0.8809313774108887,
-0.3559059798717499,
0.7659308910369873,
0.8739305734634399,
-0.1290055215358734,
0.49763813614845276,
1.8148597478866577,
0.29873597621917725,
0.8528050780296326,
-0.10017489641904831,
0.40235501527786255,
1.1000666618347168,
-0.23832491040229797,
-0.490573912858963,
0.3097662627696991,
0.46044009923934937,
0.3975013494491577,
0.35246455669403076,
0.35680216550827026,
-0.12665221095085144,
0.4484661817550659,
0.09586426615715027,
-0.3342808485031128,
0.44991254806518555,
0.36391782760620117,
-0.21308957040309906,
-0.07595054805278778,
-0.04486151039600372,
-0.8504503965377808,
-0.3747725784778595,
-0.16943368315696716,
-0.3156588673591614,
0.7581878900527954,
-0.08082188665866852,
-0.7502795457839966,
-0.7413409948348999,
0.45696258544921875,
-1.957984209060669,
0.23052023351192474,
-1.1563576459884644,
-0.4923929274082184,
1.1544280052185059,
-0.43573319911956787,
0.44315996766090393,
0.47212716937065125,
0.17011483013629913,
0.207357257604599,
-0.7041439414024353,
0.15205694735050201,
0.050919678062200546,
0.40923747420310974,
-0.44334712624549866,
-0.9220153093338013,
-0.32854366302490234,
-0.6713955402374268,
-0.6043513417243958,
-0.7096070051193237,
0.43613532185554504,
-0.18959113955497742,
-0.5273615717887878,
0.2919682562351227,
-0.4486720860004425,
0.475272536277771,
-0.3306041359901428,
0.3035847842693329,
-0.14312955737113953,
-0.8639978170394897,
-1.344476580619812,
-0.0986090749502182,
0.36849474906921387,
-0.5574706196784973,
0.4477938115596771,
-0.5655477643013,
-0.5828607082366943,
-0.2271934449672699,
-0.5404894948005676,
0.6898623108863831,
0.022038534283638,
-0.32641690969467163,
0.015935594215989113,
0.07238287478685379,
-0.47194668650627136,
-0.056579653173685074,
0.40533381700515747,
0.1666802018880844,
0.6412151455879211,
0.48562493920326233,
0.3786707818508148,
-0.41886764764785767,
0.04364398121833801,
0.193464457988739,
1.2113431692123413,
-1.2826852798461914,
-0.17934630811214447,
0.5498038530349731,
-0.8361016511917114,
-0.2966538965702057,
-0.3513917922973633,
-0.3191562294960022,
-0.2611044645309448,
-0.23412221670150757,
0.009958840906620026,
-0.44968748092651367,
0.1752626597881317,
-0.037217143923044205,
-0.41556376218795776,
-0.1763327419757843,
-0.277710884809494,
0.09185387939214706,
-0.467606782913208,
-0.46698519587516785,
-0.4668365716934204,
0.5033354759216309,
0.1738322675228119,
0.5459349751472473,
-0.11141572147607803,
-0.10188370943069458,
0.6364350318908691,
0.11535502225160599,
-0.2999211847782135,
-0.30213505029678345,
0.15749923884868622,
-0.2390241026878357,
-0.04828488826751709,
0.5832993388175964,
0.34499913454055786,
0.2915574312210083,
-0.2397005259990692,
-0.2854434549808502,
0.29678550362586975,
0.0886698067188263,
-0.11997701972723007,
-0.15221355855464935,
-0.19371673464775085,
-0.5317288041114807,
-0.4036654233932495,
0.20647326111793518,
-0.5564271807670593,
0.29317590594291687,
0.3767043650150299,
-0.19837960600852966,
0.5640401244163513,
0.2999632656574249,
0.17436431348323822,
-0.09061434864997864,
-0.31736233830451965,
0.428971529006958,
-0.1495514065027237,
-0.38638991117477417,
0.01301010511815548,
-0.46221959590911865,
0.6708864569664001,
-0.5032865405082703,
0.21662099659442902,
-0.33886954188346863,
-0.24374130368232727,
-0.1287931203842163,
0.05764380097389221,
0.31441813707351685,
-0.3112313151359558,
-0.250565767288208,
0.06635657697916031,
0.5019321441650391,
0.7721459865570068,
-0.2540033459663391,
0.2409212589263916,
-0.3627697825431824,
-0.05153152346611023,
0.3281221091747284,
-0.15462832152843475,
-0.2664030194282532,
-0.5715421438217163,
-0.3625074625015259,
-0.27235615253448486,
0.12406038492918015,
0.09694214910268784,
0.33692553639411926,
-0.03132298216223717,
-0.13429959118366241,
0.21366696059703827,
-0.0762200579047203,
0.16855394840240479,
-0.22476346790790558,
-0.19967162609100342,
0.07490413635969162,
0.34638968110084534,
-0.09978961944580078,
0.060299716889858246,
-0.040777288377285004,
-0.5104761719703674,
-0.19399835169315338,
-0.10145372897386551,
0.24788935482501984,
-0.32170796394348145,
-0.29889413714408875,
0.07507286965847015,
0.2324834018945694,
-0.09233240783214569,
-0.30966654419898987,
-0.1737784743309021,
-0.1688302755355835,
0.04249502718448639,
0.23742933571338654,
-0.46383029222488403
] |
NCT05175976
|
Patient Safety in the Operating Room: Helsinki Declaration Implementation in Ukraine
|
Athe study to evaluate the implementation of the components of the Declaration of Helsinki in Ukrainian hospitals, as well as other safety measures during surgeries.
|
A study was conducted from May 2021 to September 2021 at the Ukrainian hospitals. The study design was approved by the Ethical Committee at Bogomolets National Medical University. The survey was conducted by filling out a standard Google form. The link to the survey was distributed on the official page of the Association of Anesthesiologists of Ukraine, through social networks Facebook and Instagram on the official webpages of the Department of Surgery, Anesthesiology and Intensive Care of the Institute of Postgraduate Education of NMU. O.O. Worshipers. A total of 174 respondents took part in the survey.
To conduct the survey, we formed a questionnaire of 24 items. The questionnaire was designed to ensure sufficient collection of data from respondents on demographics, awareness of the Declaration, and the use in the everyday practice of the measures recommended in it to promote patient safety. However, the structure of the questionnaire allowed people to fill it in a short time. We also provided respondents with more descriptive and detailed answers to some questions if they wished. The survey was conducted in Ukrainian. Practitioners-anesthesiologists, as well as heads of departments, employees of departments, were invited to participate in the survey.
The survey results were imported into a Microsoft Excel spreadsheet for further analysis. Simple descriptive statistics were used for demographic data and numerical answers to individual questions. The answers, which included the free text were grouped by topic using simple qualitative techniques.
|
Inclusion Criteria:
* experienced anesthesiologists
Exclusion Criteria:
* anesthesiologists out of practice
|
[
1.434863567352295,
4.502649307250977,
-1.901918888092041,
-0.4660927355289459,
0.507231593132019,
0.9315441250801086,
0.9650622010231018,
0.8942186832427979,
-2.2873594760894775,
2.721605062484741,
-0.8215245604515076,
1.8888156414031982,
-1.3191554546356201,
-0.007282043807208538,
-0.09326039254665375,
0.2968781292438507,
0.35084086656570435,
1.8491337299346924,
2.321382999420166,
-0.9258808493614197,
-1.207833170890808,
0.3702424466609955,
0.8520294427871704,
0.00955952424556017,
2.930128335952759,
0.8949869871139526,
-1.0483111143112183,
-1.9365882873535156,
-0.563089907169342,
0.08157995343208313,
-0.3369860351085663,
-0.3528142273426056,
-0.5797265768051147,
0.9831270575523376,
0.06027851998806,
-1.833280324935913,
-0.4817984402179718,
-0.07113371789455414,
0.20091626048088074,
-0.32443082332611084,
1.4810669422149658,
1.121370553970337,
-0.367549866437912,
-1.796509027481079,
0.02307860180735588,
-0.6404983997344971,
0.28313225507736206,
-0.09129295498132706,
-0.00460193632170558,
1.1540049314498901,
-1.1665092706680298,
0.889412522315979,
-0.8204535245895386,
0.5745975971221924,
1.3677093982696533,
-0.1557069718837738,
-0.1805836707353592,
0.2664903700351715,
1.2505972385406494,
0.2188037782907486,
1.278132438659668,
-0.2881278991699219,
-0.04618183895945549,
1.5139098167419434,
-1.0395604372024536,
-0.07559305429458618,
-0.2511941194534302,
0.6517651677131653,
-0.6859550476074219,
0.08343642950057983,
-0.05831961706280708,
-0.2086995244026184,
1.3983070850372314,
0.407848984003067,
0.6667219400405884,
0.2666114568710327,
1.4806020259857178,
0.3102891445159912,
-0.026200653985142708,
0.9911558628082275,
1.1943049430847168,
-0.1195710226893425,
-0.5687403082847595,
0.6370494365692139,
0.34021225571632385,
-0.8123654723167419,
-1.3285008668899536,
-0.8492745161056519,
0.6750602722167969,
-0.5499948859214783,
-1.0071059465408325,
0.9957651495933533,
-0.4454296827316284,
0.22659064829349518,
-1.3416593074798584,
0.2944733500480652,
-0.738294243812561,
-0.6107242703437805,
0.41478225588798523,
-0.38716182112693787,
-0.6223846077919006,
0.18134979903697968,
-0.5117301344871521,
-0.21242709457874298,
0.2769840359687805,
0.21610239148139954,
-0.24383319914340973,
0.8468266129493713,
-0.8521244525909424,
2.0437073707580566,
1.3786861896514893,
-0.25313055515289307,
1.0112996101379395,
-0.10720721632242203,
-0.17929819226264954,
-0.17929138243198395,
0.5744478702545166,
0.14259789884090424,
0.5071263313293457,
0.14977839589118958,
0.5813182592391968,
0.014507547952234745,
0.8520660996437073,
0.03273634985089302,
0.11356434971094131,
-0.19011300802230835,
0.25942370295524597,
0.012148727662861347,
-1.6693575382232666,
-0.5594861507415771,
-1.2670708894729614,
0.02131497859954834,
-0.38478603959083557,
0.2375107705593109,
0.446729451417923,
0.4566800892353058,
-0.6021212339401245,
0.28320789337158203,
0.225197434425354,
-0.45219606161117554,
1.3044461011886597,
0.3709176480770111,
-0.026289939880371094,
-0.5715002417564392,
-0.5214569568634033,
-0.11974414438009262,
-0.37576714158058167,
-0.5917376279830933,
-1.222009539604187,
0.07520642876625061,
0.29634296894073486,
0.6564599871635437,
1.0834957361221313,
-0.3005562722682953,
-0.1062362790107727,
-0.17098316550254822,
0.6838743686676025,
0.4322766661643982,
-0.11360365897417068,
0.08781705796718597,
-0.8114001750946045,
-0.5252091884613037,
-0.3408195972442627,
-0.10143537819385529,
-0.39404553174972534,
0.6479581594467163,
-0.15458200871944427,
-0.41595935821533203,
0.8473707437515259,
0.7520436644554138,
-0.519474983215332,
1.288691759109497,
-0.42630746960639954,
0.09594228118658066,
0.46340423822402954,
0.004313753917813301,
-0.5363632440567017,
1.2927006483078003,
0.8981467485427856,
0.9658789038658142,
0.0704304426908493,
0.5685070753097534,
0.6262293457984924,
0.2784607708454132,
0.637290358543396,
-0.08040449768304825,
-0.7141323089599609,
-0.4605931043624878,
-0.37818947434425354,
0.40850088000297546,
-0.3604952394962311,
-0.07090988755226135,
0.036168985068798065,
-0.2831367254257202,
0.7589125633239746,
0.33456090092658997,
-0.1900441199541092,
-0.5610119104385376,
-0.3493692874908447,
-0.041715167462825775,
-0.1413770616054535,
0.19379781186580658,
-0.6195845603942871,
-0.0553290955722332,
0.13309338688850403,
0.12388202548027039,
-0.4790235757827759,
0.2691774368286133,
-0.009667327627539635,
0.12111669778823853,
0.05440672114491463,
0.16171465814113617,
-0.353688508272171,
-0.2252068817615509,
-0.045951224863529205,
-0.13761655986309052,
0.09012363851070404,
0.5841406583786011,
-0.541294515132904,
0.05914866924285889,
-0.05026976019144058,
-0.5283108949661255,
-0.9033846259117126,
0.06962363421916962,
0.27454039454460144,
-0.4164464771747589,
-0.48422348499298096,
-0.17365522682666779,
0.8209017515182495,
0.2550819218158722,
-0.16522197425365448,
0.024738110601902008,
-0.11651740968227386,
-0.2130768746137619,
-0.021992353722453117,
0.15307427942752838,
-0.38336244225502014,
-0.14780516922473907,
0.4423423111438751,
0.42781543731689453,
0.11700019985437393,
-0.5523040890693665,
0.6852224469184875,
-0.6525586843490601,
0.18549835681915283,
0.3190443515777588,
0.3812195062637329,
0.7976936101913452,
0.11795662343502045,
0.3427122235298157,
-0.7200300693511963,
-0.462378591299057,
-0.3225034475326538,
0.3517691195011139,
-0.3053576946258545,
0.11434095352888107
] |
NCT03395041
|
Periodontal Disease, Inflammation and Acute Coronary Syndromes
|
Recent studies have shown that the systemic inflammation caused by periodontal disease (PD) can determine important changes in the coronary arteries, favoring atherosclerosis progression and development of acute coronary syndromes (ACS). The aim of ATHERODENT study is to assess the interrelation between PD, inflammation and progression of coronary atherosclerosis in patients with ACS. Material and methods: This case-control observational study will enroll 100 patients (group 1 - ACS and associated PD, and group 2 -ACS and no PD), in whom the following data will be collected: (1) demographic and clinical data, (2) cardiovascular risk factors, (3) full characterization of PD markers, (4) systemic inflammatory biomarkers, (5) imaging biomarkers derived from transthoracic echocardiography, computed tomography, coronary angiography, optical coherence tomography and intravascular ultrasound, and (6) assessment of the presence of specific oral bacteria in samples of coronary plaques collected by coronary atherectomy, which will be performed during percutaneous revascularization interventions, when indicated in selected cases, in the atherectomy sub-study. The follow-up will be performed at 1, 3, 6, 12, 15, 18 and 24 months. The primary endpoint of the study will be represented by the rate of major adverse cardiovascular events (MACE rates) in PD vs non-PD patients and in correlation with: (1) the level of systemic inflammation triggered by PD and/or by ACS at baseline; (2) the vulnerability degree of atheromatous plaques in the coronary tree (culprit and non-culprit lesions); and (3) the presence and burden of oral bacteria in atheromatous plaques. Secondary endpoints will be represented by: (1) the rate of progression of vulnerability degree of non-culprit coronary plaques; (2) the rate of progression of atheromatous burden and calcium scoring of the coronary tree; and (3) the rate of occurrence of left ventricular remodeling and postinfarction heart failure.
|
ATHERODENT is a case-controlled observational clinical study, conducted in two clinical sites: University of Medicine and Pharmacy Tirgu Mures, Romania, and Cardio Med Medical Center - Laboratory of Advanced Research in Multimodality Imaging.
The primary objective of ATHERODENT is to assess the interrelation between PD, inflammation and atherosclerosis progression in patients who suffered an ACS and have concomitant PD vs those with ACS and no PD, using (1) invasive and non-invasive imaging techniques for characterization of vulnerable coronary plaques; (2) full characterization of PD; and (3) complex assessment of systemic vulnerability based on systemic inflammation-related biomarkers.
The secondary objectives of ATHERODENT are:
1. to study the correlation between PD and coronary plaque vulnerability
2. to assess the correlation between PD and severity of coronary atherosclerosis
3. to assess the presence and burden of oral bacteria in coronary atheromatous plaques collected during atherectomy and their relation with plaque vulnerability and evolution following an ACS (in the atherectomy sub-study).
Baseline will be considered as the moment of the index event and related hospitalization. The index event will be considered the ACS and patients will be randomized in the study at maximum 7 days post ACS. The follow-up visits will be performed at 1, 3, 6, 12, 15, 18 and 24 months after randomization.
The following procedures will be performed at baseline:
1. recording of demographic and clinical data (age, gender, personal history)
2. determination of serum lipids, blood counts, glycemia, urea, creatinine, liver enzymes
3. determination of the biomarkers expressing the severity of the acute coronary syndrome and heart damage (hs-Troponin, NT-proBNP)
4. determination of serum levels inflammatory biomarkers and adhesion molecules at the moment of the index event (hs-CRP, matrix metalloprotease, interleukin-6, VCAM, ICAM)
5. determination of specific micro-RNAs related to plaque vulnerability
6. echocardiography (+ speckle tracking) for assessment of left ventricular function and size
7. full characterization of PD (dental plaque/tartar, gingival retraction, gingival bleeding, etc.)
8. microbiological determination of oral bacteria from the periodontal pockets
9. non-invasive imaging by coronary angioCT for all the coronary tree and characterization of vulnerability markers and atherosclerosis severity, using surrogate imaging biomarkers such as calcium score, necrotic core, plaque burden, low density atheroma, positive remodeling, epicardial fat volume
10. invasive imaging performed during invasive revascularization procedures, using intracoronary imaging techniques (OCT, IVUS) and quantification of invasive imaging biomarkers in culprit and non-culprit lesions, such as macrophage content, thickness of fibrous cap and necrotic core.
11. atherectomy of coronary culprit atheromatous plaques (in the atherectomy sub-study), performed during the revascularization procedure when indicated, in selected cases, followed by histological examination of the samples collected in order to identify specific antigens related to oral microbiota in the atheromatous tissue of coronary vulnerable plaques.
Follow-up will be performed at 1, 3, 6, 12, 15, 18 and 24 months after randomization, including assessment of clinical data, echocardiography and registration of MACE and adverse events.
In addition, complex imaging assessment using Angio CT will be performed at 2 years to assess atherosclerosis progression.
|
Inclusion Criteria:
* Patients aged at least 18 years;
* Patients who have signed the written informed consent;
* Patients with ACS (unstable angina or non-ST segment elevation myocardial infarction) occurring with maximum 7 days prior to enrollment
Exclusion Criteria:
* Patient's refusal to participate in the study;
* Sensitivity to the contrast substance;
* Women of reproductive age who do not use contraceptive methods;
* Pregnant women;
* Any malignancy within the last 5 years;
* Any disease or comorbidity that can reduce life expectancy to less than 2 years;
* Acute or chronic renal failure;
* Non-compliant patients who, in the opinion of the investigators, will not present to follow-up.
|
[
1.3352984189987183,
2.5284104347229004,
-2.1396775245666504,
-1.5425021648406982,
0.005241622216999531,
-0.6197635531425476,
0.08398088812828064,
-0.4826488494873047,
-1.9659302234649658,
0.3934554159641266,
0.9752890467643738,
0.18773750960826874,
-0.191010981798172,
0.5184445381164551,
-0.3493737578392029,
1.0763249397277832,
0.47515299916267395,
0.011465596966445446,
1.2709797620773315,
-0.8616440296173096,
-0.7843474745750427,
-0.8386597037315369,
0.08931855112314224,
0.15445655584335327,
0.2896331250667572,
-1.2737623453140259,
0.3422439694404602,
-0.044747140258550644,
-0.5349525809288025,
1.697703242301941,
0.4329032003879547,
0.3399188816547394,
-0.10510354489088058,
0.1028217300772667,
0.12581908702850342,
-1.1756281852722168,
0.10071979463100433,
0.055622681975364685,
-0.7117356657981873,
0.9388817548751831,
0.07150635868310928,
-0.45086029171943665,
-0.8080212473869324,
0.6670222878456116,
0.270343154668808,
0.010965021327137947,
-0.8983263373374939,
-0.20989860594272614,
-0.03907227888703346,
-0.5081779956817627,
-0.8814796209335327,
0.7571812272071838,
-0.881278395652771,
0.4047645032405853,
1.4250222444534302,
0.845425009727478,
0.4612475633621216,
1.0132670402526855,
0.6810566186904907,
0.42133405804634094,
-0.30334827303886414,
0.22716234624385834,
0.40208491683006287,
-0.2838372588157654,
-0.41316643357276917,
-0.3500032126903534,
-0.6760576963424683,
-0.009587975218892097,
-1.1395984888076782,
0.3692832589149475,
0.04848043993115425,
0.8255077600479126,
0.7976763248443604,
-0.14740237593650818,
0.9315622448921204,
0.5063435435295105,
-0.014139979146420956,
1.133536696434021,
-0.22724348306655884,
-0.7923809885978699,
-0.45057228207588196,
-0.0024027496110647917,
-0.9919826984405518,
-0.03454906865954399,
0.5399305820465088,
-0.12392639368772507,
-0.7440059781074524,
-1.121168613433838,
0.3695106506347656,
-0.5703187584877014,
0.4582599997520447,
-0.3142250180244446,
-0.8513550758361816,
-0.14640706777572632,
-0.07206762582063675,
0.5314657688140869,
-0.2323848307132721,
-0.32417434453964233,
-0.7875398993492126,
-0.16383111476898193,
0.13779623806476593,
-0.8074192404747009,
-0.48437100648880005,
-0.21929588913917542,
0.2660364806652069,
0.3434414267539978,
0.34829777479171753,
-0.23019921779632568,
-0.31680792570114136,
-0.5320942401885986,
0.47408536076545715,
-0.3139175772666931,
0.2456231713294983,
-0.07463596016168594,
-0.5887027382850647,
0.2114664912223816,
0.3640316128730774,
0.1948309987783432,
-0.22929830849170685,
-1.1281794309616089,
-0.19150258600711823,
0.38139113783836365,
-0.2699662148952484,
0.7247119545936584,
-0.15280231833457947,
-0.3718777000904083,
-0.26680469512939453,
0.242924302816391,
-0.08699674904346466,
0.04376533627510071,
-0.49542003870010376,
0.1353488266468048,
0.5173048377037048,
-0.4534938633441925,
-0.4521237313747406,
0.15349799394607544,
-0.12212186306715012,
0.7000938653945923,
-0.34194716811180115,
-0.14410315454006195,
0.09957365691661835,
-0.09412867575883865,
0.12661755084991455,
0.41085848212242126,
-1.2612755298614502,
-0.41366714239120483,
-0.10602737963199615,
0.646689236164093,
-0.2712166905403137,
-0.05298231914639473,
0.21912628412246704,
-0.1605287343263626,
-0.06081398203969002,
0.09600463509559631,
-0.06717269867658615,
0.32026639580726624,
0.13937059044837952,
-0.1830141395330429,
0.31720322370529175,
-0.0778941884636879,
-0.10863842070102692,
0.44863998889923096,
-0.4826098382472992,
0.06611316651105881,
0.3967684209346771,
-0.00953800231218338,
-0.04894183576107025,
-0.1592572182416916,
0.14030827581882477,
0.41811561584472656,
-0.013362961821258068,
0.3151978552341461,
-0.10070601105690002,
0.3322640359401703,
-0.6966556310653687,
0.5336897373199463,
0.08908781409263611,
0.1552506387233734,
0.18865032494068146,
-0.10570047050714493,
0.1408538818359375,
0.181442990899086,
0.32701799273490906,
0.00608070008456707,
-0.39068174362182617,
0.10877706855535507,
0.3263503909111023,
-0.09766347706317902,
0.10785432159900665,
0.12996932864189148,
0.3160381317138672,
0.4402945339679718,
-0.12185724079608917,
-0.11339541524648666,
0.7443484663963318,
0.19043698906898499,
-0.19919759035110474,
-0.1537439525127411,
0.31909745931625366,
0.08957802504301071,
0.33868587017059326,
0.22019235789775848,
-0.16509559750556946,
0.5389492511749268,
0.40395113825798035,
0.005910167004913092,
-0.23683884739875793,
0.15940387547016144,
-0.12091922014951706,
0.13446849584579468,
-0.08035501837730408,
-0.04412297159433365,
-0.3772401809692383,
-0.46826356649398804,
-0.013137295842170715,
0.2620215117931366,
-0.314683735370636,
-0.13689175248146057,
-0.216824471950531,
-0.11515659838914871,
-0.19144882261753082,
0.18478305637836456,
-0.06661603599786758,
-0.016631560400128365,
-0.3925040066242218,
0.00571746751666069,
0.2187255620956421,
0.03795463219285011,
0.18950681388378143,
-0.10784167796373367,
-0.6476041674613953,
0.32445862889289856,
-0.031216759234666824,
-0.1893848329782486,
0.03131046146154404,
0.3081073760986328,
-0.02801857702434063,
0.10391228646039963,
-0.09085670858621597,
0.4425676763057709,
0.27376285195350647,
-0.21809376776218414,
0.06873302161693573,
-0.16536033153533936,
0.09231068193912506,
-0.23728331923484802,
-0.035281091928482056,
-0.1270555704832077,
-0.020791517570614815,
-0.30054381489753723,
-0.0429365336894989,
-0.09495725482702255,
0.373445600271225,
0.024781575426459312,
-0.030071549117565155,
-0.2616412341594696
] |
NCT05420987
|
Effect of Jing Si Herbal Tea on Inflammation in Patients With Cardiovascular Disease
|
Jing Si herbal tea includes eight Chinese herbs: such as mugwort leaves, fish needle grass, Ophiopogon japonicus, platycodon, perilla leaves, chrysanthemum, and licorice. In vitro, these ingredients were found to be able to block the binding of SARS-CoV-2 and human ACE2 receptor, and further reduce the penetration ability of the virus. Now, Jing Si herbal tea liquid packets have obtained the special license for export from the Ministry of Health and Welfare in Taiwan.
The aim of the study is to investigate (1) the effect of Jing Si herbal tea liquid on blood pressure, blood sugar, and cholesterol in patients with cardiovascular diseases. (2)The human gut microbiota change which is associated with TMAO production (3) The proinflammatory and inflammatory biomarkers change.
We are going to recruit 100 participants from cardiovascular clinics, including patients with hypertension, hyperlipidemia, ischemic heart disease and diabetes, aged 20-75 years old. We exclude those who are cancer patients, have comorbidities with poor control, patients with eGFR\< 40 ml/min/1.73m2, those who are pregnant, breastfeeding, and in their menstrual period when recruiting.
The study has two parts. The first part is a pilot study with 20 subjects all take active Jing Si herbal tea. The second part is a double-blind randomized controlled study with 40 subjects in each arm.
|
Jing Si herbal tea includes eight Chinese herbs: such as mugwort leaves, fish needle grass, Ophiopogon japonicus, platycodon, perilla leaves, chrysanthemum, and licorice. In vitro, these ingredients were found to be able to block the binding of SARS-CoV-2 and human ACE2 receptor, and further reduce the penetration ability of the virus. Now, Jing Si herbal tea liquid packets have obtained the special license for export from the Ministry of Health and Welfare in Taiwan.
The aim of the study is to investigate (1) the effect of Jing Si herbal tea liquid on blood pressure, blood sugar, and cholesterol in patients with cardiovascular diseases. (2)The human gut microbiota change which is associated with TMAO production (3) The proinflammatory and inflammatory biomarkers change.
We are going to recruit 100 participants from cardiovascular clinics, including patients with hypertension, hyperlipidemia, ischemic heart disease and diabetes, aged 20-75 years old. We exclude those who are cancer patients, have comorbidities with poor control, patients with eGFR\< 40 ml/min/1.73m2, those who are pregnant, breastfeeding, and in their menstrual period when recruiting.
The study has two parts. The first part is a pilot study with 20 subjects all take active Jing Si herbal tea. The second part is a double-blind randomized controlled study with 40 subjects in each arm.
All the patients' specimens and questionnaires are going to be collected on Day0, Day28, and Day84.
|
Inclusion Criteria:
* hypertension,
* hyperlipidemia,
* ischemic heart disease
* diabetes
Exclusion Criteria:
* cancer patients,
* have comorbidities with poor control
* patients with eGFR\< 40 ml/min/1.73m2
* who are pregnant, breastfeeding, and in their menstrual period when recruiting
|
[
1.7984544038772583,
0.2987799346446991,
-1.780078649520874,
-1.3549565076828003,
0.5263513922691345,
0.5061367750167847,
-0.17964136600494385,
-0.6639208197593689,
-0.2597668766975403,
-0.6270439028739929,
1.1264203786849976,
1.8836803436279297,
-0.04414651542901993,
0.9071906805038452,
1.4126956462860107,
0.040559399873018265,
-0.26596599817276,
-0.05829818174242973,
1.2063761949539185,
-1.0520435571670532,
0.9175397753715515,
-0.18031516671180725,
-0.4496145248413086,
-0.30094072222709656,
0.40142491459846497,
0.08846472203731537,
0.19487452507019043,
1.0349693298339844,
0.2635139524936676,
1.0304253101348877,
0.06953824311494827,
-0.759151816368103,
-0.37717241048812866,
0.41625478863716125,
-0.19025397300720215,
-1.031970500946045,
2.1045830249786377,
0.24266447126865387,
-0.28050854802131653,
0.205179825425148,
0.32351920008659363,
0.22475939989089966,
0.05530206114053726,
-0.004743166267871857,
0.12419980019330978,
-0.05041051283478737,
0.41775795817375183,
0.25365954637527466,
-0.0476829819381237,
1.0164021253585815,
-0.4798072278499603,
1.1207174062728882,
-1.1051013469696045,
-0.25906985998153687,
2.002204179763794,
0.6033915281295776,
0.7132385969161987,
0.2219320386648178,
0.9278393387794495,
0.2805916368961334,
-0.487650990486145,
-0.2797194719314575,
0.3454057276248932,
0.532317042350769,
-0.4867797791957855,
-0.6275424957275391,
-0.364501029253006,
0.3800700306892395,
-0.3800213038921356,
-0.13936951756477356,
0.058542754501104355,
-0.3937819302082062,
0.23712007701396942,
0.6200563311576843,
0.3029499053955078,
0.48738744854927063,
0.049285322427749634,
1.1634632349014282,
0.30642184615135193,
-0.29677075147628784,
0.25887471437454224,
0.6017805933952332,
-0.7011074423789978,
-0.10884347558021545,
0.2741081416606903,
0.17943570017814636,
-1.5307033061981201,
-0.8246262073516846,
-0.17111846804618835,
-1.2367955446243286,
0.8209595680236816,
-0.5946759581565857,
-0.7767847180366516,
0.25739601254463196,
0.260904461145401,
-0.08369722962379456,
-0.03137391433119774,
-0.2840794324874878,
0.450542688369751,
-0.08117552846670151,
0.14225216209888458,
0.3863093852996826,
-0.2455436885356903,
-0.35004958510398865,
-0.2791629731655121,
-0.2249767780303955,
0.4440920352935791,
-0.12781354784965515,
-0.4882485866546631,
-0.6994482278823853,
0.06697175651788712,
-0.7068848609924316,
-0.3500058948993683,
0.04228316619992256,
0.24836881458759308,
0.2596317231655121,
0.6968748569488525,
-0.14197570085525513,
0.011032488197088242,
-0.5814661979675293,
-0.8065968155860901,
1.2493566274642944,
-0.024647429585456848,
0.34373345971107483,
0.03093775361776352,
-0.2931758165359497,
0.11331860721111298,
0.2946529984474182,
0.019612634554505348,
0.07249528914690018,
-0.6349548101425171,
0.32600948214530945,
0.01593310944736004,
-0.17040522396564484,
-0.55797278881073,
-0.22489190101623535,
0.02884676679968834,
0.4846951961517334,
0.23575806617736816,
-0.1982625275850296,
-0.14290542900562286,
-0.5779872536659241,
-0.3404892086982727,
0.5896456241607666,
-1.1825132369995117,
-0.27711641788482666,
-0.2455599009990692,
0.262015163898468,
-0.4754627048969269,
-0.48605668544769287,
0.3907528817653656,
-0.058200255036354065,
0.11697924882173538,
-0.1161135584115982,
0.06201358884572983,
0.12372209131717682,
0.029154986143112183,
-0.2974964380264282,
0.4063318967819214,
0.1555246114730835,
-0.03787393495440483,
-0.4656577706336975,
-0.10584217309951782,
0.24682514369487762,
0.8802513480186462,
0.08601199090480804,
0.18834826350212097,
-0.00031119483173824847,
0.012831206433475018,
-0.013051929883658886,
-0.6554747223854065,
0.2105592042207718,
-0.4575604200363159,
0.3185826539993286,
0.022809423506259918,
-0.10539751499891281,
0.3355284035205841,
0.8339899182319641,
0.2233811318874359,
-0.06088325008749962,
0.03279559686779976,
0.03225206211209297,
-0.09519834816455841,
0.062061045318841934,
-0.21994051337242126,
0.027872085571289062,
-0.12567998468875885,
0.031940169632434845,
0.22378642857074738,
0.09601755440235138,
-0.021040132269263268,
0.039343301206827164,
0.10004998743534088,
0.058970775455236435,
0.299857497215271,
0.07673891633749008,
0.0009163427748717368,
-0.02040802501142025,
0.39649128913879395,
0.337072491645813,
0.5430812239646912,
0.11090413480997086,
0.1275513470172882,
0.034209053963422775,
0.023309241980314255,
-0.10213960707187653,
-0.037398722022771835,
-0.055721670389175415,
0.0501604825258255,
0.188043475151062,
0.2955537438392639,
0.08426500111818314,
-0.15154993534088135,
-0.042617738246917725,
0.4373987913131714,
-0.09414399415254593,
0.16159263253211975,
-0.2906050980091095,
-0.23341692984104156,
0.00545776030048728,
-0.06934213638305664,
-0.061353813856840134,
-0.3461742699146271,
-0.3409678339958191,
-0.26301389932632446,
-0.09353440254926682,
-0.028257276862859726,
0.12003155052661896,
0.07525918632745743,
-0.23340263962745667,
-0.048184677958488464,
-0.3443353474140167,
-0.07691509276628494,
-0.19522646069526672,
-0.11796128749847412,
-0.10611017793416977,
-0.13994771242141724,
0.1037464290857315,
-0.129350945353508,
-0.029282189905643463,
-0.11293733865022659,
-0.3362088203430176,
0.012750855647027493,
-0.20863452553749084,
0.041131701320409775,
0.08483254164457321,
-0.2168833613395691,
-0.06055373325943947,
-0.021017111837863922,
0.133705735206604,
0.02592509426176548,
-0.14002582430839539,
0.09061763435602188,
0.14144134521484375,
-0.11666634678840637,
-0.15734751522541046
] |
NCT00003278
|
Radiation Therapy and High-Dose Corticosteroids in Treating Older Patients With Primary CNS Non-Hodgkin's Lymphoma
|
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with a corticosteroid, such as dexamethasone, may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy and high-dose dexamethasone in treating older patients with primary CNS non-Hodgkin's lymphoma.
|
OBJECTIVES:
* Assess the effectiveness of high-dose dexamethasone after whole-brain radiotherapy in maintaining response and preventing recurrence in elderly patients with primary central nervous system non-Hodgkin's lymphoma.
* Assess the toxic effects of this regimen in these patients.
* Assess the survival rate of patients after this regimen.
* Identify the anatomic rates of recurrence and frequency of systemic involvement in patients treated with this regimen.
* Identify the factors that appear to be associated with outcome in patients treated with this regimen.
OUTLINE: Patients undergo whole-brain radiotherapy (WBRT) daily 5 days a week for 4.5 weeks. Beginning 30 days after WBRT is completed, patients receive high-dose dexamethasone IV on days 1-5 during course 1 and on day 1 only during all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month after radiotherapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study within 6 years.
|
DISEASE CHARACTERISTICS:
* Pathologically confirmed non-Hodgkin's lymphoma with intracranial lesions
* Intraocular lymphoma eligible, if not sole site of disease
* No occult systemic lymphoma
* Measurable or evaluable disease by CT scan or MRI
* No neoplastic meningitis or gross spinal cord involvement
PATIENT CHARACTERISTICS:
Age:
* 70 and over
Performance status:
* ECOG 0-3
Other:
* No prior history of lymphoma
* No other active malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* HIV negative
* No active peptic ulcer disease
* No uncontrolled diabetes mellitus
* No active pancreatitis
* No active bleeding
* No poorly controlled major psychiatric illness
* No serious uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior bone marrow transplantation
Chemotherapy:
* No prior chemotherapy
Radiotherapy:
* No prior radiotherapy to the brain or head and neck region
Surgery:
* No prior transplantations (renal, hepatic, or cardiac)
|
[
1.1894924640655518,
-0.3821949064731598,
-2.3903605937957764,
-2.6433753967285156,
0.13315042853355408,
-0.746706485748291,
0.013887552544474602,
1.1843085289001465,
-1.44560968875885,
0.5996798276901245,
1.0680997371673584,
2.1089203357696533,
0.24079690873622894,
-0.17281779646873474,
-1.348099708557129,
0.7338746786117554,
-0.9008824229240417,
1.9633327722549438,
0.32292431592941284,
-0.718254566192627,
0.1581295281648636,
-0.9484816789627075,
1.5515658855438232,
0.6994729042053223,
1.7377963066101074,
-0.1872899979352951,
-0.3369460701942444,
2.767608642578125,
1.4489176273345947,
0.9854334592819214,
-1.7228977680206299,
-1.4151990413665771,
0.4741891622543335,
-0.5537958145141602,
0.5972992777824402,
0.9083338379859924,
1.9239561557769775,
0.1495610922574997,
-0.5411497354507446,
1.9483592510223389,
0.04449659585952759,
-0.8245805501937866,
-0.16912855207920074,
-0.40195608139038086,
-0.36151087284088135,
0.46549975872039795,
-0.7759079337120056,
1.0419063568115234,
1.2167699337005615,
-0.3274436295032501,
-1.4771003723144531,
1.1392285823822021,
-1.378195881843567,
-0.6365118026733398,
3.086599111557007,
0.11095378547906876,
-0.4786604642868042,
0.016814855858683586,
0.9583058953285217,
1.530156135559082,
0.8184826374053955,
-0.25489377975463867,
-0.8894510269165039,
-0.039907414466142654,
-1.03628671169281,
-0.537876546382904,
-0.11088254302740097,
-0.40454840660095215,
0.8378351926803589,
-0.7754459381103516,
0.17080920934677124,
0.6535032391548157,
1.0226210355758667,
0.2865072190761566,
0.21228951215744019,
0.7185200452804565,
0.254690945148468,
-0.15696623921394348,
1.2628556489944458,
-0.6429552435874939,
0.30726301670074463,
-0.10414421558380127,
-1.0974998474121094,
0.5810248255729675,
-0.37078720331192017,
-0.1594877988100052,
-0.5986995100975037,
-0.6448529958724976,
0.08452051877975464,
-1.1769427061080933,
0.5097617506980896,
0.08399379998445511,
-2.079537868499756,
1.5669560432434082,
-0.244251549243927,
-0.2151717096567154,
-0.22661568224430084,
-0.27574193477630615,
0.18811999261379242,
-0.46471357345581055,
1.2108324766159058,
0.29896366596221924,
-1.6724984645843506,
-0.5969269275665283,
-1.3403295278549194,
-0.7494076490402222,
0.1362309455871582,
-0.8212490081787109,
-1.0964514017105103,
-0.6168463230133057,
1.3148527145385742,
-1.2336831092834473,
-0.2997443377971649,
0.24162745475769043,
1.0096102952957153,
-0.08161648362874985,
0.5297437906265259,
0.7447328567504883,
-1.0580575466156006,
-0.026210568845272064,
0.13471412658691406,
1.332099199295044,
-0.07493868470191956,
0.0835179015994072,
-0.5638461112976074,
0.1809014230966568,
-0.23279854655265808,
0.28639692068099976,
-0.9246130585670471,
-0.18426211178302765,
-0.2702067792415619,
0.39977312088012695,
0.5016469359397888,
-0.04548366740345955,
-0.5797528028488159,
-0.25421977043151855,
0.7962157130241394,
1.4661133289337158,
0.8356500864028931,
-0.047047365456819534,
0.22227095067501068,
0.4716293513774872,
-0.03912447392940521,
-0.7062652707099915,
-0.7188055515289307,
-0.4396267533302307,
-0.059399157762527466,
0.9389461278915405,
0.24212105572223663,
-0.18519651889801025,
-0.014996693469583988,
0.43241429328918457,
-1.0790551900863647,
0.5948079824447632,
0.7815492749214172,
0.9587699770927429,
-0.25914090871810913,
-0.9010465741157532,
-0.1473000943660736,
0.2302515059709549,
-0.47082948684692383,
-0.754065990447998,
0.39795058965682983,
-0.20855490863323212,
1.1240485906600952,
-0.3124338984489441,
-0.5051611661911011,
0.080848827958107,
0.8383486866950989,
-0.5528286695480347,
-0.1180882379412651,
0.31696242094039917,
0.5439534783363342,
0.3268960118293762,
-0.1596374362707138,
-0.15191727876663208,
0.7989574074745178,
0.12878616154193878,
0.5246289968490601,
-0.7368242144584656,
-0.7477448582649231,
0.269275426864624,
0.6429792046546936,
-0.4638555347919464,
-0.26960161328315735,
0.1349276751279831,
0.1394914835691452,
0.23472900688648224,
-0.4997614324092865,
-0.04369320347905159,
0.6670251488685608,
-0.5491222739219666,
-0.1589694619178772,
0.313981294631958,
-0.6119938492774963,
-0.5628968477249146,
-0.44770288467407227,
0.08790191262960434,
0.7742680907249451,
-1.0127776861190796,
0.7065628170967102,
0.39595410227775574,
0.28828081488609314,
0.28709676861763,
0.12650670111179352,
-0.45579907298088074,
0.14083044230937958,
-0.2709161341190338,
-0.3019173741340637,
1.031126618385315,
0.214378222823143,
0.20403000712394714,
0.15392370522022247,
-0.3559860587120056,
0.012283102609217167,
0.1842609941959381,
0.5725520253181458,
0.09598245471715927,
-1.2965747117996216,
-0.25720614194869995,
-0.5457258820533752,
-0.03687833249568939,
0.10553178191184998,
0.14699101448059082,
0.08112983405590057,
0.4158768355846405,
-0.10714446753263474,
0.24169249832630157,
0.2626737952232361,
-0.559949517250061,
-0.013829496689140797,
-0.16878250241279602,
-0.35116904973983765,
-0.04753485321998596,
-0.49715813994407654,
-0.2566484808921814,
0.3569352328777313,
0.20563507080078125,
-0.3065667450428009,
0.3615741431713104,
0.3339264988899231,
0.11792939156293869,
-0.6707772612571716,
-0.0058802468702197075,
-0.037025853991508484,
-0.3891066014766693,
0.11691345274448395,
-0.3662452697753906,
-0.1910298466682434,
0.3686325252056122,
-0.5845921635627747,
-0.2854914963245392,
0.1282501369714737,
0.5888888835906982,
-0.4667874872684479,
-0.3096676170825958
] |
NCT00600288
|
Study of the Effect of Diquafosol Tetrasodium Ophthalmic Solution, 2% Versus Placebo in Dry Eye Subjects (P08634)
|
The purpose of this pilot study is to evaluate the effect of diquafosol tetrasodium Ophthalmic Solution, 2% in dry eye subjects.
|
Inclusion Criteria:
* Provide written informed consent prior to any study procedures being performed.
* Have a best corrected visual acuity (BCVAof +0.7 or better.
* Have a history of dry eye (keratoconjunctivitis sicca) in both eyes
* Have ongoing dry eye disease, in the same qualifying eye or both eyes.
Exclusion Criteria:
* Have previously had LASIK refractive surgery.
* Use of topical ophthalmic medications, preps, gels and lid scrubs during study.
* Have had penetrating intraocular surgery in the past 90 days.
* Have had other ocular surface surgery (e.g., refractive, pterygium) within the past year.
* Have a diagnosis of an on-going ocular infection, clinically significant blepharitis, lid margin inflammation, Stevens-Johnson syndrome or pemphigoid.
* Any serious ocular systemic disease or uncontrolled medical condition.
* Exposure to any investigational drug within 30 days of study start.
|
[
0.34040772914886475,
1.7278242111206055,
-4.003165245056152,
-4.297197341918945,
-0.8839168548583984,
-1.3841184377670288,
2.0860798358917236,
1.0598130226135254,
-2.4223177433013916,
1.5313915014266968,
-0.05794627591967583,
1.4142341613769531,
-1.5910526514053345,
0.8521124124526978,
0.09523157775402069,
0.050749652087688446,
-0.9916592240333557,
1.8235440254211426,
0.7528151869773865,
-2.229518413543701,
1.5136659145355225,
-0.46754834055900574,
0.010270257480442524,
0.5401120185852051,
2.0480117797851562,
-0.9429426193237305,
1.0092263221740723,
1.0683298110961914,
0.1856965720653534,
-0.7561884522438049,
-0.5959966778755188,
-0.7847722172737122,
1.4185540676116943,
-1.496962308883667,
0.6126629710197449,
-0.3041316568851471,
1.4744757413864136,
2.168118953704834,
-0.5573524832725525,
0.8776748776435852,
-0.7757720351219177,
-0.13876411318778992,
-1.1952714920043945,
0.6295900344848633,
2.6105120182037354,
0.3178071081638336,
1.1052073240280151,
0.5456222891807556,
-1.3407485485076904,
1.1032508611679077,
0.21390949189662933,
0.629098117351532,
-1.0392694473266602,
-0.34767287969589233,
2.067451238632202,
0.7269687056541443,
0.4501728117465973,
0.4465702772140503,
1.0048749446868896,
1.7051522731781006,
1.521651029586792,
-0.4275096356868744,
0.4973994195461273,
0.7294504642486572,
-1.1498122215270996,
2.7602157592773438,
-0.6385766863822937,
-1.069471836090088,
-0.8718327283859253,
1.0642398595809937,
-0.45177093148231506,
0.6728248596191406,
0.5538045763969421,
-0.26069921255111694,
0.957588255405426,
-0.7938070297241211,
0.5488155484199524,
0.7779871225357056,
0.2583864629268646,
-0.8172711730003357,
0.11167444288730621,
0.002680188277736306,
-2.2637991905212402,
-0.8782642483711243,
-0.48193544149398804,
-0.5076944828033447,
-0.21696989238262177,
-0.5244340896606445,
1.2346428632736206,
0.8554100394248962,
-0.1651345193386078,
-0.5866433382034302,
-1.4577713012695312,
1.4801993370056152,
0.508764922618866,
0.3619050681591034,
0.9233425855636597,
1.1471954584121704,
-0.5815474987030029,
0.536711573600769,
0.6660848259925842,
-0.27730926871299744,
1.6762382984161377,
-0.07320745289325714,
-0.49011096358299255,
-0.9119672775268555,
-2.3034324645996094,
-0.18664340674877167,
-0.15807393193244934,
-1.2260786294937134,
0.7386090755462646,
-0.8752349019050598,
-0.6869850754737854,
1.1886582374572754,
1.9918469190597534,
-0.0010818971786648035,
0.2971011698246002,
-0.6381977200508118,
-0.698158860206604,
0.28420719504356384,
0.508357048034668,
0.33673202991485596,
0.36868470907211304,
0.5364862084388733,
-0.6189550161361694,
0.8435899019241333,
0.2221769392490387,
0.3534383177757263,
-0.5344910025596619,
-0.4582800269126892,
-0.2011309266090393,
-0.34775829315185547,
0.03170701116323471,
1.512044906616211,
-1.6235339641571045,
-0.924558162689209,
0.5297566056251526,
0.1475549191236496,
-0.09366825222969055,
-0.04597469046711922,
-0.2811046540737152,
0.23939886689186096,
-0.7956686019897461,
-1.0628432035446167,
-1.2771456241607666,
-0.7109593749046326,
0.5923777222633362,
0.3009786009788513,
-0.5651648044586182,
-0.4538625478744507,
0.8633105158805847,
0.4765600860118866,
0.3074658513069153,
-0.8834971785545349,
-0.1651277244091034,
-0.699467122554779,
0.997809648513794,
-0.4038091003894806,
0.0961843729019165,
-0.7082815170288086,
-0.20581071078777313,
-0.04375844448804855,
0.13537980616092682,
-0.9100621938705444,
-0.06287818402051926,
0.2462759017944336,
-0.542725682258606,
0.10651729255914688,
0.6049626469612122,
-0.4579514265060425,
-0.48661908507347107,
0.028143038973212242,
-0.343255877494812,
-0.6180055141448975,
0.36240682005882263,
-0.02760051190853119,
0.572199285030365,
0.7574660778045654,
0.9913821220397949,
0.35495638847351074,
-0.30164480209350586,
0.893509566783905,
-0.7067417502403259,
0.13659147918224335,
0.36163437366485596,
-0.12875492870807648,
-0.9263206720352173,
0.8059688210487366,
0.46317529678344727,
1.0104451179504395,
-0.7034372091293335,
0.1205485612154007,
0.02853662334382534,
-0.03978374972939491,
0.39675918221473694,
-0.23323385417461395,
0.340727299451828,
-1.047672152519226,
0.19280631840229034,
0.08573122322559357,
0.9349077939987183,
0.8612499237060547,
0.7360479235649109,
-0.07406444102525711,
-0.24193741381168365,
-0.1008649691939354,
-0.2500062584877014,
0.6601434350013733,
-0.186971053481102,
0.01098562404513359,
-0.3579656779766083,
0.48791053891181946,
-0.6569681167602539,
-0.1132834404706955,
1.2059532403945923,
-0.28689464926719666,
-0.6319355964660645,
-0.20543332397937775,
-0.2550796866416931,
-0.11439554393291473,
-0.15912660956382751,
-0.05515104904770851,
-0.4385845363140106,
-0.14467406272888184,
0.2633688449859619,
0.03183896094560623,
-0.11729501187801361,
-0.2564774751663208,
0.011887756176292896,
-0.009066014550626278,
0.25978726148605347,
0.6889134049415588,
-0.688825786113739,
0.1468505859375,
-0.0142094437032938,
0.6888169646263123,
-0.06749331951141357,
-0.5490149855613708,
-0.148884579539299,
0.4567644000053406,
0.031411342322826385,
0.2687295973300934,
-0.6138069033622742,
0.4886746406555176,
-0.33477842807769775,
0.6733524203300476,
-0.0635296106338501,
-0.021849457174539566,
-0.12954269349575043,
0.2781721353530884,
-0.38785186409950256,
-0.03917103633284569,
-0.09405934065580368,
0.0036851130425930023,
0.28179046511650085,
-0.1698979288339615
] |
|
NCT01438996
|
Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults
|
The purpose of this study is to evaluate the immunogenicity and the kinetics of the anti-Vi antibody response following secondary vaccination with the Novartis Vaccines Institute for Global Health (NVGH) Vi-CRM197 vaccine in healthy adults previously vaccinated with either the NVGH Vi-CRM197 or Vi-polysaccharide (Typherix) in the H01_04TP study (NCT01193907) and the immunogenicity and the kinetics of the anti-Vi antibody response following primary vaccination with the NVGH Vi-CRM197 vaccine in naïve healthy adults.
|
Inclusion criteria
All Subjects:
1. Males and females of age ≥18 to ≤42 years.
2. Individuals, who, after the nature of the study have been explained to them, have given written consent according to local regulatory requirements.
3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
4. If women, use of birth control one month before study start, a negative pregnancy test and willingness to use birth control measures for the entire study duration.
H01_04TP subjects only:
5. Individuals who previously participated in the H01_04TP study and were vaccinated with either NVGH Vi-CRM197 (5μg) or with the licensed Vi-PS.
6. Individuals who have received no Vi vaccination subsequent to the one received in the H01_04TP study.
Inclusion criteria
All subjects:
1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
2. Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
3. Individuals who are not able to understand and to follow all required study procedures for the whole period of the study.
4. Individuals with history of any illness that, in the opinion of the investigator, pose additional risk to the subjects due to participation in the study.
5. Individuals with known or suspected HIV infection or HIV related disease, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 30 days, or were in chemotherapy treatment within the past 6 months.
6. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
7. Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
8. Individuals who have any malignancy or lymphoproliferative disorder.
9. Individuals with history of allergy to vaccine components.
10. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
11. Individuals who received any vaccines within 4 weeks prior to enrolment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccine
12. Individuals who have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks.
13. Individuals who are part of study personnel or close family members to the personnel conducting this study.
14. Individuals with body temperature \> 38.0 degrees Celsius within 3 days of intended study immunization.
15. BMI \> 35 kg/m2.
16. Individuals with history of substance or alcohol abuse within the past 2 years.
17. Women who are pregnant or breast-feeding or of childbearing age who have not used any birth control measure one month prior to study start or do not plan to use acceptable birth control measures, for the duration of the study.
18. Females with history of stillbirth, neonatal loss, or previous infant with anomaly.
19. Individuals who have a previously ascertained or suspected disease caused by S. Typhi.
20. Individuals who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. Typhi.
21. Any condition which, in the opinion of the investigator may interfere with the evaluation of the study objectives.
Naïve subjects only:
22. Individuals who have previously received any vaccine against typhoid fever (either oral live attenuated or injectable vaccines)
|
[
1.1195149421691895,
1.1419599056243896,
-2.721874713897705,
-1.4614909887313843,
1.434140682220459,
0.8587866425514221,
-0.8688430190086365,
0.7773554921150208,
0.3719532787799835,
-0.7526378035545349,
-0.6844766736030579,
0.5438476204872131,
-2.2867431640625,
0.4960962235927582,
-1.594303011894226,
-0.5827454328536987,
-1.0648068189620972,
1.5675703287124634,
0.4437156021595001,
-2.571370840072632,
0.601558268070221,
-0.12528476119041443,
-0.8774368762969971,
1.2642309665679932,
0.06092999875545502,
0.19480614364147186,
-2.1204209327697754,
-2.1127283573150635,
-1.2293435335159302,
1.3926515579223633,
0.083378866314888,
-1.207322359085083,
-0.03813799470663071,
1.9635376930236816,
0.5226083397865295,
0.4979105293750763,
1.754760503768921,
0.18747183680534363,
0.3283783197402954,
-0.6004546284675598,
-0.9015337228775024,
-0.6983617544174194,
1.9893653392791748,
-0.14664557576179504,
0.8974753618240356,
-0.16825295984745026,
0.8885282278060913,
0.11974864453077316,
0.9708885550498962,
0.00877078901976347,
-1.4298255443572998,
-0.8582412004470825,
-0.5046488642692566,
1.2357213497161865,
3.281385660171509,
0.4145839512348175,
0.5706472992897034,
1.9097727537155151,
0.8778592944145203,
1.7647860050201416,
1.0302761793136597,
-0.7557626366615295,
1.9890353679656982,
-0.3021824061870575,
-1.1781140565872192,
-0.2387526035308838,
0.04371608793735504,
-0.14856034517288208,
0.41438549757003784,
0.030902080237865448,
0.20318029820919037,
0.7484086155891418,
0.03513522446155548,
1.4104442596435547,
-1.3870172500610352,
0.8595061898231506,
-0.5761978030204773,
1.0737673044204712,
0.5254839062690735,
1.4829524755477905,
-0.6435679793357849,
-0.8511976599693298,
-0.5311393141746521,
0.296695739030838,
-0.2435791790485382,
-0.2347697764635086,
-1.5555487871170044,
-0.8403467535972595,
0.3920342028141022,
-1.3035303354263306,
0.7446631193161011,
-0.522354006767273,
-0.8048383593559265,
-0.4538803696632385,
-0.3183629512786865,
-0.10303115099668503,
1.1041405200958252,
0.3009096682071686,
0.13678526878356934,
-1.20122492313385,
0.19596175849437714,
0.012385115958750248,
-0.7728613018989563,
-0.4452315866947174,
-0.7974844574928284,
0.48043105006217957,
-0.65140300989151,
-0.6783164739608765,
-1.1806883811950684,
0.8790397644042969,
-0.6127840876579285,
-0.2598549723625183,
-1.1375470161437988,
-0.08650900423526764,
0.3812565803527832,
-0.5782462358474731,
-0.901719331741333,
-0.39018771052360535,
-0.022440556436777115,
-0.39046645164489746,
-1.1233842372894287,
0.9373704791069031,
0.19320516288280487,
0.39971643686294556,
-1.215848445892334,
-0.14391091465950012,
-0.34455209970474243,
-0.4649553894996643,
0.32434388995170593,
-1.0187324285507202,
-0.8608286380767822,
0.7366228699684143,
0.6023103594779968,
0.09657265990972519,
-0.9911801815032959,
-0.7564323544502258,
-0.4601542055606842,
0.7363724112510681,
0.04631883651018143,
0.6723493337631226,
-0.3526484966278076,
0.5819492936134338,
0.5731157660484314,
-0.21952083706855774,
-1.335509181022644,
-0.18148083984851837,
0.20676131546497345,
0.00021455733804032207,
0.18807101249694824,
-0.06719900667667389,
-0.19279180467128754,
-0.1368497610092163,
-0.1690956950187683,
0.4646551012992859,
0.5038756728172302,
-0.23268860578536987,
-0.1201825737953186,
-0.48711448907852173,
-0.025146549567580223,
-0.2306349277496338,
0.1742875874042511,
0.1144828125834465,
-0.0959257036447525,
-0.1822567880153656,
-0.2941763997077942,
-0.6761535406112671,
-0.8024909496307373,
-0.3660601079463959,
-0.8782960176467896,
0.0901692658662796,
-0.15265235304832458,
-0.5615454316139221,
-0.033045005053281784,
0.194948211312294,
0.6143608093261719,
0.3777211308479309,
0.8413562774658203,
1.284481406211853,
-0.19109387695789337,
-0.27234357595443726,
-0.00891138892620802,
-0.009567934088408947,
-0.24387186765670776,
0.9217331409454346,
-0.11481212079524994,
0.10806189477443695,
-0.10346926748752594,
-0.37191399931907654,
-0.875807523727417,
0.19470244646072388,
0.1396171748638153,
-0.49996256828308105,
0.5559864044189453,
0.2044886201620102,
0.5607818365097046,
-0.10424892604351044,
-0.022024624049663544,
-0.18027611076831818,
0.44985726475715637,
0.18136918544769287,
1.0005165338516235,
-0.4605959951877594,
0.06156715378165245,
0.591797947883606,
0.31501731276512146,
0.5505164861679077,
0.16333627700805664,
0.22538825869560242,
0.2565823793411255,
0.0961693823337555,
-0.059007540345191956,
0.13490329682826996,
-0.0351470410823822,
-0.1642269641160965,
0.4140750765800476,
0.20765259861946106,
-0.6122479438781738,
0.4292038679122925,
0.10125337541103363,
0.598506510257721,
0.3352543115615845,
-0.3574940264225006,
-0.13029681146144867,
-0.19271668791770935,
-0.5077072381973267,
-0.07636367529630661,
-0.27241501212120056,
0.005203015636652708,
-0.4635583758354187,
0.3487805128097534,
-0.505197286605835,
0.2061907798051834,
-0.37642449140548706,
-0.2076159417629242,
0.4769793748855591,
0.1669343113899231,
-0.1507350355386734,
-0.10229691863059998,
-0.327886164188385,
0.27249643206596375,
0.5955782532691956,
0.1753958761692047,
-0.20636993646621704,
0.735453724861145,
0.015310297720134258,
-0.44468042254447937,
0.29663947224617004,
-0.003748909570276737,
-0.2652014493942261,
-0.28922244906425476,
-0.5666211247444153,
0.3443424701690674,
-0.03634218871593475,
-0.6528832912445068,
0.32044968008995056,
0.08456657081842422
] |
|
NCT06565741
|
EEAP Using Moses 2.0 Technology Vs the Thulium Fiber Laser in Medium-Large Prostates
|
Introduction: Endoscopic anatomical enucleation of the prostate (EEAP) with lasers has emerged as an effective and less invasive surgical option compared to traditional methods. Among the various available laser options, Holmium laser and Thulium Fiber laser have stood out as two prominent approaches for performing endoscopic prostate enucleation. These technologies have 3 showcased their effectiveness in ablating prostatic tissue and improving urinary symptoms. Nevertheless, differences in their physical properties and modes of action may impact their success rates and clinical outcomes. In our institution it is standard practice to use one laser or the other according to their availability in the operating room.
Primary Objective: To demonstrate the superiority of MoLEP over ThuFLEP in terms of enucleation efficiency.
Secondary Objectives: a) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of perioperative bleeding.
b) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of postoperative hospital stay.
c) To demonstrate the non-inferiority of ThuFLEP compared to ThuFLEP in terms of perioperative complications.
d) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in urinary symptoms.
e) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in flowmetric variables.
Study Type: Prospective, randomized, non-blind, multicentric clinical trial. Intervention: Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure.
|
Surgery and Follow-up Schedule
* Surgeries will be performed between September 2024 and September 2025.
* Initial follow-up at 3 months.
* Completion of the first phase of the study: March 2026.
Scheduled of Visits: Selection Visit, 1-Month Postoperative Visit, 3-Month Follow-up, 6-Month Follow-up, Annual Follow-up Visit (1-3 years).
Sample size calculation was done using the main outcome variable (total surgical time). Previous studies indicate that surgical time for ThuFLEP is 71.6 minutes \[8\]. The time for MoLEP may be at least 5 minutes less. Accepting an alpha risk of 5% and a beta risk of 20% in a two-tailed test, a total of 120 patients are needed (60 in each study group). A common standard deviation of 9 minutes change is assumed. A loss to follow-up rate of 15% has been estimated.
Randomization between the two surgery groups will be performed using the Efron procedure to balance the groups in terms of the number of subjects. The calculation will be carried out with the !RndSeq macro for SPSS Statistics. It will be conducted centrally by a person independent of the surgeon.
Statistical Analysis: For quantitative variables, measures of central tendency and dispersion will be .provided. Normality tests will be conducted using the Shapiro-Wilk test. For qualitative variables, valid percentages will be shown. Sociodemographic and clinical data, as well as the main study variables, will be compared between study groups using the Student's t-test (Mann-Whitney U test in case of non-normality). Chi-square test or Fisher's test (if any observed frequency is \<5) will be used for qualitative variables. A multivariate linear regression model will be constructed to determine variables related to surgical time. Beta coefficients and 95% confidence intervals (CI) will be determined. A preliminary study will be conducted on potential confounding and interacting factors. Adjustment will be made for clinically or bibliographically relevant variables. Interaction will be tested using the likelihood ratio test. A significant difference will be accepted in all tests with a p-value \<0.05. R Studio statistical package (V2.5.1) will be used for data analysis.
|
Inclusion Criteria:
* Males aged between 40 and 90 years.
* Patients who, due to their lower urinary tract symptoms, are candidates for
BPH surgery, including:
* Obstructive urinary symptoms evaluated through IPSS with a score \>7 and QoL \> 2 or acute urinary reten on refractory to catheter removal.
* Obstructive urinary flow evaluated through uroflowmetry with Qmax\< 15 ml/s, obstruction demonstrated by pressure/flow study, prostatic origin haematuria refractory to medical treatment, or acute urinary retention refractory to catheter removal.
* Prostatic volume measured by transabdominal ultrasound, transrectal ultrasound, or magnetic resonance imaging of more than 80 cc.
* Prostate-specific antigen (PSA) \< 4 ng/ml, or with multiparametric prostate magnetic resonance imaging reporting PIRADS \< 3 or equal to 3 with PSA density \< 15%.
Exclusion Criteria:
* Diagnosis, suspicion, or history of urethral stenosis or urethral surgery.
* History of prostate surgery or pelvic radiotherapy.
* Diagnosis or suspicion of prostate cancer or urothelial cancer.
* Body mass index superior to 30.
|
[
-0.6622658967971802,
2.52982497215271,
-3.4460408687591553,
-2.5636651515960693,
-0.33967986702919006,
-0.03268972411751747,
0.6291666626930237,
-0.43060579895973206,
-1.5302960872650146,
0.4873768985271454,
0.9010612964630127,
0.17640040814876556,
0.20591391623020172,
1.0274709463119507,
0.3081654906272888,
1.2096149921417236,
0.3822347819805145,
0.5058156251907349,
-1.1172746419906616,
-0.9529556632041931,
0.07261504232883453,
0.2881983816623688,
0.5323796272277832,
-0.7532199025154114,
1.1227121353149414,
-0.8202764987945557,
-0.14576250314712524,
-0.5951398611068726,
0.07565246522426605,
0.8029536008834839,
0.959074079990387,
0.7053146958351135,
-0.5864018797874451,
0.4139924943447113,
-1.3222225904464722,
0.42600342631340027,
-0.4296833872795105,
-0.24668502807617188,
-0.68441241979599,
-0.13847632706165314,
0.9946552515029907,
0.2431229054927826,
0.47198745608329773,
0.0003030725347343832,
1.0403077602386475,
0.2696100175380707,
-0.11170878261327744,
0.1698608249425888,
-0.20436537265777588,
0.6283164620399475,
-0.5975602865219116,
0.5308106541633606,
-1.5997191667556763,
-0.3247227966785431,
1.0548466444015503,
0.6162158846855164,
0.5731222629547119,
0.42800021171569824,
0.13053935766220093,
-0.18380969762802124,
1.593412160873413,
-0.2836291790008545,
0.19584545493125916,
0.3821404278278351,
-0.4438559412956238,
0.20019295811653137,
-0.03396580368280411,
0.7065969705581665,
-1.2187308073043823,
0.11891864240169525,
0.24287907779216766,
-0.4790477156639099,
0.6177877187728882,
-0.2117815911769867,
0.7550725340843201,
0.17982976138591766,
-0.7550899386405945,
0.3021530508995056,
0.8763133883476257,
0.9033170938491821,
0.971823513507843,
-1.058517575263977,
-0.6903268694877625,
-0.3105912506580353,
-0.18951714038848877,
-0.7354751229286194,
-0.7931115627288818,
-1.1629527807235718,
0.8096808791160583,
-0.3856201171875,
0.5464940667152405,
0.656094491481781,
-1.0855470895767212,
0.9126284122467041,
0.5901448130607605,
-0.500648021697998,
0.0025241433177143335,
-1.3595335483551025,
-0.6255003809928894,
0.13014177978038788,
0.6384897828102112,
-0.01595686748623848,
0.2904225289821625,
-0.4009281396865845,
0.3977465033531189,
-0.5112053751945496,
-0.6896705031394958,
-0.685493528842926,
-0.0858895406126976,
-0.2469370812177658,
1.0565234422683716,
-0.861484944820404,
0.49754083156585693,
-1.1562474966049194,
-0.31397750973701477,
0.45276930928230286,
0.03854741156101227,
-0.25716865062713623,
0.07303830236196518,
-0.46728408336639404,
-0.856356143951416,
0.5105428099632263,
0.31381309032440186,
0.6108301877975464,
-0.5997691750526428,
0.027652617543935776,
0.4116610586643219,
0.6278810501098633,
0.005979857873171568,
-0.7465903759002686,
-0.09517864882946014,
0.2753630578517914,
0.855368971824646,
0.22532159090042114,
-0.2689773142337799,
-0.08193202316761017,
0.8454996943473816,
0.837860643863678,
-0.2410302758216858,
-0.46966877579689026,
-0.20443561673164368,
0.6401048302650452,
-0.5280607342720032,
-0.44017818570137024,
-0.5468584299087524,
-0.375838041305542,
-1.135475754737854,
0.727350652217865,
-1.135182499885559,
0.7181766629219055,
-0.6570237874984741,
-0.021809658035635948,
0.5414233207702637,
0.243535578250885,
0.18129579722881317,
0.3147050738334656,
-0.07306776940822601,
0.1423756629228592,
0.3813617527484894,
0.5759187936782837,
-0.28448212146759033,
-0.20810331404209137,
0.010873742401599884,
-0.18113653361797333,
0.06547229737043381,
-0.011123559437692165,
-0.08516029268503189,
-0.20831464231014252,
0.37914392352104187,
-0.6884599924087524,
-0.42056867480278015,
0.3814784288406372,
0.23990054428577423,
0.27061042189598083,
-0.23056304454803467,
0.018156040459871292,
0.41292521357536316,
-0.0010392109397798777,
0.38379156589508057,
-0.16383714973926544,
0.02757086604833603,
-0.18514800071716309,
0.2835625112056732,
0.19115552306175232,
0.01618780568242073,
-0.5943448543548584,
0.052317798137664795,
0.016093721613287926,
-0.28598907589912415,
0.3898971974849701,
-0.2641456723213196,
0.06410669535398483,
-0.051468390971422195,
-0.07104670256376266,
0.3492051661014557,
0.2241845428943634,
-0.1502053439617157,
-0.0825604796409607,
0.3579755127429962,
0.025024838745594025,
0.26398563385009766,
0.694801926612854,
-0.09861674159765244,
0.3530219793319702,
0.40539658069610596,
-0.27816110849380493,
-0.48464837670326233,
-0.18056611716747284,
-0.5776836276054382,
0.21035520732402802,
0.13005201518535614,
-0.043608974665403366,
0.33851075172424316,
-0.09130816906690598,
0.03315272554755211,
0.30279070138931274,
0.28518667817115784,
-0.2882373332977295,
-0.3575068414211273,
-0.24346840381622314,
0.3388127088546753,
-0.22850482165813446,
-0.15363287925720215,
0.036556947976350784,
-0.3457256257534027,
-0.12747137248516083,
0.0529506616294384,
0.24410009384155273,
0.30515435338020325,
-0.08133065700531006,
-0.37819114327430725,
0.06182079017162323,
0.022899694740772247,
0.35641685128211975,
-0.3182050883769989,
0.03663327172398567,
-0.10488828271627426,
0.13913306593894958,
0.4300439655780792,
-0.1559796929359436,
0.019991854205727577,
-0.030507342889904976,
0.04427672550082207,
-0.4418325424194336,
0.17014794051647186,
0.024575240910053253,
0.24432046711444855,
-0.0846109390258789,
-0.17215779423713684,
-0.1182883009314537,
0.1840009242296219,
-0.16765324771404266,
0.33359870314598083,
-0.052377212792634964,
-0.26160377264022827,
-0.1325215846300125
] |
NCT03790787
|
Drug Interaction Study Between Dorzagliatin and Empagliflozin
|
This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of glucokinase activator dorzagliatin and empagliflozin in subjects with T2DM. Pharmacokinetics and pharmacodynamics when dorzagliatin and empagliflozin given alone and in combination will be studied.
|
Inclusion Criteria:
1. Subjects diagnosed with T2DM within at least 3 months prior to screening
2. Male and/or female subjects between the ages of 30 and 65 years, inclusive;
3. Body Mass Index (BMI) of 19 to 38 kg/m2, inclusive, at screening;
4. Fasting C-peptide test result \>0.3 nmol/L (\>0.90 ng/mL);
5. HbA1c ≥7% and ≤10.5%;
Exclusion Criteria:
1. Fasting blood glucose at screening or Day -1 ≤110 or ≥270 mg/dL ;
2. Type 1 diabetes mellitus;
3. Reported incidence of severe hypoglycemia within 3 months prior to screening;
4. Known contraindications to empagliflozin;
5. Clinically significant gastrointestinal disorder;
6. History or symptoms of clinically significant cardiovascular disease;
7. History of more than three urinary tract infections and/or more than three genital fungal infections in the last 12 months;
8. Reported history of clinically significant central nervous system disease including within one year prior to screening;
9. Reported history of liver disease;
10. Reported history of clinically significant renal disease;
11. Estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m2;
12. Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
13. Known or suspected malignancy;
14. Any reported hypersensitivity or intolerance to empagliflozin;
15. Antidiabetic treatment with insulin, sulfonylureas, thiazolidinediones or GLP-1 agonist within 3 months prior to screening;
16. Systolic blood pressure \<90 or \>160 mmHg or diastolic blood pressure \<60 or \>100 mmHg at screening;
17. A hospital admission or major surgery within 90 days prior to screening;
18. Uncontrolled hypertriglyceridemia \>500 mg/dL;
19. Positive blood screen for HIV, HBsAg, or hepatitis C antibody;
20. Positive pregnancy test result;
21. Treated with any investigational drugs within 6 weeks prior to screening;
22. Reported history of prescription drug abuse;
23. Reported history of alcohol abuse
24. Reported history of donation or acute loss of blood during the 90 days prior to screening;
|
[
2.6138577461242676,
0.1267658770084381,
-2.614636182785034,
-4.9266533851623535,
0.229312464594841,
0.16009530425071716,
0.609476625919342,
1.5989058017730713,
-0.6014864444732666,
-1.0949596166610718,
0.6817485094070435,
2.327160358428955,
0.026027563959360123,
2.3296570777893066,
1.9012285470962524,
-1.807137131690979,
0.1563389152288437,
-0.07004804909229279,
0.13155263662338257,
-1.651498794555664,
0.6152482628822327,
-0.8967314958572388,
-1.030717134475708,
0.7978218793869019,
-0.024445855990052223,
-1.7879612445831299,
0.22100314497947693,
2.4426536560058594,
0.7871184349060059,
1.4315531253814697,
0.3557189702987671,
-0.8447252511978149,
1.8891792297363281,
1.022245168685913,
0.4938400387763977,
-0.13345810770988464,
-0.2128870040178299,
0.5037307143211365,
-0.8934308290481567,
0.39951199293136597,
-1.5865248441696167,
0.48855382204055786,
-0.21843795478343964,
-1.272186040878296,
1.4750555753707886,
1.912013053894043,
0.25368890166282654,
1.0658382177352905,
-0.5438967943191528,
0.09939923882484436,
-0.4315694272518158,
0.6104594469070435,
-1.4814671277999878,
-0.8650128245353699,
1.0455968379974365,
-0.6680442094802856,
-0.2573784291744232,
2.054701328277588,
0.9532734155654907,
0.24145881831645966,
-1.0220643281936646,
0.23884300887584686,
0.7412773370742798,
0.35883015394210815,
-0.8437892198562622,
0.6178821921348572,
-0.2359122484922409,
0.470144659280777,
-1.0028996467590332,
0.25694480538368225,
-1.3365118503570557,
1.2628133296966553,
-1.128194808959961,
1.8729594945907593,
1.3084394931793213,
0.5979061126708984,
1.4109218120574951,
-0.13533058762550354,
0.8504443168640137,
0.2321750372648239,
-0.17148497700691223,
-0.2932491898536682,
0.28880247473716736,
0.8242732286453247,
-0.9110673666000366,
0.1582653820514679,
-1.265676736831665,
-0.43958431482315063,
-0.06931997835636139,
-1.2426382303237915,
0.5040515065193176,
0.19822447001934052,
-1.4487849473953247,
0.33469557762145996,
-1.3814144134521484,
-0.7165061235427856,
-0.5602390766143799,
-0.40272825956344604,
-0.566381573677063,
-0.13887900114059448,
-0.16637256741523743,
-0.0424230620265007,
-0.7604986429214478,
-0.16883589327335358,
-1.4618862867355347,
-0.30105578899383545,
-0.22439377009868622,
-1.1255418062210083,
-1.3389564752578735,
-0.8600503206253052,
0.7111059427261353,
-0.7453229427337646,
0.40959352254867554,
-0.05633033439517021,
0.7735768556594849,
0.12573575973510742,
-0.18133248388767242,
0.02784084901213646,
-0.6569395661354065,
-0.752468466758728,
-0.2917453348636627,
0.7691847085952759,
-0.13111436367034912,
1.7633283138275146,
0.2696550190448761,
-0.7394915819168091,
0.6595147848129272,
-0.6339001655578613,
0.6863739490509033,
-0.9965704679489136,
-0.9662567973136902,
0.18018604815006256,
0.7158922553062439,
0.7610477209091187,
-0.7565571069717407,
-1.906495451927185,
1.7667344808578491,
1.0266255140304565,
0.7797146439552307,
-0.28153058886528015,
-0.13462549448013306,
0.3194965422153473,
0.43774810433387756,
-0.6073022484779358,
-1.2194440364837646,
0.15648481249809265,
0.29621702432632446,
0.23484699428081512,
0.5263733863830566,
-0.31673508882522583,
-0.5794895887374878,
0.25668132305145264,
-0.19424302875995636,
-0.35191845893859863,
0.7548345327377319,
-0.2891755700111389,
0.9586864709854126,
-0.49549293518066406,
0.5526818633079529,
-0.022811949253082275,
-0.10575313866138458,
-0.22685888409614563,
0.07309400290250778,
0.05731635540723801,
0.06333242356777191,
-0.028850430622696877,
-0.16581687331199646,
0.4580968916416168,
0.3575631082057953,
0.5131077170372009,
-1.278076171875,
-0.490967333316803,
0.08641458302736282,
0.16768284142017365,
0.29722386598587036,
-0.04347473755478859,
0.48375797271728516,
-0.039409346878528595,
0.43318018317222595,
0.0699441060423851,
-0.6547621488571167,
0.6917095184326172,
-0.28241652250289917,
-0.00471865851432085,
0.864253044128418,
-0.7026733160018921,
-0.20537468791007996,
0.27745047211647034,
-0.037575554102659225,
-0.025526627898216248,
-0.10040710121393204,
-0.45977774262428284,
0.4092223644256592,
0.10399208217859268,
0.09852587431669235,
-0.505531907081604,
0.031956132501363754,
0.7879207134246826,
0.1285887360572815,
-0.7361382842063904,
0.6383882761001587,
0.22676661610603333,
1.0467205047607422,
0.7291913032531738,
0.6894983053207397,
0.19510024785995483,
0.2895960807800293,
0.6265808343887329,
-0.0063969967886805534,
0.006350819952785969,
0.13402195274829865,
-0.5786028504371643,
-0.5590478181838989,
0.2938308119773865,
0.5636720061302185,
-0.47866708040237427,
-0.7785245180130005,
0.5920783281326294,
0.4007888436317444,
0.44211238622665405,
-0.2068203240633011,
0.6126085519790649,
-0.1397179812192917,
0.38282302021980286,
-0.08173142373561859,
-0.20224794745445251,
-0.47234106063842773,
-0.34576642513275146,
0.05880602449178696,
-0.7359253168106079,
0.30439314246177673,
-0.0072695910930633545,
-0.5264402031898499,
0.056499116122722626,
0.3321708142757416,
0.041283220052719116,
-0.05332281067967415,
0.7393946647644043,
0.1917750984430313,
-0.30577564239501953,
0.2261265218257904,
-0.09610112011432648,
-0.39888185262680054,
-0.8079978227615356,
0.1915806233882904,
-0.21202798187732697,
-0.27515923976898193,
0.12698616087436676,
0.029570061713457108,
-0.2242766171693802,
-0.5086162686347961,
0.18544794619083405,
-0.1568368375301361,
0.4398738741874695,
-0.1491159051656723,
0.09770964086055756
] |
|
NCT05275920
|
Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF)
|
Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF) is a pragmatic, cluster-randomized, three-arm intervention trial that will compare the effectiveness of two targeted clinical decision support (CDS) intervention tools (best practice alert (BPA) and automated in-basket massage) to inform providers when a patient with heart failure and reduce ejection fraction (HFrEF) is not on appropriate medical therapy, as compared to usual care.
|
An estimated 68,000 deaths per year nationwide can be attributed to gaps in care for patients with heart failure and reduced ejection fraction (HFrEF), with the majority being due to lack of mineralocorticoid receptor antagonists (MRA). Despite proven benefits in randomized trials, class I guideline recommendations, and published clinical performance measures, patients with HFrEF are often not on guideline-directed medical therapy (GDMT). While successful interventions for improvement in prescription of GDMT have often included multidisciplinary approaches with dedicated staff, the relatively high cost of hiring additional personnel has led to an interest in electronic health record (EHR)-based interventions. Prior studies on EHR-based interventions in this arena have mainly been conducted in the inpatient setting, which is limited to one encounter during acute hospitalization, a setting often complicated by renal dysfunction or hypotension that can limit prescription of MRA. The development and study of outpatient EHR-based alerts for HFrEF GDMT are needed. Two types of outpatient EHR-based interventions include best practice alerts (BPA) and automated in-basket messages. Both of these methods have limited data, with some studies showing benefit and others demonstrating provider fatigue and burnout. To our knowledge, there is no study that has directly compared these different types of EHR-based interventions.
BETTER CARE - HF is a pragmatic, cluster-randomized, three-arm intervention trail that will compare the effectiveness of two targeted CDS intervention tools (BPA and automated in-basket message) as compared to usual care on the primary outcome of MRA prescription at end of study period.
|
Inclusion Criteria:
* Cardiologist visit
* Transthoracic echocardiogram with the most recent EF \>= 40%
Exclusion Criteria:
* Hypotension: SBP \< 95
* Hyperkalemia: most recent K \> 5.1, or any K \>5.5
* Renal dysfunction: eGFR \< 30
* Ventricular assist device
* Hospice care
* Cardiac amyloid
|
[
-1.342336654663086,
4.312900543212891,
-1.6430357694625854,
-3.2630481719970703,
1.3850524425506592,
0.4651319980621338,
-0.03424014523625374,
1.0698816776275635,
-0.5743772387504578,
-0.35700178146362305,
0.496533066034317,
0.3422209918498993,
-1.2203869819641113,
0.9848271608352661,
0.9882603883743286,
0.627107560634613,
0.6931196451187134,
1.2125824689865112,
1.2564302682876587,
-0.7398476004600525,
0.8964425325393677,
-0.287112832069397,
1.0016242265701294,
0.1802792251110077,
0.27702611684799194,
0.2668924331665039,
0.5366188883781433,
2.165304183959961,
0.6358708143234253,
0.963740348815918,
0.0036755006294697523,
-1.0065463781356812,
-0.1562727391719818,
1.1273562908172607,
0.08967255800962448,
-0.46248939633369446,
0.10251852124929428,
-0.3536880314350128,
-0.7954232692718506,
0.18337354063987732,
1.0015660524368286,
0.31939661502838135,
-0.6112043857574463,
0.45851415395736694,
1.677947998046875,
-0.09779591113328934,
0.5098616480827332,
-0.8192739486694336,
0.41095203161239624,
0.8310167789459229,
-1.0302046537399292,
2.2400827407836914,
-0.032666515558958054,
0.13753533363342285,
1.600211501121521,
0.26768195629119873,
0.18150673806667328,
-0.46018508076667786,
1.8335349559783936,
1.9420456886291504,
-0.01278754323720932,
-1.2899154424667358,
-0.013680366799235344,
1.010865569114685,
-0.9879661202430725,
-0.6443267464637756,
0.10061538219451904,
-0.5009827017784119,
-0.7781316637992859,
0.34426814317703247,
-0.07244434952735901,
0.5638310313224792,
1.1242247819900513,
0.7252302169799805,
0.5512162446975708,
0.9024432301521301,
-0.937827467918396,
1.173754334449768,
0.32332298159599304,
0.5288113355636597,
0.37807783484458923,
0.3262117803096771,
0.05657538026571274,
-0.50698322057724,
0.38794535398483276,
-1.2644829750061035,
-0.8755671381950378,
-0.5596483945846558,
0.2303341031074524,
-0.6180950403213501,
1.3320342302322388,
0.06625627726316452,
0.08933208882808685,
0.43337202072143555,
-0.47531458735466003,
0.7519611120223999,
-0.22097021341323853,
-0.20765632390975952,
-0.9349192380905151,
-0.07135558128356934,
-0.23775842785835266,
-0.17025978863239288,
-0.3193700909614563,
-0.09526262432336807,
-0.8682919144630432,
0.7984579801559448,
0.34321436285972595,
-0.15515178442001343,
-0.29478245973587036,
0.12073036283254623,
0.45650163292884827,
-0.8979926109313965,
1.2194751501083374,
0.01723533123731613,
-0.2532348930835724,
1.2803186178207397,
0.5712494850158691,
0.7096137404441833,
0.4157312512397766,
-0.3433164358139038,
-0.12553808093070984,
0.9232532978057861,
0.6490205526351929,
-0.44577789306640625,
-0.5136038064956665,
-0.051579538732767105,
0.2055373340845108,
0.7954867482185364,
-0.796569287776947,
-0.0022358037531375885,
-0.28987956047058105,
-0.3361995220184326,
0.19913099706172943,
-0.08291855454444885,
-1.0710545778274536,
-0.20729845762252808,
-0.3172105848789215,
0.3960135579109192,
-0.7169110774993896,
-0.9191536903381348,
0.3863617181777954,
0.5912211537361145,
0.5251758098602295,
0.09238112717866898,
0.3540649712085724,
-0.40212109684944153,
-0.37962251901626587,
-0.22146408259868622,
-0.9528035521507263,
-0.4427059590816498,
-0.6464752554893494,
0.8742996454238892,
-0.14320945739746094,
0.413387268781662,
-0.16342996060848236,
0.4449880123138428,
0.12361614406108856,
-0.5069119930267334,
0.08432331681251526,
0.30096209049224854,
0.15510202944278717,
-0.7971374988555908,
-0.09258762747049332,
-0.406749427318573,
-0.4034782648086548,
-0.02803361602127552,
-0.1645328402519226,
-0.4633297920227051,
0.3669223189353943,
-0.08927783370018005,
-0.8548017740249634,
-0.10777845978736877,
-0.8240009546279907,
0.4264494478702545,
-0.06139204651117325,
-0.08190713822841644,
0.5439965724945068,
-0.4032953083515167,
0.3673166334629059,
-0.5543757677078247,
0.5501382946968079,
0.12199743092060089,
0.23221629858016968,
0.6575362682342529,
0.10493887960910797,
-0.6701733469963074,
0.3657969832420349,
-0.8755824565887451,
0.10350500792264938,
0.664695143699646,
-0.30981552600860596,
-0.27989712357521057,
-0.7105634212493896,
0.36721423268318176,
0.1926606446504593,
-0.4010600447654724,
-0.41854408383369446,
-0.4540194869041443,
0.5047210454940796,
0.06394609808921814,
0.05828080698847771,
0.6481431126594543,
-0.1960638165473938,
0.7640402913093567,
0.45870131254196167,
0.1339595466852188,
-0.3460659384727478,
-0.892508864402771,
-0.526524543762207,
0.5072387456893921,
0.463893324136734,
0.6952436566352844,
0.1672840118408203,
-0.8410604596138,
-0.40408051013946533,
0.3937914967536926,
0.5575045347213745,
-0.04903393238782883,
0.05275225266814232,
-0.44785964488983154,
0.038683656603097916,
-0.3572598099708557,
-0.04945598542690277,
0.3219847083091736,
0.12717387080192566,
0.5698571801185608,
0.054990820586681366,
0.3252716064453125,
-0.10098596662282944,
-0.2653568685054779,
-0.36698535084724426,
0.1607232391834259,
0.5218749642372131,
0.22501201927661896,
-0.2830268442630768,
-0.4952724874019623,
-0.07186874002218246,
0.5484091639518738,
-0.2868519127368927,
0.7185348868370056,
0.6323410272598267,
0.32203370332717896,
0.1606234461069107,
-0.4910510778427124,
0.07770955562591553,
-0.32997697591781616,
-0.04503503814339638,
-0.11951426416635513,
0.2503737509250641,
0.02995212934911251,
-0.37527358531951904,
-0.014376558363437653,
-0.1221938356757164,
0.0034822069574147463,
-0.3623462915420532,
-0.17655006051063538
] |
NCT05600894
|
Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm
|
This phase II trial tests whether decitabine and cedazuridine (ASTX727) in combination with venetoclax work better than ASTX727 alone at decreasing symptoms of bone marrow cancer in patients with chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) with excess blasts. Blasts are immature blood cells. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. The combination of ASTX727 and venetoclax may be more effective in reducing the cancer signs and symptoms in patients with CMML, or MDS/MPN with excess blasts.
|
PRIMARY OBJECTIVE:
I. To evaluate the complete remission rates of ASTX727 and ASTX727 plus venetoclax in subjects with CMML and non-CMML MDS/MPN with excess (\>= 5%) blasts.
SECONDARY OBJECTIVES:
I. To evaluate the overall response rate (complete response \[CR\] + partial response \[PR\] + marrow response with erythroid response) of ASTX727 versus ASTX727 + venetoclax in this patient population.
II. To determine the overall survival, progression-free survival, allogeneic hematopoietic stem cell transplantation rate, clearance of the malignant clone, clonality at time of hematologic remission, number of red cell and platelet transfusions required and toxicity of ASTX727 versus ASTX727 + venetoclax.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (COMBINATION THERAPY): Patients receive ASTX727 orally (PO) once daily (QD) on days 1-5 of each cycle and venetoclax PO QD on days 1-14 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy and aspiration and collection of blood samples throughout the study and undergo buccal swab sample collection at screening.
ARM II (MONO THERAPY): Patients receive ASTX727 PO QD on days 1-5 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who do not have response to treatment may cross over to Arm I. Patients also undergo bone marrow biopsy and aspiration and collection of blood samples throughout the study and undergo buccal swab sample collection at screening.
After completion of study treatment, patients are followed up every 6 months for 5 years or until death, whichever occurs first.
|
Inclusion Criteria:
* A diagnosis of an MDS/MPN "overlap" syndrome with \>= 5% marrow blasts (including monocytic blast equivalent in case of CMML). Hydroxyurea may be used to control counts up until the start of therapy
* White blood cell (WBC) \< 25,000/mm\^3. Treatment with hydroxyurea is permitted to lower the WBC to reach this criterion
* Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of ASTX727 in combination with venetoclax in patients \< 18 years of age, children are excluded from this study
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) (unless considered due to Gilbert's syndrome)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional ULN OR =\< 5.0 x institutional ULN for patients with liver metastases
* Glomerular filtration rate (GFR) \>= 30 mL/min/1.73 m\^2
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Hormonal therapy for prior or concurrent malignancy is allowed
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) and/or family member available will also be eligible
* Ability to swallow pills
Exclusion Criteria:
* Patients with need for emergent disease-directed therapy excluding hydroxyurea
* More than one cycle of previous MDS/MPN-directed therapy, or MDS-directed therapy including lenalidomide and hypomethylating agent (HMAs) such as decitabine or azacitidine, excluding hydroxyurea. Prior use of erythropoietin stimulating agents (ESA) and thrombopoietic agents is allowed, but must be discontinued 4 weeks prior to study treatment
* Patients currently or previously receiving an investigational agent or device within 4 weeks of the first dose of treatment
* Patients with symptomatic uncontrolled central nervous system (CNS) disease. Imaging to confirm the absence of brain metastases is not required. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
* Patients who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit within 3 days prior to the initiation of study treatment and are unwilling to discontinue consumption of these throughout the receipt of study drug
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASTX727 or venetoclax
* Patients with uncontrolled intercurrent illness (e.g. requiring intravenous therapy) at the discretion of the investigator
* Pregnant women are excluded from this study because venetoclax and ASTX727 have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax. These potential risks may also apply to other agents used in this study. Patients must be post-menopausal or with evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1
* Post-menopausal is defined as:
* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments
* Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50 years of age
* Radiation-induced oophorectomy with last menses \> 1 year ago
* Chemotherapy-induced menopause with \> 1 year interval since last menses
* Surgical sterilization (bilateral oophorectomy or hysterectomy)
* Women of child-bearing potential must agree to use adequate contraception (hormonal birth control or abstinence) prior to study entry and for the duration of study participation, and for 6 months following completion of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception (latex or synthetic condom or abstinence) prior to the study, for the duration of study participation, and 3 months after completion of venetoclax and ASTX727 administration
* Patients with any other medical condition for which the expected survival is below 12 months
* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or assessment of the investigational regimen
* Patients with uncontrolled infection at the time of study entry
|
[
1.3685227632522583,
-0.6223932504653931,
-1.0071769952774048,
-2.876413583755493,
0.6163877844810486,
-0.46012595295906067,
-0.7152326703071594,
0.3397211730480194,
-1.4829074144363403,
0.14047594368457794,
-1.0299376249313354,
1.5339114665985107,
-0.16769231855869293,
0.7667862772941589,
0.25862330198287964,
-0.5707045793533325,
-1.0212870836257935,
0.8268983960151672,
1.1056714057922363,
-1.8819875717163086,
0.38467514514923096,
-1.1842854022979736,
-0.7314924597740173,
-1.0170574188232422,
0.658695638179779,
-1.7027196884155273,
0.605793833732605,
1.4438756704330444,
1.4086275100708008,
1.0829700231552124,
-0.6135192513465881,
-0.08983439952135086,
0.8005015254020691,
0.33815160393714905,
-0.23116850852966309,
0.6046045422554016,
0.7898727059364319,
0.2069556713104248,
-0.8678196668624878,
-0.09218579530715942,
-0.4197025001049042,
0.18905417621135712,
0.3939396142959595,
0.22347486019134521,
-0.9208207726478577,
-0.25624579191207886,
1.0811125040054321,
-0.00818204041570425,
1.0010879039764404,
0.585183322429657,
-1.7723246812820435,
1.8912203311920166,
-1.5944658517837524,
-0.7061413526535034,
1.210963487625122,
0.38778021931648254,
-0.3125263452529907,
0.6678667068481445,
0.8727415800094604,
0.7275683283805847,
0.651716947555542,
0.32213735580444336,
-0.4272858202457428,
-0.05432727560400963,
-1.3895496129989624,
0.1329149454832077,
-0.19807064533233643,
-1.288546085357666,
-0.6630083918571472,
0.017825834453105927,
-0.21128228306770325,
0.19549152255058289,
0.8722052574157715,
0.002913872944191098,
-0.16768145561218262,
0.10345977544784546,
0.12399314343929291,
1.1251263618469238,
0.8370965719223022,
-0.3235803544521332,
-1.129647970199585,
-0.37186577916145325,
-0.27532336115837097,
0.8179582953453064,
-0.365872323513031,
-0.5634634494781494,
-0.7443987131118774,
-0.763761579990387,
0.12744486331939697,
-1.1706241369247437,
0.8799391984939575,
-0.6496316194534302,
-0.6402984261512756,
1.046574592590332,
-0.4431806802749634,
0.4622214734554291,
-0.0373845174908638,
-0.26842400431632996,
-0.40842267870903015,
-0.8742820024490356,
0.19928574562072754,
-0.3673996925354004,
-1.0086231231689453,
-0.1114230751991272,
-0.03064109943807125,
-0.3755602240562439,
0.035037703812122345,
-1.3926963806152344,
-1.315736174583435,
-0.8623619675636292,
-0.008271459490060806,
-0.8289888501167297,
-0.7107328772544861,
0.03165171667933464,
0.16682173311710358,
0.7177277207374573,
0.4323335587978363,
0.1853734403848648,
0.07496052235364914,
0.6035232543945312,
0.010477785021066666,
0.5886585116386414,
-0.25390851497650146,
-0.03324298560619354,
0.34421613812446594,
-0.23117148876190186,
-0.7411055564880371,
-0.3420146703720093,
0.6324043869972229,
-0.8215255737304688,
0.02209768258035183,
0.06350277364253998,
0.10917507112026215,
-0.352140873670578,
-0.7434453964233398,
-0.15470388531684875,
0.012705601751804352,
1.2362031936645508,
0.6269577145576477,
-0.3596038818359375,
0.6900503039360046,
-0.33748555183410645,
-0.25410258769989014,
-0.046744197607040405,
-0.7421560287475586,
0.20725829899311066,
0.4477744996547699,
0.4219677150249481,
-0.05908571928739548,
-0.3007606267929077,
-0.143103688955307,
0.7707725763320923,
0.5658397078514099,
-0.012362980283796787,
0.05169472098350525,
0.6598199009895325,
0.08705662190914154,
-0.3918193578720093,
0.40648341178894043,
-0.2631224989891052,
-0.3002258837223053,
-0.3171820044517517,
0.06543368101119995,
-0.14694708585739136,
0.5012192726135254,
0.012251260690391064,
0.6982665061950684,
-0.15198522806167603,
0.4381133019924164,
0.013233843259513378,
-0.5066596269607544,
-0.4568917751312256,
0.05786880850791931,
0.22627364099025726,
-0.4923134446144104,
0.2550482749938965,
0.13831160962581635,
0.30180227756500244,
-0.16422004997730255,
-0.40427088737487793,
0.05067642405629158,
-0.10455279797315598,
0.09227705001831055,
-0.49926623702049255,
0.37260618805885315,
-0.06812198460102081,
0.23842042684555054,
-0.4016830325126648,
-0.3117867410182953,
0.44693073630332947,
0.19461601972579956,
0.04427504166960716,
-0.18266674876213074,
0.5610480308532715,
-0.19545350968837738,
-0.20023885369300842,
-0.4885193407535553,
0.1765100508928299,
0.6414492130279541,
-0.6126218438148499,
0.029198167845606804,
0.22457198798656464,
0.11360761523246765,
0.1856624335050583,
-0.026573767885565758,
-0.06775583326816559,
-0.024990305304527283,
-0.15786270797252655,
0.41690364480018616,
0.19040851294994354,
-0.15364499390125275,
-0.5041823983192444,
0.4782187044620514,
0.024174783378839493,
0.676205575466156,
-0.3307811915874481,
0.3698519468307495,
-0.19587315618991852,
-0.20104973018169403,
0.021503381431102753,
-0.2494724839925766,
-0.4551243782043457,
-0.06693056970834732,
-0.10873643308877945,
0.4973410964012146,
0.2597854435443878,
-0.20432023704051971,
0.15738874673843384,
-0.2756809890270233,
-0.29154303669929504,
-0.3493301570415497,
-0.3106982111930847,
-0.18902848660945892,
-0.2522651255130768,
0.24013197422027588,
-0.14801272749900818,
0.2371276468038559,
0.018303854390978813,
-0.11589762568473816,
0.10322217643260956,
0.03694793954491615,
0.01639586314558983,
-0.16179528832435608,
-0.5161086916923523,
0.13434073328971863,
-0.3075924515724182,
0.0669456347823143,
-0.3824464678764343,
0.04487670958042145,
0.0906032919883728,
-0.1443232297897339,
-0.1139858067035675,
-0.23691444098949432,
0.2574976086616516,
0.3288034200668335,
-0.1616058647632599
] |
NCT02643810
|
Exercise Training in Adults With Corrected Tetralogy of Fallot
|
In this controlled trial, patients with tetralogy of Fallot will be randomized to either interval training, continuous training, or usual care groups.
|
Patients after surgical correction of tetralogy of Fallot (cTF) have impaired exercise tolerance as compared to healthy age-matched individuals. In this controlled trial, patients with cTF will be randomized to either interval training, continuous training, or usual care.
The aim of the study is to compare the effect of interval vs. continuous exercise training on:
i) exercise capacity ii) vascular function iii) arrhythmogenic potential iv) parameters of inflammation, hemostasis and heart failure severity v) health-related quality of life adults with cTF
|
Inclusion Criteria:
* congenital tetralogy of Fallot surgically corrected in childhood
Exclusion Criteria:
* contraindications for exercise training,
* uncontrolled dysrhythmias,
* uncontrolled heart failure (New York Heart Association (NYHA) stage IV),
* unstable coronary or other arterial disease,
* intellectual development disorder,
* pregnancy.
|
[
-1.7771475315093994,
1.767055630683899,
-1.3448854684829712,
-2.440330982208252,
-0.9915395975112915,
0.16808614134788513,
-0.19745780527591705,
-0.45894134044647217,
-1.2372722625732422,
1.8747985363006592,
1.3742393255233765,
0.6879810094833374,
-1.2935870885849,
-1.0431084632873535,
-1.6176592111587524,
0.6695505380630493,
0.960606575012207,
-0.18295733630657196,
0.1700030118227005,
-0.14709427952766418,
-1.2139981985092163,
-0.38524457812309265,
-1.0373703241348267,
-0.8018873333930969,
-1.8548470735549927,
1.3814151287078857,
-0.008514580316841602,
0.6339364647865295,
1.2279174327850342,
0.017041103914380074,
1.100725531578064,
-0.2603016793727875,
1.1686351299285889,
-0.8329212665557861,
-0.3576134443283081,
1.3908360004425049,
0.6686641573905945,
-0.7996923327445984,
0.2997928857803345,
0.6972064971923828,
0.9012775421142578,
0.7983025312423706,
-0.7102414965629578,
-0.6239509582519531,
1.3103370666503906,
2.248194932937622,
0.5128678679466248,
0.66860032081604,
1.4268296957015991,
-0.33197906613349915,
-1.1828495264053345,
1.9264620542526245,
-1.3162825107574463,
0.27799397706985474,
1.8331996202468872,
1.82290518283844,
0.18112261593341827,
-0.5070175528526306,
1.67964506149292,
-0.005036267451941967,
1.521005392074585,
1.5802744626998901,
1.2124102115631104,
-0.05386484041810036,
-1.5253962278366089,
-0.01580520160496235,
0.6493200063705444,
-0.7925857901573181,
-0.741759717464447,
-1.0400481224060059,
0.1693616658449173,
-0.006695936433970928,
0.5489190816879272,
1.0067588090896606,
0.6313705444335938,
0.6655653715133667,
-1.3124759197235107,
0.3726542592048645,
0.41813114285469055,
-0.2276448756456375,
0.03462791070342064,
1.1745489835739136,
-0.5932599902153015,
-1.1132197380065918,
0.3851907551288605,
-0.3616209030151367,
-1.337981939315796,
-0.13271993398666382,
1.3651764392852783,
0.28122541308403015,
1.0916818380355835,
0.3991078734397888,
0.9339243769645691,
-0.31081533432006836,
-1.0963566303253174,
0.15189124643802643,
0.7058737277984619,
0.4741109609603882,
-0.3253147304058075,
-0.5146664381027222,
0.3809709846973419,
-0.6031430959701538,
0.009333822876214981,
-0.8204220533370972,
-1.2938778400421143,
0.07409008592367172,
0.0748167559504509,
-0.6472638845443726,
-0.16744208335876465,
-0.6391361951828003,
-1.5727264881134033,
-0.47775354981422424,
0.3708864152431488,
0.20485994219779968,
0.44339725375175476,
-0.15817366540431976,
0.7734327912330627,
-0.3457654118537903,
-0.8300275802612305,
-0.5619868040084839,
-0.5340348482131958,
0.4099542796611786,
1.4427860975265503,
-1.1177449226379395,
0.03674320504069328,
-0.39934295415878296,
0.43874362111091614,
1.2848213911056519,
-0.39161285758018494,
-0.16665618121623993,
-0.9145583510398865,
-0.6475265026092529,
0.46814611554145813,
-1.6096607446670532,
-2.003368377685547,
-1.4113909006118774,
0.23821185529232025,
1.7212361097335815,
-1.2948673963546753,
0.08828186988830566,
0.9735611081123352,
-0.10468033701181412,
-0.5530469417572021,
0.32992738485336304,
-0.6312609910964966,
-0.2000744789838791,
-1.47606360912323,
0.026377452537417412,
0.10087898373603821,
-1.1314619779586792,
-1.1020255088806152,
-0.6713522672653198,
0.7827611565589905,
0.2019645869731903,
-0.4046730101108551,
0.38757652044296265,
-0.421966016292572,
-0.237787663936615,
0.6899433135986328,
-1.1009176969528198,
0.31666067242622375,
0.3059696853160858,
0.3907717764377594,
-0.6510955095291138,
0.7830559015274048,
0.5766308903694153,
-0.6882746815681458,
0.721903383731842,
0.9288966059684753,
0.7042253017425537,
-1.0827223062515259,
-0.24480755627155304,
0.010263514705002308,
0.8080989122390747,
-0.7529634833335876,
-0.2815840542316437,
1.7230225801467896,
-0.0002150509535567835,
-0.6394355297088623,
-0.6100914478302002,
0.6131920218467712,
-0.02976146712899208,
0.6200705766677856,
-0.4648829698562622,
-0.34057334065437317,
-0.6568790078163147,
0.2906058132648468,
0.27421092987060547,
0.7521675229072571,
-0.3116845190525055,
0.07981923222541809,
0.3968219459056854,
-0.5243366956710815,
0.9239970445632935,
-0.029519028961658478,
0.7771421074867249,
0.5278401374816895,
-0.33214616775512695,
0.6818225979804993,
-0.1457289755344391,
0.6362552046775818,
0.1850104033946991,
-0.25419485569000244,
0.4333803057670593,
0.4444337487220764,
-1.1111990213394165,
0.5603177547454834,
-0.4788140058517456,
0.47554266452789307,
-0.10198506712913513,
0.09916483610868454,
0.7184867262840271,
0.09676308184862137,
0.10312805324792862,
-0.33100178837776184,
0.746512234210968,
0.7972186207771301,
0.6230432391166687,
-0.6809127330780029,
-0.42392268776893616,
0.09056652337312698,
-0.847132682800293,
-0.1536562591791153,
0.09865488857030869,
-0.72733473777771,
0.443021297454834,
0.03071698732674122,
-0.2481049746274948,
0.5403963327407837,
-0.2377811074256897,
0.07226468622684479,
0.7471730709075928,
0.39999935030937195,
-0.04439980909228325,
-0.04892778396606445,
-1.1192643642425537,
-0.9532232880592346,
-0.0005955753731541336,
-0.8944734930992126,
1.0260909795761108,
0.769785463809967,
-0.9958980083465576,
-0.3936249613761902,
-0.7246002554893494,
0.12208501994609833,
-0.6843678951263428,
0.28576895594596863,
0.20688918232917786,
-0.015532156452536583,
0.02246171049773693,
-0.5835098028182983,
-0.6955649256706238,
0.7917619347572327,
-0.03001868724822998,
0.20932166278362274,
-0.3952702283859253
] |
NCT01125579
|
Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness
|
Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of nervous restlessness in children aged 6 to 12.
Each patient is treated with NPB. No placebo group is established. Course and severity of symptoms is documented by a questionnaire on 13 common symptoms of nervous restlessness and a Visual Analogue Scale (VAS). A standardized questionnaire (Parent Child Behaviour Checklist (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physician's discretion. The planned treatment and observation period is 2 - 4 weeks.
|
Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of nervous restlessness in children aged 6 to 12.
Patients and methods: A prospective, non-interventional, non-randomized, observational study conducted in German pediatric practices. Each patient is treated with NPB. No placebo group is established. As subjective criteria to document course and severity of symptoms, a questionnaire on 13 common symptoms of nervous restlessness and a Visual Analogue Scale (VAS) is used. As an objective criterion, a standardized questionnaire (Parent Child Behaviour Checklist (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physician's discretion. The planned treatment and observation period is 2 - 4 weeks.
|
Due to the design as an Observational Study no inclusion or exclusion criteria are named. The included patient group is described under "Cohort / Group".
Observational Criteria:
* age 6 - 11 (extremes included)
* nervous restlessness and/or
* agitated depression and/or
* affective disorders
Exclusion Criteria:
* patients \<6 and \>12 years of age
|
[
-1.186173439025879,
3.2572100162506104,
-1.4319556951522827,
-0.32370153069496155,
-0.7944611310958862,
0.06650601327419281,
0.46616870164871216,
-0.5816565155982971,
0.342456191778183,
-1.073874592781067,
0.02002187818288803,
2.747324228286743,
-0.4124787151813507,
0.49171900749206543,
-1.096909761428833,
0.5142225027084351,
-0.08644634485244751,
-0.41036826372146606,
0.9649836421012878,
-1.308789610862732,
0.347004771232605,
-0.47728753089904785,
-0.7992700934410095,
-1.1349962949752808,
-0.33608803153038025,
0.5791904926300049,
-1.4870760440826416,
1.1211564540863037,
-0.28347522020339966,
0.6431154608726501,
0.4641750752925873,
-0.046317994594573975,
0.41070714592933655,
0.10957567393779755,
0.279643177986145,
-0.6870148777961731,
0.5599925518035889,
-0.23022906482219696,
-0.3575977683067322,
0.27457335591316223,
0.7693650126457214,
-0.1988227218389511,
-0.42068201303482056,
-0.581606388092041,
0.9080811738967896,
0.8289341926574707,
-0.7578154802322388,
0.5396721363067627,
0.4050685167312622,
-0.8775103092193604,
-0.38716885447502136,
0.6843349933624268,
-0.7523364424705505,
-0.140193909406662,
1.4820904731750488,
-0.4719364643096924,
0.8347230553627014,
0.022726550698280334,
1.104296088218689,
-0.29927417635917664,
0.5269876718521118,
0.04182492569088936,
1.325939416885376,
0.23728173971176147,
0.059041183441877365,
-0.2452535778284073,
-0.6949172019958496,
0.4482853412628174,
-0.6341460943222046,
0.5015437006950378,
-0.1722210943698883,
-0.24881161749362946,
0.7299638390541077,
-0.019585125148296356,
-0.1500522345304489,
-0.6583383679389954,
-0.6188396215438843,
0.7549823522567749,
0.6415523290634155,
0.025555890053510666,
-0.24110868573188782,
0.08109694719314575,
0.2879456579685211,
-0.36443912982940674,
0.18872372806072235,
0.5839917063713074,
-1.5573821067810059,
-0.13169364631175995,
0.0951867550611496,
-0.22304117679595947,
-0.33706873655319214,
-0.027780460193753242,
-0.6587290167808533,
0.5444809794425964,
-1.1608275175094604,
0.15854890644550323,
0.15691153705120087,
-0.1804223656654358,
-0.9710484743118286,
-0.2961079478263855,
0.03768397867679596,
-0.626652717590332,
0.7175283432006836,
-0.20673853158950806,
-0.7556451559066772,
0.4574301838874817,
0.15753209590911865,
-0.5496487021446228,
-0.3342238962650299,
-0.9538629055023193,
0.3304655849933624,
-0.3207751214504242,
0.12081296741962433,
-0.5361990928649902,
0.5258604884147644,
0.06863809376955032,
0.28121742606163025,
0.05016183853149414,
-0.5693761110305786,
0.37588533759117126,
-0.4396897852420807,
0.32400909066200256,
-0.5941523909568787,
-0.021266430616378784,
-0.23697136342525482,
0.005022853147238493,
0.6525053977966309,
-0.5618765354156494,
-0.059884216636419296,
-0.8606299161911011,
-0.9401260614395142,
0.32988566160202026,
-0.24673695862293243,
-0.09402721375226974,
-1.1965278387069702,
-0.12691211700439453,
-0.0524509958922863,
0.8780462741851807,
-0.11313468217849731,
-0.9587932825088501,
0.4774446487426758,
0.5397347211837769,
-0.3859870433807373,
-0.3383646011352539,
-1.2399556636810303,
-0.12072692811489105,
-0.19335044920444489,
-0.1776725798845291,
-0.7904496192932129,
-0.2762698233127594,
0.08210690319538116,
-0.1812991350889206,
-0.027757834643125534,
0.2689724564552307,
0.3775671124458313,
0.2273259162902832,
0.38444992899894714,
-0.4756810665130615,
0.6409363150596619,
-0.3448169231414795,
0.3409048020839691,
-0.7048068642616272,
-0.3204754590988159,
-0.6023237705230713,
-0.14810748398303986,
0.1708555370569229,
-0.586851954460144,
-0.10215074568986893,
0.38422343134880066,
0.5305994153022766,
-0.0346086248755455,
0.17572814226150513,
0.79509437084198,
0.22275137901306152,
-0.4235113561153412,
0.5377404093742371,
0.39273178577423096,
-0.04207438975572586,
0.4599885046482086,
0.2159527987241745,
0.01508297398686409,
0.019250355660915375,
0.2128777951002121,
0.24574153125286102,
-0.34958675503730774,
-0.5250095129013062,
-0.2914442718029022,
0.2312813103199005,
-0.44072163105010986,
0.40822115540504456,
-0.278074711561203,
0.2540310323238373,
0.3328340947628021,
0.24443629384040833,
-0.07802926748991013,
-0.3551124036312103,
-0.14444291591644287,
-0.3921455144882202,
0.48520779609680176,
0.05004620924592018,
-0.09560094028711319,
0.7406684160232544,
-0.33711349964141846,
0.6372772455215454,
0.1513267308473587,
-0.06301530450582504,
-0.3952506482601166,
-0.4643469750881195,
0.19035068154335022,
0.2601536810398102,
0.2690240442752838,
0.17967915534973145,
-0.24503016471862793,
0.20945607125759125,
-0.12757477164268494,
0.05435262992978096,
-0.10047449916601181,
-0.02547880820930004,
-0.16778424382209778,
-0.18424156308174133,
-0.5387784838676453,
-0.6574572920799255,
-0.26384633779525757,
0.05975113809108734,
-0.40358492732048035,
-0.2892213463783264,
-0.159030020236969,
0.161423921585083,
-0.3097982108592987,
-0.25111228227615356,
-0.19391439855098724,
-0.11124774068593979,
0.24839045107364655,
0.15981343388557434,
-0.4944925010204315,
-0.22869284451007843,
0.049729157239198685,
-0.22318899631500244,
-0.048712048679590225,
0.24263480305671692,
0.05019422993063927,
-0.2916891574859619,
0.2225850224494934,
-0.11877666413784027,
-0.4840056002140045,
-0.442770391702652,
-0.38492870330810547,
0.0007865150109864771,
-0.06259999424219131,
-0.09510941803455353,
-0.3687482476234436,
-0.22084376215934753,
-0.11624360829591751,
-0.22691427171230316,
0.22070881724357605,
-0.3416374623775482
] |
NCT00255749
|
Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer
|
RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy.
PURPOSE: This randomized phase II trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer.
|
OBJECTIVES:
Primary
* Determine the efficacy, in terms of maintenance of target hemoglobin and hematocrit levels, of interval dosing with epoetin alfa in patients with anemia undergoing chemotherapy for nonmyeloid cancer.
* Determine the safety of this drug in these patients.
Secondary
* Determine the quality of life of patients treated with this drug.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
* Arm I (early intervention): Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.
* Arm II (standard intervention): Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.
Quality of life is assessed prior to start of study treatment, at week 7 during study treatment, and after completion of study treatment.
After completion of study treatment, patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.
|
DISEASE CHARACTERISTICS:
* Histologically confirmed nonmyeloid cancer
* No history of myelodysplasia
* Baseline hemoglobin 11-12 g/dL
* No anemia due to factors other than cancer or chemotherapy (e.g., iron, cyanocobalamin \[vitamin B_12\], or folate deficiencies, hemolysis, or gastrointestinal bleeding)
* Receiving chemotherapy that meets the following criteria:
* Administered weekly OR every 3 weeks
* Must begin chemotherapy on or before the first day of study treatment
* No known, untreated CNS metastases
PATIENT CHARACTERISTICS:
Performance status
* ECOG 0-2
Life expectancy
* At least 6 months
Hematopoietic
* See Disease Characteristics
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3 (transfusion independent)
* Iron transferrin saturation \> 20%
* No history of chronic hypercoagulable disorders (e.g., activated protein C resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency)
Hepatic
* Bilirubin \< 2.0 mg/dL
* SGPT ≤ 3 times upper limit of normal
Renal
* Creatinine ≤ 1.5 mg/dL
* No significant, uncontrolled genitourinary disease or dysfunction
Cardiovascular
* No uncontrolled cardiac arrhythmia in the past 6 months
* No uncontrolled hypertension
* No deep vein thrombosis, ischemic stroke, or other arterial or venous thrombotic events
* Superficial thromboses allowed
* No other significant, uncontrolled cardiovascular disease or dysfunction
Pulmonary
* No significant, uncontrolled pulmonary disease or dysfunction
* No pulmonary emboli
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No infection requiring hospitalization or antibiotics in the past 14 days
* No known hypersensitivity to mammalian cell-derived products or to human albumin
* No new onset (in the past 3 months) poorly controlled seizures
* No other active malignancy except basal cell carcinoma or carcinoma in situ
* Not an employee of the investigator or study center or family members of the employee or the investigator
* No significant, uncontrolled neurological, endocrine, or gastrointestinal disease or dysfunction
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Chemotherapy
* More than 3 months since prior erythropoietic agent (e.g., epoetin alfa, darbepoetin alfa, or gene-activated erythropoietin)
* More than 4 weeks since prior packed red blood cell transfusion
* No concurrent stem cell harvest of bone marrow
* No concurrent interleukin-11
* No other concurrent erythropoietic agent
Chemotherapy
* See Disease Characteristics
* No concurrent high-dose chemotherapy with stem cell transplantation
Radiotherapy
* No concurrent nonpalliative radiotherapy
Surgery
* More than 2 weeks since prior major surgery
Other
* At least 1 month since prior investigational agents or devices
* No concurrent high-dose IV iron supplementation
|
[
0.6100805401802063,
0.8173805475234985,
-2.0798003673553467,
-1.1958527565002441,
-0.7169453501701355,
-0.603478193283081,
-0.043278589844703674,
-0.813194215297699,
-2.2205145359039307,
-0.38032156229019165,
-0.8516620397567749,
2.5407774448394775,
0.8136149644851685,
1.084746241569519,
1.2801971435546875,
-0.2848402261734009,
-0.7025659084320068,
0.4450618028640747,
1.937688946723938,
-2.25685453414917,
1.072007656097412,
-1.8211184740066528,
-1.2835702896118164,
0.7592758536338806,
1.069055438041687,
-0.28327158093452454,
-1.3179489374160767,
1.4139022827148438,
2.2736353874206543,
1.0919874906539917,
-0.6654226779937744,
1.4020640850067139,
0.5946946740150452,
-1.1565337181091309,
-0.7774120569229126,
1.4769740104675293,
2.260340452194214,
1.0532280206680298,
-1.55204176902771,
-0.24620607495307922,
0.1832268089056015,
0.5293644070625305,
0.2004355788230896,
0.5033053755760193,
0.6591349244117737,
-0.41595813632011414,
1.018876552581787,
0.22149495780467987,
0.06093144789338112,
1.6844085454940796,
-1.3176441192626953,
3.087846279144287,
-1.4047231674194336,
-0.4785116910934448,
2.178046464920044,
1.2366920709609985,
0.16071011126041412,
1.2045822143554688,
1.8980666399002075,
0.5982346534729004,
0.7212618589401245,
-1.5659865140914917,
-0.7722464799880981,
-0.31963881850242615,
-2.3317933082580566,
0.12596386671066284,
1.1555655002593994,
-1.749864935874939,
-0.20354637503623962,
0.5478248596191406,
1.7136600017547607,
1.369405746459961,
-0.11525854468345642,
-0.9239446520805359,
-0.16864784061908722,
1.4683802127838135,
-0.7061915993690491,
-0.08532692492008209,
0.6296812295913696,
-0.8873475790023804,
-1.5581847429275513,
-0.46401894092559814,
-0.6256242394447327,
0.40094348788261414,
-0.4886801242828369,
-0.16328753530979156,
-1.5102293491363525,
0.1695280522108078,
-0.04815317317843437,
-1.959895133972168,
1.288662314414978,
-0.3398200571537018,
-0.8665605187416077,
1.7079565525054932,
-1.2600908279418945,
0.7035108208656311,
-0.9263288378715515,
-0.6756990551948547,
-0.3035221993923187,
-0.14084893465042114,
0.2228630930185318,
0.8816807866096497,
-0.5083299875259399,
0.08323288708925247,
-0.35807690024375916,
0.2388637512922287,
1.2732065916061401,
-0.9799609184265137,
-1.1160407066345215,
-0.03602985292673111,
0.7815049886703491,
-1.5619642734527588,
0.13973373174667358,
0.6388076543807983,
0.06648056954145432,
-0.658359944820404,
0.8471758961677551,
-0.035659417510032654,
0.583547055721283,
0.4810599088668823,
-0.45396557450294495,
0.938636064529419,
-1.3273952007293701,
0.05495818704366684,
-1.5515753030776978,
0.5077574253082275,
0.10415001213550568,
-0.2704395651817322,
-0.5622664093971252,
-1.4454559087753296,
0.26136890053749084,
-0.08512882143259048,
0.8969459533691406,
-0.20246852934360504,
-0.6748290657997131,
-0.648702085018158,
0.9726709723472595,
2.1914479732513428,
1.346988320350647,
-0.401132732629776,
1.110328197479248,
-0.2540295720100403,
0.4646427631378174,
-0.19218647480010986,
-0.9360271096229553,
0.3748313784599304,
0.4027450680732727,
-0.023420264944434166,
-0.25163164734840393,
-0.7795558571815491,
0.15867900848388672,
0.5318089723587036,
0.9139223098754883,
0.16872505843639374,
-0.2358372062444687,
0.32100045680999756,
0.06955573707818985,
-0.38765114545822144,
0.31674402952194214,
0.2025013267993927,
-1.141191840171814,
-0.33831292390823364,
0.6182109117507935,
-1.0352863073349,
0.7909260988235474,
-0.18891523778438568,
0.2318209409713745,
0.6217765808105469,
0.5834447741508484,
0.520715594291687,
-0.2242528349161148,
-0.4585094749927521,
0.20672431588172913,
1.1965912580490112,
-0.6062029600143433,
-0.4447747766971588,
0.5943531394004822,
-0.21969854831695557,
0.7470685839653015,
-0.7926878333091736,
-0.7735244631767273,
0.08958837389945984,
0.7161661386489868,
-0.8868755102157593,
-0.20301824808120728,
-0.06020127609372139,
0.05627113953232765,
0.8777526617050171,
0.08265349268913269,
-0.40506356954574585,
1.2644397020339966,
1.001603603363037,
0.49346405267715454,
0.8442660570144653,
-0.4830966591835022,
-0.14780311286449432,
-0.45909246802330017,
0.3864244222640991,
1.1275635957717896,
-0.5709551572799683,
0.5833503007888794,
0.09792368859052658,
0.2628614008426666,
0.2947978377342224,
-0.6618163585662842,
-0.770209550857544,
0.3366119861602783,
-0.31835028529167175,
0.252539724111557,
0.2402140349149704,
-0.11699283123016357,
0.0023716639261692762,
1.20857572555542,
-0.028972232714295387,
0.35370802879333496,
0.15414971113204956,
-0.026207322254776955,
-0.3652769923210144,
-1.2474631071090698,
-0.7051259279251099,
-0.49066752195358276,
-0.5611189007759094,
0.1020936593413353,
0.41360875964164734,
0.19266267120838165,
0.0027965414337813854,
0.4716816246509552,
-0.17547741532325745,
-0.21716776490211487,
0.08955982327461243,
0.09960832446813583,
-0.32641395926475525,
-0.34613579511642456,
0.2830890417098999,
0.20304320752620697,
-0.6213189363479614,
1.2876524925231934,
0.4765549600124359,
0.2207428365945816,
0.3836717903614044,
0.4103703498840332,
0.07350694388151169,
-0.17438550293445587,
-0.9330929517745972,
0.25499963760375977,
0.1729278266429901,
0.44883930683135986,
-0.09089745581150055,
0.036865588277578354,
1.0291659832000732,
-0.428633451461792,
-0.20309233665466309,
-0.2733233571052551,
0.014286491088569164,
-0.220315620303154,
-0.7216845750808716
] |
NCT03265249
|
BRIDGE Device for Post-operative Pain Control
|
Auricular neurostimulation is a potential novel and non-invasive method of pain control following liver transplantation in a growing patient population with the probability of significant impact on economics and morbidity. The investigators propose a pilot study to investigate the effects of auricular neurostimulation in patients receiving a liver transplantation. The investigator will investigate the effects of auricular neurostimulation with this novel device and compare it to the current standard of care for pain management following liver transplantation.
|
This is a prospective, randomized study to determine the efficacy of the BRIDGE device in reducing pain and opioid use in patients following liver transplantation. Subjects will be randomized in a 1:1 ration to one of the below groups:
Group 1: BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia
Group 2: Subjects will receive the standard of care pain control analgesia
|
Inclusion Criteria:
* Inclusion criteria:
* ≥18 years of age but \<70 years of age
* Actively listed for isolated liver transplantation
* Subject or legally authorized representative able to sign informed consent
* Not currently treated with opioids or any medications that may interact with opioids
* English speaking
* Willing and able to participate and consent to this study
Exclusion Criteria:
* Diagnosis of acute liver failure or primary sclerosing cholangitis (PSC)
* Anticipated that the subject will require a new roux-en-y hepaticojejunostomy
* Current use of opioid use or other substance abuse.
* Chronic pain disorders
* Need for regional anesthesia (regional nerve blocks or epidurals)
* Adhesive allergy/sensitivity
* Subject admitted to the ICU at the time of transplant
|
[
1.0684551000595093,
2.593381404876709,
-2.1350483894348145,
-1.3497751951217651,
-0.7739301919937134,
-1.0367602109909058,
-0.13078907132148743,
-0.32644224166870117,
-2.283862590789795,
1.821810007095337,
0.7128932476043701,
2.4561386108398438,
-0.7375603914260864,
1.3829922676086426,
0.9015128016471863,
1.7661614418029785,
-0.928188145160675,
0.5138460397720337,
-0.7270405888557434,
-0.47181081771850586,
0.929219663143158,
-0.7281035780906677,
-0.68124920129776,
0.09926673024892807,
0.4371391236782074,
-0.8803495168685913,
-0.10083866119384766,
1.9791837930679321,
0.7459742426872253,
0.863265872001648,
0.608522891998291,
-2.9079415798187256,
-0.01028140727430582,
1.744680404663086,
1.1271629333496094,
-0.787464439868927,
1.8802534341812134,
0.2818175256252289,
0.1148640513420105,
-1.0619637966156006,
0.1988649070262909,
2.0689048767089844,
-0.6491681933403015,
1.341385006904602,
0.20454798638820648,
0.41388094425201416,
-0.9300224184989929,
1.2729591131210327,
1.0916694402694702,
-0.29415977001190186,
-0.40316224098205566,
2.355952024459839,
-1.3688302040100098,
0.13014182448387146,
0.8231691718101501,
0.8695911765098572,
1.353628396987915,
-0.26245376467704773,
1.5587060451507568,
-0.4078366160392761,
0.29689106345176697,
-0.47834017872810364,
-1.0703151226043701,
0.12832871079444885,
-0.7758198380470276,
-0.4168793857097626,
-0.44958773255348206,
-0.21757625043392181,
-0.8031602501869202,
0.31385254859924316,
0.7215540409088135,
-0.19407178461551666,
0.8437792658805847,
0.2700318396091461,
0.13959060609340668,
1.9725421667099,
-1.0170446634292603,
-0.29412975907325745,
1.0207730531692505,
0.12728817760944366,
-0.031433213502168655,
-1.408607006072998,
-2.466362953186035,
1.0150907039642334,
0.9118365049362183,
-0.7781602144241333,
-1.0898799896240234,
-0.7039576172828674,
0.799187421798706,
-1.4247297048568726,
-0.3404470682144165,
-0.39183834195137024,
-0.021003197878599167,
0.723871111869812,
0.03241072967648506,
0.11213722825050354,
-0.3996966481208801,
-1.103079915046692,
-0.9242154359817505,
-0.329501748085022,
0.43475341796875,
0.5329610705375671,
-0.5251071453094482,
-0.9175581932067871,
1.1559373140335083,
0.48600390553474426,
-0.2259255051612854,
-1.0477442741394043,
0.1724885255098343,
-0.7237353920936584,
0.5059350728988647,
-0.2148667871952057,
-0.4262903928756714,
-1.2954199314117432,
-1.4664301872253418,
0.38262978196144104,
0.8703138828277588,
1.0260223150253296,
0.09376314282417297,
-0.7712569236755371,
0.7077244520187378,
0.24996918439865112,
0.5668198466300964,
1.0298858880996704,
-0.4205183982849121,
0.21871168911457062,
-0.950653612613678,
0.1942289024591446,
-0.8731428384780884,
-1.028735876083374,
-0.349774569272995,
1.0167425870895386,
0.03686985373497009,
-0.2457241714000702,
-0.45633238554000854,
-0.5790429711341858,
-0.09580027312040329,
0.049920037388801575,
-0.4561101496219635,
-0.2600829303264618,
-0.14827141165733337,
0.46490275859832764,
-0.3197387456893921,
0.39866191148757935,
-1.5814615488052368,
-0.8580285906791687,
0.5392047166824341,
0.7458853125572205,
-0.794969916343689,
-0.7162965536117554,
0.02545079030096531,
0.4632668197154999,
1.0357393026351929,
-0.01264218706637621,
0.14015385508537292,
0.32878196239471436,
0.525184154510498,
-0.6057239174842834,
0.5816962122917175,
-1.1719800233840942,
-0.6511671543121338,
-0.2117156982421875,
-0.0888788253068924,
0.00041506197885610163,
0.28925877809524536,
-0.7215068340301514,
-1.2149806022644043,
-0.0026704263873398304,
-0.11707857996225357,
-0.268510103225708,
-0.24668599665164948,
0.7522612810134888,
-0.06569565832614899,
0.2812664210796356,
-1.0948995351791382,
-0.46294254064559937,
0.10919418185949326,
0.827564001083374,
0.8111554384231567,
0.13340727984905243,
0.9172731637954712,
0.20271658897399902,
-0.019992420449852943,
0.8604554533958435,
-0.10790912806987762,
-0.3484254777431488,
-0.4455689787864685,
-0.1540757119655609,
-0.09689338505268097,
0.2707405686378479,
0.0032547798473387957,
-0.6392905116081238,
-0.1483268439769745,
-0.17886070907115936,
1.567323088645935,
-0.11837839335203171,
-0.15051080286502838,
-1.2321434020996094,
0.207820862531662,
-0.2977871000766754,
0.3026483356952667,
1.1823902130126953,
-1.276739478111267,
-0.03187111020088196,
0.22320236265659332,
-0.12099086493253708,
0.3611997365951538,
-0.026640992611646652,
0.02969193086028099,
-0.26052120327949524,
0.5070472955703735,
-0.28121593594551086,
-1.035219669342041,
-0.23700398206710815,
0.24562031030654907,
0.19506733119487762,
-0.4930199384689331,
0.6032630801200867,
-1.0574687719345093,
0.4752424359321594,
0.4993371069431305,
-0.28670206665992737,
0.08976650983095169,
0.37792178988456726,
0.05305306613445282,
0.28039464354515076,
0.15260249376296997,
-0.20372268557548523,
-0.28988999128341675,
-0.6576193571090698,
-0.50752192735672,
0.5831606388092041,
0.19741076231002808,
-0.18584275245666504,
-0.4297006130218506,
0.5506084561347961,
-0.2553531527519226,
0.3027198016643524,
-0.18628405034542084,
0.0746791884303093,
-0.013258485123515129,
-0.38657045364379883,
0.19565366208553314,
0.18296906352043152,
-0.38628432154655457,
-0.3699956238269806,
-0.5698012709617615,
-0.20213928818702698,
-0.30335623025894165,
0.17178048193454742,
0.15723086893558502,
-0.3503236174583435,
-0.19797128438949585,
0.2495299130678177,
-0.15863724052906036,
-0.08923011273145676
] |
NCT00037700
|
Evaluation of the Efficacy of Combination Treatment With Anakinra and Pegsunercept in Improving Rheumatoid Arthritis
|
The purpose of this study is to evaluate the effect of anakinra (IL-1 ra) and pegsunercept (PEG sTNF-RI) when they are used together in improving the signs and symptoms of rheumatoid arthritis. The study will also evaluate the safety of the combination treatment and its effect on slowing down bone and joint destruction due to rheumatoid arthritis. The results will be compared to the effect when only 1 single medication (anakinra or pegsunercept) is used.
|
* diagnosed with rheumatoid arthritis for at least 6 months
* must be taking methotrexate \* must not take DMARDS other than methotrexate during the study
* must not have had previous treatment with and protein-based TNF-alpha inhibitor (eg. etanercept, infliximab, PEG sTNF-RI, or D2E7)
* must not have had previous treatment with anakinra
* subjects must meet tender and swollen joint requirements at screening, have morning stiffness, and/or have elevated acute phase reactants
|
[
-0.027659950777888298,
0.366883784532547,
-1.8391716480255127,
-3.0341107845306396,
0.8799053430557251,
-0.3851965069770813,
0.8414496183395386,
0.45122990012168884,
-1.7587381601333618,
-1.3023459911346436,
0.10477302223443985,
1.3936758041381836,
-1.1842296123504639,
-0.5951716303825378,
1.0093587636947632,
-0.24465897679328918,
0.09241395443677902,
0.1953631192445755,
0.7257341146469116,
-1.0329885482788086,
-0.4533739984035492,
-0.018672971054911613,
-0.3699079751968384,
0.39783453941345215,
0.8150603771209717,
0.17899690568447113,
-0.8278900980949402,
0.9914424419403076,
-0.3322061598300934,
0.4181513786315918,
-1.4458568096160889,
-0.4134938716888428,
-0.3612990975379944,
1.0157897472381592,
-0.3879581689834595,
-1.5154458284378052,
0.37569621205329895,
-0.23037631809711456,
-2.3259201049804688,
1.9518853425979614,
0.733673095703125,
0.6518263220787048,
1.1065077781677246,
0.33434373140335083,
1.1359115839004517,
-0.4541405141353607,
-0.3755275011062622,
0.38306957483291626,
-0.14354228973388672,
-0.5972068905830383,
0.1496708244085312,
0.6204851865768433,
-0.19515573978424072,
0.17594929039478302,
1.7344993352890015,
-0.9047741293907166,
0.38312333822250366,
0.37548190355300903,
0.4602908790111542,
1.0474380254745483,
-0.3712841272354126,
-0.6635040044784546,
-0.22565189003944397,
0.6423525214195251,
-0.42026057839393616,
-0.5031264424324036,
0.6089675426483154,
-0.6770517230033875,
-1.221285343170166,
0.7022380232810974,
0.1549467295408249,
0.6663084030151367,
0.22355012595653534,
-0.6018828749656677,
0.14287422597408295,
0.5792095065116882,
0.13024425506591797,
-0.4434930980205536,
0.699718177318573,
0.20888645946979523,
0.10344071686267853,
-0.535485029220581,
-0.7305187582969666,
-0.15700675547122955,
-0.5102049112319946,
0.08497677743434906,
-0.4311676621437073,
-0.9199484586715698,
0.20976196229457855,
-0.20989347994327545,
0.2639695703983307,
-0.39578038454055786,
-1.510599136352539,
0.9059452414512634,
-0.8817431330680847,
0.11941633373498917,
-0.5200169682502747,
-0.3302423357963562,
-0.41407346725463867,
-0.18464621901512146,
-0.02397293969988823,
-0.4316067695617676,
0.4298458397388458,
0.23223987221717834,
0.3589308559894562,
0.45817646384239197,
-0.23568737506866455,
-0.2664280831813812,
-0.59795081615448,
-0.8103142380714417,
1.398759365081787,
-0.6947047114372253,
-0.031813304871320724,
-0.19467468559741974,
0.05223402380943298,
0.3801387846469879,
0.3292231559753418,
0.294107049703598,
-0.15191350877285004,
0.058527152985334396,
0.17631511390209198,
0.7739846110343933,
-0.027688980102539062,
1.3059269189834595,
-0.3769473433494568,
0.020130885764956474,
0.5657429695129395,
0.006564526818692684,
-1.12003493309021,
-0.10498061776161194,
0.18304139375686646,
0.11575651168823242,
0.303508460521698,
-0.061371516436338425,
-0.7242999076843262,
-0.14728835225105286,
-0.05547773092985153,
0.8747317790985107,
0.5362146496772766,
-0.34453240036964417,
-0.7716123461723328,
0.2319130003452301,
0.525044858455658,
0.16256919503211975,
-1.2596673965454102,
-0.5507569313049316,
0.06561751663684845,
-0.0773887038230896,
0.08888968825340271,
-0.6137551069259644,
-0.3797517716884613,
0.025212882086634636,
0.19325080513954163,
0.4787593185901642,
0.46820154786109924,
0.41834744811058044,
0.46527668833732605,
-0.24466963112354279,
1.2341500520706177,
0.22026190161705017,
-0.19454078376293182,
-0.4117169678211212,
-0.1545816957950592,
-0.4028831720352173,
0.47389426827430725,
0.07568205147981644,
0.06445106863975525,
-0.14402318000793457,
0.7091276049613953,
-0.235236257314682,
-0.8021830916404724,
0.8257527947425842,
0.3883921205997467,
0.06365872174501419,
-0.07886949181556702,
0.11163810640573502,
-0.007154218852519989,
0.44603750109672546,
0.3430495262145996,
-0.2797069847583771,
-0.010844772681593895,
-0.20131899416446686,
0.04970916733145714,
-0.5740233063697815,
0.26273560523986816,
-0.28875645995140076,
0.09116794168949127,
0.14999769628047943,
-0.0973869115114212,
-0.11306789517402649,
-0.22676898539066315,
-0.1316518932580948,
0.39157065749168396,
0.0904594138264656,
0.14427602291107178,
0.2802099585533142,
0.046413492411375046,
-0.5959931015968323,
0.7274819016456604,
-0.2625757157802582,
-0.010115101002156734,
0.700567901134491,
0.15851876139640808,
0.2750283479690552,
-0.4819861054420471,
-0.6924625635147095,
-0.48435235023498535,
-0.1583038717508316,
0.001316624111495912,
0.6581674814224243,
0.2670026123523712,
-0.18017123639583588,
-0.34111306071281433,
0.1839572787284851,
0.3564279079437256,
0.37087714672088623,
-0.21467794477939606,
0.2244761884212494,
-0.2748332917690277,
-0.1856197565793991,
0.1794583946466446,
0.0941057875752449,
-0.026832791045308113,
0.08345869928598404,
-0.02148887701332569,
0.03037753701210022,
-0.1561371386051178,
0.4586062431335449,
0.8052088618278503,
-0.28915947675704956,
0.040169134736061096,
-0.053549520671367645,
-0.16033412516117096,
0.06919767707586288,
-0.2859635055065155,
0.34672054648399353,
0.1728709191083908,
0.22302617132663727,
-0.10808143764734268,
0.01770019344985485,
0.40433284640312195,
-0.49884429574012756,
0.08504543453454971,
-0.33485469222068787,
-0.11409600079059601,
0.24416521191596985,
-0.030795035883784294,
0.3561045527458191,
0.033863287419080734,
-0.036194343119859695,
0.21479684114456177,
-0.33058518171310425,
-0.15803079307079315,
0.293975830078125,
0.0713825672864914,
-0.729063093662262
] |
|
NCT05579262
|
Evaluating the Metabolic Effects of Dietary Nitrate Supplementation
|
Dietary nitrate is found to enhance muscle fatty acid oxidation/glucose uptake and increase mitochondrial biogenesis, which in turn, aid in the prevention and management of metabolic diseases. In recent years, inorganic nitrate supplementation is clinically emerging as a therapeutic strategy for possible treatment and management of metabolic diseases and cardiometabolic disorders. This is mostly explored in healthy/obese subjects, for improving blood pressure, endothelial function, insulin response and vascular effects. However, the metabolic effects of dietary nitrate for improving skeletal muscle glucose/lipid metabolism, muscle mitochondrial metabolism, muscle blood flow and body fat composition are not comprehensively studied in diabetic/pre-diabetic subjects. Hence, this study aims to evaluate the therapeutic efficacy of a natural nitrate supplement (beetroot juice) for improving overall metabolic health in obese pre-diabetic and non-diabetic subjects.
|
Skeletal muscle plays a key role in glucose and energy homeostasis and is involved in metabolizing a substantial proportion of glucose through glucose oxidation as well as through non-oxidative pathways. Skeletal muscle insulin resistance is one of the key driving factors associated with the pathophysiology of type 2 diabetes (T2D) and muscle dysfunction. Further, mitochondrial dysfunction is implicated in the pathogenesis of insulin resistance, insulin secretion and T2D. Enhancement of muscle fatty acid oxidation/glucose uptake along with increased mitochondrial biogenesis using natural supplements is an emerging strategy for preventing and managing metabolic diseases. One such natural supplements is nitrate (NO3). The oral microbiome plays a prominent role in the bioactivation of dietary nitrate (NO3) to nitrite (NO2), which is further reduced to nitric oxide (NO) in the gastrointestinal tract to maintain NO homeostasis and vascular health. NO is an important physiological signaling molecule and is involved in the modulation of skeletal muscle functions including regulation of blood flow (hemodynamic effect), muscle contractility, glucose, calcium homeostasis, mitochondrial respiration and biogenesis.
The use of dietary NO3 supplementation has been explored in the literature for mainly improving blood pressure, endothelial function, insulin response, and vascular effects in healthy/obese subjects. However, the metabolic effects of dietary NO3 for improving skeletal muscle glucose/lipid metabolism, muscle mitochondrial energetics, muscle blood flow, and body fat composition are not well studied in diabetic/pre-diabetic subjects.
In view of the potential health benefits of NO3/NO, this study plans to evaluate the therapeutic efficacy of a natural supplement, beetroot juice (rich in NO3) for improving the skeletal muscle mitochondrial function, muscle energetics, insulin sensitivity/glucose homeostasis, body fat composition and overall metabolism in middle aged (40 - 65 years) healthy and pre-diabetic male subjects. This would be the very first pilot study in the domain of metabolic diseases to evaluate the overall metabolic health of both obese pre-diabetic and non-diabetic male subjects using an advanced and comprehensive multi-model metabolic imaging approach.
|
Inclusion Criteria:
1. Males aged 40 - 65 years old, residing in Singapore
2. Body mass index (BMI) 23 - 30 kg/m2
3. Glucose metabolism: a. Normal group with having FPG \< 5.6 mmol/L and HbA1c \< 5.7, b. Pre-diabetes group FPG 5.6 to 6.9 mmol/L, and HbA1c \< 6.5 %.
4. Willing to refrain from using oral mouth wash during study participation
5. Willing to adhere to study protocol
Exclusion Criteria:
1. Any current diagnosis or history of cardiovascular, hepatic, renal, metabolic (e.g. diabetes), gastrointestinal diseases, psychiatric disorders or diseases having impact on the study
2. Suffering from current oral health conditions such as gum diseases, oral cancer or mouth injury
3. Having medication and/or supplements which are known to influence glucose and insulin and muscle mitochondrial metabolism (e.g. Vitamin A, B, C and D, peroral corticosteroids)
4. Having medication for oral health conditions in the last 4 weeks and/or using oral mouth wash (e.g Listerine) in the last 2 weeks
5. Uncontrolled hypertension (blood pressure \> 160/100 mmHg)
6. Current smoker or excessive alcohol intake (\>4 standard drinks per day)
7. Known allergy/intolerance to beetroot family (eg: beetroot, spinach)
8. Undergoing weight loss diet and/or programs
9. Having contraindications for MRI e.g. metallic implants such as cardiac pacemaker
10. Receiving antibiotics or suffering from diarrhoea in the last 4 weeks
11. Consuming supplement(s) which contains nitrate
|
[
2.8479301929473877,
1.864418864250183,
-3.209028720855713,
-4.617490768432617,
0.13212428987026215,
-0.7696011066436768,
-1.606511116027832,
-0.8667062520980835,
-1.5424154996871948,
-1.0479573011398315,
2.4189867973327637,
2.346770763397217,
0.9114113450050354,
1.3341476917266846,
-0.16511215269565582,
0.9792617559432983,
-1.2887630462646484,
-0.07997141033411026,
0.899782657623291,
-2.7486164569854736,
2.1947500705718994,
-0.8271096348762512,
-0.9717694520950317,
0.3005322813987732,
1.009661316871643,
-0.5891364812850952,
-0.08468285948038101,
1.189724326133728,
-0.13642621040344238,
1.825917363166809,
-0.17400960624217987,
-2.257037878036499,
-0.7582816481590271,
0.22066062688827515,
0.34875476360321045,
1.4099807739257812,
2.7039129734039307,
0.2404198795557022,
-1.817903995513916,
1.275801181793213,
1.1791223287582397,
2.7735755443573,
-0.1794835478067398,
0.8943278789520264,
0.7095137238502502,
1.2159122228622437,
2.3685073852539062,
0.5245388746261597,
0.3540378212928772,
1.4320920705795288,
1.3432694673538208,
2.695634365081787,
-2.7708699703216553,
-0.3766571879386902,
2.7483325004577637,
1.7508645057678223,
1.030066728591919,
-0.10957980901002884,
1.1885427236557007,
0.38723593950271606,
-0.08178464323282242,
-0.3682413399219513,
-0.2135976105928421,
0.3069373369216919,
-2.0407891273498535,
-1.9190869331359863,
2.001356601715088,
0.452140212059021,
-1.2104873657226562,
-0.9870491623878479,
0.1294286847114563,
-0.9954641461372375,
-0.38899511098861694,
-1.0409750938415527,
1.4496328830718994,
1.7660322189331055,
-1.0127016305923462,
2.120354175567627,
0.031962089240550995,
0.262145072221756,
0.016487522050738335,
-0.09771084040403366,
-0.4505578875541687,
-0.06540872156620026,
0.6226781606674194,
0.8551865220069885,
-1.521033525466919,
-0.932689905166626,
0.8463967442512512,
-1.6781046390533447,
-0.3237725496292114,
-1.1392031908035278,
-1.968170166015625,
0.10347186028957367,
-0.08960279077291489,
0.3895542621612549,
-0.7295755743980408,
0.17326480150222778,
-0.7406240105628967,
-0.7012380957603455,
-0.5126784443855286,
1.5148488283157349,
-0.4615323841571808,
0.21888944506645203,
0.5525895357131958,
0.08394911885261536,
0.2754843235015869,
-0.5763406753540039,
-0.9671717286109924,
0.05946207419037819,
-0.2788793444633484,
-1.3011319637298584,
-0.2822923958301544,
-0.26142600178718567,
1.3042796850204468,
0.3778810203075409,
0.14564092457294464,
0.6306040287017822,
-0.04958739131689072,
0.09578985720872879,
-0.3451838493347168,
0.8189839124679565,
-0.4717589020729065,
0.04906027019023895,
-0.43401268124580383,
-0.7166302800178528,
-0.3352494537830353,
-0.08705303072929382,
0.7452531456947327,
-1.282328486442566,
0.6361730098724365,
0.4078825116157532,
0.1898546665906906,
-0.5846541523933411,
-0.4707581698894501,
0.41457489132881165,
1.0781062841415405,
0.544888436794281,
-0.45722973346710205,
0.5993483662605286,
-0.7862462997436523,
-0.20015586912631989,
-0.00067403499269858,
1.1886025667190552,
-1.4405425786972046,
-0.428329199552536,
-0.08800141513347626,
-0.4251970946788788,
0.11232080310583115,
-0.29267412424087524,
1.00802743434906,
0.30706700682640076,
0.7795777320861816,
0.33493250608444214,
-0.3709154725074768,
-0.5350736379623413,
-0.7054052352905273,
-0.9466825723648071,
-0.41179007291793823,
0.41985684633255005,
0.37965691089630127,
0.27083930373191833,
-0.39148592948913574,
-0.6044004559516907,
0.9891317486763,
-0.5761419534683228,
-0.23820318281650543,
-0.501258909702301,
1.0926016569137573,
0.45132192969322205,
0.2922324240207672,
-0.21557031571865082,
-0.8574288487434387,
-0.15155890583992004,
-1.0566595792770386,
-0.004174011293798685,
0.5620102882385254,
-0.15192143619060516,
0.23518060147762299,
-0.5079398155212402,
-0.4733375906944275,
0.48251470923423767,
0.15302245318889618,
0.054957617074251175,
-0.30010733008384705,
0.10407307744026184,
-0.031246917322278023,
-0.05648528039455414,
-0.24436119198799133,
0.4488309323787689,
-0.17057110369205475,
0.382778137922287,
-0.39369073510169983,
-0.31734299659729004,
-0.004292943514883518,
0.014024616219103336,
-0.4682938754558563,
-0.32119467854499817,
0.017420610412955284,
0.5145054459571838,
0.18925419449806213,
0.255565881729126,
-0.1657778024673462,
0.4954413175582886,
-0.6891669631004333,
-0.3153465986251831,
-0.10390198230743408,
-0.018534693866968155,
0.5528289079666138,
0.5886213779449463,
-0.10828826576471329,
1.0701178312301636,
-0.21679773926734924,
-0.01507406122982502,
0.4908636212348938,
-0.3298550546169281,
-0.6607931852340698,
0.24545036256313324,
0.18751370906829834,
-0.24289503693580627,
-0.2700527310371399,
0.22194603085517883,
0.3717649579048157,
-0.38021719455718994,
-0.3161109685897827,
-0.06272367388010025,
-0.2856880724430084,
0.12976519763469696,
0.40407684445381165,
-0.23798424005508423,
-0.5489850640296936,
0.23888343572616577,
-0.18420958518981934,
-0.28929170966148376,
-0.10383382439613342,
0.05473414435982704,
0.4451790153980255,
0.44138264656066895,
0.00790307018905878,
0.18511761724948883,
0.017092199996113777,
-0.07069005072116852,
-0.08617149293422699,
-0.08037415891885757,
-0.2481687366962433,
0.06123661994934082,
-0.5636159777641296,
-0.1495017260313034,
0.09157311916351318,
0.22943024337291718,
-0.5405459403991699,
-0.12599752843379974,
-0.1061173677444458,
0.39751332998275757,
0.3934067487716675,
-0.4138197600841522
] |
NCT03916549
|
Acupuncture in Low Anterior Resection Syndrome Treatment
|
Acupuncture has it's role in treating patients with fecal incontinence and diarrhea-predominant irritable bowel syndrome. There is no trial or case-report assessing it's role in treatment of Low anterior resection syndrome.
|
Colorectal cancer is common in Western countries. For thirty years rectal cancer treatment is standardized: patients are undergoing low anterior resection with mesorectal excision +/- (chemo)radiotherapy. Unfortunately around 80% of patients undergoing low anterior resection will experience complex bowel dysfunction including fecal incontinence, soiling, urgency, incomplete evacuation, fragmented defecation and impaired rectal sensation known as low anterior resection syndrome (LARS) causing a "toilet dependence" which severely affects quality of life.
Still there is no standardized treatment for LARS.
|
Inclusion Criteria:
* patients over 18 year
* signed written consent
* patients experiencing major low anterior resection syndrome
* patients at least one year following the surgery
Exclusion Criteria:
* allergy to stainless steal
* implanted pacemaker
* current skin infection
* needle phobia
* metastatic disease to the central nervous system (brain, spinal cord)
* at the same time, application of smecta, dicetel, cisapride or traditional Chinese medicine;
|
[
0.73232501745224,
0.6707504987716675,
-4.067201137542725,
-1.136690616607666,
0.010013007558882236,
-3.496575355529785,
1.867226481437683,
2.540369749069214,
-0.8050896525382996,
-0.7406755089759827,
0.34189456701278687,
3.491319417953491,
-0.7644782662391663,
-0.48506468534469604,
0.24340416491031647,
0.8116664290428162,
0.29780375957489014,
0.5565989017486572,
0.9684284925460815,
-0.7548324465751648,
0.7743302583694458,
0.2510945200920105,
0.7377898693084717,
-0.5027686357498169,
0.21949341893196106,
-1.061706304550171,
-1.2099146842956543,
1.4650037288665771,
1.0308657884597778,
0.056934598833322525,
0.7823665738105774,
-0.7076809406280518,
-0.3752073049545288,
1.3274365663528442,
-0.31632667779922485,
-1.1942481994628906,
-0.017596857622265816,
0.3181513547897339,
-1.6971924304962158,
1.5302149057388306,
0.19549976289272308,
-0.5590605139732361,
-0.1952909231185913,
0.3746587932109833,
1.0400980710983276,
-0.4912993609905243,
-1.0745878219604492,
-0.9536858797073364,
0.913597822189331,
-0.8855156898498535,
-1.2111549377441406,
0.613217830657959,
-1.0294748544692993,
-0.37501299381256104,
0.8604601621627808,
0.2642363905906677,
0.5321597456932068,
0.29391491413116455,
1.553161382675171,
-0.5449273586273193,
2.040579080581665,
0.7437062859535217,
-0.2292426973581314,
-0.30251047015190125,
-1.3204870223999023,
-0.003130138386040926,
0.10285287350416183,
0.16164249181747437,
-0.9339070320129395,
0.07787813991308212,
0.6159080862998962,
1.4813119173049927,
1.2577351331710815,
0.03547957167029381,
-0.03899550065398216,
-0.6477293968200684,
-1.3923696279525757,
0.5830981135368347,
0.16024154424667358,
0.06877323985099792,
0.22622278332710266,
0.23358167707920074,
-0.6003900170326233,
0.5514125227928162,
-0.4756423234939575,
0.37609902024269104,
-1.6050138473510742,
-1.2630945444107056,
1.1302434206008911,
-1.7017927169799805,
-0.6114272475242615,
-0.6816374659538269,
-2.0928382873535156,
0.294156551361084,
-0.21930859982967377,
-0.09497909992933273,
-0.438844233751297,
-0.4045979678630829,
-1.4902455806732178,
0.502309262752533,
-0.8926525712013245,
-0.3832688629627228,
-0.8790599703788757,
-0.18159036338329315,
-0.7396101355552673,
0.47782957553863525,
0.33597299456596375,
-1.0095112323760986,
-0.7884200811386108,
-0.43631723523139954,
0.8010194301605225,
-1.2743406295776367,
-0.004381634760648012,
-0.5115928053855896,
0.18680956959724426,
-0.43271809816360474,
0.5961142182350159,
-0.0002929102338384837,
-0.03256906196475029,
0.7181755900382996,
0.1758149415254593,
0.08168444782495499,
-0.39361026883125305,
0.5676509737968445,
0.4047917127609253,
0.02983584813773632,
-0.6836400628089905,
0.5071220993995667,
-0.7279747128486633,
0.6247355341911316,
-0.2911442518234253,
-0.20203806459903717,
0.6200148463249207,
-0.7492532134056091,
-1.2133893966674805,
-0.06231607869267464,
0.5714544057846069,
0.6778966188430786,
0.17105558514595032,
0.7028904557228088,
-1.045577049255371,
0.48969098925590515,
0.4929245114326477,
1.037764549255371,
-1.517927646636963,
-0.2166728377342224,
-0.7703902721405029,
0.28603965044021606,
-0.9120209217071533,
-0.8848302364349365,
-0.08836991339921951,
0.17799772322177887,
0.7164566516876221,
0.48682600259780884,
-0.14229276776313782,
0.45232704281806946,
1.0181453227996826,
0.060180824249982834,
0.48925361037254333,
-0.40972450375556946,
-0.14570710062980652,
-0.8111868500709534,
0.23154275119304657,
-0.42427241802215576,
-0.08617696911096573,
-0.6528803706169128,
-0.07105148583650589,
-0.2702072560787201,
0.369883269071579,
-0.039130743592977524,
0.4491521418094635,
0.10356535762548447,
-0.17652122676372528,
0.5929163694381714,
-0.5502490997314453,
0.5692397356033325,
0.6310970783233643,
-0.9202046394348145,
0.008795884437859058,
-0.40285658836364746,
-0.5774691700935364,
-0.9057915210723877,
0.06605991721153259,
-0.18225787580013275,
-1.0818471908569336,
-0.221430703997612,
-0.0746908187866211,
-0.13403022289276123,
-0.32041680812835693,
0.6839643120765686,
0.40970462560653687,
0.1432819664478302,
0.7105669975280762,
0.43318119645118713,
-0.6569231748580933,
-0.6780229210853577,
0.36085134744644165,
-0.05211615934967995,
0.3364722430706024,
-0.20271484553813934,
1.265897512435913,
0.045826736837625504,
-0.45432624220848083,
-0.481930136680603,
0.1059085950255394,
-0.48695099353790283,
0.28959953784942627,
-0.51675945520401,
0.1635807305574417,
0.20062531530857086,
0.5086503624916077,
0.25351476669311523,
0.13035894930362701,
-0.3162599802017212,
0.30990272760391235,
-0.06514579057693481,
0.6748597621917725,
0.7063004374504089,
-0.8478203415870667,
0.21131044626235962,
-0.31894248723983765,
-0.32127824425697327,
0.13194423913955688,
0.675582230091095,
-0.10654163360595703,
-0.38564565777778625,
0.7318126559257507,
0.5735298991203308,
-0.334443598985672,
0.30484917759895325,
0.33416837453842163,
-0.4194561243057251,
-0.509539783000946,
0.00240895408205688,
-0.4913425147533417,
0.2270088940858841,
-0.32190266251564026,
0.4888514280319214,
-0.6657544374465942,
0.4849786162376404,
0.3923284411430359,
-0.22546817362308502,
0.854965090751648,
-0.19234059751033783,
-0.32717883586883545,
-0.17366734147071838,
-0.5443024039268494,
-0.11049197614192963,
-0.05738568305969238,
0.12730048596858978,
-0.532291829586029,
0.24327145516872406,
-0.09737878292798996,
0.33032867312431335,
0.5380641222000122,
-0.3153500258922577
] |
NCT03007745
|
Remote Diagnosis and Management of Obstructive Sleep Apnea
|
Although obstructive sleep apnea, a breathing disorder during sleep, is prevalent and recognized as a major public health concern, most Veterans with this disorder are undiagnosed and therefore untreated. Access to sleep laboratories for testing is limited particularly for those Veterans living in rural areas and Veterans with disabilities that prevent travel to a sleep center. The goal of this study is to compare a web-based telehealth management strategy to in-person management. The telehealth pathway will enable Veterans to be diagnosed and treated without visiting a sleep center. The investigators believe that telehealth management will increase Veterans' access to this specialized care at a cost that is less than in-person delivery but with similar improvements in daytime function.
|
Obstructive sleep apnea (OSA) is estimated to be the third most common chronic disease in Veterans and is associated with an increased risk of hypertension, heart attacks, strokes, depression, and driving accidents. Current in-person management at a sleep center limits Veterans' access to care, prolongs patient wait times, and requires Veterans living in remote areas to travel long distances. This proposal will evaluate an innovative web-based clinical pathway to diagnose and manage Veterans with OSA. In Fiscal Year 13, the investigative team received a Veterans Health Administration (VHA) Innovation Award to create the Remote Veteran Apnea Management Portal (REVAMP), a personalized, interactive website that, when combined with other emerging telehealth technologies, is designed to improve access to care, reduce patient wait times, and allow Veterans to receive care without travelling to a sleep center. Veterans complete intake and follow-up questionnaires on the REVAMP website and perform an unattended home sleep test (HST) without in-person instructions. Sleep specialists review the findings with the patient during an initial phone clinic. REVAMP auto-populates the Veteran's questionnaire responses into templated progress notes that are exported to CPRS, the electronic medical record. Veterans diagnosed with OSA are treated with automatically adjusting positive airway pressure (APAP) units. These devices transmit data wirelessly to the website where treatment use and its effectiveness can be monitored by both Veterans and practitioners, thereby promoting patient self-management and productive patient-practitioner interactions.
The investigators' proposed prospective, randomized intervention will compare the clinical and cost-effectiveness of REVAMP management of Veterans with OSA to in-person care. Aim 1 will determine if management with REVAMP is clinically non-inferior to in-person care in terms of improvement in functional outcomes and APAP adherence. Non-inferiority of clinical effectiveness following 3 months of APAP treatment will be expressed in terms of improvement in the score of the Functional Outcomes of Sleep Questionnaire (FOSQ-10), the investigators' primary outcome measure. Adherence to APAP will be objectively monitored by wireless transmission of data from the participant's home unit. In Aim 2, patient preference, medical service use and cost will be collected every 3 months for the entire observation period to compare cost effectiveness of the two managements. Preference will be assessed by the Short Form-6D (SF 6D), and the EuroQol-5D (EQ-5D). Differences in the ratio of cost and quality-adjusted life years saved by REVAMP compared to in-person management will test the hypothesis that REVAMP management will have lower cost and equivalent outcomes. The results of Aims 1 and 2 will provide evidence to support widespread dissemination of REVAMP. Formative evaluation in Aim 3 will use qualitative (targeted phone interviews) and quantitative measures (attrition, work alliance, and patient satisfaction) to inform clinicians, administrators and other stakeholders how to implement this innovative chronic disease pathway.
Aim 1 (primary). To compare functional outcomes following 3 months of APAP treatment in Veterans with OSA randomized to REVAMP versus in-person management. The primary outcome measure in this modified intent-to-treat analysis (i.e., subjects initiated on APAP with at least one FOSQ follow-up score) will be the change from baseline in the FOSQ-10 score. Analysis will also compare the mean daily hours of APAP use in participants in the two groups initiated on APAP treatment.
Hypothesis 1a: Mean change in FOSQ-10 score among participants randomized to REVAMP management will be no more than one point less than that in participants receiving in-person management.
Hypothesis 1b: Mean daily hours of APAP use among participants receiving REVAMP management will be no more than 0.75 hour less than that in participants randomized to in-person management.
Aim 2 (secondary): To compare the differences in cost and quality-adjusted life years (QALY) between REVAMP management and in-person management. The perspective of the analysis will be that of the VA and the intention to treat analysis set will include all randomized participants.
Hypothesis 2a: Average total health-care delivery cost will be lower for participants receiving REVAMP compared to in-person management.
Hypothesis 2b: The 90% lower limit of cost per QALY ratio comparing in-person versus REVAMP manage-ment will be \> $100,000 (i.e., the investigators will have 90% confidence that REVAMP is good value for the cost).
Aim 3 (exploratory): To conduct a mixed methods formative evaluation that will guide REVAMP's widespread implementation. Quantitative component: The investigators will track quantitative outcome measures across both groups including attrition, participant- and practitioner-rated therapeutic alliance (Working Alliance Inventory-Short Revised \[WAI-SR\]),9 and participant treatment satisfaction (Client Satisfaction Questionnaire \[CSQ-8\]).10 The investigators will compare the scores of the WAI-SR and CSQ-8 and attrition rates between treatment arms. Qualitative component: The investigators will explore participant- and practitioner-level perspectives, attitudes, and preferences regarding REVAMP versus in-person management, as well as barriers and facilitators to participation in either clinical pathway through phone interviews with participants from the two intervention groups, participants who withdraw from either intervention, and staff who provide care through REVAMP.
Our primary aim was to demonstrate that the efficacy of REVAMP management is not clinically inferior to in-person care. Efficacy was measured as the change in FOSQ-10 score from pretreatment to 3 months following initiation of APAP treatment. An increase of more than 1 point in mean FOSQ score is felt to indicate an important clinical difference. Based on previous studies, we assumed a common SD=2.80. Similar calculations were performed for the APAP adherence outcome based on a non-inferiority delta of -0.75 hr/day and assuming a SD=2.2. 114 participants/group were estimated to be required to achieve at least 85% power to reject the null hypothesis, i.e., find that the change in FOSQ score among patients receiving the telehealth-based management is \> 1 point lower than that in participants assessed in-person and that APAP adherence among participants receiving the telehealth-based management is \> 0.75 hours lower that that in participants assessed in-person.
|
Inclusion Criteria:
Veterans must meet the following inclusion criteria prior to enrollment:
* Referral to one of the participating sleep centers for evaluation of suspected OSA
* Access in the home to the internet, e-mail, and phone on all days
* Fluent in English as assessed on the initial phone contact
Exclusion Criteria:
Veterans will be excluded from the study for the following reasons:
* Unable or unwilling to provide informed consent and complete required questionnaires
* Previous diagnosis of:
* obstructive sleep apnea (OSA)
* central sleep apnea (50% of apneas on diagnostic testing are central apneas)
* Cheyne-Stokes breathing
* obesity hypoventilation syndrome
* narcolepsy
* Previous treatment with positive airway pressure, non-nasal surgery for OSA, or current use of supplemental oxygen
* A clinically unstable medical condition in the previous 2 months as defined by a new diagnosis, e.g.:
* pneumonia
* myocardial infarction
* congestive heart failure
* unstable angina
* thyroid disease
* depression or psychosis
* ventricular arrhythmias
* cirrhosis
* surgery
* recently diagnosed cancer
* Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 3 months
* Women who are pregnant or women who are sexually active and of child-bearing age who are not using some form of contraceptive
* Unable to perform tests due to inability to communicate verbally, inability to read and write, and visual, hearing or cognitive impairment
|
[
-0.9439902305603027,
2.9057247638702393,
-1.0399938821792603,
-0.9464340806007385,
-0.2723349630832672,
0.6745777726173401,
1.2209092378616333,
0.5727868676185608,
-0.5257301330566406,
-0.20537348091602325,
1.1982567310333252,
2.297637462615967,
-0.9526724815368652,
-1.456479549407959,
-0.7578744888305664,
1.936343789100647,
1.1927964687347412,
0.563142716884613,
0.381635457277298,
-0.8945751786231995,
0.8967411518096924,
-0.0019368909997865558,
0.10100903362035751,
-0.9929323792457581,
0.8466286063194275,
0.7757716178894043,
-0.38442349433898926,
0.6829627752304077,
-1.56884765625,
0.4023139774799347,
-0.07009571045637131,
-1.088179349899292,
-0.5788629055023193,
0.6995810270309448,
-0.02011246234178543,
0.6112207770347595,
0.3539985418319702,
0.3741971552371979,
-0.8347211480140686,
0.17961637675762177,
-0.11840211600065231,
1.3573439121246338,
0.35369816422462463,
-1.4722293615341187,
0.8175221681594849,
1.0206056833267212,
0.6137263774871826,
0.3762304484844208,
0.4884786903858185,
-0.23613597452640533,
-1.218876838684082,
0.022819971665740013,
-0.9234270453453064,
0.1112743690609932,
1.375557780265808,
0.06411965936422348,
0.3342433273792267,
0.7727707028388977,
0.9310189485549927,
0.5309840440750122,
2.0823609828948975,
-0.15598638355731964,
0.30923840403556824,
0.7087971568107605,
-2.1113672256469727,
0.23210695385932922,
-0.410198837518692,
0.3788958787918091,
-0.43960991501808167,
0.09318838268518448,
-0.4966078996658325,
-0.040618058294057846,
0.31371864676475525,
0.031838688999414444,
0.660365104675293,
-0.7438742518424988,
0.22781750559806824,
0.7959625124931335,
0.9919032454490662,
-0.8677199482917786,
-1.0082480907440186,
0.4090252220630646,
-0.5746008157730103,
-1.2302674055099487,
-0.40902388095855713,
-0.6051960587501526,
-1.1675139665603638,
-0.6084298491477966,
0.8834283351898193,
0.07330779731273651,
0.19167852401733398,
-0.8699043989181519,
0.2418007254600525,
0.12890468537807465,
-0.5354211330413818,
-0.3840015232563019,
0.9323385953903198,
-0.6252545714378357,
-1.464837908744812,
-0.9206464290618896,
0.87095046043396,
-0.08604434877634048,
-0.4897635281085968,
-0.5350148677825928,
-0.5974950194358826,
-0.3828674256801605,
-0.7319075465202332,
0.30878737568855286,
-0.6971678137779236,
0.31665462255477905,
0.5723294019699097,
-0.5849568843841553,
0.11850687861442566,
0.3821397125720978,
-0.39529260993003845,
0.4370962381362915,
0.8113909363746643,
0.529240608215332,
0.7141937017440796,
-0.23210027813911438,
-0.012476353906095028,
0.41388946771621704,
-0.37208321690559387,
-0.3500514328479767,
-0.8680583834648132,
-0.27533602714538574,
-0.5491036176681519,
-0.35631558299064636,
-0.5094935894012451,
-0.052714310586452484,
0.567687451839447,
-0.30997174978256226,
-0.09638659656047821,
-0.2296186089515686,
-0.7127886414527893,
-0.6326777935028076,
0.4933282732963562,
0.7627294063568115,
0.02471473254263401,
-0.5372540354728699,
0.06369584053754807,
0.12316208332777023,
-0.2662469446659088,
-0.31815141439437866,
-0.3103078007698059,
-0.7052462100982666,
0.029391832649707794,
0.11007203906774521,
-0.9222303032875061,
-0.25087854266166687,
-0.12221843004226685,
0.8537846207618713,
0.7825617790222168,
0.16734515130519867,
0.07068105041980743,
-0.12395604699850082,
-0.3683473467826843,
-0.5185731053352356,
0.5236726403236389,
0.4270389974117279,
-0.3468044698238373,
-0.023049090057611465,
0.29386961460113525,
0.175342857837677,
-0.13200728595256805,
-0.19117440283298492,
0.28363680839538574,
0.5674973130226135,
0.008252328261733055,
-0.07848650217056274,
0.779883086681366,
0.15765978395938873,
-0.24887095391750336,
-0.207300066947937,
-0.2788551151752472,
0.7877407670021057,
0.9507390856742859,
0.7865195870399475,
0.35431694984436035,
0.4854357838630676,
0.2206670045852661,
0.04953589662909508,
-0.40954455733299255,
-0.48784875869750977,
-0.2762700319290161,
-0.4993020296096802,
-0.5252985954284668,
-0.20031559467315674,
0.2880989611148834,
-0.1266832947731018,
-0.09413132816553116,
0.4461132287979126,
-0.4173002541065216,
0.09540949016809464,
-0.08140005171298981,
0.07554077357053757,
0.00696018198505044,
-0.09495214372873306,
-0.15910343825817108,
-0.03951767832040787,
-0.023558342829346657,
0.5498197674751282,
-0.40820378065109253,
-0.5590527057647705,
-0.3302812874317169,
0.12221765518188477,
-0.015880132094025612,
-0.5335002541542053,
-0.1436285525560379,
-0.2607797682285309,
0.4836844503879547,
0.414917916059494,
-0.3485372066497803,
-0.523130476474762,
0.365971177816391,
0.30454084277153015,
0.38861480355262756,
0.4733930230140686,
-0.7027207612991333,
-0.10761851817369461,
-0.09336008876562119,
0.03538662567734718,
0.04946884885430336,
0.13062381744384766,
0.18483547866344452,
0.15795031189918518,
0.43884196877479553,
0.27406254410743713,
0.15161365270614624,
-0.17019161581993103,
-0.7311040163040161,
0.10575893521308899,
-0.6532743573188782,
0.07774151116609573,
-0.20254309475421906,
-0.3268767297267914,
0.36581119894981384,
0.23188650608062744,
0.31763264536857605,
-0.06595262140035629,
0.4373619556427002,
0.19976702332496643,
-0.06274909526109695,
-0.4841034710407257,
0.03544258326292038,
0.33696556091308594,
-0.21584390103816986,
0.14240220189094543,
0.22789885103702545,
0.026473136618733406,
0.05165687948465347,
-0.28580570220947266,
0.18435515463352203,
-0.0008347713155671954,
0.1650679111480713,
-0.1529473215341568
] |
NCT02983604
|
GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer
|
The primary objectives of the Phase 1b Dose Escalation part of this study are to characterize the safety and tolerability of GS-5829 in combination with exemestane or fulvestrant and to determine the maximum tolerated dose (MTD) or the recommended Phase 2 dose of GS-5829 in combination with fulvestrant in women with advanced estrogen receptor positive, HER2-negative (ER+/HER2-) breast cancer.
The primary objective of the Randomized Phase 2 Dose Expansion portion of this study is to evaluate the efficacy of GS-5829 in combination with fulvestrant compared to fulvestrant alone in women with advanced ER+/HER2- breast cancer.
This study was terminated early and the Phase 2 portion of the study was not conducted.
|
Key Inclusion Criteria:
* Histologically or cytologically confirmed breast cancer with evidence of metastatic or locally advanced disease not amenable to resection or radiation therapy with curative intent and who have progressed during treatment with at least one prior hormonal therapy
* Phase 1b Dose Escalation - Individuals may have had unlimited prior hormonal therapy and a total of 2 prior chemotherapy regimens (adjuvant chemotherapy is considered 1 regimen). Individuals may have progressed on fulvestrant or exemestane.
* Randomized Phase 2 Dose Expansion - Individuals may have disease progression during treatment or within 12 months of completion of endocrine therapy (tamoxifen, and/or AI) in the adjuvant setting, or disease progression during treatment with endocrine therapy (tamoxifen, AI or CDK4/6 inhibitor plus AI) for advanced/metastatic disease. Individuals may have had unlimited prior hormonal therapy, but must be naive to fulvestrant in the metastatic setting. A total of 2 prior chemotherapies are allowed, however, only one for metastatic disease is permitted.
* Documentation of ER positive (≥ 1% positive stained cells by local standards) based on the most recent tumor biopsy, unless bone-only disease
* Documented HER2-negative tumor based on local testing on most recent tumor biopsy (immunohistochemistry score 0/1+ or negative by in situ hybridization HER2/CP17 ratio \< 2 or for single probe assessment HER2 copy number \< 4)
* Post-, pre- or peri-menopausal women considered to be in the post-menopausal state as defined by one of the following:
* Age ≥ 60 years
* Age \< 60 years and cessation of regular menses for at least 12 consecutive months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and serum estradiol and follicle-stimulating hormone (FSH) level within the post-menopausal range
* Prior bilateral oophorectomy
* Pre-/peri-menopausal women can be enrolled if amenable to be treated with the luteinizing-hormone releasing hormone (LHRH) agonist, goserelin. Individuals must have commenced treatment with goserelin or an alternative LHRH agonist at least 4 weeks prior to Cycle 1 Day 1 (C1D1). If individuals have received an alternative LHRH agonist prior to study entry, they must switch to goserelin on or before Cycle 1 Day 1 (C1D1) for the duration of the study
* Measurable disease defined per RECIST v. 1.1, or bone-only disease must have a lytic or mixed lytic blastic lesion that can be accurately assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Individuals with bone-only disease and blastic-only metastases are not eligible
* All acute toxic effects of any prior antitumor therapy resolved to Grade ≤ 1 before the start of study drug dosing (with the exception of alopecia \[Grade 1 or 2 permitted\] and neurotoxicity \[Grade 1 or 2 permitted\])
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
* Life expectancy of ≥ 3 months, in the opinion of the investigator
* Adequate organ function defined as follows:
* Hematologic: Platelets ≥ 100 x 10\^9/L; Hemoglobin ≥ 9.0 g/dL; absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (without platelet transfusion or any granulocytic growth factors within previous 7 days of the hematologic laboratory values obtained at screening visit)
* Hepatic: aspartate transaminase (AST) / alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN) (if liver metastases are present, ≤ 5 x ULN); total or conjugated bilirubin ≤ 1.5 x ULN
* Renal: Serum Creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min as calculated by the Cockroft-Gault method
* Coagulation: International Normalized Ratio (INR) ≤ 1.2
* Negative serum pregnancy test
* Females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the study protocol
* Females who are nursing must agree to discontinue nursing before the first dose of GS-5829
* Able and willing to provide written informed consent to participate in the study
Key Exclusion Criteria:
* History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the investigator or the Gilead medical monitor would pose a risk to individual safety or interfere with the study evaluations, procedures, or completion
* Known brain metastasis or leptomeningeal disease (Note: if treated and stable at least 6 months prior to enrollment, individual is eligible).
* Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection, active or chronic bleeding event within 28 days prior to C1D1, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician
* Myocardial infarction, symptomatic congestive heart failure (New York Heart Association Classification \> Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of C1D1
* Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube) within 28 days of C1D1
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of GS-5829, including any unresolved nausea, vomiting, or diarrhea that is Common Terminology Criteria for Adverse Events (CTCAE) Grade \> 1
* Minor surgical procedure(s) within 7 days of enrollment or randomization, or not yet recovered from prior surgery (placement of central venous access device, fine needle aspiration, or endoscopic biliary stent ≥ 1 day before enrollment or randomization is acceptable)
* History of a concurrent or second malignancy, except for: adequately treated local basal cell or squamous cell carcinoma of the skin; cervical carcinoma in situ; superficial bladder cancer; adequately treated Stage 1 or 2 cancer currently in complete remission; any other cancer that has been in complete remission for ≥ 5 years
* Anti-tumor therapy (chemotherapy, chemoradiation, radiation, antibody therapy, molecular targeted therapy) within 21 days or 5 half-lives whichever is longer, of C1D1 (6 weeks for nitrosoureas, mitomycin C, or molecular agents with t1/2 \> 10 days); 5 half-lives of any investigational drug; concurrent use of goserelin for pre-/peri-menopausal breast cancer and exemestane or fulvestrant per the protocol are permitted
* History of long QT syndrome or whose corrected QT interval (QTc) measured (Fridericia method) at screening is prolonged (\> 470 ms). Individuals who screen fail due to this criterion are not eligible to be re-screened
* Prior exposure to any bromodomain (BET) inhibitors
* Known hypersensitivity to the study drugs (GS 5829, fulvestrant or exemestane), the metabolites, or formulation excipients
* Immunotherapy within 6 months of C1D1
* Evidence of bleeding diathesis or clinically significant bleeding, within 28 days of C1D1 or history of hemoptysis of \> 2.5 mL/1 teaspoon within 6 months of C1D1
* Anticoagulation/antiplatelet therapy within 7 days of C1D1, including acetylsalicylic acid, low molecular weight heparin, or warfarin
* Known human immunodeficiency virus (HIV) infection
* Hepatitis B surface Antigen (HBsAg) positive
* Hepatitis C virus (HCV) antibody positive with HCV RNA positive
* Use of moderate/strong cytochrome P450 (CYP)3A4 inhibitors or moderate/strong CYP3A4 inducers within 2 weeks prior to C1D1
* History of high grade esophageal or gastric varices
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
|
[
-0.1187453493475914,
1.6351433992385864,
-2.8133063316345215,
-3.028007745742798,
1.5275903940200806,
0.3758561313152313,
0.020375968888401985,
-0.4026525914669037,
-0.4027296006679535,
-0.3400355577468872,
1.0334830284118652,
0.5908801555633545,
-1.1440032720565796,
-1.309730887413025,
0.7562520503997803,
0.3998582363128662,
-0.5894850492477417,
-0.39286017417907715,
0.3262872099876404,
-2.709003448486328,
-0.36023473739624023,
-0.829674243927002,
-0.3493867516517639,
-0.3671592175960541,
0.15604741871356964,
0.41630029678344727,
-0.5649785399436951,
1.6380201578140259,
-0.14518015086650848,
1.481871485710144,
0.13768841326236725,
-0.4554254412651062,
0.8229414820671082,
0.020859727635979652,
1.0385842323303223,
-0.5081028342247009,
1.2809255123138428,
-0.396828293800354,
-1.4178366661071777,
1.0553324222564697,
0.6683475375175476,
1.2630196809768677,
0.9903568029403687,
-0.5859203934669495,
1.5058733224868774,
0.3875155448913574,
-0.7796832323074341,
-1.230452060699463,
0.19384317100048065,
-0.025713525712490082,
-0.6087402701377869,
0.24765737354755402,
-0.38221991062164307,
-0.6429725289344788,
1.1200686693191528,
0.532225489616394,
-0.07562753558158875,
0.05840470641851425,
1.4228339195251465,
-0.8911741971969604,
1.0983176231384277,
0.6884127259254456,
-0.16816088557243347,
-0.8890497088432312,
0.6637464761734009,
0.30253902077674866,
0.7824675440788269,
0.7528185248374939,
-0.8686965107917786,
0.6393014192581177,
-0.018018165603280067,
-0.0955534502863884,
1.5626702308654785,
0.5529319047927856,
0.7030776143074036,
0.8827426433563232,
0.8657917976379395,
0.3674686849117279,
0.985066831111908,
0.8780865669250488,
0.3747585415840149,
-0.10842636972665787,
-0.8739836812019348,
-0.1077021136879921,
0.4274255335330963,
-1.1106456518173218,
-0.6472590565681458,
-0.6650141477584839,
0.5502498149871826,
-1.921523094177246,
1.1213692426681519,
0.19122618436813354,
-2.0632498264312744,
-0.019719183444976807,
-0.6281798481941223,
0.04166620969772339,
0.1456039845943451,
0.4442214369773865,
-0.4748035669326782,
-0.24810126423835754,
0.16123066842556,
1.3630379438400269,
-0.3672351837158203,
1.055907130241394,
-1.0262190103530884,
-0.36462152004241943,
0.2884056866168976,
-0.6470745205879211,
-0.11905728280544281,
-1.4577337503433228,
-0.23972204327583313,
-1.078078031539917,
-0.05423017218708992,
-0.4926736056804657,
-0.038495950400829315,
0.5500462055206299,
-0.011832179501652718,
-0.020616348832845688,
0.34746819734573364,
-0.4962138533592224,
1.081695795059204,
0.0772382840514183,
0.026426097378134727,
0.8621912002563477,
0.7523931860923767,
0.5956926345825195,
-0.23768512904644012,
0.5855993032455444,
-0.38613978028297424,
-0.6583285927772522,
-0.532437264919281,
-0.49910247325897217,
0.5358196496963501,
0.8525997996330261,
-0.19804760813713074,
-0.5690212845802307,
0.38884997367858887,
0.8274204730987549,
0.4823366105556488,
-0.24392659962177277,
0.26578012108802795,
0.806915283203125,
0.008462231606245041,
-0.2195671647787094,
-1.3271548748016357,
0.8248704075813293,
-0.4658736288547516,
-0.011862277053296566,
0.242610901594162,
-0.5433641076087952,
-0.16316574811935425,
-0.015859775245189667,
0.03278697654604912,
-0.543519914150238,
0.24136066436767578,
-0.37050771713256836,
0.3833950161933899,
-0.29348909854888916,
0.47769179940223694,
-0.263734370470047,
0.024672191590070724,
0.03421885147690773,
-0.11996069550514221,
-0.2983875870704651,
0.8042082190513611,
0.8060836791992188,
0.20343084633350372,
-0.7501745223999023,
0.14108280837535858,
0.14625294506549835,
-0.7508482933044434,
-0.44333210587501526,
-0.07049859315156937,
0.643795907497406,
0.4839980900287628,
-0.4220940172672272,
0.46879345178604126,
-0.28446605801582336,
0.35918018221855164,
-0.12875863909721375,
0.233721062541008,
0.27799612283706665,
-0.23704415559768677,
-0.4791632890701294,
-0.06229496747255325,
-0.34191614389419556,
0.05287383869290352,
-0.0014512590132653713,
0.11411310732364655,
0.34532487392425537,
0.28157567977905273,
-0.39009717106819153,
-0.5375434756278992,
0.5503314137458801,
-0.35164597630500793,
-0.3758908808231354,
-0.32536953687667847,
-0.3850696086883545,
0.3614053726196289,
-0.05233871191740036,
0.48174527287483215,
0.06609699130058289,
0.07575604319572449,
0.10212120413780212,
0.250466525554657,
0.027840157970786095,
0.23727072775363922,
0.18229460716247559,
0.0179572943598032,
0.2724370062351227,
0.5029546022415161,
0.006400871556252241,
0.13074485957622528,
0.26416733860969543,
0.5064530372619629,
-0.05472438409924507,
-0.5821779370307922,
0.8125618696212769,
-0.5200064778327942,
-0.06840761750936508,
-0.08511993288993835,
0.3133915364742279,
0.2909533977508545,
0.4731871485710144,
0.6353739500045776,
-0.22240087389945984,
-0.6583067178726196,
-0.5374165177345276,
-0.320976197719574,
-0.4747597277164459,
0.30338263511657715,
-0.23503147065639496,
-0.7317361831665039,
-0.03327373042702675,
0.23036333918571472,
0.02783551812171936,
0.5319865942001343,
0.16091090440750122,
-0.2485227882862091,
0.40038755536079407,
0.9664305448532104,
-0.3540932536125183,
-0.4157911241054535,
-0.3526207208633423,
0.33597853779792786,
-0.6379721760749817,
0.09766566753387451,
0.12287162989377975,
-0.027665775269269943,
0.5342069268226624,
-0.2910816967487335,
-0.02363729476928711,
-0.12024422734975815,
0.6121137738227844,
-0.009396431967616081,
0.3060055375099182
] |
|
NCT00496587
|
Capecitabine, Gemcitabine, and Bevacizumab in Combination for Patients With Sarcomatoid Renal Cell Carcinoma
|
The goal of this clinical research study is to learn if the combination of 3 drugs (gemcitabine, capecitabine, and bevacizumab) can help to control metastatic or unresectable renal cell carcinoma. The safety of this drug combination will also be tested.
|
Gemcitabine and capecitabine are designed to disrupt the growth of cancer cells, which may cause cancer cells to start to die. Bevacizumab is a drug that binds to and inhibits Vascular Endothelial Growth Factor (VEGF), a blood-vessel stimulating agent with unusually high levels in kidney cancer.
If you are found to be eligible to take part in this study, you will receive gemcitabine, capecitabine, and bevacizumab on a 28 day cycle. Capecitabine will be taken by mouth (with food), twice daily, on Days 1-21. Gemcitabine will be given through a needle in your vein in your arm over 30 minutes on Days 1 and 15. Bevacizumab will be given through a needle in your vein in your arm on Days 1 and 15. It will be given over 120 minutes for Cycle 1 and over 60 minutes for all other cycles. Your doctor may decided to give you bevacizumab over 30 minutes if you tolerate the treatment well.
On the first day of each cycle, blood (about 2 teaspoons) and a urine will be collected before treatment for routine tests. You will also have blood drawn on Day 15 (about 2 teaspoons) for routine tests.
Every 8 weeks, you will have a CT scan of your chest, abdomen, and pelvis and a chest x-ray. You will be asked about any drugs that you are currently taking and you will have a complete physical exam. You will be asked about any side effects that you might have experienced since the last visit and your ability to perform daily activities will be evaluated. Repeat bone scans and MRI of the brain may be done if your doctor thinks it is necessary.
You will continue receiving treatment for a maximum of 12 months. However, if you are benefitting from treatment, you may be able to continue receiving it off study. You will be taken off study if the disease gets worse, if the side effects are intolerable, or if you develop another illness that prevents you from receiving the treatment.
This is an investigational study. Gemcitabine, capecitabine, and bevacizumab are all FDA approved and commercially available. Up to 40 participants may take part in this study. All will be enrolled at MD Anderson.
|
Inclusion Criteria:
1. Histologically demonstrated, metastatic or unresectable sarcomatoid carcinoma of the kidney, defined as the following: • A tumor biopsy (primary or metastasis) must show at least one focus of RCC (one of the recognized types); and, • A tumor biopsy (primary or metastasis) must have at least 10% of the sample showing sarcomatoid histology.
2. (# 1 cont'd) • Patients with primary tumor in place are eligible if there is any percentage of sarcomatoid dedifferentiation on a needle biopsy (primary or metastasis), and the radiographic appearance of the primary tumor on CT scan is typical of RCC. For these patients, due to the small tumor sample, it is not required to identify an area of typical RCC histology as long as the morphologic and immunostaining characteristics are consistent with RCC.
3. At least one site of measurable disease (may include primary tumor).
4. No prior cytotoxic chemotherapy. Any prior immunotherapy is permitted.
5. No prior bevacizumab treatment. Prior sorafenib or sunitinib is permitted.
6. Zubrod performance status 2 or better
7. Adequate organ and bone marrow function: • Absolute Neutrophil Count (ANC) \>/= 1,500 • Platelets \>/=100,000 • Total bilirubin \</= 1.5 mg/dl • AST and ALT \</= 3x upper limit normal • Creatinine clearance \> 50 cc/min (measured or calculated by Cockcroft formula: Creatinine Clearance = \[(140 - age) x wt (kg)\]/\[72 x creat (mg/dl)\], for females x 0.85. Patients with creatinine clearance of 30-50 ml/min are eligible with an initial dose-reduction of capecitabine to the (-1) dose level.
8. Female patients of childbearing potential (last menses \< 2 years) must have a negative blood pregnancy test within 7 days prior to starting treatment.
9. All patients must agree to practice adequate contraception if sexually active for the duration of the trial and for 2 months after discontinuation of the study drugs
10. Written informed consent.
Exclusion Criteria:
1. Patients with history of myocardial infarction, transient ischemic attack (TIA), stroke, pulmonary embolism, or history of deep vein thrombosis within the preceding 12 months.
2. Patients with major risk of bleeding, such as active brain metastases. Patients with controlled or small brain metastases will be eligible based on clinical assessment of the actual bleeding risk.
3. Patients with history of any major surgical procedure within the preceding 28 days.
4. Patients with baseline blood pressure \>/= 140 systolic or \>/= 90 diastolic.
5. Patients with nephrotic syndrome (proteinuria \> 2 grams per 24 hours)
6. History of other malignancy, unless it is clinically non-threatening (such as non-melanoma skin cancer) or controlled for 2 years prior to study entry.
7. Prior treatment with gemcitabine, capecitabine, or any fluoropyrimidine.
8. Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-FU.
9. Any concurrent chemotherapy or radiotherapy.
10. Lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome.
11. Clinically significant cardiac disease not well controlled with medication, such as symptomatic coronary artery disease, congestive heart failure, and cardiac arrhythmias.
12. Serious concurrent infections or other serious medical conditions, including uncontrolled diabetes.
13. Any serious non-healing wound, ulcer, or active bone fracture.
14. Any concurrent coumadin therapy. Patients who were previously on coumadin maintenance may switch to aspirin or low-molecular-weight heparin.
15. Patients who have had an organ allograft.
16. Unwillingness to give written informed consent.
|
[
1.4254281520843506,
1.316023588180542,
-1.4366345405578613,
-3.4970126152038574,
0.6146599650382996,
0.8893681168556213,
-0.6480157971382141,
0.7572848796844482,
-0.8682915568351746,
-0.38559842109680176,
0.6205938458442688,
1.072148323059082,
-1.7178813219070435,
0.5972386002540588,
1.430107831954956,
-0.5445602536201477,
-0.4909476041793823,
1.3066242933273315,
1.389782190322876,
-1.032999873161316,
2.358628749847412,
-1.6300381422042847,
-0.14818179607391357,
0.8682366609573364,
0.788394033908844,
0.28668826818466187,
-0.8282005786895752,
1.3178257942199707,
0.8459899425506592,
1.3675833940505981,
-0.8461942076683044,
-0.02365836314857006,
-0.1514502763748169,
-0.00393773103132844,
-0.9958810210227966,
0.6187136173248291,
0.8590239882469177,
0.273099809885025,
-1.1237599849700928,
-0.08805885165929794,
0.5873463749885559,
1.3568235635757446,
0.4087451994419098,
0.4701107144355774,
0.5140203833580017,
0.8697038292884827,
1.1100542545318604,
-0.19399422407150269,
0.3062599301338196,
0.07296139001846313,
-1.581380009651184,
1.0867223739624023,
-0.03362727537751198,
1.0322880744934082,
1.3101664781570435,
-0.8828884363174438,
0.6596221327781677,
1.2119520902633667,
1.8130154609680176,
0.8257967233657837,
0.6685003638267517,
-0.5478774309158325,
-0.7413414716720581,
0.8382448554039001,
-0.4182109236717224,
-0.34933334589004517,
-0.022016994655132294,
-0.5812051296234131,
0.18297265470027924,
1.5904840230941772,
0.1899568885564804,
1.4485570192337036,
1.1139717102050781,
-0.4759692847728729,
0.3486878573894501,
0.7623816728591919,
0.09131669998168945,
0.6744999885559082,
0.6033193469047546,
0.4143962264060974,
-0.17627789080142975,
-1.1531448364257812,
-0.5761841535568237,
-0.36630064249038696,
-0.7965319752693176,
-0.5838804841041565,
-0.8195881247520447,
-1.7627938985824585,
0.6541578769683838,
0.16517916321754456,
0.35523682832717896,
-0.7094838619232178,
0.2064879834651947,
0.11735039949417114,
-1.4306484460830688,
0.15179699659347534,
-0.048527076840400696,
-0.48043420910835266,
-0.6513381600379944,
-0.5378903150558472,
0.09061789512634277,
0.821819543838501,
-0.30624884366989136,
-0.17278315126895905,
-0.42930957674980164,
0.32820403575897217,
0.290149986743927,
-0.8709191679954529,
0.01763344183564186,
-0.7618399858474731,
0.6299929022789001,
-0.6101542115211487,
-0.6990321278572083,
-0.44502004981040955,
-0.20378796756267548,
0.1089542806148529,
1.2020180225372314,
0.24871864914894104,
-0.8405684232711792,
0.5933177471160889,
-0.3353787064552307,
0.7417751550674438,
-0.13417518138885498,
0.3790268003940582,
0.5252562761306763,
-0.10887278616428375,
-1.038165807723999,
-1.655207872390747,
0.3963432312011719,
-1.8405070304870605,
-0.9224612712860107,
-0.11470939964056015,
0.7288045287132263,
-0.04065437242388725,
-0.29223087430000305,
-0.6228607296943665,
0.10331261903047562,
1.3718758821487427,
0.5293682217597961,
0.1689666360616684,
1.0447596311569214,
0.5773764252662659,
0.8961595892906189,
-0.18207822740077972,
-1.4901527166366577,
-0.4587588608264923,
0.668779730796814,
0.1904531568288803,
0.1412051022052765,
-0.44610264897346497,
-0.8979390859603882,
-0.1917562037706375,
0.43822330236434937,
0.03971703350543976,
0.6475806832313538,
0.6995506882667542,
0.5228034257888794,
0.11928772926330566,
0.31164199113845825,
0.04986058175563812,
-0.7959654331207275,
-0.2540617287158966,
-0.5447716116905212,
-0.1900448054075241,
0.39724546670913696,
-0.4403619170188904,
-0.09640362113714218,
0.10579046607017517,
0.04506293684244156,
-0.056314997375011444,
-1.303466796875,
-0.5554900765419006,
-0.26568448543548584,
-0.09746585786342621,
-0.22117017209529877,
-0.8202011585235596,
-0.1501394659280777,
-0.26371556520462036,
0.4047018885612488,
0.13745440542697906,
-0.13639159500598907,
0.6417294144630432,
-0.18062184751033783,
-0.4728328585624695,
0.5948693752288818,
0.4048916697502136,
0.42664623260498047,
-0.5459035634994507,
0.4329824447631836,
0.008564094081521034,
-0.072840616106987,
0.45392611622810364,
0.11232228577136993,
0.741823136806488,
0.04030631482601166,
-0.039777569472789764,
-0.18202278017997742,
-0.14651939272880554,
0.724014401435852,
-0.04616440087556839,
-0.008705241605639458,
0.33963125944137573,
-0.1438734084367752,
0.02542816288769245,
-0.08946599066257477,
-0.4931972324848175,
-0.2915050983428955,
0.1099538579583168,
0.23562881350517273,
0.32114139199256897,
0.49509212374687195,
-0.42636892199516296,
-0.11841775476932526,
-0.02943694032728672,
0.39550137519836426,
0.4852471649646759,
-0.09664340317249298,
0.6172662377357483,
-0.5200416445732117,
0.1262488067150116,
-0.40007394552230835,
0.8843603730201721,
-0.2753448784351349,
-0.4286730885505676,
0.155282661318779,
0.07020606100559235,
-0.23588021099567413,
-0.5212459564208984,
-0.548818051815033,
-0.5339123010635376,
-0.09094651788473129,
0.2045775204896927,
-0.09188701957464218,
-0.031174831092357635,
-0.15252381563186646,
0.449309378862381,
0.07514379173517227,
0.33287596702575684,
0.17681603133678436,
0.6257407665252686,
0.8444575667381287,
-0.21423932909965515,
0.06456255167722702,
-1.0265203714370728,
-0.1418394148349762,
-0.3812740743160248,
-0.09600230306386948,
-0.3939383029937744,
-0.28771600127220154,
0.060021985322237015,
-0.3562784492969513,
-0.07544121146202087,
0.14461997151374817,
0.11310320347547531,
-0.4624357521533966,
-0.71418696641922
] |
NCT06757933
|
Comparison Of Spencer Technique And Isotonic Exercise In Patients With Adhesive Capsulitis
|
This study examines the efficacy of two forms of therapy for Adhesive Capsulitis, a condition characterized by stiffness, pain, and limited mobility in the shoulder joint. It is also commonly known as "Frozen Shoulder".
|
Patients between the ages of 30 and 55 were randomly assigned to one of two groups for the trial held at the Saleem Free Hospital Okara and Dar-ul-Shifa Hospital. Group 2 engaged in isotonic exercises that emphasized concentric and eccentric motions of forward flexion and extension, whereas Group 1 was given the Spencer approach, which involved seven different movements. A goniometer and the Numeric Pain Rating Scale were used to measure the range of motion and pain. SPSS 20 was used to analyze the data and assess how well the treatments worked. The findings provided light on how well manual therapy and exercise compare in terms of reducing pain and increasing shoulder movement in people with adhesive capsulitis.
|
Inclusion Criteria
* Both genders aged 30-55 years
* Unilateral Adhesive Capsulitis
* Pain lasting for more than one month
* Capsular pattern of motion restriction
* Diabetic patients were included.
Exclusion Criteria
* Participants with rotator cuff tear
* Rheumatoid and gouty arthritis
* Tumors of the shoulder region
* Peripheral nerve injuries
* Shoulder girdle fracture and dislocation
* History of shoulder surgery were excluded.
|
[
-1.050272822380066,
1.3318251371383667,
-1.838193416595459,
-3.0923991203308105,
-1.0369787216186523,
-0.6337496042251587,
-0.9051811099052429,
-1.1715961694717407,
-1.1296637058258057,
-2.0557687282562256,
0.4352837800979614,
0.8239043951034546,
2.1338937282562256,
-0.6645044684410095,
-1.2277201414108276,
0.32223162055015564,
0.47732099890708923,
-0.5053322315216064,
0.3005470931529999,
-0.4458102881908417,
0.10385697335004807,
0.37754473090171814,
0.5703731179237366,
-0.1761876493692398,
2.677948474884033,
-0.1825897991657257,
-0.776111364364624,
0.2511940896511078,
1.0844612121582031,
-0.417619913816452,
-1.0563098192214966,
-1.5367579460144043,
0.8243739008903503,
1.1984080076217651,
-1.344830870628357,
-1.457850456237793,
0.030710672959685326,
0.427597314119339,
-2.1150293350219727,
-0.5010924935340881,
-0.3672809898853302,
-0.4846152365207672,
-1.409605622291565,
-0.4775254428386688,
0.45866191387176514,
0.23006409406661987,
0.8156495094299316,
0.600793719291687,
-0.5063364505767822,
-0.09567517042160034,
1.636191964149475,
1.6933389902114868,
-0.5517489314079285,
0.28429439663887024,
1.8235445022583008,
-0.9259442687034607,
2.015634775161743,
0.4790332019329071,
-0.13191746175289154,
1.233134150505066,
0.5382264256477356,
-0.03543348237872124,
-0.5809863209724426,
0.9863499402999878,
0.2003447711467743,
-1.7348359823226929,
-0.9658873081207275,
1.2559959888458252,
-0.563138484954834,
0.21108578145503998,
0.5850208401679993,
0.3864264488220215,
-0.42556262016296387,
0.0666302889585495,
-0.16016682982444763,
-1.4751105308532715,
0.6740321516990662,
1.1563822031021118,
0.5664380192756653,
-1.0440590381622314,
-0.4477185010910034,
-0.285895973443985,
-0.9455372095108032,
0.6290109157562256,
1.0764667987823486,
-0.17182137072086334,
-1.5247372388839722,
-1.3027158975601196,
-0.21008941531181335,
0.8307884931564331,
0.04288595914840698,
-0.6230769753456116,
0.40080875158309937,
-0.09483527392148972,
-0.9205605983734131,
0.1709403246641159,
0.001721111824735999,
-0.7433858513832092,
-1.3759297132492065,
-0.19666580855846405,
0.04134204238653183,
0.10561597347259521,
0.475394606590271,
-0.03871670737862587,
-0.24233843386173248,
-0.18193702399730682,
0.29838836193084717,
0.8214079141616821,
-0.08882512897253036,
-1.4716508388519287,
0.5049268007278442,
-0.24007466435432434,
0.20210935175418854,
-0.76985102891922,
0.28123560547828674,
0.24019277095794678,
-0.09368108212947845,
-0.45339545607566833,
-0.475109726190567,
-0.32792747020721436,
0.2467517852783203,
0.6612725257873535,
-0.4675508141517639,
1.019576072692871,
-0.7032307386398315,
0.27840083837509155,
0.33069875836372375,
1.09908926486969,
-0.9774531722068787,
-0.9930261373519897,
0.8133653998374939,
-0.29820606112480164,
0.8976573348045349,
0.1187778040766716,
-1.3940098285675049,
0.1913708746433258,
-1.168350100517273,
-0.35099563002586365,
0.9007717370986938,
0.08467750251293182,
-0.3614438772201538,
0.6327009201049805,
0.6248096823692322,
-0.3370390832424164,
-0.3309837281703949,
-0.2959641218185425,
0.2733753025531769,
0.004433658439666033,
0.08277449756860733,
-0.4242853820323944,
0.4803280830383301,
-0.2763923406600952,
0.23986873030662537,
-0.04691731184720993,
0.6045573353767395,
-0.5364425778388977,
-0.4967651069164276,
-0.6258183121681213,
1.2641918659210205,
-0.3729037046432495,
0.11830046772956848,
-0.7762648463249207,
-0.15109539031982422,
0.4640762209892273,
-0.18955044448375702,
-0.5979770421981812,
-0.2676461338996887,
-0.23304784297943115,
1.249824047088623,
0.24132423102855682,
0.0572781041264534,
-0.2573758661746979,
0.001171850715763867,
0.3034822940826416,
-0.9339418411254883,
0.12177982181310654,
0.15572631359100342,
-0.056209735572338104,
-0.41303330659866333,
0.01926775462925434,
-0.25593462586402893,
-0.5928738713264465,
0.8792576193809509,
0.43725281953811646,
-0.3641199469566345,
-0.8821117877960205,
-0.5807915329933167,
0.31300729513168335,
0.15778514742851257,
0.37112295627593994,
0.01508261263370514,
0.3324553668498993,
0.5891686081886292,
0.08585654199123383,
-0.7348215579986572,
0.5870406031608582,
-0.02928517572581768,
-0.4960978627204895,
0.5307927131652832,
-0.7232633829116821,
0.7101244926452637,
0.10503307729959488,
-0.6821363568305969,
0.3859345614910126,
0.3537556231021881,
0.03827185183763504,
-0.19498363137245178,
0.048549894243478775,
-0.0412730947136879,
-0.2294260412454605,
0.012672042474150658,
-0.2630288004875183,
0.04671085253357887,
-0.6360457539558411,
-0.2656283974647522,
1.2888754606246948,
0.7149183750152588,
0.012736774981021881,
-0.8932729363441467,
-0.5287591218948364,
-0.04542728513479233,
-0.431390643119812,
-0.5146005153656006,
0.30498984456062317,
0.18101276457309723,
0.29400673508644104,
0.20341412723064423,
0.31667765974998474,
0.4709508717060089,
-0.019917596131563187,
-0.2660297453403473,
-0.27138903737068176,
-0.20490114390850067,
0.12774315476417542,
-0.8562263250350952,
0.5211979150772095,
1.103611707687378,
0.06815474480390549,
-0.05529298260807991,
-0.31378015875816345,
0.6279439926147461,
-0.895620584487915,
-0.3717896044254303,
0.4057334363460541,
0.014018922112882137,
-0.10894788801670074,
-0.5874345898628235,
0.014280932024121284,
0.03879985958337784,
0.4544205963611603,
-0.4920697808265686,
-0.29120174050331116,
-0.06843376904726028,
-0.21775871515274048,
-0.34818172454833984,
-0.3870941996574402
] |
NCT00331695
|
Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery
|
To demonstrate that the intramuscular administration of 17 alpha hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length egal and inferiority 26 mm between 20 and 32 weeks of gestation and:
* either a first episode of preterm labor stopped by acute tocolysis;
* either a history of late miscarriage or premature delivery or uterine malformation or DES
* either a twin pregnancy. Therefore, a randomised, multicentre trial has been designed with initial stratification according to these three risk groups, opened with two parallel arms.
|
Objective
To demonstrate that the intramuscular administration of 17 alpha - hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length 26 mm between 20 and 32 weeks of gestation and:
* either a first episode of preterm labor stopped by acute tocolysis;
* either a history of late miscarriage or premature delivery or uterine malformation or DES
* either a twin pregnancy. Experimental design Prospective, randomized, multicenter, trial with initial stratification according to three risk groups, opened with two parallel arms.
The maximal duration for treatment will be 16 weeks for each included patient. The duration for inclusions will be 30 months. The duration for participation of each patient will be 10 to 22 weeks. The foreseen inclusion period for this trial is from 06/01/2006 to 12/31/2008 Description Two therapeutic strategies will be compared in each risk group and attributed by uniform randomisation.
Arm A :IM injection of 17 alpha hydroxyprogesterones caproate, 500 mg, twice a week until 36 W or until preterm delivery in high risk symptomatic group and high risk twin pregnancies group.
IM injection of 17 alpha-hydroxyprogesterones caproate, 500 mg, once a week until 36 W or until preterm delivery in high risk asymptomatic group.
Arm B :No treatment with 17 alpha-hydroxyprogesterones caproate. (usual management) Presentation : Progesterone retard Pharlon 500 mg Tolerance criteria
* nausea,vomiting,
* weakness
|
Inclusion Criteria:
* ultrasonographic cervical length 26 mm between 20 and 32 weeks of gestation and:
* either a first episode of preterm labor stopped by acute tocolysis
* either a history of late miscarriage or premature delivery or uterine malformation or DES;
* either a twin pregnancy.
Exclusion Criteria:
* cervical dilatation \> 3 cm,
* chorioamnionitis,
* fetal distress,
* placenta praevia,
* abruptio placenta,
* preterm premature rupture of membranes,
* polyhydramnios,
* Twin-twin transfusion syndrome,
* IUGR,
* preeclampsia or hypertension,
* other pathology justifying a preterm delivery,
* epilepsy drugs
* participation to another therapeutic trial,
* any patient for whom informed consent cannot be obtained.
|
[
-0.2979026138782501,
1.4405813217163086,
-2.5236892700195312,
-2.1150710582733154,
0.7697692513465881,
0.42630162835121155,
0.40237849950790405,
-1.116495132446289,
-1.7673711776733398,
0.2335449606180191,
-0.08559345453977585,
1.1352980136871338,
-0.5939198732376099,
0.07192981243133545,
0.2208079993724823,
0.718245267868042,
-0.5680104494094849,
0.05560872331261635,
-0.35102421045303345,
-1.0692672729492188,
-0.27841025590896606,
0.35455387830734253,
-0.7248141169548035,
0.2580391466617584,
-0.4761035144329071,
-0.5243465304374695,
0.3849249482154846,
-0.03432982787489891,
0.042319588363170624,
0.413237988948822,
0.4231632649898529,
-0.5275139212608337,
1.0308798551559448,
0.5071349143981934,
-0.15203770995140076,
-0.3910263776779175,
0.4087589383125305,
-0.2717771828174591,
-0.550808310508728,
-0.08572959899902344,
-0.6776581406593323,
-0.03311123326420784,
0.5282436013221741,
-0.5536413192749023,
0.9608359336853027,
-0.6789024472236633,
-0.36085039377212524,
-0.529090166091919,
-0.13623571395874023,
-0.38888588547706604,
-0.7348951697349548,
-0.10137365758419037,
-1.4249950647354126,
0.38458359241485596,
0.555362343788147,
0.8897914290428162,
-0.4119430482387543,
0.2868427038192749,
1.119223952293396,
0.30221062898635864,
0.8445063233375549,
-0.14431633055210114,
0.8417872786521912,
-0.8431515693664551,
-0.08129188418388367,
-1.182801365852356,
0.05703992769122124,
1.1352907419204712,
-0.9744060039520264,
1.2584052085876465,
0.02167442813515663,
0.6555020809173584,
0.7503846287727356,
-0.6181617975234985,
-0.32898303866386414,
1.32211172580719,
0.10020124167203903,
0.01361280307173729,
0.404083788394928,
-0.5348464846611023,
-0.7339566946029663,
0.3191275894641876,
0.12703122198581696,
0.5527297258377075,
-0.13487400114536285,
0.06065963953733444,
-0.9307615160942078,
0.034680623561143875,
0.028287848457694054,
-0.9214828014373779,
0.8933039307594299,
0.05811121314764023,
-0.4006994962692261,
0.7095630168914795,
0.1583375781774521,
0.651179850101471,
-0.361501008272171,
-0.6725392937660217,
-0.6080991625785828,
0.0004614130302798003,
0.16664481163024902,
-0.1896969974040985,
-0.6704288125038147,
0.3895951211452484,
-0.4773953855037689,
-0.10126078873872757,
-0.16124263405799866,
0.6312400698661804,
-0.7840112447738647,
0.005016496870666742,
0.26661670207977295,
-0.06873561441898346,
-0.43625137209892273,
-0.4395217299461365,
0.3265093266963959,
0.1255428045988083,
-0.6424123048782349,
-0.3588443696498871,
0.004619667772203684,
-1.2518763542175293,
-0.0342693068087101,
0.6818864941596985,
0.4997282922267914,
0.5618446469306946,
-0.36845532059669495,
0.1927875429391861,
0.19194772839546204,
0.8747808933258057,
0.18272122740745544,
0.8925045728683472,
-1.1508110761642456,
1.0637807846069336,
0.22358494997024536,
-0.5252394676208496,
-0.8897638320922852,
-0.2180454283952713,
-0.13836508989334106,
0.3941190242767334,
0.2964901924133301,
-0.3348850607872009,
-0.022403430193662643,
0.31214290857315063,
0.0629766434431076,
-0.012290656566619873,
-0.85850989818573,
-0.20168687403202057,
-0.49150970578193665,
0.0636327937245369,
-0.3795141279697418,
0.773848295211792,
-1.0194324254989624,
0.4186171889305115,
0.35837864875793457,
-0.04563312977552414,
0.10239338129758835,
0.2667034864425659,
0.35295093059539795,
0.47882938385009766,
0.28881174325942993,
0.034701865166425705,
-0.02741462178528309,
-0.49762508273124695,
-0.23838914930820465,
0.1072017028927803,
0.010943405330181122,
0.06550842523574829,
-0.17667827010154724,
0.1966772824525833,
0.22095346450805664,
-0.49977055191993713,
-0.7449372410774231,
0.08772410452365875,
-0.3552432656288147,
0.6020990610122681,
-0.44352519512176514,
-0.45870357751846313,
0.2077408730983734,
0.23854728043079376,
-0.20894701778888702,
-0.26866811513900757,
0.13965807855129242,
-0.2808679938316345,
-0.18769031763076782,
-0.3476073741912842,
0.4008330702781677,
-0.49261367321014404,
-0.25429031252861023,
-0.3647457957267761,
-0.4082711637020111,
0.36398378014564514,
0.6389214396476746,
0.23083479702472687,
-0.4211380183696747,
-0.29053282737731934,
-0.42949914932250977,
-0.07180739939212799,
-0.16146264970302582,
-0.09396786242723465,
0.7674583196640015,
-0.0390799380838871,
0.7313607335090637,
-0.06498513370752335,
0.2645444869995117,
0.7070218920707703,
0.08597729355096817,
-0.3697054088115692,
-0.1833176463842392,
0.660959005355835,
0.2140907198190689,
-0.44954580068588257,
-0.04142380505800247,
0.036712780594825745,
-0.3045007884502411,
-0.28343474864959717,
-0.13947123289108276,
0.21174894273281097,
0.17901933193206787,
-0.06847486644983292,
-0.19566504657268524,
0.015227065421640873,
0.4521268606185913,
0.2966817021369934,
-0.2969464361667633,
-0.18688659369945526,
0.21549257636070251,
0.1337011307477951,
0.18067406117916107,
0.0824798196554184,
0.24769876897335052,
0.19815677404403687,
-0.19472743570804596,
0.12667730450630188,
-0.21318796277046204,
-0.21513767540454865,
0.2286534607410431,
-0.22865594923496246,
-0.18451976776123047,
-0.024747658520936966,
-0.24101465940475464,
0.001798405428417027,
0.013554587960243225,
-0.8031357526779175,
0.001930799800902605,
-0.372807115316391,
-0.09272725880146027,
-0.02204388752579689,
-0.4163917899131775,
0.5086865425109863,
-0.2201586812734604,
0.04680754616856575,
-0.05131421983242035,
-0.05677483230829239,
0.00920958537608385,
-0.06538434326648712,
-0.05904418230056763,
-0.0618785098195076
] |
NCT04120415
|
A HIV Vaccine Trial in Individuals Who Started Antiretrovirals During Primary or Chronic Infection (EHVA T02)
|
EHVA T02 is an international, phase II, double-blind study to evaluate two experimental arms each compared to placebo control in HIV-1 positive participants to see if either has a clinically relevant impact on viral replication.
|
Screening will take place during the 6 weeks prior to randomisation. Eligible participants will be enrolled at week 0 and randomised to MVA HIV-B vaccine followed by vedolizumab, vedolizumab + placebo vaccine, or placebo vaccine + placebo infusions.
Participants will be randomised at each centre through web-based randomisation after entering the eligibility criteria. There will be two strata: one for those who started treatment during primary infection, and one for those who started treatment during chronic infection.
69 eligible individuals from collaborating European Countries will be enrolled, aiming for approximately half who started cART in primary infection and half who started in chronic infection. Participants continue from the screening visit (up to 6 weeks before enrolment) to the last visit, a maximum of 60 weeks (around 14 months), although follow-up will continue through to the time when virus is fully suppressed.
Treatment will be interrupted at week 18 and resumed when the viral load is confirmed to have rebounded to ≥100,000 copies/ml, or the CD4 falls to ≤350 cells/mm3, confirmed, or there is evidence of disease progression, or they have completed 24 weeks of treatment interruption.
|
Inclusion Criteria:
1. HIV-1-infected
2. Aged 18 - 65 years old on the day of screening
3. Weight \>50kg
4. Willing and able to provide written informed consent
5. Nadir CD4 count \> 300 cells/mm3
6. CD4 count at screening \> 500 cells/mm3
7. Viral load \<50 copies/ml at screening.
8. Started cART after 2009 and on cART for at least one year prior to screening
9. Willing to interrupt cART for up to 24 weeks and change cART regimen if required
10. If sexually active, willing to use a reliable method of reducing the risk of transmission to their sexual partners during treatment interruption (which could include PrEP for their sexual partners)
11. If heterosexually active and able to have children, willing to use a highly effective method of contraception with partner (combined oral contraceptive pill; injectable or implanted contraceptive; IUD/IUS; physiological or anatomical sterility (in self or partner) from 2 weeks before enrolment until 18 weeks after the last injection/infusion
12. If women of childbearing potential\*, willing to undergo urine pregnancy tests prior to administration of an injection and an infusion
13. Willing to avoid all other vaccines within 4 weeks of scheduled study injections
14. Willing and able to comply with visit schedule and provide blood samples
15. Being covered by medical insurance or in National Healthcare System
* A woman will be considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
Exclusion Criteria:
1. Pregnant or lactating
2. HIV-2 infection (either isolated or associated with HIV-1)
3. VL \>200 copies/ml on 2 occasions in the 12 months prior to screening
4. Previous interruptions in cART
5. Previous virological failures defined by loss of virological suppression with the presence of resistant mutations
6. Haemoglobin (Hb \<12g/dL for males, \<11g/dL for females)
7. Concomitant or previous conditions that preclude injection of vaccines/infusion of monoclonal antibody and PML in the past
8. History of experimental vaccinations against HIV
9. Previous treatment with chemotherapy (except for chemotherapy injected into skin lesions for Kaposi's sarcoma)
10. Treatment with systemic corticoids or immuno-suppressive agents ongoing or in the 12 weeks prior to randomisation in the trial
11. Received natalizumab or rituximab ever in the past
12. Received a TNF blocker in the past 60 days
13. Administration of an inactivated vaccine within 30 days or a live vaccine within 60 days prior to randomisation
14. Presence of a skin condition or marking that precludes inspection of the injection/infusion site
15. History of cancer (except basal cellular skin carcinoma or Kaposi's sarcoma)
16. History of significant neurological disease or cardiovascular disease (angina, myocardial infarction, transient ischemic attack, stroke); participants with controlled blood pressure are eligible
17. History of clinical autoimmune disease
18. Ongoing diseases including uncontrolled active severe infection, cardiac, pulmonary (excluding mild asthma), thyroid, renal or neurological (peripheral or central) diseases
19. Active or latent tuberculosis (unless prophylaxis in past as per local practice) - (participant must be screened for tuberculosis before starting infusions, according to routine practice)
20. Presence of pathogenic bacteria or parasites in faeces at screening
21. Participating in another biomedical research study within 30 days of randomisation
22. Known hypersensitivity to any component of the vaccine formulation used in this trial including eggs or have severe or multiple allergies to drugs or pharmaceutical agents, or any hypersensitivity to the active substance or to any of the excipients of vedolizumab.
23. Liver disease including hepatitis B (surface antigen positive) or hepatitis C (antigen or PCR positive)
24. A clinically significant abnormality on ECG
25. Hypernatraemia or hyperchloraemia
26. History of severe local or general reaction to vaccination defined as
1. local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours
2. general: fever \>= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
27. Grade 2 or worse routine laboratory parameters. Hyperbilirubinaemia to be considered an exclusion criterion only when confirmed to be conjugated bilirubinaemia
|
[
-1.3401732444763184,
2.9005982875823975,
-2.2391252517700195,
-1.9312825202941895,
0.3891560435295105,
1.7442846298217773,
-1.075556993484497,
-1.0462738275527954,
-0.5672224164009094,
0.13538511097431183,
-1.950601577758789,
1.0109422206878662,
-1.306965708732605,
1.0737686157226562,
-0.857862114906311,
1.6084388494491577,
-0.4237731099128723,
-0.48289793729782104,
0.5519955158233643,
-2.443228006362915,
-0.5420519113540649,
-0.13079941272735596,
-0.7062734961509705,
-1.1100414991378784,
0.22395727038383484,
-0.610722005367279,
-0.74386066198349,
0.047205593436956406,
-1.3987103700637817,
1.6501882076263428,
-0.08407577127218246,
-0.772485613822937,
-0.7262698411941528,
1.3701752424240112,
0.9725313186645508,
-0.7878178358078003,
0.23561696708202362,
1.7096024751663208,
-0.6814057230949402,
0.740021824836731,
1.1636931896209717,
0.2583128809928894,
0.1337374448776245,
0.7524081468582153,
1.4249156713485718,
-0.10762644559144974,
-0.7690078020095825,
-0.19957205653190613,
-0.08872652053833008,
2.007660150527954,
0.13205434381961823,
0.9410420656204224,
0.14595434069633484,
1.1389740705490112,
2.87774658203125,
-0.06578278541564941,
-0.2602161169052124,
0.9964691996574402,
1.140102505683899,
0.17415538430213928,
0.6551843881607056,
-0.33880624175071716,
0.34289461374282837,
0.6269361972808838,
-0.7607619166374207,
1.165083408355713,
0.051522839814424515,
0.4821501672267914,
-0.8064725995063782,
-0.14629800617694855,
0.2274225950241089,
0.5276919603347778,
0.2795475721359253,
-0.5475046038627625,
-0.4184541404247284,
0.1287607103586197,
-0.1677016019821167,
0.44900572299957275,
0.5153118371963501,
1.2042759656906128,
0.3823295831680298,
-1.0597999095916748,
-0.10736728459596634,
-0.09896045923233032,
0.20154915750026703,
-0.7517348527908325,
-0.11706497520208359,
-0.060549844056367874,
0.09690463542938232,
-0.8313186168670654,
0.4166249632835388,
0.6683829426765442,
-0.7962884306907654,
-0.060374915599823,
-0.08582059293985367,
0.1135978177189827,
-0.6002081036567688,
-0.6023622155189514,
-0.9943353533744812,
-0.373346209526062,
-0.2572070062160492,
-0.27683451771736145,
0.20546633005142212,
-0.317676842212677,
-0.7329702973365784,
-0.48261067271232605,
-0.5609363317489624,
-0.25710535049438477,
-0.19270038604736328,
0.02738961949944496,
-0.3671976923942566,
-0.7269930839538574,
-0.12019246816635132,
-0.2780505120754242,
1.506576418876648,
-0.26736101508140564,
0.8587287068367004,
0.4298816919326782,
0.1890491098165512,
-0.35243842005729675,
0.4060834050178528,
0.5405265092849731,
0.5677356123924255,
0.4394148588180542,
-0.3894237279891968,
0.3082830607891083,
0.34869417548179626,
0.6742919683456421,
-1.7450193166732788,
-0.6831915974617004,
-0.5940183997154236,
-0.4202457666397095,
1.002216100692749,
0.048798978328704834,
-1.1988513469696045,
-0.42397966980934143,
0.5615110397338867,
0.7301862239837646,
0.3520528972148895,
-1.2800984382629395,
-0.48659929633140564,
0.08985159546136856,
1.2415392398834229,
-0.5360530018806458,
-0.9052251577377319,
0.3522297739982605,
-0.6707466244697571,
1.1455837488174438,
-0.48516395688056946,
-0.3026197850704193,
-0.45576339960098267,
0.9722607135772705,
0.3143486976623535,
0.2674138844013214,
-0.3127680718898773,
0.13208332657814026,
0.21943648159503937,
-1.2761662006378174,
-0.4333750903606415,
0.11906912177801132,
-0.7996758222579956,
0.605348527431488,
0.0866892859339714,
-0.2999189794063568,
0.32988452911376953,
0.25895217061042786,
-0.3046065866947174,
0.19446031749248505,
-0.2318212389945984,
-0.2252904623746872,
-0.2876339256763458,
0.3982853293418884,
0.8662091493606567,
0.8927178978919983,
0.5783909559249878,
0.05001199617981911,
0.4759175181388855,
0.623754620552063,
-0.15740510821342468,
0.3632104694843292,
-0.23351356387138367,
0.4745728075504303,
-0.2843885123729706,
0.3887200355529785,
0.2299979031085968,
0.08522717654705048,
0.01286343578249216,
-1.396004557609558,
-0.5191454887390137,
-0.018724706023931503,
-0.40787214040756226,
0.5661986470222473,
-0.014366822317242622,
-0.44013288617134094,
0.051391616463661194,
0.5104679465293884,
0.013846554793417454,
0.13666395843029022,
0.23157928884029388,
0.10338008403778076,
0.07093241810798645,
0.42494696378707886,
0.18867728114128113,
0.3914893865585327,
0.36334866285324097,
0.023132532835006714,
-0.7973558306694031,
0.3826538324356079,
-0.029138242825865746,
-0.2320164442062378,
-0.04710833728313446,
-0.7541763782501221,
-0.5397301912307739,
0.8218348622322083,
0.5109065175056458,
0.11394909769296646,
0.0929257720708847,
-0.18376125395298004,
-0.4916851818561554,
-0.5549139380455017,
0.1319342702627182,
0.2920573353767395,
0.07161346822977066,
0.31746789813041687,
-0.006231413222849369,
-0.08058372884988785,
-0.20774930715560913,
-0.4221542477607727,
-0.043861277401447296,
-0.40404266119003296,
-0.2919355630874634,
-0.5047484636306763,
-0.49465078115463257,
0.34032735228538513,
-0.3805157542228699,
-0.14016954600811005,
0.40551647543907166,
0.06553270667791367,
0.28812530636787415,
0.39403036236763,
0.6752325296401978,
-0.6292406320571899,
-0.5248483419418335,
-0.5791767239570618,
-0.2478598952293396,
0.20418696105480194,
0.16598282754421234,
-0.4990443289279938,
-0.47866249084472656,
0.6009267568588257,
0.060405489057302475,
0.01477892603725195,
0.23680183291435242,
0.18146894872188568,
-0.8104750514030457,
-0.17853030562400818
] |
NCT04981951
|
Th Effects of a Drug Dexmedotemidine in Regional Anesthesia in Participants Undergoing Upper Limb Surgeries
|
In this study, we will assess the effect of combined Dexmedetomidine and Bupivacaine analgesia on the onset and duration of anesthesia in supraclavicular plexus block compared to Bupivacaine alone.
|
Participants who fulfill the inclusion criteria will be enrolled in this study to achieve sample size of 140 participants, 70 participants in each group.
Participants were blindly randomized into two groups: group A (Bupivacaine alone) and group B (Bupivacaine with Dexmedetomidine).
On the morning of the surgery day, and before performing the procedure on the targeted hand, a venous cannula 18gauze was secured on the opposite hand. Routine monitors like pulse oximetry, non-invasive blood pressure, and electrocardiogram were attached during the procedure.
Study medications were prepared for each group, which is Bupivacaine (30ml) only for group A and Bupivacaine (30 ml) with Dexmedetomidine (1 mcg /kg) for group B. Then, SCPB was done under ultrasound guidance which increases the safety due to improved monitoring of anatomy and needle placement. A needle was placed within the brachial plexus sheath posterior to the subclavian artery, and the local anesthetic injected to surround the trunks and divisions of the brachial plexus at this level.
Patients were evaluated for the onset of the sensory and motor block every 3 minutes after completion of injection till their onset, and, at 15, 30, 45, 60, 90, and 120 min; and then hourly (even after surgery), until they had resolved.
|
Inclusion Criteria:
* Aged between 18-75 years.
* Classified as grades 1 or 2 by the American Society of Anesthesiology Classification of .physical status.
* Willing and able to sign a consent form.
Exclusion Criteria:
* Patients under the following conditions will be excluded: Known hypersensitivity to Bupivacaine, Dexmedetomidine, and local anesthetics.
* Uncontrolled diabetes mellitus.
* Peripheral neuropathy.
* SevereCoagulopathy.
* Infection at the site of block.
* Pregnancy.
* Cardiac arrhythmias.
* Prescription of beta blockers.
* Psychological disorders.
|
[
2.3910934925079346,
-1.0383572578430176,
-2.8730695247650146,
-3.870525598526001,
-1.2369214296340942,
-2.0070865154266357,
2.3980629444122314,
2.180715799331665,
-2.0763003826141357,
0.5327673554420471,
1.1447349786758423,
1.364405870437622,
0.713291347026825,
1.554976463317871,
-0.33119475841522217,
-0.4836673438549042,
2.040224552154541,
-1.031177282333374,
-0.5995872020721436,
-1.6471863985061646,
0.8780850172042847,
-0.5774093866348267,
-1.5002479553222656,
-0.9170651435852051,
0.3182579278945923,
-0.36209946870803833,
1.9489665031433105,
-0.13454435765743256,
0.7730823755264282,
0.5281704068183899,
0.7118514776229858,
-0.3210911154747009,
0.2490430772304535,
2.2332499027252197,
-1.8754174709320068,
0.35003283619880676,
0.571774423122406,
2.560225248336792,
-1.6703214645385742,
-2.777061700820923,
-0.06849998235702515,
1.777703046798706,
-0.0012711160816252232,
1.1145389080047607,
3.152322769165039,
0.48237836360931396,
-0.8364916443824768,
0.3419642746448517,
2.258939027786255,
-1.4298547506332397,
0.37594375014305115,
0.8800549507141113,
-0.943661630153656,
0.17370069026947021,
2.544370174407959,
-1.7342408895492554,
-0.24622030556201935,
1.2344704866409302,
1.8086426258087158,
-0.5196930766105652,
0.7415236830711365,
-0.7784851789474487,
-0.0491379052400589,
-0.1770065724849701,
-0.2467336505651474,
-1.086353063583374,
-1.0405683517456055,
-0.47079527378082275,
-0.6713406443595886,
0.12656138837337494,
-0.8052732944488525,
1.831630825996399,
0.4449008107185364,
0.9939635396003723,
1.1498249769210815,
0.5388857126235962,
0.36116787791252136,
3.0006613731384277,
1.0894805192947388,
1.5477064847946167,
-0.43015071749687195,
-1.2035253047943115,
0.41537365317344666,
-0.2065415233373642,
-0.36273449659347534,
0.5542544722557068,
-1.2668217420578003,
-0.7911049723625183,
0.751353919506073,
-0.7278380393981934,
-0.9978461265563965,
-0.8563823699951172,
-0.44866085052490234,
0.9684865474700928,
-2.5074143409729004,
0.32513245940208435,
-0.25731098651885986,
0.35188519954681396,
-1.1231310367584229,
0.35148051381111145,
-0.4606379270553589,
0.15905871987342834,
-0.47518718242645264,
1.2338811159133911,
-0.16621221601963043,
-0.7788578271865845,
-0.5836010575294495,
0.19363035261631012,
1.7959460020065308,
0.15802337229251862,
2.475160837173462,
-0.3324728310108185,
-0.6811784505844116,
-2.327224016189575,
1.2822294235229492,
0.7623026967048645,
-0.06743036210536957,
-0.07207849621772766,
0.3252004384994507,
-0.9356793761253357,
0.6685885787010193,
0.6182131767272949,
-0.08128442615270615,
1.5887436866760254,
0.09437665343284607,
-0.035824984312057495,
0.13938221335411072,
0.7450951933860779,
-0.3728056252002716,
-1.1442360877990723,
-0.4930914640426636,
0.35883384943008423,
0.13143867254257202,
-0.8755695223808289,
-0.21783997118473053,
0.3212363123893738,
0.14985500276088715,
0.30497288703918457,
0.3343624472618103,
-0.6023548245429993,
0.012032976374030113,
0.3316146731376648,
-0.2051117718219757,
-1.1127067804336548,
-0.41547679901123047,
-0.2541620433330536,
0.5858664512634277,
0.6350847482681274,
-1.4737608432769775,
0.19379130005836487,
0.2742077708244324,
0.5523388385772705,
1.3114029169082642,
-0.4098278880119324,
0.80865478515625,
0.3480362296104431,
1.1286731958389282,
0.6399787664413452,
0.545452356338501,
-0.34801656007766724,
0.17173390090465546,
-0.044432464987039566,
-0.8764452338218689,
-0.01391605380922556,
0.17144368588924408,
-0.04790537431836128,
-0.4800921678543091,
-0.426286518573761,
0.07843046635389328,
0.45314303040504456,
-1.5422877073287964,
-0.6189725399017334,
0.9112767577171326,
-0.26651981472969055,
-0.9335780143737793,
0.48927128314971924,
-0.6229290962219238,
0.28027504682540894,
0.2865544259548187,
-0.1624002307653427,
-0.20391212403774261,
-0.3467509150505066,
1.3531999588012695,
0.012186079286038876,
0.12202122062444687,
-0.8994725942611694,
0.21389995515346527,
-0.724504292011261,
-0.2501372992992401,
-0.028933081775903702,
0.10925159603357315,
-0.6552020311355591,
-0.6133745312690735,
0.4436779022216797,
-0.7956327199935913,
-0.017350973561406136,
-0.25193291902542114,
-0.033116038888692856,
0.5367820858955383,
-0.3468896746635437,
-0.2160966843366623,
0.31988704204559326,
0.04474234953522682,
0.8737877607345581,
0.33287692070007324,
0.03272649273276329,
-0.5451096892356873,
0.23077748715877533,
-0.7548936605453491,
0.4238201975822449,
-0.08429914712905884,
-0.2727353572845459,
-0.35428357124328613,
0.001797922421246767,
0.21199166774749756,
0.22483602166175842,
-0.14316655695438385,
0.5688554644584656,
0.20298554003238678,
0.42194920778274536,
0.07866698503494263,
0.2601848840713501,
0.057420793920755386,
0.29265493154525757,
-0.012265772558748722,
-0.06895712018013,
-0.8385216593742371,
0.28709346055984497,
0.6101707816123962,
0.23013423383235931,
0.6787862181663513,
0.26689326763153076,
-0.4311591386795044,
-0.18802793323993683,
-0.30232056975364685,
0.9387688636779785,
-0.13007710874080658,
0.22031250596046448,
1.0372099876403809,
0.03188936412334442,
-0.06894070655107498,
-0.3009466826915741,
-0.1814471185207367,
-0.7182177901268005,
0.6061800122261047,
-0.032818179577589035,
0.13909755647182465,
0.1700412929058075,
0.21671879291534424,
0.2431447058916092,
0.6560212969779968,
0.3136545419692993,
0.22729289531707764,
-0.15777528285980225,
0.20856493711471558,
-0.049490369856357574
] |
NCT04926740
|
Intravenous Fluids in Adults With Diabetic Ketoacidosis in the Emergency Department
|
Diabetes mellitus is a common chronic disease. It is estimated that up to 40% of adults may develop diabetes in their lifetime. Patients with poorly controlled blood sugars often visit the emergency department for treatment of potentially dangerous and life-threatening complications of diabetes, including "diabetic ketoacidosis" (DKA), a condition where the body does not have enough insulin or cannot effectively use the insulin that is produced. As a result, the body produces a chemical called "ketones" as another source of energy, which increase the acid levels of blood and impairs organ function throughout the body.
In the emergency department, patients with DKA are usually treated with insulin and large amounts of intravenous fluid. Recent research suggests the fluid type used may be important in treating DKA. Normal saline (0.9% sodium chloride) is the most commonly used intravenous fluid in treating DKA, but it has a very high concentration of chloride and can lead to additional acid production when given in large volumes. Ringer's lactate is another type of intravenous fluid that more closely matches the chemistry of fluid in our bodies and in theory, does not increase the acidity of blood. While there may be benefits to giving Ringer's lactate instead of normal saline, past studies have included very few patients and thus, definite recommendations on preferred fluid type still cannot be made.
This study's research question is: In adults with DKA, does giving Ringer's Lactate result in faster resolution of DKA compared to normal saline? The investigators hypothesize that patients who are given Ringer's Lactate will have faster resolution of DKA. If the hypothesis is correct, results will provide scientific proof that current diabetic ketoacidosis guidelines should change with respect to fluid choice.
In this study, patients with DKA presenting to the emergency department will be randomly assigned to receive either normal saline or Ringer's Lactate. As this is an exploratory (pilot) study, the main goal is to ensure that a larger study will be practical and feasible on a scale involving multiple emergency departments across Canada. Completion of a larger study across multiple sites with more patients will improve our understanding of how fluid choice influences patient-important outcomes such as faster resolution of DKA (meaning patients can leave hospital sooner), fewer admissions to the intensive care unit, fewer deaths and fewer cases of permanent kidney damage. A total of 52 participants (26 per group) will be recruited for this pilot trial.
This pilot study will assess the practicality of enrolling patients in London and help identify barriers and problems with running a larger trial. The overall goal is to determine if Ringer's Lactate will resolve DKA faster than normal saline. If this is true, patients may spend less time in the hospital, which benefits both individual patients and the healthcare system overall. If this hypothesis is correct, findings could provide high-level proof to change current practice guidelines and affect DKA management globally.
|
BACKGROUND AND SIGNIFICANCE Diabetic ketoacidosis (DKA) is an acute, life-threatening complication of diabetes which requires treatment with intravenous (IV) fluid and insulin to correct hyperglycemia and reverse acidosis. Current DKA management guidelines recommend normal saline (0.9% sodium chloride) for resuscitation and treatment.1-3 However, saline's chloride content is higher than that of human plasma and can cause a hyperchloremic metabolic acidosis, particularly when administered in large volumes (often needed in patients with DKA). Use of saline may thus worsen the clinical condition of patients who are already in an acidotic state.4-7 Alternatives to saline are balanced crystalloids (e.g. Ringer's lactate-RL) which have chloride concentrations similar to human plasma; therefore, treatment with balanced crystalloids may lead to faster DKA resolution. One recent study (Self et al.) of emergency department (ED) patients presenting with DKA demonstrated that treatment with balanced crystalloids resulted in more rapid DKA resolution compared to saline (13.0 vs 16.9 hours, p=0.004).8 While the difference in resolution time between groups was small, the authors suggested that "consistent implementation of interventions that deliver small improvements in outcomes...can translate into substantial improvements in population health and health system function." However, this study was single-centred, non-blinded, and was a post-hoc subgroup analysis of completed trials (i.e. SMART9 and SALT-ED10) and power was not prospectively calculated. Other studies on this topic have been limited due to small sample sizes (45-77 patients) leading to low power with limited conclusions.11-14
STUDY OBJECTIVE(S); INCLUDING SPECIFIC AIMS AND/OR HYPOTHESES The investigators hypothesize that patients who are administered IV RL will have faster DKA resolution without a concomitant increase in adverse outcomes when compared with normal saline. However, a pilot randomized controlled trial (RCT) is necessary to assess the feasibility of a future multi-centre trial. The specific objectives for this pilot study are to determine the feasibility of conducting a full-scale multi-centred RCT and to use this pilot data to inform the future trial.
METHODS Design and Setting This will be a single-centre, triple-blind pilot RCT evaluating the superiority of IV RL (intervention) compared to saline (comparator) in treating adult ED patients presenting with DKA over a one-year period. The study setting is London Health Sciences Centre (LHSC)'s Victoria Campus, an academic tertiary care centre with \~90,000 ED visits/year in London, Ontario. Study conduct will be in accordance with the CONSORT statement for pilot feasibility trials.15
Study Procedures Screening, Consent, and Enrolment During weekday business hours (M-F 0700-1700), research assistants (RAs) will screen and identify eligible patients using the ED tracking board. They will approach the treating physician to confirm eligibility before discussing the study with the patient and seeking informed consent. Because the diagnosis of DKA requires laboratory confirmation, all patients with a point-of-care blood glucose confirming hyperglycemia (≥14mmol/L) will be approached for enrolment as a "possible DKA patient". If the treating physician agrees that DKA is possible and IV fluid is indicated, study fluid will be administered per the randomization protocol after consent is obtained. If patients are initially enrolled but the physician ultimately confirms they do not meet DKA criteria, they will be excluded from the analysis. During evening and weekend hours, RAs will be available on-call, however nighttime coverage (after 2300h) will not be feasible for this pilot. After hours (and in the event study processes are affected by a prolonged COVID-19 pandemic), treating physicians can directly enroll patients as there will be study posters to outline enrolment processes and physicians will receive email and in-person reminders on study recruitment. Study personnel will review daily ED visit logs to identify missed patients to screen for bias.
Intervention and Comparator The intervention is administration of IV Ringer's lactate and the comparator is administration of IV normal saline. Rate of study fluid will be at the treating physician's (both ED and inpatient, if consulted for admission) discretion. Apart from fluid administered, there will be no other changes to the patient's clinical care, and patients will receive standard DKA treatment which may include insulin, electrolyte replacement, and/or supportive management. Pharmacy-prepared kits of 8 x 1L bags of study fluid (in Self et al., a maximum of 7090mL was given8) will be kept in a secure space within the ED. Once packaged, IV bags are useable for 30 days before expiration. If a kit is opened but not used completely, individual 1L bags may be returned to the pharmacy to save on costs.
Randomization, Blinding, Allocation Concealment Enrolled patients will be block randomized to treatment or comparator in a 1:1 allocation ratio. The block size will be unknown to investigators and those involved in patient care and will be small enough to ensure balance between each arm throughout the trial. The randomization list will be prepared by the pharmacy. The patients, treating physicians, and outcome assessors will be blinded to assigned treatment. The pharmacy will prepare an opaque covering over each fluid bag within study kits, which will not be removed during the infusion to maintain blinding. Each bag will be labelled with a kit number and scannable bar code to ensure the patient receives study fluid as ordered which will be entered on their Medication Administration Record (Figure 1).
DATA COLLECTION Study data for each enrolled patient will be abstracted from the hospital's electronic medical records into the Lawson REDCap data storage platform. Study data will include minimal demographic information (e.g. sex, date of birth), the patient's medical history (e.g. comorbidities, medications), arrival ED information (e.g. CTAS, arrival vitals), hospital interventions (e.g. IV fluids administered), comprehensive bloodwork results, and discharge and outcome information (e.g. length of stay, intubation, diagnosis).
DATA ANALYSIS The investigators will follow an intention-to-treat analysis. Descriptive statistics will be used to summarize patient characteristics. Chi-square tests with 95% confidence intervals will be used to examine differences in categorical variables between groups, and two-tailed unpaired t-tests will be used to compare continuous variables. For this pilot study, no interim analysis, Data Safety Monitoring Board, or adjudication committee is planned, but these will be developed for the full-scale trial. This trial will be registered with ClinicalTrials.gov.
Sample Size The full-scale multi-centred will include 516 participants (258 per arm), assuming α=0.05, power=80%, 1:1 allocation, a 40% (6.76 hours) minimal clinically important reduction in DKA resolution time, and 10% attrition rate. This trial will be conducted at 6 ED sites over 2 years. Based on this, the sample size for this local pilot RCT is 52 participants (26 per arm).
Sample size for Full-Scale Trial The sample size calculation for this trial was based on a study of Clinical Effects of Balanced Crystalloids vs Saline in Adults with Diabetic Ketoacidosis8 which compared the clinical effects of balanced crystalloids with the clinical effects of saline for the acute treatment in DKA in two clinical trials (Isotonic Solutions and Major Adverse Renal Events Trial \[SMART\]9 and the Saline Against Lactated Ringer's or Plasma-Lyte in the Emergency Department \[SALT-ED\]10). The primary outcome for this comparison was the time between ED presentation and DKA resolution, measured in hours. Self et al. (2020) found an absolute reduction in time to DKA resolution of 3.9 hours. In the balanced crystalloids group (n=94), the median time to resolution of DKA was 13.0 hrs \[IQR: 9.5-18.8\], while in the saline group (n=78) the median time to resolution was 16.9 hrs \[IQR: 11.9-34.5\]. The IQR was used to calculate the standard deviation for each group based on the following assumption for normally distributed data: SD=IQR/1.35. The pooled standard deviation was then calculated based on the sample size and standard deviation of each group from the Self et al. (2020) study \[√((n1-1)\*SD12 + (n2- 1)\*SD22)/(n1+n2-2))\] and was determined to be 12.37. To establish superiority of balanced crystalloids versus saline in the time to resolution of DKA, a superiority margin for a clinically significant difference was chosen to be a 40% (=6.76 hours) reduction in time to resolution of DKA based on expert consensus and patient partner feedback. A conservative attrition rate of 10% was selected for the sample size calculation, as loss to follow-up rates should be low given the nature of the intervention (IV fluids) and follow-up period (\<24 hours). The actual attrition rate determined by this pilot study will inform the sample size calculation for the full-scale multicentre study. Therefore, to achieve 80% power at the 5% level of significance with equal allocation, the sample size for the balanced crystalloids (Ringer's lactate) group and the saline group, while accounting for a 10% loss to follow up and a 25% reduction in time to DKA resolution, is 516 participants (258 per group). The sample size was calculated using Wang and Ji's (2020) method16 for common clinical study designs available at http://riskcalc.org:3838/samplesize/.
The investigators plan to conduct the full-scale trial at 6 ED sites over 2 years, which would require an average minimum recruitment of 86 participants per site (43 per site per year). This research group has established relationships with these other Canadian EDs and have previously conducted successful studies. If further sites are needed for recruitment, the investigators will leverage the Network of Canadian Emergency Researchers (NCER).
Sample size for Pilot Trial For the full-scale trial, a minimum of 43 participants must be recruited annually per site on average. The LHSC Victoria Campus ED treats approximately 130 patients with DKA annually, based on the hospital's Decision Support data from the most recent fiscal year (Mar 1 2019 - Feb 29 2020).
DKA by Site Patients Victoria Hospital 130 (E1010) Type 1 DM with ketoacidosis 70 (E1110) Type 2 DM with ketoacidosis 51 (E1112) Type 2 DM with keto \& lactic acidosis 1 (E1410) Unspecified DM with ketoacidosis 8
Based on research team hours of coverage (0700-2300) and past data from ED presentation time of potentially eligible patients, the investigators expect to approach at least 104 (80%) of eligible patients in the one-year pilot study period, and a minimum of 43 approached participants (41.3%) must be recruited to meet the feasibility target. According to data from similar past trials, the investigators anticipate being able to recruit at least 50% of approached patients (target sample size of 52 patients, 26 in each arm). With 104 patients approached per year, a 90% two-sided confidence interval around the anticipated recruitment rate will have a total width of 0.17, i.e. a lower limit of 0.415 and an upper limit of 0.585. Because the lower limit excludes the minimum feasibility target of 41.3%, the investigators can be 90% confident that the future trial is feasible.
RISKS Participation in this study is entirely voluntary. Patients may refuse to participate, refuse to answer any questions, or withdraw from the study at any time with no effect on their future care. Participants do not waive any legal rights by signing the consent form. They will receive a copy of the letter of information should they be willing to consent.
There are no anticipated risks to participating in this study, other than a low possibility of a privacy breach occurring with the data collected during this study. However, the study team will take all necessary precautions to prevent this from happening and will remove any personal identifiers from all data collection forms.
BENEFITS For participants who are randomized to the Ringer's Lactate Group, there is a possibility that they may benefit from this intervention. The hypothesized benefit from the administration of the IV Ringer's Lactate may include improved faster resolution of DKA than if IV normal saline was administered. However, there is no guarantee that participants will benefit personally from participating in this pilot study.
This study will contribute important knowledge regarding DKA treatment. This pilot study will directly inform if a full-scale clinical trial evaluating the use of a Ringer's Lactate compared to normal saline as part of DKA care in the ED is possible.
|
Inclusion Criteria:
* There are no definitive criteria for diagnosing DKA.3 Thus, using the criteria employed by Self et al.8 and the Diabetes Canada guidelines3 we will include ED patients ≥18 years with a clinical diagnosis and laboratory values consistent with DKA, including:
* plasma glucose concentration ≥14mmol/L
* plasma bicarbonate concentration ≤18mmol/L and/or blood pH ≤7.30
* calculated anion gap \>10mmol/L
* presence of ketones/beta-hydroxybutyrate in serum and/or urine
Exclusion Criteria:
* We will exclude patients who:
* Are initially seen at another ED and transferred to LHSC for care and/or admission
* Receive \>1L of IV fluid prior to enrolment (e.g. pre-hospital by EMS or while waiting to be seen) - this may cause study contamination
* Are initially enrolled due to clinical suspicion of DKA based on elevated point-of-care glucose, but ultimately do not meet clinical/laboratory criteria for DKA (e.g. "hyperglycemia" only)
* Have euglycemic DKA (generally those on SGLT-2 inhibitors)
|
[
-0.3690992295742035,
2.311088800430298,
-1.5163588523864746,
-1.6085178852081299,
0.3620554804801941,
0.7389305233955383,
-0.17947134375572205,
-0.7245487570762634,
-0.28287556767463684,
0.1319040209054947,
0.2751612663269043,
2.08797550201416,
0.07186112552881241,
1.1287492513656616,
-0.5427799820899963,
0.1527298539876938,
-0.6807628870010376,
0.3702201843261719,
0.5797260999679565,
-0.9432887434959412,
0.7141157984733582,
1.0563124418258667,
-0.19193631410598755,
-0.0732041448354721,
0.8477151989936829,
-0.49775370955467224,
-0.059695061296224594,
0.5998088121414185,
0.5864264965057373,
0.5221729278564453,
0.31472477316856384,
-0.347511351108551,
-0.9696426391601562,
-0.306875616312027,
0.6040906310081482,
-0.40985122323036194,
0.3945038318634033,
0.4195370078086853,
-0.5470534563064575,
0.04799314960837364,
1.0476456880569458,
1.0439484119415283,
0.3699839115142822,
-0.5111654996871948,
0.09247785806655884,
0.42405956983566284,
0.8270561695098877,
-0.25698238611221313,
0.9122973084449768,
0.6877758502960205,
0.2663836181163788,
1.1916959285736084,
-1.0102858543395996,
0.4413991868495941,
0.7701141238212585,
0.6730673313140869,
0.09741652011871338,
-0.05739235505461693,
1.4203025102615356,
-0.17246900498867035,
-0.04972557723522186,
0.24242860078811646,
0.03636551648378372,
0.13560080528259277,
-1.1105504035949707,
-0.46379563212394714,
0.305399090051651,
-0.2448222041130066,
-0.6681002974510193,
0.503902018070221,
-0.7751172780990601,
-0.14781321585178375,
0.4224381446838379,
-0.242277130484581,
0.3510810136795044,
0.7037176489830017,
0.30295461416244507,
0.679151713848114,
-0.03168456256389618,
0.027335593476891518,
-0.8197054862976074,
-0.48229387402534485,
-0.24716544151306152,
-0.05046938359737396,
0.5785331130027771,
0.17272673547267914,
-0.5064212679862976,
-0.8323296904563904,
0.32879090309143066,
-0.05239349603652954,
0.37123048305511475,
-0.5219792127609253,
-0.18774749338626862,
0.36457130312919617,
-0.771248459815979,
-0.0008646245114505291,
0.18103231489658356,
-0.2053314745426178,
-0.5903956294059753,
-0.33111175894737244,
-0.2906404733657837,
-0.27291780710220337,
-0.015717478469014168,
0.13092227280139923,
-0.17615224421024323,
0.10650184005498886,
-0.14934702217578888,
-0.03687005490064621,
-0.8544020056724548,
-0.19392679631710052,
0.3318970501422882,
-1.017125129699707,
0.22865769267082214,
-0.04594039171934128,
0.44179585576057434,
-0.1822136640548706,
0.4274806082248688,
0.426100492477417,
-0.16917598247528076,
-0.47633227705955505,
-0.21138997375965118,
-0.03672248125076294,
0.037647124379873276,
0.24878177046775818,
-0.2856692373752594,
-0.3415553867816925,
0.1487594097852707,
0.4219573140144348,
-0.23452973365783691,
0.04363070800900459,
0.2741335332393646,
0.31009113788604736,
0.14275914430618286,
-0.4091290533542633,
-0.461182564496994,
-0.16300220787525177,
0.3459475040435791,
0.3871244788169861,
-0.3303312659263611,
-0.2961312234401703,
0.6935048699378967,
0.10785695910453796,
-0.02597438171505928,
0.19334688782691956,
-0.7958784103393555,
0.046509142965078354,
-0.33433982729911804,
0.18180498480796814,
-0.538847029209137,
-0.293071448802948,
-0.15260232985019684,
0.8964517116546631,
0.20495860278606415,
0.17713168263435364,
-0.08424944430589676,
0.2366979420185089,
0.3285340964794159,
-0.40165165066719055,
-0.173619344830513,
-0.251674622297287,
0.4025755524635315,
0.29898402094841003,
-0.3842771351337433,
-0.3751656115055084,
0.650571882724762,
-0.5127451419830322,
0.01637670397758484,
-0.428048700094223,
0.8101024031639099,
-0.14106015861034393,
-0.1836179941892624,
0.2542414367198944,
0.24711312353610992,
0.1833435744047165,
-0.1548033505678177,
-0.34276819229125977,
0.45717787742614746,
-0.14218470454216003,
0.5938981771469116,
-0.163828507065773,
0.4399486780166626,
0.187250554561615,
-0.09337656199932098,
-0.1696634590625763,
0.27679359912872314,
-0.2027074694633484,
0.02157243713736534,
-0.44186070561408997,
-0.2997179925441742,
0.15426573157310486,
0.013547408394515514,
-0.2877213954925537,
-0.0639704018831253,
0.14632689952850342,
0.3310844600200653,
0.022431930527091026,
-0.21429908275604248,
-0.10877680778503418,
0.5054187774658203,
-0.28424641489982605,
0.489871084690094,
0.22903262078762054,
0.017788328230381012,
0.539862334728241,
-0.035587552934885025,
-0.4961669445037842,
-0.045784272253513336,
0.18589824438095093,
-0.059629157185554504,
0.12647049129009247,
0.11866694688796997,
0.18212293088436127,
0.004411314148455858,
-0.2848261892795563,
0.1870502233505249,
0.1842229664325714,
-0.15487411618232727,
0.07999788969755173,
-0.522670567035675,
0.019650261849164963,
-0.18915528059005737,
-0.032838936895132065,
0.0884169340133667,
0.0868174284696579,
0.18922220170497894,
-0.007419072091579437,
0.24195869266986847,
0.46953243017196655,
0.1094532310962677,
-0.03951030969619751,
-0.2422085553407669,
-0.18543286621570587,
-0.1446489542722702,
-0.2545834481716156,
-0.23171396553516388,
0.07252385467290878,
-0.020429734140634537,
0.3645412027835846,
0.0190958883613348,
0.00875568762421608,
0.21838028728961945,
-0.3725742995738983,
0.0138498954474926,
-0.22129224240779877,
0.164560005068779,
0.08080966770648956,
-0.1679057776927948,
0.1102481484413147,
-0.08685135096311569,
-0.16266685724258423,
0.05907140299677849,
-0.4317702054977417,
0.20320512354373932,
0.1010863333940506,
0.021466009318828583,
-0.3516281247138977
] |
NCT02074150
|
ASIS for Botox in Upper Limb Spasticity
|
Botox act on nerve endings, yet there are no nerve endings inside the muscle, where they are typically injected. All nerves terminate on the fascia, where ASIS device can precisely deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse reactions and distant spread, especially since Botox has no reason to travel to the rest of the body any way.
|
Aim 1 over 6 months will demonstrate ASIS device's consistent performance on 60 adult subjects with Upper limb Spasticity. Gadolinium will be injected with ASIS subdermally (30) or conventional intramuscularly (30) for these 7 muscle groups: Biceps Brachii, Flexor Carpi Radialis, Flexor Carpi Ulnaris, Flexor Digitorum Profundus, Flexor Digitorum Sublimis, Adductor Pollicis, and Flexor Pollicis Longus. An MRI will be taken promptly after Gadolinium injection, as starting reference, to which subsequent MRI taken at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %. Since there isn't a way to measure level of Gadolinium within it, or any other (e.g. Botox) for that matter, at least the Prolongation of Gadolinium may be approximated by the greater or longer Persistent % on MRI. However, this approximation can only work if the variables are minimized to the same population with Upper limb Spasticity, and these particular 7 muscle groups. Case in point, patients with Upper limb Spasticity presumably have hyperactivity in these 7 muscle groups, so expectantly will have shortened Gadolinium intramuscularly Persistent %, and somewhat reduced Gadolinium subdermally Persistent % as well due to agitation, thus these Persistent % values in Upper limb Spasticity patients will not be like those of normal patients, or even the same between these 7 different muscle groups. Therefore, the Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % intramuscularly, will be specific and valuable indicators to help us modify the Botox dosage and duration to inject into that "unknown" subdermal bloodless space for Aim 2.
Aim 2 over 12 months, using Botox, instead of Gadolinium, to demonstrate the advantages of ASIS device subdermally over intramuscularly, for the same 60 adult subjects with Upper limb Spasticity, on these particular 7 muscle groups: Biceps Brachii, Flexor Carpi Radialis, Flexor Carpi Ulnaris, Flexor Digitorum Profundus, Flexor Digitorum Sublimis, Adductor Pollicis, and Flexor Pollicis Longus. Hypothetically speaking, if that subdermal bloodless space in patients with e.g., Upper limb Spasticity somehow failed to show prolongation of half-life for Gadolinium in Aim 1, we can still proceed with primary interest being therapeutic comparison for Botox in Aim 2, in terms of improvement on the Physician Global Assessment Scale and Ashworth score (force required to move an extremity around a joint), at 6,12,18,24, and 30 weeks, and reduction in adverse reactions.
|
Inclusion Criteria:
* Adults with history of stroke that resulted in a unilateral, upper-limb focal spasticity
* Wrist flexor tone of more than 2 and finger flexor tone of more than 2 as measured by the Ashworth Scale
* Ability to understand and follow verbal directions
* At least 1 functional disability item (hygiene, dressing, pain, or limb posture) with a rating of more than 2 on the Disability Assessment Scale (DAS)
* At least 1 functional task score at Day 0 that met the following criteria: nail filing less than 6, hand cleaning less than 6, holding a water bottle less than 4, brushing teeth less than 4, holding fruit (small, medium, or large equals no.
Exclusion Criteria:
* Stroke within 6 months of the study enrollment visit
* Females who are pregnant, nursing, or planning a pregnancy during the study period or who are not using a reliable means of contraception
* Previous or current Botox therapy of any type in the study limb
* Any medical condition that may put the patient at increased risk with Botox exposure or any other disorder that might have interfered with neuromuscular function
* Presence of fixed contracture of the study limb
* Limited use of the wrist and fingers
|
[
-2.8234262466430664,
-0.2816982865333557,
-1.489937663078308,
-2.548715114593506,
0.4469439387321472,
-0.5409589409828186,
-0.3722671568393707,
-0.2776026725769043,
-1.2429540157318115,
-0.24728739261627197,
0.4242604672908783,
0.12433966249227524,
-0.007912389002740383,
1.1293880939483643,
1.2487834692001343,
1.4003628492355347,
-0.212228924036026,
1.3303455114364624,
1.3262466192245483,
-1.0720385313034058,
1.453275442123413,
-0.10443635284900665,
-1.3653925657272339,
-0.8311871290206909,
0.2645462155342102,
0.4041244089603424,
1.2668461799621582,
-0.6653637886047363,
-0.5594089031219482,
-0.1344369798898697,
-1.6388545036315918,
0.025474850088357925,
0.5734344124794006,
1.156904935836792,
-0.40911665558815,
1.0498666763305664,
1.4433774948120117,
0.3983015716075897,
-1.6499533653259277,
-0.1726042628288269,
1.4208649396896362,
0.580814778804779,
-1.1618387699127197,
0.12537617981433868,
1.3985464572906494,
0.5206624865531921,
-0.18012450635433197,
0.02315654419362545,
2.3232240676879883,
-0.4748836159706116,
0.7311305999755859,
0.0062861512415111065,
-0.6373872756958008,
-0.32226935029029846,
1.21908700466156,
-0.960864245891571,
-0.11950917541980743,
0.04126133769750595,
-1.4923362731933594,
0.0920664519071579,
1.039286494255066,
-0.914473295211792,
0.3939865827560425,
-0.47505271434783936,
-0.6199674606323242,
-0.21529552340507507,
0.5855311751365662,
0.09489168971776962,
-0.5289775133132935,
0.6550138592720032,
0.5441192388534546,
-0.572478175163269,
-0.37721264362335205,
0.3422798216342926,
-0.8835541605949402,
0.19595451653003693,
-0.4359550178050995,
0.4129631519317627,
0.7598416805267334,
-0.4214509129524231,
-0.05906739458441734,
0.09712997078895569,
-1.072982907295227,
-0.06863287091255188,
0.25814270973205566,
0.2761436402797699,
0.4965153634548187,
-0.204302117228508,
-0.10106881707906723,
-2.515146255493164,
1.0573030710220337,
0.3385378122329712,
-0.06393731385469437,
0.4223615527153015,
-1.3858829736709595,
-0.16262957453727722,
-0.2330649197101593,
0.22884291410446167,
0.07191077619791031,
-0.08448820561170578,
-0.2681712508201599,
0.05844440683722496,
0.26650404930114746,
-0.4823605418205261,
0.6531316041946411,
-0.49395468831062317,
-0.6640428304672241,
-0.8494130969047546,
-0.39879292249679565,
-0.8691708445549011,
0.27735042572021484,
-0.8609929084777832,
0.06086314097046852,
0.13183832168579102,
-0.34431329369544983,
1.0214662551879883,
-0.20150496065616608,
-0.6321712732315063,
-0.07302653789520264,
0.11198790371417999,
-0.263152539730072,
0.3651394546031952,
1.0747021436691284,
-0.12429201602935791,
-0.22729766368865967,
-0.8786410093307495,
0.03960852697491646,
0.2895316183567047,
-0.3538130521774292,
-0.2869325876235962,
-0.6544960141181946,
1.2734589576721191,
-0.24441176652908325,
-1.2695484161376953,
-1.2021974325180054,
-0.2946418225765228,
0.25621339678764343,
0.44907745718955994,
-0.33200132846832275,
-0.4565422534942627,
0.314400315284729,
0.7496262192726135,
-0.546302318572998,
0.899549663066864,
-0.08927606791257858,
0.6588025093078613,
-0.5061380863189697,
0.8013672828674316,
0.14322762191295624,
-0.12718695402145386,
0.7060662508010864,
0.2515821158885956,
-0.6299962997436523,
-0.25591087341308594,
0.7389817833900452,
-0.6641849279403687,
0.007324686273932457,
0.32898184657096863,
-0.21054388582706451,
-0.7438374161720276,
0.5381258130073547,
-0.4002000093460083,
0.31479722261428833,
0.014376617968082428,
-0.1248483881354332,
-0.06592787057161331,
-0.4396677613258362,
-0.35048359632492065,
0.8209412693977356,
-0.5033342242240906,
0.19234085083007812,
-0.5117891430854797,
-0.7137519717216492,
0.5841225981712341,
-0.0751553550362587,
0.9207678437232971,
0.588114857673645,
-0.15673883259296417,
0.6877149939537048,
-0.1974649727344513,
-0.4930797517299652,
0.059659432619810104,
0.2830558121204376,
0.32708171010017395,
0.04071672260761261,
-0.8829496502876282,
-0.6189067363739014,
0.20372453331947327,
-0.4424614906311035,
0.5577457547187805,
-0.19382870197296143,
0.26081377267837524,
-0.14433549344539642,
0.2565245032310486,
0.03249108046293259,
0.837533175945282,
-0.605827271938324,
0.0445534773170948,
1.6076463460922241,
-0.03757517784833908,
-0.1884130984544754,
0.20860424637794495,
-0.7331343293190002,
0.34678763151168823,
-1.1180896759033203,
-0.006035740487277508,
-0.1878775954246521,
0.20035743713378906,
0.18368007242679596,
-0.17113707959651947,
0.13234207034111023,
0.3429195284843445,
0.7115029692649841,
0.09429137408733368,
0.22287382185459137,
0.17425015568733215,
-0.7150578498840332,
0.189835786819458,
-0.0619434230029583,
-0.08496670424938202,
-0.21259133517742157,
-0.1776808351278305,
0.6361454129219055,
0.17825712263584137,
0.08547050505876541,
-0.1422867625951767,
0.18337920308113098,
0.4472709596157074,
0.08881968259811401,
-0.10326635092496872,
-0.30056464672088623,
0.24637898802757263,
-0.0548100471496582,
-0.04502158239483833,
-0.3878992795944214,
-0.26413479447364807,
0.10936475545167923,
-0.03396476432681084,
0.18839077651500702,
-0.16753576695919037,
-0.2003130167722702,
-0.9756830334663391,
-0.0014888476580381393,
-0.14787665009498596,
-0.23091402649879456,
0.5068141222000122,
0.12374509871006012,
0.6749535202980042,
0.22593022882938385,
-0.3007639944553375,
0.1511511504650116,
-0.27257102727890015,
-0.3714551031589508,
-0.20259732007980347,
0.05331553518772125,
-0.47615769505500793
] |
NCT05661474
|
Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Diabetic Foot Ulcers
|
Diabetes Mellitus (DM) is one of the most widespread metabolic diseases and the alarming rise in its prevalence worldwide poses enormous challenges. The microvascular and macrovascular complications of DM heavy impact on longevity and quality of life, and in particular diabetic foot ulcers (DFUs) are among the ten top causes of worldwide disease burden and disability Essential components of the standard care, management, and treatment of DFUs are represented by health education, strict control of blood glucose and cardiovascular risk factors, offloading, local debridement, and adequate dressing. A wide variety of dressing is available, and these include basic contact dressings (low adherence dressings such as saline gauze, paraffin gauze or simple absorbent dressings) and advanced dressings (alginate, hydrogel, films, hydrocolloid, foam).
It is important underline that due to lack of evidence from head-to-head randomized controlled trials (RCTs), the relative effects of any of these dressings in DFUs remain unclear. Consequently, so far clinical evidence supporting the choice for either hydrogel or saline gauze dressing, has been related mostly on clinician perception rather than high quality evidence. Here we evaluated the efficacy and safety of Fitostimoline® hydrogel dressing versus saline gauze dressing in patients with DFUs in a monocentric, two-arm, open-label, randomized, controlled trial.
|
Inclusion Criteria:
* Type 1 diabetes and type 2 diabetes,
* adult patients with DFUs at Grades IC or IIC for a period of at least 12 weeks,
* an akle brachial index \>0.8,
* be able to understand simple instructions,
* provided voluntary, signed informed consent
Exclusion Criteria:
* active infection
* evidence of ischaemia in the limb,
* osteomyelitis,
* gangrene,
* systemic inflammatory or autoimmune disease,
* use of corticosteroids, immunosuppressive agents, radiation therapy and chemotherapyan,
* known hypersensitivity to any of the dressing components.
|
[
-0.25069913268089294,
1.957597255706787,
-1.4998695850372314,
-2.6201705932617188,
-0.8898100852966309,
-0.359102338552475,
-0.1253533810377121,
0.3726651072502136,
-1.1212700605392456,
-0.9900287985801697,
0.5210725665092468,
2.124152421951294,
0.7564356923103333,
0.23642949759960175,
-0.15696357190608978,
0.45356059074401855,
-0.8929281234741211,
0.41165971755981445,
-0.11188653856515884,
-1.0255870819091797,
0.5639515519142151,
0.28836187720298767,
-0.05758773162961006,
0.004066886845976114,
0.6501829028129578,
-0.5005439519882202,
0.7742260098457336,
-0.39882296323776245,
0.6690769791603088,
0.6492698192596436,
-0.08257116377353668,
-1.2450134754180908,
-0.4145185649394989,
0.583500325679779,
0.6827061176300049,
0.19357851147651672,
-0.8731812238693237,
0.6138908863067627,
0.07075916230678558,
0.5897815823554993,
0.40233564376831055,
0.4278811514377594,
0.84627765417099,
-0.4024646282196045,
0.5103029012680054,
0.23860225081443787,
1.4804517030715942,
-0.5220545530319214,
0.43070197105407715,
0.4919586181640625,
-0.02171279489994049,
1.1319183111190796,
-0.7563670873641968,
0.4389064311981201,
1.2299668788909912,
1.1555168628692627,
-0.11687018722295761,
1.1068063974380493,
1.4490665197372437,
1.0190502405166626,
0.7330106496810913,
0.5740312933921814,
0.8681318163871765,
0.5312724709510803,
-1.3039060831069946,
-0.8775377869606018,
0.10064055025577545,
0.7096604704856873,
-0.36908406019210815,
0.5212857723236084,
-0.799485981464386,
-0.10412540286779404,
0.02918015979230404,
-0.4127730131149292,
0.4353829324245453,
0.2781045734882355,
-0.041884370148181915,
1.0612688064575195,
-0.7358648180961609,
0.4949629008769989,
-0.6020457148551941,
-0.14692367613315582,
0.15412050485610962,
0.4522022008895874,
0.11871268600225449,
0.5046072006225586,
-0.5015344619750977,
-0.49266067147254944,
0.14121456444263458,
-0.26711398363113403,
0.25161516666412354,
-0.5786327123641968,
-0.24697785079479218,
0.3420088291168213,
-0.7812179923057556,
-0.16002224385738373,
-0.20121392607688904,
0.2907582223415375,
-0.6846964359283447,
-0.23318131268024445,
-0.6658929586410522,
-0.43945786356925964,
-0.8015519976615906,
-0.08359253406524658,
-0.04482860490679741,
0.3482816815376282,
-0.4942290186882019,
0.3515981435775757,
-0.4226873815059662,
-0.5181661248207092,
0.7692609429359436,
-0.526944637298584,
-0.4302103817462921,
0.453964501619339,
0.0544176809489727,
0.23948504030704498,
0.44838953018188477,
-0.27092838287353516,
-0.34959837794303894,
-0.5347483158111572,
0.006390250287950039,
0.25279539823532104,
0.5052974224090576,
0.11528993397951126,
-0.8551024198532104,
0.4474231004714966,
0.1650814563035965,
0.14965127408504486,
-0.17943471670150757,
0.07434392720460892,
-0.7273906469345093,
0.08383295685052872,
-0.08597615361213684,
-0.5941491723060608,
-0.9032047390937805,
-0.35181567072868347,
0.5614763498306274,
0.5648741126060486,
0.22980058193206787,
0.30317822098731995,
-0.28981783986091614,
0.13122740387916565,
-0.5500870943069458,
0.6007814407348633,
-0.513751745223999,
0.12209238857030869,
-0.3332420885562897,
0.26846060156822205,
0.022746967151761055,
-0.9078930020332336,
-0.27785277366638184,
0.6446428298950195,
0.2570439875125885,
0.10592033714056015,
0.11388250440359116,
-0.18041741847991943,
-0.09290792793035507,
0.1159590408205986,
-0.3333614468574524,
-0.2806471884250641,
-0.1071186363697052,
0.19363617897033691,
0.03398222103714943,
-0.14231674373149872,
0.4148098826408386,
-0.24997852742671967,
-0.0793263167142868,
-0.43289613723754883,
0.3180851936340332,
0.0683751329779625,
-0.10970541089773178,
-0.14532451331615448,
-0.46988600492477417,
0.28620225191116333,
0.0023995207156986,
-0.27878934144973755,
0.8046851754188538,
0.07832404226064682,
0.25728079676628113,
-0.4837152659893036,
0.0013460229383781552,
-0.25509142875671387,
0.21192847192287445,
0.1279311329126358,
-0.3659513294696808,
-0.19361881911754608,
0.11247366666793823,
-0.6438711881637573,
-0.35064977407455444,
0.21640190482139587,
-0.39776039123535156,
-0.15423694252967834,
0.2737537622451782,
-0.289169579744339,
0.35198333859443665,
0.012925333343446255,
0.035872139036655426,
-0.19128358364105225,
0.2947548031806946,
0.10126511752605438,
0.2078397572040558,
0.025054113939404488,
-0.05490044504404068,
0.3397696018218994,
0.19061316549777985,
0.04387985169887543,
0.07999492436647415,
0.09603672474622726,
-0.23239527642726898,
0.12347517907619476,
-0.45146283507347107,
0.4800744950771332,
0.23744741082191467,
-0.27174100279808044,
0.4008057117462158,
-0.0039033989887684584,
0.05405128374695778,
-0.06947015225887299,
-0.37841445207595825,
-0.14922070503234863,
0.020451541990041733,
-0.14774172008037567,
-0.09597432613372803,
0.3093743920326233,
-0.13903367519378662,
-0.1792241632938385,
0.2801875174045563,
0.3477013111114502,
0.1618964970111847,
-0.11911366134881973,
-0.14088858664035797,
0.20606791973114014,
-0.1578277200460434,
-0.042961485683918,
-0.1812315583229065,
-0.09209166467189789,
-0.40852195024490356,
-0.2534007132053375,
-0.30850082635879517,
0.10754521936178207,
0.2813597619533539,
-0.30797091126441956,
0.1353134959936142,
-0.0919976457953453,
0.0588008388876915,
-0.13357435166835785,
-0.2849043011665344,
0.06719252467155457,
-0.3032835125923157,
0.10963714122772217,
0.0347338505089283,
-0.13001662492752075,
-0.13683384656906128,
0.13267067074775696,
-0.0423140823841095,
-0.2605101466178894
] |
|
NCT00994474
|
Comparison of Outcome Parameters in Laser Rhytide Treatment
|
We previously published a comparative split-face study which has shown a significant, albeit moderate, effect of ablative fractional laser treatment. While indicating that a single session with fractional ablative lasers can be effective in the treatment of peri-orbital wrinkles, the trial also revealed substantial disagreement between the different end points (profilometry, Fitzpatrick wrinkle score, patient satisfaction). Since the PBI is a patient-related index it could not be included in the aforementioned split-face trial; the present study therefore attempts to further elucidate the patient-related benefit of a single fractional ablative laser treatment session as well as carefully analyse the respective correlations between the outcome parameters employed.
|
Inclusion Criteria:
* mild to moderate peri-orbital rhytides ('crow's feet') at rest (Class II according to Fitzpatrick)
Exclusion Criteria:
* unrealistic expectations
* inability to meet follow-up criteria
* Fitzpatrick skin phototype \>III
* coagulation disorders or anti-coagulant treatment
* allergy to lidocaine or tetracaine
* oral isotretinoin within the last 6 months
* any active skin disease within the treatment areas (e.g., psoriasis, cancer, or autoimmune disease)
* synthetic implants in the treatment area
* facial cosmetic procedures affecting the treatment area within the last 6 months
* photosensitizing medications (e.g., tetracycline, gold)
* history of keloid formation
* pregnancy
|
[
-1.3683969974517822,
1.7574373483657837,
-4.290484428405762,
-1.400414228439331,
0.08496589213609695,
-0.19888292253017426,
0.06307554990053177,
-1.0167399644851685,
-1.1810978651046753,
-0.5859193205833435,
-0.47243717312812805,
0.5527583360671997,
-1.0044420957565308,
0.37311893701553345,
-0.7338165640830994,
1.0668712854385376,
0.07395689189434052,
-0.1445576548576355,
1.2076421976089478,
-1.186108112335205,
-0.42529651522636414,
-0.22824719548225403,
0.6676596999168396,
0.15477041900157928,
1.0397673845291138,
-0.995315432548523,
0.047772422432899475,
0.5908840894699097,
0.09022459387779236,
0.5511510372161865,
-0.4310853183269501,
0.19419845938682556,
0.0641278624534607,
0.6910232305526733,
-0.2797918915748596,
-0.07369586825370789,
-0.8893775939941406,
0.566712498664856,
-1.302631139755249,
-0.5204482674598694,
0.7365753650665283,
0.1605720967054367,
0.4739009141921997,
0.33888617157936096,
0.6434299945831299,
1.0383347272872925,
-2.0060441493988037,
-0.7843358516693115,
-1.1532107591629028,
-0.06082271784543991,
0.14349058270454407,
1.9550124406814575,
-1.4151285886764526,
0.5324234366416931,
0.7246440649032593,
0.9068179726600647,
1.0659468173980713,
0.353103369474411,
0.6265223026275635,
-0.44724321365356445,
-0.526549756526947,
-0.12108055502176285,
0.07009133696556091,
0.17024190723896027,
-0.5846036076545715,
0.33036038279533386,
-0.13509169220924377,
0.4235401153564453,
-1.3232057094573975,
0.6247109174728394,
0.1290450394153595,
-0.31059637665748596,
0.04363538324832916,
-0.33509311079978943,
0.3571784794330597,
0.21679244935512543,
-0.7568067312240601,
-0.4027264714241028,
0.03397650271654129,
0.4507322907447815,
0.6722572445869446,
-0.4635605216026306,
-0.9259875416755676,
-0.5514147877693176,
0.25166043639183044,
0.13363763689994812,
-0.04467219486832619,
-0.7566025257110596,
0.46167171001434326,
-0.649752676486969,
-0.23366843163967133,
0.5303723216056824,
-1.506494164466858,
0.5324721336364746,
-0.5872519016265869,
0.25672152638435364,
-0.2471206933259964,
-1.1051585674285889,
0.14188385009765625,
-0.30169036984443665,
0.22698357701301575,
0.13114187121391296,
0.6271196603775024,
0.2810165584087372,
-0.39857038855552673,
-0.8614028692245483,
-0.34658583998680115,
-0.2797805070877075,
-0.6012867093086243,
-0.12269658595323563,
0.9821909666061401,
-1.4189426898956299,
-0.22907307744026184,
-0.7264195084571838,
0.6698909997940063,
0.8014656901359558,
0.05851663649082184,
-0.4330306649208069,
-0.008493158034980297,
-0.13115936517715454,
0.4500752091407776,
-0.29569971561431885,
0.12739703059196472,
0.8264864087104797,
-0.22149044275283813,
0.3626227378845215,
0.9514037370681763,
1.384192705154419,
-0.15058717131614685,
-0.12702535092830658,
-0.7094509601593018,
-0.15441688895225525,
-0.38786551356315613,
-0.3336150646209717,
-1.7247902154922485,
0.3512033224105835,
0.4117428958415985,
0.46595361828804016,
0.17975053191184998,
0.01472106110304594,
-0.07015947997570038,
0.7634642720222473,
0.8440448045730591,
0.014919542707502842,
-0.07629456371068954,
0.26313185691833496,
-0.2759910821914673,
0.8849396109580994,
-1.0114526748657227,
0.28524869680404663,
-0.4337852895259857,
0.16024428606033325,
0.33245590329170227,
-0.17920535802841187,
-0.2751244604587555,
0.148329958319664,
-0.19202880561351776,
-0.4522845447063446,
0.13274231553077698,
-0.006674680858850479,
0.2671750485897064,
-0.4495853781700134,
0.43118399381637573,
-0.6463305950164795,
0.5478283762931824,
-0.3543495833873749,
0.2266269028186798,
0.03638564050197601,
-0.13770467042922974,
0.19120143353939056,
-0.34461331367492676,
-0.14245225489139557,
0.4849511682987213,
0.16911573708057404,
0.27284136414527893,
0.5647962093353271,
0.7131427526473999,
-0.14422553777694702,
0.655836820602417,
-0.6765397191047668,
-0.2204982340335846,
0.24885566532611847,
-0.3790742754936218,
0.13274981081485748,
-0.365083247423172,
-0.46943342685699463,
-0.1781136691570282,
0.024520106613636017,
0.19122032821178436,
0.013964684680104256,
0.08066055178642273,
-0.31994473934173584,
0.12459198385477066,
0.10218074917793274,
0.28029322624206543,
0.07396165281534195,
-0.01978335529565811,
0.1465412974357605,
0.4745110273361206,
0.13839325308799744,
-0.08725489675998688,
0.39650553464889526,
-0.09752238541841507,
0.23128873109817505,
0.04472292959690094,
-0.20026442408561707,
-0.47880691289901733,
-0.0642281249165535,
-0.31879889965057373,
0.29009726643562317,
0.5532947778701782,
0.10336268693208694,
0.07113994657993317,
-0.29222986102104187,
0.2176593542098999,
0.6354882717132568,
0.056108508259058,
-0.35877567529678345,
-0.6113150119781494,
-0.47090762853622437,
-0.29430678486824036,
0.05013135448098183,
0.23017923533916473,
0.5335001945495605,
-0.3932762145996094,
0.6514718532562256,
0.49165597558021545,
0.3161134719848633,
0.13704241812229156,
-0.42406782507896423,
-0.28249990940093994,
-0.09064308553934097,
-0.24301129579544067,
0.057776015251874924,
0.021824831143021584,
0.3312755525112152,
-0.22958320379257202,
0.21650061011314392,
-0.3375268280506134,
0.823302149772644,
-0.23558466136455536,
-0.3432181179523468,
-0.22176599502563477,
-0.14366987347602844,
0.08248873054981232,
-0.04372516646981239,
-0.32725071907043457,
0.461772084236145,
0.13449372351169586,
0.025824999436736107,
0.06400127708911896,
0.29097631573677063,
0.5362341403961182,
0.11356423795223236,
-0.7461733818054199,
-0.27351921796798706
] |
|
NCT04730583
|
Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas
|
This study will evaluate the tolerability and effectiveness of three FDA-approved treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 1064nm laser, a 755nm laser, and a Kybella injection. Each patient will have a treatment and a control site.
|
Inclusion Criteria:
* Adult males and females ≥18 years of age
* Have a diagnosis of Neurofibromatosis Type 1
* Patients must be seeking treatment for cutaneous Neurofibromas
* Patients must have ≥ 6 paired cutaneous Neurofibromas (3 to be treated and 3 untreated) that are visible and measure between 2-4mm in size.
* Able and willing to comply with all visit, treatment and evaluation schedules and requirements
* Able to understand and provide written informed consent
* Access to a Smart Phone to be able to take and upload photographs to an application
Exclusion Criteria:
* Patients who are undergoing other treatment modalities or investigational agents for their cNF lesions
* Individuals who cannot give informed consent or adhere to study schedule
* Actively tanning during the course of the study
* Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists;
* Known allergy to injectable anesthetics or deoxycholic acid
* Any condition which, in the Investigator's opinion, would make it unsafe (for the participant or study personnel) to treat the participant as part of this research study;
* Pregnant females, due to possible discomfort with the procedure even though the procedure is localized and there is no new drug.
|
[
2.3204925060272217,
1.49214506149292,
-1.953692078590393,
-3.2062020301818848,
-0.4997311234474182,
0.06295669823884964,
-0.5833958387374878,
0.16904917359352112,
-0.05265849456191063,
0.652328372001648,
-0.04150989279150963,
2.6399402618408203,
-1.3577015399932861,
0.7593579292297363,
0.4647594094276428,
0.946024477481842,
-0.7734366059303284,
1.802647590637207,
0.9427005648612976,
-2.569314956665039,
0.3157427906990051,
-0.76747065782547,
1.0258042812347412,
-0.08053725957870483,
1.8684759140014648,
-0.8838367462158203,
0.4849817752838135,
1.8189982175827026,
0.9540639519691467,
0.14197242259979248,
-2.6725215911865234,
-0.10435876995325089,
1.9903783798217773,
2.0750577449798584,
0.8528755903244019,
-0.4745086133480072,
0.645766019821167,
0.426591694355011,
-1.782512903213501,
-0.2751365602016449,
0.32549500465393066,
-0.505797266960144,
1.1898993253707886,
0.062580905854702,
-0.12515132129192352,
0.28047987818717957,
-0.6470977663993835,
-1.0783404111862183,
0.8987330794334412,
-0.4473077952861786,
0.31343552470207214,
1.6259475946426392,
-0.9204990267753601,
-1.010981559753418,
1.5931425094604492,
0.06467855721712112,
0.8943438529968262,
-0.15407900512218475,
-0.321069598197937,
-0.346101313829422,
1.3467024564743042,
-0.12978269159793854,
0.6131302118301392,
1.0002857446670532,
-0.29432204365730286,
-0.5861786007881165,
0.19944337010383606,
0.5548281669616699,
-0.6165056228637695,
0.4348699450492859,
-0.46778371930122375,
-0.7523751258850098,
-0.51204514503479,
1.7943744659423828,
0.727237343788147,
-0.19952374696731567,
-0.10022196918725967,
0.2345840036869049,
1.7088127136230469,
-0.7875874042510986,
0.4089893102645874,
-0.6971209645271301,
0.4880546033382416,
0.3580786883831024,
-0.07856979221105576,
-0.6598584055900574,
-0.2641085982322693,
-0.9935532808303833,
0.6749743819236755,
-1.6432411670684814,
0.05231083929538727,
-0.9687117338180542,
-1.0070511102676392,
0.8154098987579346,
-0.32799264788627625,
-0.6711052060127258,
0.583537757396698,
-1.5980229377746582,
-0.38712817430496216,
0.41293802857398987,
-0.43229272961616516,
0.028985455632209778,
-0.35498830676078796,
-0.5775289535522461,
-0.5902851819992065,
1.2014566659927368,
-0.08827048540115356,
-1.672939658164978,
0.19849510490894318,
-1.561959147453308,
1.5258375406265259,
-0.375296950340271,
-0.8036183714866638,
-0.8342756032943726,
-0.5221554636955261,
1.3025633096694946,
0.01347147673368454,
0.570883572101593,
-0.46041250228881836,
0.17507191002368927,
0.8046700954437256,
0.2801622748374939,
-0.0960044115781784,
-1.0751378536224365,
-0.4323183298110962,
0.08330264687538147,
0.49534282088279724,
0.7487730383872986,
-0.7616877555847168,
-1.1549220085144043,
-0.19995447993278503,
0.6394451856613159,
0.33831867575645447,
0.5430909991264343,
-2.1885182857513428,
-0.5417954921722412,
0.33188074827194214,
1.6368005275726318,
-1.041818380355835,
-0.9983233213424683,
-0.23043547570705414,
1.1125869750976562,
-0.17542025446891785,
0.17573118209838867,
-1.2643412351608276,
-0.7309627532958984,
-0.10937075316905975,
0.5917254090309143,
-1.0824270248413086,
0.23849327862262726,
0.23600877821445465,
-0.2350136786699295,
0.07797243446111679,
0.2323933094739914,
0.11796778440475464,
0.4691082239151001,
0.13135528564453125,
-0.5913017392158508,
0.5748555660247803,
-0.5439215302467346,
-0.6749709844589233,
-0.5225804448127747,
-0.319261372089386,
-0.7140686511993408,
0.5202153921127319,
-0.10319842398166656,
-0.7888272404670715,
-0.1226925179362297,
0.3384607136249542,
0.619575023651123,
0.21874657273292542,
0.06072734296321869,
-0.12386222183704376,
-0.009203889407217503,
0.13449564576148987,
-0.27242305874824524,
0.805611252784729,
-0.18689396977424622,
0.05201312154531479,
-0.28740066289901733,
0.4538765847682953,
-0.06981237977743149,
0.033544570207595825,
0.2998550236225128,
-0.5288175940513611,
-0.3270424008369446,
-0.36674943566322327,
-0.005290821194648743,
0.16361381113529205,
0.6798144578933716,
0.4723396897315979,
-0.39922085404396057,
-0.18629860877990723,
0.11558542400598526,
0.27276110649108887,
-0.4059194326400757,
-0.2981165945529938,
-0.13411034643650055,
0.4184997081756592,
-0.19412018358707428,
-0.46058154106140137,
0.7841665148735046,
-0.12555043399333954,
0.21617695689201355,
0.3459377884864807,
0.11929573863744736,
0.06880417466163635,
-0.37542781233787537,
-0.5039258003234863,
0.4937278628349304,
0.1129174530506134,
0.27572524547576904,
-0.16695159673690796,
0.11661569029092789,
0.11799809336662292,
-0.21316510438919067,
0.18146273493766785,
0.05857325345277786,
-0.293588250875473,
-0.2296314537525177,
-0.296586275100708,
-0.797783374786377,
-0.03971685469150543,
0.020693879574537277,
-0.3564069867134094,
-0.19875523447990417,
0.46901175379753113,
-0.05726251378655434,
0.4257314205169678,
0.30072006583213806,
-0.21270348131656647,
0.9842050075531006,
0.14949141442775726,
-0.10922765731811523,
-0.5976961255073547,
0.5777447819709778,
0.38258451223373413,
-0.14560255408287048,
-0.2727940082550049,
0.6577332019805908,
0.11043310165405273,
-0.3054322898387909,
0.10750515013933182,
-0.15332357585430145,
-0.4614097774028778,
-0.6755640506744385,
-0.1344985067844391,
0.14238569140434265,
-0.14320148527622223,
-0.30211949348449707,
-0.24550507962703705,
-0.39531195163726807,
-0.3807135224342346,
-0.168212428689003,
-0.12022963911294937,
-0.6300421357154846
] |
|
NCT02457481
|
An Alternative Culture Medium to Better Support Preimplantation Embryo Development in Vitro
|
The purpose of this research study is to evaluate a newly developed embryo culture media system for human clinical use in ART.
|
Egg retrieval will be performed as per standard operating procedures. Eggs from a single patient are mixed together in a single group during the normal recovery and washing procedure following egg retrieval. The single group of eggs will be divided in half, then the embryologist will randomly place each half into one of the two culture media treatments, commercial or experimental. All mature eggs collected at retrieval will undergo fertilization per standard operating procedures according to physician recommendations. After fertilization (day 0), standard procedures involve in vitro embryo culture in a sequential two step media system. After confirmation of fertilization success on day 1, embryos are cultured until day 3 in step 1 medium (both commercial and experimental media are two step sequential culture systems). On day 3, embryos are evaluated and moved from step one to step two culture medium. On day 5 and day 6, embryo development will be assessed. Good quality blastocysts will either be transferred fresh or cryopreserved for later transfer and/or genetic testing.
|
Inclusion Criteria:
* Adult women of any age who come to Colorado Center for Reproductive Medicine for fertility treatment using IVF.
* Patients can be of any race, culture, sexual orientation or ethnicity.
Exclusion Criteria:
* Minors are excluded from the study
|
[
0.20735661685466766,
3.8713505268096924,
-3.00899338722229,
-0.9853090047836304,
-1.5574514865875244,
0.7367355227470398,
-1.5145263671875,
-1.160354495048523,
-3.315925359725952,
-0.07627438753843307,
0.5324887633323669,
2.640817165374756,
-0.45140329003334045,
2.338013172149658,
-1.4644089937210083,
2.434682607650757,
-0.17435413599014282,
0.26577654480934143,
1.0312284231185913,
0.2627069652080536,
0.11420494318008423,
-1.1343401670455933,
0.802761971950531,
-0.28806397318840027,
-0.8068887591362,
0.8337996006011963,
-1.979912519454956,
0.6842078566551208,
-0.2815816104412079,
1.6841827630996704,
-0.4255645275115967,
-2.1248440742492676,
-0.8979464173316956,
-0.5990136861801147,
0.4556795656681061,
-1.2254316806793213,
0.8982211947441101,
0.8371647596359253,
-1.045680284500122,
0.5897573828697205,
0.3048783242702484,
1.1734704971313477,
-0.9030957221984863,
1.3044843673706055,
-0.19386671483516693,
0.23702289164066315,
-0.27505412697792053,
0.20120106637477875,
0.5019490122795105,
0.7728084921836853,
0.20516113936901093,
0.830191969871521,
-1.871944546699524,
0.8662227988243103,
1.1308070421218872,
1.2301465272903442,
0.03940439969301224,
-1.376163125038147,
2.3937745094299316,
1.111727237701416,
-0.33467167615890503,
-1.2377055883407593,
0.4641011357307434,
1.1757797002792358,
-1.4867957830429077,
0.07228177785873413,
-0.18683312833309174,
-0.0037624428514391184,
0.7978897094726562,
0.14971022307872772,
2.197861433029175,
0.07876252382993698,
3.1707940101623535,
0.6889936327934265,
0.12082888931035995,
0.9955974817276001,
-0.49780598282814026,
0.02280592732131481,
0.922385573387146,
0.6853001117706299,
0.7106744647026062,
-2.5609774589538574,
-0.0019103677477687597,
-0.28722068667411804,
1.3560166358947754,
-0.7021713852882385,
-1.297531008720398,
0.19151341915130615,
0.7390524744987488,
-0.7263017892837524,
0.8207723498344421,
-0.4807724356651306,
0.9643330574035645,
0.3081894516944885,
-0.027698887512087822,
1.2711751461029053,
0.7800390124320984,
-1.523289680480957,
-1.297592282295227,
1.6158976554870605,
-0.48757457733154297,
-0.4561258852481842,
-0.33417588472366333,
0.866481602191925,
-0.3739551603794098,
-0.6009401679039001,
-0.39569008350372314,
-0.07108084112405777,
-0.12072211503982544,
-0.49464932084083557,
-0.07438120990991592,
-0.36989825963974,
-0.0823865681886673,
-0.795005738735199,
0.7711418867111206,
-0.7962082028388977,
1.3802294731140137,
0.9803025722503662,
0.7243035435676575,
0.7453469038009644,
0.20585781335830688,
1.3906974792480469,
0.803145706653595,
0.5506559014320374,
-1.62737238407135,
0.11509156227111816,
-0.04238571971654892,
0.30904048681259155,
-0.31451180577278137,
-0.6987460851669312,
-0.3796382546424866,
0.5029540061950684,
0.4702203869819641,
0.26937106251716614,
0.6763120889663696,
-0.16666345298290253,
0.7936786413192749,
0.2330537885427475,
-0.0077064004726707935,
-1.1089931726455688,
-0.019642332568764687,
0.6934042572975159,
0.5480870008468628,
-0.32166579365730286,
-1.2225894927978516,
-0.6925025582313538,
-0.506934642791748,
-1.0329511165618896,
-0.1776241660118103,
-0.5632439851760864,
-0.46287909150123596,
0.03048599325120449,
-0.7400885820388794,
-0.22506211698055267,
0.7452078461647034,
1.3391520977020264,
0.1756328046321869,
-0.7803025245666504,
0.7400677800178528,
0.04683408513665199,
-0.03820067271590233,
-0.9409109354019165,
-0.7476667165756226,
-0.710929274559021,
-0.37096500396728516,
1.275488257408142,
1.2430880069732666,
-0.2792356014251709,
0.6350054144859314,
0.027991164475679398,
0.0742214173078537,
0.8024575710296631,
-1.5637016296386719,
0.19909849762916565,
0.29182323813438416,
-0.9731101393699646,
0.805106520652771,
0.2679980397224426,
1.455731749534607,
-0.029951918870210648,
-0.2594052255153656,
1.4302737712860107,
0.1125657856464386,
0.09570291638374329,
0.5601528286933899,
-0.06964612007141113,
-0.06535091251134872,
-0.16815796494483948,
0.1036720722913742,
0.10328707844018936,
0.46967634558677673,
0.8648325800895691,
-0.6860657930374146,
0.673069179058075,
-0.3616815507411957,
0.275923490524292,
-0.1656196415424347,
-1.3279621601104736,
0.8115549683570862,
-0.42214319109916687,
1.2532243728637695,
0.2538011372089386,
-0.817578911781311,
0.34352201223373413,
-0.09663502871990204,
0.9137142896652222,
-0.9943326115608215,
0.0019040104234591126,
0.8575828671455383,
0.37801775336265564,
0.4258595407009125,
0.24042291939258575,
-0.8548775315284729,
0.37479379773139954,
1.3379343748092651,
-0.5366133451461792,
0.01633744314312935,
0.5379176139831543,
-0.6909443140029907,
-1.0926450490951538,
-0.5663399696350098,
-0.5868224501609802,
-1.112892508506775,
0.7063570618629456,
0.6422182321548462,
-0.7959948182106018,
-0.10585805773735046,
-0.15434978902339935,
0.3013666570186615,
-0.5586749911308289,
-0.12394489347934723,
0.5800352692604065,
0.27932366728782654,
0.0483182929456234,
-0.8606030941009521,
0.6131205558776855,
0.17407752573490143,
-0.38185715675354004,
0.5414160490036011,
0.3863143026828766,
0.7702773809432983,
-1.1883254051208496,
-0.04111418128013611,
0.502630352973938,
0.5186480283737183,
-0.16781853139400482,
0.10262001305818558,
0.019033003598451614,
-1.4144383668899536,
-0.17756667733192444,
-0.19308646023273468,
-0.41715365648269653,
0.5190443396568298,
-0.527550458908081,
-0.5415478944778442,
-0.7573539018630981
] |
NCT02742974
|
Fluid Resuscitation Optimization in Surgical Trauma Patients (FROST)
|
The aim of this study is to determine if the incidence of post-operative complications can be decreased by the implementation of intra-operative, minimally invasive hemodynamic monitoring (MIHM) via FloTrac™ and EV1000™ in trauma patients.
|
Numerous factors are known to contribute to post-traumatic morbidity and mortality. Acute blood loss, hypovolemia, and systemic inflammatory response syndrome can often develop following severe traumatic injury and are, frequently, further exacerbated by the presence of pre-existing health conditions. The culmination of these insults and/or pre-existing conditions can precipitate an imbalance in oxygen delivery and consumption leading to tissue ischemia and resultant organ dysfunction.
Tissue ischemia precipitates a disruption in the balance of oxygen delivery and consumption often yielding a conversion from aerobic to anaerobic processes in order to maintain metabolic functionality. The conversion to anaerobic processes leads to the production of lactic acid and a resulting consumption of the body's basic buffers. Clinically, the consumption of the body's basic buffers is frequently referred to as the development of a base deficit. Both the production of lactic acid and the development of a base deficit have been positively linked to the increased morbidity and mortality in multiple critically ill patient populations, including those with traumatic injuries.
Multiple studies have linked the rate at which base deficit corrects or lactic acid clears to the likelihood of survival. Accordingly, hemodynamic monitoring can provide vital information concerning cardiovascular function including vascular volume, vascular capacitance, and cardiac performance. Obtaining this information enables clinicians to tailor interventions to target specific components of the cardiovascular system in order to most effectively reverse the cause of tissue hypoxia, elevation in lactic acid, and base deficit, while simultaneously decreasing the likelihood of causing harm through unnecessary or unwarranted changes in management.
Advancements in hemodynamic monitoring technology now allow clinicians to obtain data by using minimally invasive techniques. Devices utilizing this technology can be connected to vascular access routinely utilized in the intensive care setting such as arterial lines. These devices provide parameters such as systolic pressure variation (SPV), pulse pressure variation (PPV) and stroke volume variation (SVV) to predict fluid responsiveness of critically ill, mechanically ventilated patients. Studies evaluating these parameters have shown them to have a 84-94% positive predictive value for fluid responsiveness. In addition, higher variability in studied parameters were indicative of patients who were more likely to be responsive to fluid challenges.
Modern clinical management in critically ill patients with cardiovascular dysfunction hinges on reversal of the underlying cause of cardiovascular dysfunction. Recent management strategies have used a multi-faceted approach in which multiple processes of potential dysfunction can be monitored and managed simultaneously. Management is goal directed with clearly defined endpoints for the management of vascular volume, cardiac performance as well as maintenance of vascular capacitance. Hemodynamic monitoring technology is essential in providing data that will allow clinical interventions to be tailored to patient-specific physiology and provide goals for titration of therapy.
In recent years, data has emerged using goal directed therapy in the surgical patient population with favorable outcomes suggesting a decrease in post-operative organ dysfunction, ICU and hospital length of stay, however, there is limited data in the trauma patient population. This study endeavors to determine if the implementation of intra-operative monitoring will decrease the incidence of post-operative complications such as acute lung injury, infections, thromboembolism, cerebral vascular accident, acute kidney injury, myocardial infarction; in addition to the traditional outcome measures of mortality and length of stay.
|
Inclusion Criteria:
1. 18 years of age or older
2. Injury Severity Score \> 15 (indicator of anticipated trauma mortality)
3. Admission to Surgical-Trauma ICU (STICU)
4. Anticipated surgery within 72 hours of admission
5. American Society of Anesthesiology patient classification status (ASA) 2-5
6. Lactic acid \> 2.5 within 24 hours of surgical procedure or Base deficit ≥ - 5 mmol/L, or persistent requirement for vasopressor support within 24 hours of surgical procedure
7. Patient requires mechanical ventilation prior to consenting surgery
8. Vascular devices that include a minimum of an arterial line
9. Minimally invasive hemodynamic monitoring initiated prior to first surgical procedure unless patient is taken emergently, e.g. OR from trauma bay
10. Patients requiring emergent initial operative procedures will be eligible for consenting if above criteria are met prior to their second surgical procedure
11. Anticipated operative procedure precipitating evaluation and/or consenting for study must be \> 30 minutes in duration
* Procedures \< 30 minutes would not result in significant metabolic stress necessitating a continuation of MIHM
Exclusion Criteria:
1. Pregnancy
2. Exclusions due to limitations with respect to accuracy of MIHM:
* Patients not intubated prior to surgical procedure
* Patients requiring an open thoracotomy
* Patients with known history of surgical intervention for peripheral vascular disease
* Patients with pre-existing atrial arrhythmias
* Patients who are on cardiopulmonary bypass
3. Isolated acute cerebral injury and/or traumatic cerebral injury
* Hemodynamic management in this patient population does not always follow typical/standard endpoints due to nuances of managing intracranial pressures
4. Cardiac arrest prior to enrollment
5. Patients with pre-existing, dialysis dependent, renal failure upon admission
* Hemodynamic management in this patient population does not always follow typical/standard endpoints due to nuances of managing renal failure
6. Patients with pre-existing cirrhosis
* Hepatic failure results in abnormal clearance of lactic acid
7. Patients with no survival injuries, e.g. gunshot wound to the head
|
[
-0.5495337843894958,
2.455960512161255,
-2.4800655841827393,
-3.7628023624420166,
0.9479627013206482,
-0.17524929344654083,
0.8872522115707397,
0.7513195276260376,
0.07205657660961151,
1.9431008100509644,
-1.2787927389144897,
1.9619988203048706,
-0.9725381135940552,
0.28267213702201843,
0.4511481523513794,
1.723262906074524,
-0.5357649326324463,
1.4732660055160522,
-0.2839118242263794,
-2.5353472232818604,
-0.7215351462364197,
-1.0364640951156616,
-0.7373844385147095,
-0.2157893031835556,
2.582627296447754,
-0.28156018257141113,
1.4087083339691162,
0.1430736780166626,
0.12344065308570862,
0.49975425004959106,
1.3148181438446045,
-0.4020564556121826,
-1.3678197860717773,
0.8157080411911011,
-0.6291672587394714,
-0.44728612899780273,
1.3681128025054932,
1.1413781642913818,
-0.3044884204864502,
0.25948598980903625,
1.0347508192062378,
-0.08537648618221283,
-1.313649296760559,
-0.5716364979743958,
0.9564228653907776,
1.0309027433395386,
-0.2970235347747803,
0.7712007761001587,
0.532442033290863,
-0.20902961492538452,
-1.6971274614334106,
0.838956356048584,
-1.2096452713012695,
0.6222745776176453,
1.2310980558395386,
0.9721527099609375,
1.2270212173461914,
0.4555034339427948,
0.45193615555763245,
0.5271152853965759,
0.48672717809677124,
-0.6410266160964966,
0.38964739441871643,
-0.11108297854661942,
-1.6220026016235352,
1.01353919506073,
-1.076579213142395,
1.3692535161972046,
-0.6883135437965393,
1.2138042449951172,
0.46103671193122864,
0.45550766587257385,
0.32885631918907166,
0.6250771284103394,
-0.6604531407356262,
0.5622205138206482,
-0.1310022622346878,
0.6480377316474915,
-0.18539711833000183,
-0.013280174694955349,
0.18603964149951935,
-0.9070737361907959,
-0.3390710949897766,
0.1512613594532013,
0.3980879783630371,
-0.5867183208465576,
-1.265731692314148,
-0.15594662725925446,
1.0140094757080078,
-1.072493314743042,
0.2412044107913971,
-0.6317463517189026,
-0.7241103649139404,
-0.08538531512022018,
-0.9316110610961914,
0.593562126159668,
-0.5976052284240723,
-0.0678718164563179,
-1.5615655183792114,
-0.9457882046699524,
-0.012955818325281143,
-0.09204787760972977,
-0.9486871361732483,
0.7593675851821899,
0.016458680853247643,
0.6204529404640198,
0.07445429265499115,
-0.420835018157959,
-0.5089101195335388,
-0.32658106088638306,
0.25489985942840576,
-0.2729349136352539,
-0.5548362135887146,
-1.042802333831787,
0.06452079117298126,
0.6436143517494202,
-0.05839663743972778,
0.9371427893638611,
1.5318111181259155,
-0.23525036871433258,
0.6056323051452637,
1.3355982303619385,
0.49867045879364014,
0.5054749846458435,
-1.4952400922775269,
-0.20793339610099792,
0.30998092889785767,
1.3331118822097778,
-0.24509042501449585,
0.005129390861839056,
-1.1060987710952759,
0.7329375147819519,
1.104628086090088,
0.24638326466083527,
-1.4630930423736572,
0.3069145977497101,
1.1049412488937378,
-0.12012845277786255,
-0.20712877810001373,
0.46617069840431213,
1.1618831157684326,
0.7278019189834595,
-0.17486104369163513,
-0.26950058341026306,
-1.7797086238861084,
-0.3155667781829834,
-0.8528876304626465,
-0.025139352306723595,
-0.6309593915939331,
-0.8568590879440308,
-0.9579489231109619,
0.3952159583568573,
1.0793375968933105,
-0.19791057705879211,
0.24560683965682983,
-1.4207665920257568,
0.28425389528274536,
-0.0905214175581932,
0.053166892379522324,
-0.44101181626319885,
-0.2817809283733368,
-0.5497156977653503,
-0.9759754538536072,
-0.21535858511924744,
-0.1036875993013382,
0.4397861957550049,
-0.611834704875946,
-0.6612986922264099,
0.08848113566637039,
-0.419907808303833,
0.0029733083210885525,
0.4274175763130188,
0.34787678718566895,
-0.564278781414032,
-1.3896815776824951,
-0.6143658757209778,
0.1931406408548355,
0.23770169913768768,
-0.0008745774975977838,
0.45165231823921204,
0.7191344499588013,
0.718451976776123,
1.0275152921676636,
0.2955797612667084,
0.00894227996468544,
-0.6517928242683411,
0.28153207898139954,
0.38948601484298706,
0.16028395295143127,
0.025502195581793785,
0.39108675718307495,
0.3882765471935272,
-0.20450268685817719,
-0.1173606738448143,
0.4027256965637207,
-0.23733265697956085,
-1.4436709880828857,
0.03280997276306152,
-0.6014700531959534,
-0.28453174233436584,
0.8222749829292297,
0.3434770703315735,
-0.5216034054756165,
0.9686058759689331,
0.4318675398826599,
-0.21386349201202393,
0.5524290800094604,
-0.13059324026107788,
0.11765531450510025,
0.7170253992080688,
-0.4272271394729614,
-0.33621054887771606,
-0.19403846561908722,
-0.018920646980404854,
-0.08380455523729324,
-0.17898531258106232,
1.294487476348877,
0.15715555846691132,
-0.426239550113678,
0.5170788168907166,
-0.4416349530220032,
-0.34670740365982056,
0.15681536495685577,
0.2986754775047302,
0.12450790405273438,
0.5065843462944031,
0.07635823637247086,
-0.1153600886464119,
0.2053568810224533,
-0.3916821777820587,
0.26848241686820984,
-0.22826986014842987,
0.12291337549686432,
0.19442176818847656,
0.11970660090446472,
-0.16743440926074982,
0.9012659788131714,
-0.10935653746128082,
-0.0941215306520462,
0.4508555829524994,
0.1921575516462326,
0.21837729215621948,
0.14909905195236206,
-0.4818402826786041,
0.22605988383293152,
0.38345009088516235,
0.3301115930080414,
-0.13111288845539093,
0.12876886129379272,
-0.2288929671049118,
-0.4938857853412628,
0.6508504152297974,
1.0889042615890503,
0.341040700674057,
0.1227358803153038,
0.46543803811073303
] |
NCT02248597
|
Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases
|
This pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in treating patients with hematological diseases. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclophosphamide after the transplant may stop this from happening.
|
PRIMARY OBJECTIVES:
I. To determine if haploidentical stem cell transplant using post-transplant cyclophosphamide results in 60% or better disease free survival (DFS) at 12 months at our institution.
SECONDARY OBJECTIVES:
I. To determine the rate of acute and chronic graft-versus-host disease (GvHD), non-relapse mortality, and relapse.
OUTLINE:
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) once daily (QD) on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2
TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35.
After completion of study treatment, patients are followed up periodically for 2 years.
|
Inclusion Criteria:
* Diagnosis of a hematological malignancy requiring an allogeneic stem cell transplant consistent with the standard of care
* Remission of any acute hematologic malignancy or adequate disease control for chronic malignancies.
* Ages 18-69 years old.
* Available familial haploidentical (4 to 6 out of 8 HLA loci-matched) donor
Exclusion Criteria:
* Significant organ dysfunction defined as: LV EF \< 50% (evaluated by echocardiogram or MRI), DLCO or FEV1 \< 65% predicted, AST/ALT \> 2.5 x ULN, Bilirubin \> 1.5 x ULN, Serum creatinine \> 2mg/dL, dialysis, or prior renal transplant
* HIV positive (Recipients who are positive for hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-I/II) are not excluded from participation)
* Positive pregnancy test for women of childbearing age.
* Major anticipated illness or organ failure incompatible with survival form transplant.
* Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and informed consent impossible.
|
[
1.4889111518859863,
1.7470279932022095,
0.3746468126773834,
-1.000815749168396,
-1.0178219079971313,
0.4745543301105499,
-1.3981767892837524,
0.09281002730131149,
-3.5613441467285156,
-0.38881874084472656,
-0.4765200614929199,
2.731795310974121,
2.549241065979004,
1.4060665369033813,
-0.7033212184906006,
0.7844827175140381,
-2.391446113586426,
0.950415849685669,
1.7118520736694336,
-0.5602338314056396,
2.5067596435546875,
0.7536312937736511,
1.4575926065444946,
-0.16723507642745972,
1.2665520906448364,
-1.4131733179092407,
0.400294691324234,
2.41664457321167,
2.9298601150512695,
1.5115721225738525,
-1.3734936714172363,
-0.9927347898483276,
-0.048201754689216614,
0.12370165437459946,
-0.5171164870262146,
0.034810688346624374,
4.063987731933594,
1.8338230848312378,
0.9211350679397583,
0.9532073140144348,
0.9503379464149475,
0.6320676803588867,
-0.49097171425819397,
0.1843918263912201,
-1.1594449281692505,
-2.4418885707855225,
1.9028780460357666,
0.2089810073375702,
1.133878469467163,
1.5859802961349487,
-1.1705816984176636,
2.447920322418213,
-1.653599500656128,
1.1814615726470947,
1.616189956665039,
1.1085028648376465,
0.5909832715988159,
1.8893293142318726,
1.906646490097046,
0.7705280184745789,
1.3627395629882812,
0.2558528184890747,
-0.8280439376831055,
-1.097650408744812,
-3.041084051132202,
-0.5731322765350342,
0.9695075154304504,
-2.1664323806762695,
-1.9050203561782837,
-0.28678572177886963,
1.647473931312561,
-1.256269097328186,
0.37090766429901123,
1.003983974456787,
-0.8700294494628906,
1.501381754875183,
-0.5916876196861267,
0.8231203556060791,
0.7902722954750061,
-0.7412382364273071,
-0.7196635603904724,
-1.2362868785858154,
-1.2349023818969727,
1.2704095840454102,
-1.0525583028793335,
-1.004935622215271,
-1.07735013961792,
0.14555247128009796,
0.7253569960594177,
-3.08449649810791,
1.5030100345611572,
0.12337785214185715,
-0.5488492846488953,
1.4670891761779785,
-1.0592375993728638,
-0.02982974983751774,
0.47859498858451843,
0.6239835023880005,
-1.5097215175628662,
0.6179310083389282,
0.3014509379863739,
0.7245256900787354,
-0.22669509053230286,
-1.4857921600341797,
0.27425888180732727,
-0.3703753352165222,
-1.0338338613510132,
-1.3937268257141113,
-1.2030904293060303,
-1.5025781393051147,
-1.1267645359039307,
-1.0956215858459473,
-0.7427046298980713,
1.3364428281784058,
-0.2816166877746582,
-1.4240456819534302,
1.680281639099121,
-0.9002497792243958,
0.43996167182922363,
1.0797828435897827,
-0.962671160697937,
0.1535525918006897,
-0.3130737543106079,
0.045274488627910614,
-0.28125622868537903,
-0.6589697599411011,
-0.8480112552642822,
-0.9095867872238159,
0.15179505944252014,
-1.4693355560302734,
0.317604660987854,
0.40434208512306213,
0.3227064609527588,
-0.0326424241065979,
-0.9532243013381958,
-0.6004570722579956,
0.3421790897846222,
1.21059250831604,
1.1101775169372559,
-1.3173377513885498,
0.9459765553474426,
-0.8347561359405518,
0.4556198716163635,
0.2719159722328186,
-1.9318251609802246,
0.5397335886955261,
0.3679192364215851,
2.2160375118255615,
-0.49552494287490845,
-1.061511754989624,
0.2326868176460266,
0.15517547726631165,
0.005182890221476555,
0.7662296295166016,
-0.03711472079157829,
2.06778621673584,
-1.3884947299957275,
-0.36317116022109985,
-0.7640286087989807,
-0.19285272061824799,
-2.350764513015747,
0.36932265758514404,
-0.41806963086128235,
-0.4530271291732788,
1.0945625305175781,
0.40413573384284973,
0.12651680409908295,
0.17020922899246216,
0.36541545391082764,
-0.2723943889141083,
0.3578566014766693,
-0.5303254127502441,
-0.20987249910831451,
0.7370611429214478,
-1.4669827222824097,
-1.2251958847045898,
1.172711968421936,
0.22570616006851196,
0.5783236026763916,
-1.2401957511901855,
-0.23231035470962524,
-0.7020021677017212,
0.9650797247886658,
-0.9786688685417175,
0.520839512348175,
0.8410135507583618,
0.25711381435394287,
-0.3270854949951172,
0.17054647207260132,
-0.2092166543006897,
-0.06341294944286346,
0.3577800393104553,
0.4431018531322479,
0.6625902652740479,
0.6004623770713806,
-0.2856210768222809,
-0.14451801776885986,
-0.41061198711395264,
0.9387584328651428,
-0.6224609017372131,
0.7465147376060486,
0.26613301038742065,
0.0430845208466053,
0.807077169418335,
-0.3339647948741913,
-0.13134153187274933,
0.6054887175559998,
0.3446713984012604,
0.47829559445381165,
-0.2985694408416748,
0.2260887324810028,
-0.057768840342760086,
0.12917505204677582,
-0.1895466446876526,
0.18661662936210632,
-0.29687610268592834,
0.40956467390060425,
-0.18313834071159363,
-0.8209032416343689,
-1.0306813716888428,
-0.6051895022392273,
-1.0787419080734253,
0.20621168613433838,
-0.23751568794250488,
0.3946978747844696,
0.4613136649131775,
0.20091983675956726,
-0.4145437479019165,
0.10859911888837814,
-0.7918049693107605,
-0.49261754751205444,
-0.0893927589058876,
-0.3952229917049408,
-0.4339112937450409,
0.11094720661640167,
0.09751708060503006,
0.21892055869102478,
0.1802641898393631,
-0.188351571559906,
0.19610624015331268,
-0.1314239501953125,
0.10821513086557388,
-0.11730420589447021,
-0.46318838000297546,
0.3352551758289337,
-1.01054048538208,
0.47481074929237366,
-0.11832994967699051,
0.5310660004615784,
0.19981761276721954,
0.1746557652950287,
-0.9362362623214722,
-0.20487916469573975,
-0.8038720488548279,
-0.27874884009361267,
-0.9265616536140442
] |
NCT06368102
|
Prophylactic Effects for Preventing Surgical Site Infection in Third Molar Surgery
|
The purpose of this study is to determine the incidence of surgical site infection (SSIs) after third molar surgery for different duration of intravenous ampicillin administration.
|
In recent years, the increase in drug-resistant bacteria and associated infections has become one of the major issues in the international community as adverse events associated with the inappropriate use of antimicrobial agents. Although the frequency and percentage of inappropriate use is currently unknown, it has been shown that at least 30% of antimicrobials prescribed in the U.S. are inappropriately used. If no action is taken against inappropriate antimicrobial use, it is estimated that 10 million people will die annually worldwide from drug-resistant organisms by 2050, with an estimated 4.9 million deaths related to drug-resistant organisms and 1.2 million deaths due to drug-resistant organisms already estimated for 2019. In addition, while the development of new antimicrobial agents has declined since the 1980s, the threat of new drug-resistant organisms, especially in hospitals, has increased, and if antimicrobial agents are not used appropriately, there is concern that there will be no effective antimicrobial agents available to treat infections in the future. It is important to avoid such situations by using antimicrobial agents, which are a limited resource, appropriately at this stage, and appropriate use of antimicrobial agents is necessary to prevent drug resistance (Antimicrobial Resistance: AMR).
Third molar extraction is the most commonly performed procedure in oral and maxillofacial surgery. One of the main complications after third molar extractions is surgical site infection (SSIs), which is reported to manifest as swelling, pain, abscess, and fever. According to a Cochrane review of randomized controlled trials, the risk of SSIs after third molar extraction in physically fit young patients is about 10%, but in patients with low immunity before extraction, the risk increases up to 25%. Prophylactic administration of antimicrobial agents has an important role in preventing SSIs. However, the efficacy of antimicrobial prophylaxis against SSIs in third molar extractions is controversial. While some studies have reported that antimicrobials are effective in preventing SSIs after third molar extraction, others have reported that they are not.
Guidelines for third molar extraction vary widely in the duration of antimicrobial administration (e.g., Japanese guidelines state a single dose to within 48 hours). In clinical practice, the final decision lies with the surgeon, but this difference in dosing period is a source of confusion. If the duration of administration could be shortened without increasing SSIs, it would contribute to the current presentation of AMR. Therefore, the purpose of this study is to examine the effect of different durations and doses of penicillins, which are considered first-line drugs after third molar surgery, on the prevention of SSIs.
|
Inclusion Criteria:
* Minimum age of 20 years
* American Society of Anesthesiologists (ASA) physical status of 1
* Planned extraction of bilateral mandibular third molar with the necessity of bone removal based on panoramic radiography in an inpatient setting under IV sedation
* Agreement to follow the study protocol
Exclusion Criteria:
* Pregnancy or suspicion of pregnancy
* Allergy and/or contraindication to ampicillin
* History of a known SSI risk factors, such as diabetes, steroid or immunosuppressant use, and endocarditis
* Receiving any antibiotic therapy
* Active infection of the third molars with pus, edema, and trismus
|
[
2.1999683380126953,
1.1859055757522583,
-2.584550142288208,
-1.7821018695831299,
-1.3254127502441406,
-1.2030926942825317,
0.49145790934562683,
-0.23323430120944977,
-2.2281718254089355,
-0.03657790645956993,
0.39080485701560974,
2.5883421897888184,
-2.069416046142578,
1.4899572134017944,
1.5551729202270508,
-0.6454656720161438,
0.018116582185029984,
1.7485615015029907,
1.2794444561004639,
-0.3809550404548645,
-1.6958765983581543,
1.626975655555725,
-1.835876226425171,
-0.8096106648445129,
4.340679168701172,
-0.8739436268806458,
0.25393617153167725,
0.8023828864097595,
0.619069516658783,
0.8482258915901184,
1.8261505365371704,
-1.946982741355896,
-0.029894301667809486,
2.5573551654815674,
0.5516862869262695,
0.4588262140750885,
-0.12587164342403412,
0.6058948040008545,
-0.24886758625507355,
0.1262475699186325,
1.6215168237686157,
1.5299259424209595,
-1.1024922132492065,
0.3561057150363922,
1.5078555345535278,
0.2912372648715973,
0.7029807567596436,
0.8587185740470886,
1.568613886833191,
0.20039570331573486,
-0.7091054916381836,
1.3876590728759766,
-0.16910633444786072,
0.14666183292865753,
-0.03315293788909912,
0.47383275628089905,
0.7435665726661682,
-0.5063275694847107,
0.3117965757846832,
-0.2686946988105774,
0.6880420446395874,
-0.9966651797294617,
-0.6862363815307617,
0.09436549991369247,
-0.8772448897361755,
1.19020676612854,
0.15845131874084473,
1.0865192413330078,
-1.550770878791809,
0.6287727355957031,
0.8531697988510132,
0.23592627048492432,
1.0526448488235474,
0.48530492186546326,
-0.4843376576900482,
1.6139826774597168,
-0.3036058843135834,
0.4692637324333191,
-0.7362765073776245,
0.9161257147789001,
-0.6791321635246277,
-1.5359985828399658,
-0.20143234729766846,
-0.22685588896274567,
-0.9516972303390503,
0.46533748507499695,
0.6566890478134155,
-0.5946528911590576,
1.7989773750305176,
-0.688194751739502,
0.14848659932613373,
-0.2463843822479248,
-0.7987286448478699,
0.7474923133850098,
-0.7645102739334106,
0.08326630294322968,
0.7343658208847046,
-0.4212862551212311,
-1.4178810119628906,
-1.1499700546264648,
-0.7707037925720215,
-0.412962406873703,
-0.036068957298994064,
0.06711111217737198,
-0.19538076221942902,
-1.0185073614120483,
-0.967252254486084,
-1.2753137350082397,
-1.390649676322937,
-0.6640764474868774,
0.889377236366272,
-1.215187668800354,
0.20646709203720093,
-1.2733513116836548,
-1.4972397089004517,
-0.8101251125335693,
-0.009479090571403503,
-0.05196408927440643,
0.9669593572616577,
-0.8059519529342651,
-0.236580029129982,
0.616286039352417,
0.7804777026176453,
0.8564926385879517,
-1.0301276445388794,
0.06552493572235107,
-0.1404430866241455,
1.7410489320755005,
-0.25616389513015747,
0.3134576678276062,
0.204519584774971,
0.3868858814239502,
1.1450741291046143,
0.29961854219436646,
-0.2605830132961273,
-0.4000947177410126,
0.38236671686172485,
0.06694792956113815,
1.061934232711792,
-0.11517482250928879,
1.6529372930526733,
0.3955219089984894,
-1.288222074508667,
-0.4855116307735443,
-1.1334328651428223,
-0.21075497567653656,
-0.6067171096801758,
0.29264751076698303,
-0.4541965126991272,
-0.6212273240089417,
0.2864701747894287,
0.5931500196456909,
1.2664117813110352,
1.0214042663574219,
0.36480483412742615,
0.3496549427509308,
0.9714493751525879,
0.06419598311185837,
0.48818549513816833,
-0.5638032555580139,
0.45289552211761475,
-0.3577899634838104,
0.202226921916008,
-0.928557813167572,
0.9034528732299805,
-0.18733176589012146,
0.22695696353912354,
-0.2782354950904846,
-0.024244356900453568,
-0.2502039968967438,
0.11534062772989273,
0.8428214192390442,
0.7693280577659607,
0.12574774026870728,
-0.08226026594638824,
-0.08688372373580933,
0.5128270387649536,
0.026141440495848656,
0.2334693968296051,
0.2385326325893402,
-0.6902359127998352,
-0.9651065468788147,
0.8130147457122803,
0.6465548872947693,
-0.36169126629829407,
0.08310454338788986,
0.16087013483047485,
-0.5992467403411865,
0.020307762548327446,
0.8404725790023804,
0.5579824447631836,
-0.45660707354545593,
0.42109033465385437,
0.797020673751831,
0.5808837413787842,
1.1284834146499634,
-0.6679958701133728,
-0.5371372103691101,
0.5321685075759888,
0.5139496326446533,
0.862224817276001,
0.11046930402517319,
-1.480102777481079,
1.0339322090148926,
0.019186120480298996,
0.13965174555778503,
0.5276181697845459,
0.10106116533279419,
0.2608046531677246,
-0.6130443215370178,
-0.219181090593338,
-0.7964826822280884,
-0.49975481629371643,
-0.19501392543315887,
-0.28479552268981934,
0.45462551712989807,
-0.11728719621896744,
-0.2656666934490204,
-1.401868224143982,
-0.8831831812858582,
0.07995259016752243,
0.11254257708787918,
-0.005444476380944252,
0.40321192145347595,
0.5029146671295166,
-0.23966868221759796,
0.26179039478302,
0.41259142756462097,
-0.13141323626041412,
-0.2909117043018341,
-0.23639242351055145,
0.5529175996780396,
0.5888893604278564,
0.547080934047699,
0.4750426709651947,
0.7185110449790955,
0.4343378245830536,
-0.21435600519180298,
0.46635034680366516,
0.4498956799507141,
-0.20376470685005188,
-0.616520881652832,
-0.3632410168647766,
-0.3874906003475189,
-0.6771926283836365,
0.20312733948230743,
-0.06761238723993301,
0.5510632395744324,
-0.09260991215705872,
-0.11114621162414551,
-0.15199735760688782,
0.26713183522224426,
-0.06213011220097542,
-0.05424842983484268,
0.02407955564558506,
-0.7592931985855103
] |
NCT02032719
|
Improved Self Management in Uncontrolled Systolic Hypertension
|
Patients who receive smartphone-assisted health coaching will have a significantly lower 24 hour ambulatory blood pressure mean than patients who receive just health coaching
|
Primary Outcome Measure: Mean 24 hour ambulatory blood pressure
Secondary Outcome Measures: Profile of Mood States-SF Vigor Scale; Satisfaction with Life Scale; Positive and Negative Affect Schedule; Hospital Anxiety and Depression Scale; SF - 12
|
Inclusion Criteria:
* 25 - 70 years old;
* mean daytime systolic BP\> 130 mm. Hg.
Exclusion Criteria:
* Severe or end-stage organ disease (liver, kidney, heart, lung) or history of diabetic ketoacidosis, or any other illness with expected survival less than 1 year;
* severe cognitive impairment;
* diagnosed psychiatric illness or disability;
* clinical significant cardiac arrhythmia;
* symptomatic orthostatic hypertension;
* pregnancy;
* not fluent in english.
|
[
-1.9379743337631226,
4.818850517272949,
-0.6415356993675232,
1.0697383880615234,
1.4257564544677734,
3.735666275024414,
1.1347664594650269,
0.4000934660434723,
1.3114210367202759,
-1.5400837659835815,
0.37361088395118713,
1.8201504945755005,
0.08421949297189713,
1.3760331869125366,
-1.685544729232788,
1.294966697692871,
2.8066811561584473,
-1.1017507314682007,
-0.18446199595928192,
-1.920393943786621,
1.616004228591919,
0.24588660895824432,
0.27733853459358215,
-0.8515853881835938,
-1.4408128261566162,
-0.11451162397861481,
-1.231481909751892,
3.6280674934387207,
0.8847285509109497,
2.337751626968384,
2.184558153152466,
-0.6072526574134827,
-0.034968119114637375,
1.4227445125579834,
-0.1781270056962967,
0.955449640750885,
1.4373791217803955,
1.7094546556472778,
-2.426558017730713,
0.3586704730987549,
1.7715529203414917,
0.9664743542671204,
-0.5271439552307129,
0.31321007013320923,
-0.39916667342185974,
0.5961564183235168,
-0.1950005441904068,
0.7342769503593445,
1.3483837842941284,
1.9568637609481812,
0.8673081994056702,
0.578639805316925,
-2.04649019241333,
1.1994726657867432,
1.8474797010421753,
0.7729665040969849,
1.5613136291503906,
-0.016352994367480278,
-0.223165363073349,
-0.38134345412254333,
0.6360110640525818,
0.4881637990474701,
1.7577863931655884,
0.5707818865776062,
-1.073664903640747,
-0.19868549704551697,
0.11005384474992752,
-0.5816793441772461,
-1.753182053565979,
1.0195801258087158,
-0.8867383599281311,
-0.4488371014595032,
-0.14331698417663574,
-1.4407165050506592,
1.290944218635559,
0.8866037726402283,
-0.05768159404397011,
0.8821746110916138,
-0.31524917483329773,
-0.3997059464454651,
-1.7096515893936157,
0.8779588341712952,
-0.8232325315475464,
0.48987746238708496,
0.42669907212257385,
-1.1612471342086792,
-1.9995700120925903,
0.6465873718261719,
1.10813307762146,
-0.7825682759284973,
0.9654961824417114,
-0.9588103890419006,
1.0924636125564575,
0.6408674120903015,
-1.4492733478546143,
2.0199830532073975,
0.49228987097740173,
-0.5130243897438049,
-1.6544584035873413,
-0.027653081342577934,
0.2897903621196747,
0.06546058505773544,
-1.2963076829910278,
-0.6528387069702148,
0.33584123849868774,
0.5893829464912415,
-0.2740004360675812,
0.1753315031528473,
-1.359636902809143,
-0.9755072593688965,
0.14002874493598938,
-2.106442928314209,
-0.7375466227531433,
-0.09767288714647293,
-1.0545185804367065,
0.42217713594436646,
0.8399260640144348,
0.12397740036249161,
0.6033129096031189,
-0.5830913782119751,
-0.35424500703811646,
0.9565842747688293,
-0.7690242528915405,
-1.0923302173614502,
0.1811121553182602,
-1.2014487981796265,
0.3073449432849884,
0.24335892498493195,
-0.5154721140861511,
-0.7796527147293091,
0.07790148258209229,
0.7716124653816223,
0.3455393612384796,
-1.08867609500885,
-1.0051075220108032,
-0.46621063351631165,
-0.24550071358680725,
0.808200478553772,
-0.02623496763408184,
-1.0360218286514282,
-0.2957162857055664,
0.5198889970779419,
-1.8293124437332153,
0.2871914803981781,
-0.6480937600135803,
0.4158916771411896,
-0.1496887058019638,
1.4085195064544678,
-1.9708573818206787,
-0.7495589256286621,
-0.8746558427810669,
0.3495137393474579,
-2.1212997436523438,
0.0034925085492432117,
-1.0868159532546997,
-0.386176198720932,
-1.2788875102996826,
-0.3131088614463806,
-0.3369062840938568,
-1.094015121459961,
1.3070939779281616,
0.0970371812582016,
-1.2671557664871216,
-1.63990318775177,
-0.06317894905805588,
0.6088242530822754,
0.6096052527427673,
1.2957879304885864,
0.8720348477363586,
-0.05265974998474121,
-0.5946887731552124,
0.6736605763435364,
0.3561282455921173,
0.1967807561159134,
-0.5699906349182129,
-0.21625645458698273,
1.566016435623169,
1.3744218349456787,
1.9159022569656372,
-0.9373896718025208,
0.6228805184364319,
-1.1710196733474731,
0.3212857246398926,
-0.942406952381134,
0.12734587490558624,
-0.965215802192688,
0.14311790466308594,
-0.3049491345882416,
0.1104603186249733,
0.46174055337905884,
-0.7791606187820435,
-0.7068200707435608,
0.011009045876562595,
1.2460030317306519,
-0.1315152496099472,
-0.31610316038131714,
-1.6172904968261719,
0.7338966131210327,
1.3866956233978271,
0.19070839881896973,
0.7180337905883789,
-1.0784337520599365,
-0.4823540151119232,
1.5549062490463257,
-0.4669528603553772,
-0.8932374715805054,
0.20808526873588562,
-0.013575034216046333,
-0.24068103730678558,
-0.02740800380706787,
1.2268154621124268,
0.29764121770858765,
1.331311583518982,
-0.35256025195121765,
-0.45706334710121155,
0.39799341559410095,
1.0499829053878784,
-0.14321096241474152,
-0.3823252320289612,
0.7258623838424683,
-0.2968039810657501,
-0.33148500323295593,
-0.22338040173053741,
0.14591100811958313,
0.10549777001142502,
0.5754925608634949,
0.14579322934150696,
0.7371054291725159,
1.4694877862930298,
0.12239674478769302,
0.3327510356903076,
0.22647081315517426,
-0.11947505921125412,
-0.064308762550354,
0.02495494857430458,
-0.45949786901474,
-0.1872660368680954,
1.2440932989120483,
-1.0157369375228882,
0.1484934538602829,
0.2513546347618103,
-0.811213493347168,
1.5307426452636719,
0.9142752885818481,
0.3016539514064789,
0.6193013191223145,
0.6102589964866638,
0.5669888257980347,
-0.7317180037498474,
0.9070131182670593,
-0.4282552897930145,
-1.2390016317367554,
0.26708194613456726,
0.33704543113708496,
0.5402899384498596,
-0.15061961114406586
] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.