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
|
|---|---|---|---|---|---|
NCT04658134
|
Glycine "Deficiency" and the Kinetics of Acylglycine in Morbid Obesity
|
This study aims to evaluate the effects of oral glycine supplementation on plasma glycine concentration, intracellular glutathione (GSH) concentration, plasma acylglycine concentration, urine acylglycine concentration, and insulin resistance in subjects with morbid obesity.
This is an open-labelled trial. 20 adults with morbid obesity will be recruited. Following screening and baseline metabolic evaluations, eligible subjects will be given oral glycine supplements for 14 ± 5 days. Upon completing glycine supplementation, subjects will return for their post-supplement metabolic assessment.
The investigators hypothesize that oral glycine supplementation in morbidly obese patients normalizes plasma glycine concentration, increases intracellular GSH concentration, increases plasma and urinary acylglycine concentration, and improves insulin resistance.
|
Inclusion Criteria:
1. Age: 21-65 years
2. BMI ≥ 32.5 kg/m2
3. Able to provide informed consent
4. Able to maintain present diet throughout the study duration
Exclusion Criteria:
1. Weight \> 150 kg
2. Type 2 Diabetes Mellitus
3. Allergy to soy
4. Ongoing treatment with weight-loss medications (e.g. orlistat, phentermine, liraglutide)
5. Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone)
6. Renal impairment (estimated creatinine clearance estimated by Cockcroft-Gault Equation \< 60 ml/min)
7. Haemoglobin concentration \< 10 g/L
8. Serum alanine aminotransferase or aspartate aminotransferase above 2x upper limit of normal
9. Uncontrolled hypertension (BP \> 180/110 mmHg)
10. Pregnancy
11. Nursing mothers
12. Uncontrolled thyroid disease
13. Surgery requiring general anaesthesia within 4-weeks before enrolment
14. Psychiatric disorders requiring medication
15. Significant alcohol intake (\> 1 unit per day for women and \> 2 units per day for men)
16. Cancer within the last 3-years (except squamous cell and basal cell cancer of the skin)
17. Any factors likely to limit adherence to study protocol
|
[
0.48620888590812683,
1.659952163696289,
-3.777451992034912,
-3.881625175476074,
0.3472576439380646,
-1.1495296955108643,
-1.5789127349853516,
-0.8307996988296509,
-1.0974583625793457,
-1.7478251457214355,
2.9802448749542236,
0.7654100656509399,
0.46422967314720154,
1.195447564125061,
0.4081699848175049,
-1.3752880096435547,
-2.343682289123535,
0.36943331360816956,
1.1123844385147095,
-1.7869808673858643,
0.27598732709884644,
0.015227098949253559,
-1.284444808959961,
-0.7201809883117676,
1.8681029081344604,
-0.963567316532135,
-0.9639581441879272,
1.096656084060669,
0.5046528577804565,
2.107025384902954,
0.13056299090385437,
-2.066743850708008,
0.021538104861974716,
0.8181175589561462,
-0.36460837721824646,
1.315651774406433,
2.077510118484497,
0.21526893973350525,
-0.17070335149765015,
-0.8509512543678284,
0.30503222346305847,
1.8777974843978882,
0.36674097180366516,
-0.30388033390045166,
1.301498293876648,
0.6242121458053589,
0.467808336019516,
0.5671365857124329,
0.6772833466529846,
-0.3331977128982544,
0.018343012779951096,
0.7768000960350037,
-2.072557210922241,
-0.37862643599510193,
2.076601982116699,
-0.18639904260635376,
0.38458287715911865,
0.03992925211787224,
2.3991148471832275,
0.6349356770515442,
-0.05991075932979584,
0.965699315071106,
-0.5095514059066772,
-0.10642154514789581,
-2.287820339202881,
-0.4477492868900299,
1.6178971529006958,
0.573019802570343,
0.01883413828909397,
1.0907396078109741,
-0.9117313623428345,
-0.49977993965148926,
0.26924702525138855,
-0.36883121728897095,
1.508806824684143,
1.6114531755447388,
0.6292766332626343,
1.090831995010376,
0.054420098662376404,
0.890717089176178,
-0.10038051009178162,
-0.15300731360912323,
-0.48632267117500305,
-0.42985326051712036,
0.30396199226379395,
-0.14668622612953186,
-2.1345694065093994,
-0.6333242654800415,
0.2779919505119324,
-1.099629282951355,
-0.2747846245765686,
-1.4116922616958618,
-2.0405678749084473,
-0.0071097188629209995,
-0.2924298942089081,
0.9730427861213684,
-0.8419004678726196,
0.7760834097862244,
-1.0234864950180054,
-0.12554682791233063,
-0.02252662181854248,
0.4272744059562683,
-0.6543380618095398,
-0.7142106294631958,
0.47340938448905945,
-0.9656231999397278,
-1.2844734191894531,
-0.21051669120788574,
-1.4370278120040894,
-0.4073369801044464,
-0.2752588093280792,
-0.5550669431686401,
0.20662973821163177,
-0.6994385123252869,
0.23168282210826874,
0.03218786045908928,
0.7730231285095215,
-0.39034953713417053,
-0.21314942836761475,
-0.9159703850746155,
0.2589671313762665,
0.609266459941864,
-0.6347360014915466,
-0.13730299472808838,
-0.3240929841995239,
-0.8879404067993164,
0.5328120589256287,
-1.455480933189392,
0.8212875723838806,
-0.7185474038124084,
0.00917366798967123,
0.13780297338962555,
0.22899559140205383,
-0.5610650181770325,
-0.46129879355430603,
-0.09873544424772263,
0.841217577457428,
0.4809741675853729,
-0.6738243103027344,
-0.014607290737330914,
-1.235159993171692,
-0.23168045282363892,
-0.8060176968574524,
0.7684945464134216,
-1.7323012351989746,
0.2479490041732788,
0.1218770369887352,
0.3162529468536377,
0.5578331351280212,
-0.14524435997009277,
0.554813802242279,
0.8146600127220154,
0.4911568760871887,
0.7869254946708679,
-0.41979119181632996,
-0.6614552140235901,
-0.6929882168769836,
-0.6551457047462463,
-0.40783774852752686,
-0.0669880211353302,
-0.13684336841106415,
0.47040876746177673,
-0.02429470606148243,
-0.3265479803085327,
1.1977709531784058,
0.13829046487808228,
-0.6551903486251831,
0.18159370124340057,
0.24882525205612183,
-0.178702250123024,
-0.9619299173355103,
0.11630366742610931,
-0.2831447720527649,
-0.08422436565160751,
-0.6654031276702881,
-0.5663653612136841,
0.49605217576026917,
-0.09567189961671829,
0.46018701791763306,
0.3248191177845001,
-0.304874449968338,
0.3475089967250824,
0.06361743807792664,
-0.7926005125045776,
-0.46335336565971375,
0.11512690037488937,
0.2538323998451233,
-0.4526619017124176,
-0.18207578361034393,
-0.28843095898628235,
0.21505999565124512,
0.03151419758796692,
0.19798223674297333,
0.09174826741218567,
-0.2849791646003723,
-0.6461463570594788,
0.1576741337776184,
-0.3470297157764435,
0.5992742776870728,
-0.5298430323600769,
0.8124198913574219,
1.0061702728271484,
0.12259797006845474,
0.8020537495613098,
-0.19766221940517426,
-0.2830198109149933,
-0.03466232493519783,
0.34125062823295593,
0.13686613738536835,
0.42636826634407043,
-0.15244817733764648,
0.7271967530250549,
-0.3025483787059784,
0.18466150760650635,
0.5568079948425293,
-0.34091082215309143,
-0.2307467758655548,
0.22789719700813293,
0.2832869291305542,
-0.145163431763649,
-0.2895146608352661,
-0.0699639618396759,
-0.0607074536383152,
0.046152565628290176,
0.18385033309459686,
-0.5216810703277588,
0.0509326308965683,
0.4573400318622589,
0.4793555736541748,
-0.16513168811798096,
-0.7221779227256775,
-0.09982308745384216,
0.3466169536113739,
-0.23579861223697662,
-0.05685129389166832,
0.7491384148597717,
-0.4653756022453308,
0.27772021293640137,
-0.18625912070274353,
0.04309527575969696,
0.3401626944541931,
-0.6057140231132507,
0.43631717562675476,
0.37506765127182007,
-0.03927469626069069,
0.22451342642307281,
-0.18441908061504364,
0.6823846697807312,
0.5097005367279053,
-0.2845553457736969,
-0.5419098138809204,
-0.04407002031803131,
-0.040157854557037354,
0.42384228110313416,
0.06216438487172127,
0.043473340570926666
] |
|
NCT00784147
|
Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1
|
The investigational product, ibalizumab, is a humanized IgG4 monoclonal antibody administered via intravenous infusion at 800 mg every 2 weeks or at 2000 mg every 4 weeks. In addition to study drug, all patients will receive an optimized background regimen (OBR), which is a standard-of-care regimen selected by the investigator prior to randomization that is comprised of 2-4 antiretroviral agents. These agents must have been approved by the local regulatory agency or be available through expanded-access programs for treatment of human immunodeficiency virus (HIV).
|
The primary objectives of this study are to:
* Evaluate the dose-response relationship of antiviral activity of the ibalizumab dose regimens at Week 24 in order to determine the optimal dose and regimen. The primary evaluation of effectiveness will be based on the proportion of patients achieving undetectable viral loads at Week 24.
* Evaluate the safety and tolerability of two dose regimens of ibalizumab for dose selection
The secondary objectives of this study are to:
* Evaluate changes from Baseline in viral load, CD4+ cell counts, and time to loss of virologic response (TLOVR)
* Characterize HIV-1 sensitivity/susceptibility changes associated with ibalizumab administration in combination with OBR
* Determine the presence and significance of anti-ibalizumab antibodies, if any (immunogenicity of ibalizumab)
* Assess CD4 receptor density and occupancy
* Determine the impact of ibalizumab on quality of life as assessed by patient-reported outcomes on questionnaires
* Evaluate the pharmacokinetic profile of two dose regimens of ibalizumab at steady state
|
Inclusion Criteria:
1. Are capable of understanding and have voluntarily signed the informed consent document
2. Have documented HIV-1 infection by official, signed, written history (eg, laboratory report), otherwise an HIV-antibody test will be performed
3. Have no acquired immunodeficiency syndrome (AIDS)-defining events in the 3 months before screening, other than cutaneous Kaposi's sarcoma or wasting syndrome due to HIV
4. Are able and willing to comply with all protocol requirements and procedures
5. Are 18 years of age or older
6. Have a life expectancy that is \>6 months.
7. Have a viral load \>1,000 copies/mL and documented decreased susceptibility to at least one NRTI, one NNRTI, and one PI, as measured by resistance testing
8. Are receiving a stable highly active antiretroviral regimen for at least 8 weeks before screening and are willing to continue that regimen until the baseline visit, OR (in the past 8 weeks) have failed and are off therapy and are willing to stay off therapy until the baseline visit
9. Have viral sensitivity/susceptibility to at least one agent (OSS criteria) as determined by the screening resistance tests and be willing and able to be treated with at least one agent to which the patient's viral isolate is sensitive/susceptible according to the screening resistance tests as a component of OBR
10. If sexually active, are willing to use an effective method of contraception during the study and for 30 days after the last administration of the study drug
Exclusion Criteria:
1. Any active AIDS-defining illness per Category C conditions according to the Center for Disease Control (CDC) Classification System for HIV Infection, with the following exceptions: cutaneous Kaposi's sarcoma and wasting syndrome due to HIV
2. Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history and/or physical examination that, in the investigator's opinion, would preclude the patient from participating in this study
3. Any significant acute illness within 1 week before the initial administration of study drug
4. Any active infection secondary to HIV requiring acute therapy; however, patients that require maintenance therapy (ie, secondary prophylaxis for opportunistic infections) will be eligible for the study
5. Any immunomodulating therapy (including interferon), systemic steroids, or systemic chemotherapy within 12 weeks before randomization
6. Any investigational therapy within 30 days before randomization, except for HIV-agents available in expanded-access programs
7. Any prior exposure to ibalizumab (formerly TNX-355 and Hu5A8)
8. Any vaccination within 21 days before randomization
9. Any female patient who either is pregnant, intends to become pregnant, or is currently breast-feeding
10. Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the patient's ability to comply with the study schedule and protocol evaluations
11. Any previous clinically significant allergy or hypersensitivity to any excipient in the ibalizumab formulation
12. Any radiation therapy during the 28 days before first administration of investigational medication
13. Any grade 3 or 4 toxicity according to the Division of AIDS grading scale, except for the following asymptomatic grade 3 events: triglyceride elevation \& total cholesterol elevation
|
[
0.802101194858551,
2.284505844116211,
-2.5256714820861816,
-1.9777960777282715,
0.6362175941467285,
0.012106955982744694,
-1.1590538024902344,
0.9233232736587524,
-0.5365265011787415,
-0.6898369789123535,
-0.29642724990844727,
1.3813886642456055,
-1.113895297050476,
0.3322497010231018,
0.8252431154251099,
-0.06446611136198044,
-1.632712721824646,
0.40670302510261536,
0.7505079507827759,
-1.235337734222412,
-0.3949930667877197,
-0.8559588193893433,
-1.82173752784729,
0.47888243198394775,
0.7318212985992432,
-0.6012678742408752,
-0.5822853446006775,
0.8045875430107117,
0.422700971364975,
0.9483880400657654,
-0.16010542213916779,
-0.9778396487236023,
0.6608530282974243,
0.3592201769351959,
0.45672959089279175,
0.6685055494308472,
0.7854747772216797,
0.44680681824684143,
-0.947400689125061,
-0.22639498114585876,
-1.1932004690170288,
0.5388578176498413,
0.32285767793655396,
-0.42363250255584717,
1.6591743230819702,
0.12553885579109192,
0.32764291763305664,
-0.4302056133747101,
1.463748574256897,
0.815369725227356,
-0.887287437915802,
1.1236871480941772,
0.36513933539390564,
0.16608043015003204,
1.016065001487732,
0.7580509185791016,
0.009397079236805439,
0.17902600765228271,
1.1484719514846802,
-0.37448081374168396,
0.3140692710876465,
-0.26804983615875244,
0.26223960518836975,
-0.47742700576782227,
-0.9087923169136047,
0.36219218373298645,
-0.47618213295936584,
0.7722862362861633,
0.14785349369049072,
0.2518898844718933,
-0.7838132977485657,
0.4487299621105194,
0.5462592840194702,
0.9281617999076843,
-0.180070698261261,
1.666601300239563,
-0.3053183853626251,
0.5662062168121338,
0.18708565831184387,
0.3000580370426178,
-0.8585343360900879,
-0.3234894275665283,
0.1561668962240219,
-0.36092525720596313,
-0.639960765838623,
-0.35051947832107544,
-0.1608009785413742,
-0.16806909441947937,
-0.5038189888000488,
-0.6442475318908691,
1.044457197189331,
-0.4184098541736603,
-0.623985767364502,
0.53275066614151,
-0.03978561982512474,
0.12191951274871826,
-0.017102554440498352,
0.04931333288550377,
-0.3604983687400818,
0.5716522932052612,
-0.6351668238639832,
-0.5763489603996277,
-0.09280742704868317,
-0.055700499564409256,
-0.8448123335838318,
0.2467910200357437,
0.3998739719390869,
-0.46278512477874756,
-0.6984451413154602,
-0.7201268672943115,
-0.6392257809638977,
-0.6387209892272949,
-0.39972782135009766,
-0.1852235198020935,
-0.1545598953962326,
-0.16406939923763275,
0.5630484819412231,
-0.13082773983478546,
-0.37920358777046204,
-0.48353996872901917,
-0.05601777508854866,
0.4339386820793152,
-0.21263274550437927,
-0.15680117905139923,
-0.5724729895591736,
-0.411625474691391,
0.14007195830345154,
-0.021433532238006592,
-0.32430320978164673,
-0.4551333487033844,
-0.4699307382106781,
0.47748589515686035,
0.6549757719039917,
0.08650559931993484,
-1.3948402404785156,
-0.8709918856620789,
0.21643227338790894,
0.765396237373352,
-0.46168842911720276,
-0.04090971499681473,
0.2606859803199768,
0.6305489540100098,
-0.5140796303749084,
0.006502412259578705,
-1.3249881267547607,
0.18352758884429932,
-0.22629113495349884,
0.16929075121879578,
-0.3560295104980469,
-0.3616267144680023,
-0.3604801595211029,
0.5412636399269104,
0.36048609018325806,
0.22516490519046783,
0.06961604207754135,
0.09673720598220825,
0.1600770503282547,
0.08524823188781738,
0.2340511828660965,
-0.8528034687042236,
-0.5783745646476746,
-0.11863818019628525,
-0.009872018359601498,
-0.37932878732681274,
0.49036821722984314,
-0.1702091544866562,
-0.022844934836030006,
0.18642835319042206,
0.4190985858440399,
-0.452680766582489,
-0.13230180740356445,
0.5067570805549622,
-0.09270928800106049,
0.31810471415519714,
-0.350410133600235,
-0.10660414397716522,
0.5324527621269226,
0.46283116936683655,
-0.005019071977585554,
-0.25415968894958496,
0.2037031203508377,
0.784924328327179,
0.11250071227550507,
-0.2957195043563843,
-0.5127765536308289,
-0.2703739106655121,
0.14496615529060364,
0.4251363277435303,
-0.13259728252887726,
0.553985059261322,
0.7996097207069397,
-0.33676981925964355,
0.3486357629299164,
0.5202325582504272,
0.25199687480926514,
-0.14394903182983398,
-0.03200614079833031,
-0.23281076550483704,
0.5508360266685486,
-0.49498677253723145,
-0.014773191884160042,
0.12271301448345184,
0.08468958735466003,
0.6173651218414307,
0.18511369824409485,
0.43828603625297546,
-0.08414700627326965,
0.3424217998981476,
0.0870005339384079,
-0.0353744737803936,
0.3254171907901764,
-0.23045700788497925,
-0.28800565004348755,
0.010409808717668056,
0.40054064989089966,
0.34861359000205994,
-0.1575590819120407,
0.07031300663948059,
0.12695910036563873,
0.0726640522480011,
0.1325053572654724,
-0.16268670558929443,
-0.12510646879673004,
0.058941684663295746,
0.17936766147613525,
-0.10232154279947281,
0.029339585453271866,
-0.17160898447036743,
-0.12022103369235992,
-0.25497713685035706,
-0.2578662931919098,
0.381600558757782,
-0.2911994457244873,
-0.3512691557407379,
-0.023848529905080795,
-0.2998459041118622,
-0.15741728246212006,
-0.09818221628665924,
-0.43485987186431885,
-0.3634096086025238,
0.2992916405200958,
-0.5012009143829346,
-0.2520519196987152,
-0.08143731951713562,
0.12239467352628708,
-0.27783218026161194,
0.18704098463058472,
0.21889092028141022,
0.14336052536964417,
-0.4199777841567993,
-0.23003876209259033,
-0.10870613902807236,
-0.04290136322379112,
0.34197738766670227,
0.25770658254623413,
-0.23316247761249542
] |
NCT02856243
|
Direct Antiviral Agents for Hepatitis C Virus-associated Cryoglobulinaemia Vasculitis
|
Cryoglobulinemia are responsible for systemic vasculitis, and the most frequently targeted organs are the skin, joints, kidney and peripheral nervous system. Cryoglobulinemia vasculitides are associated with significant morbidity and mortality, and require therapeutic intervention. With the discovery of hepatitis C virus (HCV) as the etiologic agent for most cases of mixed cryoglobulinemia new opportunities and problems for crafting therapy of HCV mixed cryoglobulinemia (MC) have emerged. A new and major concern was the potential adverse effects that immunosuppressive therapy with glucocorticoids and cytotoxic drugs could have on an underlying chronic viral infection. Alternatively the discovery of HCV provided the opportunity to control HCV-MC with antiviral therapy based on the belief that the underlying infection was driving immune complex formation and resultant vasculitis. Inducing a sustained virologic and clinical response and minimizing the use of immunosuppressive drugs are the main goals in the treatment of patients with HCV-MC vasculitis. Aggressive antiviral therapy has been shown to induce a complete remission of HCV-MC in up to 70% of patients. New antiviral combination, Interferon (IFN)-free regimens have recently proved very high virological response rate and with a very good safety profile and now need to be evaluated in severe and/or refractory HCV-MC patient's population.
|
Inclusion Criteria:
* at least 18 years of age or older
* present an active HCV vasculitis defined by a clinically active vasculitis with skin, joint, renal, peripheral nerve, central neurological, digestive, pulmonary and/or cardiac involvement (no histological evidence needed if patient had purpura)
* chronic active HCV infection (positive HCV RNA)
* informed consent
Exclusion Criteria:
* non-active cryoglobulinaemia vasculitis
* HIV
* active hepatitis B virus (HBV) infection
* current decompensated cirrhosis.
|
[
0.028526918962597847,
0.9132070541381836,
-1.4152019023895264,
-2.147953510284424,
0.3793603181838989,
0.5140706300735474,
-0.786479651927948,
0.40509167313575745,
-1.2441914081573486,
0.660081684589386,
0.026691190898418427,
1.9540235996246338,
-1.3592082262039185,
0.9554927349090576,
-0.9352465867996216,
0.7098268866539001,
-1.4765444993972778,
1.452435851097107,
1.2855517864227295,
-0.7160928249359131,
0.9155730605125427,
-0.14923106133937836,
-0.08750170469284058,
-0.03002982586622238,
0.9581735134124756,
-0.5719427466392517,
-0.9020293354988098,
0.097884900867939,
-0.7392067909240723,
1.2743828296661377,
-0.11425898224115372,
-1.70831298828125,
-0.011178659275174141,
1.7191462516784668,
0.261665940284729,
-0.04563051834702492,
1.0068951845169067,
0.8350518345832825,
-0.4627895951271057,
-0.9667940735816956,
-0.5363038182258606,
-0.531139612197876,
0.40908992290496826,
-0.6479458808898926,
0.4434780776500702,
0.10124339908361435,
0.43881648778915405,
1.6054749488830566,
2.1098310947418213,
0.767680823802948,
-1.1406035423278809,
1.3228423595428467,
-1.1841384172439575,
0.8436706066131592,
1.3856045007705688,
1.2177541255950928,
0.6107358932495117,
1.2346168756484985,
0.6893675327301025,
0.24433258175849915,
0.048794250935316086,
-0.09877334535121918,
0.11111482977867126,
-0.012975139543414116,
-1.2801220417022705,
0.3780628740787506,
-0.8606361150741577,
-0.3318123519420624,
-0.6402895450592041,
0.6065114736557007,
-0.7029114961624146,
0.028610307723283768,
-0.1075591892004013,
1.0824952125549316,
-0.07919950038194656,
0.8097264766693115,
-0.8898208737373352,
1.1225473880767822,
-0.30176088213920593,
0.2528381049633026,
-0.5182981491088867,
-0.21941742300987244,
-0.43605488538742065,
0.1859912872314453,
-0.013379343785345554,
-0.3548739552497864,
-1.3238364458084106,
-0.8886074423789978,
0.061434634029865265,
-0.4003973603248596,
0.41285017132759094,
-0.8126261234283447,
-1.1315685510635376,
0.3112265467643738,
-0.7353060841560364,
-0.23025059700012207,
-0.31872013211250305,
0.015752773731946945,
-1.0243184566497803,
-0.19023434817790985,
0.0488630086183548,
-0.6081737279891968,
-0.0636303499341011,
-0.6352441310882568,
-0.8584829568862915,
0.3574938476085663,
0.18241891264915466,
-0.054331645369529724,
-0.8837924599647522,
-0.3752056956291199,
0.1956052929162979,
-0.5417166352272034,
0.19839076697826385,
-0.4955967664718628,
0.013261140324175358,
0.0074751428328454494,
0.2413385957479477,
-0.2970869541168213,
-0.18552134931087494,
-0.34033915400505066,
-0.4564349949359894,
1.0447192192077637,
-0.49611008167266846,
0.03495148569345474,
-1.1762824058532715,
-0.19867783784866333,
0.030640684068202972,
-0.0003838657576125115,
-0.3393508195877075,
-0.7500292658805847,
-0.58788001537323,
0.4815414845943451,
0.6362263560295105,
-0.19675911962985992,
-1.2589746713638306,
-0.4242541790008545,
-0.22152544558048248,
0.8315678238868713,
0.4558643102645874,
0.45554396510124207,
0.5954020619392395,
0.37525880336761475,
0.5722438097000122,
0.24949118494987488,
-0.7095142602920532,
-0.20931968092918396,
0.03386760875582695,
0.8778740167617798,
-0.9679368138313293,
-0.34093135595321655,
0.03898245096206665,
0.5294391512870789,
0.3315548300743103,
-0.055081263184547424,
0.5314921736717224,
0.2745087146759033,
0.08313414454460144,
-0.41623055934906006,
-0.08158635348081589,
-0.42717888951301575,
-0.04022592678666115,
-0.10976549237966537,
0.07886788249015808,
0.020176831632852554,
0.056726276874542236,
-0.40084049105644226,
0.1570870727300644,
0.0075188144110143185,
0.4104287028312683,
-0.2874254584312439,
-0.6682029366493225,
-0.1512027084827423,
-0.351605087518692,
0.049143511801958084,
-0.36606401205062866,
0.17107269167900085,
0.37718465924263,
0.31506970524787903,
0.5250864624977112,
-0.7030032873153687,
0.13171878457069397,
-0.019067103043198586,
-0.1636040210723877,
-0.2060318887233734,
-0.1902068555355072,
0.07330916076898575,
-0.1927226334810257,
-0.26542913913726807,
-0.6587430834770203,
0.3728114366531372,
0.16378499567508698,
0.2314280867576599,
-0.4613761007785797,
0.0634889155626297,
-0.1547965705394745,
-0.22516541182994843,
-0.008198492228984833,
-0.2378293126821518,
0.25952228903770447,
-0.450600802898407,
0.26415035128593445,
0.1258455067873001,
0.028972363099455833,
0.5392882227897644,
0.05093099921941757,
0.4445115923881531,
0.12296931445598602,
0.2838916480541229,
-0.28423836827278137,
0.41533374786376953,
0.18127919733524323,
-0.17852871119976044,
-0.1978835165500641,
0.3420749008655548,
0.4746229350566864,
0.22329020500183105,
0.2542304992675781,
0.19870911538600922,
-0.5374447107315063,
-0.11988844722509384,
0.08675947040319443,
0.3632836937904358,
0.14866270124912262,
-0.14199435710906982,
-0.1962692141532898,
0.4270549416542053,
0.1431901901960373,
0.3822152316570282,
-0.05371877923607826,
-0.19639897346496582,
-0.608978271484375,
-0.08842116594314575,
0.15258386731147766,
-0.29537662863731384,
-0.12671299278736115,
0.2701905071735382,
0.030931806191802025,
0.03462475538253784,
0.18046221137046814,
0.25511449575424194,
0.2574179470539093,
-0.3700922727584839,
-0.31221434473991394,
-0.043195825070142746,
0.2242252081632614,
-0.4399714469909668,
0.11513274163007736,
-0.009284392930567265,
-0.15964943170547485,
-0.1848844289779663,
-0.21375231444835663,
0.08493132144212723,
-0.0642281323671341,
-0.43181827664375305,
0.44270622730255127,
-0.17740541696548462
] |
|
NCT01894061
|
NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma
|
NovoTTF-100A is a device and Bevacizumab is a study drug that have both been approved by the FDA (Food and Drug Administration) for use as monotherapy in treating glioblastoma multiforme. The NovoTTF-l00A is a portable battery operated device which produces TTFields within the human body using surface electrodes (transducer arrays). Intermediate frequency electric fields (TTFields) stunt the growth of tumor cells.
The purpose of this study is to determine the efficacy of the combination of Bevacizumab and NovoTTF-100A in Bevacizumab naive (meaning have never received bevacizumab before) patients with recurrent glioblastoma (GBM) as measured by 6-month progression free survival.
|
This will be an open label Phase II trial in adults with recurrent glioblastoma (GBM). The NovoTTF-100A treatment and Bevacizumab will be administered on an outpatient basis; NovoTTF-100A treatment will be initiated in the outpatient clinic.
PRIMARY OBJECTIVES:
I. To determine the efficacy of the combination of bevacizumab and NovoTTF-100A in bevacizumab-naive patients with recurrent glioblastoma (GBM) as measured by 6-month progression-free survival (PFS6).
SECONDARY OBJECTIVES:
I. To assess safety and tolerability of the combination of bevacizumab and Novo-TTF-100A in this patient population.
II. To evaluate overall survival in this population. III. To determine objective response rate (ORR) by modified Revised Assessment in Neuro-Oncology (RANO) criteria in this population.
IV. To assess time-to-progression in this population. V. To assess neurocognitive function (NCF) and quality of life (QOL) in this population.
OUTLINE:
Patients receive bevacizumab intravenously (IV) on days 1 and 15. Patients also undergo electric field therapy with NovoTTF-100A for at least 18 hours daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 28 days.
|
Inclusion Criteria:
* Patients with histologically confirmed glioblastoma or other grade IV malignant glioma (i.e. gliosarcoma, small cell glioblastoma, etc.), recurrent after prior external-beam fractionated radiotherapy and temozolomide chemotherapy.
* Patients with up to two prior recurrences are allowed.
* Karnofsky performance status ≥70.
* Patients must have the following laboratory values:
* Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L
* Platelets ≥ 100 x 10\^9/L
* Hemoglobin (Hgb) \> 9 g/dL
* Serum total bilirubin: ≤ 1.5 x ULN
* ALT and AST ≤ 3.0 x ULN
* Serum creatinine ≤ 1.5 x ULN
* Blood coagulation parameters: INR ≤ 1.5
* Minimum interval since completion of radiation treatment is 12 weeks
* Minimum interval since last drug therapy:
* 3 weeks since last non-cytotoxic therapy
* 3 weeks must have elapsed since the completion of a non-nitrosourea-containing chemotherapy regimen
* 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen.
* Patients must have signed an approved informed consent and authorization permitting release of personal health information.
* Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. The effects of bevacizumab on developing fetus or nursing infant are not known. Female patients of child-bearing potential must have a negative pregnancy test.
* Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission. Patients with other prior malignancies must be disease-free for ≥ three years.
* Patients must be maintained on a stable corticosteroid regimen from the time of their baseline scan until the start of treatment and/or for at least 5 days before starting treatment.
Exclusion Criteria:
* Patients who have had previous treatment with bevacizumab, and or NovoTTF 100A system.
* Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
* Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:
* History or presence of serious uncontrolled ventricular arrhythmias
* Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE)
* Uncontrolled hypertension (defined by a systolic blood pressure (SBP) ≥ 160 mm Hg or diastolic blood pressure (DBP) ≥ 100 mm Hg while on anti-hypertensive medications)
* Patients with cirrhosis, or active viral or nonviral hepatitis.
* Implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias.
* Infra-tentorial tumor
* Evidence of increased intracranial pressure (clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
* Known sensitivity to conductive hydrogels
* Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
* Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
* Pregnant or breast-feeding women
* Patients unwilling or unable to comply with the protocol
* Patients with leptomeningeal disease
|
[
1.780412197113037,
1.4358539581298828,
-1.5473731756210327,
-4.056150913238525,
1.8113261461257935,
2.036720037460327,
0.27456134557724,
0.7120790481567383,
-0.8796300888061523,
0.7590551376342773,
1.048538088798523,
0.03247934207320213,
-1.2926344871520996,
0.052929241210222244,
0.14612871408462524,
-0.005800602491945028,
-1.6318929195404053,
0.7010534405708313,
0.037134114652872086,
-2.0211143493652344,
0.8757575750350952,
-2.0898916721343994,
-1.1783976554870605,
-0.7008346319198608,
0.01490181963890791,
0.7088571190834045,
0.7465837597846985,
1.307746171951294,
0.5350353121757507,
1.0285981893539429,
-0.5772616267204285,
-1.1467654705047607,
0.09658421576023102,
1.0105785131454468,
-0.5036904811859131,
0.906280517578125,
1.2262444496154785,
1.6174442768096924,
-1.8861379623413086,
-0.41459527611732483,
-0.9112393260002136,
0.49943670630455017,
0.43100404739379883,
0.3374953269958496,
-0.029997989535331726,
-0.14356867969036102,
0.05665196105837822,
-0.10944714397192001,
0.49059075117111206,
-0.7199427485466003,
0.14899252355098724,
0.5013189911842346,
0.3216552436351776,
-0.3289952576160431,
1.880422830581665,
0.8724024891853333,
0.37037643790245056,
0.23504620790481567,
0.23378409445285797,
-0.13357791304588318,
0.1138693243265152,
-0.08408360928297043,
0.44005659222602844,
-0.21479734778404236,
-0.5424953699111938,
-0.463614821434021,
-0.6617510914802551,
-0.20892393589019775,
-0.5460711121559143,
0.664413571357727,
0.5061933398246765,
0.23690113425254822,
0.779705822467804,
0.0778716653585434,
-0.6977876424789429,
0.5676878690719604,
-0.38144776225090027,
-0.06649299710988998,
0.6931650042533875,
-0.08261362463235855,
0.36511877179145813,
-0.8016514778137207,
-0.2513536214828491,
0.07032088935375214,
-0.485378623008728,
0.4112619459629059,
0.15923424065113068,
-0.6456831693649292,
0.06574392318725586,
-0.2475568652153015,
0.024472545832395554,
0.024254467338323593,
0.17057034373283386,
0.18671144545078278,
-1.7197396755218506,
-0.6247546076774597,
0.9043529033660889,
-0.23003537952899933,
-0.16961616277694702,
0.25070279836654663,
-0.22443784773349762,
0.8269941806793213,
-0.1464751809835434,
0.2576829493045807,
-0.28462421894073486,
0.14645537734031677,
0.390365868806839,
-1.0885143280029297,
0.023016691207885742,
-0.8478196859359741,
1.084959626197815,
-0.7852045297622681,
-0.24899502098560333,
-0.08245306462049484,
-0.6729864478111267,
0.9153046607971191,
0.835671067237854,
0.40807628631591797,
-0.4780448079109192,
-0.15766295790672302,
-0.17031051218509674,
0.871703565120697,
0.4922104477882385,
0.17861580848693848,
0.028618130832910538,
-0.23430554568767548,
0.06070459634065628,
-0.31129130721092224,
0.377690851688385,
-1.0142402648925781,
-0.7979093790054321,
-0.1846158653497696,
-0.051390428096055984,
-0.066700778901577,
-1.0834664106369019,
-0.5289493799209595,
-0.015155338682234287,
1.1427377462387085,
0.06838921457529068,
-0.02709776535630226,
-0.12981152534484863,
0.12755568325519562,
0.24920552968978882,
-0.1460549682378769,
-1.0344234704971313,
0.4633892774581909,
0.26275762915611267,
0.24296000599861145,
-0.8569914698600769,
-0.5744617581367493,
-0.3402653932571411,
-0.2544921934604645,
-0.35510316491127014,
-0.16469596326351166,
0.12861424684524536,
0.5638106465339661,
0.06031570956110954,
-0.27575960755348206,
0.302154004573822,
-0.1912975013256073,
-0.5141524076461792,
-0.02646920457482338,
0.10721959173679352,
-0.1685848981142044,
0.5587262511253357,
-0.9162590503692627,
-0.45540499687194824,
-0.2425745576620102,
0.3541545271873474,
-0.27015021443367004,
-0.7197374105453491,
0.3990021347999573,
-0.14719876646995544,
-0.1454547792673111,
-0.5417661070823669,
0.07498277723789215,
0.43204715847969055,
0.1097029447555542,
0.2875432074069977,
-0.24318544566631317,
-0.08169500529766083,
0.10119714587926865,
0.539422869682312,
0.021181290969252586,
0.051034361124038696,
0.3376522958278656,
0.1899377852678299,
0.3449459373950958,
-0.038596171885728836,
0.4100107252597809,
-0.06988239288330078,
0.16079191863536835,
0.2961958050727844,
0.7042778730392456,
-0.13023731112480164,
-0.25597402453422546,
-0.05779203400015831,
-0.16085900366306305,
0.7991787195205688,
-0.46822190284729004,
0.3142274022102356,
0.23570922017097473,
-0.0773359090089798,
0.45198798179626465,
0.2403876632452011,
-0.4001621603965759,
0.2022865265607834,
0.34829089045524597,
-0.07099398225545883,
0.3812503218650818,
-0.1170576736330986,
-0.2769215404987335,
0.11076664924621582,
0.25362628698349,
0.04203168675303459,
0.20921719074249268,
-0.6491060853004456,
0.4802432954311371,
-0.05913245305418968,
0.209964320063591,
-0.16798833012580872,
0.18428052961826324,
-0.2969778776168823,
0.01051431242376566,
0.3744227886199951,
0.1979518085718155,
0.24049142003059387,
-0.28216829895973206,
-0.22504672408103943,
-0.13048413395881653,
-0.12657178938388824,
0.2794366180896759,
-0.4547171890735626,
-0.12203295528888702,
-0.5064963102340698,
-0.11496417969465256,
-0.1442890763282776,
0.2864518463611603,
0.2693321108818054,
0.5179600715637207,
0.33434268832206726,
-0.48325806856155396,
-0.447255402803421,
-0.17298392951488495,
-0.26400360465049744,
-0.3113167881965637,
-0.0031957782339304686,
-0.21164795756340027,
-0.15766146779060364,
-0.30880141258239746,
-0.2429376244544983,
-0.18199953436851501,
-0.06621209532022476,
0.10364805161952972,
-0.05691983178257942,
-0.6143603324890137
] |
NCT06718881
|
Investigation of the Effect of Virtual Reality Environment on Developing Clinical Skills in Nursing Students
|
To reduce the negative consequences of these problems in clinical practice on the quality of education in the nursing profession, laboratory applications of vocational courses in undergraduate education have become more important. In this context, the research aimed to determine the use of a virtual reality application, an innovative training method to increase the quality of nurses' clinical practice training, in the Obstetrics-Gynecology and Diseases Nursing (DKSH) course and its effect on students' course success. I
|
When considering the duties and responsibilities of nurses in the health system, it is necessary to train well-educated, professional nurses to ensure patient safety and quality of care. However, nurses' many problems with their clinical practice are important obstacles to getting a good education. To reduce the negative consequences of these problems in clinical practice on the quality of education in the nursing profession, laboratory applications of vocational courses in undergraduate education have become more important. In this context, the research aimed to determine the use of a virtual reality application, an innovative training method to increase the quality of nurses' clinical practice training, in the Obstetrics-Gynecology and Diseases Nursing (DKSH) course and its effect on students' course success. In the study, the virtual reality application was prepared for preeclampsia, postpartum care and condom counseling, which are the most frequently encountered by students in professional practice and are of great medical importance. In addition, the effect of simulation training in the virtual reality environment on the student's decision-making self-confidence and anxiety in real clinical practice was also evaluated. In this context, the research aims to determine the effect of a virtual reality environment on improving clinical skills in nursing students.
|
Inclusion Criteria:
* Being 18 years of age or older, taking the Obstetrics, Gynecology and Obstetrics Nursing course for the first time, attending the course and taking the information technology course.
Exclusion Criteria:
* Being visually or hearing impaired, graduating from a health vocational high school, arriving late or leaving early for case discussions or role-play scenarios, and staying in the virtual environment for less than 5 minutes.
|
[
0.4434643089771271,
4.113669395446777,
-1.9435663223266602,
-2.222935914993286,
-1.2153443098068237,
-0.6405494809150696,
-0.2639005184173584,
0.0435311533510685,
-1.2272881269454956,
0.4535389244556427,
0.323310524225235,
2.191486358642578,
-0.6468381285667419,
2.171170234680176,
-1.0404211282730103,
0.47046777606010437,
-0.043079543858766556,
0.43168002367019653,
0.6302706599235535,
0.07397476583719254,
0.057945702224969864,
0.09653307497501373,
0.02188923768699169,
-0.6823214292526245,
0.500751793384552,
1.6873254776000977,
-0.737074077129364,
0.8455989360809326,
-0.1067265048623085,
2.1458706855773926,
0.815278172492981,
-0.5916286110877991,
-0.34166809916496277,
0.27485793828964233,
0.24743151664733887,
-0.010355888865888119,
0.03932655230164528,
0.7100008726119995,
-1.2187714576721191,
-0.3793359398841858,
1.3021360635757446,
1.440800428390503,
0.5071513652801514,
-0.1919276863336563,
-0.7016971111297607,
1.309349775314331,
0.28002238273620605,
0.7329941391944885,
0.4245595335960388,
0.9425490498542786,
-0.2810802459716797,
0.5041336417198181,
-1.044101357460022,
-0.7949196100234985,
2.336472511291504,
1.2289607524871826,
-0.5106050372123718,
1.1209259033203125,
2.063925266265869,
0.7181881070137024,
1.2457935810089111,
-0.37692058086395264,
1.2214168310165405,
-0.2721339464187622,
-1.3459309339523315,
0.43906304240226746,
-0.30793482065200806,
0.2868618965148926,
-0.08129915595054626,
0.11324333399534225,
1.0531301498413086,
0.37038087844848633,
1.0373961925506592,
0.22363057732582092,
0.20001216232776642,
-0.6545410752296448,
-0.5315080881118774,
0.489798903465271,
0.7183520793914795,
-0.1368529200553894,
1.6460413932800293,
-0.6375627517700195,
-0.6103246808052063,
0.3322744071483612,
1.117111325263977,
-0.6914588212966919,
-1.7163337469100952,
-0.08200831711292267,
0.7978627681732178,
-0.4304564893245697,
0.19031743705272675,
0.10760901868343353,
0.4088364839553833,
0.38750970363616943,
0.5799109935760498,
0.8873100280761719,
0.3687008023262024,
-1.0515809059143066,
-1.521767020225525,
-0.9235174059867859,
-0.05996148660778999,
0.8075945973396301,
-0.27733251452445984,
1.1199496984481812,
0.7935281991958618,
0.8190915584564209,
-0.6919625997543335,
-0.3564585745334625,
-0.3997882008552551,
-0.18038834631443024,
0.3739454448223114,
-0.06618940830230713,
0.5183016061782837,
0.9600591659545898,
0.02071266621351242,
-1.2912750244140625,
0.884742021560669,
-0.523079514503479,
0.7862401008605957,
0.46932318806648254,
0.12890610098838806,
1.1870641708374023,
0.03429378196597099,
-0.09906940907239914,
-0.5857454538345337,
0.002635881071910262,
-0.7653388977050781,
-0.09998069703578949,
-1.045257568359375,
-0.16657668352127075,
-0.6979610323905945,
-0.6158739328384399,
0.16461946070194244,
0.6372445821762085,
0.4388945698738098,
-0.7950146198272705,
0.8105636835098267,
0.9042595624923706,
-0.3145105838775635,
-0.13485954701900482,
0.04373808577656746,
0.17246757447719574,
0.6539563536643982,
-0.07900834828615189,
-0.712792158126831,
-0.622497022151947,
-0.2390713393688202,
-0.15078626573085785,
-0.10543382912874222,
0.3422783315181732,
-0.3897835314273834,
0.060636959969997406,
0.14905710518360138,
0.13358676433563232,
0.6143662929534912,
-0.5824893116950989,
0.19030436873435974,
-0.20401613414287567,
0.8370510935783386,
-0.05953136458992958,
1.1609987020492554,
-0.23445837199687958,
-0.18172523379325867,
-0.27800777554512024,
-0.014159602113068104,
-0.29083630442619324,
0.8481343984603882,
-0.2950577735900879,
0.6684517860412598,
-0.02724689431488514,
-0.40363219380378723,
-0.19413699209690094,
-0.32434698939323425,
-0.048006705939769745,
-0.37972110509872437,
0.769317626953125,
0.8520041704177856,
0.06213899329304695,
1.1902457475662231,
0.029300928115844727,
0.3601882755756378,
0.7779310345649719,
0.3620903789997101,
-0.0983210951089859,
0.5411569476127625,
-0.025240248069167137,
-0.131816565990448,
0.10367681831121445,
-0.1354173868894577,
-0.18215295672416687,
0.3800579607486725,
0.07170677185058594,
0.00549636036157608,
0.08118204772472382,
0.7968336939811707,
0.41787251830101013,
0.0018147820373997092,
-0.06393523514270782,
0.6126046776771545,
-0.03793066367506981,
0.46521613001823425,
0.33558735251426697,
0.19021397829055786,
0.405886173248291,
0.46326443552970886,
-0.12467210739850998,
0.33898070454597473,
0.074753038585186,
0.09130151569843292,
-0.009637664072215557,
0.008851761929690838,
0.07230999320745468,
0.4298117756843567,
-0.03803149610757828,
0.5204606056213379,
0.35683876276016235,
0.6276319026947021,
-0.4457091987133026,
-0.23669365048408508,
-0.4726240336894989,
-0.370443195104599,
-0.5681827068328857,
-0.11278996616601944,
0.07989449054002762,
-0.47210779786109924,
0.4126451909542084,
-0.03048677183687687,
0.12132056057453156,
0.4071511924266815,
-0.39558228850364685,
0.17812323570251465,
-0.07179448753595352,
0.14704333245754242,
0.43161019682884216,
-0.1805495023727417,
0.11328796297311783,
0.20108294486999512,
0.15694384276866913,
0.08160912245512009,
0.5114318132400513,
0.4928213059902191,
-0.35229432582855225,
-0.045326754450798035,
-0.32991042733192444,
0.18139934539794922,
0.2865349054336548,
-0.18590247631072998,
-0.10795530676841736,
-0.3389155864715576,
-0.39733919501304626,
-0.12651969492435455,
0.18252445757389069,
0.003740662010386586,
-0.20640727877616882,
0.08151311427354813,
-0.8310273885726929
] |
NCT04093921
|
Ready for Change: Enhancing Motivational Engagement Prior to IIPT
|
This is a randomized, motivational-interviewing-based intervention to improve readiness-to-change, or willingness to engage in a self-management approach to chronic pain, for patients referred to our intensive interdisciplinary pain rehabilitation day program.
|
Readiness to change, or willingness to engage in a self-management approach to chronic pain and disability, is the most powerful predictor of children's success in intensive pediatric pain rehabilitation. Motivational Enhancement Therapy (MET) is an approach that has been effective in increasing readiness to change and treatment engagement for other behaviorally-oriented health interventions. However, MET has never been systemically employed in the context of treating pediatric chronic pain and disability.
This demonstration project seeks to test the effects of a novel telehealth intervention using motivation enhancement therapy to improve patient and parent engagement in, and outcomes of, an intensive interdisciplinary day hospital program for children with complex chronic pain conditions and associated disability, the Pediatric Pain Rehabilitation Center (PPRC). The intervention, PPRC-Prep, is a 4 week MET-based telehealth intervention that will be offered to families of children with refractory chronic pain conditions awaiting admission to the PPRC at Boston Children's Hospital at Waltham. Families approved for and awaiting PPRC admission will be randomized to receive PPRC-Prep along with usual care or to a comparison group receiving treatment as usual. Study aims include assessing the feasibility and acceptability of the intervention along with measuring its potential to increase readiness to engage in a self-management approach assessed at time of admission to the PPRC using established measures of readiness to change, pain acceptance, and committed action. Investigators will also evaluate the effects of PPRC-Prep on program length of stay and on reductions of disability and pain at PPRC discharge and short-term (8-week) follow up through comparison of families who undergo PPRC-prep with families who do not undergo PPRC-prep. Demonstrating the feasibility and preliminary effectiveness of PPRC-Prep will enable the study team to establish this as a routine component of our approach to care for children with complex, refractory chronic pain and disability.
|
Inclusion Criteria:
* Patient age 8-18 at enrollment
* Presence of chronic pain condition for \> 3 months with moderate or severe disability
* Accepts referral to PPRC and awaiting admission
Exclusion Criteria:
* Non-English speaking
* No access to device with telehealth capability
|
[
-2.8539557456970215,
4.507821083068848,
-2.262566328048706,
-2.3906257152557373,
-0.4226755201816559,
-0.9168683290481567,
-1.1753604412078857,
0.9481356143951416,
0.42060455679893494,
0.845382034778595,
-1.1550480127334595,
1.8177037239074707,
-1.3516907691955566,
1.0106747150421143,
-1.086050033569336,
1.9862349033355713,
1.6423773765563965,
-0.17203781008720398,
0.16133520007133484,
0.9948056936264038,
0.03947307914495468,
0.10875169932842255,
1.379305124282837,
-0.13456246256828308,
1.594323992729187,
1.4641735553741455,
-3.2257683277130127,
1.6129298210144043,
0.5567266941070557,
2.6928815841674805,
-0.6497316360473633,
-1.4920523166656494,
-0.33058422803878784,
0.5963446497917175,
-0.2920750677585602,
0.4960818290710449,
0.413120836019516,
0.556384801864624,
-2.3328981399536133,
0.6754976511001587,
0.33838576078414917,
0.9359427690505981,
-1.1897474527359009,
-0.5882042646408081,
1.3359450101852417,
1.018128752708435,
-0.10898903757333755,
1.2055641412734985,
-0.362848699092865,
0.9404730200767517,
0.26823002099990845,
1.3117220401763916,
0.03294210135936737,
-1.0506103038787842,
0.421863853931427,
0.4859878420829773,
0.849333643913269,
0.39216580986976624,
0.8774099946022034,
0.22941508889198303,
-0.3893755376338959,
-0.40837106108665466,
-1.0269010066986084,
1.5213871002197266,
0.13708975911140442,
-0.1766158640384674,
0.05279030650854111,
0.6323708295822144,
0.2737177014350891,
-0.7492825984954834,
0.4013841152191162,
-0.07545799762010574,
0.7279577851295471,
0.47250455617904663,
0.2736486494541168,
-0.000865388021338731,
-0.9090975522994995,
0.9727053642272949,
-0.13676662743091583,
1.0622830390930176,
-0.16103403270244598,
0.09318043291568756,
0.07036834210157394,
-0.05044211819767952,
1.270999789237976,
-1.2898296117782593,
-0.6391203999519348,
-0.3062434494495392,
0.7669227123260498,
0.9856024384498596,
1.0827478170394897,
-0.8784698247909546,
0.23872807621955872,
0.3672446012496948,
-0.5035914182662964,
0.4818185865879059,
0.853335440158844,
-0.017705457285046577,
-1.0643823146820068,
0.6972110867500305,
0.4243001639842987,
-0.012021968141198158,
0.09772229939699173,
-0.19757741689682007,
-0.5649131536483765,
1.1024105548858643,
0.1028851643204689,
-0.49622106552124023,
0.2805863618850708,
1.5700454711914062,
-0.38030725717544556,
-0.5050689578056335,
0.25804057717323303,
-0.2034938931465149,
0.26124507188796997,
0.5258962512016296,
-0.010691201314330101,
0.6084172129631042,
0.22053799033164978,
-1.0397547483444214,
0.7063578367233276,
0.3606085777282715,
-0.24812954664230347,
-0.7748807668685913,
-0.0022284251172095537,
-0.5754518508911133,
-0.44104114174842834,
0.8741351366043091,
-0.6765089631080627,
-0.2165924608707428,
-0.25836992263793945,
-0.32271960377693176,
0.017821284011006355,
-0.686853289604187,
-0.18052257597446442,
-0.5640610456466675,
-0.21093693375587463,
1.034604787826538,
-0.40653982758522034,
-0.18219217658042908,
0.42612749338150024,
-0.6498786807060242,
-0.7925183176994324,
0.28939178586006165,
-0.3546193242073059,
-0.31653663516044617,
0.014814584515988827,
0.46061134338378906,
-0.6949948072433472,
-1.0217570066452026,
-0.8607729077339172,
-0.5506455898284912,
-0.031245790421962738,
-0.3308395445346832,
-0.2928253412246704,
-0.33611783385276794,
-0.12010885775089264,
-1.0227049589157104,
0.8386518359184265,
-0.7258080244064331,
0.01670253835618496,
-0.36465364694595337,
-0.350198894739151,
-0.6775215268135071,
-0.3041362762451172,
0.0002682799531612545,
-0.8220388293266296,
0.3634408712387085,
0.653067946434021,
-0.014103278517723083,
-0.3581923246383667,
0.14801983535289764,
0.4739939570426941,
0.2405899316072464,
-0.7534882426261902,
0.2801509499549866,
1.2621361017227173,
-0.5387853980064392,
0.5443787574768066,
-0.6406723260879517,
0.5086632966995239,
-0.7472503185272217,
0.2969153821468353,
0.462770015001297,
0.2531082034111023,
-0.04243605583906174,
-0.29063066840171814,
0.18614599108695984,
-0.19672343134880066,
0.16380611062049866,
0.045690540224313736,
-0.5206090807914734,
0.11363019049167633,
0.7443434596061707,
-0.20718546211719513,
0.0884270966053009,
-1.067031979560852,
-0.9623076915740967,
0.503662109375,
-0.39740821719169617,
0.627012312412262,
0.6683760285377502,
-0.05327979102730751,
0.5992065668106079,
0.16125734150409698,
-0.15013568103313446,
0.31077322363853455,
-0.22789572179317474,
0.35044074058532715,
-0.11697876453399658,
0.29100075364112854,
0.5128054618835449,
0.21884021162986755,
-0.2842061519622803,
0.15102306008338928,
0.019489234313368797,
0.7610283493995667,
0.2711011469364166,
-0.28855007886886597,
0.2647395133972168,
-0.665473997592926,
-0.13526032865047455,
0.5200906991958618,
0.8380038738250732,
-0.4835781753063202,
-0.2929992377758026,
-0.24014337360858917,
0.2874053716659546,
0.012030216865241528,
-0.19570866227149963,
-0.10623769462108612,
-0.5550427436828613,
-0.02886063978075981,
0.38020336627960205,
-0.31966689229011536,
0.03635023906826973,
0.24350126087665558,
-0.11672965437173843,
-0.2151268720626831,
0.5978926420211792,
0.05188015103340149,
-0.2526467740535736,
0.37176820635795593,
0.20986996591091156,
0.11903822422027588,
-0.5667290091514587,
0.14658379554748535,
-0.17624357342720032,
0.048042211681604385,
0.28916069865226746,
-0.49578678607940674,
-0.2518269717693329,
0.6943839192390442,
0.41616111993789673,
0.766438901424408,
-0.016256552189588547
] |
NCT02229994
|
Development of a New Tool for Dyspnea Measurement in Chronic Respiratory Diseases
|
The purpose of this study is the psychometric validation of a self-administered dyspnea questionnaire, usable in clinical practice in order to assess dyspnea and its impact on patients with chronic respiratory diseases.
|
Dyspnea is a cardinal Respiratory symptom.
According to the ATS dyspnea is the term used to characterize a subjective experience of breathing discomfort, covering qualitatively distinct sensations of varying intensity.
The subjective nature of dyspnea and the high complexity of its determinants explain the often moderate correlations obtained with physiological data. Dyspnea must therefore be measured specifically.
The aim of this study is the cross-sectional and longitudinal psychometric validation of a self-administered dyspnea questionnaire (assessing the impact of dyspnea on activities restriction), usable in clinical practice in order to assess dyspnea and its alterations in adult patients with chronic respiratory diseases.
(COPD, diffuse interstitial lung diseases, Pulmonary arterial hypertension, Cystic fibrosis)
Like any psychometric instrument, an efficient evaluation of dyspnea scale should ideally satisfy all the following required features: evaluative, discriminant, good reproducibility, and high sensitivity to change.
The desired features apart from content validity are reproducibility and especially a high sensitivity to change, particularly following pulmonary rehabilitation.
Thus, this questionnaire should precisely enable to assess the benefit of rehabilitation and it's sustainment in maintenance phase.
|
Inclusion Criteria:
* 1) Sample1: COPD GOLD / ATS \> 2 without major co-morbidity
* Sample 1A: n = 50: group of patients with no change in usual care and no acute event (evaluation of reproducibility)
* Sample1B: n = 60: patients assessed before and after a qualifying period of pulmonary rehabilitation
* 2) Sample 2 (n = 30): diffuse interstitial lung diseases Criteria: Pulmonary Fibrosis: Idiopathic or nonspecific interstitial lung diseases (NILD) according to international criteria (ATS), sarcoidosis with parenchymal lesions (old classification stage II and III), and exceptionally alveolar proteinosis.
* 3) Sample 3 (n = 30) primary or secondary arterial pulmonary hypertension (post embolic .....).
* 4) Sample4 (n = 30): Adult with Cystic fibrosis.
* 5) patient with stable Status (no exacerbation for at least one month)
Exclusion Criteria:
* 1) Patient under 18 years
* 2) Inability to fill in questionnaires
* 3) Other respiratory disease
* 4) left symptomatic heart failure
* 5) Obesity with a BMI\> 35 kg/m2
* 6) Inability to perform PFT (Pulmonary Function Testing)
* 7) Pregnant or breastfeeding woman
* 8) Patient unable to consent
* 9) Lack of social insurance coverage
* 10) Patient in exclusion period because of another protocol
|
[
0.02201554737985134,
2.6143479347229004,
-4.316141128540039,
-2.881242513656616,
-0.6081667542457581,
0.05997345596551895,
0.1932976245880127,
0.044577110558748245,
-0.7051608562469482,
-1.0084835290908813,
1.0317916870117188,
3.651951551437378,
-1.981115698814392,
1.1718178987503052,
-0.44339579343795776,
0.8038017749786377,
1.4916541576385498,
0.28729012608528137,
1.5591660737991333,
-2.528686761856079,
1.3908495903015137,
0.3758090138435364,
-0.3008115589618683,
-0.4866744875907898,
0.9405759572982788,
0.9702543020248413,
1.0652862787246704,
2.6388051509857178,
-1.4502662420272827,
1.3214097023010254,
0.4996306300163269,
-1.0535141229629517,
0.5586240887641907,
1.6940361261367798,
-0.0737173855304718,
-0.7593929171562195,
0.18861441314220428,
1.541255235671997,
-1.0690101385116577,
-0.6089819669723511,
-0.40533047914505005,
2.32432222366333,
-1.4641995429992676,
-1.3443773984909058,
0.5467033386230469,
0.9767917394638062,
0.04539473354816437,
1.4135901927947998,
-0.9734743237495422,
-0.14785867929458618,
0.0712989941239357,
-0.2846088707447052,
-2.3611502647399902,
0.8831081986427307,
1.9959949254989624,
-0.1269540935754776,
2.1648366451263428,
0.865479052066803,
0.7211481332778931,
2.217039108276367,
0.31844839453697205,
0.19647978246212006,
0.9193119406700134,
0.053457941859960556,
-1.0860629081726074,
0.9252161383628845,
1.015302300453186,
1.708855152130127,
-0.38489264249801636,
0.7097225785255432,
-0.16707131266593933,
0.08715914934873581,
0.5393198728561401,
0.5558884143829346,
0.3995794355869293,
-0.9647780060768127,
-0.020584750920534134,
1.1544547080993652,
0.28987959027290344,
0.13540823757648468,
0.1480865329504013,
-0.20082445442676544,
-1.2705633640289307,
-0.178519144654274,
0.8978445529937744,
-0.6809896230697632,
-1.6835746765136719,
-0.41011473536491394,
0.5388538837432861,
-0.4919476807117462,
-0.28027498722076416,
-1.1682202816009521,
0.6357357501983643,
-0.1361534595489502,
-0.20082411170005798,
1.498824954032898,
-0.1369367390871048,
-0.9513963460922241,
-2.1387205123901367,
-1.1442147493362427,
-0.8276914358139038,
-0.8206230401992798,
0.43180790543556213,
0.32351160049438477,
-0.4252382516860962,
0.4273037910461426,
1.1809654235839844,
-0.9062341451644897,
-0.07776785641908646,
0.46000996232032776,
1.1671992540359497,
-0.5152090787887573,
0.8005128502845764,
0.3550143539905548,
0.4466428756713867,
-0.09312140941619873,
1.11298668384552,
1.0145833492279053,
-0.20332401990890503,
0.33012112975120544,
0.049117375165224075,
1.1595953702926636,
0.2529956102371216,
-0.41972532868385315,
-0.9419248104095459,
-0.7993307709693909,
-1.60639226436615,
0.19809867441654205,
-1.195146083831787,
-0.7934719324111938,
-0.9469490647315979,
0.04097398743033409,
0.43072444200515747,
-0.41389143466949463,
-0.9872064590454102,
-0.03277876600623131,
0.9055244326591492,
1.3067829608917236,
-1.2687697410583496,
-0.25016793608665466,
-0.004874408710747957,
0.7852097153663635,
0.18025928735733032,
0.1044374406337738,
-0.5694626569747925,
-0.18770451843738556,
0.08342179656028748,
-0.031222140416502953,
-0.48929885029792786,
-0.6975953578948975,
-0.09645485132932663,
1.154945969581604,
0.6165651082992554,
-0.15947890281677246,
-0.2850783169269562,
0.49148455262184143,
0.23968850076198578,
-1.1542185544967651,
0.09298539161682129,
-1.1693780422210693,
-0.24193139374256134,
-0.627751886844635,
-0.30956780910491943,
-1.487143635749817,
1.3516066074371338,
0.24388927221298218,
0.22662042081356049,
0.5546478033065796,
0.7762033939361572,
1.452756643295288,
-0.349226176738739,
0.5222415924072266,
0.05144479498267174,
-0.3704237639904022,
-0.8230481743812561,
0.19370661675930023,
0.7947453856468201,
0.5740086436271667,
0.46429651975631714,
-0.6423431634902954,
-0.4235703647136688,
0.8714953064918518,
0.6544585824012756,
-0.6639453768730164,
-0.22308383882045746,
0.3701983690261841,
-0.01027358416467905,
-0.34174200892448425,
-1.3257172107696533,
-0.04448864609003067,
-0.3873281478881836,
-0.3177173137664795,
-0.04302253946661949,
0.6747288107872009,
0.5692419409751892,
0.7556827068328857,
-1.2438597679138184,
-1.0341780185699463,
1.1965851783752441,
-0.46871188282966614,
0.48549821972846985,
0.797481119632721,
0.33439382910728455,
0.27389076352119446,
0.25061556696891785,
-0.7872732281684875,
-0.7116864323616028,
-0.17058666050434113,
0.13414208590984344,
0.7436290383338928,
0.18192313611507416,
0.6783310770988464,
-0.7973156571388245,
-0.6590919494628906,
0.5423404574394226,
-0.2124287188053131,
0.06258358061313629,
0.8394523859024048,
-0.5605645179748535,
-0.3700425922870636,
0.04238953813910484,
-0.4550315737724304,
-0.6260766386985779,
0.0900946632027626,
-0.7185284495353699,
0.12058863043785095,
-0.2978428900241852,
0.14248286187648773,
0.26694151759147644,
0.3702278435230255,
-0.09496736526489258,
-0.021988844498991966,
-0.15905359387397766,
0.4736277759075165,
-0.25083020329475403,
0.24366459250450134,
0.19944095611572266,
-0.20150874555110931,
0.0680810958147049,
0.7095800638198853,
-0.1469590663909912,
0.11087138950824738,
0.5560120940208435,
0.06654774397611618,
-0.6833004951477051,
0.08083077520132065,
-0.038482025265693665,
-0.005790799390524626,
-0.5512345433235168,
-0.11664514988660812,
-0.7742671966552734,
-0.3938799202442169,
0.10555854439735413,
0.3404766023159027,
0.09198398888111115,
-0.3737994432449341
] |
NCT02408081
|
Family Focused Nursing for Elderly Medical Patients
|
The purpose of this study is to determine whether Family Focused Nursing are effective in the treatment of elderly medical patients with respect to prevalence of depression
|
Psychosocial issues such as lack of social support and symptoms of depression, are risk factors associated to readmission for elderly medical patients. Families with elderly members in general want to be involved in the caring and want to maintain a close relation to their elderly family member. However, disease in a single family can have a negative effect on all members and may result in dysfunction of the family. International guidelines recommend that the patient's relatives are involved in patient education as well as the treatment. Family interventions might contribute to decline depression and readmissions, besides enhanced quality of life and family function among elderly medical patients and their next of kin.
|
Inclusion Criteria:
* acute hospitalized
* an expected hospitalization of minimum two days
* speak and understand Danish
* signed informed consent
Exclusion Criteria:
* dementia (evaluated by the Mini Mental State Examination \[MMSE\] \< 24)
* terminally ill patients whose survival rate is assessed to be less than a month
|
[
-0.5242457985877991,
4.909127235412598,
-1.6104369163513184,
0.3470052182674408,
-0.5089608430862427,
0.09451175481081009,
0.06203407794237137,
-0.34309935569763184,
0.3790409564971924,
-2.60969877243042,
1.2102669477462769,
3.4402995109558105,
-1.0920509099960327,
1.1769684553146362,
-0.987228274345398,
1.4240076541900635,
-0.3133191764354706,
0.8617790937423706,
1.1640318632125854,
-1.5408810377120972,
0.29639843106269836,
-0.6366831660270691,
1.103697657585144,
-1.489153265953064,
1.3518998622894287,
1.1581367254257202,
-0.721419095993042,
2.7943453788757324,
1.0523436069488525,
1.2944499254226685,
0.1889706403017044,
-1.6052460670471191,
-1.1228442192077637,
1.0742508172988892,
0.5552334189414978,
-1.5049364566802979,
0.6159653663635254,
0.27405065298080444,
-2.789008617401123,
0.2346215844154358,
0.9513020515441895,
1.724413514137268,
-0.8529316186904907,
-0.13566753268241882,
0.5961261987686157,
2.3156840801239014,
0.738451361656189,
0.4398340582847595,
-0.30821868777275085,
1.0618008375167847,
-0.5213896632194519,
3.1857974529266357,
-1.8403921127319336,
-1.1626380681991577,
2.5393946170806885,
-0.41476136445999146,
0.8963400721549988,
-0.4115675389766693,
0.6021891236305237,
1.6539019346237183,
1.3221391439437866,
-0.449212908744812,
0.008314132690429688,
0.4098118245601654,
-1.0983893871307373,
-0.0722542330622673,
-0.8919559121131897,
0.30915719270706177,
-0.414963960647583,
0.6650012135505676,
0.2708108127117157,
0.07204924523830414,
0.9544740319252014,
-0.47068819403648376,
0.5441184639930725,
-0.52601557970047,
0.2881530225276947,
1.4218577146530151,
1.354567050933838,
-0.5718291401863098,
-0.43329158425331116,
-0.7070125937461853,
-1.2998601198196411,
-0.25516197085380554,
1.9145605564117432,
-1.39905846118927,
-1.7222182750701904,
0.6260721683502197,
1.7539247274398804,
-1.361298680305481,
0.3615090847015381,
-0.8351293206214905,
-0.8334826827049255,
0.6041061878204346,
-1.2575238943099976,
0.8297337293624878,
0.6554879546165466,
-0.2843421697616577,
-2.123990297317505,
-1.237317442893982,
-0.502438485622406,
-0.58991539478302,
-1.816615104675293,
-0.02820756658911705,
-1.069075345993042,
0.4244290590286255,
-1.0908254384994507,
0.25415149331092834,
-1.2404052019119263,
-0.8386527895927429,
1.0686066150665283,
-0.7010487914085388,
0.5970718264579773,
0.297181099653244,
0.583357036113739,
-0.5295803546905518,
1.8862688541412354,
0.613618791103363,
0.14379112422466278,
0.9154112339019775,
0.6720777153968811,
0.8471012711524963,
0.02589345909655094,
-0.10435997694730759,
-1.2989424467086792,
0.17037126421928406,
0.5766613483428955,
0.8327546715736389,
-0.5986955165863037,
-0.11488901078701019,
0.12047090381383896,
-0.573815107345581,
0.04076719656586647,
0.46951377391815186,
-0.922071099281311,
-0.6812363862991333,
0.266188383102417,
1.0018725395202637,
-0.43441808223724365,
-0.9807962775230408,
1.108199119567871,
0.7259795665740967,
0.6090866327285767,
0.23585312068462372,
-1.5534553527832031,
-0.1802988052368164,
-0.5090950131416321,
-0.010027037933468819,
-2.033118963241577,
-2.0394763946533203,
0.3646244406700134,
0.45287758111953735,
0.028361055999994278,
-0.6584346890449524,
0.7681102156639099,
0.29055848717689514,
-0.7284682989120483,
-0.7468304634094238,
-0.11419769376516342,
0.5421252846717834,
0.24217765033245087,
-0.303493469953537,
-0.37896063923835754,
-0.49513188004493713,
0.7795192003250122,
-0.3196669816970825,
0.6511799693107605,
1.2581626176834106,
0.8227372169494629,
0.6651114821434021,
-0.12263248860836029,
0.5081744194030762,
0.30697500705718994,
0.4408636689186096,
0.7597705125808716,
0.05159897357225418,
1.1636276245117188,
0.898335874080658,
0.5038127303123474,
-0.5966073274612427,
-0.195040762424469,
0.33959275484085083,
0.27623534202575684,
-0.2736084759235382,
-0.41469213366508484,
0.10647886246442795,
-1.2234528064727783,
-1.1464816331863403,
-0.04814457893371582,
0.45178887248039246,
-0.1252496838569641,
-0.471098393201828,
-0.04153338074684143,
0.5068508982658386,
-0.149198979139328,
0.08983440697193146,
-1.531385898590088,
-0.37114405632019043,
0.5600221157073975,
-0.6089274287223816,
1.737627387046814,
0.000614236923865974,
-1.0506609678268433,
0.7995533347129822,
-0.2094610184431076,
-0.11975978314876556,
0.9457641839981079,
-0.5458350777626038,
-0.06350526213645935,
0.7412550449371338,
0.3645881116390228,
0.5285435318946838,
0.02358652465045452,
-1.8410979509353638,
-0.1157827079296112,
0.32973945140838623,
-0.3735355734825134,
-0.3342721164226532,
-1.5392937660217285,
-0.8970505595207214,
-0.274967223405838,
0.003956264816224575,
-0.22397753596305847,
0.6888262629508972,
-0.4837397038936615,
-0.5766050815582275,
0.3523726761341095,
-0.13347865641117096,
0.4424372911453247,
-0.10032183676958084,
-0.0017555025406181812,
0.008776258677244186,
0.03410501405596733,
1.029586672782898,
-0.4684635102748871,
-0.23397520184516907,
1.1532386541366577,
-0.053905222564935684,
-0.29165786504745483,
0.070908322930336,
0.36523839831352234,
-0.004175874870270491,
0.7300472259521484,
-0.6370784640312195,
-0.17514079809188843,
-0.06340005993843079,
-0.5192835927009583,
0.18181708455085754,
-0.2856600284576416,
0.521047830581665,
-1.3879915475845337,
-0.14276836812496185,
0.010025923140347004,
-0.7619621753692627,
-0.8941527605056763,
-0.5514313578605652
] |
NCT05130008
|
Implementing a Digitally-enabled Community Health Worker Intervention for Patients With Heart Failure
|
The purpose of this study is to assess the acceptability, feasibility, and preliminary effectiveness of implementing a 30-day digitally-enabled community health worker intervention compared to usual care with a community health worker in reducing heart failure 30-day readmissions within a pilot randomized controlled trial.
|
Heart failure (HF) is a highly prevalent disease in the United States, with elevated morbidity and mortality. Nearly 6.2 million people in the US are affected by HF and this number is expected to rise to 8.5 million by 2030. Total direct medical costs of HF, mostly generated by inpatient hospitalizations, are estimated to increase from $21 billion in 2012 to $53 billion by 2030. HF is the leading cause of 30-day readmissions in the US; a quarter of these are considered to be preventable. Most patients with HF are readmitted to hospital medicine services for non-HF co-morbidities (e.g. pneumonia) with clinical, social, and behavioral factors driving readmissions. Despite numerous interventions designed to prevent readmissions, including telemetry monitoring, only marginal HF outcome improvement has been observed. HF readmission rates remain elevated and could be prevented by a multidisciplinary approach promoting better connections to and communication with clinical care teams while addressing social and behavioral barriers to HF care.
One approach that has demonstrated improved chronic disease outcomes by addressing social, behavioral, and basic clinical barriers to care- and has yet to be formally studied in HF populations- is community health workers (CHWs). CHWs are members of clinical teams who address social, economic, educational, behavioral, and basic clinical factors influencing health outcomes while fostering patient connections to care teams. CHW care delivery is one of a few interventions shown to reduce readmissions in patients with chronic disease. CHWs have basic clinical knowledge of specific conditions, along with a skillset designed to address social and behavioral drivers of health outcomes like 30-day readmissions. However, CHW care is challenged by key factors, including intensive 1:1 care delivery, limiting its scale and efficiency.
In 2016, a biotechnology company launched a HF digital platform within a mobile phone application to help reduce 30-day readmissions in patients with HF by 1) leveraging artificial intelligence to minimize false alarms in biometric monitoring, 2) promoting early identification of decline in HF patients, and 3) encouraging digital and in-person communication between patients and care teams. In preliminary findings, digital platform clinical trial data has shown promise in reducing HF 30-day readmissions. This study will investigate the effectiveness of this platform in combination with CHW care in reducing readmissions for medically and socially complex patients with HF. Through a partnership with the digital platform creators, our team has helped develop a prototype for patients with HF cared for by CHWs ("digitally-enabled" CHW care). Specifically, the aim of this proposal are to assess the acceptability, feasibility, and preliminary effectiveness of implementing a digitally-enabled CHW intervention compared to CHW care to reduce HF 30-day readmissions within a pilot RCT (n=50) My central hypothesis is that pairing patients with a digitally-enabled CHW intervention that addresses social and behavioral barriers to HF care, promotes communication with clinical care teams, and improves CHW efficiency will reduce 30-day readmissions while improving patient engagement with HF care.
|
Inclusion Criteria:
* Age ≥18 years
* HF diagnosis
* English proficiency
* Residence within 30 miles of MGH
* Being cared for by a cardiologist or primary care provider who manages their HF
* Current use and ownership of a smart phone
Exclusion Criteria:
* Cognitive deficits that prevent digital or human engagement
* Lack of health insurance
* Invoked health proxy or guardianship status
* History of smart phone use
|
[
-2.7930123805999756,
6.488348007202148,
-1.8085415363311768,
-2.840834856033325,
0.3172680735588074,
1.1557183265686035,
-0.144089475274086,
0.8101975321769714,
0.999846339225769,
0.8227274417877197,
-1.636736273765564,
1.1843059062957764,
-2.116678237915039,
0.6350288391113281,
-0.07887357473373413,
1.2079862356185913,
0.33523717522621155,
0.26980915665626526,
0.9541746973991394,
-0.03750446438789368,
0.6686585545539856,
-0.18464498221874237,
1.4549387693405151,
-0.21959692239761353,
-0.2208678275346756,
1.0596797466278076,
-1.445861577987671,
1.061143398284912,
0.4539833664894104,
1.1675468683242798,
0.3697357177734375,
-0.12845800817012787,
-0.3605668544769287,
0.7284078598022461,
0.2392689734697342,
0.5995786190032959,
0.15702170133590698,
0.4973282516002655,
-1.14667809009552,
0.23576435446739197,
0.7631945610046387,
1.2012771368026733,
-0.822040319442749,
-1.0525624752044678,
1.631813406944275,
-0.44554054737091064,
0.029853492975234985,
0.387031227350235,
-1.1349897384643555,
1.614845633506775,
-0.19436649978160858,
1.08346688747406,
-0.6885890364646912,
0.24979005753993988,
1.7653499841690063,
0.04394666105508804,
0.09500271081924438,
-0.3021022379398346,
1.747706651687622,
1.1418668031692505,
0.38685670495033264,
-0.6376129984855652,
-0.5075729489326477,
0.3820398449897766,
-1.1573715209960938,
-0.5021682381629944,
-0.35007917881011963,
-0.9058440923690796,
-0.6168208718299866,
0.7828527688980103,
0.36916524171829224,
-0.5809861421585083,
0.8546618819236755,
0.6092383861541748,
-0.27216002345085144,
-0.12429825216531754,
-0.1286614090204239,
1.2586102485656738,
0.3405013084411621,
0.15658234059810638,
-0.2996218800544739,
-0.04051584005355835,
0.36852627992630005,
-0.5379214882850647,
1.1629796028137207,
-0.769148051738739,
-0.724438488483429,
-0.2220119684934616,
1.4683053493499756,
-0.7785405516624451,
0.6771679520606995,
-0.5621517896652222,
0.2132834494113922,
0.5328360795974731,
-0.12863607704639435,
0.5414101481437683,
0.30912572145462036,
-1.5620306730270386,
-0.9289915561676025,
-0.2979905307292938,
-0.2219972312450409,
-1.09316885471344,
0.28396379947662354,
-0.4692051410675049,
-1.6466968059539795,
0.09288884699344635,
0.4061714708805084,
0.021398721262812614,
-0.356767475605011,
-0.08865610510110855,
0.30457305908203125,
-0.08416382968425751,
0.20258893072605133,
-0.31273242831230164,
1.236761450767517,
0.9326818585395813,
1.3491135835647583,
1.0007094144821167,
0.06820131838321686,
-0.3131299316883087,
0.484406054019928,
0.8894883394241333,
0.6055324673652649,
0.33924877643585205,
-0.40076151490211487,
0.225248321890831,
0.07167746871709824,
1.4046127796173096,
-0.6450681686401367,
-0.5108597874641418,
-0.613807201385498,
-0.095728799700737,
0.032758116722106934,
-0.4753442108631134,
-0.7432386875152588,
-0.7216103672981262,
0.4402654767036438,
0.5987051725387573,
0.08916782587766647,
-0.21393297612667084,
0.3064899146556854,
0.10359693318605423,
-0.28780901432037354,
0.27040258049964905,
-1.6393035650253296,
-0.5871793031692505,
-0.9005336165428162,
0.3351590037345886,
-0.9470877647399902,
-0.9254099726676941,
-1.2611610889434814,
1.4653842449188232,
0.34388723969459534,
-0.05828257277607918,
-0.44791755080223083,
0.13074104487895966,
0.1753058284521103,
-1.156456708908081,
0.3423006534576416,
-0.3384261429309845,
0.2625246047973633,
-0.8304117321968079,
-0.1220928207039833,
-0.8886787295341492,
-0.3389546275138855,
0.24194735288619995,
-0.30575037002563477,
-0.11306975781917572,
0.20245875418186188,
-0.3603003919124603,
-0.6414213180541992,
1.4763410091400146,
-0.7821973562240601,
-0.07221203297376633,
-0.89069002866745,
-0.17941507697105408,
0.8029685020446777,
-0.4179084599018097,
0.49646520614624023,
-0.4890744984149933,
-0.1819888949394226,
0.21692252159118652,
-0.5080330967903137,
0.2154190093278885,
-0.10097096115350723,
-0.6278932690620422,
0.09595569968223572,
-0.8492457866668701,
0.140052929520607,
-0.41656339168548584,
-0.41075095534324646,
0.0950283333659172,
-0.4168640673160553,
0.7768458127975464,
0.05444943159818649,
-0.6173086166381836,
-0.652409553527832,
0.17003577947616577,
0.5471628904342651,
-0.27953848242759705,
0.001148638897575438,
0.6866185665130615,
-0.8856099247932434,
-0.5814714431762695,
-0.43413808941841125,
0.564428985118866,
-0.7175709009170532,
-0.34760722517967224,
-0.35322141647338867,
0.01213526725769043,
0.23280268907546997,
-0.05410424992442131,
-0.46607205271720886,
-0.6732223629951477,
0.1414908766746521,
0.04866941273212433,
0.1454535871744156,
0.3526632487773895,
-0.38736945390701294,
0.2597481906414032,
-0.35296088457107544,
-0.942123532295227,
-0.1263008713722229,
0.16107076406478882,
-0.07320532202720642,
-0.7183457016944885,
0.18521898984909058,
0.031482160091400146,
0.6884293556213379,
0.09361778944730759,
-0.19114145636558533,
0.04961458593606949,
-0.21041084825992584,
0.05004395171999931,
-0.7525791525840759,
-0.04468980431556702,
0.01600033976137638,
0.059484001249074936,
-0.4814912974834442,
0.1494326889514923,
1.5136085748672485,
-0.45972940325737,
-0.018450403586030006,
-0.11282257735729218,
0.26353681087493896,
0.5009697079658508,
-0.23416124284267426,
0.4697861671447754,
-0.10653181374073029,
0.712019681930542,
-0.3483511507511139,
-0.8155551552772522,
-0.29609593749046326,
0.23870523273944855,
-0.2884766459465027,
0.3221461772918701
] |
NCT03155152
|
Decremental Exercise: a New Training Approach?
|
Different types of high-intensity interval training (HIIT) sessions are used by athletes in order to improve their physical performance, but innovative approaches to training are lacking. Therefore, in Part A of this study the physiological response to a standard HIIT and a new decremental exercise training (DECT) will be compared in runners and cyclists. Next, in Part B the training effects of a 4-week block of the HIIT and DECT will be compared.
|
Inclusion Criteria:
* Age: 18-40 years
* Healthy, i.e. normal physical and mental status (not taking any medication on a regular basis for more than a month, except contraceptive medication)
* Normal Body-Mass-Index (BMI): 18.5-24.9 kg·m-2
* Well-trained athletes: V̇O2max \> 55.1 ml·min-1·kg-1 for men and \> 50.1 ml·min-1·kg-1 for women
* Normal lung function
* Non-smoking
* Willing to adhere to the general study rules
Exclusion Criteria:
* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the study
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Previous enrolment into the same part (A or B) of the current study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Acute or chronic illness
* Intake of medications affecting performance or the respiratory, cardiovascular or neuromuscular system
* Insufficient training history (\<3 yrs of participation in competitive cycling/running) or training volume (\<40 km running/week or 150 km cycling/week) in the previous 6 months
* Recent (\<3 months) history of orthopaedic injury or participation in structured high-intensity training blocks
|
[
-1.3273189067840576,
1.9891483783721924,
-1.885944128036499,
-3.4218316078186035,
1.3616737127304077,
-0.21217522025108337,
0.17005161941051483,
-0.9366246461868286,
-0.7960764169692993,
1.0223543643951416,
0.2771914601325989,
0.11381861567497253,
-0.8169561624526978,
-0.3887893259525299,
-1.0233190059661865,
0.8996586203575134,
1.486437201499939,
-0.48138105869293213,
1.2794907093048096,
-0.6210814118385315,
-0.4631146788597107,
0.45047131180763245,
-0.7327245473861694,
0.5620679259300232,
-0.06168455258011818,
1.5837546586990356,
-0.9343892335891724,
0.7305682301521301,
-0.3609341084957123,
0.6881904006004333,
0.2768692970275879,
-0.5837215781211853,
1.0733046531677246,
-0.2644614577293396,
-0.4959067106246948,
0.4433296322822571,
0.679760217666626,
-0.004769292660057545,
0.108009472489357,
1.2324999570846558,
0.8011734485626221,
1.5266032218933105,
-0.14903134107589722,
0.26103436946868896,
0.04865235462784767,
0.3930884003639221,
0.7976179122924805,
-0.0378141775727272,
0.25188741087913513,
-0.23590120673179626,
0.7078441977500916,
0.05054574832320213,
-1.042557716369629,
0.49057233333587646,
1.4686063528060913,
1.258548378944397,
0.43950381875038147,
0.17416229844093323,
-0.055362995713949203,
-0.5562458038330078,
1.1648526191711426,
0.560306966304779,
0.6206597089767456,
1.2146549224853516,
-0.5847375988960266,
-0.5870676636695862,
0.9102093577384949,
-0.47783997654914856,
-1.058903455734253,
-0.7526860237121582,
1.3145054578781128,
-0.8309916257858276,
0.6690415143966675,
0.7111528515815735,
0.727074146270752,
0.6964848041534424,
-0.8799055218696594,
1.2967263460159302,
0.29189011454582214,
0.8014192581176758,
-0.2577654719352722,
-0.8226138353347778,
-0.16629602015018463,
-0.657364547252655,
1.0938392877578735,
0.010073868557810783,
-1.3889092206954956,
-0.0005526220775209367,
0.09054438769817352,
-0.30695584416389465,
0.08067702502012253,
-0.13235309720039368,
-1.1653211116790771,
-0.05149435997009277,
-0.34152141213417053,
0.7676337957382202,
-0.016264276579022408,
-0.18687507510185242,
-0.036315031349658966,
-0.3065671920776367,
0.5647605657577515,
-0.4957069754600525,
0.8294053673744202,
1.538282871246338,
-0.4102621376514435,
0.23764286935329437,
-0.7461009621620178,
-0.7977170944213867,
-0.27031123638153076,
0.6789953112602234,
-0.06367842853069305,
-1.096629023551941,
-0.8913602828979492,
0.008674976415932178,
0.6549798250198364,
0.37747722864151,
0.2134338915348053,
0.7642174363136292,
-0.5185263752937317,
-1.446184515953064,
-0.270588219165802,
0.15205945074558258,
1.2406408786773682,
-0.2039344310760498,
0.14233291149139404,
-0.42541199922561646,
0.5213906168937683,
0.2802003026008606,
-0.07269562780857086,
0.2808912992477417,
-0.2518058121204376,
-0.3781965970993042,
0.09599652141332626,
-0.1324433535337448,
-0.39625415205955505,
-0.5458506941795349,
0.09021487832069397,
0.5884854197502136,
-0.40213698148727417,
0.3035127520561218,
-0.7820180654525757,
-0.5819340348243713,
-0.2030157744884491,
0.1910945177078247,
0.11119071394205093,
-0.3928346335887909,
-0.4582308828830719,
-0.23889434337615967,
-0.029256608337163925,
0.0044993930496275425,
-0.7366408705711365,
0.7990242838859558,
0.5219813585281372,
-0.21136265993118286,
-0.3608768582344055,
0.05775328725576401,
-0.23045653104782104,
-0.694981038570404,
0.16793079674243927,
-0.357917457818985,
0.9516343474388123,
-0.1333421915769577,
0.19384612143039703,
0.7852380871772766,
0.8800348043441772,
-0.2824978530406952,
-0.42741042375564575,
0.12605580687522888,
0.8350878953933716,
0.41487517952919006,
-0.8582438230514526,
-0.7856118083000183,
-0.5099289417266846,
-0.4537985026836395,
-0.1302996128797531,
0.5280711650848389,
0.7085497379302979,
-0.061055224388837814,
-0.01446485798805952,
-0.17367026209831238,
0.8497292399406433,
0.3929044008255005,
0.30000483989715576,
0.006287017837166786,
0.05176684632897377,
-0.056304942816495895,
0.23852986097335815,
-0.17385123670101166,
0.3947504758834839,
0.02596311643719673,
-0.5129854083061218,
0.251819372177124,
-0.10308751463890076,
-0.2433328479528427,
0.09790527820587158,
0.08768058568239212,
-0.6973756551742554,
-0.43628615140914917,
0.8815556764602661,
0.2689315974712372,
0.2782401144504547,
0.4539036750793457,
-0.30766767263412476,
0.762348473072052,
0.08892104774713516,
-0.17956385016441345,
-0.5622894763946533,
0.15032708644866943,
-0.3551969826221466,
-0.1291024535894394,
0.04811785742640495,
-0.20441149175167084,
-0.015824677422642708,
0.45534583926200867,
0.07770560681819916,
0.6513413786888123,
-0.08843961358070374,
0.28218722343444824,
-0.1975681036710739,
-0.12091471254825592,
0.2502506375312805,
-0.5368543267250061,
-0.09233742207288742,
-0.08025355637073517,
-0.04412108659744263,
0.14551012217998505,
0.33353862166404724,
-0.23905660212039948,
0.026237942278385162,
-0.3597569465637207,
-0.3061973750591278,
-0.3436283767223358,
-0.43559032678604126,
-0.1778097152709961,
-0.014927833341062069,
-0.4613199532032013,
-0.07924363762140274,
-0.40160754323005676,
0.32387515902519226,
0.03692106902599335,
0.14413845539093018,
-0.7219851613044739,
-0.312785267829895,
0.05574119836091995,
-0.05691616237163544,
-0.14876849949359894,
0.18744586408138275,
0.3200179636478424,
-0.16632497310638428,
0.2245228886604309,
0.43766075372695923,
0.20238719880580902,
0.30032315850257874,
-0.3379354476928711,
-0.3693365156650543,
-0.5973671674728394
] |
|
NCT01169727
|
Observational Study to Evaluate Health Status of Chronic Obstructive Pulmonary Disease (COPD) Patients in Response to Real-life Treatments in Thailand
|
The purpose of this study is to evaluate health status of uncontrolled Chronic Obstructive Pulmonary Disease (COPD) patients in response to treatments in clinical practice.
|
MC MD
|
Inclusion Criteria:
1. Provision of informed consent prior to any study specific procedures
2. Male or non-pregnant female aged \>40 years
3. A clinical diagnosis of COPD with FEV1/ FVC \<0.70 and require combination or modified therapy
4. Smoke \> 10 Pack Year
Exclusion Criteria:
1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
2. Participation in a clinical study (precluding non-interventional study or registry) during the last 3 months
|
[
-0.6942803859710693,
3.7608416080474854,
-2.474626064300537,
-1.25664484500885,
0.8020609021186829,
-0.3625715672969818,
0.8787499070167542,
2.054335594177246,
-2.239039659500122,
1.4073148965835571,
0.8514352440834045,
2.7003307342529297,
-0.4382600486278534,
1.6805839538574219,
-0.5879336595535278,
-0.2358832210302353,
-0.8404909372329712,
1.086104154586792,
0.8374539017677307,
-0.47900310158729553,
0.3118152320384979,
-1.3430507183074951,
-0.216238871216774,
0.06669875234365463,
1.0484849214553833,
-0.2960699796676636,
-0.6710023880004883,
0.6205790638923645,
-0.6704496145248413,
0.38058921694755554,
0.21531710028648376,
-0.48054036498069763,
-0.21151673793792725,
1.0704289674758911,
0.10069698095321655,
-0.7054256796836853,
-0.24739015102386475,
1.3159021139144897,
-2.3423831462860107,
0.6808111667633057,
1.1776565313339233,
1.1100990772247314,
-1.5954900979995728,
-1.7206073999404907,
2.6456778049468994,
1.2746272087097168,
0.09972383081912994,
0.4236891269683838,
-0.9536531567573547,
-0.8273417353630066,
-0.7635437250137329,
1.003015160560608,
-1.8401228189468384,
1.2361773252487183,
2.450840711593628,
0.9995052814483643,
0.576261043548584,
0.8434322476387024,
1.1285234689712524,
0.44198930263519287,
0.8275264501571655,
-0.016846023499965668,
-0.1499364674091339,
0.7009832859039307,
-2.0760626792907715,
-0.5069506168365479,
-0.8940516114234924,
-0.7608041167259216,
-0.6632211804389954,
-0.34513887763023376,
0.13352319598197937,
0.26745331287384033,
1.0787056684494019,
0.4380217492580414,
0.38504138588905334,
-0.026213428005576134,
-1.2653065919876099,
1.662419080734253,
1.1327626705169678,
-1.212422251701355,
0.8264786601066589,
-0.007867208682000637,
-1.8320794105529785,
-0.6385770440101624,
0.1195768341422081,
-0.27731096744537354,
-2.3258230686187744,
-0.5854635834693909,
0.922900915145874,
-0.8495007157325745,
0.04943035542964935,
-1.2357679605484009,
-0.497840017080307,
1.7885596752166748,
-1.1315069198608398,
0.4125363826751709,
-0.011239010840654373,
-0.5565389394760132,
-1.3031177520751953,
-1.8963640928268433,
-0.2030085176229477,
-0.026243237778544426,
1.4229099750518799,
-0.13928745687007904,
-0.8267685174942017,
0.6581049561500549,
0.25093284249305725,
0.6060282588005066,
-0.8808750510215759,
-1.092145323753357,
0.8916929960250854,
-0.4801066219806671,
0.19301097095012665,
0.0510006919503212,
0.9605227708816528,
-0.06826678663492203,
0.30871671438217163,
0.6944195032119751,
0.2432563453912735,
0.9671545028686523,
-0.4084948003292084,
1.8727351427078247,
-0.23322927951812744,
0.22436122596263885,
-0.7923197150230408,
-1.3541666269302368,
-2.093674898147583,
-0.25255727767944336,
-1.0563790798187256,
-0.4234248697757721,
-1.0301151275634766,
-0.7782701253890991,
0.5363844633102417,
1.284690499305725,
-1.4492934942245483,
0.5789979696273804,
1.016775131225586,
1.7756952047348022,
0.13149458169937134,
-0.4079524278640747,
-0.19917526841163635,
-0.2626632750034332,
0.4609336256980896,
0.13011975586414337,
-1.8730920553207397,
-1.0006846189498901,
0.19927409291267395,
0.7637023329734802,
-1.0109364986419678,
-0.8300138711929321,
0.5045291781425476,
0.7332452535629272,
0.5010708570480347,
0.3462250828742981,
0.6171135902404785,
0.6547415852546692,
0.4276563227176666,
-0.14331915974617004,
0.14051339030265808,
0.035710714757442474,
-0.0952400490641594,
-0.4480092227458954,
-0.0930403396487236,
-0.5714486837387085,
0.5419621467590332,
-0.5179278254508972,
-0.020364537835121155,
0.2527232766151428,
0.1276007443666458,
1.0910879373550415,
-0.9008099436759949,
-0.27891531586647034,
0.7242462635040283,
-0.4152259826660156,
-1.983498215675354,
1.68467378616333,
1.1546335220336914,
0.5887361168861389,
1.3881161212921143,
-0.5844979286193848,
0.17267076671123505,
-0.022385248914361,
0.939039409160614,
0.4366792142391205,
0.2987460494041443,
0.7461948394775391,
-0.8222055435180664,
0.3971807062625885,
-0.8305103778839111,
0.22947798669338226,
-0.265190064907074,
0.09424939006567001,
-0.2538793981075287,
0.5922636389732361,
0.4603133201599121,
0.24871690571308136,
-0.27596578001976013,
-1.0459635257720947,
1.0539425611495972,
-0.028088442981243134,
1.1494110822677612,
-0.3202441930770874,
-0.6526205539703369,
1.0596522092819214,
-0.26049959659576416,
0.04566942900419235,
0.6011821031570435,
0.04345877841114998,
-0.5520151853561401,
0.8788416385650635,
1.049351453781128,
0.2122439593076706,
-0.4740721583366394,
-0.4065820574760437,
0.46906739473342896,
0.31939828395843506,
-0.0039644259959459305,
0.7293696403503418,
-0.8698287606239319,
-0.4320238530635834,
-1.0627638101577759,
-0.08856916427612305,
-0.4455690085887909,
0.4613983631134033,
0.39171460270881653,
-0.30808278918266296,
0.2375737875699997,
0.27014997601509094,
-0.10447776317596436,
-0.06175389140844345,
-0.17944744229316711,
0.36296477913856506,
-0.0390985831618309,
-0.03570904582738876,
-0.16753187775611877,
1.1860264539718628,
0.47751855850219727,
0.20507490634918213,
0.21388639509677887,
0.4702785015106201,
0.43151575326919556,
-0.26898860931396484,
0.5212113857269287,
-0.6543482542037964,
-0.32105371356010437,
-0.34137043356895447,
0.18832534551620483,
-0.05779659375548363,
0.007197096478193998,
-0.18173080682754517,
-0.9742100238800049,
-0.20313654839992523,
0.06636093556880951,
0.1679634302854538,
0.46554550528526306,
-0.8051360249519348
] |
NCT06783517
|
Evaluation of Hyaluronic Acid in Addition to Xenograft in Immediate Implant Placement Within Maxillary Esthetic Zone
|
Study design:
The present study will be carried out on twenty patients selected from the department of Oral Medicine, Periodontology, Oral Diagnosis and Radiology, Faculty of Dentistry, Mansoura University for replacement of non restorable maxillary anterior and/or premolar teeth within esthetic zone by immediate implant divided into two groups. A written informed consent will be obtained from all patients before their participation in this study.
Evaluation of study:
All patients will be seen at regular time interval for evaluation at the visit of surgical intervention , follow up of clinical parameter will be recorded monthly then three , six months postoperative and six month after loading(with twelve month follow up study).
1. Clinical evaluation:
Implant stability evaluation Soft tissue evaluation
2. Radiographic evaluation:
* Marginal bone loss(MBL).
|
Study design:
The present study will be carried out on two groups of patients.
A-Patients Sample:
Twenty patients selected from the department of Oral Medicine, Periodontology, Oral Diagnosis and Radiology, Faculty of Dentistry, Mansoura University for replacement of non restorable maxillary anterior and/or premolar teeth within esthetic zone by immediate implant. A written informed consent will be obtained from all patients before their participation in this study.
i. Group (1): Comprised of ten patients with hopeless non-restorable maxillary anterior and/or premolar tooth within the esthetic zone will be extracted and replaced by an immediately placed dental implant in conjunction with Bovine bone mineral graft material( cerabone®,Botiss biomaterial) followed by healing abutment.
ii. Group (2): Comprised of ten patients with hopeless non-restorable maxillary anterior and/or premolar tooth within the esthetic zone will be extracted and replaced by an immediately placed dental implant in conjunction with Bovine bone mineral with sodium hyaluronate graft material (cerabone®plus,Botiss biomaterial) followed by healing abutment.
Inclusion criteria:
• Patients who are medically free from any systemic diseases.
• Patients with good oral hygiene and regular maintenance.
* Age of patients will be \>20 years.
* Presence of at least single non restorable maxillary anterior and/or premolar tooth due to caries, root resorption, endodontic failure, root fracture or tooth with open apex.
* No acute infection is present within both periodontal and/or peri-apical area within the tooth of concern and/or adjacent teeth.
* Patients with extraction socket type I.
* Free from history of clenching, tapping and bruxism.
* Patients prepared to co-operate and comply with the follow-up and maintenance program.
Exclusion criteria:
• Patients taking medications known to influence bone metabolism ( such as heparin, warfarin, corticosteroid).
• Smoking and alcoholic patients.
* History of radiation in the head and neck region.
* Insufficient interocclusal distance for implant placement and restoration.
* Patient with lack of stable posterior occlusion.
* Pregnant, lactating and post-menopausal female patients. Complete medical history, dental history will be taken to all of patients in the study.
Materials:
A. Dental Implants: Conventional 2 pieces screw type dental implants. B. Bone substitute: Bovine bone graft material (cerabone®,Botiss biomaterial) and Bovine bone substitute with sodium hyaluronate graft material (cerabone®plus,Botiss biomaterial).
C. Trephine bur: to create intentional bony defect in experimental rabbits. D. Ostell: to measure the primary and secondary stability of the implant.
Methods:
1. Pre-operative measurements:
A. Photographs: for all items under research. B. Preoperative Radiographs: CBCT will be taken for clinical patients before treatment.
C. Antibiotic administration for both patients and rabbits before implant placement.
2. Surgical Procedures:
1. Clinical sample (patients) :
• Atraumatic removal of remaining root or tooth will be performed using periotome, appropriate forceps and elevators in an attempt to preserve the buccal plate of bone and soft tissue.
• Implant will be placed in fresh socket using implant motor with saline coolant after curettage and its size is determined according to pre-operative CBCT within both groups.
* Group (1): Bovine bone graft (cerabone®,Botiss biomaterial)will be added to the implant.
* Group (2): Bovine bone substitute with sodium hyaluronate graft (cerabone®plus,Botiss biomaterial) will be added to the implant.
* followed by healing abutment.
* Post-operative care: The patients will be instructed to consume soft food for eight weeks Patients will be maintained on amoxicillin twice a day for six days and Ibuprofen 400mg 2 to 4 times daily
* loading will begin at three to four months from surgical intervention.
3-Evaluation of study:
A. Patients evaluation:
All patients will be seen at regular time interval for evaluation at the visit of surgical intervention , follow up of clinical parameter will be recorded monthly then three , six months postoperative and six month after loading(with twelve month follow up study).
1. Clinical evaluation:
i. Soft tissue evaluation: This will be done in both groups where, soft tissue evaluation will be done using probing depth(PD) and pink esthetic score (PES) around dental implant.
ii. Implant stability evaluation: Using Osstell implant stability will be assessed in both groups soon after implant placement to assess primary implant stability then three , six and twelve months after surgery to assess secondary implant stability.
2. Radiographic evaluation:
Radiographic assessment will be held preoperative ,six and twelve months after implant placement for evaluation of:
• Marginal bone loss(MBL).
Statistical Analysis:
All data will be collected and statistically analyzed.
|
Inclusion Criteria:
* • Patients who are medically free from any systemic diseases.
* Patients with good oral hygiene and regular maintenance.
* Age of patients will be \>20 years.
* Presence of at least single non restorable maxillary anterior and/or premolar tooth due to caries, root resorption, endodontic failure, root fracture or tooth with open apex.
* No acute infection is present within both periodontal and/or peri-apical area within the tooth of concern and/or adjacent teeth.
* Patients with extraction socket type I.
* Free from history of clenching, tapping and bruxism.
* Patients prepared to co-operate and comply with the follow-up and maintenance program.
Exclusion Criteria:
* • Patients taking medications known to influence bone metabolism ( such as heparin, warfarin, corticosteroid).
* Smoking and alcoholic patients.
* History of radiation in the head and neck region.
* Insufficient interocclusal distance for implant placement and restoration.
* Patient with lack of stable posterior occlusion.
* Pregnant, lactating and post-menopausal female patients. Complete medical history, dental history will be taken to all of patients in the study.
|
[
-0.023467538878321648,
3.862673044204712,
-2.632859230041504,
-0.7328584790229797,
-0.40318119525909424,
0.05704370141029358,
-0.2822750508785248,
-0.7125911116600037,
-2.1520140171051025,
0.1041332557797432,
0.6640324592590332,
1.0868480205535889,
-1.1224026679992676,
1.166196346282959,
-0.10232020914554596,
0.44247207045555115,
0.5697422027587891,
-1.0952709913253784,
0.42227280139923096,
-1.3224354982376099,
-0.3424087166786194,
-0.36720871925354004,
-0.20022840797901154,
-1.3203928470611572,
0.34779512882232666,
-0.5583854913711548,
-1.0955489873886108,
0.9871605038642883,
0.12360718846321106,
1.7445662021636963,
0.5915290713310242,
-1.3071714639663696,
-0.4760861098766327,
1.2015200853347778,
0.47839200496673584,
0.5128486752510071,
0.22958050668239594,
0.8577788472175598,
-0.9856275320053101,
-0.07987479120492935,
1.1945284605026245,
0.252366304397583,
-0.8481895327568054,
0.7294550538063049,
0.15790341794490814,
0.6286898851394653,
-0.12243887782096863,
-0.0439768023788929,
0.5639614462852478,
-0.18009299039840698,
-0.5752835869789124,
0.8902465105056763,
-1.2771512269973755,
-0.06596210598945618,
0.871200680732727,
0.8005548715591431,
1.4078983068466187,
-0.5064018368721008,
1.185314416885376,
-0.2666085660457611,
0.3610811233520508,
0.4152260422706604,
0.6189859509468079,
0.668916642665863,
-1.0806827545166016,
-0.06140787899494171,
-0.6249568462371826,
0.7742559313774109,
-0.0670485571026802,
-0.2869730293750763,
0.8621624112129211,
-0.16523362696170807,
1.3574705123901367,
0.27324026823043823,
0.5412607192993164,
0.7633860111236572,
-0.7686244249343872,
0.3026016354560852,
0.6090627312660217,
-0.5281113386154175,
-0.6390873193740845,
-0.5862573981285095,
-0.4760323166847229,
-0.1575166881084442,
0.1993952989578247,
-0.2585887908935547,
-1.0611532926559448,
-0.23270654678344727,
0.9057281017303467,
0.06533149629831314,
0.5247803330421448,
0.1966213434934616,
-0.8745070099830627,
0.6838542222976685,
-1.445741891860962,
0.8551431894302368,
1.0551785230636597,
-0.9468984007835388,
-0.968593955039978,
-0.5200868844985962,
-0.24445347487926483,
-0.1040545403957367,
0.3351706862449646,
-0.6419165134429932,
-0.0005667966324836016,
-0.2517780363559723,
-0.7831945419311523,
0.27427712082862854,
-0.280372679233551,
-0.40993428230285645,
0.2963953912258148,
-0.8298019766807556,
-0.19333259761333466,
-0.34814319014549255,
-0.29561659693717957,
-0.36245328187942505,
0.54285728931427,
-0.03576203063130379,
0.44003379344940186,
-0.18123486638069153,
0.42763635516166687,
0.38479354977607727,
0.38790738582611084,
0.04923425614833832,
-0.6013450622558594,
-0.9839154481887817,
-0.018735157325863838,
0.5276943445205688,
-0.3441521227359772,
-0.2935981750488281,
-1.1105401515960693,
0.6992626786231995,
-0.38590267300605774,
-0.003598164999857545,
-1.4014034271240234,
-0.1971205472946167,
0.0009333175257779658,
0.23521491885185242,
-0.8323665857315063,
-0.47758081555366516,
0.1800590306520462,
0.10215391963720322,
0.048452384769916534,
-0.14035475254058838,
-1.6122843027114868,
-0.7240908145904541,
-0.34095141291618347,
0.15000998973846436,
-0.5056031346321106,
0.31808236241340637,
-0.3642295300960541,
0.3547590672969818,
0.7948628067970276,
0.33758223056793213,
0.11695791780948639,
0.45259010791778564,
0.2002117931842804,
-0.3039652407169342,
0.3330610692501068,
-0.24602407217025757,
0.034021154046058655,
-0.4098832309246063,
-0.03227947652339935,
-1.1062891483306885,
0.1541730761528015,
0.6905118227005005,
-0.3266602158546448,
-0.4994628429412842,
0.46132463216781616,
0.2203260362148285,
-0.6353458762168884,
0.9609043598175049,
0.37482187151908875,
0.331787109375,
-0.4493427872657776,
-0.4029256999492645,
0.9598175883293152,
0.3123305141925812,
0.34376224875450134,
-0.08242177218198776,
-0.14384077489376068,
-0.23765945434570312,
0.062258005142211914,
-0.007418605964630842,
-0.03141961991786957,
-0.14303775131702423,
0.3342376947402954,
-0.4357477128505707,
0.011065090075135231,
0.14796507358551025,
0.16418714821338654,
-0.002949814312160015,
0.164630725979805,
0.6917192339897156,
0.2674255669116974,
0.45722901821136475,
0.1490149050951004,
-0.3600068688392639,
0.283150315284729,
0.24712052941322327,
0.05896545574069023,
-0.0925871804356575,
-0.47718530893325806,
1.0795379877090454,
0.1325579136610031,
0.08324406296014786,
-1.217981219291687,
-0.014186748303472996,
0.14755988121032715,
0.4277017116546631,
-0.02661394141614437,
-0.2898637056350708,
-0.3240059018135071,
0.28526386618614197,
-0.19803796708583832,
-0.07747383415699005,
0.20982852578163147,
-0.15888772904872894,
-0.3237093687057495,
0.05174434557557106,
0.3565048277378082,
-0.1839664727449417,
-0.6874797940254211,
0.1539096087217331,
-0.36448734998703003,
-0.332120418548584,
-0.22664281725883484,
0.2037794589996338,
-0.07620193064212799,
-0.12754105031490326,
0.11187119036912918,
0.593919575214386,
0.4208233952522278,
0.05100927874445915,
0.1714504212141037,
0.05012564733624458,
0.2133488804101944,
0.1575665920972824,
-0.13720941543579102,
0.503634512424469,
0.03349332883954048,
-0.4826664924621582,
0.5150402188301086,
-0.3251579701900482,
0.10443135350942612,
-0.10995949059724808,
0.17858441174030304,
0.543278157711029,
-0.10963562875986099,
0.05228326842188835,
-0.2765411138534546,
-0.6942874193191528,
0.3777385354042053,
-0.04655575379729271,
0.2767159044742584,
-0.3661942481994629
] |
NCT05408247
|
A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder
|
To explore the effectiveness of n-acetylcysteine in improving treatment outcomes for alcohol use disorder in a double-blind randomised placebo-controlled trial.
|
Australia urgently requires new treatment strategies for the treatment of alcohol dependence. Although alcohol use disorders are a leading cause of preventable death in Australia, their treatment is generally not evidence based. The medications currently approved for use in Australia for the management of alcohol dependence have limited efficacy, and existing research does not address the heterogeneity of treatment response. Targeted personalised medicine addresses this heterogeneity with better medicine selection for patients based on their genotype and clinical comorbidities.
Following on from a recent pilot study conducted by CI Morley (NCT03879759), this project will evaluate the clinical efficacy and tolerability of NAC, relative to a placebo, in heavy drinkers. We hypothesise that NAC-treated participants will be better able to achieve a reduction in heavy drinking. We will utilise a double-blind, randomised, controlled design. A sample of 280 individuals will receive 12 weeks of treatment with NAC (2400 mg/day) or placebo.
|
Inclusion Criteria:
* Alcohol Use Disorder according to the DSM-V criteria
* A desire to reduce or stop drinking
* Consumed at least 21 standard drinks per week or 2 heavy drinking days per week (HDD: ≥ 5 standard drinks/day for men; ≥4 for women) in the month prior to screening
* Adequate cognition and English language skills to give valid consent and complete research interviews
* Stable housing
* Willingness to give written informed consent
Exclusion Criteria:
* Pregnancy or lactation (women will be advised to use reliable contraception during the trial and a pregnancy test will be performed were necessary)
* Concurrent use of any psychotropic medication other than antidepressants (provided these are taken at stable doses for at least two months)
* Any substance dependence other than nicotine
* Clinically unstable systemic medical (e.g. cancer, end stage liver disease: e.g. MELD score ≥ 10) or psychiatric disorder (e.g. active psychosis, borderline personality disorder, active suicide risk: e.g. MADRAS item 10 score of 6) that precludes trial participation
* Concurrent use of selenium, vitamin D or other anti-oxidants
* Any alcohol pharmacotherapy within the past month
|
[
-1.384192943572998,
2.3822762966156006,
-1.4852904081344604,
-3.268026828765869,
-2.1155011653900146,
-0.16934120655059814,
0.3162846267223358,
1.1599246263504028,
-0.4610574543476105,
0.7830453515052795,
-1.4585129022598267,
1.240203619003296,
-2.0128753185272217,
0.6397081017494202,
0.1587582677602768,
-0.4398879110813141,
0.6505963206291199,
0.29008129239082336,
1.1121796369552612,
-0.9285321235656738,
1.0186570882797241,
1.021456003189087,
-1.243318796157837,
-0.6691184043884277,
-0.45500922203063965,
-0.5218836069107056,
0.25116950273513794,
1.3568822145462036,
-0.4113621413707733,
2.0664398670196533,
-0.5170878767967224,
0.25356030464172363,
-0.5607101321220398,
-0.9742374420166016,
0.01866697147488594,
1.225670337677002,
-0.42612215876579285,
-0.7861498594284058,
-0.6066243648529053,
0.34471452236175537,
0.5023190379142761,
0.754550576210022,
0.29665184020996094,
1.0367437601089478,
0.93529212474823,
1.1935769319534302,
-0.48524022102355957,
0.25300052762031555,
-1.3781405687332153,
1.4145114421844482,
0.07226811349391937,
1.5215834379196167,
0.26580342650413513,
-0.8018659949302673,
2.328878164291382,
-0.1279641091823578,
-0.17241787910461426,
0.7674150466918945,
2.1309380531311035,
-0.3206513822078705,
1.877699851989746,
-0.2478140890598297,
-0.2746794819831848,
1.0723999738693237,
-2.7757210731506348,
-0.15868334472179413,
0.2168474793434143,
0.14239586889743805,
-0.6400003433227539,
0.5582515597343445,
-1.3095836639404297,
0.6333776712417603,
0.7626414895057678,
-0.1694689691066742,
-0.3173104226589203,
0.6127326488494873,
-1.5208405256271362,
0.058004021644592285,
1.7925091981887817,
0.6710555553436279,
1.7252163887023926,
0.18872950971126556,
0.2659306228160858,
-1.8245301246643066,
0.6182490587234497,
0.664271354675293,
-0.3140643835067749,
-0.45646870136260986,
0.9179518222808838,
-1.0463330745697021,
1.5568541288375854,
-0.011635469272732735,
-0.0284099243581295,
-0.6791332364082336,
0.9763646125793457,
0.17563138902187347,
-1.9063482284545898,
-1.2422113418579102,
-0.9972338080406189,
-0.2605834901332855,
-0.44578632712364197,
-0.16696809232234955,
0.213100865483284,
-1.1308199167251587,
-0.9919341802597046,
-0.9518870115280151,
0.22686752676963806,
-0.2802076041698456,
-0.32514840364456177,
0.2226916253566742,
-0.18308298289775848,
-0.6351965069770813,
0.13801318407058716,
0.42764681577682495,
0.37951111793518066,
0.7767032980918884,
0.3568498492240906,
2.0622200965881348,
-1.093341588973999,
0.7418890595436096,
-0.272102028131485,
0.6540495157241821,
-0.31498241424560547,
0.34387457370758057,
-0.6785215139389038,
0.6118509769439697,
-0.16738168895244598,
0.2930774688720703,
-1.2117687463760376,
-1.4131495952606201,
-0.47293388843536377,
0.16172438859939575,
0.6430745124816895,
-0.20621027052402496,
-1.4754120111465454,
-0.7928367257118225,
0.4006579518318176,
1.7835253477096558,
0.4870260953903198,
-1.485520601272583,
-1.1347211599349976,
0.8814098238945007,
0.032825954258441925,
0.19822755455970764,
-1.8185933828353882,
-1.1950254440307617,
-0.749363362789154,
1.2617566585540771,
-0.8465713262557983,
-0.44043177366256714,
-0.0752875953912735,
0.9644539952278137,
0.35846734046936035,
0.15716592967510223,
-0.5050260424613953,
1.1371064186096191,
0.372545450925827,
-0.9233875274658203,
1.5445646047592163,
-0.6980041265487671,
-0.4065590798854828,
-0.27419933676719666,
-0.16738463938236237,
-1.0885989665985107,
0.4455147981643677,
0.061081044375896454,
-0.23956094682216644,
0.3489101231098175,
0.2833977937698364,
-0.32713404297828674,
-0.7961020469665527,
-0.19430750608444214,
-0.6328043937683105,
0.3095039129257202,
-0.32154133915901184,
0.28751540184020996,
1.1924861669540405,
-1.1020281314849854,
0.3529088795185089,
0.5941758155822754,
-0.4565376937389374,
0.0657515674829483,
-0.5408604741096497,
-0.12118086963891983,
-0.45365110039711,
-1.3838777542114258,
-0.11021441221237183,
-0.33397936820983887,
0.20511937141418457,
0.9306902289390564,
0.30653464794158936,
-0.060567889362573624,
0.4367871582508087,
0.24411293864250183,
0.05132099986076355,
-0.44145768880844116,
0.40505048632621765,
-0.5720277428627014,
0.16538535058498383,
-0.4612414836883545,
0.686454176902771,
1.7713390588760376,
-0.24011561274528503,
0.04494909569621086,
-0.03783012926578522,
0.04258037731051445,
0.1260857880115509,
-0.670885443687439,
-0.04351595789194107,
0.5302357077598572,
0.5004784464836121,
0.32155823707580566,
-0.4840271472930908,
-0.3057323396205902,
0.4018370807170868,
0.6043851971626282,
0.6367689371109009,
0.7750362753868103,
-0.4950598478317261,
-0.2794000506401062,
-0.8497105240821838,
-0.3707653880119324,
-0.08662725985050201,
0.551537036895752,
-0.0915919691324234,
0.18236896395683289,
0.12559500336647034,
0.24072366952896118,
0.43092110753059387,
-0.37711435556411743,
-0.11654295772314072,
-0.15877437591552734,
0.6414522528648376,
-0.252193808555603,
-0.25396883487701416,
-0.09915482252836227,
0.5347456932067871,
0.2989625930786133,
-0.14450350403785706,
0.5607292652130127,
0.82439124584198,
-0.372422993183136,
0.416984885931015,
-0.3919600546360016,
-0.13662883639335632,
-1.0501224994659424,
-0.6270403265953064,
0.00010677394311642274,
-0.2750966250896454,
0.10215426236391068,
-0.5180544853210449,
-1.156996250152588,
-0.264540433883667,
-0.06470681726932526,
-0.30130505561828613,
-0.5536037087440491
] |
NCT06553768
|
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)
|
The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric and adult participants who have cholestatic liver disease with pruritus that has been refractory to other therapies, and who have no other treatment options.
|
This study will be conducted in multiple sites in North America, Europe, Middle East and South America.
|
Inclusion Criteria:
1. Informed consent and assent (as applicable)
2. Age ≥6 months at time of baseline visit
3. Diagnosis of cholestatic liver disease with cholestatic pruritus based on the presence of chronic liver biochemical abnormalities (\>90 days) and/or pathological evidence of progressive liver disease.
4. If taking antipruritics or ursodeoxycholic acid, the participant has to be on a stable dosing regimen (i.e., same dose and frequency in the 30 days prior to the screening visit and will continue this dosing regimen up to Week 40 \[adjustment for body weight is allowed\]).
5. Access to email or telephone for scheduled participant contacts and access to smart phone or tablet for PROs.
6. Ability to read and/or understand the questionnaires (both caregivers and participants ≥9 years of age).
7. For participants ≤18 years of age: Access to consistent caregiver(s) during the study.
Exclusion Criteria:
Those who meet any of the following criteria are NOT eligible to participate in the study:
1. Diagnosis of ALGS, ICP, PBC, PFIC, or PSC with native liver.
2. Current or recent history (\<1 year) of atopic dermatitis or other non-cholestatic diseases associated with pruritus.
3. History of decompensated cirrhosis or complications of cirrhosis (e.g., esophageal/gastric varices, ascites, hepatic encephalopathy, hepatorenal syndrome). In patients who have had a liver transplant, this exclusion criterion applies to the post-transplant period only. Patients with compensated cirrhosis with preserved hepatic synthetic function and absence of complications are eligible.
4. Suspected or proven cholangiocarcinoma or hepatocellular carcinoma.
5. Unstable and/or serious medical disease that is likely to impair the ability to participate in all aspects of the study, confound efficacy and/or safety assessments, or result in substantially shortened life expectancy (e.g., any active malignancy including hematological malignancy, end-stage heart failure, active infection, acute and chronic diarrhea). Exceptionally, previous history of malignancy, adequately treated/in remission, that in opinion of investigator and medical monitor does not impact participant safety and participation in the study, may be allowed.
6. Laboratory results during the screening visit as follows:
1. Platelet count ≤150,000/mm3
2. Albumin \<30 g/L
3. INR ≥1.5 (after intravenous or subcutaneous supplementation of vitamin K)
4. Total bilirubin \>10 mg/dL
5. ALT \>10× ULN
7. Use of an IBAT inhibitor within 8 weeks prior to the screening visit.
8. Known intolerance/hypersensitivity to maralixibat or its excipients.
9. History of nonadherence to medical regimens, unreliability, medical condition, mental instability, or cognitive impairment that, in the opinion of the investigator, could compromise the validity of informed consent, compromise the safety of the participant, or lead to nonadherence with the study protocol or inability to conduct the study procedures.
|
[
1.7404735088348389,
1.3193014860153198,
-1.6327378749847412,
-0.7723968029022217,
0.28078174591064453,
-0.16425786912441254,
-0.8790432810783386,
-0.07186875492334366,
-1.097957730293274,
-0.6273565292358398,
0.2658819258213043,
2.4681761264801025,
-0.48350974917411804,
-0.10894573479890823,
-0.1262226700782776,
0.5888096690177917,
0.7054974436759949,
1.8169503211975098,
1.1777154207229614,
-0.4925501048564911,
1.5663975477218628,
-0.3975476324558258,
-0.43358638882637024,
0.34576863050460815,
0.19223904609680176,
-0.04940515756607056,
-1.1882507801055908,
1.3259804248809814,
-0.11647238582372665,
0.8612099885940552,
-0.7770774960517883,
-0.368990421295166,
-0.7401651740074158,
0.74973464012146,
-0.15215492248535156,
-0.08589396625757217,
0.9192823171615601,
-0.01145728025585413,
-1.3145387172698975,
-0.02821270562708378,
-0.4047342538833618,
-0.2123885601758957,
0.45879632234573364,
0.3188716471195221,
1.1899527311325073,
1.0042297840118408,
-0.8897817730903625,
1.3941404819488525,
0.5616078972816467,
0.9370957612991333,
-1.3910603523254395,
1.941131830215454,
-0.9449847936630249,
0.6333728432655334,
-0.19195939600467682,
0.3104337155818939,
1.3346893787384033,
0.6445402503013611,
0.3390902578830719,
0.6502131223678589,
1.1593235731124878,
-0.01712951995432377,
-0.02851889468729496,
0.5530926585197449,
-0.5952112674713135,
-0.1667192280292511,
-0.06823145598173141,
-0.2569277286529541,
-0.854866623878479,
0.9601608514785767,
0.4551735818386078,
0.7172081470489502,
0.04425637051463127,
0.6703357100486755,
-0.2127179652452469,
0.45199182629585266,
-0.8379058241844177,
1.2981727123260498,
-0.2922196090221405,
-0.07229963690042496,
0.128057599067688,
0.4298774003982544,
-0.5699437260627747,
0.0046808067709207535,
0.4986194968223572,
-0.19431538879871368,
-0.4723761975765228,
-2.40162992477417,
1.1999342441558838,
-0.6703635454177856,
0.37626054883003235,
-0.9356103539466858,
-0.9850080609321594,
1.0830169916152954,
-0.06199072673916817,
-0.3923514783382416,
-0.03700779378414154,
0.34861278533935547,
-0.4258720278739929,
0.3928205370903015,
0.07180381566286087,
-0.8335002660751343,
-0.9034536480903625,
-0.7449327111244202,
-0.44264644384384155,
-0.3594295382499695,
-0.9787349700927734,
-0.4011853337287903,
-1.2828755378723145,
-1.3850444555282593,
-0.2992112338542938,
-1.199473261833191,
0.12951193749904633,
-0.5389025807380676,
1.3444945812225342,
0.8236097693443298,
-0.07036412507295609,
0.6321824789047241,
-0.23014715313911438,
0.6045658588409424,
0.08701048791408539,
0.5850895047187805,
0.7191303968429565,
-0.1399839073419571,
-0.8824025988578796,
0.1895051747560501,
0.7639118432998657,
0.11232295632362366,
-0.8038331866264343,
-0.3145037293434143,
-1.166604995727539,
0.12943698465824127,
0.39045780897140503,
0.17218062281608582,
-0.558388352394104,
0.2601049542427063,
0.8875333666801453,
-0.07309034466743469,
-0.2077815979719162,
-0.3799038231372833,
-0.008587696589529514,
0.2891004681587219,
-0.4136761724948883,
-0.28634127974510193,
-1.0626749992370605,
0.27344924211502075,
0.4694364368915558,
0.2020965963602066,
-0.3609541654586792,
-0.24097971618175507,
0.19452166557312012,
0.23799557983875275,
0.4198641777038574,
0.2802945673465729,
0.14264144003391266,
0.8430051207542419,
0.011453489772975445,
-1.2634494304656982,
0.20122650265693665,
-0.2962018847465515,
0.38390982151031494,
-0.32746267318725586,
0.00806676410138607,
-0.3555653393268585,
0.7193252444267273,
-0.7846993207931519,
-0.27823764085769653,
0.298676073551178,
0.16562312841415405,
0.19148612022399902,
-0.13810916244983673,
0.2446622997522354,
0.16107064485549927,
0.40120694041252136,
0.2446306347846985,
0.3724135756492615,
0.2509074807167053,
-0.7252426147460938,
-0.1213582381606102,
-0.6116028428077698,
-0.09629971534013748,
0.7476869225502014,
0.31758326292037964,
0.5102002620697021,
0.24548955261707306,
-0.3800670802593231,
-0.5302478075027466,
-0.06477378308773041,
-0.13685820996761322,
0.8925285339355469,
0.3724218010902405,
0.0982046127319336,
-0.458063006401062,
0.11204750090837479,
0.3653125464916229,
-0.24891532957553864,
-0.13597901165485382,
-0.2030971497297287,
0.3431907594203949,
-0.14316755533218384,
0.944991409778595,
0.8571739196777344,
-0.2883520722389221,
0.45402443408966064,
-0.2200913429260254,
0.3256319463253021,
0.17494110763072968,
-0.07262860238552094,
0.11390949785709381,
0.3917693793773651,
0.6094347834587097,
0.3638056516647339,
-0.11038333922624588,
-0.6646692156791687,
0.18165847659111023,
0.9849786758422852,
0.006363232154399157,
0.37149566411972046,
-0.6903080344200134,
-0.14394047856330872,
-0.47622916102409363,
-0.5417354702949524,
0.30241912603378296,
0.1692989617586136,
-0.07451915740966797,
0.5057132244110107,
-0.004616250284016132,
0.3984582722187042,
-0.251505970954895,
-0.807977557182312,
-0.04595011845231056,
0.2333003580570221,
0.033457450568675995,
0.05842895805835724,
-0.2723846435546875,
0.5349941849708557,
0.3038664758205414,
0.5787599682807922,
0.06612829118967056,
-0.07010646909475327,
0.44675806164741516,
-0.27079692482948303,
-0.24144329130649567,
0.21191327273845673,
-0.4831075966358185,
-0.17516615986824036,
0.04204036667943001,
0.2217276692390442,
0.4043324887752533,
-0.2514229118824005,
-0.3033517897129059,
-0.04607756435871124,
0.21084712445735931,
0.3527897894382477,
0.42534542083740234,
-0.5519988536834717
] |
NCT03974113
|
Fitusiran Prophylaxis in Male Pediatric Subjects Aged 1 to Less Than 12 Years With Hemophilia A or B
|
Primary Objective:
- To confirm appropriate dose levels of fitusiran when administered to male pediatric participants (ages 1 to \<12 years of age) with severe hemophilia A or B
Secondary Objectives:
* To characterize the safety and tolerability
* To determine fitusiran plasma concentrations at selected time points
|
The estimated total time on study is up to 256 weeks for participants who roll over into the extension study and up to 280 weeks for participants who do not roll over into the extension study (due to the requirement for up to an additional 6 months of follow-up for monitoring of AT levels).
|
Inclusion Criteria:
* Male, aged 1 to \<12 years at the time of enrollment.
* Severe hemophilia A or B (Factor VIII (FVIII) \<1% or Factor IX (FIX) ≤2%)
* Participants must have inhibitory antibodies to FVIII or FIX and must meet one of the following Nijmegen-modified Bethesda assay results criteria:
* Inhibitor titer of ≥0.6 BU/mL at screening, OR
* Inhibitor titer of \<0.6 BU/mL at screening with medical record evidence of 2 consecutive titers ≥0.6 BU/mL, OR
* Inhibitor titer of \<0.6 BU/mL at screening with medical record evidence of 1 inhibitor titer ≥0.6 BU/mL and a history of anamnestic response or severe allergic reaction (anaphylaxis or nephrotic syndrome)
* Adequate peripheral venous access, as determined by the Investigator, to allow the blood draws required by the study protocol
* Weight requirements at the time of enrollment: 8 to \<45 kg
* Willing and able to comply with the study requirements and to provide signed written informed consent obtained from parent(s)/legal guardian (hereinafter the "parent") and written or oral assent obtained from participant, per local and national requirements
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Known co-existing bleeding disorders other than hemophilia A or B
* Antithrombin (AT) activity \<60% at Screening
* Co-existing thrombophilic disorder
* Clinically significant liver disease
* Active Hepatitis C virus infection
* Acute or chronic Hepatitis B virus infection
* Acute Hepatitis A or hepatitis E infection
* HIV positive with a CD4 count of \<400 cells/μL
* History of arterial or venous thromboembolism, unrelated to an indwelling venous access
* Inadequate renal function
* History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine (GalNAc)
* Subjects with central or peripheral indwelling catheters, with history of venous access complications leading to hospitalization and/or systemic anticoagulation therapy.
* History of intolerance to subcutaneous (SC) injection(s)
* Use of emicizumab (Hemlibra®) within 6 months prior to screening
* Any other conditions or comorbidities that would make the patient unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgment
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
|
[
0.03967335820198059,
1.9212524890899658,
-3.7028512954711914,
-1.9027856588363647,
1.54348623752594,
0.8675227761268616,
-0.4636596143245697,
-0.1742212474346161,
0.08939973264932632,
-1.4619998931884766,
0.47938162088394165,
1.0856248140335083,
-0.9192885160446167,
-0.021773306652903557,
0.8666747808456421,
2.1217408180236816,
-0.7115050554275513,
0.37085598707199097,
1.2165952920913696,
-2.376220941543579,
0.8198102116584778,
1.1500142812728882,
0.015443588607013226,
0.0013514490565285087,
0.7344868183135986,
-0.1382400095462799,
-0.8307799696922302,
-0.6679186224937439,
-0.0794144868850708,
0.11242977529764175,
0.4456784725189209,
-0.47776955366134644,
0.8829854726791382,
0.0008857538923621178,
0.23524904251098633,
0.23732046782970428,
0.12458785623311996,
0.49811530113220215,
-0.9329165816307068,
0.09326087683439255,
0.6308795809745789,
0.47801080346107483,
0.16894645988941193,
-0.5457420945167542,
1.4038513898849487,
-0.06603407859802246,
-1.2286350727081299,
-0.42715951800346375,
-0.12624140083789825,
0.7615877389907837,
-0.02152355946600437,
0.7709594964981079,
-1.5345432758331299,
0.4977366626262665,
1.2669358253479004,
-0.22160616517066956,
1.1899274587631226,
0.26777949929237366,
1.4646705389022827,
-0.06193912401795387,
0.6954048275947571,
0.059081900864839554,
1.2430031299591064,
-0.08184969425201416,
-0.5487163662910461,
-0.06929891556501389,
0.5576270222663879,
0.24048052728176117,
-1.1395872831344604,
1.2454699277877808,
-0.1800485998392105,
0.39794668555259705,
0.7797279953956604,
0.9789384603500366,
0.25001227855682373,
1.5138570070266724,
0.47794660925865173,
0.818061113357544,
-0.6241199970245361,
1.0828235149383545,
-0.5040221214294434,
0.6593244075775146,
0.1726982444524765,
-0.020027345046401024,
0.9860448241233826,
0.35774093866348267,
-0.8390873670578003,
-0.2522266209125519,
1.295184850692749,
-0.7028070092201233,
-0.10161654651165009,
-0.0569365955889225,
-1.501301646232605,
1.14426589012146,
-0.10782820731401443,
-0.09205283224582672,
0.460719496011734,
0.8077646493911743,
-1.1402337551116943,
-0.2843692898750305,
0.25224798917770386,
-0.49333369731903076,
0.6234215497970581,
-0.08687832206487656,
-0.7773954272270203,
-0.9905471801757812,
-0.15379507839679718,
-0.4346493184566498,
-0.5853849053382874,
0.004007281735539436,
-0.12216160446405411,
-1.2405357360839844,
-0.045991718769073486,
-0.25190114974975586,
0.5670573115348816,
0.1743738353252411,
1.1362015008926392,
-0.5217346549034119,
-0.16732589900493622,
-1.1717503070831299,
0.10338417440652847,
0.4721669852733612,
-0.5895256400108337,
-0.6544787287712097,
-0.6277022361755371,
-0.0006921471795067191,
0.636208713054657,
-0.2516476809978485,
-0.2594852149486542,
-0.4710661768913269,
-1.5445045232772827,
0.5209205150604248,
0.3519127070903778,
0.5591369867324829,
0.015979228541254997,
-0.9064664244651794,
0.26488256454467773,
0.4611063599586487,
0.6095064282417297,
-0.5811224579811096,
0.3646121621131897,
1.4353435039520264,
-0.8769153952598572,
-0.20399633049964905,
-1.2080938816070557,
0.8710509538650513,
-0.504309356212616,
-0.001082134316675365,
-0.5747596621513367,
-0.3601688742637634,
-0.2529415488243103,
0.036141227930784225,
-0.426644504070282,
1.4351471662521362,
0.761455774307251,
0.4924536645412445,
0.26718851923942566,
-0.06917805969715118,
0.4801149368286133,
0.49789613485336304,
0.09217343479394913,
-0.5320326685905457,
-0.8351597189903259,
-0.23552733659744263,
0.35613295435905457,
0.007972601801156998,
-1.2480624914169312,
0.2844904661178589,
0.4336453080177307,
0.568833589553833,
0.19527702033519745,
0.09350617974996567,
-0.42576658725738525,
0.7442197203636169,
0.675151526927948,
-0.8975213170051575,
0.1551196426153183,
0.0438060536980629,
-0.14720042049884796,
1.0339611768722534,
-0.15050986409187317,
0.6586480736732483,
0.6924039125442505,
-0.7726857662200928,
0.09784124046564102,
-0.3280178904533386,
-0.013110153377056122,
-0.04703420400619507,
-0.7506313920021057,
0.23969070613384247,
0.630893886089325,
-0.9576542973518372,
-0.5350827574729919,
0.06391799449920654,
0.0825728327035904,
-1.0653761625289917,
-0.18473924696445465,
-0.33319786190986633,
0.5412476658821106,
-0.36304426193237305,
0.3723829984664917,
-0.06676165759563446,
0.414298415184021,
-0.272195041179657,
-0.26192137598991394,
0.41206181049346924,
0.07898913323879242,
0.13789191842079163,
-0.03977620229125023,
-0.7433052062988281,
0.24048270285129547,
-0.17460021376609802,
-0.9872644543647766,
-0.04594282805919647,
0.236918106675148,
-0.024440253153443336,
-0.6121058464050293,
0.27392879128456116,
-0.22733065485954285,
0.3976556658744812,
-0.11623016744852066,
-0.6186619400978088,
0.43452081084251404,
0.3648734986782074,
-0.43249431252479553,
-0.310981810092926,
-0.4461454451084137,
-0.025162668898701668,
-0.7299669981002808,
-0.1553356647491455,
-0.2959100008010864,
-0.1342209428548813,
-0.30616265535354614,
0.22813421487808228,
-0.5810507535934448,
0.0846240371465683,
0.07511874288320541,
-0.2435222715139389,
-0.25132033228874207,
-0.022730162367224693,
-0.19408944249153137,
-0.25844767689704895,
0.035392824560403824,
-0.6037236452102661,
-0.45173534750938416,
-0.1610528528690338,
0.01776484213769436,
0.1792544722557068,
0.047328367829322815,
-0.47493305802345276,
-0.08320646733045578,
-0.17281383275985718,
-0.4201112389564514,
-0.16322576999664307,
0.1800682693719864,
-0.07626048475503922
] |
NCT05711173
|
Clonal Hematopoiesis and NETs Formation in Venous Thrombosis (CLODETTE)
|
Thrombo-embolic venous diseases are represented by deep venous thrombosis and/or pulmonary embolism. In some patients with repeated thrombosis or occurrence of thrombosis in unusual sites, the etiological workup remains negative, which represents a problem for the management of the anticoagulant treatments. Recently, two factors have been identified as important in the physiopathology of hemostasis and coagulation: the presence of clonal hematopoiesis of indetermined potential (CHIP) and the formation of neutrophil extracellular traps (NETs). In this study, these two factors will be studied in patients with repeated venous thrombosis or thrombosis occurring in unusual site.
|
It has recently been shown that some patients clonal have mutations at a low level in hematopoietic cells (this phenomenon is named clonal hematopoiesis of indetermined potential (CHIP)) and that the presence of a clonal hematopoiesis is associated with an increased cardiovascular risk. However, few data exist about the implication of CHIP in venous thrombosis. Neutrophils extracellular traps are involved in the activation of hemostasis and coagulation. Murine models have highlighted the crucial role of NETs in the physiopathology of venous thrombosis. In patients, studies have demonstrated that NETs markers were present in arteries lesions as coronary plaques. However, few studies have analyzed the NETosis in the setting of venous thrombosis.
The study hypothesis is that patients with venous thrombosis may have an increased prevalence of CHIP and/or an increased NETosis formation, which may represent a predisposition for the occurrence of venous thrombosis. We also speculate that patients with CHIP may have an increased NETosis, due to the presence of activating clonal mutations in neutrophils.
Patients included will be : younger than 50-years-old with repeated thrombosis or thrombosis of unusual sites (cerebral venous thrombosis, splanchnic thrombosis) with a negative etiological workup and notably the absence of constitutional or acquired venous thrombosis risk factors. In this population, we will analyze the prevalence of CHIP and the NETosis via the study of 4 different NETosis plasmatic markers.
|
Inclusion Criteria:
* Patients (male or female) less than 50 y.o with :
* Splanchnic venous territory thrombosis or
* Cerebral venous thrombosis or
* Venous thrombosis of the upper limb or
* Pulmonary embolism (1st episode if male, 2nd episode if female) unprovoked or
* 1 episode of deep vein thrombosis + 1 episode of arterial thrombosis
Exclusion Criteria:
* Presence of a major or minor transient venous thrombosis risk factor:
* Surgery within the last 3 months preceding the qualifying thrombotic episode
* Lower limb fracture with immobilization \> 3 days in the last 3 months preceding the qualifying thrombotic episode
* Presence of estro-progestational contraception
* Pregnancy
* Immobilization for acute medical reasons within the last 3 months preceding the qualifying thrombotic episode
* Air or car travel \> 6 hours
* Presence of a major or minor persistent risk factor for venous thrombosis:
* Presence of active cancer (solid cancer or hematologic malignancy)
* Chronic inflammatory digestive or joint diseases
* Ongoing treatment with heparin (low molecular weight heparin (LMWH) or unfractionated heparin (UFH))
* Presence of an abnormality on the thrombophilia test among the following abnormalities
* Protein C deficiency
* Protein S deficiency
* Anti-thrombin deficiency
* Heterozygous or homozygous factor II mutation
* Heterozygous or homozygous factor V mutation
* Presence of anti-phospholipid syndrome
* Presence of myeloproliferative neoplasia
* Presence of paroxysmal nocturnal hemoglobinuria
|
[
1.6389507055282593,
0.8754304051399231,
-3.1291866302490234,
-1.8027509450912476,
0.048909056931734085,
-0.9095022082328796,
-0.05813667178153992,
-1.5884710550308228,
-1.482751727104187,
0.39779454469680786,
1.6914087533950806,
0.8757184147834778,
0.7213967442512512,
-0.2622467875480652,
1.6744556427001953,
0.7144841551780701,
-1.0735688209533691,
-0.23366467654705048,
1.749053716659546,
-1.9098418951034546,
-0.17475762963294983,
-0.09248407185077667,
-0.12716113030910492,
-1.5872986316680908,
1.6495497226715088,
0.038882624357938766,
-0.40418916940689087,
-0.31499412655830383,
-0.44827142357826233,
1.6227840185165405,
-0.1421644240617752,
-0.07525712251663208,
1.0825212001800537,
0.2699148952960968,
0.7138320207595825,
-1.226638913154602,
1.0801761150360107,
1.0394880771636963,
-1.3555654287338257,
-0.5647003650665283,
-0.36755359172821045,
0.12298534065485,
0.20938828587532043,
0.34568852186203003,
0.012670041993260384,
-0.05511385202407837,
-0.1334385722875595,
2.297229766845703,
-0.0295596681535244,
-0.3256860375404358,
-0.9746567606925964,
0.46537476778030396,
-0.6645935773849487,
0.6577240228652954,
1.5899150371551514,
0.9488903880119324,
0.6781622767448425,
0.6130486726760864,
0.30982741713523865,
-1.2020854949951172,
1.7282098531723022,
-0.6443474888801575,
0.09617641568183899,
0.4439331591129303,
0.05276423692703247,
-0.20409941673278809,
-0.2473280131816864,
0.996799111366272,
-0.7858416438102722,
0.07614623755216599,
-1.0735888481140137,
0.7568713426589966,
0.29048043489456177,
0.04541132226586342,
-0.048106394708156586,
1.2550840377807617,
-1.0551502704620361,
1.254751443862915,
-0.4420616626739502,
-0.7075241804122925,
-0.3510952591896057,
0.48225897550582886,
-1.224682092666626,
1.4914699792861938,
-1.1950318813323975,
-0.992996335029602,
-0.4405876100063324,
-1.048997163772583,
0.0636204183101654,
-0.28903135657310486,
0.10124216973781586,
0.06155464053153992,
-0.9733664393424988,
-0.5059462785720825,
0.33180099725723267,
-0.31846708059310913,
0.3197362720966339,
-0.33077019453048706,
-0.4086853563785553,
-0.6781652569770813,
0.30277714133262634,
-0.10651229321956635,
-0.4506073594093323,
-0.6938537359237671,
-0.4605347216129303,
-0.2145099937915802,
0.27936822175979614,
-0.7189229130744934,
-0.846215546131134,
-0.9378536939620972,
0.34267812967300415,
-0.07912781834602356,
0.6822869181632996,
-0.07004957646131516,
-0.2651492655277252,
0.6941195726394653,
0.327352911233902,
-0.345661461353302,
0.5511853098869324,
-0.46605730056762695,
-0.3825417160987854,
1.4493011236190796,
-0.3679870367050171,
0.059238024055957794,
-0.44121941924095154,
0.8109878301620483,
0.5828627943992615,
0.025894081220030785,
-0.03818855434656143,
-0.5194846391677856,
-0.2118488848209381,
0.2438887655735016,
0.21388080716133118,
-0.5449317693710327,
-0.9663825035095215,
-0.15180650353431702,
0.885766863822937,
1.6758315563201904,
-0.01773891970515251,
-0.7247129082679749,
0.40331411361694336,
0.4689748287200928,
-0.06781333684921265,
0.01587049663066864,
-0.1540333330631256,
-0.7190214395523071,
0.08520630747079849,
0.3947376012802124,
-0.19166678190231323,
0.6927135586738586,
0.2765474319458008,
0.9812498092651367,
0.5535346269607544,
0.14877764880657196,
0.3243802487850189,
-0.9077752232551575,
0.1713515967130661,
-0.09261399507522583,
0.23170454800128937,
-0.08643992245197296,
-0.39887315034866333,
-0.06599926948547363,
-0.04772529378533363,
0.9227797389030457,
0.42244282364845276,
-0.8250681757926941,
-0.02510197088122368,
-0.4150725305080414,
0.38672682642936707,
-0.7719401121139526,
-0.23043318092823029,
-0.38610243797302246,
-0.5262128114700317,
0.7366048097610474,
-1.204737663269043,
-0.008847574703395367,
0.7144798040390015,
0.28144365549087524,
-0.5970335006713867,
-0.29742181301116943,
0.1273488700389862,
-0.403583288192749,
0.15310803055763245,
-0.3645192086696625,
0.7068658471107483,
0.3144198954105377,
0.1378525346517563,
0.49241822957992554,
-0.09665795415639877,
0.5873125791549683,
0.2585078179836273,
-0.4137951731681824,
-0.1865413337945938,
0.4060080647468567,
-0.15630565583705902,
0.30123308300971985,
-0.00862761028110981,
-0.17033858597278595,
0.04899367690086365,
-0.04246039316058159,
0.3656146228313446,
0.6569573283195496,
0.41278544068336487,
0.7587124109268188,
0.04680236801505089,
0.19315971434116364,
0.03333659842610359,
0.34727662801742554,
-0.23965778946876526,
0.2833685576915741,
-0.5572493672370911,
0.04310055449604988,
-0.11153960227966309,
0.25503262877464294,
0.4547431468963623,
0.13449954986572266,
-0.41222986578941345,
-0.11349423229694366,
-0.6793709397315979,
-0.2917693555355072,
0.22407877445220947,
-0.2281583845615387,
-0.20928442478179932,
-0.442434161901474,
0.25177931785583496,
0.057056039571762085,
0.6903277635574341,
-0.08971692621707916,
-0.18779757618904114,
0.33318278193473816,
-0.36141669750213623,
0.12426666915416718,
0.11925546824932098,
-0.4445663392543793,
0.0802106112241745,
0.2020934522151947,
-0.08937276154756546,
-0.3181571066379547,
0.9865906834602356,
0.2734155058860779,
-0.09494465589523315,
-0.005750274285674095,
-0.2907840609550476,
0.030038293451070786,
-0.32292765378952026,
-0.05446230247616768,
0.2668623924255371,
-0.40178781747817993,
-0.5467601418495178,
-0.04688647761940956,
0.004822093062102795,
-0.3887880742549896,
-0.10380736738443375,
-0.15721210837364197,
0.16689753532409668,
-0.26101717352867126
] |
NCT05163600
|
The Acute Cardiorespiratory Response to Blood-flow Restricted Versus Traditional Exercise Training Regimens (CaRe BFR)
|
The investigators hypothesize that BFR exercise regimens result in a different acute cardiorespiratory response pattern compared to traditional exercise regimens. Furthermore, the investigators hypothesize that these patterns differ between healthy participants and participants with COPD.
Regarding secondary objective, the investigators hypothesize that BFR results in lower blood pressure responses compared to traditional exercise training in both healthy and COPD participants.
|
The investigatorscarry out a monocentric project with 4 randomized crossover studies.
CaRe-BFR Healthy and COPD:
Strength training is performed bilaterally on a Leg Press machine (Leg Press VR2, Cybex International Inc. Medway, MA, USA) using the three set methodology, which is proven to be most effective in enhancing muscle strength.16 Each set is performed to muscular failure, which should be reached within 8-12 repetitions. Training rhythm is set at 1-0-1-0 (i.e. one second for the concentric phase, no pause, one second for the eccentric phase, no pause) and externally paced by a metronome. The training load is 80% of the 1RM. Rest in between sets is 1 minute and participants remain
Strength training BFR is performed bilaterally on a Leg Press machine (Leg Press VR2, Cybex International Inc. Medway, MA, USA) in accordance with evidence-based application guidelines to apply the most effective methodology to enhance muscle strength.17 The exercise consists of a total of 75 repetitions during 4 sets. Training rhythm is set at 1-0-1-0 (i.e. one second for the concentric phase, no pause, one second for the eccentric phase, no pause) and externally paced by a metronome. Set 1 covers 30 repetitions, and the subsequent sets 15 repetitions each. The training load is 30% of the 1RM. Cuffs are mounted bilaterally at the most proximal part of the thigh and inflated to 70% of the individual AOP. Rest in between sets is 1 minute and participants remain seated with the cuffs inflated.
-Endurance is performed bilaterally on a stationary bicycle ergometer (kardiomed 521, proxomed Medizintechnik GmbH, Alzenau, Germany) in an interval setting with loading phases of 1 set with 3 intervals lasting for 2 minutes each; training load is 65% of the peak work rate (PWR). In between the intervals, breaks are standardised to 1 minute. Before the exercise bout, warm-up cycling at 30% PWR for 5 minutes is done to reach a steady state in HR and RER.
Endurance BFR is performed bilaterally on a stationary bicycle ergometer (kardiomed 521, proxomed Medizintechnik GmbH, Alzenau, Germany) in an interval setting with loading phases of 1 set with 3 intervals lasting for 2 minutes and 18 seconds each (matching the overall work performed in EN); training load is 50% of the PWR while limb blood flow is restricted to 50% of the AOP. In between the intervals, breaks are standardised to 1 minute (cuff inflated). Before the exercise bout, warm-up cycling (without BFR) at 30% PWR for 5 minutes is done to reach a steady state in HR and RER.
Measurements:
During exercise, the investigators collect breath-by-breath data (Ergostik, Geratherm Respiratory GmbH, Bad Kissingen, Germany). In addition, continuous SpO2 and HR data via an earlobe probe, and BP response immediately after exercise sets are collected
|
Inclusion and exclusion for the healthy participants are defined by the following criteria.
Inclusion criteria:
* Age ≥ 18 years
* Clinically healthy
Exclusion criteria:
* Physical or intellectual impairment precluding informed consent or protocol adherence
* Non-German speaking (precluding informed consent)
* Pain during exercise of any origin
* Pregnancy
* History of thromboembolic event in the lower extremity
* Resting systolic blood pressure \<100 mmHg
Inclusion and exclusion for the COPD participants are defined by the following criteria.
Inclusion criteria:
* Age ≥ 18 years
* Diagnosed COPD according to GOLD-guidelines12
Exclusion criteria:
* Physical or intellectual impairment precluding informed consent or protocol adherence
* Non-German speaking (precluding informed consent)
* Acute or recent (within the last 6 weeks) exacerbation of COPD
* Pain during exercise of any origin
* Pregnancy
* History of thromboembolic event in the lower extremity
* Resting systolic blood pressure \<100 mmHg
|
[
-0.34153440594673157,
3.017072916030884,
-3.280775547027588,
-2.5438828468322754,
1.6403228044509888,
-0.8486077785491943,
-0.6058844923973083,
-1.2464799880981445,
-0.4191129505634308,
-1.0691063404083252,
1.1399800777435303,
1.8493038415908813,
0.6600191593170166,
-0.01874450594186783,
1.4563759565353394,
1.6286072731018066,
2.0358238220214844,
-0.6933985352516174,
1.6967109441757202,
-2.373117685317993,
-0.39573800563812256,
1.0200644731521606,
0.2893258035182953,
-0.7372300624847412,
0.25251713395118713,
0.5054186582565308,
-0.37455910444259644,
-0.4989425539970398,
-0.7855516076087952,
0.8391635417938232,
1.450268268585205,
-0.20501424372196198,
0.8253461718559265,
-1.233589768409729,
-1.5556645393371582,
-0.5544440746307373,
0.39544394612312317,
-0.6749325394630432,
-0.9535227417945862,
0.39535605907440186,
0.5444057583808899,
2.1877710819244385,
1.382200837135315,
0.07008316367864609,
1.4156272411346436,
1.3507258892059326,
0.4471811056137085,
2.168170928955078,
-0.4397134780883789,
-0.5182714462280273,
-1.2429189682006836,
0.46000996232032776,
-1.392189860343933,
0.8293424844741821,
2.3797073364257812,
-0.3935718834400177,
-0.40656062960624695,
1.0751811265945435,
0.14574672281742096,
-0.8481512069702148,
1.7992515563964844,
0.24616219103336334,
0.9164104461669922,
0.14862102270126343,
0.05457420274615288,
-0.5141413807868958,
0.8781169652938843,
-0.958583652973175,
-0.637990415096283,
-0.17921669781208038,
0.39446499943733215,
-1.0178381204605103,
0.7827101349830627,
1.4567269086837769,
0.4410656988620758,
0.28162848949432373,
0.016213135793805122,
1.4038513898849487,
-0.8355756402015686,
1.3449633121490479,
-0.584478497505188,
0.5637001395225525,
-0.6654632687568665,
0.2714376449584961,
-0.018250390887260437,
-0.5544341206550598,
-1.4720324277877808,
-0.5874894261360168,
1.0066543817520142,
-0.9887976050376892,
-0.12726259231567383,
-0.17547760903835297,
-1.101744532585144,
1.2251619100570679,
0.9824956655502319,
-0.055783700197935104,
-0.21059846878051758,
0.5493323802947998,
-0.8413377404212952,
-0.018632013350725174,
0.2770068347454071,
0.007553981151431799,
-0.05027344450354576,
0.9927864074707031,
-0.2960343062877655,
-0.6438818573951721,
-0.46282240748405457,
-1.5473803281784058,
0.01092055905610323,
0.8278608322143555,
-0.07155254483222961,
-1.8104431629180908,
-0.655718982219696,
-0.0007363507174886763,
1.7374347448349,
0.8850110769271851,
1.459564208984375,
1.1467928886413574,
0.7367293834686279,
-1.6534912586212158,
-1.2624226808547974,
0.6872813701629639,
1.2362138032913208,
0.013153478503227234,
-0.16209173202514648,
0.6472114324569702,
0.1705572009086609,
0.4048512578010559,
-0.13691090047359467,
0.0011986320605501533,
-0.8589840531349182,
-0.15689405798912048,
0.7251670360565186,
-0.40020257234573364,
-0.30836036801338196,
-0.05503464117646217,
0.6255201697349548,
1.5601893663406372,
-0.9239601492881775,
-0.07076219469308853,
-0.3973941504955292,
1.2088910341262817,
0.3339405357837677,
-0.42142942547798157,
-0.5418490767478943,
-0.5681443810462952,
-0.022569674998521805,
-0.042377278208732605,
-0.7707841992378235,
0.0018329437589272857,
-0.5166893601417542,
0.6267723441123962,
0.052399083971977234,
0.7721744179725647,
-0.8189054131507874,
0.13683269917964935,
-0.705729067325592,
0.27477535605430603,
-0.14733165502548218,
0.5940990447998047,
0.35680970549583435,
-1.09675133228302,
-0.004561285953968763,
0.3660596013069153,
0.25456345081329346,
-0.9798645377159119,
-0.3003444969654083,
0.29267680644989014,
0.5195654630661011,
-0.34761664271354675,
-0.09450754523277283,
0.12241382151842117,
0.9759449362754822,
0.8286857008934021,
-0.2686954140663147,
0.6721609234809875,
0.5799065828323364,
0.1491948813199997,
0.6402583122253418,
-0.17429253458976746,
0.3404974937438965,
0.3058835566043854,
0.2804659605026245,
-0.052240315824747086,
-0.04416677728295326,
-0.5690110325813293,
-0.4234059154987335,
-1.065205454826355,
0.016313878819346428,
-0.2619653642177582,
-0.7495980858802795,
0.12430107593536377,
-0.31046003103256226,
0.07818607985973358,
-0.1703290492296219,
-0.3096592426300049,
-0.5495156645774841,
-0.8855682015419006,
0.6053351759910583,
-0.46792325377464294,
0.3606134057044983,
-0.08589678257703781,
0.13679610192775726,
1.3413363695144653,
-0.4861021935939789,
-0.027178144082427025,
0.12341708689928055,
-0.052286162972450256,
-0.20929323136806488,
0.21959376335144043,
0.4872114956378937,
-0.738844633102417,
-0.18009088933467865,
0.59767746925354,
0.6942752599716187,
0.34099751710891724,
0.4896354377269745,
0.5574575662612915,
-0.5990252494812012,
0.8954794406890869,
-0.20979560911655426,
-0.33021271228790283,
0.012083008885383606,
-0.10333602875471115,
-0.06647372990846634,
0.03056156449019909,
0.2814626097679138,
0.10004729777574539,
-0.11414358764886856,
0.37141311168670654,
-0.8180015683174133,
-0.31726643443107605,
-0.3511524498462677,
0.042308345437049866,
-0.404922753572464,
-0.35246869921684265,
-0.3951413035392761,
0.43602272868156433,
0.3918295204639435,
0.3206195533275604,
-0.0009882963495329022,
-0.6362062096595764,
-0.21841520071029663,
-0.39016520977020264,
0.8144979476928711,
-0.536522626876831,
-0.397969514131546,
0.18376412987709045,
-0.2183809131383896,
-0.21721796691417694,
0.33209431171417236,
-0.18584467470645905,
0.3654281497001648,
0.3257331848144531,
-0.2984354496002197,
-0.1927921622991562
] |
NCT05350436
|
More Singing, Less Swinging - Is Singing Related to Improved Postural Control?
|
This study will investigate the extent to which singing affects balance and breathing.
Singing therapy has potential as an adjunct or component of falls prevention programmes and in the treatment of breathing hypervigilance. Reducing fall risk, and levels of hypervigilance and anxiety could have widespread benefits on participants participation and quality of life.
Investigators will aim to recruit both singers and non singers from older and younger adult age groups. Investigators will then be able to determine the balance response in untrained healthy young adults to understand the affects of singing training and aging on balance. The participants' balance will be measured via a force plate as they perform a series of speaking and singing tasks. Other outcomes will include breathing specific anxiety and attention to breathing, and balance specific anxiety and attention to balance.
|
Singing has become a popular arts-in-therapy activity used by physiotherapists as part of their clinical treatment. For example, Singing for Lung Health (SLH) programmes are used in the management of long-term respiratory conditions. These programmes involve group-based singing activities with a focus on breathing control and posture. There are indications that SLH is effective at alleviating symptoms of respiratory disease, likely due to a combination of physical, psychological and social mechanisms.
One main factor that could directly impact on breathing are affective and attentional changes. Reduced anxiety and depression through singing therapy has been suggested to improve breathing control and functioning in those with chronic respiratory conditions. Qualitative surveys have reported that participants find singing to be an "uplifting" activity and that singing with a group of peers may also help to combat isolation.
These changes may be accompanied by changes in allocation of attention. I.e., it is thought that anxiety leads to heightened vigilant monitoring of breathing, and that this hypervigilance leads to a switch in control of breathing from automatic to consciously processed, resulting in breathing dysfunction and breathlessness. Notably, normalisation of such excessive anxiety related vigilance may underpin the improvements that patients report after singing therapy, in terms of control of breathing and breathlessness during exacerbations. Singing therapy may therefore improve breathing control through reducing anxiety as well as associated attention to breathing. One aim of this study is to test this idea further, and to determine if singing impacts on breathing vigilance.
An additional potentially very important effect of singing interventions is that people may improve their balance control as well, both directly and indirectly. Breathing and postural control are tightly linked. We continuously need to make postural adjustment in response to disturbances due to (changes in) breathing - and especially so when breathing is effortful and accelerated. Several studies of SLH in patients with COPD report participants perceive singing had a positive impact on their posture. Also, recent studies suggest that expert singers have better postural control compared to novices. Better control over breathing thus may also improve postural control.
Indirectly, and similar to breathing vigilance, singing interventions may also help normalise individual's attention toward posture and balance. Fear of falling is common in people with respiratory conditions such as COPD. Typically, such fear / anxiety will lead to a strong, potentially excessive, increase in attention to balance. As with breathing, this "hypervigilance" can itself lead to distorted perception of unsteadiness. Singing therapy may therefore improve balance control through reducing anxiety and associated attention to movement.
Therefore, this study will also explore the effects of singing on balance control and associated changes in balance-related hypervigilance.
To investigate these questions, investigators planned a scoping study in which they:
* Aim to investigate the effects of singing on breathing control (e.g., breathing rate, breathing pattern assessment; see all outcomes below)
* Immediate: Effects of singing (varying demands) vs no-singing condition
* Long-term: differences between people with and without regular singing experience in terms of breathing control during no-singing vs singing conditions.
* Aim to investigate the effects of singing on breathing-related anxiety \& vigilance (state anxiety, breathing vigilance; self-reported)
* Immediate effects (balance vs. balance + singing) \& long-term effects (differences between groups with and without singing experience)
* Aim to investigate the effects of singing on balance control (sway, sway frequency)
* Immediate effects (balance vs. balance + singing) \& long-term effects (differences between groups with and without singing experience)
* Aim to investigate the effects of singing on balance-related anxiety and vigilance (state anxiety, balance hypervigilance, conscious processing of balance; all self-reported)
* Again, immediate effects (balance vs. balance + singing) \& long-term effects (differences between groups with and without singing experience)
|
Inclusion Criteria:
* For young adults: 18 - 35 years of age
* For older adults: 60 years of age or older
* The "Older Adult" age group will be defined as adults aged 60 and older, based on the specifications of the World Health Organization (2017).
* The "Younger Adult" age group will be defined as adults aged 18 to 35 inclusive. There will be a buffer range of ages 36 to 59. This is being done to get a clear delineation between age groups.
Exclusion Criteria:
For all:
* Any respiratory, neurological, cardiac disease or deficit (and are on regular medication for it), and/or mobility issues.
* Have tested positive for COVID-19 in the last 15 days (van Kampen et al., 2021)
* Are diagnosed with Chronic COVID Syndrome
* Conditions limiting the ability to stand for \>1 minute independently (e.g., chronic fatigue, recent injury affecting balance)
* Pregnancy (although this will not apply to older adults)
* Conditions limiting participating in singing activities (aphasia, dysarthria, dysphonia, speech impairments)
Investigating young adults allows to better isolate the effects of singing, as these individuals will not suffer from co-morbidities that may confound, modify or attenuate the effects. Conversely, the older adult group is relevant to study from a clinical point of view.
|
[
-2.3947765827178955,
4.135566711425781,
-1.4315786361694336,
-1.3283060789108276,
-0.49202245473861694,
1.1283783912658691,
-0.5569460988044739,
-0.8542329668998718,
0.12218756973743439,
-0.4446352422237396,
0.8226266503334045,
1.7118868827819824,
-1.5660388469696045,
-0.1378168910741806,
-0.17374929785728455,
2.0769243240356445,
0.55836421251297,
-0.3265831172466278,
1.6498593091964722,
-1.1938363313674927,
-0.19994446635246277,
-0.01440365519374609,
0.4554077982902527,
-1.2064255475997925,
0.34820306301116943,
1.1013461351394653,
0.2838539481163025,
1.4958542585372925,
0.027684027329087257,
0.00986065436154604,
0.7656503915786743,
-1.6935887336730957,
1.0279234647750854,
-0.2873999774456024,
0.4928992688655853,
-0.5615068078041077,
0.5733867287635803,
0.280092716217041,
-0.5444603562355042,
-0.07568100839853287,
0.9966854453086853,
1.0867698192596436,
1.0382367372512817,
-0.3851769268512726,
-0.3339378237724304,
1.1656243801116943,
-0.37541067600250244,
1.1699246168136597,
0.14730104804039001,
0.13455654680728912,
0.22342140972614288,
0.6349238753318787,
-0.01731833815574646,
-0.1833639144897461,
2.3315389156341553,
-1.582271933555603,
0.6767721176147461,
-0.433601975440979,
-0.2285260260105133,
0.910883903503418,
0.5108330249786377,
0.33190855383872986,
0.7842276692390442,
0.9553988575935364,
-1.1220718622207642,
-0.4368571937084198,
0.7195033431053162,
-0.30807799100875854,
-0.7392444014549255,
0.008006316609680653,
-0.4630466401576996,
0.760881781578064,
0.6041237711906433,
-0.2998292148113251,
0.26588016748428345,
-0.23964449763298035,
-0.7914882898330688,
0.7546325922012329,
-0.06700550019741058,
0.5067269206047058,
-1.349015474319458,
1.1013127565383911,
-0.054948076605796814,
-1.599596381187439,
2.2884745597839355,
-0.36322087049484253,
-0.9412902593612671,
-1.3568212985992432,
0.6616242527961731,
-0.41400328278541565,
-0.6468104720115662,
0.5831796526908875,
-0.8894514441490173,
1.1040542125701904,
-0.6758378148078918,
-0.36558809876441956,
0.03087298944592476,
-0.16272369027137756,
-0.9698054790496826,
-0.5976194739341736,
0.314854234457016,
0.4747656583786011,
-0.6220924258232117,
-0.24046699702739716,
-0.5210264921188354,
-0.6301677823066711,
-0.4604256749153137,
-0.4992346167564392,
-0.5247989892959595,
0.7194145321846008,
0.3481568992137909,
-0.45316842198371887,
0.38328132033348083,
-0.3066861927509308,
1.2929010391235352,
-1.0796892642974854,
0.7638088464736938,
0.2784268856048584,
0.4872135818004608,
-0.9365257024765015,
0.3252285122871399,
0.577578604221344,
-0.23593562841415405,
-0.09440324455499649,
-0.8551758527755737,
-0.040904853492975235,
0.06532515585422516,
-0.5774421691894531,
0.319196492433548,
0.13046444952487946,
-0.39090263843536377,
-0.3400084674358368,
0.2851198613643646,
-0.8375729918479919,
-0.7158409357070923,
-0.006336557678878307,
0.40099236369132996,
0.13229577243328094,
-0.29389524459838867,
0.36171168088912964,
-0.1548616737127304,
0.5120387077331543,
-0.67751145362854,
0.5859672427177429,
-0.5829105973243713,
-0.11140073835849762,
0.38577574491500854,
-0.45440393686294556,
-0.3814634084701538,
-0.7078467607498169,
-0.16666702926158905,
0.09455069899559021,
0.17897486686706543,
0.015201480127871037,
-0.1852470338344574,
0.23895330727100372,
-0.714546263217926,
-0.44148313999176025,
-0.14887362718582153,
0.17281626164913177,
0.6650484800338745,
0.16295985877513885,
-0.6946892142295837,
-0.036375951021909714,
0.7706650495529175,
-0.926180899143219,
0.36560583114624023,
-0.19474880397319794,
-0.010455777868628502,
-0.11935088038444519,
0.04335528984665871,
-0.04908238351345062,
0.7958801984786987,
-0.5151529312133789,
0.2873348295688629,
-0.15031038224697113,
0.42312830686569214,
0.19530899822711945,
-0.1179153248667717,
0.03255379945039749,
0.15597198903560638,
0.4159386456012726,
0.25091707706451416,
0.18225285410881042,
0.2838107943534851,
-0.9358097910881042,
-0.07739546149969101,
-0.2361566126346588,
-0.20587760210037231,
-0.7192431092262268,
-0.1449718475341797,
0.1886955052614212,
0.0600413903594017,
-0.3522893190383911,
0.22031979262828827,
0.042259715497493744,
-0.46368324756622314,
-0.8247987627983093,
0.8255883455276489,
0.36548301577568054,
0.32714638113975525,
-0.08152344077825546,
-0.2425004541873932,
-0.08785882592201233,
-0.5389510989189148,
0.5362242460250854,
0.02281959541141987,
0.11583739519119263,
0.3405182361602783,
0.5199308395385742,
0.34475594758987427,
-0.12286560237407684,
-0.6672801375389099,
0.15266941487789154,
0.4127725660800934,
0.3289361000061035,
-0.6234403848648071,
-0.3663107454776764,
-0.24395018815994263,
0.29296648502349854,
0.34754228591918945,
-0.24032407999038696,
-0.2706041932106018,
-0.04451282322406769,
-0.41003233194351196,
-0.11545640975236893,
0.26952630281448364,
-0.03612438961863518,
0.05588492378592491,
0.2142317295074463,
-0.27625665068626404,
-0.3776545226573944,
-0.1600046157836914,
-0.14202626049518585,
0.16939899325370789,
0.030748600140213966,
-0.14453785121440887,
0.1481109857559204,
-0.17454425990581512,
-0.4729537069797516,
0.23786211013793945,
-0.09291749447584152,
0.43647927045822144,
-0.24942438304424286,
-0.06324832141399384,
-0.14880838990211487,
-0.16275979578495026,
0.43315085768699646,
0.03519365191459656,
-0.2225225865840912,
-0.02359863370656967,
-0.2881719172000885,
-0.27779534459114075,
-0.1576930582523346,
0.1725461184978485,
-0.590297520160675
] |
NCT06139822
|
Hamstring Stretching in Plantar Fasciitis
|
The purpose of the study is to compare the effects of Hamstring stretching versus conventional treatment for plantar fasciitis. A randomized control trial was conducted at Cena Medical Center Rawalpindi and Midland Doctors Institute Muzaffarabaad. The sample size was 64 calculated through open-epi tool. The participants were divided into two groups, interventional and control group each having 32 participants. The study duration was 1 year. Sampling technique applied was Purposive sampling for recruitment and group randomization using flip coin method. Only 25to 45 years participants with plantar fasciitis along with hamstring tightness were included in the study. Tools used in this study are Goniometer, Visual Analogue Scale(VAS) for pain, and Functional Foot Index (FFI) for pain and disability. Data was collected before treatment at baseline and after 1st and 2nd week of the application of interventions. Data analyzed through SPSS version 25.
|
Plantar fasciitis is one of the main causes of heel pain. it is caused by the micro trauma to the site of attachment of plantar fascia at its origin on the medial tubercle of calcaneus resulting in inflammation. Plantar fascia is a fibrous band present at the bottom of foot which attaches heel to each of the toes.plantar fascia has a windlass mechanism which continuously stretches and shortens facilitating foot movements during walk.
During the standing phase all the tension forces are gathered at calcaneal tuberosity, which is a site of attachment for plantar fascia on heel. Pain is generally present at the medial side of heel to the medial arch of the foot.
Plantar fasciitis is often caused in people who have long periods of standing, involved in activities like running, jumping or other repeated activities. After knowing the exact mechanism it is suggested that it should be termed as planter fasciosis.Plantar fasciitis accounts for almost 80% of the total heel pain experienced by the people.
Planter fasciitis is treated with various treatment options. Initially it is treated by conservative treatments such as, rest, ice massage, foot ware modification, oral analgesics, stretching techniques, physical therapy modalities, and night splinting. If pain do not resolve with conservative treatment then further treatment options will be extracorporeal shock wave therapy, cortisone injections and surgery.
Diana et al concluded that addition of manual techniques for trigger point release along with stretching of plantar fascia is more effective than stretching alone. In a randomized control trial with a follow up of 12 months high load strength training was found to be quicker and more efficient treatment for plantar fasciitis. another RCT conducted in 2017 reported that stretching of Achilles tendon along with plantar fascia is twice effective than only plantar fascia stretching.
Immobilization done by using splints at night is one of the best treatments to avoid contracture in plantar fascia during night. But they are also related to sleep disturbances and discomfort during night. By using night splint there has been a pain relief for shorter period of time. Night splints used alongside custom foot orthotics have better results than used alone. Controlled Ankle Movement is very effective in reducing pain in heel. It can be done by using walking boots and casts. These boots and casts will help to reduce over stretching of plantar fascia with unloading mechanism over heel. The reported reduction of pain by this mechanism of controlled ankle movement is in up to 40% of individuals.
Jonathan et al reported that there is a role of hamstring tightness in plantar fasciitis. A correlation study found a strong relationship between hamstring tightness and plantar fasciitis. patients having hamstring tightness are 8.7% more prone towards developing planter fasciitis.
Hamstring is found to be affected in patients with plantar fasciitis. Many studies found relationship of hamstring tightness with plantar fasciitis. Hamstring tightness affects the posterior muscles increasing load on plantar fascia. There is scarce evidence about the hamstring stretching in patients having plantar fasciitis. So this study will focus on hamstring stretching along with plantar fascia stretching and strengthening to improve pain, range of motion and disability.
|
Inclusion Criteria:
1. Both Genders
2. 25 to 45 years of age
3. Participants having heel pain for more than one month.
4. Participants having Windlass positive test.
5. Participants having hamstring tightness.
6. sit and reach test positive.
7. Bilateral plantar fasciitis.
Exclusion Criteria:
* Patients with corticosteroid injection
* Fracture around ankle and Calcaneal
* Any soft tissue injuries around ankle.
* Other Neurological/ Musculoskeletal disorder
* Congenital foot anomalies
* Systemic medical illness
|
[
0.8874444365501404,
2.4389991760253906,
-2.235379457473755,
-3.000669479370117,
0.7568297386169434,
0.21439014375209808,
0.5903883576393127,
-1.3762792348861694,
-0.7417830228805542,
-0.23734109103679657,
-0.8919808864593506,
1.3607021570205688,
-1.6195234060287476,
0.08227397501468658,
0.5052180886268616,
0.632960855960846,
0.30080360174179077,
0.1878824234008789,
1.8202781677246094,
-0.31479132175445557,
-0.08910425752401352,
0.7082222104072571,
-0.28593558073043823,
-0.43787336349487305,
0.6088225841522217,
0.5362160205841064,
-0.5683247447013855,
1.28220534324646,
0.5657300353050232,
1.2648206949234009,
0.2320338934659958,
-0.8746200799942017,
0.7258033752441406,
0.29057297110557556,
-0.11183015257120132,
-1.0711722373962402,
0.8008273243904114,
0.015183227136731148,
-0.13796943426132202,
0.6334018111228943,
0.6171688437461853,
1.0835031270980835,
-0.2890157997608185,
0.3499864339828491,
1.9335825443267822,
-0.38074102997779846,
0.43790096044540405,
0.792442262172699,
-0.6198445558547974,
0.06508190184831619,
0.1582454890012741,
0.920932412147522,
-0.9768055081367493,
-0.06801734119653702,
1.2161340713500977,
-0.22894030809402466,
0.15770523250102997,
0.237581267952919,
0.7068901062011719,
0.06907208263874054,
-0.48916149139404297,
0.5184437036514282,
0.4307369589805603,
0.11508544534444809,
0.30553585290908813,
-0.647895872592926,
-0.33901774883270264,
0.6676956415176392,
-0.3295130133628845,
0.08035320043563843,
0.8020076751708984,
0.23859630525112152,
1.150752305984497,
0.5472186803817749,
-0.5879696011543274,
-0.008884265087544918,
-0.9033228158950806,
0.6741442084312439,
0.15622058510780334,
1.0564532279968262,
-0.01233927346765995,
0.2502724230289459,
0.4158913195133209,
-0.0429527685046196,
0.15144409239292145,
-0.5316094756126404,
-0.5000268220901489,
-0.6684029698371887,
0.6080505847930908,
-0.3242994248867035,
-0.10796110332012177,
-0.5182139873504639,
-0.5550349950790405,
0.21636374294757843,
-0.6391430497169495,
0.5565685629844666,
0.17781899869441986,
-0.14386554062366486,
-0.844932496547699,
0.4278395175933838,
-0.6596948504447937,
-0.10325424373149872,
0.09342847019433975,
0.08110490441322327,
-1.1667510271072388,
-0.7028616666793823,
-0.805510938167572,
-0.10534989088773727,
-0.38719865679740906,
-0.07550898939371109,
0.24468210339546204,
-0.17927435040473938,
0.08221779018640518,
0.39423733949661255,
0.23741531372070312,
0.08419350534677505,
0.8738499879837036,
0.14908520877361298,
0.20325307548046112,
-1.2205106019973755,
-0.01228720135986805,
0.6094047427177429,
0.7143970131874084,
0.6759044528007507,
-0.4385719895362854,
0.28799328207969666,
0.22706007957458496,
0.26566770672798157,
-0.5078927278518677,
-0.9071050882339478,
-0.7378543019294739,
-0.548291802406311,
0.04261256009340286,
0.04526960849761963,
-1.2325774431228638,
-0.3219856321811676,
0.29226550459861755,
0.5078336596488953,
-0.4919891655445099,
-0.33852913975715637,
-0.48816004395484924,
0.03552369773387909,
-0.2983727753162384,
0.012859602458775043,
-1.2818444967269897,
0.0788363367319107,
-0.4373767673969269,
0.3246133029460907,
-0.7213956713676453,
-0.456542044878006,
-0.8046528697013855,
-0.18727673590183258,
-0.2364538013935089,
-0.31748589873313904,
-0.43797963857650757,
0.34064623713493347,
0.16281507909297943,
-0.4375644326210022,
0.3332984149456024,
-0.35775649547576904,
0.254067063331604,
-0.7772350907325745,
-0.295444130897522,
-0.27076447010040283,
0.2579405605792999,
-0.10482565313577652,
-0.7094572186470032,
0.11199472844600677,
0.2831040620803833,
0.10876423865556717,
-0.32144373655319214,
-0.00663092453032732,
0.3524364233016968,
0.08643757551908493,
0.01585838571190834,
0.2825900912284851,
0.5279303193092346,
0.06395738571882248,
0.22835512459278107,
-0.09768717736005783,
-0.21578234434127808,
-0.19406658411026,
0.018077166751027107,
0.5330018997192383,
-0.38857659697532654,
-0.39907217025756836,
-0.2753249704837799,
-0.04940532147884369,
0.029269874095916748,
0.25618433952331543,
0.3224357068538666,
0.03141763433814049,
-0.003734506666660309,
-0.05445214733481407,
0.4270099997520447,
0.190272256731987,
0.07166361808776855,
-0.503197193145752,
0.18484175205230713,
0.14471393823623657,
0.38363534212112427,
0.3201170861721039,
-0.09120015799999237,
0.20386722683906555,
0.2677474915981293,
-0.05358083173632622,
-0.6476567983627319,
-0.3098016679286957,
-0.3886631727218628,
0.23762065172195435,
0.34052279591560364,
-0.5320931077003479,
-0.05196855217218399,
-0.1831553429365158,
0.7380366325378418,
0.5781056880950928,
-0.02674451284110546,
0.6444246172904968,
-0.3327382802963257,
0.205854594707489,
-0.24048569798469543,
-0.6027960181236267,
-0.06585393846035004,
0.2867996096611023,
0.09515181183815002,
0.23248305916786194,
-0.4224410355091095,
0.16146855056285858,
-0.1779128909111023,
0.1762467920780182,
-0.16285516321659088,
0.2393873929977417,
-0.2155580073595047,
-0.13325585424900055,
-0.1609066128730774,
-0.007045901380479336,
0.3902030885219574,
0.240458682179451,
-0.21973371505737305,
0.3028348684310913,
0.15586379170417786,
-0.7306508421897888,
-0.11170410364866257,
-0.11855164170265198,
-0.04590652137994766,
-0.42838147282600403,
-0.30568596720695496,
0.6510283946990967,
0.19776323437690735,
0.30296725034713745,
-0.45228341221809387,
-0.18249531090259552,
-0.06941679865121841,
0.14334718883037567,
0.10018280148506165,
-0.34793710708618164
] |
NCT04757792
|
Back to the Traditional: Anti-COX Drugs Can Improve the Outcome of COVID-19 Patients Admitted to ICU
|
Retrospective multicenter study to evaluate the data of COVID-19 patients who were admitted to university hospitals in relation to their recent administration or maintenance on non-steroidal anti-inflammatory drugs (NSAID) prior to have COVID-19 disease and to analyze it in relation to outcome of these patients.
|
The data contained in hospital registry were collected, categorized into demographic, previous medical history, the use of NSAID as maintenance therapy or its recent administration before diagnosis of COVID-19 disease, presenting manifestations, laboratory and CT findings, applied therapies or interventions. Outcomes will be categorized as survival and non-survival outcome. Survivors will be subdivided as complete recovery or recovery with getting new morbidities. Mortality was subdivided as total hospital and ICU mortality. Data will be statistically analyzed in relation to outcomes
|
Inclusion Criteria:
* assured diagnosis of COVID-19 by RT-PCR
Exclusion Criteria:
* No
|
[
1.3985775709152222,
2.2764244079589844,
-1.8332767486572266,
-0.9189232587814331,
0.44625383615493774,
-0.8884317874908447,
-0.9611907005310059,
0.58514803647995,
-0.8024263978004456,
-0.4465959370136261,
0.7636429667472839,
1.9131125211715698,
-1.4357448816299438,
0.9738181233406067,
-0.8443600535392761,
-0.28171592950820923,
0.17874887585639954,
0.5171302556991577,
1.3454101085662842,
-1.173585295677185,
-1.467462420463562,
0.7037131190299988,
-0.009303473867475986,
-0.3300860822200775,
1.1232401132583618,
-1.2952479124069214,
-0.48788779973983765,
-0.2066800892353058,
-0.6888681054115295,
1.8613874912261963,
-0.1419866532087326,
-1.7768207788467407,
0.9097545742988586,
0.1983955055475235,
0.7881403565406799,
-0.4135500490665436,
0.5060312747955322,
0.9393477439880371,
-0.9952322244644165,
0.7467880845069885,
-0.2005532681941986,
-0.004416625015437603,
-0.08519041538238525,
-0.3362807333469391,
1.909974217414856,
0.7207196950912476,
-0.10992714017629623,
0.6509259939193726,
0.26512864232063293,
-0.48378774523735046,
-0.7219609022140503,
1.302654504776001,
-0.5619766712188721,
0.3188985288143158,
2.039092540740967,
1.5861952304840088,
0.5626899003982544,
0.6267915964126587,
1.4670915603637695,
0.41142019629478455,
-0.5716632008552551,
0.2848352789878845,
0.838874876499176,
1.1085951328277588,
-1.0104312896728516,
-0.040376897901296616,
-0.6220239996910095,
-0.8831484913825989,
-0.5932518243789673,
0.3788401186466217,
-1.414097785949707,
0.016151925548911095,
0.7265365123748779,
-0.16941142082214355,
0.9017156958580017,
-0.301372766494751,
-1.1221779584884644,
-0.018532268702983856,
0.4930500090122223,
-0.5382494330406189,
-0.5080660581588745,
-1.0010303258895874,
-1.3262346982955933,
0.4143363833427429,
-1.0303101539611816,
0.19095191359519958,
-1.6736491918563843,
-0.8087994456291199,
0.30899909138679504,
-1.2688318490982056,
0.3294249176979065,
-0.6630682945251465,
-0.7183941602706909,
-0.08167371898889542,
-0.5312355160713196,
1.1788051128387451,
-1.0722856521606445,
-0.5274728536605835,
-1.2414705753326416,
0.1524038165807724,
-0.07057470828294754,
-1.0037600994110107,
-0.6605924963951111,
-0.3206197917461395,
-0.3424868881702423,
-0.3331892192363739,
0.3983410596847534,
0.7636367678642273,
-1.3878095149993896,
-1.3480074405670166,
0.6428564786911011,
-0.9985116720199585,
0.5466008186340332,
-0.06453494727611542,
-0.6658571362495422,
-0.07948334515094757,
0.3240683674812317,
0.5726498365402222,
-0.08296280354261398,
0.27455222606658936,
-0.1641957014799118,
-0.08912795782089233,
-0.02090344950556755,
0.7015376091003418,
-0.35452067852020264,
-0.4985525608062744,
-0.053956322371959686,
-0.33816561102867126,
0.19545313715934753,
-0.04844219610095024,
-0.9585484862327576,
0.19282761216163635,
0.03962419554591179,
-0.011324203573167324,
-0.3220510184764862,
0.040360160171985626,
0.2954621911048889,
1.2221189737319946,
0.17317652702331543,
-0.45793601870536804,
0.07165921479463577,
0.4998590052127838,
0.902140736579895,
-0.26726749539375305,
-0.9152193069458008,
-0.37911155819892883,
-0.4450845420360565,
0.42573001980781555,
-0.8886541128158569,
-0.45298102498054504,
-0.07974250614643097,
0.012939931824803352,
0.7442003488540649,
-0.06386499851942062,
0.6228626370429993,
0.38606494665145874,
-0.37958061695098877,
-0.5916435122489929,
0.09716912358999252,
0.8362582921981812,
-0.07140521705150604,
-0.1319420486688614,
-0.13377223908901215,
-0.8860559463500977,
-0.19322527945041656,
-0.6054615378379822,
0.9065870642662048,
0.14563463628292084,
0.28867867588996887,
0.2795523703098297,
-0.7391751408576965,
0.26141077280044556,
0.30237388610839844,
1.4431642293930054,
0.07902829349040985,
0.134987935423851,
-0.6116980910301208,
0.8456610441207886,
0.643528938293457,
0.03991921246051788,
0.17707903683185577,
-0.2885179817676544,
-0.015096268616616726,
0.061892662197351456,
0.010904543101787567,
0.7806529402732849,
-0.24802137911319733,
-0.45240598917007446,
-0.39824342727661133,
0.1895274668931961,
-0.2590993344783783,
-0.35213223099708557,
0.06988689303398132,
-0.04863279312849045,
1.2100982666015625,
0.1062210351228714,
-0.4266386926174164,
-0.709256649017334,
0.79278564453125,
0.44687598943710327,
0.24321044981479645,
-0.31167837977409363,
-0.3075599670410156,
1.2675280570983887,
-0.0933985710144043,
-0.46250465512275696,
-0.012377776205539703,
-0.2506364583969116,
0.17006313800811768,
0.4464600384235382,
0.5307844877243042,
-0.26039284467697144,
-0.21786971390247345,
0.14256517589092255,
0.06781543046236038,
-0.08621498942375183,
0.15446990728378296,
-0.2627323269844055,
-0.22216610610485077,
0.3794427812099457,
-0.01981159672141075,
-0.05388106033205986,
-0.141204372048378,
-0.26053422689437866,
-0.5046043395996094,
0.1754738986492157,
-0.2761116027832031,
0.25380051136016846,
0.2799648344516754,
0.3843330442905426,
0.25021007657051086,
0.06375645846128464,
-0.3867362141609192,
-0.2494152933359146,
-0.23506838083267212,
0.7609213590621948,
0.271859347820282,
0.2152002453804016,
0.09361311048269272,
0.8656858801841736,
0.3704545795917511,
-0.8365328311920166,
0.1276688277721405,
-0.1880631297826767,
-0.06053601950407028,
-0.3329639732837677,
0.20982930064201355,
0.0939556285738945,
-0.2194078415632248,
0.09723243117332458,
-0.607338547706604,
-0.05237981304526329,
0.17939795553684235,
0.08836077153682709,
-0.1349060833454132,
-0.36792248487472534
] |
NCT00559780
|
Muscle Function in Elderly Postoperative Patients
|
During the last decades there has been an increase in the relative proportion and life expectancy of elderly people in the industrialised countries. Consequently the amount of elderly with diseases and disabilities related to aging has increased. It therefore appears paramount to gain a better understanding of how disuse and immobilisation affects neuromuscular properties in the elderly, as well as to identify training regimes that ensures an effective rehabilitation.The population of interest in the present study was elderly individuals with long term hip-osteoarthritis undergoing a hip-replacement operation. The study was divided in two parts, a cross-sectional study and an intervention study.
The cross-sectional study investigated muscle size, maximal muscle strength, specific force, neural drive and explosive muscle force characteristics in elderly individuals who were affected by unilateral prolonged disuse due to hip-osteoarthritis. The data clearly indicated that the side with hip-osteoarthritis was affected by a marked decrease in muscle mass, maximal muscle strength, neural drive and explosive muscle force characteristics compared to the unaffected side.
The intervention study investigated if elderly patients that undergo hip-replacement surgery could benefit from additional training in the early postoperative phase. The data clearly demonstrated that resistance training was an effective and safe way to increase muscle mass, maximal muscle strength, neuromuscular activity, functional performance and decrease the hospitalisation period compared to regimes of conventional rehabilitation regimen or electrical muscle stimulation. Additionally the intervention study demonstrated that resistance training effectively induced marked increases in explosive muscle force characteristics in elderly subjects compared to rehabilitation regimes using electrical muscle stimulation or conventional rehabilitation. Furthermore, the gains in maximal muscle strength and explosive muscle force characteristics were accompanied by significant increases in EMG amplitudes. Furthermore, the demonstration that explosive muscle force capacity of the neuromuscular system remains trainable in elderly recovering from prolonged limb disuse and major surgery may have important implications for future rehabilitation programs, especially when considering the importance of rapid muscle force capacity on postural balance, maximal walking speed and other tasks of daily life actions.
|
Inclusion Criteria:
* Age over 60 years
* Unilateral primary hip replacement due to hip osteoarthritis in patients
Exclusion Criteria:
* Cardiopulmonary, neurological or cognitive problems
|
[
-0.593616783618927,
3.0509116649627686,
-1.375866413116455,
-2.9263079166412354,
1.9997347593307495,
0.17890235781669617,
-0.8159114718437195,
-0.18223489820957184,
-1.6638103723526,
0.02822246588766575,
0.29938647150993347,
2.532498598098755,
-0.5004606246948242,
-0.7045139670372009,
-0.10443834215402603,
2.1801209449768066,
-0.4475972056388855,
-0.7762094140052795,
-0.42142972350120544,
-1.0505322217941284,
-0.1281551867723465,
0.6501678228378296,
-0.06001616641879082,
-0.18162913620471954,
1.8667775392532349,
0.32955509424209595,
-0.2743813991546631,
-0.21660259366035461,
1.1605511903762817,
0.5512204170227051,
-0.21027511358261108,
-1.7833455801010132,
0.8190642595291138,
1.066343069076538,
-0.6584181785583496,
-0.12776830792427063,
0.2155219316482544,
-0.3448508679866791,
-1.4342108964920044,
-0.6596954464912415,
0.9862275123596191,
1.8765089511871338,
-0.08727932721376419,
1.0033308267593384,
0.27121734619140625,
1.241600513458252,
0.169852614402771,
0.1726350039243698,
0.06161782145500183,
0.31763601303100586,
-0.23665374517440796,
0.9477877616882324,
-0.33196935057640076,
-1.153588891029358,
1.399241328239441,
0.17823097109794617,
1.5296080112457275,
-1.038785696029663,
-0.5254365801811218,
0.3890792429447174,
1.445772409439087,
0.38064536452293396,
-0.1991037130355835,
1.5313042402267456,
-0.4338163435459137,
-1.7401827573776245,
0.07457582652568817,
0.7548713684082031,
-1.149955153465271,
0.40562576055526733,
0.6986335515975952,
0.24669253826141357,
-0.0638204887509346,
-0.48899757862091064,
0.12567995488643646,
-0.2767556607723236,
0.06813103705644608,
0.5595420598983765,
1.4961411952972412,
-0.009274408221244812,
-0.2668759226799011,
-1.0603728294372559,
-1.1870006322860718,
0.7479323148727417,
0.7431240677833557,
0.29603931307792664,
-0.4276753067970276,
0.03709747642278671,
0.6867021918296814,
-0.7869376540184021,
-0.22727341949939728,
-0.8486178517341614,
-1.639251947402954,
-0.0609176829457283,
-0.3855760097503662,
0.2185225635766983,
-0.24138528108596802,
-0.4891667366027832,
-0.675290584564209,
-0.5433674454689026,
0.1518089324235916,
0.3881141245365143,
0.19436442852020264,
-0.47244593501091003,
-0.8331453204154968,
-0.39545437693595886,
-0.6562076807022095,
-0.4128267168998718,
-0.35019591450691223,
0.5702327489852905,
0.08497029542922974,
-0.5486345887184143,
0.25958192348480225,
0.07206981629133224,
0.6342606544494629,
-0.26366299390792847,
0.4094342887401581,
1.0536446571350098,
0.08218535780906677,
-1.0380122661590576,
0.2078576534986496,
0.8137496709823608,
-0.49979865550994873,
-0.3559640347957611,
-1.6143689155578613,
-0.6576574444770813,
0.6735701560974121,
0.6714187860488892,
-0.5655152797698975,
-0.16421161592006683,
0.34496885538101196,
-0.07097629457712173,
0.4038938581943512,
-0.42565619945526123,
-0.500665545463562,
-0.07276314496994019,
-0.3912258446216583,
0.3116130530834198,
0.13391204178333282,
-0.24643215537071228,
-0.35048598051071167,
0.2140446901321411,
-0.38708123564720154,
0.7449682950973511,
0.11801090836524963,
-0.2537027895450592,
-0.12750175595283508,
0.4179724156856537,
0.015104688704013824,
-0.09976881742477417,
0.14977897703647614,
0.5488319396972656,
0.16776341199874878,
-0.037469532340765,
-0.10443492233753204,
-0.029168901965022087,
-0.31457436084747314,
-0.3786235749721527,
0.3014116883277893,
-0.16394704580307007,
0.9390435814857483,
-0.32592445611953735,
-0.237069234251976,
0.19043682515621185,
0.3959995210170746,
-0.5895089507102966,
-0.02420675754547119,
-0.06917593628168106,
0.5564466714859009,
0.18605157732963562,
0.11416670680046082,
-0.46615028381347656,
0.08872044086456299,
0.22163310647010803,
0.06854590773582458,
0.3567511737346649,
0.3999181091785431,
0.2868388593196869,
0.2776925563812256,
0.013991654850542545,
0.4440089762210846,
-0.41601303219795227,
0.2941955626010895,
0.12160196155309677,
0.4336243271827698,
-0.01151344832032919,
-0.27609971165657043,
-0.24176223576068878,
-0.06032095476984978,
0.18695494532585144,
-0.02935301512479782,
-0.06239166483283043,
-0.3332516849040985,
-0.39955198764801025,
0.047029368579387665,
0.27574706077575684,
-0.6611313819885254,
-0.4371373951435089,
0.37844574451446533,
0.31545689702033997,
0.2477431446313858,
0.40264517068862915,
-0.7656624913215637,
0.2916261553764343,
-0.26176783442497253,
-0.2441718727350235,
-0.5468500256538391,
-0.06464913487434387,
-0.25598835945129395,
0.039230599999427795,
0.44421085715293884,
0.36160847544670105,
-0.5057671666145325,
0.028763102367520332,
-0.07617787271738052,
0.6538426876068115,
-0.6973109245300293,
-0.051706235855817795,
-0.618051290512085,
0.15482044219970703,
0.28791967034339905,
0.1430862545967102,
0.18263393640518188,
0.1774033010005951,
-0.3521798551082611,
-0.12403314560651779,
0.23039858043193817,
0.267105370759964,
0.42233985662460327,
-0.47531816363334656,
-0.2706250846385956,
0.07548227906227112,
0.07164659351110458,
0.13403089344501495,
-0.03285098820924759,
0.19447922706604004,
0.2296551764011383,
0.3083972930908203,
0.23723675310611725,
0.3345474898815155,
0.003013402223587036,
-0.5275759100914001,
-0.36093077063560486,
-0.45164254307746887,
0.051549140363931656,
-0.210332453250885,
-0.22638465464115143,
0.27531272172927856,
-0.05270183086395264,
-0.04218874126672745,
0.058455031365156174,
-0.3368014991283417,
-0.08891183137893677,
0.1960158795118332,
-0.032387904822826385,
-0.44462457299232483
] |
|
NCT01393457
|
Cognitive Remediation for Cocaine Dependence
|
The purpose of this study is to evaluate treatments designed to improve cocaine treatment success by combining medications that target cocaine-related cognitive impairments.
|
Inclusion Criteria:
* meet criteria for cocaine dependence
* seeking treatment for cocaine dependence
* be in acceptable health based on medical history and physical exam
Exclusion Criteria:
* dependent on drugs other than cocaine, nicotine, marijuana
* have a medical condition contraindicating treatment with study medications
* having conditions of probation or parole requiring reports of drug use to officers of the court
|
[
-1.0051461458206177,
5.201327323913574,
-1.425012469291687,
-4.533397197723389,
-1.0721515417099,
-2.6580190658569336,
-2.2745168209075928,
-0.9666233658790588,
0.07550859451293945,
-0.11676985770463943,
-1.0849162340164185,
3.656486749649048,
0.738797664642334,
1.3643882274627686,
-0.17082202434539795,
-1.240365743637085,
0.8426197171211243,
3.013456344604492,
2.249957799911499,
-1.114709734916687,
0.47835877537727356,
-0.08582211285829544,
-0.10330133885145187,
0.9461872577667236,
0.3580705523490906,
0.1983400583267212,
-0.4932042360305786,
2.883000612258911,
0.2548297643661499,
3.044926643371582,
-2.335183620452881,
-0.6250083446502686,
-0.5225871205329895,
-0.625024139881134,
0.4936130940914154,
-0.11160816252231598,
0.46635496616363525,
-1.050576090812683,
-2.323330879211426,
-0.5186293125152588,
0.7568075656890869,
2.8546671867370605,
0.26250797510147095,
0.8198825716972351,
0.8934004306793213,
2.9278101921081543,
-1.5247632265090942,
0.9081866145133972,
0.233244389295578,
0.6213821172714233,
2.6839029788970947,
1.0746136903762817,
0.2737588584423065,
-1.0930283069610596,
2.620877504348755,
-1.422275424003601,
1.9059168100357056,
-0.3846827745437622,
1.6111341714859009,
-0.0018974242266267538,
-1.31118905544281,
-0.7249429225921631,
-1.6610143184661865,
2.3539316654205322,
-2.3723905086517334,
1.8130102157592773,
0.1523478478193283,
-0.538047730922699,
-1.350039005279541,
0.3865256607532501,
0.2666810154914856,
1.613718867301941,
0.5083714127540588,
0.4431743919849396,
1.0046484470367432,
-0.036248914897441864,
-0.005060783587396145,
0.48681125044822693,
0.9137127995491028,
-0.276946485042572,
0.6228266954421997,
0.40484750270843506,
-0.07683557271957397,
-1.4477440118789673,
1.2919644117355347,
-1.5672492980957031,
-0.2508034110069275,
0.41636162996292114,
0.32358813285827637,
-0.875882625579834,
0.8800017237663269,
-0.3141382932662964,
-1.458410382270813,
1.0761682987213135,
-0.6091354489326477,
0.20050936937332153,
-0.28821465373039246,
-0.9903566837310791,
-0.7506507039070129,
-0.5720423460006714,
0.8956172466278076,
-0.10834108293056488,
-1.1773039102554321,
-0.494606077671051,
-2.5290110111236572,
-1.0878682136535645,
-0.6585192680358887,
-0.6127108335494995,
-2.0845701694488525,
0.7720097899436951,
1.3718255758285522,
-2.4546968936920166,
-0.47977274656295776,
0.21987980604171753,
1.1011426448822021,
1.2971885204315186,
0.8767097592353821,
1.2825782299041748,
-0.20891115069389343,
0.4535146951675415,
2.225268602371216,
0.052507463842630386,
-0.4980207681655884,
-0.6000338196754456,
-0.2548839747905731,
-0.4442651867866516,
-0.36413609981536865,
0.3823226988315582,
-1.077530026435852,
-0.7859900593757629,
-0.43581822514533997,
-0.1465838998556137,
0.8468838334083557,
1.30012845993042,
-0.9210391640663147,
-0.8491813540458679,
0.7245471477508545,
2.1895527839660645,
-0.21118666231632233,
0.007570922840386629,
-0.2541825473308563,
1.2437132596969604,
1.884761095046997,
0.35669854283332825,
-1.281708002090454,
-0.9206915497779846,
0.6176169514656067,
0.04149690642952919,
-0.38734450936317444,
-1.0877741575241089,
0.8085815906524658,
-0.07932979613542557,
0.7971295714378357,
1.0526700019836426,
0.48457571864128113,
1.454561471939087,
-0.6855224967002869,
-1.4582620859146118,
1.4974579811096191,
-0.2911157011985779,
-0.5410037040710449,
-1.4487767219543457,
-0.4700338840484619,
-1.6862871646881104,
0.9450469613075256,
-1.1257113218307495,
0.7362766265869141,
0.6343490481376648,
-0.2438914030790329,
-0.1884365677833557,
-0.7412400841712952,
-0.8636338114738464,
-1.671788215637207,
-0.06730665266513824,
0.47365015745162964,
0.5648230910301208,
1.0267373323440552,
-0.7627964019775391,
0.8123120069503784,
0.6174706816673279,
-0.2728360593318939,
0.9825080633163452,
-0.5824170708656311,
-0.7858113050460815,
-0.11088920384645462,
-0.6908041834831238,
-0.45024627447128296,
-0.20213939249515533,
1.0240386724472046,
0.20171119272708893,
0.3715516924858093,
-0.7377156019210815,
-0.21835120022296906,
-0.16310392320156097,
0.08451705425977707,
-0.3795495927333832,
-0.04275114834308624,
-0.9992172122001648,
-0.3021129369735718,
-1.3421859741210938,
0.445333331823349,
1.0782814025878906,
-0.2269783914089203,
0.06073305755853653,
-0.8075295686721802,
-0.43787306547164917,
-0.3189171254634857,
-1.0702226161956787,
0.42620906233787537,
0.6261735558509827,
0.25782912969589233,
0.006668746005743742,
-1.3074811697006226,
-0.3329015374183655,
0.5897164940834045,
0.7397274971008301,
-0.050848059356212616,
-0.1215667650103569,
-0.6833599209785461,
-0.4458315372467041,
-0.6830304265022278,
-0.30129751563072205,
-0.1481853425502777,
0.0401284359395504,
0.4382569491863251,
-0.28827008605003357,
0.1263202428817749,
0.4791974723339081,
-0.41374561190605164,
0.10108579695224762,
0.16473270952701569,
0.294232577085495,
-0.29421550035476685,
-0.029101107269525528,
-0.7505702376365662,
0.7433652281761169,
0.7064343094825745,
-0.8282862305641174,
-0.2090688943862915,
-0.22682227194309235,
0.08952450007200241,
-0.17122630774974823,
0.39520782232284546,
-0.11658015847206116,
-0.26050376892089844,
-0.9146924018859863,
-0.7013612389564514,
0.8877776861190796,
0.3878355622291565,
0.2827523946762085,
-1.2860318422317505,
-0.7938010096549988,
0.12022753804922104,
0.27412107586860657,
-0.0912414938211441,
-0.5257256031036377
] |
|
NCT02146482
|
Access to a Sit-stand Computer Workstation and Back Pain
|
The purpose of the study is to evaluate the changes in back pain from access to a sit-stand workstation. Other muscle and joint pain and/or discomfort will also be evaluated. We hypothesize that access to a sit-stand workstation will allow one to experience postural variation and reduce back pain.
|
Inclusion Criteria:
* Back pain lasting ≥3 months and reported at a minimum of 4 out of 10 on the pain scale.
* Sits \>6 hours out of an 8-hour work day for work purposes
* Able and willing to fill out a daily survey for the first week prior to randomization
* Participants must be \>18 years of age. There are no gender/race-ethnic restrictions.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Unable to stand for at least 10 minutes.
* Currently using a sit-stand desk
|
[
-2.199625253677368,
2.880863904953003,
-2.1066739559173584,
-3.0014095306396484,
-0.9988517165184021,
-0.17876942455768585,
1.2326440811157227,
-0.06535615772008896,
-1.9156562089920044,
-2.080655097961426,
-0.3265397250652313,
0.7735052704811096,
0.035856690257787704,
-0.42143505811691284,
-0.7392681837081909,
1.0056501626968384,
1.3161702156066895,
-0.638318657875061,
-0.8258801102638245,
-0.33838149905204773,
0.3034842312335968,
0.8919042944908142,
-0.3582336902618408,
-1.9000269174575806,
2.114063024520874,
0.5575692653656006,
-0.6462580561637878,
0.8188849091529846,
0.8673220872879028,
-0.2501787841320038,
-0.8586207628250122,
-1.636281967163086,
-1.3323723077774048,
1.015973448753357,
-0.9846174716949463,
0.2661139667034149,
1.8377976417541504,
-0.2779996991157532,
-0.8998208045959473,
0.6462374925613403,
1.655453085899353,
0.08016514778137207,
-1.5241097211837769,
-0.7482642531394958,
1.5606602430343628,
0.07755188643932343,
-0.7040237188339233,
1.404992938041687,
0.2162366509437561,
-0.5181068778038025,
0.6639443039894104,
-0.07362879067659378,
-0.7123078107833862,
0.13457651436328888,
1.0526946783065796,
-0.6118892431259155,
0.21313975751399994,
-0.6340122818946838,
-0.03857943043112755,
0.910195529460907,
-0.4453992545604706,
-0.4120555520057678,
-0.14989875257015228,
1.768682837486267,
0.1574031263589859,
0.006184692960232496,
-0.33340761065483093,
-0.8655409812927246,
-0.3297360837459564,
0.8292524814605713,
1.0653889179229736,
0.915701687335968,
1.7581462860107422,
0.35191041231155396,
0.015283281914889812,
-0.664909303188324,
-0.9307790398597717,
-0.6725376844406128,
1.1882840394973755,
0.5774727463722229,
0.3097912669181824,
0.42233866453170776,
0.7217934131622314,
-0.15194188058376312,
-0.04307424649596214,
-0.32521215081214905,
-1.586944580078125,
-0.21941940486431122,
0.560722827911377,
-0.026396317407488823,
0.4834873676300049,
-1.3648619651794434,
-0.5843794345855713,
0.28351715207099915,
-0.4400671422481537,
0.05873899906873703,
-0.13958477973937988,
-1.4370166063308716,
-1.515494704246521,
0.569014847278595,
0.6345656514167786,
0.13491518795490265,
0.5440178513526917,
-0.5218335390090942,
-0.817516565322876,
0.26233240962028503,
-0.17586053907871246,
-0.9387035965919495,
-0.3210848271846771,
-0.5767250061035156,
1.9323194026947021,
-0.290574848651886,
-0.23399293422698975,
-0.36271047592163086,
0.13590280711650848,
0.0805756226181984,
0.5166634321212769,
0.41803041100502014,
0.33437538146972656,
-1.0444036722183228,
0.2977553904056549,
0.7317759394645691,
0.4659246504306793,
0.714653730392456,
-0.03816452622413635,
-0.43505099415779114,
0.038222890347242355,
-0.16901254653930664,
0.02266775257885456,
-0.14116574823856354,
0.18682198226451874,
-0.018662167713046074,
0.3282501995563507,
-0.21423226594924927,
-0.25554659962654114,
-0.4627317786216736,
0.28895848989486694,
-0.33618196845054626,
0.12344200164079666,
0.617499053478241,
0.10746322572231293,
0.6141214370727539,
0.5951927304267883,
-0.523644745349884,
0.05540573596954346,
0.18260504305362701,
-0.16618910431861877,
0.4303019642829895,
-0.35481441020965576,
0.6128059029579163,
-0.4889945387840271,
0.9917495846748352,
-0.14063553512096405,
-0.17983940243721008,
-0.08682014048099518,
-0.35440030694007874,
-0.2797201871871948,
-0.7011693716049194,
0.3856920301914215,
0.1174575611948967,
0.03177850320935249,
-0.26390933990478516,
0.26520055532455444,
-0.20113207399845123,
0.3790300786495209,
-0.2442348301410675,
-0.6205902695655823,
-0.15066729485988617,
0.9168720245361328,
-0.4313007593154907,
-0.9720356464385986,
0.6584113240242004,
0.8075810670852661,
-0.029368774965405464,
-0.1729086935520172,
0.7890427708625793,
0.24573387205600739,
-0.407011479139328,
0.5414577722549438,
-0.15623581409454346,
-0.15191179513931274,
-0.10602239519357681,
0.5521499514579773,
0.15614794194698334,
0.12562821805477142,
-0.9467955827713013,
-0.3516068756580353,
-0.3129722774028778,
0.08470416814088821,
0.18701568245887756,
0.41905900835990906,
0.594057023525238,
-0.3211778998374939,
0.6076064109802246,
0.35311654210090637,
0.13587644696235657,
-0.36413443088531494,
-0.3864816725254059,
0.45624658465385437,
-0.6315425038337708,
0.5115818381309509,
0.45591771602630615,
-0.5088667869567871,
-0.06736652553081512,
-0.48536044359207153,
0.3600425720214844,
-0.23452994227409363,
0.10322610288858414,
0.3122945725917816,
-0.21789290010929108,
-0.11344055831432343,
-0.092210553586483,
-0.4428864121437073,
0.5385271310806274,
0.6478893160820007,
0.3233489692211151,
0.35520488023757935,
0.6624034643173218,
-0.3153059184551239,
-0.30019429326057434,
0.08516836911439896,
0.001877383328974247,
-0.13025018572807312,
-0.1539020836353302,
-0.49399086833000183,
0.05967015027999878,
-0.08286028355360031,
0.4055498540401459,
0.26647835969924927,
0.2719118893146515,
-0.07469234615564346,
-0.08901064842939377,
-0.08359400928020477,
0.19574952125549316,
-0.3108900189399719,
0.3362409472465515,
-0.07718581706285477,
0.3775525391101837,
0.2569226622581482,
-0.008797161281108856,
0.1332588642835617,
-0.6647775173187256,
-0.2956268787384033,
-0.23628617823123932,
-0.44409316778182983,
-0.08969593048095703,
-0.10016585886478424,
0.475854754447937,
0.21805411577224731,
-0.42881810665130615,
-0.4710557162761688,
-0.7093449234962463,
0.35632485151290894,
0.006729349493980408,
0.4145740270614624,
-0.5536026954650879
] |
|
NCT02976415
|
In-Bed Cycling in ICU Patients Post Cardiac Surgery
|
The purpose of this study is to determine if in-bed cycling is safe and feasible in critically-ill patients after open heart surgery. The investigators hypothesize that in-bed cycling can be safely used with this population and that it is feasible to use in a fast-paced cardiac intensive care unit.
|
Background: Advances in medical science and technologies have lead to more effective management of critically-ill patients with a subsequent improvement in ICU survival rates. Patients who survive their ICU stay are often left with post-ICU impairments including muscle weakness and functional limitations. Cardiac surgeries are commonly performed worldwide with the majority of patients requiring post-operative ICU care. In the past decade, patients who qualify for cardiac surgery tend to be older, have a great number of co-morbidities and are more likely to require a prolonged ICU stay. The effectiveness of physiotherapy and various rehabilitation modalities in patients both pre- and post cardiac surgery has been investigated. However, to date no study specifically addresses the feasibility and safety of in-bed cycling in patients undergoing cardiac surgery who require prolonged critical care.
Principle Research Question: Is in-bed cycling a safe and feasible intervention in patients post cardiac surgery that require a prolonged stay in critical care?
Methods: Adult patients post-cardiac surgery admitted to the cardiac surgery ICU who will remain intubated and ventilated for at least 72 hours will be eligible for enrollment. Participants will receive 20 minutes of in-bed cycling plus routine physiotherapy performed by critical care physiotherapists. Patients will be enrolled for 28 days or until they are able to ambulate.
Primary Outcomes: Safety of bedside cycling will be evaluated by monitoring the number of adverse events that occur during each cycling session. Feasibility of implementing in-bed cycling into daily physiotherapy practice will be evaluated by determining if cycling sessions can be conducted at least eighty percent of the time that cycling is appropriate.
Relevance: Before conducting a larger randomized controlled trial investigating the effectiveness of in-bed cycling in the critically-ill cardiac surgery population, the safety of this intervention needs to be determined. This will be the first study in a program of research evaluating bedside cycling in the cardiac surgical ICU.
|
Inclusion Criteria:
* Male and female adults patients aged 18 years and greater
* History of cardiac surgery in the past seven days
* Admitted to the cardiac surgery ICU for greater than 3 days but less than 7 days
* Mechanically ventilated for at least 72 hours and expected to remain ventilated for at least two more days
* Able to ambulate independently, with or without a gait aid, prior to hospital admission
Exclusion Criteria:
* Uncomplicated post-operative course with expected discharge to ward within 24 to 72 hours
* Previous lower extremity amputation
* Open or unstable saphenous vein graft sites
* Inability to understand English
* Body size and/or weight that is incompatible with the bedside ergometer
* Patients who are not expected to survive their ICU stay
|
[
-1.1656662225723267,
3.321817636489868,
-0.052223388105630875,
-2.441607713699341,
-0.04628852382302284,
1.733386516571045,
0.6019808053970337,
-0.6376473307609558,
0.32039979100227356,
1.112418532371521,
1.1972476243972778,
1.0745511054992676,
-0.2207484394311905,
-0.7144904136657715,
0.07806739956140518,
1.4204717874526978,
-0.16268372535705566,
0.037701718509197235,
0.2589890658855438,
-1.3573203086853027,
0.8243622779846191,
0.4567050635814667,
0.2095252424478531,
-0.3486470878124237,
1.481920838356018,
0.16979365050792694,
-0.26712965965270996,
0.06514722108840942,
0.755734384059906,
0.7306280136108398,
0.9638933539390564,
-2.3081727027893066,
-1.2701054811477661,
0.15577389299869537,
-0.2765972316265106,
1.0172358751296997,
-0.1557299941778183,
-0.4393962025642395,
-0.9314194917678833,
-0.23351602256298065,
2.115100860595703,
1.8882079124450684,
-0.8829984664916992,
-1.084333062171936,
0.6391841769218445,
0.9130926132202148,
0.3227379620075226,
0.043390825390815735,
1.222451090812683,
0.15745888650417328,
-1.7636381387710571,
0.39533838629722595,
-0.5343028903007507,
1.4045898914337158,
1.2208843231201172,
0.6040658354759216,
0.32737645506858826,
-1.3811241388320923,
1.8734118938446045,
0.1280931681394577,
1.6853570938110352,
-0.2546795606613159,
-0.7098945379257202,
0.6074029803276062,
-1.0667012929916382,
0.1437733918428421,
1.2735422849655151,
-0.37823328375816345,
-0.8726549744606018,
0.17916519939899445,
0.7249113321304321,
-0.5086277723312378,
-0.16793856024742126,
0.1716836392879486,
-0.18705898523330688,
1.5830104351043701,
-0.5804378390312195,
2.256176471710205,
0.33718448877334595,
1.0449413061141968,
0.021474476903676987,
0.026861928403377533,
-0.8230761885643005,
0.2790699601173401,
0.10473818331956863,
-0.05754569545388222,
-1.2086471319198608,
-0.36580294370651245,
1.3495126962661743,
-1.281914234161377,
0.20360226929187775,
0.0583832673728466,
-0.6005324125289917,
0.1890580803155899,
-0.3692081570625305,
-0.4342046082019806,
0.0262670386582613,
-0.4095745086669922,
-0.6875468492507935,
-0.4499567151069641,
0.10147519409656525,
-0.015334272757172585,
-0.03538362681865692,
0.2695521414279938,
0.8829342126846313,
-0.589154064655304,
0.1793840080499649,
-1.0538270473480225,
-0.8079807162284851,
0.11746196448802948,
0.25104010105133057,
-0.9861100316047668,
-0.5329616069793701,
-0.055622175335884094,
0.04626723378896713,
0.5653406381607056,
1.7292921543121338,
1.3372271060943604,
0.6071640849113464,
-1.0434571504592896,
-0.17685726284980774,
0.940478503704071,
0.4359056353569031,
-0.6531510949134827,
-0.3543320298194885,
0.07173414528369904,
-0.527978241443634,
0.1614372283220291,
0.4304087162017822,
0.2538604438304901,
-1.1139700412750244,
-0.19404250383377075,
0.8352862596511841,
0.3244575262069702,
0.15068337321281433,
0.20761501789093018,
0.14472682774066925,
0.0030798204243183136,
-0.6728386878967285,
-0.3918047249317169,
0.8077318668365479,
0.34608301520347595,
0.46143123507499695,
-0.7685863375663757,
-1.3548232316970825,
-0.40177783370018005,
-0.42590031027793884,
0.18385690450668335,
-0.5956370234489441,
-1.0337477922439575,
-0.29760536551475525,
0.868457555770874,
-0.6200550198554993,
-0.42281556129455566,
0.601197361946106,
0.45398005843162537,
-0.05482262000441551,
-0.6598234176635742,
-0.3099247217178345,
-0.03199717029929161,
-0.020267726853489876,
-0.09390770643949509,
0.09550053626298904,
-0.3597652018070221,
0.4574774503707886,
-0.43819570541381836,
0.28356999158859253,
0.12035753577947617,
1.0006457567214966,
0.1550465077161789,
0.11913041770458221,
0.28058674931526184,
-0.23007915914058685,
-0.055480603128671646,
0.5097256898880005,
0.05663987621665001,
0.06969109922647476,
-0.4901741147041321,
-0.5390772223472595,
0.5338273048400879,
0.06559868156909943,
0.4985993802547455,
0.006895024329423904,
-0.36717239022254944,
0.24300238490104675,
-0.5520537495613098,
-0.07599324733018875,
-0.07981538027524948,
-0.05650191009044647,
-0.17820985615253448,
0.17119909822940826,
0.6355760097503662,
-0.6593421101570129,
0.38969776034355164,
-0.04321707785129547,
-0.3554361164569855,
-0.8531354665756226,
-0.7136361598968506,
0.03331540897488594,
-0.21574647724628448,
0.27246537804603577,
0.3004021644592285,
-0.659122109413147,
0.5364435911178589,
0.015085230581462383,
0.3162265419960022,
-0.0949830561876297,
0.2880532145500183,
0.34470802545547485,
-0.006015370599925518,
-0.29731422662734985,
-0.5566462874412537,
-0.3242562711238861,
-0.3904753625392914,
0.4691145420074463,
-0.0008616462582722306,
0.029420796781778336,
-0.0953725054860115,
-0.660033106803894,
-0.08139250427484512,
-0.3248724043369293,
-0.20994821190834045,
0.3297278881072998,
0.091244637966156,
0.2327064573764801,
-0.23575539886951447,
0.7452493906021118,
-0.441326767206192,
-0.1958935707807541,
0.19381281733512878,
-0.12334763258695602,
0.4651389420032501,
0.11141571402549744,
-0.12140069156885147,
-0.07084881514310837,
-0.23981750011444092,
-0.14260876178741455,
-0.016533073037862778,
0.04238688573241234,
0.04901910200715065,
0.11895589530467987,
-0.02041417732834816,
0.07493768632411957,
-0.6468749046325684,
-0.1136794462800026,
-0.20225739479064941,
-0.2463214099407196,
0.2826201021671295,
-0.31175315380096436,
0.5574167370796204,
0.19660750031471252,
-0.5214502811431885,
-0.18025928735733032,
-0.38016435503959656,
-0.4072304368019104,
-0.24142663180828094
] |
NCT01876797
|
PKPD Study of Ticagrelor and Prasugrel in Healthy Korean Males
|
This study is to characterize the pharmacokinetic and pharmacodynamics of ticagrelor and prasugrel in healthy Korean male subjects.
The study is open label, one sequence, crossover design. In period 1, a single oral dose of 180 mg ticagrelor will be administrated. After at least 7 days washout period, in period 2, a single oral dose of 60 mg prasugrel will be administrated.
After dosing each period, blood sampling for PK and PD assessment will be conducted.
1. Blood Sampling Times
1. PK :predose,10 min,15 min,25 min, 0.5,1,1.5,2,2.5,4,6,8,12 and 24h post-dose
2. PD :predose,15 min,0.5,1,2,4,6,8,12 and 24h post-dose
2. Bioanalysis
1. plasma Ticagrelor
2. plasma AR-C124910XX (active metabolite of ticagrelor)
3. plasma R-95913 (inactive metabolite of prasugrel)
4. plasma R-13727 (active metabolite of prasugrel)
3. Platelet Aggregation Test using turbidometric Method Maximal Platelet Aggregation(MPA)
4. PK-PD Modeling analysis
|
Inclusion Criteria:
1. male aged 19 - 45 years at screening visit
2. body weight at least 60 kg at screening visit
3. body mass index 18 - 30 kg/m2
4. SBP 90 - 149 mmHg and DBP 60 - 99 mmHg and pulse rate(beat per minute) 45 - 100 at screening visit
Exclusion Criteria:
1. any history of or having any clinically significant abnormalities
2. any gastrointestinal disorder having impact on absorption of study drug
3. any history of hypersensitivity of ticagrelor or prasugrel or compounds related study drugs
4. any history of taking original medicines within 30 days before dosing or history of taking prescribed drug within 14 days before dosing or history of taking OTC drug within 7 days before dosing
5. any history of taking other study drug within 60 days before dosing
6. any history of whole blood transfusion within 60 days before dosing or history of blood elements transfusion or history of heaving been transfused within 30 days before 30 days
7. any history of taking metabolic inducer or inhibitor
8. overuse (caffeine: \> 5 units/day , alcohol: \> 21 units /week, smoking: \> 10 cigarettes/day)
9. positive serology testy(Hbs antigen, HIV, Hepatitis C virus, Syphilis)
10. any abnormality in clinical laboratory tests result or any ECG finding considered to be inadequate by investigator
|
[
1.6994787454605103,
0.6174057722091675,
-2.1977102756500244,
-2.6751630306243896,
1.5553480386734009,
0.7629850506782532,
0.809459924697876,
-0.2015182375907898,
-0.9119083285331726,
-0.4799495339393616,
0.3996250033378601,
0.7103739976882935,
-0.29702091217041016,
-0.8697697520256042,
0.2701393961906433,
-0.5169681310653687,
-0.12124834209680557,
-0.2297927439212799,
0.30337366461753845,
-1.7467316389083862,
0.3982311487197876,
-1.2738218307495117,
-1.1624642610549927,
0.22533480823040009,
-0.9038679003715515,
-1.0582056045532227,
0.027351245284080505,
1.7899175882339478,
0.07482963800430298,
1.8336589336395264,
0.350541353225708,
0.5412595272064209,
1.138739824295044,
0.8578694462776184,
0.18982359766960144,
-0.7767587900161743,
1.0661249160766602,
0.09346339851617813,
0.32214879989624023,
-0.27177634835243225,
-0.0719464123249054,
-0.3121258020401001,
0.5263859629631042,
-0.0367189384996891,
1.5726255178451538,
-0.031146295368671417,
0.35798636078834534,
-0.26295197010040283,
0.04699457436800003,
-0.4761268198490143,
-0.9076939225196838,
0.08334660530090332,
-0.6411502361297607,
-0.16252325475215912,
1.1273999214172363,
1.403307557106018,
-0.004915837198495865,
-0.10576584935188293,
0.9582647085189819,
0.15053719282150269,
-0.6572234034538269,
0.7405693531036377,
0.3448743224143982,
-0.3762628436088562,
0.5375843644142151,
0.2967361807823181,
-0.29206275939941406,
-0.04241233319044113,
-1.026151418685913,
1.80231773853302,
-0.8135018348693848,
0.698567807674408,
1.3209420442581177,
-0.23813802003860474,
1.1117843389511108,
1.315692663192749,
0.12797017395496368,
1.459289789199829,
-0.3224692940711975,
0.0814904198050499,
-0.22283971309661865,
0.3432360887527466,
0.08610998094081879,
-0.04032527282834053,
0.28462183475494385,
0.3484445810317993,
-0.10006299614906311,
-0.3562803566455841,
-0.11846696585416794,
0.29052743315696716,
0.5781564116477966,
-0.39804649353027344,
-0.8576486706733704,
-0.17634980380535126,
-0.22857561707496643,
0.010795427486300468,
0.23833534121513367,
0.4086071252822876,
-0.585412323474884,
0.4102288484573364,
-0.15987765789031982,
-0.8379160165786743,
-0.1779065728187561,
0.5876784324645996,
-0.833520770072937,
-0.4093973934650421,
-0.5598863363265991,
-0.17162072658538818,
-0.16664445400238037,
-0.9158710837364197,
0.07445328682661057,
-0.47275856137275696,
-0.3785129189491272,
-0.04084789380431175,
0.2871743440628052,
0.6665642857551575,
0.02096865139901638,
0.3623119592666626,
-0.686479389667511,
-0.16598494350910187,
0.22049379348754883,
1.0968801975250244,
-0.2606874108314514,
-0.1580592393875122,
-0.20446108281612396,
-0.4214737117290497,
0.16814221441745758,
-0.24502530694007874,
0.6024011969566345,
-0.6360315084457397,
-1.4548087120056152,
0.6763687133789062,
-0.6327464580535889,
-0.141208678483963,
-0.7860172986984253,
-0.17626835405826569,
0.09083765000104904,
0.5834309458732605,
0.3983481526374817,
0.07498956471681595,
0.18991601467132568,
-0.12081592530012131,
0.10000856220722198,
-0.2581669092178345,
-1.0959357023239136,
0.41338786482810974,
-0.26121583580970764,
0.6553124189376831,
0.13535477221012115,
0.6080376505851746,
-0.11676697432994843,
0.31175780296325684,
-0.4203396141529083,
-0.32161325216293335,
0.3208853006362915,
0.03947347775101662,
0.2826370894908905,
0.3188101351261139,
0.34284543991088867,
-0.6464113593101501,
-0.2338961809873581,
-0.7260513305664062,
-0.08767876029014587,
-0.039183955639600754,
0.06524429470300674,
0.6694398522377014,
-0.2919602692127228,
-0.06916514784097672,
0.27836132049560547,
0.3188003599643707,
-0.6572737097740173,
0.1933920532464981,
0.5462248921394348,
0.5309693217277527,
-0.13073797523975372,
0.27044156193733215,
-0.09276506304740906,
0.26934418082237244,
-0.0299252700060606,
0.8593494892120361,
-0.2792099416255951,
-0.24207505583763123,
-0.3277728259563446,
-0.15398144721984863,
0.13307428359985352,
-0.36526963114738464,
-0.09862364828586578,
0.04421105608344078,
-0.017085036262869835,
-0.00044577018707059324,
0.7747498154640198,
-0.3977149426937103,
-0.3805033266544342,
0.15946774184703827,
0.40841275453567505,
-0.08121924847364426,
-0.035718951374292374,
0.5884009599685669,
0.6239890456199646,
-0.45768651366233826,
0.1400192528963089,
0.19566474854946136,
0.09058218449354172,
0.7199066281318665,
0.2805090844631195,
-0.18639446794986725,
-0.7509857416152954,
0.2848116457462311,
-0.02841302938759327,
-0.5397268533706665,
0.031716108322143555,
0.10351152718067169,
-0.6000484824180603,
0.24761179089546204,
0.46252256631851196,
-0.4467400908470154,
-0.13265474140644073,
0.1616954803466797,
0.19722701609134674,
0.10409379005432129,
-0.06412287801504135,
-0.010227384977042675,
-0.33335065841674805,
0.2705095112323761,
-0.018165281042456627,
-0.4479258954524994,
-0.20820890367031097,
-0.04803809896111488,
-0.2270897775888443,
-0.18355733156204224,
-0.21812660992145538,
0.4488677978515625,
0.17892292141914368,
-0.16815440356731415,
0.3195704221725464,
-0.11670155078172684,
-0.04808828607201576,
0.3359488546848297,
-0.020406782627105713,
-0.012954581528902054,
0.027381157502532005,
-0.43706628680229187,
0.013199571520090103,
-0.202033132314682,
0.23117592930793762,
-0.22524307668209076,
0.0560666099190712,
0.5928221344947815,
0.20320773124694824,
0.0028571372386068106,
0.3361244201660156,
-0.1338820904493332,
-0.3035081624984741,
0.4866158068180084,
-0.24073727428913116,
-0.28140580654144287
] |
|
NCT01622725
|
Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.
|
Since abdominal wall hernia repair is currently performed with the use of a mesh, side effects associated with the mesh are frequently reported during long term follow-up. These side effects are related to shrinkage of the mesh, adhesions to the bowl, pain, and inflammation of the skin and bowl. To reduce or prevent these effects, a fully resorbing mesh has been developed, which provides sufficient support and strength to allow efficient recovery of the abdominal wall, but also disappear from your body in three years time, so that you no longer have any synthetic material in your body. Previous resorbing meshes also disappeared but over a much shorter period of time, so that the hernia was insufficiently healed, with recurrence as a result.
The TIGR™ mesh (the resorbable mesh used in the study) is in principle a synthetic mesh, made of two commonly used polymers, however it will retain 50% of its initial strength after six months. This in theory is enough to provide support of the collagen healing process during the initial wound-healing phase, but also to support the transition of initial collagen to functional collagen.
The aim of this study is to compare TIGR™ with large pore mesh used in the repair of the anterior abdominal wall repair (incisional hernia, umbilical hernia, etc..Inguinal hernias are not part of the study).
Therefore the patients will be divided into two groups, one group will be treated with a resorbing mesh, the other group will be treated with a permanent mesh. Otherwise there will be no difference in the medication or the surgical techniques used.
|
Inclusion Criteria:
* Primary and secondary ventral hernia
* less than 20 cm in length
* less than 6 cm in width
Exclusion Criteria:
|
[
-0.3243636190891266,
1.1216249465942383,
-0.9927516579627991,
-2.5950660705566406,
-0.33438360691070557,
0.1616917848587036,
0.8005149960517883,
-0.2458643764257431,
-1.649429440498352,
-0.16746652126312256,
-1.3844552040100098,
1.1784731149673462,
-0.0965968519449234,
0.0946812704205513,
0.9160115718841553,
0.19659173488616943,
-0.7031136751174927,
0.034609269350767136,
0.2739141583442688,
-1.7113455533981323,
-0.6229286789894104,
-0.4978907108306885,
-0.13447386026382446,
-0.5725347399711609,
1.7678755521774292,
0.6060689687728882,
-0.3564680814743042,
0.308691143989563,
0.7888845205307007,
0.9381687641143799,
-0.48341307044029236,
-1.0341256856918335,
-1.2868239879608154,
0.5654742121696472,
-0.36939457058906555,
0.08227217197418213,
-0.6894698143005371,
0.8514399528503418,
-0.7171097993850708,
0.21995481848716736,
-0.6415436267852783,
-0.3612785339355469,
0.20521529018878937,
-0.6941962838172913,
-0.11821385473012924,
-0.009534797631204128,
0.11081278324127197,
-0.38552725315093994,
0.47838354110717773,
-1.0838183164596558,
0.4758199155330658,
-0.6446832418441772,
0.18775881826877594,
-0.15209105610847473,
0.6937673687934875,
0.6466553211212158,
0.5638319253921509,
0.6327027082443237,
0.34459924697875977,
0.3916516900062561,
0.07827169448137283,
-0.021590661257505417,
-0.5843133330345154,
0.13200296461582184,
-0.03609126806259155,
-1.6548750400543213,
0.45224738121032715,
0.5931769013404846,
-0.02448338083922863,
1.019040584564209,
0.2327961027622223,
-0.37179213762283325,
0.20194555819034576,
0.8469400405883789,
0.5637797117233276,
0.5432105660438538,
-0.5309945940971375,
-0.054124634712934494,
-0.38786885142326355,
0.7645063400268555,
-0.011754831299185753,
0.5052732825279236,
-0.23702774941921234,
-0.20088927447795868,
-0.496481716632843,
0.04200299456715584,
-0.024953126907348633,
-0.3157545030117035,
0.9041451811790466,
-0.8736332654953003,
0.7214609384536743,
-0.022409504279494286,
-1.2733244895935059,
0.4801683723926544,
-0.5852778553962708,
0.3334175944328308,
-0.5272709131240845,
-0.5776556134223938,
-0.6157859563827515,
0.17586344480514526,
0.5387676358222961,
0.21326614916324615,
0.5473624467849731,
-0.07807739824056625,
-0.09475240111351013,
-0.08316268771886826,
-0.29594483971595764,
-0.4433380365371704,
-0.4539170563220978,
-1.0086636543273926,
0.06926994770765305,
-1.031388521194458,
-0.13082849979400635,
-0.36055245995521545,
-0.35835257172584534,
0.15537980198860168,
0.34147927165031433,
-0.2943262755870819,
-0.138719379901886,
-0.14900323748588562,
0.4813457131385803,
0.2035273164510727,
-0.15596674382686615,
0.36722275614738464,
0.16335774958133698,
0.12742918729782104,
0.17157018184661865,
1.2665185928344727,
-0.22188527882099152,
0.08816077560186386,
0.03888702392578125,
0.46594300866127014,
-0.12461508810520172,
-0.47537437081336975,
-0.9853652715682983,
0.12313832342624664,
-0.04442222788929939,
0.2131134420633316,
-0.11771371215581894,
0.09861938655376434,
0.1415375918149948,
0.36241018772125244,
-0.4522440731525421,
0.029276246204972267,
-0.8508074283599854,
-0.3539983630180359,
-0.3299204707145691,
-0.017766669392585754,
-0.4047337770462036,
-0.32844221591949463,
-0.04163975268602371,
0.017556753009557724,
0.539088249206543,
0.2549632787704468,
0.5661436915397644,
0.42044469714164734,
0.00827480386942625,
-0.4610583186149597,
-0.3951769173145294,
0.07364652305841446,
0.4501389265060425,
-0.00031495222356170416,
-0.05096033960580826,
-0.18492719531059265,
0.17117033898830414,
-0.5408292412757874,
-0.0815151110291481,
0.09489258378744125,
0.3602689206600189,
-0.19359606504440308,
-0.49215689301490784,
-0.36736413836479187,
0.0019229494500905275,
0.5323786735534668,
-0.1791369616985321,
0.36070993542671204,
0.39385613799095154,
-0.007296787109225988,
0.5079472661018372,
0.04526575282216072,
0.01695731282234192,
-0.2361762374639511,
0.20873451232910156,
0.05364339053630829,
-0.058121226727962494,
-0.41491565108299255,
0.0930461436510086,
0.12409792840480804,
-0.23538127541542053,
0.48657140135765076,
0.5701155066490173,
0.17589958012104034,
0.35016077756881714,
0.19848330318927765,
0.019880158826708794,
0.4753822088241577,
-0.10974292457103729,
-0.12347160279750824,
0.49671927094459534,
-0.11728699505329132,
0.2138766050338745,
0.31759774684906006,
-0.23202799260616302,
0.3642984628677368,
0.4479736089706421,
-0.3314780294895172,
-0.5700097680091858,
0.40400364995002747,
0.23876546323299408,
0.27185681462287903,
0.007813443429768085,
0.25159144401550293,
-0.05918802693486214,
0.1334017664194107,
-0.06340167671442032,
0.256680965423584,
-0.10686186701059341,
-0.051571909338235855,
-0.18860551714897156,
-0.21105855703353882,
0.26102694869041443,
0.0012304759584367275,
-0.046807460486888885,
0.032006554305553436,
0.21568958461284637,
0.17862434685230255,
0.2887308895587921,
-0.05391440913081169,
-0.23538275063037872,
0.19306975603103638,
0.17550285160541534,
-0.12191984802484512,
-0.14093360304832458,
0.02796921133995056,
-0.2611968517303467,
-0.2728073298931122,
0.07132085412740707,
-0.08320503681898117,
-0.043888192623853683,
-0.14184148609638214,
0.12131655961275101,
-0.7776639461517334,
-0.2676079273223877,
-0.09156075865030289,
0.03483954071998596,
0.11685378849506378,
0.11047019809484482,
0.46704572439193726,
-0.04539751634001732,
0.015194931998848915,
0.3150409460067749,
-0.5103170275688171,
0.34240177273750305,
-0.14057978987693787,
0.20204733312129974,
-0.33767250180244446
] |
|
NCT05775900
|
Efficacy and Safety of Triweekly Cetuximab in Combination With Capecitabine as First-line Maintenance Treatment for KRAS/BRAF Wild-type Metastatic Colorectal Cancer
|
To explore the safety, efficacy and pharmacokinetic (PK) characteristics of triweekly cetuximab in combination with capecitabine as first-line maintenance treatment for KRAS/BRAF wild-type metastatic colorectal cancer: a single-arm, a single-center, Phase 1b trial. Meanwhile, Exploring the maximum tolerant dose or recommended II research dose of triweekly cetuximab combined with a fixed dose of capecitabine using '3+3' dose climbing Phase I experiment.
|
Inclusion Criteria:
* Provide a written informed consent form (ICF) before any research procedure is carried out.
* Patients must be ≥18 years old and have an expected life span of at least 12 weeks when signing the ICF.
* Patients have histologically or cytologically confirmed RAS and BRAF wild-type metastatic colorectal adenocarcinoma (mCRC), excluding appendiceal and anal cancers.
* After being diagnosed with mCRC, patients have only received cetuximab combined with chemotherapy (FOLFOX or FOLFIRI) as first-line induction therapy. Imaging progression during adjuvant therapy or within 6 months after completion of adjuvant therapy is considered as first-line treatment.
* Patients have completed 8 cycles of cetuximab combined with chemotherapy induction therapy and the disease is controlled (including CR/PR and SD).
* There is at least one measurable metastatic lesion, defined as per RECIST version 1.1. Patients who have achieved CR without measurable lesions after induction therapy, and those who have achieved no evidence of disease (NED) through R0 resection, interventional ablation, or other local destructive therapies can be included in this study.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Within 7 days before treatment, the following laboratory test values are obtained and appropriate organ function is present:
Hemoglobin ≥ 90g/L, neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥ 75 × 10\^9/L; Serum total bilirubin ≤ 1.5 × upper limit of normal (UNL); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × UNL; if there are liver metastases, AST or ALT ≤ 5 × UNL; Serum creatinine ≤ 1.5 × UNL.
* Patients are not allowed to participate in other clinical trials during the study period.
* Patients are willing and able to comply with the study protocol and visit plan.
Exclusion Criteria:
* Excluding adjuvant therapy that ended more than 9 months ago (including oxaliplatin-containing therapy) or more than 6 months ago (excluding oxaliplatin-containing therapy), any chemotherapy for metastatic colorectal cancer (mCRC) other than induction therapy consisting of cetuximab in combination with FOLFOX or FOLFIRI.
* Concurrent active malignancy, excluding malignancies with disease-free survival of 5 years or more or in situ carcinoma considered cured after adequate treatment.
* Known brain metastases or leptomeningeal metastases. Patients with neurological symptoms should undergo brain CT/MRI to exclude metastases.
* Any unresolved toxicities greater than or equal to Grade 2 per the Common Terminology Criteria for Adverse Events (CTCAE) caused by previous treatment, excluding alopecia, skin pigmentation, and anemia. Patients with unresolved neurotoxicity greater than or equal to CTCAE Grade 3 caused by platinum-based drugs should be excluded.
* Ascites, pleural effusion, or pericardial effusion requiring drainage within the past 4 weeks.
* Patients with bowel obstruction, gastrointestinal bleeding, pulmonary fibrosis or interstitial pneumonia, renal failure, liver failure, or cerebrovascular disease.
* Uncontrolled diabetes, defined as HbA1c \>7.5% after the use of antidiabetic drugs, or uncontrolled hypertension, defined as systolic/diastolic blood pressure \>140/90mmHg after the use of antihypertensive drugs.
* Myocardial infarction within the past 12 months, severe/unstable angina pectoris, or New York Heart Association (NYHA) Class III or IV congestive heart failure symptoms.
* A history of allergy to any study drugs (such as cetuximab or capecitabine).
* Known infection with human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS) related diseases, hepatitis B or C.
* Autoimmune diseases or a history of organ transplantation requiring immunosuppressive therapy.
* Mental illness that may increase the risk associated with participation in the study or interfere with the interpretation of study results.
* Received any of the following treatments within a specified time period prior to receiving the study drug:
Major surgery within 4 weeks (excluding diagnostic biopsy, surgical incision should be completely healed before administering the study drug).
Radiotherapy within 4 weeks. Other anti-tumor treatments or participation in other clinical trials within 4 weeks, except for induction therapy as specified in the protocol.
* Pregnant (confirmed by serum human chorionic gonadotropin \[hCG\] test) or lactating women, or women of childbearing potential who plan to become pregnant during the treatment period and within 2 months after the end of cetuximab treatment, or within 6 months after the end of capecitabine treatment. Women of childbearing potential or sexually active men who are unwilling to use contraception during the study period and for at least 2 months after the end of cetuximab treatment, or 6 months after the end of capecitabine treatment. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
* Presence of any other serious illness that, in the investigator's opinion, would preclude the patient's participation in the study.
|
[
0.3019641041755676,
1.0708353519439697,
-2.349822998046875,
-4.584124565124512,
0.3781483769416809,
0.853236198425293,
-0.6069067120552063,
0.24108730256557465,
-0.9039884805679321,
0.1193242147564888,
0.1091519221663475,
0.8758870363235474,
-1.0875768661499023,
-0.801753580570221,
0.7955846190452576,
0.11646268516778946,
-0.5837591886520386,
0.05670563131570816,
0.37190109491348267,
-0.7977237701416016,
1.1426447629928589,
-0.9510723948478699,
-0.14929243922233582,
1.1166956424713135,
-0.3078438341617584,
-0.06112207844853401,
-1.4619207382202148,
1.4664055109024048,
0.2159796506166458,
0.9173129200935364,
-0.3958311676979065,
0.19252608716487885,
0.8229487538337708,
0.8553150296211243,
0.2131144106388092,
0.16965289413928986,
0.7819153666496277,
0.5109689831733704,
-1.4798661470413208,
1.1815365552902222,
1.2264368534088135,
0.3593215048313141,
-0.28321802616119385,
0.06418772041797638,
0.4748590886592865,
0.4409211277961731,
-0.3400314748287201,
-0.42383235692977905,
0.135565385222435,
0.31624406576156616,
-1.492915153503418,
1.3642219305038452,
0.12875254452228546,
-0.3916201591491699,
2.0765268802642822,
-0.6774793863296509,
-0.038414519280195236,
0.9811677932739258,
1.730749487876892,
0.02673245035111904,
0.5846424698829651,
-0.24187564849853516,
-0.6761211156845093,
0.9030728340148926,
0.24512287974357605,
-0.16252568364143372,
0.17655852437019348,
-0.20486421883106232,
-0.4262230098247528,
1.4815489053726196,
-0.093384750187397,
0.9468021988868713,
0.41439834237098694,
0.8005638718605042,
0.29631307721138,
0.9556307196617126,
0.04982047528028488,
1.1665207147598267,
0.1728402078151703,
0.2577921450138092,
-0.2759067416191101,
-0.16833770275115967,
-0.08764106780290604,
0.09743616729974747,
-0.7334458231925964,
0.1293155401945114,
-0.4861091673374176,
-1.6607961654663086,
0.41500672698020935,
-0.41141608357429504,
0.5749459266662598,
-0.7148924469947815,
-1.2132726907730103,
0.37004247307777405,
-0.9576838612556458,
0.03315838426351547,
0.6203007102012634,
-0.3430608808994293,
-0.3331200182437897,
-0.4129396080970764,
0.36815330386161804,
1.1948392391204834,
-0.8532907366752625,
-0.7165680527687073,
-1.3014763593673706,
-0.004083051811903715,
-0.21591708064079285,
-1.0093621015548706,
-0.8014746904373169,
-1.2384185791015625,
0.16871951520442963,
-1.1829490661621094,
-0.35744771361351013,
-0.7407770752906799,
0.9104318022727966,
0.5608932375907898,
0.6130915284156799,
0.23237453401088715,
-0.663347601890564,
0.14431115984916687,
-0.41109660267829895,
0.5372099280357361,
0.3988173007965088,
-0.02808627486228943,
0.42491477727890015,
0.42510226368904114,
-0.16239993274211884,
-0.5837764143943787,
0.3031747341156006,
-1.0565580129623413,
-1.1826541423797607,
-0.028060296550393105,
-0.09853198379278183,
-0.3947799801826477,
-1.0941256284713745,
-0.4969030022621155,
0.34069451689720154,
1.314186930656433,
0.551132082939148,
0.4287301003932953,
0.6329507827758789,
0.5660733580589294,
0.7652434706687927,
-0.5117097496986389,
-0.9778382182121277,
1.177247166633606,
-0.09670452028512955,
0.42142751812934875,
0.2644806206226349,
-0.12644141912460327,
-0.1411072015762329,
0.3743160665035248,
0.3540337383747101,
0.043853409588336945,
0.6088002920150757,
0.5718523859977722,
0.9088131785392761,
-0.3083164691925049,
0.7091223001480103,
-0.5010433793067932,
-0.5214520692825317,
-0.5445195436477661,
-0.0017092091729864478,
-0.14227710664272308,
0.4303433299064636,
0.8021842837333679,
-0.756822943687439,
-0.5765553712844849,
-0.330928236246109,
-0.2300024777650833,
-1.1095612049102783,
0.08000529557466507,
0.5175892114639282,
0.5765165090560913,
0.25463247299194336,
-0.3056280314922333,
0.1691989153623581,
-0.3880416750907898,
0.3560485541820526,
-0.014297635294497013,
-0.5857315063476562,
0.14598269760608673,
-0.2348777949810028,
-0.15134938061237335,
0.1130138486623764,
-0.4507766366004944,
0.27385812997817993,
0.21513278782367706,
0.3579539954662323,
0.19006218016147614,
0.6843143105506897,
0.054664142429828644,
-0.27012959122657776,
0.8852598071098328,
-0.1862238645553589,
-0.8783584833145142,
0.4428572952747345,
-0.40175315737724304,
0.7911198735237122,
-0.44184038043022156,
0.4343450367450714,
1.1496913433074951,
-0.000005091690127301263,
0.12690600752830505,
0.5907543301582336,
-0.1489974409341812,
0.09282851964235306,
0.10860566049814224,
-0.26374831795692444,
0.1485348492860794,
0.7130624651908875,
0.015952065587043762,
-0.15494254231452942,
0.2936614453792572,
-0.03483595326542854,
0.3027209937572479,
0.018334928900003433,
0.591387927532196,
-0.7551520466804504,
0.4017114043235779,
-0.014058609493076801,
0.0740187019109726,
-0.5004873275756836,
-0.12365927547216415,
0.3257613480091095,
-0.4977931082248688,
0.011374992318451405,
-0.41514578461647034,
-1.0288028717041016,
-0.2071346491575241,
0.3148646354675293,
0.17125484347343445,
-0.17375527322292328,
-0.3734062612056732,
0.28838562965393066,
0.36303481459617615,
-0.13053478300571442,
0.27358680963516235,
-0.5273877382278442,
0.46182212233543396,
0.7282816767692566,
-0.7946282625198364,
-0.7500318288803101,
-0.6548475027084351,
0.5467292666435242,
-0.5414584875106812,
0.18885794281959534,
0.025028971955180168,
-0.5354569554328918,
0.375485360622406,
-0.27047887444496155,
-0.03594166785478592,
0.02360984869301319,
0.5959094762802124,
-0.47171106934547424,
-0.45973914861679077
] |
|
NCT05678075
|
The Stanford Plant-based Educational Study: Providers Learning About Nutrition Together (PLANT)
|
More than 70% of chronic illnesses can be prevented or reversed with a whole-food, plant-based diet (WFPBD). This dietary pattern is also more sustainable for our planetary health. The majority of physicians receive fewer than 20 hours of nutrition education during the entire course of their medical training. Although many physicians are aware of the importance of diet on their well-being, they face significant barriers in following a healthy diet. Because physicians' own habits strongly influence patient health habits, the investigators theorize that physicians who eat a WFPBD themselves will be much more likely to successfully counsel their patients on nutrition and recommend a WFPBD.
The most effective methods that can be successfully used to encourage busy physicians to adopt a WFPBD have not yet been identified. Given the increasing rates of diet-related chronic illnesses, if proven effective, this study may offer a new scalable approach to encourage physicians, and ultimately their patients, to adopt a WFPBD.
The aims of this study are to:
1. Assess the impact of a multimodal 6-week educational program on WFPBD on a) change in physicians' diet type and quality, b) change in mindset about WFPBD, and c) stage of change based on the transtheoretical model of behavior change (Figure 1), compared to the delayed-intervention (control group) from baseline to week 6.
2. Assess the impact of the 6-week educational program on the development of skills and knowledge required to a) adopt a WFPBD and b) counsel patients on the same.
|
Study overview:
This is a randomized, delayed intervention trial testing a flexible, multimodal WFPBD educational program for 6 weeks for providers at Stanford in any department.
Research Activities:
1. Screening: Interested participants will participate in a Qualtrics survey, which will determine eligibility.
2. Enrollment: If the provider expresses interest in participating, the research team will send an email that explains details about the study. A waiver of consent will be utilized given minimal risk.
3. Intervention: a 6-week multimodal educational intervention program. We will utilize a pre- and post-study survey which will include information on current dietary habits and use of Diet ID (assessment of diet type and quality). We will also assess their mindset for adopting a WFPBD. Finally, we will assess measures of motivation and confidence to adopt a WFPBD and to prescribe a WFPBD to patients. The educational program will include interactive didactic sessions, cooking classes, and weekly emails with suggested resources and activities including movies, recipes, and websites.
|
Inclusion Criteria:
* Clinical personnel at Stanford who agree to participate in this nutritional intervention study
Exclusion Criteria:
* None
|
[
-0.7276279330253601,
3.363781452178955,
-1.9588680267333984,
-1.195397138595581,
0.8337085843086243,
0.048800282180309296,
-1.508414387702942,
-0.13299959897994995,
0.6334245800971985,
-0.1072234958410263,
0.20910842716693878,
1.331993579864502,
-0.25592756271362305,
-0.11211250722408295,
-0.20457230508327484,
0.24559737741947174,
-0.6413047313690186,
-0.6286961436271667,
0.5873379707336426,
-1.0773231983184814,
1.1658499240875244,
-0.10390866547822952,
1.353609561920166,
-0.559148907661438,
0.16240127384662628,
0.23052048683166504,
-1.2435665130615234,
1.3833560943603516,
-0.8818051218986511,
1.2076890468597412,
1.3219058513641357,
0.04897715896368027,
-0.0853038802742958,
-0.0969143658876419,
1.0629802942276,
0.2560349106788635,
0.3848847448825836,
0.5090330243110657,
-1.2685608863830566,
1.4569358825683594,
0.23562198877334595,
0.6657495498657227,
-0.3910593092441559,
-0.00969659723341465,
0.49050888419151306,
0.7481349110603333,
0.3994617462158203,
-0.0874471515417099,
-1.0834407806396484,
0.650395393371582,
-0.3852619230747223,
1.6318509578704834,
-0.4347836971282959,
-0.313649982213974,
1.3019776344299316,
-0.06629811972379684,
-0.08784502744674683,
0.5414389371871948,
0.7472026348114014,
0.3246793746948242,
-0.22053806483745575,
-0.47356587648391724,
-0.29830050468444824,
0.6000937223434448,
-0.6559246182441711,
-1.0710288286209106,
0.22193306684494019,
0.5095945596694946,
-0.6301597952842712,
1.0440603494644165,
0.35352182388305664,
-0.03362460434436798,
-0.03148439899086952,
0.44848260283470154,
0.21654045581817627,
-0.031713493168354034,
-0.28212010860443115,
0.8657152056694031,
0.03522126376628876,
0.507338285446167,
-0.15135027468204498,
0.23778454959392548,
-0.3858915865421295,
-0.5597431659698486,
0.2548578977584839,
-0.5152154564857483,
-0.6377747058868408,
-0.8189161419868469,
0.7889039516448975,
-0.8377710580825806,
0.0009670840227045119,
-0.4244639277458191,
-0.11399490386247635,
0.786759078502655,
-0.37668871879577637,
0.24284318089485168,
0.4912184178829193,
-0.4304717481136322,
-0.5330765247344971,
-0.573231041431427,
-0.007199136074632406,
0.45145383477211,
-0.23994247615337372,
-0.4635203182697296,
0.00016923279326874763,
0.33450379967689514,
-0.139695405960083,
-0.5719159245491028,
-0.6273748874664307,
-0.3941870927810669,
-0.21181069314479828,
-0.6140215396881104,
0.4165813624858856,
0.23320965468883514,
0.27475860714912415,
0.33251798152923584,
0.6053082942962646,
0.12958179414272308,
0.261746346950531,
-0.7037241458892822,
-0.1477130800485611,
0.6060141921043396,
-0.018874529749155045,
-0.46851837635040283,
-0.18880867958068848,
-0.13257218897342682,
-0.253007173538208,
0.2381582260131836,
0.15281009674072266,
0.1546086221933365,
-0.2843261957168579,
-0.3985182046890259,
-0.09933548420667648,
-0.348425030708313,
0.1270257532596588,
-0.4551814794540405,
0.06571657210588455,
0.29684942960739136,
-0.4382004141807556,
-0.13691820204257965,
0.34722235798835754,
0.02347320318222046,
-0.465819388628006,
0.7205355763435364,
-1.176601529121399,
-0.2675972580909729,
-0.08085673302412033,
-0.4300505816936493,
-0.6443650126457214,
0.1998850405216217,
-0.009634171612560749,
0.4777619540691376,
0.13445217907428741,
-0.2929857671260834,
-0.6039341688156128,
0.08606062084436417,
0.5178735256195068,
-0.38907289505004883,
-0.29812392592430115,
-0.14016780257225037,
0.4757729172706604,
-0.1698393076658249,
-0.14340859651565552,
0.10356301814317703,
0.06497147679328918,
0.4506530165672302,
0.23447728157043457,
-0.05464668571949005,
0.6653854250907898,
0.14826694130897522,
-0.0674784705042839,
0.08480673283338547,
0.11216524988412857,
-0.3464909791946411,
-0.2372910976409912,
0.2620643377304077,
0.6356086730957031,
0.4980145990848541,
0.5090044140815735,
-0.1270052045583725,
0.006187883205711842,
-0.3488534986972809,
-0.2756788432598114,
-0.12495393306016922,
0.17616623640060425,
-0.1873897910118103,
-0.3144778907299042,
-0.23687100410461426,
-0.44440793991088867,
0.6577688455581665,
-0.39302146434783936,
-0.015569821931421757,
-0.013958945870399475,
0.06740804016590118,
0.525941014289856,
-0.08385498076677322,
-0.14009515941143036,
-0.06953135132789612,
0.4054183065891266,
-0.12756821513175964,
-0.2156972438097,
-0.059557776898145676,
-0.2860368490219116,
0.350269615650177,
-0.029700415208935738,
-0.5625851154327393,
-0.15755748748779297,
-0.26603609323501587,
-0.21275797486305237,
0.276779443025589,
0.19853845238685608,
0.27916082739830017,
0.2800309956073761,
-0.2093985676765442,
0.036666423082351685,
0.3773747980594635,
0.4683675467967987,
-0.1240517720580101,
-0.06051909551024437,
0.04098866507411003,
0.11650572717189789,
-0.22358669340610504,
0.012637060135602951,
0.33497583866119385,
-0.48547279834747314,
-0.1518048197031021,
0.11874306946992874,
0.013676607050001621,
0.27409809827804565,
0.013574274256825447,
0.05129897966980934,
-0.018922369927167892,
0.02402959205210209,
0.14600315690040588,
-0.40619421005249023,
-0.16048800945281982,
-0.11705813556909561,
-0.04003510996699333,
-0.21034975349903107,
0.04341525956988335,
0.23681287467479706,
-0.13414305448532104,
0.13953019678592682,
-0.06343463063240051,
-0.36083367466926575,
0.10239514708518982,
-0.06910516321659088,
0.30321475863456726,
-0.19756516814231873,
-0.13924019038677216,
0.136666938662529,
-0.17517496645450592,
0.3302367031574249,
-0.09877996891736984,
0.6178383231163025,
-0.04714081063866615
] |
NCT01163929
|
A Study to Look at the Combination of Chemotherapy, Trastuzumab and RAD001 in HER2 Positive Breast Cancer
|
The primary objective of this study is to assess whether a combination of chemotherapy, Trastuzumab and RAD001 will result in no evidence of microscopic disease at the time of surgery in 50% of enrolled patients.
|
This is an open-label Phase 2 neoadjuvant study for patients with histologically confirmed, HER-2 positive operable breast cancer. All patients will receive 18 weeks of neoadjuvant treatment.
The trial has an initial 2 week "biomarker lead in" phase. During this two week phase patients will either receive Trastuzumab alone or Trastuzumab + Everolimus. This two week lead in phase will be randomized open label. The rest of the 16 weeks of the neoadjuvant trial treatment is non randomized open label.
For the first two weeks of neoadjuvant treatment the eligible subjects will be randomly assigned to either receive or not receive Everolimus. This assignment will be accomplished by a previously prepared schedule (maintained by the investigational pharmacy), such that investigators are unaware of assignment until after the subject has been enrolled on the study and received assignment of Everolimus or not.
|
Inclusion Criteria:
* Female ≥ 18 to 65 years of age
* Histologically proven stage I, II or III adenocarcinoma of breast
* Candidate for adjuvant chemotherapy and Trastuzumab (Tumor size \> 1 cm, T2, T3, T4 and/or clinical N1 or N2)
* HER-2 positive breast cancer (IHC 3+ or FISH ratio of \> 2.0)
* ECOG Performance status 0-2
* No prior chemotherapy or HER-2 targeted therapy for breast cancer
* Not pregnant or breast feeding or adult of reproductive potential using effective birth control methods. If barrier contraceptives are used, these must be continued throughout trial by both sexes. Hormonal contraceptives not acceptable as a sole method of contraception. Women of childbearing potential must have negative urine or serum pregnancy test within 7 days before administration of RAD001
* Adequate bone marrow function: ANC \> 1500/mm3, platelet count \> 100,000/mm3, and hemoglobin \> 11 g/dL
* Adequate kidney function: serum creatinine of \< 1.5mg/dl and/or creatinine clearance of \> 60 mL/min
* Adequate hepatic function: transaminase \< 2 x upper limit of normal and total bilirubin \< 1.5 mg/dL.
* INR ≤2.0 and PTT 1.5 X the upper limit of institution normal range. Oral anticoagulants, eg,warfarin are CYP2C9 substrates and as such, no interaction with RAD001 is expected. Anticoagulation with Coumadin allowed if target INR is ≤2.0 and stable for \> 2 weeks. Anticoagulation with LMWH is allowed.
* Must sign informed consent
* Pretreatment lab values for CBC and CMP performed within 14 days of registration and other baseline studies within 30 days.
* Will have baseline mammogram, bone scan, CT chest and abdomen within 60 days of registration.
* Adequate cardiac function (Cardiac ejection fraction ≥ 50% as measured by echocardiogram or MUGA scan).
* Fasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, patient can only be included after initiation of appropriate lipid lowering medication.
Exclusion Criteria:
* Prior HER-2 targeted therapy for breast cancer
* Metastatic disease
* Uncontrolled intercurrent illness including but not limited to, ongoing or active infection requiring parenteral antibiotics or psychiatric illness/social situations that would limit compliance with study requirements.
* GI tract disease resulting in inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease eg, Crohn's, ulcerative colitis).
* Current active hepatic or biliary disease (exception of patients with Gilbert's syndrome, asymptomatic gallstones)
* Renal function as measured by creatinine clearance \<30ml/min (ratio to norm \<0.1)
* Pregnant
* Inflammatory breast cancer
* Active cardiac disease, defined as:
* History of uncontrolled or symptomatic angina
* History of arrhythmias requiring medications, or clinically significant, with exception of asymptomatic atrial fibrillation requiring anticoagulation
* Myocardial infarction \< 6 months from study entry
* Uncontrolled or symptomatic congestive heart failure
* Any other cardiac condition, which in opinion of treating physician, would make this protocol unreasonably hazardous for the patient
* History of another primary cancer, with the exception of:
* curatively resected nonmelanomatous skin cancer
* curatively treated cervical carcinoma in-situ
* other primary solid tumor curatively resected,treated with no known active disease present and no treatment administered for the last 3 years.
* Life expectancy of \< 2 months
* Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
* Should not receive immunization with attenuated live vaccines within 1 week of study entry or during study period
* Severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air
* Uncontrolled diabetes as defined by fasting serum glucose \>1.5 x ULN
* Active (acute or chronic) or uncontrolled severe infections
* Known history of HIV seropositivity
* Active, bleeding diathesis
* Patients who have received prior treatment with an mTOR inhibitor (Sirolimus, Temsirolimus, Everolimus).
* Known hypersensitivity to RAD001 (Everolimus) or other rapamycins (Sirolimus, Temsirolimus) or to its excipients
* Active Hepatitis B or C infection
* \> 65 years of age
|
[
1.3691246509552002,
2.487589120864868,
-1.7768594026565552,
-1.6366029977798462,
1.1257367134094238,
0.9240385293960571,
-0.24449880421161652,
-0.524263322353363,
-1.2743372917175293,
-0.012297040782868862,
-0.08259814232587814,
2.255948066711426,
-1.9690769910812378,
-1.2960896492004395,
-0.4057646095752716,
-1.0304033756256104,
0.01252871472388506,
0.22064386308193207,
0.3796415627002716,
-1.0661821365356445,
-0.13003458082675934,
-0.63340163230896,
-0.7590091228485107,
0.6245502233505249,
1.1326630115509033,
-1.014485478401184,
-0.101455457508564,
1.136481523513794,
-0.41808009147644043,
0.21930383145809174,
-0.6345617175102234,
-0.1161118745803833,
0.16655370593070984,
0.6552868485450745,
-0.042928654700517654,
-0.528011679649353,
0.7149127721786499,
1.0862072706222534,
-1.7595175504684448,
0.26204776763916016,
0.15832160413265228,
0.8720328211784363,
-0.6517554521560669,
0.8268221616744995,
0.7116195559501648,
0.2672407925128937,
-0.2579917907714844,
0.6046469807624817,
0.01667788438498974,
0.6942451596260071,
-1.1521179676055908,
0.360188752412796,
-0.5955166816711426,
0.22933140397071838,
1.5805333852767944,
0.8480130434036255,
1.2004460096359253,
0.3013345003128052,
1.8854162693023682,
0.6448601484298706,
-0.09952715784311295,
0.8130699992179871,
0.2168997824192047,
-0.412697434425354,
-0.05760825425386429,
0.6379995942115784,
-1.021149754524231,
0.39385727047920227,
-0.07671573758125305,
0.27639657258987427,
1.0312323570251465,
-0.34835684299468994,
0.6892065405845642,
-0.06349150836467743,
0.6494136452674866,
0.1148999035358429,
-1.1008094549179077,
0.49069562554359436,
0.22553610801696777,
0.43570807576179504,
-0.7198759913444519,
-1.3575598001480103,
-1.4770865440368652,
-0.9167060852050781,
0.033381685614585876,
-0.7629067897796631,
-0.7272300124168396,
-1.3120685815811157,
0.5527379512786865,
-1.630380392074585,
0.04619018733501434,
0.21968676149845123,
-0.298949271440506,
1.2013890743255615,
-0.8669997453689575,
0.760588526725769,
1.0981366634368896,
-0.48956599831581116,
-0.7347496151924133,
-0.6674178838729858,
0.1100674644112587,
-0.10024996846914291,
0.2916267216205597,
0.04528983309864998,
0.06260987371206284,
-0.3745782673358917,
-0.17526406049728394,
0.12279603630304337,
-0.38163045048713684,
-1.192130208015442,
0.9093469977378845,
-0.9021076560020447,
-0.7367533445358276,
-1.0777949094772339,
-0.16802790760993958,
-0.18917053937911987,
0.7112287878990173,
0.33303773403167725,
0.8603515028953552,
0.32018283009529114,
-0.39135709404945374,
-0.23718971014022827,
-0.970579981803894,
1.0944538116455078,
-0.9532069563865662,
-0.15452170372009277,
-0.13527005910873413,
0.29841211438179016,
-0.32458946108818054,
-0.9132706522941589,
-0.23569157719612122,
-0.1687486320734024,
0.024556994438171387,
0.7017454504966736,
-0.4709664285182953,
-0.286795973777771,
0.29943913221359253,
0.9453194737434387,
0.13246385753154755,
-0.40656739473342896,
0.42035070061683655,
1.040560007095337,
0.1915152668952942,
-0.2358970195055008,
-1.7220869064331055,
0.49115806818008423,
-0.31642889976501465,
0.8584180474281311,
-0.22413083910942078,
-0.43066850304603577,
-0.02282743528485298,
-0.12078770250082016,
0.43754497170448303,
0.1419648975133896,
0.1109863892197609,
0.17497901618480682,
0.403754860162735,
0.2733924984931946,
0.562632143497467,
0.23556995391845703,
-0.28060057759284973,
-0.5169312953948975,
-0.2767871916294098,
-1.1137160062789917,
0.9485232830047607,
-0.2800053358078003,
-0.08624983578920364,
0.4830254018306732,
0.345344215631485,
0.44554609060287476,
-1.0250999927520752,
0.17979814112186432,
0.24149514734745026,
0.04572056233882904,
-0.19347932934761047,
0.18910649418830872,
0.5896007418632507,
0.5637352466583252,
0.40722784399986267,
-0.6294124722480774,
-0.0055653732270002365,
-0.2818937599658966,
0.45838695764541626,
-0.09304580837488174,
0.1721576452255249,
0.0025241305120289326,
-0.2491304874420166,
-0.5228414535522461,
-0.24324892461299896,
-0.03146827965974808,
-0.43428149819374084,
-0.11866851150989532,
0.5921437740325928,
0.485429972410202,
0.4113162159919739,
-0.5214138627052307,
-0.5673569440841675,
-0.37369605898857117,
1.023280382156372,
-0.19244158267974854,
0.8724215030670166,
0.15311747789382935,
0.523515522480011,
0.8784183263778687,
0.4587167203426361,
0.0013329897774383426,
0.13006587326526642,
-1.0419079065322876,
-0.5959123373031616,
0.06730452924966812,
-0.42320892214775085,
0.333987832069397,
-0.640795111656189,
-0.09205961227416992,
0.08188724517822266,
0.23459520936012268,
-0.0646514818072319,
-0.08154856413602829,
-0.888365626335144,
-0.10654572397470474,
-0.10644163191318512,
0.5167773365974426,
-0.061625659465789795,
0.05458121374249458,
0.48075467348098755,
-0.6431028842926025,
0.7693489193916321,
-0.2236371785402298,
0.09904209524393082,
-0.03156465291976929,
-0.27904996275901794,
-0.19544170796871185,
-0.10041076689958572,
0.12599821388721466,
-0.35640257596969604,
0.16274751722812653,
0.5247061252593994,
-0.18112613260746002,
0.12012669444084167,
0.43233349919319153,
0.18759670853614807,
-0.6264333128929138,
0.011750446632504463,
-0.3403828740119934,
0.003972839098423719,
-0.04832061752676964,
-0.06790893524885178,
-0.010576244443655014,
-0.3873896598815918,
0.31091687083244324,
-0.11819159239530563,
-0.40982675552368164,
-0.20196518301963806,
0.18078835308551788,
0.5723485350608826,
-0.3071361482143402
] |
NCT04464772
|
FreeStyle Libre Continuous Glucose Monitoring System Accuracy Study
|
The purpose of this study is to characterize the Freestyle Libre Glucose Monitoring System in pediatric and adult subjects with respect to YSI reference venous plasma sample measurements.
|
Up to 100 subjects will be enrolled at up to six (6) clinical research sites in the United States. Subjects will wear two Sensors. Each Sensor will have a paired Reader that will be given to the subject. Subjects will be asked to perform at least 4 capillary Blood Glucose (BG) tests per day using the primary Reader.
Interstitial glucose readings from each Sensor will be obtained with the corresponding Readers immediately following each BG test. Subjects will be instructed to report any problems with the device. Subjects will make up to six (6) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Based on the subjects' age and
/or weight, subjects will have up to three (3) in- clinic visits during which intravenous blood draws and YSI reference testing will occur.
|
Inclusion Criteria:
1. Subject must be at least 4 years of age.
2. Subject must have type 1 or type 2 diabetes.
3. Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily).
4. Willing to perform a minimum of 4 finger sticks per day while wearing the sensor in the study.
5. Subject must be able to read and understand English.
6. For subjects age 6 and older: willing to allow medical personnel to insert an IV catheter in the arm to allow for venous blood samples to be obtained per the study protocol.
7. In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
8. At the time of enrollment, subject must be available to participate in all study visits.
9. Subjects aged 18 years and older must be willing and able to provide written signed and dated informed consent.
10. Subjects aged 17 years and younger must have a parent, guardian or legally authorized representative willing and able to provide written informed consent.
11. Subjects aged 7 - 17 years of age must be willing and able to provide written signed and dated informed assent.
Exclusion Criteria:
1. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
2. Subjects age 18 and older: Subject is known to be pregnant, attempting to conceive or is not willing and able to practice birth control during the study duration (applicable to only to female subjects age 18 and older).
3. Subjects age 17 and younger: Subject is known to be pregnant or becomes pregnant during the study (only applicable to female subjects age 17 years and younger)
4. Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. Such conditions include, but are not limited to extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, redness, infection or edema.
5. Subject is currently participating in another clinical trial.
6. Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
7. For subjects age 6 and older: subject has a hemoglobin (Hb) level that is below the normal range (for reference the low end of the normal range for Hb for adult males is 14 g/dL and for adult females is 12 g/dL; for pediatric males and pediatric 13.0 g/dL; for pediatric females aged 12 - 17 it is 12.0 g/dL2).
8. Subject has a known concomitant medical condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff.
9. Subject has X-ray, MRI, CT or diathermy appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends.
10. Subject is unsuitable for participation due to any other cause as determined by the Investigator.
|
[
1.6946803331375122,
2.2087340354919434,
-5.041258811950684,
-3.0576248168945312,
-1.079634666442871,
0.12490439414978027,
-0.8291223049163818,
-0.7999826669692993,
-0.4691446125507355,
-2.052333354949951,
1.2575498819351196,
1.0272990465164185,
0.3145892024040222,
1.8466237783432007,
0.3050661087036133,
0.7439212203025818,
-0.8705394864082336,
0.3486764430999756,
0.6087256073951721,
-1.8777168989181519,
0.325786828994751,
0.6401847004890442,
-1.8418259620666504,
-0.8248918652534485,
0.8122789263725281,
0.5676577091217041,
1.1700361967086792,
-1.1751786470413208,
0.3835445046424866,
3.1546809673309326,
0.569595456123352,
-0.4374958276748657,
0.3001323938369751,
1.5549545288085938,
-0.554343044757843,
-0.6841486096382141,
0.4829329550266266,
1.889620065689087,
0.3157874345779419,
0.4638903737068176,
0.13613450527191162,
2.0629236698150635,
0.8422067165374756,
-1.7896865606307983,
0.10302303731441498,
0.13044610619544983,
0.7223995327949524,
1.095940351486206,
-0.2638203203678131,
-0.8503513336181641,
0.6647734045982361,
0.16231992840766907,
-2.773013114929199,
0.14035376906394958,
2.763112783432007,
2.035489797592163,
0.8999311327934265,
-1.3546539545059204,
1.0834314823150635,
1.9921940565109253,
-0.3333018720149994,
-0.23378239572048187,
1.4053651094436646,
1.1482092142105103,
-0.8362401127815247,
1.5348618030548096,
1.351369857788086,
-0.2623966336250305,
-0.02113221399486065,
-0.11565228551626205,
-1.1488977670669556,
-0.13535073399543762,
2.364988327026367,
1.2794066667556763,
-0.07997750490903854,
-0.8673450350761414,
-0.5051764845848083,
2.2222049236297607,
-0.255057692527771,
2.4178919792175293,
0.03332783654332161,
-0.6188021302223206,
-0.746873140335083,
0.15748456120491028,
0.9437060952186584,
0.20175980031490326,
-1.003873348236084,
0.9317358136177063,
-0.16081635653972626,
-0.2657671570777893,
-1.1280570030212402,
-0.566052258014679,
-0.44699880480766296,
0.054532360285520554,
-0.8144382238388062,
0.10399194061756134,
1.1316673755645752,
0.4565131664276123,
-1.2781083583831787,
0.09084443002939224,
-1.2976192235946655,
-1.3387494087219238,
-0.6244491338729858,
0.42420148849487305,
1.0325782299041748,
-1.1508851051330566,
0.23562273383140564,
-0.3530580699443817,
-0.6488437056541443,
0.12174145877361298,
-0.7184468507766724,
0.29312247037887573,
0.1926175206899643,
-1.1309722661972046,
0.6503900289535522,
-0.33683979511260986,
0.578766405582428,
0.9184229373931885,
-0.2171412855386734,
-1.2847155332565308,
-0.9086208939552307,
0.3377613127231598,
0.1395774483680725,
-0.6031737923622131,
0.07900197058916092,
-0.48714569211006165,
0.04960329085588455,
-1.1069785356521606,
-1.0415681600570679,
-0.8056196570396423,
-0.25901931524276733,
-0.4095769226551056,
0.6084727644920349,
-0.8818058967590332,
0.7913776636123657,
0.25637879967689514,
0.6395955681800842,
-0.7036616802215576,
-0.5501306653022766,
0.43659117817878723,
-0.6652056574821472,
0.7329491376876831,
-1.0280206203460693,
-1.0797827243804932,
-0.5546412467956543,
0.6868173480033875,
0.4689655601978302,
-1.1362296342849731,
0.23909874260425568,
-0.9800657033920288,
-0.17178966104984283,
1.3240405321121216,
0.2278403490781784,
0.7555719017982483,
0.8770247101783752,
-0.17858381569385529,
-0.11154033988714218,
-0.33215364813804626,
0.12758399546146393,
0.19723214209079742,
1.0245925188064575,
-0.8368937373161316,
-0.9291596412658691,
-0.9704015851020813,
1.065716028213501,
-0.5362726449966431,
-0.523611843585968,
0.05698980763554573,
0.7101627588272095,
0.3570302426815033,
-0.3560348153114319,
0.02543909288942814,
-0.3440200686454773,
0.31702446937561035,
0.27259165048599243,
-0.45435068011283875,
0.1502407342195511,
-0.35194775462150574,
0.9328185319900513,
0.3001074492931366,
-0.1681097000837326,
0.746223509311676,
1.4021267890930176,
0.27711454033851624,
0.569369912147522,
-0.403854638338089,
0.4404107630252838,
-0.05040678754448891,
-0.017195135354995728,
-0.3844030499458313,
0.888485848903656,
0.040232498198747635,
-0.6072923541069031,
0.22200337052345276,
0.1906425654888153,
-0.7786526679992676,
-0.32560139894485474,
-0.5023587942123413,
0.07338470220565796,
0.361693412065506,
0.7090486884117126,
0.49384379386901855,
-0.4963372051715851,
-0.39853140711784363,
0.4235357940196991,
0.02797485515475273,
-0.1880287528038025,
0.3420664668083191,
0.37255996465682983,
0.5329868197441101,
0.3719649016857147,
0.5086275935173035,
-0.30403974652290344,
0.1915750950574875,
0.8438926339149475,
-0.5842627286911011,
-0.5591952204704285,
0.36629921197891235,
0.25061336159706116,
-0.4784427583217621,
0.19371715188026428,
-0.8702117800712585,
-0.3236595392227173,
-0.650401771068573,
-0.18332619965076447,
0.4146098792552948,
-0.3306748569011688,
-0.13308009505271912,
-0.3279164731502533,
-0.3406440019607544,
-0.7979678511619568,
0.16758188605308533,
-0.03504429757595062,
0.6650437116622925,
-0.500167727470398,
-0.34038951992988586,
0.2783299684524536,
0.23646342754364014,
0.14274005591869354,
0.627830445766449,
-0.028215473517775536,
0.4051443040370941,
0.855100691318512,
0.14751441776752472,
-0.26408493518829346,
-0.012424279004335403,
-0.11116144061088562,
0.03359748050570488,
0.37399834394454956,
0.35885149240493774,
-0.5104288458824158,
0.015033343806862831,
0.6532366275787354,
-0.4897993505001068,
0.4690137505531311,
-1.0437251329421997
] |
NCT00312104
|
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes
|
The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients with Type 1 Diabetes.
|
Inclusion Criteria:
* Type 1 diabetes for at least 12 months
* Current daily insulin dose of more than 1.4 IU/kg
* BMI lesser than or equal to 35 kg/m2
* HbA1c greater than 7.5% and less than or equal to 12.0%
* In Austria, age more than 19 years
Exclusion Criteria:
* Proliferate retinopathy or maculopathy
* Recurrent major hypoglycaemia
* Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator
|
[
1.4400733709335327,
1.2790981531143188,
-2.4188146591186523,
-1.6307575702667236,
0.8925331234931946,
-0.7591386437416077,
0.8116552829742432,
0.25109049677848816,
0.8098027110099792,
-0.5580734610557556,
1.4454607963562012,
0.9544128179550171,
-1.055001139640808,
1.106540322303772,
3.1006696224212646,
-0.5877348184585571,
0.435869038105011,
0.31540900468826294,
0.5846819877624512,
-3.3063857555389404,
0.07161100953817368,
-0.16278716921806335,
-3.0852339267730713,
0.6640859842300415,
0.8375399708747864,
-0.744885265827179,
-2.5993854999542236,
2.698549747467041,
0.8208209276199341,
2.574579954147339,
-0.8591538667678833,
0.21271392703056335,
0.4487677216529846,
1.3991608619689941,
-0.16346502304077148,
-0.4378806948661804,
2.672322988510132,
-0.25449931621551514,
-2.724152088165283,
0.5763007998466492,
0.7751321196556091,
0.3024611175060272,
-0.4842103123664856,
2.0904815196990967,
1.45516836643219,
0.28760772943496704,
1.2942272424697876,
-0.08799218386411667,
-0.5688283443450928,
2.0078883171081543,
-0.10422829538583755,
0.6149796843528748,
-2.1219098567962646,
1.7923184633255005,
0.33922961354255676,
1.4142309427261353,
-0.3464696705341339,
-0.3308080732822418,
1.025390863418579,
-0.831285297870636,
0.3569440543651581,
1.0735713243484497,
-1.0239471197128296,
-0.0014740676851943135,
-1.5931577682495117,
-1.0114978551864624,
0.8853020668029785,
-0.0045721339993178844,
-1.137506127357483,
-0.8634098172187805,
-1.6108163595199585,
-1.0588552951812744,
1.324123501777649,
-0.6595032215118408,
0.08821430802345276,
0.8195701837539673,
0.2593696415424347,
0.5508789420127869,
0.9337583780288696,
1.7300639152526855,
-0.0028211569879204035,
0.449771910905838,
1.2257368564605713,
-0.8694894909858704,
1.1192526817321777,
-0.02831525355577469,
-0.5611588358879089,
-0.13364072144031525,
0.5993360280990601,
-1.815091609954834,
0.8103073239326477,
-0.7683495283126831,
-0.33836957812309265,
0.9642861485481262,
-2.302258014678955,
-1.0910491943359375,
0.2241154909133911,
-0.17960719764232635,
-0.40527573227882385,
-0.7099990844726562,
-0.5418211221694946,
0.5857925415039062,
-0.47464415431022644,
1.6789194345474243,
-0.7250913977622986,
0.33931446075439453,
0.07953881472349167,
0.5832531452178955,
-3.1545896530151367,
-0.19009985029697418,
0.10463735461235046,
-1.6795679330825806,
0.2667093276977539,
-0.06614380329847336,
1.7464746236801147,
0.3266788423061371,
0.03693551570177078,
0.4059237241744995,
-1.00069260597229,
0.35042303800582886,
-0.721051812171936,
-0.49023953080177307,
0.4066140353679657,
1.1447088718414307,
0.0965309888124466,
-0.02694750390946865,
0.437630832195282,
0.7497182488441467,
-0.11582068353891373,
0.292021781206131,
0.3212875425815582,
-0.18678919970989227,
0.17380186915397644,
-1.5861587524414062,
-1.2589330673217773,
-1.0107194185256958,
-0.16299262642860413,
0.5795741081237793,
0.06096836179494858,
0.7468972206115723,
-0.5971404910087585,
1.1784312725067139,
0.07613635063171387,
0.40024346113204956,
-0.5533134937286377,
0.9054860472679138,
0.609998345375061,
0.6221216917037964,
-0.032378263771533966,
0.2736318111419678,
-0.37765172123908997,
-0.14288273453712463,
0.8351210355758667,
0.6379762291908264,
-0.4510170519351959,
0.7186416983604431,
-0.29373154044151306,
-0.3198084235191345,
-0.230397567152977,
0.8554100394248962,
0.10549602657556534,
-0.4739205241203308,
0.7891668081283569,
-1.1617282629013062,
1.6290671825408936,
-0.008958217687904835,
-0.3827359974384308,
0.22693303227424622,
0.05879874527454376,
-0.25518733263015747,
-0.6957210898399353,
0.4380817711353302,
-0.052365388721227646,
-0.8609058856964111,
-1.0582548379898071,
0.017293140292167664,
0.9141407012939453,
0.556938886642456,
0.619377076625824,
-0.5007274746894836,
-0.44905903935432434,
-0.01810544729232788,
-0.1804886907339096,
-0.09445440024137497,
0.10910630226135254,
0.3136189579963684,
0.5080901980400085,
-0.3840709328651428,
0.42269864678382874,
0.7507413625717163,
-0.32178911566734314,
-0.46091535687446594,
0.13764570653438568,
1.4715434312820435,
-0.6465335488319397,
-0.5494361519813538,
0.6062257289886475,
-0.26081234216690063,
-0.1771613359451294,
-0.08389971405267715,
1.08572256565094,
-0.5427811145782471,
-1.0415061712265015,
0.6819887757301331,
0.05569892376661301,
-0.4303125739097595,
-0.4151693284511566,
-0.3674910366535187,
0.042093027383089066,
-0.2781938314437866,
0.40681326389312744,
-0.7021721601486206,
-0.38959524035453796,
0.6312505602836609,
0.08146452903747559,
-0.7425525188446045,
-0.13749739527702332,
0.2890481948852539,
-0.3332425355911255,
-0.36097049713134766,
-0.08291016519069672,
-0.030660871416330338,
-0.24249695241451263,
0.2365138679742813,
-0.19555681943893433,
-0.5102793574333191,
0.14128027856349945,
0.6871168613433838,
0.3919319808483124,
0.0029772811103612185,
-0.7548064589500427,
0.20020370185375214,
0.08286815136671066,
0.27482500672340393,
-0.35392993688583374,
-0.722143292427063,
-0.8831366896629333,
-0.2683337330818176,
-0.7107700705528259,
0.3139277398586273,
0.22214290499687195,
-0.6041601896286011,
-0.15334366261959076,
-0.5418113470077515,
-0.13906241953372955,
-0.14990513026714325,
-0.45962604880332947,
0.3890973627567291,
-0.12085676938295364,
0.11452791094779968,
0.27222925424575806,
-0.9552894830703735,
0.038922931998968124,
-0.19478918612003326,
-0.5413864850997925,
-0.07355743646621704
] |
|
NCT01174654
|
Development of a Methamphetamine Early Intervention
|
Methamphetamine abuse has a strong and consistent epidemiologic association with high-risk sexual behavior and both prevalent and incident HIV in men who have sex with men (MSM), and some authorities have advocated methamphetamine treatment as an HIV prevention strategy. However, methamphetamine interventions have not been evaluated in controlled trials, nor have they been implemented and assessed outside of substance abuse treatment programs. This application proposes preliminary investigations to adapt a methamphetamine treatment intervention previously associated with decreased sexual-risk taking among MSM for use as an early intervention among MSM in Seattle, Washington. Sixty methamphetamine-using MSM will be enrolled in a randomized controlled trial of contingency management (CM) versus no intervention. CM participants will have their urine tested for methamphetamine 3 times weekly for 12 weeks, and will receive vouchers of escalating value when their urines test negative; vouchers will be withheld when participants' urines test positive for methamphetamine or participants miss urine testing visits. All participants will undergo urine methamphetamine testing and audio-computer assisted self-interviews on sexual behavior and substance use at baseline and at 6 week intervals for 6 months. Participants will be tested for HIV, syphilis, rectal gonorrhea and chlamydial infection, and pharyngeal gonorrhea at baseline and at 3 and 6 month follow-up. The study will determine how often MSM will initiate and complete the early intervention, and will longitudinally measure unsafe sexual behaviors among intervention and control participants. Study results will determine the feasibility of instituting and studying CM as an early intervention; define whether the intervention is sufficiently promising to justify a larger, definitive randomized controlled trial; and will provide estimates for defining the number of participants such a trial would require.
|
Inclusion Criteria:
* Anal sex with another man in the month prior to enrollment
* Use of methamphetamine on at least 2 days in the month prior to enrollment
Exclusion Criteria:
* Plans to move from the study catchment area within 6 months of enrollment
* A mutually monogamous relationships with a man of the same HIV status lasting 2 or more years
|
[
-1.342778205871582,
3.375710964202881,
-2.226522922515869,
-1.4875043630599976,
0.4935111701488495,
0.02100745216012001,
-0.22191034257411957,
-0.08785536140203476,
-0.03296825662255287,
-0.47460511326789856,
-0.4012746214866638,
1.512803316116333,
-0.44704368710517883,
-0.6269456744194031,
0.4699997901916504,
0.6963610053062439,
0.33161038160324097,
0.9932800531387329,
1.2441606521606445,
-0.5944116711616516,
0.6507813334465027,
-0.43812280893325806,
-1.3715065717697144,
-0.14328086376190186,
0.948836624622345,
0.5336427688598633,
-0.9997851848602295,
1.8839033842086792,
0.28860360383987427,
2.0635321140289307,
-0.17580772936344147,
-0.643194854259491,
0.09204652160406113,
-0.21715250611305237,
-0.14667460322380066,
-0.14345206320285797,
1.9467147588729858,
1.1968358755111694,
-0.9987707734107971,
1.3124486207962036,
-0.8605270981788635,
0.525839626789093,
0.20387141406536102,
-0.461186021566391,
0.6730691194534302,
1.2624657154083252,
-0.3193345069885254,
-0.16320930421352386,
-0.23634786903858185,
1.4263978004455566,
-0.5903615355491638,
0.9115808606147766,
-0.6763222813606262,
0.22918762266635895,
2.3165442943573,
0.10831622034311295,
0.8890778422355652,
0.5122910141944885,
1.576641321182251,
-0.46122825145721436,
0.07052946090698242,
0.12119369953870773,
0.30654412508010864,
0.6248656511306763,
-0.6180132627487183,
0.6902308464050293,
-0.08663789927959442,
1.1283156871795654,
-1.1629854440689087,
-0.03398456051945686,
0.2284744679927826,
0.8090829849243164,
0.9377235174179077,
0.45478981733322144,
0.021037479862570763,
0.914391815662384,
-0.3351416289806366,
0.37102970480918884,
1.3033952713012695,
0.2560504078865051,
-0.7026199698448181,
-0.2066056877374649,
-0.1476888805627823,
-0.368445485830307,
-0.3616137206554413,
-0.20286239683628082,
-0.24301181733608246,
-1.6565121412277222,
0.9653380513191223,
0.08364691585302353,
-0.33837318420410156,
-0.3113844394683838,
0.14651429653167725,
0.4461936056613922,
-0.07866974920034409,
0.840959370136261,
-0.06684629619121552,
-0.009099512360990047,
-0.4555719792842865,
-0.17001092433929443,
0.2834513485431671,
0.10504699498414993,
-0.47805556654930115,
-0.5241955518722534,
-1.3742749691009521,
-0.6517900228500366,
-0.007863803766667843,
-0.7223312258720398,
-0.6050379276275635,
0.6815299391746521,
-0.5754120349884033,
-0.24911202490329742,
0.15326307713985443,
0.03542830049991608,
0.2929038107395172,
-0.0834328755736351,
0.41396453976631165,
0.6702935695648193,
-0.504477322101593,
-0.5867493152618408,
1.3771158456802368,
0.48995593190193176,
0.3134199380874634,
-0.31556782126426697,
-0.4679132103919983,
-0.48330333828926086,
0.2631138265132904,
-0.767359733581543,
-0.01955261081457138,
-0.6057748198509216,
-1.017216444015503,
0.7022547125816345,
0.13084004819393158,
-0.44577303528785706,
-0.6075787544250488,
-0.3058036267757416,
-0.17246493697166443,
1.369503378868103,
-0.20782257616519928,
-0.6523556709289551,
-0.5302215218544006,
0.5461419224739075,
0.12484011054039001,
0.1927456110715866,
-1.9225047826766968,
-0.39919644594192505,
-0.3014903664588928,
0.03532736375927925,
-0.0682457908987999,
0.12923060357570648,
-1.1516387462615967,
0.8287549018859863,
0.19268865883350372,
-0.20857013761997223,
-0.6770917773246765,
0.25597184896469116,
0.23345449566841125,
-0.14747901260852814,
0.1419059932231903,
-0.4415285885334015,
0.061901725828647614,
-0.9109556078910828,
-0.08003585040569305,
-0.18497347831726074,
0.4137427806854248,
0.49667903780937195,
-0.42490631341934204,
0.11154238134622574,
0.4642523229122162,
-0.2086399793624878,
-0.1751747876405716,
-0.09822767227888107,
0.32125940918922424,
0.135671928524971,
-0.023436585441231728,
-0.2027667611837387,
0.21222667396068573,
-0.009568199515342712,
-0.1974240392446518,
-0.003763106418773532,
-0.11911303550004959,
-0.10912162065505981,
0.058667197823524475,
-0.23652859032154083,
0.3251911699771881,
-0.6985595226287842,
-0.42493775486946106,
-0.4049835503101349,
-0.09432649612426758,
-0.13147816061973572,
0.5656940937042236,
-0.08289584517478943,
0.05098801106214523,
0.0879022553563118,
0.2631474733352661,
-0.5848765969276428,
0.052241433411836624,
-0.7668392062187195,
-0.034301284700632095,
0.22076180577278137,
0.21389812231063843,
0.686510443687439,
-0.49703449010849,
0.15857353806495667,
0.30991455912590027,
-0.05561503395438194,
-0.22321324050426483,
0.1199958547949791,
-0.23678365349769592,
0.16464947164058685,
0.01917899027466774,
-0.05582752451300621,
-0.13811948895454407,
-0.3118581771850586,
-0.26086094975471497,
0.4460146725177765,
-0.058933939784765244,
0.21099893748760223,
-0.42138928174972534,
0.09951675683259964,
-0.24958670139312744,
-0.7075069546699524,
-0.0004951111623086035,
-0.04487783461809158,
-0.0010890034027397633,
0.17711961269378662,
-0.09190317988395691,
0.22633560001850128,
-0.1549261212348938,
0.18692614138126373,
-0.12567201256752014,
0.1385425478219986,
-0.4353962242603302,
-0.22793442010879517,
-0.35064512491226196,
-0.15951888263225555,
-0.27043014764785767,
-0.18287251889705658,
-0.3064974546432495,
0.5881207585334778,
0.3191945552825928,
-0.3465508222579956,
-0.013870641589164734,
-0.357053279876709,
0.009188064374029636,
-0.38888081908226013,
0.1918213665485382,
0.35699668526649475,
0.3286721110343933,
0.28243714570999146,
0.044472843408584595,
-0.2746383547782898,
-0.18027549982070923,
-0.10570462793111801,
0.17170679569244385,
-0.23090887069702148
] |
|
NCT03201172
|
Univation® X Follow-Up Study
|
The study is designed as a monocentric, prospective, observational, comparative follow-up study based on two previously treated patient groups. The first group consists of patients treated with the patient-specific unicondylar knee implant iUni®. For that group, 30 patients will be included in the study and analyzed. The final follow-up after 24 months has already been documented by the study center. Compared to that, a consecutive series of 50 Univation® X patients will be invited for a 24 months follow-up in 2018. In total, it is planned to include 80 retrospective patients for that historical control study design.
The products under investigation were used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).
|
Inclusion Criteria:
* Patients who underwent UKA in 2015/2016 (using one of the products under investigation)
* Signed informed consent
Exclusion Criteria:
* pregnancy
* patients \< 18 years
|
[
-0.1941535621881485,
3.177013635635376,
-1.614099144935608,
-0.7798914313316345,
0.7708920240402222,
1.1254076957702637,
-0.5766814351081848,
-0.7463335394859314,
-0.5026593804359436,
0.02352515235543251,
-0.2792176306247711,
0.7478304505348206,
-0.723102867603302,
0.4277087152004242,
-0.13917994499206543,
0.11967992782592773,
0.05561868101358414,
-0.3760887682437897,
0.564792811870575,
-0.4499756693840027,
-1.1857050657272339,
0.05002138763666153,
-0.17075765132904053,
-0.23840609192848206,
1.0010836124420166,
-0.3104768395423889,
-0.8690257668495178,
0.6869165897369385,
0.6412652134895325,
1.2853374481201172,
-0.446594774723053,
-0.06841199100017548,
0.009585315361618996,
0.3491802513599396,
0.18749016523361206,
-0.12145612388849258,
0.029268348589539528,
0.32405245304107666,
-1.5861636400222778,
0.49504661560058594,
0.11609447747468948,
0.6863042712211609,
-0.600048303604126,
-0.5267759561538696,
0.9290181398391724,
0.11875198036432266,
0.3653673231601715,
0.06388707458972931,
0.7929295897483826,
-0.7200490236282349,
-0.5504527688026428,
0.8289423584938049,
-0.6400899887084961,
-0.2539016306400299,
0.5227697491645813,
0.622768759727478,
0.052833616733551025,
0.5981045365333557,
0.8927980065345764,
0.1354834884405136,
0.7658680081367493,
0.5503953099250793,
0.2236228585243225,
0.6602432131767273,
-1.0484896898269653,
0.13120929896831512,
-0.6299888491630554,
0.6376076936721802,
-0.10239877551794052,
0.10884451121091843,
-0.24370449781417847,
-0.09608592092990875,
0.5038405656814575,
0.6497032046318054,
0.2354891300201416,
0.44345584511756897,
-0.27400079369544983,
-0.043032173067331314,
-0.10241984575986862,
0.23926076292991638,
-0.4849342703819275,
-0.19623669981956482,
-0.42275893688201904,
0.006708850152790546,
0.24821412563323975,
-0.4813690185546875,
-1.6071335077285767,
-0.08471935987472534,
0.22833073139190674,
-0.6263898611068726,
0.3623664677143097,
-0.6504713296890259,
-0.5305136442184448,
0.5741001963615417,
-0.9410199522972107,
0.6567246913909912,
0.26847487688064575,
-0.5215508341789246,
-0.2523551285266876,
-0.09572726488113403,
0.008879170753061771,
-0.9905160665512085,
0.162306547164917,
0.29503628611564636,
-0.8638632893562317,
-0.12408029288053513,
-0.43257084488868713,
0.11159349977970123,
-0.7354987263679504,
-0.8952993750572205,
0.5845679044723511,
-0.4838084578514099,
0.31230250000953674,
0.030143536627292633,
0.06536007672548294,
-0.24295271933078766,
0.5492523312568665,
-0.1844339817762375,
-0.03160393238067627,
-0.46896201372146606,
0.4045623540878296,
0.30427971482276917,
0.47529980540275574,
0.14999689161777496,
-0.7693722248077393,
0.03629295900464058,
0.06482361257076263,
-0.02342243678867817,
-0.1545685976743698,
-0.3004993796348572,
-1.3426231145858765,
-0.23313994705677032,
-0.2530270218849182,
-0.5484639406204224,
-0.5974020957946777,
-0.15995633602142334,
0.15646471083164215,
0.5137220025062561,
-1.0449553728103638,
-0.42488932609558105,
0.2977912425994873,
0.4213661551475525,
0.16477587819099426,
-0.13769593834877014,
-1.047977089881897,
0.4677075445652008,
-0.19476079940795898,
-0.33847469091415405,
-1.0619075298309326,
-0.2845647931098938,
0.09675591439008713,
0.18942537903785706,
0.15430545806884766,
0.44698941707611084,
0.2681754231452942,
0.04288404807448387,
-0.10268163681030273,
-0.48995116353034973,
0.3737444579601288,
-0.37991487979888916,
-0.10143271088600159,
-0.5846319198608398,
0.12566687166690826,
-0.7929894328117371,
0.47733503580093384,
0.4923895597457886,
0.05479618161916733,
-0.22627371549606323,
0.33893823623657227,
0.2530613839626312,
-0.2890622913837433,
-0.1493312418460846,
0.15897881984710693,
0.3324911594390869,
-0.22132259607315063,
-0.022649114951491356,
0.6993155479431152,
0.47818702459335327,
0.2615141272544861,
0.1000797227025032,
-0.07676824182271957,
-0.3543711304664612,
0.10217134654521942,
0.11736910045146942,
0.09163043648004532,
-0.2515564262866974,
-0.12868528068065643,
-0.36894991993904114,
0.34231436252593994,
-0.210042342543602,
0.2301020324230194,
-0.06124445050954819,
0.36789780855178833,
0.3247125744819641,
0.6674398183822632,
0.13802938163280487,
-0.044657088816165924,
-0.6504849195480347,
0.6684373617172241,
0.10443997383117676,
0.34312179684638977,
0.1075066551566124,
-0.3308924436569214,
0.6906994581222534,
0.07739213109016418,
-0.054916977882385254,
-0.7822473645210266,
-0.3690306544303894,
0.1878640055656433,
0.45039239525794983,
0.5198040008544922,
-0.2756294012069702,
-0.20906223356723785,
0.03701915964484215,
0.0772942528128624,
0.3609747290611267,
0.17318971455097198,
0.25663402676582336,
-0.6238954663276672,
-0.05029480904340744,
0.0586630217730999,
-0.06316725164651871,
-0.389161080121994,
0.5231641530990601,
-0.22273749113082886,
0.02843039482831955,
0.23516137897968292,
0.028350219130516052,
0.04412471130490303,
-0.3704853057861328,
-0.32338884472846985,
0.36816489696502686,
0.19545996189117432,
0.4246278703212738,
-0.11621438711881638,
-0.05748148635029793,
0.023520806804299355,
0.5062296986579895,
-0.22365598380565643,
0.4418307840824127,
0.03370031341910362,
-0.6740975975990295,
0.23456451296806335,
-0.7034100294113159,
0.30765271186828613,
0.0037417449057102203,
0.06305354088544846,
0.3835531771183014,
-0.010196664370596409,
0.2563443183898926,
0.06257223337888718,
-0.6421637535095215,
0.2363252192735672,
0.10089126974344254,
-0.033232834190130234,
-0.3480755090713501
] |
|
NCT06497010
|
An Exploratory Study of Individualized Neo-antigen mRNA Cancer Vaccine InnoPCV in Advanced Solid Tumor Treatment
|
This is an open-label, prospective, exploratory clinical study, which is divided into two phases: dose escalation phase (Phase Ia) and expansion phase (Phase Ib). After completing the dose-escalation phase (Stage Ia) (5-11 patients), the investigator will select the dose group (RP2D) based on safety, tolerability, and preliminary immune-related characteristics and efficacy data, and choose 2-3 advanced solid tumors to enter the expansion phase (Stage Ib).
|
Inclusion Criteria:
* 18-75 years, male or female.
* Histologically/cytologically or clinically confirmed advanced unresectable protocol-specified solid malignancies.
* Participants with Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Life expectation \>= 12weeks.
* Participants must have a formalin-fixed paraffin-embedded (FFPE) tumor sample available (for example, from their prior surgery) that is suitable for the next-generation sequencing (NGS) required for this study.
* Adequate organ function.
* Participants must agree to use adequate contraception from the first dose of study medication through 180 days after the last dose of study medication (male and female participants of childbearing potential).
Exclusion Criteria:
* Not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the adverse events (except for alopecia, vitiligo, neurotoxicity, hypothyroidism hormone replacement therapy) caused by therapy administered within 4 weeks before the first dose of PD-1.
* Participants with a history of (non-study tumor) malignancy (except for skin squamous cell carcinoma and basal cell carcinoma, in situ cervical or breast carcinoma) within 3 years before the first dose of PD-1.
* Participation in a study of an investigational agent or using an investigational device within 30 days before the first dose of PD-1.
* Previously received any adoptive cell therapy (including but not limited to tumor-infiltrating lymphocyte TILs, chimeric antigen receptor T cells (CAR-T) and T cell receptor chimeric T cells (TCR-T)), therapeutic tumor vaccines, etc.
* Participants received chemotherapy, radiotherapy (palliative radiotherapy is allowed), and immune activator (including but not limited to IL-2) and other antitumor therapy within 21 days before the first dose; Participants received Chinese herbal medicine within 2 weeks before the first dose of PD-1.
* Major surgery (excluding diagnostic biopsy) or significant trauma had not been fully recovered within 28 days before the first dose of PD-1.
* Participants received live attenuated vaccine within 28 days before starting study treatment or planned to receive live attenuated vaccine during the study and within 60 days after ending the study drug treatment.
* Active autoimmune disease or a documented history of autoimmune disease or the syndrome that requires systemic steroids or immunosuppressive agents, except vitiligo or resolved childhood asthma/atopy.
* Positive for Human Immunodeficiency Virus (HIV), Hepatitis B (HBV-DNA≥ 500IU/ml), or Hepatitis C virus (Hepatitis C Virus Ribonucleic Acid \[HCV RNA\] (qualitative) is detected).
* Previously identified hypersensitivity to components of the formulations used in this study.
|
[
1.1722441911697388,
2.8389923572540283,
-1.8470250368118286,
-2.6669700145721436,
0.2429228276014328,
-0.23768968880176544,
-0.5710012316703796,
-0.9270126819610596,
-0.37536507844924927,
0.4087072014808655,
-0.011589729227125645,
0.16066278517246246,
-2.6028614044189453,
-0.06386260688304901,
0.33452311158180237,
2.131295919418335,
-0.08116450905799866,
-0.6416323781013489,
1.0824307203292847,
-1.23542058467865,
0.09609011560678482,
-1.532730221748352,
-0.27701976895332336,
-0.2474939525127411,
0.7563371658325195,
-1.2430620193481445,
-1.506326675415039,
0.9132484197616577,
0.4572221636772156,
0.7436296939849854,
-0.13306385278701782,
0.040184471756219864,
0.8099081516265869,
-0.11400901526212692,
-0.38807111978530884,
0.9541329145431519,
0.5494236946105957,
0.3754950761795044,
-0.9384483098983765,
0.6956583857536316,
0.7203555107116699,
0.835176944732666,
-0.9365381598472595,
-0.8673080205917358,
0.34112170338630676,
-0.40256568789482117,
-1.298072099685669,
-0.5711984634399414,
1.1804126501083374,
1.1242547035217285,
-0.40794837474823,
1.4615930318832397,
-0.294807106256485,
-0.37234875559806824,
0.9214897751808167,
0.2816687822341919,
-0.4667510390281677,
0.6002692580223083,
2.5826659202575684,
-0.7504502534866333,
-0.3329054117202759,
0.4186423420906067,
0.679813027381897,
-0.37183496356010437,
0.061999667435884476,
0.542239785194397,
0.29155996441841125,
0.31525930762290955,
-0.9987443089485168,
0.4410022795200348,
0.20934686064720154,
0.25442251563072205,
1.3253719806671143,
0.8874104619026184,
-0.45760583877563477,
0.9173853993415833,
0.5788885951042175,
-0.18634860217571259,
-0.23475395143032074,
0.6406490206718445,
-0.16318665444850922,
-0.41773509979248047,
-0.6064810752868652,
0.3165360689163208,
0.18466560542583466,
-0.22187913954257965,
-0.18311528861522675,
-1.3518340587615967,
-0.5746113657951355,
-1.1942698955535889,
0.9241378307342529,
-0.2291022539138794,
-1.664401650428772,
0.8319061994552612,
-1.5256017446517944,
0.015866674482822418,
-0.34803107380867004,
-0.4052119553089142,
-0.6527718305587769,
-0.4319794476032257,
-0.38839104771614075,
-0.3427680432796478,
0.42906010150909424,
0.9995803236961365,
-0.6578035354614258,
0.341523140668869,
0.6835970878601074,
-2.0332963466644287,
-0.11021869629621506,
-0.5154171586036682,
0.10073231905698776,
-1.3172882795333862,
-0.2500537931919098,
-0.38748785853385925,
0.017769163474440575,
0.356080561876297,
0.2202153354883194,
-0.23999495804309845,
0.3833361566066742,
-0.5205490589141846,
-0.4259117543697357,
-0.5305815935134888,
0.04751959815621376,
0.5561095476150513,
0.8221132755279541,
0.07982685416936874,
0.8521994948387146,
0.11438501626253128,
-0.5260152220726013,
-0.3810504674911499,
-1.0551700592041016,
-0.22123610973358154,
0.5435802340507507,
0.3087901175022125,
-0.137042835354805,
-0.6610319018363953,
-0.03459906205534935,
0.9458714127540588,
0.7493287324905396,
-0.6678772568702698,
0.0554083026945591,
0.556894838809967,
0.11923957616090775,
-0.6407634019851685,
-1.0375453233718872,
0.7563329339027405,
-0.6145554780960083,
0.11957765370607376,
-0.05476943030953407,
-0.5026133060455322,
-0.24718856811523438,
0.6715779900550842,
-0.348060667514801,
0.5613516569137573,
0.7501131892204285,
0.2984333336353302,
0.12635692954063416,
-0.6337719559669495,
0.2936032712459564,
0.06034815311431885,
-0.8704540729522705,
0.31784141063690186,
-0.5145555734634399,
-0.6967194676399231,
0.46684882044792175,
0.11218486726284027,
-0.47629812359809875,
-0.19289325177669525,
0.38452649116516113,
0.44685375690460205,
-0.2732671797275543,
-0.09701161831617355,
0.9473713040351868,
-0.45521119236946106,
0.1349320411682129,
-0.5409259796142578,
0.893052875995636,
-0.5757087469100952,
0.023878851905465126,
0.20467424392700195,
-0.5060538649559021,
-0.13772067427635193,
-0.5018813014030457,
-0.6615880727767944,
-0.3534370958805084,
0.10720989108085632,
0.30577123165130615,
0.3127686083316803,
0.0005496424273587763,
-0.12496912479400635,
0.3982442319393158,
-0.5058773756027222,
-0.10238641500473022,
0.5532407164573669,
-0.3716488480567932,
-0.7785511612892151,
0.0069922530092298985,
-0.22422194480895996,
0.025953078642487526,
-0.13279245793819427,
0.48807528614997864,
0.136710986495018,
0.24698778986930847,
-0.21412155032157898,
0.6974011063575745,
0.09244990348815918,
-0.7618342638015747,
0.600864052772522,
0.09804757684469223,
-0.13628676533699036,
0.03372884541749954,
-0.569071888923645,
0.5781624913215637,
0.2889157831668854,
0.04609901085495949,
-0.23214785754680634,
-0.4849051833152771,
0.206101655960083,
-0.47793734073638916,
-0.20437990128993988,
0.24244992434978485,
-0.06762437522411346,
0.3796466886997223,
0.5423517823219299,
-0.1371127963066101,
-0.18027976155281067,
-0.2609225809574127,
-0.06981009989976883,
-0.25895100831985474,
-0.15116317570209503,
-0.08120229840278625,
-0.38487765192985535,
0.07203250378370285,
0.06352735310792923,
0.2951887249946594,
-0.7174134850502014,
0.5518290400505066,
0.6806283593177795,
-0.3399072587490082,
0.35299625992774963,
0.21987342834472656,
-0.1939336508512497,
-0.884535014629364,
-0.410132497549057,
0.16709685325622559,
0.3384740650653839,
0.23661519587039948,
0.1004464402794838,
-0.48325175046920776,
0.4052340090274811,
-0.4221717119216919,
0.17915232479572296,
0.39705535769462585,
0.6009947657585144,
-0.005258231423795223,
-0.1629801094532013
] |
|
NCT02831140
|
The Fast Track Rehabilitation in Thoracic Surgery
|
This prospective, randomized study is designed to evaluate the effectiveness of postoperative care pathway using the Fast Track Rehabilitation protocol (FTR) in comparison with the traditional postoperative care.
In order to conduct this study, patients having a thoracic surgery will be randomly attributed to FTR protocol group or control group.
|
Traditionally, patients who underwent thoracic surgery have been treated with a classical protocol which include; bed rest, ambulation prohibited for 24-48 hours and starvation for several postoperative days till the recovery of bowel. Some studies reported the efficacy of early rehabilitation protocols or FTR protocols in thoracic surgery to reduce postoperative complications and to minimize hospital stay. But these studies are few and retrospective. Prospective randomized trials focuses based on the "fast track regimen" or medical fast track that interest only on the medical component .
This prospective, randomized study is designed to evaluate the effectiveness of postoperative care pathway using FTR protocol in comparison with the traditional postoperative care.
In order to conduct this study, patients having a thoracic surgery will be randomly attributed to FTR protocol group or control group.
|
Inclusion Criteria:
* All patients who have lung surgery during the study period after their consents are included.
Exclusion Criteria:
* Patients who have bad general state are unable to move or require a wake in the resuscitation.
* The Patients with thoracic soft tissue surgery.
* patients having mediastinoscopy, surgery of the chest wall or mediastinum.
|
[
-0.6318402886390686,
4.927346706390381,
-2.8699283599853516,
-2.9149625301361084,
0.32437247037887573,
0.8003997206687927,
-0.754875659942627,
0.3707956075668335,
-1.9129801988601685,
0.8345703482627869,
-0.038213275372982025,
1.0326274633407593,
-0.36726629734039307,
0.45132696628570557,
0.2618680000305176,
1.5692236423492432,
-0.3486640453338623,
0.137979656457901,
-0.35895299911499023,
0.9090308547019958,
-0.5036744475364685,
-0.886971652507782,
0.08480877429246902,
-0.2733825445175171,
-0.2765997648239136,
0.6762399077415466,
-0.38325315713882446,
0.4667927324771881,
0.4635137617588043,
1.023834228515625,
-0.19454675912857056,
-0.5969699025154114,
0.25405746698379517,
1.8960213661193848,
-0.7231571078300476,
-0.13934527337551117,
0.6866686940193176,
-0.27119210362434387,
-0.5740329623222351,
1.317102074623108,
1.9664182662963867,
0.4734421670436859,
-0.6242220997810364,
-0.7052963972091675,
1.5337086915969849,
0.22171595692634583,
-0.5660623908042908,
0.27172112464904785,
-0.5451065897941589,
-0.3558441996574402,
-0.1486610770225525,
0.38644567131996155,
-1.3869407176971436,
-0.1425764262676239,
0.45570895075798035,
1.5827010869979858,
0.12150869518518448,
-0.9300541877746582,
0.85753333568573,
0.005885050166398287,
1.1231645345687866,
-0.3854841887950897,
-0.174354687333107,
-0.08678311109542847,
-1.7089622020721436,
-0.3710005581378937,
0.5126567482948303,
-0.07900369167327881,
-0.28797897696495056,
-0.6405348181724548,
0.9790220856666565,
-0.021033186465501785,
1.4833520650863647,
1.0939537286758423,
0.15619836747646332,
0.08534707874059677,
-0.7203518748283386,
0.10371798276901245,
0.12003372609615326,
0.6353564262390137,
-0.19723081588745117,
-0.9808624982833862,
-0.4775833487510681,
-0.8887494206428528,
0.30469563603401184,
-0.23882628977298737,
-1.0612035989761353,
-0.5686354041099548,
0.7939642667770386,
0.10035990923643112,
0.6079272627830505,
-0.2049587219953537,
-0.6364685297012329,
-0.46496397256851196,
-1.4890573024749756,
-0.28218287229537964,
0.08538566529750824,
-0.1996883600950241,
-1.3560385704040527,
-0.16879628598690033,
-0.3316459059715271,
-1.0993667840957642,
0.30463406443595886,
-0.1343509554862976,
-0.7525331974029541,
-0.06487811356782913,
-0.1955561637878418,
0.24513013660907745,
0.22191809117794037,
-1.0260159969329834,
0.09352932870388031,
-0.7474721074104309,
0.3679851293563843,
-0.5504974722862244,
-0.043632395565509796,
0.9970042109489441,
0.8229926824569702,
0.2400236874818802,
0.3331352174282074,
-0.16740214824676514,
-0.5537087917327881,
0.9754085540771484,
0.884850800037384,
0.35224708914756775,
-1.0304628610610962,
0.12526552379131317,
-0.06644631177186966,
0.5891844630241394,
-0.6886345744132996,
-0.518857479095459,
0.2579546570777893,
0.631873369216919,
0.7355426549911499,
0.6546388864517212,
-1.3052372932434082,
0.024855656549334526,
0.3262923061847687,
1.099068522453308,
-0.008107438683509827,
-0.32333818078041077,
-0.06033351644873619,
-0.6735223531723022,
0.2565757930278778,
0.29974281787872314,
-0.6931720972061157,
-0.9846580028533936,
-0.6956460475921631,
0.6787176728248596,
-0.8518996834754944,
-0.0021858280524611473,
-0.022851936519145966,
0.050223175436258316,
-0.5428107976913452,
0.1853836178779602,
0.1882854849100113,
-0.1271776705980301,
0.33676862716674805,
-0.7755551934242249,
0.09145280718803406,
0.09500620514154434,
-0.20890744030475616,
-0.2959637939929962,
-0.5107975006103516,
-1.0886589288711548,
-0.5637794733047485,
-0.2793906331062317,
0.09605483710765839,
-0.16859818994998932,
0.5169118642807007,
0.2666354775428772,
-0.1417067050933838,
0.43764492869377136,
0.02835497446358204,
-0.0799606665968895,
-0.7216545939445496,
0.18020600080490112,
0.6637484431266785,
0.05795377492904663,
0.21058504283428192,
0.3671130836009979,
0.3441585302352905,
-0.5043626427650452,
-0.2734098434448242,
0.46990472078323364,
0.0956258773803711,
-0.28390446305274963,
-0.18029893934726715,
-1.3615628480911255,
-0.10379599779844284,
0.2907319962978363,
0.6089169979095459,
-0.047698479145765305,
-0.13001573085784912,
0.4645695984363556,
0.5433235168457031,
0.1378028392791748,
-0.8140212297439575,
0.20520725846290588,
-0.006479232106357813,
-0.09659368544816971,
0.2273709625005722,
0.7080199718475342,
-0.6545047760009766,
0.5715765357017517,
-0.06455521285533905,
-0.694730818271637,
-0.9441173076629639,
0.2063973844051361,
-0.6376109719276428,
0.030201872810721397,
-0.09856235235929489,
-0.3681587278842926,
-0.5625537633895874,
-0.5512730479240417,
0.3022308945655823,
-0.0650772750377655,
0.16583316028118134,
1.2267576456069946,
-0.6281306743621826,
-0.1330661177635193,
0.448274701833725,
-0.03920485079288483,
0.28260183334350586,
0.22926998138427734,
0.3112882077693939,
0.031569600105285645,
-0.5676774382591248,
-0.38238418102264404,
0.4584922790527344,
0.1835888773202896,
-0.23490211367607117,
0.42869919538497925,
-0.18452873826026917,
0.5805384516716003,
0.04940808564424515,
0.02397141605615616,
0.2515035569667816,
0.01218300312757492,
-0.2849180996417999,
0.49284490942955017,
0.1654103398323059,
-0.5474764108657837,
-0.21676316857337952,
-0.27204030752182007,
0.3633202612400055,
-0.19623522460460663,
-0.16033877432346344,
0.9061787128448486,
0.1602366864681244,
0.7696125507354736,
-0.4958712160587311,
-0.15185995399951935,
0.2863878905773163,
0.19642210006713867,
-0.168663889169693,
-0.6146931052207947
] |
NCT04335929
|
Internet-based Cognitive Behavioural Therapy for Spanish Tinnitus Sufferers
|
Nearly 50 million people in the U.S. experience tinnitus, of which about 20 million people have burdensome chronic tinnitus. Tinnitus can be very debilitating as many aspects of daily life can be affected, such as sleep, mood, and concentration. Currently, there is no cure for tinnitus. Pharmacological or sound-therapy based interventions are sometimes provided but may be of limited value to certain individuals. Research suggests that Cognitive Behavior Therapy (CBT) based approaches have the most evidence of effectiveness in the management of tinnitus. However, CBT is rarely offered to tinnitus sufferers in the U.S. (less than 1%), partly because of lack of trained professionals who can deliver CBT. To improve access to CBT for tinnitus, an online CBT program has been developed which is also available in Spanish. However, the outcomes of the Spanish version of the program has not been evaluated. The purpose of the current study is to determine the feasibility of guided Spanish version of the Internet-based CBT (ICBT) using audiological support on tinnitus distress and tinnitus-related comorbidities.
|
Objective: The purpose of the current study is to determine the feasibility of guided Spanish version of the Internet-based CBT (ICBT) using audiological support on tinnitus distress and tinnitus-related comorbidities.
Hypothesis: It is hypothesized that Spanish version of the ICBT will reduce the tinnitus-related distress, decrease sleep disturbance, decrease anxiety and depression, and improve health-related quality of life in Spanish speaking tinnitus suffers. The investigators also hypothesize that these results will be stable in both short- and long-term post-intervention.
Design: A single group assignment, with a one-year follow-up design will be used to evaluate the feasibility of Spanish version of the ICBT on tinnitus distress.
Setting: This will be an Internet-based study for Spanish speaking tinnitus suffers living across the globe.
Participants: Eligible participants will include adults with tinnitus for a minimum period of 3 months with internet access and no major medical or psychiatric conditions. 50 Spanish speaking participants will be recruited.
Intervention: The intervention offered is a guided CTB-based internet intervention (ICBT), providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Outcome measures: The main outcome measure is the Tinnitus Functional Index (TFI). Secondary outcome measures are the Tinnitus and Hearing Survey (THS), Tinnitus Cognition Questionnaire (TCQ), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder (GAD-7), Insomnia Severity Index (ISI), and EuroQol EQ-5D-5L VAS.
|
Inclusion Criteria:
1. aged 18 years and older adults from across the globe;
2. the ability to read and type in Spanish;
3. no barriers to using a computer (e.g. no significant fine motor control or visual problems);
4. Internet and e-mail access and the ability to use it;
5. commitment to completing the program;
6. completion of the online screening and outcome questionnaires;
7. agree to participate in either group and be randomized to one of these groups;
8. understand and work towards the end goal of reducing the impact and distress of tinnitus, although the strength of the tinnitus may remain the same;
9. be available for 12 months after starting the study to complete a 1-year follow-up questionnaire; and
10. experience bothersome tinnitus for a minimum period of 3 months;
Exclusion Criteria:
1. reporting any major medical or psychiatric conditions;
2. reporting pulsatile, objective or unilateral tinnitus, which has not been investigated medically;
3. tinnitus as a consequence of a medical disorder, still under investigation; and
4. undergoing any other tinnitus therapy while participating in this study.
|
[
-0.36704742908477783,
0.9697520136833191,
-2.183541774749756,
-2.1784729957580566,
0.3907570242881775,
-0.5431051850318909,
-0.5707488059997559,
-0.3433627486228943,
-0.08545665442943573,
0.9362658262252808,
1.0658386945724487,
0.5505388975143433,
-1.4231494665145874,
-0.521338701248169,
-1.0489641427993774,
0.32999539375305176,
-0.04232580214738846,
0.680424153804779,
0.2865293622016907,
-1.1519246101379395,
1.1031807661056519,
-0.3038536012172699,
-0.3134770691394806,
-0.19238197803497314,
0.1307874470949173,
2.1218085289001465,
-1.0408711433410645,
1.424562931060791,
-0.32988235354423523,
0.37330999970436096,
-0.1810942143201828,
-0.27052661776542664,
0.4831518828868866,
0.8842291831970215,
1.080489993095398,
0.3149431347846985,
1.4385154247283936,
0.6397371292114258,
-0.6635621786117554,
0.34008851647377014,
0.5395286083221436,
0.40689942240715027,
0.4382360577583313,
0.7544560432434082,
0.3072885572910309,
0.44827982783317566,
0.322323739528656,
-0.25644823908805847,
0.41986018419265747,
-0.40472060441970825,
-0.6219186782836914,
1.327606201171875,
0.49916544556617737,
0.35069650411605835,
0.098222516477108,
0.36145660281181335,
1.8269203901290894,
1.7660712003707886,
0.21817749738693237,
-0.822502851486206,
0.32130154967308044,
-1.1574411392211914,
-0.04393100365996361,
0.22059814631938934,
-0.7179537415504456,
-0.19507217407226562,
-0.10286156833171844,
-0.14074589312076569,
-0.8208515644073486,
-1.2013940811157227,
0.12260604649782181,
0.5077805519104004,
-0.30833664536476135,
-0.6554663181304932,
-0.04827404022216797,
-0.33420711755752563,
-1.6325098276138306,
1.1066854000091553,
0.08863209933042526,
0.46535420417785645,
0.36370906233787537,
0.6105092763900757,
0.3625739812850952,
-0.5842412710189819,
0.905134379863739,
-0.1149025410413742,
-0.7436130046844482,
0.0910782516002655,
1.3849170207977295,
-0.7670753598213196,
0.034004855901002884,
-0.47891056537628174,
-0.10583110898733139,
0.28057336807250977,
-0.4770069718360901,
-0.20145510137081146,
-0.3856904208660126,
-0.44862380623817444,
-0.06640937924385071,
-0.28320935368537903,
1.2623255252838135,
-0.02089800126850605,
-0.3568469285964966,
-0.19303442537784576,
-0.38987118005752563,
-0.5733484029769897,
0.07428441941738129,
-0.2106594741344452,
-0.22001582384109497,
-0.8152368068695068,
0.23685260117053986,
-0.8494353890419006,
0.39521557092666626,
-0.4193541407585144,
0.7186343669891357,
-0.08415228128433228,
0.309422105550766,
0.42349496483802795,
0.1395082026720047,
-1.0641443729400635,
0.15830187499523163,
0.3815690279006958,
-0.2619449198246002,
-0.026819486171007156,
-0.7764347195625305,
0.23984642326831818,
-0.1673462837934494,
0.07511161267757416,
-0.32289958000183105,
-0.8481163382530212,
-0.15454798936843872,
-0.058738432824611664,
0.04102267697453499,
0.09949672967195511,
-0.7957267165184021,
0.35300925374031067,
0.7821606397628784,
0.6726335287094116,
0.002763708122074604,
-0.5748298168182373,
0.330654501914978,
0.48942041397094727,
-0.583335280418396,
-0.17462216317653656,
-0.7324467301368713,
-0.7854835987091064,
-0.824699878692627,
0.07883919775485992,
-1.1000702381134033,
-1.155061960220337,
-0.6757676601409912,
0.21954862773418427,
0.08592236042022705,
0.5679441690444946,
-0.3881668150424957,
0.02891506440937519,
0.3588922917842865,
-0.6818587779998779,
0.652421236038208,
-0.32777637243270874,
0.48465052247047424,
-0.1249723881483078,
0.19331862032413483,
0.30299675464630127,
0.07071429491043091,
-0.695974588394165,
0.09257636964321136,
-0.5107181072235107,
-0.17256169021129608,
-0.3108697533607483,
-0.8348384499549866,
-0.3770538568496704,
-0.142933651804924,
0.08854679763317108,
-0.32885557413101196,
0.5989490151405334,
0.46286025643348694,
-0.12818488478660583,
-0.06652330607175827,
-0.06982114911079407,
0.3067527413368225,
0.11352037638425827,
-0.40176600217819214,
0.1776939034461975,
-0.33060938119888306,
-0.5694679617881775,
-0.3623712658882141,
0.027229266241192818,
-0.2199733704328537,
0.5745075941085815,
-0.2502605617046356,
-0.330587774515152,
-0.5891610383987427,
-0.043789878487586975,
0.16541609168052673,
-0.27971887588500977,
0.005246070679277182,
0.2173072099685669,
0.3383384943008423,
-0.9786766767501831,
-0.17390547692775726,
0.6601032614707947,
0.11020895838737488,
0.05502139404416084,
-0.31075194478034973,
-0.12140698730945587,
-0.05367925763130188,
-0.09449329972267151,
-0.37986424565315247,
0.4698437750339508,
0.055449891835451126,
0.43449920415878296,
-0.2169548124074936,
-0.34180185198783875,
0.7579455375671387,
0.1840301901102066,
0.08649892359972,
0.518036961555481,
-0.27837371826171875,
0.16783611476421356,
-0.13576875627040863,
-0.16493816673755646,
-0.35026389360427856,
0.23545223474502563,
-0.6745663285255432,
-0.006890872493386269,
0.03308098018169403,
0.7885022163391113,
-0.23910591006278992,
0.0006567460368387401,
-0.22863322496414185,
-0.40030208230018616,
-0.37164753675460815,
-0.3059383034706116,
-0.21586182713508606,
-0.2522008717060089,
0.10356049984693527,
0.06367573142051697,
-0.2310844212770462,
-0.5524420738220215,
0.10261675715446472,
-0.9945300817489624,
-0.057538360357284546,
0.18180157244205475,
-0.09425988048315048,
-0.20221325755119324,
0.41542863845825195,
-0.10136338323354721,
0.19779841601848602,
-0.01200016774237156,
0.2939402759075165,
0.024510525166988373,
0.25622278451919556,
0.07256162166595459,
0.0030760890804231167,
-0.28659746050834656
] |
NCT01031303
|
Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age
|
The purpose of this study is to provide further immunogenicity and safety information of sanofi pasteur's DTacP-IPV combined vaccine (TETRAXIM™) as a booster dose during the 4th and 6th year of life in children that previously received in Study E2I34 (NCT 00255021), sanofi pasteur DTacP-IPV// PRP\~T vaccine (PENTAXIM™) as a three-dose primary and booster vaccinations.
Primary Objective :
* To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to acellular Pertussis antigens (Pertussis toxoid \[PT\], Filamentous Haemagglutinin \[FHA\]) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after the booster dose given at 4 to 6 years of age.
Secondary Objectives :
* To describe the antibody persistence in terms of anti-pertussis antibody levels (anti-PT, and -FHA) and in terms of seroprotection rates and GMTs for Diphtheria, Tetanus, and Poliovirus types 1, 2 and 3, just before administration of the booster dose (at Visit 1) in all subjects at 4-6 years of age.
* To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/ vaccine response rates to acellular Pertussis antigens (PT, FHA) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after administration of the booster dose given at 4 to 6 years of age.
* To describe the safety after the booster dose of the study vaccine.
|
All participants that previously completed the three-dose primary and the booster vaccinations in the study E2I34 (NCT 00255021) will be contacted to enroll in this study to receive sanofi pasteur's DTacP IPV combined vaccine (Tetraxim™) at 4 to 6 years of age.
Participants will receive the study vaccine \[sanofi pasteur's DTacP-IPV vaccine (TETRAXIM™)\] at 4 to 6 years of age (at visit 1).
|
Inclusion Criteria :
* Aged 4-6 years inclusive on the day of inclusion
* Child having completed the three-dose vaccination and the booster vaccination with DTacP-IPV//PRP\~T combined vaccine (PENTAXIM™) of the study E2I34
* Informed consent form signed by the parent(s) or other legal representative
* Able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria :
* Participation in another clinical trial in the 4 weeks preceding the trial inclusion
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
* Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion
* Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins)
* Any vaccination in the 4 weeks preceding the trial vaccination
* History of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
* Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human immunodeficiency virus (HIV) infection
* Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases infection with the trial vaccine or another vaccine after completion of previous study E2I34
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of/current major neurological diseases or seizures
* Febrile illness (temperature ≥ 38°C) or acute illness on the day of inclusion.
* Serious or severe reaction after a previous dose of any vaccine containing pertussis antigen, such as
* encephalopathy (with or without convulsions) in the 7days following previous administration of a pertussis containing vaccine,
* temperature more than 39.5°C within 48 hours following vaccine injection, not due to another identifiable cause
* inconsolable crying equal or more than 3 hours within 48 hours following vaccine injection,
* hypotonic hyporesponsive episode within 48 hours following vaccine injection,
* seizures with or without fever within 3 days following vaccine injection.
|
[
1.4595859050750732,
1.4319815635681152,
-3.19155216217041,
-2.509399175643921,
1.4337619543075562,
-0.024178041145205498,
0.12023989856243134,
1.186503529548645,
-1.8806257247924805,
-0.39122840762138367,
0.3422452211380005,
0.6932405233383179,
-0.5361637473106384,
0.38528355956077576,
0.13112306594848633,
-0.3793680667877197,
-0.29439640045166016,
0.7806808352470398,
0.13821421563625336,
-1.3548157215118408,
0.818620502948761,
0.47384312748908997,
-1.2474230527877808,
0.5212596654891968,
0.4856416881084442,
0.08057668805122375,
-1.5412555932998657,
0.0053393179550766945,
-0.9194043278694153,
0.5496960878372192,
-0.09343220293521881,
0.15965038537979126,
1.5287593603134155,
0.8234118223190308,
0.5017526149749756,
-0.07781460881233215,
2.2274813652038574,
0.7242761850357056,
-0.49043020606040955,
0.7008720636367798,
-0.11114834994077682,
0.03143477812409401,
0.2996020019054413,
0.5919888615608215,
1.2962630987167358,
0.20379778742790222,
-0.7687692046165466,
-0.45440474152565,
0.595180869102478,
-0.6539292931556702,
-1.2015769481658936,
-0.316423624753952,
-0.904979407787323,
0.32999151945114136,
1.8208948373794556,
-0.42111241817474365,
-0.14751245081424713,
1.2573983669281006,
0.8882137537002563,
0.1873144805431366,
0.8129965662956238,
-0.029472213238477707,
0.2904384434223175,
-0.5328083038330078,
-0.28873756527900696,
0.07780978083610535,
-0.052627187222242355,
0.09774212539196014,
-0.44012168049812317,
0.5916246175765991,
-0.12218540906906128,
0.7923268675804138,
0.05959334224462509,
0.8665381669998169,
-0.4577924609184265,
0.15285460650920868,
0.3050295114517212,
1.3879972696304321,
0.510703444480896,
0.08698612451553345,
-0.27504047751426697,
0.1291286051273346,
0.131220281124115,
-0.4632399082183838,
0.21632377803325653,
-0.43510550260543823,
-0.9024915099143982,
-0.9365093111991882,
0.5582756400108337,
-0.8982850313186646,
0.8394038081169128,
-0.15882250666618347,
-0.8388010263442993,
0.780368447303772,
-0.7501044869422913,
-0.8798402547836304,
0.3854232728481293,
0.36193758249282837,
-0.5761572122573853,
-0.17406494915485382,
0.174989715218544,
0.044855352491140366,
-0.2005896270275116,
-0.08758335560560226,
-1.1189792156219482,
-0.07517612725496292,
-0.6297643184661865,
-0.6703725457191467,
-0.4256228804588318,
-0.37555137276649475,
-0.520576000213623,
-0.38948750495910645,
-0.651652991771698,
-0.08946359157562256,
0.2555188536643982,
-0.08095958083868027,
-0.3823799788951874,
-0.5251142382621765,
-0.26424750685691833,
-0.5374257564544678,
-0.32950612902641296,
0.7723998427391052,
0.004355453420430422,
0.5254418253898621,
-0.6992590427398682,
0.05632774531841278,
0.6220790147781372,
0.714449942111969,
0.10164153575897217,
-0.20675863325595856,
0.1940469741821289,
0.43725159764289856,
0.12928952276706696,
0.19950418174266815,
-1.1508640050888062,
-0.4430476725101471,
-0.0647127628326416,
0.38249194622039795,
0.4305035471916199,
0.442138135433197,
-0.04895363003015518,
0.7624396085739136,
-0.5011451840400696,
-0.12003208696842194,
-0.92336106300354,
0.3305150866508484,
0.09623425453901291,
0.3603760600090027,
-0.4754260778427124,
-0.09345711767673492,
-0.0338418148458004,
-0.5502361059188843,
0.02364025078713894,
0.49849796295166016,
0.0984073132276535,
0.7022832036018372,
-0.04929753765463829,
0.182193323969841,
-0.1325245499610901,
-0.19427573680877686,
0.22573955357074738,
0.3389148414134979,
0.025589559227228165,
-0.131670743227005,
0.1648532599210739,
0.6298092007637024,
-0.6000299453735352,
-0.15860168635845184,
0.01226882915943861,
0.14396320283412933,
-0.7402209639549255,
0.5017931461334229,
-0.3648971617221832,
0.2639859616756439,
-0.15847669541835785,
0.17959491908550262,
0.41413044929504395,
0.28374460339546204,
0.2919907569885254,
0.37992268800735474,
-0.21150866150856018,
0.18133758008480072,
0.18012411892414093,
-0.21687057614326477,
0.02772161364555359,
-0.024561557918787003,
0.004423236008733511,
0.22773407399654388,
-0.1701083928346634,
0.4459344446659088,
0.16569489240646362,
-0.4664337933063507,
-0.17489586770534515,
0.25033116340637207,
0.4479769766330719,
-0.1599760502576828,
0.19716671109199524,
-0.0059480369091033936,
0.11305909603834152,
-0.06163410469889641,
0.29629650712013245,
0.30809277296066284,
0.6573137044906616,
0.007114322856068611,
0.14035579562187195,
0.21372714638710022,
-0.011825595051050186,
0.35017603635787964,
-0.1420222818851471,
-0.0013419209280982614,
-0.08121850341558456,
0.20278587937355042,
-0.4895648658275604,
-0.17396792769432068,
0.2674374282360077,
0.15000958740711212,
-0.36569857597351074,
0.03446989879012108,
0.07571204751729965,
0.2610452175140381,
0.15342622995376587,
-0.056669674813747406,
-0.20782725512981415,
0.07225537300109863,
-0.251670777797699,
0.09542689472436905,
-0.24199621379375458,
-0.2977874279022217,
-0.12757906317710876,
-0.18795575201511383,
-0.11340659111738205,
0.5209174752235413,
-0.34862464666366577,
-0.2938886880874634,
0.36721399426460266,
-0.12539862096309662,
-0.1745079606771469,
0.04030635207891464,
0.029181785881519318,
-0.18033649027347565,
0.09793426096439362,
-0.5818799138069153,
-0.1711301952600479,
-0.3240513503551483,
0.0778542309999466,
-0.42969414591789246,
0.21973630785942078,
-0.12929654121398926,
-0.2740757167339325,
-0.5308374166488647,
-0.09908062219619751,
0.10316389799118042,
0.011226181872189045,
0.14568406343460083,
0.21041235327720642,
-0.1021786481142044
] |
NCT05749744
|
Effects of Cardiac Telerehabilitation During COVID-19 on Cardiorespiratory Capacities in Coronary Artery Disease Patients.
|
After an acute coronary syndrome, an adapted cardiac rehabilitation program is necessary to restore or increase physical capacities and decrease cardiovascular risk. This multidisciplinary care combines physical training sessions and therapeutic education workshops.
The COVID-19 pandemic imposed restrictions such as the closure of rehabilitation centres. To remedy this problem, one solution was to adapt the existing program to a remote cardiac telerehabilitation, i.e., medical and paramedical supervision of rehabilitation sessions and therapeutic patient education meetings via digital tools. Recent studies have shown that it was a safe (no reported adverse effects), effective (similar gains in peak oxygen consumption compared to traditional cardiac rehabilitation and patient-adherence alternative.
|
The hypothesis of this study is that telerehabilitation was more effective on cardiorespiratory functions.
|
Inclusion Criteria:
Both groups:
* Acute Coronary Syndrome treated in the last 6 months
* Medical revascularization (angioplasty ± stenting) or surgical (coronary artery bypass)
For Telerehabilitation group:
* Internet connexion (computer or digital tablet)
* Equipped with an exercise bike
Exclusion Criteria:
Both groups:
* Pulmonary hypertension
* Aortic pathway anomaly
* Uncontrolled ventricular rhythm disorders
For Telerehabilitation group:
* Important muscular deconditioning
* Patient requiring medical supervision in institute
|
[
-0.2697788178920746,
5.264233589172363,
-0.9928223490715027,
-3.1563940048217773,
-1.1064728498458862,
0.483305960893631,
0.6743903160095215,
1.1615195274353027,
-1.1018818616867065,
1.2319138050079346,
-1.0763365030288696,
3.0208182334899902,
-0.9182327389717102,
0.6196889281272888,
-0.4767748713493347,
1.3494726419448853,
0.3330276906490326,
0.9858153462409973,
0.14833182096481323,
-1.3490148782730103,
0.7810637354850769,
0.2066032886505127,
-0.5525743365287781,
0.18717363476753235,
0.9646067023277283,
0.6027355194091797,
0.13536162674427032,
1.4939409494400024,
1.0459628105163574,
1.8789567947387695,
-0.24325095117092133,
-1.866063117980957,
0.368776798248291,
1.2715981006622314,
-0.8249346613883972,
0.15562455356121063,
0.0303778275847435,
-0.34558185935020447,
-1.5832934379577637,
-0.09967266023159027,
1.0372536182403564,
0.4127962589263916,
-0.6464619040489197,
-0.35020482540130615,
0.3541496992111206,
0.8281735777854919,
0.10644161701202393,
0.7408917546272278,
0.31406140327453613,
-0.622215986251831,
-1.2762902975082397,
1.2846636772155762,
-0.20414189994335175,
0.3424718976020813,
2.2471818923950195,
1.1546326875686646,
1.1032658815383911,
0.6144840717315674,
-0.13352230191230774,
0.6479687690734863,
0.8089243769645691,
-0.007689472753554583,
-0.5295783281326294,
1.3419259786605835,
-1.0334796905517578,
-1.5719045400619507,
0.8348845839500427,
-0.04129929468035698,
-0.9947428107261658,
0.47784027457237244,
0.13071782886981964,
0.6453268527984619,
0.2064889669418335,
0.8549486398696899,
0.3183484971523285,
-0.43423402309417725,
0.3016093075275421,
1.2261408567428589,
0.29361462593078613,
-0.7952486276626587,
0.5262142419815063,
0.29458627104759216,
-0.20408324897289276,
-0.3241148293018341,
0.34746381640434265,
-0.2014387995004654,
-2.0092480182647705,
-0.11908508092164993,
0.4647122919559479,
-0.8458081483840942,
0.3743971288204193,
-0.7431889772415161,
-0.7440776228904724,
0.33120688796043396,
0.0230159442871809,
0.6928898692131042,
-1.0072101354599,
-0.2214653491973877,
-0.38268303871154785,
0.2353277951478958,
0.8608826994895935,
-0.3596746623516083,
-0.5993108749389648,
-0.6804255247116089,
-0.5232742428779602,
-0.08923514187335968,
0.7051218152046204,
-1.1582635641098022,
-0.5857435464859009,
-0.19393625855445862,
0.12097399681806564,
-0.22767136991024017,
0.9246726036071777,
0.18810604512691498,
1.04327392578125,
0.41984760761260986,
0.2695411145687103,
0.006601231172680855,
-0.02780836448073387,
-0.1329338550567627,
0.20298662781715393,
1.37444269657135,
0.43021464347839355,
-0.4955886900424957,
-1.1791905164718628,
0.08513855934143066,
-0.6408397555351257,
0.5656815767288208,
-0.5339820384979248,
-0.6454920172691345,
-0.876384437084198,
-0.023431943729519844,
0.27143773436546326,
-0.04839392006397247,
-0.08096393197774887,
-0.021396560594439507,
0.22336076200008392,
0.43843400478363037,
-0.9163630604743958,
0.27407634258270264,
-0.07663478702306747,
0.3047769069671631,
0.4367833137512207,
0.3372202515602112,
-0.18301722407341003,
-0.9184761047363281,
-0.06429009884595871,
0.43671736121177673,
-0.17129476368427277,
-0.4864290654659271,
-0.5239392518997192,
0.11932267993688583,
0.4565393924713135,
0.2792660892009735,
-0.6633934378623962,
0.04268123582005501,
0.1113373264670372,
-0.5881540179252625,
0.3091628849506378,
-0.24108906090259552,
0.624812662601471,
-0.15366488695144653,
0.23143784701824188,
-0.49251633882522583,
0.730135440826416,
-0.707213282585144,
0.2991599440574646,
-0.2863037884235382,
0.5593196153640747,
0.31517210602760315,
0.3703061640262604,
0.049198925495147705,
-0.49705129861831665,
0.21713542938232422,
-0.6852797269821167,
0.799146294593811,
1.035771369934082,
-0.42335620522499084,
0.0671219453215599,
-0.07700634747743607,
0.557257890701294,
-0.13680176436901093,
0.35114988684654236,
0.5220214128494263,
-0.18283773958683014,
-0.5757868885993958,
0.0709030032157898,
0.05959702283143997,
-0.025528546422719955,
-0.11651058495044708,
0.029219413176178932,
-0.10539504885673523,
-0.6643296480178833,
-0.06853406131267548,
0.2559426426887512,
-0.20518141984939575,
-1.1048674583435059,
-0.13245511054992676,
0.39520716667175293,
-0.16714167594909668,
-0.21539445221424103,
0.3962724208831787,
-0.30258506536483765,
0.7673011422157288,
-0.004717537667602301,
0.09397713840007782,
-0.23904813826084137,
-0.3062061369419098,
0.4165557026863098,
0.5706284642219543,
0.6758372783660889,
-0.11697912216186523,
0.1653495579957962,
0.2476615607738495,
-0.1991327702999115,
0.9900180101394653,
0.6055994629859924,
0.12685257196426392,
0.033017612993717194,
0.23027946054935455,
-0.2959301471710205,
0.4074677526950836,
0.3867575526237488,
-0.131014883518219,
-0.15662753582000732,
0.2749406397342682,
-0.026664670556783676,
0.12954528629779816,
0.21595917642116547,
-0.2193576544523239,
-0.22289231419563293,
-0.006010538898408413,
0.15493175387382507,
-0.016692830249667168,
0.11740465462207794,
0.10383182764053345,
-0.0632675439119339,
0.3062135875225067,
0.136368989944458,
0.18219859898090363,
0.5010325312614441,
-0.13133151829242706,
0.13664445281028748,
-0.09125331044197083,
0.37746334075927734,
-0.1606282740831375,
-0.1567915678024292,
-0.33008643984794617,
-0.2537546455860138,
0.17849494516849518,
-0.38609910011291504,
-0.24650077521800995,
0.13971686363220215,
-0.2512461841106415,
0.02364426851272583,
-0.30718106031417847
] |
NCT04074902
|
Role of Chest Sonography in Evaluation of Pleurodesis in Patients With Malignant Pleural Effusion
|
Thoracic ultrasonography easily detects the movement of the visceral pleura on the parietal pleura This sign is absent when pleurodesis is successful.
|
Malignant pleural effusion (MPE) imposes a significant burden on patients and health-care providers. Most of the malignant pleural effusions are the result of metastases to the pleura from other sites. The primary tumors were, in the decreasing order of frequency: lung (37%), breast (17%), unknown site (10%), lymphoma (9%), gastrointestinal (8%), ovary (7%) and mesothelioma (3%) .
Management of malignant effusions depends on palliation of dyspnea and prevention of the re accumulation of pleural fluid to provide the highest possible quality of life, regardless of the need for other treatment modalities. Most patients require definitive treatment, usually drainage and chemical pleurodesis to relieve symptoms and prevent fluid recurrence. Pleurodesis is defined as the symphysis between the visceral and parietal pleural surfaces; its function is to prevent accumulation of either air or fluid into the pleural space. Effusions of malignant origin are the most common indication for pleurodesis Thoracic ultrasound (TUS) can easily visualize pleural effusions and help in identifying malignant effusion and the presence of pleural adhesions or thick pleural peel and could therefore have a role in predicting long-term pleurodesis success or failure in MPE.
One of the easiest sign to identify during chest sonography is the movement of the visceral pleura compared to immobility of the parietal pleura. This sign of 'pleural sliding', firstly described in veterinary medicine and was used to exclude the presence of pneumothorax when present and to suspect atelectasis, fibrosis or pleural adhesions (pleurodesis) when absent. Thoracic ultrasonography easily detects the sign of 'pleural sliding', due to the movement of the visceral pleura on the parietal pleura This sign is absent when pleurodesis is successful. Contrast-enhanced chest CT has become the imaging modality of choice to detect pleural effusions and assist the differentiation between benign andmalignant effusions detected bystandard radiographs. Chest CT findings characteristic of malignant pleural disease include (i) circumferential pleural thickening, (ii) nodular pleural thickening, (iii) parietal pleural thickening greater than 1 cm, and (iv) mediastinal pleural involvement or evidence of a primary tumour.(9'10) The reported specificities of each of these individual findings range from 22% to 56% and sensitivities range from 88% to 100%.(9;11) Histological confirmation of the diagnosis, however, remains necessary. Chest CT should be performed before large-volume thoracocentesis to allow visualization of both the visceral and parietal pleurae, which may identify a pleural mass and appropriate site for needle biopsy.
|
Inclusion Criteria:
* Any patient with malignant pleural effusion who will undergo palliative treatment with insertion of intercostal tube.
Exclusion Criteria:
1. Patients \<18 years old, unable to provide informed consent.
2. Had an allergy or other contraindication to intrapleural pleurodesis.
3. Had evidence of unexpandable lung believed by the responsible clinician to represent insufficient.
4. pleural apposition that would preclude pleurodesis, and/or had an expected survival of\<1 month.
|
[
1.7733054161071777,
-0.6625984907150269,
-2.7968647480010986,
-2.759073257446289,
1.6338266134262085,
1.5177205801010132,
-2.09293532371521,
1.314348816871643,
-3.902916431427002,
1.2438139915466309,
-0.5078432559967041,
-1.5668731927871704,
1.0419929027557373,
0.5048238039016724,
0.8175125122070312,
1.785646677017212,
0.4399586617946625,
1.1787161827087402,
0.6146588325500488,
-0.6677323579788208,
1.8219391107559204,
-0.12368680536746979,
-1.6409977674484253,
0.16654227674007416,
1.7568906545639038,
-0.4349122643470764,
-0.020466065034270287,
0.0171901173889637,
0.4621482193470001,
-0.24207821488380432,
2.5881435871124268,
1.4271912574768066,
-0.497396856546402,
1.6157851219177246,
-1.4206944704055786,
-2.2219314575195312,
-0.6122707724571228,
-2.6693499088287354,
-1.7362982034683228,
0.3038894236087799,
-0.25261592864990234,
-0.21070797741413116,
0.05685168132185936,
0.13661977648735046,
2.8413078784942627,
-1.70111882686615,
-1.6025443077087402,
0.5275396704673767,
0.9939590096473694,
-0.15441541373729706,
-1.2526408433914185,
-1.5768330097198486,
0.7295337319374084,
0.8342591524124146,
-1.9966440200805664,
-1.0228863954544067,
0.3319694995880127,
-0.7644780278205872,
0.4996436536312103,
0.674828052520752,
0.9378935694694519,
0.20033754408359528,
-0.854213535785675,
-0.3345610797405243,
0.9240391254425049,
0.7156589031219482,
-1.251789927482605,
-0.13328750431537628,
-1.4882209300994873,
0.7420335412025452,
-0.8365599513053894,
-0.19751927256584167,
1.1079180240631104,
0.4442238509654999,
-0.11210649460554123,
1.2353450059890747,
1.4245455265045166,
2.8285441398620605,
1.2666089534759521,
0.15838727355003357,
-1.7544018030166626,
0.16025479137897491,
-0.27603816986083984,
-0.8960821628570557,
-0.7298944592475891,
0.07571344822645187,
-0.5742392539978027,
-1.4690403938293457,
0.8621470332145691,
-1.0350382328033447,
1.777551293373108,
0.5589459538459778,
-0.12663410604000092,
0.6334856748580933,
-1.698559284210205,
-1.3118441104888916,
-0.760198175907135,
0.7562445402145386,
-2.1785995960235596,
0.20328103005886078,
-0.6407766342163086,
-0.7719570398330688,
0.7928619980812073,
0.75684654712677,
0.743897557258606,
-0.48189759254455566,
-0.2647354006767273,
1.403554916381836,
1.3394354581832886,
-1.5490243434906006,
1.464935064315796,
0.03946045786142349,
-1.3230700492858887,
-0.1353388875722885,
0.9516626000404358,
0.7814716696739197,
1.7338370084762573,
-0.13582246005535126,
-0.7753911018371582,
-1.4434459209442139,
-0.2516319751739502,
1.4081937074661255,
0.3069251477718353,
0.8994162082672119,
-1.2758078575134277,
-0.2728152275085449,
0.6735506057739258,
0.5042357444763184,
0.24841533601284027,
-1.1855137348175049,
0.24179884791374207,
-0.5832045674324036,
-1.1059131622314453,
-1.345485806465149,
0.42945611476898193,
1.1154004335403442,
-1.156379222869873,
0.17702539265155792,
-0.9696767926216125,
0.5705121159553528,
0.12168582528829575,
0.3251807987689972,
-0.0725720226764679,
0.7677499055862427,
0.09929658472537994,
-1.451198697090149,
0.05233734846115112,
-0.2589600384235382,
0.528830349445343,
1.4081076383590698,
0.7613813877105713,
0.7618144154548645,
0.9823824763298035,
0.39511343836784363,
0.7719392776489258,
-0.4832245409488678,
2.050271511077881,
-0.9331437349319458,
0.20609307289123535,
-0.9025097489356995,
-0.8096846342086792,
-0.369453102350235,
0.17542652785778046,
0.5499846339225769,
0.21694344282150269,
-0.26929107308387756,
-1.478858470916748,
-0.6434323191642761,
-0.3718011975288391,
-1.3416311740875244,
-0.02747385948896408,
0.5834882855415344,
-0.22895903885364532,
-0.07152773439884186,
-1.0749623775482178,
0.33195778727531433,
-0.7432522177696228,
0.3835965096950531,
-1.02428138256073,
1.1430857181549072,
-0.37611958384513855,
-0.5095668435096741,
-0.07601947337388992,
0.6295143365859985,
0.760612428188324,
-0.46326446533203125,
-0.19425354897975922,
-0.2781594693660736,
-0.0674145519733429,
0.37352749705314636,
1.4621095657348633,
-0.763360857963562,
-0.9788021445274353,
-0.05495545268058777,
-0.595546305179596,
1.0147442817687988,
-0.8154433369636536,
0.5552745461463928,
0.2809145450592041,
0.20525428652763367,
0.17401453852653503,
-0.041127339005470276,
0.3249134421348572,
0.40826305747032166,
0.6578627228736877,
0.6910629272460938,
-0.14826910197734833,
-0.7034940123558044,
-0.6599805355072021,
-0.5833035707473755,
-0.4867255985736847,
-0.02479425258934498,
0.39987438917160034,
-0.22025252878665924,
0.5669723749160767,
0.6911929249763489,
-0.508812427520752,
-0.4534161388874054,
-0.49754220247268677,
-0.10404004901647568,
0.21203316748142242,
0.07911041378974915,
0.7129837274551392,
-0.12591378390789032,
0.9930251836776733,
0.4123685359954834,
-0.1447155773639679,
0.1386042833328247,
0.2564052641391754,
-0.4540172517299652,
-0.7158985137939453,
-0.525171160697937,
-0.3935982584953308,
-0.12226499617099762,
0.5390468239784241,
-0.2767055034637451,
-0.18576018512248993,
0.6267520189285278,
-0.21300934255123138,
-0.3708382844924927,
-0.4805266559123993,
-0.7326375246047974,
-0.24860621988773346,
0.523278534412384,
0.5953442454338074,
-0.18764197826385498,
0.584201455116272,
0.11982330679893494,
0.05075985938310623,
-0.49019041657447815,
0.9066543579101562,
0.6238890886306763,
0.5837278962135315,
0.004723218735307455,
-0.010864492505788803,
-0.3282864987850189
] |
NCT02294201
|
Spatial Repellent Products for the Control of Vector Borne Diseases - Malaria - Kenya
|
The primary objective of the study is to demonstrate and quantify the protective efficacy (PE) of spatial repellent products in reducing the incidence of malaria infection in human cohorts. The null hypothesis (H0) is that there is no difference in malaria incidence between intervention and control arms.
|
The primary epidemiological endpoint will be the incidence density of first time malaria infections among human cohorts during the follow-up period as detected by polymerase chain reaction assay (PCR). This measure will inform PE (the reduction of incidence) between intervention and control study arms using the formula: PE =\[(Ip - Ia)/Ip\]\* 100%; based on an expected minimum effect size of 30%. First time infections in these subjects will offer relatively unambiguous evidence of the extent of exposure to infectious mosquito bites. The primary entomological endpoint will be adult densities of vector species via human-landing catch (HLC) from sentinel households from intervention and control arms over the follow-up period.
Secondary epidemiological endpoints will be the incidence density of first time malaria infections among human cohorts during the follow-up period as detected by microscopy and the total number of cases averted (i.e., all Plasmodium spp. infections in cohort subjects). Secondary entomological endpoints include number of sporozoite infected mosquitoes, parity and species-specific effects of the spatial repellent product.
Both epidemiological and entomological endpoints will be utilized to look at the relationship between SR and PE based on product coverage (to include diversion and community effects) and insect behavior. The prospect of SR associated temporal cumulative effects on study endpoints (epidemiological and entomological) over transmission seasons will also be investigated by using the cumulative incidence of infection over the season and applying a survival curve analysis of the cohort data.
|
Inclusion Criteria:
* Children aged 6-59 months
* glucose-6-phosphate dehydrogenase (G6PD) normal (qualitative screen) in sites where P. vivax or P. ovale known prevalence rates represent major burden) and whose treatment with primaquine is implemented within national guidelines
* Hb \> 5mg/dl
* Temperature ≤38.0°C) and no moderate or severe acute illness/infection on the day of inclusion
* Sleeps in cluster \>90% of nights during any given month
* No plans for extended travel (\<1month) outside of home during study
* Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
* Provision of assent/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative
Exclusion Criteria:
* children \< 6 months or \> 5 years
* G6PD deficiency (qualitative screen) in sites where P. vivax or P. ovale known prevalence rates represent major burden and whose treatment with primaquine is implemented within national guidelines
* Severe anemia
* Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of inclusion
* Sleeps in cluster \<90% of nights during any given month
* Plans for extended travel (\>1month) outside of home during study
* Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
* No provision of assent/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative
|
[
0.3642040491104126,
3.3609607219696045,
-1.913026213645935,
-2.6123135089874268,
-0.6143438220024109,
-2.5985329151153564,
-1.027924656867981,
0.865941047668457,
-1.1622258424758911,
-0.8384482264518738,
0.13460250198841095,
1.72109854221344,
-1.6678135395050049,
-0.1148255318403244,
0.620349645614624,
1.2209103107452393,
0.4189295470714569,
-0.24146093428134918,
1.052751898765564,
-2.3895535469055176,
-0.28613296151161194,
-0.13089381158351898,
-1.613670825958252,
0.38928139209747314,
1.9524813890457153,
0.9779332876205444,
-0.13691265881061554,
-0.32126152515411377,
-0.2696661353111267,
0.9997810125350952,
1.2703779935836792,
0.8391237854957581,
0.17305685579776764,
-0.3329407274723053,
-0.8578605055809021,
-0.8395220041275024,
0.8011131882667542,
0.20724232494831085,
-0.8741113543510437,
1.1214841604232788,
-0.23600265383720398,
0.6107606291770935,
0.005210090894252062,
0.1605159044265747,
0.9717845320701599,
-0.9537016749382019,
-0.1434963345527649,
-0.9548348188400269,
-0.8013046979904175,
0.007143058814108372,
-0.22709804773330688,
1.6270018815994263,
-1.1365610361099243,
-0.3400759994983673,
2.8707222938537598,
-1.4412809610366821,
-0.7733212113380432,
0.7113844156265259,
1.3081589937210083,
0.5114542841911316,
0.9111157655715942,
-0.21467925608158112,
0.6585229635238647,
-0.13244032859802246,
-0.25785309076309204,
-0.2230122685432434,
0.4657838046550751,
-0.5371532440185547,
-1.372332215309143,
-0.08875633776187897,
0.5404720902442932,
-0.21061861515045166,
0.19715669751167297,
-1.0319205522537231,
-0.8276030421257019,
1.0166511535644531,
0.027226047590374947,
1.646956205368042,
0.9371672868728638,
1.5566035509109497,
-1.0636003017425537,
-1.0435549020767212,
-0.8168205618858337,
-1.1551319360733032,
0.52463299036026,
-1.0942569971084595,
-0.23854397237300873,
0.9952393770217896,
1.0003807544708252,
-1.1895138025283813,
0.5765271186828613,
0.15843302011489868,
-0.7261536121368408,
-0.18165777623653412,
0.6927586197853088,
0.6228642463684082,
-0.641548216342926,
0.16152365505695343,
-1.0196856260299683,
-0.3647945821285248,
1.9084854125976562,
-0.43285948038101196,
-0.7115631103515625,
-0.5891465544700623,
0.4786205291748047,
-0.7207708358764648,
-0.4249751567840576,
-0.4719547927379608,
-1.009542465209961,
-0.5751043558120728,
0.31697341799736023,
-1.6923433542251587,
-0.46091559529304504,
0.25604620575904846,
0.9944586753845215,
-0.345449835062027,
0.06573189795017242,
0.7029122114181519,
0.2692391574382782,
-0.517268717288971,
0.360106885433197,
1.7604953050613403,
1.1215200424194336,
1.183337688446045,
-1.0109668970108032,
-0.17364254593849182,
-0.049784764647483826,
0.6433950662612915,
-0.795714795589447,
-0.8812606930732727,
-0.8191800117492676,
0.6890482306480408,
0.4092395603656769,
-0.27309906482696533,
-0.5675280094146729,
-0.5072330832481384,
0.450757771730423,
0.3071691691875458,
0.7392210364341736,
-0.23162151873111725,
0.01369810476899147,
0.3611714839935303,
0.2751554846763611,
0.13711154460906982,
-1.771009922027588,
-0.6027032136917114,
-0.37875670194625854,
1.43367338180542,
-0.7049171924591064,
-0.8211538791656494,
0.13449636101722717,
0.6011254787445068,
0.786679744720459,
0.24945388734340668,
-0.19030852615833282,
-0.31957146525382996,
0.47360333800315857,
0.3065703213214874,
-0.14982326328754425,
0.6525509357452393,
0.8275085091590881,
-0.7783506512641907,
0.08988913148641586,
0.41707319021224976,
0.5367432832717896,
0.8110184073448181,
0.18883156776428223,
-0.9977991580963135,
0.14231576025485992,
-0.5841096639633179,
-0.4345763921737671,
0.08771559596061707,
-0.33640891313552856,
0.5905522704124451,
-0.058037832379341125,
-0.6681200265884399,
0.2650810182094574,
-0.06448448449373245,
-0.453289270401001,
-0.31992122530937195,
0.12254828214645386,
0.5327491164207458,
0.5448896288871765,
1.0271921157836914,
0.5490584373474121,
-0.2128235101699829,
-0.5083665251731873,
-0.43353623151779175,
-0.34315770864486694,
0.19516406953334808,
-0.278324156999588,
0.18229632079601288,
0.7084015011787415,
-0.3795609772205353,
0.6504016518592834,
0.0503290593624115,
-0.686212956905365,
0.08969403803348541,
-0.27718865871429443,
-0.6163240075111389,
0.43166235089302063,
0.32475966215133667,
0.2986455261707306,
0.256462037563324,
0.10313264280557632,
0.4645001292228699,
0.44334176182746887,
-0.37869301438331604,
-0.4996105134487152,
-0.18958060443401337,
0.24096228182315826,
0.054355356842279434,
-0.08571012318134308,
0.0021269770804792643,
0.2571847438812256,
0.4629274606704712,
-0.23537077009677887,
0.5133629441261292,
-0.36053934693336487,
-0.20368358492851257,
-0.3029601275920868,
-0.1745092123746872,
-0.30659791827201843,
-0.2411300092935562,
0.6359825730323792,
0.06628016382455826,
0.01703142188489437,
-0.0052956631407141685,
0.41884276270866394,
-0.3840091824531555,
-0.5340089201927185,
0.3243424892425537,
-0.09889877587556839,
0.6389089822769165,
-0.44058266282081604,
-0.39993736147880554,
1.004517674446106,
-0.49590203166007996,
0.1443106085062027,
0.16962260007858276,
0.49256739020347595,
-0.41981643438339233,
-0.5501085519790649,
0.03371993452310562,
0.41029536724090576,
-0.03789002448320389,
0.09183168411254883,
0.08364982903003693,
-0.8489061594009399,
0.13853362202644348,
-0.034667447209358215,
0.105885349214077,
-0.2737225592136383,
-0.07594174891710281,
0.4202415943145752,
-0.44767287373542786
] |
NCT00530101
|
The Magnetic Resonance Imaging Evaluation of Doxorubicin Cardiotoxicity
|
The purpose of this research study is to evaluate MR imaging in subjects receiving doxorubicin chemotherapy to see if MR can detect heart damage as well as or better than MUGA scans.
This research study is expected to enroll approximately 10 subjects over 12 months at the University of Miami / Miller School of Medicine.
|
Doxorubicin (Adriamycin) is one of the most widely used chemotherapy agents, despite its well-known causation of cardiac toxicity. Doxorubicin causes apoptotic cell death, as shown with uptake of antimyosin antibodies on nuclear medicine studies (1,2). Myocyte damage is dose-related, and produces left ventricular dysfunction that may lead to clinically significant heart failure, especially in patients with limited cardiac reserve. An estimated 7% of patients develop doxorubicin-related congestive heart failure (CHF) after a cumulative dose of 550 mg/m2 (3).
Methods to detect and prevent doxorubicin-induced cardiotoxicity have been investigated for years. Serial evaluation of left ventricular function using Multigated Acquisition (MUGA) scans (radionuclide angiocardiography) was proposed over 20 years ago as one method for detecting cardiotoxicity (4). More sophisticated nuclear imaging (PET) has not been able to demonstrate early changes of cardiotoxicity (5). There are a number of potential indicators of early cardiotoxicity such as toxic effects on the right ventricle and on left ventricular diastolic (vs. systolic) function that MUGA is not optimally suited to demonstrate. Even earlier, an imaging manifestation of cell death could provide the first clue to impending cardiotoxicity (1,2,6). Cardiac MR (CMR) has the potential to address all of these facets of doxorubicin toxicity. Biventricular function can be assessed from cine images, and CMR is well-established as a highly reliable method for cardiac functional assessment. Of even greater potential interest, cell injury and death can be demonstrated using gadolinium enhancement, both for myocardial infarction (focal enhancement) as well as myocarditis (both focal and diffuse enhancement) (7,8). Doxorubicin toxicity may in fact share pathophysiological characteristics with myocarditis (9). It is our hypothesis that CMR will be able to show both functional and cellular (infarct, microinfarct, or myocarditis-type) effects of doxorubicin toxicity as determined during and at the conclusion of doxorubicin therapy. Specifically, we hypothesize that myocardial tissue will demonstrate a greater increase in signal (decrease in T1 after contrast administration) after chemotherapy as compared to before chemotherapy.
Methods 1. Patient Selection: Ten patients selected to receive doxorubicin for breast cancer treatment will be recruited from Oncology Services at the Sylvester Cancer Center and Jackson Memorial Hospital. This pilot study will select patients who are at increased likelihood to develop cardiotoxicity, due to borderline cardiac function at baseline, advanced age, or the anticipation of a high cumulative dose of administered doxorubicin. Patients who will receive radiation therapy to the left chest during chemotherapy (i.e., left breast cancer) will be excluded so as to eliminate possible cardiotoxic effects from radiation. CMR studies will be performed at no charge to the patient, supported by the sponsor of this study. CMR imaging will be subject to IRB approval, informed consent, and HIPAA regulations. Contrast-enhanced CMR will be obtained at three time points:
1. Prior to the first dose of doxorubicin (image characteristics will serve as control values to indicate later changes).
2. After first cycle of doxorubicin.
3. At conclusion of therapy, typically 4-6 cycles; cumulative dose of 360 to 600 mg/m2 doxorubicin.
In addition to standard screening for contraindications to MR imaging, patients will be evaluated for estimated Glomerular Filtration Rate (GFR) within 30 days prior to each MR scan. This is to avoid the rare but potential complication of Nephrogenic Systemic Fibrosis in patients with severe or end-stage renal failure who receive gadolinium MR contrast (10). GFR will be calculated from serum creatinine, patient age, gender, and race, using the MDRD GFR Calculator ( Stephen Z. Fadem, M.D.) at:
http://www.kidney.org/professionals/kdoqi/gfr_calculator.cfm
Patients will not undergo contrast-enhanced MR unless calculated GFR is equal to or greater than 60 mL/min/1.73 m2
2. Imaging: CMR will be performed on the Siemens 1.5T Sonata located at the University of Miami Outpatient Diagnostic Imaging Center. It is anticipated that each scan will require approximately 60 minutes. Three imaging planes (short axis \[SA\] series through the ventricles, and individual 4 chamber \[4CV\] and 2 chamber \[2CV\] views) will be utilized. Sequences will consist of:
A. Precontrast imaging:
1. T1-weighted (SA series)
2. TI scout (single mid-ventricular SA) \[The TI scout sequence obtains images at multiple inversion (TI) times at a single slice level\]
3. TrueFISP cine gradient echo imaging (SA series, 2CV, 4CV)
B. Postcontrast imaging: after 0.1 mmol/kg OptiMARK intravenous
1. 1 minute post-injection: TI scout (single mid-ventricular SA)
2. 2-4 minutes post-injection: Turboflash inversion recovery (single mid-ventricular SA) at serial TI values to determine time of myocardial nulling
3. 5 minutes post-injection: TI scout (single mid-ventricular SA)
4. 6-9 minutes post-injection: Turboflash inversion recovery (single mid-ventricular SA) at serial TI values to determine time of myocardial nulling
5. 10-14 minutes post-injection: Segmented IR delayed imaging using TI of myocardial signal nulling (SA series, 2CV, 4CV)
6. 15 minutes post-injection: TI scout (single mid-ventricular SA)
7. 16-19 minutes post-injection : Turboflash inversion recovery (single mid-ventricular SA) at serial TI values to determine time of myocardial nulling
8. 20 minutes post-injection: TI scout (single mid-ventricular SA)
9. 21 minutes post-injection : T1-weighted (SA series)
3. Analysis: ANOVA will be used to assess for differences in measured values of the discrete variables listed in A, B, C, and D below. Data will be analyzed for all three imaging sessions together using ANOVA, and for each pair of sessions (pretreatment vs. first cycle of doxorubicin, first cycle of doxorubicin vs. maximum cumulative dose, and pretreatment vs. maximum cumulative dose) using the paired t-test (or Wilcoxon signed-rank test if variances unequal). The MR image sets will be analyzed in random order.
A. TrueFISP cine: analysis will utilize the ARGUS software package on the Siemens system. End-diastolic and end-systolic endocardial contours will be generated using a semi-automated technique whereby initial manual contouring is followed by automated contour generation, which are then manually edited before final calculations are performed.
1. Ejection fraction (biventricular) and ventricular volumes (end-systole and end-diastole).
2. Diastolic left ventricular function I. 1/3 peak filling rate (PFR) II. 1/3 filling fraction (1/3 FF)
3. Wall motion: The AHA 17-segment model will be utilized (6 segments each at basal, mid-ventricular, and near-apical levels, and a single apical segment). A five-point scale will be assigned to each segment (normal, mildly hypokinetic, severely hypokinetic, akinetic, dyskinetic). Summed values will yield a single measure of contractility for each imaging study.
B. T1-weighted
Region-of-interest signal intensity in the myocardium will be measured in the mid-left ventricular free wall, the mid-interventricular septum, and skeletal muscle for both precontrast and postcontrast T1-weighted imaging. We will calculate a variable representing "percent enhancement" for each location as follows:
% enhancement = signal intensity (postcontrast) - signal intensity (precontrast) signal intensity (precontrast)
C. The TI scout image sets will provide a single TI value of optimal myocardial nulling as well as an exponential curve to reflect the T1 recovery of myocardium at each time point of acquisition (precontrast, 1 minute postcontrast, 5 minutes postcontrast, 15 minutes postcontrast, 20 minutes postcontrast). The TI scout will be performed at multiple time points due to the dynamic nature of tissue enhancement after gadolinium administration.
D. The turboflash inversion recovery image (mid-ventricular) will provide an alternative single TI value of optimal myocardial nulling at each time point of acquisition (2-4 minutes, 6-9 minutes, and 16-19 minutes postinjection). The turboflash inversion recovery image will be performed at multiple time points due to the dynamic nature of tissue enhancement after gadolinium administration.
E. Segmented IR delayed imaging will provide images of the entire myocardium which will be evaluated for focal myocardial signal hyperintensities, whether due to infarction or myocarditis. The optimum TI value determined from (D) above will be used. If identified, lesions will be manually contoured with use of the irregular region of interest tool on the console. The infarct size will then be calculated as total infarct area multiplied by the section thickness and the specific gravity (assumed to be 1.05 g/mL) of the myocardium.
Medical records will provide data regarding cardiac morbidity or mortality.
|
Inclusion Criteria:
* Subject must have breast cancer and undergoing radiation treatment with a likelihood of developing cardiotoxicity.
Exclusion Criteria:
* Healthy subjects
* Males
* Subjects under the age of 18
|
[
0.06816580146551132,
3.7742702960968018,
-1.8922476768493652,
-0.40600326657295227,
0.8109667301177979,
1.0369977951049805,
-0.5999694466590881,
-0.4604216516017914,
-0.9095696806907654,
0.012945545837283134,
0.43041449785232544,
2.688814640045166,
-0.6302895545959473,
1.4994704723358154,
1.60225248336792,
0.9710249900817871,
-0.10132721066474915,
0.002167652826756239,
0.45974090695381165,
-0.8611953258514404,
-0.9481543302536011,
-0.814095675945282,
0.22126522660255432,
0.7923846244812012,
1.555410385131836,
-0.6170158386230469,
-0.4323262870311737,
0.9912229180335999,
0.26239246129989624,
1.1479690074920654,
-0.3733993172645569,
-0.24890978634357452,
0.45200446248054504,
-0.12907478213310242,
0.3911084234714508,
0.07409670948982239,
1.557695746421814,
1.7567789554595947,
0.08570626378059387,
0.28495320677757263,
0.21348728239536285,
0.8804752826690674,
-0.4601694345474243,
1.341455340385437,
0.8889418244361877,
-0.005433352664113045,
-0.08575337380170822,
0.1251850575208664,
-0.3760492503643036,
-0.4326440989971161,
-0.5611965656280518,
0.39313504099845886,
0.018089622259140015,
0.21032854914665222,
1.5259190797805786,
-0.057414259761571884,
0.451779305934906,
-0.7628191709518433,
2.0493507385253906,
0.1535288691520691,
0.23584921658039093,
-1.303810477256775,
1.364119529724121,
0.4698556661605835,
-0.6136757731437683,
0.9028459191322327,
-0.9352190494537354,
-0.621033787727356,
-0.8898152709007263,
-0.27568936347961426,
1.7684718370437622,
0.7603814005851746,
0.7596626877784729,
-0.033641520887613297,
0.9177727699279785,
0.2899690866470337,
-0.2705122232437134,
0.5276547074317932,
0.49162980914115906,
0.37065234780311584,
-0.3415068984031677,
-1.3772255182266235,
-1.4961650371551514,
0.5954729914665222,
0.38331589102745056,
-0.041126251220703125,
-1.1195398569107056,
-1.2186399698257446,
0.6521923542022705,
-1.4894285202026367,
0.16728706657886505,
-0.16963820159435272,
-0.2668312191963196,
1.809754729270935,
-0.39341649413108826,
0.43011561036109924,
0.8937925100326538,
-1.4681851863861084,
-0.8554481863975525,
0.6357946395874023,
-0.17597562074661255,
-0.02820417284965515,
-0.5058402419090271,
0.7882484197616577,
0.10257523506879807,
-0.30027738213539124,
-0.5291039347648621,
0.4555075764656067,
-0.06882891058921814,
-0.015446383506059647,
0.7173696756362915,
-0.7382531762123108,
-0.18347673118114471,
-0.32418447732925415,
0.10653676837682724,
-0.8736141920089722,
1.2492395639419556,
0.5902378559112549,
0.5549909472465515,
-0.6308123469352722,
0.48277077078819275,
0.6960473656654358,
-0.21853472292423248,
-0.21459980309009552,
-0.2363024353981018,
-0.23963923752307892,
-0.3754059672355652,
-0.12791557610034943,
-0.4655996859073639,
-0.8898804783821106,
-0.632034420967102,
0.19248969852924347,
-0.13504603505134583,
0.006201107054948807,
-0.3829382658004761,
-0.28560373187065125,
0.6197980642318726,
0.24602799117565155,
0.02208341471850872,
-0.05182633176445961,
0.2838953137397766,
0.8087659478187561,
0.2252800464630127,
-0.5080040693283081,
-1.955661416053772,
-0.4256797134876251,
-0.20931091904640198,
0.003932200372219086,
0.531217098236084,
-0.16664940118789673,
0.38499516248703003,
0.8599831461906433,
0.870191752910614,
0.8575848340988159,
0.4505664110183716,
0.5926297903060913,
0.3514745533466339,
-0.5793746113777161,
0.2656264305114746,
-0.13327999413013458,
0.2696611285209656,
-1.0206135511398315,
0.06484586745500565,
-0.3767207860946655,
0.526587188243866,
0.26968586444854736,
-0.14610572159290314,
0.19305764138698578,
0.4072169363498688,
0.5019969940185547,
-0.42096635699272156,
0.8771925568580627,
-0.600979745388031,
0.5155788660049438,
0.010074753314256668,
0.0034528253600001335,
-0.2929580807685852,
0.8519453406333923,
0.8239971399307251,
-0.07933115214109421,
0.3133346140384674,
1.1967958211898804,
0.14632610976696014,
-0.10161780565977097,
0.4047442078590393,
-0.4586986005306244,
-0.715793251991272,
-0.03356325253844261,
0.33508801460266113,
0.09055515378713608,
0.8399300575256348,
-0.014252622611820698,
0.3509465456008911,
0.4888309836387634,
1.0223698616027832,
0.2776687741279602,
-0.15561743080615997,
-0.3131507933139801,
0.5826317071914673,
-0.05628800019621849,
0.37591099739074707,
0.3114584684371948,
-0.050411615520715714,
0.7796469926834106,
0.1275850236415863,
0.008747700601816177,
-0.618762731552124,
-0.2283063530921936,
0.18633432686328888,
0.3056369423866272,
0.2702467739582062,
0.21339945495128632,
-0.6292790770530701,
-0.21357981860637665,
0.12325068563222885,
0.415088951587677,
-0.33325397968292236,
0.014180691912770271,
-0.6312955617904663,
-0.24648986756801605,
-0.7120956182479858,
0.05210137367248535,
-0.23742082715034485,
0.04425249621272087,
0.24539697170257568,
-0.5084088444709778,
-0.28197258710861206,
-0.1762768179178238,
0.5407143831253052,
-0.5803423523902893,
-0.021022090688347816,
-0.005084342323243618,
-0.19389128684997559,
-0.19423417747020721,
0.11591427028179169,
-0.10466807335615158,
-0.13164876401424408,
0.201371431350708,
0.05984785780310631,
0.149826318025589,
-0.01482505165040493,
-0.8116504549980164,
0.23368580639362335,
-0.15965087711811066,
-0.8534094095230103,
0.3085904121398926,
-0.07749734073877335,
0.37980538606643677,
0.42422381043434143,
0.07433237135410309,
-0.1255127191543579,
-0.7023987770080566,
-0.2719627618789673,
0.05131736397743225,
0.5847604870796204,
-0.5360380411148071
] |
NCT05666388
|
Rescue Stenting in the Severe Atherosclerotic Stenosis After the Failure of Intravenous Thrombolysis
|
Intravenous (IV) recombinant tissue plasminogen activator is the standard of care for patients with acute ischemic stroke (AIS) who present to the hospital within 4.5 hours of symptom onset. However, IV thrombolysis, even bridging thrombolysis (combining intravenous thrombolysis and mechanical thrombectomy) has limited efficacy among patients who had occlusive lesions associated with highgrade arterial stenosis requiring revascularization to improve neurological deficits. The investigators evaluated whether rescue stenting results in good outcomes among patients after the failure of intravenous thrombolysis and bridging thrombolysis.
|
Stroke is the second most common cause of death worldwide, with an annual mortality rate of approximately 5.5 million. Depending on the timing of presentation, intravenous (IV) administration of recombinant tissue plasminogen activator can be an effective treatment, but is most effective when used between 3 and 4.5 hours of symptom onset. Bridging thrombolysis, which describes the combination of IV thrombolysis and mechanical thrombectomy, can lead to long-term functional independence after 90 days with higher recanalization success rates than IV thrombolysis alone without increased risk. The HERMES meta-analysis of fve trials (MR CLEAN, ESCAPE, REVASCAT, SWIFT PRIME, and EXTEND IA) indicated the potential benefits of mechanical thrombectomy (MT) in case of proximal circulation occlusions. The recanalization failure rate of this treatment, defined as a modified Thrombolysis in Cerebral Ischemia (mTICI) score of 2a or worse, remained high, ranging from 13% to 29%, and most patients experienced poor clinical outcomes. Permanent stent placement has been suggested as a potential approach for achieving successful recanalization, which is the goal of endovascular therapy in the early management of acute ischemic stroke (AIS). However, the risk of intracranial hemorrhage associated with the combined use of IV thrombolysis and a loading dose of dual antiplatelet therapy (DAPT) increases when rescue stenting is applied. The investigators hypothesize that stent deployment might serve as a feasible treatment for large artery occlusion after the failure of intravenous thrombolysis and bridging thrombolysis.
|
Inclusion Criteria:
* Acute ischemic stroke who underwent rescue stenting for large vessel occlusions underlying severe atherosclerotic stenosis after the failure of intravenous alteplase therapy.
* Absence of intracranial hemorrhage.
Exclusion Criteria:
* Premorbid modified Rankin Scale (mRS) ≥ 2
* Initiation to rescue stenting beyond 24 hours after symptom onset
|
[
-0.8967013359069824,
2.3456778526306152,
-3.6321887969970703,
-3.305924892425537,
0.43596410751342773,
-0.7156105041503906,
-0.7558929920196533,
1.1253185272216797,
-2.3711347579956055,
1.4019036293029785,
0.7049310803413391,
0.87575763463974,
-1.6759382486343384,
1.2669527530670166,
1.4525281190872192,
0.5463893413543701,
-0.4512668550014496,
-0.1752443164587021,
0.8719531297683716,
-1.7331315279006958,
0.6589697003364563,
-0.5502718687057495,
-0.3802664279937744,
1.5772875547409058,
2.1612555980682373,
-2.142946720123291,
-0.42701131105422974,
1.219325065612793,
-0.1775088906288147,
2.479541063308716,
0.17761075496673584,
-1.1130479574203491,
0.13102221488952637,
2.182009220123291,
0.14889588952064514,
-0.8692019581794739,
1.4573513269424438,
1.248364806175232,
-0.22901920974254608,
0.5113366842269897,
0.45406705141067505,
-1.0193549394607544,
-0.5210568904876709,
1.2541602849960327,
0.2648722529411316,
0.740225613117218,
0.18418917059898376,
0.712774932384491,
1.2113738059997559,
0.7172850966453552,
-0.6345792412757874,
0.6349710822105408,
-1.2593755722045898,
-0.5710784792900085,
2.238966464996338,
2.3109140396118164,
1.6373498439788818,
0.7083123326301575,
0.9157946109771729,
-1.2113056182861328,
1.3224750757217407,
-0.5467215180397034,
-0.3229418098926544,
-0.18980593979358673,
-1.2313275337219238,
-0.08229763060808182,
-0.6330540180206299,
0.5584026575088501,
-1.2289775609970093,
0.8920806050300598,
-0.2575245499610901,
0.7911432981491089,
0.7820876240730286,
0.1599137932062149,
-0.15051400661468506,
2.1836330890655518,
-0.4932522475719452,
1.1165411472320557,
0.16207146644592285,
-0.693294107913971,
-0.1940201073884964,
-0.5834265947341919,
-1.6191833019256592,
0.9990532398223877,
-1.9981625080108643,
-0.5880997180938721,
-1.2342991828918457,
-1.2681419849395752,
1.0855228900909424,
-1.5171338319778442,
2.099184989929199,
-0.3057645559310913,
-1.8799749612808228,
-0.45681342482566833,
-0.027104372158646584,
-0.3380422294139862,
-0.1688707172870636,
0.3868328928947449,
-1.275170922279358,
-0.12204576283693314,
-0.3827674090862274,
0.12047144770622253,
-0.3414275646209717,
-0.9861052632331848,
0.19183044135570526,
0.34452977776527405,
0.5346789360046387,
-0.18434841930866241,
-0.715203046798706,
-0.5498655438423157,
0.6064901351928711,
-0.7100850343704224,
0.231057271361351,
-0.21189317107200623,
-0.08819891512393951,
1.57004976272583,
0.5006709098815918,
-0.005510940216481686,
0.6560544371604919,
-0.8132627606391907,
-0.14120256900787354,
0.792073130607605,
-0.5313378572463989,
-0.05210217460989952,
-0.7630971074104309,
0.4271186888217926,
0.12879563868045807,
0.5511230230331421,
-0.3192662298679352,
-0.7645107507705688,
-0.6898906230926514,
-0.18389321863651276,
-0.08656991273164749,
0.154582679271698,
-0.9100467562675476,
0.047802653163671494,
1.071651816368103,
1.6592531204223633,
-0.2830772399902344,
-0.28106531500816345,
0.6328968405723572,
0.9972183108329773,
-0.19229869544506073,
-0.20679666101932526,
-0.9212639331817627,
-1.0916739702224731,
-0.7035199999809265,
0.47900307178497314,
-0.8275392651557922,
0.18211178481578827,
0.23439137637615204,
1.2231861352920532,
0.39483803510665894,
0.40143975615501404,
0.4930202066898346,
0.14491328597068787,
0.24653173983097076,
0.9938545227050781,
0.08115734905004501,
0.13357074558734894,
-1.2924952507019043,
0.09875402599573135,
0.10390443354845047,
-0.03971270099282265,
0.7823475003242493,
-1.097027063369751,
-0.2044333666563034,
0.3645671308040619,
1.002451777458191,
-0.7869090437889099,
-0.9046609997749329,
0.14538614451885223,
-0.045944202691316605,
0.6656806468963623,
-0.9851779937744141,
-0.13830813765525818,
0.33702531456947327,
-0.04528987780213356,
-0.20276674628257751,
0.37724849581718445,
0.7159039974212646,
-0.24165228009223938,
0.5923120975494385,
-0.15505580604076385,
-0.05143743008375168,
0.15567785501480103,
0.3299630284309387,
0.05525166168808937,
-0.04904599487781525,
0.4378211200237274,
0.23104964196681976,
0.009279687888920307,
-0.4171213209629059,
0.04459941014647484,
0.6288270950317383,
-0.3818354606628418,
-0.23410148918628693,
-0.16481439769268036,
0.786517322063446,
-0.20394949615001678,
0.28049981594085693,
0.31307458877563477,
-0.3038466274738312,
1.010825276374817,
-0.08590298891067505,
0.6312058568000793,
-0.30190443992614746,
-0.0029180252458900213,
-0.47663646936416626,
0.126520037651062,
-0.1915837526321411,
0.06872224807739258,
0.3008032441139221,
0.08677138388156891,
0.44677385687828064,
0.3650817275047302,
-0.31365615129470825,
-0.0759376510977745,
-0.3840560019016266,
-0.6351407170295715,
0.42024508118629456,
-0.2803100347518921,
0.1996738761663437,
-0.031085219234228134,
0.11076666414737701,
-0.5074635148048401,
0.8108684420585632,
0.3847048282623291,
0.21845556795597076,
0.27303576469421387,
0.3334062993526459,
0.6429007649421692,
0.1347236931324005,
0.1567082703113556,
0.09319906681776047,
0.04953676089644432,
-0.5637799501419067,
-0.13609722256660461,
0.5100035667419434,
-0.12976379692554474,
0.5538773536682129,
0.05355257913470268,
0.15269866585731506,
-0.2207142561674118,
0.031431302428245544,
0.21209418773651123,
0.24930422008037567,
-0.6899102926254272,
-0.27432820200920105,
0.01465187780559063,
-0.11449787765741348,
-0.0850481167435646,
0.2466014176607132,
-0.191238671541214,
-0.2720983326435089,
0.14569786190986633
] |
NCT01435499
|
Safety Study of a Melanoma Vaccine (GVAX) With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma
|
The primary objective of this study is to evaluate the safety and feasibility of administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine ("melanoma GVAX"), alone or in combination with low dose cyclophosphamide (CPM), for the adjuvant treatment of patients with surgically resected stage IIB-IV melanoma. Secondarily, the investigators will assess in vitro correlates of anti-melanoma immunization by melanoma GVAX, including serological and cellular immune responses in patients treated with either the vaccine alone or the vaccine given with low dose CPM.
|
Inclusion Criteria:
* Any patient age ≥18 years with melanoma of cutaneous or mucosal origin, and with clinicopathologic stage IIB, IIC, III or IV that has been completely resected
* Patients must be able to provide informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least 6 months.
* Adequate hematologic function.
* Adequate renal function
* Adequate hepatic function
* Patients of both genders must agree to practice effective birth control during the study period and for at least 4 weeks after the last treatment.
Exclusion Criteria:
* Patients whose primary site of melanoma is ocular.
* Are undergoing or have undergone in the past 4 weeks any systemic treatment for melanoma.
* Are undergoing or have undergone in the past 2 weeks any surgery or focal radiation therapy.
* Have active systemic infections, coagulation disorders (including therapeutic anticoagulation), or other major medical or psychiatric illnesses.
* Are known to be positive for hepatitis B surface antigen, anti-Hepatitis C Virus or anti-Human Immunodeficiency Virus (HIV) antibody (because of possible immune effects of these conditions).
* Documented history of autoimmune disease, for example, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis.
* Any form of primary or secondary immunodeficiency. This would include hereditary disorders such as ataxia-telangiectasia or Wiskott-Aldrich syndrome, or acquired immune deficiencies such as following bone marrow transplantation.
* Requirement for systemic steroid therapy or immunosuppressive therapy.
* Have received any type of cancer immunotherapy, including but not limited to interleukin-2, interferon alfa or melanoma vaccines.
* Have been diagnosed with another invasive cancer within the past 3 years.
* Radiographic evidence of melanoma recurrence.
* Pregnant or lactating women.
* Known or suspected hypersensitivity to GM-CSF, pentastarch, hetastarch, corn, Dimethyl sulfoxide, fetal bovine serum or trypsin (porcine origin).
|
[
1.2313036918640137,
1.3706012964248657,
-2.7587006092071533,
-1.8269658088684082,
0.2546309232711792,
0.10967196524143219,
-1.1773380041122437,
1.5027796030044556,
-0.521355390548706,
-0.5482305884361267,
-0.7326214909553528,
2.338543653488159,
-1.5886708498001099,
1.7443541288375854,
0.2512187659740448,
0.8619328737258911,
-1.38676118850708,
1.6764860153198242,
0.059925150126218796,
-2.6523845195770264,
0.16349276900291443,
-1.4326854944229126,
-1.8265275955200195,
1.0052016973495483,
0.7952045202255249,
-1.2050762176513672,
-1.1120730638504028,
1.0887635946273804,
0.002668549306690693,
0.568591296672821,
-1.1817532777786255,
-1.1380751132965088,
-0.3090507686138153,
0.9737266898155212,
1.0477548837661743,
0.48414191603660583,
0.21958132088184357,
1.5822668075561523,
-1.2936028242111206,
0.005402717273682356,
0.5010940432548523,
-0.8742599487304688,
-0.01638323813676834,
-0.6223181486129761,
0.28167393803596497,
-0.17651419341564178,
-0.2184368073940277,
-0.23921969532966614,
1.348341464996338,
0.7439031004905701,
-1.7830579280853271,
0.2163289189338684,
-0.8650665283203125,
0.02186066098511219,
2.8089168071746826,
-0.14283162355422974,
0.13733628392219543,
1.0456736087799072,
1.3502378463745117,
0.1384563148021698,
0.23126667737960815,
0.5280696749687195,
0.727982759475708,
-0.35891976952552795,
-0.5000567436218262,
0.0034485014621168375,
-0.15658174455165863,
-0.4384245276451111,
-0.4115586578845978,
0.6961459517478943,
0.3295077085494995,
0.9866178035736084,
-0.3119991719722748,
0.336579829454422,
-0.041667189449071884,
1.2658635377883911,
0.5740774869918823,
0.32292163372039795,
0.8276141881942749,
0.05294705927371979,
0.5230064392089844,
-0.030121885240077972,
0.42405980825424194,
-0.02363085374236107,
0.368228018283844,
-0.37315478920936584,
-0.6391633749008179,
-0.9023323059082031,
0.7128624320030212,
-1.4299790859222412,
0.7262080907821655,
-0.5761411190032959,
-1.2038092613220215,
1.0808666944503784,
-1.2640631198883057,
-0.02003468945622444,
0.2811264991760254,
0.783352792263031,
-0.5747153759002686,
-0.07206454128026962,
0.750270664691925,
-0.6887598633766174,
-1.1007710695266724,
-0.9960639476776123,
-0.6865256428718567,
0.5708158612251282,
-0.5474022030830383,
-1.2351018190383911,
-0.46323642134666443,
-0.3755808174610138,
0.448148638010025,
-1.3448549509048462,
-0.869968831539154,
0.26143404841423035,
0.5210484862327576,
0.7293099761009216,
0.7714519500732422,
-0.18089139461517334,
0.056257735937833786,
-0.28377100825309753,
-0.2579083740711212,
0.863065779209137,
-0.47255581617355347,
1.1682511568069458,
-0.4033489227294922,
-0.5595373511314392,
-0.070929154753685,
-0.3835185170173645,
0.5279356241226196,
-0.7877125144004822,
-0.5392078757286072,
0.889761745929718,
0.5373252034187317,
-0.2276415377855301,
-1.448530673980713,
-0.42700833082199097,
0.6112821102142334,
1.273788571357727,
0.13914094865322113,
0.19840596616268158,
-0.2487257570028305,
0.4722329080104828,
-0.25384029746055603,
-0.09930400550365448,
-1.749913215637207,
0.4097059965133667,
-0.27639153599739075,
1.3640726804733276,
-0.16411463916301727,
-0.7809928059577942,
-0.23062844574451447,
-0.2799854278564453,
0.4036152958869934,
0.3421016335487366,
0.502792477607727,
0.4184313714504242,
0.19577762484550476,
-0.13647495210170746,
-0.537748396396637,
-0.48270532488822937,
-0.5938288569450378,
-0.10256021469831467,
0.11510459333658218,
-0.44541820883750916,
0.5248141288757324,
-0.16041144728660583,
-0.8130185604095459,
-0.41735783219337463,
0.18717916309833527,
0.22363992035388947,
-0.9792737364768982,
0.13240626454353333,
0.12088964879512787,
0.1786193996667862,
0.26876139640808105,
0.22546571493148804,
0.9231380224227905,
0.2162395715713501,
0.037390369921922684,
-0.4336012601852417,
-0.7388242483139038,
0.5423858761787415,
0.1350633203983307,
-0.24250322580337524,
-0.04041002690792084,
0.40801653265953064,
0.16362428665161133,
-0.10855162143707275,
0.17715033888816833,
0.3411453664302826,
0.46895208954811096,
-0.8282787203788757,
0.5024235248565674,
0.7549796104431152,
-0.13904038071632385,
-0.24422919750213623,
0.11912769079208374,
-0.3326539993286133,
0.5300739407539368,
0.031503934413194656,
-0.1485414206981659,
0.6264536380767822,
0.12299901992082596,
0.4719201326370239,
0.3679659962654114,
-0.3583405911922455,
0.6181167364120483,
0.4919103682041168,
-0.5286795496940613,
0.027635442093014717,
-0.13489627838134766,
0.3746170997619629,
0.17378950119018555,
0.15285325050354004,
0.7473758459091187,
-0.18046239018440247,
0.15833991765975952,
0.6134313941001892,
-0.5580070614814758,
0.5132285952568054,
0.1552644968032837,
-0.27751320600509644,
-0.14095331728458405,
-0.02133835293352604,
0.4624989926815033,
-0.15505236387252808,
0.09217266738414764,
-0.005126649979501963,
-0.5669645071029663,
0.23584076762199402,
-0.421434223651886,
0.20265215635299683,
-0.09702733904123306,
-0.4764583706855774,
0.025064511224627495,
0.3217743933200836,
-0.10557615756988525,
-0.31130823493003845,
0.3052694499492645,
-0.1474018692970276,
-0.05043700709939003,
-0.7256869673728943,
0.07680898904800415,
-0.6390215754508972,
0.19842590391635895,
-0.4178187847137451,
-0.12567956745624542,
-0.6896511912345886,
-0.0024802922271192074,
-0.276608407497406,
-0.22910232841968536,
0.3168087601661682,
0.09939233958721161,
0.04049735888838768,
0.08795871585607529,
-0.12179333716630936
] |
|
NCT03307668
|
Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee
|
The purpose of this trial is to investigate the safety and effect of CaReS-1S to repair knee cartilage defects.
|
CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I. It is indicated for the defect filling of focal, full layer and clearly defined knee and ankle cartilage defects of longest diameter 1.1-2.2cm. The fixation of CaReSR-1S is made for all sizes with fibrin glue, whereas the 11 mm implants also allow a press-fit anchoring due to the elasticity of the implant.
The physical nature of the CaReSR-1S allows the in-growth of healthy chondrocytes, as well as progenitor cells from the surrounding healthy tissue.
|
Inclusion Criteria:
1. Aged from 18 to 55 years old;
2. Diagnosed with isolated knee cartilage defects in condyles of femur by arthroscopy, and the longest diameter is 1.1-2.2cm. The degree of the cartilage defects is Outerbridge IV degree or III degree but approximate to IV degree;
3. Outerbridge degree of cartilage in the other articular facet ≤Ⅱ;
4. Normal lower limb mechanical force line (varus or valgum \< 5°);
5. Skeletal mature;
6. 18Kg/M2 ≤ BMI ≤ 30Kg/M2;
7. Agree to sign the informed consent form;
8. Can cooperate in a post-operative rehabilitation program.
Exclusion Criteria:
1. Superficial cartilage defects;
2. Concomitant with subchondral bone defect;
3. Varus or valgum \> 5°;
4. Serious meniscus injury;
5. Fractures around the knee;
6. Cannot join in the post-operative rehabilitation program;
7. The contralateral lower-limb cannot stand weight-bearing;
8. A history of knee surgery within 6 months;
9. Secondary arthritis affecting cartilage;
10. Serious arthrocleisis;
11. Undergoing clinical trial;
12. Serious illness of the heart, lung, and other vital organs;
13. Liver function test equal to two times or greater than the upper normal limits; serum creatinine equal to two times or greater than the upper normal limit;
14. Have a contagious disease;
15. Allergic to the agents;
16. Lactating or pregnant women;
17. Serious neuropathy or mental disease;
18. Be addicted with drug or alcohol.
|
[
-2.4558022022247314,
2.5149776935577393,
0.8795566558837891,
-2.079611301422119,
-1.7105259895324707,
-0.675121545791626,
0.9608272314071655,
0.37384048104286194,
-0.8786516785621643,
0.13272728025913239,
1.4971166849136353,
2.6030890941619873,
-2.1098034381866455,
-1.9064778089523315,
0.47924408316612244,
0.7277401685714722,
0.13986851274967194,
1.1422921419143677,
0.7429555654525757,
-0.4385555684566498,
0.3230423033237457,
1.717850923538208,
0.8550061583518982,
-0.029373694211244583,
2.021368980407715,
-0.24024738371372223,
1.0690613985061646,
0.6944838762283325,
0.20646803081035614,
2.3305699825286865,
-0.4239386320114136,
0.2012433409690857,
-0.8525857329368591,
0.7458145022392273,
-1.7989426851272583,
-0.2881565988063812,
-1.08940851688385,
-0.4495203495025635,
-1.042961597442627,
0.8138441443443298,
-1.1880735158920288,
1.0887585878372192,
1.5516307353973389,
-1.293168544769287,
1.7014164924621582,
-1.6292976140975952,
1.3457454442977905,
0.905962347984314,
-1.2601450681686401,
0.33937641978263855,
0.8841464519500732,
-0.21552276611328125,
0.619173526763916,
0.829628586769104,
0.2726171016693115,
0.005812059622257948,
0.7295861840248108,
-0.382572740316391,
2.9684317111968994,
2.12764573097229,
0.652953028678894,
-0.8045011162757874,
-0.3255127966403961,
0.6228846907615662,
-0.05535558611154556,
1.326890468597412,
-0.9035664200782776,
-2.597005844116211,
-1.151850700378418,
0.8052016496658325,
1.4122118949890137,
1.047623634338379,
1.310940146446228,
0.07306843996047974,
1.0767422914505005,
1.7539231777191162,
-0.19814404845237732,
0.40285050868988037,
-0.34811633825302124,
0.6761105060577393,
0.1510753482580185,
-1.5946016311645508,
-1.2121421098709106,
0.30701491236686707,
0.9802651405334473,
0.7265309691429138,
-0.13345937430858612,
-0.7782341241836548,
1.740492343902588,
-1.6914695501327515,
0.02930849976837635,
0.8031497001647949,
-0.6591097116470337,
0.643943190574646,
-0.5493950843811035,
-0.7554872632026672,
0.42535895109176636,
0.3407318890094757,
0.23041336238384247,
-0.31162285804748535,
-0.973910927772522,
-0.13312315940856934,
1.030734896659851,
-2.005988121032715,
-0.38388070464134216,
1.085631012916565,
-0.5323442220687866,
0.24872785806655884,
-0.5726637840270996,
0.19542841613292694,
0.9845717549324036,
-0.33040398359298706,
-1.1161432266235352,
0.6007933020591736,
-0.4418269991874695,
-1.1881017684936523,
-0.20557710528373718,
0.3163895010948181,
0.6297008395195007,
0.6564770340919495,
0.9780512452125549,
0.8237939476966858,
0.2573803961277008,
-0.5048564672470093,
-0.3006843626499176,
-0.27916643023490906,
1.2164422273635864,
-0.1663067489862442,
-2.164320945739746,
-0.5085412859916687,
0.949074387550354,
0.23488132655620575,
1.0317602157592773,
-1.1080191135406494,
-0.2654899060726166,
-0.36153966188430786,
0.3014761507511139,
-0.16427631676197052,
0.46989139914512634,
0.6587069630622864,
0.36055877804756165,
0.981046736240387,
-0.025463761761784554,
0.17447778582572937,
-0.9050808548927307,
0.538877546787262,
0.5998034477233887,
0.4801112711429596,
-0.7474662661552429,
-1.2121566534042358,
0.10125763714313507,
0.8670315742492676,
0.4584835469722748,
-0.7248992919921875,
0.7407925128936768,
0.48156386613845825,
0.30916333198547363,
-0.8370935320854187,
1.0903505086898804,
0.19448024034500122,
0.3653390407562256,
-0.43511590361595154,
-0.2862570881843567,
-0.3621508479118347,
1.7164928913116455,
-0.6022947430610657,
0.05981677025556564,
-0.24971017241477966,
-0.4899592995643616,
-1.102908730506897,
-0.41376355290412903,
1.277642011642456,
0.4296096861362457,
0.6450893878936768,
-0.03385448455810547,
-0.28903505206108093,
0.5665475726127625,
-0.9870955944061279,
-0.010614518076181412,
-0.4856952428817749,
-0.02768653631210327,
1.1421983242034912,
0.43706485629081726,
0.48321110010147095,
-0.5024319291114807,
-1.2739607095718384,
-0.8893150091171265,
0.4881942868232727,
-0.2538246214389801,
-0.09444358199834824,
1.1140192747116089,
-0.22510802745819092,
-0.17209230363368988,
0.35031309723854065,
0.13072367012500763,
0.6466056108474731,
-0.13052046298980713,
-0.18990911543369293,
1.2332179546356201,
-0.4027233123779297,
0.48474016785621643,
0.5677469372749329,
0.4005250930786133,
-0.3300009071826935,
0.3782835900783539,
0.1038871482014656,
-0.8643703460693359,
-0.6960641741752625,
0.5955978035926819,
-0.3075103759765625,
-0.4231588840484619,
0.34952312707901,
-1.0248209238052368,
-0.6064929962158203,
0.5317215323448181,
-0.3766561448574066,
-0.2325681746006012,
-0.4343987703323364,
-0.8584665060043335,
-0.13567858934402466,
0.7713210582733154,
-0.1143270805478096,
0.4449414014816284,
0.4422513544559479,
-0.2105930894613266,
-0.6665632724761963,
0.021213769912719727,
-0.08296921849250793,
0.24957355856895447,
-0.22326664626598358,
0.05748853087425232,
0.5265318751335144,
0.2780042290687561,
0.7114189863204956,
-0.1396944224834442,
-0.2389443963766098,
0.25963735580444336,
-0.13587383925914764,
-0.5640692710876465,
-0.3147238492965698,
-0.046834081411361694,
-0.552140474319458,
-0.514327883720398,
-0.14857488870620728,
0.06153299659490585,
-0.6772187948226929,
-0.35070618987083435,
0.7489202618598938,
-0.027307279407978058,
0.7336133718490601,
-0.015277661383152008,
-0.8137091994285583,
-0.35553500056266785,
0.3279620110988617,
0.35150477290153503,
-0.6590767502784729
] |
NCT00907543
|
Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment Trial
|
The purpose of this study is to compare the results of preoperative chemotherapy and radiation followed by surgery to surgery followed by postoperative chemotherapy and radiation for esophageal cancer.
|
Patients will be randomized to neo-adjuvant or adjuvant treatment. Quality of life questionnaires will be completed every 2 months up to 1 year.
|
Inclusion Criteria:
* Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (\> 20 cm from the incisors) or gastroesophageal junction are included.
* No distant metastases (M0).
* Patients will be stratified by stage (clinical N0 versus clinical N1), and surgeon.
* Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy.
* Resectable mediastinal nodes are eligible.
* No prior chemotherapy for this malignancy.
* No prior radiotherapy that would overlap the field(s) treated in this study.
* Patients with other malignancies are eligible only if \> 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer.
* Age \> 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon.
Exclusion Criteria:
* Cancers of the cervical esophagus (\< 20 cm are excluded).
* Tumours that have \> 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible.
* Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible.
* Patients with biopsy proven metastatic celiac nodes are ineligible.
|
[
0.9221025705337524,
2.2332351207733154,
-2.2060251235961914,
-1.985273003578186,
-0.3028793931007385,
0.7820250988006592,
-0.46301907300949097,
0.7946942448616028,
-4.744856834411621,
1.112107276916504,
0.5173749923706055,
1.5041601657867432,
0.2037738412618637,
-0.20288407802581787,
0.9967696666717529,
1.4714596271514893,
-0.3576640486717224,
1.1975398063659668,
-0.04613734409213066,
0.1820954978466034,
-0.0045297760516405106,
-2.346163034439087,
-0.777503490447998,
0.1699962317943573,
1.2365819215774536,
-1.1337580680847168,
0.3654610514640808,
-0.4361269474029541,
0.9791120290756226,
1.8633884191513062,
-0.3885478079319,
0.07280479371547699,
-0.8705193400382996,
-0.052726514637470245,
0.11733095347881317,
1.1656293869018555,
0.22365383803844452,
-0.2735461890697479,
-2.1325790882110596,
0.5827902555465698,
3.0231943130493164,
0.5970863103866577,
-0.11424561589956284,
-1.050906777381897,
2.0297398567199707,
0.39169278740882874,
0.11458930373191833,
2.1256022453308105,
-0.46963396668434143,
1.7800533771514893,
-3.571786880493164,
0.075480617582798,
-1.254883050918579,
-1.8625446557998657,
1.746793270111084,
2.188828706741333,
-0.06879314035177231,
-0.1398039609193802,
2.718146324157715,
0.8817660808563232,
0.979762613773346,
-0.0827537477016449,
-0.8223665952682495,
-0.35354623198509216,
-0.6842237710952759,
-0.3974188566207886,
0.8622408509254456,
-1.177715539932251,
0.962745189666748,
0.7120073437690735,
2.588885545730591,
-0.00007537036435678601,
1.7749149799346924,
0.7199773788452148,
1.9731005430221558,
0.598492443561554,
0.24603457748889923,
-0.4002475440502167,
0.9474691152572632,
-0.32189491391181946,
0.682445764541626,
-1.9194153547286987,
-1.2751327753067017,
-0.7334775924682617,
-1.2499066591262817,
-0.8232489824295044,
-1.0775798559188843,
-0.7228439450263977,
1.044228434562683,
-1.7405322790145874,
-1.017629623413086,
0.09214144200086594,
-2.5159504413604736,
2.003218650817871,
-1.1871391534805298,
1.1316097974777222,
0.5351714491844177,
-1.0668295621871948,
-1.634078025817871,
-1.156854271888733,
0.6185876727104187,
0.6773504614830017,
-0.26292547583580017,
-0.008443799801170826,
-1.2510544061660767,
-0.4729669392108917,
-1.4577866792678833,
-1.1034386157989502,
-1.2429394721984863,
-1.344040870666504,
2.407048463821411,
-3.1680829524993896,
0.0799887403845787,
-1.15558922290802,
-0.5301643013954163,
0.9761407971382141,
0.986505389213562,
-0.14642687141895294,
1.147526741027832,
-0.12739777565002441,
-1.0276983976364136,
0.756972074508667,
-0.4811060130596161,
1.2693580389022827,
-0.9079842567443848,
1.4271072149276733,
-1.3477344512939453,
1.0686421394348145,
-0.35800114274024963,
-1.2839748859405518,
-0.17102424800395966,
0.5791147947311401,
0.5872443914413452,
0.9205765724182129,
-1.1087985038757324,
0.03026554547250271,
-0.3567744195461273,
0.12034880369901657,
0.15678107738494873,
-0.4837232530117035,
0.9333600401878357,
0.20697909593582153,
-0.1411599963903427,
-0.6343312859535217,
-0.8398385643959045,
0.08762694150209427,
-0.354218065738678,
0.7513527274131775,
-0.6824068427085876,
0.3490760922431946,
1.213521957397461,
-0.038031626492738724,
0.4229161739349365,
0.7037273049354553,
-0.00043450374505482614,
0.9480372071266174,
-0.8477283120155334,
-0.6047164797782898,
-0.2087215930223465,
1.0327012538909912,
-1.0695644617080688,
-0.520524799823761,
-0.27507930994033813,
-2.551203489303589,
-0.2469239979982376,
-0.035048991441726685,
0.5613473653793335,
-0.2609117031097412,
-0.1725841462612152,
0.05482575297355652,
-0.6428583264350891,
0.05536482110619545,
0.9669908285140991,
0.28924673795700073,
-0.5537269115447998,
0.5177850127220154,
0.44520729780197144,
0.2968752384185791,
1.1195321083068848,
-0.8339652419090271,
-0.04297071322798729,
0.1056009978055954,
1.2280335426330566,
-0.2108927071094513,
-0.40580829977989197,
0.033060699701309204,
0.2152957171201706,
-0.9085636138916016,
0.30887213349342346,
0.8753566741943359,
0.034825582057237625,
0.33208364248275757,
0.16175737977027893,
0.8682743906974792,
0.45875364542007446,
0.24684202671051025,
-1.2216789722442627,
-0.3829721510410309,
0.7260730266571045,
-0.15047447383403778,
-0.14414528012275696,
0.4749505817890167,
-1.429608941078186,
0.6463100910186768,
0.4557620584964752,
-0.5697333216667175,
-0.024768665432929993,
0.27324211597442627,
-0.9575570821762085,
-0.4947706460952759,
-0.7616336345672607,
-0.4308750331401825,
0.7776913642883301,
-0.40036436915397644,
-0.3038017749786377,
-0.5506751537322998,
0.021906718611717224,
-0.3000989556312561,
-1.4672881364822388,
-0.45140522718429565,
0.5778302550315857,
0.24405713379383087,
0.8122848272323608,
0.497496098279953,
-0.38228121399879456,
-0.14736057817935944,
-0.7069577574729919,
-0.9889527559280396,
-0.007644064258784056,
-0.5264897346496582,
-0.7663496136665344,
-0.16543331742286682,
0.3692297041416168,
0.016503263264894485,
0.8899711966514587,
-0.17272429168224335,
1.2438938617706299,
-0.15335972607135773,
0.20692530274391174,
0.46203532814979553,
0.0590045340359211,
-0.4698042571544647,
-1.5074418783187866,
-0.5202793478965759,
0.8958137035369873,
0.0863802582025528,
0.14260171353816986,
0.3506035804748535,
-0.0023574186488986015,
0.908190906047821,
0.2097807675600052,
0.2581651508808136,
0.2920245826244354,
0.4021381437778473,
-0.5011277794837952,
-0.7321362495422363
] |
NCT02121808
|
EPO2-PV: Evaluation of Pre-Oxygenation Conditions in Morbidly Obese Volunteer: Effect of Position and Ventilation Mode
|
The risk of complications associated with airway management in obese patients is significant. The results of pre-oxygenation allow a prolonged non-hypoxic apnea time for the clinician. The increase in FRC and non-hypoxic apnea time is correlated. The best condition to accomplish the pre-oxygenation in morbidly obese patient is still undetermined in medical literature.
This study is designed to evaluate the effect of different positions combined with different ventilation modes during the pre-oxygenation phase of anesthesia's induction. EPO2: PV will evaluate the effect of different combinations of positions and ventilation modes on pulmonary volumes (mainly functional residual capacity) in a morbidly obese volunteer.
|
Complications related to airway management are the major contributing factor to morbidity in anesthesiology. This risk of complications markedly increases when faced with a difficult airway in an obese patient. Pre-oxygenation creates a safety margin by increasing the patient's oxygen stores, through a higher functional residual capacity (FRC). When pre-oxygenated, the clinician may proceed to intubation after a variable period of apnea, while maintaining oxygen saturation over 92%. In non-obese individuals, pre-oxygenation allows a non-hypoxic apnea time of eight minutes. In the obese population, however, this non-hypoxic apnea time decreases to two to three minutes.
Different methods of pre-oxygenation have been proposed in order to increase apnea time before significant oxygen desaturation. Amongst these methods, the following are of particular interest: pre-oxygenation to vital capacity, pre-oxygenation with spontaneous ventilation and positive pressure, and pre-oxygenation with elevated head positioning ("beach-chair"). These methods have been extensively studied in individuals of normal height and weight.
The main objective of pre-oxygenation is to raise oxygen levels available at the alveolar level in order to increase the non-hypoxic apnea time, before a significant desaturation occurs. This raised alveolar oxygen concentration can be done by maintaining a higher inspired oxygen fraction and by promoting a larger FRC which is the oxygen reserve build through the pre-oxygenation phase. In morbid obese patients, these parameters are affected by a lower expiratory flow, lower expiratory flow and closing of small radius airways. The final result probably come from a more cephalad position of the diaphragm induced by a larger intra-abdominal volume.
Actually, different studies demonstrate the advantage of a beach-chair position and non-invasive positive pressure ventilation for pre-oxygenation of obese patients. These advantages are shown by a shorter time of pre-oxygenation to obtain an end-tidal O2 \> 90 % and a longer non-hypoxic apnea time (Sat O2 \>90%). Up to date, there is no published data on the FRC as a result of different combinations of position and ventilation mode. This study will evaluate FRC by helium dilution technique.
We propose a crossover randomised trial on volunteers waiting for a bariatric surgery. We want to compare, in pre-oxygenation situation, without induction of general anesthesia, the effect of three positions and two ventilation modes on the FRC measure.
|
Inclusion Criteria:
* BMI 40 - 80 kg / m2
* Waist circumference: Men: More than 130 cm
* Waist circumference: Women: More than 115 cm
Exclusion Criteria:
* Facial hair
* Cranio-facial abnormality
* Claustrophobia
* Asthma
* COPD (defined by FEV1 \< 80 %)
* Severe cardiovascular disease (defined by NYHA ≥3)
* Pregnancy
* Tobacco use
* NI-CPPV Intolerance documented by a respiratory specialist (pneumologist).
|
[
0.33993956446647644,
2.9217166900634766,
-3.39054536819458,
-3.3798255920410156,
-0.017531584948301315,
0.6703562140464783,
0.5885053873062134,
0.24080660939216614,
-1.7588272094726562,
1.1675549745559692,
0.3033863306045532,
1.6818132400512695,
0.3607867658138275,
1.3386372327804565,
0.2877536714076996,
1.307942509651184,
-0.802895188331604,
-0.642419159412384,
0.5549304485321045,
-1.6439285278320312,
0.38805070519447327,
-0.1049727350473404,
-0.4878130853176117,
-0.0260199885815382,
0.6017913818359375,
-0.7341669797897339,
1.1517069339752197,
-0.07358173280954361,
-0.3048550486564636,
-0.5773228406906128,
0.04095182940363884,
-1.4885808229446411,
-0.40045222640037537,
0.7715128064155579,
-0.49991706013679504,
1.1651443243026733,
-1.1200332641601562,
0.24733363091945648,
-1.1463329792022705,
-0.9338876605033875,
0.9221847057342529,
2.012216567993164,
0.8621852993965149,
-1.779903769493103,
1.146031141281128,
0.5337939858436584,
-0.7024043798446655,
1.475062370300293,
0.5408928990364075,
-0.3100828230381012,
-1.9555250406265259,
0.021353527903556824,
-1.0868451595306396,
0.033384282141923904,
1.9027256965637207,
-0.5244935154914856,
-0.12436770647764206,
0.026325583457946777,
0.28025323152542114,
-0.055624302476644516,
0.20938695967197418,
-0.6753372550010681,
0.22442185878753662,
0.08135902136564255,
-0.9552451372146606,
-0.4947207272052765,
1.121003270149231,
0.4332009553909302,
-0.6511488556861877,
0.47484979033470154,
0.3113492727279663,
0.22062255442142487,
0.4620177447795868,
-0.41745275259017944,
0.4892413318157196,
1.2321189641952515,
-0.5692157745361328,
0.41622209548950195,
0.0037692892365157604,
0.09374364465475082,
-0.24686892330646515,
0.4163414537906647,
-1.2766919136047363,
-0.2587406635284424,
-0.35513243079185486,
-0.02773081697523594,
-0.9357234239578247,
-0.8666702508926392,
1.2156263589859009,
0.0395067036151886,
0.11953206360340118,
-0.26193180680274963,
-1.4616812467575073,
0.7354233860969543,
-0.4962787628173828,
0.12924234569072723,
0.09311171621084213,
-0.12833675742149353,
-1.2610894441604614,
-1.1571781635284424,
-0.06704454123973846,
0.4797646403312683,
0.18060661852359772,
0.19056865572929382,
-0.2656964957714081,
-0.04700954630970955,
0.5275759100914001,
-1.234054684638977,
0.3587586581707001,
-0.31986838579177856,
0.46176740527153015,
-0.3452579379081726,
0.21676938235759735,
-0.4619618356227875,
0.05641137808561325,
0.12468712776899338,
-0.06612446159124374,
-0.22169212996959686,
0.5824813842773438,
-0.7169471979141235,
-0.11368905007839203,
0.357708215713501,
0.29170528054237366,
0.3939869701862335,
-0.8728402256965637,
0.1822529286146164,
-0.5341183543205261,
0.3943312168121338,
0.0916823148727417,
-0.19522298872470856,
0.030370337888598442,
-0.33849966526031494,
-0.23500396311283112,
-0.5227393507957458,
-0.7996871471405029,
0.3483579456806183,
0.512510359287262,
1.2894870042800903,
0.43515121936798096,
-0.3187004327774048,
0.02688855305314064,
0.009534124284982681,
0.028323404490947723,
-0.24910032749176025,
-0.5386480689048767,
-0.2028455287218094,
0.08750677108764648,
0.06936915963888168,
-0.5732012987136841,
0.12561357021331787,
-0.6497042179107666,
0.5843726992607117,
0.25892719626426697,
0.4155780076980591,
-0.1283717006444931,
0.22510702908039093,
0.13812978565692902,
-0.23299525678157806,
0.23454730212688446,
-0.24190838634967804,
0.3455910086631775,
0.3371953070163727,
0.09124840050935745,
-0.6792676448822021,
1.3595951795578003,
0.40666717290878296,
0.017377059906721115,
0.23869726061820984,
0.9712567329406738,
-0.1960410475730896,
-0.5909249186515808,
0.049968842417001724,
0.32416728138923645,
-0.33507397770881653,
-0.38699206709861755,
-0.22195035219192505,
-0.14831142127513885,
-0.3831590414047241,
0.31443434953689575,
-0.3190925717353821,
-0.06900747865438461,
-0.0488751046359539,
0.11445515602827072,
0.2983749806880951,
-0.22896870970726013,
-0.44204333424568176,
0.04816533997654915,
-0.5539864301681519,
-0.040183939039707184,
0.1831902265548706,
-0.15375496447086334,
-0.42099595069885254,
-0.3452886939048767,
0.1483311504125595,
-0.12330035865306854,
0.6837073564529419,
-0.9237013459205627,
-0.07692412286996841,
0.5994231104850769,
0.41595393419265747,
0.47289639711380005,
0.1421387493610382,
-0.2191053032875061,
0.13869121670722961,
-0.1766127049922943,
-0.12125024199485779,
-0.037627629935741425,
0.2675684094429016,
-0.28208455443382263,
0.2399115115404129,
-0.25330817699432373,
0.34176427125930786,
-0.13306023180484772,
0.22810976207256317,
0.1939467191696167,
0.3571299910545349,
-0.19868269562721252,
0.19016608595848083,
-0.4401649236679077,
0.15482158958911896,
0.21312162280082703,
0.3698447048664093,
-0.22592711448669434,
0.22139762341976166,
-0.28938570618629456,
-0.29664313793182373,
0.08485469967126846,
-0.13881827890872955,
0.36289694905281067,
-0.2094103991985321,
-0.23010121285915375,
-0.10116051882505417,
-0.4802684783935547,
0.05840655416250229,
0.37140172719955444,
0.13351085782051086,
-0.06699960678815842,
0.6727636456489563,
-0.14174595475196838,
0.1635155975818634,
-0.0705697312951088,
-0.45927080512046814,
-0.33674356341362,
-0.23522160947322845,
-0.14938853681087494,
-0.0884455144405365,
-0.13007871806621552,
0.2996698021888733,
-0.1838386505842209,
0.01795518770813942,
0.06273099035024643,
-0.23843251168727875,
0.10961510986089706,
0.245637446641922,
-0.0829840674996376,
-0.24970248341560364
] |
NCT03414905
|
Management of Malignant Pleural Effusions Using an Indwelling Tunneled Pleural Catheter and Non-Vacuum Collection System
|
In this study, the investigators will collect data on patients who are using the Aspira system as part of their clinical care for the management of recurrent pleural effusion. Data will be collected on patient demographics, placement of the pleural catheter, palliation of dyspnea, complication rates, and rates of spontaneous pleurodesis.
|
Inclusion Criteria:
* Male or female, at least 18 years of age, inclusive
* Subject has a symptomatic malignant pleural effusion requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true
* There is cytological confirmation of pleural malignancy
* The effusion is an exudate (per Light's criteria Pleural fluid protein/Serum protein \>0.5, Pleural fluid LDH/Serum LDH \>0.6, or Pleural fluid LDH \>2/3 the upper limit of normal) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified
* Subject is able to provide informed consent
* Subject has sufficient pleural fluid to allow safe insertion of an indwelling tunneled pleural catheter as determined by the PI
* Subject is able to perform home drainage of the pleural effusion or has sufficient resources (family member, caregiver, home health).
Exclusion Criteria:
* Subject is pregnant
* Subject has evidence, in the opinion of the PI, of either ongoing systemic or pleural infection
* Subjects with uncorrected coagulopathy
|
[
2.3417460918426514,
2.0529398918151855,
-2.149449348449707,
-1.8935707807540894,
-0.3052849769592285,
-0.026291340589523315,
-0.34383922815322876,
-0.2552659809589386,
-2.303422689437866,
1.1566883325576782,
0.517577052116394,
1.107884168624878,
0.18799109756946564,
0.8733676075935364,
2.3626465797424316,
-0.02851652167737484,
0.6506409645080566,
0.3172279894351959,
0.5064116716384888,
-1.171988606452942,
0.615675151348114,
0.9890905618667603,
-0.16880734264850616,
0.49763426184654236,
0.5180948376655579,
-0.10073885321617126,
-0.8032323122024536,
1.3601154088974,
0.8898489475250244,
0.48180586099624634,
1.7743297815322876,
0.5711188912391663,
0.2547042667865753,
0.7201762795448303,
-0.39707380533218384,
-2.4366116523742676,
-0.36426061391830444,
-0.3827667534351349,
-0.7450087070465088,
-0.1922401487827301,
-1.4230778217315674,
0.5808583498001099,
-0.2779107987880707,
-0.4108056426048279,
1.2425224781036377,
0.3675137758255005,
-1.6591806411743164,
0.7014626264572144,
1.2479252815246582,
-0.7769362330436707,
-1.9531750679016113,
-0.06269380450248718,
-0.45486700534820557,
0.6352401375770569,
-0.8583085536956787,
0.7161464691162109,
-0.21014201641082764,
0.2184879630804062,
0.8727685809135437,
0.34848108887672424,
0.5908015966415405,
0.68667072057724,
0.3229372203350067,
-1.0260202884674072,
0.4258028268814087,
0.7013087868690491,
-0.14770320057868958,
0.07399646192789078,
-1.5673571825027466,
1.3799854516983032,
-0.7984589338302612,
0.15434139966964722,
1.2877490520477295,
0.7281812429428101,
0.19727720320224762,
0.24605168402194977,
-0.1372336745262146,
1.1697313785552979,
0.9298861622810364,
0.06306568533182144,
-0.8536720275878906,
0.11963232606649399,
-0.8755713105201721,
-0.6523553133010864,
-0.534539520740509,
-0.5059767961502075,
-0.7990670204162598,
-1.194679856300354,
0.7366337776184082,
-0.627623975276947,
0.9695324897766113,
-0.4095170199871063,
-1.034205675125122,
0.2859314978122711,
-1.0104984045028687,
0.3355313241481781,
-0.671474277973175,
0.13894782960414886,
-1.8470218181610107,
0.4812822937965393,
-0.5104442238807678,
-0.44376876950263977,
-0.6607747077941895,
0.24957233667373657,
0.05612056702375412,
-0.60875004529953,
0.5531133413314819,
-1.2608928680419922,
0.47926270961761475,
-0.38980916142463684,
1.0689759254455566,
0.4485006630420685,
-0.3696015477180481,
-0.5141505002975464,
-0.009857065044343472,
0.8678843379020691,
1.0690925121307373,
-0.10281751304864883,
0.1236741691827774,
-0.3170385956764221,
0.10441267490386963,
1.0264551639556885,
0.727502703666687,
0.499244749546051,
-0.8514882326126099,
-0.6692659854888916,
0.23967567086219788,
0.9129599332809448,
0.44897347688674927,
0.03872889652848244,
-0.3155513107776642,
-0.058170873671770096,
-0.6153395771980286,
-1.1232082843780518,
-0.4013221561908722,
0.6062180995941162,
0.189403235912323,
0.5575048923492432,
-0.28967782855033875,
-0.38320574164390564,
0.54913330078125,
0.20785847306251526,
-0.004671657457947731,
0.14155717194080353,
-0.1959153115749359,
0.5054453611373901,
-0.5484431982040405,
0.7123664617538452,
-1.0725808143615723,
-0.23650936782360077,
-0.38470011949539185,
0.12336403131484985,
0.3701227307319641,
0.3860296607017517,
0.06142835691571236,
0.7228435277938843,
1.2590734958648682,
-0.27128738164901733,
-0.2699876129627228,
-1.313148021697998,
-0.2958908975124359,
-0.452484130859375,
-0.08881515264511108,
-0.7521188259124756,
0.5689578056335449,
0.1354639232158661,
-0.1663237363100052,
0.5779880285263062,
0.37425243854522705,
0.07130394876003265,
0.26536744832992554,
0.03355802595615387,
0.2655442953109741,
-0.031033411622047424,
-0.7647891044616699,
-0.43662703037261963,
-0.11105747520923615,
0.24471595883369446,
0.2330733835697174,
0.5548791885375977,
-0.3459274172782898,
-0.5154719352722168,
0.49028128385543823,
0.27489373087882996,
0.015914833173155785,
0.1201036274433136,
0.060111332684755325,
-0.2257179170846939,
0.2073487490415573,
0.1384749710559845,
0.5792570114135742,
-0.45314374566078186,
-0.32159504294395447,
0.39354971051216125,
0.6776736378669739,
0.20884498953819275,
-0.3726053833961487,
-1.0128633975982666,
0.5599871873855591,
0.2620118260383606,
0.14989277720451355,
0.08096177130937576,
-0.36782994866371155,
0.8853575587272644,
0.2457144856452942,
-0.1873331516981125,
-0.07682251185178757,
-0.40424367785453796,
-0.8058900833129883,
0.28857502341270447,
0.16686445474624634,
0.17453236877918243,
0.5523703098297119,
-0.7601804733276367,
-0.14359328150749207,
0.22310173511505127,
0.04606550186872482,
-0.11955450475215912,
-0.6212338805198669,
0.2625572383403778,
0.02318957820534706,
-0.32656967639923096,
-0.05167270451784134,
0.12526056170463562,
-0.42952048778533936,
0.11539668589830399,
-0.1738874614238739,
-0.37111496925354004,
0.07076572626829147,
-0.055251847952604294,
-0.3936905562877655,
-0.08865739405155182,
0.5270941257476807,
-0.10318867117166519,
0.039884984493255615,
0.17802414298057556,
0.4274396598339081,
0.35575124621391296,
-0.2595926523208618,
0.46237221360206604,
0.14038822054862976,
-0.4459245204925537,
-0.2243661880493164,
0.27816635370254517,
0.413665771484375,
-0.20794227719306946,
0.3767816722393036,
-0.6435893774032593,
-0.641503095626831,
-0.058804843574762344,
0.14412733912467957,
-0.209647074341774,
0.28362372517585754,
-0.26122546195983887,
0.5232671499252319,
-0.05946647375822067
] |
|
NCT04707443
|
Enteral Nutrition in Infants With Ileostomy
|
This study is a prospective, single center, practical, and observational open clinical study.
|
Infant enterostomy is one of the emergency surgeries in pediatric gastroenterology. The most common underlying conditions during infancy include necrotizing enterocolitis, intestinal necrosis, intestinal perforation, and congenital gastrointestinal malformations. Necrotizing enterocolitis also serves as a major cause of short bowel syndrome in infants. Infants with small bowel stoma leading to short bowel syndrome face a higher incidence of complications compared to adults. Additionally, small intestinal stomy inevitably come with various complications such as infection, electrolyte imbalance, nutrient deficiencies, and malnutrition.
Currently, both domestic and international studies have shown that breast milk is the preferred choice for infant nutrition. The benefits of breastfeeding have been widely reported. For postoperative infants with digestive tract surgery, breast milk's immunoglobulins and prebiotics can help promote beneficial gut bacteria and bioactive proteins (such as lactoferrin, lysozyme, and lipoproteins), growth factors that facilitate intestinal adaptation and maturation processes while enhancing feeding tolerance and preventing infections or inflammatory disorders.
However, according to literature reports on clinical practice operations after digestive tract surgery even if early breastfeeding was initiated in 88% of cases; only 44% of infants were still being breastfed at discharge. This is due to feeding intolerance following breastfeeding which manifests as gastric retention, abdominal distension, diarrhea etc., not only delaying growth but also prolonging hospital stay while causing other adverse clinical outcomes. Some discharged infants who started breastfeeding experienced diarrhea and dehydration leading to readmission. Clinically speaking this issue has often been addressed by substituting feeds with enteral nutrition preparations (deep hydrolyzed formulas or free amino acid formulas).
The objective of this study is to assess the impact of enteral nutrition, which involves selecting appropriate preparations and human breast milk based on the child's intestinal tolerance, on growth and developmental outcomes in children following enterostomy. Additionally, we aim to investigate its effects on postoperative intestinal permeability, stoma output, gut microbiota and metabolites, sepsis incidence, colitis occurrence as well as bile stasis.
|
Inclusion Criteria:
* After birth, infants aged 0-6 months (including neonates) undergo small bowel ostomy for various reasons.
Exclusion Criteria:
* Primary liver and kidney dysfunction, congenital multiple malformations and chromosomal abnormalities.
|
[
0.5799751877784729,
3.9105634689331055,
-3.598177909851074,
-0.5242903232574463,
-2.160315752029419,
1.1007869243621826,
-0.9452762603759766,
-1.252351999282837,
-0.5222728848457336,
0.7218289375305176,
1.032057523727417,
-0.20132043957710266,
-2.746037721633911,
0.9282926917076111,
-0.4210524260997772,
2.837350368499756,
-1.077872633934021,
-0.7578995823860168,
0.7645054459571838,
-0.22150833904743195,
0.16574901342391968,
-1.0229530334472656,
0.5626704692840576,
-0.905785858631134,
3.053626775741577,
0.061623360961675644,
-1.7603957653045654,
1.5474544763565063,
-0.6651303768157959,
1.1849136352539062,
0.4507782757282257,
-1.0484784841537476,
-1.0298641920089722,
0.5099642276763916,
1.1842855215072632,
0.13192716240882874,
0.09954503178596497,
-0.17853033542633057,
-1.096907138824463,
0.14155583083629608,
2.090144395828247,
0.9927204847335815,
-1.902163028717041,
0.6940822601318359,
1.8333081007003784,
1.6007990837097168,
-0.0725988894701004,
0.11530889570713043,
-1.2975231409072876,
0.40490323305130005,
-2.023068428039551,
1.3627588748931885,
-2.426907539367676,
-0.9178416728973389,
1.2942763566970825,
0.3021433651447296,
1.1583456993103027,
-0.10158761590719223,
2.7869200706481934,
0.5457597374916077,
0.5814155340194702,
-1.180696964263916,
0.7972925901412964,
0.9855614900588989,
-3.166477918624878,
1.5832210779190063,
-0.672202467918396,
0.8756806254386902,
-0.8723958134651184,
0.520003080368042,
2.031085252761841,
0.5615465641021729,
1.552290439605713,
-0.7582166194915771,
-0.04507211223244667,
-0.1851283460855484,
-0.009011948481202126,
0.6016470789909363,
-0.27345460653305054,
0.7351863384246826,
0.5675604343414307,
0.1003846600651741,
-1.5373789072036743,
0.7895967364311218,
0.5343018174171448,
-0.695966899394989,
-1.3699663877487183,
-0.5972235798835754,
0.3964119255542755,
1.2562636137008667,
0.44518905878067017,
0.5418076515197754,
0.453078955411911,
1.0279041528701782,
1.0226192474365234,
0.4578261375427246,
1.0834779739379883,
-1.7225191593170166,
-1.2325252294540405,
0.9450304508209229,
-0.13719810545444489,
-0.8413373231887817,
0.20532812178134918,
1.9646748304367065,
0.01604856550693512,
-0.6002187728881836,
-0.9280173182487488,
0.42004358768463135,
-0.898813009262085,
-1.7566518783569336,
0.5831840634346008,
-0.8992164134979248,
0.7795308232307434,
0.28391793370246887,
1.0063958168029785,
-1.2197279930114746,
0.4710617661476135,
-0.02955639362335205,
0.6479504108428955,
-0.3034008741378784,
-0.5150521397590637,
1.4137479066848755,
0.4466547966003418,
1.1750460863113403,
-0.6218831539154053,
-1.0589261054992676,
-1.3491902351379395,
-0.288674920797348,
-0.8614441156387329,
-0.5085518956184387,
-1.5280169248580933,
-0.8693330883979797,
0.4647957384586334,
0.19379207491874695,
-1.5077269077301025,
1.819398045539856,
0.1133594885468483,
-0.5012940168380737,
-0.5785980224609375,
-0.8194833397865295,
0.9825798869132996,
-1.127202033996582,
1.2755199670791626,
-0.5634098052978516,
-2.662118673324585,
0.5368755459785461,
0.015488531440496445,
0.6905375123023987,
-0.8277671337127686,
-0.21884652972221375,
-0.2558933198451996,
1.21000337600708,
0.9418485164642334,
-0.24307852983474731,
0.6645829677581787,
-0.27519023418426514,
0.697576105594635,
-1.1655423641204834,
0.03403046354651451,
-1.3515456914901733,
0.11542359739542007,
-0.2313920110464096,
0.3212215304374695,
0.0016381223686039448,
0.16468052566051483,
1.075960636138916,
-0.6361043453216553,
-0.42952078580856323,
0.14369581639766693,
-0.008279331959784031,
-0.9632660746574402,
-0.4048616886138916,
-0.38246577978134155,
0.5856898427009583,
-0.21663905680179596,
0.33899930119514465,
0.3824915587902069,
-0.9997961521148682,
0.09009823203086853,
0.6840803623199463,
0.21442413330078125,
-0.06195393577218056,
-0.41900384426116943,
0.2537898123264313,
0.9411336183547974,
-0.14290422201156616,
0.8180224895477295,
-0.11364693194627762,
-0.490900456905365,
0.04289877042174339,
-0.12022630125284195,
0.3899177312850952,
0.08298495411872864,
0.9086934328079224,
0.5666082501411438,
0.6439225673675537,
-0.5578396916389465,
-0.9013020396232605,
0.4461871385574341,
-0.14033031463623047,
0.2153356671333313,
1.7368255853652954,
0.07863929867744446,
0.49557435512542725,
0.5434092879295349,
0.8617637753486633,
-0.8760064840316772,
0.43706071376800537,
0.2948497533798218,
-1.3063908815383911,
0.1733725219964981,
-0.8727701306343079,
-0.6751934885978699,
-0.637346625328064,
1.6986172199249268,
0.03288920223712921,
0.3827160596847534,
-0.025036802515387535,
-1.1905810832977295,
-0.7482609152793884,
-1.1161346435546875,
0.8001881241798401,
0.43112707138061523,
-0.6829774975776672,
-0.5845820903778076,
0.11614654958248138,
-0.2840207815170288,
-0.7306155562400818,
1.3003078699111938,
-0.5304965376853943,
-0.3773695230484009,
0.2236400991678238,
-0.37695541977882385,
0.4637870192527771,
-0.13932693004608154,
0.010870786383748055,
0.5169893503189087,
-0.12718723714351654,
0.09937480837106705,
0.9467380046844482,
1.400083065032959,
-1.3287619352340698,
-0.41048696637153625,
-0.7489603757858276,
0.29585298895835876,
0.5242701172828674,
-0.7044864892959595,
-0.14146949350833893,
-0.32625052332878113,
-0.024959539994597435,
-0.34921568632125854,
0.1256546676158905,
-0.0401296503841877,
0.6557773351669312,
-0.2044447511434555,
-1.283820390701294
] |
NCT00405808
|
Rimonabant in Abdominally Obese Patients With Impaired Fasting Blood Glucose
|
Primary objective:
To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with impaired fasting blood glucose and with or without associated comorbidities.
Main Secondary objectives:
To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic parameters and lipid parameters.
To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.
|
Inclusion Criteria:
* BMI ≥ 30Kg/m², or \> 27kg/m² if associated with risk factor(s) such as dyslipidemia, and \< 40kg/m²,
* Waist Circumference \> 88 cm in women; \> 102 cm in men,
* Confirmed (by at least 2 measurements) impaired Fasting Plasma Glucose (FPG ≥ 100 mg/dl (5.6 mmol/L) and \< 126 mg/dl (7.0 mmol/L) in non diabetic patients,
* LDL cholesterol up to 155 mg/dl (4.00 mmol/L) including patients on a stable dose of statin therapy for at least 8 weeks prior to screening,
* Current treatment with statins and/or ezetimibe and/or antihypertensive therapy must be at fixed and stable dose for at least 8 weeks prior to screening visit,
* Patients, who are willing and in the opinion of the Investigator safely assumed to remain on stable and fixed doses of antihypertensive, and/or statins and/or ezetimibe without adding additional medications or changing current treatment for the duration of the trial.
Exclusion Criteria:
* Pregnant or breast-feeding women, or women planning to become pregnant or breastfeed (excluded by pregnancy test),
* Absence of medically approved contraceptive methods for female of childbearing potential,
* History of very low-calorie diet within 3 months prior to screening visit (lower than 1200 Kcal/day),
* Weight change \> 5 kg within 3 months prior to screening visit,
* History of surgical procedures for weight loss (e.g., stomach stapling, bypass),
* History of bulimia or anorexia nervosa as per DSM-IV criteria,
* Presence of any clinically significant endocrine disease according to the investigator, in particular known abnormal TSH and free T4 blood level (Patients treated with thyroid replacement therapy must be on fixed and stable dose for at least 3 months prior to screening and must be in euthyroïd status),
* Established type 1 or 2 diabetes treated, or with at least 2 measures of fasting blood glucose ≥ 126 mg/dl /L,
* Triglyceride level \> 400 mg/dL (4.52 mmol),
* Systolic blood pressure \> 160 mm Hg or diastolic blood pressure \>100 mmHg at screening visit,
* Known severe renal dysfunction (creatinine clearance \< 30 ml/min) or nephrotic syndrome or urinalysis (performed at screening by dipstick) showing 2+ or more protein,
* Known severe hepatic impairment or AST and/or ALT \> 3 times the upper limit of normal at screening,
* Presence of any condition (medical, including clinically significant abnormal laboratory tests, psychological, social or geographical) actual or anticipated that the investigator feels would compromise the patient's safety or limit his/her successful participation to the study. In particular :
* Cardiac abnormalities: cardiac failure status NYHA III or IV, relevant acute abnormal finding seen on ECG at screening or within 6 months before screening,
* Any current malignancy or any cancer within the past five years (except adequately treated basal cell skin cancer or cervix carcinoma in situ),
* Significant haematology abnormalities (haemoglobin \< 100 g/L and/or neutrophils \< 1.5 G/L and/or platelets \< 100 G/L),
* Acute psychiatric disorders or mental condition which could interfere with the patient's compliance or safe participation in the study,
* Patient treated for epilepsy,
* Ongoing major depressive illness,
* Uncontrolled psychiatric illness,
* History of alcohol or other substance abuse,
* Hypersensitivity /intolerance to the active substance or to any of the excipients such as lactose,
* Administration of any investigational treatment (drug or device) within 30 days prior to screening,
* Previous participation in a Rimonabant study or previous administration of Rimonabant,
* Administration of any of the following within 3 months prior to screening visit:
1. Anti obesity drugs (eg, sibutramine, orlistat),
2. Other drugs for weight reduction (phentermine, amphetamines),
3. Herbal preparations for weight reduction,
4. Nicotinic acid, fibrates or bile acid sequestrants ,
5. Prolonged use (more than one week) of systemic corticosteroids, neuroleptics.
6. Omega-3 fatty acid approved medication
* Ongoing antidepressive treatment(including bupropion)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
|
[
1.896759033203125,
1.8758230209350586,
-3.090871572494507,
-3.489591121673584,
0.4359760284423828,
-0.49585363268852234,
0.8330160975456238,
-0.026752416044473648,
0.4645897150039673,
-0.7430261373519897,
1.1790205240249634,
1.2466821670532227,
-0.33724579215049744,
0.24866412580013275,
1.0246635675430298,
0.1749221831560135,
-0.7007238268852234,
-0.20214231312274933,
0.986555278301239,
-1.6748833656311035,
1.32943856716156,
0.447480708360672,
-0.7819212079048157,
-1.0409162044525146,
0.8798739910125732,
-1.7156598567962646,
-0.3969391882419586,
1.410101294517517,
-0.2957155704498291,
1.679581880569458,
-0.09816823154687881,
-0.7378095388412476,
-0.579083263874054,
0.4202195107936859,
0.29002833366394043,
0.48353585600852966,
0.27469953894615173,
-0.13842475414276123,
-0.06018848717212677,
0.3875329792499542,
1.0138801336288452,
-0.66411954164505,
1.1041725873947144,
-0.5239068269729614,
0.7178089022636414,
1.1009689569473267,
-0.6209888458251953,
-0.3312242031097412,
-0.9717366099357605,
0.029733365401625633,
0.0640348568558693,
0.913362979888916,
-1.493877649307251,
0.7803177237510681,
1.575027346611023,
0.8924223184585571,
0.8627087473869324,
0.8387780785560608,
1.5498019456863403,
-0.5887327194213867,
-0.24547310173511505,
0.16000492870807648,
0.70005863904953,
-0.0456831194460392,
-0.46139606833457947,
-0.8519259095191956,
0.22907891869544983,
-0.017341405153274536,
-0.48664042353630066,
0.313859224319458,
-0.913891613483429,
0.7107023000717163,
0.36777251958847046,
-0.6321247816085815,
0.17686563730239868,
0.6399372220039368,
-0.06687610596418381,
1.2876263856887817,
-0.6356320977210999,
0.4878057539463043,
-0.07585321366786957,
0.4217213988304138,
0.2527594566345215,
0.16920983791351318,
-0.046736717224121094,
0.19925159215927124,
-1.314955711364746,
0.01567533053457737,
0.8794307708740234,
-0.6419078707695007,
-0.5243167877197266,
-0.011932955123484135,
-2.1578381061553955,
-0.09131383895874023,
0.31116217374801636,
-0.13384610414505005,
-0.9889205098152161,
0.396024614572525,
-0.8727221488952637,
-0.44509732723236084,
0.21927836537361145,
0.2930951714515686,
0.12574931979179382,
0.26527222990989685,
0.4822879731655121,
-0.3227768838405609,
-0.1281312108039856,
-0.5093218684196472,
-1.212925910949707,
-0.35245364904403687,
-0.15632624924182892,
-1.3120429515838623,
0.05129079893231392,
-0.843490719795227,
0.1957835704088211,
0.4414449632167816,
0.6383355855941772,
-0.12335294485092163,
-0.2868233621120453,
-0.7541884779930115,
-0.6173308491706848,
0.38174116611480713,
0.499174565076828,
-0.08536778390407562,
0.2613092362880707,
-0.5585455894470215,
0.4444310963153839,
-0.11541513353586197,
0.3381303548812866,
-0.21049991250038147,
-0.9801269173622131,
0.48748713731765747,
0.36059316992759705,
-0.44273272156715393,
-0.5325375199317932,
-0.26437604427337646,
0.12600138783454895,
0.4508894979953766,
-0.5196827054023743,
-0.5063396096229553,
0.1418272703886032,
-0.38031017780303955,
-0.8926202654838562,
0.09549019485712051,
-1.1683794260025024,
-0.6716411709785461,
-0.2838062345981598,
0.1374727487564087,
-0.40589478611946106,
-0.25684359669685364,
0.6301461458206177,
0.38532257080078125,
0.7132858037948608,
0.35678619146347046,
0.4290982782840729,
0.02640187181532383,
-0.21925890445709229,
-0.2359440177679062,
-0.6415609121322632,
0.17891228199005127,
-0.3661015033721924,
-0.907940685749054,
-0.19720883667469025,
-0.19097237288951874,
0.9526301026344299,
-0.05613971874117851,
-0.4373520314693451,
-0.22946536540985107,
0.3615249693393707,
-0.5858349800109863,
-0.5442711114883423,
0.2508452534675598,
0.19956457614898682,
0.1843613088130951,
-0.45131149888038635,
0.22907593846321106,
0.22344358265399933,
0.3040931224822998,
0.3275279104709625,
0.023959415033459663,
-0.41768866777420044,
-0.14622612297534943,
0.3157373368740082,
0.011482737958431244,
-0.10097402334213257,
-0.8248844146728516,
0.29270777106285095,
0.1060309186577797,
-0.23314528167247772,
0.08895698934793472,
0.2951440215110779,
-0.0001434580481145531,
-0.19252920150756836,
0.28963372111320496,
0.09740477800369263,
-0.271074116230011,
-0.33860430121421814,
0.058511883020401,
0.691382110118866,
-0.030471159145236015,
0.15114378929138184,
0.6714240908622742,
0.2880929708480835,
0.8264758586883545,
-0.22009581327438354,
-0.1560547947883606,
-0.1645207703113556,
0.327562153339386,
-0.16037100553512573,
0.6935267448425293,
-0.03468911349773407,
0.44080719351768494,
-0.31581735610961914,
0.15022514760494232,
0.28886547684669495,
0.3745599687099457,
-0.012458117678761482,
-0.25708475708961487,
-0.07811035215854645,
0.15591277182102203,
0.0611303485929966,
-0.07934829592704773,
0.31530120968818665,
-0.13076478242874146,
-0.01611148752272129,
-0.41971513628959656,
-0.3429010212421417,
0.49547460675239563,
-0.3704579174518585,
0.25916993618011475,
-0.11943364143371582,
-0.32851076126098633,
0.07217663526535034,
-0.28311851620674133,
0.10640934854745865,
0.22496527433395386,
0.37231218814849854,
-0.2535870671272278,
-0.0392875112593174,
0.4739128351211548,
0.07693532109260559,
-0.16471365094184875,
0.5446290969848633,
-0.3601754605770111,
-0.45836690068244934,
-0.2586313784122467,
-0.08919842541217804,
0.30704185366630554,
0.08376666903495789,
0.15231546759605408,
-0.3605591654777527,
-0.45945996046066284,
-0.11272386461496353,
-0.008996570482850075,
0.2261262983083725,
-0.20028293132781982
] |
|
NCT00664235
|
The Analysis of Skin Temperature by Long Wave Infrared Imaging to Determine Its Effectiveness as a Predictor of Tissue Injury
|
Long-wave infrared imaging can be used to identify skin temperature changes associated with underlying tissue changes. We want to determine if the use of Long Wave infrared Imaging is as effective as the Braden Score in predicting nosocomial pressure ulcers.
|
The Trillennium Medical Imaging system will be used to gather skin temperature data on 100 subjects. The subjects will be enrolled from Duke North floors 8100 or 8300 in a prospective controlled trial. All eligible patients who have signed a consent form will be assessed using the Long Wave Infrared imaging.
Subjects eligible for this study who have signed a consent form will be scanned on bilateral heels and sacrum. Subjects with ulcers on those areas will also be scanned due to the fact that they are at a high risk of developing additional pressure ulcers. The intent is not to capture images of the existing ulcer, but to focus on areas that could potentially develop into additional pressure ulcers. The subjects who already have an ulcer will only be scanned on non ulcerated tissue. The areas of interest must be off-loaded for 3 minutes from any pressure in order to acclimate to ambient temperature. The device will be held approximately 36 inches from the area of interest in order to obtain an image. The subjects will be assessed within 24 hours of admission and every 24 hours until discharge or they develop a pressure ulcer. The subject's routinely recorded Braden scores (By on the floor nursing staff) will also be captured in order to effectively compare the effectiveness of the Imaging system. The nurse conducting the imaging will also record a Braden score.
All subjects will be included in the trial unless they refuse to participate or are incapacitated to the degree that imaging becomes unreasonable.
|
Inclusion Criteria:
* To be admitted to 8100 or 8300 and be willing to participate in the study
Exclusion Criteria:
* Unwillingness to participate
|
[
1.839615821838379,
2.724346160888672,
-2.382725715637207,
-5.219470977783203,
-0.23961752653121948,
-0.005440409295260906,
-0.6147179007530212,
-1.2191228866577148,
-0.6584060192108154,
0.22419823706150055,
1.5647435188293457,
2.74863862991333,
-2.025982141494751,
-0.3588956296443939,
-1.3721305131912231,
2.4956209659576416,
0.11036775261163712,
0.7188336253166199,
-0.5018925666809082,
-0.5902546048164368,
0.4991770088672638,
-0.527055025100708,
2.0748918056488037,
0.14478743076324463,
0.3656476140022278,
0.2587586045265198,
0.4721750020980835,
-0.061812639236450195,
0.2931545674800873,
1.2268800735473633,
0.9460139870643616,
0.5221002697944641,
0.30314093828201294,
0.2678971290588379,
-0.3405389189720154,
-1.5093947649002075,
0.4190141260623932,
0.4937422275543213,
-0.867292046546936,
-0.36196157336235046,
1.1512056589126587,
-0.513239860534668,
0.2498171031475067,
-1.1120167970657349,
-0.0716700553894043,
-1.7418088912963867,
-1.196547269821167,
-1.1353298425674438,
-0.06833487749099731,
-1.4785232543945312,
-0.49097496271133423,
1.9470006227493286,
-0.15975061058998108,
0.017891889438033104,
1.628084659576416,
0.2949177026748657,
0.9339240789413452,
0.44664016366004944,
0.024193797260522842,
-0.10558555275201797,
0.08201277256011963,
0.12352648377418518,
1.115126132965088,
0.6160458922386169,
-1.7088334560394287,
-0.28520143032073975,
-1.5407769680023193,
-0.21738892793655396,
-0.030016185715794563,
0.2704852521419525,
1.1632215976715088,
-0.22881045937538147,
-0.300232857465744,
-0.4871995151042938,
0.3399565517902374,
0.724348247051239,
0.5897738933563232,
-0.11930504441261292,
-0.6135448217391968,
1.0241106748580933,
-0.8118780255317688,
-1.047739028930664,
-1.5740197896957397,
1.0967984199523926,
0.4926021695137024,
0.0582355298101902,
0.3911502957344055,
-0.7376075983047485,
-0.0720573365688324,
0.8114542961120605,
-0.8500595092773438,
-0.7862319350242615,
-0.9479169845581055,
1.7629436254501343,
-0.31709468364715576,
0.9474958181381226,
-0.6778461933135986,
-0.8092895150184631,
-1.4342647790908813,
0.17790795862674713,
-0.20612221956253052,
-0.09349600970745087,
-0.6864609718322754,
1.3792521953582764,
0.0763469785451889,
0.036698196083307266,
0.06915109604597092,
0.04485291242599487,
0.3873189389705658,
-0.8247072696685791,
0.04481121525168419,
-0.5800456404685974,
0.9158880114555359,
-1.0066015720367432,
-0.8749906420707703,
-0.7921457886695862,
0.7433261275291443,
1.4952223300933838,
0.43244677782058716,
-1.2762218713760376,
-0.7843347787857056,
0.17594964802265167,
0.6974683403968811,
0.9314979314804077,
0.565985381603241,
0.27579718828201294,
0.03274930641055107,
0.1683288812637329,
0.02779654785990715,
0.5113273859024048,
-0.5835087299346924,
-0.154033362865448,
1.109009861946106,
-0.20906302332878113,
-0.3703991174697876,
-0.2434404194355011,
-0.5893701314926147,
1.0288143157958984,
-0.5718989372253418,
0.7616569995880127,
0.9245158433914185,
-0.5587802529335022,
0.071035236120224,
1.2015539407730103,
-1.1985950469970703,
-0.9668118357658386,
-0.4802217185497284,
0.15786166489124298,
0.3599461019039154,
-0.1852450668811798,
-1.0036141872406006,
-1.2849692106246948,
0.2456396073102951,
0.5338928699493408,
-0.10743480175733566,
-0.4031303822994232,
-0.4103699028491974,
-0.7957786917686462,
0.5581443309783936,
-0.1945025622844696,
-0.21694636344909668,
-0.029792174696922302,
0.05910572409629822,
0.20313160121440887,
0.6915993690490723,
-1.052899956703186,
0.2282148152589798,
-0.0010781465098261833,
0.5822070837020874,
0.0893014520406723,
0.39996376633644104,
0.002409539883956313,
0.4884124994277954,
0.33167147636413574,
0.03958684951066971,
-0.05355970561504364,
-0.10345443338155746,
0.22738908231258392,
0.5402986407279968,
-0.5977028012275696,
-0.22442831099033356,
0.10461024940013885,
-0.20347052812576294,
-0.2110036313533783,
-0.03289371728897095,
-0.12910136580467224,
0.9676715135574341,
-0.20615172386169434,
0.2694585621356964,
-0.28968581557273865,
0.8232150673866272,
0.2806781828403473,
-0.752066969871521,
0.29422444105148315,
-0.16621804237365723,
0.38586097955703735,
-0.07645437121391296,
-0.8748751878738403,
1.1713862419128418,
-0.11738420277833939,
0.15025848150253296,
1.123595952987671,
-0.4870232939720154,
-0.07982153445482254,
0.5238913893699646,
0.3311556577682495,
-0.17504245042800903,
0.34355759620666504,
0.8279356956481934,
0.9621586203575134,
-0.6485385298728943,
0.28925949335098267,
-0.21631795167922974,
-0.5514675974845886,
0.314164936542511,
0.3153080940246582,
0.11295299977064133,
0.16168595850467682,
-0.6318367719650269,
-1.0405956506729126,
-1.0056805610656738,
0.13814450800418854,
0.22272492945194244,
0.5565295219421387,
-0.19342733919620514,
0.17927950620651245,
0.43224793672561646,
0.585263192653656,
0.23719604313373566,
-0.18127338588237762,
0.18244566023349762,
1.1552214622497559,
-0.16052353382110596,
0.09371605515480042,
-0.8669608235359192,
0.13234902918338776,
0.006769826635718346,
0.7233700752258301,
0.14977097511291504,
-0.1268712282180786,
0.15948912501335144,
0.6858178973197937,
0.27766406536102295,
-0.24291203916072845,
-1.2723630666732788,
-0.48520103096961975,
-0.3732563257217407,
-0.28616875410079956,
-0.0217033289372921,
-0.6311741471290588,
0.42254236340522766,
-0.24668557941913605,
0.04200911521911621,
-0.42265525460243225,
0.11541718244552612,
-0.5325881242752075
] |
NCT02095431
|
Acute Kidney Injury Biomarkers: Diagnosis and Application in Pre-operative Period of Liver Transplantation
|
Acute kidney injury (AKI), is a common complication of patients undergoing liver transplantation. Timing and definition of AKI, usually based on serum creatinine, have been inaccurate and inconsistent.
We hypothesized that the pattern of novel biomakers elevation could be a prognostic tool to provide information on the risk of progression of AKI, the need for RRT and mortality.
|
Inclusion Criteria:
* Older than 18 years
* Reception liver transplantation
Exclusion Criteria:
* CKD stage 4 / 5
* Combined organ transplants
* Patients receiving dialysis before liver transplant operation
|
[
0.23575448989868164,
2.1629040241241455,
-1.9557445049285889,
-2.788240432739258,
1.1337593793869019,
-0.6305583715438843,
0.5067410469055176,
-0.7455366849899292,
-1.5376540422439575,
0.4846912622451782,
0.37348902225494385,
2.098266124725342,
-0.07504955679178238,
0.21990156173706055,
-1.0102450847625732,
0.08750835061073303,
0.058286018669605255,
0.8988202810287476,
-0.24139346182346344,
-1.7050622701644897,
-0.18360772728919983,
0.8680364489555359,
-0.7750110626220703,
1.7760088443756104,
0.09363514184951782,
0.45726895332336426,
-0.6787310242652893,
0.8318091034889221,
-0.852776050567627,
0.9871536493301392,
0.6563502550125122,
-0.15139460563659668,
0.15249240398406982,
0.46074211597442627,
-0.23997348546981812,
-0.6004849076271057,
1.5958163738250732,
0.24403820931911469,
-1.4506133794784546,
0.9464789032936096,
0.7979630827903748,
0.82363361120224,
-0.029583707451820374,
0.09705464541912079,
-0.034029025584459305,
-0.0508275143802166,
0.13624319434165955,
0.30539318919181824,
1.3282544612884521,
0.2055598795413971,
-0.3522059917449951,
0.3125014901161194,
-2.6985716819763184,
1.0143117904663086,
0.2485770434141159,
-0.1961098164319992,
0.13470713794231415,
0.6230772137641907,
1.601840615272522,
1.1265873908996582,
0.55519700050354,
-0.15734334290027618,
-0.5145376920700073,
0.2969092130661011,
-1.3113112449645996,
-0.5193507671356201,
0.07455189526081085,
-0.1799323409795761,
-1.1816437244415283,
0.10101782530546188,
-0.05066072940826416,
0.3181527554988861,
0.6474785804748535,
0.0185660682618618,
-0.8152406811714172,
1.9056907892227173,
0.009743118658661842,
-0.12107378989458084,
-1.596986174583435,
-0.042836859822273254,
-0.9058749675750732,
-0.2613900899887085,
-0.39711225032806396,
0.3367621898651123,
0.3390406668186188,
-0.06704559177160263,
-1.0925122499465942,
-0.8075578808784485,
0.4896112382411957,
-0.4295442998409271,
-0.18408487737178802,
-0.24694553017616272,
0.08502458781003952,
0.6236028671264648,
-0.9470148682594299,
-0.3524228632450104,
-0.7558405995368958,
0.14692233502864838,
-1.4715237617492676,
-0.5579233169555664,
-0.1215347945690155,
0.7212589979171753,
-0.08943499624729156,
0.17172281444072723,
0.25412631034851074,
-0.13028231263160706,
0.9904217720031738,
-0.5679497122764587,
-0.5081000328063965,
-0.716523289680481,
0.11552370339632034,
-0.22443683445453644,
0.24340540170669556,
-0.6271876692771912,
-1.315066933631897,
0.4363866150379181,
0.23412065207958221,
0.07870618999004364,
-0.11386468261480331,
-1.012973427772522,
-0.4648456275463104,
0.207433819770813,
0.6681351065635681,
0.7509033679962158,
-0.5763811469078064,
-0.8439827561378479,
0.4088723659515381,
0.1094151958823204,
-0.18807685375213623,
0.15632177889347076,
-0.204450324177742,
0.4446216821670532,
-0.29511526226997375,
0.3138655126094818,
0.3338165879249573,
-0.419746994972229,
-0.3944566249847412,
1.3538274765014648,
-0.058713819831609726,
-0.9058477282524109,
0.1424090415239334,
0.3975030481815338,
0.1991584450006485,
0.47617805004119873,
-0.4477705955505371,
-0.14971177279949188,
0.008990847505629063,
0.3212142288684845,
-0.31891095638275146,
-0.28961506485939026,
-0.2240312248468399,
0.36045384407043457,
0.6373598575592041,
0.4542910158634186,
-0.4441947042942047,
-0.016170600429177284,
-0.6234302520751953,
0.2703731060028076,
-0.2339557707309723,
0.07037430256605148,
-0.4134933352470398,
0.36119234561920166,
0.18031248450279236,
-0.3846712112426758,
1.1210956573486328,
-1.080267071723938,
0.3785478472709656,
0.0417666994035244,
-0.25200745463371277,
0.43354907631874084,
-0.5974130034446716,
-0.1809878647327423,
-0.36318904161453247,
0.5623117685317993,
-1.1222494840621948,
-0.3578905165195465,
-0.06292858719825745,
-0.13896436989307404,
-0.5801151990890503,
0.09407814592123032,
0.07087034732103348,
0.1296587735414505,
-0.022427504882216454,
-0.7094722390174866,
0.18888415396213531,
-0.44415900111198425,
-0.3780025541782379,
-0.3695318102836609,
0.05214273929595947,
0.06721070408821106,
0.15449149906635284,
0.23831380903720856,
0.2571079432964325,
1.048657774925232,
-0.05353163555264473,
-0.45516401529312134,
0.19075441360473633,
-0.19538052380084991,
0.08013983815908432,
-0.1926688402891159,
-1.0113813877105713,
0.09658452868461609,
-0.4140862226486206,
0.3971167802810669,
0.03872918710112572,
-0.25774338841438293,
0.27633723616600037,
0.008244761265814304,
-0.3347507417201996,
-0.43122178316116333,
0.0963527262210846,
-0.22028332948684692,
-0.14162085950374603,
-0.604755163192749,
0.20873142778873444,
0.538341760635376,
-0.052906520664691925,
0.048458393663167953,
-0.5182245373725891,
0.27370285987854004,
0.04575690999627113,
-0.35715386271476746,
-0.15250711143016815,
0.3079484701156616,
-0.44558459520339966,
0.7744649052619934,
0.5226749777793884,
0.37102246284484863,
0.20231658220291138,
-0.3756306767463684,
-0.0775875449180603,
0.277261883020401,
-0.3646084666252136,
-0.3332337439060211,
-0.13959935307502747,
-0.4599216878414154,
-0.021890679374337196,
0.30704265832901,
-0.031286466866731644,
0.3908188045024872,
-0.29095953702926636,
-0.3507407605648041,
0.3001515865325928,
0.5735703706741333,
0.4956894814968109,
-0.16151238977909088,
0.02047194540500641,
-0.6010493636131287,
-0.469474732875824,
0.3814347982406616,
0.13885731995105743,
-1.0095572471618652,
0.23473387956619263,
-0.14612674713134766,
0.5282176733016968,
-0.41790536046028137
] |
|
NCT02892474
|
HCR vs. CABG Study
|
The purpose of the study is to find out if hybrid coronary revascularization (HCR) and coronary artery bypass grafting (CABG) procedure outcomes are similar. HCR is a combination of surgery and catheter procedures to open up clogged heart arteries. CABG is a surgical procedure to open up clogged heart arteries.
|
Currently, it is not clear how the outcomes of hybrid coronary revascularization (HCR) compare with other treatments. The purpose of the study is to find out if HCR and coronary artery bypass grafting (CABG) procedure outcomes are similar. HCR is a combination of surgery and catheter procedures to open up clogged heart arteries. CABG is a surgical procedure to open up clogged heart arteries.
This study will collect information about the medical care participants receive during their planned procedure. No new testing or procedures will be done. Participants will have only the tests or procedures already planned by their doctor. The investigators will look at how well participants do after the procedure by assessing the outcomes of interest 30 days after surgery and, potentially, one year after surgery (funding dependent).
|
Inclusion Criteria:
* Able to give informed consent
* Have multi-vessel coronary artery disease (CAD) involving the Left Anterior Descending (LAD) artery
* Have a clinical indication for revascularization
* Are a candidate for either HCR or CABG or both
* Anatomy suitable for HCR shall include
1. Multi-vessel CAD involving the LAD and/or
2. LAD disease and involvement of a major diagonal artery, both of which require revascularization
Exclusion Criteria:
* Prior cardiac operations
* Severe left ventricular dysfunction with ejection fraction (EF) \< 30%
* Patients with chest radiation
* Body mass index (BMI) \> 35
* Severe peripheral vascular disease (PVD)
* Acute ischemia requiring emergent traditional coronary artery bypass graft (CABG)
|
[
1.2905597686767578,
3.1513724327087402,
-0.6003583669662476,
-2.6490378379821777,
-0.3081035614013672,
0.7783180475234985,
0.7793782949447632,
1.3781920671463013,
-2.4594826698303223,
1.6449580192565918,
0.8557180762290955,
0.19643153250217438,
1.821850299835205,
1.6357604265213013,
1.1306546926498413,
2.4689419269561768,
-0.1857435405254364,
1.0039430856704712,
0.8497036695480347,
1.886106252670288,
0.6670283675193787,
0.196873277425766,
-0.8341307640075684,
0.24998585879802704,
0.9805397987365723,
-1.6923127174377441,
2.201080799102783,
-0.40801575779914856,
-1.1505330801010132,
0.7749626040458679,
0.3571821451187134,
-0.37515443563461304,
-1.6303386688232422,
0.5087847113609314,
0.5896176099777222,
-0.35436058044433594,
1.356465458869934,
-1.547770380973816,
-0.14453653991222382,
0.24814119935035706,
0.5697686076164246,
1.4985531568527222,
-0.3809688687324524,
-1.4168446063995361,
1.448762059211731,
0.6068268418312073,
1.0432016849517822,
2.0259125232696533,
1.5439389944076538,
-0.9848107099533081,
-2.086265802383423,
0.27241435647010803,
-0.039158038794994354,
1.0078563690185547,
-0.009719870053231716,
2.534599542617798,
1.1557602882385254,
0.8106208443641663,
1.8828740119934082,
1.8051366806030273,
0.12639892101287842,
-0.7151298522949219,
-0.7684768438339233,
1.0492620468139648,
-2.357210874557495,
0.29426270723342896,
1.27051842212677,
-0.5011695623397827,
-0.7067752480506897,
0.18197976052761078,
1.0915242433547974,
0.7497817873954773,
1.0845742225646973,
1.1597709655761719,
0.644267201423645,
0.6654961109161377,
-1.722525954246521,
1.6238998174667358,
0.07323050498962402,
-1.3888828754425049,
0.06443529576063156,
0.8987332582473755,
-0.7999618649482727,
-0.38955458998680115,
-0.9524405598640442,
-1.6721889972686768,
-0.5331191420555115,
-1.479764699935913,
1.0548501014709473,
-1.7696683406829834,
1.502780556678772,
0.10829801857471466,
-2.130113124847412,
-0.4581166207790375,
0.5775701999664307,
0.7988671064376831,
0.982525110244751,
0.03790043666958809,
-1.5831471681594849,
0.21351562440395355,
-0.6576251983642578,
-0.05261014401912689,
0.48903974890708923,
-0.4546486735343933,
-0.14375226199626923,
-0.23470906913280487,
0.3212718963623047,
-0.3707214593887329,
-1.614033579826355,
-0.35397911071777344,
0.9356392621994019,
-0.5566546320915222,
-0.5061240196228027,
0.0012305791024118662,
-1.2995554208755493,
1.2715842723846436,
0.8440622091293335,
0.2886558473110199,
0.02507895790040493,
-1.4931870698928833,
-0.8976350426673889,
-0.32127004861831665,
0.13651084899902344,
-0.11735047399997711,
-0.740913987159729,
-0.3897301256656647,
-1.3125635385513306,
1.1271171569824219,
-0.021663077175617218,
-0.07660672068595886,
-0.46633848547935486,
0.7486087679862976,
0.3582181930541992,
0.8214195370674133,
-0.7546259164810181,
0.8003118634223938,
-0.16264401376247406,
0.3453618586063385,
-1.0242050886154175,
-0.4973948895931244,
1.3523497581481934,
0.12970846891403198,
0.3462976813316345,
-0.34449076652526855,
-1.4973772764205933,
-0.18853875994682312,
-0.5107118487358093,
1.0742013454437256,
-1.562951922416687,
0.4410994052886963,
0.27475517988204956,
-0.25190025568008423,
0.9678683280944824,
-0.5107347965240479,
0.1611085683107376,
0.7254380583763123,
-0.2890893816947937,
0.6330565810203552,
0.5103803277015686,
-0.3466359078884125,
-0.7103641033172607,
-0.2214900255203247,
-0.10395007580518723,
-0.7402230501174927,
1.1258764266967773,
-0.8733306527137756,
-0.3523157835006714,
-0.04243705794215202,
1.2576688528060913,
0.03189036250114441,
-1.2847062349319458,
0.7907907366752625,
-0.6126022934913635,
0.7154597043991089,
-1.727652668952942,
0.9397889375686646,
-0.04204637184739113,
0.11304296553134918,
-0.45708000659942627,
-0.1125764325261116,
-0.4060641825199127,
0.7283903360366821,
0.26706311106681824,
0.49033433198928833,
-0.6884134411811829,
-1.0306967496871948,
0.7715003490447998,
-0.6469281315803528,
-0.3718022108078003,
1.1180700063705444,
-0.1537555307149887,
0.6816220283508301,
-0.6397041082382202,
-0.11965299397706985,
-0.11782174557447433,
0.4398699104785919,
-0.6642343401908875,
-0.6322003602981567,
0.3600684702396393,
-0.1551891416311264,
0.5847733616828918,
-0.05939441919326782,
-1.1300468444824219,
0.9605019092559814,
0.49730050563812256,
0.5927894115447998,
0.032811302691698074,
0.06709867715835571,
-0.9565905332565308,
-0.15615075826644897,
-0.030894501134753227,
-1.1334233283996582,
-0.5240570306777954,
-0.3817038834095001,
0.5478343963623047,
0.21526440978050232,
0.7764618992805481,
-0.35023313760757446,
-0.6996298432350159,
-0.04525440186262131,
0.3945484161376953,
0.704910397529602,
0.6052913665771484,
-0.28385791182518005,
0.4597437083721161,
-0.11417805403470993,
0.9624608755111694,
-0.030681245028972626,
-0.39233195781707764,
-0.38927745819091797,
-0.1950283944606781,
-0.007334761321544647,
0.4916110634803772,
0.021850116550922394,
-0.8571279048919678,
0.5747687220573425,
-0.012754654511809349,
-0.10704974085092545,
0.6944290399551392,
-0.009707583114504814,
0.0812855213880539,
0.011328556574881077,
0.012666369788348675,
-1.2547211647033691,
0.5303441286087036,
-0.19613812863826752,
-0.3148053288459778,
-0.09961435943841934,
-0.27365124225616455,
-0.2370837777853012,
-0.19239208102226257,
-0.31242430210113525,
0.25841617584228516,
-0.38120266795158386,
-0.1272372007369995,
-0.3578874170780182
] |
NCT02059746
|
Perineal Consequences of Twin Pregnancies According to Mode of Delivery
|
This is an ancillary study to the "JUMODA" (National Prospective and Comparative Study on the Mode of Delivery of Twins) study: please see NCT01987063.
The main objective of this study is to investigate the role of the mode of delivery (vaginal versus cesarean) as a risk factor for the occurrence of urinary incontinence at 3 months post-delivery in primiparous women delivering twins after 34 weeks of pregnancy.
|
The secondary objectives of this study are to compare the following elements between primiparous mothers giving birth to twins vaginally versus by caesarean section after 34 weeks of pregnancy (comparisons will be made at 3 months ant at 12 months post-partum):
A. Diagnosis, type and severity of urinary incontinence via the ICIQ-UI questionnaire
B. Urinary, anorectal and perineal symptoms via the PFDI-20 questionnaire
C. Quality of life related to urinary, anorectal and pelvic floor symptoms via the PFIQ-7 questionnaire
D. Sexuality via the PISQ-12 questionnaire
E. General quality of life via the SF-12 questionnaire
|
Inclusion Criteria:
* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 12 months of follow-up following delivery
* The patient was included in the JUMODA study
* Primiparous
* Birth of 2 live children after 34 weeks of pregnancy
Exclusion Criteria:
* Adult patient under guardianship
* Patient under judicial protection
* It proves impossible to correctly inform the patient
* Birth occurring before 34 weeks of pregnancy
* Birth not resulting in 2 living children
|
[
1.487082600593567,
1.9729435443878174,
-2.6431002616882324,
-1.0297080278396606,
0.3759937882423401,
0.4184034466743469,
0.07726801931858063,
-0.31943151354789734,
-0.4883307218551636,
-0.2837052345275879,
-0.7460871934890747,
0.05777934566140175,
-1.2911189794540405,
0.3105989694595337,
0.8970988988876343,
-0.3597082793712616,
0.23069581389427185,
-0.40227368474006653,
0.7379094362258911,
-0.5760673880577087,
-0.1320972889661789,
-0.12072818726301193,
-0.2062559574842453,
-0.5754117369651794,
1.0005801916122437,
-0.28190720081329346,
-0.5622624754905701,
0.10753635317087173,
-0.4232963025569916,
0.20826856791973114,
0.9540256261825562,
-0.44220268726348877,
0.7142807841300964,
1.6670743227005005,
-0.05201846361160278,
0.6416776180267334,
1.313281536102295,
-0.3959961235523224,
-1.1919846534729004,
0.33992889523506165,
0.21389137208461761,
1.0343409776687622,
0.7102724313735962,
0.7873916029930115,
0.4510781168937683,
0.1896330863237381,
-0.15328925848007202,
-1.245352029800415,
0.10414227843284607,
0.02742098830640316,
-1.5707098245620728,
-0.44524696469306946,
-2.0827226638793945,
-0.6823564767837524,
0.2726499140262604,
1.0560686588287354,
-0.31226617097854614,
1.0678046941757202,
1.4912383556365967,
-1.0520261526107788,
0.700107991695404,
-0.2975846230983734,
1.4001762866973877,
-0.47910234332084656,
-0.3190228044986725,
-0.9919058084487915,
-0.3423672616481781,
0.480953186750412,
-0.5294315814971924,
0.6743199229240417,
0.6238459348678589,
1.2567765712738037,
0.6140809059143066,
-0.8563090562820435,
0.6550594568252563,
-0.1941995471715927,
-1.055904507637024,
0.37083110213279724,
0.400971382856369,
0.5073179602622986,
-0.4769817292690277,
-0.4279400706291199,
-1.0384807586669922,
0.3083854913711548,
-0.14166468381881714,
-0.3222164511680603,
-1.755079746246338,
-0.2258399873971939,
0.7912431955337524,
-1.6547826528549194,
0.16606354713439941,
0.39860913157463074,
-0.4085220694541931,
0.5815483331680298,
-0.16174307465553284,
0.4058319926261902,
0.474077045917511,
-0.867708146572113,
-0.5878366231918335,
-0.18567195534706116,
-0.030430711805820465,
-0.2833326756954193,
-0.5435172319412231,
1.3954830169677734,
-0.35715141892433167,
-0.24904225766658783,
0.1116427630186081,
0.4035998582839966,
-0.12628348171710968,
0.26465287804603577,
-0.01400473341345787,
0.38738763332366943,
0.00023932394105941057,
-0.2679087221622467,
0.4742533266544342,
0.3292911946773529,
-0.0015573309501633048,
0.2502632141113281,
0.25498104095458984,
-0.517477810382843,
0.20749427378177643,
0.5127758979797363,
0.1783672422170639,
1.2751710414886475,
-1.0461132526397705,
-0.5133863687515259,
0.18247631192207336,
0.42070597410202026,
0.23666633665561676,
-0.12231969088315964,
-0.11076673120260239,
0.8056530356407166,
1.1906567811965942,
-0.5098124146461487,
-1.2576197385787964,
-0.5190736651420593,
0.22982117533683777,
-0.17355483770370483,
-0.0004423878563102335,
-1.0078202486038208,
-0.29352039098739624,
0.05606979876756668,
0.17663119733333588,
-0.8554214835166931,
-1.0100102424621582,
-0.41253942251205444,
0.024041125550866127,
0.23033541440963745,
0.2637370228767395,
0.5133011341094971,
-0.5822561979293823,
0.5483534336090088,
1.156982660293579,
0.12489864975214005,
-0.6746962070465088,
-0.17741912603378296,
0.49764493107795715,
-0.07999701797962189,
0.5118212699890137,
0.015459626913070679,
0.5864027142524719,
-0.5181663036346436,
-0.2912669777870178,
0.6746212840080261,
-0.573943018913269,
0.20596443116664886,
-0.3330038785934448,
0.24592432379722595,
-0.5073630213737488,
-0.3628530502319336,
-0.5380182862281799,
-0.3268691301345825,
0.1730467677116394,
0.2896822392940521,
0.03324050083756447,
-0.693274736404419,
0.4742361605167389,
-0.18745724856853485,
-0.7346478700637817,
-0.09208042174577713,
0.22544336318969727,
0.3651784658432007,
0.0740763396024704,
0.6555491089820862,
-0.08092055469751358,
-0.1707533895969391,
0.4469267427921295,
-0.9697307348251343,
-0.27977454662323,
0.6585327982902527,
0.5974864959716797,
-0.48454904556274414,
0.23230046033859253,
0.18958163261413574,
0.2771630585193634,
0.8571667075157166,
-0.11819323897361755,
0.3413600027561188,
0.19590353965759277,
-0.1102357804775238,
0.8456850647926331,
0.4885058104991913,
-0.5655604600906372,
0.993541419506073,
-0.020650038495659828,
0.19148309528827667,
0.14716476202011108,
0.2568409740924835,
0.38818323612213135,
-0.1801508516073227,
0.3581863045692444,
0.28571197390556335,
-0.45940330624580383,
-0.32677000761032104,
0.22899292409420013,
0.37399742007255554,
-0.23537564277648926,
0.21763329207897186,
-0.2711518108844757,
0.6911802291870117,
0.4974597692489624,
0.7171832919120789,
0.3617456555366516,
0.030466360971331596,
0.14582934975624084,
-0.00957314483821392,
-0.19672058522701263,
-0.12558186054229736,
0.17589254677295685,
-0.2972659766674042,
-0.0009934435365721583,
0.05228279531002045,
-0.5457360148429871,
-0.23001828789710999,
-0.0867452546954155,
-0.6321039199829102,
0.3127315938472748,
-0.1522057205438614,
-0.4531790316104889,
0.5323818325996399,
0.3994278311729431,
-0.8273123502731323,
-0.0021111450623720884,
-0.39823997020721436,
-0.32654717564582825,
0.023179613053798676,
-0.33355018496513367,
0.4690592586994171,
-0.33259478211402893,
-0.0784684494137764,
-0.17474126815795898,
0.0226289052516222,
0.34899649024009705,
-0.18161101639270782,
-0.0022773267701268196,
-0.4692554771900177
] |
NCT05531734
|
MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT
|
To develop an easy-to-use measurement tool for monitoring fatigue and alertness, particularly in sleep-deprived subjects.
|
Objective and primary endpoint:
Demonstrate that the NaoX measurement tool detects sleep deprivation in medical residents performing medical shifts.
The primary endpoint is the detection of a significant decrease in Coefficient Alpha Attenuation (CAA) between the pre- and post-sleep deprivation measurements.
The data analysis will be blinded to the measurement.
Secondary endpoints and objectives :
Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by the NaoX measurement tool and the vigilance tests.
Endpoint: significant increase in PVT (Psychomotor Vigilance Task) time associated with a significant decrease in Alpha Attenuation Coefficient (AAC).
Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by the NaoX measurement tool and the state of fatigue experienced.
Endpoint: significant increase in Karolinska Sleepiness Scale (KSS) score associated with a significant decrease in Alpha Attenuation Coefficient (AAC).
Experimental scheme:
3 cycles of 2 recordings with the NaoX measurement tool associated with a self-questionnaire and vigilance tests (approximately 30 minutes per recording), carried out before and after a night shift by a medical resident.
Population targeted:
Medical residents performing night shifts of at least 12 hours.
|
Inclusion Criteria:
* Healthy volunteers.
* Male, female.
* Medical residents.
* Aged between 24 and 34 years.
* Doing emergency, intensive care or "inside" shifts.
* Working in a health institution.
* No history of epilepsy.
* No background treatment that could have an impact on the EEG (electroencephalogram) data (type: benzodiazepines, anti-epileptics).
* No significant change in background treatment during the study, if any.
* Affiliation to the social security system.
* Informed volunteer who has signed a consent form.
Exclusion Criteria:
-
|
[
-3.192279815673828,
2.5285606384277344,
-0.8677529692649841,
-3.549481153488159,
-0.6790030598640442,
-0.19885265827178955,
1.3667207956314087,
0.44610103964805603,
-0.2606419026851654,
-0.12825222313404083,
4.754738807678223,
3.0696287155151367,
-3.209808111190796,
-1.355301022529602,
-0.35141244530677795,
1.5736280679702759,
-0.40220320224761963,
0.2572060227394104,
0.17274266481399536,
-1.5579147338867188,
-0.8442153930664062,
-1.163456678390503,
-0.17873716354370117,
-0.7461689114570618,
1.784988522529602,
1.4486125707626343,
0.19648200273513794,
2.9192187786102295,
0.30639001727104187,
0.9156691431999207,
1.0842441320419312,
-0.8521203994750977,
1.6260799169540405,
0.9281931519508362,
-0.7825074195861816,
-0.16263353824615479,
0.8991119265556335,
0.08715749531984329,
-0.884651243686676,
0.6436748504638672,
0.1804867833852768,
1.1050113439559937,
-1.0181000232696533,
0.05162157118320465,
1.325482726097107,
-1.3956602811813354,
0.38219544291496277,
2.2973315715789795,
-0.442240834236145,
0.8569086194038391,
0.04758501052856445,
0.4278818666934967,
-0.8232495784759521,
-1.1778942346572876,
1.570554256439209,
-1.0991640090942383,
0.7884185314178467,
-2.096346139907837,
0.588162362575531,
0.531890332698822,
1.3774471282958984,
-1.348556637763977,
1.0584405660629272,
1.5321159362792969,
-2.037667751312256,
1.368039608001709,
-0.03173786774277687,
-1.2309573888778687,
0.4738571345806122,
0.8777766227722168,
-0.33499252796173096,
-0.1770389825105667,
-0.8409567475318909,
-0.8905842304229736,
0.2328718900680542,
-1.6414456367492676,
-0.08010715246200562,
1.7576961517333984,
0.37721821665763855,
1.5027718544006348,
-0.5093929767608643,
-0.0031122334767132998,
-0.07602710276842117,
0.24216116964817047,
0.7092730402946472,
0.4189451038837433,
0.17613649368286133,
0.09572616964578629,
1.3097513914108276,
-0.3090038299560547,
-0.08653482049703598,
0.9658885598182678,
0.40184637904167175,
-0.06810333579778671,
-0.6567108035087585,
1.550848364830017,
0.7015140652656555,
-0.052879076451063156,
-1.6971502304077148,
-0.7817699909210205,
0.37709665298461914,
-1.1267651319503784,
-0.18033915758132935,
0.1773388534784317,
0.37886881828308105,
-0.5103707909584045,
-0.41567036509513855,
0.8584606647491455,
0.11451733857393265,
1.9182499647140503,
-0.03343430534005165,
-0.2930619418621063,
-0.4992433488368988,
-1.4092044830322266,
-0.0710463747382164,
0.8319099545478821,
1.0898603200912476,
1.0765732526779175,
0.4880882501602173,
0.007321098353713751,
0.5708183646202087,
0.3310409486293793,
-0.022555170580744743,
0.005273694172501564,
0.7690160870552063,
-1.4246994256973267,
0.44105103611946106,
-0.6734726428985596,
-0.9866445064544678,
-1.642066478729248,
-1.1804295778274536,
-0.5169733166694641,
-0.07781277596950531,
-2.06709885597229,
-0.3338037431240082,
-0.21601076424121857,
-0.6683833003044128,
-0.6086891293525696,
-0.5220245718955994,
0.9542117118835449,
-0.2535584270954132,
1.6096649169921875,
-1.0364023447036743,
0.4515342712402344,
-0.6670539975166321,
-0.028611114248633385,
-0.17254813015460968,
-1.2045339345932007,
0.5447248816490173,
-1.161021113395691,
-0.4751909077167511,
0.7610124945640564,
0.041592128574848175,
-0.17951731383800507,
0.6338949203491211,
-0.7256221175193787,
0.2880493104457855,
0.27486053109169006,
0.7697027325630188,
-0.3147515654563904,
-0.014012448489665985,
-0.31888529658317566,
-0.8231814503669739,
0.2930828630924225,
-0.3041618764400482,
0.15299618244171143,
1.2303210496902466,
-0.6075332760810852,
-0.2880268096923828,
0.17134492099285126,
-0.291294664144516,
-0.040510136634111404,
0.24655117094516754,
0.06650158762931824,
-0.5503160953521729,
0.6855781078338623,
-0.6403924822807312,
0.9824534058570862,
0.6690537333488464,
0.06416968256235123,
0.029689671471714973,
0.6710841655731201,
0.26696518063545227,
-0.2661915719509125,
-0.5680088996887207,
-0.909568727016449,
0.21210138499736786,
0.12426543980836868,
0.6840892434120178,
0.16584475338459015,
-0.22240681946277618,
1.3027231693267822,
0.016369851306080818,
-0.15311263501644135,
-1.1250804662704468,
-0.6735754609107971,
-0.05890743061900139,
-1.0375922918319702,
-0.0329241044819355,
0.004723896738141775,
0.24452273547649384,
0.05505836009979248,
-0.39144623279571533,
-0.3283913731575012,
0.28491297364234924,
0.11932235211133957,
-0.19151157140731812,
-0.3523217737674713,
1.0166643857955933,
-0.666401743888855,
0.7532897591590881,
0.5566859841346741,
-0.4474155902862549,
-0.07845164090394974,
0.26030370593070984,
-0.4842539131641388,
0.02694098837673664,
-0.3903292715549469,
-0.15918870270252228,
-0.4465114176273346,
-0.27970317006111145,
-0.13950777053833008,
0.0807332769036293,
-0.033110361546278,
0.45072707533836365,
0.4054461717605591,
-0.10635074973106384,
0.32603031396865845,
-0.40052127838134766,
0.3393315076828003,
-0.7861053347587585,
0.5542323589324951,
-0.4909992218017578,
-0.6024337410926819,
-0.6291906237602234,
-0.15956084430217743,
-0.28225260972976685,
0.39839625358581543,
-0.09416431933641434,
0.5234740376472473,
-0.6075461506843567,
0.1449679285287857,
0.35982075333595276,
-0.02146225981414318,
0.6135470271110535,
0.25111329555511475,
1.212457537651062,
-0.48819848895072937,
0.19236598908901215,
0.4511053264141083,
0.13036637008190155,
-0.45810404419898987,
0.10196223855018616,
0.31945928931236267,
0.08363336324691772,
-0.5487604737281799
] |
NCT02364219
|
Impact of Prewarming on Perioperative Body Core Temperature and the Outcomes of Cytoreductive- and Major Open Abdominal Surgery: A Randomised Trial
|
The primary purpose of this study is to determine whether a prewarming period of at least 30 minutes during induction of general and combined epidural anesthesia reduces the core temperature drop normally occuring in patients undergoing cyto-reductive and major abdominal surgery. In addition the effect of prewarming on intra and postoperative body core temperature will be evaluated.
|
Inclusion Criteria:
* age \> 18
* elective cytoreductive or major abdominal surgery caused by ovarian cancer, primarily or secondary
Exclusion Criteria:
* age \< 18
* refusal participate in study
* pregnant or breast-feeding women
* cardiac ejection fraction \< 30%
* terminal renal insufficiency requiring dialysis
* severe pulmonary disease (Gina-Classification\< 3)
* neurological and/or psychiatric disease
* patient is placed in an institution due to court order
* lack of language skills/understanding
* employee of Charité Berlin
* alcohol addiction
* refusal of epidural anesthesia or failure to insert epidural catheter
* participation in other perioperative, invasive studies which prohibit further study inclusion
|
[
-0.7523747682571411,
3.714989423751831,
-2.828036069869995,
-3.2751808166503906,
0.33420130610466003,
0.3706877827644348,
0.4009014666080475,
-0.22631019353866577,
-1.5795798301696777,
1.4093414545059204,
0.8130620718002319,
2.344130516052246,
0.053385015577077866,
1.7398020029067993,
-0.6012502908706665,
0.281595379114151,
-0.5193232297897339,
-0.9706080555915833,
0.5034710168838501,
-0.3754245340824127,
-1.1565097570419312,
-0.5677299499511719,
-0.44477927684783936,
-0.7089560031890869,
1.5965807437896729,
-0.5200319290161133,
-0.7325931787490845,
-1.0221707820892334,
0.5476604700088501,
0.13432680070400238,
0.4126003682613373,
0.1856744885444641,
-0.7712548971176147,
1.2750979661941528,
-1.1714626550674438,
0.19975094497203827,
0.3714655339717865,
0.010485787875950336,
-0.9205920100212097,
-0.6152072548866272,
1.4276864528656006,
0.5486133694648743,
-0.07151530683040619,
-0.4278026819229126,
0.7117292284965515,
0.5498712062835693,
-0.7430628538131714,
-0.2689693868160248,
-0.049269311130046844,
-0.5907790660858154,
-0.802625834941864,
0.7209585309028625,
-1.7330517768859863,
-0.4442192316055298,
1.1177318096160889,
0.20235513150691986,
0.6895442008972168,
-0.8526080250740051,
1.443540334701538,
-0.7948552966117859,
0.274288535118103,
0.3706320822238922,
0.39118891954421997,
-0.19230404496192932,
-0.6190740466117859,
-2.0704185962677,
0.44183865189552307,
-0.6393057703971863,
0.45144858956336975,
0.5713688135147095,
1.2471240758895874,
0.3202805519104004,
1.1197295188903809,
-0.34202203154563904,
0.7697538137435913,
0.8605494499206543,
-0.43004345893859863,
0.1463852971792221,
0.4276331961154938,
0.5662015676498413,
-0.3397906422615051,
0.4177085757255554,
-0.16855211555957794,
0.28117433190345764,
0.6011796593666077,
0.04531702771782875,
-0.986757218837738,
-0.5524314045906067,
1.167054533958435,
-0.1403878629207611,
-0.5636240839958191,
-0.016041681170463562,
-1.7544025182724,
0.21438437700271606,
-0.782060444355011,
0.2633175849914551,
0.19730305671691895,
-0.1992396116256714,
-0.919738233089447,
0.2332451045513153,
0.2194197177886963,
-0.039941780269145966,
-0.20609965920448303,
0.11826430261135101,
-0.22843603789806366,
-0.12147048860788345,
-0.10725127160549164,
-0.514948844909668,
-1.2588987350463867,
-0.6775521636009216,
0.9846067428588867,
-1.3524506092071533,
0.23748451471328735,
-0.9878994822502136,
-0.2051256000995636,
0.6785936951637268,
-0.03143240883946419,
0.10285861790180206,
0.8636186718940735,
-1.4592235088348389,
-0.14462535083293915,
0.32447686791419983,
0.38201791048049927,
0.48302608728408813,
0.1050172746181488,
0.3771391808986664,
-0.36484336853027344,
1.4134119749069214,
-0.04303654655814171,
0.20551949739456177,
-0.628259003162384,
1.3447853326797485,
1.0113599300384521,
-1.2852122783660889,
-1.55765962600708,
-0.333932489156723,
0.07137754559516907,
-0.0330704003572464,
0.4844242334365845,
0.15916834771633148,
0.400327205657959,
0.025148119777441025,
-0.15910238027572632,
-0.6020457744598389,
-1.7044776678085327,
0.1754893809556961,
-0.6863180994987488,
0.13213813304901123,
-0.9290449023246765,
0.10238247364759445,
0.2875899374485016,
0.5560268759727478,
0.9547794461250305,
0.0555502325296402,
0.7258933186531067,
-0.7363786697387695,
0.10803721100091934,
0.6042696237564087,
0.08750297874212265,
-0.02097930759191513,
-0.24221548438072205,
-0.20235365629196167,
0.10422316193580627,
-0.8130171895027161,
0.23217956721782684,
-0.8838952779769897,
-0.6009189486503601,
0.5115957260131836,
0.8265001773834229,
-0.0245561134070158,
-0.9556941390037537,
0.9557811617851257,
1.049696683883667,
0.3802317976951599,
-0.7898916602134705,
-0.33974260091781616,
0.0519091822206974,
0.218545600771904,
0.3941844701766968,
-0.13387560844421387,
0.7688145041465759,
-0.18568797409534454,
-0.156728595495224,
0.012388247065246105,
0.2526722848415375,
-0.317658007144928,
-0.2627314627170563,
-0.1969827115535736,
-0.3938380181789398,
0.1311359405517578,
0.18962931632995605,
0.30689695477485657,
-0.4826265275478363,
-0.01616903394460678,
-0.15291644632816315,
0.3213883340358734,
-0.38808315992355347,
-0.7063700556755066,
0.8484333753585815,
0.2715810239315033,
0.2435636967420578,
0.2972855567932129,
-0.5755152106285095,
0.6880232691764832,
-0.18871401250362396,
-0.14513972401618958,
-0.6184598803520203,
0.7832435965538025,
0.1527794450521469,
-0.03419100493192673,
-0.4980451166629791,
0.44665098190307617,
-0.4190424084663391,
0.6429176330566406,
0.01465331856161356,
0.047007616609334946,
-0.18343614041805267,
-0.3491690158843994,
-1.0109593868255615,
-0.12931285798549652,
0.28236624598503113,
0.5627138018608093,
-0.05427628010511398,
0.6697247624397278,
-0.10948788374662399,
-0.8362590074539185,
0.4767687916755676,
0.22935588657855988,
0.1571512669324875,
0.25934898853302,
-0.08606864511966705,
0.4439231753349304,
-0.4182303845882416,
0.11925305426120758,
0.36236485838890076,
0.254386842250824,
0.8553017973899841,
-0.10795469582080841,
0.3616776466369629,
-0.0432792492210865,
-0.41757670044898987,
-0.6496254205703735,
0.1774672120809555,
-0.046916231513023376,
0.11431696265935898,
0.4796904921531677,
0.20558911561965942,
0.030786192044615746,
0.06691968441009521,
0.03436458855867386,
0.40343695878982544,
-0.2690867483615875,
-0.6076421737670898,
-0.2087746113538742,
0.24850326776504517,
-0.40089017152786255
] |
|
NCT02389309
|
Dasatinib, Temsirolimus, and Cyclophosphamide in Treating Patients With Advanced, Recurrent, or Refractory Solid Tumors
|
This phase I trial studies the side effects and best dose of dasatinib and temsirolimus when given together with cyclophosphamide in treating patients with solid tumors that have spread to other places in the body, have come back, or have not respond to previous treatment. Dasatinib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, 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. Giving dasatinib and temsirolimus together with cyclophosphamide may be a better treatment for advanced solid tumors.
|
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of combination treatment with dasatinib, cyclophosphamide and temsirolimus.
II. To define and describe the toxicities of the combination of dasatinib, cyclophosphamide and temsirolimus administered on this schedule.
SECONDARY OBJECTIVES:
I. To preliminarily define the antitumor activity of the combination of dasatinib, cyclophosphamide and temsirolimus within the confines of a phase 1 study.
II. Preliminary assessment of biological markers and correlates of response.
OUTLINE: This is a dose-escalation study of dasatinib and temsirolimus.
Patients receive dasatinib orally (PO) twice daily (BID) on days 1-21, cyclophosphamide PO once daily (QD) on days 1-21, and temsirolimus intravenously (IV) over 30-60 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing stable disease or better may continue treatment with the approval of the study chair.
After completion of study treatment, patients are followed up for 4 weeks.
|
Inclusion Criteria:
* Patients must be \>/= 12 months and \< 21 years of age at the time of study enrollment.
* Patients must have had a previous histological verification of a solid tumor at the original diagnosis and/or recurrence including brain tumors; for patients with brain stem gliomas and optic pathway tumors, the requirement for histological evaluation may be waived; the patient's disease must be considered refractory to conventional/standard therapy, or a disease for which no conventional therapy exists and is progressive
* The patient must have a stable clinical (neurologic in case of brain tumors) exam and be on a stable dose of steroids for at least 1 week prior to study entry; the patient should have a measurable and/or evaluable disease; measurable disease which is defined as the presence of at least one lesion that can be accurately measured in two dimensions (each measures at least 10 mm) or evaluable disease which is defined as at least one lesion that can be accurately measured in at least one dimension (measure at least 10 mm)
* Karnofsky performance status \>= 50 for patients \>= 16 years of age and a Lansky performance status \>= 50 for patients aged \< 16 years
* Life expectancy: must be \>= 12 weeks
* Chemotherapy:
* Must not have received myelosuppressive chemotherapy within 3 weeks of the study entry (6 weeks if prior nitrosourea); prior treatment with either dasatinib or temsirolimus but not both is allowed; at least 3 weeks must have elapsed from the last dose
* Biologic therapy (anti-neoplastic)
* Must not have received oral tyrosine kinase inhibitors (other than dasatinib) or other similar agents within 3 weeks of the study entry and all toxicities must have resolved to \< grade 2 prior to enrollment
* Must not have received bevacizumab or other monoclonal antibody therapy within 4 weeks of study the entry
* Radiotherapy (XRT): at least 4 weeks for focal XRT or 8 weeks for craniospinal XRT must have elapsed prior to study entry
* Stem cell transplant (SCT): at least 8 weeks following autologous SCT and 12 weeks for allogeneic SCT
* Surgery: at least 2 weeks following surgery including brain and spine provided post-operative magnetic resonance imaging (MRI) shows no active bleeding
* Concomitant medications: the following drugs need to be stopped at the time of beginning therapy: patient cannot be on liver enzyme inducing anticonvulsants; patients must not have received growth factors to support the number or function of white cells or platelets within the past 7 days and pegfilgrastim within the past 14 days; patients must not be receiving any anti-thrombotic or anti-platelet agents; patient cannot be on drugs that cause significant prolonged QT (category I drug)
* Absolute neutrophil count (ANC) greater than or equal to 1000/mm\^3
* Platelets greater than or equal to 75,000/mm\^3 (transfusion independent; no transfusion for \>= 7 days prior to study enrollment)
* Hemoglobin greater than 8.0 g/dL (transfusion independent; no transfusion for \>= 7 days prior to study enrollment)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x upper limit of normal for age (ULN)
* Bilirubin =\< 1.5 x ULN
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \> 70 ml/min/1.73 m\^2 OR serum creatinine based on age/gender as follows:
* Age 1 to \< 2 years, 0.6 mg/dL (male) and 0.6 mg/dL (female)
* Age \> 2 and \< 6 years, 0.8 mg/dL(male) and 0.8 mg/dL (female)
* Age \> 6 and \< 10 years, 1.0 mg/dL (male) and 1.0 mg/dL (female)
* Age \> 10 and \< 13 years, 1.2 mg/dL (male) and 1.2 mg/dL (female)
* Age \> 13 and \< 16 years, 1.5 mg/dL (male) and 1.4 mg/dL (female)
* Age \> 16 years, 1.7 mg/dL (male) and 1.4 mg/dL (female)
* All post-menarchal females must have a negative serum beta-human chorionic gonadotropin (beta HCG); sexually active patients of childbearing potential must agree to use an effective method of contraception during the study and for at least 6 months after
* Adequate pulmonary function as defined as: no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination
* Adequate cardiac function defined as: normal 12 lead electrocardiogram (EKG) with corrected QT interval (QTc) \< 450 msec, and either shortening fraction of \>= 28% by echocardiogram and qualitatively normal left ventricular function, or ejection fraction of \>= 55% by echocardiogram
* Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and well controlled
* Serum cholesterol and serum triglyceride levels must be \< grade 2
* A written informed consent MUST be obtained from the patients and/or their parents/legal guardians prior to enrollment indicating their awareness of investigational nature of this study
Exclusion Criteria:
* Patients with evidence of recent intratumoral hemorrhage (within 3 months of study enrollment), gastrointestinal bleeding, history of coronary artery disease or on anticoagulation therapy
* Pregnant or breast-feeding women will not be entered on this study
* Uncontrolled current illness including, but not limited to, uncontrolled infection, need for hemodialysis, need for ventilatory support, psychiatric illness/social situations that would limit compliance with study requirements
* History of hypersensitivity to any component of the formulation
* Patients with known human immunodeficiency virus (HIV) are ineligible for this study
* Patients must not have received prior therapy with dasatinib and temsirolimus for any indication
* Patients with clinically significant cardiovascular disease: history of ischemic or hemorrhagic stroke within past 6 months; uncontrolled hypertension, on at least 2 repeated determinations on separate days within past 3 months; myocardial infarction or unstable angina within past 6 months; New York Heart Association grade III or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris within past 6 months; clinically significant peripheral vascular disease within past 6 months; pulmonary embolism, deep vein thrombosis (DVT), or other thromboembolic event within past 6 months; diagnosed congenital long QT syndrome; any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes); prolonged QTc interval on pre-entry electrocardiogram (\> 450 msec); subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration
* Anticonvulsants: patients on enzyme inducing anticonvulsants (EIAED) will be excluded; if patients were previously on EIAEDs that have been discontinued, patients must have been off EIAEDs for \>= 2 weeks prior to initiation of dasatinib
* Anticoagulants/anti-platelets: patients on therapeutic (treatment) dose of anticoagulants (e.g. warfarin, low molecular-weight heparin) are not eligible; patients are not allowed to take aspirin, clopidogrel, ticlopidine, Aggrenox; patients on prophylactic anticoagulation may be enrolled and treated on study as long as their platelet count is monitored closely and maintained at \> 75,000 while they are receiving dasatinib
* Inducers and Inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4): patients required to be on any CYP3A4/5 inhibitors or inducers will be excluded (with the exception of dexamethasone, but all efforts should be made to reduce the dose of dexamethasone); patients must discontinue drug at least 7 days prior to starting dasatinib
* Angiotensin-converting enzyme (ACE) inhibitors: patients who are currently receiving ACE inhibitors are not eligible
* Anti-graft-versus-host disease (GVHD) or agents to prevent organ rejection post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial
* Category I drugs that are generally accepted to have a risk of causing torsades de pointes including: (patients must discontinue drug at least 7 days prior to starting dasatinib)
* Quinidine, procainamide, disopyramide
* Amiodarone, sotalol, ibutilide, dofetilide
* Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
* Cisapride, bepridil, droperidol, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, sparfloxacin, lidoflazine
* Other drugs permitted but use with caution include; drugs are not recommended but can be used with caution
* Antacids: use of H2 blockers and proton pump inhibitors is not recommended; patients who require antacids should use short acting, locally active agents (e.g., Maalox, Mylanta etc.); however, these agents should not be taken within either 2 hours before or 2 hours after the dasatinib dose
* Drugs prolong QT interval; erythromycin, clarithromycin, pentamidine, ondansetron, granisetron, and methadone
|
[
1.2539921998977661,
0.6086565256118774,
-1.3947080373764038,
-2.4047412872314453,
0.1298019289970398,
-1.410225749015808,
0.46630528569221497,
-0.5021944046020508,
-0.9106953144073486,
-0.30642324686050415,
-0.659569501876831,
1.5665407180786133,
-0.23799490928649902,
-0.4400566518306732,
1.5576071739196777,
1.3328135013580322,
-1.0579540729522705,
1.167919397354126,
1.3828734159469604,
-1.137510061264038,
2.633730173110962,
-0.27521812915802,
-0.10602530092000961,
-0.1861233115196228,
1.0931733846664429,
-2.0910747051239014,
-0.445654034614563,
1.908945918083191,
1.792503833770752,
0.6986965537071228,
-1.2968744039535522,
-0.03048115037381649,
-0.33479005098342896,
-0.03818679228425026,
-0.03592566028237343,
0.45918768644332886,
1.349325180053711,
1.0504320859909058,
0.34299296140670776,
0.47947144508361816,
0.014440344646573067,
-0.4140933156013489,
-0.7663046717643738,
-0.5324073433876038,
-1.3041291236877441,
0.5422869324684143,
0.007296945434063673,
0.8382253646850586,
1.403718113899231,
1.5487067699432373,
-0.9478007555007935,
1.780304193496704,
-0.7927855253219604,
0.3503574728965759,
2.542175054550171,
-0.19460538029670715,
-0.6446430683135986,
0.4778163731098175,
0.6895829439163208,
-0.1481257826089859,
0.09960104525089264,
0.6979176998138428,
-1.028777837753296,
0.7706267833709717,
-0.3902723789215088,
-0.32394272089004517,
0.5858148336410522,
-1.029405117034912,
-0.7545157670974731,
0.9886837601661682,
0.8367487788200378,
-0.19655220210552216,
0.9692174792289734,
-0.11350102722644806,
-0.02383538708090782,
0.02858227863907814,
-0.1796596199274063,
0.8933121562004089,
0.30804264545440674,
0.46500229835510254,
-0.02579401060938835,
0.013111296109855175,
0.5379374027252197,
0.221145361661911,
-1.6214442253112793,
-0.4812060296535492,
0.15997670590877533,
-0.30076372623443604,
0.11554291844367981,
-1.658775806427002,
0.9616253972053528,
-0.3534008860588074,
-0.5644733309745789,
1.7626296281814575,
-1.0774977207183838,
-0.07997052371501923,
-0.10060980916023254,
0.5037909746170044,
0.10559685528278351,
0.11851613223552704,
0.6397769451141357,
0.44322440028190613,
-0.7693420648574829,
-0.32409733533859253,
-0.9302201867103577,
-0.2177513688802719,
-0.3018546998500824,
-1.8852314949035645,
-0.1970084011554718,
-1.5178827047348022,
0.4041469395160675,
-1.0413403511047363,
-0.24817050993442535,
0.426405131816864,
0.2457207441329956,
-0.14561346173286438,
1.0528632402420044,
-0.9252827763557434,
0.2875180244445801,
0.06179376691579819,
-0.36411917209625244,
0.4322587549686432,
-0.8621313571929932,
0.7334896326065063,
0.8336191177368164,
-0.15965282917022705,
-0.3223155736923218,
0.05634133890271187,
0.4816626310348511,
-1.0739742517471313,
-0.1273615062236786,
0.6463514566421509,
0.47893232107162476,
0.1569596379995346,
-0.9584380388259888,
-0.953517496585846,
1.033873200416565,
1.453460931777954,
1.5016378164291382,
-0.15995225310325623,
-0.022794198244810104,
0.11490856856107712,
0.6756204962730408,
-0.38852372765541077,
-1.1458683013916016,
0.5591128468513489,
0.3385074734687805,
0.7777448892593384,
0.1569962352514267,
-0.0400814488530159,
0.2971581518650055,
0.17188185453414917,
-0.19105322659015656,
0.3880564272403717,
0.5933888554573059,
0.6835197806358337,
-0.28047072887420654,
-0.8341056108474731,
-0.20334550738334656,
-0.5354217886924744,
-0.9507997035980225,
-0.06467340886592865,
0.13931651413440704,
-0.007389590609818697,
0.5600122809410095,
-0.7082710862159729,
-0.5394238829612732,
-0.2149464339017868,
0.1151108667254448,
0.08499988913536072,
-0.6122937202453613,
-0.35497018694877625,
-0.03377377986907959,
0.7874247431755066,
-0.4502163827419281,
-0.9124497771263123,
0.5592295527458191,
-0.11301460862159729,
0.24124570190906525,
-0.718713104724884,
-0.3431016802787781,
-0.011357881128787994,
0.8805599808692932,
-0.9125054478645325,
-0.00745179271325469,
-0.1473769098520279,
0.08570721000432968,
0.6104820966720581,
0.38774508237838745,
0.6448665857315063,
0.7841138243675232,
-0.15822936594486237,
0.04078753665089607,
0.6539145112037659,
0.6650288701057434,
-0.15888075530529022,
0.49619826674461365,
-0.5223347544670105,
1.0950884819030762,
-0.33025726675987244,
0.18662793934345245,
0.5395435094833374,
0.12009831517934799,
0.113448366522789,
0.009334255941212177,
-0.18819735944271088,
0.5413500666618347,
0.20478983223438263,
0.07749063521623611,
0.2562439441680908,
-0.16407278180122375,
-0.06925471127033234,
0.29329073429107666,
0.11514335870742798,
-0.0029600642155855894,
0.13081131875514984,
-0.33690130710601807,
-0.06489116698503494,
-0.44753581285476685,
-0.056540943682193756,
-0.0909183919429779,
-0.00822816975414753,
-0.05721273273229599,
0.46000128984451294,
0.37193045020103455,
0.5395448803901672,
0.2945646643638611,
-0.10883903503417969,
0.2296375334262848,
0.2641480565071106,
-0.6044747829437256,
-0.10619277507066727,
0.03366456553339958,
-0.6712951064109802,
-0.2755516767501831,
-0.431919127702713,
-0.25371912121772766,
-0.29863283038139343,
0.20855452120304108,
0.35331887006759644,
0.14419491589069366,
0.5477885007858276,
-0.32461339235305786,
-0.3415908217430115,
-0.2823217213153839,
-0.6201277375221252,
0.15293265879154205,
-0.16184785962104797,
-0.12262226641178131,
0.02647555246949196,
0.22139543294906616,
-0.16122809052467346,
0.019601017236709595,
0.30295413732528687,
-0.37072083353996277,
-0.6743170619010925
] |
NCT06470048
|
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
|
The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo
|
The study consists of the following periods:
* Screening Period, with a duration of up to 6 weeks;
* Treatment Period 1, with a duration of 52 weeks;
* Treatment Period 2 (Open-label treatment), with a duration of 52 weeks;
* Post-treatment Follow-up Period, with a duration of at least 20 weeks post last dose and up to 2 years.
|
Key Inclusion Criteria:
* Male and female participants \>= 18 and =\< 70 years (at the time of the screening visit).
* Diagnosis of systemic sclerosis, as defined by the 2013 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) classification criteria for SSc (van den Hoogen et al 2013) and meet the dcSSc subset classification according to LeRoy (LeRoy 1988)
* Disease duration of =\< 60 months (defined as time from the first non-Raynaud phenomenon manifestation, e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea)
* mRSS units of \>= 15 and =\< 45 at the time of the screening visit
* Active disease that meets at least one of the following criteria at screening:
* Disease duration of =\< 18 months defined as time from the first non-Raynaud phenomenon manifestation
* Increase in mRSS of \>= 3 units compared with the most recent assessment performed within the previous 6 months
* Involvement of one new body area and an increase in mRSS of \>= 2 units compared with the most recent assessment performed within the previous 6 months
* Involvement of two new body areas within the previous 6 months
* Elevated acute phase reactants (ESR) \>= 30 mm/hr or high-sensitivity C-reactive protein (hsCRP) \>= 6 mg/dL)
* Presence of interstitial lung disease (ILD) and ATA autoantibody positivity
* Modified EUSTAR disease activity index (mDAI) \> 2.5
* Participant must be positive for at least one of the following autoantibodies:
* anti-topoisomerase I (ATA) (also known as anti-SCL-70)
* anti-RNA polymerase III (anti-RNAP3)
* anti-nuclear antibody (ANA) (≥ 1:80) Participants who are positive only for ANA (while being negative for both ATA /anti-RNAP3) will be limited to 30% of the overall randomized study population.
Key Exclusion Criteria:
* Rheumatic disease other than dcSSc, including limited cutaneous disease (lcSSc) or sine scleroderma at the screening visit. Secondary Sjogren's disease and scleroderma myopathy are not exclusionary.
* Positive anti-centromere antibody (ACA+) without positive ATA or anti-RNAP3 autoantibody result at the screening visit
* Previous improvement (decrease) in mRSS \> 10 units
* Pulmonary disease with FVC ≤ 50% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO, corrected for hemoglobin) ≤ 40% of predicted at the screening visit
* WHO Functional Class 3 or higher assessment for pulmonary arterial hypertension (PAH, as defined on right heart catheterization), receiving IV therapy for PAH or evidence of other moderately severe pulmonary disease
* Participants treated with cyclophosphamide within 12 weeks prior to Baseline.
* Prior use of a B-cell depleting therapy other than ianalumab (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) administered within 36 weeks prior to randomization, or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower)
* Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 12 weeks or 5 half-lives (whichever is longer) prior to baseline visit, unless explicitly allowed in inclusion criteria
* Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit
* Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone, or tyrosine kinase inhibitors (e.g., nintedanib, nilotinib, imatinib, dasatinib) in the 4 weeks prior to baseline visit.
* Previous treatment with chlorambucil, bone marrow transplantation or total lymphoid irradiation.
Other protocol-defined inclusion/exclusion criteria may apply.
|
[
-0.10875022411346436,
2.586895704269409,
-2.5985465049743652,
-2.615044116973877,
-0.08668029308319092,
-0.013200857676565647,
-0.9921769499778748,
0.10608343034982681,
0.4056687355041504,
0.07374266535043716,
-0.2022084891796112,
2.5103089809417725,
-2.0634453296661377,
-0.07191236317157745,
0.5454944968223572,
2.035327911376953,
-0.3233237862586975,
1.1891897916793823,
1.8396332263946533,
-2.049058437347412,
0.32605645060539246,
-0.9048792719841003,
0.8246821761131287,
0.6078568696975708,
2.5169687271118164,
0.33277076482772827,
0.6186246275901794,
-0.26193636655807495,
0.3045213520526886,
0.8589861989021301,
0.35696646571159363,
-0.7929829359054565,
0.4706772565841675,
2.089416742324829,
0.3264457881450653,
0.21664193272590637,
-0.8316202163696289,
0.6180082559585571,
-1.6664538383483887,
-0.4244277775287628,
-0.2920229136943817,
0.2793334722518921,
-0.9643880128860474,
1.3726106882095337,
0.33932918310165405,
-0.08035794645547867,
-0.16398011147975922,
0.5406914949417114,
-1.149827003479004,
-0.19103620946407318,
0.6979106664657593,
1.972341537475586,
0.02647283673286438,
0.4285123348236084,
0.8629034757614136,
-0.2598330080509186,
1.7524077892303467,
-0.09630569070577621,
1.2366008758544922,
0.17113760113716125,
0.806209146976471,
-0.09368713945150375,
0.4345606863498688,
-0.6002355813980103,
-0.12667272984981537,
0.014034809544682503,
-0.20034894347190857,
0.42387855052948,
-1.1556144952774048,
0.6988781690597534,
-0.0537986159324646,
0.08970003575086594,
0.5652763247489929,
0.009327729232609272,
-0.5187410712242126,
1.4306755065917969,
0.4712369441986084,
0.4366619288921356,
0.2303394377231598,
1.2559436559677124,
0.2789272367954254,
-0.4755135476589203,
-1.5074259042739868,
-0.5382161736488342,
-0.0817757323384285,
-1.269145131111145,
-0.0976477563381195,
-0.7475432753562927,
1.7833685874938965,
0.8537007570266724,
0.42464515566825867,
-0.2552049458026886,
-1.3778355121612549,
0.47636696696281433,
-0.27066242694854736,
-0.39091435074806213,
-0.39780059456825256,
0.08712076395750046,
-0.7660605311393738,
-0.07597941905260086,
0.16185200214385986,
-0.7581363916397095,
0.048000480979681015,
-0.26497358083724976,
-0.06809886544942856,
0.639712393283844,
-0.6500635743141174,
-0.16688214242458344,
-0.936936616897583,
-1.9611932039260864,
0.5009561777114868,
-1.0194498300552368,
-0.1099562793970108,
-0.33017289638519287,
0.7800410389900208,
0.643742561340332,
0.7121883630752563,
0.3149392902851105,
-0.11599952727556229,
-0.29423442482948303,
-0.8815929889678955,
1.3001081943511963,
0.32243040204048157,
0.6161466836929321,
-0.04741240665316582,
0.6536500453948975,
-0.31595873832702637,
1.2357829809188843,
-1.009541630744934,
-1.2578991651535034,
-1.251980185508728,
0.6857011318206787,
0.8368427753448486,
0.5414107441902161,
-1.870798945426941,
0.38125601410865784,
0.24452270567417145,
0.823672354221344,
0.34022781252861023,
-1.6541763544082642,
-0.3659464120864868,
1.1095733642578125,
-0.5287067294120789,
0.22774659097194672,
-2.182030439376831,
0.9452782869338989,
-0.86842280626297,
0.7509838938713074,
-0.21815507113933563,
-0.7316908240318298,
0.20247964560985565,
0.1898009479045868,
-0.20815856754779816,
0.1758861541748047,
-0.5137438178062439,
0.384902685880661,
0.7811850309371948,
-0.7367560267448425,
0.9755771160125732,
0.025889066979289055,
-0.04340295493602753,
-0.8084036707878113,
0.04983792081475258,
-0.48976945877075195,
0.2957709729671478,
0.001074020634405315,
-0.10434360057115555,
0.21518291532993317,
-0.05158616229891777,
0.4916805326938629,
-1.1179519891738892,
0.5393533706665039,
-0.5186868906021118,
-0.3620014786720276,
-0.26899468898773193,
0.41078606247901917,
-0.006527370307594538,
-0.6908385157585144,
-0.6070972681045532,
0.13529609143733978,
0.16184605658054352,
1.0910863876342773,
0.33280837535858154,
0.2947888672351837,
-0.6983453035354614,
-0.43787476420402527,
-0.27939939498901367,
-0.1627911776304245,
0.663029670715332,
0.6699889898300171,
-0.27477407455444336,
0.19933533668518066,
0.5859986543655396,
-0.16080375015735626,
-0.1467742919921875,
-0.9054882526397705,
0.36350563168525696,
-1.0917154550552368,
0.37577444314956665,
-0.36359795928001404,
-0.24095992743968964,
0.6444735527038574,
-0.3949858248233795,
0.35795295238494873,
-0.034702546894550323,
-0.009978165850043297,
-0.3022315800189972,
0.05181020870804787,
0.34699711203575134,
-0.1409117877483368,
-0.21284694969654083,
-0.7375010251998901,
-0.014411911368370056,
0.3362743556499481,
0.37329164147377014,
-0.27101993560791016,
-0.34848758578300476,
0.02523273043334484,
-0.24788910150527954,
0.0932624414563179,
-0.26013725996017456,
-0.1541062444448471,
0.0788411945104599,
0.12582813203334808,
-0.05391675978899002,
0.12616120278835297,
-0.11873937398195267,
-0.2592625916004181,
-0.3188072443008423,
0.19669966399669647,
-0.16031640768051147,
0.733829915523529,
-0.21953457593917847,
0.15211987495422363,
-0.46933844685554504,
0.31388357281684875,
0.5353687405586243,
-0.5062405467033386,
0.3311382234096527,
0.6857283711433411,
0.562123715877533,
-1.0972470045089722,
0.06003103032708168,
0.08062722533941269,
0.02552323415875435,
0.013303573243319988,
0.4080601930618286,
0.07422531396150589,
-0.5585830211639404,
0.10380829125642776,
-1.1367931365966797,
-0.10769227892160416,
-0.43578749895095825,
-0.45604950189590454,
-0.32102200388908386,
-0.42850202322006226
] |
NCT03765723
|
Prediction Model of Acute Postoperative Pain in Bilateral Total Knee Replacement Arthroplasty Patient
|
This study aims to predict risk factors of acute postoperative pain of the patients undergoing Total Knee Replacement Arthroplasty(TKRA).
|
Patients undergoing bilateral TKRA are recruited. The time interval between the surgery of each leg is within 2 weeks. Before each surgery, patients will be asked to conduct questionnaires of Hospital Anxiety and Depression Scale(HADS) and Pain Catastrophizing Scale(PCS). In addition, the patients will have their preoperative knee pain(measured by Knee injury and Osteoarthritis Outcome Score), preoperative pain in other sites, expectation of postoperative pain(measured by Numerical Rating Scale), and morbidity of diabetic neuropathy recorded. Demographic factors including age, sex, and BMI of patients will be collected. Twenty four and forty eight hours after completion of the surgery, each patient will be asked to report thier acute postoperative pain on Numerical Rating Scale.
This study aims to find out risk factors of acute postoperative pain, including identical surgical history within 2 weeks, in patients undergoing bilateral TKRA.
|
Inclusion Criteria:
* 1) patients undergoing bilateral TKRA with spinal anesthesia
* 2) patients who have their second TKRA in one leg within 2 weeks after their first TKRA in the other leg.
* 3) patients who are classified to the state of ASA physical status classification system Ⅰ,Ⅱ, or Ⅲ.
Exclusion Criteria:
* 1) patients incapable of communication
|
[
0.1618349850177765,
4.006319046020508,
-2.252718448638916,
-3.5158698558807373,
0.6900106072425842,
0.6752614378929138,
0.8240187764167786,
-0.24809448421001434,
-4.292377948760986,
0.13896062970161438,
0.7641000747680664,
2.4702584743499756,
-0.08770148456096649,
0.11009283363819122,
-0.8781586289405823,
0.5861567258834839,
0.4299478232860565,
-0.1597171127796173,
0.0011524998117238283,
-0.1944650113582611,
-1.5627368688583374,
1.5322139263153076,
-0.038906168192625046,
0.3087000548839569,
0.674392580986023,
1.1479214429855347,
-1.2917019128799438,
0.8822786808013916,
-0.011938365176320076,
2.4511420726776123,
-0.022166436538100243,
-1.9581897258758545,
0.7378576397895813,
1.749975323677063,
-0.6412586569786072,
-2.2541775703430176,
-0.24895283579826355,
0.12184972316026688,
-2.8392021656036377,
-0.0928124189376831,
3.5034191608428955,
0.6992127299308777,
-0.4097886383533478,
-0.9123757481575012,
1.6296184062957764,
-0.1210821345448494,
-2.7495601177215576,
0.8122193813323975,
-0.33175185322761536,
-0.0712125301361084,
-0.7948125600814819,
0.8909121751785278,
-2.631955623626709,
0.4088902771472931,
1.1738349199295044,
0.6280999779701233,
1.4930635690689087,
0.0015069602522999048,
2.173288106918335,
-0.6148435473442078,
-0.007626608479768038,
0.7129924893379211,
0.5544763207435608,
0.8832641243934631,
-1.3849823474884033,
-0.997651219367981,
-0.21704167127609253,
-1.1507233381271362,
-0.9630556106567383,
0.8012445569038391,
0.4531082510948181,
0.06386085599660873,
1.4918915033340454,
-0.9101981520652771,
1.1537983417510986,
2.0051286220550537,
0.48632922768592834,
0.2198200523853302,
-0.15547576546669006,
1.001916527748108,
1.46724534034729,
-1.1388291120529175,
-1.1559147834777832,
0.2810121774673462,
-0.037877339869737625,
0.1335032731294632,
-2.0708680152893066,
-1.4774428606033325,
0.6976813673973083,
0.5684163570404053,
0.7161813974380493,
-0.7359387278556824,
-1.2017730474472046,
0.6324396133422852,
-0.48875704407691956,
0.5847680568695068,
0.6629225611686707,
-0.7009343504905701,
-2.303424596786499,
-0.5272898077964783,
0.9238446354866028,
-0.04297677427530289,
0.3882555067539215,
-0.03433198854327202,
-0.40318650007247925,
1.058648943901062,
0.3053647577762604,
0.9753777980804443,
0.16651134192943573,
-0.5264886617660522,
1.4914039373397827,
-1.4641462564468384,
0.3824900686740875,
-0.27995410561561584,
-0.8607857823371887,
0.12414451688528061,
-0.8353424072265625,
0.13300204277038574,
1.677490234375,
-1.3841133117675781,
-0.23179587721824646,
0.43750184774398804,
-0.5032766461372375,
0.47026246786117554,
-0.9741147756576538,
0.34642159938812256,
-0.2872222661972046,
0.6230024695396423,
-0.11321703344583511,
0.32009077072143555,
-0.6024754047393799,
1.317350149154663,
-0.27562952041625977,
0.4985823333263397,
-2.270242214202881,
0.4489056468009949,
0.14342069625854492,
0.2997092604637146,
0.2763173282146454,
-1.4607819318771362,
0.588391900062561,
-0.05457298085093498,
0.43099820613861084,
0.41991424560546875,
-1.4762327671051025,
-0.38995274901390076,
-0.46687057614326477,
1.1694124937057495,
-0.017169136554002762,
0.411413311958313,
0.15645760297775269,
0.35187873244285583,
0.008215846493840218,
-0.8656045198440552,
0.19073520600795746,
-0.4564979374408722,
-0.1289164274930954,
0.0678790882229805,
1.3258973360061646,
-1.1402668952941895,
-0.15648050606250763,
-0.05265958234667778,
-0.9540126323699951,
-1.4846421480178833,
-0.24682965874671936,
-0.13837333023548126,
0.5285729765892029,
-0.28211867809295654,
0.0339006669819355,
0.7100493311882019,
-0.6566505432128906,
1.1028512716293335,
0.302217036485672,
-0.40657463669776917,
-1.1111007928848267,
-1.31949782371521,
0.522363543510437,
0.9452137351036072,
0.3683226704597473,
0.6907705068588257,
1.0715053081512451,
-1.5616334676742554,
0.5536124110221863,
0.32357358932495117,
1.2864843606948853,
-0.0037974317092448473,
0.7313833832740784,
-1.3649283647537231,
-0.25940999388694763,
0.4437728822231293,
0.907457709312439,
-0.2725624442100525,
-0.07223612815141678,
-0.2559136748313904,
-0.12194447219371796,
0.045115575194358826,
-0.6264825463294983,
-0.4171220362186432,
0.47091159224510193,
-0.5353858470916748,
0.05544455721974373,
0.5828917622566223,
-0.36728376150131226,
0.8083916902542114,
0.8497782945632935,
-0.12029388546943665,
-0.1354561299085617,
0.47215110063552856,
-0.23875996470451355,
0.03941101208329201,
-0.18802015483379364,
0.17372117936611176,
0.05439908802509308,
-0.8219232559204102,
-0.28045719861984253,
0.12240535765886307,
0.3590974807739258,
0.733270525932312,
-1.0606989860534668,
0.8676318526268005,
0.2147231251001358,
0.18023096024990082,
0.014375386759638786,
0.2246786504983902,
-0.156404048204422,
-0.5111832022666931,
-0.19143691658973694,
0.6224387288093567,
0.11569058150053024,
-0.23659807443618774,
-0.19080966711044312,
1.1989169120788574,
-0.5819674730300903,
0.17914368212223053,
0.7326319813728333,
0.4040609300136566,
0.8789612054824829,
0.5042969584465027,
-0.17828866839408875,
0.382599800825119,
-0.0883251503109932,
-0.19762441515922546,
-0.9275264143943787,
0.29892483353614807,
0.3895643651485443,
-0.04493933916091919,
-0.385956346988678,
0.1177104040980339,
-0.19968634843826294,
0.05981506034731865,
0.08226557821035385,
0.10037697851657867,
0.37539348006248474,
-0.2641516327857971,
1.1406911611557007,
-0.47095298767089844
] |
NCT04659031
|
A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients with (IBM)
|
An open-label, ascending dose study for adult patients with Inclusion Body Myositis (IBM).
|
Participants who successfully complete the SAD EOT visit, and have no emerging safety issues, will be eligible to enroll in Part 2 (MAD). Eligible participants for the MAD part will have inclusion and exclusion criteria (same as those for Part 1) reviewed prior to dosing on MAD Day 1.
Participants who successfully complete the MAD EOT visit, and have no emerging safety issues, will be eligible to enrol in Part 3, MAD Extension.
After the final MAD visit (W48), participants will have the option to continue on to Part 3 MAD Extension.
For Part 3 (MAD Extension), participant dosing will be at 8-week intervals starting at Day 1. Duration of dosing in Part 3 will be up to approximately 80 weeks (18 months), or until a new long-term extension study has been initiated. The SMC will review all participant safety data approximately every 6 months while the Part 3 dosing continues.
|
Key Inclusion Criteria:
* Diagnosis of either clinico-pathologically defined IBM, clinically defined IBM, or probable IBM according to the European Neuromuscular Center (ENMC) IBM 2011
* Able to arise from a chair (with or without armrests) without support from another person or device
* Able to ambulate at least 20 feet / 6 meters with or without assistive device
Exclusion Criteria:
* Taking \> 7.5 mg prednisolone (or equivalent) or on intravenous immunoglobulin (IVIg) or other immunosuppressants within the last 3 months. Topical, nasal, and ocular corticosteroids are allowed unless they are being widely applied or the severity of the underlying condition makes them unsuitable in the Investigator's opinion. Local steroid injections are allowed
|
[
1.8123010396957397,
0.9204869270324707,
-4.39555549621582,
-2.777189254760742,
-0.4717754125595093,
0.830207109451294,
-1.8741350173950195,
-2.396608591079712,
-0.3033736050128937,
1.2393265962600708,
0.25450003147125244,
2.4937169551849365,
-1.1183937788009644,
0.8591415882110596,
0.30844005942344666,
-0.7691166996955872,
0.5466915369033813,
0.25413089990615845,
1.9184441566467285,
-0.7455072999000549,
2.3699512481689453,
1.2042485475540161,
0.1314370334148407,
-1.7639174461364746,
2.9555916786193848,
-0.2803844213485718,
-0.026842419058084488,
1.5458685159683228,
2.056920289993286,
0.9570575952529907,
-0.5036641359329224,
-2.431668996810913,
0.8859154582023621,
1.5013864040374756,
-1.222137689590454,
-0.07428517192602158,
2.692380905151367,
0.4356144368648529,
-0.7678919434547424,
-1.4383291006088257,
0.8620944023132324,
2.447402238845825,
-2.580626964569092,
0.26079297065734863,
-0.2762485444545746,
-0.6597487330436707,
-1.9427837133407593,
0.46564754843711853,
-1.112293004989624,
1.175514817237854,
-0.5337419509887695,
1.0171794891357422,
-0.5097407102584839,
1.1290183067321777,
1.7453092336654663,
1.289772629737854,
0.5916974544525146,
0.24393372237682343,
1.037400245666504,
-0.5432860255241394,
1.035626769065857,
0.6578470468521118,
0.16971026360988617,
1.071314811706543,
-0.7682893872261047,
0.08804301172494888,
-0.3232020437717438,
0.5368356704711914,
-1.3114347457885742,
-1.3793108463287354,
0.4363304376602173,
0.2787439227104187,
-1.9072459936141968,
2.2773425579071045,
0.9953526854515076,
0.10046285390853882,
-0.830264151096344,
0.7126396894454956,
-0.1844629943370819,
0.7743068933486938,
-0.6804879307746887,
0.6994568109512329,
0.275634765625,
0.7591474056243896,
1.4555768966674805,
0.6202242374420166,
-3.2300596237182617,
-0.33387982845306396,
-1.0206459760665894,
-2.6466429233551025,
1.0204226970672607,
-2.156000852584839,
-1.4749481678009033,
1.3324670791625977,
-0.5877634286880493,
-0.202560693025589,
-0.6124839186668396,
-0.1004064753651619,
-1.6337648630142212,
-0.8620248436927795,
-0.4920003116130829,
-0.1632552444934845,
0.4802883267402649,
-1.1754965782165527,
-0.5939275622367859,
0.8954110741615295,
0.27747079730033875,
-0.3309352397918701,
-1.9532893896102905,
-1.0606077909469604,
0.6675872206687927,
0.17824040353298187,
-0.33598312735557556,
-0.35824310779571533,
1.4026601314544678,
0.4353567659854889,
-0.2862597107887268,
1.0477291345596313,
1.0933258533477783,
-0.7979531288146973,
-0.6087372899055481,
0.5905978083610535,
-1.1755281686782837,
-0.07751878350973129,
0.42199838161468506,
0.015293176285922527,
0.29628434777259827,
-1.4683504104614258,
-0.18588927388191223,
0.5477519035339355,
0.6388568878173828,
-0.21342837810516357,
0.24782951176166534,
-0.21592235565185547,
-0.5740710496902466,
-0.16377492249011993,
-0.054086558520793915,
0.6193338632583618,
-0.4098140597343445,
-0.22655348479747772,
0.20499661564826965,
1.2489045858383179,
-0.6613911986351013,
-0.5188992619514465,
-1.6582072973251343,
0.6006100177764893,
0.869025468826294,
0.5458911061286926,
-0.02125605195760727,
-0.4877742528915405,
0.5893229246139526,
1.3185503482818604,
-0.3534722328186035,
-0.40593257546424866,
0.12160905450582504,
-0.06240418925881386,
-0.5327407717704773,
-0.14057855308055878,
0.2685014307498932,
-0.6612663269042969,
-0.6575595140457153,
-0.96336430311203,
1.1216691732406616,
-1.0016673803329468,
-0.13733060657978058,
0.19160769879817963,
-0.3669578731060028,
-0.37250521779060364,
2.1175479888916016,
0.38824185729026794,
-0.12582457065582275,
0.191029891371727,
0.1870116889476776,
0.6400617957115173,
0.6981155872344971,
0.13661573827266693,
0.03768221288919449,
-0.6381270289421082,
0.03448597714304924,
0.06832772493362427,
-0.17191922664642334,
0.5768386125564575,
2.221672534942627,
-0.943862795829773,
0.7699662446975708,
0.380842924118042,
0.8287636637687683,
0.4418499767780304,
0.6851499080657959,
0.219570130109787,
0.08315849304199219,
-1.2368385791778564,
-0.315312922000885,
1.3674546480178833,
0.7119689583778381,
-0.45528194308280945,
0.39971551299095154,
-0.14780117571353912,
0.5835620760917664,
-0.571911096572876,
0.38079944252967834,
0.13056257367134094,
0.2498558759689331,
-0.28342121839523315,
-0.5367075800895691,
-0.06122618168592453,
0.5236986875534058,
-0.3020263910293579,
0.12433569878339767,
0.003365742741152644,
0.6703295707702637,
-0.162704735994339,
0.16256076097488403,
0.2069329470396042,
1.1679704189300537,
0.432716429233551,
-0.8872582316398621,
0.3784613013267517,
-0.4147533178329468,
-0.11069096624851227,
-1.0957911014556885,
0.16761086881160736,
-0.09750333428382874,
0.5206307172775269,
0.017505522817373276,
-0.11254089325666428,
0.34632986783981323,
0.8717364072799683,
0.1810629516839981,
-0.6406980752944946,
0.31942060589790344,
0.1638270914554596,
-0.09968157857656479,
-0.39483338594436646,
-0.2019781768321991,
-0.3074101209640503,
0.7219461798667908,
0.4134569764137268,
0.5685805678367615,
0.9462043046951294,
1.1776689291000366,
-0.04989554360508919,
-0.8609973192214966,
-0.7387667298316956,
0.9814409613609314,
0.6837629079818726,
0.2943439185619354,
0.7391477823257446,
0.7682037353515625,
-0.029339313507080078,
-0.7296156883239746,
0.09340072423219681,
-0.19785912334918976,
0.1563309282064438,
0.22861558198928833,
-0.9432028532028198
] |
NCT03983018
|
Rituximab for Schizophrenia Spectrum Disorder (RITS-PS-2019)
|
This study evaluates the addition of rituximab to 12 patients diagnosed with treatment resistant schizophrenia spectrum disorder in an open trial.
|
Immunological factors may be determinants for some psychiatric disorders, thus immunomodulation may be helpful. Rituximab (antibodies against CD20, cluster of differentiation), a standard treatment for multiple sclerosis, is an anti-inflammatory drug, hitherto not tested for psychiatric disorders.
The aim of this study is to investigate whether the psychiatric symptoms of treatment-resistant adult psychiatric patients, diagnosed with schizophrenia spectrum disorder (SSD), are significantly improved after treatment with rituximab. Our purpose is to implement recent insights from "Immunopsychiatry" to find efficacious, but still tolerable treatment for these patients.
This is a single-site, 20-week, open pilot, add-on treatment as usual, trial, where the patients will be followed for 1 year.
Rituximab will be administered with one single dose of 1000 mg. Investigators will analyse inflammatory and metabolic biomarkers in relation to the primary outcome, treatment response (defined as clinically relevant reduction in the validated measure PANSS). Other outcomes are "much" or "very much improved" on Clinical Global Impression - Improvement scale (CGI-I) and change in Personal and Social Performance Scale measuring overall disability.
|
Inclusion Criteria (Swedish citizens):
1. patient ages 18 to 40 years
2. a duration of illness exceeding 2 years
3. correspond to "Markedly ill", "Severely ill" or "Among the most extremely ill patients" on the Clinical Global Impression - Severity scale (CGI-S)
4. Global Assessment of Functioning below 50
5. Schizophrenia spectrum disorder according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
6. treatment resistance, i.e. failing to remit despite adequate treatments
7. if female and with any risk for pregnancy, willing to use contraceptives
8. if antipsychotic treatment is prescribed the plasma concentrations of the drug must be tested and shown to be within therapeutic interval.
9. subjects should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent.
10. immunoglobulin levels within the normal range
Exclusion Criteria:
1. on-going immunomodulatory treatment
2. pregnancy or breast-feeding
3. weight below 40 kg
4. clinically relevant on-going infection
5. chronic infections
6. positive screening test for hepatitis B, C, HIV or tuberculosis
7. any change of psychotropic medication within the previous 4 weeks
8. "much" or "very much improved" already at baseline according to CGI-I i.e. scores of 1 or 2 by the clinician
9. severe heart failure (NYHA grade IV) or other severe heart disease or history of cardiac arrhythmia or myocardial infarction
10. unable to make an informed decision to consent to the trial
11. in compulsory treatment
12. treatment with clozapine within the last 2 months
13. previous treatments with immunosuppressive agents
14. malignancy currently or within 2 years prior to inclusion
|
[
0.4260620176792145,
2.3217644691467285,
-1.712828278541565,
-1.8415275812149048,
0.9715308547019958,
-0.729960560798645,
1.4555124044418335,
0.13046735525131226,
-0.931390106678009,
0.9160085320472717,
-0.1537754237651825,
4.713343143463135,
-2.707672357559204,
0.3163102865219116,
0.33401787281036377,
0.34700652956962585,
-1.0184370279312134,
1.358411192893982,
2.3928754329681396,
-0.7308374047279358,
-1.1261929273605347,
0.6888168454170227,
-0.22802360355854034,
-0.4639420807361603,
-0.8635383248329163,
0.22959557175636292,
-3.5314645767211914,
3.4980413913726807,
1.0384536981582642,
1.0487580299377441,
-1.1458826065063477,
-0.7864221930503845,
-0.3135840594768524,
0.07738644629716873,
2.27685546875,
0.6200176477432251,
-0.4639109969139099,
0.6571477055549622,
-3.4996519088745117,
0.14370860159397125,
1.6071619987487793,
1.4600526094436646,
-0.14186684787273407,
0.6803684234619141,
-0.0430695004761219,
0.4422975480556488,
-1.3162697553634644,
0.5036587119102478,
-0.49974092841148376,
-1.2112740278244019,
-0.10972004383802414,
1.9896939992904663,
-0.12391523271799088,
-0.11699096113443375,
3.4905893802642822,
0.6533557772636414,
1.9059621095657349,
0.24295365810394287,
2.020277976989746,
0.28697893023490906,
0.6919002532958984,
0.24875713884830475,
-0.6601776480674744,
0.7830150723457336,
-2.2897725105285645,
0.4518461525440216,
-1.8037071228027344,
1.2891030311584473,
-1.6071447134017944,
-1.6620097160339355,
-1.4177179336547852,
0.1964094191789627,
0.4946218430995941,
0.5433546900749207,
0.9825359582901001,
0.2194262593984604,
-0.6468981504440308,
1.6871685981750488,
0.6378098726272583,
0.823553740978241,
-0.36299723386764526,
-1.6702488660812378,
-1.3742674589157104,
-1.4890810251235962,
-0.34024614095687866,
-1.6433831453323364,
-2.5066752433776855,
-1.5294058322906494,
1.185704231262207,
-1.5890541076660156,
1.6369277238845825,
-1.4345197677612305,
0.3657585382461548,
1.8568426370620728,
-1.0788249969482422,
-0.769213080406189,
0.242832750082016,
-0.2676115036010742,
-0.9962430596351624,
-1.5416914224624634,
0.4980580508708954,
0.48503610491752625,
-1.3070439100265503,
-1.4430409669876099,
-2.6939632892608643,
-0.5959153771400452,
0.3054702877998352,
0.22585172951221466,
-0.9573482871055603,
-1.1630784273147583,
-0.3522213399410248,
-0.8138378262519836,
-0.4579974412918091,
-0.9655289053916931,
1.0320408344268799,
-1.2050834894180298,
1.792455792427063,
0.8107839226722717,
0.20486094057559967,
1.3465523719787598,
0.1337382048368454,
0.1258414387702942,
-1.2900233268737793,
-1.2599784135818481,
-0.851991593837738,
-0.10400804132223129,
-0.9115012288093567,
-1.4271612167358398,
-1.141799807548523,
-1.272817850112915,
-1.0280855894088745,
-0.7841464877128601,
-0.9877915978431702,
1.0711174011230469,
-1.0893014669418335,
0.08003529161214828,
0.24009639024734497,
1.7713377475738525,
0.3066771924495697,
-1.1198194026947021,
-0.51853346824646,
0.7425668239593506,
0.6084358096122742,
0.001970113953575492,
-1.8335013389587402,
-0.6051104068756104,
0.7215411067008972,
0.8901397585868835,
-0.8215899467468262,
-0.1898052990436554,
0.3036670386791229,
0.5984584093093872,
0.35594868659973145,
0.7147136926651001,
0.1988753378391266,
1.533677101135254,
0.6477451920509338,
-0.25218167901039124,
1.4425454139709473,
-0.1282791942358017,
-1.1717631816864014,
-0.6873067021369934,
1.7106819152832031,
-1.241098165512085,
1.4537371397018433,
0.5333303809165955,
-0.46551966667175293,
-0.7526488900184631,
0.96186363697052,
0.779016375541687,
-1.1376348733901978,
0.0806642696261406,
0.23503704369068146,
-0.45068004727363586,
0.14775705337524414,
0.5125206112861633,
0.1838303655385971,
-0.4619426131248474,
1.0036020278930664,
-0.39731094241142273,
0.14433372020721436,
-0.6475477814674377,
0.022383715957403183,
-0.49502575397491455,
-0.71553635597229,
0.0961221382021904,
-0.28941139578819275,
1.281511664390564,
-0.14300133287906647,
-0.0700419470667839,
-0.5680586695671082,
0.006136483978480101,
0.15795376896858215,
0.17009210586547852,
0.4273066818714142,
-0.6892198920249939,
0.33282825350761414,
-0.40704619884490967,
-0.5381770133972168,
-0.45803624391555786,
1.1670681238174438,
1.029139518737793,
0.2762455344200134,
-0.021144112572073936,
-0.6297491788864136,
-0.13709968328475952,
0.00690781744197011,
-1.353162169456482,
0.20185814797878265,
0.8574575781822205,
0.33555367588996887,
0.2949591279029846,
-0.6280259490013123,
-0.9204650521278381,
0.19245849549770355,
0.5079016089439392,
0.7850926518440247,
0.5738483667373657,
-0.7336512804031372,
0.07732295989990234,
-0.8598490357398987,
-0.8811907768249512,
0.5982080101966858,
0.30941957235336304,
0.17903953790664673,
-0.2528805434703827,
0.7670681476593018,
0.3932923972606659,
0.501191258430481,
0.20831120014190674,
-0.2074137032032013,
0.3931996524333954,
-0.664972722530365,
0.4974367618560791,
-0.4507947266101837,
-0.01902458257973194,
-0.4407729506492615,
0.23220501840114594,
-0.019934944808483124,
1.1715552806854248,
0.46837562322616577,
-0.7879974246025085,
0.6512093544006348,
-1.128643274307251,
-0.3316105008125305,
0.6804133653640747,
-0.40856918692588806,
0.4102221727371216,
0.4437563717365265,
0.02154495380818844,
-0.5051190257072449,
-0.47687509655952454,
0.6470634341239929,
0.4463942050933838,
0.018388662487268448,
-0.46201515197753906
] |
NCT06473376
|
Comparison Between Hegab Splint, Arthrocentesis, and Arthroscopy in Treatment of TMJ Closed Lock
|
This prospective, randomized control study aimed to compare the Clinical Outcome of Hegab splint, Arthrocentesis, and Arthroscopy in treatment of TMJ closed lock. The study sample was derived from the population of patients who presented for evaluation and treatment of TMJ disorders.
|
This prospective, randomized control study aimed to compare the Clinical Outcome of Hegab splint, Arthrocentesis, and Arthroscopy in treatment of TMJ closed lock. The study sample was derived from the population of patients who presented for evaluation and treatment of TMJ disorders. The patients were randomly assigned to one of the following three groups: Group I (Control): patients treated by Hegab splint. Group II: patients treated by arthrocentesis with injection of HA/PRP mix plus Hegab splint. Group III: arthroscopy with injection of HA/PRP mix plus Hegab splint. The primary outcome variable was the change in pain using a visual analog scale, and improvement of maximum voluntary mouth opening. The secondary outcome variable was the change in joint sound. The third category of variables (age and sex) was evaluated in relation to the outcomes.
|
Inclusion Criteria:
* Patients with TMJ closed lock confirmed
Exclusion Criteria:
* rheumatoid arthritis psoriatic arthritis juvenile arthritis those receiving anticoagulant therapy
|
[
1.4474570751190186,
2.2390754222869873,
-1.5232398509979248,
-1.356332540512085,
0.7337745428085327,
-0.6872711777687073,
0.13048310577869415,
-0.6435726881027222,
-1.2034794092178345,
0.7043281197547913,
0.2287735641002655,
1.762699842453003,
-0.8744737505912781,
1.7349785566329956,
-1.1044975519180298,
0.6333969235420227,
0.6882981061935425,
0.05356047675013542,
1.0255582332611084,
-0.39925938844680786,
-0.1950642317533493,
0.37938567996025085,
0.5714648962020874,
0.13860653340816498,
-0.10140077024698257,
-0.13778096437454224,
-0.7094277143478394,
1.2021846771240234,
-0.01185821183025837,
1.3808881044387817,
-1.1323786973953247,
-0.6879926919937134,
0.44098061323165894,
0.746455192565918,
0.06349389255046844,
-0.379100501537323,
0.8850562572479248,
-0.0033871496561914682,
-1.7932003736495972,
0.3352716565132141,
0.10479141771793365,
-0.29744282364845276,
-0.9637166857719421,
-0.7794240713119507,
0.7929737567901611,
1.0355949401855469,
0.3830735385417938,
1.01349675655365,
-0.2419031262397766,
0.012403415516018867,
-0.7198364734649658,
0.2991882860660553,
-1.750386118888855,
0.5298623442649841,
1.395089030265808,
0.5354299545288086,
1.238547921180725,
-0.12684457004070282,
1.6699045896530151,
-0.2204051911830902,
0.4243380129337311,
-0.2565029561519623,
-0.08801791816949844,
0.9818850755691528,
-0.9220410585403442,
0.15839630365371704,
-1.1905248165130615,
-0.1904779076576233,
-0.5682839155197144,
-0.0031909169629216194,
-0.7034605741500854,
0.3634776771068573,
0.9682548642158508,
0.42139479517936707,
0.18885275721549988,
-0.17270827293395996,
-0.1453733593225479,
-0.07284681499004364,
0.43444985151290894,
0.7117127180099487,
1.7319384813308716,
-1.241816520690918,
-0.3881409168243408,
-0.7202460765838623,
-0.2591187655925751,
-0.9210752248764038,
-0.46932852268218994,
0.6726682186126709,
1.0735336542129517,
-0.9328063726425171,
0.8052903413772583,
-0.779055118560791,
0.009901861660182476,
0.5122162699699402,
-0.5997446179389954,
0.8210645914077759,
-0.03881538659334183,
-1.1936763525009155,
-0.8501729369163513,
0.06612154841423035,
0.1780032515525818,
-0.6079990267753601,
-0.654730498790741,
-0.2847577929496765,
-1.002076506614685,
0.1496371179819107,
-0.4347834289073944,
-0.2119278758764267,
0.12323007732629776,
-0.017955707386136055,
0.6386303305625916,
-0.3448326587677002,
-0.3038721978664398,
-0.7670350670814514,
1.4176119565963745,
-0.025616763159632683,
-0.032544832676649094,
-0.7175613045692444,
0.5685678720474243,
-0.1002986878156662,
-0.6039808988571167,
0.41600272059440613,
0.7555695176124573,
-0.17595629394054413,
-0.575721800327301,
-0.1276448369026184,
-0.38155215978622437,
-0.18343591690063477,
-0.631432056427002,
-0.7156269550323486,
-0.4693872630596161,
-0.5633721351623535,
0.5251039266586304,
0.60671466588974,
-1.1809438467025757,
0.07566994428634644,
0.6853752732276917,
0.9074457883834839,
0.4877351224422455,
-1.3273613452911377,
-0.3118925392627716,
0.7762520909309387,
0.07526405155658722,
0.1073693186044693,
-1.197676658630371,
-0.8991908431053162,
-0.2514147162437439,
-0.041889358311891556,
-0.783880889415741,
-0.06458199769258499,
0.0544569157063961,
0.5013277530670166,
-0.06246505677700043,
0.012203040532767773,
0.4362122118473053,
0.4459742605686188,
0.37238579988479614,
-0.18234127759933472,
0.47720757126808167,
-0.8276845216751099,
-0.17844709753990173,
-0.9474886059761047,
-0.24071530997753143,
-0.4531109035015106,
-0.003354044631123543,
0.6095675230026245,
-0.023378681391477585,
0.11987794935703278,
0.7755537033081055,
0.5985019207000732,
-0.7832732796669006,
0.13222388923168182,
0.001938480418175459,
0.5605801343917847,
-0.5537493824958801,
0.5372469425201416,
1.1437727212905884,
-0.025759520009160042,
0.8160304427146912,
-0.3188210725784302,
-0.19805292785167694,
0.1641850620508194,
0.8332040905952454,
-0.13776887953281403,
0.4100647270679474,
-0.29520753026008606,
-0.3887329697608948,
-0.21425075829029083,
0.2042396366596222,
0.11256982386112213,
-0.2501266300678253,
0.0537542961537838,
-0.0026599226985126734,
0.1635591983795166,
0.12298443168401718,
-0.9665236473083496,
-0.19237586855888367,
-0.8835135102272034,
-0.0033551661763340235,
0.15056179463863373,
0.8134410381317139,
0.7280963659286499,
-0.22021885216236115,
0.23894421756267548,
-0.37761151790618896,
-0.1184006854891777,
0.48317480087280273,
-0.4804677665233612,
-0.6518641114234924,
0.6871585845947266,
0.39478155970573425,
-0.5014210343360901,
-0.31568968296051025,
-0.8779874444007874,
0.5015554428100586,
0.46326711773872375,
0.5795869827270508,
0.4038631319999695,
-0.7751829624176025,
0.06484837085008621,
-0.03600152209401131,
-0.5094210505485535,
0.2758116126060486,
0.5636712908744812,
0.33248230814933777,
0.3654983341693878,
-0.020464090630412102,
0.47876307368278503,
0.33146074414253235,
0.38161447644233704,
-0.5261022448539734,
0.8323425054550171,
-0.07267621904611588,
0.1729433834552765,
0.2523030638694763,
0.08088421821594238,
0.352295458316803,
0.48443543910980225,
-0.18172112107276917,
0.03126755356788635,
0.5902233123779297,
-0.38175657391548157,
-0.02601701207458973,
-0.27942338585853577,
0.005476751364767551,
-0.22754770517349243,
-0.3253132402896881,
0.3815560042858124,
-0.26427575945854187,
0.08508312702178955,
-0.4175131320953369,
-0.24648445844650269,
0.07210725545883179,
0.45961031317710876,
0.2247866839170456,
-0.8992440104484558
] |
NCT05556252
|
The Effect of Hydrogen-rich Water on Premenstrual Symptoms and Quality of Life
|
The aim of this study is to determine the effect of hydrogenated water on premenstrual symptoms and quality of life in students with premenstrual syndrome.
Research Hypotheses H1 1 Hydrogenated water consumption reduces premenstrual symptoms in students with premenstrual syndrome.
H1 2 Hydrogenated water consumption increases the quality of life in students with premenstrual syndrome.
The research will consist of intervention and control groups. Individuals consuming hydrogen-rich water will be included in the intervention group, whereas individuals consuming normal water will be in the control group. The block randomization method will be used to randomly assign participants who meet the research criteria to the groups. Participants will be provided with hydrogenated water for three cycles.
|
Inclusion Criteria:
* The length of the menstrual cycle is within normal limits (21-35),
* Getting a score of 132 or more from the Premenstrual Syndrome Scale,
* Not receiving medical treatment for PMS,
* Not having any psychiatric diagnosis.
Exclusion Criteria:
* • Irregular menstruation in the last three cycles
* Having received a psychiatric diagnosis,
* Having any gynecological disease (abnormal uterine bleeding, myoma, ovarian cyst, etc.)
* Using contraceptive medication.
* Individuals' refusal to participate in the study,
* Participants' non-compliance with the research plan,
* Participants start receiving PMS treatment during the study period.
|
[
-0.33640438318252563,
2.719111204147339,
-2.9950454235076904,
-1.8360894918441772,
0.7101903557777405,
-0.29838478565216064,
1.0303821563720703,
0.08893273770809174,
-2.321897268295288,
0.418981671333313,
0.8066695928573608,
2.12520170211792,
-0.591688871383667,
1.555120587348938,
0.4632076919078827,
0.6879012584686279,
-0.5717553496360779,
-1.3365267515182495,
1.4263006448745728,
-1.38588547706604,
1.1979838609695435,
0.2778465747833252,
-0.336590975522995,
-1.406314492225647,
-1.195586085319519,
-0.17790435254573822,
-2.4145267009735107,
1.8198484182357788,
0.18757344782352448,
-0.19107121229171753,
1.0421545505523682,
0.133647620677948,
0.26327863335609436,
-1.3332600593566895,
-0.18596236407756805,
-0.8263483643531799,
1.6899443864822388,
0.19756725430488586,
0.44292163848876953,
0.8171308636665344,
-0.1853918731212616,
1.5902620553970337,
0.6159861087799072,
-0.5969939827919006,
-0.2086869478225708,
0.19876642525196075,
0.5526056885719299,
-0.2681368887424469,
-0.3156476318836212,
0.47345900535583496,
0.5272238850593567,
-0.08694757521152496,
-0.839790403842926,
0.0450921393930912,
1.472530484199524,
0.4072181284427643,
-0.4353988766670227,
-0.6035902500152588,
2.299818754196167,
-0.9677073955535889,
1.6231575012207031,
-0.1574678272008896,
-0.2177821546792984,
0.41069698333740234,
-1.0687603950500488,
-0.022969143465161324,
0.7821934223175049,
0.7090245485305786,
-0.4641894996166229,
1.288668155670166,
0.5148100256919861,
-0.286152720451355,
0.927821934223175,
-0.0709206759929657,
0.039183419197797775,
0.7150349020957947,
0.16919828951358795,
0.8530374765396118,
0.7136877775192261,
0.8210850358009338,
-0.6955012083053589,
0.9599912762641907,
-0.3383481204509735,
0.8820285797119141,
0.6340634226799011,
-0.8972376585006714,
-0.9404147267341614,
-0.8082337379455566,
0.751548171043396,
-0.006027868017554283,
1.1480461359024048,
0.12116038054227829,
-0.29452040791511536,
0.2938106656074524,
0.617150068283081,
0.3188195526599884,
0.5651488304138184,
-0.5356876850128174,
-0.01996566914021969,
0.15093325078487396,
0.42537015676498413,
-0.7783645391464233,
-0.6385917067527771,
-1.1602911949157715,
-0.1433490663766861,
0.29483237862586975,
0.4010438024997711,
0.8458564281463623,
-0.5412554144859314,
1.2058959007263184,
-0.3731946647167206,
-0.012534852139651775,
-0.17343439161777496,
-0.5421477556228638,
1.010209083557129,
-0.06998185813426971,
0.8811860084533691,
0.11278920620679855,
-0.6870887279510498,
-1.740146517753601,
-0.38263002038002014,
0.683159351348877,
0.6087194085121155,
0.5489462018013,
-1.4196933507919312,
0.08789026737213135,
-0.49449875950813293,
1.0092968940734863,
-0.4223804473876953,
-0.3821755349636078,
-0.707897424697876,
-0.07924949377775192,
0.12724846601486206,
-0.4108917713165283,
-0.47958093881607056,
0.10716157406568527,
0.5787353515625,
0.454666405916214,
-0.07272478938102722,
-0.37783145904541016,
0.020149052143096924,
0.6768679022789001,
0.3143826127052307,
0.033128514885902405,
-1.590572476387024,
-0.5090984106063843,
0.2625837028026581,
-0.6394760608673096,
-0.24936823546886444,
0.07664834707975388,
-0.012040691450238228,
0.08987393975257874,
-0.19400253891944885,
0.286744624376297,
-0.20087535679340363,
-0.14023855328559875,
0.06264778971672058,
-0.10519887506961823,
0.47710204124450684,
-0.060320232063531876,
-0.4566938877105713,
-0.14026235044002533,
-0.7530866265296936,
-0.8642266988754272,
0.6177809238433838,
-0.2000814825296402,
-0.2525172829627991,
0.7852837443351746,
0.4892365634441376,
-0.5947873592376709,
0.811898946762085,
-0.08089952915906906,
-0.036577317863702774,
0.20015384256839752,
-1.0058767795562744,
-0.03722427040338516,
0.7099819183349609,
0.7935539484024048,
-0.20286774635314941,
0.44312840700149536,
0.5693562030792236,
-1.040960669517517,
-0.5197523832321167,
-0.09572313725948334,
-0.3331315815448761,
-0.2678431272506714,
-0.44446656107902527,
-0.5497857928276062,
0.4267589747905731,
-0.42806223034858704,
0.17933526635169983,
-0.05674567073583603,
0.15468774735927582,
0.4820312559604645,
0.2500429153442383,
0.27021247148513794,
0.06711149215698242,
-0.6331834197044373,
-0.0005673274281434715,
-0.255217045545578,
0.10539141297340393,
0.4875134825706482,
0.46130457520484924,
0.40897056460380554,
0.012698589824140072,
-0.054909832775592804,
-0.2825777232646942,
0.20119628310203552,
0.0035093394108116627,
0.3146628141403198,
0.2879856824874878,
-0.30338528752326965,
-0.11808540672063828,
-0.057220712304115295,
0.602575421333313,
-0.28849512338638306,
0.15412816405296326,
-0.111044742166996,
-0.44364145398139954,
0.483786940574646,
-0.4854518175125122,
-0.13037839531898499,
-0.12078767269849777,
0.06952325999736786,
-0.232034832239151,
-0.005400187335908413,
-0.23866823315620422,
0.3497005105018616,
-0.10337086021900177,
0.4130542576313019,
-0.36105653643608093,
-0.20185506343841553,
-0.06584347039461136,
0.17285892367362976,
0.6423842310905457,
-0.3790339529514313,
0.15157577395439148,
0.08541174978017807,
-0.08263906091451645,
0.3535937964916229,
0.4884783923625946,
-0.48194605112075806,
-0.2738012969493866,
-0.47361207008361816,
0.13735376298427582,
-0.08390173316001892,
-0.3082694709300995,
0.24896331131458282,
-0.025304704904556274,
0.31691378355026245,
-0.04540112242102623,
-0.29882195591926575,
0.06370039284229279,
0.40449121594429016,
0.20091523230075836,
-0.00974386278539896
] |
|
NCT03371628
|
Electrical Impedance Tomography in Evaluating the Effects of Noninvasive Ventilation in Post-Operative Cardiac Surgery
|
NTRODUCTION: cardiac surgery can lead to pulmonary complications such as hypoxemia and atelectasis. Noninvasive ventilation has been used to prevent and treat such complications. Electrical impedance tomography has been a useful tool in bedside evaluation of ventilation and pulmonary ventilation. OBJECTIVE: To compare the effects of non-invasive ventilation with oxygen therapy in cardiac post-operative patients. MATERIALS AND METHODS: It will be a randomized controlled clinical trial where patients will be divided into two groups: a group that will perform NIV for 1 hour and the group that will only use oxygen therapy. They will be evaluated through Electrical Impedance Tomography and arterial gasometry analysis just before extubation, soon after extubation, during the intervention and after the intervention for a period of 2 hours after extubation. EXPECTED RESULTS: It is expected that the NIV group will present higher pulmonary ventilation and aeration and better gas exchange than the oxygen therapy group, and that the time of therapeutic effect will be higher in the NIV group.
|
The proposal basically consists of Validation of the hypothesis: The use of Non-invasive Ventilation in patients in the postoperative cardiac surgery results in greater ventilation, greater aeration, and improved gas exchange when compared to the oxygen therapy group.
The use of noninvasive ventilation in the postoperative cardiac surgery has been widely used in clinical practice, but the evidence of the benefits of this technique in this population in relation to some criteria have not yet been elucidated in the scientific literature, such as the effect of NIV in ventilation and pulmonary ventilation, and how long does this effect last.
|
Inclusion Criteria:
* Immediate postoperative period of cardiac surgery
* age between 18 and 65 years
* BMI between 18.5 and 30 kg / m2
* Patients still intubated when admitted to the ICU
* without previous history of severe pulmonary diseases such as chronic obstructive pulmonary disease, pulmonary fibrosis, or chronic renal failure, or associated neuromuscular diseases
Exclusion Criteria:
* Patients considered to be at risk for extubation failure (hypercapnia, more than failure in the autonomic test, AVM time greater than 72 hours, ineffective cough)
* Cardiopulmonary bypass time more than 150 minutes
* Hemodynamic instability (arrhythmias, cardiogenic shock, severe hypotension with SBP \<90mmHg)
* Episodes of abdominal distension, nausea and vomiting
* Hypoxemia (PO2 \<50mmHg with FiO2 50%) or hypercapnia (PaCO2\> 55mmHg with pH \<7.30)
* Patients who are at high surgical risk according to Euroscore II
|
[
-0.38113296031951904,
3.1241772174835205,
-1.6965458393096924,
-3.3972294330596924,
-0.1093410849571228,
0.09453124552965164,
1.2878304719924927,
0.6201012134552002,
-2.3257734775543213,
1.2025022506713867,
0.16022536158561707,
1.587504506111145,
0.09289964288473129,
1.1414644718170166,
-0.6177849769592285,
1.4285128116607666,
-0.1673506200313568,
0.6046130061149597,
0.6368544697761536,
-0.9688674807548523,
0.48081713914871216,
-0.318172812461853,
-0.5130813121795654,
0.32415392994880676,
0.6653880476951599,
0.4904629588127136,
0.8611716032028198,
0.2711044251918793,
0.08612712472677231,
0.7952717542648315,
0.8284339308738708,
-1.590039610862732,
-0.16203880310058594,
0.3801151216030121,
-0.6281771659851074,
0.7880668044090271,
0.5388869047164917,
1.4256974458694458,
-0.6174903512001038,
-0.09705279022455215,
1.4255139827728271,
1.7080973386764526,
-0.049675144255161285,
-0.8024535179138184,
0.8604052662849426,
0.3283624053001404,
0.32940343022346497,
0.5000983476638794,
0.4967210292816162,
-0.654049277305603,
-1.644726276397705,
0.37245282530784607,
0.5102888941764832,
0.4753473401069641,
2.5462839603424072,
0.7164746522903442,
0.19537067413330078,
-0.3582042455673218,
0.2642284631729126,
0.3613528907299042,
0.3726901710033417,
-0.09830239415168762,
0.37857621908187866,
-0.02100040391087532,
-1.8399070501327515,
-0.10554321110248566,
0.7256847620010376,
0.33486059308052063,
-0.17832884192466736,
0.08940063416957855,
0.44408029317855835,
0.08287142962217331,
0.16931834816932678,
0.27123647928237915,
0.3539663851261139,
0.8350133299827576,
-0.6073933243751526,
0.3568652868270874,
0.3914182186126709,
0.3044976592063904,
-0.19569534063339233,
0.2903192937374115,
-0.7615939378738403,
-0.43592411279678345,
0.20966394245624542,
-0.17362089455127716,
-0.6892128586769104,
-0.4493286907672882,
0.6992878317832947,
-0.8428455591201782,
0.2806780934333801,
-0.22617848217487335,
-1.2234772443771362,
1.2924115657806396,
-0.9221389889717102,
0.21835200488567352,
-0.2096996009349823,
-0.04025696963071823,
-1.0468664169311523,
-0.8498528599739075,
0.015054639428853989,
0.1904529184103012,
-0.06256675720214844,
0.3889322578907013,
0.1100434809923172,
0.17735153436660767,
0.3763369023799896,
-0.8733964562416077,
-0.2857670783996582,
-0.4758374094963074,
0.5883176922798157,
-0.20074865221977234,
0.7990766763687134,
-0.6568770408630371,
0.2576510012149811,
0.417287677526474,
0.2886812686920166,
0.27017709612846375,
0.11140520125627518,
-0.29742178320884705,
-0.19533298909664154,
0.22915847599506378,
0.39061689376831055,
0.23693563044071198,
-1.0434339046478271,
-0.16615667939186096,
-0.10427118837833405,
0.3282812833786011,
-0.21772581338882446,
-1.180023193359375,
0.23630064725875854,
0.5831727385520935,
0.50038743019104,
-0.15481895208358765,
-0.6415023803710938,
0.10526235401630402,
0.480927050113678,
1.1853569746017456,
0.10323222726583481,
-0.1701297014951706,
0.33498889207839966,
0.3889923691749573,
0.6364960074424744,
-0.2246336191892624,
-0.9417628049850464,
-0.6929051876068115,
-0.4311816096305847,
-0.32736772298812866,
-0.8497925400733948,
0.02103085070848465,
0.13140909373760223,
0.5538663864135742,
-0.1496044546365738,
0.39460375905036926,
-0.03237862139940262,
0.6644629240036011,
-0.015133986249566078,
-0.28970056772232056,
-0.38475310802459717,
0.0820511132478714,
-0.27346867322921753,
0.5628581643104553,
-0.03843914717435837,
-1.2140352725982666,
0.8328545689582825,
-0.13611827790737152,
-0.43928539752960205,
-0.21939519047737122,
0.5545589923858643,
0.26339223980903625,
-0.46003276109695435,
0.4443717896938324,
0.1491948813199997,
0.2292308211326599,
-0.5217152833938599,
-0.11773741245269775,
0.3733680248260498,
-0.17244362831115723,
-0.233086958527565,
-0.21587276458740234,
0.34549015760421753,
-0.2192176729440689,
0.24386639893054962,
0.2140878140926361,
-0.5745725631713867,
-0.8681975603103638,
0.015841634944081306,
-0.5945897698402405,
0.3372819423675537,
0.03551475703716278,
0.19961990416049957,
0.4015865623950958,
-0.4964924454689026,
0.1590789407491684,
0.052121296525001526,
0.4152410626411438,
-0.7451865673065186,
-0.7911012172698975,
0.1398911029100418,
0.35736945271492004,
0.285283625125885,
0.28958770632743835,
-0.3124518096446991,
0.9607862830162048,
0.6424807906150818,
-0.09910622984170914,
-0.10008295625448227,
-0.1660086214542389,
-0.06056864187121391,
0.9136137366294861,
-0.2550339698791504,
0.30215659737586975,
-0.22348423302173615,
0.029914280399680138,
-0.05237652361392975,
0.20202091336250305,
-0.10889806598424911,
0.030853375792503357,
-0.37753573060035706,
0.2843005955219269,
0.043557509779930115,
-0.30620574951171875,
0.34826236963272095,
0.05285264551639557,
0.0405721515417099,
-0.1942673921585083,
-0.05356369540095329,
0.19795134663581848,
0.1895778924226761,
-0.24930305778980255,
-0.34955912828445435,
0.047278277575969696,
-0.17335113883018494,
-0.1628435105085373,
-0.23052825033664703,
-0.0747404620051384,
0.06432102620601654,
0.5176177620887756,
0.14631907641887665,
0.1935388445854187,
0.32060009241104126,
-0.5685961842536926,
0.023997372016310692,
-0.3321409523487091,
-0.17264679074287415,
-0.30292949080467224,
-0.004744539503008127,
0.0004953816533088684,
-0.026137452572584152,
-0.10706520080566406,
0.2242426723241806,
-0.6029430627822876,
0.24721530079841614,
-0.14484815299510956,
-0.14960840344429016,
-0.2769376039505005
] |
NCT03051178
|
Wearable Sensor for Responsive DBS for ET
|
The purpose of this study is evaluate the effectiveness and safety of a possible new treatment for Essential Tremor (ET) using external wearable sensors, which have the capability of recording acceleration and Electromyography (EMG). This therapy is called Responsive Deep Brain Stimulation (R-DBS). R-DBS systems will communicate with a computer, and apply stimulation when the computer detects patterns associated with tremor. This detection will suppress pathological activity and improve or alleviate the tremor.
Currently, DBS is approved for the treatment of ET; however, stimulation is delivered continuously even when tremor or other symptoms are absent. Continuous DBS can lead to unwanted side effects such as stuttering and gait\\balance problems. On the other hand, R-DBS will turn on only if activity associated with ET from the external sensors is detected.
|
The overall purpose of this application is to capture pathological activity related to essential tremor using external wearable sensors to responsively initiate or terminate DBS. To this end, the researchers propose to use the Nexus-D system, which requires a firm ware update to an Activa Implantable Neurostimulator (INS), and it will in a smart way turn DBS on/off in patients. The study team will recruit subjects with Activa SC or PC neurostimulator implants during 6 post-operative programming visits. The research group is already familiar with and is in possession of the Nexus-D system, and the investigators have successfully performed responsive DBS in two patients with Tourette syndrome (TS) and in four patients with Parkinson's disease in acute settings. The lab is also equipped with wireless wearable sensor and amplifier systems, such as a 16-unit wireless EMG+ acceleration+inertia Trigno Wireless Bio Acquisition System (Delsys Inc, Natick, MA). The study team aims to combine these signal modalities to capture pathological symptoms and generate commands to initiate or terminate DBS (also record adverse side effects, if any). The project goal is to characterize the clinical efficacy, side effect profile, and battery life of closed-loop DBS in acute settings using wearable sensors in essential tremor patients.
|
Inclusion Criteria:
* Provide informed consent
* Patient is over 21 years of age
* Patient has had a significant disabling, medication-refractory upper extremity tremor with no evidence of non-ET central nervous system disease or injury for at least three (3) months prior to implantation of Activa SC, PC, or RC device.
* Patient receives Vim electrode and Activa SC, PC or RC device implants, and recovers fully after surgery.
* Patient is available for study participation after their clinical programming appointments for six months.
Exclusion Criteria:
* Medication related movement disorders.
* Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability.
* Severe medical co-morbidity including cardiovascular disorder, lung disorder, kidney disease, continuous neurological disease, hematological disease, or frailty that impact tolerability of the surgery as judged by the screening physicians.
* Patient is undergoing a lead revision surgery.
|
[
-2.721160888671875,
3.0454273223876953,
-0.674553632736206,
-3.2148983478546143,
0.5346359610557556,
-0.03550415486097336,
-0.7485677599906921,
-0.39873963594436646,
-1.2466412782669067,
1.6362435817718506,
0.8204209208488464,
2.376211404800415,
-0.9485242962837219,
0.621293842792511,
0.20260003209114075,
0.9037051796913147,
-0.383291095495224,
0.3783549666404724,
1.887739658355713,
-0.036972180008888245,
0.7037173509597778,
-1.847969651222229,
0.18001261353492737,
-1.8652669191360474,
0.06909014284610748,
-0.03443364426493645,
0.0961579903960228,
1.6881253719329834,
-0.23758231103420258,
0.08468195796012878,
-0.2654106020927429,
0.605978786945343,
0.1309097409248352,
1.3567577600479126,
0.8837330341339111,
-0.2228982150554657,
1.8109630346298218,
-0.9152666926383972,
-1.6836622953414917,
-0.15177644789218903,
0.46546056866645813,
0.5975422859191895,
0.12546192109584808,
0.653223991394043,
0.9802939295768738,
0.21641865372657776,
0.16281215846538544,
0.6971430778503418,
0.5882183313369751,
-0.45562344789505005,
0.7088335156440735,
0.28172263503074646,
0.08563872426748276,
0.9429612159729004,
1.9043447971343994,
0.2321932166814804,
0.86078941822052,
-0.28201934695243835,
0.06631631404161453,
-0.3303993046283722,
0.34582486748695374,
0.8071597218513489,
0.6585280299186707,
0.5583336353302002,
-0.5538688898086548,
-0.5921856760978699,
-0.3663398325443268,
-0.412850558757782,
-0.768805980682373,
-0.0028013698756694794,
0.13270461559295654,
0.13843369483947754,
0.44350913166999817,
0.6273661851882935,
-0.2590518295764923,
-0.5290611982345581,
-0.3894898295402527,
-0.04579826071858406,
0.6176106929779053,
0.31324851512908936,
-0.32481205463409424,
-0.5989338755607605,
-0.03674289584159851,
0.3285432755947113,
0.5959675312042236,
0.378601610660553,
0.08606261759996414,
-0.00042899223626591265,
0.23668363690376282,
0.3676759898662567,
0.42221391201019287,
0.4369182288646698,
-0.327205091714859,
-0.12151820212602615,
-0.3849390745162964,
0.130555659532547,
-0.22963537275791168,
-0.3759736120700836,
-0.32334399223327637,
-0.5382722020149231,
0.034701261669397354,
-0.08236457407474518,
-0.09906837344169617,
-0.22948893904685974,
-0.174004927277565,
0.4164283275604248,
-0.17491614818572998,
-0.7279624938964844,
-0.3236829340457916,
-1.1760495901107788,
0.11687686294317245,
-0.34642720222473145,
0.42646539211273193,
-0.14125020802021027,
-0.01362997479736805,
0.2906409502029419,
0.6952763795852661,
0.058991845697164536,
-0.10478672385215759,
0.24858151376247406,
0.592534065246582,
0.5666603446006775,
0.2455081045627594,
-0.14506977796554565,
-0.2771309018135071,
-0.1933349221944809,
-0.14011655747890472,
0.27458059787750244,
-0.8540371060371399,
-0.6130234003067017,
-0.036133866757154465,
0.2364804595708847,
-0.20430614054203033,
-0.7918851971626282,
-0.1306283175945282,
0.19001570343971252,
0.26497381925582886,
-0.42207396030426025,
-0.26512274146080017,
0.3149494528770447,
-0.33445554971694946,
0.20322325825691223,
0.23762473464012146,
0.3364311754703522,
-0.49974653124809265,
-0.5786325931549072,
-0.431564599275589,
-0.23377829790115356,
-0.03195439651608467,
-0.29749077558517456,
-0.007757325656712055,
0.7429397702217102,
0.6883158087730408,
0.20257076621055603,
0.02134612388908863,
-0.34792956709861755,
-0.2479408234357834,
-0.5879727005958557,
0.68657386302948,
-0.3864913582801819,
-0.05268677696585655,
-0.19883789122104645,
0.04699090123176575,
-0.17343981564044952,
0.18718259036540985,
-0.483998566865921,
0.3411935567855835,
-0.14397184550762177,
0.19197697937488556,
-0.45270466804504395,
0.35509270429611206,
-0.48968222737312317,
-0.09184740483760834,
0.5176913738250732,
0.0017543273279443383,
0.628568172454834,
0.2815573215484619,
-0.06275197863578796,
0.4238604009151459,
-0.07461872696876526,
0.20029981434345245,
-0.05511581152677536,
0.19085124135017395,
0.05243818089365959,
0.23342807590961456,
-0.3830735683441162,
0.07162006944417953,
0.202742338180542,
0.14344677329063416,
-0.43092018365859985,
0.30522656440734863,
-0.07576129585504532,
0.02960028685629368,
-0.16230008006095886,
-0.08479028195142746,
0.03764916956424713,
-0.47621092200279236,
0.1789613664150238,
0.3408222496509552,
-0.13335908949375153,
0.2642291784286499,
0.32001155614852905,
-0.23687756061553955,
-0.19676841795444489,
-0.29297900199890137,
-0.052346229553222656,
-0.39737388491630554,
0.2450248897075653,
0.20055736601352692,
0.448523610830307,
0.2867431640625,
0.5628796815872192,
-0.6282859444618225,
0.2844288647174835,
0.11808450520038605,
0.2774680256843567,
-0.19251826405525208,
0.1982739120721817,
-0.5378109812736511,
-0.16753029823303223,
-0.3710714876651764,
-0.2032427340745926,
-0.1109352707862854,
0.16269679367542267,
-0.0381711944937706,
-0.06018621101975441,
0.6416438221931458,
0.41975969076156616,
0.36740970611572266,
0.0005119236884638667,
-0.13351909816265106,
-0.507819652557373,
-0.00721804378554225,
0.03445763513445854,
-0.6111905574798584,
-0.05546118691563606,
0.2761942446231842,
-0.2810826599597931,
0.1316501498222351,
0.3731516897678375,
0.48834940791130066,
0.19361457228660583,
0.1544848382472992,
-0.28505924344062805,
-0.12479079514741898,
0.00544726150110364,
0.46937820315361023,
-0.0821797251701355,
0.09605873376131058,
-0.11525727808475494,
-0.457267701625824,
0.04894407093524933,
0.3985687792301178,
0.23169158399105072,
0.27157366275787354,
-0.4715946316719055
] |
NCT02707900
|
Pilot Trial of the Effect of Vorinostat and AGS-004 on Persistent HIV-1 Infection
|
The purpose of this research study is to 1) evaluate the safety of a series of injections with the AGS-004 product in combination with a series of Vorinostat doses and 2) to help scientists evaluate ways of reactivating latent (non-acting) HIV virus and determine if the immune system can be made stronger to eliminate the activated HIV virus.
|
Purpose: Phase I study to measure the potential of AGS-004 combined with Vorinostat to: 1) stimulate expression of persistent proviral HIV from resting CD4+ cells, 2) generate an HIV-specific immune response, and 3) when combined, clear persistent infection in HIV-infected participants in whom viral replication and spread is inhibited by uninterrupted antiretroviral therapy (ART).
This is a phase I, single-site, pilot study intended to evaluate the association of serial AGS-004 vaccinations in combination with serial VOR doses on the expression of persistent proviral HIV, HIV-specific immune responses, and the frequency of resting CD4+T cell infection. Twelve participants with durable viral suppression will be enrolled. All participants will receive the same treatment and doses of AGS-004 and VOR and continue their baseline ART regimen throughout the study.
|
Inclusion Criteria:
1. Confirmation of HIV-1 infection HIV infection is defined as documentation by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
NOTE: The term "licensed" refers to a US FDA-approved kit.
WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.
2. Ages ≥ 18 to \< 65 years old.
3. Karnofsky performance status \>70.
4. Ability and willingness of participant to give written informed consent. Note: Due to the lack of foreseeable benefit to study volunteers, illiterate or mentally incompetent volunteers will not be enrolled.
5. Able and willing to provide adequate locator information.
6. On antiretroviral therapy (ART) for at least 24 months and on potent ART for \> or equal to 6 months prior to Screening (Visit 1).
Note: Potent ART is defined by current treatment guidelines and consists of at least 2 nucleoside/nucleotide reverse transcriptase inhibitors plus a non-nucleoside reverse transcriptase inhibitor, integrase inhibitor, or a protease inhibitor without interruption (defined as missing doses for more than two (2) consecutive days or more than four (4) cumulative days) in the 24 weeks immediately prior to Screening (Visit 1). Other potent fully suppressive antiretroviral combinations will be considered on a case-by-case basis. Prior changes in or elimination of medications for easier dosing schedule, intolerance, toxicity, or other reasons are permitted if an alternative suppressive regimen was maintained.
7. All participants must continue cART throughout the study.
8. Able and willing to adhere to protocol therapy and judged adherent to antiretroviral therapy.
9. Plasma HIV-1 RNA \< 50 copies/mL at screening (Visit 1).
10. Plasma HIV-1 RNA\< 50 copies/mL at two time points in the previous 12 months prior to study screening and never \> or equal to 50 copies/mL on two consecutive time points in the last 24 months prior to screening.
Note: A single unconfirmed plasma HIV RNA \> or equal to 50 copies (c)/mL but \< 1000 c/mL is allowed if a subsequent assay was \< 50 c/mL but not in the 6 months preceding the study screening visit (Visit 1).
11. CD4+ cell count ≥ 300 cells/mm3 at screening (Visit 1).
12. No history of auto-immune disease or auto-immune manifestations.
13. No active HCV infection (HCV antibody negative or no measureable HCV RNA) at or within 90 days of screening (Visit 1).
14. No active HBV infection (measureable HBV DNA or HBVsAg+) at or within 90 days of screening (Visit 1).
15. Ability and willingness to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
16. Adequate vascular access for leukapheresis.
17. Able to swallow pills without difficulty.
18. Able and willing to receive Intradermal (ID) injections without difficulty.
19. Women with written documentation of any of the following:
1. prior hysterectomy OR bilateral oophorectomy (removal of both ovaries)
2. bilateral tubal ligation or non-surgical permanent sterilization
3. Women with intact uterus and ovaries who have not had a period for ≥ one year AND have a documented FSH level indicating postmenopausal status.
20. All male study volunteers must agree not to participate in a conception process (e.g. active attempt to impregnate, sperm donation, in vitro fertilization) and, if participating in sexual activity that could lead to pregnancy, the male study volunteer and his female partner must use two reliable methods of contraception (condoms, with or without a spermicidal agent; a diaphragm or cervical cap with spermicide; an IUD; or hormonal-based contraception) simultaneously while receiving the protocol-specified study products and for 6 weeks after stopping the study products. Participants must use a reliable barrier method of contraception (condom, cervical cap) along with another form of contraception.
For the female partners of male study volunteers who are receiving ritonavir, estrogen-based contraceptives are not reliable and an alternative method should be suggested.
21. Potential participant must have adequate organ function as indicated by the following laboratory values:
System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1,500 /mcL Platelets ≥125,000 / mcL Hemoglobin ≥ 12 g/dL (males) and ≥ 11.5 g/dL (females) Coagulation Prothrombin Time or INR ≤1.1 x upper limit of normal (ULN) Chemistry K+ levels Within normal limits Mg++ levels ≥ 1.4 mEq/L Glucose Screening serum glucose ≤ Grade 1 (fasting or non-fasting) Albumin ≥ 3.5 g/dL Renal Creatinine clearance determined eGFR \> 60mL/min by the CKD-Epi equation found at: https://www.qxmd.com/calculate/calculator_ 251/egfr-using-ckd-epi Hepatic Serum total bilirubin Total bilirubin \<1.1 X ULN range, unless history of Gilbert's disease or deemed related to treatment with atazanavir. If total bilirubin is elevated, direct bilirubin must be \<2 X ULN range.
AST (SGOT) and ALT (SGPT) \<1.25 X ULN Lipase \<1.1 X ULN Alkaline Phosphatase \<1.25 X ULN
Exclusion Criteria:
1. Known allergy or sensitivity to the components of the investigational immunotherapy or the components of VOR or its analogs or DMSO.
2. HIV-2 antibody positive in the absence of a positive HIV-1 Western Blot as measured at the Screening Visit (Visit 1).
3. Untreated syphilis infection (defined as a positive rapid plasma reagin (RPR) without clear documentation of treatment).
Note: In cases of untreated syphilis, participant may re-screen following documentation of adequate treatment of syphilis
4. Received any infusion blood product, immune globulin, or hematopoetic growth factors within 90 days prior to study entry.
5. All women unless there is written documentation of menopause (absence of a period for ≥ one year and FSH level indicating menopause), hysterectomy, oophorectomy, or tubal ligation.
6. All male participants expecting to father children within the projected duration of the study.
7. Use of any of the following within 90 days prior to screening: immunomodulatory, cytokine, or growth stimulating factors such as systemic cytotoxic chemotherapy, systemic corticosteroids, immune globulin, interferon, cyclosporine, methotrexate, azathioprine, anti-CD25 antibody, IFN, interleukins, interleukin-2 (IL-2), hydroxyurea, thalidomide, sargramostim (granulocyte macrophage-colony stimulating factor \[GM-CSF\]), growth factors, dinitrochlorobenzene (DNCB), thymosin alpha, thymopentin, inosiplex, polyribonucleotide, or ditiocarb sodium, coumadin, warfarin, or other Coumadin derivative anticoagulants.
8. Use of the following medications that carry risk of torsade des pointes: amiodarone, arsenic trioxide, astemizole, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide, dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozide, probucol, procainimide, quinidine, sotalol, sparfloxacin, terfenadine, thioridazine.
9. Receipt of compounds with HDAC inhibitor-like activity, such as valproic acid within 30 days prior to screening. Potential participants may enroll after a 30-day washout period.
10. Use of any investigational antiretroviral agents within 30 days prior to Screening (Visit 1).
11. Use of antiretroviral medications that cannot be co-administered with Vorinostat within the 4 weeks of the first dose and anytime thereafter while on the study.
12. If the HIV care provider or study investigator is unable, as assessed by the study PI or protocol team, to construct a fully active alternative ART regimen based on previous resistance testing and/or treatment history.
13. Use of systemic corticosteroids or use of topical steroids over a total area exceeding 15 cm2 within 30 days prior to Screening, or anticipated need for periodic use of corticosteroids during the study.
NOTE: For participants receiving ritonavir (as a booster or protease inhibitor (PI) as part of their ART regimen, the concomitant use of oral/systemic/topical/inhaled/intranasal corticosteroids is prohibited.
14. Any serious illness requiring systemic treatment or hospitalization, the participant must either complete therapy or be clinically stable on therapy, in the opinion of the site investigator, for at least 90 days prior to entry.
15. Known history of a bone marrow disorder
16. Treatment for an active AIDS-defining opportunistic infection within 90 days prior to Screening.
17. Any active malignancy that may require chemotherapy or radiation therapy.
18. History of lymph node irradiation or dissection.
19. Evidence of hepatic decompensation in cirrhotic participants: history of ascites, hepatic encephalopathy, or bleeding esophageal varices.
20. History or other clinical evidence of significant or unstable cardiac disease (e.g., angina, congestive heart failure, recent myocardial infarction, significant arrhythmia) or clinically significant electrocardiogram (ECG) abnormalities. Any history of cardiac rhythm disturbance requiring medical or surgical therapy.
21. Any history of acute or chronic pancreatitis.
22. Any renal disorder deemed clinically significant by the investigator.
23. Active autoimmune disease or condition including, but not limited to:
Rheumatoid arthritis (RF positive arthritis with current or recent flare); Inflammatory bowel disease/ulcerative colitis/Crohn's Disease; Systemic lupus erythematosis (clinical evidence confirmed with ANA \>1:80); Ankylosing spondylitis; Hashimoto's disease; Scleroderma; Multiple sclerosis; Autoimmune hemolytic anemia (AHA); Thyroiditis Immune thrombocytopenic purpura; and, Type I diabetes mellitus (insulin therapy for Type II diabetes is permitted).
24. History or other evidence of severe illness, malignancy, immunodeficiency other than HIV, or any other condition that would make the participant unsuitable for the study in the opinion of the investigator (or designee) Note: A history of non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell skin cancer) is not exclusionary with documentation of complete resection.
25. History of neoplastic disease with extensive involvement of the bone marrow or lymphatic system or participants severely compromised hematopoietic function.
26. Inability to communicate with study personnel.
27. Compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric illness or a physical illness, e.g., infectious disease.
28. Prisoner recruitment and participation is not permitted.
29. Known psychiatric or substance abuse disorders that would interfere with participant's ability to fully cooperate with the requirements of the trial as assessed by the study investigator (or designee).
30. Participation in another investigational clinical research study (with the exception of an antiretroviral treatment trial that uses FDA approved antiretroviral agents) or use of investigational agents within 30 days prior to Screening (Visit 1).
|
[
-0.794765830039978,
2.540287971496582,
-1.1560051441192627,
-3.3138420581817627,
0.3075675070285797,
0.8101785182952881,
-1.6607109308242798,
0.5200279355049133,
-1.7996857166290283,
-0.6348323225975037,
-1.4645150899887085,
1.425015926361084,
-1.1912970542907715,
1.2709965705871582,
-0.2546076774597168,
-0.015208465047180653,
-1.0065720081329346,
1.4107660055160522,
1.7116894721984863,
-1.1001306772232056,
0.6559771299362183,
0.050688356161117554,
-0.8165126442909241,
-0.13176441192626953,
0.6431710124015808,
0.899600625038147,
-1.360405683517456,
0.45184198021888733,
0.08632206171751022,
0.9300754070281982,
-0.5132933259010315,
-1.0071806907653809,
0.2718351483345032,
0.43088293075561523,
0.7793170809745789,
-0.23331815004348755,
1.5167858600616455,
-0.021293288096785545,
-1.2634954452514648,
0.27069056034088135,
0.6803011894226074,
0.8464875221252441,
0.9126909375190735,
-0.16477416455745697,
2.135016679763794,
-0.537693202495575,
0.2962847650051117,
0.16015547513961792,
1.7952725887298584,
0.5408272743225098,
0.05017132684588432,
0.18967784941196442,
0.4379325807094574,
0.2968031167984009,
3.151761770248413,
-0.12875445187091827,
0.6533567905426025,
-0.11211057007312775,
0.47058114409446716,
0.37993526458740234,
-0.06373140960931778,
-0.857974648475647,
0.7413063049316406,
-0.8117628693580627,
-0.8329706788063049,
-0.042486466467380524,
0.3299773037433624,
-0.6464374661445618,
0.057568542659282684,
0.037821367383003235,
0.05229579284787178,
0.480100154876709,
0.12978728115558624,
0.8692083954811096,
-0.10105610638856888,
0.681393563747406,
-0.058340124785900116,
0.1916026622056961,
0.7521793842315674,
-0.19569404423236847,
-0.6807243227958679,
-0.15410013496875763,
-0.5103685855865479,
-0.131149560213089,
0.7653310298919678,
-1.1233041286468506,
0.3540497422218323,
-0.4901205897331238,
0.2546805143356323,
-1.033111333847046,
0.037733159959316254,
0.25727441906929016,
0.13455910980701447,
0.19463248550891876,
0.13858948647975922,
-0.33503538370132446,
0.5373472571372986,
0.013867635279893875,
-0.23948422074317932,
-0.5279543399810791,
-0.10885731875896454,
-0.49772098660469055,
-0.4451424181461334,
-0.16505073010921478,
-1.019309639930725,
-0.36544883251190186,
-1.1724884510040283,
0.06591259688138962,
-0.6893720030784607,
-0.034649260342121124,
0.3851745128631592,
-0.8717413544654846,
-0.10755202919244766,
-1.197763204574585,
0.2194196581840515,
-1.1120123863220215,
-0.4088042378425598,
0.36559998989105225,
-0.10048254579305649,
0.726198673248291,
0.43341243267059326,
-0.10602733492851257,
0.2992476522922516,
0.12722548842430115,
-0.09132789075374603,
0.23466087877750397,
0.28418484330177307,
-0.290132999420166,
-0.24244189262390137,
-1.0186022520065308,
-0.38548511266708374,
-0.21064938604831696,
0.35240766406059265,
0.45272043347358704,
0.03016030043363571,
-0.9538910984992981,
0.03516721725463867,
0.43791067600250244,
0.3821987807750702,
0.1987360417842865,
-0.42911824584007263,
0.9364000558853149,
0.13055849075317383,
-0.21506381034851074,
-1.4703736305236816,
0.12655283510684967,
0.05653694272041321,
1.0310393571853638,
0.47456395626068115,
-0.5889448523521423,
-0.1702677309513092,
0.5981539487838745,
-0.6165254712104797,
-0.3215799927711487,
-0.14867526292800903,
-0.08311358094215393,
-0.6604391932487488,
-0.661078691482544,
-0.186420738697052,
0.945188581943512,
-0.438912570476532,
0.3223426640033722,
-0.1283271461725235,
-0.5881526470184326,
0.12205624580383301,
0.38615474104881287,
-0.11551149934530258,
-0.10497481375932693,
-0.1891121119260788,
-0.41993603110313416,
-0.262146919965744,
0.5647109150886536,
-0.06287896633148193,
-0.0538473017513752,
0.5401687026023865,
0.10953409969806671,
0.35291123390197754,
0.3989969491958618,
-0.038191359490156174,
-0.1854741871356964,
0.1747083216905594,
0.937839150428772,
-0.41855037212371826,
-0.05682112276554108,
0.47341421246528625,
-0.5132033824920654,
-0.26452386379241943,
-0.33753302693367004,
-0.22759012877941132,
0.08467122167348862,
0.43688324093818665,
-0.09827957302331924,
0.2031393200159073,
0.4383133351802826,
-0.31116095185279846,
0.5937095880508423,
-0.11810079962015152,
-0.6295040249824524,
0.3524395525455475,
-0.49084487557411194,
0.7540621757507324,
-0.08839106559753418,
0.3856741189956665,
0.6953164935112,
-0.37708064913749695,
0.2649632692337036,
-0.058444034308195114,
-0.3365912139415741,
0.4011135995388031,
0.3765925168991089,
-0.22610555589199066,
0.11474787443876266,
-0.3809492290019989,
0.24146881699562073,
0.5279300212860107,
0.16873891651630402,
-0.45491302013397217,
-0.1870415210723877,
-0.17860639095306396,
-0.2316441386938095,
-0.3004070818424225,
-0.0006895030965097249,
-0.11392994970083237,
0.3287446200847626,
-0.0610615611076355,
-0.3559795618057251,
0.3399501144886017,
-0.32758641242980957,
-0.2062927633523941,
0.08730548620223999,
-0.23784443736076355,
0.1851777285337448,
0.21141238510608673,
-0.2894657850265503,
-0.0717456191778183,
0.08199798315763474,
0.01409811619669199,
-0.07760130614042282,
-0.2754426598548889,
-0.26621538400650024,
0.3573070168495178,
-0.36633598804473877,
0.2450316846370697,
-0.5389246344566345,
0.029854819178581238,
-0.4678456485271454,
0.8140919208526611,
0.5885449051856995,
0.20944809913635254,
-0.20163756608963013,
-0.07379652559757233,
-0.44804123044013977,
-0.23134663701057434,
-0.151850625872612,
-0.12691661715507507,
-0.5741412043571472
] |
NCT06635785
|
Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors
|
BIPAVE-001 is a Phase 1-2 study for evaluating the safety, pharmacokinetics (PK), and efficacy of AI-081 in solid tumors.
|
AI-081 is a bispecific antibody against PD-1 and VEGF. The study BiPAVE-001 is consisting of two integrated parts: Part A is the first-in-human dose escalation study to determine the recommended Phase 2 dose (RP2D) of AI-081 monotherapy, while Part B are dose optimization trials comparing the safety and clinical activities of AI-081 at RP2D and one dose level lower than RP2D (RP2D-1), either as monotherapy or in combination therapy with standard of care (SOC) in selected indications.
|
Inclusion Criteria:
* Patient is ≥ 18 years of age on the day of signing informed consent.
* Male or female, female patient of childbearing potential must have negative pregnancy test.
* Patient must have a performance status of ≤ 1 on the ECOG Performance Scale.
* Patients must have a histological or cytological diagnosis of solid tumors and have metastatic disease or locally advanced disease.
* Measurable disease as determined by RECIST 1.1
* Patient must have adequate organ function as indicated by the following laboratory values
* Patient has voluntarily agreed to participate by giving written informed consent.
* Female patients enrolled in the study, if having childbearing potential (WOCBP) and sexually active, must agree to use adequate and effective birth control starting with the first dose of study drug through 90 days after the last dose of study therapy.
* Male patients, if sexually active, must agree to use adequate and effective methods of contraception starting with the first dose of study drug through 90 days after the last dose of study therapy.
Exclusion Criteria:
* Patients who have not recovered to NCI CTCAE grade ≤ 1 from an adverse event (AE) due to cancer therapeutics except the chemotherapy-associated peripheral neuropathy (motor or sensory) or alopecia. Patients with ongoing and adequately controlled endocrine immune-related AEs are considered stable and eligible for enrollment. The washout period for treatment regimen containing monoclonal antibodies is 28 days. Palliative radiotherapy for painful metastases or metastases in potentially sensitive locations (e.g., epidural space) ≥ 7 days prior to the first dose of study drug. Best supportive care, such as thyroxine, insulin, steroid replacement treatment, blood transfusion and therapy for non-cancer condition are allowed.
* Patients who are currently enrolled in any other clinical trial testing an investigational agent or device, or with concurrent anticancer treatment (except palliative bone-directed radiotherapy), immune therapy, or cytokine therapy or anticipated to require another antineoplastic therapy during the study.
* Patients who are on chronic systemic steroid therapy at doses higher than 10 mg/day prednisone or equivalent within 7 days before first treatment.
* Patients who have brain metastases or leptomeningeal metastases.
* Patient with a different cancer other than the one treated under this protocol, which requires systemic treatments within 24 months prior to C1D1.
* Patient has history of grade ≥3 allergic or hypersensitivity to IV infusion medications, or severe allergic reactions to food, pollen, oral medications, or atopic dermatitis or asthmatic episodes that required hospitalization.
* Within past 6 months with history of significant cardiovascular acute myocardial infarction, acute coronary syndrome, ischemic or hemorrhagic stroke, revascularization procedures, acute pulmonary embolism or any disorders resulted in LVEF \< 40% at the time of screening or colitis, small bowel obstruction, hepatitis or pancreatitis adrenal insufficiency, or severe immunotherapy related AE (irAE≥ grade 3).
* Patients who have acute infections which require systemic treatments within 14 days prior to C1D1.
* Patients who, in the opinion of the treating Investigator, have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or make study participation not in the best interest of the patient, in the opinion of the treating Investigator. Investigators should discuss the case with the Sponsor and/or study leaders.
* Patients with known psychiatric or substance abuse disorders may interfere with cooperation with the requirements of the trial.
* Patients who are pregnant or breastfeeding or plan pregnancy or fathering the child during the study or within 6 months after the last dosing of study drug
* Patients with tumor surrounds important blood vessels or has obvious necrosis, cavitation, or invades surrounding important organs and blood vessels or otherwise with high risk of fatal hemorrhage
* Uncontrolled hypertension: systolic pressure ≥ 150 millimeters of mercury (mmHg) or diastolic pressure ≥ 90 mmHg on repeated measurements that cannot be managed by standard antihypertension medications ≤ 28 days before the first dose of study drug(s).
* Medical history of cardiovascular diseases, gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose.
* Patients with clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
* With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc.
|
[
1.009447693824768,
3.4034264087677,
-2.638993263244629,
-3.3713622093200684,
0.1651768982410431,
0.21588267385959625,
-0.6954039931297302,
-0.9340353012084961,
0.5715575814247131,
-1.235641598701477,
-0.9800387620925903,
2.2966372966766357,
0.2581067681312561,
0.7908951640129089,
0.2733418047428131,
1.404613971710205,
-0.029513049870729446,
-0.31357964873313904,
0.9941179156303406,
-1.3120416402816772,
0.19963008165359497,
-0.8639721870422363,
0.24568785727024078,
2.0563559532165527,
-0.26457729935646057,
-0.6840062141418457,
-0.8627514243125916,
2.477980375289917,
-0.11290424317121506,
1.2627524137496948,
-0.40224483609199524,
0.03628653660416603,
-0.46719232201576233,
2.088226795196533,
-0.7060109972953796,
0.1686898171901703,
0.9175784587860107,
0.5746412873268127,
-0.9218775629997253,
-0.6902772188186646,
0.6358106136322021,
0.4619355797767639,
0.31814688444137573,
-0.6811295747756958,
-0.045531027019023895,
-0.39115139842033386,
-0.3525857627391815,
0.46497583389282227,
1.0490394830703735,
0.36770355701446533,
-1.5191633701324463,
0.21173565089702606,
-1.8244750499725342,
0.03211168944835663,
2.800511598587036,
-0.7030560374259949,
-0.6199082732200623,
0.16070996224880219,
1.9158529043197632,
-0.3693074584007263,
-0.7856432199478149,
-1.2022942304611206,
0.4650126099586487,
0.7623618245124817,
-0.20327939093112946,
0.5265609622001648,
0.18375520408153534,
0.37514859437942505,
-1.323243498802185,
0.3990595042705536,
0.3898993134498596,
0.863508939743042,
-0.2809942960739136,
0.7481229305267334,
1.3700447082519531,
0.9152316451072693,
1.5450468063354492,
0.4763249158859253,
0.5522453188896179,
0.6383330225944519,
-0.448000431060791,
-1.6074028015136719,
-0.8535923957824707,
-0.4141451418399811,
-0.37723806500434875,
1.1155683994293213,
0.23610760271549225,
-0.758496105670929,
-0.6446940898895264,
-0.6932322978973389,
0.27820533514022827,
0.42854902148246765,
-1.0578409433364868,
0.12701617181301117,
-0.664272129535675,
-0.391793817281723,
-0.16225872933864594,
0.24501538276672363,
-1.0772767066955566,
0.33443310856819153,
-0.568748414516449,
0.8119216561317444,
-1.1364704370498657,
-0.16981151700019836,
-0.8832393288612366,
0.45251020789146423,
-0.40259939432144165,
-1.0458258390426636,
0.48444604873657227,
-1.020099401473999,
0.7619410753250122,
-1.1403323411941528,
0.3355126678943634,
-0.019648700952529907,
0.6998866200447083,
0.17982785403728485,
0.4743422567844391,
0.23043860495090485,
0.504561722278595,
0.19701740145683289,
-0.15412163734436035,
0.4037870764732361,
0.1960970163345337,
0.7127693295478821,
0.2686942219734192,
0.021936364471912384,
0.5269773602485657,
-0.2931039333343506,
-0.8284329175949097,
-0.8926313519477844,
-0.9345473051071167,
0.13196241855621338,
0.34847673773765564,
0.1051076352596283,
-0.7027432322502136,
-0.3801065981388092,
0.3676418364048004,
0.5569221377372742,
0.3690336048603058,
-0.5918138027191162,
0.4223988354206085,
0.8258137106895447,
0.41220399737358093,
-1.1418023109436035,
-0.7557871341705322,
-0.07812436670064926,
-0.4205356538295746,
0.32697248458862305,
0.01459231786429882,
-0.2541670501232147,
-0.0920545905828476,
0.5459442138671875,
0.3198639452457428,
0.09721112251281738,
0.5995519757270813,
0.28763648867607117,
0.4781239926815033,
-1.1096558570861816,
0.23915621638298035,
0.41594114899635315,
-0.7553707957267761,
0.011066294275224209,
-0.020290762186050415,
-0.483479380607605,
-0.5487907528877258,
0.2570820450782776,
-0.30292055010795593,
-0.9043185710906982,
-0.7943986058235168,
0.3954397439956665,
-1.3627212047576904,
0.23746630549430847,
0.8700485229492188,
0.7277029156684875,
0.0733317956328392,
-0.538013756275177,
0.4935457706451416,
-0.01882541924715042,
0.016835488379001617,
0.43735939264297485,
-0.9107348918914795,
0.2578588128089905,
0.286954790353775,
0.2870026230812073,
0.357409805059433,
0.1269480139017105,
0.3309609889984131,
0.2419421672821045,
0.20391550660133362,
-0.015405433252453804,
-0.3300946056842804,
-0.4952794015407562,
0.04469820484519005,
0.32714468240737915,
0.03910906985402107,
-0.4968504309654236,
0.5449455976486206,
0.11202440410852432,
0.4680264890193939,
-0.6952170133590698,
0.4274825155735016,
0.2345861792564392,
0.8603096008300781,
0.2640068233013153,
0.6900299787521362,
0.19940298795700073,
-0.47999444603919983,
0.8797823786735535,
0.013597344979643822,
0.3870750367641449,
-0.594538688659668,
-0.14403249323368073,
0.10411859303712845,
-0.14411166310310364,
0.7097411155700684,
-0.31223705410957336,
-0.2771255671977997,
0.4385327100753784,
-0.2795363664627075,
0.10439176857471466,
-0.28822657465934753,
0.18528109788894653,
-0.09918316453695297,
0.22341717779636383,
0.2840157449245453,
0.10448600351810455,
-0.6594616770744324,
-0.5066180229187012,
-0.07422014325857162,
-0.5830665826797485,
-0.453084796667099,
-0.0242803655564785,
-0.4866793751716614,
0.539373517036438,
0.15782880783081055,
-0.4079245924949646,
0.7457707524299622,
0.34134384989738464,
0.06328295916318893,
0.43536025285720825,
0.11164672672748566,
-0.26173287630081177,
-0.3126037120819092,
0.0046896361745893955,
0.18913817405700684,
0.31245121359825134,
-0.39354732632637024,
-0.23794586956501007,
0.077842116355896,
0.34339407086372375,
0.15974807739257812,
-0.37872716784477234,
-0.27418047189712524,
0.7795712947845459,
-0.3694443702697754,
-0.5267580151557922
] |
NCT00199056
|
German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (06/99)
|
The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy. Thereafter patients receive individualised treatment stratified according to relapse risk with stem cell transplantation for patients with high and very high risk of relapse. Patients with standard risk receive further consolidation and reinduction chemotherapy. In parallel minimal residual disease (MRD) is evaluated. A MRD based risk stratification and treatment decision is developed.
|
Inclusion Criteria:
* Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, T)
* Age 15-65 yrs (\*55-65 years if biologically younger according to general condition)
Exclusion Criteria:
* Severe comorbidity
* Cytostatic pre-treatment
* Pregnancy
* Missing written informed consent
|
[
-1.4431082010269165,
3.8199784755706787,
-1.445023775100708,
-2.452796697616577,
-0.4930739998817444,
-0.4881690740585327,
-1.7532775402069092,
1.6860671043395996,
-2.63751220703125,
0.16424767673015594,
-2.174445152282715,
2.476487874984741,
-0.5553771257400513,
0.05729571729898453,
-0.3713209927082062,
-0.09129452705383301,
-0.8578991889953613,
1.0249009132385254,
0.6703068614006042,
-1.9020940065383911,
0.21757839620113373,
-0.3936334252357483,
1.5360952615737915,
2.2299747467041016,
0.09592679142951965,
-1.1489540338516235,
-0.8350025415420532,
1.9048172235488892,
1.4022613763809204,
1.7630892992019653,
0.2389354258775711,
-1.0709599256515503,
0.4916713535785675,
0.019064800813794136,
-0.22332313656806946,
-0.6272444725036621,
0.6575765013694763,
-0.9462112188339233,
-1.565166711807251,
0.5301311612129211,
-0.21401995420455933,
0.5785999298095703,
-0.6780269742012024,
-0.3496837317943573,
0.9241921305656433,
0.4782153069972992,
-0.888746440410614,
0.14012044668197632,
0.6872429847717285,
0.06574978679418564,
-0.532228410243988,
0.3810637295246124,
-1.4363511800765991,
1.2543282508850098,
0.9936124682426453,
2.067319631576538,
0.814744770526886,
0.41929638385772705,
2.1090166568756104,
0.10519587248563766,
0.8753060102462769,
0.3010546863079071,
-1.127061128616333,
-0.029201671481132507,
-1.601638674736023,
-0.7013309597969055,
-0.015173565596342087,
0.42504411935806274,
-1.265729546546936,
-0.2091449499130249,
0.7635267376899719,
-0.8748080730438232,
0.8982719779014587,
1.2478458881378174,
-0.2600487172603607,
0.35765644907951355,
0.09459351748228073,
-0.3481612801551819,
0.24044379591941833,
-0.17160524427890778,
-0.09993305802345276,
-0.4336143732070923,
-1.0201714038848877,
0.11733926087617874,
0.25637921690940857,
-1.7877780199050903,
-0.7631194591522217,
-0.7830384373664856,
0.043360088020563126,
-1.6828064918518066,
-0.1383344978094101,
-0.7106503844261169,
-0.9573495388031006,
1.2456666231155396,
-0.7566213607788086,
1.4035530090332031,
-0.5886287689208984,
-1.4245413541793823,
-1.451438307762146,
-0.26128512620925903,
1.2390642166137695,
-0.7389202117919922,
-0.40924450755119324,
-0.3383778929710388,
-0.8906394243240356,
0.49050307273864746,
-0.1312861293554306,
-0.6577824354171753,
-0.5299023389816284,
-0.4863799810409546,
0.8057651519775391,
-1.7150930166244507,
0.6670283675193787,
-0.7305692434310913,
0.27836382389068604,
-0.19787833094596863,
0.1740986555814743,
-0.1482122242450714,
0.080071821808815,
-0.06294302642345428,
0.7019810676574707,
0.44136133790016174,
0.4288405478000641,
0.15658682584762573,
-0.6138743162155151,
-0.03179740533232689,
-0.506777822971344,
0.6861977577209473,
-0.3415455222129822,
-0.4420592784881592,
-0.5980194807052612,
0.4843251407146454,
-0.3957618474960327,
0.30744752287864685,
-1.133021354675293,
-0.1990777552127838,
0.2685304582118988,
1.9672707319259644,
0.10035431385040283,
-0.897890567779541,
0.07603161782026291,
0.7850361466407776,
0.5592783093452454,
0.313623309135437,
-1.2856801748275757,
-0.5958728790283203,
0.32310542464256287,
0.8460488319396973,
-0.8116947412490845,
-0.3071821630001068,
-0.014299835078418255,
0.10867168009281158,
-0.29484066367149353,
0.13278734683990479,
-0.1023385301232338,
1.1174753904342651,
0.5294026732444763,
-0.7665969133377075,
0.33761483430862427,
-1.0283890962600708,
-0.28867846727371216,
-0.6149916648864746,
0.40007442235946655,
-1.7157976627349854,
0.9083422422409058,
0.3951410949230194,
0.44596704840660095,
0.03592947870492935,
0.6574019193649292,
0.31970933079719543,
-0.29289737343788147,
0.9560065269470215,
0.7656564712524414,
0.29225051403045654,
-0.24728886783123016,
-0.42667821049690247,
0.7472591400146484,
0.01597284898161888,
0.24155792593955994,
0.04994233325123787,
0.5077261328697205,
0.08539095520973206,
0.23544950783252716,
-0.526724100112915,
0.42313680052757263,
-0.06173950433731079,
0.04768452048301697,
0.2379707396030426,
0.24980726838111877,
0.45680755376815796,
0.27821093797683716,
0.22350355982780457,
0.30339962244033813,
0.38531678915023804,
0.08078793436288834,
-0.8170514106750488,
-0.19856669008731842,
-0.6073241233825684,
0.4029000997543335,
-0.03444508835673332,
0.3874875605106354,
-0.3243802785873413,
0.3686966300010681,
0.6021261811256409,
-0.12336239218711853,
-0.4161378741264343,
0.08629976212978363,
-0.49648138880729675,
-0.5715643763542175,
0.09193183481693268,
0.8350041508674622,
-0.32534465193748474,
0.25405779480934143,
0.1472749412059784,
0.07240983843803406,
0.5479416847229004,
0.3841502070426941,
0.9435096383094788,
-0.9639892578125,
0.24774330854415894,
-0.2932741641998291,
-0.9150229692459106,
-0.1480858474969864,
0.7920646071434021,
0.021617740392684937,
0.5718925595283508,
0.20720861852169037,
0.22275997698307037,
-0.548483669757843,
-0.8555602431297302,
-0.02823503315448761,
-0.08198487758636475,
-0.010824170894920826,
-0.09590934216976166,
0.46645277738571167,
-0.00340862525627017,
-0.5329229831695557,
0.2522987127304077,
-0.38477152585983276,
0.22326885163784027,
0.4983425438404083,
-0.9501118063926697,
0.29045116901397705,
0.17210906744003296,
0.12601929903030396,
0.2834200859069824,
-0.3067832291126251,
0.03682965040206909,
0.13464392721652985,
0.15122361481189728,
-0.4807973802089691,
-0.2444722056388855,
0.08164995908737183,
-0.047941144555807114,
0.33925577998161316,
-0.7621470093727112
] |
|
NCT03521375
|
VIdeo Assisted Thoracoscopic Lobectomy Versus Conventional Open LobEcTomy for Lung Cancer
|
Lung cancer is the leading cause of cancer death worldwide and survival in the United Kingdom (UK) remains amongst the lowest in Europe. Surgery is the main method of managing early stage disease and is traditionally undertaken via conventional open surgery. However, over the last decade there has been a surge in the number of minimal access resections performed using Video-assisted thoracoscopic surgery (VATS). However, there remains a need for well-designed and conducted randomised controlled trial (RCT) to provide the evidence base for the wide spread uptake and delivery of this surgical approach.
|
The uptake of surgery for lung cancer in the UK is low and minimal access surgery may be regarded as a more acceptable intervention (compared to open surgery) by patients, referring respiratory physicians and oncologists. However, a large multi-centre RCT is essential to inform patient and clinician decision making and influence surgical practice in the UK.
The VIOLET study will compare the effectiveness, cost-effectiveness and acceptability of VATS lobectomy versus open surgery for treatment of lung cancer and will test the hypothesis that VATS surgery is superior to open surgery with respect to self-reported physical function five weeks after randomisation (approx. one month after surgery).
Specific objectives are to estimate:
A. The difference between groups in the average self-reported physical function at five weeks.
B. The difference between groups with respect to a range of secondary outcomes including assessment of efficacy (hospital stay, pain, proportion and time to uptake of chemotherapy), measures of safety (adverse health events), oncological outcomes (proportion of patients upstaged to pN2 disease and disease free survival) and overall survival.
C. The cost effectiveness of VATs and open surgery.
|
Inclusion Criteria:
1. Adults aged ≥16 years of age
2. Able to give written consent, undergoing either:
i. Lobectomy or bilobectomy for treatment of known or suspected primary lung cancer beyond lobar orifice\* in TNM8 stage cT1-3 (by size criteria, equivalent to TNM7 stage cT1a-2b) or cT3 (by virtue of 2 nodules in the same lobe), N0-1 and M0 or ii. Undergoing frozen section biopsy with the intention to proceed with lobectomy or bilobectomy if primary lung cancer with a peripheral tumour beyond a lobar orifice\* in TNM8 stage cT1-3 (by size criteria, equivalent to TNM7 stage cT1a-2b) or cT3 (by virtue of 2 nodules in the same lobe), N0-1 and M0 is confirmed
3. Disease suitable for both minimal access (VATS) and open surgery
Exclusion Criteria:
1. Adults lacking capacity to consent
2. Previous malignancy that influences life expectancy
3. Patients in whom a pneumonectomy, segmentectomy or non-anatomic resection (e.g. wedge resection) is planned
4. Patients with a serious concomitant disorder that would compromise patient safety during surgery.
5. Planned robotic surgery
|
[
-0.4529630243778229,
3.296473979949951,
0.11741605401039124,
-1.2903451919555664,
-0.29789358377456665,
1.4512948989868164,
-0.8310954570770264,
0.09716616570949554,
-1.7809488773345947,
1.559576392173767,
-0.1417977511882782,
0.9028196334838867,
-0.6849395632743835,
-0.9775344729423523,
0.027981238439679146,
0.4013831615447998,
0.06267596036195755,
0.7555393576622009,
-0.09794142097234726,
0.04863552004098892,
0.7141009569168091,
-0.03723761811852455,
-0.13050231337547302,
0.33842626214027405,
0.6347495913505554,
-0.416104257106781,
0.18667103350162506,
-0.6670176386833191,
0.00520450109615922,
0.5517799258232117,
0.20473560690879822,
-0.6701724529266357,
-0.8206221461296082,
0.9491512179374695,
-0.1304021030664444,
0.13412068784236908,
0.49456673860549927,
-0.29776179790496826,
-0.870777428150177,
0.12147152423858643,
2.011253595352173,
0.8343794345855713,
-0.43484607338905334,
-0.676868200302124,
1.0599610805511475,
0.35014334321022034,
1.108080267906189,
0.3091578781604767,
0.2030845433473587,
0.31545498967170715,
-1.2305611371994019,
0.5907267332077026,
-0.9181619882583618,
0.7590923309326172,
0.8026412129402161,
0.810971200466156,
0.33277907967567444,
0.5903013944625854,
0.713394820690155,
0.022410081699490547,
0.4946819245815277,
0.5045967698097229,
0.244810089468956,
0.43464788794517517,
-0.016651354730129242,
-1.4137214422225952,
-0.6022079586982727,
0.7190973162651062,
0.18679167330265045,
0.027619151398539543,
1.2860902547836304,
0.24464909732341766,
0.9479030966758728,
-0.10618817061185837,
-0.3215196430683136,
0.2799338400363922,
-0.5224334001541138,
-0.025902630761265755,
0.849879801273346,
-0.3040635883808136,
-0.03960747271776199,
0.07690027356147766,
-0.11817296594381332,
-0.4413743317127228,
-0.7840953469276428,
0.4488674998283386,
-0.35027244687080383,
-0.7801852226257324,
0.3344023823738098,
-0.7608494758605957,
0.6049109697341919,
0.11898680031299591,
-0.7678026556968689,
-0.13374799489974976,
-1.4369711875915527,
0.8832138180732727,
0.03730201721191406,
-0.3647695779800415,
-1.4233286380767822,
-1.0057871341705322,
0.7042942047119141,
-0.06516411900520325,
0.42413362860679626,
-0.15379741787910461,
-1.2225679159164429,
-0.7648447155952454,
-0.631199300289154,
-0.08025294542312622,
-0.10365104675292969,
-0.77985680103302,
0.7788467407226562,
-1.481053352355957,
0.36415156722068787,
-0.3146153390407562,
0.26846981048583984,
-0.5069674253463745,
0.20080876350402832,
0.2557000517845154,
0.24447032809257507,
-0.9362958073616028,
-0.5083308815956116,
0.6130021214485168,
-0.027384791523218155,
0.5575422048568726,
-0.6706061363220215,
0.13815544545650482,
-0.6567336320877075,
0.9058903455734253,
0.076718270778656,
-0.46401089429855347,
-0.39708223938941956,
0.619589626789093,
0.3649282455444336,
-0.8759624361991882,
-0.022373948246240616,
-0.33498021960258484,
0.4349116086959839,
1.2542818784713745,
0.5400519967079163,
-0.6039322018623352,
0.3768671452999115,
0.48010432720184326,
-0.47009947896003723,
-0.1578466296195984,
-1.0587369203567505,
0.04150921851396561,
-0.867844820022583,
0.3234446048736572,
-1.0790446996688843,
-0.6168872117996216,
0.36960774660110474,
0.28725647926330566,
0.09416785091161728,
-0.05697793513536453,
0.13526995480060577,
0.21892565488815308,
0.3179846405982971,
0.040498267859220505,
-1.0422930717468262,
-0.3989395499229431,
-0.3038273751735687,
0.2722102999687195,
0.17346473038196564,
-1.147119164466858,
0.2497195452451706,
-0.3972793221473694,
0.23909015953540802,
-0.12922333180904388,
0.2951871156692505,
0.2786107063293457,
-0.03427158296108246,
-0.5607197284698486,
0.269603431224823,
0.08534712344408035,
-0.354450523853302,
0.20756685733795166,
0.507847249507904,
-0.26306286454200745,
0.1026226282119751,
0.018362153321504593,
0.21552564203739166,
-0.34656137228012085,
0.11201994121074677,
0.15938995778560638,
-0.44948574900627136,
-0.029974661767482758,
0.4711190164089203,
-0.5063146948814392,
-0.3415747284889221,
0.2896873652935028,
-0.04503881186246872,
-0.03889557719230652,
0.28321170806884766,
0.29983022809028625,
0.24870097637176514,
0.5310528874397278,
-0.2528062164783478,
0.10115474462509155,
0.36064964532852173,
-0.005311340559273958,
0.574882447719574,
-0.06221078336238861,
-0.521409273147583,
-0.043754756450653076,
-0.2719450294971466,
0.006014958489686251,
0.534751296043396,
-0.4034210741519928,
-0.65204918384552,
0.2956708073616028,
-0.2109423279762268,
-0.14682187139987946,
-0.14438849687576294,
-0.6430819630622864,
0.39319300651550293,
-0.4573247730731964,
-0.028713198378682137,
0.20864254236221313,
-0.9775881171226501,
-0.35478508472442627,
0.2508378028869629,
0.04034882038831711,
0.1444181203842163,
0.4627764821052551,
0.057434942573308945,
0.04059101641178131,
0.1317852884531021,
-0.11574363708496094,
0.06514760106801987,
-0.39671826362609863,
-0.05157087743282318,
-0.20748986303806305,
0.16288428008556366,
-0.042203713208436966,
-0.2774052023887634,
-0.5919851064682007,
0.5039092302322388,
-0.2322731465101242,
-0.7353543043136597,
-0.030812740325927734,
0.016030924394726753,
-0.25115108489990234,
0.03452135622501373,
-0.14563095569610596,
0.13635064661502838,
0.5686001777648926,
-0.32021620869636536,
0.06998607516288757,
-0.034256335347890854,
0.13226929306983948,
0.38568246364593506,
-0.02038223296403885,
0.08236759901046753,
-0.3676344156265259,
-0.24286861717700958,
-0.2977677881717682
] |
NCT04698486
|
Hepatic and Cardiac Metabolic Flexibility in Subjects With T2DM With and Without NAFLD
|
Non-alcoholic fatty liver disease (NAFLD) covers a spectrum from simple reversible hepatic steatosis to inflammation and fibrosis termed steatohepatitis (NASH) and cirrhosis. Accumulating evidence indicates that NAFLD is associated with development of heart failure, abnormal ventricular glucose and fatty acid (FA) utilisation and cardiac steatosis. The mechanisms behind why some subjects progress from NAFLD to NASH and the link between cardiac involvement and NAFLD are poorly understood, but must include altered cardiac and intrahepatic lipid handling. Investigators plan comprehensive kinetic studies of heart and liver FA uptake and oxidation, ventricular function and substrate utilisation, and hepatic triglyceride (TG) secretion in order to assess mechanisms governing cardiac and hepatic lipid and glucose trafficking in subjects with type 2 diabetes with and without NAFLD and NASH and the relationship with heart function. In addition, the investigators will assess skeletal muscle and adipose tissue enzyme activities, gene expression and protein concentrations in type 2 diabetic subjects to define mechanisms involved in the cross-talk between heart, liver, muscle and adipose tissues. Investigators will address these questions using tracer techniques (11Cpalmitate PET tracers and triglyceride (TG) tracers) to study cardiac and liver substrate trafficking, as well as MR spectroscopy, echocardiography, muscle and fat biopsies in combination with state-of-the art muscle and adipose tissue enzyme kinetics, gene- and protein expression. The overarching goals are to define abnormalities and differences between NAFLD and NASH in hepatic lipid (FA and TG) metabolism.
|
Inclusion Criteria:
* Subjects with Type 2 Diabetes with and without NAFLD (steatosis FF% \> 5,6% on MR spectroscopy for NAFLD and NASH groups)
Exclusion Criteria:
* Active smoking
* Comorbidity other than hypertension and hyperlipidemia
* Fixed medical drug consumption (including insulin) except statins and anti-diabetic medications. However, statins and weekly based GLP-1 agonist must be paused 1 week before the examination date and other antidiabetic medication 3 days before the study date.
* Patients with cancer or former cancer patients
* Blood donation within the last 3 months prior to the study
* Participation in experiments involving radioactive isotopes within the last 3 months
* Alcohol abuse (over 21 items per week for men and over 14 for women)
* Pregnancy
|
[
1.506902813911438,
1.2883903980255127,
-2.1772093772888184,
-3.2903707027435303,
0.11437010020017624,
-0.9706943035125732,
-0.58658367395401,
0.3210788071155548,
-1.9243162870407104,
-1.353790044784546,
1.4978786706924438,
1.590896725654602,
0.13338512182235718,
0.6607802510261536,
0.04932139068841934,
0.19173024594783783,
0.18820679187774658,
0.5218846797943115,
1.6210813522338867,
-0.6361085772514343,
0.8648092746734619,
-0.38778528571128845,
-0.08938223123550415,
0.27376997470855713,
1.3400622606277466,
-0.8781005144119263,
0.021638454869389534,
0.6084228754043579,
-0.4625716507434845,
0.3210073709487915,
0.047631364315748215,
-1.041172981262207,
0.8622989654541016,
0.5057069063186646,
1.0858927965164185,
-0.8517711758613586,
1.010643720626831,
0.45044803619384766,
-0.8156775832176208,
1.5869812965393066,
-0.6485741138458252,
1.930178165435791,
-0.47200942039489746,
-0.08594489842653275,
0.6026425957679749,
-0.10604466497898102,
0.6859526634216309,
0.3481579124927521,
-0.6290162801742554,
0.10135352611541748,
0.23391690850257874,
2.0522725582122803,
-1.562568187713623,
0.33181384205818176,
0.546059787273407,
0.9458295702934265,
0.5009078979492188,
-0.38551390171051025,
0.6995192766189575,
0.6221330761909485,
-0.5812436938285828,
0.052665602415800095,
0.07104574888944626,
0.016738494858145714,
-0.7466245293617249,
-0.5870361328125,
0.9180970788002014,
0.49392977356910706,
-0.5897161960601807,
-0.5183881521224976,
0.6819854974746704,
0.12912005186080933,
-0.20006228983402252,
0.7607505321502686,
0.4894546866416931,
0.3424873948097229,
-0.9741162061691284,
1.5405832529067993,
-0.0963456779718399,
0.17423531413078308,
-0.8062615394592285,
-0.17379245162010193,
-0.8650829792022705,
0.2058551013469696,
-0.1739339530467987,
0.03993091359734535,
-0.813107430934906,
-1.3540135622024536,
0.587287187576294,
-1.0552939176559448,
0.19693779945373535,
-0.09733052551746368,
-2.3152456283569336,
0.0345383919775486,
-0.353046715259552,
0.045933011919260025,
-1.104359745979309,
0.04022100195288658,
-1.2419812679290771,
-0.32951968908309937,
-0.7397711277008057,
0.34931954741477966,
0.05089379847049713,
-0.5904231667518616,
0.4624159634113312,
-0.5930307507514954,
0.14167730510234833,
-0.5398594737052917,
-0.7268149852752686,
-0.5774089694023132,
0.34860315918922424,
-0.6979407668113708,
0.6048117876052856,
-0.28055500984191895,
-0.6665244102478027,
-0.16269071400165558,
0.09490734338760376,
0.7752718329429626,
0.3324921131134033,
-0.3303631842136383,
-1.4980394840240479,
0.5729557275772095,
-0.15408551692962646,
1.1150450706481934,
0.12232139706611633,
-0.5584995746612549,
0.053630679845809937,
0.2107488214969635,
0.31425029039382935,
-0.6784218549728394,
-0.6984468698501587,
-0.10212348401546478,
-0.0279679074883461,
-0.1923469752073288,
0.22638282179832458,
0.06691665947437286,
-0.15845781564712524,
0.6026186347007751,
-0.4119408130645752,
0.23104266822338104,
-0.11844132095575333,
-0.30317258834838867,
0.46467000246047974,
0.8211649060249329,
-0.7121010422706604,
-0.36005085706710815,
0.6498986482620239,
0.23199844360351562,
0.03902596980333328,
0.11504685133695602,
0.6169489026069641,
0.26219624280929565,
0.5973322987556458,
0.4643144905567169,
0.12805593013763428,
0.08280178159475327,
-0.40751567482948303,
-0.16311749815940857,
0.05218523368239403,
0.6635400056838989,
-0.3195439875125885,
0.5437608361244202,
-0.3462437391281128,
0.0866447165608406,
0.5514177083969116,
-0.6289709210395813,
-0.35923442244529724,
-0.4287276864051819,
0.2770507335662842,
-0.29606664180755615,
0.25388702750205994,
-0.1961382031440735,
-0.8488008379936218,
0.0279794093221426,
-1.1168290376663208,
0.18680979311466217,
0.2866624593734741,
-0.18302969634532928,
-0.186597540974617,
-0.12519747018814087,
0.000621073879301548,
0.21786729991436005,
-0.11217884719371796,
0.37466686964035034,
-0.01754452846944332,
-0.461539626121521,
0.05401559919118881,
-0.2125408947467804,
-0.4950459897518158,
0.7627718448638916,
-0.1971210241317749,
0.5412370562553406,
-0.33635398745536804,
0.18470239639282227,
0.012526273727416992,
-0.0012188837863504887,
-0.5141292810440063,
0.04680406302213669,
0.12328984588384628,
0.37853512167930603,
0.0030112473759800196,
0.27223917841911316,
-0.3055996596813202,
0.8156545162200928,
0.11872842162847519,
-0.3706839382648468,
0.5370962023735046,
0.045426879078149796,
0.41216346621513367,
0.4295959770679474,
0.24439607560634613,
0.2983858287334442,
-0.5122621655464172,
-0.19272589683532715,
0.0910160169005394,
0.2788201570510864,
-0.5915191173553467,
0.42292520403862,
-0.12614242732524872,
0.4737330973148346,
0.0027777166105806828,
0.07187888771295547,
0.3973578214645386,
-0.537168025970459,
0.18234914541244507,
-0.22142206132411957,
0.2234027087688446,
-0.13463860750198364,
-0.07074413448572159,
-0.10046073794364929,
-0.2418408989906311,
0.5401652455329895,
-0.17769989371299744,
-0.2994271218776703,
-0.21809114515781403,
0.1359807550907135,
-0.16006521880626678,
0.0376034714281559,
0.2941083312034607,
0.021378377452492714,
0.28664231300354004,
-0.14340238273143768,
0.08380483835935593,
-0.12308209389448166,
-0.09205653518438339,
-0.712615966796875,
-0.3478544056415558,
-0.004355479031801224,
0.13175569474697113,
0.15807563066482544,
-0.20109620690345764,
-0.22750329971313477,
0.3759627044200897,
0.2673802971839905,
0.11369822174310684,
-0.44093057513237
] |
|
NCT00622349
|
Randomised Study Comparing Three Chemotherapy Regimens in Non-small Cell Lung Cancer
|
The purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC
|
Inclusion Criteria:
* Histological or cytological diagnosis of non-small cell lung cancer
* Advanced (unresectable or functionally inoperable) stage III or stage IV disease
* Availability for participating in the detailed follow-up of the protocol
* Presence of an evaluable or measurable lesion
* Informed consent
Exclusion Criteria:
* Prior treatment with chemotherapy
* Operable patient with resectable tumour
* Performance status \< 60 on the Karnofsky scale
* A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
* Polynuclear cells \< 2,000/mm³
* Platelet cells \< 100,000/mm³
* Serum bilirubin \>1.5 mg/100 ml
* Serum creatinine \> 1.5 mg/100 ml and/or creatinine clearance \< 60 ml/min
* Perception hypoacousia
* Peripheral neuropathy
* Recent myocardial infarction (less than 3 months prior to date of diagnosis)
* Congestive cardiac failure requiring medical therapy or uncontrolled cardiac arrhythmia
* Uncontrolled infectious disease
* Serious medical or psychological factors which may prevent adherence to the treatment schedule
|
[
4.337069511413574,
0.6597113609313965,
-4.155764102935791,
-5.187763214111328,
0.6012215614318848,
-1.6875293254852295,
0.06588222831487656,
1.0174676179885864,
-0.7154108285903931,
0.9933515191078186,
-1.3014599084854126,
1.0875648260116577,
-1.9542641639709473,
0.045381251722574234,
0.9226551651954651,
-0.21027949452400208,
-1.8372973203659058,
1.282505750656128,
0.23431867361068726,
-1.2034682035446167,
2.0363712310791016,
-0.07952776551246643,
0.5287408232688904,
-0.7056356072425842,
1.1754329204559326,
-2.084401845932007,
-0.5671714544296265,
2.1374921798706055,
1.3599210977554321,
0.15399257838726044,
0.244162455201149,
0.42656975984573364,
1.4254640340805054,
-1.0897351503372192,
-1.442785620689392,
0.34201493859291077,
0.47729727625846863,
1.1670420169830322,
0.056848086416721344,
0.5757744908332825,
0.6251821517944336,
-0.4359842836856842,
-0.5032811760902405,
-0.34725630283355713,
-0.13173146545886993,
-0.5533959269523621,
1.174821376800537,
0.20350949466228485,
0.5269507765769958,
0.41318008303642273,
-2.660750389099121,
1.297091007232666,
-0.7280073761940002,
0.43298542499542236,
-1.637471318244934,
0.19602802395820618,
-0.38043320178985596,
1.9994925260543823,
2.9253406524658203,
0.39029818773269653,
0.7504098415374756,
0.6687890291213989,
-2.6615147590637207,
0.7601379156112671,
-0.5082863569259644,
0.43218085169792175,
-0.35290515422821045,
-1.0742461681365967,
-0.12582562863826752,
0.3125372529029846,
0.5582836866378784,
1.169814109802246,
2.147925615310669,
-0.8600233197212219,
0.3674960434436798,
0.4039146602153778,
1.4258201122283936,
0.9794102311134338,
0.20929831266403198,
0.3014625608921051,
-0.12270372360944748,
-0.16632866859436035,
0.2159339338541031,
-1.2370636463165283,
-0.026627814397215843,
-1.2369593381881714,
-1.7876653671264648,
-1.4790592193603516,
1.6473397016525269,
-1.4872626066207886,
0.01825379580259323,
-0.9950858950614929,
-1.232369303703308,
1.7943689823150635,
-1.5245245695114136,
-0.8394924998283386,
-1.1471483707427979,
1.1703559160232544,
-1.1356098651885986,
0.5753607153892517,
-0.07183705270290375,
-0.30738726258277893,
-0.4076041877269745,
0.307794988155365,
-0.7336345314979553,
-0.48734617233276367,
-0.4114782512187958,
-1.7000786066055298,
0.47787994146347046,
-1.3312020301818848,
1.9720311164855957,
-1.0795528888702393,
-0.14235791563987732,
0.009474735707044601,
0.022222094237804413,
1.1047422885894775,
1.3438771963119507,
0.33718302845954895,
-1.3927757740020752,
0.5507257580757141,
-0.5650847554206848,
1.5289431810379028,
-0.21674484014511108,
1.2126632928848267,
-0.19972488284111023,
-0.044079091399908066,
0.08926805853843689,
-0.6824147701263428,
0.12116134166717529,
-1.3295377492904663,
-0.13072484731674194,
0.43233880400657654,
-0.04852057620882988,
1.1985899209976196,
-0.6819148659706116,
-0.7467215061187744,
0.39071473479270935,
1.1367954015731812,
0.3465180993080139,
-0.3712162971496582,
0.17268338799476624,
0.057485342025756836,
0.4941845238208771,
-0.268980473279953,
-0.8058682084083557,
-0.6785936951637268,
-0.3402411937713623,
-0.29608169198036194,
-0.15893693268299103,
0.31900253891944885,
-0.32323604822158813,
0.48819154500961304,
0.5553135871887207,
1.7426104545593262,
-0.5898901224136353,
-0.22818776965141296,
1.3801170587539673,
-1.534670352935791,
-0.5224829912185669,
0.3293363153934479,
-0.28848809003829956,
-0.8470297455787659,
-0.2891905605792999,
0.0875396877527237,
-0.5828564167022705,
-0.22377924621105194,
0.3123869299888611,
-0.48416200280189514,
-0.21127484738826752,
-0.3100711703300476,
-0.7901038527488708,
-0.443631649017334,
0.9686360955238342,
-0.3449431359767914,
0.12228237092494965,
-0.36808961629867554,
1.1663447618484497,
-0.05624134838581085,
-0.3059771955013275,
-0.1777079552412033,
-0.45187199115753174,
-0.12326743453741074,
-0.21769742667675018,
-0.5816161036491394,
0.01198407169431448,
0.18194527924060822,
-0.4424351751804352,
-0.20666930079460144,
0.6901795864105225,
0.8620582818984985,
0.4682299494743347,
-0.15725265443325043,
-0.23636029660701752,
1.1499066352844238,
0.3383620083332062,
-0.14822766184806824,
-0.22423559427261353,
-0.19197393953800201,
0.9386790990829468,
0.12412402778863907,
0.356070876121521,
1.0543159246444702,
0.07630087435245514,
0.6790395379066467,
-0.36380934715270996,
-0.332340270280838,
-0.1480860561132431,
0.2076125591993332,
-0.11443917453289032,
0.41924506425857544,
0.10229024291038513,
0.6071317791938782,
0.5458000302314758,
-1.3204456567764282,
-0.21388113498687744,
-0.03257323428988457,
-0.5416911244392395,
1.068062663078308,
-0.34433338046073914,
0.6216441988945007,
-0.6021062731742859,
0.3186681568622589,
0.7273350954055786,
-0.09927229583263397,
0.12058940529823303,
0.4057103395462036,
-0.5695935487747192,
-0.01148195844143629,
-0.21659933030605316,
-0.7754606604576111,
-0.1516784131526947,
-0.9233954548835754,
-0.16741858422756195,
-0.22819755971431732,
-0.3247002065181732,
0.3241293728351593,
0.5579988360404968,
0.33072128891944885,
0.2831714153289795,
0.37024757266044617,
0.6085687279701233,
-0.0464160218834877,
-0.390604168176651,
-0.5510791540145874,
0.42321354150772095,
-0.4371670186519623,
0.32384979724884033,
-0.4587126672267914,
-0.07681399583816528,
0.11158248037099838,
-0.42889654636383057,
0.06405657529830933,
-0.2785465717315674,
1.1958893537521362,
-0.5847187638282776,
-0.7971753478050232
] |
|
NCT02862470
|
Anaplastic Thyroid Cancer and Follicular Thyroid Cancer-derived Exosomal Analysis Via Treatment of Lovastatin and Vildagliptin and Pilot Prognostic Study Via Urine Exosomal Biological Markers in Thyroid Cancer Patients
|
The investigators expected to enroll 30 patients with papillary, follicular or anaplastic thyroid cancer, and collect their urine samples before operation, immediately after operation, post-operative 3, 6 12 months. The investigators will analyze the urine exosomal proteins and probable biological markers. The investigators hope to find the prognostic biological markers via this prospective study. The investigators further hope to find newly therapeutic mechanism and medications for such patients with poorly-differentiated or anaplastic thyroid cancer.
|
Although papillary and follicular thyroid cancers are low-grade endocrine malignancy, they were fatal if the cancer cells were poorly-differentiated or anaplastic change. Prior researches indicated that one-third well-differentiated thyroid cancers could transform to poorly-differentiated patterns, even to be anaplastic thyroid cancer (ATC), a fatal malignancy, and no effective therapeutic strategies was noted, including surgical intervention, chemotherapy and radiotherapy. The poorly-differentiated or anaplastic change of thyroid cancer cells proliferates rapidly and always invades local tissues with distant metastasis. Cellular de-differentiation is the most pivotal cause for malignant transformation and invasion. De-differentiation usually in papillary thyroid cancer and follicular thyroid cancer, and definitely in ATC. The Poorly-differentiated thyroid cancer cell will rapidly proliferate and metastasize. The poorly-differentiated tumor cells lost apoptotic mechanism with de-differentiation, and such phenomenon is fatal for such patients. The investigators started research of thyroid cancer since 1999, and the investigators initially found TNF-α could induce cyto-morphological re-differentiation of thyroid cancer cells. Later, the investigators further found Lovastatin could induce re-differentiation of anaplastic thyroid cancer (ATC) cells in 25μM, but induce apoptosis in 50μM, in 2001. In 2006, the investigators designed nude mice model, and found tumor will shrink via treatment of Lovastatin in 5 or 10 mg/kg/day, but tumor will proliferate significantly in 1 mg/kg/day. The investigators called this phenomenon as "Duality effects" of statins. In 2012, the investigators found FLOT1 and transketolase (TKT) as important regulatory factor of re-differentiation and proliferation in ATC cells, respectively. The investigators also found that inhibition of Dipeptidyl peptidase-4 (CD26) will influence proliferation of ATC cells. Exosomes are nanovesicels secreted into extracellular environments. A growing evidence suggests theat exosomes could be used as biomarkers to be the diagnosis and prognosis of malignant tumors. Exosomes are 50-100 nm diameters, and correspond to the intrluminal vesicles of endosomal multivesicular bodies. Because of their cellular orgins, exosomes have specific protein markers, like CD63, CD9, CD81 and heat shock protein (HSP). Urine was used to be the biosamples in the past five years in baldder cancer, prostate cancer, breast cancer and ovarian cancer. Urine sample is usually easy to obtain and non-invasive. Exosomes secreted by cells could micro-molecularly transfer messages between cells and to be biological markers of cancer. The investigators now found Vildagliptin and Lovastatin could influence tumor cells survival via exosomal proteins. For patients of thyroid cancer, the investigators could obtain the urine samples without invasive procedures. Furthermore, the investigators could find the biological markers and therapeutic targets via the exosomal expression in urine. On the continuing basis of ATC cells culture experiments, the investigators expected to enroll 30 patients with papillary, follicular or anaplastic thyroid cancer, and collect their urine samples before operation, immediately after operation, post-operative 3, 6 12 months. The investigators will analyze the urine exosomal proteins and probable biological markers. The investigators hope to find the prognostic biological markers via this prospective study. The investigators further hope to find newly therapeutic mechanism and medications for such patients with poorly-differentiated or anaplastic thyroid cancer.
|
Inclusion Criteria:
* Newly diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer
Exclusion Criteria:
* Thyroid papillary, follicular and anaplastic thyroid cancer with prior operation, chemotherapy, or isotope treatment, or target therapy.
|
[
1.4336988925933838,
3.0062198638916016,
-1.8978151082992554,
-2.007918119430542,
-0.695426344871521,
-0.43535932898521423,
-1.706601619720459,
-1.8378151655197144,
-0.7376678586006165,
-0.2962471842765808,
1.5332551002502441,
0.7351981997489929,
-0.6244912147521973,
0.384551078081131,
0.14621077477931976,
0.5098580718040466,
-0.17742101848125458,
1.6453065872192383,
0.3778092563152313,
-1.852611780166626,
0.482629656791687,
-0.5276264548301697,
0.15521152317523956,
-0.04898705333471298,
0.8175348043441772,
-0.286836177110672,
-0.09766129404306412,
0.9385040998458862,
-0.3367503881454468,
0.5162263512611389,
0.774701714515686,
1.2950153350830078,
-0.5931426286697388,
-1.336166501045227,
-0.47599804401397705,
-0.8839579224586487,
1.3009010553359985,
-0.3058699667453766,
-2.0359394550323486,
-0.47453176975250244,
-0.23266516625881195,
0.7233620285987854,
-0.9967262148857117,
-0.3137076199054718,
2.437755823135376,
0.28934523463249207,
-1.0692678689956665,
1.3939285278320312,
2.359930992126465,
0.5180020332336426,
-2.446840524673462,
1.7177284955978394,
-1.2681636810302734,
-0.11937904357910156,
0.3419100344181061,
0.21790707111358643,
1.0666583776474,
-1.079352855682373,
2.333587408065796,
-0.21131853759288788,
0.6590232849121094,
-0.3822966516017914,
0.5406113266944885,
-0.7583260536193848,
-1.2041388750076294,
-0.47030308842658997,
-1.1406316757202148,
-0.05470169708132744,
-0.5407308340072632,
-0.7663886547088623,
0.5564026236534119,
-0.5574936866760254,
0.4191458821296692,
0.32845038175582886,
1.2408825159072876,
2.0644588470458984,
0.2152460813522339,
0.28171029686927795,
0.8003237247467041,
-0.012324873358011246,
-0.45812010765075684,
-0.7961584329605103,
-1.7674564123153687,
1.1386412382125854,
-0.2242492139339447,
-0.4632502496242523,
-2.4407551288604736,
-0.1310218721628189,
0.4627912938594818,
-0.8576897382736206,
-0.048147641122341156,
0.5636455416679382,
-0.9497267007827759,
2.2419538497924805,
-0.7127223610877991,
0.2071191817522049,
0.006946974899619818,
0.273226797580719,
-0.5696114897727966,
0.7213246822357178,
-0.7593470811843872,
-0.8824198246002197,
-0.6672561168670654,
-0.7853040099143982,
-1.0308306217193604,
-1.3901770114898682,
0.6165180802345276,
-1.0737686157226562,
-0.8632149696350098,
-0.6325674057006836,
1.377293348312378,
-1.176107406616211,
0.25252100825309753,
-0.02889505960047245,
-0.0011817619670182467,
-0.31565937399864197,
0.31734347343444824,
0.48383384943008423,
0.5907996892929077,
0.06617370992898941,
0.08303464204072952,
-0.21077053248882294,
-0.6114844083786011,
-0.0471620187163353,
0.11332029104232788,
-0.09622305631637573,
0.68839031457901,
-1.0442968606948853,
0.8220080733299255,
-2.044172763824463,
-0.7580011487007141,
0.9357494711875916,
-0.4416225850582123,
-0.5202875137329102,
-0.17906369268894196,
-0.3992999196052551,
0.3693319857120514,
0.867487370967865,
0.2698569893836975,
-1.1358885765075684,
0.677582859992981,
0.08369307965040207,
0.6584798693656921,
1.1232284307479858,
-1.3170322179794312,
-0.10919911414384842,
-0.04761473834514618,
0.13424646854400635,
0.1245618462562561,
-0.45363885164260864,
-0.3820408284664154,
0.8570826053619385,
1.2810163497924805,
0.06568699330091476,
0.2233048677444458,
0.1303701251745224,
-1.1904399394989014,
-0.062062300741672516,
0.5179371237754822,
-0.3951418399810791,
-0.15145328640937805,
-0.6488100290298462,
-0.3387911319732666,
-1.0940756797790527,
0.27020764350891113,
-0.29238879680633545,
-0.14869147539138794,
-0.18577921390533447,
0.5412760972976685,
-0.25189682841300964,
-0.6030086874961853,
-0.10902098566293716,
0.7031409740447998,
0.5275782942771912,
-0.5802124738693237,
-0.3422538638114929,
0.03479684516787529,
0.6880828142166138,
-0.41516757011413574,
0.1638282835483551,
-0.08462594449520111,
-0.26479634642601013,
-0.2556231617927551,
-0.12461275607347488,
0.29384845495224,
-0.05654069781303406,
0.27335694432258606,
0.36940476298332214,
0.43054449558258057,
0.18530941009521484,
0.5482662320137024,
-0.3959994316101074,
0.08807734400033951,
0.3562766909599304,
0.3515172004699707,
0.3892019987106323,
-0.8911958932876587,
-0.7395424842834473,
-0.15169475972652435,
0.5946734547615051,
0.056424230337142944,
0.20199230313301086,
0.2573085129261017,
1.1640623807907104,
0.2980864644050598,
-0.08020725846290588,
-0.08215370774269104,
0.05467086285352707,
0.5523151755332947,
0.5110840201377869,
-0.17762655019760132,
0.2603171467781067,
-0.2905121445655823,
-0.6854616403579712,
0.0983753502368927,
-0.19076500833034515,
-0.003767885034903884,
-0.032734863460063934,
-0.4728632867336273,
0.4933263063430786,
0.13977515697479248,
0.08828531205654144,
0.25716063380241394,
0.23917058110237122,
0.04517390951514244,
-0.22682659327983856,
-0.11090462654829025,
-0.07735069841146469,
0.16197001934051514,
-0.04110226035118103,
-0.4647005498409271,
0.27103695273399353,
0.1572541743516922,
-0.5023415088653564,
0.324338436126709,
-0.04429572448134422,
0.2524856626987457,
0.3195270895957947,
-0.010702629573643208,
0.5643338561058044,
0.36647889018058777,
-0.057691045105457306,
0.37598949670791626,
-0.46296095848083496,
-0.17037378251552582,
0.10625867545604706,
-0.24810096621513367,
-0.3024693429470062,
-0.025007901713252068,
0.6758150458335876,
0.4501950740814209,
-0.7755485773086548,
0.41883277893066406,
0.14719153940677643,
-0.28627893328666687,
-0.25502729415893555
] |
NCT03984838
|
Study to Evaluate Pharmacokinetics, Safety and Tolerability of Dolutegravir and Rilpivirine (JULUCA™) 50 Milligram (mg)/25 mg Tablets in Healthy Subjects of Japanese Descent
|
Dolutegravir (DTG), a human immunodeficiency virus (HIV)-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1 reverse transcriptase inhibitor (NNRTI), are each approved in the United States (US), European Union, and other countries for the treatment of HIV-1 infection. JULUCA is a combination of Dolutegravir and Rilpivirine indicated for the treatment of HIV-1 infection in antiretroviral (ARV) experienced adult subjects who are switching from their current antiretroviral treatment to the 2-drug combination. Although, the pharmacokinetics (PK), safety and tolerability of DTG/RPV (50 milligram \[mg\]/25mg) fixed-dose combination (FDC) tablets have been extensively studied, these parameters have not been assessed exclusively in Japanese subjects. This study will evaluate the pharmacokinetics, safety and tolerability of a single dose DTG/RPV 50 mg/25 mg FDC in a healthy adult Japanese population to support a post-approval commitment for DTG/RPV 50 mg/25 mg FDC in Japan.
|
Inclusion Criteria:
* Subject must be 18 to 55 years of age, at the time of signing the informed consent
* Subjects who were born in Japan with 4 ethnic Japanese grandparents. Subjects who have not lived outside Japan for more than 10 years and who are Japanese passport holders (current or expired)
* Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and electrocardiogram \[ECG\])
* Subjects with body weight \>=50 kilogram (kg) (110 pounds) for men and \>=45kg (99 pounds) for women and body mass index (BMI) within the range 18.5-31.0 kg per square meter (kg/m\^2)
* Male or female subjects; Male subjects with no specific restrictions
* A female subject is eligible to participate if she is not pregnant or breastfeeding, and not a woman of childbearing potential (WOCBP)
* The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
* Subjects capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Exclusion Criteria:
* Subjects with history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data
* Subjects with abnormal blood pressure (as determined by the investigator)
* Subjects with alanine transaminase (ALT) \>1.5 times upper limit of normal (ULN)
* Subjects with bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
* Subjects with current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* Subjects with QTcF \>460 millisecond (msec)(Based on the average of the 12-Lead-electrocardiogram (ECG) triplicate readings obtained at Screening) (Note: The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read. The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial)
* Subjects with past or intended use of over-the-counter or prescription medication including herbal medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing. Acetaminophen, at doses of \<=2 grams per day, is allowed for use any time during the study
* Participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 56 days
* Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day
* Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research
* Subjects with presence of Hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention
* Subjects with positive Hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention (Note: Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained)
* Subjects with positive Hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention (Note: Test is optional and subjects with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing)
* Subjects with positive pre-study drug or alcohol screen
* Subjects with positive human immunodeficiency virus (HIV) antibody test
* Subjects with regular use of known drugs of abuse
* Subjects with creatinine clearance (CrCL) \<60 milliliter per minute
* Employment with Janssen, ViiV, GlaxoSmithKline(GSK), or with the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, as well as family members of the employees or the Investigator
* Subjects with urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g. nicotine patches or vaporizing devices) within 6 months prior to screening
* Subjects with regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of \>14 units for males or \>7 units for females. One unit is equivalent to 8 gram of alcohol: a half-pint (approximately 240mL) of beer, 1 glass (125mL) of wine or 1 (25mL) measure of spirits
* Subjects with sensitivity to heparin or heparin-induced thrombocytopenia
* Subjects with sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study
|
[
1.4569478034973145,
1.3011956214904785,
-2.191131353378296,
-3.277719736099243,
0.8963226675987244,
0.4601608216762543,
0.5589906573295593,
1.4362798929214478,
-1.338989496231079,
-1.3799126148223877,
-1.428389310836792,
2.400953531265259,
-0.552182137966156,
0.5332047343254089,
0.6866530776023865,
-1.1303097009658813,
-0.9126845002174377,
0.32569020986557007,
0.707412600517273,
-1.6240047216415405,
0.043512530624866486,
0.49450016021728516,
-1.4838812351226807,
1.0632810592651367,
-0.07876600325107574,
-0.504969596862793,
-2.0795116424560547,
1.0407496690750122,
0.08069001138210297,
1.8288499116897583,
0.6151602864265442,
-1.0421500205993652,
0.00387825770303607,
1.3930743932724,
-0.13328786194324493,
-1.053694725036621,
0.387131005525589,
-0.05710676684975624,
-0.7298306226730347,
0.4170416593551636,
-0.722376823425293,
0.21541166305541992,
0.4660588204860687,
-0.0716785416007042,
2.1461269855499268,
0.9283786416053772,
0.5955647230148315,
-0.37618279457092285,
-0.06016451120376587,
0.2986350655555725,
-1.2556719779968262,
0.7867079377174377,
-0.5004697442054749,
0.875190019607544,
1.9378221035003662,
0.717017412185669,
0.6293964982032776,
0.6212342977523804,
1.036233901977539,
-0.27065855264663696,
0.11767932027578354,
0.37299439311027527,
0.17073699831962585,
-0.33976396918296814,
-0.3739865720272064,
0.25047600269317627,
0.042082712054252625,
-0.05573534592986107,
-0.3716374933719635,
0.6004762053489685,
-1.3079488277435303,
0.655115008354187,
0.41816937923431396,
1.2056306600570679,
0.7447395324707031,
0.795287013053894,
-0.6845395565032959,
1.151827335357666,
0.7126399278640747,
0.055265139788389206,
-0.8956958651542664,
-0.7910492420196533,
0.32764801383018494,
-0.16026301681995392,
-0.1314641833305359,
-0.632398784160614,
-0.5152812600135803,
-0.9869930148124695,
-0.4902024269104004,
-0.9112746119499207,
0.7646888494491577,
-0.6369839906692505,
-0.6947415471076965,
0.1508726179599762,
-0.513526201248169,
0.13875643908977509,
-0.45157894492149353,
0.41281288862228394,
-0.22374822199344635,
-0.3428540825843811,
-0.03227417916059494,
0.08882693201303482,
-0.45524871349334717,
-0.5614657402038574,
-0.6613931059837341,
-0.2650827467441559,
-0.8496027588844299,
-0.17106203734874725,
-0.5612449049949646,
-0.1616906225681305,
0.05693935602903366,
-0.418897807598114,
-0.3489396870136261,
-0.5056136250495911,
0.5464503169059753,
0.3161372244358063,
-0.1799919307231903,
-0.02665150724351406,
-0.7886849045753479,
0.09870243072509766,
0.6234081983566284,
0.3072616159915924,
0.2713783085346222,
0.3813035488128662,
-0.6119418740272522,
-0.3745206892490387,
-0.0927763283252716,
-0.27288395166397095,
0.35144880414009094,
-0.0020582808647304773,
-0.5147767663002014,
0.3660319447517395,
0.16779103875160217,
-0.053771402686834335,
-0.7212997078895569,
-0.8635737895965576,
0.7088765501976013,
0.8160741925239563,
0.07722648233175278,
-0.19653409719467163,
-0.19571976363658905,
0.19679446518421173,
0.21666917204856873,
-0.18553981184959412,
-1.624855637550354,
0.6478123664855957,
-0.196452334523201,
0.5160953998565674,
-0.014657590538263321,
-0.3302726745605469,
-0.44936490058898926,
0.18496058881282806,
0.17167381942272186,
0.20325148105621338,
0.4704543650150299,
0.52829909324646,
0.5713115334510803,
-0.03288248926401138,
0.34814491868019104,
-0.40437057614326477,
-0.5965311527252197,
-0.1256958395242691,
0.14020121097564697,
-0.37969574332237244,
0.46003344655036926,
0.2552874684333801,
-0.036661308258771896,
-0.3080286383628845,
-0.12758472561836243,
-0.17325755953788757,
-0.47304654121398926,
0.13068167865276337,
0.006006913725286722,
0.37893566489219666,
0.0368787944316864,
0.05994141101837158,
0.245268315076828,
0.4777601361274719,
-0.21992799639701843,
0.1857282817363739,
0.01607571728527546,
0.2877066731452942,
0.13294264674186707,
-0.02880489081144333,
0.280529260635376,
-0.2703147232532501,
0.44022470712661743,
0.30320173501968384,
-0.17795193195343018,
0.19476667046546936,
0.07931719720363617,
-0.22012768685817719,
-0.34621483087539673,
-0.023422198370099068,
0.30018848180770874,
-0.24836866557598114,
0.08823598921298981,
0.38105058670043945,
0.18368811905384064,
-0.38108476996421814,
0.2883665859699249,
-0.05325087159872055,
0.2865258455276489,
0.2695091962814331,
-0.0076208580285310745,
-0.36692067980766296,
-0.0037181645166128874,
0.2988271415233612,
-0.0061975158751010895,
0.4451524019241333,
0.0516650564968586,
-0.44538336992263794,
-0.28856146335601807,
0.18573470413684845,
0.3296782374382019,
0.2208753377199173,
0.034623678773641586,
0.0928565189242363,
-0.09255480766296387,
0.5579823851585388,
-0.22145646810531616,
0.03994925320148468,
-0.15609265863895416,
0.01322047971189022,
0.032830096781253815,
0.17687419056892395,
-0.4944559931755066,
-0.2441830337047577,
-0.19701464474201202,
-0.25390249490737915,
-0.4867023229598999,
0.016854213550686836,
-0.24051032960414886,
-0.11782459914684296,
0.09139274060726166,
-0.14231917262077332,
-0.007060193456709385,
0.0023990252520889044,
-0.12281358987092972,
0.02203773893415928,
0.5582412481307983,
-0.07371322065591812,
-0.23435838520526886,
-0.13955813646316528,
0.4561711549758911,
-0.6901141405105591,
-0.03702843189239502,
0.5088151693344116,
-0.025529805570840836,
-0.23008506000041962,
0.010660775937139988,
0.26246240735054016,
0.049663297832012177,
0.2626805007457733,
-0.01848904974758625,
-0.12393403053283691
] |
|
NCT01944124
|
Exercise and Technology to Reduce Risk in a Rural Population With Metabolic Syndrome
|
Cardiovascular diseases are the leading cause of death among Canadians. In those with diabetes, cardiovascular complications are responsible for more than 70% of deaths. While there is much interest in identifying and treating risk factors, the exact biological mechanisms, their measurement and optimal ways to prevent and manage them are poorly understood.
Physical activity and regular exercise can prevent diabetes and effectively manage risk factors, but most Canadians do not exercise enough to beneficially manage risk. Tailored exercise prescribed by a family physician has shown promise as a means to increase fitness and reduce risk, but optimal implementation practices remain unknown - especially in rural and remote communities with reduced access to healthcare. Mobile health technologies have proved to be a beneficial tool to achieve blood pressure and blood glucose control in patients with diabetes. These technologies may address the limited access to health interventions in rural and remote regions. However, the potential as a tool to support exercise-based prevention activities unknown.
Therefore, this study was undertaken to investigate the effects of a tailored exercise prescription alone or supported by mobile health technologies to improve cardiovascular risk factors in rural community-dwelling adults at risk for cardiovascular disease and type 2 diabetes.
Adults with cardiovascular risk factors were recruited from rural communities and randomized to either: 1) an intervention group receiving an exercise prescription and devices for monitoring of risk factors with a smartphone data portal equipped with a mobile health application; or 2) an active control group receiving only an exercise prescription.
It was hypothesized that the intervention group would reduce their risk to a greater extent than the active control group following 12 weeks, and that these improvements would be better maintained in the intervention group at 24 and 52 weeks compared to the active control group.
|
Inclusion Criteria:
* aged 18-70 years
* two or more metabolic syndrome risk factors according to National Cholesterol Education Program Adult Treatment Panel III criteria: waist circumference ≥ 88 cm (women) or ≥ 102 cm (men); systolic blood pressure ≥ 135 mmHg and/or diastolic blood pressure ≥ 85 mmHg; fasting plasma glucose ≥ 6.1 mmol/L; triglycerides ≥ 1.7 mmol/L; and high density lipoprotein cholesterol ≤ 1.29 mmol/L (women) or ≤ 1.02 mmol/L (men)
Exclusion Criteria:
* systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 110mmHg
* type 1 diabetes
* history of myocardial infarction, angioplasty, coronary artery bypass or cerebrovascular ischemia/stroke
* symptomatic congestive heart failure
* atrial flutter
* unstable angina
* unstable pulmonary disease
* use of medications known to affect heart rate
* second or third degree heart block
* history of alcoholism, drug abuse or other emotional cognitive or psychiatric problems
* pacemaker
* unstable metabolic disease and orthopedic or rheumatologic problems that could impair the ability to exercise
|
[
-0.6295086741447449,
5.445738792419434,
-0.7172523736953735,
-2.826988935470581,
0.454842209815979,
0.1293170005083084,
-0.19946034252643585,
-0.4372398257255554,
0.5437677502632141,
-0.12090753018856049,
0.8215246796607971,
1.3402187824249268,
-0.09145766496658325,
-0.14863388240337372,
0.6173550486564636,
1.1894972324371338,
0.21431833505630493,
0.14294587075710297,
1.0836633443832397,
-1.8053717613220215,
0.088951475918293,
0.39070791006088257,
0.9704530239105225,
-0.7147645950317383,
0.18424487113952637,
0.8637371063232422,
0.05516142025589943,
0.4628089666366577,
0.5111938118934631,
1.0176267623901367,
0.35288774967193604,
-1.2041631937026978,
0.4079786539077759,
0.5778548717498779,
0.29378876090049744,
0.41248586773872375,
1.1485533714294434,
-0.9599790573120117,
-1.130781650543213,
0.16094456613063812,
1.1388020515441895,
1.1036522388458252,
-0.07607421278953552,
-0.3823949098587036,
1.6886192560195923,
0.8227546215057373,
0.768172562122345,
0.22052399814128876,
-0.1905912309885025,
0.8833804726600647,
-0.263184517621994,
1.9959198236465454,
-1.1344671249389648,
0.7712695598602295,
1.984129548072815,
-0.09614000469446182,
0.16614258289337158,
0.7702574729919434,
0.6566644310951233,
0.13668419420719147,
0.4503517746925354,
-0.26628533005714417,
-0.018098793923854828,
0.7591459155082703,
-0.9045030474662781,
-1.323705792427063,
0.15183421969413757,
0.016763631254434586,
-0.9790623784065247,
1.0312241315841675,
-0.0926203653216362,
-0.4670734107494354,
0.047947026789188385,
-0.12417647242546082,
-0.6178563833236694,
0.11730881035327911,
-0.21610508859157562,
1.1665077209472656,
0.2996465563774109,
0.19165794551372528,
-0.5578397512435913,
0.2405904233455658,
-0.014207841828465462,
-0.5054850578308105,
0.8224771618843079,
-0.16377849876880646,
-1.2100366353988647,
-0.32281216979026794,
0.7751489877700806,
-1.0798168182373047,
0.41343551874160767,
-0.5365200042724609,
0.19129513204097748,
0.44241654872894287,
-0.3689793348312378,
0.47344285249710083,
-0.26009345054626465,
-0.4097631573677063,
-0.36044570803642273,
-1.4096139669418335,
0.5585799813270569,
0.00003556826413841918,
-0.8765129446983337,
-0.2573535740375519,
0.053684718906879425,
0.3541548550128937,
-0.06379582732915878,
0.3888384699821472,
-0.7240656018257141,
0.2759091258049011,
0.46969953179359436,
-1.0067335367202759,
1.0268945693969727,
0.4319405257701874,
0.5389905571937561,
0.15798306465148926,
0.8687474131584167,
0.9972322583198547,
-0.316116064786911,
-0.318006306886673,
0.14260730147361755,
0.7475247383117676,
0.09110762923955917,
0.42012837529182434,
-1.0573468208312988,
-0.04085421562194824,
-0.33222702145576477,
0.45027780532836914,
0.6863718032836914,
-0.22267745435237885,
-0.4168129861354828,
0.2748914659023285,
-0.06299316138029099,
-0.5203462839126587,
-0.14874505996704102,
0.0887880027294159,
-0.2187478095293045,
0.35444045066833496,
-0.2850172817707062,
-0.3251669704914093,
0.2691953182220459,
0.0607684962451458,
-0.18099188804626465,
0.23273468017578125,
-1.086583137512207,
-0.8797354698181152,
0.3709666132926941,
-0.22374500334262848,
-0.371513307094574,
-0.9034008979797363,
-0.4422546625137329,
0.6701839566230774,
-0.12927334010601044,
-0.1086488664150238,
-0.793488085269928,
-0.6319388747215271,
-0.07311347872018814,
-0.8216240406036377,
0.33734285831451416,
0.07547926902770996,
0.4945773482322693,
-0.39610594511032104,
-0.5955587029457092,
-0.4329431354999542,
0.0007272967486642301,
-0.281593382358551,
0.8151843547821045,
-0.3388969600200653,
0.7583968043327332,
0.0964425578713417,
0.3953222632408142,
0.17749647796154022,
-0.6771283149719238,
0.14943400025367737,
-0.11209678649902344,
-0.15810123085975647,
0.8754608631134033,
-0.0267945509403944,
0.3389964997768402,
-0.1602870523929596,
0.3488619029521942,
0.1299188882112503,
0.5030731558799744,
0.22415384650230408,
0.04511933773756027,
-0.5422055721282959,
-0.07780255377292633,
-0.7801082730293274,
0.006380286067724228,
-0.004562737885862589,
-0.1182205006480217,
0.1721745729446411,
-0.17009949684143066,
0.19456610083580017,
0.02335224114358425,
0.4309075176715851,
-0.09541108459234238,
-0.3947659134864807,
0.12262222915887833,
0.12575267255306244,
0.14308325946331024,
-0.1615391969680786,
-0.015188990160822868,
0.5988097190856934,
-0.20785140991210938,
0.09875920414924622,
-0.14110250771045685,
0.06699775904417038,
-0.31190094351768494,
0.01381616573780775,
-0.018157366663217545,
0.5603434443473816,
0.06561484932899475,
-0.4947752058506012,
0.20859982073307037,
0.1363638937473297,
0.08367951214313507,
0.01776369847357273,
-0.3691406846046448,
-0.022122394293546677,
0.13320212066173553,
-0.3201412558555603,
0.23647168278694153,
-0.3488799035549164,
0.13694995641708374,
-0.07668005675077438,
0.7302277088165283,
0.18277953565120697,
0.20527862012386322,
-0.18507833778858185,
-0.35286444425582886,
0.27046066522598267,
-0.14947804808616638,
-0.20906181633472443,
0.14619262516498566,
-0.10997000336647034,
0.12920670211315155,
0.6543550491333008,
-0.0014072045451030135,
-0.10008672624826431,
0.35771405696868896,
-0.2805209457874298,
0.27571937441825867,
-0.2860235273838043,
0.29061785340309143,
-0.22398599982261658,
-0.02126435935497284,
0.379791796207428,
0.24000973999500275,
0.0940665677189827,
-0.26383891701698303,
-0.13845524191856384,
-0.097480408847332,
-0.11194127798080444,
0.14114241302013397,
-0.4984476864337921
] |
|
NCT02904642
|
Mobile and Scalable Innovations for Measles Immunization: a Randomized Controlled Trial
|
The overall objective is to test the impact of short message service (SMS) reminders, with or without unconditionally provided mobile-money incentives, can improve measles vaccination coverage in rural western Kenyan infants.
|
Primary Objective The primary objective is to determine if text message reminders, with or without unconditionally provided incentives, can increase the proportion of children who receive measles vaccination by 15% at age ten months as compared to control arm children.
Secondary Objectives
1. To conduct a secondary analysis of the primary outcome using survival analysis and time-to-immunization curves.
2. To determine if there is a differential effect on measles vaccine coverage based on mobile phone ownership and distance to the clinic.
3. To examine the effect of the interventions on measles coverage measured at twelve months of age.
4. To examine the completeness and costs of identifying children through a CHW approach versus the standard HDSS approach.
5. To evaluate the effect of the interventions on coverage of second dose of measles vaccine at 24 months. This secondary objective is contingent on receiving additional funding.
|
Inclusion Criteria:
* Caregiver of infant aged 6-8 months at time of enrollment
* Self-reported resident of one of the study villages; where the definition of a resident is defined by caregiver
* Willing to sign informed consent for the study
Exclusion Criteria:
* Child of enrolled caregiver has already received one dose of measles vaccine, not including any supplemental measles vaccines
* Caregiver plans to move away in the next 6 months
|
[
-0.8030232191085815,
3.837831974029541,
-2.4038803577423096,
-1.599316120147705,
0.9739038944244385,
1.2866401672363281,
-1.4108597040176392,
0.15152473747730255,
-0.01481661293655634,
-0.1536274403333664,
0.20223671197891235,
0.8661679625511169,
-1.3394826650619507,
-0.4487670063972473,
0.2812952697277069,
-1.2743141651153564,
1.3811513185501099,
0.952973484992981,
0.24671056866645813,
-0.39656394720077515,
0.762235701084137,
1.0946614742279053,
0.3067207336425781,
-0.03082776628434658,
-0.29195770621299744,
0.6122113466262817,
-0.7965593934059143,
-0.9505757093429565,
-0.48148250579833984,
2.358750104904175,
-0.213998943567276,
-1.1768814325332642,
1.2244068384170532,
0.29824259877204895,
0.8954406976699829,
0.8766083717346191,
1.7104018926620483,
0.9030159115791321,
-0.18086497485637665,
-0.918010950088501,
-1.1559547185897827,
-0.6049264073371887,
0.5024576187133789,
0.6242987513542175,
1.198900580406189,
-1.7423083782196045,
0.858018696308136,
-0.9103617668151855,
-0.7704703211784363,
2.2473461627960205,
0.03250575438141823,
0.39006656408309937,
0.18374356627464294,
0.7975007891654968,
1.2694146633148193,
-0.3789535462856293,
0.5447075963020325,
1.4755858182907104,
0.39516186714172363,
1.3811761140823364,
1.2209488153457642,
0.5026136636734009,
1.3578647375106812,
0.45746031403541565,
-0.8876525163650513,
0.09463749825954437,
0.24193449318408966,
-0.7801059484481812,
-1.0345271825790405,
-0.5613932609558105,
0.03448151797056198,
1.0766346454620361,
0.06384079158306122,
-1.8211899995803833,
-1.6946144104003906,
-0.17618803679943085,
0.86346036195755,
0.17440950870513916,
0.3993538022041321,
0.6174494624137878,
0.3666563332080841,
-0.07215297222137451,
0.12906788289546967,
-1.6595062017440796,
0.5916710495948792,
-0.48929598927497864,
-1.267958402633667,
1.1805976629257202,
0.9080938100814819,
0.16799716651439667,
-0.8062962293624878,
-0.09224551916122437,
-0.05165012553334236,
-0.18842282891273499,
0.012045967392623425,
0.4575529992580414,
1.3507564067840576,
0.44526368379592896,
0.32610270380973816,
-0.9584435820579529,
0.6120368838310242,
-0.49285876750946045,
-0.7287390232086182,
-1.023494839668274,
-0.1928674429655075,
0.8057529330253601,
-0.76735919713974,
0.1139325499534607,
-0.02420773170888424,
1.2425178289413452,
-0.03713935986161232,
-1.1120851039886475,
0.45466557145118713,
0.18395428359508514,
-0.05200045183300972,
0.1853576898574829,
-0.0005884713027626276,
0.3681885302066803,
-0.3265060782432556,
0.29474449157714844,
0.18664705753326416,
0.1963510662317276,
0.03812729939818382,
0.30412358045578003,
-0.37250712513923645,
-1.2842925786972046,
0.001622724812477827,
0.36864346265792847,
-0.5039993524551392,
-0.2399464249610901,
-0.2885906398296356,
1.468896508216858,
0.792219340801239,
0.004123006481677294,
-1.1084258556365967,
0.19080449640750885,
0.27832120656967163,
0.4847566783428192,
-0.19360952079296112,
0.2669571042060852,
-0.25854572653770447,
0.19692516326904297,
-0.6085181832313538,
-0.7996799349784851,
-0.48317041993141174,
-0.878935694694519,
0.17430734634399414,
-0.43947353959083557,
-0.7903175950050354,
0.69770747423172,
-0.6283554434776306,
0.2082880437374115,
-0.10757721960544586,
-0.12282111495733261,
-0.6534073352813721,
-0.3290744721889496,
-0.2948414981365204,
0.3213794529438019,
-0.8291141390800476,
-1.0645755529403687,
0.6056160926818848,
0.03625737503170967,
0.30286669731140137,
-0.11652716249227524,
0.09977281838655472,
-0.13372814655303955,
-0.012676652520895004,
-0.55717933177948,
-0.9664016366004944,
0.1835731416940689,
0.22650893032550812,
1.183761715888977,
-0.6444001793861389,
-0.9554786682128906,
-0.0835932046175003,
0.11390884220600128,
0.8161314129829407,
-0.08831291645765305,
0.4673612415790558,
-0.6142936944961548,
-0.1868075728416443,
0.5073211789131165,
0.18365198373794556,
0.032627448439598083,
-0.23696422576904297,
0.11044852435588837,
-0.5752661228179932,
-0.26113593578338623,
0.20273637771606445,
-0.5222663283348083,
0.4777412712574005,
-0.44449183344841003,
-0.1408476084470749,
0.185176283121109,
0.09165368229150772,
-0.06286316365003586,
-0.009612461552023888,
0.3164088726043701,
0.6450237035751343,
0.5346385836601257,
0.3605550229549408,
0.16859617829322815,
0.3670676350593567,
0.004227190278470516,
0.2545709013938904,
0.25371357798576355,
-0.36668071150779724,
-0.214867502450943,
-0.3963146507740021,
-0.23668554425239563,
0.9313123226165771,
0.7250205278396606,
-0.1524474322795868,
-0.17121146619319916,
0.4367906451225281,
-0.0811053141951561,
-0.3242511749267578,
0.23266823589801788,
-0.4450914263725281,
0.09719482809305191,
0.6303400993347168,
0.11105885356664658,
-0.04982313886284828,
-0.2843146026134491,
0.719683825969696,
-0.10586623847484589,
-0.24293655157089233,
-0.13889352977275848,
0.2682363986968994,
-0.06127228960394859,
-0.18419933319091797,
0.0002690287947189063,
0.33714696764945984,
0.18927307426929474,
-0.005456862039864063,
0.5947324633598328,
0.14051249623298645,
0.4756588339805603,
-0.389478862285614,
-0.16721898317337036,
0.27447226643562317,
0.08963190019130707,
0.6853317022323608,
-0.2350727617740631,
0.25349587202072144,
0.8311019539833069,
-0.13156820833683014,
0.48904862999916077,
0.5521021485328674,
-0.26358214020729065,
0.0047232164070010185,
0.418827623128891,
-0.11040467768907547,
0.06102471426129341,
1.1327811479568481,
0.1715640127658844
] |
NCT04812691
|
CD19-targeted CAR T Cells （JWCAR029） for Primary Refractory Diffuse Large B Cell Lymphoma
|
This is a phase I, open-label, single-arm, multicenter study to assess the safety and efficacy of JWCAR029 in adult primary refractory DLBCL subjects in China
|
This is a phase I, open-label, single-arm, multicenter study conducted in adult subjects with primary refractory DLBCL in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and collect immune response after JWCAR029 treatment.
One dose level of 1.0 x 10\^8 CAR+ T cells is adopted in this study. All sujects will be followed for 2 years after JWCAR029 infusion.
|
Inclusion Criteria:
1. ≥ 18 years old;
2. Sign on the informed consent;
3. Subject must have histologically confirmed diffuse large B lymphoma and primary refractory with first-line therapy;
4. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
6. Adequate organ function;
7. Adequate vascular access for leukapheresis procedure;
8. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
9. Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029;
10. Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029
Exclusion Criteria:
1. Subjects who have received second-line treatment or above
2. CD19 negative
3. Primary CNS lymphoma;
4. History of another primary malignancy that has not been in remission for at least 2 years;
5. Subjects has HBV, HCV, HIV or syphilis infection at the time of screening;
6. Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
7. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;
8. Presence of acute or chronic graft-versus-host disease (GVHD);
9. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
10. Pregnant or nursing women;
11. Subjects using of any chemotherapy, corticisteriod, experiment agents, GVHD therapies, radiation, allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
12. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
13. Received CAR T-cell or other genetically-modified T-cell therapy previously.
|
[
1.3505048751831055,
3.408557653427124,
-0.9444257020950317,
-2.0316991806030273,
1.2176443338394165,
1.5546071529388428,
-1.6220072507858276,
-0.47101983428001404,
-0.15408983826637268,
0.9632646441459656,
-1.110702633857727,
1.1634767055511475,
-2.7653286457061768,
1.7339366674423218,
-1.1366602182388306,
0.6108310222625732,
-0.6209527850151062,
-0.04968930408358574,
0.7581453919410706,
-1.2432861328125,
0.48780250549316406,
0.1274915486574173,
-0.2916845977306366,
0.4762512743473053,
0.9603464007377625,
0.12680432200431824,
-0.14868256449699402,
0.3827403783798218,
-1.0696556568145752,
1.3585848808288574,
0.3068395256996155,
0.29264625906944275,
-0.006734342779964209,
2.0379550457000732,
-0.8242807984352112,
-0.13090944290161133,
0.784729540348053,
-0.9141927361488342,
-0.2643270492553711,
0.38050347566604614,
-0.18826793134212494,
-0.8803592920303345,
-1.01731276512146,
0.4562528729438782,
-0.29518845677375793,
0.2546885907649994,
-1.7236193418502808,
-1.6816353797912598,
-0.6418203115463257,
-0.703239381313324,
-0.9612343311309814,
1.8560856580734253,
-0.5121258497238159,
-0.19295892119407654,
0.13978233933448792,
0.6759885549545288,
-0.12707360088825226,
1.040220022201538,
1.6052156686782837,
0.8267504572868347,
-0.1742275506258011,
-0.6344947814941406,
0.6942131519317627,
1.2394224405288696,
-0.7100092172622681,
1.4147236347198486,
-0.5026227831840515,
-0.8391246795654297,
-1.3546651601791382,
0.7165340185165405,
-0.25881901383399963,
0.44638869166374207,
1.1147570610046387,
0.21343466639518738,
-0.31227678060531616,
-0.8988738059997559,
0.07694686204195023,
0.3037351965904236,
0.024480022490024567,
0.9977909922599792,
-0.02076956257224083,
0.5678183436393738,
-0.7290818691253662,
-1.0260157585144043,
0.3366023898124695,
0.5226970911026001,
-1.8708752393722534,
-1.1823569536209106,
-0.42380577325820923,
-0.5851158499717712,
0.6332967877388,
-0.2663682699203491,
-1.0120811462402344,
-0.9915418028831482,
0.3314734101295471,
-0.2647249102592468,
0.07182453572750092,
-0.5122011303901672,
-0.5336925983428955,
0.4733924865722656,
-0.17117035388946533,
-0.3197804391384125,
-0.255075603723526,
-0.0632568746805191,
-0.29747578501701355,
-0.5390610098838806,
-1.3083891868591309,
-1.1857630014419556,
-0.6373679041862488,
-0.8748911619186401,
0.525956392288208,
-0.9664889574050903,
0.02869965136051178,
-0.5739023685455322,
0.8383551836013794,
0.07772251218557358,
0.6501820683479309,
-0.3584652245044708,
0.428680419921875,
-0.7377868294715881,
-0.20088818669319153,
1.6030824184417725,
0.22115902602672577,
0.49078041315078735,
0.6750590205192566,
-0.26567840576171875,
0.4601083993911743,
0.6365679502487183,
-0.7814913988113403,
0.4568800628185272,
-0.6832645535469055,
-0.4230368137359619,
0.49123910069465637,
-0.26137885451316833,
-1.1447985172271729,
0.24911849200725555,
-0.8048477172851562,
-0.11314474046230316,
-0.06308440864086151,
-0.820752739906311,
-0.3310587704181671,
-0.0348452627658844,
0.2506358027458191,
0.04934919625520706,
-1.6417523622512817,
0.9430399537086487,
0.1019076257944107,
-0.43200212717056274,
-0.011409078724682331,
0.1708560436964035,
-0.3234425187110901,
-0.09082959592342377,
0.14345037937164307,
-0.1526976078748703,
0.450991690158844,
-0.5320662260055542,
0.09858628362417221,
-0.8008502125740051,
0.2784968614578247,
-0.0726962462067604,
0.18889828026294708,
-0.11268798261880875,
0.15781085193157196,
-0.31334054470062256,
1.0345560312271118,
0.47320419549942017,
-0.02468113973736763,
-0.10541664063930511,
0.49664923548698425,
0.28614816069602966,
-1.2802282571792603,
0.2597416043281555,
0.4980972409248352,
0.3624822199344635,
0.41203874349594116,
-0.46189385652542114,
0.09641662240028381,
-0.195877805352211,
0.3478173613548279,
-0.4464178681373596,
0.2548341155052185,
0.27631676197052,
-0.15818339586257935,
1.1293411254882812,
-0.45619356632232666,
-0.10276605933904648,
-0.17659108340740204,
-0.04591139778494835,
0.01489485427737236,
0.8714070916175842,
0.13158755004405975,
-0.3213425278663635,
0.5329609513282776,
0.6872361302375793,
-0.031200891360640526,
-1.278046727180481,
-0.36450323462486267,
-0.12271193414926529,
0.526627242565155,
-0.34705328941345215,
0.5650067329406738,
0.4049374759197235,
0.4917643964290619,
-0.21541205048561096,
0.515532910823822,
0.05071815475821495,
0.10477089881896973,
0.10132082551717758,
0.1123746708035469,
-1.0254333019256592,
0.18226811289787292,
-0.4865644574165344,
-0.04240131378173828,
0.09169132262468338,
0.4553486406803131,
0.5902721881866455,
-0.37598827481269836,
0.5927785634994507,
-0.35180723667144775,
-0.6079978346824646,
-0.47810474038124084,
0.537562906742096,
0.15952031314373016,
-0.04960278049111366,
0.5598095655441284,
-0.2624063491821289,
-0.307898610830307,
-0.20912787318229675,
-0.01685386709868908,
-0.6107880473136902,
-0.29963669180870056,
0.04448140785098076,
-0.6025492548942566,
0.4824061095714569,
0.04304134473204613,
0.5742889642715454,
-0.25389185547828674,
0.1827966272830963,
0.06949961930513382,
0.0015552951954305172,
0.7507376670837402,
-0.20119336247444153,
-0.37914666533470154,
0.5776944160461426,
0.8665803074836731,
-0.06822363287210464,
-0.5744062662124634,
0.5602575540542603,
-0.11543997377157211,
-0.0031493562273681164,
0.097873754799366,
0.2563221752643585,
-0.09230910986661911,
0.10464560240507126,
0.16086776554584503,
-0.401544988155365
] |
NCT06907693
|
The Effects of Drug Candidate CS1 on Lung Structure and Function Utilizing FRI
|
Explore the impact of drug candidate CS1 on pathological vascular remodeling of small pulmonary arteries in the disease pulmonary arterial hypertension (PAH). This sub-study for CS1-004 aims to utilize FRI, an innovative, non-invasive imaging technology to visualize how long-term use of CS1 influences structural changes in pulmonary arteries. This sub-study seeks to provide valuable insights into the potential of CS1 to transform PAH treatment in some patients enrolled in the Expanded Access Program (CS1-004).
|
Inclusion Criteria:
* Participation in the CS1-004 clinical trial
Exclusion Criteria:
* Inability to undergo a CT pulmonary angiography scan (i.e., claustrophobia)
* Individuals who are pregnant or who become pregnant during the sub-study
* eGFR \<30 mL/min/1.73m2 as calculated by Modification of Diet in Renal Disease (MDRD)
* Allergy to Iodine contrast agents
|
[
2.544747829437256,
3.954817295074463,
-2.2158877849578857,
-1.9823904037475586,
-1.226576805114746,
-0.798761785030365,
0.2506785988807678,
-0.5980464220046997,
-0.9952797293663025,
0.3189515769481659,
-0.1829318106174469,
1.5149749517440796,
-0.5328452587127686,
-0.148516446352005,
0.6530855298042297,
2.2955291271209717,
0.3345792591571808,
0.8715383410453796,
0.9459910988807678,
-0.12432374060153961,
0.35890549421310425,
-0.7044143080711365,
1.4556688070297241,
0.5959978699684143,
1.555911660194397,
-0.7550528645515442,
1.235207200050354,
-0.5488883852958679,
-0.0485418438911438,
1.2024059295654297,
0.42699339985847473,
-0.41467994451522827,
0.6395000219345093,
0.7186652421951294,
0.2783706486225128,
-0.3527505099773407,
0.9138506054878235,
0.4721917510032654,
-0.25250348448753357,
-0.5821376442909241,
0.9976182579994202,
1.55008864402771,
-0.06141478568315506,
-0.7457677721977234,
0.14135824143886566,
-0.44071313738822937,
-0.27365612983703613,
0.19957147538661957,
0.053602591156959534,
-0.630977988243103,
-0.17912356555461884,
0.37192365527153015,
0.4158838987350464,
-0.690140962600708,
1.4267674684524536,
0.18316839635372162,
-0.18513835966587067,
0.9981191158294678,
0.9066594839096069,
0.4664997160434723,
-0.2795845866203308,
-0.20019879937171936,
0.43749096989631653,
1.6931315660476685,
-0.8282805681228638,
1.0386627912521362,
0.3143848776817322,
-0.47437217831611633,
-0.6842475533485413,
-0.39379799365997314,
0.6024928092956543,
-0.39802706241607666,
1.3161131143569946,
0.5506553053855896,
-0.2054876685142517,
0.24243010580539703,
-0.8743985295295715,
1.4146695137023926,
-0.02974373660981655,
0.2591114938259125,
-1.112929105758667,
0.31467992067337036,
-1.6418277025222778,
-0.10069475322961807,
-0.397205114364624,
-1.4776334762573242,
-1.4100760221481323,
-0.9033302664756775,
0.2519732117652893,
-1.604839563369751,
-0.10257455706596375,
-0.8918655514717102,
-0.2986365854740143,
0.7734069228172302,
0.9237739443778992,
0.3640141189098358,
-0.21591122448444366,
-0.25014907121658325,
-1.2123379707336426,
-0.21000534296035767,
-0.001979714259505272,
-0.2264978289604187,
-0.13291621208190918,
-0.4854407012462616,
-0.4116804003715515,
0.37946993112564087,
0.7032894492149353,
-0.43701282143592834,
-0.7658417224884033,
-0.3189241886138916,
0.3038303554058075,
-0.8439534902572632,
0.21367037296295166,
-0.4174167513847351,
-0.2196028232574463,
-0.9232556223869324,
-0.14167366921901703,
0.4266245663166046,
0.6742238402366638,
-1.2399471998214722,
-0.9646196365356445,
0.4951200485229492,
-0.7890692353248596,
0.5067761540412903,
-0.37407419085502625,
-0.4415830373764038,
-1.012010931968689,
0.42088231444358826,
-0.11975610256195068,
-0.4765918552875519,
0.7816715836524963,
-0.7487190961837769,
0.8397360444068909,
0.8965315222740173,
0.3047869801521301,
-1.1252552270889282,
0.08775261044502258,
0.22819304466247559,
-0.04060789570212364,
-0.5552573800086975,
-0.4626520872116089,
0.19754095375537872,
0.9974015355110168,
0.5035286545753479,
-1.4344112873077393,
-0.32149839401245117,
0.744945764541626,
0.04467260465025902,
0.03729252517223358,
-0.055260706692934036,
0.004615450743585825,
0.015289082191884518,
0.15802167356014252,
-0.27539801597595215,
-0.30424967408180237,
0.82161945104599,
-0.10716266185045242,
-0.5896093249320984,
0.7451375722885132,
0.27820107340812683,
0.4572190046310425,
-0.387093186378479,
-0.8618476390838623,
-0.5847680568695068,
1.0682486295700073,
-0.304137259721756,
-0.4222812056541443,
0.1839112639427185,
-0.10130131244659424,
-0.1851683109998703,
0.5420576930046082,
-0.20746256411075592,
0.008419635705649853,
-0.15158884227275848,
-0.9643100500106812,
-0.22294150292873383,
0.501981258392334,
-0.2714338004589081,
0.08142043650150299,
0.2771288752555847,
-0.13542746007442474,
0.16551488637924194,
0.308091402053833,
0.1769329160451889,
0.007591176312416792,
-0.2805732190608978,
0.28847700357437134,
0.2239837795495987,
-0.09793493896722794,
-0.5891737341880798,
0.35524678230285645,
0.04357057809829712,
-0.6244751811027527,
0.4695216715335846,
0.2575918138027191,
0.10341981798410416,
-0.12870512902736664,
-0.44857752323150635,
0.34079739451408386,
0.11265844106674194,
0.5486785769462585,
0.19123521447181702,
-0.005067101679742336,
0.9985755085945129,
1.1263093948364258,
0.2669285833835602,
-0.27382445335388184,
-0.5304001569747925,
0.44205859303474426,
0.12732289731502533,
0.16130705177783966,
0.2110077142715454,
-0.026899999007582664,
-0.15245714783668518,
1.228785514831543,
0.04910456761717796,
0.30487415194511414,
-0.10243652760982513,
-0.6565794944763184,
0.07564941793680191,
-0.30904316902160645,
-0.02951115183532238,
0.3922588527202606,
-0.23752351105213165,
0.2768527567386627,
-0.34809744358062744,
0.33047083020210266,
0.23573920130729675,
-0.8885025978088379,
0.10548969358205795,
-0.04729249328374863,
-0.4642839729785919,
0.3550763726234436,
-0.08407184481620789,
-0.39428412914276123,
0.5506706833839417,
0.37760022282600403,
-0.3667147755622864,
-0.16729317605495453,
0.3639009892940521,
0.15208245813846588,
-0.062466032803058624,
-0.4555778503417969,
-0.08079683780670166,
-0.004262544680386782,
0.08181789517402649,
-0.11885936558246613,
0.013841320760548115,
-0.25219687819480896,
-0.0677071064710617,
0.6256613731384277,
-0.7724061608314514,
0.20544901490211487,
0.6003082990646362,
0.4183520972728729,
-0.42097389698028564
] |
|
NCT05326373
|
Stannous Fluoride and Gingivitis
|
8-week study using stannous fluoride toothpaste on subjects with gingivitis ("unhealthy") and without gingivitis ("healthy"). Gingivitis index will be performed at BL, Week 4 and Week 8. A number of biological samples will be collected at each timepoint.
|
Inclusion Criteria:
* Be 18 years of age or older;
* Provide written informed consent and receive a signed copy of consent;
* Agree to delay any elective dentistry, including dental prophylaxis, and to report any non-study dentistry received during the course of this study;
* Agree not to participate in any other oral care studies for the duration of this study;
* Agree to refrain from any form of non-specified oral hygiene during the treatment periods, including but not limited to the use of products such as floss or whitening products;
* Agree to return for all scheduled visits and follow study procedures;
* Have at least 16 natural teeth;
* Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study.
For Unhealthy Group:
* Have at least 20 bleeding sites (sites with a score of 1 or 2 on the Screening GBI exam); and
* Have a minimum of 3 sampling sites with bleeding and pocket depth \>/=3mm but not deeper than 4mm at the Screening visit.
For Healthy Group:
* Have a maximum of 3 bleeding sites (sites with a score of 1 or 2 on the Screening GBI exam); and
* No pockets deeper than 2mm.
Exclusion Criteria:
* Self-reported pregnancy or the intent to become pregnant anytime during the course of the study;
* Inability to comply with study procedures;
* Rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
* Severe periodontal disease, including but not limited to purulent exudate, generalized mobility, and/or severe recession;
* Fixed orthodontic appliances or attachments for aligner treatment;
* Having had a dental prophylaxis within 2 weeks of plaque sampling visits;
* Having taken antibiotics or used anti-gingivitis/anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;
* Needing an antibiotic prophylaxis prior to dental visits;
* Presenting with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study; or
* Having any condition or disease, as determined by the Investigator/Designee which could be expected to interfere with examination procedures or with the subject's safe completion of the study.
|
[
1.7444833517074585,
-1.3040634393692017,
-3.0715835094451904,
-1.9839041233062744,
-0.011227020993828773,
-0.05291297286748886,
-0.3972357213497162,
-1.61697256565094,
0.38626277446746826,
-1.81526780128479,
1.753065824508667,
1.790709376335144,
-1.4437206983566284,
-0.9658277034759521,
1.6690374612808228,
-0.0494438037276268,
1.0273951292037964,
-1.2470937967300415,
3.824474811553955,
-1.5872772932052612,
2.220998525619507,
1.9046298265457153,
-0.23957547545433044,
0.9513956904411316,
0.30369582772254944,
1.6402591466903687,
-0.9927448630332947,
-0.685654878616333,
0.34345772862434387,
2.6489219665527344,
1.5012891292572021,
-0.3876968026161194,
-0.03772694617509842,
0.5084757208824158,
0.950453519821167,
-0.4896512031555176,
1.8853296041488647,
1.3803170919418335,
-0.9858911037445068,
-0.12334728240966797,
-0.34862086176872253,
0.6446434855461121,
0.4940914213657379,
1.6425225734710693,
1.53121018409729,
1.6442084312438965,
2.0881078243255615,
0.6317195296287537,
1.2241244316101074,
-0.3716447651386261,
0.5133918523788452,
0.41944992542266846,
-0.48290613293647766,
0.36604925990104675,
2.4689676761627197,
0.09790311753749847,
-0.4745006859302521,
0.8431285619735718,
0.2633030414581299,
1.2602026462554932,
1.0030467510223389,
-0.9358574151992798,
0.7928629517555237,
-1.8944300413131714,
-1.346709966659546,
-1.0614827871322632,
-0.5380329489707947,
0.6916751861572266,
0.21651871502399445,
-0.539088785648346,
0.599513828754425,
0.42908212542533875,
0.5720975995063782,
-0.31725192070007324,
0.8816565275192261,
0.7324398159980774,
-0.3425193130970001,
1.022765874862671,
0.1922760009765625,
0.09044159948825836,
0.5751921534538269,
-0.09071040898561478,
0.056190505623817444,
0.5145943760871887,
-1.115622878074646,
-1.3106274604797363,
-0.6362139582633972,
-0.5737514495849609,
-1.1367381811141968,
-0.9163290858268738,
0.39717933535575867,
-0.6948187947273254,
-1.5415897369384766,
-0.05182811990380287,
-1.2081602811813354,
-0.3342202603816986,
-0.7444851398468018,
0.9128015041351318,
-0.6422985196113586,
-0.7695726156234741,
-0.12433386594057083,
-0.440653532743454,
-0.5725117921829224,
-0.8959783911705017,
-1.6165062189102173,
-0.6589134335517883,
-0.16381438076496124,
1.0881744623184204,
-0.7966476082801819,
0.21966452896595,
0.30955737829208374,
-0.4132230579853058,
-0.048357900232076645,
-0.2666738033294678,
0.08590696007013321,
-0.27272629737854004,
0.6096062064170837,
0.5218376517295837,
0.04834138602018356,
-0.3549205958843231,
0.060283225029706955,
1.1224929094314575,
-0.22901803255081177,
-0.5555230379104614,
-0.4328288733959198,
0.23196464776992798,
0.6584548950195312,
-0.8367598652839661,
0.23776331543922424,
-0.5812232494354248,
-1.5412646532058716,
1.1066935062408447,
-0.487202912569046,
-0.48854634165763855,
-0.21823568642139435,
0.08444378525018692,
0.3382914662361145,
-0.145478755235672,
-0.45648205280303955,
0.7256374359130859,
0.2826175093650818,
0.10056743770837784,
-0.04473194107413292,
0.3121139109134674,
-0.6202403903007507,
-0.12749187648296356,
-0.4679579436779022,
0.5524455904960632,
-1.2166112661361694,
-0.08642929047346115,
0.3411116898059845,
0.526550829410553,
0.10307873785495758,
-0.20830635726451874,
-0.4031626284122467,
-0.5407698750495911,
0.49137094616889954,
0.35835039615631104,
0.09964727610349655,
-0.3001462519168854,
0.19118642807006836,
-0.1549917608499527,
0.2777409553527832,
0.07564650475978851,
-0.12806853652000427,
0.3415040969848633,
-0.0759105384349823,
-0.5005597472190857,
-0.06913183629512787,
-0.10453084856271744,
0.06318143755197525,
0.014325271360576153,
0.48968833684921265,
-0.19081561267375946,
-0.36148470640182495,
0.7655912637710571,
0.6780648827552795,
-0.47330614924430847,
-0.109209805727005,
-0.8003503084182739,
-0.7100053429603577,
0.09223764389753342,
-0.4170292615890503,
0.5031821131706238,
0.4850502610206604,
-0.10908923298120499,
1.1686761379241943,
-0.15269944071769714,
-0.3710704445838928,
0.07982826977968216,
-0.42726412415504456,
0.07434365153312683,
-0.5007637143135071,
0.5918263792991638,
0.2652567923069,
-0.7076476812362671,
0.1319926530122757,
-0.278851181268692,
0.6372872591018677,
-0.10587134957313538,
0.17585161328315735,
-0.0882597491145134,
-0.22532936930656433,
0.5857260823249817,
0.5035049915313721,
0.03041902743279934,
0.1868666112422943,
0.16873471438884735,
-0.4266020953655243,
0.5505029559135437,
0.39942458271980286,
0.06505285203456879,
-0.6251538395881653,
0.016943547874689102,
0.6265997290611267,
-0.2231261283159256,
0.5342119336128235,
0.07925910502672195,
-0.3441694378852844,
0.07388292998075485,
-0.17899848520755768,
-0.534352719783783,
-0.008398511447012424,
-0.5517799854278564,
-0.3727607727050781,
0.31232428550720215,
-0.1496172696352005,
-0.07622704654932022,
-0.29939377307891846,
0.05576691776514053,
-0.37671226263046265,
0.16224074363708496,
0.11374321579933167,
-0.4405204951763153,
-0.1312754601240158,
0.5397898554801941,
-0.24824731051921844,
0.2447815239429474,
0.3326703608036041,
0.3971845507621765,
-0.046786725521087646,
-0.5059237480163574,
0.35293927788734436,
-0.2916529178619385,
0.052353858947753906,
-0.4872037470340729,
0.4798954725265503,
0.7183860540390015,
-0.05085371062159538,
-0.06027265265583992,
0.2586749792098999,
-0.02543536014854908,
-0.6411805748939514,
-0.5798718333244324,
0.30185526609420776,
-0.32090821862220764
] |
|
NCT05963919
|
Determinants of Functional Capacity in Children With Asthma
|
The primary aim of this study is to compare the respiratory function, respiratory muscle strength, functional capacity, and lower extremity strength of children with asthma and healthy children in the same age group. The secondary aim of our study is to determine the determinants of functional capacity in children with asthma.
|
Asthma Group Inclusion Criteria:
* Being between the ages of 6-17
* Being diagnosed with asthma
* Able to walk, cooperate and clinically stable
* Being a volunteer to participate in the study
* To be able to speak, read, understand, and cooperate in Turkish
Asthma Group Exclusion Criteria:
* History of previous lung or liver transplant
* Having an acute exacerbation and/or a history of hospitalization in the last 1 month
* Having diagnosed orthopedic problems affecting mobility or a history of musculoskeletal surgery
Control Group Inclusion Criteria:
* Being between the ages of 6-17
* To be able to speak, read, understand, and cooperate in Turkish
* Being a volunteer to participate in the study
Control Group Exclusion Criteria:
* Having a diagnosed vision, hearing, or neurological disease that may affect balance
* Having any other neurological, orthopedic, cardiovascular, thoracic, or metabolic disease or pathological condition that would affect assessments
* Resting saturation below 90% during exercise tests
|
[
0.32670632004737854,
2.842189311981201,
-1.9311493635177612,
-3.4750452041625977,
1.8608494997024536,
0.31611746549606323,
0.3085886538028717,
0.3367239534854889,
-1.2186611890792847,
-1.6580363512039185,
0.7569044232368469,
1.8150408267974854,
-1.2205815315246582,
0.5236519575119019,
-0.5811914801597595,
1.1770075559616089,
-0.35205522179603577,
1.3495001792907715,
1.9230998754501343,
-1.7428278923034668,
0.17964105308055878,
-0.38567015528678894,
0.577722430229187,
0.04661250114440918,
0.673059344291687,
1.7610301971435547,
0.18558290600776672,
0.7950635552406311,
-0.8736355304718018,
-1.0636191368103027,
-1.4811900854110718,
-2.065533399581909,
-0.31045740842819214,
0.13621880114078522,
-0.520149290561676,
-0.20080871880054474,
1.1046284437179565,
-0.28160467743873596,
-0.33668097853660583,
-0.283645898103714,
0.8374785780906677,
2.1754868030548096,
-0.07974134385585785,
0.10590354353189468,
0.42516037821769714,
0.43406280875205994,
0.008471432141959667,
0.4667187035083771,
-1.0281062126159668,
2.2122275829315186,
0.0014015721390023828,
0.5451210737228394,
-0.6437713503837585,
-1.67253577709198,
2.0479958057403564,
-1.3996663093566895,
1.2703641653060913,
-0.3166238069534302,
-1.199906826019287,
1.5938003063201904,
1.5532033443450928,
-0.8174107670783997,
1.6064600944519043,
0.8723879456520081,
0.41800400614738464,
-0.7420976161956787,
1.0166335105895996,
0.5395098328590393,
-0.7443296313285828,
0.3540742099285126,
0.10506519675254822,
-0.9715303182601929,
0.9415437579154968,
0.2485513538122177,
-0.34428009390830994,
0.5578985214233398,
0.6346323490142822,
1.0298058986663818,
1.333810567855835,
1.2843196392059326,
-0.6146933436393738,
-0.03661069646477699,
-1.3051165342330933,
-0.32865557074546814,
-0.07728639990091324,
0.566607654094696,
-1.0447462797164917,
0.9046050906181335,
0.5562164783477783,
-1.0114532709121704,
-0.08735092729330063,
-0.08813229203224182,
-1.4469234943389893,
0.8914068341255188,
-0.18016581237316132,
0.03607994318008423,
0.2965458631515503,
0.5023620128631592,
-1.3213863372802734,
-0.31205591559410095,
0.04870973527431488,
-1.0614339113235474,
-0.4827347695827484,
0.8286093473434448,
-0.6707330346107483,
-0.8927059769630432,
-0.442225843667984,
0.4910959005355835,
-0.36204108595848083,
-0.49439412355422974,
-0.01419773604720831,
-1.1994765996932983,
0.30186331272125244,
0.08152290433645248,
1.6917707920074463,
-0.500312328338623,
0.8701221942901611,
1.3422235250473022,
-0.11014065146446228,
-0.3084779679775238,
0.3015604615211487,
1.499639868736267,
0.2177731990814209,
0.4411260187625885,
-0.098941370844841,
-2.092545509338379,
0.049405381083488464,
0.3493143618106842,
-0.10879170894622803,
-1.7509896755218506,
-0.7476516962051392,
-0.7112740278244019,
0.6187872290611267,
-0.3016400933265686,
-0.27740585803985596,
-0.5389512181282043,
0.8327159881591797,
-0.1430942714214325,
1.184997797012329,
-0.5226989984512329,
-0.6405895948410034,
0.6414921879768372,
-0.4948210120201111,
-0.663868248462677,
-0.7017520666122437,
0.3791957497596741,
0.7071868777275085,
-0.10626033693552017,
-0.24499812722206116,
0.2513063848018646,
0.37615519762039185,
0.28496628999710083,
-0.2898082435131073,
-0.19349952042102814,
-0.3069966435432434,
0.8468829989433289,
0.23836660385131836,
-0.40560945868492126,
0.17750348150730133,
1.3517587184906006,
1.4192416667938232,
0.08287643641233444,
-0.9864758253097534,
-0.41781049966812134,
0.8217585682868958,
-0.24974983930587769,
0.6897856593132019,
0.5597837567329407,
-0.6024221777915955,
0.7447014451026917,
-0.5244317650794983,
-0.7168341279029846,
0.05791477859020233,
0.5017675161361694,
1.0861047506332397,
-0.03738076984882355,
0.7959575653076172,
0.17036046087741852,
-0.47734445333480835,
-0.2997479736804962,
-0.09462619572877884,
0.6789404153823853,
0.014682352542877197,
0.7268897891044617,
0.026861637830734253,
-0.21368061006069183,
-0.27132654190063477,
-1.2675334215164185,
-0.4575463831424713,
0.07490872591733932,
-0.2752438485622406,
-0.48697429895401,
0.020634498447179794,
-0.638695478439331,
-0.07866214215755463,
-0.15900540351867676,
-0.6937045454978943,
-0.49434518814086914,
0.6355606317520142,
-1.0398706197738647,
0.5788105130195618,
-0.7467454075813293,
-0.3181953728199005,
-0.08282656967639923,
-0.773685097694397,
0.5017957091331482,
-0.027850372716784477,
0.033701468259096146,
0.12172211706638336,
0.21505312621593475,
-0.20540009438991547,
0.46903184056282043,
-0.43078315258026123,
-0.5512917637825012,
0.3463743329048157,
0.16042906045913696,
-0.46336662769317627,
0.044688630849123,
-0.025941232219338417,
0.004218497313559055,
-0.2865714430809021,
0.20962952077388763,
0.2529545724391937,
0.17252963781356812,
-0.0577857531607151,
0.0298289991915226,
-0.4971639811992645,
0.02787347324192524,
-0.2965485453605652,
-0.6989914178848267,
-0.4598158299922943,
-0.3620527386665344,
-0.5254040360450745,
0.12926390767097473,
-0.014741653576493263,
0.36297672986984253,
-0.058657217770814896,
0.5483192205429077,
0.3297670781612396,
-0.48340627551078796,
0.11322075873613358,
-0.35262128710746765,
0.23396536707878113,
0.23121710121631622,
-0.8466820120811462,
-0.6318367123603821,
-0.08984173834323883,
-0.09774564951658249,
-0.3783329427242279,
0.25191977620124817,
0.07541249692440033,
-0.07486467063426971,
0.3308599591255188,
-0.2339865267276764,
0.4554392695426941,
-0.48325788974761963
] |
|
NCT03114878
|
The Value of EMDR in the Treatment of Tinnitus
|
A prospective, randomized, controlled, clinical trial with blind evaluator that uses TRT and EMDR as a treatment for tinnitus.
|
Patients with subjective, chronic, non-pulsatile tinnitus will be randomized in two treatment groups: TRT and CBT versus TRT and EMDR. Evaluations will take place at baseline before therapy starts, at the end of the treatment, after 3 months (10 treatment sessions) and 3 months after therapy ends. The Tinnitus Functional Index (TFI) will be used as the primary outcome measurement. Secondary outcome measurements will be the Visual Analogue Scale of Loudness (VAS), Tinnitus Questionnaire (TQ), Hospital Anxiety and Depression Scale (HADS), Hyperacusis Questionnaire (HQ), psychoacoustic measurements and Event-related potentials (ERP). The objective is to evaluate whether the bimodal therapy TRT and EMDR can provide faster and/or more relief from the annoyance experienced in chronic tinnitus patients' daily lives compared to the bimodal therapy TRT and CBT.
|
Inclusion Criteria:
* Tinnitus type: chronic, subjective, non - pulsatile tinnitus
* Duration of tinnitus = more than 3 months
* Minimum age of the patient is 18 years old - maximum age is 75 years old
* Tinnitus Functional Index (TFI) score ≥ 25 - \< 90
* Stable use of medication during therapy
Exclusion Criteria:
* HADS - score: anxiety and depression-subscores \> 15
* HQ - score \> 40
* Objective, pulsatile tinnitus
* Active middle ear pathology
* Neurological and psychiatry co-morbidity for which currently psychotherapy is ongoing
* Psychosis, schizophrenia, epilepsy
* Pregnancy
|
[
-1.1658273935317993,
0.2062511146068573,
-2.037951707839966,
-2.4990735054016113,
-0.9878783822059631,
-0.23893162608146667,
0.6537413001060486,
2.5182995796203613,
-1.7554149627685547,
0.3504447042942047,
-0.7249760031700134,
1.4890271425247192,
-2.2993032932281494,
0.7829519510269165,
0.37013116478919983,
0.9571298360824585,
-0.01553953718394041,
2.230546712875366,
-0.4609518349170685,
-3.1331942081451416,
-0.4207501709461212,
-0.44789373874664307,
-0.9971879720687866,
2.0210795402526855,
-1.1212941408157349,
1.3610823154449463,
-0.6118572354316711,
1.8752061128616333,
1.0663564205169678,
1.503650188446045,
-0.9081165790557861,
1.9190175533294678,
0.1960766464471817,
0.7798967957496643,
1.4270142316818237,
-0.19821371138095856,
1.404859185218811,
0.1756596714258194,
-0.3469759523868561,
0.7897351980209351,
-1.1924922466278076,
0.4801205098628998,
-0.7280803918838501,
1.3308870792388916,
1.7419962882995605,
-0.05204344913363457,
-0.06334128975868225,
-0.20513194799423218,
1.0813242197036743,
-0.6418328881263733,
0.5420073866844177,
1.6440918445587158,
1.085030436515808,
1.1485066413879395,
-0.09010215103626251,
1.6301935911178589,
0.44838398694992065,
1.1387463808059692,
1.0994014739990234,
0.1661134511232376,
1.6089040040969849,
0.6690674424171448,
0.911584734916687,
1.5412333011627197,
-2.0769057273864746,
-0.07797329127788544,
0.34709692001342773,
1.1786359548568726,
0.5370355844497681,
-0.9342473149299622,
0.1339632123708725,
0.5592502355575562,
-0.4864991009235382,
0.33836832642555237,
-0.4778270125389099,
-0.5027957558631897,
-0.6348050832748413,
0.5991613268852234,
1.047332763671875,
-0.3199344277381897,
0.3762442469596863,
0.1038879007101059,
0.855092465877533,
-0.9039901494979858,
0.6584054827690125,
-1.2275843620300293,
-0.7153317928314209,
-0.03568954020738602,
0.882531464099884,
-0.35265180468559265,
1.2989041805267334,
-1.0797464847564697,
-0.25719645619392395,
0.7828065156936646,
-0.6337375640869141,
-0.769927442073822,
-0.9514650702476501,
-0.02420777641236782,
0.7468722462654114,
-0.28736642003059387,
0.3703681528568268,
0.4705696403980255,
-0.18851958215236664,
-0.18297535181045532,
-0.7757133841514587,
-1.271312952041626,
0.5618049502372742,
0.14930833876132965,
-0.4814460873603821,
-1.6493319272994995,
-0.3723924458026886,
-0.1750166416168213,
0.762458086013794,
-0.48940137028694153,
0.32169201970100403,
1.0834771394729614,
-0.7141674160957336,
0.575368344783783,
-0.47255751490592957,
0.38753923773765564,
-0.4141007661819458,
0.8581072092056274,
0.6828317642211914,
-0.773978590965271,
-1.662337064743042,
0.37547799944877625,
-0.6346569061279297,
0.47350013256073,
-0.7082319855690002,
-1.1317822933197021,
0.08074682205915451,
-0.04804224520921707,
-0.571250855922699,
0.30133816599845886,
-1.8891385793685913,
-0.22329577803611755,
0.6350204944610596,
1.8874403238296509,
1.0854660272598267,
-1.4842400550842285,
-0.18873660266399384,
0.6151387095451355,
0.43669024109840393,
0.12261193245649338,
-1.539988398551941,
-1.4875988960266113,
-1.9165757894515991,
0.9513552784919739,
-1.0774449110031128,
-1.2890301942825317,
-1.587568998336792,
0.017136432230472565,
0.20397420227527618,
-0.2520681321620941,
0.5479972958564758,
1.0604312419891357,
0.7716838121414185,
-0.8755829930305481,
0.9425693154335022,
-1.6890175342559814,
-0.3732648491859436,
-0.21293982863426208,
0.53885817527771,
-1.2802929878234863,
0.6254376769065857,
0.2169048935174942,
-1.2519912719726562,
-0.21222694218158722,
0.9306363463401794,
-0.25478503108024597,
0.2611715793609619,
-1.0105544328689575,
-0.8605215549468994,
0.8060868978500366,
-0.2572222352027893,
0.3421419560909271,
0.875802218914032,
-0.20752854645252228,
-0.5553147196769714,
0.1521550863981247,
-0.6625882983207703,
-0.9424170255661011,
-0.3192782700061798,
-0.06443409621715546,
-0.3529077470302582,
-1.1923677921295166,
0.39230605959892273,
-0.07106077671051025,
0.17522437870502472,
0.48892179131507874,
-0.30516302585601807,
-0.40607792139053345,
-1.049912929534912,
0.09969698637723923,
0.06565490365028381,
-1.1692065000534058,
-0.09281200915575027,
-0.06423677504062653,
-0.20871813595294952,
-0.6146088242530823,
1.347382664680481,
1.0939685106277466,
0.24880486726760864,
0.23381870985031128,
0.1600407063961029,
-0.3020417392253876,
0.11565358191728592,
-0.39248165488243103,
-0.46130093932151794,
-0.16086474061012268,
-0.11625771969556808,
0.1295165866613388,
-0.9119226932525635,
0.21409007906913757,
0.1901220977306366,
-0.3160051107406616,
0.23762239515781403,
0.9623821377754211,
-1.1856220960617065,
-0.4474104940891266,
-0.5315574407577515,
-0.36244022846221924,
-0.485604465007782,
0.4459729492664337,
-0.16821572184562683,
0.536321759223938,
0.30774986743927,
0.6107303500175476,
0.5118206739425659,
0.6486969590187073,
-0.40230435132980347,
0.2128324806690216,
0.20764504373073578,
-0.4479753375053406,
-0.06542115658521652,
-0.31908443570137024,
0.11882209777832031,
0.6289711594581604,
0.4046025574207306,
0.14613237977027893,
0.7319456338882446,
-0.9988670945167542,
-0.004408269189298153,
-0.2605535089969635,
-0.40864425897598267,
-0.4684359133243561,
0.29366543889045715,
0.32729050517082214,
-0.14422693848609924,
-0.017058121040463448,
-1.063997745513916,
-0.28236934542655945,
0.8984118103981018,
0.23906713724136353,
-0.15554198622703552,
-0.16820088028907776
] |
NCT06265272
|
Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis
|
A total of fifty-five (55) patients with liver cirrhosis will be enrolled in this study to produce and validate dedicated Ga-PSMA-PET/MRI acquisition protocols.
The specific hypotheses include:
* Ga-PSMA PET/MRI may allow robust and reproducible noninvasive in vivo quantitation of hepatic macro and microhemodynamics in cirrhotic patients
* Dedicated simultaneously acquired DWI sequences might quantitate liver fibrosis and improve hemodynamic quantitation.
* Ga-PSMA PET/MRI may allow noninvasive and reproducible quantitation of portal venous hypertension and predict its evolution, as well as response to treatments
* Ga-PSMA PET/MRI may improve noninvasive and reproducible qualitative and quantitative assessment of liver function, structure, nodules and predict evolution of cirrhosis
|
\[68Ga\]Ga-PSMA-11(Ga-PSMA) is a novel radiotracer approved by the FDA in late 2020 to investigate prostate cancer in men. This compound targets the prostate-specific membrane antigen, which unlike the name suggests, has been detected in other anatomical regions, mainly associated with neoangiogenesis. The high affinity of PSMA toward neoangiogenesis can play several roles in imaging liver cirrhosis. In particular, it may highlight neovasculature and help distinguish microhemodynamic changes caused by shunting from those caused by increased vascular permeability associated to neoangiogenesis. Thus, Ga-PSMA may improve the interpretation of MRp maps, of DWI data (which is also influenced by microperfusion) and might add more confidence on Li-Rad classifications.
For each candidate patient subject, the study staff will first contact the treating clinician to inquire as to their willingness to allow investigators to approach the subject to participate in this study. The clinician will initially introduce the study to the patient and will obtain the patient's permission to be contacted by the study staff. One of the investigators or other study staff will then approach the subjects in accordance with PHRC policy. At the time of initial discussions about potentially participating in this study, the investigators will make it clear to potential subjects that the study scan is performed at the Charlestown Navy Yard to allow them to decide if travel associated with participation is too inconvenient. Subjects will be informed that a decision to participate or not in the PET/MRI protocol will not affect their care within MGH or any other Mass General Brigham facility. Informed consent will be obtained from the subjects by licensed physician principal investigator, licensed physician co-investigator, or licensed nurse practitioners listed as co-investigators with backup from a licensed physician investigator listed on study staff.
PET/MRI images will be acquired using the Biograph mMR combined 3 Tesla PET/MRI scanner. The image quality on these 3 Tesla devices will be very high, typical, or better than any other standard clinical MRI system. Subjects will be asked to lie still for the duration of the study. The investigators expect the entire imaging session to last about 80 minutes and not to exceed 120 minutes.
The investigators will be comparing:
1. Different sequences, acquisition protocols and reconstruction modeling in term of image quality, reduction of artifacts, improved signal and contrast to noise ratios, reproducibility of the quantitative features.
2. PSMA-PET/MRI quantitative and qualitative features, including hybrid biomarkers obtained incorporating PSMA uptake with MRp and/or 4D-MRI and/or DWI extracted parameters, with clinical data that provide insights into liver function and liver hemodynamics
3. PSMA-PET/MRI qualitative and quantitative features (for example vascular permeability or median velocity), including hybrid biomarkers, with clinical data to explore possibility of assessing liver function, quantify fibrosis, facilitate Li-Rad classification, measure hemodynamics in cirrhotic patients including those treated/ to be treated for portal hypertension.
4. Comparison of fused Ga-PSMA PET/MRI images with stand-alone MRI images and stand-alone PET images obtained in the same scan in terms of qualitative and quantitative imaging features, for example confidence in characterization of band-like fibrosis or differentiation of mild from moderate degree of fibrosis.
5. The investigators will also follow up patients to ascertain if Ga-PSMA PET/MRI result might have impacted on clinical management.
Descriptive statistics will be used to compare the performance (detection rates, sensitivity, and specificity) of PET/MRI and MRI alone. When calculating sensitivity and specificity for each imaging modality, the gold standard will be considered whole-liver pathology for patients who undergo liver transplant; or biopsy/surgical pathology results in patients that do not undergo liver transplantation but are directed to biopsy; or finally imaging follow-up in patients who undergo follow-up only. No biopsy or image follow-up will be ever ordered for the sake of this study. They will be ordered only for standard clinical care. Means and standard deviations or median and (IQR) will be reported for continuous variables according to the variable distributions. Categorical variables will be reported as counts and proportions, and 95% Confidence Intervals will be included when applicable. A p-value \<0.05 will be considered statistically significant. For the primary endpoint analysis, confusion matrices will be constructed comparing PET/MRI to PET alone ant to MRI alone. Each lesion described by the readers of the imaging modalities will then be classified accordingly into true positive, false positive, true negative or false negative. Sensitivity, specificity, accuracy, positive predictive value, and negative predictive value will then be computed using the adequate proportions as estimates. Additional parameters that will be evaluated include region of interest location, size, apparent diffusion coefficient value, and standardized uptake value, and quantitative MRp metrics.
|
Inclusion Criteria:
* Liver cirrhosis as diagnosed by imaging and/or clinical data, including pathology
Exclusion Criteria:
* Any contraindication to PET, as in attached screening form
* Any contraindication to MRI, as in attached screening form
* Any contraindication to gadolinium-based contrast agent, including allergy to gadolinium, as in attached screening forms.
* Pregnancy
* Breast feeding.
* Cumulative radiation exposure for research studies during the prior 12 months, combined with the exposure from this study, \> 50 mSv
* Inability to fit in the scanner: weight \> 300 lbs or BMI \> 33
|
[
1.472658395767212,
0.5893828868865967,
-4.531585693359375,
-2.432014226913452,
0.22705577313899994,
-0.016707681119441986,
-1.3406482934951782,
-0.6108304262161255,
-1.9274530410766602,
-0.566949188709259,
0.02226327545940876,
1.0105291604995728,
-1.641964077949524,
-0.6564501523971558,
1.04497230052948,
0.37884223461151123,
-0.3375861942768097,
0.6762391924858093,
1.2698270082473755,
-0.8033037185668945,
0.8794736266136169,
-1.6120641231536865,
0.752809464931488,
1.3148455619812012,
-0.9160924553871155,
-1.0858910083770752,
-1.4464055299758911,
0.7853242754936218,
0.7684768438339233,
-0.3064797520637512,
0.5104072093963623,
-1.1727911233901978,
0.3946247696876526,
1.5288809537887573,
0.34876304864883423,
-1.0770814418792725,
2.080965757369995,
0.24641776084899902,
-1.1210858821868896,
0.07614965736865997,
0.6286967396736145,
0.6163362264633179,
0.07190144807100296,
-0.9866355657577515,
1.099501609802246,
0.3309188783168793,
0.10339146852493286,
0.47640714049339294,
0.6811714768409729,
0.22219397127628326,
-0.497590571641922,
-0.028412753716111183,
-1.9178845882415771,
0.9754993319511414,
2.1748645305633545,
0.5547228455543518,
0.6189802885055542,
1.2111620903015137,
0.8733577728271484,
0.24732035398483276,
-0.09919653832912445,
-0.2591247856616974,
0.30570197105407715,
0.83089679479599,
0.08265835046768188,
-0.4595615565776825,
0.9571821689605713,
0.36126938462257385,
-1.829785704612732,
0.28941699862480164,
0.050783686339855194,
1.3859834671020508,
-0.8866128325462341,
0.9972251653671265,
0.4387052059173584,
0.6046257019042969,
-1.4775261878967285,
0.8349623680114746,
0.11731861531734467,
0.47502294182777405,
-0.0700799971818924,
-1.7262403964996338,
-0.4845179319381714,
1.1160237789154053,
-0.8212647438049316,
-0.908850371837616,
-1.0020893812179565,
-1.1076371669769287,
1.2645940780639648,
-0.5622109174728394,
0.7296185493469238,
-1.1477779150009155,
-0.7810907363891602,
-0.27528026700019836,
-0.8109749555587769,
0.4600096642971039,
-0.8815678358078003,
-0.32781073451042175,
-1.3686035871505737,
0.820250928401947,
-0.43981316685676575,
0.007972261868417263,
-0.7479236721992493,
-0.8617984056472778,
-0.6953169107437134,
-0.3310168981552124,
1.364111304283142,
-1.348415493965149,
-0.6253247261047363,
-0.5977769494056702,
0.03128420561552048,
-1.4915002584457397,
0.02096099779009819,
-0.3503424823284149,
-0.1931925117969513,
-0.3759554624557495,
-0.3177807033061981,
0.7964885830879211,
-0.03897908702492714,
-0.08888959884643555,
-0.21851696074008942,
0.42867738008499146,
0.021054096519947052,
-0.017901327461004257,
-0.6823405027389526,
0.19513513147830963,
-0.4133051633834839,
0.19921448826789856,
-0.15982678532600403,
-0.33666715025901794,
-1.1437702178955078,
0.4337913393974304,
0.08789833635091782,
-0.3717694878578186,
-0.5687077641487122,
-0.4251750707626343,
0.4878436326980591,
0.11724220961332321,
0.11753242462873459,
0.11849275231361389,
0.06883206218481064,
-0.24074669182300568,
0.5683068037033081,
0.7243078351020813,
-0.4171547591686249,
-0.7785662412643433,
-0.2630687952041626,
0.2530433237552643,
0.6966891288757324,
-0.004301435314118862,
0.2819545865058899,
-0.5889192223548889,
0.18609727919101715,
0.28016215562820435,
0.13234001398086548,
-0.06991318613290787,
0.004289044067263603,
-0.4417444169521332,
-0.24185049533843994,
0.03350307419896126,
-0.6022084951400757,
-0.12087289243936539,
0.4801485240459442,
-0.0002758818445727229,
1.0133918523788452,
-0.6465070247650146,
-0.05731518939137459,
-0.7232584357261658,
0.6136102676391602,
0.16404277086257935,
-0.33029353618621826,
0.03571861609816551,
0.2760029435157776,
-0.1467512547969818,
-0.8307033181190491,
-0.35419604182243347,
-0.26715633273124695,
-0.35512015223503113,
-0.4107060134410858,
-0.05870670825242996,
-0.4123542010784149,
-0.0771319568157196,
-0.3772478401660919,
0.10056114196777344,
0.11234231293201447,
-0.19532029330730438,
-0.39637553691864014,
0.06670563668012619,
-0.06166021153330803,
0.15010018646717072,
0.1028643548488617,
0.05278092995285988,
0.018368860706686974,
-0.20033280551433563,
0.25588834285736084,
0.08641599118709564,
-0.1881633996963501,
-0.34872016310691833,
-0.5197247266769409,
0.38365980982780457,
0.6224105954170227,
0.6633313894271851,
0.13742773234844208,
0.48316875100135803,
0.41219303011894226,
0.14133869111537933,
-0.14891107380390167,
-0.17965321242809296,
0.13640430569648743,
0.25410106778144836,
0.2686741054058075,
0.7764888405799866,
0.2241853028535843,
0.0135513786226511,
0.14034228026866913,
0.14849241077899933,
-0.07466695457696915,
0.533845067024231,
-0.318645179271698,
0.17656469345092773,
-0.682167112827301,
-0.12286610156297684,
-0.16433393955230713,
-0.29727309942245483,
0.09525956958532333,
-0.4471798539161682,
0.3208885192871094,
0.2438371479511261,
0.6430152058601379,
-0.34075355529785156,
-0.10187219828367233,
0.41849344968795776,
-0.09656334668397903,
-0.5621938705444336,
0.27541956305503845,
0.30135291814804077,
0.13985516130924225,
-0.09928819537162781,
-0.037962641566991806,
0.7889743447303772,
-0.22816376388072968,
-0.20638781785964966,
-0.17478139698505402,
0.21325750648975372,
-0.3945063054561615,
0.08144598454236984,
-0.008579528890550137,
-0.5758244395256042,
-0.19850800931453705,
-0.5621356964111328,
-0.40203335881233215,
-0.3536709249019623,
0.5472584366798401,
0.35727933049201965,
0.040575459599494934,
0.08370305597782135
] |
NCT06607484
|
Study Investigating the Safety, Tolerability and Blood Concentration of the Substance SR-878
|
SR-878 is a newly developed medicine that aims to treat autoimmune disorders. It inhibits a protein (iRhom2), that regulates enzymes that are involved in the production of cytokines (small proteins that are crucial in controlling the activity of immune system cells). This is the first study in humans, and SR-878 will be administered once to each participant in 6 different doses to establish a safe dosage and investigate, what are potential side effects.
This clinical trial includes six study groups, called cohorts, and each cohort includes 8 participants. In each cohort, 6 participants will receive SR-878 and 2 participants will receive a placebo, a dummy drug with no active ingredients that looks identical. The comparison with placebo will be used to better assess the side effects of SR-878. The dose of SR-878 will be gradually increased between cohorts. Participants in the first cohort will receive the lowest dose, and if this is considered safe 10 days after dosing, the next cohort will be initiated at a higher dose. Participants visit the hospital regularly over the next 12 weeks after receiving SR-878 or placebo. During these visits, medical condition will be checked and blood will be taken.
Participants in the third to sixth cohort will be injected with a product called LPS 24 hours after the infusion of the investigational product, which may stimulate the immune system and cause a temporary inflammatory response in the body. During this time, participants may have mild "flu-like" symptoms. 12 weeks after dose of investigational product, the LPS injection and saline infusion will be repeated.
|
Rationale: SR-878 is a newly developed medicine that aims to treat autoimmune disorders. It works by blocking a protein called iRhom2, which controls the production of small proteins called cytokines. Cytokines are the drivers that keep the inflammatory process ongoing in autoimmune diseases important for regulating the activity of cells in the immune system. This is the first study in humans, and SR-878 will be administered once to each participant in 6 different doses to investigate potential side effects.
Objectives:
* To assess the safety and tolerability of a single dose of SR-878;
* To select the optimal dose that is safe and tolerable;
* To explore any effects of a single dose of SR-878 in the human body;
* To investigate the connection between the concentration of SR-878 and potential side effects;
* To assess the amount of immune response against SR-878. Trial design: This clinical study will have six treatment groups, so called cohorts, and each cohort will include 8 participants. In each cohort 6 participants will receive SR-878, and 2 participants will receive a placebo, that is a dummy treatment without active ingredients. The comparison with the placebo is used to better assess the side effects of SR-878. The dose of SR-878 will be gradually increased between cohorts.
After the screening period, participants will be randomly assigned to receive SR-878 or placebo. This is a double-blind study, which means neither the participant nor the study staff, including the study doctor, will know which study medication was used.
The study medication will be administered in a 1-hour long infusion. The participants will be requested to stay 24 hours in the hospital after the infusion, and their medical condition will be monitored, and they will undergo several blood draws.
24 hours after the study medication infusion, participants in the 3rd-6th cohorts, will be injected with a product, called lipopolysaccharide (LPS). It has the ability to boost the body's immune response, even without causing an actual infection. LPS might trigger slight flu-like symptoms (i.e. uneasiness, little fever). Participants will be requested to stay an additional 8 hours in the hospital, and they will undergo several blood samplings and their body's reaction will be monitored. In the first 6 hours, they will receive a saline infusion to keep them hydrated, and in case they find the potential symptoms of the provoked inflammation unbearable, the study doctor will provide a medication (paracetamol) to relieve them.
In the following 12 weeks, participants will be requested to return regularly to the hospital, 10 times in total. During these visits, their medical status will be examined, and blood will be collected. For participants in the 3rd-6th cohorts, 12 weeks after their study medication dose, the LPS injection and the saline infusion will be repeated, and they will stay 8 hours again on the site. They will undergo several blood draws, and their medical condition will be monitored. They will also be requested to return to the site on the next day to repeat these assessments.
Interventions:
* Participants will receive SR-878 in a 1-hour long infusion once. The dose will depend on the cohort;
* Participants in the 3rd-6th cohorts will receive LPS injections twice, in a dose of 2 ng/kg body weight.
|
Inclusion Criteria:
1. Healthy male or female subjects aged 18 to 40 years inclusive on the day of informed fonsent form (ICF) signature and with a body weight ≥ 45 kg and body mass index (BMI) ≤ 30 kg/m2;
2. Subjects willing to sign a written informed consent and able to comply with the study protocol for the duration of the study, including the inpatient confinement for about 24 or 32 hours;
3. Has adequate venous access for blood collection;
4. In female subjects of childbearing potential, a negative serum pregnancy test at screening;
5. Females of childbearing potential agreeing to use highly effective methods of contraception for the duration of the study; Males agreeing to use highly effective methods of contraception and not to donate sperm until 90 days after the study drug administration.
Exclusion Criteria:
1. Treatment with an investigational drug within one month or two half-lives prior to screening, whichever is longer;
2. Abnormal findings in medical history and physical examination that the investigator considers to be a clinically relevant abnormality;
3. Clinically significant abnormal screening laboratory tests, including but not limited to:
* Haemoglobin (HGB) \< 120 g/L for males or \< 110 g/L for females
* White Blood Cells (WBC) \> 1.5 upper limit of normal (ULN)
* C-reactive Protein (CRP) \> 1.5 ULN
* Serum Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) or Alkaline Phosphatase (ALP) \> 1.5 ULN
* Estimated Glomerular Filtration Rate (eGFR) \< 55 mL/min/1.73 m2
4. Subjects infected with human immunodeficiency virus (HIV), hepatitis B and C viruses (HBV and HCV);
5. Clinically relevant ECG (12 leads) abnormalities;
6. Subjects with acute infectious diseases within 2 weeks prior to screening;
7. History of any autoimmune diseases or any chronic inflammation;
8. Relevant history of other renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory, chronic infectious, or neurological diseases;
9. History of anaphylaxis to drugs or major allergic reactions in general, which in the view of the investigator may compromise the safety of the subjects;
10. Known hypersensitivity to the active substance or to any of the excipients of the investigational medicinal products or auxiliary medicinal products;
11. Drug abuse, alcohol \>1 drink/day, defined according to the Food-based Dietary Guidelines in Europe;
12. Females who are pregnant, breastfeeding, or planning to become pregnant during the study.
|
[
-0.186336487531662,
2.7847163677215576,
-0.9486006498336792,
-1.4985440969467163,
0.3788450360298157,
0.8137505054473877,
-0.42003172636032104,
0.012969795614480972,
0.156902015209198,
0.05332110822200775,
0.6147090792655945,
1.2533661127090454,
-0.9703913331031799,
0.9716069102287292,
0.48719173669815063,
-0.3944278955459595,
-0.40004342794418335,
0.1104959025979042,
1.5973517894744873,
-1.0946855545043945,
-0.6419959664344788,
-0.014438432641327381,
-0.5134532451629639,
0.05196795240044594,
1.2820203304290771,
0.36698561906814575,
-0.8298348784446716,
0.8378891944885254,
0.4253455698490143,
1.3960191011428833,
-0.20149056613445282,
-0.2787996828556061,
1.0618945360183716,
-0.2782756984233856,
0.6066733002662659,
0.11000561714172363,
1.3295124769210815,
0.386282742023468,
-0.4326607286930084,
0.5728616118431091,
0.7019990682601929,
-0.10655258595943451,
-0.6710138320922852,
0.32637909054756165,
1.0759105682373047,
-0.4089922606945038,
-0.2725084125995636,
0.26811620593070984,
0.0752120167016983,
-0.058985378593206406,
-0.6592011451721191,
0.6371082663536072,
-0.5117926001548767,
0.16302715241909027,
1.233218789100647,
0.03854097053408623,
0.3376544713973999,
0.5871134400367737,
0.6602079272270203,
-0.7287313342094421,
0.8450008630752563,
0.24592621624469757,
0.5432438850402832,
0.10608743876218796,
-0.3973875045776367,
0.1227676048874855,
0.2804519236087799,
0.4064101278781891,
-0.5603227019309998,
0.31817618012428284,
0.7503109574317932,
0.27604761719703674,
0.5466681122779846,
-0.162870854139328,
-0.01471080631017685,
1.1184741258621216,
0.2714262902736664,
0.05244525521993637,
-0.15387611091136932,
0.30272868275642395,
-0.8625099658966064,
0.14709828794002533,
-0.13922829926013947,
0.34424662590026855,
0.5206071138381958,
0.28481224179267883,
-0.8616561889648438,
0.1417253166437149,
0.22868667542934418,
-0.9171279668807983,
0.6071369647979736,
-0.04132239148020744,
-1.4138392210006714,
0.19745254516601562,
-0.3050059676170349,
0.10854256898164749,
0.0688440203666687,
0.4889048933982849,
-0.5231642127037048,
-0.35730165243148804,
-0.1004716008901596,
-0.35035160183906555,
0.0343906432390213,
-0.1153392642736435,
-0.8149479627609253,
-0.010460012592375278,
0.22032897174358368,
-0.1775120049715042,
-0.6665234565734863,
-0.36772266030311584,
0.2937147617340088,
-1.0426844358444214,
-0.617720365524292,
-0.13266488909721375,
0.41252511739730835,
-0.14054147899150848,
0.33287808299064636,
-0.07136057317256927,
-0.09749022126197815,
-0.25110456347465515,
0.3065023422241211,
0.5754629373550415,
0.038864556699991226,
0.18790654838085175,
0.11633992195129395,
-0.38544294238090515,
0.5515941381454468,
-0.006081535015255213,
-0.09742335975170135,
-0.26361480355262756,
-1.1710501909255981,
0.5251359939575195,
0.34581851959228516,
-0.1344023048877716,
-1.0371042490005493,
-0.6488806009292603,
0.4135033190250397,
0.6289435625076294,
0.27663448452949524,
-0.5674002170562744,
-0.4593082666397095,
0.29064127802848816,
-0.13300035893917084,
0.5141103267669678,
-1.278365969657898,
0.6337853670120239,
0.031536079943180084,
0.4428141117095947,
-0.06454028934240341,
-0.36438632011413574,
0.19733771681785583,
0.340597003698349,
0.029431937262415886,
-0.08365408331155777,
-0.5297276377677917,
0.27448734641075134,
0.18493595719337463,
0.06767090409994125,
0.410144180059433,
-0.36593595147132874,
0.05777654051780701,
-0.42307448387145996,
0.2076711803674698,
-0.059430718421936035,
0.33663904666900635,
0.2661145329475403,
-0.033047523349523544,
0.039760787039995193,
0.4240585267543793,
0.1465771347284317,
-0.19391822814941406,
0.09344301372766495,
0.5714229345321655,
0.6248172521591187,
0.06178369000554085,
-0.2659580707550049,
0.7036753296852112,
0.15820282697677612,
0.4475608468055725,
0.1774819940328598,
-0.10241934657096863,
0.051085248589515686,
-0.08765506744384766,
-0.04201740026473999,
0.2951192259788513,
-0.47984588146209717,
-0.36119329929351807,
0.24662107229232788,
-0.3495118319988251,
-0.34687522053718567,
0.7146006226539612,
0.11906229704618454,
0.5510939359664917,
0.40318483114242554,
0.5254493951797485,
-0.08458033949136734,
-0.1240093931555748,
-0.5144574046134949,
0.7889947295188904,
-0.20157934725284576,
0.07380948960781097,
0.5093452334403992,
0.1893392652273178,
0.7599852681159973,
-0.39621326327323914,
0.5515164732933044,
-0.05482945218682289,
0.22123833000659943,
0.20966596901416779,
0.07429445534944534,
0.4155040979385376,
-0.00286468886770308,
-0.3784724175930023,
0.5490290522575378,
-0.06339887529611588,
0.035461295396089554,
-0.028033368289470673,
0.3287634551525116,
0.08034339547157288,
0.09780535101890564,
0.2267325520515442,
-0.3468504250049591,
-0.3524996340274811,
0.10707404464483261,
-0.17454369366168976,
0.01932433806359768,
0.07720950245857239,
-0.16389569640159607,
-0.45591115951538086,
-0.2959163188934326,
0.36999890208244324,
0.33115047216415405,
-0.04585002735257149,
-0.2607843577861786,
0.09328285604715347,
-0.03731309249997139,
0.026918040588498116,
0.4646041989326477,
0.027447307482361794,
0.0549294576048851,
0.14913855493068695,
-0.6810287237167358,
0.048891399055719376,
-0.37626931071281433,
-0.09845995903015137,
-0.49191606044769287,
-0.07653335481882095,
0.10091859847307205,
-0.1495489478111267,
0.08462893217802048,
0.2044471800327301,
-0.29299959540367126,
0.035658832639455795,
-0.19248387217521667,
0.10989794135093689,
-0.25565803050994873
] |
NCT04538586
|
Influence of the COVId-19 Pandemic on STRESS, and Screening Procedures (COVISTRESS Screening)
|
Coronavirus has caused containment of more than a third of the world's population. Some countries have used a major screening strategy. Screening procedures, such as waiting (or resulting) for the test, can be stressful and can attract the most stressed people. However, there is currently no data on the relationship between stress and screening for SARS-CoV2
|
This is an observational study by REDCap questionnaire® via a flyer deposited in the waiting room of the COVID screening centres. No incentive to complete the questionnaire will be made. The self-survey will assess stress and its relationship to SARS-CoV2 screening procedures, socio-demographic factors or lifestyle habits. This Screening questionnaire includes 31 questions.
|
Inclusion Criteria:
* All volunteers who are screened
Exclusion Criteria:
* None
|
[
-1.2629203796386719,
2.8625998497009277,
0.6466243863105774,
-0.4809112548828125,
-0.4669683873653412,
0.13840043544769287,
-0.48769232630729675,
-0.47182366251945496,
-0.16871482133865356,
-1.1442945003509521,
0.6501310467720032,
0.9749867916107178,
-0.7862552404403687,
0.5988487601280212,
-0.6041033267974854,
1.0864043235778809,
0.0803411453962326,
0.6292424201965332,
1.5302611589431763,
-1.50054132938385,
0.22622531652450562,
-0.39362719655036926,
-0.4771652817726135,
-2.078883647918701,
-0.26797592639923096,
0.1041138619184494,
-0.38591238856315613,
-0.47284919023513794,
-0.7169941663742065,
0.41269806027412415,
0.13214558362960815,
-0.9622194766998291,
0.39820507168769836,
-0.5089055895805359,
0.7279558777809143,
-0.23129695653915405,
1.6232354640960693,
0.2377929389476776,
-0.8052501678466797,
-0.3523499369621277,
0.9734207391738892,
0.3882364332675934,
-0.2961375117301941,
-0.860980212688446,
1.7881927490234375,
0.1870575249195099,
-0.012581028044223785,
-0.44346457719802856,
0.0694800391793251,
0.35191452503204346,
-0.9044749736785889,
0.12028749287128448,
-0.3127736747264862,
0.4864078760147095,
1.6499470472335815,
-0.43394023180007935,
-0.37497904896736145,
-0.054314494132995605,
1.6356356143951416,
0.30427560210227966,
0.06526409089565277,
-0.5534207820892334,
0.12015099823474884,
0.4878320097923279,
-0.49272704124450684,
-1.2155646085739136,
-0.6665387749671936,
-1.2649668455123901,
-0.2755376100540161,
0.5980983376502991,
0.6854104399681091,
0.22761397063732147,
1.0655728578567505,
-0.341732382774353,
-0.07759109884500504,
-0.39138951897621155,
-0.48782065510749817,
1.2625622749328613,
0.3504507839679718,
0.6714079976081848,
-0.32278406620025635,
0.11391890794038773,
-0.769863486289978,
0.8341178894042969,
0.5259127020835876,
-0.872961699962616,
0.01893381029367447,
-0.6983109712600708,
0.6108255982398987,
-1.0250800848007202,
0.3253141939640045,
0.32365530729293823,
-0.012147240340709686,
0.5409564971923828,
0.32753047347068787,
1.0359511375427246,
-0.1938372403383255,
-1.3442763090133667,
0.2394070327281952,
0.07839073240756989,
-0.3068830668926239,
-0.74763423204422,
-0.2815439701080322,
0.22568485140800476,
-0.7597122192382812,
-0.15191732347011566,
0.10723372548818588,
0.7897510528564453,
-0.15401098132133484,
-0.2939037084579468,
1.0353111028671265,
0.10262472927570343,
-0.23446302115917206,
-0.6107786893844604,
0.47016608715057373,
-1.3864046335220337,
0.5114662051200867,
-0.35675764083862305,
-1.039128303527832,
-0.52491295337677,
0.4123627543449402,
-0.536220133304596,
0.33582621812820435,
-0.01945539377629757,
0.17300255596637726,
1.0426353216171265,
-0.08393152803182602,
0.11910753697156906,
0.5227078199386597,
0.3522939682006836,
-0.7601333856582642,
-0.23039449751377106,
0.2861335873603821,
-0.6354162096977234,
-0.6909627914428711,
0.08233465254306793,
0.2660790681838989,
0.6260156035423279,
0.4987095296382904,
-0.6533579230308533,
0.11541827768087387,
-0.5936511754989624,
0.3014591634273529,
0.2425653338432312,
-0.8462793827056885,
-0.6985942721366882,
0.01939963921904564,
0.08840946853160858,
0.3653118312358856,
-0.9389172792434692,
-0.5984109044075012,
0.5117512941360474,
0.5854167938232422,
-0.4898098409175873,
-0.13875392079353333,
-0.18248263001441956,
0.814566433429718,
-0.6975772976875305,
-0.26411718130111694,
0.4984588623046875,
0.116822749376297,
0.7079487442970276,
-0.5622429847717285,
0.06747380644083023,
-0.32518190145492554,
-0.6369822025299072,
0.8682403564453125,
0.6125805974006653,
-0.3094779849052429,
-0.0047010378912091255,
-0.08488742262125015,
-0.23156404495239258,
1.0197608470916748,
0.5316123366355896,
0.12029533088207245,
0.2356494814157486,
0.10874930024147034,
1.1040120124816895,
0.6878339052200317,
-0.18919223546981812,
0.32741644978523254,
0.5448405742645264,
-0.1187751442193985,
0.4467281103134155,
0.0010579318040981889,
0.10594851523637772,
-0.1670275777578354,
-0.43210136890411377,
-0.612554669380188,
0.4703808128833771,
-0.17112475633621216,
0.5575041770935059,
-0.35935473442077637,
-0.1408618837594986,
0.05321817845106125,
0.9791168570518494,
-0.17675265669822693,
-0.1807887703180313,
-0.1767631471157074,
-0.03366265818476677,
0.881078839302063,
-0.6149776577949524,
-0.3403623700141907,
-0.31231993436813354,
0.004281701985746622,
-0.42237588763237,
-0.47555306553840637,
0.05884315446019173,
0.26851513981819153,
-0.29037314653396606,
-0.2609720230102539,
0.0035207949113100767,
0.195622518658638,
-0.18885567784309387,
0.26866599917411804,
0.30706143379211426,
0.1264943778514862,
0.13830678164958954,
-0.8389734625816345,
0.04164064675569534,
0.09487266093492508,
0.4667758047580719,
-0.30950024724006653,
-0.07511433959007263,
0.2546456754207611,
0.16671687364578247,
0.3929043114185333,
0.5910985469818115,
-0.1506456583738327,
-0.18029098212718964,
0.09511616080999374,
-0.4291797876358032,
-0.21364113688468933,
0.15532873570919037,
-0.7271243929862976,
-0.036721453070640564,
0.0697489082813263,
0.007372297812253237,
0.05654214322566986,
-0.06574670970439911,
0.4469626545906067,
0.057369429618120193,
0.3884755074977875,
0.5257785320281982,
0.07838495075702667,
0.37634706497192383,
0.21562790870666504,
-0.3107617497444153,
-0.2315666526556015,
-0.2299615740776062,
0.2823265790939331,
-0.21273310482501984,
-0.04674157872796059,
0.047320373356342316,
-0.3078635334968567,
-0.3506065011024475
] |
NCT04146064
|
Breathomics as Predictive Biomarker for Checkpoint Inhibitor Response
|
Immunotherapy with agents stimulating the immune system to act against cancer are now a new standard of care in various cancers as lung cancer and melanoma, but also bladder cancer, kidney cancer and head \& neck cancer. However, even though a subset of patients derives long-term benefit from these agents, depending of cancer type still at least half of patients do not respond to these new drugs. Our understanding of possible factors predicting whether a patient might actually benefit from immunotherapy is poor. Volatile organic compounds (VOCs) are gases exhaled with a person's breath, which are released into the lung from blood and bacteria and therefore can give information about infections as well as inflammation and possibly cancer cells in a person's body. Breath analysis of these VOCs with special devices called electronic noses (eNose) generate a specific electric signals patterns called breathprints. There is early evidence that specific breathprints can actually help to select patients who will be likely to benefit from immunotherapy.
This study is being undertaken in an effort to evaluate breathprint analysis as a potential predicting factor for benefit from immunotherapy, so that treatment selection can further be improved.
This study is designed to help us identify the role of breathprint analysis to better select patients for immunotherapy.
|
Immune checkpoint blockade with anti-PD-1 and anti-PD-L1 antibodies has become a new standard of care in several cancer types as NSCLC and melanoma. However, in biomarker-unselected patient populations, overall response rate (ORR) depending on type of cancer and whether single or combination treatment is chosen remains still only 20%-60%. Though overall well tolerated approximately 5-10% of patients treated with PD1/PD-L1 targeting agents will experience grade 3 or 4 toxicities, including potentially life-threatening auto-immune toxicities such as colitis, hepatitis, and pneumonitis. Therefore, due to high costs of treatment and its possible complications, improved selection of patients is a crucial goal and an easily available non-invasive, point-of-care test for better patient selection is very much needed.
A promising approach in this regard is the analysis of volatile organic compounds (VOCs) in breath. Breath analysis for the detection of VOCs is increasingly investigated for its utility in diagnosis and management of cancer. Electronic noses (eNoses) are promising as cheap and clinically-practical devices that are designed to detect patterns of VOCs. Recently published prospective observational data showed very promising discriminant function for breathprint analysis for non-response to immunotherapy in NSCLC patients.
The principle goal of this study is to validate a prior study that found that breathomics-based classifiers predicted 12-week early progression vs non-progression in advanced NSCLC patients treated with nivolumab or pembrolizumab. Secondarily, we will expand assessment of breathomic-based classifiers to include other cohorts of advanced tumors treated with ICI, and also consider using response instead of non-progression as an endpoint. Exploratory goals include refinement of the breathomics classifier using alternative machine-learning techniques, and correlate with other biomarkers of immunotherapy outcomes.
|
INCLUSION CRITERIA
* Patients 18 years of age or older
* Histologically confirmed advanced/metastatic non-small cell lung cancer, melanoma or solid tumor such as urothelial, kidney or head and neck cancer and planned treatment with
* NSCLC validation cohort: Pembrolizumab or Nivolumab
* NSCLC Cohort 1: Pembrolizumab-chemotherapy combination therapy 1L
* Melanoma Cohort 2: Nivolumab/ipilimumab combination treatment 1L, Pembrolizumab or nivolumab monotherapy treatment 1L , Ipilimumab
* Solid tumors Cohort 3: Any ICI-treatment, any line
* NSCLC Cohort 4: Chemotherapy-only (either platinum-based combination treatment or docetaxel monotherapy)
* At least one measurable lesion as defined by RECIST 1.1. A lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation.
* Able to provide informed consent.
EXCLUSION CRITERIA
* Patients who are unable to perform the breathing manoeuvres needed for eNose-analysis of exhaled air.
* Patients who are unable to independently consent to participation in the trial.
* Patients with severe, acute, or chronic medical conditions (including uncontrolled diabetes mellitus) or psychiatric conditions or laboratory abnormalities that in the opinion of the Investigator or their physician may cause undue harm or inconvenience to the patient, or that may interfere with the interpretation of study results.
|
[
0.4564701318740845,
1.6690855026245117,
-2.2064669132232666,
-1.600649118423462,
0.07232800871133804,
-0.15943384170532227,
-1.8779155015945435,
-0.7570063471794128,
-1.3903688192367554,
-0.046638306230306625,
1.621532678604126,
2.1709978580474854,
-0.576274573802948,
0.625954270362854,
0.059624772518873215,
0.2068672478199005,
0.019243396818637848,
0.8656638860702515,
0.4755316972732544,
-1.140105962753296,
0.3733527362346649,
-0.31145933270454407,
0.28448614478111267,
-0.23817574977874756,
-0.23650233447551727,
0.1541675180196762,
-0.49084222316741943,
1.0263950824737549,
0.3085957467556,
0.4185560345649719,
-0.19358044862747192,
-0.03360195457935333,
-0.46633461117744446,
0.19450266659259796,
-0.5451474189758301,
-0.031866610050201416,
2.415806531906128,
0.5908328294754028,
-1.0530929565429688,
-0.7644167542457581,
0.32098230719566345,
0.4537380039691925,
-0.07961609214544296,
-0.47819432616233826,
0.34222277998924255,
-0.5662380456924438,
0.09188415855169296,
0.18910586833953857,
-0.1311292201280594,
0.39238154888153076,
-0.5751894116401672,
0.776371955871582,
-0.36013227701187134,
0.5257514119148254,
1.9065548181533813,
-0.010584463365375996,
0.06041249260306358,
0.7891981601715088,
0.2684771716594696,
-0.0252505075186491,
0.5947156548500061,
-0.4373060166835785,
1.2195889949798584,
-0.22122639417648315,
-0.8042305111885071,
-0.6195747256278992,
0.07074408233165741,
-0.38528281450271606,
0.6206405758857727,
-0.3535658121109009,
0.677361249923706,
-1.0178724527359009,
-0.3644520342350006,
-0.013947510160505772,
0.633357584476471,
0.7260189652442932,
0.9131154417991638,
0.385765939950943,
0.8002923727035522,
0.9188086986541748,
-0.6152666807174683,
-0.3939627707004547,
-1.2053388357162476,
-0.23116889595985413,
-0.3812635540962219,
-0.09796404093503952,
-0.6495581269264221,
-0.4605201184749603,
0.4784529507160187,
-1.3705631494522095,
0.019856592640280724,
0.32189539074897766,
-0.6958223581314087,
1.2408140897750854,
-0.41558563709259033,
-0.5032763481140137,
-0.03862999379634857,
-0.34688350558280945,
-1.0121344327926636,
-0.07571127265691757,
0.08930420875549316,
0.12892788648605347,
-0.3614911139011383,
-0.1304517388343811,
-0.8056977391242981,
0.21148711442947388,
0.17745032906532288,
-0.9589768648147583,
-0.24802520871162415,
-0.6725371479988098,
1.2042642831802368,
-0.9418126940727234,
0.08544012904167175,
0.23389612138271332,
0.08558600395917892,
0.16721667349338531,
0.3795017898082733,
0.6523316502571106,
0.2535361051559448,
-0.634245753288269,
-0.46575063467025757,
0.4366997480392456,
0.07766284048557281,
0.15077409148216248,
-0.28945261240005493,
-0.4915933609008789,
-1.3599530458450317,
-0.2153146117925644,
-0.1343262642621994,
-0.521124541759491,
0.09886962175369263,
0.1905127316713333,
0.4574891924858093,
-0.8497871160507202,
-1.0330677032470703,
-0.6318550109863281,
-0.07822314649820328,
1.044166088104248,
0.4320409595966339,
-0.1498735398054123,
0.6381725072860718,
0.21986861526966095,
0.5327353477478027,
0.7360783815383911,
-0.25555840134620667,
-0.10736009478569031,
-0.09234844893217087,
0.3473600745201111,
-0.2180260270833969,
-0.38644224405288696,
-0.05144761875271797,
0.25112783908843994,
-0.14920824766159058,
0.04126617684960365,
-0.07722357660531998,
0.862298846244812,
-0.06764831393957138,
-0.4991620182991028,
-0.6584159135818481,
-0.02865210548043251,
0.13218054175376892,
0.24816425144672394,
-0.49093109369277954,
-0.6281115412712097,
0.5537439584732056,
-0.2592678666114807,
0.7457480430603027,
0.351950466632843,
0.37301909923553467,
0.267782062292099,
-0.8336083292961121,
-0.3770218789577484,
0.02432982437312603,
0.06829685717821121,
-0.3523654639720917,
0.13215847313404083,
0.3926127254962921,
0.6820061802864075,
0.15523959696292877,
-0.7246463298797607,
0.34954771399497986,
0.21796591579914093,
0.17825102806091309,
-0.4270899295806885,
-0.242539644241333,
0.2533086836338043,
0.11665785312652588,
-0.20922265946865082,
0.3285255432128906,
0.09738531708717346,
0.10522690415382385,
0.0457637719810009,
0.36681243777275085,
0.5040603876113892,
-0.031103814020752907,
0.15151239931583405,
-0.4003909230232239,
0.21729114651679993,
0.7173594832420349,
0.14584369957447052,
0.278923898935318,
-0.3554903268814087,
0.3950115144252777,
0.425149530172348,
0.029025938361883163,
-0.297120064496994,
-0.5375785231590271,
0.13178128004074097,
0.03432806581258774,
0.3823353052139282,
-0.04820618778467178,
0.06425701081752777,
0.2437061220407486,
-0.03779887408018112,
0.32828468084335327,
0.3797212839126587,
-0.20193606615066528,
-0.3235010504722595,
-0.8238770365715027,
0.03591884672641754,
-0.10577704757452011,
-0.1582833081483841,
0.33167320489883423,
0.15459929406642914,
-0.15524353086948395,
0.19470715522766113,
0.24979856610298157,
0.2972206771373749,
0.30804648995399475,
-0.023261865600943565,
-0.25782614946365356,
0.06825342029333115,
0.22794406116008759,
-0.09538900852203369,
-0.09970799833536148,
-0.04459156095981598,
-0.033705662935972214,
0.4138619899749756,
-0.05890326201915741,
0.0586538165807724,
0.19559314846992493,
0.36399635672569275,
0.12516659498214722,
-0.4568995237350464,
-0.7023308277130127,
-0.2586279511451721,
0.3029640316963196,
0.016236092895269394,
-0.121505968272686,
0.08225961774587631,
-0.2968398928642273,
0.14723166823387146,
0.30779775977134705,
0.2507548928260803,
0.30394476652145386,
-0.8224266767501831
] |
NCT06248788
|
Salivary Immunoglobulin A (sIgA) Normal Range Study
|
Salivary Immunoglobulin A (sIgA) is a marker of immune system activity. Typically, sIgA is determined by an ELISA test in which samples have to be sent to a specialized laboratory for testing. Investigators have developed a new instrument that is small, portable, and easy to use. This instrument is available for consumers to purchase and test their own sIgA at home.
|
Inclusion Criteria:
* Adults committed to attend the session and follow the instructions described in Experimental Design will be included.
Exclusion Criteria:
* Participant with mouth infection or oral disease
|
[
0.4536770284175873,
0.8172847032546997,
-2.636476516723633,
-2.6577954292297363,
0.7911945581436157,
0.8837607502937317,
-0.5363950729370117,
-0.6941525936126709,
0.7950108647346497,
-0.42559123039245605,
2.0145533084869385,
0.823754608631134,
-1.4016778469085693,
0.5910495519638062,
0.1357913762331009,
0.6428463459014893,
-0.7583528161048889,
1.21348237991333,
0.5647715330123901,
-0.2041400969028473,
0.9641966223716736,
0.23655903339385986,
-1.649257779121399,
-0.49881479144096375,
-0.024623475968837738,
0.8790547847747803,
-0.5613724589347839,
0.3965602219104767,
-0.28144562244415283,
1.120368480682373,
0.6887239217758179,
0.45984452962875366,
-0.14945027232170105,
-0.4640757441520691,
-1.085717797279358,
-0.23893263936042786,
1.2204421758651733,
-0.09854353219270706,
-0.36606132984161377,
-0.692123532295227,
-1.4096821546554565,
0.4109046161174774,
0.33059343695640564,
-0.8860390782356262,
1.6395148038864136,
-1.2650506496429443,
0.7626000642776489,
0.622294545173645,
-0.3835260570049286,
0.5900704860687256,
-0.6040222644805908,
-0.1921619325876236,
-0.11131635308265686,
0.4005572199821472,
0.11709748953580856,
0.8219562768936157,
1.5852229595184326,
-1.2259236574172974,
1.8306034803390503,
0.8021717071533203,
-1.1152628660202026,
0.05010516196489334,
0.9531497359275818,
-0.6380057334899902,
-1.0387351512908936,
0.1220417395234108,
-1.50626802444458,
0.7094026207923889,
0.3517422378063202,
-0.6991123557090759,
0.1657959520816803,
0.6496258974075317,
0.35196653008461,
1.227450966835022,
-0.08761569112539291,
0.9504709243774414,
0.18588575720787048,
-0.17504386603832245,
-0.5952711701393127,
1.001641869544983,
0.32372143864631653,
-0.931862473487854,
0.6650041341781616,
0.6486384272575378,
0.6139673590660095,
-0.6860617399215698,
-0.4187765121459961,
-0.3324061632156372,
0.5811695456504822,
0.042098402976989746,
0.4479520320892334,
0.5627179145812988,
0.47755977511405945,
0.3733800947666168,
-0.3331841230392456,
-0.791277289390564,
0.4491043984889984,
0.0776374340057373,
0.03079470805823803,
-0.1351134330034256,
-0.7332800626754761,
-2.236900568008423,
0.09875071048736572,
-0.4795621931552887,
-0.07349387556314468,
-0.22383974492549896,
0.29256507754325867,
0.374935120344162,
-0.78535395860672,
-0.04639170318841934,
0.5621801614761353,
-0.3900982439517975,
-0.529301643371582,
-0.15360797941684723,
0.18297936022281647,
-0.5983284711837769,
1.3020182847976685,
0.44850969314575195,
-0.1195102408528328,
-0.6297999620437622,
-0.34419184923171997,
1.4717345237731934,
0.0581851489841938,
1.109969973564148,
-0.6191828846931458,
0.08458607643842697,
0.05259750038385391,
-0.7834572792053223,
-0.7968288660049438,
-0.8970115780830383,
-0.016324326395988464,
0.5793079137802124,
0.11878345906734467,
-0.2926361858844757,
-0.46702122688293457,
0.07212252914905548,
-0.2655080258846283,
0.3528866171836853,
-1.1030495166778564,
-0.13051125407218933,
-0.21526403725147247,
0.15694107115268707,
-0.07316828519105911,
-0.12654051184654236,
-0.3856010138988495,
0.8394403457641602,
-0.2887614965438843,
0.24987198412418365,
0.6096869707107544,
-0.4024144113063812,
-0.9445735216140747,
0.9876164197921753,
0.20022352039813995,
-0.21819175779819489,
-0.014273015782237053,
-0.13763761520385742,
0.33931854367256165,
0.34542879462242126,
0.625988245010376,
0.30743950605392456,
0.29554182291030884,
0.28799471259117126,
-0.5549390316009521,
-0.09020460397005081,
1.175101637840271,
-0.11444808542728424,
0.10047134011983871,
-0.05393438786268234,
0.6832968592643738,
-0.15775161981582642,
-0.6852481961250305,
0.010900097899138927,
0.7777510285377502,
0.3936688005924225,
0.41462644934654236,
0.4567182958126068,
0.7141116261482239,
0.9420008659362793,
0.25111427903175354,
-0.15820981562137604,
0.01646752841770649,
0.531534731388092,
0.29876288771629333,
-0.13011257350444794,
-0.4740997552871704,
-0.3030104637145996,
-0.06283073127269745,
-0.08086319267749786,
0.3059147298336029,
0.2243826687335968,
0.13711358606815338,
0.06343915313482285,
0.814178466796875,
0.670676589012146,
-0.02503916807472706,
-0.6790173053741455,
-0.15203306078910828,
-0.1690029799938202,
0.4948159158229828,
-0.18355019390583038,
0.49157145619392395,
0.12656667828559875,
-0.2620762884616852,
0.23334036767482758,
0.5333556532859802,
0.28678032755851746,
-0.20248951017856598,
-0.10835207253694534,
0.7530809640884399,
0.2608880400657654,
-0.04613849148154259,
-0.2598305344581604,
-0.15408886969089508,
-0.4128077030181885,
0.8342276215553284,
-0.38295429944992065,
0.07688084989786148,
-0.012246726080775261,
-0.362539142370224,
0.2687745690345764,
-0.030539143830537796,
-0.5580395460128784,
-0.09227494895458221,
-0.404535174369812,
0.2324751913547516,
-0.16208390891551971,
0.587526261806488,
0.8264030814170837,
-0.22851569950580597,
-0.055780380964279175,
-0.1213311180472374,
0.011400227434933186,
-0.10225480794906616,
0.2756369411945343,
-0.37991929054260254,
-0.3208795487880707,
-0.14462347328662872,
0.22388458251953125,
-0.1685459166765213,
0.5083916187286377,
0.34478843212127686,
-0.14640378952026367,
0.24573126435279846,
0.22564615309238434,
0.05595194548368454,
-0.007372794207185507,
0.13579440116882324,
-0.11600944399833679,
0.12553223967552185,
-0.5367385149002075,
0.3094886541366577,
0.22172671556472778,
0.3903886675834656,
-0.2917458117008209,
0.31387656927108765,
-0.603370189666748
] |
|
NCT03535506
|
Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery
|
This is a feasibility study which will evaluate the effects of pre-operative treatment of DCIS of the breast with palbociclib. Patients with biopsy-proven DCIS are eligible for the study.
There will be 2 independent and unrelated study groups of 12 patients each, for a total of 24 patients:
1. Group A, of male or female patients treated with palbociclib single agent (n=12);
2. Group B, untreated, of male or female patients who consented translational studies in blood, as well as diagnostic and definitive surgical specimen, but not the pre-operative treatment with palbociclib (n=12).
|
Inclusion Criteria for all patients (Groups A and B):
* Signed informed consent obtained prior to any study specific assessments and procedures
* Age ≥18 years
* Premenopausal and postmenopausal women, or men
* Current pathologic diagnosis of DCIS of the breast of any receptor status; History of previous DCIS allowed provided that the patient is currently off systemic risk-reduction endocrine therapy; History of previous invasive breast cancer adequately treated and that is currently in remission and unrelated to current DCIS (based on primary tumor location) is allowed as long as patient is currently off systemic therapy for that invasive cancer for at least 4 weeks prior to pre-treatment biopsy (diagnostic biopsy); Patients with multifocal or multicentric lesions are allowed, as long as at least one lesion is histologically confirmed DCIS and overall clinical AJCC Stage 0 or I.
* A formalin-fixed paraffin-embedded (FFPE) tumor tissue block from diagnostic biopsy must be transmitted to MedStar Georgetown University Hospital Pathology Department repository and confirmation of receipt must be available prior to enrollment.
* Positive Rb by immunohistochemistry in the DCIS component of the lesion - must be performed at CLIA-approved setting (for instance, MGUH); Rb staining will be considered positive when 1+ or above (in a scale of 0, 1+, 2+ or 3+)
* In the absence of histologic diagnosis of DCIS, patient may undergo fresh biopsy for eligibility, provided: this invasive procedure is not a Fine Needle Aspiration (FNA); AND this procedure is a core biopsy, stereotactic biopsy or incisional biopsy of the suspicious breast lesion; AND the primary lesion is not completely resected during the procedure.
* The patient is candidate for and is willing to receive definitive surgical therapy for DCIS
* ECOG performance status 0-1
* Willingness to provide a sample of tissue collected at definitive surgery for research
Inclusion criteria specific to treatment Group A:
* Patients must be able and willing to swallow and retain oral medication
* Absolute neutrophil count (ANC) ≥ 1,500/mm3
* Platelets ≥ 120,000/mm3
* Hemoglobin ≥ 10g/dL
* Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome.
* Aspartate amino transferase (AST or SGOT) and alanine amino transferase (ALT or SGPT) ≤ 1.5 × institutional ULN
* Serum creatinine within normal institutional limits or creatinine clearance ≥ 50 mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.
* Pregnancy must be ruled out: serum or urine pregnancy test must be negative within 14 days of treatment start in women of childbearing potential. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before enrollment, or who have undergone tubal ligation, bilateral oophorectomy, total hysterectomy.
* Willingness to undergo adequate contraception if childbearing potential; women of childbearing potential and male patients randomized into treatment Group A must use adequate contraception for the duration of protocol treatment and for 3 months after the last treatment with palbociclib if they are in Group A; adequate contraception is defined as one highly effective form (i.e. abstinence, (fe)male sterilization) OR two effective forms (e.g. non-hormonal IUD and condom / occlusive cap with spermicidal foam / gel / film / cream / suppository).
Exclusion Criteria for all patients (Groups A and B):
* Concurrent therapy with other Investigational Products
* Invasive carcinoma present in the diagnostic biopsy, microinvasion is allowed
* Uncontrolled intercurrent illness including (active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, pulmonary embolism in the past 6 months, or psychiatric illness/social situations that would limit compliance with study requirements).
* Unable to comply with study requirements
* Hormone therapies containing estrogen, progesterone, GnRH agonists and antagonists within 4 weeks from diagnostic biopsy.
* Therapy with any CDK inhibitor in the past 3 months
Exclusion criteria specific to treatment Group A:
* History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib
* Presence of a condition that would interfere with enteric absorption of palbociclib
* Pregnant women, or women of childbearing potential without a negative pregnancy test (serum or urine) within 7 days prior to enrollment; breastfeeding must be discontinued prior to study entry (Group A only).
* Patients on combination antiretroviral therapy, i.e. those who are HIV+ (potential for pharmacokinetic interactions or increased immunosuppression with palbociclib).
* Patients receiving any medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days of enrollment or during participation on study
* Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis, etc.
|
[
1.2992300987243652,
2.265838623046875,
-2.011728048324585,
-0.5092692375183105,
0.6160075664520264,
0.3312738239765167,
-1.6371837854385376,
-0.17947041988372803,
-0.81846684217453,
0.3535774052143097,
0.2564910650253296,
1.6681451797485352,
0.5957334041595459,
0.7412360310554504,
-0.3699880540370941,
-0.0452631413936615,
-0.9146952033042908,
-0.024532167240977287,
0.2775859534740448,
-0.5564504861831665,
0.16730575263500214,
0.6583347320556641,
-0.8826497793197632,
-1.229385495185852,
-0.04441491886973381,
-0.9626768827438354,
-0.31200483441352844,
0.8044428825378418,
-0.5167182683944702,
0.7883012294769287,
0.5911973118782043,
0.1240706741809845,
0.4730890393257141,
1.0612609386444092,
0.44876590371131897,
0.4195302426815033,
0.5550283789634705,
0.521052360534668,
-0.7416582107543945,
-0.0682070255279541,
1.269767165184021,
0.3859058916568756,
-0.34933769702911377,
-0.0396035835146904,
0.4247070550918579,
0.645337700843811,
0.11609269678592682,
0.30422243475914,
0.35490530729293823,
0.2043491154909134,
-1.479921579360962,
1.3105854988098145,
-0.2375434935092926,
0.6672914624214172,
-0.5104769468307495,
0.4266655445098877,
1.0085949897766113,
0.04306034743785858,
0.9174996018409729,
-0.006375638768076897,
0.9499003291130066,
0.0005963555304333568,
0.01706644706428051,
-0.2796672284603119,
-0.42836737632751465,
-0.4471043646335602,
-0.6010373830795288,
-0.16656795144081116,
-0.741235077381134,
0.8700268864631653,
-0.36799103021621704,
-0.5894491076469421,
0.24221067130565643,
0.3944064676761627,
0.7358410358428955,
0.24075782299041748,
-0.6732374429702759,
1.184333324432373,
0.16370752453804016,
0.3342106342315674,
0.16752423346042633,
-0.7674077749252319,
-0.27907994389533997,
0.4906776547431946,
-0.15477734804153442,
0.0016102729132398963,
-1.2085978984832764,
-0.7307950258255005,
0.3678077459335327,
-0.4198939800262451,
0.6046878099441528,
-0.09744610637426376,
-0.3894236385822296,
0.6563635468482971,
-1.31020987033844,
-0.2324235737323761,
-0.15212392807006836,
-0.6148467063903809,
-0.6062830686569214,
0.24138113856315613,
-0.5623917579650879,
0.3322106897830963,
0.16994544863700867,
-0.47409287095069885,
-0.23884236812591553,
-0.6259987354278564,
-0.08628972619771957,
-0.6138620376586914,
-0.4790280759334564,
-1.150403380393982,
1.3523859977722168,
-0.24026009440422058,
0.27882614731788635,
-0.4894025921821594,
0.5544800758361816,
0.3250238299369812,
0.3572979271411896,
0.23089148104190826,
0.11702945828437805,
-0.5055027604103088,
0.3480123281478882,
0.9176334738731384,
-0.12371063232421875,
0.11723528057336807,
-0.19167491793632507,
-0.47201812267303467,
-0.32090291380882263,
0.17392894625663757,
-0.07419411092996597,
-0.7562114000320435,
-1.0238646268844604,
-0.34013962745666504,
-0.7581300735473633,
0.5361202955245972,
-0.9017496109008789,
0.3040955066680908,
0.5424241423606873,
0.22731339931488037,
-0.4160153865814209,
-0.106699638068676,
0.7941288948059082,
0.38485845923423767,
0.2787233591079712,
-0.4699366092681885,
-1.9485328197479248,
0.07834916561841965,
-0.6679506301879883,
0.4037560820579529,
-0.9856043457984924,
-0.33118224143981934,
0.3150952458381653,
0.021757064387202263,
-0.2095765769481659,
-0.14939852058887482,
0.22479674220085144,
0.40058645606040955,
-0.2238929569721222,
-0.5206794142723083,
-0.12998417019844055,
-0.15928709506988525,
-0.28711998462677,
-0.43371397256851196,
0.8489384651184082,
-0.7431307435035706,
0.7731152772903442,
-0.1524524986743927,
-0.20128914713859558,
-0.16398091614246368,
0.9606837034225464,
0.17614911496639252,
-0.9236809611320496,
0.10816133767366409,
0.4019365906715393,
0.18534056842327118,
-0.407078355550766,
0.10081394016742706,
0.6557010412216187,
0.35634922981262207,
0.08462177962064743,
-0.046646758913993835,
-0.019882025197148323,
0.3304104506969452,
0.08664427697658539,
0.3951340615749359,
-0.22364984452724457,
0.07945181429386139,
-0.29779350757598877,
0.21446716785430908,
0.15788401663303375,
0.44881415367126465,
-0.11499566584825516,
-0.24024394154548645,
-0.02812664583325386,
0.4696972668170929,
0.2196291834115982,
-0.21943414211273193,
-0.2232234925031662,
-0.019918642938137054,
0.23884627223014832,
-0.0004692893417086452,
0.46967220306396484,
0.30170804262161255,
-0.826628565788269,
0.6347516179084778,
0.10325335711240768,
-0.08519826829433441,
-0.4587075412273407,
0.0039937724359333515,
-0.21256275475025177,
0.09527263045310974,
0.34307369589805603,
0.07870806753635406,
-0.05572352185845375,
0.5752854943275452,
-0.14245367050170898,
0.3088890314102173,
-0.304246187210083,
0.13073550164699554,
-0.42038798332214355,
0.13966839015483856,
-0.2629414200782776,
-0.10393571108579636,
0.22516106069087982,
0.3079907298088074,
0.02269574999809265,
-0.04972458630800247,
0.07557925581932068,
-0.024768302217125893,
-0.3979094326496124,
-0.10770928859710693,
-0.18831995129585266,
0.03814534470438957,
-0.1858207732439041,
-0.003972349688410759,
0.051746513694524765,
-0.15394766628742218,
0.1380878984928131,
0.35888877511024475,
-0.2989106774330139,
0.7347182631492615,
-0.005431664176285267,
-0.408515989780426,
-0.23723280429840088,
-0.42551782727241516,
-0.41750800609588623,
0.3294810950756073,
-0.09955064207315445,
0.02250572293996811,
-0.12363321334123611,
-0.008879231289029121,
-0.08768413960933685,
-0.28874802589416504,
-0.04305248707532883,
0.40972498059272766,
0.09041231870651245,
-0.18883399665355682
] |
|
NCT01011036
|
Effects of GABA-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers
|
The investigators will use an intradermal capsaicin injection in the forearm to induce a state of localized pain. This localized pain will be measured by different means, and analysed locally and distally by so called quantitative sensory testing. The primary endpoint of measure is the difference in pain perception with and without benzodiazepines/GABA-Agonists around the injection point of capsaicin. The secondary endpoints are to measure pain modulation locally and distally by different quantitative tests as electricity, pressure pain thresholds, and ice water tests.
The investigators' hypothesis is that clobazam induces higher pain thresholds as placebo and less sedation than the control medication clonazepam.
|
Background
Neuropathic and nociceptive pain are linked to plastic changes of the central nervous system. These lead to lower pain thresholds. An important component of this neuronal plasticity is a diminished inhibition-control of the neurons on the level of the spine, where an alpha-3 subunit of the glycine receptor plays an important role. Modulation of this receptor subunit with specific and non-specific GABA-Agonists produce antinociception. The new fact is, that a subunit specific medication does not induce sedation in animals. The relationship of pain modulation and Gaba-Agonists is not well studied in humans. The benzodiazepine used in pain therapy in humans is clonazepam, which induces a strong sedation, reason why it is not much used in a chronic pain setting. Clobazam is another GABA-Agonist, which is less sedative. To our knowledge its effects on pain modulation has never been studied in humans.
Objective
The aim is an analysis and description of clobazam on the central pain mechanisms. We will use well known quantitative sensory testing methods therefore.
The primary objective is to gather data about potential clinical use of clobazam in pain therapy. The secondary aim would be to do the same tests on new specific alpha-3 agonists, which are being developed by pharmaceutical industry.
Methods
Quantitative sensory testing is being made after eliciting an area of hyperalgesia on the forearm by capsaicin.
The area of hyperalgesia around the injection point will be the primary issue of this study.
The medication given to our patients will be a cross-over, double blind randomized administration of clobazam, clonazepam (positive control) and tolterodine (active placebo). Quantitative sensory testing will be made before and after study medication administration.
The quantitative sensory testing consists of the area of hyperalgesia around capsaicin injection point, pressure pain elicited with an electronic pressure algometer, ice-water testing of the hand, single and multiple electrical skin and muscle stimulation, pressure-cuff algometry and the side effects of the administered medication with psychomotor testing.
Before we start the study protocol each patient will have a blood sample drawn for genetic testing of the different cytochrome subunits (CYP P450 2C19, 3A4).
|
Inclusion Criteria:
* European males
* 18-55 years old
* non smoking status or less than 10 cigarettes per day
* no disease
Exclusion Criteria
* any medication
* any drug abuse
* diseases of any type
|
[
-0.15581542253494263,
1.0729283094406128,
-2.663957357406616,
-3.437140703201294,
-0.5345178842544556,
-1.2403018474578857,
0.9328819513320923,
-0.4167288541793823,
-0.3671934902667999,
-0.5068514943122864,
0.9385951161384583,
1.3758498430252075,
-0.23509855568408966,
0.4911801218986511,
0.09580449759960175,
1.082180380821228,
0.7778067588806152,
0.47474485635757446,
0.5714025497436523,
-0.880510151386261,
0.5084572434425354,
0.1292894035577774,
-0.7882561087608337,
-0.6522879004478455,
0.7066156268119812,
-0.3337057828903198,
0.24920304119586945,
0.6999772787094116,
0.3658994734287262,
1.7101255655288696,
-0.5855556726455688,
0.1757073700428009,
-0.22455140948295593,
0.4865777790546417,
-0.8481552004814148,
0.033453866839408875,
0.6629366278648376,
-0.191903755068779,
-0.09709003567695618,
-0.48576968908309937,
1.1829744577407837,
0.5911608934402466,
-0.9903120994567871,
0.5722939372062683,
1.7707098722457886,
0.34702596068382263,
-0.9389027953147888,
0.29669225215911865,
0.9620703458786011,
-0.08762127161026001,
-0.20853258669376373,
0.7684431076049805,
-0.5301377177238464,
0.3494146168231964,
2.038222551345825,
-1.4238805770874023,
0.815557599067688,
0.4105287790298462,
1.331251859664917,
-0.19712060689926147,
-0.14348053932189941,
0.405217707157135,
-0.1873610019683838,
0.3098883628845215,
0.28333598375320435,
0.3408573269844055,
-0.46572473645210266,
0.16392908990383148,
0.0884627103805542,
0.2450166642665863,
-1.012963891029358,
0.4127674102783203,
0.33833155035972595,
-0.08028833568096161,
-1.3426989316940308,
0.06626532226800919,
0.22793897986412048,
0.5291591882705688,
0.989676833152771,
0.9509525895118713,
-0.44269365072250366,
-0.008606179617345333,
-0.07109368592500687,
1.065144658088684,
0.41021019220352173,
-0.11977040022611618,
-0.4576076865196228,
-0.4631194472312927,
0.6792480945587158,
0.63702791929245,
0.5743364095687866,
-0.37950947880744934,
-0.2477228045463562,
-0.07863057404756546,
-0.7637646794319153,
0.8490880131721497,
0.33518704771995544,
-0.12663011252880096,
-0.7734265923500061,
0.9769704937934875,
0.50834059715271,
-0.08897858113050461,
-0.1951952576637268,
0.3888760805130005,
0.17938588559627533,
0.41876715421676636,
-0.043907396495342255,
-0.561089813709259,
-0.26743268966674805,
-0.05443437024950981,
1.1147284507751465,
-0.4191262125968933,
-0.7415592074394226,
-0.7534732222557068,
-0.30227088928222656,
0.5037130117416382,
-0.008850856684148312,
0.39251595735549927,
-0.029512833803892136,
-0.2430133819580078,
-0.18601404130458832,
0.32206329703330994,
-0.2873023748397827,
0.8066411018371582,
0.311528742313385,
-0.17478109896183014,
0.04886544495820999,
-0.4194943308830261,
-0.9409908652305603,
-1.1644176244735718,
0.210907980799675,
0.5610185861587524,
0.10600045323371887,
-0.03584754094481468,
-1.0139576196670532,
-1.000968098640442,
0.25371426343917847,
0.1235777884721756,
-0.2816459834575653,
-0.12529881298542023,
0.15697750449180603,
1.0758579969406128,
-0.23332281410694122,
0.22780129313468933,
-0.32986003160476685,
0.0044800350442528725,
-0.5457590222358704,
0.7691469192504883,
-0.44565922021865845,
0.10964089632034302,
-0.7104644179344177,
0.3321685791015625,
0.6904112696647644,
-0.5356587767601013,
-0.13850434124469757,
-0.1486806422472,
-0.798512876033783,
1.0176581144332886,
0.528106689453125,
-0.6510050892829895,
-0.2875758111476898,
0.14306731522083282,
-0.5052484273910522,
0.5369510650634766,
0.6291703581809998,
-1.1727416515350342,
-0.725935161113739,
-0.6592355966567993,
0.8236106038093567,
-0.4679103493690491,
-0.7128430008888245,
0.41258129477500916,
0.34283190965652466,
0.7988716959953308,
-0.45870673656463623,
0.08190393447875977,
-0.03857765719294548,
0.24654363095760345,
0.14701291918754578,
-0.2982248067855835,
0.07874933630228043,
0.2195620983839035,
0.5204101800918579,
-0.19162142276763916,
-0.16226868331432343,
-0.5636835694313049,
-0.003304299432784319,
-0.6795333623886108,
-0.010804986581206322,
-0.268208384513855,
0.2542831599712372,
0.35174745321273804,
0.5502928495407104,
-0.02965683862566948,
0.28734272718429565,
0.014354231767356396,
-0.13116024434566498,
-0.27798330783843994,
0.3590092658996582,
-0.7529648542404175,
0.45455026626586914,
0.7055480480194092,
-0.45782527327537537,
0.11612304300069809,
0.15466037392616272,
0.24641408026218414,
0.1350637525320053,
-0.31422996520996094,
-0.029026521369814873,
-0.019099829718470573,
0.18570078909397125,
-0.047388117760419846,
0.3192698359489441,
0.18304209411144257,
0.0795227438211441,
0.22892998158931732,
-0.20883581042289734,
0.05342422425746918,
-0.42614930868148804,
0.02858186699450016,
-0.37988895177841187,
-0.1856418401002884,
-0.2665083110332489,
0.21812322735786438,
0.208693265914917,
-0.1482963114976883,
0.26470518112182617,
0.7131175994873047,
-0.12805715203285217,
-0.15391525626182556,
-0.13862253725528717,
-0.0975443422794342,
0.23285728693008423,
-0.40068498253822327,
-0.5264807343482971,
-0.2076796144247055,
-0.18491056561470032,
-0.27424517273902893,
-0.16520829498767853,
0.04311227425932884,
0.30001652240753174,
-0.12320728600025177,
-0.02282838150858879,
0.28055235743522644,
-0.46680209040641785,
0.30474230647087097,
-0.23064002394676208,
0.24820712208747864,
0.3505154848098755,
-0.6090141534805298,
-0.29269078373908997,
-0.07801709324121475,
0.07002037763595581,
0.2507091760635376,
-0.16189920902252197,
-0.23074743151664734
] |
NCT00041236
|
Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma
|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have advanced soft tissue sarcoma.
|
OBJECTIVES:
* Determine the anticancer activity of exatecan mesylate, in terms of objective response and duration of response, in patients with advanced soft tissue sarcoma.
* Determine the safety of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to histological diagnosis (leiomyosarcoma vs other histologies).
Patients receive exatecan mesylate IV over 30 minutes daily on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks until disease progression. After disease progression, patients are followed every 12 weeks for survival.
PROJECTED ACCRUAL: A total of 32-50 patients (16-25 per stratum) will be accrued for this study.
|
DISEASE CHARACTERISTICS:
* Histologically confirmed soft tissue sarcoma
* Malignant fibrous histiocytoma
* Liposarcoma
* Rhabdomyosarcoma
* Synovial sarcoma
* Malignant paraganglioma
* Fibrosarcoma
* Leiomyosarcoma
* Angiosarcoma including hemangiopericytoma
* Malignant peripheral nerve sheath tumor
* Unclassified sarcoma
* Miscellaneous sarcoma including mixed mesodermal tumors of the uterus
* The following tumor types are excluded:
* Gastrointestinal stromal tumor
* Chondrosarcoma
* Malignant mesothelioma
* Neuroblastoma
* Osteosarcoma
* Ewing's sarcoma
* Embryonal rhabdomyosarcoma
* Prior chemotherapy for metastatic disease required
* One line of combination chemotherapy containing anthracycline OR
* No more than 2 single-agent regimens including anthracycline
* Adjuvant chemotherapy not considered first line unless tumor progresses within 6 months after treatment
* Must have 1 measurable lesion
* Clinical evidence of progression within 6 weeks prior to study
* Osseous lesions and pleural effusions not considered measurable
* No known or symptomatic CNS metastases
PATIENT CHARACTERISTICS:
Age:
* 15 to 75
Performance status:
* WHO 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.8 mg/dL
* Albumin at least 2.5 g/dL
Renal:
* Creatinine no greater than 1.4 mg/dL OR
* Creatinine clearance greater than 65 mL/min
Cardiovascular:
* No history of severe cardiovascular disease
Other:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for up to 6 months after study participation
* No other severe medical illness, including psychosis
* No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* More than 4 weeks since prior chemotherapy
* No other concurrent cytotoxic therapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No radiotherapy to the sole measurable lesion
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* No other investigational drugs for 28 days prior to, during, and for 28 days after completion of study drug
* No other concurrent anticancer therapy
|
[
-0.9014020562171936,
2.2987093925476074,
-1.620574951171875,
-2.663881778717041,
-0.5974640250205994,
-1.4578317403793335,
-1.7249479293823242,
-1.0701435804367065,
-1.4430842399597168,
-1.9667441844940186,
-0.43025436997413635,
2.283853054046631,
-1.4958630800247192,
-0.5002806782722473,
1.210538387298584,
-0.1594214141368866,
0.0747988298535347,
1.135767936706543,
1.662983775138855,
0.05601612851023674,
2.2021875381469727,
-1.3791420459747314,
-0.0602586567401886,
-0.037726279348134995,
0.4535530209541321,
-0.5257740616798401,
0.5603886246681213,
1.3171579837799072,
2.8855600357055664,
1.2059444189071655,
-1.5395784378051758,
-1.6119842529296875,
0.6548608541488647,
-0.08748643845319748,
-0.3504032790660858,
0.08609461039304733,
0.6121135950088501,
0.9110902547836304,
-1.259256362915039,
0.20406024158000946,
0.20640933513641357,
0.5452539324760437,
-0.2950672209262848,
-0.2691097855567932,
0.21680687367916107,
0.6237136721611023,
0.43517112731933594,
0.46926677227020264,
1.4259049892425537,
0.7425094842910767,
-0.5027903914451599,
2.1428022384643555,
-1.0767401456832886,
-0.23758076131343842,
1.153505563735962,
0.48587772250175476,
-0.2838810384273529,
0.014069304801523685,
1.149095892906189,
1.2954291105270386,
-0.2432718276977539,
0.20724259316921234,
-1.4427579641342163,
-0.5240329504013062,
-1.113479733467102,
0.49012091755867004,
1.1394176483154297,
-0.8694829940795898,
0.3018331229686737,
0.6271583437919617,
1.3355053663253784,
0.9593591690063477,
1.672910213470459,
0.3182668387889862,
-1.0320857763290405,
0.13727404177188873,
1.5570439100265503,
0.7296444773674011,
2.078836679458618,
-0.2250777631998062,
-1.6211704015731812,
-0.11613787710666656,
-0.523565411567688,
-0.0005443493719212711,
-0.07470669597387314,
0.2672806978225708,
-0.3315402865409851,
-0.7225868105888367,
0.40871694684028625,
-2.4057538509368896,
1.7320921421051025,
-0.04525298252701759,
-1.4581454992294312,
1.6571950912475586,
-0.7894802689552307,
0.6166695356369019,
0.023180769756436348,
-0.8038433790206909,
-0.3629271984100342,
-0.22232474386692047,
-0.04003455489873886,
-0.05789760500192642,
0.35850661993026733,
0.29300472140312195,
-1.0996334552764893,
-0.5110685229301453,
-0.9455606341362,
-1.6792638301849365,
0.08910468965768814,
-1.482283353805542,
1.559848427772522,
-1.9240868091583252,
-0.3812731206417084,
0.27389389276504517,
-0.025980038568377495,
-0.20984524488449097,
1.4689987897872925,
0.038575541228055954,
-0.32721033692359924,
0.1637054830789566,
-0.6514075994491577,
0.5333888530731201,
-0.7099354863166809,
0.8369680643081665,
-0.44943565130233765,
-0.3150933086872101,
-0.3760795295238495,
1.1811195611953735,
-0.1816183179616928,
-1.236640214920044,
-0.10801098495721817,
-0.34356850385665894,
0.6537848711013794,
0.03842015936970711,
0.15780000388622284,
-0.9418771862983704,
0.4987426698207855,
1.6697371006011963,
0.15611903369426727,
-0.10684681683778763,
0.6461997032165527,
-0.2126813381910324,
0.5511226654052734,
-0.5856993794441223,
-0.45314261317253113,
0.1325584053993225,
-0.32001689076423645,
1.1340264081954956,
-0.24039854109287262,
-0.9890970587730408,
0.10903673619031906,
0.31440556049346924,
-0.4959181547164917,
0.13805393874645233,
0.8598073124885559,
0.8363368511199951,
-0.26859888434410095,
-0.9773792028427124,
0.23701828718185425,
-0.2240494191646576,
-0.9252477884292603,
-0.1997302770614624,
-0.1506999284029007,
-0.7333150506019592,
0.21524524688720703,
-0.512218177318573,
-0.14674867689609528,
0.5711692571640015,
0.042124275118112564,
0.0152438934892416,
-0.731904149055481,
-0.5998935699462891,
-0.07101103663444519,
0.2210228443145752,
-0.3835940659046173,
-0.5307528376579285,
0.9508599638938904,
-0.2143411487340927,
0.8020517230033875,
0.10401399433612823,
-0.3581963777542114,
0.5497450232505798,
0.7196336388587952,
-0.19722944498062134,
-0.04049571231007576,
-0.2511620819568634,
-0.11875630170106888,
0.28813931345939636,
0.22803613543510437,
0.1478140652179718,
1.1144381761550903,
0.01396199781447649,
0.24090126156806946,
1.32658851146698,
0.18978698551654816,
-0.2116779237985611,
-0.2655588686466217,
-0.15659762918949127,
1.4274449348449707,
-0.25139376521110535,
0.8175535202026367,
0.545860230922699,
-0.07137548923492432,
0.29666778445243835,
0.480170339345932,
-0.5126690864562988,
0.05971275642514229,
0.046546149998903275,
0.48718133568763733,
0.3673468828201294,
-0.34531375765800476,
-0.04636663198471069,
0.8405577540397644,
-0.22559207677841187,
0.3405158221721649,
0.17867057025432587,
0.19557693600654602,
0.7577584981918335,
-0.7869579792022705,
-1.401254653930664,
-0.23881039023399353,
-0.4581444561481476,
-0.022775374352931976,
0.4469066262245178,
0.48700669407844543,
0.38110336661338806,
-0.23189818859100342,
0.004609942901879549,
-0.22447288036346436,
0.0202686358243227,
0.16011512279510498,
-0.21180877089500427,
0.3956845998764038,
0.23621588945388794,
0.11698184907436371,
-0.319527268409729,
0.5682360529899597,
0.3376416563987732,
0.007033903617411852,
0.36414510011672974,
0.10179990530014038,
0.1482052356004715,
-0.7301856875419617,
-0.02537662535905838,
-0.528618335723877,
-0.23219265043735504,
0.28545883297920227,
-0.009395917877554893,
0.07499242573976517,
0.4505990743637085,
-0.48833492398262024,
-0.19654537737369537,
0.039728231728076935,
0.29964572191238403,
-0.5655759572982788,
-0.9357815384864807
] |
NCT06916013
|
Focal Laser Ablation in Prostate Cancer
|
To assess the effectiveness of MRI-US or PSMA PET/CT-U/S fusion-guided focal laser ablation (FLA) for the treatment of a localized, intermediate-risk prostate cancer in terms of short-term oncological \& functional outcomes.
|
Prostate cancer (PCa) is the second most common neoplasm diagnosed in men with an estimated 1.4 million diagnoses and 375,000 deaths worldwide in 2020.
For localized prostate cancer (PCa), active surveillance (AS) or whole gland treatment (ie, radical prostatectomy \[RP\] and radiotherapy) are considered standard treatment options. Unfortunately, treatment-related morbidity is high.
The ProtecT trial showed urinary incontinence rates of 3% and 20% and erectile dysfunction rates of 66% and 79% for radiotherapy and radical prostatectomy, respectively. Radiotherapy can also cause rectal problems with a small increased risk of radiotherapy-induced secondary malignancy.
Consequently, over the past few years, there has been a notable escalation in scholarly attention towards the implementation of focal therapeutic interventions for patients diagnosed with low- and intermediate-risk prostate cancer (PCa).
This tissue-preserving strategy has at its core the reduction of treatment-related toxicity by minimizing damage caused to the prostate and adjacent structures while attempting to retain the benefits of treating cancer.
The rationale of focal therapy (FT) is based on the theory that the largest lesion with the highest grade, the so-called "index lesion," determines the risk of metastases and thus the patient's prognosis.
FT involves ablating only the index lesion, thereby minimizing damage to collateral tissue such as neurovascular bundles, external urinary sphincter, bladder neck and rectum.
Over the past few years, different types of energy sources in FT have been studied. These consist of high-intensity focused ultrasound (HIFU), irreversible electroporation (IRE), cryotherapy, photodynamic therapy (PDT), focal laser ablation (FLA) or laser interstitial thermotherapy, radiofrequency ablation (RFA), and focal brachytherapy.
According to the European Association of Urology (EAU), low-risk and intermediate-risk patients may undergo local procedures using HIFU or cryotherapy within clinical trials or registries, with the aim of achieving long-term cancer control and reducing morbidity associated with surgery and radiation therapy.
Many groups have published limited data on outcomes following in-bore MRI-guided focal therapy, and many others are actively engaged or considering prospective comparative effectiveness research in this area.
The primary objective encompasses a thorough evaluation of the short-term oncological \& functional outcomes of MRI-US or PSMA PET/CT-U/S fusion-guided focal laser ablation (FLA) for the treatment of a small, localized, intermediate-risk prostate cancer.
Concurrently, the secondary aim involves an assessment of the utility of multiparametric magnetic resonance imaging (mpMRI) as a diagnostic pre-treatment tool and during the post-treatment follow-up to examine the morphostructural alterations in the prostate gland resulting from FLA. Additionally, the investigatirs aim to assess its reproducibility in determining the response to FLA therapy, correlating these findings with biopsy results, with the ultimate objective of establishing its predictive diagnostic value in identifying residual or recurring tumors.
|
Inclusion Criteria:
* Prostate cancer visible on mpMRI or PSMA PET/CT and positive in the targeted biopsy.
* Gleason score 7 (ISUP grade 2/3)
* PSA 10-20 ng/mL
* Clinical stage T2b
* Refusing radical prostatectomy.
Exclusion Criteria:
* Prostate cancer invisible on mpMRI or PSMA PET/CT but positive in the systematic biopsies.
* Presence of \>2 MRI-visible lesions and positive in the biopsies.
* Extracapsular extension
* Seminal vesicle invasion
* Presence of metastases detected by imaging
* Gleason Score \> 7
* Stage \> T2b
* PSA \> 20 ng/mL
* Urinary tract infection (UTI)
* Severe lower urinary tract symptoms defined as an IPSS \>20
* Severe coagulation disorders
* Inadequate compliance
* Contraindications to MRI
* Paramagnetic contrast agent allergy
* Acute and/or chronic renal failure
|
[
1.0121690034866333,
3.6644351482391357,
-2.8288979530334473,
-3.314809560775757,
0.538089394569397,
-0.9483230710029602,
-1.174729585647583,
-0.4096852242946625,
-1.576994776725769,
0.4827944040298462,
0.5969556570053101,
0.5202440023422241,
-1.264896035194397,
0.009308628737926483,
-1.595350980758667,
0.9734365344047546,
0.08088614046573639,
0.6288196444511414,
0.3006247878074646,
-0.02679351717233658,
0.999097466468811,
-1.5302437543869019,
0.5312098860740662,
0.020907701924443245,
0.6485394835472107,
-1.2794780731201172,
0.2515501081943512,
0.5873897671699524,
0.23953650891780853,
0.8804818987846375,
-0.9224563837051392,
0.1795593649148941,
-0.668846070766449,
0.581815779209137,
0.5116668939590454,
-0.2731693685054779,
1.118769884109497,
0.3094659149646759,
-1.332241415977478,
0.14940932393074036,
0.6230841875076294,
-0.3913760483264923,
-0.9392518997192383,
0.09366782009601593,
0.46187275648117065,
1.045865535736084,
-1.1312199831008911,
-0.8633206486701965,
0.11817921698093414,
-0.07790274918079376,
-0.6824229955673218,
2.311025381088257,
-1.611652135848999,
-0.9019672870635986,
1.7028700113296509,
-0.3189357817173004,
0.3106629550457001,
0.1437528133392334,
0.8158885836601257,
0.9608514308929443,
-0.053160056471824646,
-0.051395390182733536,
-0.06886051595211029,
0.4213220477104187,
0.6303414106369019,
-0.3604033589363098,
-1.0302478075027466,
0.28168049454689026,
0.1379798948764801,
0.04940943792462349,
2.0053932666778564,
0.5418658256530762,
1.1038252115249634,
0.8442535996437073,
0.9547643065452576,
0.8995943665504456,
-0.07586072385311127,
0.25882574915885925,
1.700721025466919,
-0.310613214969635,
1.4320452213287354,
-0.6135241985321045,
-1.1293658018112183,
-0.16384944319725037,
0.6981070637702942,
-0.5376891493797302,
-0.5052410960197449,
-1.5457830429077148,
-0.14285115897655487,
0.6480046510696411,
-0.13230691850185394,
0.5591930150985718,
-0.8064689636230469,
0.8177773356437683,
-1.8294787406921387,
-0.2247428447008133,
-0.4263184070587158,
-0.46222496032714844,
0.049325358122587204,
-0.008012923412024975,
-0.526158332824707,
-0.29747551679611206,
-0.5371779799461365,
0.10039029270410538,
-0.38409164547920227,
0.3015105426311493,
-0.5738441348075867,
-0.7727791666984558,
-0.5825332403182983,
0.3385961353778839,
1.499074935913086,
-1.4393903017044067,
0.06750723719596863,
-1.0652960538864136,
-0.4838447868824005,
0.21810702979564667,
-0.5703174471855164,
0.04921044781804085,
0.3876655101776123,
-0.19393759965896606,
-0.2657226622104645,
0.3918897211551666,
-0.3811551034450531,
0.5185316205024719,
-0.14394041895866394,
0.5915963053703308,
-0.15198485553264618,
1.5429697036743164,
-0.24386635422706604,
-0.8298287391662598,
0.015565793961286545,
-0.12454519420862198,
-0.15849435329437256,
0.6988975405693054,
-1.4855685234069824,
0.1407652646303177,
-0.47463515400886536,
0.5825709104537964,
0.12878262996673584,
-0.46968623995780945,
0.17981934547424316,
0.3197948932647705,
1.2217447757720947,
0.22658909857273102,
-1.0189906358718872,
-1.123729944229126,
-0.5352004766464233,
0.8552420139312744,
-0.5733039975166321,
-0.3079846203327179,
-0.2662685513496399,
-0.3577226400375366,
-0.6562594771385193,
0.31159693002700806,
-0.24018578231334686,
0.5336864590644836,
0.5915162563323975,
-0.5053178071975708,
0.4009992182254791,
-0.09066195785999298,
-0.3955817222595215,
-1.035471796989441,
0.3703206181526184,
-0.8820634484291077,
0.38505151867866516,
-0.4232868552207947,
-0.5952843427658081,
-0.17907175421714783,
-0.7475935220718384,
-0.37836354970932007,
-0.37935638427734375,
-0.48669207096099854,
0.36443376541137695,
0.3217085003852844,
-0.18921568989753723,
0.13392870128154755,
0.8027560114860535,
-0.9220220446586609,
-0.03836844488978386,
-0.4709513485431671,
0.29921194911003113,
0.5259995460510254,
0.4223996698856354,
0.440310537815094,
0.03032863140106201,
-0.6414660215377808,
-0.28018441796302795,
-0.5866618752479553,
0.0010054482845589519,
-0.2751452326774597,
0.9642900824546814,
0.07922876626253128,
0.3814428746700287,
0.3927711844444275,
0.4254707098007202,
-0.6381754875183105,
-0.5806382298469543,
0.3515574634075165,
0.43261992931365967,
0.07786666601896286,
-0.010883430019021034,
-0.05271562188863754,
0.5401838421821594,
0.7556368112564087,
0.5987808108329773,
0.038987573236227036,
0.06657455116510391,
0.5137436985969543,
-0.4328845739364624,
0.5450993776321411,
0.19468407332897186,
0.4016587436199188,
-0.3732973039150238,
-0.8605077862739563,
-0.04339266195893288,
0.5339959859848022,
0.23892147839069366,
-0.12894529104232788,
-0.12658385932445526,
-0.022952528670430183,
-0.2993581295013428,
-0.08182334154844284,
-0.12710674107074738,
0.6259346604347229,
0.5178030729293823,
-0.11939089000225067,
-0.2789682447910309,
0.1908918023109436,
0.2263137400150299,
-0.2315971702337265,
0.39936167001724243,
0.40005382895469666,
0.21518029272556305,
-0.27371180057525635,
0.05603563040494919,
-0.2858898639678955,
-0.09891675412654877,
-0.3968571424484253,
-0.08417832106351852,
0.7200684547424316,
0.25341930985450745,
0.020858759060502052,
0.6482089757919312,
-0.37209847569465637,
-0.11387687921524048,
0.045260924845933914,
-0.2895260751247406,
-0.4116753339767456,
-0.02267208695411682,
0.23120614886283875,
-0.31377923488616943,
-0.04262455925345421,
0.7384509444236755,
0.21387141942977905,
-0.027711382135748863,
-0.30446144938468933
] |
NCT02916602
|
A Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605
|
A phase 3 study to evaluate efficacy and safety of HCP1401
|
A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of HCP1401 for stage 2 hypertension patients not controlled by HCP0605
|
Inclusion Criteria:
* Hypertension patient who satisfied below condition at Visit 1.
* patient who takes antihypertensive drug
* 140mmHg \<= sitSBP \<= 200mmHg
* patient who doesn't take antihypertensive drug
* 160mmHg \<= sitSBP \<= 200mmHg
* 140mmHg \<= sitSBP \<= 200mmHg at Visit 2
Exclusion Criteria:
* Patient who have received 4 or more antihypertensive drug
* Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 3 times of BP measuring at Visit 1
* Patient with sitDBP \>= 120mmHg at Visit 2
* Patient with secondary hypertension
|
[
0.8535013794898987,
6.67224645614624,
-2.250643014907837,
-4.479769706726074,
1.808095932006836,
-0.7964714765548706,
1.5660942792892456,
0.30983641743659973,
0.608837902545929,
-0.6937187910079956,
-3.631343364715576,
2.3989264965057373,
-2.3710098266601562,
2.740507125854492,
-0.41643622517585754,
3.8661272525787354,
-0.8906607031822205,
-0.863073468208313,
1.7532514333724976,
-3.2862112522125244,
0.8796266317367554,
-0.6496046185493469,
1.267080307006836,
0.3341403603553772,
2.4499614238739014,
-0.08238303661346436,
-2.1913092136383057,
2.4310896396636963,
-0.44577130675315857,
0.9644224047660828,
0.8247695565223694,
3.0313267707824707,
0.26673346757888794,
-0.13174079358577728,
0.6792500615119934,
0.6017748713493347,
2.750164031982422,
-0.006279792170971632,
-0.2755395770072937,
0.11718126386404037,
1.934586524963379,
-0.20702128112316132,
0.17125532031059265,
-2.631218433380127,
0.7677202224731445,
0.45338788628578186,
-0.37302783131599426,
-1.0112180709838867,
0.06566524505615234,
1.814898133277893,
-0.25446680188179016,
0.9381017088890076,
-4.723307132720947,
1.5654165744781494,
3.8424530029296875,
-1.1122311353683472,
-0.10498970001935959,
0.4937661588191986,
4.135971546173096,
1.2571932077407837,
1.3460458517074585,
-1.8118228912353516,
1.6637132167816162,
0.467142254114151,
-1.4603866338729858,
1.5148414373397827,
0.04994339495897293,
0.7993542551994324,
-2.5912458896636963,
0.3114147484302521,
0.012028396129608154,
0.7568572759628296,
2.2021167278289795,
0.1946982890367508,
2.1303372383117676,
0.4461504817008972,
-0.13764609396457672,
1.9843817949295044,
0.17180182039737701,
0.8586920499801636,
1.3722765445709229,
-1.9495134353637695,
-1.9113835096359253,
-0.42705848813056946,
1.420227289199829,
-0.9312742948532104,
0.19432510435581207,
-1.5789673328399658,
1.0075547695159912,
-3.069429874420166,
0.2859157919883728,
0.2387894243001938,
-1.3596036434173584,
0.16249486804008484,
-1.162541389465332,
-0.33572572469711304,
-0.10293013602495193,
-1.7374818325042725,
-0.3060615360736847,
0.34058767557144165,
-0.35814279317855835,
-0.7445521354675293,
0.8080036044120789,
1.245222806930542,
-1.3537667989730835,
0.20644252002239227,
-0.10290837287902832,
-1.3722095489501953,
0.5684627294540405,
-0.7090953588485718,
0.42228665947914124,
-0.6570529937744141,
0.23883266746997833,
-0.3627738356590271,
1.482601523399353,
0.26079392433166504,
1.2574478387832642,
-0.10623251646757126,
1.1593037843704224,
1.1453627347946167,
0.856870174407959,
0.4882238507270813,
1.7260992527008057,
0.9103879928588867,
-0.6675620675086975,
0.12918250262737274,
1.6700184345245361,
0.45287132263183594,
-2.322277784347534,
-1.26681649684906,
-2.55710768699646,
0.23820218443870544,
1.3348948955535889,
1.767141580581665,
-1.5494953393936157,
0.4713435173034668,
-0.3881515860557556,
0.27396827936172485,
0.5828791260719299,
-1.276387095451355,
-0.07876560837030411,
1.3046578168869019,
0.3331737816333771,
0.26850584149360657,
-2.6068570613861084,
0.9154825210571289,
-0.3279126286506653,
-0.9719825387001038,
-0.32963547110557556,
-0.055393416434526443,
-1.0899032354354858,
0.6887978315353394,
-0.5147326588630676,
0.15338493883609772,
0.1490984857082367,
-0.2787501811981201,
0.6517152786254883,
-2.0096499919891357,
0.8569123148918152,
0.9351272583007812,
0.8186268210411072,
-1.315346360206604,
0.7111360430717468,
-0.5824919939041138,
0.039631810039281845,
1.850861668586731,
-0.2098589688539505,
-0.7134557366371155,
-0.4868328273296356,
0.3903328478336334,
-2.0305497646331787,
1.190153956413269,
0.37545910477638245,
-0.21499477326869965,
0.013266977854073048,
-1.5418578386306763,
1.6304559707641602,
-0.40382692217826843,
-1.816115379333496,
0.19030369818210602,
-0.5978907346725464,
0.42456871271133423,
-0.34079796075820923,
1.3579732179641724,
0.017241647467017174,
-0.5744829773902893,
-0.1402992457151413,
-0.3698034882545471,
-0.5421168208122253,
0.02438732609152794,
-0.3459579646587372,
0.10163215547800064,
0.015048925764858723,
-0.08119135349988937,
0.11028138548135757,
0.41428110003471375,
0.5030930042266846,
-1.6298348903656006,
0.0997852236032486,
-1.2869473695755005,
0.7837487459182739,
0.8952600359916687,
0.03359108418226242,
0.2743130922317505,
0.0343170166015625,
1.0725090503692627,
-1.0970933437347412,
0.7844114303588867,
-0.7305620312690735,
0.938373863697052,
-0.8490225076675415,
-1.2998712062835693,
0.1667369157075882,
0.22691451013088226,
0.8753916621208191,
0.09361474961042404,
-0.7811365723609924,
0.7974257469177246,
0.5611734986305237,
0.3202366232872009,
0.48390477895736694,
-0.4511106312274933,
-1.7965198755264282,
0.6456559300422668,
1.464546799659729,
-0.24248430132865906,
-0.6327937245368958,
-0.7454777956008911,
0.06427925080060959,
-0.46989011764526367,
-0.6536377668380737,
0.9384215474128723,
-1.049674153327942,
0.4511798024177551,
-0.6549552083015442,
0.44619661569595337,
0.5353456139564514,
0.13095392286777496,
-0.18542955815792084,
0.40391138195991516,
0.9413924217224121,
-0.7313341498374939,
-0.5240865349769592,
-1.3003898859024048,
0.559468150138855,
-1.4304779767990112,
0.2919447422027588,
1.0414984226226807,
0.06363829225301743,
-0.5500942468643188,
-1.581712007522583,
-0.9406899809837341,
-0.7094883918762207,
1.4608465433120728,
0.5423964858055115,
-1.0728625059127808
] |
NCT02482298
|
A Study to Assess the Effect of Ticagrelor in Reducing the Number of Days With Pain in Patients With Sickle Cell Disease
|
The purpose of this study is to determine whether ticagrelor is effective in reducing the number of days of pain, intensity of pain, and reducing the use of analgesics due to sickle cell disease
|
This is a randomised, double-blind, double-dummy, parallel-group, placebo-controlled, study evaluating 2 doses of ticagrelor in 90 patients aged 18 to 30 years, with sickle cell disease (SCD). Patients will be randomised to double-blind double-dummy treatment period in a 1:1:1 ratio (30 to each treatment group) to receive ticagrelor 10 mg twice daily (bid), or ticagrelor 45 mg bid, or placebo bid to determine the frequency of days with pain using an electronic diary (eDiary) every day. Approximately 180 patients will be enrolled. Patient will be followed for safety assessment during and after 2 weeks of treatment completion.
During the 16 week treatment period, patients will complete a daily eDiary concerning daily pain intensity, pain location, use of analgesics and absence from school or work. At the end of the study patients will be asked to rate the change in their sickle cell pain compared to the start of treatment. Platelet aggregation will be measured and reported as P2Y12 reaction units (PRU) pre-dose and 2 hours post-dose at week 4 and week 5 after treatment start. Pharmacokinetic (PK) parameters will be measured at 2 hours post-dose at week 4, and pre-dose and at 2 hours post-dose at week 5. Biomarkers will be assessed pre-dose at week 4, week 5 and week 8. During the study, patients will be evaluated for adverse events (AEs) including bleeding and vaso-occlusive crisis (VOC).
|
Inclusion Criteria:
* Confirmed medical history or diagnosis of homozygous sickle cell (HbSS) or sickle beta-zero-thalassaemia (HbS/β0) by HPLC
* If treated with hydroxyurea, the dose must have been stable for 3 months
Exclusion Criteria:
* History of transient ischaemic attack or clinically overt cerebrovascular accident
* Moderate or severe hepatic impairment
* Treatment with chronic red blood cell transfusion therapy
* Pre-dominate cause of pain is not sickle cell disease related
* Chronic treatment with anticoagulants or antiplatelet drugs.
|
[
0.04025713726878166,
0.7318502068519592,
-2.1224660873413086,
-3.891756057739258,
0.01441836915910244,
-1.9673389196395874,
1.169269323348999,
-1.0676378011703491,
-0.9547370076179504,
-1.2774134874343872,
0.8916106224060059,
2.6593120098114014,
-0.3541070520877838,
-0.6240832209587097,
-0.9797942638397217,
0.004452694207429886,
0.5055035948753357,
-0.1930663287639618,
2.0376811027526855,
-0.7752436399459839,
0.5849937200546265,
0.587372899055481,
-0.10564593970775604,
-0.2522575259208679,
1.9205471277236938,
0.14472375810146332,
0.9087186455726624,
1.8614214658737183,
0.22207659482955933,
2.85947322845459,
-0.4069841802120209,
-1.1533401012420654,
-0.1563509851694107,
0.6736308336257935,
-1.1972774267196655,
-1.1779406070709229,
1.4728295803070068,
-0.31710878014564514,
-1.6015580892562866,
-1.3630144596099854,
0.30642396211624146,
1.0808042287826538,
-0.453313410282135,
-1.0150095224380493,
2.6770339012145996,
0.8198955059051514,
0.0873018205165863,
0.8537310361862183,
-0.16411136090755463,
0.27355435490608215,
0.4259098172187805,
1.4617807865142822,
-0.8889772295951843,
0.950472891330719,
1.1664166450500488,
0.0674649327993393,
0.23303449153900146,
-0.5560795664787292,
0.5366806387901306,
0.4440622925758362,
0.5267033576965332,
-0.19617444276809692,
0.15146736800670624,
-2.0020618438720703,
0.015397724695503712,
-0.33933374285697937,
0.4300609827041626,
-1.5037903785705566,
0.546592116355896,
0.756618320941925,
1.441084384918213,
-0.03347242623567581,
1.485878586769104,
-1.3341751098632812,
-0.1369910091161728,
0.6857234239578247,
0.1388588845729828,
1.6549030542373657,
0.6289615631103516,
0.38007399439811707,
-0.5950202941894531,
-0.37985408306121826,
-0.2700679898262024,
0.3409925699234009,
-0.48584333062171936,
-0.3011663556098938,
-0.31733959913253784,
0.33893370628356934,
1.377250075340271,
-0.5471284985542297,
1.0517981052398682,
-1.197240948677063,
-0.821350634098053,
0.6210737228393555,
-0.3813331127166748,
0.48210906982421875,
0.15214493870735168,
-1.5693577527999878,
-0.9063913226127625,
0.0000034740992305160034,
-0.5880815982818604,
-0.8890864849090576,
-0.4072554409503937,
-0.1051865965127945,
0.3880692422389984,
0.7779547572135925,
-1.4185787439346313,
0.1506725400686264,
-1.207421898841858,
-0.32178929448127747,
1.4395679235458374,
-1.1214642524719238,
0.032615434378385544,
0.6049765348434448,
-0.8524022698402405,
0.3451632857322693,
0.4369567632675171,
0.886673629283905,
0.06928076595067978,
0.041698239743709564,
0.8970516920089722,
1.2361066341400146,
-0.3717898428440094,
1.2254488468170166,
-0.22929368913173676,
-0.21553099155426025,
-0.15682654082775116,
0.5675929188728333,
-0.015745677053928375,
-1.0775476694107056,
-0.6575671434402466,
0.00033066386822611094,
-0.45284929871559143,
-0.7930447459220886,
0.10094302147626877,
-0.15407979488372803,
1.2275340557098389,
0.7265498042106628,
0.5536110997200012,
0.2785889506340027,
0.7485626935958862,
0.2761242687702179,
0.6632018685340881,
-0.10550973564386368,
-1.5356292724609375,
-0.9776408076286316,
-0.5447845458984375,
0.5764687061309814,
-0.5511201024055481,
-0.49854061007499695,
-0.3257245421409607,
0.5380201935768127,
-0.24231533706188202,
-0.5277329683303833,
0.18282492458820343,
-0.13852402567863464,
0.012886660173535347,
-0.6868239641189575,
0.6918734312057495,
0.3176805078983307,
-0.657488226890564,
-0.25690293312072754,
-0.3252180218696594,
0.20191864669322968,
-0.5711104273796082,
-0.3746248781681061,
-0.004520756658166647,
-0.31425946950912476,
0.4063987731933594,
-0.37650829553604126,
-0.15077242255210876,
0.057866163551807404,
-0.29761192202568054,
0.2780705988407135,
0.1168329119682312,
0.8891391754150391,
0.1855045109987259,
0.5491898655891418,
-0.13692635297775269,
-0.09389122575521469,
0.6477980017662048,
-0.06882181763648987,
-0.5427479147911072,
0.7288140058517456,
0.1249399185180664,
-0.24798935651779175,
-0.8881853818893433,
-0.1640251874923706,
-0.09204696863889694,
0.5817776322364807,
0.7688872218132019,
-0.5045132040977478,
0.04190433770418167,
0.19835135340690613,
-0.3440498113632202,
0.5875675678253174,
-1.016607642173767,
-0.1761394888162613,
1.4038007259368896,
-1.1757330894470215,
0.8414252996444702,
0.8056362867355347,
-0.28742289543151855,
1.3627359867095947,
-0.8673747181892395,
-0.10191796720027924,
-0.2678072452545166,
0.07058046013116837,
-0.1326514184474945,
-0.3823767304420471,
-0.761804461479187,
0.21786364912986755,
-0.3909273147583008,
-0.3916313052177429,
0.230488121509552,
0.5627384185791016,
0.16449621319770813,
0.25910958647727966,
-0.715061366558075,
-0.7173407673835754,
-0.21613819897174835,
-0.16260011494159698,
-0.5657699108123779,
-0.2381722629070282,
0.45549827814102173,
-0.04346746951341629,
-0.00985225010663271,
0.37682488560676575,
-0.05790242180228233,
0.2859012484550476,
-0.037561915814876556,
0.4194832742214203,
0.14797374606132507,
0.2875904142856598,
-0.16134653985500336,
0.9934602379798889,
1.1297870874404907,
0.09564776718616486,
-0.18936774134635925,
-0.42280465364456177,
0.6473639011383057,
-0.5714676380157471,
-0.3095455765724182,
-0.29056069254875183,
-0.22891101241111755,
0.21508178114891052,
0.4278990924358368,
0.3437715470790863,
-0.21994750201702118,
0.6258989572525024,
-0.41965165734291077,
-0.4825698733329773,
-0.06599869579076767,
-0.06928374618291855,
0.015670906752347946,
-0.6537197232246399
] |
NCT01368991
|
Clinical Trial of Kryptonite for Prevention of Sternal Complications in High Risk Patients Undergoing Cardiac Surgery
|
Kryptonite is a non-toxic biologic polymer, that has previously been used in orthopedic surgery. The objective of our study is to demonstrate the benefits of Kryptonite in cardiac surgery patients at high risk for sternal wound complications. The investigators have designed a randomized clinical trial of 48 high risk patients, with a 1:2 randomization of kryptonite to conventional closure. The primary outcome will be quality of life. Secondary outcomes include sternal complications, pain, hospital length of stay, and respiratory function.
|
Purpose: To compare clinical outcomes following sternal closure with Kryptonite and conventional sternal closure, in cardiac surgery patients at high risk for sternal wound complications.
Hypothesis: Patients receiving sternal closure with Kryptonite will have a shorter post-operative length of stay, fewer sternal wound complications, improved respiratory function, better quality of life, and less pain than patients receiving a conventional sternal closure. The investigators hypothesize that patients receiving sternal closure with Kryptonite will be discharged from hospital, on average, 1 day earlier than patients receiving conventional sternal closure.
Justification: Kryptonite is a biologic polymer from the castor bean and is non-toxic. It is osteoconductive i.e. bone regrows through it. It is adhesive, and only requires 24 hours to completely cure, although sternal stability is achieved even sooner. In human cadaver studies, sternal edges adhered together with Kryptonite could not be broken after 2 hours. The proposed benefits of Kryptonite in cardiac surgery patients are the prevention of pathologic sternal displacement, the elimination of regional non-union, the enhancement of functional recovery, and the reduction of sternal wound complications.
The use of Kryptonite to close sternal wounds in cardiac surgery was first described in Calgary, Alberta. This group conducted a small, single-blind randomized clinical trial in 34 patients at low risk for sternal complications (personal communication, Fedak, P). Patients in the Kryptonite group experienced significantly less pain, required less analgesia, and demonstrated a faster return to baseline pulmonary function. The limitations of this study were the small sample size and blinding of patients only. Furthermore, hospital length of stay was not evaluated. A multi-center randomized clinical trial is planned, pending funding.
Objectives: The primary outcome of our trial is quality of life. Secondary endpoints are pain, sternal complications, and respiratory function.
Research Method: All patients undergoing non-emergent cardiac surgery through a primary sternotomy at Vancouver General Hospital will be screened for enrollment in the trial. Potentially eligible patients will be approached by a research nurse.
Forty-eight eligible patients will be randomized 2:1 intra-operatively to receive either conventional sternal closure or closure with Kryptonite. Sealed envelopes with treatment allocation will be utilized for the randomization process, and will be randomly selected in the operating room. Conventional sternal closure will be with single interrupted or figure-of-eight surgical steel wires. Conventional techniques such as vancomycin paste and bone wax can be utilized in the usual fashion to obtain hemostasis in these patients. Patients in the Kryptonite group will have surgical steel wires placed in the usual fashion, prior to the application of Kryptonite. However, bone wax and vancomycin paste will not be used in the Kryptonite group, as it impairs the adherent properties of Kryptonite.
Post-operatively, patients will not be made aware of which type of sternal closure they received. Furthermore, the post-operative care team in the Cardiac Surgery Intensive Care Unit (CSICU), as well as the surgical ward will also be blinded. The cardiac surgery ward is run by a single cardiologist who will be blinded to the patients' group allocations. Battery powered sternal saws will be available in the CSICU and on the cardiac surgery ward, in the event of emergent resternotomy.
All patients will be followed prospectively. The primary outcome will be quality of life. Secondary outcomes will be hospital length of stay, pain, sternal complications, and respiratory function. All patients will be required to answer a quality of life questionnaire pre-operatively (SF12), as well as at both 2 weeks and 5 weeks post-operatively. Pain scales will also be administered on post-operative day 2 and day 5, or on day of discharge if less than day 5. Questionnaires will be administered by the research nurse, either in hospital or by phone. Respiratory function will be measured by bedside spirometry, which will be measured pre-operatively, as well as on post-operative day 2 and 5. In-hospital sternal complications will be recorded, and following discharge the research nurse will ask about and sternal complications during follow-up telephone calls. Sternal complications of interest are sternal dehiscence requiring re-operation or sternal wound infection requiring antibiotics or re-intervention. Post-operative follow-up will otherwise be routine.
A data safety monitoring board will be assembled to perform an interim analysis when 24 of the 48 patients have been enrolled in the trial. If any safety risks are identified at this interim analysis, no further patients will be randomized in the trial.
Statistical Analysis:
Baseline characteristics will be compared between groups using Student's T-tests, for continuous variables and Chi-square tests for categorical variables.
The physical component score (PCS) and the mental component score (MCS) from the SF-12 will be compared between groups at baseline using the Student's T-test, as will the change in scores between baseline and 2 weeks and baseline and 5 weeks. The investigators will also explore the change over time using all three time points, baseline, 2 weeks, 5 weeks, using a general estimating equation (GEE).
Length of stay (LOS), change in pain score, rate of sternal complications, and respiratory function will also be evaluated. LOS will be reported as medians and interquartile ranges, given the high likelihood that this data will be significantly skewed. Differences between the groups will therefore be tested using the Mann-Whitney U test. Pain scores will be measured at 2 and 5 days. The mean and standard deviations for each of these time points will be reported and differences at 2 days will be assessed using the Student's T-test. The change in pain score between 2 and 5 days will also be compared using the Student's T-test.
The rate of sternal complications will be compared as simple proportions using the Chi-square test for differences. Respiratory function, specifically FEV1 and FVC, will be compared for the three time points using GEE, thus allowing us to compare the change in function over time.
With the exception of LOS, the investigators have assumed all continuous variables will be normally distributed. Outcomes will be tested for the normality assumption prior to carrying out the parametric tests. If a variable is not normally distributed, then either a log transformation will be applied or nonparametric tests (ie. Wilcoxon rank-sum test) will be considered to test for differences between groups.
|
Inclusion Criteria:
* To be included in the study, patients must satisfy ONE of the following criteria:
1. Body mass index (BMI) \> 30kg/m2 AND at least one other risk factor. Additional risk factors include insulin dependent diabetes ≥ 5 years, active smoking until time of hospitalization, chronic obstructive pulmonary disease, long-term steroid use equivalent to ≥ 5mgof prednisone daily for \> 1 month pre-operatively, alcohol/drug abuse, and mobilization with aid of a walker, cane, scooter, etc.
2. BMI \> 40kg/m2
3. Limited mobility with dependence on upper body for mobilization.
Exclusion Criteria:
* age \<18 years
* cardiac surgery through incision other than sternotomy
* emergent surgery
* previous sternotomy (i.e. redo cardiac surgery)
* surgery for sternal dehiscence or mediastinitis, and
* inability to obtain informed consent
|
[
0.185542032122612,
2.3887577056884766,
-1.3416435718536377,
-2.642515182495117,
0.2871911823749542,
-0.11368700861930847,
-0.7826604843139648,
-0.29402661323547363,
-0.768653392791748,
0.86942058801651,
-0.47030913829803467,
0.9754155874252319,
0.09580153226852417,
0.1640530526638031,
-0.37607377767562866,
0.47676554322242737,
-1.4737592935562134,
0.24868206679821014,
0.1371859908103943,
-0.8340528607368469,
-0.2441994994878769,
1.0025765895843506,
-0.14845840632915497,
0.4848625659942627,
0.8714020252227783,
-0.573096513748169,
-0.6210522055625916,
0.06941664218902588,
-0.2557094991207123,
1.137622356414795,
-0.37738659977912903,
-1.0332375764846802,
-1.5191344022750854,
0.9849377870559692,
-1.064788579940796,
0.22070951759815216,
0.20856934785842896,
-1.1086721420288086,
-1.4440251588821411,
1.0407629013061523,
1.2824655771255493,
0.1836916208267212,
-0.07621308416128159,
-0.7339239716529846,
0.02142513543367386,
-0.36626607179641724,
-0.5238252878189087,
0.7263458371162415,
0.6228991150856018,
-0.25326845049858093,
-1.7522438764572144,
0.7680739760398865,
-0.36728784441947937,
0.6823841333389282,
0.4161285161972046,
0.5313869118690491,
0.6284511089324951,
-0.41611242294311523,
1.2631900310516357,
1.1647019386291504,
1.1191987991333008,
0.16127485036849976,
-0.13003535568714142,
-0.02454276941716671,
-0.7202171683311462,
0.12968051433563232,
-0.24119502305984497,
0.37985876202583313,
-0.19282107055187225,
0.07578221708536148,
-0.244974285364151,
0.30339184403419495,
0.7781124114990234,
0.32151487469673157,
0.3282110095024109,
1.2424570322036743,
-0.6671228408813477,
0.4178825616836548,
-1.2027660608291626,
-0.4454300105571747,
-0.2926110327243805,
-1.1725131273269653,
-1.2679482698440552,
0.1702442318201065,
-0.09615679830312729,
-0.5732480883598328,
-0.37968018651008606,
-1.0787893533706665,
1.4540742635726929,
-1.4722448587417603,
0.49076488614082336,
0.058973535895347595,
-0.8316562175750732,
0.5997729897499084,
-0.29446741938591003,
0.540363609790802,
0.3538137674331665,
0.39430007338523865,
-1.5680807828903198,
0.12305328994989395,
0.6266272664070129,
0.10059427469968796,
0.2690746784210205,
-0.5767396092414856,
0.12044502049684525,
0.768786609172821,
0.6126444935798645,
0.6708673238754272,
-0.022324159741401672,
-0.204465851187706,
1.3404122591018677,
-1.2960151433944702,
0.6462200880050659,
-0.29602187871932983,
-0.3094686269760132,
0.5483359694480896,
-0.1625543236732483,
-0.5910856127738953,
0.06758477538824081,
-0.00777756841853261,
-0.6496565341949463,
0.6665883660316467,
0.712984025478363,
0.7469258904457092,
-0.44823387265205383,
-0.4268496036529541,
-0.49086931347846985,
1.452692985534668,
-0.05414935573935509,
-1.3184490203857422,
-0.6210657954216003,
0.9370224475860596,
0.31491702795028687,
-0.20881833136081696,
-0.5382455587387085,
0.14250022172927856,
0.4824219346046448,
1.0768392086029053,
0.11627905815839767,
-0.7711088061332703,
0.12182480841875076,
0.5035106539726257,
-0.7686918377876282,
0.1816159337759018,
-0.9773961901664734,
-0.39293932914733887,
-0.17319996654987335,
0.11603264510631561,
-0.6195235252380371,
-0.5293229222297668,
0.2367834448814392,
0.7674365639686584,
0.14692698419094086,
-0.3081605136394501,
0.32142511010169983,
0.3919191360473633,
0.16677643358707428,
-0.27867141366004944,
0.3209609389305115,
-0.4232649505138397,
0.2787666618824005,
-0.3961869776248932,
-0.3673997223377228,
-1.201073408126831,
1.315395474433899,
0.07060112059116364,
0.2765984535217285,
-0.5316920876502991,
0.2076794058084488,
0.08468811213970184,
-0.687079906463623,
0.7205959558486938,
-0.6903340816497803,
0.46414637565612793,
-0.22639870643615723,
-0.3433886468410492,
0.7913101315498352,
-0.3091881275177002,
-0.1863386034965515,
0.23467512428760529,
-0.017936475574970245,
-0.28592294454574585,
-0.138050377368927,
0.35703450441360474,
0.07750241458415985,
-0.3988859951496124,
0.2475464791059494,
-0.40172573924064636,
-0.5668812394142151,
0.21933530271053314,
0.14368900656700134,
0.3167707026004791,
-0.19718892872333527,
0.29963865876197815,
0.5602856278419495,
0.18218116462230682,
-1.0039613246917725,
-0.8273854851722717,
0.15175586938858032,
-0.22850407660007477,
0.20820662379264832,
-0.04763185605406761,
-0.012282769195735455,
0.16487181186676025,
0.48938414454460144,
0.07081189751625061,
-0.05378546938300133,
0.26959994435310364,
-0.7027052044868469,
-0.34140270948410034,
0.03757927939295769,
0.08532676845788956,
0.4671122431755066,
-0.6109378337860107,
0.020591773092746735,
0.315047949552536,
0.20579706132411957,
0.2774899899959564,
-0.40268322825431824,
-0.0537533313035965,
-0.0257775466889143,
-0.08546285331249237,
0.615635871887207,
-0.06862873584032059,
-0.3429848253726959,
0.18437057733535767,
-0.3388349115848541,
0.04881944879889488,
-0.07533860206604004,
-0.38434964418411255,
-0.1585593968629837,
0.05283061042428017,
-0.0993499681353569,
-0.17340855300426483,
0.20348073542118073,
0.029296930879354477,
0.2098734974861145,
0.06933522969484329,
0.15331213176250458,
0.35744762420654297,
-0.15493491291999817,
-0.7357717156410217,
0.12407752126455307,
-0.38331514596939087,
-0.11734255403280258,
0.40480858087539673,
-0.28864359855651855,
-0.14488062262535095,
-0.03785157948732376,
0.6195787787437439,
-0.5458328127861023,
-0.8967782855033875,
0.07721471041440964,
-0.2483007311820984,
-0.011171308346092701,
-0.2788049876689911
] |
NCT05493371
|
Empagliflozin in Pulmonary Arterial Hypertension
|
The aim of the study is to determine whether conducting a randomized placebo-controlled clinical trial is feasible, safe for the patient and whether the treatment is well tolerated in patients with idiopathic pulmonary arterial hypertension.
|
This study is designed as a prospective, single-center, phase IIa, single-arm, open-label, interventional proof-of-concept trial in patients diagnosed with idiopathic pulmonary arterial hypertension (IPAH) who are currently on stable therapy. Patients will be administered a once-daily oral dose of 10 mg empagliflozin for a duration of 12 weeks along with standard treatment. The primary objective of this study is to assess safety and tolerability of empagliflozin and to assess whether a potential future randomized, double-blind, placebo-controlled study is feasible.
|
Inclusion Criteria:
1. Age ≥ 18 years
2. Diagnosis of idiopathic PAH
3. Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming diagnosis of WHO diagnostic pulmonary hypertension Group I: PAH with subtype idiopathic PAH. The documented RHC shows all of the following criteria:
1. mPAP \> 20 mmHg at rest
2. Pulmonary artery wedge pressure (PAWP) or left ventricular end-diastolic pressure (LVEDP) ≤ 15 mmHg at rest
3. PVR ≥ 240 dyn·sec/cm5 (3 Wood units) at rest
4. Symptomatic pulmonary hypertension classified as World Health Organization (WHO) functional class (FC) II, III or IV
5. PAH therapy is at stable (per investigator) dose levels of standard of care (SoC) therapies for at least 90 days prior screening. SoC therapy refers to a therapy consisting of at least 1 agent from a list including: an endothelin-receptor antagonist (ERA), a phosphodiesterase 5 (PDE5) inhibitor, a soluble guanylate cyclase stimulator, and/or a prostacyclin analogue or receptor agonist (SC/inhaled/PO).
Exclusion Criteria:
1. Any subject who received any investigational medication within 1 month prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study. Patients participating in a purely observational trial will not be excluded
2. Females of childbearing potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 months), unable or unwillingly to either:
1. Use highly effective methods of birth control according to the International Conference on harmonisation of pharmaceuticals for human use (ICH) that result in a low failure rate of less than 1% per year when used consistently and correctly 43. Highly effective methods include hormonal contraception (for example, birth control pills, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation (having your tubes tied); or a partner with a vasectomy who has completed follow-up to confirm a successful procedure
2. Have a negative pregnancy tests as verified by the investigator prior to starting study therapy and agrees to have an extra pregnancy test 8 weeks after start of the study
3. Contraindication for CMR imaging as defined in the protocol of the Amsterdam UMC "Kwaliteitsdocument Cardiale MRI (Versie 1)". The list of contra-indications includes: claustrophobia, ferromagnetic implants, implanted cardioverter defibrillator (ICD) or pacemaker (except for the MR conditional) and ball-in-cage mechanic heart valve.
4. Impaired renal function, defined as eGFR \< 30 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis
5. History of chronic severe (Child Pugh classification score \>10, Appendix 1) or active liver disease defined as serums transaminases \>5 x upper limit of normal (ULN) or bilirubin \> 1.5 x ULN
6. History of ketoacidosis
7. Known allergy, intolerance or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
8. Use of lithium compounds and being unable or unwillingly to increase the monitoring frequency of lithium levels
9. Current or scheduled use of the following Uridine glucuronosyltransferase (UGT) inducers: phenytoin, rifampicin, carbamazepine, lamotrigine, ritonavir, efavirenz, tipranavir, phenobarbital, testosterone propionate and nelfinavir.
10. Current or prior use of a SGLT-2 inhibitor
11. Heart transplant recipient or listed for heart transplant
12. Chronic pulmonary disease requiring home oxygen or steroid maintenance therapy
13. Symptomatic hypotension and/or a systolic blood pressure (SBP) \< 90 mmHg at screening
14. Gastrointestinal (GI) surgery or GI disorder that could interfere with absorption of trial medication in the investigator's opinion
15. Presence of any other disease than pulmonary arterial hypertension with a life expectancy of \<1 year in the investigator's opinion
16. Women who are pregnant, nursing, or who plan to become pregnant while in the trial
17. History of severe (previously required or prolonged patient hospitalization, resulted in persistent or marked disability/incapacity) or recurrent (≥2 infections in six months or ≥3 infections in one year) genital infections.
18. History of severe hypoglycaemia (\<40 - 30 mg/dL = \<2.2 - 1.7 mmol/L), previous hospitalisation for hypoglycaemia or seizures attributed to hypoglycaemia
19. Active solid or haematological malignancy, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas of the skin
20. History or suspicion of inability to cooperate adequately
21. Any condition that, in the investigator's opinion, makes them an unreliable trial subject or unlikely to complete the trial
|
[
-2.0042197704315186,
3.2888059616088867,
-2.6465203762054443,
-1.669688105583191,
0.14470040798187256,
0.0045184665359556675,
-0.02873571403324604,
0.8883287310600281,
0.7638345956802368,
-0.13320031762123108,
0.9697280526161194,
1.6718101501464844,
0.38640204071998596,
0.701761782169342,
1.2201969623565674,
3.0567514896392822,
-1.3079906702041626,
1.0367774963378906,
1.814551591873169,
-1.5620001554489136,
1.1357007026672363,
-1.1926954984664917,
0.7355031371116638,
-0.06046128645539284,
0.5689964890480042,
-1.0865459442138672,
-0.6605498194694519,
0.960317075252533,
0.5455712676048279,
0.8650817275047302,
0.3785202205181122,
-0.514646589756012,
-0.46139413118362427,
1.323397159576416,
-0.1286364197731018,
0.7982359528541565,
0.7720386385917664,
1.0311591625213623,
-0.6314558386802673,
0.17549502849578857,
1.8030775785446167,
1.003157138824463,
-1.2711957693099976,
-1.688574194908142,
2.1714894771575928,
1.9123317003250122,
-1.3434001207351685,
0.3798947036266327,
0.2622164785861969,
0.39059343934059143,
-1.079999566078186,
1.904699683189392,
-0.6252683401107788,
1.0327649116516113,
1.6306138038635254,
0.2850685119628906,
1.6527098417282104,
0.7405639886856079,
1.3790339231491089,
0.7785798907279968,
0.18005411326885223,
-0.09997141361236572,
-0.031899552792310715,
1.897964596748352,
-1.264987587928772,
0.3436582684516907,
-0.08932042866945267,
0.11849410831928253,
-0.126090869307518,
-1.1192913055419922,
-0.9069871306419373,
-0.7529360055923462,
-0.14562343060970306,
1.2088327407836914,
-0.305449515581131,
1.1839367151260376,
-0.3052225410938263,
1.1234179735183716,
0.30155983567237854,
0.6495289206504822,
-0.7320255041122437,
-0.749006986618042,
-0.8204997777938843,
1.044683575630188,
0.5117069482803345,
-0.29372698068618774,
-1.0715919733047485,
-0.7213812470436096,
1.0521794557571411,
-1.9019511938095093,
0.29035356640815735,
0.026580197736620903,
0.4712831676006317,
1.326182246208191,
-1.0676442384719849,
-0.2673824727535248,
-0.6669549345970154,
-0.6153184771537781,
-1.0271514654159546,
-1.1926727294921875,
0.10765295475721359,
-0.10013878345489502,
-0.12941914796829224,
-0.6694039702415466,
-0.7180132269859314,
-0.07854501157999039,
1.8980556726455688,
-0.40489137172698975,
-0.4330641031265259,
-0.7421938180923462,
0.2736830413341522,
-0.8238332867622375,
0.5469746589660645,
0.3928033113479614,
0.43951237201690674,
0.16579048335552216,
0.8838739395141602,
0.3033521771430969,
0.27186471223831177,
0.37428590655326843,
-0.7608886361122131,
1.7898013591766357,
0.7556005716323853,
-0.2795239984989166,
-1.2195130586624146,
-0.21025870740413666,
0.3125353157520294,
-0.20578226447105408,
-1.23286771774292,
-1.4123828411102295,
-0.5680361986160278,
-0.3575047254562378,
0.6801578998565674,
0.02184581570327282,
-1.0570906400680542,
-0.2552119791507721,
0.7442577481269836,
1.326414942741394,
-0.1431857943534851,
-0.6454950571060181,
0.4075976312160492,
1.1884602308273315,
0.13033056259155273,
-0.022266654297709465,
-1.1772211790084839,
-0.52595055103302,
-0.7538950443267822,
0.11066367477178574,
-0.38853833079338074,
-0.5250507593154907,
-0.1883551925420761,
0.77549147605896,
-0.03247256204485893,
0.23845171928405762,
0.9458349347114563,
0.8166348934173584,
0.19859151542186737,
-0.1557779163122177,
-0.25730758905410767,
-0.37693583965301514,
-0.41127708554267883,
-0.10783421248197556,
-0.42324087023735046,
-1.2401694059371948,
1.7751526832580566,
0.19698528945446014,
-0.24815526604652405,
-0.04209152236580849,
0.7172032594680786,
0.6715424656867981,
-0.17817750573158264,
0.30476588010787964,
-0.14787544310092926,
0.9931651949882507,
-0.9182239770889282,
-0.5716404318809509,
0.4480515420436859,
-0.21649032831192017,
-0.05439275503158569,
-0.22657404839992523,
-0.5353354811668396,
0.2735323905944824,
0.37959620356559753,
-0.6373319029808044,
-0.1465594619512558,
-0.3022119402885437,
0.11247143149375916,
0.011318663135170937,
0.17705123126506805,
-0.27802279591560364,
-0.12239870429039001,
0.49355658888816833,
-0.8660210967063904,
0.4206031560897827,
0.026378488168120384,
-0.3016946613788605,
-0.5980170369148254,
-0.7933756113052368,
0.639247477054596,
-0.633624792098999,
0.3389246463775635,
0.6011765003204346,
-0.6627457141876221,
0.6034730076789856,
-0.3601795434951782,
-0.3200344443321228,
0.49326029419898987,
0.05396297201514244,
0.11869790405035019,
0.8109550476074219,
-0.567686915397644,
0.09982652217149734,
-0.17065660655498505,
-0.7345958352088928,
0.46486738324165344,
-0.07057133316993713,
0.5200216770172119,
-0.02409205585718155,
-1.3310115337371826,
-0.5302390456199646,
-0.8403838872909546,
0.06023063883185387,
0.6053089499473572,
0.07644544541835785,
-0.7432830929756165,
0.2354658544063568,
0.4861724078655243,
0.28947749733924866,
-0.00744596729055047,
0.1314597725868225,
-0.8401594758033752,
0.2332114279270172,
0.29303839802742004,
-0.22710858285427094,
-0.22540393471717834,
-0.21012286841869354,
0.2696835696697235,
0.10660002380609512,
-0.12046521157026291,
0.6260191798210144,
-0.14349567890167236,
-0.07861513644456863,
0.25798413157463074,
-0.7655126452445984,
-0.84482342004776,
0.019662927836179733,
-0.08944601565599442,
0.268451452255249,
0.08864447474479675,
0.5077352523803711,
-0.6012078523635864,
-0.5241194367408752,
0.1319044977426529,
0.0003756772493943572,
-0.21008111536502838,
-0.17469705641269684
] |
NCT01141777
|
The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients
|
Spirulina, a widely used food supplement, improves the lipid profile and glycemic control in people living with diabetes, suggesting that it could have some effects on insulin sensitivity. Since HIV-infected patients develop metabolic abnormalities due to the virus and/or to antiretroviral (ARV) drugs, the investigators therefore proposed to evaluate the effect that spirulina can have on HIV/HAART-associated insulin resistance
|
Even though antiretroviral therapy (ART) has dramatically improved the health of people living with HIV/AIDS, the prospect of maintaining patients long term on ART can be severely restricted by the development of serious long term effects in their metabolism. These abnormalities include dyslipidemia, lipodystrophy and disorders of glucose metabolism with insulin resistance believed to be the underlying pathophysiological mechanism.
Spirulina, has recently drawn attention on its cholesterol and blood pressure lowering effects, including improvement of glycaemic control in diabetics subjects, suggesting it can have some effects on insulin sensitivity.
The aim of this three month, experimental, prospective, randomised trial was to evaluate the effect of Spirulina on HIV/HAART-associated insulin resistance on 33 subjects. Primary outcome was change in insulin sensitivity during the trial, over two time periods; t=0 and t=12 weeks. The second objective was to compare between the two groups, the percentage of subjects who improved insulin sensitivity by the end of the study.
Recruitment started in October 2008 and the trial ended in February 2009.
|
Inclusion Criteria:
* Confirmed HIV infection
* Accepted to participate in the study
Exclusion Criteria:
* Acute intercurrent infection
* Treatment that modifies glucose or lipid profile
* Pregnancy
* Known diabetic patient
* Chronic renal failure with calculated creatinine clearance \< 60ml/min
|
[
0.960510790348053,
1.2615351676940918,
-1.3147673606872559,
-2.107994794845581,
-1.1224117279052734,
-0.32787948846817017,
-0.26855045557022095,
0.003477504476904869,
-1.5414179563522339,
-1.1573959589004517,
0.8912857174873352,
2.448723793029785,
-0.5249330997467041,
0.7161146998405457,
1.367526650428772,
0.1977468729019165,
-1.3453902006149292,
1.484520435333252,
1.4261984825134277,
-2.6029436588287354,
0.6019631028175354,
1.4739793539047241,
-1.9215164184570312,
0.2297680675983429,
0.7485126256942749,
-0.3302476406097412,
-2.121422290802002,
1.197466492652893,
0.6102195978164673,
1.1636996269226074,
0.01700824871659279,
-0.4654465913772583,
-0.7799381017684937,
1.8807016611099243,
-0.2905822694301605,
-1.3713868856430054,
0.8682576417922974,
1.2250558137893677,
-2.297962188720703,
1.0444295406341553,
0.15603172779083252,
-0.0880206823348999,
0.4714847207069397,
0.15563105046749115,
2.2953717708587646,
0.3426588177680969,
1.282544493675232,
-0.20491430163383484,
1.2219128608703613,
0.1397879272699356,
-0.3324880599975586,
2.642247200012207,
-0.705859899520874,
1.1430413722991943,
2.7241010665893555,
0.9236239790916443,
0.1594698429107666,
0.8452168107032776,
0.8437134623527527,
-0.7655181884765625,
0.3192354738712311,
-0.6102750897407532,
-1.1974538564682007,
0.12128975987434387,
-1.5546140670776367,
0.49155759811401367,
0.2019905298948288,
0.06558366119861603,
-1.1740485429763794,
-0.057545941323041916,
-0.6230438947677612,
-0.8258670568466187,
0.38664165139198303,
0.11320167034864426,
0.357511430978775,
1.5919442176818848,
0.09509488195180893,
1.4609030485153198,
0.17397595942020416,
1.799357295036316,
-1.1934458017349243,
-1.1747801303863525,
0.08921926468610764,
-0.3006865680217743,
1.079712986946106,
0.018308358266949654,
0.1614646017551422,
-0.03483634069561958,
-0.4369235038757324,
-1.8957319259643555,
-0.020323175936937332,
-0.21112854778766632,
-0.4880380928516388,
0.01977422460913658,
-0.8204349279403687,
-0.10750532895326614,
-1.0162789821624756,
-0.06105894595384598,
-0.8455498814582825,
-1.4972069263458252,
-0.8664625287055969,
0.3338276445865631,
-0.3886044919490814,
-0.22923900187015533,
-0.7666987180709839,
0.12049681693315506,
-0.1367032378911972,
0.03705897927284241,
-1.3160117864608765,
-0.3084185719490051,
0.03701533377170563,
-1.3709286451339722,
-0.24324531853199005,
-1.2158774137496948,
1.0024621486663818,
-0.5007566809654236,
0.08217334002256393,
-0.25410154461860657,
-0.1675073206424713,
-0.4789516031742096,
-0.495379775762558,
0.032197076827287674,
-0.329123318195343,
0.5723527669906616,
-0.5455173254013062,
-0.9152718186378479,
-0.4703887403011322,
0.022730085998773575,
-0.34778261184692383,
-0.32405051589012146,
0.46477195620536804,
0.2263748198747635,
0.4678684175014496,
-1.0063824653625488,
-0.21634085476398468,
-0.4596624970436096,
0.9037174582481384,
0.4270462095737457,
0.04598894715309143,
0.542745053768158,
-0.3697783946990967,
0.36785656213760376,
0.300083190202713,
1.3061589002609253,
-1.2462165355682373,
-0.3537738025188446,
0.4006698727607727,
0.06135975942015648,
0.2541064918041229,
-0.6571179032325745,
-0.028228504583239555,
0.9226531982421875,
0.5191733837127686,
0.3995039165019989,
-0.07577436417341232,
-0.07832720875740051,
-0.07753399759531021,
-1.232850193977356,
0.4443603456020355,
0.6539973616600037,
-0.055062856525182724,
-0.06265755742788315,
-0.3848875164985657,
-0.3638114631175995,
0.8074360489845276,
-0.6362788081169128,
0.2254093587398529,
-0.44847047328948975,
0.33313748240470886,
-0.17053550481796265,
-0.10749910026788712,
0.10266721248626709,
-0.7975431084632874,
-0.021776530891656876,
-0.3683406114578247,
0.2941848337650299,
0.164606973528862,
0.4445948600769043,
0.5077119469642639,
-0.04943552613258362,
-0.2553230822086334,
0.18079833686351776,
0.15921206772327423,
-0.1472834050655365,
0.37555748224258423,
-0.10656923800706863,
-0.10506665706634521,
-0.3794476389884949,
0.057613372802734375,
-0.19162417948246002,
-0.3152107298374176,
0.04387110471725464,
-0.023293236270546913,
0.2630457878112793,
0.4180448353290558,
0.4416671693325043,
0.1499519646167755,
-0.5237447619438171,
0.47539710998535156,
0.49164098501205444,
0.8037244081497192,
0.2540193200111389,
-0.22872507572174072,
0.37205544114112854,
-0.32488012313842773,
-0.36062583327293396,
-0.7977110743522644,
-0.03671833127737045,
0.2978390157222748,
0.4636772871017456,
-0.25322431325912476,
-0.16443166136741638,
-0.495040625333786,
0.26262325048446655,
1.02127206325531,
-0.06951678544282913,
-0.20547093451023102,
0.3183944821357727,
0.1394193470478058,
-0.3940509855747223,
-0.06827468425035477,
0.2575540244579315,
0.516846239566803,
0.24154521524906158,
-0.683799684047699,
-0.18679800629615784,
0.15901537239551544,
0.35343945026397705,
0.2681225538253784,
0.07920587062835693,
0.18706169724464417,
0.7527874708175659,
-0.4750872254371643,
-0.25633788108825684,
-0.5062775611877441,
0.4765416979789734,
-0.2776629328727722,
0.10110493749380112,
-0.0156981460750103,
0.1257636547088623,
0.2633177638053894,
-0.38248109817504883,
-0.3277032673358917,
0.18793955445289612,
0.11572545021772385,
-0.19713768362998962,
0.19685986638069153,
0.34843337535858154,
0.1999189853668213,
0.19304347038269043,
-0.09953919798135757,
0.05291124805808067,
-0.4233190417289734,
-0.49421629309654236,
0.31747764348983765,
-0.547991156578064
] |
NCT05682183
|
Multi-domain Psychoeducation Self-management Program for Adults With MDD in Singapore
|
This is a single-centre, two-arm, unblinded pilot randomised controlled trial study on 60 participants (30 in each arm) from the community mental health service (CMHS) centre within a social service agency in Singapore based on inclusion criteria. The study will examine the effects of a 5-sessions of Multi-domain Psychoeducation Self-management Programme and treatment-as-usual) over 5 weeks or control (treatment-as-usual) group.
|
This is a single-centre, two-arm, unblinded pilot randomised controlled trial study. A total of 60 participants (30 in each arm) will be conveniently recruited from the community mental health service (CMHS) centre within a social service agency in Singapore based on inclusion criteria. Block randomisation with a block size of two will be used to randomise participants into the intervention (5-sessions of Multi-domain Psychoeducation Self-management Programme and treatment-as-usual) over 5 weeks or control (treatment-as-usual) group. Primary outcomes measures which include self-management competence, self-efficacy to manage emotions, mental health quality of life and depressive symptoms severity, will be collected at three timepoints: (T1) baseline, (T2) immediately post-intervention and (T3) three months post-intervention. Quantitative data will be analysed using the Statistical Package for Social Sciences (SPSS) software using non-parametric tests. Secondary outcomes include the feasibility and acceptability of the MPSP. Feasibility of the intervention will be evaluated using pre-defined recruitment, attendance and follow-up rates. Acceptability of the intervention will be evaluated using a semi-structured interview guide based on the Theoretical Framework of Acceptability, immediately post-intervention (T2) or not more than a week from the last session. Data for acceptability will be transcribed verbatim and thematically analysed based on Braun and Clarke's thematic analysis guideline.
|
Inclusion Criteria:
* Clinically diagnosed with Major Depressive Disorder
* Community-dwelling adults aged 21 to 80 years old
* Singaporean or permanent residents
* Literate in the English language
* Willing to be video or audio-recorded during the qualitative interview sessions for acceptability of intervention
Exclusion Criteria:
* Clinically diagnosed with maternal depression
* Clinically diagnosed with cognitive impairment/ intellectual disability
* Pregnant women
* Currently institutionalised in a long-term care facility
* Currently attending other psychoeducation self-management programmes
* Those who do not agree to the audio or video recording.
|
[
0.050406087189912796,
2.7452242374420166,
-1.4924174547195435,
-0.7191995978355408,
0.2824168801307678,
-0.22537972033023834,
-0.01418621838092804,
-0.1508968323469162,
0.34121018648147583,
0.682190477848053,
-0.8564035296440125,
1.676053762435913,
-1.2002795934677124,
0.6627786159515381,
-0.724744439125061,
0.7810733318328857,
0.4278740882873535,
0.07251141220331192,
1.2390997409820557,
-0.11195492744445801,
-0.6115707755088806,
-0.24709977209568024,
-0.4686925411224365,
-0.31588321924209595,
0.24012766778469086,
-0.45908159017562866,
-0.1936582773923874,
1.363345742225647,
-0.34345537424087524,
0.42359742522239685,
-0.4356549084186554,
-0.439223051071167,
0.4785703718662262,
0.7236601114273071,
0.33566564321517944,
0.18975065648555756,
0.545863926410675,
0.2554399073123932,
-0.5089555382728577,
-0.3117740750312805,
0.5389928221702576,
0.6172481179237366,
-0.451183557510376,
0.17802324891090393,
0.37305328249931335,
1.0936421155929565,
-0.6187945604324341,
0.5629526376724243,
-0.6475978493690491,
-0.282380610704422,
-0.052941109985113144,
0.808742880821228,
-0.4956095218658447,
0.2597601115703583,
0.7544082403182983,
0.11545197665691376,
-0.08472070097923279,
0.5657228827476501,
1.091582179069519,
-0.044025979936122894,
0.6099599599838257,
-0.3674856424331665,
0.2940239906311035,
0.36185184121131897,
-0.4099316895008087,
-0.6402828693389893,
0.33433079719543457,
0.08249815553426743,
-0.7809743285179138,
0.38529664278030396,
-0.0005844830884598196,
-0.38296422362327576,
1.159645915031433,
0.286353200674057,
-0.4976934790611267,
-0.38540634512901306,
-0.3961411714553833,
0.5048972964286804,
0.2997754216194153,
-0.07776795327663422,
0.3846868872642517,
0.6843027472496033,
0.5069577097892761,
-0.9888056516647339,
0.41816651821136475,
0.6756333112716675,
-1.0747590065002441,
-0.7390890717506409,
0.3934769332408905,
-0.23366102576255798,
1.0326964855194092,
0.3787024915218353,
-0.7847769260406494,
-0.33127257227897644,
0.09894760698080063,
0.8873423337936401,
0.1880635768175125,
-1.2120579481124878,
-0.565072774887085,
0.019873034209012985,
0.223382830619812,
-0.7534221410751343,
0.2245522290468216,
-0.42384669184684753,
-1.7854061126708984,
-0.7188220620155334,
0.11344286054372787,
-0.17557764053344727,
-0.41942253708839417,
0.36488646268844604,
-0.19621293246746063,
-0.06325038522481918,
0.1730661690235138,
-0.26262810826301575,
1.1369435787200928,
-0.6460996866226196,
0.7637757658958435,
0.24520213901996613,
-0.19644226133823395,
-0.612492024898529,
-0.07507061958312988,
0.9911777973175049,
0.24706199765205383,
-0.43112412095069885,
-0.43064895272254944,
0.6785223484039307,
-0.21522489190101624,
0.1827147901058197,
-0.16638098657131195,
-0.8727186322212219,
-1.0148732662200928,
0.15775801241397858,
0.14462725818157196,
-0.008969088084995747,
-1.561018943786621,
-0.3046073317527771,
-0.12848369777202606,
0.5420493483543396,
-0.7007786631584167,
-0.2933347523212433,
-0.17435838282108307,
-0.15334340929985046,
-0.8818967342376709,
-0.3729901909828186,
-1.0859758853912354,
-0.3610346019268036,
-0.19799718260765076,
0.10802394896745682,
-0.5883880853652954,
-0.3742159307003021,
-0.38640356063842773,
0.1982811540365219,
0.5495725274085999,
0.20205502212047577,
-0.09776845574378967,
0.009689691476523876,
0.03913315385580063,
-0.8246811628341675,
0.10603683441877365,
-1.3486433029174805,
-0.019415514543652534,
-0.27484169602394104,
0.27740591764450073,
-0.3406682312488556,
0.24310056865215302,
0.024853752925992012,
-0.3781438171863556,
0.12742526829242706,
0.15268680453300476,
0.2217128574848175,
0.24353265762329102,
0.6049996018409729,
-0.05211801454424858,
0.20904278755187988,
-0.5223507285118103,
0.22567030787467957,
0.505973219871521,
0.06931141018867493,
0.4554131031036377,
-0.3898897171020508,
-0.4267558753490448,
0.45137783885002136,
-0.05807533115148544,
0.08466990292072296,
-0.39025402069091797,
-0.38921883702278137,
-0.324251651763916,
-0.29609766602516174,
0.08335932344198227,
-0.08806502819061279,
0.5575031042098999,
-0.20304906368255615,
0.36782896518707275,
0.7810978889465332,
-0.2748914361000061,
-0.24485045671463013,
0.13937334716320038,
-0.27624815702438354,
0.4873028099536896,
-0.13322997093200684,
-0.07672789692878723,
0.8925347924232483,
-0.30549994111061096,
0.062003638595342636,
0.11588136106729507,
-0.15783266723155975,
-0.31970325112342834,
-0.20905837416648865,
-0.08020604401826859,
0.17402216792106628,
0.7280829548835754,
0.2741992473602295,
-0.32505080103874207,
-0.08337279409170151,
0.11170171201229095,
0.3323824107646942,
0.6301802396774292,
0.11899259686470032,
-0.513789713382721,
0.05952208861708641,
-0.3351023495197296,
-0.18567976355552673,
0.14155179262161255,
0.05727487429976463,
0.09973792731761932,
-0.5411689281463623,
-0.12376216799020767,
-0.019222449511289597,
0.11614953726530075,
0.06118662655353546,
-0.07021777331829071,
0.0708124041557312,
0.13792820274829865,
-0.10610982775688171,
0.025110572576522827,
0.029283510521054268,
-0.19224153459072113,
0.2592419385910034,
-0.17617695033550262,
-0.0021767672151327133,
0.46420276165008545,
-0.7229815721511841,
0.3636212944984436,
0.12751361727714539,
0.3907579779624939,
-0.339711993932724,
-0.5753434300422668,
0.6586207747459412,
0.18824341893196106,
-0.17298845946788788,
0.1156919002532959,
-0.39104312658309937,
-0.28742191195487976,
0.4013594388961792,
-0.019010230898857117,
-0.5068573951721191
] |
NCT05611619
|
Low Particle Emission and Low Noise Tyres
|
This study will investigate the biological mechanisms linking sleep disruption by noise and the development of disease. In a laboratory sleep study, the investigators will play synthesised automotive tyre sounds, investigating how acoustical characteristics of tyre noise impact on sleep macrostructure, cardiometabolic profile and cognitive performance (continuous traffic flow or a few individual, but higher level, traffic pass-bys). The investigators will also measure objective sleep quality and quantity, cognitive performance across multiple domains, self-reported sleep and wellbeing outcomes, and blood samples. Blood samples will be analysed to identify metabolic changes in different nights. Identifying biomarkers that are impacted by sleep fragmentation will establish the currently unclear pathways by which chronic noise exposure at night can lead to the development of diseases in the long term, especially cardiometabolic disorders.
|
The experimental sleep study has the overarching goal of deepening our understanding of sleep disruption by automotive tyre noise and changes in cardiometabolic and cognitive function. To this end, the study will address the following independent aims:
Aim 1: Determine the biological and neurobehavioural consequences of sleep disruption by tyre noise. The investigators will measure the sleep of healthy volunteers, and each morning the investigators will obtain blood samples for metabolomics analysis and administer a neurocognitive test battery. The investigators will compare effects on sleep, metabolomics and cognitive function between quiet nights and nights with road traffic noise.
Aim 2: Identify acoustical characteristics of tyre noise that are especially disturbing physiologically. The investigators will use different combinations of types of tyre noise in different noise exposure nights to determine differential effects on sleep and cardiovascular response.
This study will take place in the sound environment laboratory (SEL) at the University of Gothenburg Department of Occupational and Environmental Medicine (Arbets- och miljömedicin \[AMM\]). The SEL is a high fidelity research laboratory equipped to simulate a typical apartment, including three individually light-, sound- and vibration-isolated private bedrooms. Ceiling mounted speakers in each room allow the investigators to create a realistic acoustic environment by transmitting sound exposures from the control room to each bedroom individually. The investigators have shown previously that results from this lab with high ecological validity are comparable with results from the field.
There will be two study arms, each one affording the opportunity to investigate different acoustical characteristics of tyre noise and their physiological effects. Each of these study arms has a prospective within-subjects cross-over design. Participants (study 1 N=15; study 2 N=30; total N=45 across both arms) will each spend six consecutive nights in the SEL, with a sleep opportunity between 23:00-07:00. Daytime sleep will be prohibited, confirmed with measures of daytime activity via wrist actigraphy monitors worn continuously throughout the study. Three subjects will take part concurrently, in separate bedrooms. The first night is a habituation period to the study protocol and for familiarisation with the test procedures. Study nights 2-6 are the experimental nights and will be randomly assigned across participants using a Latin square design to avoid first-order carryover effects. Each subject will be exposed to each of the following:
One quiet night: No noise will be played, serving as a control night to assess individual baseline sleep, cardiometabolic profile, and cognitive performance;
Four traffic noise nights: Tyre noise from road traffic noise be played into the rooms to determine the effects of noise on sleep, cardiometabolic function and cognitive performance. These noise nights will be in a 2×2 factorial design so that the investigators can examine each combination of two specific noise characteristics.
Each night the investigators will record physiologic sleep with polysomnography (PSG) and cardiac activity with electrocardiography (ECG). Each study morning, subjects will provide a 4 ml blood sample, complete cognitive testing and answer questionnaires and will depart the SEL to follow their normal daytime routine. They will return to the SEL at 20:00 each evening to prepare for sleep measurements. Caffeine will be prohibited after 15:00 and alcohol will be prohibited at all times. Because extreme and/or variable dietary behaviour can affect the metabolome/lipoprotein profile, participants will be given guidance that they should eat a similar evening meal on each day of the laboratory study, confirmed with a food diary, The actual meal itself can be different for different study participants, because the study has a within-subjects design.
Sleep will be recorded with ambulatory polysomnography (PSG) and cardiac activity with electrocardiography (ECG) and finger pulse photoplethysmogram. Data are recorded offline onto the sleep recorder, and will be downloaded and checked every study morning to ensure data quality. In addition to traditional sleep analysis performed by the research group at the University of Gothenburg, raw PSG data will be used to calculate the Odds Ratio Project, a novel metric of sleep depth and stability.
Each study morning subjects will provide a 4 ml blood sample for plasma metabolomics analysis. To ensure reliable data, blood samples will be taken at the same time every day to mitigate circadian effects, before eating or drinking anything except water, and each sample will be handled in the same way i.e. centrifuged, aliquoted and stored in -80C freezers. Subjects will eat the same food each study evening to mitigate within-subject dietary effects on the blood metabolome.
Each morning, subjects will complete a computerised cognitive test battery taking approximately 20 minutes, that includes 10 tests across a range of cognitive domains (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance). Cognition data will be analysed to determine key measures of cognitive speed and accuracy, adjusting for practice effects and the difficulty of the stimulus set.
Subjects will complete a battery of one-time validated questionnaires to measure their general health (SF-36), chronotype, noise sensitivity, habitual sleep quality, environmental sensitivity, and annoyance and sleep disturbance by noise. Subjects will also answer a questionnaire each study evening and morning, involving questions on sleepiness (Karolinska Sleepiness Scale), sleep disturbance by noise, positive and negative affect (PANAS), and validated sleep and disturbance questions.
Participants will wear a wrist actigraphy monitor continuously throughout the study period, and also for the week before the study, to confirm habitual sleep-wake times and to measure physical activity levels.
|
Inclusion Criteria:
1. live in or around the city of Gothenburg area (Sweden)
Exclusion Criteria:
1. aged \<18 or \>30 years;
2. habitual sleep and wake timings more than ±1 hour different from the study sleep times (i.e. habitual sleep time should be 22:00-00:00 and habitual wake time should be 06:00-08:00);
3. BMI\>25 kg/m2;
4. regular sleep medication use (prescribed or "over-the-counter");
5. poor hearing acuity (measured during screening via pure tone audiometry);
6. diagnosed with sleep disorders;
7. indications of sleep apnea on the STOP-BANG questionnaire;
8. shift work;
9. smoking, vaping, snus, or other nicotine use.
|
[
0.24216358363628387,
2.712341785430908,
-1.207985520362854,
-3.082756996154785,
-0.5325499176979065,
-0.91703200340271,
0.030984656885266304,
-2.9939088821411133,
-1.1348674297332764,
0.5792602896690369,
2.717787504196167,
0.6987444162368774,
-1.8272265195846558,
0.043503157794475555,
-0.4527488946914673,
1.9665683507919312,
-0.42140182852745056,
0.06473241746425629,
1.5939208269119263,
-0.8906039595603943,
0.4962858259677887,
-1.064469814300537,
-0.4028989374637604,
-0.9393491744995117,
0.5712777376174927,
0.46541112661361694,
0.4778226315975189,
1.8451656103134155,
-1.2420750856399536,
1.3043231964111328,
0.8388086557388306,
-1.0637972354888916,
0.3701610565185547,
0.14907711744308472,
-0.2843107581138611,
-0.7420926094055176,
1.2183558940887451,
0.6074657440185547,
-1.2460498809814453,
0.21832627058029175,
-0.19853493571281433,
1.6082760095596313,
0.8830057382583618,
-0.11390218138694763,
-0.28515470027923584,
0.75086510181427,
0.5518922209739685,
0.9699897170066833,
-0.43166011571884155,
-0.22019453346729279,
0.362248957157135,
1.2826749086380005,
-1.12351655960083,
0.2473212033510208,
1.4173717498779297,
0.7510597705841064,
0.8397526741027832,
-0.05847812071442604,
1.3685485124588013,
-0.6401244401931763,
0.441488116979599,
-0.4485291540622711,
0.5585434436798096,
0.8395755887031555,
-0.7881605625152588,
-0.17163243889808655,
-0.04527773708105087,
0.3874223232269287,
-0.7757127285003662,
-0.13635075092315674,
-0.1949659138917923,
0.5843637585639954,
-0.213079035282135,
0.08233658224344254,
0.12022130936384201,
0.25161078572273254,
-0.7991437911987305,
0.8944761753082275,
-0.4329566955566406,
-0.2867746353149414,
-0.6112585663795471,
-0.35994982719421387,
-0.5210789442062378,
-0.13296610116958618,
0.08409704267978668,
-0.08585629612207413,
0.14159171283245087,
-1.102989912033081,
1.119186520576477,
-0.6542141437530518,
0.0928390622138977,
1.105690598487854,
0.054399944841861725,
-0.09290488064289093,
-0.00540955550968647,
-0.005727575160562992,
-0.09198512881994247,
-0.3375924229621887,
-0.9404703974723816,
-0.7179116606712341,
0.17674241960048676,
-0.3376534879207611,
-0.6028309464454651,
0.03998478502035141,
0.33930152654647827,
-0.2768133580684662,
0.2776445746421814,
-0.531501054763794,
-0.3165682852268219,
1.0278626680374146,
0.5571715831756592,
-0.5427349209785461,
-0.607607901096344,
-0.6432000398635864,
-0.8016921877861023,
-0.16936664283275604,
0.9481703042984009,
1.4724137783050537,
0.3125108480453491,
-0.3774435520172119,
0.5599986910820007,
0.6608642935752869,
0.5113049745559692,
0.7360467910766602,
0.3038758337497711,
-0.43692508339881897,
-0.14170172810554504,
-0.8372648358345032,
-0.44452008605003357,
-0.49072521924972534,
-0.37528544664382935,
0.2699461579322815,
0.16563723981380463,
-0.9813718795776367,
-0.014918854460120201,
0.2255205363035202,
0.4958312213420868,
0.5704343914985657,
0.1904754340648651,
-0.23600994050502777,
-0.432496041059494,
-0.24444426596164703,
0.43594205379486084,
0.033778753131628036,
-1.0273923873901367,
0.10558918863534927,
0.09818356484174728,
-0.36155518889427185,
0.08076905459165573,
-0.412199467420578,
-0.2384948432445526,
0.38373541831970215,
0.35754287242889404,
-0.2891277074813843,
-0.009186829440295696,
0.15536555647850037,
-0.18762671947479248,
-0.6513218879699707,
0.6957752108573914,
-0.5402214527130127,
0.22822628915309906,
-0.4080720841884613,
-0.08409880101680756,
0.5190693736076355,
0.4629066288471222,
-0.01776915416121483,
0.45488202571868896,
0.29992783069610596,
0.05049925670027733,
0.5033453106880188,
-0.03047001175582409,
0.48370394110679626,
0.1654185950756073,
0.5229701995849609,
-0.3615639805793762,
-0.16652937233448029,
0.31603196263313293,
0.6504586338996887,
0.16520529985427856,
0.24460376799106598,
-0.5610119104385376,
0.12545669078826904,
-0.7846588492393494,
-0.13010458648204803,
-0.08962807804346085,
-0.24855048954486847,
0.21727612614631653,
-0.26390379667282104,
-0.009823465719819069,
-0.433525949716568,
-0.17855201661586761,
0.66087806224823,
0.35648173093795776,
0.09581943601369858,
-0.20777589082717896,
0.5130822658538818,
-0.2317044883966446,
-0.25852328538894653,
0.09498332440853119,
-0.3390752673149109,
0.012207679450511932,
0.9572618007659912,
-0.3454314172267914,
-0.2570618689060211,
-0.19730974733829498,
-0.26452240347862244,
0.2869756519794464,
0.5623326301574707,
0.32695290446281433,
-0.4995288550853729,
0.564196765422821,
0.3089960217475891,
-0.5932403802871704,
-0.13251309096813202,
0.5666115880012512,
0.18742580711841583,
-0.17988388240337372,
0.13031427562236786,
-0.43587568402290344,
-0.5009303092956543,
-0.12091269344091415,
-0.42743217945098877,
0.12150150537490845,
0.15782876312732697,
-0.6316725611686707,
-0.2829176187515259,
-0.16783374547958374,
0.028757361695170403,
-0.17377008497714996,
0.13804996013641357,
-0.41123685240745544,
0.13348807394504547,
-0.31353864073753357,
-0.14083395898342133,
-0.09865220636129379,
0.3029225468635559,
0.14985474944114685,
-0.03400392457842827,
0.11144688725471497,
0.01698969677090645,
0.19192157685756683,
-0.17011326551437378,
-0.0830102488398552,
0.04198530316352844,
-0.09493087232112885,
-0.2665392756462097,
-0.13786669075489044,
0.3511148989200592,
-0.06352823227643967,
0.0874142274260521,
0.4400348961353302,
-0.6356706023216248,
0.37336504459381104,
0.1655726581811905,
0.22823753952980042,
-0.4984208047389984
] |
NCT02335489
|
A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg
|
14-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of neuropathic pain of the foot and/or lower limb
|
Inclusion Criteria:
1. Subject is at least 18 years old
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Chronic, intractable pain in the foot and/or lower leg for at least 6 months
4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5. Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
6. Subject is able to provide written informed consent
Exclusion Criteria:
1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
4. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months
5. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Subject is unable to operate the device
7. Subjects with indwelling devices that may pose an increased risk of infection
8. Subjects currently has an active infection
9. Subject has participated in another clinical investigation within 30 days
10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
11. Subject has been diagnosed with cancer in the past 2 years.
|
[
0.8654798269271851,
1.3689770698547363,
-3.0854549407958984,
-2.280249834060669,
0.41799676418304443,
-1.478872537612915,
0.16917400062084198,
-0.08122659474611282,
-0.8708670735359192,
-0.3402230143547058,
0.2586714029312134,
2.2873952388763428,
-1.211789608001709,
-0.8443812727928162,
0.5654211044311523,
2.59427547454834,
-0.06449734419584274,
0.16767381131649017,
-0.748406171798706,
-1.009049892425537,
1.0245651006698608,
-0.4245970845222473,
-0.6930773854255676,
-1.1545424461364746,
0.28718239068984985,
0.4285471737384796,
-0.47580665349960327,
1.6285098791122437,
0.30720552802085876,
0.7294059991836548,
-0.516794741153717,
-0.9542773365974426,
0.18215017020702362,
1.0752453804016113,
-0.08313911408185959,
-0.2739681899547577,
0.47627612948417664,
0.8320658802986145,
-0.20290535688400269,
0.07002303749322891,
0.25908979773521423,
0.4330671429634094,
-0.3647971451282501,
1.16441810131073,
0.6028872132301331,
0.7500726580619812,
-0.8921135663986206,
-0.16820688545703888,
-0.21302036941051483,
-0.4309126138687134,
0.14015835523605347,
0.3311026096343994,
-1.3695967197418213,
-1.0759148597717285,
1.5191237926483154,
0.7408754825592041,
1.3650513887405396,
-0.48159316182136536,
0.4507613480091095,
-0.6782521605491638,
0.22713497281074524,
-0.34370940923690796,
0.08918901532888412,
2.2909111976623535,
0.7100438475608826,
0.670637845993042,
-1.5195635557174683,
0.9166626930236816,
-0.26866576075553894,
0.21185150742530823,
0.36525455117225647,
-0.667020320892334,
0.2681187689304352,
-0.23262901604175568,
-0.6263381838798523,
-0.9078816771507263,
-0.40178942680358887,
0.061016034334897995,
1.1235135793685913,
0.039431773126125336,
0.7054936289787292,
-0.8368325233459473,
-2.068108558654785,
0.8764985799789429,
0.49009594321250916,
0.34357723593711853,
-1.2564632892608643,
-1.1563172340393066,
1.0050034523010254,
-0.2909446656703949,
-0.30046749114990234,
-1.431197166442871,
-0.573567807674408,
0.3559224009513855,
-1.2958505153656006,
0.07096243649721146,
0.7753077149391174,
-1.0167722702026367,
-0.7373408675193787,
-0.10669010877609253,
-0.6318145394325256,
-0.0219730194658041,
-0.2575992941856384,
0.23499011993408203,
-0.6279726624488831,
0.7618478536605835,
-0.8656999468803406,
-0.3747468888759613,
0.25734367966651917,
-0.6100984811782837,
0.7280993461608887,
-0.20708392560482025,
-0.2178664207458496,
-0.7893926501274109,
0.22827018797397614,
1.3649524450302124,
0.13322851061820984,
-0.11056599020957947,
1.1406309604644775,
0.08139102905988693,
0.6120321750640869,
1.2551463842391968,
-0.3189947009086609,
0.8776968121528625,
-0.4618721902370453,
-0.1620628982782364,
-0.2538359761238098,
-0.26953113079071045,
-0.6288923025131226,
-0.6101239323616028,
-0.3503153324127197,
0.34296485781669617,
0.18418829143047333,
-0.6805874705314636,
-0.9986498355865479,
0.5824204087257385,
0.014693107455968857,
0.8740493059158325,
-0.3765125274658203,
-0.9953538775444031,
-0.0649629682302475,
0.6578147411346436,
-0.5262969136238098,
-0.6936751008033752,
-0.9571366310119629,
-0.18561656773090363,
-0.1912243664264679,
0.419175386428833,
-1.0901308059692383,
-1.1208194494247437,
-0.4247329831123352,
-1.0399022102355957,
1.2016674280166626,
-0.159888356924057,
-0.034996453672647476,
-0.054653242230415344,
0.6067115664482117,
-0.8800612092018127,
1.2124261856079102,
-1.0633361339569092,
0.04964912310242653,
-0.8063144087791443,
0.24608391523361206,
-0.5995191335678101,
-0.48784950375556946,
-0.31141990423202515,
-1.210432529449463,
-0.4532237946987152,
0.048680540174245834,
0.898674488067627,
-0.8561607599258423,
0.3759334087371826,
-0.25083795189857483,
0.5035194754600525,
0.2883644998073578,
0.2792764902114868,
-0.44301900267601013,
0.16897417604923248,
-0.6810681223869324,
0.46795785427093506,
0.4568585157394409,
0.12857620418071747,
0.058378733694553375,
0.4309545159339905,
-0.38384711742401123,
-0.39434486627578735,
-1.0043962001800537,
-0.43065619468688965,
-0.5746748447418213,
0.36256638169288635,
-0.7109968662261963,
-0.6568338871002197,
0.628873348236084,
0.0007954931352287531,
0.9617831707000732,
0.5237872004508972,
-0.4244144856929779,
-0.6730461120605469,
0.28131064772605896,
-1.0595118999481201,
0.6989567279815674,
0.6831591725349426,
-0.5837681293487549,
-0.0864766538143158,
0.6225342154502869,
0.5188372135162354,
-0.18333131074905396,
-0.39345553517341614,
-0.2104499787092209,
0.33615171909332275,
0.18524068593978882,
0.15159261226654053,
-0.9232415556907654,
-0.28248441219329834,
0.7242952585220337,
0.3184545040130615,
-0.319396048784256,
0.24728387594223022,
-0.4963044226169586,
-0.07218526303768158,
-0.46126365661621094,
-0.7258729338645935,
-0.5997233390808105,
-0.08923698216676712,
0.25633108615875244,
-0.2557699680328369,
-0.4780732989311218,
0.004448208957910538,
-0.07251239567995071,
0.3097133934497833,
-0.42759159207344055,
0.13559511303901672,
0.3562659025192261,
-0.6309138536453247,
-0.5252344012260437,
-0.07424503564834595,
0.2028379887342453,
0.3332871198654175,
-0.3914682865142822,
0.15244698524475098,
0.11323849856853485,
-0.5935994982719421,
-0.04926000535488129,
0.42859718203544617,
-0.3981678783893585,
-0.1327272355556488,
-0.3700489103794098,
-0.1326996386051178,
-0.39212581515312195,
-0.0970383808016777,
-0.29973939061164856,
-0.4435959756374359,
-0.14233818650245667,
0.6827166080474854,
-0.4515896141529083,
-0.23814590275287628
] |
|
NCT01961830
|
Intrapulmonary Pharmacokinetics of ME1100 in Healthy Volunteers
|
This is a single-center, open-label, single-dose study. The primary objective is to determine Epithelial Lining Fluid (ELF) levels of ME1100 after a single orally inhaled dose. The secondary objectives are to determine systemic exposure to inhaled ME1100 and to assess tolerability and safety of a single dose of ME1100 inhalation solution.
|
Inclusion Criteria:
* Male (who are surgically sterile or agree to practice barrier contraception throughout their participation in the study) or Female (using oral, hormonal, or double barrier contraceptive if sexually active, surgically sterile or post-menopausal confirmed by Follicle stimulating hormone(FSH) test)
* Willing to give written informed consent
* 18 to 55 years of age at time of consent Body Mass Index (BMI) of 18-30 kg/m2
* Non-smoker (for at least 6 months prior to screening) and willing to abstain from smoking during the course of the study
* Good general health as determined by medical history, physical examination, Electrocardiogram(ECG) and clinical laboratory tests (including normal renal function and high frequency audiometry)
* Willing to abstain from alcohol, caffeine, and xanthine-containing beverages for 24 hours prior to and 72 hours after dosing.
Exclusion Criteria:
* Uncontrolled, clinically significant disease which in the opinion of the Principal Investigator or Medical Monitor would place the subject at risk through study participation or would confound the assessment of the safety of ME1100 inhalation solution
* Evidence of current or history of respiratory disease, including asthma, emphysema, chronic bronchitis, or cystic fibrosis
* History or current symptom(s) of respiratory tract inflammation within 30 days of Visit 2
* History of hearing, balance or ear disorder or surgery or injury to the ears, or with genetic mutation (\>5.0% heteroplasmy) suggestive of increased risk of hearing loss (MT-RNR1 \[A1555G\] for mitochondrial 12S ribosomal RNA gene or MT-TS1 \[A3243G\] for mitochondrial transfer RNA serine 1)
* History of parent, sibling or parental sibling reporting hearing loss before age 65 years
* History of malignancy
* History of clinically significant alcohol or drug abuse
* History within last 6 months or current use of any tobacco products including e-cigarettes.
* Positive drug screen for drugs of abuse
* Positive test for HIV, Hepatitis B or Hepatitis C
* Use of any prescription or over-the-counter medications (except oral or hormonal contraceptives), herbal supplements, or vitamins within 14 days of Visit 2
* Known hypersensitivity to any aminoglycoside or lidocaine
* Female of childbearing potential with a positive urine pregnancy test, or currently breast feeding.
* Inability to perform reproducible spirometry in accordance with American Thoracic Society (ATS) guidelines
* Abnormal Forced Expiratory Volume in the First Second(FEV1), Forced Vital Capacity(FVC), or FEV1/FVC (FEV1 or FVC \< 80% of predicted or FEV1/FVC ratio \< 0.7)
* FEV1 variability \> 10% between V1 and V2 (prior to dosing)
* Significant blood donation (or testing) in previous 8 weeks before screening.
* Use of any Investigational Product in previous 30 days or 5 half-lives, whichever is longer, preceding start of screening.
|
[
-1.2560460567474365,
1.5712292194366455,
-3.3180928230285645,
-3.4933178424835205,
0.9228159785270691,
1.2381057739257812,
0.7082756757736206,
-0.10196375846862793,
-0.2597063183784485,
0.998271107673645,
0.6137009859085083,
1.617451548576355,
-2.7427561283111572,
-0.2449178546667099,
0.16477249562740326,
0.9484490752220154,
-0.08223218470811844,
0.5608854293823242,
-0.05070933327078819,
-3.133434295654297,
0.7707553505897522,
-0.6245750188827515,
-0.16571730375289917,
0.776028037071228,
2.1767003536224365,
-0.6376281380653381,
0.8643320202827454,
-0.7591046094894409,
-0.9185864329338074,
0.589916467666626,
0.7021092176437378,
0.025555899366736412,
0.3666421175003052,
-0.7607691287994385,
-1.1491339206695557,
0.07937948405742645,
1.8392094373703003,
0.13628485798835754,
0.058692846447229385,
1.0633556842803955,
0.24775905907154083,
0.3187864124774933,
0.5127905607223511,
-1.551756501197815,
0.08262204378843307,
-0.7143287062644958,
-1.5204288959503174,
0.16213807463645935,
-1.062286376953125,
0.2305373102426529,
-1.255109429359436,
0.4512356221675873,
-0.8689688444137573,
0.5872776508331299,
1.8034647703170776,
-0.07487434893846512,
1.23906672000885,
-0.4949827194213867,
1.8223739862442017,
0.3263660669326782,
-0.37657612562179565,
0.13696923851966858,
0.765072226524353,
-1.3838024139404297,
-1.3633959293365479,
1.2227956056594849,
0.6702356934547424,
0.6084831953048706,
-1.4829267263412476,
0.12337565422058105,
-0.757114827632904,
-0.04213443025946617,
0.6518776416778564,
0.19831378757953644,
-0.2866641879081726,
0.8079966306686401,
0.6956682205200195,
0.2995852828025818,
0.6646192073822021,
0.7749965190887451,
-1.6695051193237305,
-0.11854224652051926,
-0.5591582655906677,
-0.8618556261062622,
1.1188993453979492,
0.01273375190794468,
-0.4866371750831604,
0.139579176902771,
-0.12447399646043777,
-0.9472095370292664,
0.005005404818803072,
0.27572646737098694,
-1.489123821258545,
0.23526114225387573,
-0.4028417766094208,
-0.32706549763679504,
0.6025110483169556,
0.9459555745124817,
-1.3864704370498657,
-0.13176605105400085,
0.34064579010009766,
0.010038251988589764,
0.13957060873508453,
0.3674969971179962,
-0.3598818778991699,
-0.5262397527694702,
0.3123936355113983,
0.24732866883277893,
-0.669523298740387,
-1.12321937084198,
0.9202190041542053,
-0.7404771447181702,
0.12159701436758041,
-0.4731229245662689,
0.8424913287162781,
-0.37056344747543335,
-0.2468106895685196,
0.4843537509441376,
-0.22333766520023346,
-1.0292421579360962,
0.5293163657188416,
-0.1218501403927803,
-0.14069296419620514,
0.5551878213882446,
0.3931809961795807,
-0.3259822428226471,
0.45788389444351196,
-0.04970720782876015,
0.1804845929145813,
-0.3237180709838867,
-1.3970723152160645,
0.44974464178085327,
-0.49975138902664185,
1.2745944261550903,
-1.0417406558990479,
-0.08112107217311859,
-0.043640367686748505,
0.6960663199424744,
0.3002857565879822,
0.2548421025276184,
0.07918250560760498,
0.8782687783241272,
-0.29830583930015564,
-0.32037845253944397,
-1.4273368120193481,
0.6771252751350403,
0.02784053608775139,
-0.1062188446521759,
0.2795048654079437,
-0.43441569805145264,
-0.4943923354148865,
-0.38630595803260803,
0.5600230693817139,
-0.8026967644691467,
0.03298928961157799,
0.014524227939546108,
0.8625833988189697,
-0.17210711538791656,
0.07406551390886307,
-0.5086898803710938,
0.3018766939640045,
0.4294498860836029,
-0.7876133322715759,
-1.0968161821365356,
0.791455090045929,
0.8850830793380737,
-0.6911482810974121,
0.14631007611751556,
-0.6984641551971436,
-0.06054235249757767,
-0.6181753277778625,
0.030997365713119507,
0.520698606967926,
0.09663771092891693,
0.7035250067710876,
-0.44491592049598694,
0.5957754850387573,
-0.6026995778083801,
0.04644083231687546,
0.50822913646698,
-0.06214559078216553,
1.079894781112671,
0.15803883969783783,
-0.8096325993537903,
-0.5169350504875183,
-0.3382093906402588,
0.4851550757884979,
-0.3351811170578003,
-0.12654653191566467,
0.9808872938156128,
0.2860947549343109,
-0.05922270566225052,
0.32284557819366455,
1.2418808937072754,
-0.18031786382198334,
-0.7663710117340088,
-0.4269997179508209,
0.6380400061607361,
0.3339015543460846,
-0.12330662459135056,
0.7717069387435913,
-0.12697632610797882,
0.42009758949279785,
-0.035892900079488754,
0.970220685005188,
-0.09975596517324448,
0.35790252685546875,
-0.36959052085876465,
0.505394697189331,
-0.7377467751502991,
0.14410613477230072,
0.04217159375548363,
-0.675300657749176,
-0.15194204449653625,
1.2691919803619385,
0.11954057216644287,
0.0858398899435997,
0.3388770520687103,
-0.5533665418624878,
-0.2713760733604431,
-0.4298747181892395,
-0.2860754728317261,
0.3435281813144684,
0.8882607817649841,
-0.03482918068766594,
-0.6825084686279297,
-0.033848345279693604,
-0.4848536252975464,
-0.614654541015625,
-0.20400744676589966,
-0.3138035237789154,
-0.05902384966611862,
-0.2908279597759247,
-0.026647193357348442,
-0.34144327044487,
0.22149015963077545,
0.3372769355773926,
-0.7891191244125366,
0.054343175143003464,
0.17513012886047363,
0.47054755687713623,
0.1271134465932846,
-1.0943787097930908,
-0.5820414423942566,
0.6166824698448181,
-0.3963221311569214,
-0.08712834864854813,
0.05743805691599846,
0.01930404268205166,
-0.6249907612800598,
-0.16208204627037048,
0.16920267045497894,
0.12071476876735687,
0.7039661407470703,
0.5935844779014587,
-0.1719067096710205
] |
|
NCT02638727
|
Assessment of Short-term Effect of L-Citrulline on Endothelial Function and Vasodilation in Known CAD Patients
|
The purpose of this study is to determine the efficacy of oral L-Citrulline on endothelial function and vasodilation in patients with coronary artery disease(CAD) by evaluating the brachial artery diameter in the antecubital area by ultrasonography.
|
Before prescribing the drug or placebo, the patients were evaluated via the ultrasound machine equipped. The brachial artery diameter in the antecubital area was measured by the ultrasound and was recorded. Then blood pressure cuff was attached on the arm and dilated 50mmhg above the systolic pressure and for 5 minutes remained the same level to induce ischemia at distal tissues until the occurrence of compensatory vasodilatation. Then the brachial artery diameter (as an estimation of FMD) was measured and recorded. After 4 minutes of administration of 2 puffs of nitroglycerin spray, the brachial artery diameter (as an estimation of NMD) was measured.
After 15 days treatment with the L-Citrulline or the placebo, the patients underwent the ultrasonography again and the above assessments were done.
Improvement of FMD to NMD ratio (before L-Citrulline prescription) to FMD to NMD ratio (after L-Citrulline prescription) is determined as "improvement of flow mediated dilation to nitroglycerin dependent vasodilation" evaluate.
|
Inclusion Criteria:
* history of documented CAD; flow mediated dilation to nitroglycerin dependent vasodilation (FMD/NMD)ratio less than 1
Exclusion Criteria:
* no documented CAD; flow mediated dilation to nitroglycerin dependent vasodilation (FMD/NMD)ratio equal /more than 1
|
[
3.6487855911254883,
0.9668604135513306,
-2.4457263946533203,
-3.478344440460205,
-0.9054108262062073,
-0.8307592868804932,
0.8346753120422363,
1.0754022598266602,
-3.5863208770751953,
0.7576112151145935,
1.1537960767745972,
0.3903980255126953,
-0.4043080806732178,
0.8156620264053345,
0.07977338135242462,
1.7292180061340332,
0.4520561993122101,
0.5976049900054932,
0.5690612196922302,
-1.3079756498336792,
1.440140724182129,
-0.43828579783439636,
0.32671743631362915,
-0.17167744040489197,
1.45844304561615,
-1.7009104490280151,
1.7248237133026123,
-1.169558048248291,
0.16474664211273193,
1.7130359411239624,
1.2403582334518433,
-0.537844717502594,
-1.3891395330429077,
1.51919424533844,
0.250349223613739,
-1.3696620464324951,
1.6416651010513306,
-0.26355695724487305,
-0.2659521698951721,
0.780441164970398,
0.716023862361908,
0.7108582854270935,
-0.10297141224145889,
1.1005451679229736,
1.735487461090088,
-0.06763645261526108,
-0.6342991590499878,
-0.4054102301597595,
1.3178746700286865,
0.5392035245895386,
-1.0156195163726807,
1.4351696968078613,
-0.39633873105049133,
-0.585763156414032,
0.3352073132991791,
0.6677549481391907,
0.8029651641845703,
-0.1507074236869812,
1.5976020097732544,
0.5753276944160461,
-0.6634330749511719,
0.03392519801855087,
0.744848906993866,
-0.15953123569488525,
-0.7744867205619812,
0.8836858868598938,
-0.2725682854652405,
0.21321740746498108,
-1.2312434911727905,
-0.8591316938400269,
0.7296007871627808,
0.9045465588569641,
0.6964804530143738,
0.2543037235736847,
0.048112425953149796,
1.0133473873138428,
-1.1020395755767822,
0.7679603695869446,
1.1090586185455322,
-0.0504954531788826,
-1.1979665756225586,
0.5802716612815857,
-1.1942013502120972,
-0.5432907938957214,
0.3123851716518402,
-1.015463948249817,
-1.550752878189087,
-0.6692877411842346,
1.669748067855835,
-2.5079846382141113,
0.34282931685447693,
-0.06580023467540741,
-1.2648972272872925,
0.22610938549041748,
-0.29762911796569824,
-0.023815885186195374,
-0.4703754782676697,
-0.3787606358528137,
-1.3753284215927124,
-0.940738320350647,
-1.5871886014938354,
0.2811565399169922,
0.4993473291397095,
1.1456869840621948,
0.32296377420425415,
-0.34893515706062317,
0.7490725517272949,
0.5460190176963806,
-0.38575297594070435,
-1.0516139268875122,
1.223658800125122,
-0.8870940208435059,
-0.098124660551548,
-0.09545272588729858,
-0.2028992474079132,
0.1830545961856842,
0.19988200068473816,
1.1759847402572632,
-0.17670631408691406,
-0.5365169644355774,
-0.15685835480690002,
0.625594437122345,
0.9404920935630798,
1.4385275840759277,
-1.1486053466796875,
-1.1082406044006348,
-1.1216893196105957,
0.7071628570556641,
-0.4033189117908478,
-0.8603729009628296,
-0.7011884450912476,
-0.058706432580947876,
-0.010795095935463905,
1.0827553272247314,
-0.7741673588752747,
0.29687055945396423,
0.037714362144470215,
0.7169021964073181,
-0.9091013669967651,
-0.481113463640213,
-0.9914371967315674,
0.3648096024990082,
0.02192322164773941,
0.3595799505710602,
-2.0295581817626953,
-0.22716295719146729,
-0.24529913067817688,
0.4115574061870575,
-0.22836753726005554,
-0.1982281655073166,
0.7315829992294312,
0.8490563631057739,
0.42171043157577515,
0.3013051748275757,
-0.2488149255514145,
0.6903117895126343,
-0.17350786924362183,
-0.4709914028644562,
-0.18205256760120392,
-0.15399786829948425,
-1.095002293586731,
-0.9479431509971619,
0.0732048973441124,
-0.539653480052948,
0.7287206053733826,
-0.29434630274772644,
-0.5137251615524292,
-0.1468244194984436,
0.41920214891433716,
0.20627759397029877,
-1.1771960258483887,
0.10043197125196457,
0.0879308208823204,
0.5615545511245728,
-1.1418659687042236,
0.9240898489952087,
0.3268846273422241,
0.08396165072917938,
-0.3213099539279938,
-0.4750809371471405,
-0.12763921916484833,
0.850685179233551,
0.4084475338459015,
0.03160672262310982,
0.4702688157558441,
-0.4847114384174347,
-0.11463432013988495,
-0.38945794105529785,
0.05356958135962486,
0.43155187368392944,
0.2622804045677185,
0.05021117627620697,
-0.5516699552536011,
0.28990212082862854,
-0.024693701416254044,
-0.04479169473052025,
0.22322899103164673,
-0.615062952041626,
0.6030343174934387,
-0.5284915566444397,
0.07483493536710739,
-0.12142639607191086,
-0.8714197874069214,
0.4629904329776764,
-0.05686754733324051,
-0.20043885707855225,
0.12461964786052704,
-0.18872854113578796,
-0.04047350957989693,
0.6504020690917969,
0.4228123426437378,
-0.10831727832555771,
0.3700157403945923,
-0.4227522909641266,
1.0194171667099,
0.5463380217552185,
-0.18738815188407898,
-0.5983718633651733,
-1.1979014873504639,
-0.35241827368736267,
-0.6369648575782776,
-0.3867291212081909,
-0.003040131414309144,
0.12680839002132416,
0.4179249405860901,
-0.32328155636787415,
-0.401845246553421,
0.13761469721794128,
-0.39686816930770874,
-0.03266751021146774,
-0.7128066420555115,
-0.03931988403201103,
0.0251119714230299,
-0.30202174186706543,
0.15358076989650726,
0.3402659595012665,
0.4984172284603119,
0.35358139872550964,
0.11502846330404282,
-0.061190392822027206,
-0.050998758524656296,
0.16189159452915192,
0.49283626675605774,
-0.06457606703042984,
-0.011867673136293888,
-0.03766099736094475,
-0.3071948289871216,
0.0445181168615818,
-0.1796872764825821,
0.37250223755836487,
-0.6927719116210938,
-0.5246352553367615,
0.241936594247818,
-0.1265314370393753,
-0.04698074609041214,
-0.2987811863422394
] |
NCT05451706
|
Improving College Students' Mental Help-Seeking Intention During the COVID-19 Pandemic
|
This study aimed at testing the effectiveness of a longitudinal intervention in increasing college students' intention to seek mental help during the pandemic.
|
This study aimed at testing the effectiveness of a longitudinal intervention in increasing college students' intention to seek mental help during the pandemic.
A four-armed randomized controlled experiment was conducted to compare two self-persuasion methods against two control conditions. Assessments took place at baseline (T0), post-first treatment (T1), post-second treatment (six weeks, T2), and ten-week follow-up (T3).
The results showed that the intervention significantly increased students' help-seeking intention, attitude, and efficacy at different time points. It also reduced mental help-seeking-related stigma after the first task.
|
Inclusion Criteria:
* 18 years old or older
* Full-time undergraduate students
* Had more than a moderate amount of mental distress
Exclusion Criteria:
* Under 18 years old
* Not full-time undergraduate students
* Had less than a moderate amount of mental distress
|
[
-2.8989486694335938,
5.919167518615723,
-2.9292943477630615,
-2.953681707382202,
-0.9065344929695129,
-2.8928658962249756,
-0.2538202106952667,
0.13121946156024933,
0.03645635023713112,
0.025905326008796692,
-0.8218072056770325,
1.1569446325302124,
-4.254753589630127,
1.5600264072418213,
-0.3454502522945404,
2.2111082077026367,
0.1015917956829071,
-0.3783557116985321,
1.5218422412872314,
0.7237401604652405,
1.4474934339523315,
-0.37210655212402344,
0.6339987516403198,
0.35454824566841125,
2.6522722244262695,
1.073397159576416,
-1.9445463418960571,
2.270437479019165,
-0.9948104023933411,
2.37762451171875,
-0.8635914325714111,
-0.7896888852119446,
0.05854611471295357,
0.18002672493457794,
1.2004048824310303,
-0.4914108216762543,
-0.252035915851593,
0.7182480096817017,
-1.1678626537322998,
0.6603156328201294,
-0.8174720406532288,
1.784630298614502,
-0.18647348880767822,
1.5214978456497192,
1.214051365852356,
1.8390839099884033,
0.6413797736167908,
-0.14142224192619324,
-1.3892689943313599,
2.267653465270996,
-0.8464991450309753,
1.21890389919281,
-0.6839873194694519,
-1.4050302505493164,
2.2132272720336914,
-0.40558311343193054,
-0.2353350818157196,
0.016757642850279808,
2.1333775520324707,
0.028803613036870956,
-0.0066209519281983376,
-0.37751972675323486,
0.5296363234519958,
1.0115925073623657,
-1.2997398376464844,
-1.0688978433609009,
0.29713261127471924,
0.6851712465286255,
-0.638363778591156,
0.3659016788005829,
1.6817376613616943,
1.470362901687622,
1.1929618120193481,
-0.007108299992978573,
-0.5841217637062073,
-1.367095708847046,
1.133933424949646,
1.621631383895874,
1.4800714254379272,
1.6026558876037598,
-0.34010300040245056,
0.9679036140441895,
-0.8891754150390625,
-1.113784670829773,
1.684433102607727,
-1.1614469289779663,
-0.06483662128448486,
0.22656963765621185,
1.0893789529800415,
0.22058385610580444,
0.9447190761566162,
0.7242381572723389,
-0.5189815163612366,
-0.07619035989046097,
0.23673869669437408,
1.80604088306427,
-0.5946183800697327,
-1.4573562145233154,
-0.24110113084316254,
0.06917153298854828,
0.3270309269428253,
-0.4107770323753357,
-1.557913899421692,
1.1197909116744995,
-1.149323582649231,
-0.2514253854751587,
-0.6942917704582214,
0.16246174275875092,
0.20433492958545685,
0.3779568076133728,
-0.8938222527503967,
-0.9703982472419739,
-1.318590760231018,
0.3922620713710785,
0.14516259729862213,
-0.8164764046669006,
1.5535212755203247,
0.6704686284065247,
0.2359105795621872,
-0.7819161415100098,
2.2411041259765625,
1.040088415145874,
0.9144784212112427,
-0.5312849879264832,
-1.6773123741149902,
-0.38466647267341614,
-1.0553383827209473,
-1.1009423732757568,
-0.5798202157020569,
-1.347427248954773,
-0.7259224653244019,
-0.3122592568397522,
0.26512420177459717,
0.14620588719844818,
-0.39073845744132996,
-0.8556643724441528,
0.2762766480445862,
0.7020042538642883,
-0.39858660101890564,
-0.5407214760780334,
0.30170390009880066,
-0.054386526346206665,
0.6073678135871887,
-0.7635917663574219,
-1.8857589960098267,
-0.7811370491981506,
0.5074915885925293,
-1.2628847360610962,
-0.7098433375358582,
-0.32169756293296814,
-0.45614859461784363,
2.17767596244812,
1.4931734800338745,
1.185782790184021,
-0.6157947182655334,
-0.16859276592731476,
0.3532449007034302,
-1.338610053062439,
1.0928447246551514,
-0.6291137933731079,
1.1881240606307983,
-0.6236778497695923,
-0.5163172483444214,
-0.2201084941625595,
1.1171272993087769,
-0.914469301700592,
-0.35814401507377625,
1.0748306512832642,
0.5528430342674255,
-0.18089956045150757,
-1.2137186527252197,
-0.14238989353179932,
-0.13171860575675964,
0.005926822777837515,
0.7987248301506042,
0.16972334682941437,
-1.2412562370300293,
-0.4282546639442444,
0.9214099645614624,
0.780698835849762,
-0.5060920715332031,
0.16522301733493805,
-0.39792612195014954,
0.7354315519332886,
0.14220112562179565,
-0.8169705271720886,
-1.2727867364883423,
-0.25212129950523376,
0.38231754302978516,
-0.11956464499235153,
0.4947524964809418,
-0.8899256587028503,
-0.16874922811985016,
-0.4454643428325653,
0.5685747265815735,
0.5331026911735535,
-0.9310232996940613,
0.1196403056383133,
0.40369266271591187,
-1.5738496780395508,
0.9840549230575562,
1.5220977067947388,
-0.46101588010787964,
-0.059254102408885956,
0.5670741200447083,
-0.10677224397659302,
0.36749759316444397,
-0.7232544422149658,
0.21172240376472473,
1.129798173904419,
-0.7939610481262207,
-0.05873144418001175,
0.16170580685138702,
-0.19549447298049927,
0.3656587302684784,
-0.0814180076122284,
0.45366761088371277,
-0.2061288058757782,
-0.26632586121559143,
-0.4275630712509155,
-1.361200213432312,
-0.8844001889228821,
-0.39017295837402344,
0.9973281025886536,
-0.06966529786586761,
0.2427012175321579,
-0.5502972602844238,
0.04212315008044243,
0.6631910800933838,
-0.34917697310447693,
-0.027317466214299202,
0.2749129831790924,
-0.08695068210363388,
0.4774830639362335,
0.633300244808197,
-0.25722798705101013,
1.3126306533813477,
-0.5917860865592957,
0.23745505511760712,
0.6182895302772522,
0.5922558903694153,
0.16956965625286102,
-0.1408567875623703,
0.1005796492099762,
-0.34801456332206726,
0.42561790347099304,
-0.2278718799352646,
-0.01379541028290987,
0.26125624775886536,
0.7851963639259338,
-0.31337153911590576,
-0.06467556208372116,
-0.5133503675460815,
-0.4980003833770752,
-0.15863542258739471,
-0.2800702452659607
] |
NCT03562065
|
Treatment of Refractory Systemic Lupus Erythematosus by Allogeneic Mesenchymal Stem Cells Derived From the Umbilical Cord
|
Systemic lupus erythematosus (SLE) is a rare (prevalence: 40- 50/100 000 persons) heterogeneous auto-immune and auto-inflammatory disease (AD), affecting both sexes and all races, with a peak incidence / prevalence among black people and a predilection for women in the 3rd-4th decade of life. SLE is characterized by successive periods of flares and remission, which may all vary in duration and quality. Prognosis of severe forms of SLE, which affect lung, heart or brain in addition to renal involvement, has improved, but still evolution remains pejorative in a subset of patients whose 10 years mortality remains 10-15%, even in tertiary referral centers. For 20 years, no new prospective clinical trial in the course of SLE has demonstrated its effectiveness. New biological therapies have not yet made the long awaited breakthrough in the treatment of severe SLE and only anti-Blys monoclonal antibody has gained indication in moderately active SLE. In addition, serious adverse side effects (progressive multifocal leukoencephalopathy) observed with several biologics in AD patients has dampened their expected benefits. For SLE subjects resistant to 1er or 2nd line conventional treatment, there is a need to develop more effective therapies with fewer long term side effects, based on new immunomodulatory and immunosuppressive strategies.
According to their in vitro immunomodulatory properties and ability to induce tissue repair mechanisms, mesenchymal stem cells (MSC) have been proposed as a new therapy for several AD, including SLE. The use of allogeneic umbilical cord-derived MSC is based on experimental and human clinical data, particularly produced by Nanjing team (Pr Sun) in China. It is also logical to select SLE patients with the same severity criteria as those used worldwide to validate the efficacy of anti-Blys therapies. Similarly, the analysis of the expected results should take into account criteria similar or comparable to those used for the pivotal clinical trials. This trial is a unique opportunity to set up collaboration between Saint-Louis APHP, clinical expert center for cell therapy in AD, and University College London for cell manufacturing.
|
Inclusion Criteria:
* Age \> 18 years and \< 70 years.
* Diagnosis of Systemic Lupus Erythematosus (SLE) according to the ACR criteria with positive antinuclear antibodies.
* Subjects with sustained disease activity defined by a SELENA- SLEDAI SLE activity index ≥ 6 at baseline,
* Inefficacy or adverse effects necessitating discontinuation of first and second line therapies of SLE including:
a. Prednisone orally ≥ 6 mg / day (or equivalent) for at least 28 days. b. At least one or more of the following immunosuppressive therapies for 3 months in total: i- Cyclophosphamide, iv bolus ≥500 mg / month for 3 months minimum ii- Mycophenolate mofetil, orally or equivalent at a dose\> 2000 mg / day for at least 90 days iii- Azathioprine orally at a dose\> 2 mg / kg / day for at least 90 days; iv- Methotrexate orally or parenterally, at doses \> 20mg / week for at least 90 days; v- Leflunomide orally, at a dose of\> 10-mg / day for at least 90 days; vi- Rituximab (anti-CD20) intravenous bolus 375 mg / m2, once a week for four weeks or total dose of 1 g twice a day for two weeks vii- Cyclosporine orally, at a dose of 2.5-5 mg / kg / day, for at least 90 days; viii- Belimumab intravenously at monthly bolus of 10 mg / kg infusion), for at least 3 months.
* Patient who received treatment of SLE at stable doses for a minimum of 30 days prior to eligibility, including one of the following treatments: prednisone (or equivalent) alone or combined with antimalarial treatment, an anti-inflammatory steroidal and / or an immunosuppressant.
* Negative pregnancy test for women of childbearing age.
* For men and women : Using effective contraceptive methods during treatment and within 3 months after the end of treatment for men with her partner of childbearing age
* Signed Informed Consent.
* Affiliation to social security.
Exclusion Criteria:
1- Pregnancy, breastfeeding or lack of appropriate contraception during study duration
* Presence of:
1. Renal failure: calculated creatinine clearance of \<30 ml / min
2. Cardiac failure: clinical signs of congestive heart failure; left ventricular ejection fraction \<40% on echocardiography; uncontrolled ventricular arrhythmia;
3. Hepatitis defined by abnormal levels of transaminases (AST, ALT\> 2 x normal) not related to disease activity.
4. Respiratory disease: mean PAP\> 50 mmHg (echocardiography), respiratory failure defined by a resting blood pressure of oxygen at PaO 2 \< 70 mmHg and / or PaCO2 \> 50 mmHg without oxygen
* Severe psychiatric disorders, including severe psychosis related to SLE, which would prevent to give informed consent or to undergo the procedure.
* Active neoplasia or concomitant myelodysplasia, except for basal cell carcinoma or squamous cell carcinoma or in situ cervix carcinoma.
* Bone marrow failure defined by neutropenia \<0.5.109/L, thrombocytopenia \<30. 109 / L, anemia \< 8 g / dL, lymphopenia CD4 + \<200 x 106 / L caused by another disease than SLE.
* Acute or chronic uncontrolled infection: HIV 1/2, HTLV-1/2, Hepatitis B (HBsAg surface antigen), Hepatitis C with positive PCR
* Patient having received belimumab within 2 months of belimumab within 2 months of Baseline, or having received rituximab or other B cell depleting biologic therapy within 6 months of Baseline
* Current substance abuse or recent (within 60 days) history of substance abuse
* Patient in periods of exclusion from the national roster of researchers
* Patient with Linguistic or psychological incapacity to sign informed consent
* Patient already included in another study at the same time.
* Poor patient compliance.
* Patient under legal protection.
|
[
0.01651797816157341,
1.3719009160995483,
-2.2326884269714355,
-1.336181879043579,
0.13226944208145142,
0.2444942146539688,
-0.580475389957428,
-0.002059793099761009,
-1.0242663621902466,
0.007607456762343645,
0.5764464735984802,
1.1558425426483154,
-0.7698817849159241,
0.05280588939785957,
-0.6490867137908936,
0.12345857173204422,
-0.4322814345359802,
0.19951924681663513,
0.8479042053222656,
-1.5098925828933716,
0.32842710614204407,
0.31088799238204956,
0.1391526609659195,
-0.05644364655017853,
1.2083224058151245,
-0.5771555304527283,
-0.7718061208724976,
0.8705042004585266,
-0.08100640773773193,
0.9398869276046753,
-0.25832629203796387,
-0.927786111831665,
0.545156717300415,
0.13835358619689941,
0.32432836294174194,
-0.0402509979903698,
0.2558777928352356,
0.17918451130390167,
-0.7513679265975952,
-0.2739897072315216,
0.35178786516189575,
0.20031282305717468,
-0.301614373922348,
-0.32228541374206543,
0.6811132431030273,
-0.5762760043144226,
-0.10700036585330963,
0.08182041347026825,
0.30906352400779724,
0.6085141897201538,
-0.1406194567680359,
0.6776584982872009,
-0.6579943299293518,
0.22395168244838715,
0.858283519744873,
0.7424138188362122,
0.10661768913269043,
0.8549586534500122,
0.7207421064376831,
0.010012692771852016,
0.9682764410972595,
0.47107067704200745,
0.07396341115236282,
0.6988523006439209,
-0.5677195191383362,
-0.14525961875915527,
-0.027220534160733223,
0.4499594569206238,
-0.4217457175254822,
-0.07697571814060211,
0.24198347330093384,
-0.4190509617328644,
0.3559925854206085,
-0.0943414643406868,
-0.4908873736858368,
0.5697984099388123,
0.11209701001644135,
0.38930878043174744,
0.5141575932502747,
-0.41772836446762085,
-0.07039858400821686,
-0.6540741324424744,
-0.6104307770729065,
0.1368696391582489,
-0.0009537076693959534,
-0.8352389335632324,
-0.795009434223175,
-0.8455173373222351,
0.2519334554672241,
-0.5078322291374207,
0.5015926957130432,
-0.25913676619529724,
-0.7846553325653076,
0.5857945680618286,
0.44067123532295227,
-0.1530729979276657,
-0.2977812588214874,
-0.3074164092540741,
-0.8360121250152588,
-0.2702735364437103,
-0.040130168199539185,
-0.2806108891963959,
-0.547491192817688,
-0.03496270254254341,
-0.09269137680530548,
0.1631903350353241,
-0.563437283039093,
-0.6849167943000793,
-0.6835353970527649,
-0.6747242212295532,
0.050001952797174454,
-0.8957559466362,
0.08341076225042343,
-0.6320969462394714,
0.6834171414375305,
-0.15633641183376312,
0.7351685762405396,
-0.35700538754463196,
-0.1039070412516594,
-0.1343533992767334,
0.1105135828256607,
1.0749907493591309,
0.14418773353099823,
0.3112037479877472,
-0.418165922164917,
-0.35697177052497864,
-0.1229473203420639,
0.5360392332077026,
0.038261983543634415,
-0.09858746826648712,
-0.5220702886581421,
0.5025874972343445,
0.20642736554145813,
-0.5730781555175781,
-0.9002891778945923,
-0.4151497483253479,
0.0866658017039299,
0.8846551775932312,
0.11866053938865662,
-0.4765593707561493,
-0.0994635820388794,
-0.14063522219657898,
0.33221858739852905,
0.44217947125434875,
-0.4726305902004242,
0.20574578642845154,
0.055577073246240616,
0.6631096601486206,
-0.5587222576141357,
-0.3107258081436157,
0.14140285551548004,
0.28601983189582825,
0.2283404916524887,
0.291069358587265,
0.046313293278217316,
0.5920851826667786,
0.289311021566391,
0.10661900043487549,
0.6498940587043762,
-0.28295642137527466,
-0.37929418683052063,
-0.3227815330028534,
0.16629083454608917,
-0.2708349823951721,
0.7455919981002808,
0.13633741438388824,
0.5281275510787964,
-0.26756271719932556,
0.1608525961637497,
0.0998249500989914,
-0.33350566029548645,
-0.42399924993515015,
0.0634651854634285,
0.40252259373664856,
-0.5526642799377441,
-0.043398868292570114,
0.5197926163673401,
0.32065296173095703,
0.13323302567005157,
0.035448793321847916,
0.046438757330179214,
-0.3882400393486023,
0.2345999777317047,
-0.06262199580669403,
0.0908084586262703,
-0.2766059935092926,
-0.2580259144306183,
-0.058194197714328766,
0.03482220321893692,
0.25024452805519104,
0.12391846626996994,
-0.06375723332166672,
0.397614449262619,
0.2988194525241852,
0.009640520438551903,
0.14549770951271057,
-0.0943688303232193,
0.10812176018953323,
0.6093607544898987,
0.061388690024614334,
0.3086969256401062,
0.576309859752655,
-0.05170157551765442,
0.07230734080076218,
0.06152311712503433,
-0.4822312593460083,
-0.11052603274583817,
0.06863376498222351,
-0.08646544069051743,
0.1827378273010254,
0.39962661266326904,
-0.38577529788017273,
0.15762384235858917,
-0.08585154265165329,
0.26952165365219116,
0.5683520436286926,
-0.057735756039619446,
0.18790903687477112,
-0.4383709132671356,
0.1538373976945877,
-0.06912515312433243,
0.1776891052722931,
-0.1204281896352768,
-0.21144621074199677,
-0.16179127991199493,
0.002271349309012294,
-0.166807159781456,
0.15979647636413574,
0.33050742745399475,
-0.20994503796100616,
-0.14837810397148132,
0.15331164002418518,
0.14390172064304352,
-0.17609205842018127,
-0.19750480353832245,
-0.058338139206171036,
-0.17260262370109558,
-0.023572860285639763,
-0.3577859699726105,
0.04014403000473976,
0.18090280890464783,
-0.2766333818435669,
0.00014100316911935806,
-0.08261504024267197,
0.10924021154642105,
-0.24418316781520844,
0.03250662609934807,
-0.11059986799955368,
0.023607434704899788,
-0.06916451454162598,
-0.10683699697256088,
-0.11881807446479797,
0.2584693729877472,
0.015231730416417122,
0.07242099940776825,
-0.34246331453323364
] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.