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#Study Description
Brief Summary
The aim of the present study is to evaluate the adjunctive effect of glycine-powder air-polishing (GPAP) to full-mouth ultrasonic debridement (Fm-UD) in the treatment of peri-implant mucositis, and to determine the predictive role of implant and patient-level variables for disease resolution. Both treatments are described in the literature, but few studies are available on their comparison.
Detailed Description
52 patients (132 implants) with peri-implant mucositis were included in this randomized parallel arm clinical study. Following baseline variables assessment, participants received Fm-UD. Implants allocated to the test group (n=64) were additionally treated with GPAP. Clinical outcomes were evaluated at 3 and 12 months following intervention. Complete and partial disease resolution were defined as absence of BoP (DR1) or \<2 BoP+ sites (DR2), respectively.
#Intervention
- DEVICE : Glycine powder air polishing
- Peri-implant mucositis sites treated with a glycine powder air polishing device (Air-Flow Master Piezon®).
- DEVICE : Full mouth ultrasonic debridement
- Peri-implant mucositis sites are treated with thin ultrasonic tips. | #Eligibility Criteria:
Inclusion Criteria:
* age between 18 and 70 years;
* presence of one implant loaded at least one year before;
* bleeding on probing and/or suppuration of the peri-implant mucosa;
* pain and/or tenderness of the peri-implant mucosa;
* good general health conditions.
Exclusion Criteria:
* radiographic bone loss >= 2mm;
* intake of anticoagulants, antiplatelet, antibiotic or cortisone drugs;
* inability to perform oral hygiene maneuvers.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT05801315 | {
"brief_title": "Non-surgical Treatment of Peri-implant Mucositis: FMUD vs FMUD and Air-Flow Master Piezon®",
"conditions": [
"Peri-implant Mucositis"
],
"interventions": [
"Device: Glycine powder air polishing",
"Device: Full mouth ultrasonic debridement"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT05801315",
"official_title": "Treatment of Peri-implant Mucositis: Adjunctive Benefit of Glycine Powder Air Polishing Device to Professional Mechanical Biofilm Removal. A Randomized Parallel Arm Clinical Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-20",
"study_completion_date(actual)": "2023-03-20",
"study_start_date(actual)": "2020-03-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-07-27",
"last_updated_that_met_qc_criteria": "2023-03-23",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-04-06",
"first_submitted": "2020-03-04",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
When carrying out a knee replacement operation one of the goals is to correct any deformity of the leg (bowlegged or knock kneed). The ideal alignment is the mechanical axis, which is a line from the centre of the hip joint to the centre of the ankle. This line indicates how the weight of the body is transmitted to the ground via the leg. Often the planning for a knee replacement uses an Xray which shows the hip, knee and ankle (HKA Xray) so that the mechanical axis can be drawn on.
However, the weight of the body goes to the ground from the ankle through the heel. There have been some reports recently suggesting that deformities in the heel can influence the overall leg alignment after a knee replacement; this may affect how successful the surgery is, or how long the knee replacement will last. Therefore it may make sense to take the alignment of the leg including the heel in planning for a knee replacement.
The conventional practice to assess the alignment of the heel is a hindfoot alignment view (HAV) Xray. This only shows the foot. Having two separate Xrays means more radiation exposure and makes linking the two alignments very difficult. We propose a single novel Xray extending the HKA Xray to shows hip, knee, ankle and heel (HKAH Xray) enabling measurement of both alignments.
This study is to validate the hindfoot alignment seen on the novel Xray with the standard HAV. Patients undergoing a knee replacement will be enrolled. Patients will have both a HKAH and HAV Xray before surgery. The alignment of the heel measured on the HKAH Xray will be compared with the standard HAV to see if it is accurate.
Detailed Description
Patients going on the waiting list for TKR at our hospital will be enrolled prospectively.
Each patient will have two radiographs preoperatively. One radiograph will be the novel HKAH radiograph to measure the alignment of the heel to the whole leg and the other will be the HAV radiograph which will be used as the standard to which the HKAH measure of alignment will be compared. The HKAH radiograph will be taken instead of the standard care HKA radiograph and the HAV is additional to standard care.
Each participant will receive an information sheet along with the outpatients appointment letter which is dispatched approximately a week in advance of their appointment date. This will carry information about the study, and the risks (one additional radiograph).
Participants who are going to have a knee replacement will have a written \& informed consent to take part in the study. If they agree then they will have an additional radiograph before surgery. If they don't agree then they will have a single radiograph before surgery as is the norm in our hospital.
Whether they take part or not will have absolutely no bearing on the treatment they receive, or the aftercare.
#Intervention
- RADIATION : Hindfoot alignment view x ray
- Diagnostic x rays used to measure leg alignment. | #Eligibility Criteria:
Inclusion Criteria:
* Predominant knee osteoarthritis requiring total knee replacement
* Able to give informed consent
* Able to return for 6 week follow-up
Exclusion Criteria:
* Advanced osteoarthritis in other lower limb joint(s)
* limb length discrepancy requiring a shoe-raise
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02583503 | {
"brief_title": "Hindfoot Alignment in Total Knee Replacement",
"conditions": [
"Osteoarthritis"
],
"interventions": [
"Radiation: Hindfoot alignment view x ray"
],
"location_countries": null,
"nct_id": "NCT02583503",
"official_title": "Hindfoot Alignment in TKR - Validation of a Novel Radiographic Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06-28",
"study_completion_date(actual)": "2016-06-28",
"study_start_date(actual)": "2015-12-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-03-01",
"last_updated_that_met_qc_criteria": "2015-10-20",
"last_verified": "2015-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-10-22",
"first_submitted": "2015-09-01",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The Minimed®640G system (MM640G) consists of a combination of insulin and glucose sensor for continuous glucose monitoring (CGM). Here, the glucose sensor transmits not only the continuous glucose data on the display of insulin pump but, in the case of hypoglycemia also interrupt their insulin delivery of pump. In the currently available system Paradigm®VEO, the interruption takes place at a settled threshold level. In difference in the new system MM640G the shutdown algorithm can already be proactive and help avoid hypoglycemia completely. The so called PLGM algorithm (predictive low glucose management) should be tested in the user evaluation. The main objective is to answer the question of reducing the rate of hypoglycemia by application of the new PLGM algorithm.
Included are a total of 24 patients, aged 1-21 years, in three pediatric diabetes centers.
Detailed Description
In the first phase of two weeks, the sensor-augmented pump therapy (SaP) is carried out without these interruption PLGM algorithm. In a second phase for 6 weeks, the PLGM function is set. Both phases are compared in terms of the rate of hypoglycemia, the time spent and the area under the curve (AUC) glucose range (values \<70 mg / dl (3.9 mmol / l)).
#Intervention
- DEVICE : Minimed®640G system
- Sensor augmented insulin therapy with and without use of Predictive low glucose management (PLGM) | #Eligibility Criteria:
Inclusion Criteria:
* type 1 diabetes, diagnosed since 12 month at least
* continuous subcutaneous insulin infusion (CSII) since 3 month at least
* stable outcome since 3 month at least
* willingness of patients/ parents to wear a glucose sensor for 2 month
* willingness of patients/ parents to use the Minimed®640G system
* willingness of patients/ parents to complete a diary
* willingness of patients/ parents to comply the requirements of the study protocol
Exclusion Criteria:
* longer absence of the patients (not able to attend the study visits)
* subject with allergy of sensor or specific sensor components
* communication problems
* significant history of eating disorder, anorexia, bulimia
* pregnancy
* significant history of drug abuse or/ and alcoholism
* patient do not want to attend the trial
* missing informed consent
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT02325193 | {
"brief_title": "MiniMed 640G System' User Evaluation With the Question of Reducing the Rate of Hypoglycemia",
"conditions": [
"Type 1 Diabetes"
],
"interventions": null,
"location_countries": [
"Germany"
],
"nct_id": "NCT02325193",
"official_title": "Prevention of Hypoglycaemia Using the Minimed®640G System",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-03",
"study_completion_date(actual)": "2016-03",
"study_start_date(actual)": "2015-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-03-03",
"last_updated_that_met_qc_criteria": "2014-12-19",
"last_verified": "2016-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-12-24",
"first_submitted": "2014-12-19",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
A single-center, randomized, open-labeled, 2×2 crossover phase 1 study to evaluate the pharmakinetics effect of high fat food to single dose administration of Anaprazole in healthy Chinese male subjects. 14 health male subjects is divided to A group (n=7) and B group (n=7). 2 periods (7 days) cross-over design, anaprazole 40mg single dose, one is fasting oral administration before breakfast, the other is oral administration 30 minutes after breakfast with high fat food.
#Intervention
- DRUG : Anaprazole
- single dose, oral administration 30 minutes after breakfast with high fat food.
- DRUG : Anaprazole
- single dose, oral administration before breakfast. | #Eligibility Criteria:
Inclusion Criteria:
* The subject is capable of understanding and complying with protocol requirements, and signed and dated a written informed consent form voluntarily;
* The subject is a Chinese health male adult, aged 18 <= age <= 45, inclusive;
* The subject weighed at least 50.0 kg and had a body mass index (BMI) between 19.0 kg/m^2 and 24.0 kg/m^2, inclusive;
* Has clinical laboratory evaluations, vital signs and ECG testing within the reference range, and medical history and physicial examination results are normal. Participants with evaluations outside the reference range that are deemed not clinically significant by the investigator may be included at investigator discretion;
* No medical history of allergy to proton pump inhibitors and no any other drug allergy history;
* The subjects have a good lifestyle and can keep good communication with the investigators and comply with the requirements of clinical trial.
Exclusion Criteria:
* Has postural hypotension, gastrointestinal disease (gastric ulcer, gastritis and etc), liver disease, renal disease (nephritis, pyelonephritis and etc), and other disease or medical history of any other system (cardiovascular, respiratory, psychoneural, hematology, endocrinology and etc) ;
* Has clinical significant abnormal electrolytes (especially hypopotassemia) in screening examination;
* Has clinical significant ECG abnormal history or family history of long QT syndrome(Grandparents, parents and siblings);
* Has rhinitis, allergic rhinitis, recurrent hemorrhinia, nasal deformity and abnormal nasal septum；
* With positive result of drug screening test;
* With positive result of nicotine test;
* Female participants who are pregnant, breast-feeding or menstral period, or participants has no effective contraception method, or has pregnancy plan in 6 months;
* Has received any drugs: acid-inhibitors, any priscription drug, herb medicine, non-prescription drugs and/or food suppliments (including vitamine) within 2 weeks before randomization;
* Blood donation / blood loss >=400 mL within 3 months, or participated any other clinical trials within 3 months;
* Known Human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C antibody, and Treponema pallidum specific antibody test results were positive at screening;
* Frequent alcoholics (drink more than 2 units of alcohol per day, 1 unit = 330 mL beer or 25 mL liquor or 125 mL wine), or took food or drinks with alcoholics 72 hours before randomization;
* Has taken foods or drinks with xanthine(cafeine) or intensive excercise. Has taken foods or drinks that affect CYP3A4 (such as grapefruit or beverages containing grapefruit) within 14 days before administration of investigational drugs;
* Smoke more than 5 pieces per week;
* Any conditions in which considered by investigator not be appropriate to participate in this trial.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT04463173 | {
"brief_title": "Food Effect Study of Anaprazole in Healthy Chinese Subjects",
"conditions": [
"Healthy Male Volunteers"
],
"interventions": [
"Drug: Anaprazole"
],
"location_countries": null,
"nct_id": "NCT04463173",
"official_title": "A Single-center, Randomized, Open-labeled, Crossover Phase 1 Study to Evaluate the Pharmakinetics Effect of High Fat Food to Single Dose Administration of Anaprazole in Healthy Chinese Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-07-02",
"study_completion_date(actual)": "2015-07-02",
"study_start_date(actual)": "2015-06-16"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-07-09",
"last_updated_that_met_qc_criteria": "2020-07-07",
"last_verified": "2015-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-07-09",
"first_submitted": "2020-06-30",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to monitor the cardiovascular and renal health of patients who previously took BMS-986094 (an investigational medication for hepatitis C) in comparison to hepatitis C infected patients who have never taken BMS-986094.
| #Eligibility Criteria:
Inclusion Criteria:
Subjects will be enrolled based on prior enrollment in the BMS 986094 studies or treatment-naïve HCV subjects with no known cardiovascular abnormalities.
* All Subjects must give informed consent prior to participation in the study.
* Subject participated in the Phase 1 or Phase 2 trials with BMS 986094 (including placebo arm) OR
* Subject with known hepatitis C (Control)
1. No previous exposure to BMS 986094
2. Treatment naive at study entry (No prior hepatitis C treatment experience at the time of enrollment, including but not limited to: standard interferon, pegylated interferon, ribavirin, boceprevir, telaprevir, or other experimental drugs for hepatitis C).
Exclusion Criteria
* For subjects who participated in the Phase 1 or Phase 2 trials with BMS 986094, there are no exclusion criteria
* For the control group of subjects without exposure to BMS 986094, the following exclusion criteria, based on clinically available data, apply:
1. Signs or symptoms of decompensated liver disease such as variceal bleeding, ascites, hepatic encephalopathy, active jaundice defined by an indirect bilirubin >2, ALT or AST laboratory values >= 10 times the upper limit of normal, or other evidence of decompensated liver disease or hepatocellular carcinoma
2. Chronic liver disease other than HCV not limited to Hepatitis B virus (positive test for HBsAg), hemochromatosis, auto-immune hepatitis, alcoholic liver disease or non-alcoholic fatty liver disease
3. History of liver transplantation
4. Co-infection with HIV (positive test for anti-HIV Ab)
5. Prior history of cardiomyopathy (ejection fraction <= 50%) or history of heart failure
6. Signs or symptoms of decompensated heart failure or
7. Prior history of coronary artery disease, acute myocardial infarction or coronary artery revascularization (percutaneous or coronary artery bypass grafting)
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT01846494 | {
"brief_title": "Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C)",
"conditions": [
"Hepatitis C"
],
"interventions": null,
"location_countries": [
"Puerto Rico",
"United States"
],
"nct_id": "NCT01846494",
"official_title": "Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-03-19",
"study_completion_date(actual)": "2018-03-19",
"study_start_date(actual)": "2013-05-10"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-03-22",
"last_updated_that_met_qc_criteria": "2013-05-01",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-05-03",
"first_submitted": "2013-05-01",
"first_submitted_that_met_qc_criteria": "2018-12-12"
}
}
} |
#Study Description
Brief Summary
Some people with Primary Open-angle Glaucoma (POAG) also suffer from Obstructive Sleep Apnoea (OSA), a common sleep disorder which is known to affect heart and blood vessels, and may contribute to glaucoma progression. Obstructive Sleep Apnoea is treated with Continuous Positive Airway Pressure (CPAP); however using this type of breathing support may raise intraocular pressure (IOP). The evidence for this is limited and the potential mechanisms involved are poorly understood.
In this study we will determine whether CPAP applied at night changes IOP and ocular perfusion pressure (OPP). We will also assess its possible impact on ocular microvasculature. Two groups of patients will be included: those with POAG and OSA, and those with OSA without glaucoma. They will attend for two overnight assessments: the first before starting CPAP and the second 4-6 weeks into the treatment. Repeated measurements of IOP at night will be performed and participants will continue self-measuring IOP at home in the day. An Ocular Coherence Tomography Angiography (OCT Angiography) of the optic disc and the surrounding retina will be performed at baseline and after a few weeks of CPAP treatment.
Detailed Description
People with OAG and concomitant OSA associated with the relevant symptoms, particularly daytime sleepiness, currently receive standard treatment with CPAP. However, the impact of CPAP on their glaucoma is unknown. There are concerns that CPAP increases IOP, currently the only modifiable factor in glaucoma, though the evidence for this is limited.
Understanding the influence of CPAP on IOP is important as it may inform the management of people with OSA and concomitant glaucoma. If CPAP is shown to raise IOP or alter OPP to levels that pose clinical risk it will be necessary to assess available alternative treatment options for OSA. If, however, CPAP does not alter these parameters, there would be a rationale for assessing long-term effects of CPAP, most probably in the form of a randomised interventional trial, informed by the findings of this research.
This is a prospective controlled study which will examine the impact of CPAP on nocturnal IOP and OPP in people with OSA with and without POAG. In addition, we will assess ocular microvasculature before and a few weeks into CPAP treatment.
Objectives:
Primary: to determine if IOP increases at night following treatment with CPAP in people with OSA with and without POAG.
Main Secondary:(i) to investigate whether diurnal IOP raises after CPAP treatment; (ii) to investigate whether CPAP alters peri-papillary and macular microcirculation measured with OCT Angiography.
Participants: People with newly diagnosed OSA who require treatment with CPAP will be invited. We will recruit participants with POAG and people without glaucoma (control subjects). All participant will undergo a detailed ocular assessment including: visual acuity, IOP measurement, OCT and visual field test.
Sample Size: 30 participants: 15 per group.
Study Visits:
Visit 0: Baseline ocular examination to confirm or exclude glaucoma will be undertaken during this visit unless a participant already had this examination within the last 6 months.
Visit 1: Participants will attend the sleep centre (Respiratory Support and Sleep Centre-RSSC, Papworth Hospital) where they will be admitted to a separate ward. Consented participants will undergo the following:
Baseline assessment: A brief medical history, spirometry and anthropomorphic measurements.
Repeated measurements: IOP will be measured in each eye using a rebound tonometer (Icare Pro, Finland Oy). Blood pressure and ocular perfusion pressure will be checked simultaneously.
Participants will be advised to sleep at their habitual hours. Sleep onset and duration will be recorded. All the above measurements will be repeated every 2 hours starting from 10pm and finishing at 8am. In the morning OCT Angiographic will be performed.
Participants will then self-measure IOP at home using a rebound tonometer (Icare Home, Finland Oy). The measurements will be performed in the daytime every 2 hours before they start CPAP and 4-6 weeks into the treatment.
Visit 2: Participants will return for the second overnight assessment 4-6weeks after initiation of CPAP treatment.
CPAP usage data will be downloaded. All the measurements following the same procedure as for Visit 1 will be repeated this time with participants using CPAP. OCT Angiographic will be performed immediately after removing CPAP in the morning.
#Intervention
- DEVICE : Continuous Positive Airway Pressure
- Continuous Positive Airway Pressure | #Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed, untreated OSA with indications for CPAP
* Age >40 years
* Able to give informed consent and attend for the study visits.
Exclusion Criteria:
* Known or suspected pregnancy
* Any contraindications to rebound tonometry, including: corneal scarring, microphtalmos, buphthalmos, nystagmus, keratoconus, abnormal central corneal thickness, corneal ectasia, , active corneal infection, , and corneal dystrophies
* Eye diseases known to affect IOP, including: treated wet age related macular degeneration (ARMD), central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), uveitis and diabetic retinopathy.
* Indications to start CPAP treatment urgently unless the study visits can be organised in a way there is no delay in treatment initiation.
* Irregular sleep pattern
* Insomnia
* Acute infectious diseases
* Inability to undergo screening ophthalmic examination
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03145129 | {
"brief_title": "PAIR Study-PAP And IOP Relationship: Study 2",
"conditions": [
"Obstructive Sleep Apnoea",
"Primary Open-angle Glaucoma"
],
"interventions": [
"Device: Continuous Positive Airway Pressure"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT03145129",
"official_title": "Positive Airway Pressure and Intraocular Relationship: Study 2- The Impact of CPAP on Nocturnal IOP.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-02-10",
"study_completion_date(actual)": "2018-02-10",
"study_start_date(actual)": "2017-03-24"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-06-06",
"last_updated_that_met_qc_criteria": "2017-05-04",
"last_verified": "2018-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-05-09",
"first_submitted": "2017-05-04",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study aims to assess postoperative blood loss and transfusion rates in total knee replacement after one-time administration of topical tranexamic acid.
Detailed Description
Autologous (donor) blood transfusion is an expensive and common occurrence after total knee replacement. Published data puts this rate between 9 and 40% after primary unilateral total knee arthroplasty. There have been many proposed adjunctive measures to decrease intraoperative and postoperative blood loss during such surgery. Most of these include thrombin inhibition, so-called 'minimally- invasive' techniques or instrumentation, or other adjunctive drugs. Hitherto, tranexamic acid, a specific drug that promotes part of the clotting cascade, has been used extensively in multiple areas of surgery with multiple studies evaluating its efficacy in cardiac surgery, spinal procedures, and as a dental swishing solution after tooth extraction. There have been small studies evaluating intravenous tranexamic acid and its effect on total knee replacement, with some promising results. The topical form of TA has been evaluated in only one prospective, randomized clinical trial with a significant decrease in postoperative blood loss and a trend towards decreased autologous blood transfusion rates. This study proposes to further evaluate tranexamic acid as an inexpensive and viable option for use in total knee arthroplasty. The topical form of the drug has been shown to achieve these hemostatic effects without increasing the risk of blood clots after surgery. Furthermore, the one aforementioned randomized clinical trial used a variety of postoperative deep vein thrombosis prophylaxis after surgery and introduced a potential confounding variable. A rigorous analysis of the effects of tranexamic acid demand a more standardized approach. Such a regimen is practiced at Henry Ford Hospital as all patients on the Adult Reconstruction service are placed on an identical dose of enoxaparin (a subcutaneous blood thinner) postoperatively for two weeks.
#Intervention
- DRUG : Tranexamic Acid
- Topical tranexamic acid (2g/100mL 0.9% saline)
- Other Names :
- Cyklokapron
- DRUG : Placebo
- 100mL 0.9% sterile saline | #Eligibility Criteria:
Inclusion Criteria:
* All adult patients over age eighteen
* Primary unilateral total knee arthroplasty at Henry Ford Hospital (Detroit, Michigan, United States) and Henry Ford West Bloomfield Hospital (West Bloomfield, Michigan, United States)
Exclusion Criteria:
* patient history of venous thromboembolic disease or coagulopathy
* use of anticoagulant medications within 7 days of surgery
* history of arterial embolic disease
* history of Class III or IV heart failure
* renal failure
* intraoperative cardiovascular, pulmonary, orthopaedic, or anesthetic complication (MI, intraoperative fracture, vasopressor support, emergent intubation).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01370460 | {
"brief_title": "Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty",
"conditions": [
"Acute Blood Loss Anemia",
"Osteoarthritis, Knee"
],
"interventions": [
"Drug: Tranexamic Acid",
"Drug: Placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01370460",
"official_title": "Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-09",
"study_completion_date(actual)": "2012-09",
"study_start_date(actual)": "2011-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-04-25",
"last_updated_that_met_qc_criteria": "2011-06-08",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-06-10",
"first_submitted": "2011-06-03",
"first_submitted_that_met_qc_criteria": "2013-07-03"
}
}
} |
#Study Description
Brief Summary
The purpose is to investigate whether HIV and HIV medication can affect certain areas of brain function. This study will look at possible changes in brain function including memory, concentration and thought processes to see if there are any differences between the two doses of efavirenz used in the Encore1 study and also the level of efavirenz in the blood
#Intervention
- DRUG : Efavirenz
- 400mg qd; 2 x 200mg
- DRUG : Efavirenz
- 600mg qd; 3 x 200mg qd | #Eligibility Criteria:
Inclusion Criteria:
* All subjects entering into the main study protocol at participating centres will be eligible to enter this sub-study.
Exclusion Criteria:
* Existing neurological brain disease
* Recent (<6months ) head injury
* Current major depression or psychosis
* Current alcohol abuse
* Intended use of recreational drugs during study period
* Uncontrolled medical conditions deemed to potentially interfere with cognitive function (e.g. uncontrolled diabetes, pyrexial illness, uraemia etc)
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT01516060 | {
"brief_title": "The Neurocognitive Sub-study of Encore1",
"conditions": [
"HIV"
],
"interventions": [
"Drug: Efavirenz"
],
"location_countries": [
"Thailand"
],
"nct_id": "NCT01516060",
"official_title": "The Neurocognitive Sub Study of Encore1:A Randomised, Double-Blind, Placebo-Controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz (EFV) With Standard Dose EFV Plus 2N(t)RTI in Antiretroviral-naïve HIV-Infected Individuals Over 96 Weeks A Randomised, Double-blind, Placebo-controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz (EFV) With Standard Dose EFV Plus Two Nucleotide Reverse Transcriptase Inhibitors (N(t)RTI) in Antiretroviral-naïve HIV-infected Individuals Over 96 Weeks",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-03",
"study_completion_date(actual)": "2013-03",
"study_start_date(actual)": "2012-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "SCREENING",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-09-19",
"last_updated_that_met_qc_criteria": "2012-01-19",
"last_verified": "2013-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-01-24",
"first_submitted": "2012-01-19",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The use of zein nanoparticles as vehicles for drug delivery is under study, but of the effects observed in empty nanoparticles, in laboratory animals, the reduction of glucose levels was something worth studying. Thus, the present research on patients with prediabetes has been proposed. The objective is to assess the efficacy of zein nanoparticles on the glycemic control. For this purpose, a randomized, double blind crossover study has been designed.
Target sample size is 60.
#Intervention
- DIETARY_SUPPLEMENT : Zein nanocapsules
- 1 g of Zein nanoencapsulated daily
- DIETARY_SUPPLEMENT : control
- 1 g of Zein non-encapsulated daily | #Eligibility Criteria:
Inclusion Criteria:
* Overweight or obesity (BMI between 25 and 40 kg/m2
* Presence of prediabetes (fasting glycemia in blood between 100 and 126 mg/dL)
* No weight variations considered relevant (+/- 5%) in the last 3 months
* Metformin treatment is allowed, as far as dose is stable (at least 2 months with unvaried dose).
* Good physical and psychological state.
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT05560412 | {
"brief_title": "Zein Nanoparticles for Glycemic Control",
"conditions": [
"PreDiabetes",
"Overweight and Obesity",
"Adult ALL"
],
"interventions": [
"Dietary Supplement: Zein nanocapsules",
"Dietary Supplement: control"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT05560412",
"official_title": "Zein Nanoparticles for Glycemic Control",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-19",
"study_completion_date(actual)": "2023-12-19",
"study_start_date(actual)": "2023-01-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-31",
"last_updated_that_met_qc_criteria": "2022-09-26",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-09-29",
"first_submitted": "2022-09-26",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Double-blind, randomized, cross-over trial involving 20 participants with bronchiectasis.
This trial will make an important contribution to therapeutic development in bronchiectasis by determining whether alpha-1 antitrypsin (AAT) therapy results in reduced airway inflammation and improves neutrophil function.
Patients will be randomly assigned to receive Prolastin-C 120mg/kg (n=10 patients) by weekly intravenous infusions, Prolastin-C 180mg/kg (n=10 patients) by weekly intravenous infusions or placebo (0.9% saline) for a period of 4 weeks, followed by a 3-5 week washout period and a further 4 weeks during which patients will cross-over to receive the alternative therapy.
Detailed Description
Bronchiectasis is a debilitating chronic disease associated with a vicious cycle of lung inflammation, infection and failure of mucociliary clearance.
It affects up to 566/100,000 patients in Europe and the prevalence is increasing. Excess neutrophil proteinase activity is central to the pathogenesis of bronchiectasis. Neutrophil elastase is released from activated neutrophils recruited to the bronchiectasis lung and exacerbates inflammation through multiple mechanisms. These include stimulating goblet cell hyperplasia and mucus production, altering of ciliary beat frequency, preventing neutrophil phagocytosis of pathogens through cleavage of phagocytic receptors and preventing apoptotic cell clearance through the cleavage of phosphatidylserine. Neutrophil elastase activity in the bronchiectasis lung is increased because the concentration of elastase released from neutrophils exceeds the inhibitory capacity of the natural anti-proteinase defences of the lung. Of these, alpha-1 proteinase inhibitor accounts for approximately 90% of the inhibitory capacity. The adverse effects of excess proteinase activity are observed in genetic alpha-1 antitrypsin deficiency (A1ATD) where patients develop progressive emphysema, lung function decline, and bronchiectasis.
The majority of bronchiectasis patients do not have genetic A1ATD but do have functional alpha-1 antitrypsin deficiency because elastase activity exceeds the available alpha-1 antitrypsin in the lung. There are currently no licensed treatments that directly target excessive neutrophil elastase activity in bronchiectasis.
The investigators hypothesize that augmentation of alpha-1 proteinase inhibitor could have beneficial effects in patients with bronchiectasis who have elevated sputum neutrophil elastase activity. Currently, licensed alpha-1 antitrypsin augmentation therapy is given by intravenous infusions on a weekly basis to patients with genetic A1ATD. Inhaled alpha-1 proteinase inhibitor has been used previously in trials in cystic fibrosis. While inhaled alpha1 proteinase inhibitor may have a role in the future in bronchiectasis, the investigators are proposing to conduct a trial of intravenous administration as a proof-of-concept due to the known safety profile of the licensed product and due to increasing evidence that neutrophils in bronchiectasis are dysfunctional in the systematic circulation, with an activated phenotype and evidence of systematic elastin degradation measured by serum desmosine.
The investigators propose a proof-of-concept trial which will gather important data to determine the feasibility and scientific value of a future efficacy trial of alpha-1 proteinase inhibitor augmentation in bronchiectasis.
There is an urgent unmet need for new therapies in bronchiectasis, a point that has been made by physicians, patients and regulators. There are currently no licensed therapies and off-label treatments have limited effectiveness leaving a high disease burden. European registry data shows that approximately 50% of patients experience two or more exacerbations per year and 1/3 experience at least one admission to hospital for severe exacerbations each year. Patients with elevated neutrophil elastase activity in sputum experience more rapid decline in lung function, more exacerbations and worse quality of life, yet there are no treatments which directly target lung inflammation in bronchiectasis.
This trial will make an important contribution to therapeutic development in bronchiectasis by determining whether alpha-1 antitrypsin (AAT) therapy results in reduced airway inflammation and improves neutrophil function. This in turn will inform future therapeutic development in bronchiectasis including determining the potential for a future definitive efficacy and safety trial in bronchiectasis patients. This is the 'treatable trait' that the investigators aim to target with AAT administration and this approach of treatment guided by a point-of-care biomarker will be a further innovative aspect of the trial.
This is a double-blind, randomized, cross-over trial involving 20 participants with bronchiectasis. The trial will consist of a screening period of up to 35 days followed by a total trial duration of up to 13 weeks. Patients will be randomly assigned to receive Prolastin-C 120mg/kg (n=10 patients) by weekly intravenous infusions, Prolastin-C 180mg/kg (n=10 patients) by weekly intravenous infusions or placebo (0.9% saline) for a period of 4 weeks, followed by a 3-5 week washout period and a further 4 weeks during which patients will cross-over to receive the alternative therapy.
#Intervention
- DRUG : Alpha 1-Proteinase Inhibitor 180mg/kg
- alpha1-proteinase inhibitor (human) intravenous infusion
- Other Names :
- Prolastin-C Liquid
- DRUG : Alpha 1-Proteinase Inhibitor 120mg/kg
- alpha1-proteinase inhibitor (human) intravenous infusion
- Other Names :
- Prolastin-C Liquid
- DRUG : Sodium chloride
- Sodium chloride 09.% intravenous infusion | #Eligibility Criteria:
Inclusion Criteria:
* Age >18 years
* Bronchiectasis on high resolution computerised tomography (CT) scan affecting 1 or more lobes
* Sputum neutrophil elastase activity greater than or equal to 7 µg/ml on neutrophil elastase assay at the screening visit*
* Daily sputum production as determined by the researcher from the patient's self-report
* Able to provide a sputum sample at the screening and randomization visits either spontaneously
* Ability to give informed consent
* Able to perform all trial procedures with minimal assistance
* Willing to have pregnancy testing, if appropriate
Exclusion Criteria:
* Severe alpha-1 antitrypsin deficiency (<57 mg/dl in serum) regardless of genotype#
* Immunoglobulin A (IgA) deficient patients with antibodies against IgA
* History of anaphylaxis or other severe systemic reaction to Alpha1-Proteinase Inhibitor
* Primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) in the opinion of the investigator
* Primary Diagnosis of asthma in the opinion of the investigator
* Active allergic bronchopulmonary aspergillosis, NTM, immunodeficiency or another aetiology of bronchiectasis requiring a specific treatment
* Treatment with antibiotic therapy for an exacerbation of bronchiectasis (other than long term oral or inhaled antibiotics at stable dose) in the 4 weeks prior to randomization
* Cystic fibrosis
* Unstable cardiac disease in the opinion of the investigator
* Congestive cardiac failure and in the opinion of the investigator should not receive iv infusions.
* Traction bronchiectasis due to interstitial lung disease
* Current smoker
* Pregnant or breast feeding
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT05582798 | {
"brief_title": "Bronchiectasis Alpha-1 Augmentation Trial- Modulating Airway Neutrophil Function",
"conditions": [
"Bronchiectasis Adult"
],
"interventions": [
"Drug: Sodium chloride",
"Drug: Alpha 1-Proteinase Inhibitor 120mg/kg",
"Drug: Alpha 1-Proteinase Inhibitor 180mg/kg"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT05582798",
"official_title": "A Proof of Concept Trial of Alpha-1 Antitrypsin Augmentation Therapy in Patients With Bronchiectasis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-08-12",
"study_completion_date(actual)": "2024-08-12",
"study_start_date(actual)": "2022-11-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-09-03",
"last_updated_that_met_qc_criteria": "2022-10-12",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-10-17",
"first_submitted": "2022-06-29",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to learn if a surgical technique called intraoperative lymphatic mapping can accurately identify the lymph node that is at greatest risk if endometrial or cervical cancer spreads to the lymph nodes.
Early cervical cancer is usually treated by removing the cervix, tissue around the cervix, and the upper vagina. If needed, the uterus is also removed. The treatment also includes removing lymph nodes from the pelvis. Endometrial cancer is usually treated by removing the cervix, uterus, fallopian tubes and ovaries.
The treatment also includes removing lymph nodes from the pelvis.
Detailed Description
Patients with FIGO stage I endometrial cancer or patients with FIGO stage I-IIA invasive cervical cancer and who will be undergoing surgical management to include a lymphadenectomy.
↓ Injection of radioisotope and preoperative lymphoscintigraphy with Tc99m either the day before or on the day of surgery by the Nuclear Medicine Department.
↓ Intraoperative lymphatic mapping with blue dye and gamma probe.
↓ Hysterectomy, Radical hysterectomy and/or radical trachelectomy and pelvic lymphadenectomy.
#Intervention
- OTHER : Lymphatic Mapping
- Intra-Operative Lymphatic Mapping | #Eligibility Criteria:
Inclusion Criteria:
* Patients with endometrial cancer diagnosed on endometrial biopsy or dilatation and curettage.
* Patients with invasive cervical cancer diagnosed on cervical biopsy or cone biopsy.
* Patients with a performance status of 0, 1, 2, or 3 by the Gynecologic Oncology Group criteria (Appendix).
* Patients with stage I to ~IIA invasive cervical cancer disease according to the International Federation of Gynecology and Obstetrics (FIGO) clinical staging criteria (Appendix).
* Patients with clinical stage I endometrial cancer
* Patients who will undergo surgery to include a hysterectomy, radical hysterectomy and/or radical trachelectomy and bilateral lymphadenectomy via laparotomy or laparoscopy
* Patients who have signed an approved informed consent.
Exclusion Criteria:
* Patients with history of prior pelvic or para-aortic lymphadenectomy.
* Patients with stage IIB-IV invasive cervical cancer by FIGO criteria.
* Patients with recurrent endometrial or cervical cancer.
* Patients with prior pelvic radiation.
* Any patient with endometrial or cervical cancer treated with neoadjuvant chemotherapy and radiation therapy.
* Patients with a performance score of 4 by the Gynecologic Oncology Group criteria or who are not good surgical candidates (Appendix).
* Patients with grossly infected primary tumors.
* Patients with known allergy to triphenyl-ethane compounds.
* Patients with known deficiency of Glucose-G-Phosphate Dehydrogenase.
* Patients with known Hemolytic Anemia from Pyruvate Kinase and G6PD Deficiencies.
* Severe Renal Disease.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT00595725 | {
"brief_title": "Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma",
"conditions": [
"Cervical Cancer",
"Endometrial Cancer",
"Cervical Carcinoma"
],
"interventions": [
"Other: Lymphatic Mapping"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00595725",
"official_title": "Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-09",
"study_completion_date(actual)": "2011-09",
"study_start_date(actual)": "2003-02"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-09-08",
"last_updated_that_met_qc_criteria": "2008-01-15",
"last_verified": "2011-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-01-16",
"first_submitted": "2008-01-07",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Recently, tobacco companies have developed new oral tobacco products that are purportedly less harmful than conventional tobacco products. These products have not been tested by independent research for their health effects or consumer palatability. In addition, it is not known if these products will be used in addition to cigarette smoking or as a substitute to cigarettes. These two studies will examine four oral tobacco products to answer some of these questions.
The goals of this first study will be to examine: 1) the brand of oral tobacco products which is preferred by cigarette smokers and the pattern and amount of product use when used as a switching tool; 2) the characteristics that are associated with product choice; 3) nicotine exposure from these products; and 4) the withdrawal symptoms from the tobacco products and potential for continued use.
Specifically, our primary aims hypotheses were: 1) the product that will be chosen by most smokers will be based on taste and sensory aspects of the product with products higher in nicotine content more likely to be chosen as the preferred product; and 2) subjects will experience no difficulty using the product for complete cigarette substitution, but a small minority will engage in dual product use.
For the secondary aims, we hypothesized: 1) that compared to the subjects' own brand of cigarettes, the biomarkers for exposure for the oral tobacco products will be significantly lower; 2) withdrawal symptoms from the oral products are likely to occur, but are likely to be mild compared to cigarette withdrawal.
Detailed Description
This study will be accomplished by allowing subjects to sample the products and choose one oral tobacco product that they will use instead of cigarettes for a two week period. After the two weeks, they will discontinue all tobacco use and withdrawal symptoms and abstinence rates will be observed.
Subjects will attend an orientation visit where the study will be explained in detail. Interested subjects will sign a consent form and be scheduled to return for baseline measures. Subjects will have a review of medical history to verify that they are in generally good health and do not have contraindications to the study products. Eligible subjects will collect one week of baseline measures while smoking at their normal rate: measures include daily diaries of smoking, questionnaires and urine samples. At the second baseline visit, they will receive samples of the oral tobacco products. The tobacco products tested are five novel oral products recently introduced to the market: 1) Camel Snus (higher nicotine); 2) General Snus (higher nicotine); 3) Marlboro Snus (lower nicotine); and two compressed tobacco tablets, 4) Ariva (lower nicotine), or 5) Stonewall (higher nicotine). All of these tobacco products are purported to have reduced levels of tobacco-specific nitrosamines.
During sample weeks, subjects will be given 10 pouches/tablets of each product in a within-subject design and instructed to use at least three of the daily products in the morning of sample day and resume smoking in the afternoon and through the following day. They will sample the next product in a similar manner. The order of product was randomized. All subjects will sample all five products. This design will allow a short, but adequate trial of each product to determine preference. After the sampling weeks, subjects will choose the product they will want to use to quit smoking. They will be supplied that product over the next two weeks.
During the two weeks of product use during smoking abstinence, subjects will come to weekly clinic visits and then a follow-up visits at 1 week and a phone call at 4 weeks after the end of treatment. At baseline, and 2 weeks post cigarette cessation, subjects will bring in a urine sample from their first morning void and bloods will be drawn. At each visit, subjects will have vital signs obtained (blood pressure, heart rate, weight and carbon monoxide level), they will complete several subjective forms regarding tobacco use, withdrawal symptoms, and mood. Subjects will receive brief behavioral counseling for smoking cessation at all visits.
In addition, during the sample weeks and at the end of two weeks of study product use, subjects will submit three used chews that will be sent to CDC to be analyzed for the tobacco constituents.
#Intervention
- OTHER : Camel Snus
- All subjects will sample Camel Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Camel Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Camel Snus is chosen for use) during abstinence phase.
- OTHER : Marlboro Snus
- All subjects will sample Marlboro Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Marlboro Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Marlboro Snus is chosen for use) during abstinence phase.
- OTHER : Stonewall
- All subjects will sample Stonewall and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Stonewall. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Stonewall is chosen for use) during abstinence phase.
- OTHER : Ariva
- All subjects will sample Ariva and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Ariva. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Ariva is chosen for use) during abstinence phase.
- OTHER : General Snus
- All subjects will sample General Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of General Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if General Snus is chosen for use) during abstinence phase. | #Eligibility Criteria:
Inclusion Criteria:
* Cigarette smokers who smoke 10 or more cigarettes per day
* Generally good health
Exclusion Criteria:
* Unstable medical or psychiatric condition.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT00711100 | {
"brief_title": "Evaluation of Oral Tobacco as a Harm Reduction Method for Smokers",
"conditions": [
"Tobacco Use Disorder"
],
"interventions": [
"Other: Marlboro Snus",
"Other: Stonewall",
"Other: General Snus",
"Other: Ariva",
"Other: Camel Snus"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00711100",
"official_title": "Preference, Health Effects and Efficacy of Four Oral Tobacco Products for Smoking Cessation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-10",
"study_completion_date(actual)": "2010-12",
"study_start_date(actual)": "2008-08"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-11-18",
"last_updated_that_met_qc_criteria": "2008-07-02",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-07-08",
"first_submitted": "2008-07-02",
"first_submitted_that_met_qc_criteria": "2015-08-14"
}
}
} |
#Study Description
Brief Summary
Low back pain is a very common musculoskeletal condition that affects many people each year regardless of age, gender, and ethnicity. Most people get better however, some continue suffering from painful episodes despite treatment.
Self-management strategies for the management of chronic low back pain are very important to patients as they help them develop skills to manage their pain more effectively. However, self-management strategies are not always effective as expected. It is possible that the brain has become very sensitive to signals coming from peripheral parts of the body (e.g. low back) affecting the ability of patients to self-manage their condition.
The aim of this study is to establish whether central sensitisation (sensitivity of the brain to peripheral signals) predicts how effective self-management approaches will be.
On three different occasions, scheduled sessions will include a clinical assessment session and completion of a questionnaire booklet. The clinical assessment will measure three features of central sensitisation: 1) sensitivity to blunt pressure on the forearm, 2) changes in pain, felt during repeated light pricking of the forearm skin, and 3) reduction in pain that accompanies inflation of a blood pressure cuff on the opposite arm. Participant involvement at each session is expected to last for 70 minutes.
Individuals over 18, diagnosed with chronic low back pain and enlisted to follow a pain management program are eligible to participate. The clinical assessments, questionnaire completion and subsequent statistical analysis are expected to be completed within 18 months of study commencement.
Based on our findings, future research may use similar clinical assessment to identify people who might be helped to self-manage by using treatment that reduces central sensitisation.
Detailed Description
Low Back Pain (LBP) is considered a common condition consisting of a set of complains (pain, muscle tension, or stiffness), manifesting primarily to the lower back region (below the costal margin and above the inferior gluteal folds). LBP may or may not include radiating pain to the lower limb and can be caused by a number of underlying pathologies with varying levels of severity \[1\]. The condition can be the result of complex interactions between multiple physical and psychological factors including osteoarthritis (OA), degenerated discs, disc herniation, muscle dysfunction, obesity, poor posture, mental illness, negative affect (stress, anxiety, depression) \[2\].
LBP lifespan incidence appears to be 58-84% while it is estimated that 11% of males and 16% of females suffer from chronic LBP at any point in time \[3\]. It is expected that 40-50% of individuals suffering from acute LBP will continue to experience pain at three months and will demonstrate little or none further improvement, while 60-70% of those who improve will relapse within a year \[4\]. The global prevalence of LBP demonstrates continuously growing trends with a 17.3% increase in the last 10 years \[5\].
Self-management (SM) support is a portfolio of techniques and tools to help patients choose healthy behaviours as well as a fundamental transformation of the patient-caregiver relationship into a collaborative partnership \[6\]. Self-management support has to incorporate in its approach elements that aim to increase patients' self-efficacy, develop problem-solving, decision-making and goal-setting skills as well as to promote partner-like behaviour between patients and health professionals \[7\]. SM interventions pose as ideal rehabilitation strategies for chronic low back pain (CLBP) as they aim to address biological (neurophysiological, deconditioning, lifestyle) and psychosocial (self-efficacy, maladaptive beliefs, anxiety/depression) factors that have been identified as risk factors for poor outcome \[8, 9\] and are negatively affected by central sensitisation (CS) \[10\]. SM interventions are designed to be cost-effective by reducing health care utilisation associated with LBP \[11\].
Self-management programs (SMP) for CLBP demonstrate only small to moderate effects for long-term improvements in pain and disability. Currently, it is not known what factors predict effective self-management. Evidence of CS varies between individuals with chronic pain, and may contribute to the relatively poor efficacy of SMPs.
CS is a marker of widespread and centrally augmented pain that refers to those neurophysiological processes that can occur throughout the central nervous system (CNS) distribution, leading to changes in the spinal cord as well as in the brain \[12\]. The presence of CS increases the complexity of the clinical picture \[13\] and negatively affects a range of outcomes (e.g. pain, disability, negative affect, quality of life) following treatment \[14\]. CS is not present within all patients with chronic pain \[15\] rendering identification of those patients and decision-making for the right management approach even harder \[16\]. Patients with potential development of CS should receive treatment that address the full biopsychosocial clinical spectrum consisting of cognitive behavioural therapy (CBT) as well as therapeutic pain neuroscience education \[17\]. Changes in pain mechanisms may explain the moderate levels of evidence for the effectiveness of self-management (SM) interventions in LBP populations \[7\] as CS has been shown to negatively affect the perception of back pain, pain-related disability and lead to poor physical and mental health-related quality of life as well as to greater levels of depression and anxiety \[10\].
Quantitative Sensory Testing (QST) is a reliable \[18\] and valid \[19\] method to assess for the presence of CS and demonstrates predictive capacity in relation to musculoskeletal (MSK) treatment outcomes \[20\]. The testing consists of pressure pain threshold (PPT), punctate thresholds, temperature sensitivity, temporal summation (TS) and conditioned pain modulation (CPM) used to quantify noxious or innocuous stimuli within healthy individuals and patients alike \[21\]. QST has been used, among others, as a screening and assessment tool for sensory abnormalities in patients with pain disorders \[21\], as well as to assist in the stratification of patients \[22\] and evaluate the clinical aspects of peripheral and CS \[23\].
The STarT Back screening tool \[24\] was developed for individuals of LBP with the aim to identify prognostic indicators that could potentially assist decision making concerning initial treatment options in primary care \[25\]. Start Back has been formally validated, displaying satisfactory reliability, and has demonstrated that a stratified management approach displays higher health gains for patients with LBP than a non-stratified one \[26\]. Nevertheless, the tool's predictive performance has not been examined when other biomarkers (CS) are included as prognostic indicators.
Findings from this research will have an impact on differential diagnosis of chronic pain and CS identification as potential prognostic indicators for self-management. The results will assist effective patient subgrouping (stratification) based on CS measurements, aid appropriate self-management approaches in CLBP and potentially other chronic musculoskeletal pain states.
#Intervention
- DIAGNOSTIC_TEST : Quantitative Sensory Testing
- PPT: An electronic data collection unit will be used featuring an electronic algometer connected with a laptop where the amount of pressure will be displayed on the screen. When the pressure pain detection threshold is reached (the point where the pressure sensation starts to be experienced as pain), the individual will press a button at a handheld device, that will automatically store the pressure value in the system and serve as an indication, for the examiner, to stop the testing.
TS: A pinprick stimulator (Weight: 256mNewton) will be used. The examiner will apply the pen that features a retractable blunt needle in a repetitive manner (once per second for ten seconds). The individual will be asked for the intensity of pain (NRS) at the first and at the last time and the given score will be noted.
CPM: A manual blood pressure sphygmomanometer will be used in conjunction with the electronic algometer described above (PPT).
- Other Names :
- Pain Pressure Detection Threshold (PPT), Temporal Summation (TS), Conditioned Pain Modulation (CPM) | #Eligibility Criteria:
Inclusion Criteria:
* have the ability to give informed consent.
* be 18 years or over
* be diagnosed with chronic LBP
* be enlisted for participation in a self-management program
* be able to speak and understand English as all questionnaires are validated in the English language.
Exclusion Criteria:
* Inability to give informed consent due to cognitive impairment or otherwise
* Inability to understand key aspects of the study due to cognitive impairment or otherwise
* Patients giving history of additional co-morbidities such as cancer, diabetic neuropathies, fractures or other conditions causing greater disability than their back pain.
* Pregnancy
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT03972332 | {
"brief_title": "Pain Experience in Individuals With Chronic Low Back Pain",
"conditions": [
"Low Back Pain"
],
"interventions": [
"Diagnostic Test: Quantitative Sensory Testing"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT03972332",
"official_title": "Pain Experience in Individuals With Chronic Low Back Pain: a Cohort Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-20",
"study_completion_date(actual)": "2020-03-20",
"study_start_date(actual)": "2018-07-27"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-25",
"last_updated_that_met_qc_criteria": "2019-05-30",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-06-03",
"first_submitted": "2019-05-30",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Breast cancer is one of the three most common cancers worldwide, and the primary treatment method is surgery.Since most patients are non-smokers who use opioids in the postoperative period, which are known risk factors for postoperative nausea and vomiting (PONV) according to the Apfel Risk Score. Breast surgery was identified as a strong risk factor for PONV. According to the previous studies, the incidence of PONV is 30-70% in patients undergoing the breast cancer surgery, which not only gives patients unpleasant and painful experience, but also prolongs the hospital stays and delay patient discharge and adds to hospital costs. We compared the effects of dexamethasone alone vs. in combination with Pericardium 6 (P6) electrical stimulation or granisetron for inhibition of PONV in women undergoing breast cancer surgery.
Detailed Description
186 patients who are planed to undergo elective breast cancer surgery under general anaesthesia into the following three groups: acupoint stimulation+dexamethasone (Group Acu, n=62), granisetron +dexamethasone (Group Gra, n=62), and dexamethasone alone (Group Dxm, n=62). The incidence of nausea, vomiting, and need for rescue antiemetics was recorded 2, 6, 24, and 48 h after surgery.
#Intervention
- DEVICE : electric stimulation therapy
- Transcutaneous electrical acupoint stimulation (TEAS) was achieved by an electrical neuromuscular stimulation device (JNR2; designed by the Department of Hand Surgery, Huashan Hospital, Fudan University, manufactured by Energy Conservation and Environment Protection Technology Company, Jiatong University, Shanghai,China) | #Eligibility Criteria:
Inclusion Criteria:
* women undergoing breast cancer resection under general anesthesia
* aged between 18 to 65
* American Society of Anesthesiologists grade I-II
Exclusion Criteria:
* using antiemetic drugs within 24 h before operation,
* nausea or vomiting within 24 h before operation;
* Alcoholic or drug abuse,
* abnormal liver and/or kidney function, diabetic or peripheral neuropathy patients, cardiovascular disease (excluding those with controlled hypertension).
* refuse to participate clinical trial
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT05408676 | {
"brief_title": "Comparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery",
"conditions": [
"Mammary Cancer",
"PONV"
],
"interventions": [
"Device: electric stimulation therapy"
],
"location_countries": [
"China"
],
"nct_id": "NCT05408676",
"official_title": "Comparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-30",
"study_completion_date(actual)": "2023-05-02",
"study_start_date(actual)": "2022-06-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-09-26",
"last_updated_that_met_qc_criteria": "2022-06-03",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-06-07",
"first_submitted": "2022-05-30",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC.
Additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.
#Intervention
- DRUG : peginterferon alfa-2a 180μg
- 180μg（s.c.）/week for 48 weeks
- DRUG : peginterferon alfa-2a 90μg
- 90μg(s.c.)/week for 48 weeks
- DRUG : ribavirin
- 600, 800, or 1,000 mg X 2(p.o.)/day | #Eligibility Criteria:
Inclusion Criteria:
* Patients aged 20 <= age <= 75-old with quantifiable serum HCV-RNA (>= 500 IU/mL), elevated serum alanine aminotransferase activity (>= 45 IU per liter) within sixty days of screening, and proven CHC with compensated LC (Child-Pugh A) on liver biopsy.
Exclusion Criteria:
* Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
* Thrombocytopenia (fewer than 75,000 platelets per cubic millimeter)
* Anemia (less than 12 g hemoglobin per deciliter )
* Hepatitis B co-infection; decompensated liver disease.
* Organ transplant
* Creatinine clearance less than 50 milliliters per minute
* Poorly controlled psychiatric disease
* Poorly controlled diabetes
* Malignant neoplastic disease
* Severe cardiac or chronic pulmonary disease
* Immunologically mediated disease
* Retinopathy
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00304551 | {
"brief_title": "A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)",
"conditions": [
"Liver Cirrhosis",
"Chronic Hepatitis C"
],
"interventions": [
"Drug: peginterferon alfa-2a 180μg",
"Drug: ribavirin",
"Drug: peginterferon alfa-2a 90μg"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT00304551",
"official_title": "A Phase II/III Study of Peginterferon Alfa-2a in Combination With Ribavirin for the Treatment of CHC With Compensated LC",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-12",
"study_completion_date(actual)": "2010-06",
"study_start_date(actual)": "2006-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-06-03",
"last_updated_that_met_qc_criteria": "2006-03-16",
"last_verified": "2010-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-03-20",
"first_submitted": "2006-03-05",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a reduction in mucus viscosity. As part of the search for more effective forms of therapy against H. pylori when it colonizes not only the surface of the surface mucosal cells but also the surface mucous gel layer covering the mucosal surface of the stomach. The investigators decided to investigate whether or not endonase might have additive effect of pronase on the efficacy of eradication therapy against Helicobacter pylori.
#Intervention
- DRUG : Endonase
- PPI- based triple therapy with endonase | #Eligibility Criteria:
Inclusion Criteria:
Male or Female with 18 years or more of age without history of H. pylori eradication AND
* Patients with H. pylori associated peptic ulcer in scar stage, OR
* Non-ulcer dyspepsia patients with H. pylori infection
Exclusion Criteria:
* Under 18 years, OR
* Patients with a history of previous treatment of H. pylori infection, OR
* Pregnant or Breast feeding women, OR
* Patients with severe renal, liver, or heart disease, OR
* Patients with gastric malignancy, OR
* Patients with a history of drug allergy or hypersensitivity, OR
* Patients who had received treatment with antibiotics or proton pump inhibitors, H2 Blocker, Bismuth preparation, Anticoagulant, Ketoconazole, Glucocorticoid during the 2 weeks preceding endoscopy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01645761 | {
"brief_title": "Additive Effect of Endonase on Eradication Rate of First Line Therapy for Helicobacter Pylori",
"conditions": [
"Gastric Ulcer Associated With Helicobacter Pylori"
],
"interventions": [
"Drug: Endonase"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT01645761",
"official_title": "Additive Effect of Endonase on Eradication Rate of the 7-day Standard Proton Pump Inhibitor-based Triple Therapy for Helicobacter Pylori",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-08",
"study_completion_date(actual)": "2013-08",
"study_start_date(actual)": "2012-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-01-22",
"last_updated_that_met_qc_criteria": "2012-07-18",
"last_verified": "2014-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-07-20",
"first_submitted": "2012-07-16",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The objective of this study is to evaluate the impact of VRSim 3.0 on power wheelchair (PWC) driving skills and to obtain qualitative feedback from users on the design of the virtual reality (VR) simulator to inform device development.
Detailed Description
A virtual reality platform may lead to better training of people with complex disabilities who desire to be power wheelchair users and thus allow them to benefit from living a more active life. A virtual reality training program could significantly impact the lives of people with disabilities by improving function, reducing abandonment of power wheelchairs, and reducing morbidity and mortality and associated costs occurring from power wheelchair accidents. This new virtual reality training program will reflect improvements in accessibility, customization, simulator sickness, ease of use, and will have report generating capabilities as compared to previous virtual reality training platforms. The investigators expect that virtual reality training will be a superior alternative to standard in-person wheelchair training.
#Intervention
- OTHER : VRSim 3.0
- VRSim 3.0 is a virtual reality training module.
- BEHAVIORAL : In-Person Wheelchair Training
- A therapist will be used to train power wheelchair users. | #Eligibility Criteria:
Inclusion Criteria:
* Volunteers must be >= 14 years.
* Volunteers must have a disability that prevents them from effectively and independently using a manual wheelchair, power assist wheelchair, or scooter.
* Volunteers must be able to communicate in English, follow simple commands, and give written informed consent.
Exclusion Criteria:
* Volunteers with active seizures.
* Volunteers who have active pelvic or thigh wounds.
* Volunteers who require a test wheelchair but who exceed the weight capacity of the test wheelchair (>300 lbs).
* Volunteers who require a test wheelchair but also require specialized seating that cannot be replicated for the training.
Sex :
ALL
Ages :
- Minimum Age : 14 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT03562455 | {
"brief_title": "Virtual Reality for Power Wheelchair Training",
"conditions": [
"Spinal Diseases"
],
"interventions": [
"Other: VRSim 3.0",
"Behavioral: In-Person Wheelchair Training"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03562455",
"official_title": "Assessing the Effectiveness of Virtual Reality for Power Wheelchair Driving Training",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-08-02",
"study_completion_date(actual)": "2019-08-02",
"study_start_date(actual)": "2018-06-19"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-08-09",
"last_updated_that_met_qc_criteria": "2018-06-07",
"last_verified": "2022-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-06-19",
"first_submitted": "2018-05-22",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The objective of this study is to determine the effect of 8 weeks of treatment with colesevelam HCl 3.75 g once daily with the evening meal on ß-cell function by evaluating the acute insulin response (AIRg) to an intravenous glucose load in subjects with prediabetes (impaired fasting glucose).
Detailed Description
Colesevelam is a bile acid sequestrant that was initially approved for treatment of patients with dyslipidemia. Subsequently it was observed that patients with type 2 diabetes receiving this medication had improved glucose control. However, the mechanism(s) by which it lowers glucose concentrations has not been determined.
Glucose metabolism is enhanced following oral nutrient ingestion by the action of the incretin hormones. The two major incretin hormones are the peptides glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP), which are released from the intestinal tract wall in response to a meal. Of these two peptides, GLP-1 appears to be more important in regulating glucose metabolism. In the presence of elevated plasma glucose, GLP-1 promotes insulin release from the ß-cells of the pancreas. GLP-1 also suppresses glucagon release, and thereby inhibits hepatic glucose output. Administration of GLP-1 by infusion or by subcutaneous injection has been shown to improve glucose tolerance in type 2 diabetic patients.
The purpose of this study is therefore to determine in a cohort of individuals with prediabetes, who have an elevated fasting plasma glucose and are at increased risk of developing type 2 diabetes, whether the glucose lowering properties of colesevelam occur by it improving insulin sensitivity, islet ß-cell function or both. Further, by assessing the effect of colesevelam on incretin hormone release, it will be possible to determine whether any improvement in islet ß-cell function is due to enhanced incretin stimulation.
#Intervention
- DRUG : Colesevelam
- colesevelam HCl 3.75 g once daily orally with the evening meal
- Other Names :
- colesevelam HCl
- OTHER : placebo
- tablet (s) orally given with evening meal | #Eligibility Criteria:
Inclusion Criteria:
* Males or females (postmenopausal, surgically sterile or using double-barrier method of contraception), aged 18 <= age <= 75 years, FPG 100 <= age <= 115 mg/dl at screening (average of 2 measurements during screening; no individual measurement outside of the range 92 <= age <= 125 mg/dl)
* In good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis
* HbA1c <6.5% at screening
* Body mass index (BMI) in the range of 22 <= age <= 40 kg/m2 inclusive and with a stable (+/-2.5 kg) weight for the last 6 months
* Subjects must be willing to:
* Maintain prior exercise and dietary habits throughout the study
* Comply with all study requirements
* Provide written informed consent
Exclusion Criteria:
* Pregnant or lactating females
* Patients diagnosed with type 2 diabetes or that have taken glucose-lowering agents or insulin, except during pregnancy
* Chronic oral or parenteral corticosteroid treatment (>7 consecutive days of treatment) within 8 weeks prior to screening
* HIV protease inhibitors
* Warfarin or phenytoin use
* Triglycerides >500 mg/dl
* History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
* History of dysphagia, swallowing disorders or intestinal motility disorder
* History of pancreatitis
* Uncontrolled hypothyroidism
* Individuals with clinical hepatic disease or liver function tests greater than >=2 times upper limits of normal within 30 days preceding the first dose of study drug
* On a weight loss program with ongoing weight loss, or starting an intensive exercise program within 4 weeks of study initiation
* Current or prior (within the past 3 months) treatment with a bile acid sequestrant (colesevelam, colestipol, colestimide, or cholestyramine)
* Use of any investigational drug in the last 30 days
* Donation of one unit (500 ml) or more of blood, significant blood loss equaling at least one unit of blood within the past 2 weeks or a blood transfusion within 8 weeks prior to screening
* Employment by the research center
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00990184 | {
"brief_title": "Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)",
"conditions": [
"Impaired Fasting Glucose",
"Prediabetes"
],
"interventions": [
"Other: placebo",
"Drug: Colesevelam"
],
"location_countries": null,
"nct_id": "NCT00990184",
"official_title": "A Single-Blind Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-10",
"study_completion_date(actual)": "2010-10",
"study_start_date(actual)": "2009-09"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-11-21",
"last_updated_that_met_qc_criteria": "2009-10-05",
"last_verified": "2012-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-10-06",
"first_submitted": "2009-10-02",
"first_submitted_that_met_qc_criteria": "2012-10-22"
}
}
} |
#Study Description
Brief Summary
The purpose of this research study is to learn new information about the underlying cause of aspirin-exacerbated respiratory disease (AERD) and the benefit of high-dose aspirin therapy. AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs. This study will be conducted on individuals with AERD who are referred to the Brigham and Women's Hospital AERD Center for clinical evaluation and potential aspirin desensitization. Desensitization to aspirin and subsequent treatment with daily high-dose oral aspirin is standard of care for patients with AERD who do not respond adequately to steroids and have recurrent nasal polyposis or symptomatic asthma. This study will involve five visits to Brigham and Women's Hospital and will align closely with the standard of care for the treatment of AERD.
#Intervention
- DRUG : aspirin | #Eligibility Criteria:
Inclusion Criteria:
* History of asthma
* History of nasal polyposis
* History of at least one clinical reaction to oral aspirin or other nonselective COX inhibitor with features of both lower (cough, chest tightness, wheezing, dyspnea) and upper (rhinorrhea, sneezing, nasal obstruction, conjunctival itching and discharge) airway involvement
* Stable asthma (post-bronchodilator FEV1 of >=70%, no use of oral or systemic steroids for at least 1 month, and no hospitalizations or emergency room visits for asthma for the prior 6 months) at the time of entry into the study
* Currently taking montelukast as part of standard asthma treatment for at least 4 weeks before the V1 visit
Exclusion criteria:
* Pregnancy or current breastfeeding
* History of bleeding diathesis or use of anticoagulant or antiplatelet drugs
* History of thrombocytopenia < 50 x 10^9/L
* Hypersensitivity to montelukast
* Peptic ulcer disease
* Unstable asthma (post-bronchodilator FEV1 of less than 70%, use of oral or systemic steroids for at least 1 month prior to visit 1, or hospitalizations or emergency room visits for asthma for the prior 6 months)
* Use of zileuton (which can mask symptoms of aspirin-induced reaction) within 1 month prior to the V1 visit
* Age under 18 or > 75 years
* Current smoking
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02824523 | {
"brief_title": "Role of Inflammatory Mediators in AERD",
"conditions": [
"Asthma, Aspirin-Induced"
],
"interventions": [
"Drug: aspirin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02824523",
"official_title": "Role of PDG2 in the Aspirin-Induced Reactions and in the Treatment of Aspirin-Exacerbated Respiratory Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-05-01",
"study_completion_date(actual)": "2021-05-01",
"study_start_date(actual)": "2016-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-09-30",
"last_updated_that_met_qc_criteria": "2016-07-01",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-06",
"first_submitted": "2016-06-24",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this exploratory study is to determine whether memantine can provide benefits on clinical symptoms in patients with Parkinson's Disease Dementia or Dementia with Lewy Bodies.
Detailed Description
The objective of this exploratory study is to assess the benefits of memantine compared to placebo in out-patients with a diagnosis of Parkinson's Disease Dementia or Dementia with Lewy Bodies (mild to moderate severity) over a 6-month period. This is a multinational, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study with specific cognitive (attention, executive function, visual perception and memory), behavioural, functional and global measures.
#Intervention
- DRUG : Memantine
- 20mg once daily oral dose
- Other Names :
- Ebixa®
- DRUG : Placebo
- Daily oral dose | #Eligibility Criteria:
Inclusion Criteria:
* The study population will consist of male or female outpatients at least 50 years with mild to moderate disease severity (MMSE 12 to 24 inclusive) according to UKPDS and DSM IV TR criteria (for PDD patients) and the third report of the DLB consortium (for DLB patients) and who have a knowledgeable and reliable caregiver to accompany the patient to all clinic visits during the course of the study.
Exclusion Criteria:
* Evidence of clinically significant active disease, evidence of other neurological disorders, and current treatment with AChEIs.
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00855686 | {
"brief_title": "Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies",
"conditions": [
"Parkinson's Disease Dementia",
"Dementia With Lewy Bodies"
],
"interventions": [
"Drug: Placebo",
"Drug: Memantine"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT00855686",
"official_title": "A Randomised, Double-blind, Placebo-controlled, 6-month Study of the Efficacy and Safety of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-12",
"study_completion_date(actual)": "2009-01",
"study_start_date(actual)": "2007-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-09-20",
"last_updated_that_met_qc_criteria": "2009-03-03",
"last_verified": "2013-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-03-04",
"first_submitted": "2009-03-03",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This phase II trial will investigate the combination of adjuvant 5-fluorouracil, radiation, and bevacizumab in patients with stage II and III rectal cancer, followed by FOLFOX6 and bevacizumab. Fluorouracil (FU) has proven to be an effective and safe regimen in the treatment of stage II and III rectal cancer. Recent evidence has proven fluorouracil/leucovorin (FL) in combination with bevacizumab is superior to FL alone and when combined with irinotecan is superior to (irinotecan plus fluorouracil/leucovorin (IFL) alone. This trial will be one of the first clinical trials to evaluate a combination of targeted therapy, radiation, and chemotherapy in the adjuvant treatment of a common solid tumor.
Detailed Description
All eligible patients will receive combined modality treatment initially. Systemic treatment will begin 4-6 weeks after completion of the Combined Modality portion and will complete 4 cycles of a 4 week regimen. Patients with no evidence of disease following systemic therapy may continue single agent bevacizumab for up to one year. After all treatment is completed, patients will be re-evaluated with imaging to establish a new baseline. Patients will be re-evaluated thereafter for up to a total of 5 years.
Combined Modality Treatment:
* bevacizumab 5mg/kg IV infusion days 1, 15, and 29
* fluorouracil 225mg/m2 IV continuous infusion days 1-42
* radiation 1.8 Gy/day or 28 fractions weeks 1-6
Systemic Treatment:
* 5-fluorouracil 400 mg/m2 bolus
* 5-fluorouracil 2400 mg/m2 over 46 hours days 1 and 15
* leucovorin 350 mg prior to FU on days 1 and 15
* oxaliplatin 85 mg/m2 days 1 and 15
* bevacizumab 5 mg/kg days 1 and 15
#Intervention
- DRUG : 5-Fluorouracil
- Combined Modality Treatment:
fluorouracil 225mg/m2 IV continuous infusion days 1-42
Systemic Treatment:
5-fluorouracil 400 mg/m2 bolus 5-fluorouracil 2400 mg/m2 over 46 hours days 1 and 15
- Other Names :
- Fluorouracil, Efudex, 5-FU
- DRUG : Bevacizumab
- Combined Modality Treatment:
bevacizumab 5mg/kg IV infusion days 1, 15, and 29
Systemic Treatment:
bevacizumab 5 mg/kg days 1 and 15
- Other Names :
- Avastin
- PROCEDURE : Radiation Therapy
- radiation 1.8 Gy/day or 28 fractions weeks 1-6
- DRUG : Oxaliplatin
- Systemic Treatment:
oxaliplatin 85 mg/m2 days 1 and 15
- Other Names :
- Eloxatin
- DRUG : Leucovorin
- Systemic Treatment:
leucovorin 350 mg prior to FU on days 1 and 15
- Other Names :
- Folinic acid | #Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed Stage I or II rectal cancer
* Patients must be candidates for preoperative or adjuvant chemoradiation.
* Patients enrolling in the adjuvant chemoradiation cohort must have undergone surgical resection of the primary rectal tumor between 28 and 56 days (i.e., 4 <= age <= 8 weeks) prior to study treatment.
* ECOG performance status 0 <= age <= 1
* Adequate bone marrow, liver, and kidney function
* At least 18 years
* Able to give written informed consent
Exclusion Criteria:
* Treatment with prior chemotherapy or radiation for rectal cancer
* History of myocardial infarction
* Uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication or peripheral vascular disease
* History of stroke within 6 months
* History of abdominal fistula, gastrointestinal perforation, or intrabdominal abscess within 6 months
* Symptomatic sensory or peripheral neuropathy
* Prior treatment with anti-angiogenic agents
* Prior malignancy in the past 5 years
* Active infections or serious underlying medical condition
* Major surgery less than 28 days prior
* Women who are pregnant or lactating
* Thrombolytic therapy within 10 days of starting bevacizumab
* PEG tube, G-tube, or external biliary stents
* Proteinuria
* Non healing wound, ulcer or fracture
* History of bleeding diathesis or coagulopathy
* Hemoptysis
* Participation in another experimental trial within 28 days
* Uncontrolled anticoagulant therapy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00308516 | {
"brief_title": "5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in Stage II/III Rectal Cancer",
"conditions": [
"Rectal Cancer",
"Cancer of the Rectum",
"Colorectal Cancer"
],
"interventions": [
"Drug: 5-Fluorouracil",
"Drug: Oxaliplatin",
"Procedure: Radiation Therapy",
"Drug: Bevacizumab",
"Drug: Leucovorin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00308516",
"official_title": "A Phase II Study of 5-Fluorouracil, Bevacizumab (Avastin), and Radiation in the Preoperative or Adjuvant Treatment of Patients With Stage II / III Rectal Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-04",
"study_completion_date(actual)": "2012-02",
"study_start_date(actual)": "2006-03"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-12-10",
"last_updated_that_met_qc_criteria": "2006-03-28",
"last_verified": "2021-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-03-29",
"first_submitted": "2006-03-28",
"first_submitted_that_met_qc_criteria": "2013-03-26"
}
}
} |
#Study Description
Brief Summary
The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX
Detailed Description
This was a global, multicenter, Phase III, prospective, open-label, randomized, crossover study. After obtaining informed consent and performance of screening procedures, patients who met all inclusion and exclusion criteria were randomized to one of two treatment regimens as follows:
* 75 µg/kg treatment regimen
* 225 µg/kg treatment regimen
For each treatment regimen there were two phases:
* Phase A (Initial phase)
* Phase B (Treatment phase)
The assigned treatment regimen was the dose administered in Phase A and was the starting dose in Phase B.
#Intervention
- BIOLOGICAL : Coagulation Factor VIIa (Recombinant)
- A cross over design to assess the efficacy of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX | #Eligibility Criteria:
Inclusion Criteria:
* be male with a diagnosis of congenital hemophilia A and/or B of any severity
* have one of the following:
* a positive inhibitor test Bethesda Unit (BU) >= 5 (as confirmed at screening by the institutional lab), OR
* a BU<5 but expected to have a high anamnestic response to FVIII or FIX, as demonstrated from the subject's medical history, precluding the use of Factor VIII or IX products to treat bleedings, OR
* a BU<5 but expected to be refractory to increased dosing of FVIII or FIX, as demonstrated from the subject's medical history, precluding the use of Factor VIII or IX products to treat bleedings
* be >= 12 years, up to and including 75 years (NOTE: different age restrictions may apply per local regulation and/or ethical considerations)
* have at least 3 bleeding episodes of any severity in the past 6 months be capable of understanding and willing to comply with the conditions of the protocol
* have read, understood and provided written informed consent (patient and/or parent(s)/legal guardian(s) if <18 years)
Exclusion Criteria:
* have any coagulation disorder other than hemophilia A or B
* be immuno-suppressed (i.e., the patient should not be receiving systemic immunosuppressive medication, cluster of differentiation 4 (CD4) counts at screening should be >200/µl)
* have a known allergy or hypersensitivity to rabbits
* have platelet count <100,000/mL
* have had within one month prior to first administration of the study drug in this study a major surgical procedure (e.g. orthopedic, abdominal)
* have received an investigational drug within 30 days of the first study drug administration, or is expected to receive such drug during participation in this study
* have a clinically relevant hepatic (AST and/or alanine aminotransferase (ALT) >3 times the upper limit of normal) and/or renal impairment (creatinine >2 times the upper limit of normal)
* have a history of arterial and/or venous thromboembolic events (such as myocardial infarction, ischemic strokes, transient ischemic attacks, deep venous thrombosis or pulmonary embolism) within 2 years prior to first dose of study drug, or current New York Heart Association (NYHA) functional classification score of stage II -IV
* have an active malignancy (those with non-melanoma skin cancer are allowed)
* have any life-threatening disease or other disease or condition which, according to the investigator's judgment, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome (e.g., a history of non-responsiveness to bypassing products).
Sex :
MALE
Ages :
- Minimum Age : 12 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT02020369 | {
"brief_title": "Phase III Study of Coagulation FVIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors",
"conditions": [
"Hemophilia A With Inhibitors",
"Hemophilia B With Inhibitors"
],
"interventions": [
"Biological: Coagulation Factor VIIa (Recombinant)"
],
"location_countries": [
"Israel",
"Ukraine",
"Georgia",
"United States",
"Poland",
"Romania",
"Russian Federation",
"Bulgaria",
"Belarus",
"United Kingdom"
],
"nct_id": "NCT02020369",
"official_title": "A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors to Factor VIII or IX",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-07",
"study_completion_date(actual)": "2015-08",
"study_start_date(actual)": "2014-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-06-14",
"last_updated_that_met_qc_criteria": "2013-12-18",
"last_verified": "2017-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-12-24",
"first_submitted": "2013-12-18",
"first_submitted_that_met_qc_criteria": "2017-05-15"
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of a single treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.
#Intervention
- DRUG : PRX302
- Single intraprostatic injection with an ascending dose per cohort of 0.75, 1.5, 3.0, and 6.0 µg/mL
- DRUG : Placebo
- Single intraprostatic injection of matching placebo | #Eligibility Criteria:
Inclusion Criteria:
* Lower Urinary Tract Symptoms (LUTS) attributable to BPH for >=6 months
* Written informed consent prior to enrollment in the study
* IPSS >=12
* Prostate volume of 30 - 100 mL as determined by TRUS
* Maximum urine flow (Qmax) of 4 - 15 mL/sec
* Refractory, intolerant or refused the use of alpha-blockers and/or 5 alpha-reductase inhibitors
* Unwilling or unable to undergo conventional surgical or available minimally invasive treatments
* Blood PSA values <10 ng/mL
Exclusion Criteria:
* Inability to void at least 125 mL of urine
* PVR volume >200 mL
* Presence of or history of certain conditions that could interfere with study results or endanger subject
* Use of certain prescribed medications that could interfere with study results
Sex :
MALE
Ages :
- Minimum Age : 50 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01454349 | {
"brief_title": "Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)",
"conditions": [
"Benign Prostatic Hyperplasia"
],
"interventions": [
"Drug: PRX302",
"Drug: Placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01454349",
"official_title": "A Randomized Dose-Escalation, Multicenter Safety and Efficacy Study of a Single Transrectal Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-03",
"study_completion_date(actual)": "2013-08",
"study_start_date(actual)": "2011-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-08-21",
"last_updated_that_met_qc_criteria": "2011-10-14",
"last_verified": "2013-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-10-19",
"first_submitted": "2011-09-27",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to determine the average dosage of oral vitamin D supplementation to maintain optimal vitamin D levels in the body and to see if there are differences in the response to oral vitamin D supplementation between African-American and Caucasian subjects.
Detailed Description
There is ample evidence that improvement in vitamin D nutrition retards bone loss and prevents fractures in the elderly. It is clear that many people living in areas of northern latitude have less than optimal levels of vitamin D. The current recommendations for vitamin D intake are not enough to bring a large majority of the population to the desired adequate level. Furthermore, differences have been observed in the amount of Vitamin D produced in the skin in whites and blacks.
Based on the evidence from literature and our experience from prior studies we hypothesize that:
1. the dose of oral vitamin D3 supplement exceeds current recommendations to achieve adequate desired level;
2. there may be differences in the dose-response to vitamin D supplement between Blacks and Whites; and
3. vitamin D supplementation that produces serum 25-hydroxyvitamin D (25-OHD) levels in the range proposed is safe.
The aims for this pilot study are to determine:
1. the average dose of vitamin D3 needed to attain 25-OHD levels between 80-140 nmol/L in a healthy population of mixed races; and
2. if there are differences in response to vitamin D3 supplementation between African American and Caucasians subjects.
#Intervention
- DRUG : Oral Vitamin D Supplementation | #Eligibility Criteria:
Inclusion Criteria:
* Healthy African-American and Caucasian adults aged 18 <= age <= 65 years.
Exclusion Criteria:
* Subjects who are not either African-American or Caucasian. The investigators plan to examine racial differences in response to oral vitamin D dosing and, therefore, have chosen the most affected (African-American) and the least affected (Caucasian) racial groups. Including other racial/ethnic groups may confound the results unless they are studied as separate groups.
* Any chronic medical illness including diabetes mellitus, history of myocardial infarction or heart failure, malignancy, hypertension (systolic blood pressure [SBP] > 140), obesity (body mass index [BMI] > 35 kg/m2), history of anemia, leukemia, or other hematologic abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney disease of any kind as determined by history and physical examination.
* Subjects with osteoporosis or taking medications for osteoporosis such as bisphosphonates.
* Pregnancy.
* Use of medication that influences bone metabolism (i.e. anticonvulsant medications, steroids, diuretics).
* Significant deviation from normal in either history, physical examination, or laboratory tests, as evaluated by the primary investigator.
* Patients with a history of hypercalciuria, hypercalcemia, nephrolithiasis, and active sarcoidosis.
* Participation in another investigational trial in the past 30 days prior to the screening evaluation.
* Unexplained weight loss of > 15% during the previous year or history of anorexia nervosa.
* Medications that interfere with vitamin D metabolism. Oral contraceptive use will be allowed, but will be appropriately documented.
* Smokers greater than 1 pack per day.
* Patients reporting alcohol intake greater than 2 drinks daily.
* Subjects with baseline 25-OHD level greater than 80 nmol/L or less than 20 nmol/L.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT00327847 | {
"brief_title": "Optimizing Vitamin D Nutrition in Healthy Adults",
"conditions": [
"Vitamin D Deficiency"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00327847",
"official_title": "Optimizing Vitamin D Nutrition in Healthy Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-12",
"study_completion_date(actual)": "2006-12",
"study_start_date(actual)": "2004-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-09-25",
"last_updated_that_met_qc_criteria": "2006-05-18",
"last_verified": "2008-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-05-19",
"first_submitted": "2006-05-18",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this research study is to determine whether a simple blood test measuring a hormone called renin can better determine which first drug would be most effective in controlling blood pressure, in comparison with the more traditional approach recommended by JNC7 (Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure).
Detailed Description
Hypothesis: That antihypertensive drug selection guided by activity of the renin angiotensin system will be superior to the strategy advocated in JNC 7 in achieving blood pressure control on monotherapy.
Background: the National Heart, Lung, and Blood Institute, through the Joint National Committee on the Detection, Treatment and Control of Hypertension (JNC 7) has recommended that most hypertensive patients begin therapy with a diuretic and sequentially add other classes of drugs until blood pressure is controlled. This approach appears to assume homogeneity in the mechanism by which BP is controlled in different patients. When this standardized strategy has been rigidly applied in Clinical Trials, a majority of patients generally require 2 or more agents to achieve blood pressure control.
The pioneering work of Laragh, Sealey and their colleagues, widely confirmed by others, suggests instead that heterogeneity, in fact, characterizes patterns of blood pressure control in populations. This heterogeneity can be exposed through assessment of the activity of the renin angiotensin system (RAS). Specifically, volume and vasoconstriction determine blood pressure control. Patients in whom volume predominates have suppressed RAS, and, conversely, those in whom vasoconstriction predominates will have an activated RAS. This can be simply and accurately determined by estimation of plasma renin activity (PRA).
It has been demonstrated that volume and vasoconstriction dependent hypertensive patients respond best to different drugs. By exploitation of the RAS it is possible to provide rational therapy to each patients according to the mechanism by which blood pressure is controlled. The result is that appropriate therapy can be both more effective and more efficient. A specific system the Laragh Method has been designed to translate this physiologically based paradigm into a practical scheme or patient management.
The purpose of this trial is to determine whether the Laragh Method will lead to better and more efficient blood pressure control in a general population of hypertensive patients than does the existing treatment strategy. The measure by which this hypothesis will be tested is percentage of hypertensive patients achieving blood pressure control on monotherapy.
The significance of this trial is enormous for both individuals and society. Some 50 million Americans have hypertension and more than 25 million are currently in treatment. If the Laragh Method leads to more parsimonious and effective care, it will mean literally millions of individual patients will be spared the burden of unnecessary polypharmacy. Moreover, the strain on health care costs associated with antihypertensive therapy will be redu
#Intervention
- DRUG : olmesartan, hydrochlorothiazide, amlodipine
- hydrochlorothiazide (HCTZ) 25mg OD, increased to 50 mg OD at 3 weeks. Olmesartan 20 mg OD, to be increased to 40 mg at 3 weeks. Amlodipine 5 mg, may be added at 6 weeks, if BP \>140 mmHg
- Other Names :
- Renin guided selection of treatment
- DRUG : hydrochlorothiazide (HCTZ) or olmesartan
- HCTZ 25 mg, increasing to 50 mg at 3-4 weeks or Olmesartan 20 mg, increasing to 40 mg at 3-4 weeks. If blood pressure \>140/90 mmHg at 6 weeks, amlodipine 5 mg may be added
- Other Names :
- Standard Therapy | #Eligibility Criteria:
Inclusion Criteria:
* Males and females, 40 <= age <= 85 of age
* Sustained systolic blood pressure between 140 <= age <= 180 mm Hg
* Free of antihypertensive therapy at randomization for at least 4 weeks
Exclusion criteria:
* Ages <40, or >85 years
* Systolic blood pressure >180 mm Hg
* Blood pressure >180/105 mm Hg during the washout period
* Require antihypertensive agents for non-blood pressure indications
* Taking clonidine
* On a beta-blocker drug and have known or suspected coronary artery disease
* Documented history of a heart attack, new onset of chest pain, or a coronary revascularization procedure within the past year, congestive heart failure
* Serious intercurrent illness
* An active ulcer
* Have certain abnormal laboratory tests (elevated serum creatinine >1.5 mg/dl, transaminase > 2 times upper limit of normal or active liver disease),
* Hypersensitivity, allergy or have an intolerance to angiotensin II receptor blockers (olmesartan), hydrochlorothiazide or amlodipine
* Mentally or legally unable to participate
* Have or are currently abusing alcohol, have abused drugs within the past 2 years
* Have been in another drug study in the past month.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00834600 | {
"brief_title": "Renin Profiling in Selection of Initial Antihypertensive Drug",
"conditions": [
"Hypertension"
],
"interventions": [
"Drug: hydrochlorothiazide (HCTZ) or olmesartan",
"Drug: olmesartan, hydrochlorothiazide, amlodipine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00834600",
"official_title": "A Clinical Trial of Renin Profiling in Selection of Initial Antihypertensive Drug",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-10",
"study_completion_date(actual)": "2011-10",
"study_start_date(actual)": "2005-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-04-19",
"last_updated_that_met_qc_criteria": "2009-01-30",
"last_verified": "2010-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-02-03",
"first_submitted": "2009-01-30",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
It is a phase 4 study, not randomised and multicentric. Within 2 months after the diagnosis, the patients daily receive imatinib by oral way during at least 1 year (260mg/m² once a day), i.e. until the cytogenetic analysis.
Beyond 1 year of treatment, if a haematological relapse or a loss of the cytogenetic response is observed, the nature of the treatment suggested to the patient is left with the appreciation of the investigator.
Later on, discontinuation of imatinib is discussed if a molecular remission (negative RT-PCR) is obtained and maintained for at least 2 years.
#Intervention
- DRUG : Imatinib mesylate 100 mg (Glivec)
- 260 mg/m2/day tablets | #Eligibility Criteria:
Inclusion Criteria:
* Old < 18 years, male or female.
* Chronic myeloid leukaemia confirmed on the cytogenetic level by the presence of the translocation t(9; 22) (q34; q11) or by the presence of transcript BCR-ABL in the event of absence of description of the translocation t(9; 22) (q34; q11).
* Chronic phase of a chronic myeloid leukaemia
* Absence of extra-medullary disease (except for a hepatomegaly and/or of a splenomegaly).
* Absence of any former treatment of chronic myeloid leukaemia except for hydroxyurea.
* Stop of hydroxyurea at least week before the beginning of the imatinib mesylate.
* Diagnosis of chronic myeloid leukaemia in chronic phase recent (less than 2 months).
* Score of Lansky >= 60.
* Effective contraception among patients in age to procreate.
* Written voluntary informed consent of the two parents or the legal guardian.
Exclusion Criteria:
* Patients with grade 3 / 4 cardiac disease.
* Pathology cardiac, pulmonary, hepatic, renal or neurological of grade > 2 (WHO).
* Participation in a clinical trial in the 28 days preceding the beginning by the treatment.
* Impossible Follow-up during at least 2 years, patient not compliant.
* Expectant mother or nursing.
Sex :
ALL
Ages :
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT00845221 | {
"brief_title": "Glivec in Pediatric Chronic Myeloid Leukemia (CML)",
"conditions": [
"Chronic Myeloid Leukemia"
],
"interventions": [
"Drug: Imatinib mesylate 100 mg (Glivec)"
],
"location_countries": [
"France"
],
"nct_id": "NCT00845221",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-11",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2004-07"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-10-11",
"last_updated_that_met_qc_criteria": "2009-02-17",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-02-18",
"first_submitted": "2009-02-16",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Hypertrophic Cardiomyopathy (HCM) is the most common genetic cardiomyopathy and remains the leading cause of sudden cardiac death in young people and an important cause of heart failure symptoms and death at any age. In HCM, pathological remodeling of the left ventricle involving myocardial fibrosis is likely a major contributor to cardiac dysfunction and also a nidus for the generation of ventricular arrhythmias. Serum markers of collagen turnover have been shown to reliably reflect the magnitude of myocardial fibrosis in a variety of cardiovascular diseases. In addition, aldosterone antagonist drugs have been shown to decrease fibrous tissue formation in the myocardium in certain pathologic cardiovascular states in which aldosterone production is increased. In HCM, aldosterone production is up-regulated and has been implicated in the formation of myocardial fibrosis.
Therefore, the specific aims of this proposal are to:
1. assess serum markers of collagen turnover at baseline and correlate these findings with a variety of clinical and morphologic disease parameters
2. examine the effects of a 12-month treatment with the aldosterone antagonist spironolactone on magnitude of fibrosis as measured by serum markers of collagen turnover as well as changes in clinical and morphologic disease parameters.
3. explore the effects of a 12-month treatment with aldosterone antagonist spironolactone on heart failure status, diastolic function, arrhythmic burden, and total LV mass and quantity of fibrosis by CMR.
The results of this proposal will offer important insights into the clinical significance of myocardial fibrosis in this primary genetic cardiomyopathy. The demonstration that spironolactone decreases fibrosis and improves clinical course would provide the rational for a larger multicenter clinical trial evaluating this novel therapy for improving clinical outcome in patients with HCM.
Detailed Description
Hypertrophic cardiomyopathy (HCM) is the most common inherited cardiac disease in the general population. Myocardial fibrosis has become a prominent and clinically relevant pathophysiologic component of this complex genetic disease, related to the risk for both sudden death and heart failure. For example, left ventricular replacement fibrosis and scarring has been implicated in triggering life threatening ventricular tachycardia/fibrillation and most recently has become a novel risk marker for sudden death, based on in vivo demonstration of extensive late gadolinium enhancement (LGE) with cardiovascular magnetic resonance (CMR). Extensive LGE identifies patients who benefit from primary prevention of sudden death with the implantable cardioverter-defibrillators (ICD), or who evolve to the end-stage of this disease with systolic dysfunction and consideration for heart transplant.
The mineralocorticoid aldosterone has been shown to be a mediator of myocardial fibrosis, and blockade with spironolactone normalizes collagen content in HCM murine models. In addition, aldosterone antagonists have favorable clinical effects in patients with a variety of diseases associated with myocardial scarring such as congestive heart failure, systemic hypertension, and atherosclerotic coronary artery disease. However, it is uncertain whether spironolactone would have similar effects on the clinical and phenotypic expression of a genetic disease such as HCM. Therefore, we investigated whether mineralocorticoid receptor blockade with spironolactone would reduce measures reflecting myocardial fibrosis, producing favorable LV remodeling and ultimately leading to positive clinical effects for patients with HCM.
The general aim of this study is to explore the role of fibrosis in HCM by testing the hypothesis that: the presence of magnitude of myocardial fibrosis bears clinical relevance for patients with HCM, and that mineralocorticoid receptor blockade will reduce myocardial fibrosis and thereby alter the natural history of the disease.
Experimental design: prospective, randomized, double-blind, placebo-controlled trial in a consecutive HCM population at a single clinical center (Tufts Medical Center HCM Institution).
Study procedures: HCM patients were recruited from Tufts Medical Center HCM Institution population from November 2007 to June 2009. Enrolled patients were randomized into two arms; treatment arm received 25mg at the start of study and then increased to target dose of 50mg if serum potassium was \<5.5mmol/L and serum creatinine-baseline creatinine was \<0.5mg/dl. This arm was then followed for 12 months. The control arm of the study received 25mg of placebo over 12 months. There was an additional control arm of age and gender-matched controls without HCM in the control arm to evaluate the serum markers of collagen turnover at baseline. These controls had a one time blood draw of 15mL (3 teaspoons) to assess serum biomarkers of interest and were not be followed for 12 months.
Specific outcome measures:
Primary Outcome: examine the effects of a 12-month treatment with the aldosterone antagonist spironolactone on magnitude of fibrosis as measured by serum markers of collagen turnover as well as changes in clinical and morphologic disease parameters.
Secondary Outcomes: explore the effects of a 12-month treatment with aldosterone antagonist spironolactone on heart failure status, diastolic function, arrhythmic burden, and total LV mass and quantity of fibrosis by CMR.
Secondary Outcome: assess serum markers of collagen turnover at baseline and correlate these findings with a variety of clinical and morphologic disease parameters
#Intervention
- DRUG : Spironolactone
- spironolactone 50mg daily
- Other Names :
- Aldactone
- DRUG : Placebo
- inactive placebo pill daily | #Eligibility Criteria:
Inclusion Criteria:
* Hypertrophic cardiomyopathy
* Able to swallow pills
* No prior septal reduction therapy
* Negative serum or hCG pregnancy test
Exclusion Criteria:
* Unable or unwilling to perform treadmill cardiopulmonary exercise test
* Prior surgical myectomy or alcohol septal ablation
* Known or suspected infiltrative or glycogen storage disease
* Significant coronary artery disease, defined as atherosclerotic coronary artery narrowing >70% of the luminal diameter by coronary angiography
* Severe obstructive pulmonary disease, defined as forced expiratory volume in 1 second (FEV1) <50% of predicted.
* Prior intolerance or adverse reaction to aldosterone receptor antagonist.
* History of hyper or hypoaldosteronism
* Baseline serum potassium >5.0 mmol/L.
* Calculated creatinine clearance <30 ml/min using Cockcroft-Gault formula.
* Pregnant or breast feeding
* Poorly controlled systemic hypertension, defined as systolic blood pressure >=150 mmHg or diastolic pressure >=100 mmHg, during 2 clinic visits.
* Known conditions associated with elevated serum concentrations of PIIINP (e.g., chronic liver disease, diabetes mellitus, tumors, pulmonary fibrosis, bone and rheumatoid diseases, extensive wounds) or PINP (e.g., alcoholic liver disease, metabolic bone disease, thyroid disorders), including recent trauma (<=2 weeks) or surgery (<=6 months)
* Taking drugs known to directly influence collagen metabolism including, amiodorone, ACE or angiotensin II inhibitors, aldosterone antagonists, statins, glucocorticoids and estrogens
* Patients with ICDs/pacemakers will be recruited in the study, but will be excluded from the CMR component.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT00879060 | {
"brief_title": "Clinical and Therapeutic Implications of Fibrosis in Hypertrophic Cardiomyopathy",
"conditions": [
"Myocardial Fibrosis",
"Hypertrophic Cardiomyopathy"
],
"interventions": [
"Drug: Placebo",
"Drug: Spironolactone"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00879060",
"official_title": "Clinical and Therapeutic Implications of Fibrosis in Hypertrophic Cardiomyopathy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-11",
"study_completion_date(actual)": "2012-11",
"study_start_date(actual)": "2007-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-04-27",
"last_updated_that_met_qc_criteria": "2009-04-08",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-04-09",
"first_submitted": "2009-04-08",
"first_submitted_that_met_qc_criteria": "2021-03-31"
}
}
} |
#Study Description
Brief Summary
Weight regain following weight loss is common. In rodent models of obesity and pilot studies in humans, increasing membrane arachidonic acid content improves fuel partitioning and prevents weight regain. This study aims to understand the effect of gamma-linolenic acid (GLA) supplementation on weight loss maintenance in Virta Health patients.
Detailed Description
The primary purpose of this research is to determine if GLA supplementation reduces weight regain over 24 months in Virta Health patients.
The secondary purpose is to determine the effect of GLA supplementation on diabetes-related outcomes.
#Intervention
- DIETARY_SUPPLEMENT : gamma-linolenic acid
- 3 capsules per day of GLA for 24 months
- DIETARY_SUPPLEMENT : placebo
- 3 capsules per day of placebo for 24 months | #Eligibility Criteria:
Inclusion Criteria:
* Age greater than or equal to 18 yrs
* Patients referred to Virta Health by employers or insurers
* Weight loss greater than or equal to 7% of initial weight and current BMI > 25 kg/m2
* Willing to take 3 supplement capsules daily
* Able to understand study procedures and willing to provide informed consent
* English-speaking
Exclusion Criteria:
* Patients who are pregnant or lactating
* Patients who are taking or are prescribed orlistat
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04481724 | {
"brief_title": "Gamma-linolenic Acid Supplementation Study",
"conditions": [
"Weight Trajectory"
],
"interventions": [
"Dietary Supplement: placebo",
"Dietary Supplement: gamma-linolenic acid"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04481724",
"official_title": "Effects of Gamma-linolenic Acid Supplementation on Weight Loss Maintenance in the Virta Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-02-13",
"study_completion_date(actual)": "2023-09-15",
"study_start_date(actual)": "2020-07-22"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-24",
"last_updated_that_met_qc_criteria": "2020-07-19",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-07-22",
"first_submitted": "2020-07-19",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study will evaluate the safety, tolerability and pharmacokinetics of 7HP349, an allosteric integrin activator, in healthy male subjects
Detailed Description
This first-in-human (FIH) study consists of a placebo-controlled, sequential, dose escalation study to determine the safety, tolerability and pharmacokinetics (PK) of 7HP349 following single and multiple oral dose administration to healthy male subjects, with a separate, open-label food effect cohort at the optimal pharmacokinetic dose (OPD). The study will be carried out in 3 parts.
Part A: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, single ascending dose (SAD) escalation study to determine the safety, tolerability and PK of 7HP349 following administration of single oral doses in healthy male subjects, and to define the OPD of 7HP349.
Part B: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, multiple ascending dose (MAD) escalation study to determine the safety, tolerability and PK of 7HP349 following up to 5 once daily oral doses in healthy male subjects.
Part C: This is a randomized, open label, two-treatment, three-period, crossover study to evaluate the effect of the fed or fasting prandial state on the single dose PK of 7HP349.
#Intervention
- DRUG : 7HP349 Single Ascending Dose
- Part A: 7HP349 Capsules, Single Ascending Dose (SAD)
- Other Names :
- 7HP349 SAD
- DRUG : 7HP349 Multiple Ascending Dose
- Part B: 7HP349 Capsules, Multiple Ascending Dose (MAD)
- Other Names :
- 7HP349 MAD
- DRUG : Placebo Single Ascending Dose
- Part A: Placebo Capsules, Single Ascending Dose (SAD)
- Other Names :
- Placebo SAD
- DRUG : Placebo Multiple Ascending Dose
- Part B: Placebo Capsules, Multiple Ascending Dose (MAD)
- Other Names :
- Placebo MAD
- DRUG : 7HP349 Food Effect
- Part C: 7HP349 Capsules, Food Effect
- Other Names :
- 7HP349 FE | #Eligibility Criteria:
Inclusion Criteria:
* Healthy males between the ages of 18 and 45 years, inclusive
* Normal clinical chemistry, hepatic function, hematology, thyroid function
* Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 60 kg
* Agree to refrain from consuming products containing grapefruit, pomelo, star fruit or Seville oranges for at least 7 days before the first dose of study drug until the final discharge evaluation
* Positive immune status as defined in serum as measles, mumps, varicella-zoster viruses (VZR); Antibody Index (AI) >= 1.1, and positive Rubella: AI >= 1.0
Exclusion Criteria:
* Clinically significant history of disorders, infections or drug hypersensitivity as determined by the Investigator
* History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
* Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody
* Current treatment or treatment within 30 days with another investigational medication
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT04508179 | {
"brief_title": "A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects",
"conditions": [
"Solid Tumor"
],
"interventions": [
"Drug: Placebo Multiple Ascending Dose",
"Drug: 7HP349 Multiple Ascending Dose",
"Drug: 7HP349 Food Effect",
"Drug: 7HP349 Single Ascending Dose",
"Drug: Placebo Single Ascending Dose"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04508179",
"official_title": "A Phase 1, Placebo-controlled, Within-Cohort Randomized, Double-blind, Single and Multiple Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of 7HP349 in Normal Healthy Male Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-10-25",
"study_completion_date(actual)": "2021-10-25",
"study_start_date(actual)": "2020-10-28"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-11-02",
"last_updated_that_met_qc_criteria": "2020-08-07",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-08-11",
"first_submitted": "2020-08-05",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This is a retrospective study on bladder cancer in French painters' population. The French agency ANSES collected data from all occupational and environmental diseases center in a specific database called RNV3P. We selected cases of bladder cancer in painters in four centers from 01/01/2010 to 31/12/2019. Those cases were analyzed in terms of occupational exposure, histology and sociodemographics data. Comparison between different histologic types of cancer, workplaces and occupational diseases process will be done.
| #Eligibility Criteria:
Inclusion Criteria:
* painters
* age> 18 years
* data from one of the French occupational diseases centers
* approval letter
Exclusion Criteria:
* non-approval letter
* age < 18 years
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT05937555 | {
"brief_title": "Professional Bladder Cancers and the Profession of Painter",
"conditions": [
"Bladder Cancer"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT05937555",
"official_title": "Professional Bladder Cancers and the Profession of Painter: Retrospective Study of the RNV3P Database Files",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-28",
"study_completion_date(actual)": "2022-01-28",
"study_start_date(actual)": "2021-03-15"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-07-10",
"last_updated_that_met_qc_criteria": "2023-07-06",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-07-10",
"first_submitted": "2022-04-04",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study will evaluate the ability of short-term fasting to reduce chemotherapy toxicity and enhance anti-tumour response in patients with colorectal carcinoma subjected to chemotherapy.
Detailed Description
Fasting for 24-48 hours during chemotherapy improves the response of the immune system against tumors and reduces chemotherapy toxicity through yet unknown mechanisms. The investigators have found that fasting induces the activation of p21, a protein that stops cell proliferation and plays important immune roles. The investigators hypothesize that p21 induction with short-term fasting enhances the immune anti-tumour response and reduces chemotherapy toxicity. To test this, half of the colorectal carcinoma (CRC) participants will follow 48 hours of fasting, 24 before and 24 after chemotherapy, under constant and specialized nutritional supervision. While the other half will follow a standard diet. A complete blood immunological profile at each chemotherapy cycle will be generated in collaboration with expert cytometrists, and gene expression, biochemical parameters, tumor evolution and toxicity markers will be measured. The investigators will (1) perform a complete analysis of immune cells to characterize the immune effects of fasting during chemotherapy; (2) analyze the effects of fasting on genes, metabolites and other molecules, to identify the responsible biological mechanisms, focusing on p21; (3) assess the reduction of chemotherapy toxicity in patients of colorectal carcinoma subjected to short-term fasting during chemotherapy.
Our project will further explore a safe, inexpensive, relatively unexplored and powerful nutritional intervention that can improve the quality of life and survival rates of millions of cancer patients: short-term fasting. Also, our project will have an important scientific impact, since previous reports have not yet described a clear mechanism explaining the beneficial effects of short-term fasting with chemotherapy
#Intervention
- PROCEDURE : Fasting
- Food intake restriction | #Eligibility Criteria:
Inclusion Criteria:
* Participants with malignant colorectal neoplasia
* Good metabolic state (BMI>22)
* Good nutritional tests
* Normal Haematological and biochemical parameters
* Normal renal and hepatic function
* No loss of weight during the chemotherapy treatment
Exclusion Criteria:
* BMI<22
* Pregnancy or lactating women
* Bad nutritional state
* 3% weigh loss during the last month or more than 5% in the last three months
* Diagnosis of type 2 diabetes mellitus or hypertension
* Diagnosed hepatic, renal or cardiovascular disease
* Respiratory of psychiatric disease
* Nausea or vomiting, gastrointestinal disease
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04247464 | {
"brief_title": "Short-term Fasting as an Enhancer of Chemotherapy: Pilot Clinical Study on Colorectal Carcinoma Patients",
"conditions": [
"Fasting"
],
"interventions": [
"Procedure: Fasting"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT04247464",
"official_title": "Evaluation of Short-term Fasting Effects on Chemotherapy Toxicity and Efficacy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-02-01",
"study_completion_date(actual)": "2023-02-01",
"study_start_date(actual)": "2020-09-23"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-05",
"last_updated_that_met_qc_criteria": "2020-01-27",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-30",
"first_submitted": "2020-01-14",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Removal of bile duct stones can be challenging at ERCP, particularly, when the size of the stone is at least 1.2cm, and may require more than one ERCP session. Various techniques for removal of difficult bile duct stones include using a balloon to enlarge the opening of the bile duct (large balloon sphincteroplasty), mechanical lithotripsy or single-operator cholangioscopy guided laser lithotripsy techniques. There are currently no randomized trials comparing laser lithotripsy and sphincteroplasty techniques for the removal of difficult bile duct stones and the aim of this randomized trial is to determine which technique is superior in the removal of difficult bile duct stones.
Detailed Description
Stones in the common bile duct (CBD) can result in various complications including acute cholangitis, acute pancreatitis and secondary biliary cirrhosis. Bile duct stones should therefore be removed and this can be successfully achieved in 85-90% of patients with small bile duct stones using standard endoscopic techniques. This comprises endoscopic sphincterotomy whereby the duodenal sphincter at the entrance of the bile duct is cut during endoscopic retrograde cholangiopancreatography (ERCP) and subsequent removal of the stone is achieved using standard accessories such as a basket and/or extraction balloon. However, large/difficult bile duct stones (at least 12mm in size), multiple stones and those located in non-dilated bile ducts can be difficult to remove by endoscopic sphincterotomy and using only standard accessories. In such cases, the three most commonly practiced advanced maneuvers for extraction of difficult CBD stones are mechanical lithotripsy, large balloon sphincteroplasty (LBS) of the major duodenal papilla and single operator cholangioscopy-guided laser lithotripsy (SOC-LL).
Endoscopic large balloon sphincteroplasty (using CRE Wireguided Balloon Dilatation Catheter; Boston Scientific Corp., Natick, MA, USA) is a technique in which a balloon is used to dilate the papilla located at the bile duct opening by up to 20mm (depending on size of the distal CBD) after performing an endoscopic sphincterotomy. Following dilation, the stone is removed using a basket and/or extraction balloon. This technique was shown to be effective in clearing the bile duct in 50-60% of patients with difficult bile stones in whom initial endoscopic sphincterotomy was unsuccessful.
The SpyGlass Direct Visualization System (Boston Scientific Corp., Natick, MA, USA) is a single-operator cholangioscopy system, which allows direct visualization of the bile duct stone. The main advantage of this technique is that the cholangioscope can be inserted into the endoscope and then guided through the bile duct to reach the stone. A probe can then be inserted into the cholangioscope to allow the energy from laser (laser lithotripsy) to be accurately focused onto the stone to cause stone fragmentation under direct visualization. The use of SpyGlass system with laser lithotripsy has been shown to be successful in the clearance of difficult bile duct stones in 73-100% patients.
Although various methods for removal of bile duct stones exist, there have been thus far no studies directly comparing endoscopic large balloon sphincteroplasty with cholangioscopy-guided laser lithotripsy for clearance of difficult bile duct stones. The aim of this study is therefore to compare the efficiency of the single-operator cholangioscopy-directed laser lithotripsy using the SpyGlass Direct Visualization system versus endoscopic large balloon sphincteroplasty for clearance of difficult bile duct stones.
#Intervention
- PROCEDURE : Single-operator cholangioscopy-guided laser lithotripsy
- Ability to clear the bile duct of all stones in one ERCP session using laser lithotripsy-based technique, including use of mechanical lithotripsy
- PROCEDURE : Balloon Sphincteroplasty
- Ability to clear the bile duct of all stones in one ERCP session using large balloon sphincteroplasty-based technique, including use of mechanical lithotripsy | #Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or over
* Common bile duct stones that measure at least 1.2 cm who have failed stone removal using standard techniques at ERCP
Exclusion Criteria:
* Patients unable to provide informed consent due to any diminished capacity
* Pregnant patients or age < 18 years or prisoners
* Presence of bleeding disorders
* Patients with altered post-surgical anatomy
* Pregnancy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00852072 | {
"brief_title": "Randomized Trial for Extraction of Difficult Bile Duct Stones",
"conditions": [
"Common Bile Duct Stones"
],
"interventions": [
"Procedure: Balloon Sphincteroplasty",
"Procedure: Single-operator cholangioscopy-guided laser lithotripsy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00852072",
"official_title": "A Randomized Trial to Identify the Optimal Approach for Management of Difficult Bile Duct Stones",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10-31",
"study_completion_date(actual)": "2018-12-31",
"study_start_date(actual)": "2016-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-10",
"last_updated_that_met_qc_criteria": "2009-02-25",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-02-26",
"first_submitted": "2009-02-25",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The aim of this interventional but non-invasive, clinical investigation is to demonstrate the performance and safety of two new class I medical device Absorbing Hygiene Products developed by Essity.
The primary objective is to demonstrate for each of the new products that they provide protection to leakages similar to their corresponding standard of care devices already used on the market. The target population for this clinical investigation are community living individuals suffering from moderate to severe incontinence, who may receive care by a care giving relative, by one or more caregivers and are current users of TENA Pants of the respective absorption level.
Detailed Description
The clinical investigation will be conducted to demonstrate the performance and safety of two new class I medical device Absorbing Hygiene Products developed by Essity. The performance of the new design will be compared to that of the currently marketed TENA Pants, deemed state of the art.
To ensure that the personal preference of the study subjects are met, only current users of the marketed TENA pants will be recruited. To meet the objectives, the investigation is designed to be prospective, randomized, cross-over and interventional but not invasive with two different groups each testing one investigational-reference device pair matched to the currently used product at the time of inclusion. The study subjects will act as their own control, using one device for 10 (+ max. 3) days and then switching to the other device for additional 10 (+ max. 3) days. As for most users the avoidance of urinary leakages is the primary concern, this will be the primary outcome of the clinical investigation for each of the device pairs tested.
The used products will be collected, weighed and photographed. A subject/caregiver questionnaire will collect data on subject satisfaction and preferences. A skin health assessment will also be performed to evaluate any change in subject skin health before, during and at the end of the study.
Since the devices perform well in their intended use, leakage rate of each individual device is low, so a large number of devices needs to be tested per absorption level in order to obtain a robust assessment. Since the underlying incontinence condition is not affected by participation in the investigation, a sequential measurement series should be sufficient to meet the study objectives.
#Intervention
- DEVICE : SN2
- Investigational device absorption level Normal
- DEVICE : SP3
- Investigational device absorption level Plus | #Eligibility Criteria:
Inclusion Criteria:
* criteria to be eligible for this clinical investigation:
1. Subject is diagnosed with moderate to severe urinary incontinence managed only with TENA Pants absorbent hygiene products of size Medium or Large with the same absorption level that is used in the study since at least 4 weeks.
2. Subject is living at home and should have a care giving relative supported by a professional caregiver giver to manage daily activities and incontinence related tasks.
3. Subject is willing and able to provide informed consent and to participate in the clinical investigation or has a legally designated representative willing to provide informed consent on behalf of the subject.
4. Care giving relative is willing and able to provide informed consent to participate in the clinical investigation.
5. If incontinence is managed by pharmaceuticals, the dose regime is stable.
6. Subject and care giving relative (if any) are > 18 years.
7. Post-menopausal women or no longer of child-bearing potential
Exclusion Criteria:
* Subject is cared for in a professional establishment or is institutionalized.
* Subject has severe incontinence product related skin problems corresponding to scores equal to or higher than 4 in the skin health assessment, as judged by the investigator.
* Subject suffers from regular faecal incontinence more than once a week.
* Subject has any type of urinary catheter(s) resulting in improved/treated urinary incontinence.
* Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
* Subject or care giving relative is incapable or unwilling to collect used products and fill out the bag label required for the clinical investigation.
* Participation in another investigational study of a drug, biologic, or medical device within 30 days prior to entering the clinical investigation or planned during the clinical investigation as well as prior participation in this investigation
* Subject is pregnant or nursing or of childbearing potential.
* Investigator suspects that subject or care giving relative has an alcohol or drug addiction.
* Subject and/or caregiving relative is closely affiliated with or in hierarchical dependency of the Sponsor, PI, or CRO involved in this study
* Subject's incontinence is currently managed by more than 1 type of AHP's
* Surgery or hospitalization less than 4 weeks prior to study inclusion or planned surgery hospitalization during study conduct.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT05484388 | {
"brief_title": "Evaluation of Urine Leakage of New Absorbing Incontinence Products in a Home Care Environment",
"conditions": [
"Urinary Incontinence"
],
"interventions": [
"Device: SP3",
"Device: SN2"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT05484388",
"official_title": "A Randomized Crossover Study to Evaluate Urine Leakage of Pant Type Absorbing Incontinence Products of Two Absorption Levels in a Home Care Environment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-07",
"study_completion_date(actual)": "2023-02-03",
"study_start_date(actual)": "2022-10-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-02-21",
"last_updated_that_met_qc_criteria": "2022-07-30",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-08-02",
"first_submitted": "2022-06-15",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This phase I/II trial is studying the side effects and best dose of vorinostat when given together with rituximab, ifosfamide, carboplatin, and etoposide and to see how well they work in treating patients with relapsed or refractory lymphoma or previously untreated T-cell non-Hodgkin lymphoma or mantle cell lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with rituximab and combination chemotherapy may kill more cancer cells
Detailed Description
OBJECTIVES:
I. To determine maximally tolerated dose of vorinostat that can be combined with RICE chemotherapy in patients with relapsed lymphoid malignancies.
II. To determine the safety and toxicity of the above regimen. III. To gain a preliminary assessment of the efficacy of the above regimen. IV. To determine the ability to proceed to peripheral blood stem cell collection following the above regimens (the impact of above regimen on stem cell reserve).
V. To describe vorinostat concentration attained at or near the MTD. VI. To evaluate the change of histone acetylation patterns and pro-apoptotic proteins of primary target (tumor) and non-target peripheral blood mononuclear cells (PBMC) cells following high-dose HDAC inhibition.
VII. To describe the gene expression profile changes of tumor and non-tumor cells following high-dose HDAC inhibition.
OUTLINE: This is a phase I/II dose-escalation study of vorinostat.
Patients receive vorinostat orally (PO) once daily (QD) on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 4 years.
#Intervention
- DRUG : vorinostat
- Given PO
- Other Names :
- L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
- BIOLOGICAL : rituximab
- Given IV
- Other Names :
- IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan
- DRUG : ifosfamide
- Given IV
- Other Names :
- Cyfos, Holoxan, IFF, IFX, IPP
- DRUG : carboplatin
- Given IV
- Other Names :
- Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
- DRUG : etoposide
- Given IV
- Other Names :
- EPEG, VP-16, VP-16-213
- OTHER : pharmacological study
- Correlative studies
- Other Names :
- pharmacological studies
- OTHER : laboratory biomarker analysis
- Correlative studies
- GENETIC : gene expression analysis
- Correlative studies | #Eligibility Criteria:
Inclusion Criteria:
* Patients must have relapsed or primary refractory lymphoid malignancy (including B-cell, T-cell, or Hodgkins disease), or untreated T-NHL or MCL
* Patients with other lymphomas that have not received any prior therapy and are not candidates for anthracycline-based therapies, are eligible with PI review and approval
* Revised European American classification (REAL), or World Health Organization (WHO) classification of patient's malignancies must be provided
* Patients must have measurable disease defined as lesions that can be accurately measured in two dimensions by computed tomography (CT), magnetic resonance imaging (MRI), medical photograph (skin or oral lesion), plain x-ray, or other conventional technique and a greatest transverse diameter of 1 cm or greater; or palpable lesions with both diameters >= 2 cm
* Patients must have a bone marrow aspirate and biopsy within 28 days of enrollment and no intervening anticancer therapy
* Patients must have a CT of chest, abdomen, and pelvis within 28 days of enrollment; patients with evidence of adenopathy in the neck must have a CT of neck
* Patients should not have evidence of active central nervous system lymphoma
* Electrocardiogram (EKG) must be free of any arrhythmias (excluding sinus arrhythmia or infrequent premature ventricular contractions)
* Patients must have a Southwest Oncology Group (SWOG) performance status of 0, 1, or 2
* Absolute neutrophil count (ANC) >= 1,500/mm^3
* Serum creatinine < 1.5 mg/dl or creatinine clearance greater than 60/ ml per minute by the following formula (all tests must be performed within 28 days prior to registration)
* Total bilirubin < 1.5 times upper limit of normal, aspartate aminotransferase (AST) < 5 times upper limit of normal
* Patients must have a serum lactate dehydrogenase (LDH) performed within 14 days prior to registration
* All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
* Patients must be anticipated to complete at least 2 cycles of chemotherapy
* Platelets >= 100,000/mm^3 (without transfusion)
Exclusion Criteria:
* Patients known to be human immunodeficiency virus (HIV) positive
* Pregnant or nursing women; men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
* Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, cervical cancer in situ, or other cancer from which the patient has been disease free for 5 years or greater, unless approved by the protocol Chair or Co-Chair
* Patients that are refractory (i.e. not responded or progressed within 6 months) to a carboplatin, cisplatin, ifosfamide, or etoposide-based regimen-based regimen
* Patients that have other medical conditions that would contraindicate treatment with aggressive chemotherapy (including active infection, uncontrolled hypertension, congestive heart failure, unstable angina pectoris, or myocardial infarction within the past 6 months, or uncontrolled arrhythmia)
* Patients with a history of impaired cardiac status (including history of severe coronary artery disease, cardiomyopathy, congestive heart failure or arrhythmia); if the patient's history is questionable, a measurement of left ventricular ejection fraction should be obtained within 42 days prior to registration; patients with left ventricular ejection fraction < 50% are not eligible
* Autologous or allogeneic transplantation within 12 months or radioimmunotherapy within 6 months of registration
* No concurrent treatment with valproic acid or on valproic acid within 2 weeks of study enrollment
* No prior treatment with histone deacetylase inhibitors
* No concurrent therapy for this malignancy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00601718 | {
"brief_title": "Vorinostat, Rituximab, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Lymphoma or Previously Untreated T-Cell Non-Hodgkin Lymphoma or Mantle Cell Lymphoma",
"conditions": [
"Adult Nasal Type Extranodal NK/T-cell Lymphoma",
"Anaplastic Large Cell Lymphoma",
"Angioimmunoblastic T-cell Lymphoma",
"Contiguous Stage II Mantle Cell Lymphoma",
"Cutaneous B-cell Non-Hodgkin Lymphoma",
"Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue",
"Nodal Marginal Zone B-cell Lymphoma",
"Noncontiguous Stage II Mantle Cell Lymphoma",
"Recurrent Adult Burkitt Lymphoma",
"Recurrent Adult Diffuse Large Cell Lymphoma",
"Recurrent Adult Diffuse Mixed Cell Lymphoma",
"Recurrent Adult Diffuse Small Cleaved Cell Lymphoma",
"Recurrent Adult Grade III Lymphomatoid Granulomatosis",
"Recurrent Adult Hodgkin Lymphoma",
"Recurrent Adult Immunoblastic Large Cell Lymphoma",
"Recurrent Adult Lymphoblastic Lymphoma",
"Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma",
"Recurrent Grade 1 Follicular Lymphoma",
"Recurrent Grade 2 Follicular Lymphoma",
"Recurrent Grade 3 Follicular Lymphoma",
"Recurrent Mantle Cell Lymphoma",
"Recurrent Marginal Zone Lymphoma",
"Recurrent Mycosis Fungoides/Sezary Syndrome",
"Recurrent Small Lymphocytic Lymphoma",
"Splenic Marginal Zone Lymphoma",
"Stage I Cutaneous T-cell Non-Hodgkin Lymphoma",
"Stage I Mantle Cell Lymphoma",
"Stage I Mycosis Fungoides/Sezary Syndrome",
"Stage II Cutaneous T-cell Non-Hodgkin Lymphoma",
"Stage II Mycosis Fungoides/Sezary Syndrome",
"Stage III Cutaneous T-cell Non-Hodgkin Lymphoma",
"Stage III Mantle Cell Lymphoma",
"Stage III Mycosis Fungoides/Sezary Syndrome",
"Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma",
"Stage IV Mantle Cell Lymphoma",
"Stage IV Mycosis Fungoides/Sezary Syndrome",
"Waldenström Macroglobulinemia"
],
"interventions": [
"Drug: vorinostat",
"Other: laboratory biomarker analysis",
"Drug: ifosfamide",
"Drug: etoposide",
"Genetic: gene expression analysis",
"Drug: carboplatin",
"Biological: rituximab",
"Other: pharmacological study"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00601718",
"official_title": "A Phase I/II Study of Vorinostat Plus Rituximab, Ifosphamide, Carboplatin, and Etoposide for Patients With Relapsed or Refractory Lymphoid Malignancies or Untreated T- or Mantle Cell Lymphoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-06",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2007-12"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-05-25",
"last_updated_that_met_qc_criteria": "2008-01-24",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-01-28",
"first_submitted": "2008-01-24",
"first_submitted_that_met_qc_criteria": "2017-04-17"
}
}
} |
#Study Description
Brief Summary
The purpose of this randomized clinical trial is to examine the usefulness of the addition of a pelvic compression belt to a lumbopelvic stabilization program for patients with sacroiliac joint pain by comparing lumbopelvic stabilization exercises with a pelvic compression belt to lumbopelvic stabilization exercises alone. Outcome measures including the Modified Oswestry Low Back Pain Disability Index (OSW), the percentage change of TrA and IO muscle thickness (i.e. muscle contraction from rest to contract) utilizing ultrasound imaging, the Numeric Pain Rating Scale (NPRS) for pain, and a subjective rating of overall perceived improvement using the Global Rating of Change (GROC) scale will be collected. Hypothesis: The OSW scores and NPRS scores will be lower for those who receive the compression belt in addition to the lumbopelvic stabilization program as compared to those who receive the lumbopelvic stabilization alone. The percent change of muscle thickness for the deep abdominals as well as the GROC scores will be higher for those who receive the compression belt in addition to the lumbopelvic stabilization program as compared to those who receive the lumbopelvic stabilization alone.
Detailed Description
Background: The estimated prevalence of sacroiliac joint (SIJ) pain is approximately 13-30% in patients with non-specific low back pain. One common presentation for those with SIJ pain is unilateral pain over the SIJ region, which is described as a positive Fortin's sign. Common impairments for this population include pelvic asymmetry, lumbopelvic muscle imbalance, and decreased lumbopelvic proprioceptive awareness and stability. Two common physical therapy interventions for this population are lumbopelvic stabilization programs and pelvic compression belts. The purpose of this randomized clinical trial is to examine the usefulness of the addition of a pelvic compression belt to a lumbopelvic stabilization program for patients with sacroiliac joint pain by comparing lumbopelvic stabilization exercises with a pelvic compression belt to lumbopelvic stabilization exercises alone. Participants: Thirty participants with unilateral pain near the SIJ will be recruited for the study and randomly assigned to 1 of 2 treatment groups (stabilization plus belt or stabilization alone). Both groups will receive a lumbopelvic stabilization program for 12 weeks. The stabilization plus belt group will also receive a pelvic compression belt to be worn continuously for the first 4 weeks. Outcome measures including the Modified Oswestry Low Back Pain Disability Index (OSW), the percentage change of TrA and IO muscle thickness (i.e. muscle contraction from rest to contract) utilizing ultrasound imaging, the Numeric Pain Rating Scale (NPRS) for pain, and a subjective rating of overall perceived improvement using the Global Rating of Change (GROC) scale will be collected. These outcomes will be assessed at baseline, 4 weeks, and 3 months post-intervention. Hypothesis: The OSW scores and NPRS scores will be lower for those who receive the compression belt in addition to the lumbopelvic stabilization program as compared to those who receive the lumbopelvic stabilization alone. The percent change of muscle thickness for the deep abdominals as well as the GROC scores will be higher for those who receive the compression belt in addition to the lumbopelvic stabilization program as compared to those who receive the lumbopelvic stabilization alone. Data Analysis: Two separate ANOVAs (group x time) with repeated measures will be used to examine the effect of the interventions on disability and the percent change of muscle thickness. Whitney U-test will be used to analyze the NPRS data, and descriptive statistics will be used to report the GROC scores. Clinical Relevance: The results of the study may provide evidence in prescribing pelvic compression belt for those with SIJ pain. It will also offer guidance as to how and when pelvic compression belts should be used in this population. Finally, it will guide physical therapists in prescribing effective interventions for those with SIJ pain.
#Intervention
- BEHAVIORAL : Lumbopelvic stabilization exercise
- The objective of this exercise program is to recruit and train the primary stabilizing muscles of the spine in order for them to more appropriately support the spine. Participants will complete 4 different exercises daily: one in supine, one in standing, one in quadruped, and one in a side-bridge position. The dosage for each exercise is 20 reps with an 8 second hold. In supine, the first exercise is the abdominal drawing-in maneuver. In standing, the first exercise is the abdominal drawing-in maneuver. In quadruped, the first exercise is alternating arm lifts. The final exercise is the side-bridge hold. Participants will then be asked to attend supervised physical therapy sessions twice a week for 2 weeks and once a week for another 2 weeks. They will be instructed to perform the exercises at home daily for a total of 12 weeks as well as complete a compliance log. Progression of the stabilization program will be determined by the physical therapist based on pre-established criteria.
- DEVICE : Sacroiliac joint belt
- The belt should be worn low around the pelvis just above the greater trochanter and instructed to wear the belt during all waking hours of the first four weeks of the study. The treating physical therapist will monitor the placement of belts during each exercise session. Belt usage logs will be given to each participant to assess compliance with wearing the belt. | #Eligibility Criteria:
Inclusion Criteria:
* unilateral pain near the sacroiliac joint that does not extend pass the knee
* positive result on 2 of 6 sacroiliac joint provocation tests:
* compression test
* distraction test
* posterior shear test
* Gaenslens' test (left and right)
* sacral thrust test
Exclusion Criteria:
* current pregnancy or pregnancy in the last 6 months
* history of surgery to lumbar spine, pelvis, chest, abdomen
* history of congenital lumbar or pelvic anomalies
* any neurological signs in the lower extremity
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01559948 | {
"brief_title": "Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain",
"conditions": [
"Low Back Pain"
],
"interventions": [
"Device: Sacroiliac joint belt",
"Behavioral: Lumbopelvic stabilization exercise"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01559948",
"official_title": "A Randomized Clinical Trial of the Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-02",
"study_completion_date(actual)": "2014-02",
"study_start_date(actual)": "2012-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-07",
"last_updated_that_met_qc_criteria": "2012-03-19",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-03-21",
"first_submitted": "2012-02-03",
"first_submitted_that_met_qc_criteria": "2019-09-16"
}
}
} |
#Study Description
Brief Summary
This pilot study will compare the two hypertonic solutions currently used for subarachnoid hemorrhage (SAH) - related complications and to determine if the reduction of chloride load is safer, and as efficacious as the classic hypertonic solution.
Detailed Description
This pilot study aimed to collect high-quality randomized and prospective information to help plan a future, larger multicenter trial. The study will compare the two hypertonic solutions currently used for subarachnoid hemorrhage (SAH) - related complications and to determine if the reduction of chloride load by using a sodium acetate and sodium chloride mixture can lead to a relative reduction of serum chloride, reduce kidney injury, and as efficacious as the classic hypertonic solution.
Hyperosmolar therapy is one of the mainstay treatments for SAH-related cerebral edema and vasospasm, in order to reduce delayed cerebral ischemia. Recent evidence from the literature correlates high chloride load when applying IV fluids with worse outcome in a variety of critically-ill patients. Hypertonic saline, with which most hyperosmolar treatment is done, contains a supra-physiologic chloride load. It is possible that by changing the hypertonic solution to a 'chloride-lean' one, the study team would be able to reduce the side effects of hypertonic sodium-chloride without losing its efficacy in treating SAH-related complications.
#Intervention
- DRUG : Sodium chloride /sodium acetate (16.4%)
- Sodium Acetate is a sterile, nonpyrogenic solution of Sodium Acetate intended as an alternative to sodium chloride to provide sodium ion in parenteral (IV) fluid therapy.
Sodium Chloride is sterile, nonpyrogenic hypertonic saline (concentrated sodium-chloride) solution for parenteral (IV) fluid therapy.
- DRUG : Sodium chloride (23.4%)
- Sodium Chloride is sterile, nonpyrogenic hypertonic saline (concentrated sodium-chloride) solution for parenteral (IV) fluid therapy.
- DRUG : PlasmaLyte
- PlasmaLyte is an isotonic IV solution that mimics human physiological plasma electrolyte concentrations, osmolality and pH.
- Other Names :
- Placebo solution | #Eligibility Criteria:
Inclusion Criteria:
* Spontaneous SAH with an identified aneurysmal source as identified on neuroimaging obtained at admission to Emory University Hospital or with imaging at an outside hospital
* Age >= 18 years
Exclusion Criteria:
* SAH related to non-aneurysmal vascular anomaly
* SAH thought due to trauma
* SAH occurring in relation to another medical procedure (cardiac catheterization, LVAD placement, etc.)
* SAH with a negative workup for cause ('angio-negative')
* Patients who arrive in a brain-death state or in a devastating clinical status that will be presumed to lead to brain death or early withdrawal of treatment
* Patient who suffer from end-stage renal disease at baseline and who are routinely treated with dialysis
* Known pregnancy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03204955 | {
"brief_title": "A Low ChloridE hyperTonic Solution for Brain Edema",
"conditions": [
"Subarachnoid Hemorrhage",
"Acute Kidney Injury"
],
"interventions": [
"Drug: Sodium chloride /sodium acetate (16.4%)",
"Drug: PlasmaLyte",
"Drug: Sodium chloride (23.4%)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03204955",
"official_title": "Low-chloride Versus High-chloride Containing Hypertonic Solution for the Treatment of Subarachnoid Hemorrhage-Related Complications",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-09-30",
"study_completion_date(actual)": "2018-09-30",
"study_start_date(actual)": "2017-06-28"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-01",
"last_updated_that_met_qc_criteria": "2017-06-28",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-07-02",
"first_submitted": "2017-06-28",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of the study is to find out if taking calcium and vitamin D supplements, while following a low-calorie diet, can help people lose weight.
Detailed Description
Recent studies suggest that calcium may be important for weight loss, but other studies have not had the same results. The purpose of the study is to find out if taking calcium and vitamin D supplements, while following a low-calorie diet, can help people lose weight.
We will use special orange juice with less calories than regular orange juice. Half of the subjects in this study will drink the study juice (reduced-calorie orange juice) containing extra calcium and vitamin D. The other subjects will drink reduced-calorie orange juice without any extra calcium or vitamin D in it.
Comparisons: We will compare subjects who follow the diet and take calcium and vitamin D supplements to those who only follow the diet.
#Intervention
- DIETARY_SUPPLEMENT : Reduced energy (lite) OJ fortified with Calcium and Vitamin D
- Three 240ml servings of lite OJ fortified with 350mg Ca and 100U VitD per day.
- Other Names :
- Minute Maid Light Orange Juice
- BEHAVIORAL : Nutrition Counseling
- Individual and group nutritional counseling by a registered dietician.
- DIETARY_SUPPLEMENT : Reduced energy (lite) OJ without Calcium and Vitamin D
- Three 240ml servings of lite OJ without 350mg Ca and 100U VitD per day.
- Other Names :
- Minute Maid Light Orange Juice | #Eligibility Criteria:
Inclusion Criteria:
* Men or women, between 18 and 65 years, who are capable of providing informed consent.
* BMI of 25 to 35 kg/m2.
* Non-smoker (for at least 6 months).
* In good health, as determined by the principal investigator based on medical history and physical examination.
* Clinical laboratory evaluations (including Biochemistry, Hematology, Endocrinology) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator.
* Because of the calorie-restricted diet and radiation exposure from the CT scan, females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile for at least 3 months, or be willing to use an approved method of contraception (which may include use of abstinence; intrauterine device; female condom with spermicide; diaphragm with spermicide; cervical cap with spermicide; oral or transdermal hormonal contraceptives; a condom with spermicide by the sexual partner; or a sterile sexual partner) from 35 days prior to study entry (i.e., Day -1) until 30 days following Study Completion. For all females, the pregnancy test result must be negative at the screening visit and at visits when a CT scan will be done.
* Ability to comprehend and willingness to sign the Informed Consent Form for this study.
* Ability to comply with study restrictions regarding diet and exercise.
* Stable weight (+ 5%) for at least 3 months prior to study entry.
Exclusion Criteria:
* Diabetes mellitus.
* History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders which in the opinion of the investigator would be expected to interfere with the study or increase risk to the subject.
* Participation in any other investigational diet study within 90 days prior to study entry.
* History of a medical or psychological condition or social circumstances that would impair the subject's ability to participate reliably in the study.
* Use within the last six months of medications that can result in significant weight gain or weight loss, including antipsychotics, selective serotonin reuptake inhibitors, anti-epileptic drugs, appetite-suppressants such as phentermine and sibutramine, and the lipase-inhibitor orlistat. (see Appendix 1 for detailed list)
* Active eating disorder.
* History of alcoholism or substance abuse within 5 years prior to study entry.
* Recommendation by a physician to avoid calcium supplements because of a history of kidney stones or other medical condition.
* History of hyperparathyroidism or sarcoidosis.
* Osteoporosis or other medical condition for which a physician has recommended taking a multivitamin or calcium supplementation.
* High calcium intake (more than 2 servings of dairy products per day or taking calcium supplements > 3x/wk ) for 1 month prior to study start date and for duration of study. (If participant is taking calcium supplement > 3x/wk or more than 2 servings of dairy products per day, they are eligible to participate if they agree to stop for 1 month prior to study start date and for the duration of the study. Participants will similarly be asked to stop multivitamins as the majority of these supplements contain calcium.)
* General medical conditions that are well-controlled will not be a basis for exclusion in the study. Subjects with uncontrolled conditions that are not adequately controlled or that might pose an unacceptable risk for participation, as clinically determined by the investigators, will be excluded.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT00386672 | {
"brief_title": "Calcium Supplementation for a Healthy Weight-Lite (CaSHeW Lite)",
"conditions": [
"Obesity",
"Overweight"
],
"interventions": [
"Dietary Supplement: Reduced energy (lite) OJ without Calcium and Vitamin D",
"Behavioral: Nutrition Counseling",
"Dietary Supplement: Reduced energy (lite) OJ fortified with Calcium and Vitamin D"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00386672",
"official_title": "Calcium Supplementation for a Healthy Weight- LITE",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-12",
"study_completion_date(actual)": "2006-12",
"study_start_date(actual)": "2006-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-01-10",
"last_updated_that_met_qc_criteria": "2006-10-10",
"last_verified": "2017-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-10-11",
"first_submitted": "2006-10-06",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study evaluates how Fast Bar(TM), a specially formulated energy bar, affects the physiological condition in participants after an overnight fasting. Participants will fast for 19 hours (Fast Group), consume a breakfast Bar (Breakfast Group) or a Fast Bar(TM) (Fast Bar Group) after an approximately 15-hour overnight fasting. Participants will be assessed for physiological parameters associated with fasting.
Detailed Description
Interest in fasting-based programs (i.e. intermittent fasting) for improvement of health and longevity continues to grow. While benefits of intermittent fasting have been convincingly demonstrated in rodent models, the more limited data in humans is less clear.
The short-term fasting (e.g. 12 to 48 hours in duration) utilized in many intermittent fasting programs are considered safe, but some individuals may find them subjectively difficult. As such, the question of whether the benefits of fasting can be obtained while small amounts of food are consumed is of substantial interest.
One commercially available product that is designed to be consumed during periods of intermittent fasting is the Fast Bar™,which stems out of the well-researched fasting-mimicking diet to assist prolonged fasting. The unique formulation of the Fast Bar™ is hypothesized to minimize deviations in metabolic biomarkers associated with a fasting state. This may allow for extension of a fasting period through reduced subjective difficulty of fasting.The objective of this study is to evaluate the metabolic and subjective effects of consuming a novel food product (Fast Bar™) after a short period of fasting.
#Intervention
- OTHER : Dinner
- Study subjects will consume a standardized ready-to-eat meal as dinner.
- OTHER : Fasting
- Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.
- OTHER : Study food
- Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group). | #Eligibility Criteria:
Inclusion Criteria:
* Ability and willingness to provide written informed consent;
* Ability and willingness to use Zoom teleconference;
* Ability and willingness to perform the study tests and adhere to study protocol (to the best of the participant's knowledge);
* BMI 20 <= age <= 35 kg/m2 (inclusive) at screening;
* In good health (as determined by medical history to evaluate acute or ongoing chronic medical diagnoses/conditions that have been present for at least 90 days).
Exclusion Criteria:
* Has any medical disease or condition that, in the opinion of the principal investigator (PI) or appropriate study personnel, precludes study participation* (*Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial);
* History of gastric bypass (based on medical history provided at screening);
* Under medications aimed at keeping blood glucose under control (based on medical history provided at screening);
* Type 1 diabetes (based on medical history provided at screening);
* Taking insulin, insulin analogs, or octreotide (based on medical history provided at screening);
* Food allergies which would make the subject unable to consume the food provided (based on medical history and information provided at screening) (participants will be asked to review the ingredient lists for the dinner meal, the breakfast and the Fast Bar, and to state that they are not allergic to the ingredients to the best of their knowledge);
* Women who are pregnant;
* Alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks per day for men) (based on medical history and information provided at screening).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT04499599 | {
"brief_title": "Effects of Fast Bar on Physiological Fasting",
"conditions": [
"Fasting"
],
"interventions": [
"Other: Study food",
"Other: Dinner",
"Other: Fasting"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04499599",
"official_title": "Randomized, Single-blinded, Controlled, Parallel-arm Study to Evaluate the Effect of Fast Bar(TM) on Physiological Fasting Condition",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-09-28",
"study_completion_date(actual)": "2020-09-30",
"study_start_date(actual)": "2020-07-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-09",
"last_updated_that_met_qc_criteria": "2020-07-31",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-08-05",
"first_submitted": "2020-07-28",
"first_submitted_that_met_qc_criteria": "2021-09-04"
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to learn more about what causes insulin resistance. It has been suggested that proper breakdown of fat into energy (oxidation) in the body is important to allow insulin to keep blood sugar in the normal range. The investigators want to know if having one of the fatty acid oxidation disorders could have an influence on insulin action. Fatty acid oxidation disorders are genetic disorders that inhibit one of the enzymes that converts fat into energy. The investigators will study both normal healthy people and people with a long-chain fatty acid oxidation disorder.
Detailed Description
The overall goal of this proposal is to investigate the effects of disordered mitochondrial fatty acid oxidation on insulin resistance in humans. Mitochondrial dysfunction has been implicated in the development of insulin resistance and type 2 diabetes during excess dietary fat intake and from increased release of endogenous free fatty acids , such as occurs in obesity. Controversy exists, however, as to whether this insulin resistance results from intrinsic defects in mitochondrial energy utilization or from abnormalities resulting from excess free fatty acid flux, as well as the role that subsequent accumulation of cellular metabolic intermediates play in impaired insulin signaling.
To address these controversies, the investigators will study a unique population of patients with inherited defects in each of the three mitochondrial enzymes in the fatty acid oxidation pathway: 1) very long-chain acyl-CoA dehydrogenase (VLCAD); 2) trifunctional protein (TFP, which includes long-chain 3-hydroxyacyl-CoA dehydrogenase (LCHAD)); and 3) medium-chain acyl-CoA dehydrogenase (MCAD). These proteins are required for the oxidation of sequentially shorter fatty acids . The investigators will test the hypothesis that intrinsic defects in mitochondrial function involving oxidation of long-chain, but not medium-chain, fatty acids are sufficient to prevent intralipid-induced insulin resistance.
#Intervention
- DRUG : Intralipid/Heparin
- Co-infusion of intralipid and heparin solutions during a hyperinsulinemic euglycemic clamp
- DRUG : Glycerol/Saline
- Co-infusion of a glycerol/saline solutions during a hyperinsulinemic euglycemic clamp
- DRUG : Hyperinsulinemic euglycemic clamp
- Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate. | #Eligibility Criteria:
Inclusion Criteria:
* confirmed diagnosis of VLCAD, LCHAD, TFP or MCAD deficiency or same gender, age and BMI as a subject with a fatty acid oxidation disorder
* ability to travel to Oregon Health & Science University, Portland, Oregon
* ability and willingness to complete the protocol
Exclusion Criteria:
* hemoglobin <10g/dl, international normalized ratio (INR) >1.2 Prothrombin time (PTT) >36 sec, Platelets <150K/mm3
* pregnant or lactating females
* endocrine disorder such as diabetes or untreated thyroid disease
* cardiovascular disease or elevated plasma lipids
* regularly taking meds that strongly affect bleeding, bruising or platelets
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT02517307 | {
"brief_title": "Fatty Acid Oxidation Defects and Insulin Sensitivity",
"conditions": [
"Very Long-chain Acyl-CoA Dehydrogenase Deficiency",
"Trifunctional Protein Deficiency",
"Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency",
"Medium-chain Acyl-CoA Dehydrogenase Deficiency",
"Normal Volunteers",
"Carnitine Palmitoyltransferase II Deficiency, Myopathic"
],
"interventions": [
"Drug: Intralipid/Heparin",
"Drug: Glycerol/Saline",
"Drug: Hyperinsulinemic euglycemic clamp"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02517307",
"official_title": "Role of Fatty Acid Oxidation Defects in Insulin Sensitivity",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-01",
"study_completion_date(actual)": "2021-03",
"study_start_date(actual)": "2016-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-30",
"last_updated_that_met_qc_criteria": "2015-08-06",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-08-07",
"first_submitted": "2015-07-02",
"first_submitted_that_met_qc_criteria": "2024-01-08"
}
}
} |
#Study Description
Brief Summary
In this study, iron- and zinc-biofortified pearl millet will be fed to young children in Mumbai, Maharashtra, India over a period of nine months to measure growth and immune function in comparison to children receiving non-biofortified pearl millet.
Detailed Description
Iron and zinc deficiency remain a major worldwide public health problem, especially in developing countries such as India. In this randomized study, 700 children aged 12-18 months from Mumbai, Maharashtra, India will be fed either iron and zinc biofortified pearl millet or control pearl millet three times per day, six days per week, for nine months. The goal of this study is to examine the effects of iron and zinc biofortified millet on immune function, growth, and cognitive function in this age group. The key outcome measures are biomarkers of iron and zinc status, growth, and immune function. Serum concentrations of hemoglobin, ferritin, serum transferrin receptor, and zinc will be assessed at enrollment (baseline), at an intermediate time point (midline; random serial sampling) and after 9 months of follow-up (endline). Additionally, we will measure concentrations of C-reactive protein (CRP) and alpha 1-acid glycoprotein (AGP), as iron and zinc biomarkers can be influenced by inflammation. To assess cognitive function in a subset, multiple specific aspects of memory, attention, and processing speed will be assessed. Higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will also be assessed.
#Intervention
- OTHER : FeZnPM
- Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
- Other Names :
- biofortified pearl millet, bajra, ICTP8203-Fe
- OTHER : CtrlPM
- Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
- Other Names :
- bajra, pearl millet | #Eligibility Criteria:
Inclusion Criteria:
* Age 12 months, 0 days to 18 months, 30 days (at time of screening/baseline visit)
* Hemoglobin >=9 g/dL
Exclusion Criteria:
* Age less than 12 months, 0 days or older than 18 months, 30 days (at time of screening/baseline visit)
* Hemoglobin < 9 g/dL and/or hemoglobinopathy
* Presence of severe malnutrition according to Wellcome Classification (marasmus, marasmic kwashiorkor, kwashiorkor, weight-for-height z-score < -3)
* Prior diagnoses of HIV/AIDS or Tuberculosis, or Current diagnosis of HIV/AIDS, malaria, Dengue fever, Tuberculosis requiring >1 day hospitalization
* Children who do not have a caretaker to bring him/her to feeding center
* Possibility of migrating out of the slum dwelling for longer than 4 weeks
* Prior or current consumption of iron or zinc supplements in the past 1 year
* Any known dietary allergies
Sex :
ALL
Ages :
- Minimum Age : 12 Months
- Maximum Age : 18 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT02233764 | {
"brief_title": "Effect of Iron/Zinc-Biofortified Pearl Millet on Growth and Immunity in Children Aged 12-18 Months in India",
"conditions": [
"Iron Deficiency",
"Zinc Deficiency"
],
"interventions": [
"Other: CtrlPM",
"Other: FeZnPM"
],
"location_countries": [
"India"
],
"nct_id": "NCT02233764",
"official_title": "Effect of Iron- and Zinc-Biofortified Pearl Millet (ICTP8203-Fe) Consumption on Growth and Immunity in Children Aged 12-18 Months in India",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-07-16",
"study_completion_date(actual)": "2018-07-16",
"study_start_date(actual)": "2017-05-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-01-30",
"last_updated_that_met_qc_criteria": "2014-09-04",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-09-08",
"first_submitted": "2014-09-04",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study aims to see if ultrasound can be used as a reliable and valid method to measure fatty infiltration, muscle thickness and muscle architecture to provide a quick, cheap and mobile alternative measure of muscle quality to MRI.
The MRS and MRI images will be used to validate the ultrasound images.
Detailed Description
A key hallmark of the natural biology of ageing is a progressive loss of skeletal muscle mass, strength and aerobic capacity, termed 'sarcopenia' (Cruz-Jentoft et al. 2019a). The association between muscle loss (mass and quality) and increased incidence of falls, fractures, metabolic disease and other health complications is well established. Despite exercise and physiotherapy, recovery from these is often incomplete and studies have failed to identify fully effective countermeasures (Reeves et al, 2005). Ways to objectively measure the clinical effectiveness of the countermeasures are also limited.
Muscle quality can be measured in terms of muscle thickness, architecture (pennation angle and fascicle length) and fatty infiltration. At present ultrasound muscle thickness and architecture have been shown against MRI to be a reliable and valid but fatty infiltration can only be measured reliably using MRI. MRI is an expensive, time consuming and immobile technique limiting its use as a clinical tool in a rehabilitative setting. Finding a cheaper, quicker and mobile alternative, such as ultrasound, would enable clinicians to gather useful information on patient muscle quality in an objective manner and use this information to tailor treatment accordingly.
15 old (\>50y) and 15 young (\<40y) will be recruited. MRI, MRS and Ultrasound will be measured in each participant in calf and thigh muscle, at the same location within a 1 hour time frame.
MRI and MRS will provide the validation to ultrasound fatty infiltration.
#Intervention
- DIAGNOSTIC_TEST : MRI, MRS
- Scan of right calf and thigh
- DIAGNOSTIC_TEST : Ultrasound
- Scan of right calf and thigh | #Eligibility Criteria:
Inclusion Criteria:
* Age <40y or >50yrs
Exclusion Criteria:
* Significant cognitive deficits and the inability to follow directions during assessment.
* Neurological, neuromuscular, or musculoskeletal disorders that could impair the quality of the muscle. eg. CP, muscular dystrophy or SCI
* Prosthesis with metalwork, eg. metal work from surgery
* Aneurysm clip in situ
* No metal work anywhere, history of metal fragments in eyes, spinal cord or brain.
* Previous exposure to metal flakes and metallic injury.
* No external implants; cochlear implant, spinal cord simulator, pacemaker or other implanted electronic devices.
* Non-removal hearing aids
* FEMALE ONLY Not pregnant
* Not claustrophobic
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT05729880 | {
"brief_title": "Can Ultrasound be Used as a Measure of Muscle Quality? A Validation Study Comparing Ultrasound With MRI and MRS in Older and Younger Persons.",
"conditions": [
"Muscle Atrophy"
],
"interventions": [
"Diagnostic Test: Ultrasound",
"Diagnostic Test: MRI, MRS"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT05729880",
"official_title": "Can Ultrasound be Used as a Measure of Muscle Quality? A Validation Study Comparing Ultrasound With MRI and MRS in Older and Younger Persons.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-16",
"study_completion_date(actual)": "2023-04-01",
"study_start_date(actual)": "2022-06-10"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-05-09",
"last_updated_that_met_qc_criteria": "2023-02-06",
"last_verified": "2024-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-02-15",
"first_submitted": "2023-01-16",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Study results from randomized controlled trials (RCTs) usually have been found not adequately inform practice. A RCT is optimized to determine efficacy, while real-world study is conducted in a routine care setting aimed to determine effectiveness. Thus, it is necessary to evaluate the pragmatism of clinical trials for a better understanding of the external generalizability. Nonetheless, comparative pragmatic features of RCTs and real-world studies still lack well elucidation. By capitalizing on a nasopharyngeal carcinoma (NPC)-specific big-data, real-world database and individual patient data extracted from three landmark RCTs, investigators conducted the direct comparison of NPC cohorts receiving same treatment strategy in clinical trial versus real-world settings, and examined the comparative pragmatic features and their influences on survival outcomes, safety profile, and the probability of returning to society.
Detailed Description
Study results from randomized controlled trials (RCTs) usually have been found not adequately inform practice. A RCT is optimized to determine efficacy. Such trials were performed with relatively small samples at sites with experienced investigators and highly selected participants, they could be overestimating benefits and underestimating harm. Real-world study is conducted in a routine care setting aimed to determine effectiveness. Thus, it is necessary to evaluate the pragmatism of clinical trials for a better understanding of the external generalizability. Nonetheless, comparative pragmatic features of RCTs and real-world studies still lack well elucidation. Nasopharyngeal carcinoma (NPC) is a malignant head and neck cancer with the highest incidences in endemic regions such as Southern China, where over 60,600 new cases were diagnosed in 2015 representing 40% of all cases worldwide. Studies conducted in China are critical in optimizing clinical decision-making of NPC. In the past two decades, the recommendation level of induction chemotherapy (IC) + concurrent chemoradiotherapy (CCRT) has been improved evidently from Category 3 to 2A, and CCRT alone has long been a stable (Category 2B) and classic treatment option of NPC and therefore becomes the most commonly used control group in comparative studies. By capitalizing on a NPC-specific big-data, real-world database via a cancer registry in Southern China and individual patient data extracted from the three landmark RCTs, investigators conducted the direct comparison on IC+CCRT cohort or CCRT cohort of clinical trial versus real-world settings, and examined the comparative pragmatic features and their influences on survival outcomes, safety profile, and the probability of returning to society, with the aim to provide new insight into the optimization of trial design and the translation of study evidences into tangible benefits.
#Intervention
- OTHER : Trial setting
- Study results from clinical trials usually have been found not work efficiently in clinical practice. This outcome disparity may be caused by different pragmatic features of medical environment, also known as study setting such as trial setting and real-world setting, in which biases inherent to clinical trial design restrict its applicability even though all confounding factors are avoided.
- Other Names :
- Explanatory medical environment, Non-pragmatic features | #Eligibility Criteria:
Inclusion Criteria:
* Patients treated in our center from April 2009 to December 2016;
* All patients were pathologically diagnosed, non-metastatic nasopharyngeal carcinoma;
* Only included cases staged as T3 <= age <= 4N1 & T1 <= age <= 4N2 <= age <= 3 according to the 6th or 7th edition American Joint Committee on Cancer / Union for International Cancer Control (AJCC/UICC) system;
* For trial patients, treatment strategies only limited to concurrent chemoradiotherapy, induction chemotherapy combined with concurrent chemoradiotherapy, or concurrent chemoradiotherapy combined with adjuvant chemotherapy;
* For patients from real-world database, patients are permitted to receive additional targeted therapy to standard chemoradiotherapy, as far as it met clinical needs and was approved by physicians.
* The patient's basic information, prognosis related data, and follow-up data are complete.
Exclusion Criteria:
* The clinical stage of T3 <= age <= 4N0 was excluded;
* Cases from large real-world databases need to exclude patients who participate in clinical trials;
Sex :
ALL
Ages :
- Minimum Age : 8 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT04108338 | {
"brief_title": "Prospective Comparisons of Clinical Trial and Real-world Outcomes in Nasopharyngeal Carcinoma",
"conditions": [
"Nasopharyngeal Carcinoma"
],
"interventions": [
"Other: Trial setting"
],
"location_countries": [
"China"
],
"nct_id": "NCT04108338",
"official_title": "Prospective Comparisons of Survival Outcomes, Safety Profile, and Probability of Returning to Society Between Three Randomized Controlled Trials and Real-world Evidence in Nasopharyngeal Carcinoma.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-01",
"study_completion_date(actual)": "2019-08-01",
"study_start_date(actual)": "2019-06-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-01",
"last_updated_that_met_qc_criteria": "2019-09-26",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-09-30",
"first_submitted": "2019-09-26",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This phase I trial studies the side effects and best dose of selinexor when given together with etoposide with or without mitoxantrone hydrochloride and cytarabine in treating patients with acute myeloid leukemia that has returned (relapsed) or has not responded to treatment (refractory). Selinexor may help stop the growth of tumor cells by blocking an enzyme needed for cancer cell growth. Drugs used in chemotherapy, such as etoposide, mitoxantrone hydrochloride, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy together with selinexor work better in treating relapsed or refractory acute myeloid leukemia.
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of selinexor in combination with mitoxantrone hydrochloride, etoposide, cytarabine (MEC) or oral etoposide (respective cohorts are independent of each other) in patients with relapsed or refractory acute myeloid leukemia (AML).
II. To define the specific toxicities, maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of these combinations.
III. To determine the recommended phase 2 dose (RP2D) of these combinations.
SECONDARY OBJECTIVES:
I. To determine the rate and duration of complete remission (CR) ± hematologic recovery of selinexor plus MEC therapy in AML.
II. To determine the overall response rate (ORR). III. To define the rate of complete remission (CR + CR with incomplete blood count recovery \[CRi\]) rate by the end of induction therapy.
IV. Determine the disease-free survival for patients who reached CR/CRi within 1 year.
TERTIARY OBJECTIVES:
I. To conduct pharmacodynamic studies by measuring the effect of these chemotherapy combinations on the inhibition of exportin 1 (XPO1).
II. To conduct pharmacokinetic sampling of selinexor and etoposide at limited time points to assess drug metabolism, peak plasma levels and area under curve (AUC).
OUTLINE: This is a dose-escalation study of selinexor. Patients are assigned to 1 of 2 cohorts.
COHORT A (PATIENTS FIT FOR INTENSIVE THERAPY, AGE \< 60): Patients receive mitoxantrone hydrochloride intravenously (IV), etoposide IV, and cytarabine IV once daily (QD) on days 1-6 and selinexor orally (PO) on days 1, 3, 8, 10, 15, and 17. Treatment continues for 1 course (28 days). Further treatment is based on disease response. Patients achieving CR/CRi are evaluated for stem cell transplant; patients who do not proceed to transplant may receive selinexor as monotherapy in the absence of disease progression or unacceptable toxicity.
COHORT B (PATIENTS UNFIT FOR INTENSIVE THERAPY, AGE ≥ 60): Patients receive etoposide PO QD on days 1-5 and selinexor PO on days 1, 3, 8, 10, 15, and 17. Treatment may repeat every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving response after 4 courses discontinue treatment; patients achieving response may receive up to 4 courses of maintenance therapy every 8 weeks. Patients may then continue selinexor as monotherapy at the discretion of the principal investigator.
After completion of study treatment, patients are followed up for at least 30 days.
#Intervention
- DRUG : mitoxantrone hydrochloride
- Given IV
- Other Names :
- CL 232315, DHAD, DHAQ
- DRUG : etoposide
- Given IV and PO
- Other Names :
- EPEG, VP-16, VP-16-213
- DRUG : cytarabine
- Given IV
- Other Names :
- ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U, cytosine arabinoside
- DRUG : selinexor
- Given PO
- Other Names :
- CRM1 nuclear export inhibitor KPT-330, KPT-330, selective inhibitor of nuclear export KPT-330, SINE KPT-330
- OTHER : laboratory biomarker analysis
- Correlative studies
- OTHER : pharmacological study
- Correlative studies
- Other Names :
- pharmacological studies | #Eligibility Criteria:
Inclusion Criteria:
* Patients with relapsed or refractory AML; Cohort A patients must be < 60 years and have failed at least one prior induction regimen for AML; Cohort B patients must be >= 60 years, unfit for intensive therapy (physician opinion), and have failed an induction regimen for AML. The maximum number of prior lines of induction for both cohorts is 3
* Patients with secondary AML or therapy related disease (t-AML) are eligible
* If the patient has co-morbid medical illness, life expectancy attributed to this must be greater than 6 months
* Eastern Cooperative Oncology Group (ECOG) performance status =< 2
* Total bilirubin < 2.0 mg/dL, except when patient is known to have Gilbert's Syndrome, the total bilirubin can be <=3.0 mg/dL.
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal
* Creatinine (Cr) clearance > 50 mL/min by Modification of Diet in Renal Disease (MDRD) calculation
* New York Heart Association (NYHA) congestive heart failure (CHF) class II or better
* Cardiac ejection fraction >= 50%
* Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
* Ability to understand and willingness to sign the written informed consent document
Exclusion Criteria:
* Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
* Patients receiving any other investigational agents or patients that have received other investigational agents within 14 days of enrollment
* Patients with active central nervous system (CNS) malignancy; asymptomatic small lesions are not considered active; treated lesions may be considered inactive if they are stable for at least 3 months; patients with malignant cells in their cerebrospinal fluid (CSF) without CNS symptoms may be included
* Major surgery within 2 weeks before day 1
* Uncontrolled active infection; patients with infection requiring parenteral antibiotics are eligible if the infection is controlled
* Patients with significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea
* History of seizures, movement disorders or cerebrovascular accident within the past 3 years prior to cycle 1 day 1
* Patients with macular degeneration, uncontrolled glaucoma, or markedly decreased visual acuity
* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure (New York Heart Association [NYHA) class III or IV), unstable angina pectoris, myocardial infarction within 6 months prior to enrollment, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant
* Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study
* Pregnant women or women who are breastfeeding are excluded from this study; confirmation that the subject is not pregnant must be established by a negative serum beta (β)-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
* Patients with advanced malignant solid tumors
* Patients whom, in the opinion of the investigators, are significantly below their ideal body weight
* Patients who are not able to swallow capsules or tablets
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02299518 | {
"brief_title": "Selinexor and Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia",
"conditions": [
"Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities",
"Adult Acute Myeloid Leukemia With Del(5q)",
"Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)",
"Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)",
"Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)",
"Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)",
"Recurrent Adult Acute Myeloid Leukemia",
"Secondary Acute Myeloid Leukemia"
],
"interventions": [
"Drug: selinexor",
"Drug: cytarabine",
"Other: laboratory biomarker analysis",
"Drug: etoposide",
"Drug: mitoxantrone hydrochloride",
"Other: pharmacological study"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02299518",
"official_title": "Phase 1 Study of Selinexor in Combination With Topoisomerase-II Inhibition in Acute Myeloid Leukemia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-03-06",
"study_completion_date(actual)": "2018-03-06",
"study_start_date(actual)": "2015-05-18"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-15",
"last_updated_that_met_qc_criteria": "2014-11-20",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-11-24",
"first_submitted": "2014-11-19",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Researchers in numerical cognition usually think that the greatest and most common difficulty in children suffering from dyscalculia is retrieval of arithmetic facts from long-term memory. However, we have recently shown that retrieval might not be the optimum strategy in mental arithmetic. In fact, expert adults would rather solve simple problems such as 3 + 2 by automated and unconscious procedures. Therefore, we hypothesize that children with dyscalculia might not present deficit in retrieval but, instead, in counting procedure automatization. The aim of the current project is to test this challenging position. Through a longitudinal approach, we plan to precisely examine the behavior of children suffering from dyscalculia over a 3-year period. Children will be aged between 8 to 11 years at the beginning of the study and we will precisely observe the evolution of their solution times when they solve simple addition problems involving one-digit numbers. If children with dyscalculia still struggle with simple additions three years, their solution times plotted on the sum of the problems should still follow an exponential function. Indeed, if counting is not automated, difficulties necessarily increase with the progression on the number line or the verbal sequence, hence the exponential function. On the contrary, if counting procedures tend towards automatization, moves along a number line will progressively become as easy at the beginning of the line as at the end, hence the linear function. Importantly, a retrieval model would predict exactly the inverse pattern because, according to this model, the linear function, which is unanimously considered as the hallmark of counting procedures, should progressively be replaced by a non-linear function through practice.
#Intervention
- BEHAVIORAL : Arithmetic facts solving
- The experiment will contain several tasks. The main one will be a computerized task on arithmetic facts where participants will have to solve simple additions. There will also be three additional tasks: a processing speed task where the participant will have to tell the orientation of an arrow as fast as possible, a visuo-spatial task where the participant will have to reproduce a tapping block sequence and an arithmetic task where the participant will try to solve a maximum of operations in a limited time. | #Eligibility Criteria:
Inclusion Criteria:
* Age between 8 and 11 years
* Having a dyscalculia as described in the DSM (Diagnostic and Statistical Manual) V
Exclusion Criteria:
* Presenting a global intellectual deficit
Sex :
ALL
Ages :
- Minimum Age : 8 Years
- Maximum Age : 11 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT03354481 | {
"brief_title": "Automatization of Counting Procedures in Children With Dyscalculia",
"conditions": [
"Dyscalculia"
],
"interventions": [
"Behavioral: Arithmetic facts solving"
],
"location_countries": [
"France"
],
"nct_id": "NCT03354481",
"official_title": "Automatization of Counting Procedures in Children With Dyscalculia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-09-19",
"study_completion_date(actual)": "2019-09-19",
"study_start_date(actual)": "2018-07-12"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-07-07",
"last_updated_that_met_qc_criteria": "2017-11-27",
"last_verified": "2020-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-28",
"first_submitted": "2017-11-20",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this trial is to compare the effects of treatment with tobramycin solution for inhalation (TIS) with and without azithromycin in people with cystic fibrosis (CF) age 6 months to 18 years who have early isolation of Pseudomonas aeruginosa (Pa) from a respiratory culture. Specimens of blood and sputum or throat swabs will be taken during the study along with pulmonary function testing. Participants will receive initial treatment with TIS followed additional treatment with TIS if quarterly respiratory cultures are positive for Pa in addition to either azithromycin or placebo for 18 months.
Detailed Description
Cystic fibrosis (CF) lung disease begins in the first few months of life and follows a course of recurrent lower airway bacterial infection and inflammation and progression of disease over years and decades at a variable pace. With the development of chronic lung infection, obstructive disease progressively worsens, ultimately leading to respiratory failure. Pseudomonas aeruginosa (Pa) is the most important pathogen infecting the CF lower airways, and its acquisition early in life is associated with a pro-inflammatory effect, lower lung function, poor nutritional outcomes, and decreased survival.
Pseudomonas aeruginosa (Pa) infection of the cystic fibrosis (CF) airway typically proceeds from early infection to chronic infection. Although some studies have shown that a minority of individuals with CF spontaneously clear early Pseudomonas aeruginosa (Pa) infection, data from multiple studies suggest that antibiotics are superior to no treatment in clearing Pseudomonas aeruginosa (Pa) from respiratory cultures. Understanding the transition period from early to chronic Pseudomonas aeruginosa (Pa) infection is thus of critical importance in identifying strategies to prevent this progression.
The study will assess the clinical and microbiologic efficacy and safety of azithromycin given three times weekly in combination with standardized tobramycin solution for inhalation (TIS) therapy among children with early Pseudomonas aeruginosa (Pa). TIS therapy is defined as an initial eradication treatment with 1-2 courses of 28 days TIS and subsequent 28 day treatments only at times a quarterly respiratory culture is positive for Pseudomonas aeruginosa (Pa). Eligible participants will be randomized within one month of their Pseudomonas aeruginosa (Pa) positive culture to receive one of the following two treatment strategies for 18 months: (1) oral placebo in addition to standardized TIS therapy, or (2) oral azithromycin in addition to standardized TIS therapy.
At the first study visit, participants will undergo a physical examination and a review of their medical history. Lung function will be measured via spirometry (in children greater than four years of age who are able to perform spirometry), electrocardiogram (ECG) testing will be conducted, and hearing ability will be measured via audiometry. Blood will be drawn for laboratory tests and a specimen will be obtained for a respiratory culture before randomization and study drug dispensing occurs. Subsequent study visits will take place at Day 21, Weeks 13, 26, 39, 52, 65, and 78. At each visit, participants will undergo a physical examination, a spirometry test (as appropriate), a respiratory specimen for Pseudomonas aeruginosa (Pa) culture will be collected and study drug will be dispensed (except at Week 78). Participants will complete self-report or parent-completed respiratory symptom questionnaires and signs and symptoms evaluations will be performed at all visits. Repeat hearing and laboratory tests will be performed at Weeks 39 and 78 and ECG testing will be repeated at Day 21 and Week 78. Participants will be required to maintain a medication diary throughout the study.
#Intervention
- DRUG : azithromycin
- 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months
- DRUG : placebo
- 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months
- DRUG : Tobramycin solution for inhalation
- 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
- Other Names :
- TIS | #Eligibility Criteria:
Inclusion Criteria:
* Age >= 6 months to <= 18 years
* Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype or positive CF Newborn Screening result for immunoreactive trypsinogen (IRT) IRT/DNA or IRT/IRT and one or more of the following criteria:
* sweat chloride >= 60 milliequivalent (mEq)/liter by quantitative by pilocarpine iontophoresis test (QPIT)
* two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
* Abnormal nasal potential difference (NPD) (change in NPD in response to a low chloride solution and isoproteronol of less than - 5 mV)
* Documented new positive oropharyngeal, sputum or lower respiratory tract culture for Pa within 30 days of the Baseline Visit (Visit 1), defined as: a) first lifetime documented Pa positive culture; or b) Pa recovered after at least a two-year history of Pa negative respiratory cultures (>= 1 culture/ year)
* Clinically stable with no evidence of any significant respiratory symptoms at the Baseline Visit that would require administration of intravenous anti- pseudomonal antibiotics, oxygen supplementation, and/or hospitalization as determined by the study physician
* Written informed consent obtained from participant or participant's legal representative (and assent when applicable) and ability for participant to comply with the requirements of the study
Exclusion Criteria:
* Macrolide antibiotic use within 30 days of the Baseline Visit
* Initiation of current course of treatment with TIS >14 days prior to Baseline Visit
* Weight <6.0 kg at the Baseline Visit
* History of aminoglycoside hypersensitivity or adverse reaction to inhaled aminoglycoside
* History of azithromycin hypersensitivity or adverse reaction to azithromycin or allergy to macrolide antibiotics
* History of positive respiratory culture for Non-tuberculous mycobacteria (NTM) or Burkholderia cepacia complex within 2 years of the Baseline Visit
* History of unresolved, abnormal renal function (defined as serum creatinine greater than 1.5 times the upper limit of normal for age).
* History of unresolved, abnormal liver function tests (defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 4 times the upper limit of normal range) or history of portal hypertension
* History of unresolved, abnormal neutropenia (ANC <= 1000)
* Abnormal ECG test at the Baseline Visit defined as a QT interval corrected (QTc) (B) of >=460 msec or history of ventricular arrhythmia
* History of abnormal hearing sensitivity defined as hearing threshold levels >25 dB HL (decibels Hearing Level) for visual reinforcement audiometry (VRA) at any frequency (500 <= age <= 4000Hz) or >20 Decibels Hearing Level (dBHL) for play or standard audiometry at any two frequencies (500 <= age <= 8000Hz) in either ear, not associated with middle ear disease (including infection) or a flat (Type B) tympanogram
* New initiation of chronic therapy (greater than 21 days) with drugs known to prolong QT interval (refer to Appendix III) within 30 days prior to the Baseline Visit or coadministration of nelfinavir or oral anticoagulants
* Positive serum or urine pregnancy test at the Baseline Visit (to be performed on all females of child-bearing potential) or for females of child bearing potential: pregnant, breastfeeding, or unwilling to use barrier contraception during participation in the study
* Administration of any investigational drug within 30 days prior to the Baseline Visit
* Presence of a condition or abnormality (e.g., pre-existing heart disease) that in the opinion of the site investigator would compromise the safety of the participant or the quality of the data
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT02054156 | {
"brief_title": "OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis",
"conditions": [
"Cystic Fibrosis"
],
"interventions": [
"Drug: Tobramycin solution for inhalation",
"Drug: azithromycin",
"Drug: placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02054156",
"official_title": "OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis: The OPTIMIZE Multicenter, Placebo-Controlled, Double-Blind, Randomized Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-08-23",
"study_completion_date(actual)": "2018-08-23",
"study_start_date(actual)": "2014-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-01",
"last_updated_that_met_qc_criteria": "2014-02-01",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-02-04",
"first_submitted": "2014-02-01",
"first_submitted_that_met_qc_criteria": "2019-09-12"
}
}
} |
#Study Description
Brief Summary
This is a cross-sectional, non-interventional study, consisting of three study arms, (1) Full Characterization (AIMS-Full), (2) Surgery Arm (AIMS-OR), and (3) Mucus Collection (AIMS-M). Participants will be recruited and enrolled in either AIMS-Full or AIMS-OR (based on participant availability). Participants who complete the initial characterization study (either AIMS-Full or AIMS-OR), may also go on to participate in the AIMS-M arm, which focuses mainly on sample collection. Participants who choose not to participate in either characterization arm are able to enroll directly into AIMS-M for sample collection only.
Detailed Description
This is a cross-sectional and non-interventional study to investigate mechanisms of disease in patients with asthma who have concomitant chronic sinusitis and/or nasal polyps (upper airway disease). Approximately 160 participants will be enrolled. Patients who are scheduled to undergo inpatient or outpatient endoscopic sinus surgery at the University of California San Francisco for clinical management of their upper airway disease will be invited to participate. Leftover tissues or mucus from the surgery will be collected and processed for research purposes.
This study consists of three study arms, (1) Full Characterization (AIMS-Full), (2) Surgery (AIMS-OR), and (3) Mucus Collection (AIMS-M). Participants will be recruited and enrolled in either AIMS-Full or AIMS-OR (based on participant availability). Participants who complete the initial characterization study (either AIMS-Full or AIMS-OR), may also go on to participate in the AIMS-M arm, which focuses mainly on sample collection. Participants who choose not to participate in either characterization arm are able to enroll directly into AIMS-M for sample collection only.
Suitable patients, undergoing endoscopic sinus surgery, will be identified and recruited by the study team. Patients will first be asked to participate in the AIMS-Full characterization.
If patients are unable or unwilling to participate in AIMS-Full, they will have the option to take part in the AIMS-OR or AIMS-M arms.
AIMS-OR will consist of the endoscopic sinus surgery with an optional pre-procedure visit during which consent and blood specimens will be obtained and questionnaires will be administered. If the optional pre-procedure visit is not done, consent will be obtained at the surgery visit, and blood will not be collected.
AIMS-M will consist of up to 5 visits. Patients seen in the UCSF Sinus Center clinic may have clearance of sinus mucus as part of routine clinical care; AIMS-M visits will collect these mucus samples that would otherwise be discarded. Sinus mucus obtained at the clinic visit may be used for research purposes if patients have given consent to participate in the AIMS-M arm of the study.
Participants in all three study arms will complete study-specific questionnaires on asthma and allergy history and impairment and provide samples of nasal secretions that are collected as part of routine clinical care and would otherwise be discarded. Those participating in either characterization arm (AIMS-Full or AIMS-OR) will also provide nasal tissues (part of routine surgical procedure); airway epithelial brushings and blood collection (for study purposes only). Those participating in AIMS-Full will also participate in the following study procedures: medical history and physical exam (including vital signs and body anthropometrics), spirometry, methacholine challenge or airway reversibility testing, exhaled nitric oxide, questionnaires (asthma, sinusitis, metabolic health), urine collection, and sputum induction. A participant's time commitment to the study will vary depending on which arm the participant is enrolled.
#Intervention
- PROCEDURE : Endoscopic sinus surgery
- This is an observational trial of patients with and without asthma who have concomitant chronic rhinosinusitis requiring endoscopic sinus surgery. | #Eligibility Criteria:
Inclusion Criteria:
* Male or female >=18 years at Visit 0.
* Diagnosis of bilateral chronic sinusitis with a minimum Lund-MacKay CT score of 6 and/or diagnosis of nasal polyps
* Half of the patients need to have a history of asthma
Exclusion Criteria:
* History of lung disease other than asthma (e.g., cystic fibrosis, chronic obstructive pulmonary disease, interstitial lung disease, etc.)
* History of hiatal hernia repair
* History of cigarette and/or marijuana smoking (>10 total pack years, smokes >5 cigarettes per month, smoking within 2 weeks of study participation, marijuana use within 1 month of study participation)
* If a participant has had an upper respiratory tract infection and/or an exacerbation of his/her asthma within 4 <= age <= 6 weeks of the characterization visit, this visit will be rescheduled to 4 weeks after recovery.
* Current pregnancy or breastfeeding
* History of medical disease, which, in the opinion of the investigator, may put the participant at extra risk from study-related procedures or because disease may influence the results of the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02548598 | {
"brief_title": "Analysis of Inflammation and Microbiome in Patients With Sinusitis and Asthma",
"conditions": [
"Asthma",
"Chronic Rhinosinusitis"
],
"interventions": [
"Procedure: Endoscopic sinus surgery"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02548598",
"official_title": "Analysis of Inflammation and Microbiome in Patients With Sinusitis and Asthma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-09",
"study_completion_date(actual)": "2021-04",
"study_start_date(actual)": "2017-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-05-03",
"last_updated_that_met_qc_criteria": "2015-09-10",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-09-14",
"first_submitted": "2015-08-18",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Vitamin D in the treatment of primary dysmenorrhoea. Design:Randomised controlled trial. Setting:In a university hospital. Population: 142 women aged 16-35 years. Methods: Patients were treated with 667 unit of vitamin D once a day, 200 unit of vitamin E once a day or 400 mg ibuprofen twice a day,2 days before the date of menstruation and continued through the first 3 days, for 2 months. Main outcome measures: Pain score. Results: Mean VAS of vitamin D group was 4,91, was 6,54 in the vitamin E group and was 4,02 in the ibuprofen group Conclusion:Vitamin D and vitamin E are effective in relieving the pain,but the effect of vitamin D are more prominent
Detailed Description
An excessive uterine production of prostaglandins is the pathogenic trigger of dysmenorrhoea. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the currently accepted drugs for the management of this disorder. The capacity for synthesizing vitamin D and the presence of vitamin D receptor in human cycling endometrium have also been demonstrated. Because vitamin D reduces the synthesis of prostaglandins, a beneficial effect of vitamin D for the uterus is possible.Vitamin E inhibits the release of arachidonic acid and the conversion of arachidonic acid to prostaglandin via an action on the enzymes phospholipase A2 and cyclooxygenase.
#Intervention
- DIETARY_SUPPLEMENT : Vitamin D
- Other Names :
- Devit-3 damla barcod number 8699525590435 ,DEVA Holding AŞ
- DIETARY_SUPPLEMENT : Vitamin E
- Other Names :
- Evicap d-alfa-Tokoferol, KOÇAK Farma
- DRUG : Ibuprofen
- Other Names :
- profen Dinçtaş İlaç | #Eligibility Criteria:
Inclusion Criteria:
* Women had regular menstrual cycles lasted 21 to 35 days, with menstruation lasting 3 to 7 days;
* Women had to be in good health and taking no medications including calcium, magnesium, vitamin D and oral contraceptives.
* Women had not a previous history of gynaecological disease, and a normal pelvic examination were eligible.
Exclusion Criteria:
1) Previous and current use of intrauterine contraceptive devices within the 6 months to enrollment was not permitted
Sex :
FEMALE
Ages :
- Minimum Age : 16 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT02441530 | {
"brief_title": "Effectiveness of Vitamin D in Primary Dysmenorrhoea",
"conditions": [
"Primary Dysmenorrhoea"
],
"interventions": [
"Drug: Ibuprofen",
"Dietary Supplement: Vitamin E",
"Dietary Supplement: Vitamin D"
],
"location_countries": null,
"nct_id": "NCT02441530",
"official_title": "Vitamin D in the Treatment of Primary Dysmenorrhoea: A Prospective Randomised Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-01",
"study_completion_date(actual)": "2013-10",
"study_start_date(actual)": "2012-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-05-12",
"last_updated_that_met_qc_criteria": "2015-05-11",
"last_verified": "2015-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-05-12",
"first_submitted": "2015-05-08",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Achieving results from RCTs with high internal and external validity is a major challenge within psychiatry due to the nature of psychiatric illnesses. The Investigators will conduct a 'real world' naturalistic nation-wide population-based longitudinal register linkage study comparing long-term responses to all kinds of antidepressants in patients with major depressive disorder emulating a randomized trial.
#Intervention
- DRUG : Antidepressant
- Treatment with an antidepressant according to Danish register data.
- Other Names :
- sertraline, citalopram, fluoxetine, paroxetine, escitalopram, reboxetine, venlafaxine, duloxetine, mirtazapine, vortioxetine, agomelatine, amitriptyline, imipramine | #Eligibility Criteria:
Inclusion Criteria:
All patients with a psychiatric contact (as inpatients or outpatients) in the period from 1995 to 2018 with a first main index diagnosis of a single depressive episode or recurrent depressive disorder (ICD-10 code: F32-F33.9) with an outpatient purchase of an antidepressant after the depression diagnosis (N=73.336).
Exclusion Criteria:
None.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT05952713 | {
"brief_title": "Comparative Responses to 15 Different Antidepressants in Major Depressive Disorder",
"conditions": [
"Major Depressive Disorder"
],
"interventions": [
"Drug: Antidepressant"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT05952713",
"official_title": "Comparative Responses to 15 Different Antidepressants in Major Depressive Disorder - Results From a Long-term Nation-wide Population-based Study Emulating a Randomized Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-07-01",
"study_completion_date(actual)": "2023-07-01",
"study_start_date(actual)": "2022-10-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-08-18",
"last_updated_that_met_qc_criteria": "2023-07-18",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-07-19",
"first_submitted": "2023-07-11",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The 12-month study will investigate a cognitive training augmentation of supported employment to improve cognitive performance and work outcomes, which are expected to result in improved quality of life and community integration for veterans with mild to moderate traumatic brain injuries. The primary hypothesis is that compared to veterans who receive enhanced supported employment, those who receive supported employment plus cognitive training will work more weeks during the 12 months.
#Intervention
- BEHAVIORAL : Supported employment plus cognitive training
- Supported employment for 12 months plus cognitive training for the first 12 weeks
- BEHAVIORAL : Enhanced supported employment
- Supported employment for 12 months plus one additional supported employment session per week for the first 12 weeks. | #Eligibility Criteria:
Inclusion Criteria:
* OEF/OIF veteran
* History of mild-to-moderate TBI (loss of consciousness <6 hours; post-traumatic amnesia <7 days)
* Documented impairment in at least one neuropsychological domain
* Unemployed, but stating a goal of work
* Written informed consent to participate in the study
Exclusion Criteria:
* Current alcohol/substance abuse or dependence
* Participation in other intervention studies
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00704067 | {
"brief_title": "Improving Work Outcomes for Veterans With Traumatic Brain Injury",
"conditions": [
"Traumatic Brain Injury"
],
"interventions": [
"Behavioral: Enhanced supported employment",
"Behavioral: Supported employment plus cognitive training"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00704067",
"official_title": "Improving Work Outcomes for Veterans With Traumatic Brain Injury",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-08",
"study_completion_date(actual)": "2012-08",
"study_start_date(actual)": "2008-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-02-12",
"last_updated_that_met_qc_criteria": "2008-06-20",
"last_verified": "2015-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-06-24",
"first_submitted": "2008-06-20",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The primary objective of this study is to assess the safety and tolerance of changing patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.
Detailed Description
The therapy of pulmonary arterial hypertension (PAH) has been revolutionized with the development and subsequent instruction of oral endothelin receptor antagonists (ERA). The first approved ERA, bosentan (Tracleer, Actelion, Inc.) is an effective drug widely used throughout the world in the therapy of PAH. Newer ERA's, with purported advantages over the first approved drug have since been tested and subsequently been approved for the therapy of PAH in the USA and other countries including ambrisentan (Letairis, Gilead Sciences, Inc.). However, there is little data available on the efficacy, safety and tolerability of the elective change from oral bosentan to oral ambrisentan in PAH.
#Intervention
- DRUG : ambrisentan
- ambrisentan 2.5mg, 5mg, \& 10mg. Daily dosage.
- Other Names :
- Letairis | #Eligibility Criteria:
Inclusion Criteria:
* Patients followed routinely in the pulmonary vascular disease clinic at the University of Alabama in Birmingham, greater than or equal to 19 years.
* World Health Organization (WHO) PAH Type I
* WHO class I-IV symptoms (no functional class exclusion).
* On bosentan, twice a day, with a maximum daily dose of 250mg, on a stable dose for 3 months with no clinical indication to discontinue the drug (i.e., increased liver function studies or other intolerance). Patients may be on other drug therapies for PAH, and also may be on oxygen therapy (intermittent or continuous).
Exclusion Criteria:
* Known intolerance or allergy to ambrisentan.
* Prior therapy with ambrisentan.
* Current therapy with two phosphodiesterase-5 inhibitors.
* Change in other approved therapy for PAH (including phosphodiesterase-5 inhibitors and prostanoids) within 4 weeks of baseline study visit.
* Planned addition of prostanoid for clinical reasons within 3 months of baseline study visit.
* Active participation in another clinical study involving the medical therapy of PAH.
* Uncontrolled systemic hypertension or angina pectoris
* Serum creatinine greater than 2.5 at or within 4 weeks of baseline.
* Serum liver function studies greater than 3 x normal at or within 4 weeks of baseline study visit.
* In the opinion of the investigator, a change in PAH therapy would present significant risk to the subject.
* In the opinion of the investigator, the participant is unlikely to survive for 12 weeks after study entry.
* In the opinion of the investigator, the participant is likely to undergo lung or heart-lung transplantation within 12 weeks of study entry.
* A woman of childbearing potential who is not using an acceptable form of contraception.
* Pregnancy.
* In the opinion of the investigator, a participant who is not capable or willing to follow the study procedures.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01330108 | {
"brief_title": "Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension",
"conditions": [
"Pulmonary Arterial Hypertension"
],
"interventions": [
"Drug: ambrisentan"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01330108",
"official_title": "Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-06",
"study_completion_date(actual)": "2012-06",
"study_start_date(actual)": "2011-05"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-08-11",
"last_updated_that_met_qc_criteria": "2011-04-05",
"last_verified": "2014-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-04-06",
"first_submitted": "2011-04-04",
"first_submitted_that_met_qc_criteria": "2014-07-17"
}
}
} |
#Study Description
Brief Summary
Post-market, on-label, double-blind, randomized, prospective, interventional, tolerability and clinical outcomes study to determine the number of patients achieving their final assigned VNS Therapy dose settings in patients with drug-resistant epilepsy who are being treated with adjunctive VNS Therapy using new titration protocols.
Detailed Description
Post-market, on-label, double-blind, randomized, prospective, interventional, tolerability and clinical outcomes study is designed to determine which VNS Therapy titration paradigm allows more patients to achieve a therapeutic dose within a specified time frame. Additionally, the study will collect data on the acute tolerability and clinical outcomes for patients with drug-resistant epilepsy treated with adjunctive VNS Therapy employing three different titration paradigms.
#Intervention
- DEVICE : Vagus Nerve Stimulation Therapy
- Stimulation of the left tenth cranial nerve via VNS Therapy
- Other Names :
- VNS Therapy | #Eligibility Criteria:
Inclusion Criteria:
* Patients must agree to be treated with VNS Therapy. The decision to treat with VNS Therapy must have been made independent of and prior to participation in the study.
* Patients must be >= 12 years and have partial onset seizures or must follow the indication for use statement for VNS Therapy.
* Patient and/or caregiver must be able and willing to give accurate side effect reports, global impressions data and complete study instruments with minimal assistance throughout the study.
* Patient or legal guardian understands study procedures and voluntarily signs an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional policies. In the event the patient is under the age of 18, the patient will also be required to sign an assent affirming agreement to participate in research according to local IRB requirements.
* Patient must be taking at least 1 anti-epileptic drug treatment
Exclusion Criteria:
* Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
* Patient is expected to require MRI using a body coil for transmission of RF during the clinical study.
* Patient has a progressive neurological condition (e.g. brain tumor etc.).
* In the investigator's opinion, the patient or legal guardian is unable to comply with the frequency of clinic visits during the study.
* Patient is currently using an investigational device or pharmacologic medication not approved by the FDA.
* Patient was previously implanted with VNS Therapy.
* In the investigator's opinion, the patient is considered a suicide risk or is otherwise not a good candidate for this study.
* Patient/Caregiver is unable to complete the required study follow-up visits and assessments.
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT02385526 | {
"brief_title": "Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation",
"conditions": [
"Epilepsy",
"Seizures"
],
"interventions": [
"Device: Vagus Nerve Stimulation Therapy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02385526",
"official_title": "ASCEND: Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-10-10",
"study_completion_date(actual)": "2016-10-10",
"study_start_date(actual)": "2015-04-28"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-07-23",
"last_updated_that_met_qc_criteria": "2015-03-10",
"last_verified": "2017-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-11",
"first_submitted": "2015-03-05",
"first_submitted_that_met_qc_criteria": "2017-10-03"
}
}
} |
#Study Description
Brief Summary
1. The accuracy of the sensors (Dexcom G5 vs FreeStyle Libre Flash glucose monitoring) will be evaluated by simultaneous wearing of the 2 sensors during 2 weeks. During these 2 weeks the patients will do at least four capillary blood glucose measurements to compare with the sensor results.
2. Patient satisfaction will be evaluated using a questionnaire that will be completed after the Dexcom G5 sensor has been worn for 1 month.
3. The data recorded by the FreeStyle Libre Flash glucose monitoring system (average glucose,% above target, % within target, % under target, amount of hypoglycemia) in the month prior to the 2 weeks of double sensor wear will be compared to the same data recorded by the Dexcom G5 mobile CGM system during the first month of use.
#Intervention
- DEVICE : Dexcom G5 Mobile CGM system
- The accuracy and usability ot the Dexcom G5 mobile CGM system will be evaluated | #Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes mellitus
* Treated by insulin injections
Exclusion Criteria:
* Other types of diabetes
* Treated with insulin pump
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT03602963 | {
"brief_title": "Comparison Between Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System and the FreeStyle Libre Flash Glucose Monitoring System",
"conditions": [
"Type 1 Diabetes Mellitus"
],
"interventions": [
"Device: Dexcom G5 Mobile CGM system"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT03602963",
"official_title": "A Comparative Study on the Accuracy and Usability Between the Dexcom G5 Mobile CGM System and the FreeStyle Flash Glucose Monitoring System",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12-31",
"study_completion_date(actual)": "2019-03-30",
"study_start_date(actual)": "2018-07-09"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-02-17",
"last_updated_that_met_qc_criteria": "2018-07-18",
"last_verified": "2018-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-27",
"first_submitted": "2018-07-05",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study was to evaluate the efficacy and safety of intravenous (IV) clevidipine as compared with standard of care IV antihypertensive agents for blood pressure (BP) lowering in patients with acute heart failure and elevated BP.
Detailed Description
This study was an open-label randomized efficacy and safety pilot trial in patients with acute heart failure (AHF) and hypertension (systolic blood pressure \[SBP\] ≥160 mm Hg) requiring parenteral antihypertensive therapy. Eligible patients were randomized to receive clevidipine or standard of care (SOC) intravenous antihypertensive treatment in an open-label manner in a ratio of 1:1. At the time of randomization, a patient-specific, prespecified SBP target range was determined and be recorded, prior to study drug treatment. Information on the dosing regimen, use of additional or alternative agents and transition to oral therapy if needed is detailed in the study 'ARM' and 'INTERVENTION' sections.
A Data Safety Monitoring Board was utilized periodically throughout the study to monitor the safety of patients. Adverse events were assessed for 7 days post-study randomization or hospital discharge, whichever occured first. Serious adverse events (SAEs) were assessed for 30 days following study randomization. Subjects were contacted by telephone or in person up to 5 days after their 30-day time point to determine if any SAEs occurred following study drug treatment and to follow up on the Heath Economic assessments.
#Intervention
- DRUG : Clevidipine
- Clevidipine was to be administered continuously as monotherapy during the first 30 minutes. Use of an alternative IV antihypertensive agent(s) was discouraged and was limited to where medically necessary to maintain patient safety. Patients who received an alternative antihypertensive agent along with the study drug were allowed to continue in the study. If transition to an oral antihypertensive agent was required, it was to be administered approximately 1 hour prior to the termination of clevidipine with study drug down-titrated or terminated in order to maintain the desired blood pressure level.
- Other Names :
- Cleviprex, clevidipine emulsion, clevidipine injectible emulsion
- DRUG : Standard of Care IV antihypertensive
- SOC IV antihypertensive agent will be administered for a minimum of 30 min and, if medically warranted, may continue beyond 96 hours at the investigator's discretion. As with clevidipine, the SOC agent was to be administered continuously as monotherapy during the first 30 minutes. Use of an alternative agent(s) was discouraged and was limited to where medically necessary to maintain patient safety. Higher dose titration rates were required to be attempted prior to making the decision to switch to or add on an alternative antihypertensive agent(s). Patients who received an alternative antihypertensive agent with SOC were allowed to continue in the study. If transition to an oral antihypertensive agent was required, it was to be administered per institutional practice.
- Other Names :
- nitroglycerin, nicardipine, sodium nitroprusside, isosorbide dinitrate, hydralizine, diltiazem | #Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* Presentation consistent with acute heart failure and pulmonary congestion on physical examination as evidenced by rales
* Baseline systolic blood pressure (immediately prior to initiation of study drug) of >=160 mm Hg
* Dyspnea score (sitting) of at least 5 on a 10 cm visual analog scale (VAS)
* Required IV antihypertensive therapy to lower blood pressure
* Written informed consent
Exclusion Criteria:
* Administration of an agent (IV or oral) for the treatment of elevated BP within the previous 2 hours of randomization. (Previous short-acting non-IV nitrates, continuous positive airway pressure (CPAP), and bi-level positive airway pressure (BiPAP) were permitted)
* Chest pain and/or electrocardiogram with ST segment changes consistent with acute coronary syndrome
* Known or suspected aortic dissection
* Acute myocardial infarction within the prior 14 days
* Dialysis-dependant renal failure
* Requirement for immediate endotracheal intubation
* Positive pregnancy test, known pregnancy or breast feeding female
* Intolerance or allergy to calcium channel blockers
* Allergy to soybean oil or egg lecithin
* Known liver failure, cirrhosis or pancreatitis
* Prior directives against advanced life support
* Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00803634 | {
"brief_title": "Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO)",
"conditions": [
"Hypertension",
"Heart Failure"
],
"interventions": [
"Drug: Clevidipine",
"Drug: Standard of Care IV antihypertensive"
],
"location_countries": [
"France",
"Germany",
"United States"
],
"nct_id": "NCT00803634",
"official_title": "A Safety and Efficacy Study of Blood Pressure Control in Acute Heart Failure - A Pilot Study (PRONTO)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-02",
"study_completion_date(actual)": "2012-03",
"study_start_date(actual)": "2008-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-08-29",
"last_updated_that_met_qc_criteria": "2008-12-04",
"last_verified": "2014-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-12-05",
"first_submitted": "2008-12-03",
"first_submitted_that_met_qc_criteria": "2014-07-30"
}
}
} |
#Study Description
Brief Summary
This is a Phase 3, randomized, parallel-group, multicenter, double-dummy, double-blind study with a screening period. Subjects will receive one of the following three treatment groups for 15 days: loratadine 10 mg/montelukast 10 mg combination, pseudoephedrine 240 mg, or placebo. The primary objective of this study is to assess the efficacy of the combination of loratadine/montelukast, a once-daily tablet containing 10 mg loratadine and 10 mg montelukast, compared with placebo in subjects with seasonal allergic rhinitis (SAR) in relieving the symptom of nasal congestion. The safety profile of combined loratadine/montelukast relative to placebo and pseudoephedrine will also be evaluated.
#Intervention
- DRUG : loratadine; montelukast | #Eligibility Criteria:
Inclusion Criteria:
* Aged >= 15 years, of either sex and of any race.
* At least a 2-year documented history of SAR with symptoms during the study season.
* A positive skin-prick test response to seasonal
* Clinically symptomatic at Screening and at the Baseline Visits
* General good health.
* Freedom from any clinically significant disease, other than SAR, that would interfere with the study evaluations.
* Willingness (subjects and/or a parent/guardian) to give written informed consent and ability to adhere to dosing and visit schedules and meet study requirements.
* Negative pregnancy test
Exclusion Criteria:
* A history of anaphylaxis and/or other severe local reaction(s) to skin testing.
* Asthma requiring chronic use of inhaled or systemic corticosteroids.
* Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
* Rhinitis medicamentosa.
* A history of allergies to more than two classes of medications or allergy to or intolerance of antihistamines, montelukast, or pseudoephedrine.
* An upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14 day washout prior to the Screening Visit, or a viral upper respiratory infection within 7 days before the Screening Visit.
* Nasal structural abnormalities, including large nasal polyps and marked septal deviations, that significantly interfere with nasal air flow.
* Dependence (in the opinion of the investigator) on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.
* Narrow-angle glaucoma, increased intraocular pressure, urinary retention, hypertension, severe coronary artery disease, ischemic heart disease, diabetes mellitus, hyperthyroidism, renal impairment, or prostatic hypertrophy, and those receiving monamine oxidase (MAO) inhibitor therapy.
* Use of any drug in an investigational protocol in the 30 days before the Screening Visit.
* Current immunotherapy (desensitization therapy), unless on a regular maintenance schedule prior to the Screening Visit, which should be maintained for the remainder of the study. No desensitization treatment within 24 hours before any visit.
* Requirement for chronic use of tricyclic antidepressants.
* Pregnancy or lactation.
* Family member of the investigation study staff.
* Current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subject's participation in the study. Particular attention should be given to exclude subjects with conditions that would currently interfere with the absorption, distribution, metabolism, or excretion of the study drug or interfere with the subject's ability to complete or reliably complete the diary card.
* Significant medical condition(s) that, in the judgment of the investigator, might interfere with the study or require treatment.
* Compromised ability to provide informed consent..
* A history of noncompliance with medications or treatment protocols.
Sex :
ALL
Ages :
- Minimum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT00319995 | {
"brief_title": "Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095) (COMPLETED)",
"conditions": [
"Rhinitis, Allergic, Seasonal"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00319995",
"official_title": "Efficacy and Safety of Combination Loratadine/Montelukast QD vs Pseudoephedrine and Placebo in the Treatment of Subjects With Seasonal Allergic Rhinitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-06-01",
"study_completion_date(actual)": "2006-06-28",
"study_start_date(actual)": "2006-03-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-15",
"last_updated_that_met_qc_criteria": "2006-04-28",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-04-27",
"first_submitted": "2006-04-28",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Clinical research includes Determination of efficacy and acceptability of the local medicine 'Rutan tablets 0,025' in children and teenagers 6-18 years old with COVID-19 and/or acute respiratory viral infections. And also the purpose of the study was to study clinical and laboratory changes when using Rutan in patients with Covid 19 clinical methods such as collection of anamnesis, dynamic examination of patients, catamnestic observation - a telephone survey, as well as biochemical, immunological, virologic PCR and ELISA tests.
Detailed Description
This study is a randomized, open-label, controlled trial to evaluate the safety and efficacy of a novel therapeutic agent, Rutan 25 mg, in hospitalized child patients diagnosed with COVID-19. The study will be a series of comparisons with two groups. The main group will receive the drug 'Rutan 25 mg'. The control group will not be given the study drug. There will be continuous monitoring to stop the study due to futility, efficacy or safety. Because of the likelihood that the baseline standards for maintenance therapy may evolve/improve over time, safety and efficacy comparisons will adapt.
Randomization will be based on: Card system (the patient will be asked to choose one of two cards with the same drawings on the visible side, and after choosing, when turning over the cards, it will be determined which group the patient will be included) Patients of the main group (210 patients) will be prescribed Rutan 25 mg tablets, along with the therapy recommended at the time of the study. The course of treatment will be - on the first day, 1 tablet 2 times a day. The duration of the course of treatment is 10 days, with good tolerability of the drug.
The comparison group (100 patients) will receive the current recommended treatment at the time of the study without the use of investigational medicine.
Screening failures are defined by participants who agreed to participate in a clinical trial but were not subsequently randomized to participate in the study. A minimum set of information about monitoring failures is required to ensure transparent reporting, compliance with the publication of the Consolidated Reporting Standards (CONSORT), and responses to regulatory requests. The minimum information includes demographics, monitoring failure details, eligibility criteria, and any serious adverse events (SAEs).
Discontinuation of participation/withdrawal of a participant means termination of participation in the study, and the remaining study procedures must be interrupted and replaced by another participant, as indicated in the study protocol. Any clinically significant changes in the patient's condition and/or laboratory values will be reported as an adverse event (AE) by the investigator. The researcher has the right to make changes or terminate the study.
#Intervention
- DRUG : Rutan 25 mg
- Active ingredient: (3,6-bis-O-galloyl-1,2,4-tri-O-galloyl-β-D-glucose). Active substance: 'Rutan 25 mg. Excipients: potato starch, calcium stearate, lactulose.
- Other Names :
- Rutan
- OTHER : Control group
- Taking basic therapy without Rutan | #Eligibility Criteria:
Inclusion Criteria:
Submission of a signed and dated informed consent form (guardian). Declared willingness to comply with all study procedures and accessibility during the study.
Children from 6 <= age <= 18 old. Patients with PCR-confirmed COVID-19 with mild/moderate disease. U07.1. Ability to take oral medications and willingness to adhere to the regimen.
Exclusion Criteria:
Severe form of COVID-19. U07.1. Treatment with another investigational drug. Individual intolerance to the drug. The occurrence of any allergic reactions. Weighting of the general well-being of the patient and the transition to a severe form of the disease.
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT05862883 | {
"brief_title": "Studying the Efficiency of the Natural Preparation Rutan in Children in the Treatment of COVID-19, ARVI",
"conditions": [
"COVID-19 Respiratory Infection"
],
"interventions": [
"Drug: Rutan 25 mg",
"Other: Control group"
],
"location_countries": [
"Uzbekistan"
],
"nct_id": "NCT05862883",
"official_title": "Studying the Efficiency of the Natural Preparation Rutan in Children in the Treatment of COVID-19, Acute Respiratory Viral Infections, and Developing Treatment Protocols",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-07-01",
"study_completion_date(actual)": "2022-07-01",
"study_start_date(actual)": "2021-06-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-17",
"last_updated_that_met_qc_criteria": "2023-05-16",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-05-17",
"first_submitted": "2023-05-15",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to establish the objective response rate (complete response + partial response), following treatment with Alimta plus VELCADE, Alimta alone, or VELCADE alone in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed prior preventative therapy for Stage IIIb/IV NSCLC. The Alimta alone treatment group will be used as the control. The VELCADE single-agent treatment group will be used to determine if VELCADE administered weekly can demonstrate response rates.
#Intervention
- DRUG : VELCADE
- DRUG : Alimta | #Eligibility Criteria:
Inclusion Criteria:
* Men or women, 18 years or older
* Non-small cell lung cancer (NSCLC) has been histologically or cytologically confirmed
* Has relapsed or refractory locally advanced (Stage IIIb) or metastatic (Stage IV) NSCLC
* Failed one prior line of systemic antineoplastic therapy for Stage IIIb/IV NSCLC (one additional prior line allowed if given as neoadjuvant, or adjuvant therapy to tumor resection)
* Subject must have documented progressive disease (PD) since previous systemic antineoplastic therapy
* Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Has an ECOG performance status score of 0 or 1
* Has a life expectancy greater than 3 months
* Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and have a negative serum or urine β-human chorionic gonadotropin (hCG) pregnancy test at screening.
* Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to and able to comply with the protocol requirements and participate in the study before any study-related procedure not part of normal medical care is conducted.
* In countries where health authorities have approved the pharmacogenomic and protein testing, subjects (or their legally acceptable representatives) must have signed an informed consent for testing indicating that they agree to participate in the genetic part and protein testing part of the study; participation in the genetic and protein testing component is mandatory for testing, but optional for future research.
Exclusion Criteria:
* Has peripheral neuropathy of Grade 2 or greater intensity, as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 3.0)
* Previous treatment with VELCADE or Alimta
* Has received 2 or more prior lines of antineoplastic therapies for Stage IIIb/IV NSCLC
* Any prior systemic antineoplastic therapy for NSCLC (i.e., prior chemotherapy, radiation therapy, prior monoclonal antibodies or any investigational drug or any major surgery) within 4 weeks before randomization
* Has had significant weight loss (documented equal to or greater than 10% body weight in the 6 weeks before randomization)
* Inadequate organ function at the screening visit as defined by the following laboratory values:
* Platelet count equal to or less than 100 × 10^9/L
* Hemoglobin equal to or less than 8.0 g/dL (80 g/L)
* Absolute neutrophil count (ANC) equal to or less than 1.5 × 10^9/L
* AST equal to or greater than 3 times the upper limit of the normal range (ULN) or greater than 5 times the ULN for subjects with liver metastases
* ALT equal to or greater than 3 times ULN
* Calculated creatinine clearance equal to or greater than 45 mL/min
* Total bilirubin equal to or greater than 1.5 times ULN
* Myocardial infarction within 6 months before randomization or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
* Central nervous system metastasis or brain metastases that have not been completely resected or completely eliminated by radiation therapy and/or chemotherapy, or clinical or radiographic evidence that they have recurred. Subjects with a history of brain metastases are required to have had a brain computed tomography (CT) or magnetic resonance imaging (MRI) scan conducted within 1 month of enrollment to verify the continuing absence of brain metastases.
* Uncontrolled pleural effusion (defined as more than 2 pleuracentesis within 4 weeks of the randomization)
* Active systemic infection requiring treatment
* Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) for a 5-day period (8-day period for long-acting agents, such as piroxicam)
* Unable or unwilling to take corticosteroids
* Other malignancy within the past 5 years. Exceptions for the following if treated and not active:
* basal cell or nonmetastatic squamous cell carcinoma of the skin;
* cervical carcinoma in situ; or
* International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
* History of allergic reaction attributable to compounds containing boron or mannitol
* Is pregnant or breast-feeding
* Currently enrolled in another clinical research study or has received an investigational agent for any reason within 4 weeks before randomization
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00343720 | {
"brief_title": "Study of Alimta® (Pemetrexed) Plus VELCADE® (Bortezomib) or Alimta Alone or VELCADE Alone in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Prior Therapy",
"conditions": [
"Non-Small Cell Lung Cancer"
],
"interventions": null,
"location_countries": [
"Belgium"
],
"nct_id": "NCT00343720",
"official_title": "A Randomized, Open-Label, Multicenter Study of Alimta® (Pemetrexed) Plus VELCADE® (Bortezomib) or Alimta Alone or VELCADE Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Prior Antineoplastic Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-10",
"study_completion_date(actual)": null,
"study_start_date(actual)": null
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-03-13",
"last_updated_that_met_qc_criteria": "2006-06-22",
"last_verified": "2008-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-06-23",
"first_submitted": "2006-06-22",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This is a pilot study to test the short-term effectiveness of an alternative treatment approach for precancerous cells of the cervix. The study will also explore whether this new treatment is feasible to perform and if it is acceptable to patients.
Detailed Description
Standard treatment for precancerous cells of the cervix is called electrosurgical excision procedure (LEEP). Standard LEEP involves treating the entire cervix using FDA-approved equipment. Focal LEEP utilizes the same surgery and the same equipment but only treats the visually unhealthy part of the cervix and not the entire cervix. Side effects and unusual symptoms will be monitored as well as the patient's thoughts and recommendations of the procedure. The total amount of time of study participation is six months.
#Intervention
- PROCEDURE : Focal LEEP
- Focal LEEP may or may not cause less damage to the cervix versus standard LEEP. This could potentially be an advantage by avoiding future complications during pregnancy. | #Eligibility Criteria:
Inclusion Criteria:
* Age 21 <= age <= 45 years
* Histologically confirmed high-grade cervical intraepithelial neoplasia (CIN2, CIN3, or CIN2/3). A copy of the pathology report is required at the time of enrollment. We will only include patients that had their biopsy performed at the UAB Colposcopy clinic because those that return for treatment represent a select group that is more reliable for follow-up given the standard no-show rate of 50% at the clinic.
* Focal lesion visualized in its entirety colposcopically and involving less than or equal to 2 quadrants of the cervix.
* Satisfactory (adequate) colposcopy.
* Lives within 100 miles of the University of Alabama at Birmingham.
Exclusion Criteria:
* Any suspicion for invasive cancer.
* Glandular abnormalities on cytology or histology.
* Cervical lesion incompletely visualized (e.g. extending into the endocervical canal).
* Endocervical curettage positive for high-grade cervical intraepithelial neoplasia.
* Unreliable for follow-up (drug use, planning to move out of region, etc.). Any patient that lives >100 miles away will be excluded due to concern for possible loss to follow-up.
* Immunosuppression (HIV positive, history of transplantation, lupus on immunosuppressive medication, etc.).
* Pregnancy.
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Sex :
FEMALE
Ages :
- Minimum Age : 21 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT02220192 | {
"brief_title": "An Alternative Treatment for Cervical Intraepithelial Neoplasia Using the Focal Loop Electrosurgical Excision Procedure",
"conditions": [
"High-grade Cervical Intraepithelial Neoplasia"
],
"interventions": [
"Procedure: Focal LEEP"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02220192",
"official_title": "Focal Loop Electrosurgical Excision Procedure for High-Grade Cervical Intraepithelial Neoplasia: an Alternative Treatment Approach",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12",
"study_completion_date(actual)": "2016-03",
"study_start_date(actual)": "2014-12"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-04-06",
"last_updated_that_met_qc_criteria": "2014-08-18",
"last_verified": "2016-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-08-19",
"first_submitted": "2014-08-07",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This is placebo-controlled study of three rifaximin doses in patients with DIBS. Subjects will be randomized to receive daily doses of placebo BID, rifaximin 275 mg BID, rifaximin 550 mg BID, or 1100 mg BID for 14 days. These four groups will subsequently receive an additional two weeks of placebo for a total of 4 weeks of treatment. A fifth group of subjects will receive rifaximin 550 mg BID for a period of 28 days. Subjects who successfully respond to treatment at the end of the 28-day Treatment Phase will be followed in a Post-treatment Phase that includes study visits during Weeks 6, 8, 12 and 16. Subjects who relapse during the Post-treatment Phase will be discontinued from the study.
Detailed Description
While IBS is one of the most common chronic medical conditions the etiology of IBS is unknown. Although not a life-threatening illness, IBS is considered to be a serious condition that has a substantial impact on a subject's day-to-day function. IBS is characterized by abdominal pain and altered bowel habits, including diarrhea, constipation, or alternating diarrhea and constipation. Symptoms are typically intermittent but may be continuous.
#Intervention
- DRUG : Rifaximin | #Eligibility Criteria:
Inclusion Criteria:
* Male or female subject 18 years or older.
* Irritable bowel syndrome confirmed by the Rome II Criteria
* Lower endoscopic examination that demonstrates normal colonic anatomy
Exclusion Criteria:
* Subject has exclusively constipation-predominant IBS (CIBS) that is characterized by < 3 bowel movements/week or hard and lumpy stools.
* Subject has alternating IBS, but is currently presenting with constipation associated IBS symptoms.
* Subject has had adequate control of their DIBS and their symptom of bloating the week preceding the screening visit or at the time of randomization. Bloating includes the following symptoms: abdominal fullness, bloating, gas, or swelling.
* Subjects has a positive stool culture for O & P (ovum and parasite) and/or Clostridium difficile
* Subject has failed to record 2 negative weekly global assessments during the past 10 days prior to randomization.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00269412 | {
"brief_title": "Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome",
"conditions": [
"Irritable Bowel Syndrome"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00269412",
"official_title": "Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess The Efficacy and Safety of Three Different Doses (275, 550 AND 1100 MG) of Rifaximin Administered BID For Either Two or Four Weeks in The Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-08",
"study_completion_date(actual)": "2008-09",
"study_start_date(actual)": "2005-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-11-25",
"last_updated_that_met_qc_criteria": "2005-12-22",
"last_verified": "2019-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-12-23",
"first_submitted": "2005-12-22",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Abdominal surgeries are major surgical procedures that are performed at any teaching hospital. Pain control is major concern in the intra-operative as well as post-operative period in these patients. Optimal pain control in post-operative period is directly related to patient's recovery, shortens the patients' hospital stay and overall burden on health facilities. Inadequate pain control may affect quality of life and increases patient's morbidity and mortality. Different modalities for pain control are used in post-operative period. Opioids are mainstay of treatment in post-operative period but historically are associated with significant side effect profile like dependence, nausea, vomiting, respiratory depression, constipation and many others. Dexmedetomidine is centrally acting α-2 adrenoceptor agonist.
Detailed Description
This randomized controlled trial was conducted at Department of Anesthesia, Sahiwal Teaching Hospital, Sahiwal. After institutional review board (IRB) approval, computer-generated random number table was used to randomize the patients to two groups, one group received Bupivacaine plus placebo and the other group received Bupivacaine plus dexmedetomidine. A total of 64 patients met the inclusion criteria and were enrolled in the study in a 1:1. Informed written consent was obtained from all the patients before enrolling them in the study. All patients underwent a pre-operative assessment on the day before surgery. Both groups received wound infiltration with studied drugs at the end of surgery. After surgery patients were shifted to post-surgical ward and assessed for pain using visual analogue scale (VAS) and data was collected and analyzed using Statistical Package for the Social Sciences (SPSS) version 26. Quantitative variables were presented with mean ±SD. Comparison of quantitative variable between groups was done using independent sample t-test. Comparison of qualitative variable like (Opioid sparing effect, Bradycardia, Hypotension, Nausea, Vomiting) was presented with frequency and percentages. Data was stratified on the basis of gender and age. Post-stratification chi-square test was used to compare both groups for opioid sparing effect in each stratum with p-value ≤0.05 as significant.
#Intervention
- DRUG : bupivacaine wound infilteration
- drug was given at the end of surgery
- Other Names :
- LA infiltration
- DRUG : Bupivacaine plus dexmedetomidine wound infilteration
- drug was given at the end of surgery
- Other Names :
- LA + Dex infiltration | #Eligibility Criteria:
Inclusion Criteria:
* Age limit: 18 <= age <= 60 years
* Gender of patient i.e., male or female
* Patients listed for abdominal surgeries
* American Society of Anesthesiologists (ASA) status of I or II
Exclusion Criteria:
* Patients with history of drug allergy
* Patients who undergone any analgesia in past 24 hr
* Patients with liver disease, kidney disease, cardiac disease, sickle cell anemia, severe preeclampsia or CNS disorder on history, clinical and laboratory assessment
* American Society of Anesthesiologists (ASA) status III or IV
* Patients with morbid obesity 6, Raynaud's disease Patients on adrenoceptor agonists, antagonists or narcotics before the operation.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT06531603 | {
"brief_title": "Postoperative Analgesic Effectiveness of Bupivacaine With and Without Dexmedetomidine in Patients With Abdominal Surgery",
"conditions": [
"Post Operative Pain",
"Bradycardia",
"Hypotension",
"Nausea",
"Vomiting"
],
"interventions": [
"Drug: bupivacaine wound infilteration",
"Drug: Bupivacaine plus dexmedetomidine wound infilteration"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT06531603",
"official_title": "Comparison of Postoperative Analgesic Effectiveness of Bupivacaine and Bupivacaine Plus Dexmedetomidine Wound Infiltration in Abdominal Surgeries Under General Anesthesia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-01-20",
"study_completion_date(actual)": "2023-04-20",
"study_start_date(actual)": "2022-02-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-01",
"last_updated_that_met_qc_criteria": "2024-07-29",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-08-01",
"first_submitted": "2024-07-03",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Our goal is to conduct a proof-of-concept trial to test the efficacy of KF treatment in adolescents with severe CWP not responding to the standard of care (SOC) treatment program in a multidisciplinary tertiary care chronic pain clinic. The changes associated to the interventions (KF or placebo) will be quantified using the Patients' Global Impression of Change (PGIC) scale after 16 weeks of treatment. Secondary, we aim to evaluate the effects of KF on the pain sensitivity, physical and emotional functioning, and we will also explore the potential biological underlying mechanisms.
Detailed Description
We have designed a proof-of-concept (POC) trial composed of three arms. The first two arms will be a randomized, controlled, double-blind, parallel-group study, designed to assess the potential efficacy of KF for the treatment of pain and associated symptoms in adolescent with CWP. The third arm will consists of assessing standard of care (SOC) data from patients who do not wish to participate in the study, but agree to allow us to use their SOC data to be compared with that of patients participating in the study. This arm will help to evaluate the potential beneficial effect of being part of the study ('placebo' effect) receiving a new treatment for a condition where the SOC have limited success rate.
#Intervention
- DRUG : Ketotifen Fumarate
- Ketotifen is a second-generation noncompetitive H1-antihistamine and mast cell stabilizer. It is most commonly sold as a salt with fumaric acid, ketotifen fumarate, and is available in two forms. In its ophthalmic form, it is used to treat allergic conjunctivitis, or the itchy red eyes caused by allergies. In its oral form, it is used to prevent asthma attacks.
- Other Names :
- Zaditen
- DRUG : Placebo
- OTHER : Standard of Care | #Eligibility Criteria:
Inclusion Criteria:
* Female and male adolescents aged between 14 <= age <= 18 old;
* For female adolescents of child bearing potential: negative serum pregnancy test at base line screening;
* For female adolescents of child bearing potential: being willing and able to use contraceptive methods for the duration of the study and for 30 days after receiving the last dose of the study drug;
* Diffuse body pain that has been present for at least 3 months, and who also have symptoms of fatigue, sleep disturbance, cognitive changes and mood disorder;
* Accompanied by at least one somatic symptoms to variable degree including irritable bowel syndrome, headaches, menstrual pain, lower urinary tract symptoms, myofascial pain, and temporomandibular pain;
* Symptoms cannot be explained by some other illness;
* Physical examination which should be within normal limits except for tenderness on pressure of soft tissues (i.e. tactile hyperalgesia which is increased pain following a painful stimulus)
* Overall body pain average score >= 4
* Moderate to severe physical impairment Functional Disability Inventory > 12 points.
* Stable doses of his/her current medication for at least four weeks
* Not having significant changes in their health conditions (PIGS less than 6 points) after 8 weeks of treatment
Exclusion Criteria:
* Be part of other trials;
* Have a specific diagnosis that can explain the symptoms; including rheumatoid arthritis, systemic lupus erythematosus, scleroderma and/or other connective tissue diseases
* Refuse to donate blood sample;
* Not be able to fill electronic records;
* Cognitive impairment interfering with the clinical evaluations;
* Known intolerance or allergies to KF;
* Been under treatment with other mast cell stabilizer agent;
* Seizures history or actual treatment;
* Coagulopathies or chronic thrombocytopenia;
* Atopic dermatitis (eczema) or chronic urticaria (hives)
* Schizophrenia or bipolar disorder
* Elective surgery within the study timeline
* Abnormal labs results (i.e., elevated SGPT and low platelet count, low Hb or Ht) in the last 6 months or in the base line evaluation
* Patients who are pregnant or are breast-feeding;
* Patients who are on oral antidiabetic agents;
Sex :
ALL
Ages :
- Minimum Age : 14 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT02984397 | {
"brief_title": "Chronic Widespread Pain and White Blood Cell Activation",
"conditions": [
"Widespread Chronic Pain"
],
"interventions": [
"Drug: Ketotifen Fumarate",
"Other: Standard of Care",
"Drug: Placebo"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT02984397",
"official_title": "Proof of Concept Trial to Test the Efficacy of Treatment With Ketotifen on Pain Sensitivity and Association Between Level of Activity and Reactivity of White Blood Cells and Pain Sensitivity in Teenagers With Chronic Widespread Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01",
"study_completion_date(actual)": "2020-01",
"study_start_date(actual)": "2016-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-02-20",
"last_updated_that_met_qc_criteria": "2016-12-02",
"last_verified": "2020-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-12-06",
"first_submitted": "2016-12-02",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to see if the multidrug combination of zidovudine (ZDV), lamivudine (3TC), 1592U89 (abacavir \[ABC\]), and 141W94 (amprenavir \[APV\]) is a safe and effective treatment for HIV-infected patients and if there is a reduction of active HIV in blood and other tissues.
HIV infection is a life-changing illness and new HIV treatments must be tested. This study will test if a 4-drug combination will reduce HIV virus activity in blood and other tissues and if it is safe and well tolerated. Doctors also want to know if the multidrug combination is able to decrease viral activity over a long time period.
Detailed Description
With effective combination ART, there is a decrease in HIV-1 RNA in plasma after 2 to 3 weeks. A second, slower phase of viral decay is thought to occur in long-lived macrophages, with a minimal contribution from lymphocytes. This study addresses whether there is a third reservoir such as the central nervous system. Additionally, the study aims to provide a better understanding of the type and length of ART required to suppress HIV-1 replication in multiple reservoirs.
Patients receive treatment with ZDV, 3TC, ABC, and APV daily for 24 weeks. Clinic visits occur weekly until Week 4, then every 2 weeks until Week 12, then monthly. Blood and urine samples are collected and patients are monitored for clinical or laboratory abnormalities. Laboratory tests to assess side effects and virologic and immunologic parameters, including viral quantification of CSF on all chronically infected patients and selected consenting acutely infected patients, are determined. In a pharmacoeconomic component of this study, patients have interviews and complete questionnaires at 5 clinic visits.
#Intervention
- DRUG : Abacavir sulfate
- DRUG : Amprenavir
- DRUG : Lamivudine
- DRUG : Zidovudine | #Eligibility Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
* Are at least 18 years.
* Have a chronic (long-term) HIV infection (greater than 90 days) or a recent HIV infection.
* Have a plasma viral load (level of HIV in the blood) of at least 5,000 copies/ml (for chronically infected patients only).
* Are able to follow study requirements.
* Agree to practice reliable forms of birth control such as barrier or surgical methods, starting 1 month prior to entry and while enrolled in the study.
Exclusion Criteria
Patients will not be eligible for this study if they:
* Have had prior anti-HIV treatment (for recently infected patients only).
* Have a history of blood-clotting problems.
* Have ever received treatment with protease inhibitors or 3TC.
* Are at high risk for developing an infection in the heart.
* Are critically ill.
* Are mentally disabled, a prisoner, or confined in an institution.
* Are breast-feeding or pregnant.
* Have gastrointestinal problems that might interfere with drug absorption or are unable to take medicines by mouth.
* Need regular blood transfusions.
* Have had an unexplained fever higher than 38.5 C for more than 14 days within 30 days of enrollment.
* Have an opportunistic (AIDS-related) infection that requires treatment (treatment must be completed 30 days before the start of the study).
* Are taking certain medications that may interfere with the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00006617 | {
"brief_title": "Four-Drug Combination Therapy With Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients",
"conditions": [
"HIV Infections"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00006617",
"official_title": "An Open-Label, Single Center Trial to Evaluate the Efficacy and Safety of Quadruple Chemotherapy (Zidovudine, EPIVIR, 1592U89, and 141W94) in Subjects Infected With HIV-1 (GW QUAD)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-06",
"study_completion_date(actual)": "2007-06",
"study_start_date(actual)": null
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-05-15",
"last_updated_that_met_qc_criteria": "2001-08-30",
"last_verified": "2004-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2001-08-31",
"first_submitted": "2000-12-06",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The aim of this study is to investigate the acute anabolic effects of native whey, whey protein concentrate 80 (WPC-80) and milk after a bout of strength training in young and elderly. The investigators hypothesize that native whey will give a greater stimulation of muscle protein synthesis and intracellular anabolic signaling than WPC-80, and that WPC-80 will give a stronger stimulus than milk.
Detailed Description
Increasing or maintaining muscle mass is of great importance for populations ranging from athletes to patients and elderly. Resistance exercise and protein ingestion are two of the most potent stimulators of muscle protein synthesis. Both the physical characteristic of proteins (e.g. different digestion rates of whey and casein) and the amino acid composition, affects the potential of a certain protein to stimulate muscle protein synthesis. Given its superior ability to rapidly increase blood leucine concentrations to high levels, whey is often considered the most potent protein source to stimulate muscle protein synthesis. Native whey protein is produced by filtration of unprocessed milk. Consequently, native whey has different characteristics than WPC-80, which is exposed to heating and acidification. Because of the direct filtration of unprocessed milk, native whey is a more intact protein compared with WPC-80. Of special interest is the higher amounts of the highly anabolic amino acid leucine in native whey.
The higher levels of leucine can be of great interest for elderly individuals as some studies in elderly has shown an anabolic resistance to the effects of protein feeding and strength training. By increasing levels of leucine one might overcome this anabolic resistance in the elderly.
The aim of this double-blinded, randomized, partial cross-over study is to compare the acute fractional protein synthesis and intracellular signaling response to a bout of strength training and intake of 20 grams of protein from either native whey, whey protein concentrate 80 or milk, in young and old individuals. Furthermore, the investigators wil investigate fractional protein breakdown, markers of protein breakdown, amino acid concentrations in blood.
The investigators hypothesize that native whey will induce a greater anabolic response than whey protein concentrate 80, and that whey protein concentrate 80 will give a stronger anabolic response than milk.
#Intervention
- OTHER : Strength training
- DIETARY_SUPPLEMENT : Milk 1%
- DIETARY_SUPPLEMENT : Whey protein concentrate 80
- DIETARY_SUPPLEMENT : Native whey | #Eligibility Criteria:
Inclusion Criteria:
* Healthy in the sense that they can conduct training and testing
* Able to understand Norwegian language written and oral
* Between 18 and 45, or above 70 years
Exclusion Criteria:
* Diseases or injuries contraindicating participation
* Use of dietary supplements (e.g. proteins, vitamins and creatine)
* Lactose intolerance
* Allergy to milk
* Allergy towards local anesthetics (xylocain)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT02968888 | {
"brief_title": "Anabolic Effects of Whey and Casein After Strength Training in Young and Elderly",
"conditions": [
"Healthy",
"Young",
"Elderly"
],
"interventions": [
"Dietary Supplement: Native whey",
"Dietary Supplement: Milk 1%",
"Dietary Supplement: Whey protein concentrate 80",
"Other: Strength training"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT02968888",
"official_title": "Effects of Whey and Casein Supplementation on Acute Anabolic Responses in Muscle After Strength Training in Young and Elderly",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-04",
"study_completion_date(actual)": "2017-05",
"study_start_date(actual)": "2014-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-04-10",
"last_updated_that_met_qc_criteria": "2016-11-16",
"last_verified": "2018-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-11-21",
"first_submitted": "2016-11-10",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this observational study is to evaluate the prostatic arterial embolization (PAE) with Embozene® Microspheres (Boston Scientific) in sphere sizes of 250 µm for the treatment of symptomatic benign prostatic hyperplasia (BPH).
Detailed Description
EmboProstate is an observational study that collects data of patients with benign prostatic hyperplasia that are treated with 250 µm Embozene ® Microspheres (Boston Scientific). The study evaluates the efficacy and safety of the microspheres for prostatic arterial embolization for benign prostata hyperplasia treatment. 10 adult male subjects will be enrolled in this study. If eligible patients are recruited, they will undergo the prostate artery embolization procedure in our radiology department. Once the catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate. The injected embospheres will slow the blood flow to the prostate reducing urinary tract symptoms caused by BPH. Within one week after PAE as well as after one, three and six months post-procedure an MRI examination ill occur. A follow-up visit using a questionnaire is due after 6 months.
#Intervention
- DRUG : Embozene Microspheres
- Intraarterial application
- Other Names :
- Vascular embolization | #Eligibility Criteria:
Inclusion Criteria:
* male
* adults > 40 years
* severe symptomatic BPH with IPSS > 18 and/or QoL > 3 or maximum urinary flow rate (Qmax) <= 15 ml/sec or transurethral catheter for retention
* no improvement after or intolerance of medical treatment for at least six months
* prostatic volume > 30 cm³
Exclusion Criteria:
* female
* less than 40 years
* eGFR < 45 ml/min * m²
* suspicion of prostatic malignancy
* prostatic malignancy
* acute prostatitis or cystitis
* hydronephrosis
* bladder stone or bladder diverticulum
* urethral stenosis
* major surgery within 4 weeks prior to the screening visit
* active clinically serious infection
* progressive arteriosclerosis
* contraindications against angiography
Sex :
MALE
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02206243 | {
"brief_title": "Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia",
"conditions": [
"Benign Prostatic Hyperplasia"
],
"interventions": [
"Drug: Embozene Microspheres"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT02206243",
"official_title": "An Observational Study to Evaluate the Safety and Efficacy of Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-11",
"study_completion_date(actual)": "2019-02",
"study_start_date(actual)": "2014-09"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-06-14",
"last_updated_that_met_qc_criteria": "2014-07-31",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-08-01",
"first_submitted": "2014-07-29",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Our aim was to compare 2 postoperative complication scoring systems in predicting length of hospital stay and in-hospital costs after colorectal resections.
Detailed Description
Introduction: Postoperative complications are associated with prolonged hospital stay and rise in costs of treatment. The Comprehensive Complication Index (CCI) was developed as a scoring system that does not only take the most severe complication into account, but all complications after surgery. Our aim was to compare the Clavien-Dindo scoring system with the CCI in predicting length of hospital stay (LOHS) and in-hospital costs after colorectal resections.
#Intervention
- PROCEDURE : No intervention was compared
- No intervention was compared | #Eligibility Criteria:
Inclusion Criteria:
* Only patients that underwent a colorectal resection were included
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT04849702 | {
"brief_title": "Comparison of the Clavien-Dindo and Comprehensive Complication Index",
"conditions": [
"Complication of Surgical Procedure",
"Colorectal Disorders",
"Clavien Dindo",
"Comprehensive Complication Index"
],
"interventions": [
"Procedure: No intervention was compared"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT04849702",
"official_title": "Comparison of the Clavien-Dindo and Comprehensive Complication Index Systems for Grading of Surgical Complications After Colorectal Resections.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-09-20",
"study_completion_date(actual)": "2020-12-01",
"study_start_date(actual)": "2012-10-20"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-04-19",
"last_updated_that_met_qc_criteria": "2021-04-15",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-04-19",
"first_submitted": "2021-04-02",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Transrectal ultrasound guided biopsy of prostate (TRUS-Bx) is widely used as accepted mode of investigation for prostate cancer in current urology practice. It is considered a minor procedure, which most of the patients tolerate, however 20% of patients refuse to undergo the redo procedure without any analgesia or anesthesia but on the other hand, some authors reveal that 65 to 90% of patients report pain ranging from mild to severe in intensity. Diclofenac is a local and systemic anti-inflammatory drug and it reduces local mediators involved in local pain.The purpose of this study is to find out the role of rectal administration of diclofenac suppositories as an adjunct to 2% xylocaine gel in alleviating intra and post procedural pain in prostatic biopsy with adequately calculated sample size and excluding the patients with contraindication to procedure or diclofenac administration as these were the shortcomings of previous studies.
#Intervention
- DRUG : Diclofenac suppository plus lidocaine gel
- Other Names :
- Voltral suppository
- DRUG : Lidocaine gel only | #Eligibility Criteria:
Inclusion Criteria:All male patients undergoing ultrasound guided prostate biopsy due to any one of the following:
* Raised prostate-specific antigen level (>4.0ng/ml) and palpable nodularity on digital rectal examination
* Palpable nodularity on digital rectal examination
* Hypo echoic lesion as compared to surrounding prostate on transrectal ultrasound
Exclusion Criteria:
* History of previous prostate biopsy
* Acute and/or chronic prostatitis or chronic pelvic pain syndrome
* Anal fissure, hemorrhoids, anal surgery
* Concomitant analgesic medication
* Chronic renal failure
* Allergy to diclofenac
Sex :
MALE
Ages :
- Minimum Age : 51 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT01939743 | {
"brief_title": "Efficacy of Diclofenac Suppository for Pain Control in Ultrasound Guided Biopsy of Prostate",
"conditions": [
"Carcinoma Prostate"
],
"interventions": [
"Drug: Diclofenac suppository plus lidocaine gel",
"Drug: Lidocaine gel only"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT01939743",
"official_title": "Diclofenac Suppository As a Preemptive Analgesia in Ultrasound Guided Biopsy of Prostate: Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-09",
"study_completion_date(actual)": "2012-10",
"study_start_date(actual)": "2011-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-09-11",
"last_updated_that_met_qc_criteria": "2013-09-07",
"last_verified": "2013-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-09-11",
"first_submitted": "2013-04-01",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This is an anonymous needs assessment survey of the population of an Irish urban town. We plan to collect anonymous survey data in order to better understand residents needs and to determine the desired functionality of a new coach-led wellness app operated by our partners. This platform is currently trialled for health care professionals working in the RCSI Hospital Group. The survey will collect information on participants demographics, their lifestyle (including sleep, exercise, food, relationships, meaning and purpose, substance use and stress management). We will also ask participants about their use of wellness apps to support healthy choices related to their lifestyle. We also plan to conduct a qualitative assessment to further explore needs related to lifestyle health in specific cohorts, namely, older people (65 years and older), recent migrants, members of the travelling community, perinatal women, lone-parents, individuals with physical disabilities, secondary school students and remote workers.
Detailed Description
There has been an increase in lifestyle related diseases worldwide. Living a healthy lifestyle is important to prevent lifestyle-related diseases such as heart disease, obesity, diabetes, mental health issues, certain cancers, autoimmunity and gastro-intestinal disease. The economic impact of these lifestyle-related diseases in Europe alone is set to exceed €200 billion by 2030. Worldwide, one in five people are at an increased risk of developing severe COVID-19, mostly as a result of underlying lifestyle-related diseases. Additionally, global efforts to manage COVID-19 infection have disrupted regular care required by those with these issues. Dealing with this requires that people better manage their own health and address lifestyle related factors that increase the risk associated with such diseases, including inactivity, substance abuse and unhealthy diet. These risk factors are modifiable and can be reduced by health interventions and tools to support a healthy lifestyle.
The COVID-19 pandemic caused prolonged feelings of fear, uncertainty and isolation among the general population. This is likely to impact vulnerable members of society, such as young people, elderly people and those in ethnic minority communities in greater proportions. Children and adolescents are experiencing increased adverse mental health effects such as social isolation, loneliness, depression and anxiety, during the Covid-19 pandemic. Irish adults aged 70 and over have reported worse mental health and increased feelings of loneliness due to cocooning throughout the pandemic. This social isolation and loneliness puts them at increased risk of cognitive and cardiovascular decline. It is important that we prioritise the development of strategies to maintain social engagement, manage loneliness and encourage continued physical activity among older people.
Work habits are currently changing at a rapid pace. Significant sections of our workforces are now working from home and at least 50% are expected to remain at home, even after the current pandemic has resolved. Reports indicate that a significant proportion of this workforce is experiencing issues with disconnection and mental health. As a result, understanding the impact of remote and flexible working arrangements on employee health and mental wellbeing has been included as a research priority within psychological science. While there is evidence that remote working has positive effects on well-being, these effects are not consistent. Remote working may also lead to greater levels of professional isolation, reduced work-life balance, increase work-related fatigue and have negative impacts on well-being. This study is being conducted to better understand citizen's needs in relation to living a healthier lifestyle.
| #Eligibility Criteria:
Inclusion Criteria:
* Participants will be members of the urban town being studied.
Exclusion Criteria:
* Non a member of the urban town being studied.
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT05109026 | {
"brief_title": "Connect-5 Needs Assessment Survey to Identify Healthy Lifestyle Requirements of a Rural Irish Community",
"conditions": [
"Healthy Lifestyle"
],
"interventions": null,
"location_countries": [
"Ireland"
],
"nct_id": "NCT05109026",
"official_title": "Connect-5 Needs Assessment to Identify Requirements of a Rural Irish Community Related to a an Online Digital Platform Solution, Designed to Change Behaviour, Related to Lifestyle Medicine and Mental Health.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-01-30",
"study_completion_date(actual)": "2023-01-30",
"study_start_date(actual)": "2022-09-05"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-16",
"last_updated_that_met_qc_criteria": "2021-10-26",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-11-05",
"first_submitted": "2021-10-26",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study was conducted to determine the efficacy and safety of GWP42003 compared with placebo by the percentage of participants achieving remission quantified as a Mayo score of 2 or less (with no sub-score \>1) after 10 weeks of treatment.
Detailed Description
This study was conducted by GW Research Ltd as a pilot study to determine the efficacy and safety of GWP42003 (50 milligram \[mg\] up to 250 mg twice daily \[BID\]), compared with placebo, as assessed by the percentage of participants achieving remission quantified as a Mayo score of 2 or less (with no sub-score \>1) after 10 weeks of treatment. This was the first study to determine whether the study drug has a positive benefit for participants on their ulcerative colitis symptom control, as well as effects on inflammatory marker cytokines (C reactive protein \[CRP\]), a fecal inflammatory marker (calprotectin), stool frequency, and rectal bleeding. In addition, various inflammatory bowel disease (IBD) questionnaires were implemented in the study to observe further benefits on the study drug, compared with placebo.
This study was multi-center, randomized, double-blind, placebo-controlled, and parallel-group. The study consisted of a 7-day baseline period, a 10-week treatment period, and a 1-week follow-up period. Each participant had a Mayo assessment (including endoscopy) conducted to confirm eligibility. Eligible participants were randomized in a 1:1 ratio into the GWP42003 and placebo groups. At the start of the treatment period, participants entered a 2-week dose escalation period to achieve their maximum tolerated dose, up to 250 mg BID in the GWP42003 group. Participants remained at the maximum tolerated dose for the rest of the treatment period.
#Intervention
- DRUG : GWP42003
- 1 to 5 50 mg capsules taken BID
- Other Names :
- Cannabidiol (CBD) Botanical Drug Substance (BDS)
- DRUG : Placebo
- 1 to 5 matching capsules taken BID
- Other Names :
- Placebo control | #Eligibility Criteria:
Inclusion Criteria:
* Male or female participants aged 18 years or above;
* Participant diagnosed with mild to moderate ulcerative colitis and on a fixed dose of 5-Aminosalicylic (5-ASA) treatment and have been on a stable dose for at least 2 weeks prior to screening (0 mg dose of 5-ASA was acceptable);
* Participants at screening and baseline with a Mayo assessment score of greater than or equal to 4 (>=4) but less than or equal to 10 (<=10) and with an endoscopy score of at least 1 (>=1) , following an adequate exposure to oral and/ or topical 5-ASA, in the opinion of the investigator;
* In the opinion of the investigator, capable of complying with the study requirements and completing the study;
* Willing and able to give informed consent;
* Willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable;
* Willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study;
Exclusion Criteria:
* Severe ulcerative colitis (Mayo score of greater than 10 (>10);
* Ulcerative colitis only affecting the rectum (proctitis)
* Gastrointestinal infection evident from stool culture and testing for Clostridium difficile toxin (in the opinion of the investigator);
* Currently using or had used recreational cannabis, medicinal cannabis, cannabinoid medications (including Sativex®), or synthetic cannabinoid-based medications within 1 month prior to study entry and unwilling to abstain for the duration of the study;
* Any known or suspected history of alcohol or substance abuse, epilepsy or recurrent seizures, or hypersensitivity to cannabinoids;
* Was receiving a prohibited medication prior to screening and for the duration of the study;
* Previous non-responders to mono or polyclonal anti-Tumor Necrosis Factor antibodies;
* Personal or first degree relative, with history of schizophrenia or other psychosis;
* History of other significant psychiatric disorder or severe personality disorder (at the discretion of the investigator);
* Any known or suspected history of depression sufficient to require treatment with antidepressants or disrupt ordinary life (excluding episodes of reactive depression at the discretion of the investigator);
* Clinically significant cardiac, renal or hepatic impairment in the opinion of the investigator;
* Female participants who were pregnant, lactating or planning pregnancy during the course of the study and for 3 months from the date of last dose;
* Female participants of child bearing potential, unless willing to use 2 forms of contraception, 1 of which must have been a barrier contraception (for example, a female condom or occlusive cap [diaphragm or cervical vault/caps] with spermicide) during the study and for 3 months from the date of last dose (however a male condom should not have been used in conjunction with the female condom);
* Male participants whose partner was of child bearing potential, unless willing to use an appropriate barrier method of contraception (condom and spermicide) in addition to having their female partner use another form of barrier contraception (for example, an occlusive cap [diaphragm or cervical vault/caps] with spermicide) during the study and for 3 months from date of last dose (however a male condom should not have been used in conjunction with a female condom);
* Planned to travel outside the country of residence during the treatment phase of the study;
* Received an Investigational Medicinal Product (IMP) within 30 days prior to the screening visit;
* In the opinion of the investigator, was not considered to be suitable for the study;
* Any other significant disease or disorder which, in the opinion of the investigator, may either have put the participant at risk because of participation in the study, or may have influenced the result of the study or the participant's ability to participate in the study;
* Participant with any abnormalities that, in the opinion of the investigator, would prevent the participant from safe participation in the study;
* Unwilling to abstain from donation of blood during the study;
* Participants previously randomized into this study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01562314 | {
"brief_title": "A Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis (GWID10160)",
"conditions": [
"Ulcerative Colitis"
],
"interventions": [
"Drug: Placebo",
"Drug: GWP42003"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT01562314",
"official_title": "A Randomised, Double-blind, Placebo-controlled Parallel Group, Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-08-05",
"study_completion_date(actual)": "2014-08-05",
"study_start_date(actual)": "2012-05-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-08-09",
"last_updated_that_met_qc_criteria": "2012-03-22",
"last_verified": "2018-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-03-23",
"first_submitted": "2012-03-21",
"first_submitted_that_met_qc_criteria": "2015-07-17"
}
}
} |
#Study Description
Brief Summary
Olokizumab (OKZ) has been shown to reverse the inhibitory effect of IL-6 on the activity of Cytochrome P450 (CYP450) isozymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A4/5 in vitro.
The goal of the study was to assess the effect of OKZ on the pharmacokinetics (PK) of the CYP450 probe substrates, caffeine (CYP1A2), S-warfarin (CYP2C9), omeprazole (CYP2C19), and midazolam (CYP3A4) in subjects with rheumatoid arthritis (RA).
Detailed Description
This was a Phase 1, open-label, 3-period, single-sequence, crossover study in subjects with RA with increased C-reactive protein (CRP).
Approximately 15 eligible subjects were planned to be enrolled at approximately 3 study centers to have at least 12 evaluable subjects completing the study. However, if necessary, additional subjects could be dosed to obtain the 12 evaluable subjects required.
There was a 35-day Screening Period, followed by a 29-day study duration: eligible patients were administered a cocktail of 4 substrates alone with following 7 days PK-sampling (Period 1); a single subcutaneous dose of 128 mg OKZ was administered (Period 2) approximately 2 weeks prior to the second administration of the cocktail with following 7-days PK-sampling (Period 3). After completion of the Period 3 patients were followed-up for 19 weeks (133 days) for safety evaluations.
Overall duration of the study was approximately 200 days (6 and a half months).
#Intervention
- DRUG : Olokizumab
- Sterile solution for subcutaneous (SC) injection, 128 mg (0.8 mL injection)
- DRUG : Omeprazole
- Tablets, 20 mg, oral
- DRUG : Caffeine
- Tablets, 100 mg, oral
- DRUG : Warfarin+ Vitamin K
- Warfarin -Tablets 10 mg (containing 5 mg S-warfarin), oral. Vitamin K - solution for intravenous injection, 10 mg/mL ampoule, orally.
- DRUG : Midazolam
- Syrup, 2 mg/mL, oral | #Eligibility Criteria:
Inclusion Criteria:
* Subjects willing and able to give voluntary informed consent and sign an Informed Consent Form (ICF)
* Male subjects and their female partners and female subjects of childbearing potential must agree to adhere to the contraceptive requirements for the study
Female subjects of non-childbearing potential must be:
* Surgically sterile (i.e. bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to first dosing), or
* Naturally postmenopausal (spontaneous cessation of menses) for at least 24 consecutive months prior to first dosing, with a follicle stimulating hormone level at screening of >=40 mIU/mL.
* Body mass index of 18 kg/m2 to 29.9 kg/m2, inclusive, and body weight of 55 kg to 110 kg, inclusive, if male, and 45 kg to 100 kg, inclusive, if female.
* Subjects must have a diagnosis of adult onset RA classified by the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 revised classification criteria for RA (Aletaha et al, 2010) for at least 12 weeks prior to Screening. If the subject was previously diagnosed according to ACR 1987 criteria, the Investigator may classify the subject per ACR 2010 retrospectively, based on medical history, and using available source data.
* Subjects must have received Methotrexate (MTX), sulfasalazine, or hydroxychloroquine for at least 12 weeks prior to Day 1 and in stable dose for at least 6 weeks prior to Day 1 without significant Adverse events (AEs). Stable doses of MTX should be 10 mg to 25 mg weekly with folic acid (at least 5 mg weekly or equivalent). No significant side effects based on the Investigator's judgment should be observed during treatment by these agents. The maximum allowed doses of sulfasalazine and hydroxychloroquine are:
1. Sulfasalazine: 3 g per day
2. Hydroxychloroquine: 400 mg per day
Note: The doses should remain stable and not be changed from the time of signing the ICF until the end of the treatment period (EOT, Day 29).
* Subjects must have an increased CRP at Screening (of >=1.2 × ULN).
* Female subjects of childbearing potential must have negative pregnancy test at Screening and throughout the study until the end of study (EOS) (Day 161).
Exclusion Criteria:
* Diagnosis of any other inflammatory arthritis or systemic inflammatory disease (e.g., gout, psoriatic or reactive arthritis, Crohn's disease, Lyme disease, juvenile idiopathic arthritis, or systemic lupus erythematosus). Osteoarthritis is classified as a degenerative disease rather than an inflammatory disease.
* Subjects with Steinbrocker Class III or IV functional capacity (incapacitated, largely, or wholly bed ridden, or confined to a wheelchair, with little, or no self-care).
* Prior exposure to any licensed or investigational compound directly or indirectly targeting IL-6 or IL-6R within 12 months of Day 1.
* Treatment with DMARDs other than MTX, hydroxychloroquine, or sulfasalazine. Treatment with the following DMARDs are not allowed within the specified time period prior to Day 1:
1. 4 weeks for azathioprine, cyclosporine, chloroquine, gold, penicillamine, minocycline, or doxycycline.
2. 12 weeks for leflunomide unless the subject has completed the following elimination procedure at least 4 weeks prior to Day 1: Cholestyramine at a dosage of 8 grams 3 times daily for at least 24 hours or activated charcoal at a dosage of 50 grams 4 times a day for at least 24 hours.
3. 24 weeks for cyclophosphamide.
* Treatment with any cell-depleting therapies including anti-cluster of differentiation (CD)20 or investigational agents (eg, CAMPATH®, anti-CD4, anti-CD5, anti-CD3, and anti-CD19) with the exception of rituximab. Treatment with rituximab is not allowed within 6 months of Day 1.
* Treatment with Tumor necrosis factor alpha inhibitor (TNFi) (including investigational proposed or licensed biosimilars) or any other biologic therapy for the treatment of RA within 12 weeks of Day 1.
* Use of parenteral or intra-articular glucocorticoids within 4 weeks prior to Day 1.
* Use of oral glucocorticoids greater than 10 mg/day prednisone (or equivalent) or change in dosage within 4 weeks prior to Day 1.
* Use of indomethacin and ketorolac; other nonsteroidal anti-inflammatory drugs (NSAIDs) (with the exception of aspirin, see below) must be taken at a stable dose and route of administration for at least 2 weeks prior to Day 1.
* Female subjects of nonchildbearing potential taking hormone replacement therapy within 4 weeks prior to Day 1.
* Vaccination with live vaccines in the 6 weeks prior to Day 1 or planned vaccination with live vaccines during the study.
* Participation in any other investigational drug study within 30 days or 5 times the t1/2 of the investigational drug, whichever is longer, prior to Day 1.
* Use of aspirin or other antiplatelet agents and anticoagulants including warfarin in the 4 weeks prior to Day 1.
* Has received any prescription or nonprescription drugs or other products (eg, herbal preparations, food products) known to be inhibitors/inducers of CYP3A4, CYP2C9, CYP2C19, or CYP1A2 within 4 weeks prior to Day 1 and for the duration of the study up to the EOT (Day 29) Visit. The use of MTX, as described in inclusion criterion #5, is permitted.
* Use of any herbal preparations (including foods or beverages containing herbal preparations), dietary supplements, or natural medications within 14 days of Day 1.
* Has received midazolam and/or omeprazole (or esomeprazole) within 14 days of Day 1.
* Excessive intake of caffeine (more than 5 cups of coffee or equivalent per day) and the inability to abstain from caffeine-containing drinks and foods from 2 days prior to each cocktail administration and while inpatient (Day -1 to Day 2 and Day 21 to Day 23, respectively).
* Poor metabolizers of CYP2C9 (genotype *2/*2, *2/*3, *3/*3) or CYP2C19 (genotype *2/*2, *2/*3, *3/*3), ultra-rapid metabolizers of CYP2C19 (*17/*17), or high sensitivity to warfarin (VKORCI genotype AA).
* Previous participation (enrolled) in this study or another study of OKZ in case of receiving at least one OKZ dose.
* Abnormal laboratory values as defined below. If, in the opinion of the Investigator, exclusionary results are due to laboratory error or a transient condition, these tests may be repeated once during Screening.
a. Creatinine level >=1.5 mg/dL (132 µmol/L) for females or >=2.0 mg/dL (177 µmol/L) for males.
b. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) level >=1.5 × ULN.
c. Platelets <150 × 10^9/L (<150,000/mm3).
d. White blood cell count <3.0 × 10^9/L.
e. Neutrophil count <2.0 × 10^9/L (<2000 mm3).
f. Hemoglobin level <=95 g/L.
g. Glycosylated hemoglobin (HbA1c) level >=8%.
h. International normalized ratio above the ULN (Normal range: 0.80 or 0.90 to 1.20, males and females of all ages).
* Subjects with concurrent viral hepatitis B or C infection as detected by blood tests at Screening (eg, positive for hepatitis B surface antigen (HBsAg), hepatitis B DNA (HBV DNA) or hepatitis C virus antibody (HCV Ab)).
1. HBV DNA to be tested only in anti-hepatitis B core antigen (anti-HBc) positive subjects.
2. Subject who is positive for hepatitis B surface antibody (anti-HBs) and total antiHBc but negative for HBsAg and HBV DNA, will be eligible upon qualified specialist (i.e. hepatologist) consultation with documented conclusion no additional risk is suspected for the subject.
3. Subject who is positive for hepatitis B surface antibody (anti-HBs) but negative for HBsAg and total anti-HBc, will be eligible with no additional consultation.
* Subjects with human immunodeficiency virus (HIV) infection.
* Subjects with:
1. Suspected or confirmed current active tuberculosis (TB) disease or a history of active TB disease.
2. Close contact (ie, sharing the same household or other enclosed environment, such as a social gathering place, workplace or facility, for extended periods during the day) with an individual with active TB within 1.5 years prior to Screening.
3. History of untreated latent TB infection (LTBI), regardless of QuantiFERON-TB Gold Plus interferon-gamma release assay (IGRA) result at Screening.
4. Positive IGRA result at Screening. If indeterminate, the IGRA can be repeated once during Screening. If there is a second indeterminate result, the subject will be excluded.
* Concurrent malignancy or a history of malignancy within the last 5 years (with the exception of successfully treated carcinoma of the cervix in situ or successfully treated basal cell carcinoma or squamous cell carcinoma not less than 1 year prior to Screening [and no more than 3 excised nonmelanoma skin cancers within the last 5 years prior to Screening]).
* Subjects with a history of major bleeding, bleeding tendencies (such as any prior gastrointestinal bleeding and recent ulceration of gastrointestinal track, congenital and acquired disorders by hemostasis), or other clinically significant predisposition to bleeding according to the physician's judgment.
* Subjects with a history or presence of severe cardiovascular conditions such as stroke, transient ischemic attack, or myocardial infarction in medical history.
* Uncompensated congestive heart failure, or Class III or IV heart failure defined by the New York Heart Association classification.
* Untreated, uncontrolled, or resistant arterial hypertension Grade 2 to 3 (systolic blood pressure (BP) >160 mm Hg and/or diastolic BP >100 mm Hg, based on the mean of 3 readings). If hypertension is not controlled, subjects should be excluded, and not allowed for rescreening.
* Uncontrolled diabetes mellitus (based on the Investigator's judgment).
* Subjects with a history or presence of any other cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, dermatological, neurological, psychiatric, hematological, or immunologic/immunodeficiency disorder(s) or any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, contraindicate subject participation in the clinical study, or clinically significant enough in the opinion of the Investigator to alter the disposition of the study treatment, or constitute a possible confounding factor for assessment of safety of the study treatment..
* Subjects with gastrointestinal (GI) resection (eg, partial or total gastrectomy) likely to interfere with absorption of study treatment.
* Subjects with any infection requiring any anti-infective therapy (eg, antibiotic, antiviral, or antifungal therapy) in the 4 weeks prior to Day 1, or serious or recurrent infection with history of hospitalization in the 6 months prior to Day 1 or active infection at Day 1.
* Subjects with evidence of disseminated herpes zoster infection, zoster encephalitis, meningitis, or other nonself-limited herpes zoster infections in the 6 months prior to Day 1.
* Subjects with planned surgery during the study (up to and including the EOT Visit,[Day 29]) or surgery <=4 weeks prior to Screening and from which the subject has not fully recovered, as judged by the Investigator.
* Subjects with diverticulitis or other symptomatic GI conditions that might predispose the subject to perforations, including subjects with a history of such predisposing conditions (eg, diverticulitis, GI perforation, or ulcerative colitis).
* History of chronic alcohol or drug abuse or consumption of more than 21 units (male subjects) or 14 units (female subjects) of alcohol a week (unit = 1 glass of wine [125 mL] = 1 measure of spirits = ½ pint of beer) as judged by the Investigator.
* Current smokers or those who have smoked or used nicotine products within the previous 3 months prior to Screening.
* Subjects with a known hypersensitivity or contraindication to any component of the cocktail drugs or OKZ.
* History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.
* Any self-reported symptoms of influenza-like or COVID-19 like illness in the 14 days preceding Screening OR Day 1 as per the Investigators assessment. Symptoms related to COVID-19 include, but are not limited to:
a. Respiratory symptoms (eg, sore throat, nasal congestion, post-nasal discharge, wheezing, cough, dyspnea, and bronchial breath sounds);
b. Non-respiratory symptoms, such as gastrointestinal symptoms (eg, nausea, vomiting, and diarrhea), neurologic symptoms (eg, anosmia, ageusia, headache), myalgia or fatigue.
* Active SARS-CoV-2 infection as confirmed by reverse transcription polymerase chain reaction (RT-PCR) or/and positive serology at Screening.
* Known exposure to an individual with confirmed COVID-19 or SARS-CoV-2 infection within 2 weeks before Screening OR Day 1.
* History of COVID-19 infection in the previous 3 months before Day 1 or with sever or critical illness ever.
Note: The subject can be enrolled if all of the following criteria are fulfill:
* had non-sever or non-critical COVID-19 infection more than 3 months before Day 1;
* fully recovered as per official medical records which should be documented as a source document (mild sequelae of the previous infection such as dry cough, weakness should be resolved by the time of Screening);
* there are no any concerns that the subject is infections to others;
* there are no any other local guidelines/requirements with regards of this group of subjects.
* Those subjects who have been at high risk of exposure before Screening, including but not limited to: Close contacts of confirmed COVID-19 cases, anyone who had to self-isolate as a result of a symptomatic household member, frontline healthcare professionals working in accident and emergency (A&E), ICU and other higher risk areas.
* Individuals currently working with high risk of exposure to SARS-CoV-2 (eg, active healthcare workers or emergency response personnel having direct interactions with or providing direct care to patients).
* Pregnancy and breastfeeding.
* Other medical or psychiatric conditions or laboratory abnormalities that may increase potential risk associated with study participation and administration of study treatment, or that may affect study results interpretation and, as per the Investigator's judgment.
* Subject's unwillingness or inability to follow the procedures outlined in the protocol.
* Employees or relatives of the Sponsor, Contract Research Organization, or the study center personnel.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04246762 | {
"brief_title": "Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19 and CYP3A4",
"conditions": [
"Rheumatoid Arthritis"
],
"interventions": [
"Drug: Omeprazole",
"Drug: Caffeine",
"Drug: Midazolam",
"Drug: Olokizumab",
"Drug: Warfarin+ Vitamin K"
],
"location_countries": [
"Moldova, Republic of",
"Bulgaria"
],
"nct_id": "NCT04246762",
"official_title": "A Phase 1, Open-label, Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19, and CYP3A4",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-08",
"study_completion_date(actual)": "2022-10-26",
"study_start_date(actual)": "2021-11-16"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-15",
"last_updated_that_met_qc_criteria": "2020-01-27",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-29",
"first_submitted": "2020-01-27",
"first_submitted_that_met_qc_criteria": "2024-03-05"
}
}
} |
#Study Description
Brief Summary
This study will be conducted to evaluate efficacy of ultrasound guided modified thoracoabdominal nerves block via a new perichondrial approach (M-TAPA) for postoperative analgesia in major abdominal surgeries in comparison to subcostal transverse abdominis plane (SCTAP) block.
It is hypothesized that M-TAPA block will be advantageous to SCTAP block as a promising effective alternative for analgesia for major abdominal surgeries with fewer side effects.
Detailed Description
Postoperative pain management for major abdominal surgeries can reduce postoperative respiratory dysfunction and promote early mobilization. Traditionally, opioids have been used to manage postoperative pain. However, an increasing awareness of opioid-related adverse events including respiratory depression, paralytic ileus, and sedation, has led to a shift towards utilizing opioid-sparing techniques for postoperative analgesia. As such, outcomes associated with the transverse abdominis plane block are of increasing interest. A modified thoracoabdominal nerves block via a new perichondrial approach (M-TAPA) is a novel analgesic technique that involves local anesthetic injection into the lower aspect of the chondrium. It can block thoracoabdominal nerves at T5 in cephalic direction and down to T11-T12 in caudal direction and may be an effective analgesic for major abdominal surgeries.
The aim of this study is to assess the quality of pain relief in patients who will undergo major abdominal surgery receiving either (M-TAPA) block or (SCTAP) block by comparing and evaluating the differences between the two techniques.
This prospective, randomized, comparative clinical study will include 80 patients who will be scheduled for major abdominal surgery under general anesthesia in Mansoura university hospitals. Informed written consent will be obtained from all subjects in the study after ensuring confidentiality. Eligible patients will be randomly assigned to 2 equal groups (M-TAPA group and SCTAP group) according to computer-generated table of random numbers using the permuted block randomization method. The collected data will be coded, processed, and analyzed using SPSS program. All data will be considered statistically significant if P value is ≤ 0.05.
#Intervention
- PROCEDURE : M-TAPA block
- A high-frequency linear ultrasound probe will be used, probe will be placed on the costochondral angle in the sagittal plane and angled deeply to view the lower aspect of the chondrium in the midline, then using in-plane approach, a 22 Gauge Tuohy needle will be introduced into the lower aspect of the chondrium. The same procedure will be repeated on the contralateral side.
- Other Names :
- Ultrasound guided block
- PROCEDURE : SCTAP block
- A high-frequency linear ultrasound probe will be placed obliquely on the upper abdominal wall, along the subcostal margin near the midline. After identifying the rectus abdominis muscle, the ultrasound probe will be gradually moved laterally along the subcostal margin until the transversus abdominis muscle will be identified lying posterior to the rectus muscle, then using in-plane approach, a 22 Gauge Tuohy needle will be introduced medially and directed towards the transversus abdominis plane until its tip reaches the fascia between the rectus abdominis and the transverse abdominis muscles on entering the neurofascial plane. The same procedure will be repeated on the contralateral side.
- Other Names :
- Ultrasound guided block
- DRUG : Bupivacaine Hydrochloride
- 20 ml 0.25% bupivacaine will be injected after the negative aspiration test.
- Other Names :
- Marcaine | #Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiology (ASA) I and II patients.
* Scheduled for elective major abdominal surgeries.
Exclusion Criteria:
* Patient's refusal.
* Altered mental status or un-cooperative patients.
* History of known sensitivity to the used anesthetics.
* Bleeding or coagulation diathesis.
* Infection at the injection site.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04920994 | {
"brief_title": "Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Major Abdominal Surgeries",
"conditions": [
"Abdominal Surgery"
],
"interventions": [
"Drug: Bupivacaine Hydrochloride",
"Procedure: SCTAP block",
"Procedure: M-TAPA block"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT04920994",
"official_title": "Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Comparison to Subcostal Transverse Abdominis Plane Block (TAP) in Major Abdominal Surgeries",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-07-01",
"study_completion_date(actual)": "2022-07-01",
"study_start_date(actual)": "2021-08-13"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-07-11",
"last_updated_that_met_qc_criteria": "2021-06-08",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-06-10",
"first_submitted": "2021-06-03",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg Bimodal Release Tablets) for Acute Gastroenteritis.
The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute Gastroenteritis, by comparing it to placebo.
Detailed Description
Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg Bimodal Release Tablets) for Acute Gastroenteritis.
The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute Gastroenteritis, by comparing it to placebo.
#Intervention
- DRUG : RHB-102
- RHB-102, Bimodal Release Ondansetron Tablets
- DRUG : Placebo Oral Tablet
- Placebo
- Other Names :
- Placebo | #Eligibility Criteria:
Inclusion Criteria:
* Patients must have vomited at least twice in the 4 hours preceding signing informed consent. A vomiting episode is defined as an episode of forceful expulsion of stomach contents. Retching if a patient has already emptied his or her gastric contents is also considered vomiting episode. A distinct episode is characterized by a clear break in vomiting activity of at least 5 minutes
* Emesis must have been nonbloody (streaks of blood presumed due to force of retching are allowed)
* All patients (and a parent or guardian for patients <age 18) must sign informed consent.
Exclusion Criteria:
* Severe dehydration. Severe dehydration is defined as two or more of the following criteria in the presence of decreased intake and increased output due to vomiting or diarrhea: Absent or severely decreased urine output; weak pulse and/or low blood pressure; parched mucous membranes; lethargy, confusion, delirium or loss of consciousness
* Signs and symptoms severe enough to require immediate parenteral hydration and/or parenteral antiemetic medication
* Temperature>39.0
* Likely etiologies for acute vomiting and diarrhea other than acute infectious or toxic gastroenteritis or gastritis. This includes signs of an acute abdomen, which may require surgical intervention
* Chemically-induced gastroenteritis, e.g., from alcohol, other drugs of abuse or other irritant chemicals
* Use within 24 hours of study entry of specific medication for treatment of nausea and/or vomiting, e.g., 5-HT3 antagonists or phenothiazines, or receipt of any IV fluid for any reason. Nonspecific gastrointestinal remedies, such as antacids, proton pump inhibitors and homeopathic remedies, are permitted.
* Congestive heart failure, bradyarrhythmia (baseline pulse<55/min), known long QT syndrome
* Patient who have known QTc prolongation > 450 msec, noted on prior or screening ECG, or who are taking medication known to cause QT prolongation. Note: for current list of medications known to cause QT prolongation see: https://www.crediblemeds.org/healthcare-providers/drug-list/ Use list showing drugs with known risk TdP.
* Known underlying disease which could affect assessment of hydration or modify outcome of treatment, e.g., renal failure, diabetes mellitus, liver disease, alcoholism. Patients with type 2 diet-controlled diabetes mellitus whose baseline blood glucose is <200 may be entered into the study
* Abdominal surgery within the past 3 months
* History of bariatric surgery or bowel obstruction at any time
* Hypersensitivity or other known intolerance to ondansetron or other 5-HT3 antagonists
* Patient has taken apomorphine within 24 hours of screening
* Patient has previously participated in this study
* Patient has participated in another interventional clinical trial, for any indication, in the past 30 days
* For women of childbearing potential: documented or possible pregnancy.
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT02246439 | {
"brief_title": "BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis",
"conditions": [
"Gastroenteritis",
"Gastritis"
],
"interventions": [
"Drug: Placebo Oral Tablet",
"Drug: RHB-102"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02246439",
"official_title": "Randomized, Placebo-Controlled, Phase 3 Trial of BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis (The GUARD Study)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-02-13",
"study_completion_date(actual)": "2017-02-16",
"study_start_date(actual)": "2014-12-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-20",
"last_updated_that_met_qc_criteria": "2014-09-18",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-09-22",
"first_submitted": "2014-09-16",
"first_submitted_that_met_qc_criteria": "2019-01-28"
}
}
} |
#Study Description
Brief Summary
Numerous studies demonstrate that patients have improved immediate recovery characteristics following desflurane anesthesia compared to other volatile agents, including sevoflurane. There is limited evidence in the literature to suggest that patients undergoing sevoflurane, compared to desflurane anesthesia, may suffer from limitation in function and cognitive ability for an undetermined, but prolonged period of time following surgery. These differences are not explained pharmacokinetically and may be a result of a direct neurotoxic effect of sevoflurane. An unresolved question is the time required for the ability to return to complex tasks, such as driving, following anesthesia. Commonly, patients are advised not to drive or make important decisions for 24 hours following anesthesia, but this is not well-studied and proscribed on an empiric, rather than scientific, basis with very limited data available.This study will better define recovery characteristics and characterize the severity and duration of cognitive impairment following sevoflurane or desflurane anesthesia after brief outpatient urologic surgery in elderly females using tests of cognitive ability coupled with performance on a driving simulator and cognitive task tests to objectively measure not only testing performance, but also cognitive effort in performing these tests.
Detailed Description
Following IRB-approved consent, 60 patients were be randomized (63 patients to be enrolled accounting for a \<5% screen failure and \<5% dropped patient rates) to receive either a desflurane or sevoflurane-based anesthetic for pelvic floor repair. The selection of the anesthetic gas (sevoflurane or desflurane) was determined by computer generated randomization. Only the Anesthesiologist or the CRNA knows which gas has been administered to the subject. All the investigators and the co-investigator who collected the research data were blinded to the gas selection.
Potential subjects were identified during the clinic visit in the Urology Department in Hahnemann University Hospital.
On the morning of the surgery, the study investigator who is a medical doctor asked the subjects to perform a baseline cognitive task tests to determine the baseline thinking process. The detailed description of the cognitive task is as following;
1. Mini-Mental Status Exam (MMSE): (10-15 minutes) This is a 30-item measure of global cognition (Folstein, Folstein \& McHugh, 1975) that tests orientation to time and place, object naming, repetition, attention, recall, and following complex commands.
2. Trail Making Test Part A and Part B: Part A (3 minutes) of this measure (Army Individual Test Battery, 1944; Reitan \& Wolfson, 1985) is a test of visual attention where the subjects must draw lines on a page connecting 25 consecutive number as quickly as possible. Part B (5 minutes) requires the subject to alternately sequence numbers and letters randomly distributed on a page into their ascending and alphabetical order as quickly as possible.
3. Digit Symbol Coding: (2 minutes) This subtest of the WAIS-III (Wechsler, 1997) consists of nine digit-symbol pairs followed by a list of digits. Under each digit the subject must write down the corresponding symbol as quickly as possible.
4. Hopkins Verbal Learning Test-Revised (HVLT-R): (8 minutes) Memory for verbal information will be assessed with this list learning task assessing immediate and delayed recall.
5. Stroop Color and Word Test: (5 minutes) This test (Stroop, 1935; Golden, 2002) measures cognitive control by asking subjects to suppress a habitual response in favor of an alternate response. Participants are shown a word and asked to name the color in which the word is written Total time expected for cognitive task tests is 28-33 min. If the patients' were able to drive and have been driving for at least one year, they were required to perform driving simulation. After performing the baseline cognitive task tests, baseline driving simulation (15 minutes) on the driving simulator.
After the baseline Cognitive Task Test and Virtual Driving Training session, the subjects underwent their planned surgery. The selection of the anesthetic gas was determined by a computer generated randomization list. The anesthesiologist or the CRNA in charge of the subject administered anesthesia. The investigators and the subjects were blinded to the anesthetic gas given. At the conclusion of the surgery, the anesthetic gas was shut down and the co-investigator was called into the OR to document the time the subjects take to open their eyes after the cessation of the gas.
At 30 minutes after discontinuation of the anesthetic gas, the subjects were asked to repeat the same sets of cognitive task tests (28-33 min).
And, at 2 hours after the surgery, the subjects repeated the cognitive tasks test (28-33 min) and the driving simulation (20 min) for patients who were able to drive.
On the next day of the surgery, the co-investigator had a telephone conversation with the subjects who were discharged home after the surgery. Modified Telephone Interview for Cognitive Status (TICS-M) was used to collect data (10 minutes). This is a 13-item telephone interview (Welsh, Breitner, \& Magruder-Habib, 1993) for late-life cognitive assessment that includes tests of orientation, attention, working memory, praxis, sentence repetition, naming to verbal description, recent memory, word opposites, and an additional immediate and delayed recall of a 10-word list. The subjects' participation in the study ended after this follow-up telephone call.
The participants were followed for the duration up to 28 hours. The follow-up and participation in this study ended after 24-28 hours.
From date of randomization until the date of first documented progression, end of participation or date of death from any cause, whichever came first, assessed up to 30 days.
#Intervention
- DRUG : Desflurane
- DRUG : Sevoflurane | #Eligibility Criteria:
Inclusion Criteria:
* > 65 years, female subjects
* Scheduled for brief urologic surgery (Cyctoscopy, Ureteral stent, Laserlithotripsy, Ureteroscopy, Vaginal sling, Bladder injury repair, Rectocele repair and Stone extraction)
* Ability to read, write and speak English language
* Driving at least one year
Exclusion Criteria:
* Preexisting neurological impairment in thinking process
* Renal insufficiency or failure
* Lack of command of English language
* Inability to drive
* Motion Sickness
Sex :
FEMALE
Ages :
- Minimum Age : 60 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT01310582 | {
"brief_title": "Recovery Following Desflurane Versus Sevoflurane for Outpatient Urologic Surgery in Elderly Females",
"conditions": [
"Ureteral Stent Occlusion",
"Exposure Laser",
"Ureterostomy; Functional Disturbance",
"Vaginal Diseases",
"Injury of Bladder",
"Excessive Repair",
"Calculi"
],
"interventions": [
"Drug: Sevoflurane",
"Drug: Desflurane"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01310582",
"official_title": "Recovery Following Desflurane vs Sevoflurane for Outpatient Urologic Surgery in Elderly Females",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-08",
"study_completion_date(actual)": "2013-08",
"study_start_date(actual)": "2011-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-12-24",
"last_updated_that_met_qc_criteria": "2011-03-07",
"last_verified": "2013-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-03-08",
"first_submitted": "2011-03-07",
"first_submitted_that_met_qc_criteria": "2013-11-06"
}
}
} |
#Study Description
Brief Summary
This study is designed to evaluate the ability of growth hormone (GH, also known as somatropin) to increase CD4+ cell counts in patients taking anti-HIV drugs. The study is targeted toward patients with low levels of HIV who continue to have low CD4+ cell counts.
Detailed Description
After initiation of HAART, many HIV infected patients have significant improvement in CD4+ levels. However, some patients continue to have low CD4+ counts (\< 350 cells/mm3) despite adequate viral suppression. The purpose of this study is to determine whether administration of GH will increase naïve CD4+ production. Further, the study will assess whether an increase in naïve CD4+ production will lead to increases in antigen-specific CD4+ and CD8+ T cells.
Patients enrolled in this study will be randomized to one of two groups. Patients in both groups will continue their present HAART regimen for the duration of the study. Group A patients will receive daily subcutaneous injections of GH for 48 weeks. Group B participants will receive no additional therapy for 24 weeks, and will then receive daily subcutaneous GH injections during Weeks 24-28 of the study. Both groups will receive immunocyanin (keyhole-limpet hemocyanin) injections at Weeks 16 and 20 and hepatitis A vaccination at Weeks 40 and 44. At the conclusion of Week 48, all patients will discontinue GH therapy while maintaining their HAART regimen. Patients will then be followed for an additional 24 weeks.
Patients may be asked to participate in a substudy to measure the size of the thymus in people taking GH. Patients in the substudy will have a noncontrast CT scan of the chest before beginning GH therapy and again after 24 weeks of GH therapy.
#Intervention
- DRUG : somatropin
- BIOLOGICAL : Hepatitis A virus, inactivated
- DRUG : Keyhole-Limpet Hemocyanin | #Eligibility Criteria:
Inclusion Criteria
* HIV positive
* Minimum of 1 year of treatment with HAART
* CD4+ cell count <350 cells/mm3
* HIV-1 RNA <400 copies/ml for 6 months prior to study entry
* Acceptable methods of contraception
Exclusion Criteria
* Serious medical illness requiring hospitalization within 14 days prior to study entry
* Pregnant or breast-feeding
* Taking certain medications
* Allergy to r-hGH, hepatitis A vaccine, KLH, or their formulations, including allergies to shellfish
* Active drug or alcohol dependence
* Diabetes or uncontrolled hyperglycemia
* Uncontrolled hypertension
* History of carpal tunnel syndrome
* Active neoplasm requiring treatment
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00050921 | {
"brief_title": "Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs",
"conditions": [
"HIV Infections"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00050921",
"official_title": "Improving Immune Reconstitution With Growth Hormone in HIV-infected Subjects With Incomplete CD4+ Lymphocyte Restoration on Highly Active Antiretroviral Therapy (HAART)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2005-03",
"study_start_date(actual)": null
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-11-01",
"last_updated_that_met_qc_criteria": "2002-12-31",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2003-01-01",
"first_submitted": "2002-12-30",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study tests whether people receiving clinician support to use a mobile application on their smartphone can manage their post-traumatic stress disorder (PTSD) symptoms better than those who do not. Half of the participants will receive the clinician supported smartphone application intervention and the other half will remain on the waiting list.
#Intervention
- OTHER : Clinician supported smartphone application intervention | #Eligibility Criteria:
Inclusion Criteria:
* on the waiting list for the Ontario Shores traumatic stress clinic;
* score >= 31 on the PCL-5
* have access to a smartphone or tablet to which they are willing to download the app.
Exclusion Criteria:
* active suicidal ideation
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02956902 | {
"brief_title": "A Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial",
"conditions": [
"PostTraumatic Stress Disorder"
],
"interventions": [
"Other: Clinician supported smartphone application intervention"
],
"location_countries": null,
"nct_id": "NCT02956902",
"official_title": "A Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-04",
"study_completion_date(actual)": "2017-04",
"study_start_date(actual)": "2016-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-04-18",
"last_updated_that_met_qc_criteria": "2016-11-03",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-11-06",
"first_submitted": "2016-11-03",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The primary objective is to evaluate and quantify the reproducibility of functional magnetic resonance imaging (fMRI) maps of the eloquent brain areas corresponding to specific neurological functions based on activation maps obtained with different thresholds in patients with benign and biopsy proven low-grade brain neoplasms. Another objective is to access the impairment in neurological function in image guided intracranial radiotherapy using neurocognitive assessment tools and to derive dose response curves relating the impairment in a particular neurological function to the FED received by the area of eloquent brain corresponding to it.
| #Eligibility Criteria:
Inclusion Criteria:
* Indication for brain radiotherapy.
* Ability to undergo MRI scans and time to participate in neurocognitive testing.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00214175 | {
"brief_title": "Determination of Fraction Size Equivalent Dose (FED) Levels for Intracranial Conformal Avoidance Radiotherapy",
"conditions": [
"Glioma",
"Brain Neoplasms"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00214175",
"official_title": "Determination of Fraction Size Equivalent Dose (FED) Levels for Intracranial Conformal Avoidance Radiotherapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-01",
"study_completion_date(actual)": "2011-01",
"study_start_date(actual)": "2004-06"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-02-24",
"last_updated_that_met_qc_criteria": "2005-09-13",
"last_verified": "2012-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-21",
"first_submitted": "2005-09-13",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Postpartum hemorrhage (PPH) accounts for 20-25 percent of maternal deaths worldwide. Tranexamic Acid (TXA) is an antifibrinolytic agent that has been shown to reduce the estimated blood loss after delivery and is recommended by the World Health Organization for PPH treatment. However, dosing in studies ranges from 0.5g to 4g and the optimal dose of TXA in the pregnant population has not been established. Further, the effect of TXA on global coagulation assessed by rotational thromboelastometry (ROTEM®) has not been elucidated.
The primary aim of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of TXA administered after delivery in patients at risk for PPH.
Detailed Description
PPH occurs in approximately 1-5% of deliveries in the United States and accounts for 20-25% of maternal deaths worldwide. PPH is difficult to predict, but classically, risk factors for PPH- uterine atony, abruption, retained tissue, lacerations, infection, obesity, preeclampsia, magnesium administration, and prolonged labor- impede uterine contraction, vasoconstriction, and clotting. In addition, 40% of PPH occurs in the absence of known risk factors.
Early recognition of significant bleeding, pharmacologic therapy, and correction of coagulopathy are critical measures to minimize morbidity and mortality from PPH. TXA is an antifibrinolytic agent that competitively inhibits plasminogen, preventing activation of plasmin and lysis of fibrin. TXA is used in many surgical arenas including cardiac, orthopedic, pediatric, urologic, and gynecologic surgery and has been shown to be a useful adjunct to uterotonics to reduce blood loss after vaginal or cesarean delivery without maternal adverse effects.
The efficacy and side-effect profile of TXA is dose-dependent, but the optimal dose based on the pharmacokinetics (PK) and pharmacodynamics (PD) of TXA have yet to be determined in the obstetric population. Doses given after delivery have ranged from 0.5 to 4g bolus with or without a subsequent infusion. The World Maternal Antifibrinolytic (WOMAN) trial was a multi-country placebo-controlled randomized trial of 20,060 women in which placebo or TXA 1g IV over 10 minutes was administered at the onset of PPH, with a second dose (placebo or 1g TXA) if bleeding was ongoing at 30 minutes. Women who received TXA had a lower number of laparotomies and no increase in thromboembolic events including pulmonary embolus, myocardial infarction, and cerebral vascular accident. Women who received TXA less than 1 hour or greater than 3 hours after birth had similar risks of hysterectomy or death, but women who received TXA 1 to 3 hours after birth had a lower risk of hysterectomy or death from bleeding (World Health Organization; WHO). The 1g dose in the WOMAN trial was modeled after the Clinical Randomization of an Antifibrinolytic in Significant Haemorrhage (CRASH-2) trial, in which TXA was administered to trauma patients with hemorrhage. A French multicenter trial randomized 152 women to receive either 4g of TXA administered over 1 hour followed by a maintenance dose of 1g/hour for 6 hours, or standard care without TXA. Patients who received 10g TXA had reduced EBL, enhanced response to uterotonic agents, less change in hemoglobin values, lower number of blood products transfused, and a trend toward a lower rate of invasive surgical procedures. In the pediatric population, a wide range of TXA doses from 10mg/kg to 100mg/kg have been reported, with higher dose correlating with a reduction in blood loss, but also an increase in neurologic or thromboembolic complications.
Side effects from TXA are rare and include allergic reaction, dizziness, low blood pressure, nausea/vomiting, diarrhea, muscle spasm, and vision change. Serious potential complications associated with higher doses of TXA such as those used during cardiac surgery include thrombosis and seizures. However, TXA administered at lower doses for bleeding (1g to 2g IV, or a 10mg/kg bolus) is not associated with an increased rate of thrombosis or seizure activity. Given the potential seizure risk, the use of TXA in patients with a seizure disorder or in conditions that lower the seizure threshold such as preeclampsia may be relatively contraindicated, as TXA also lowers the seizure threshold through competitive antagonism of the inhibitory neurotransmitter glycine.
ROTEM® is a whole blood point-of-care assay of coagulation. There are anticipated hypercoagulable changes in the blood at term gestation and unpredictable changes in coagulation during PPH, making ROTEM® a potentially useful tool. The effect of TXA on maternal coagulation profile after delivery assessed by ROTEM® is unknown. The use of ROTEM® during TXA therapy in correlation with plasma TXA levels may help characterize the optimal dose for its impact on the coagulation profile. Further, it may help explain why in the WOMAN trial the most effective dosing time was between one and three hours after onset of PPH.
This study proposes to evaluate the PD and PK of TXA administered after delivery, in conjunction with its impact on coagulation measured by ROTEM®. The 2017 WHO Executive Guideline Steering Group on maternal and perinatal health recommends early use of TXA, within 3 hours of birth, for women with PPH (strong recommendation, moderate quality of evidence). TXA administration is therefore increasingly common during PPH. It is meaningful to explore the optimal dose of TXA that balances efficacy and safety: optimizing maternal TXA exposure (serum level) while minimizing the risk of thrombosis (increased hypercoagulable changes on ROTEM®).
#Intervention
- DIAGNOSTIC_TEST : blood test
- 13 blood samples will be drawn: at 3 min, 7 min, 15 min, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, and 5h post-treatment with TXA. Blood samples will be processed for ROTEM® analysis and for plasma concentration of TXA. TXA plasma concentrations will be modeled with a non-linear mixed-effects strategy using Monolix 4.1 and NONMEM(®) 7.2. | #Eligibility Criteria:
Inclusion Criteria:Age 18 and 50 years, gestational age > to 23 weeks at the time of admission for labor and delivery, and normal serum creatinine (< 0.9). Patients having either vaginal or cesarean delivery are eligible. Patients must have (1) major or (2 or more) minor risk factors for PPH as described here:
Major (1) or more:
* Suspected abnormal placentation
* Placenta previa
* Known coagulopathy
* Active concern for bleeding per care team
Minor (2) or more:
* 2 prior cesarean deliveries
* 3 prior deliveries
* Prior history of PPH
* Chorioamnionitis
* Polyhydramnios
* Macrosomia
* Obesity
* Suspected placental abruption
Exclusion Criteria:
* Allergy to tranexamic acid, inherited thrombophilia, history/current/intrapartum venous thrombosis, seizure disorder, renal or liver dysfunction, preeclampsia, anticoagulation therapy, or category III fetal heart rate tracing.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT03863964 | {
"brief_title": "Tranexamic Acid Pharmacokinetics During Postpartum Hemorrhage",
"conditions": [
"Postpartum Hemorrhage"
],
"interventions": [
"Diagnostic Test: blood test"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03863964",
"official_title": "Tranexamic Acid Administered After Delivery: Maternal Pharmacokinetics, Pharmacodynamics, and Coagulation Status",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-01-31",
"study_completion_date(actual)": "2021-03-01",
"study_start_date(actual)": "2019-06-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-04-13",
"last_updated_that_met_qc_criteria": "2019-03-04",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-03-05",
"first_submitted": "2018-12-11",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Primary objective:
- To evaluate the sensitivity of the Merz Lip Fullness Assessment Scale (MLFAS).
Secondary objectives:
* To evaluate the clinical aesthetic improvement outcome in lips appearance four weeks after Etermis 4® injection.
* To evaluate safety/tolerability of Etermis 4® treatment in lips.
#Intervention
- DEVICE : Etermis 4®
- Etermis 4® is a sterile non-pyrogenic physiological gel made of reticulated hyaluronic acid (HA) of non-animal origin. | #Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female study subjects with thin to medium lips volume (grade 1 to 2 on MLFAS), seeking for hyaluronic acid (HA) for lips volume augmentation in >=1-point improvement on the MLFAS on both the upper and lower lips and fulfilling the criteria listed in the Instruction for Use (IFU) of the Study Medical Device to be injected.
Exclusion Criteria:
* Subjects with a medical condition and/or medication according to current IFU which is contra indicated for HA filler treatment, or prior facial surgeries or surgical permanent implants, lips augmentation treatment or other aesthetic procedure in the face that could interfere with performance assessment.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03256942 | {
"brief_title": "Evaluation of the Sensitivity of Merz Lips Fullness Assessment Scale Following Etermis 4® Treatment for Lips Volume Augmentation",
"conditions": [
"Subjects Desiring Lip Augmentation"
],
"interventions": [
"Device: Etermis 4®"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT03256942",
"official_title": "Evaluation of the Sensitivity of Merz Lips Fullness Assessment Scale Following Etermis 4® Treatment for Lips Volume Augmentation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11-17",
"study_completion_date(actual)": "2017-11-17",
"study_start_date(actual)": "2017-08-16"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-05-23",
"last_updated_that_met_qc_criteria": "2017-08-21",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-22",
"first_submitted": "2017-08-17",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Retained surgical items (e.g. sponges, needles, and instruments) remain the most frequently reported serious adverse event for five of the last six years. Retained surgical sponges have resulted in negative patient outcomes (reoperation, readmission/prolonged hospital stay, infection, fistulas/ bowel obstructions, and death). The national standard for prevention of retained surgical sponges relies heavily on manual counting several times before, during, and after the surgical procedure. If a sponge is missing, a series of steps are taken to reconcile the count. These steps require extra time and pull personnel away from other competing priorities. If the final closing count remains incorrect, it is common practice to obtain an intraoperative radiograph to rule out retention of a surgical sponge. This X-Ray is expensive and increases the time required for the surgery.
Novel technology using a radiofrequency (RF) is now available for detecting and preventing retained surgical sponges. The objective of this study is to evaluate the in-use effectiveness of a radiofrequency (RF) surgical sponge detection system for reducing the cost of searching for sponges and prevention of incorrect counts.
Detailed Description
Background:
Retained surgical items (e.g. sponges, needles, and instruments) remain one of the sentinel events most frequently reported to The Joint Commission, and are estimated to occur in 1: 5500 surgeries. These serious adverse events have resulted in negative patient outcomes (reoperation, readmission/prolonged hospital stay, infection or sepsis, fistulas/ bowel obstructions, visceral perforation, and death). Cotton gauze sponges account for 48-69% of retained surgical items, and result in more serious tissue reaction than metal items. The national standard for prevention of retained surgical sponges relies heavily on manual counting, a process that occurs prior to incision, at the time of closing a cavity within a cavity, closing the first layer of tissue, and closing skin. The immediate outcome of the closing counts is either correct or unresolved. If unresolved, a series of steps are taken to reconcile the count (surgeon notified, wound searched, sterile field searched, room searched, count repeated). These steps require extra time and effort, pulling personnel away from other competing priorities. If the final closing count remains incorrect, it is common practice to obtain an intraoperative radiograph to rule out retention of a surgical sponge. The practice of searching for misplaced sponges and using radiography to rule out the presence of a retained sponge extend the operating time and add to costs associated care of the patient in surgery. Novel technology is now available for detecting and preventing retained surgical sponges. The technology uses a radiofrequency (RF) chip in the sponge, and a mat or wand that scans the patient for a sponge. Only one clinical trial has evaluated the in-use effectiveness of this RF technology. No retained sponges occurred during the 18 month trial. However the sample size was not large enough to determine significance.
Primary Objective:
The objective in this Health Services Research is to evaluate the in-use effectiveness of a radiofrequency (RF) surgical sponge detection system for reducing the cost of searching for sponges and prevention of incorrect counts.
Specific Aims are:
1. To compare the estimated time and cost of searching for sponges and using radiography to rule out the presence of retained sponges before and after implementation of a RF sponge detection system.
2. To compare the incidence of incorrect final closing counts before and after implementation of a RF sponge detection system.
Study Design:
Using deidentified existing data, investigators propose a quasiexperimental study evaluating the outcomes of using RF surgical sponge detection system. The setting is the University of Iowa Hospitals and Clinics, a 711-bed academic medical center, a Level 1 trauma center, located in Iowa City, Iowa. The University of Iowa Institutional Review Board has determined that this study does not meet the regulatory definition of human subjects research.
Primary Endpoints
1. The estimated time and cost of searching for sponges and using radiography to rule out the presence of retained surgical sponges.
2. The frequency of incorrect final closing sponge counts.
Data for individual patients will be recorded by the circulating nurses in a questionnaire embedded in the surgical log of Epic Systems®, module Optime®. The questionnaire will consist of three individual counts: initial closing, final closing, and additional count. If the first question, 'was a search required' is answered 'yes', four subsequent questions will be asked: type of sponge, actions taken, number of minutes required, and the location of the sponge if found. Data will be retrieved from the Health Information System (HIS) using S.A.P. ® Business Objects™ (surgical volume, surgical service) and Crystal reports (details about searches for sponges). Incorrect final closing counts are documented in the Patient Safety Net® electronic event reporting system. Data will be retrieved from events reported within the category of 'count incomplete or not done' and 'count incorrect'. Data will be retrieved by HIS personnel and provided via a report to the Director of Clinical Functions responsible for the Main Operating Room. This report is part of the quality improvement program. Electronic data will be stored in the College of Nursing, the University of Iowa, on the college's secure server. Data will be cleaned by a data manager and analyzed by the college's statistician.
Analysis:
Aim 1: Minutes of time spent searching for misplaced sponges will be analyzed using ranges, means, and standard deviations. Comparison before and after implementation of the RF detection technology will be described as percentages and analyzed using chi square with Yates correction. To provide the best estimate of the resources used in searching for sponges, investigators will use published data on operating room costs per minute to estimate search costs ($17.23). However, there are significant differences across institutions. To accommodate this broad range of potential adopters of this RF detection technology and show differences in potential cost-effectiveness, in addition to using the average estimate of operating room time cost from the literature, investigators will construct lower bound and upper bound estimates of the operating room time costs to provide a range of cost estimates to use in assessing the RF detection technology intervention.
Investigators further adjust search costs for variation in practices during searches. At times surgeons continue with the procedure (e.g. closing the wound) while in other cases surgeons will assist with efforts to locate the sponge. As investigators are interested in time spent on non-productive searches, investigators will use a range of estimates of non-productive search costs. Investigators start with 100% non-productive and also estimate based on 75% non-productive (25% of the search time moving forward with the procedure) and 50% non-productive (50% of the search time moving forward with the procedure). Investigators will use the average radiography costs from published literature ($286) in addition to the operating room time associated with obtaining an intraoperative radiograph (30minutes). All times and costs will be analyzed using ranges, means, and standard deviations. Comparison before and after implementation of the RF detection technology will be described as percentages and analyzed using chi square with Yates correction.
Aim 2: To compare the incidence of incorrect final closing counts The number of incorrect final closing counts before and after implementation of a RF sponge detection system will be analyzed using ranges, means, and standard deviations. Comparison before and after implementation of the RF detection technology will be described as percentages and analyzed using chi square with Yates correction.
#Intervention
- DEVICE : The Situate Detection System
- The Situate Detection System for locating surgical sponges
- Other Names :
- RF Assure | #Eligibility Criteria:
Inclusion Criteria:
* We estimate including 27,000 patients during the total of 18 months.
1. The first part of the sample will be retrospective, all patients undergoing surgery in the Main Operating Room during a 9 month period of time of the RF sponge detection system (February through October, 2014) This time frame was selected to allow inclusion of data from our previous study.
2. The second part of the sample will be prospective, for nine months after implementation of the RF sponge detection system.
Exclusion Criteria:
* ophthalmology, dentistry, non-surgical procedures, aborted surgical procedures, surgeries during which the patient expired, and surgeries performed outside of the Main Operating Room.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT02837224 | {
"brief_title": "Effectiveness of a RF Sponge Detection",
"conditions": [
"Surgical Complication Nec"
],
"interventions": [
"Device: The Situate Detection System"
],
"location_countries": null,
"nct_id": "NCT02837224",
"official_title": "Effectiveness of a Radiofrequency Surgical Sponge Detection System for Preventing Retained Surgical Sponges",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-05-31",
"study_completion_date(actual)": "2017-05-31",
"study_start_date(actual)": "2016-08"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-11-30",
"last_updated_that_met_qc_criteria": "2016-07-14",
"last_verified": "2017-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-19",
"first_submitted": "2016-07-07",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Various digestive manifestations are common in infants less than 6 months and have a significant impact on morbidity and quality of life of the family. In a prospective study on more than 2800 Italian infants followed by 0-6 months of life, it was determined that 55% of these children had gastrointestinal symptoms such as regurgitation (23%), colics (20%), constipation (17%) or poor weight gain (15%). However, these symptoms are not very accurate, and their cause is often difficult to determine. Frequently, the pediatrician will exclude cow's milk protein in infant feeding, but without a clear etiological diagnosis was asked. This measure causes significant additional costs through the use of extensively hydrolyzed milk specifically for children and involves an elimination diet of all foods containing cow's milk sometimes for several years. This can negatively influence the growth of the child.
If the involvement of milk in these pathologies is suggested by some early studies (35% for colics, 68% in constipation, 42% in gastroesophageal reflux), it is unclear in the current state of knowledge if these gastrointestinal symptoms are actually due to an 'allergy' to milk. Moreover, there is no validated diagnostic test for non-IgE-mediated gut allergy. However, various tests have proven their effectiveness in the investigation of non IgE-mediated allergy (eg. LAT, patch tests) and will be used in this study.
#Intervention
- DIETARY_SUPPLEMENT : Formula milk free of cow's milk protein
- DIETARY_SUPPLEMENT : Placebo
- Infant formula milk | #Eligibility Criteria:
Inclusion Criteria:
* Infants 0 <= age <= 6 month old with at least one of the following symptoms : constipation, gastroesophageal reflux, colics
Exclusion Criteria:
* Prematurity
* exclusive breastfeeding
* Other cause for symptoms
Sex :
ALL
Ages :
- Maximum Age : 6 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT01684319 | {
"brief_title": "Milk-induced Gastrointestinal Symptoms in Infants",
"conditions": [
"Gastrointestinal Symptoms in Young Infants"
],
"interventions": [
"Dietary Supplement: Placebo",
"Dietary Supplement: Formula milk free of cow's milk protein"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT01684319",
"official_title": "Prospective, Randomized, Double Blind and Placebo Controlled Study With the Aim to Establish the Role of Milk Proteins in Gastrointestinal Diseases (GERD, Constipation and Colics) of Young Infants and to Determine the Diagnostic Value of Immunological Tests in These Pathologies.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-08",
"study_completion_date(actual)": "2013-11",
"study_start_date(actual)": "2012-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-01-06",
"last_updated_that_met_qc_criteria": "2012-09-11",
"last_verified": "2014-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-09-12",
"first_submitted": "2012-09-10",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements
Detailed Description
Existing Adult Continuous Positive Airway Pressure (CPAP) therapy users will be recruited for an overnight polysomnography (PSG) sleep study. The participants will use the investigational CPAP device and be connected to a PSG during their session. The device performance during the session will be assessed. Outcomes of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires and PSG data.
#Intervention
- DEVICE : Auto CPAP + comfort feature A
- Auto CPAP + comfort feature A using Fisher \& Paykel Healthcare CPAP Device
- DEVICE : Auto CPAP with comfort feature B
- Auto CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device
- DEVICE : Auto CPAP with no comfort feature
- Auto CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device
- DEVICE : Auto CPAP with comfort feature A+B
- Auto CPAP with comfort feature A+B using Fisher \& Paykel Healthcare CPAP Device
- DEVICE : CPAP with comfort feature A
- CPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device
- DEVICE : CPAP with comfort feature B
- CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device
- DEVICE : CPAP with no comfort feature
- CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device
- DEVICE : CPAP with comfort feature A + B
- CPAP with comfort feature A + B using Fisher \& Paykel Healthcare CPAP Device
- DEVICE : CPAP at Sub therapeutic level
- CPAP at Sub therapeutic level using Fisher \& Paykel Healthcare CPAP Device | #Eligibility Criteria:
Inclusion Criteria:
* >= 18 years
* Diagnosed with OSA by a practicing physician and prescribed PAP therapy (fixed or auto CPAP)
* Fluent in spoken and written English.
Exclusion Criteria:
* Be contraindicated for PAP (fixed or auto CPAP) therapy.
* Have another significant sleep disorder(s) (e.g. periodic leg movements or insomnia).
* Have obesity hypoventilation syndrome or congestive heart failure.
* Require supplemental oxygen with your PAP (fixed or auto CPAP) device.
* Have any implanted electronic medical devices (e.g. cardiac pacemakers).
* Be pregnant or think they might be pregnant.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02948010 | {
"brief_title": "CPAP Device In-lab Assessment NZ",
"conditions": [
"Obstructive Sleep Apnea"
],
"interventions": [
"Device: Auto CPAP with comfort feature A+B",
"Device: CPAP with comfort feature B",
"Device: CPAP with comfort feature A + B",
"Device: Auto CPAP + comfort feature A",
"Device: CPAP at Sub therapeutic level",
"Device: Auto CPAP with no comfort feature",
"Device: CPAP with comfort feature A",
"Device: CPAP with no comfort feature",
"Device: Auto CPAP with comfort feature B"
],
"location_countries": [
"New Zealand"
],
"nct_id": "NCT02948010",
"official_title": "CPAP Device In-lab Assessment NZ",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-03",
"study_completion_date(actual)": "2017-03",
"study_start_date(actual)": "2016-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-06-27",
"last_updated_that_met_qc_criteria": "2016-10-26",
"last_verified": "2017-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-10-28",
"first_submitted": "2016-10-26",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Study included all pregnant women admitted with threatened preterm labor during the study period. All participants underwent estimation of maternal serum homocysteine level and assessment of uterine artery Doppler indices.
Detailed Description
Prospective cohort study. Study approval by local ethics committee. Informed written consent. Study included all pregnant women admitted with threatened preterm labor during the study period. All participants underwent estimation of maternal serum homocysteine level and assessment of uterine artery Doppler indices.
#Intervention
- DIAGNOSTIC_TEST : Uterine artery doppler
- Uterine artery Doppler pulsatility indices
- DIAGNOSTIC_TEST : Maternal serum homocysteine estimation | #Eligibility Criteria:
Inclusion Criteria:
* Singleton pregnancy
* More than 28 and less than 35 gestational weeks.
* Threatened preterm labor
Exclusion Criteria:
* Medical disorders complicating pregnancy
* Obstetric conditions complicating pregnancy (e.g., placenta previa, multiple gestation,PPROM, ....etc)
* Fetal anomalies or distress
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT03440281 | {
"brief_title": "Maternal Serum Homocysteine Levels and Uterine Artery Pulsatility Indices in Preterm Labor",
"conditions": [
"Preterm Labor"
],
"interventions": [
"Diagnostic Test: Maternal serum homocysteine estimation",
"Diagnostic Test: Uterine artery doppler"
],
"location_countries": null,
"nct_id": "NCT03440281",
"official_title": "Maternal Serum Homocysteine Levels and Uterine Artery Pulsatility Index as Predictors of Spontaneous Preterm Labor",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11-01",
"study_completion_date(actual)": "2017-11-01",
"study_start_date(actual)": "2015-08-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-02-22",
"last_updated_that_met_qc_criteria": "2018-02-14",
"last_verified": "2018-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-02-22",
"first_submitted": "2018-02-05",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Pulmonary Rehabilitation became a vital part of management in COPD patients in form of activity modification, dietary and pharmacological optimisation. But access to traditional supervised aerobic (treadmill) walking is debatable fact due to economical and staffing expertise in developing countries like India. The investigators designed a randomised controlled trial to evaluate the effectiveness of ground based walking over traditional treadmill walking in improving quality of life in COPD patients.
Detailed Description
Background: COPD is increasing mortality and morbidity globally. Pulmonary rehabilitation is a promising management in COPD management. Exercise training in form of aerobic (walking, cycling) and strength training is an important part of pulmonary rehabilitation. However access to traditional supervised exercise programs is questionable debate even in developed western countries. Unsupervised ground walk programs are often told by physicians but not properly prescribed.
Objective: To assess whether ground or treadmill walk is better in improving functional capacity and quality of life in COPD patients Design: Randomised controlled trial Procedure: Two arms 1) supervised ground walk training 2) supervised treadmill walk training. The intensity and progression of walk is based on 6 minute walk test. Quality of life will be gauged through Chronic respiratory questionnaire and functional capacity through 6 minute walk test.
Statistical analysis: Descriptive analysis for characterisation. Normality though Kolmogorov and Variables will be compared through paired and unpaired student t tests
#Intervention
- BEHAVIORAL : Ground walk training
- 3 times a week and 6 weeks
- BEHAVIORAL : Supervised Treadmill Walk training
- 3 times a week and 6 weeks | #Eligibility Criteria:
Inclusion Criteria:
* stable COPD
* Stage II - IV
* Both genders
Exclusion Criteria:
* Cardiovascular diseases uncompensated
* uncompensated pleural diseases
* uncompensated liver diseases
* Recent surgeries less than 3 weeks
* malignancy receiving chemo and radiotherapy
* Recent exacerbations less than 3 months
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02218918 | {
"brief_title": "Comparison of Supervised Ground Walk Training and Treadmill Walk Training in COPD Patients",
"conditions": [
"Chronic Obstructive Pulmonary Disease (COPD)"
],
"interventions": [
"Behavioral: Supervised Treadmill Walk training",
"Behavioral: Ground walk training"
],
"location_countries": [
"India"
],
"nct_id": "NCT02218918",
"official_title": "Phase 0 Study of Comparison Between Ground Walk Training and Treadmill Walk Training in COPD Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-08",
"study_completion_date(actual)": "2016-10",
"study_start_date(actual)": "2014-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-10-20",
"last_updated_that_met_qc_criteria": "2014-08-14",
"last_verified": "2017-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-08-18",
"first_submitted": "2014-08-11",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This is a clinical trial to evaluate the safety and immunogenicity of a recombinant adenovirus 5 vectored COVID-19 vaccine (Ad5-nCoV) with two doses and with different adminstration routes in healthy adults aged 18 years and older.
Detailed Description
A total of 168 healthy adult volunteers will be vaccinated in this clinical trial according to open, partly randomized design from the healthy adults aged 18 years and older. The safety and immunogenicity of intramuscular vaccination and mucosal vaccination of two doses of Ad5-nCoV in different administration schedules will be evaluated.
#Intervention
- BIOLOGICAL : Ad5-nCoV
- Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) | #Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years and older;
* Able to provide consent to participate in and having signed an Informed Consent Form (ICF);
* Able and willing to complete all the scheduled study procedures during the whole study follow-up period (about 6 <= age <= 8 months, depending on group);
* Negative result of HIV screening;
* Axillary temperature <=37.0°C.
* Negative IgG and IgM antibodies against COVID-19;
* Good general health status, as determined by history and physical examination.
Exclusion Criteria for the first vaccination:
* Hematological examination is abnormal, or clinically significant as assessed by the study investigator (including white blood cell count, lymphocyte count, neutrophil count, eosinophil count, platelet, hemoglobin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, blood glucose and creatinine);
* With oral ulcers, throat swelling and other oral diseases.
* With symptoms of upper respiratory tract infection.
* Personal history of seizure disorder, encephalopathy or psychosis;
* Allergic history to any vaccine, or allergic to any ingredient of the Ad5-nCoV;
* Any acute febrile disease or active infectious disease on the day of vaccination;
* History of SARS or COVID-19;
* History of COVID-19 candidate vaccine administration;
* History of chronic obstructive pulmonary disease (COPD).
* Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension not controlled with medication;
* Serious chronic disease or in the advanced stage that cannot be controlled well， such as asthma, diabetes and thyroid disease, etc.;
* Congenital or acquired angioedema;
* Suffered from urticaria within 1 year before receiving the trial vaccine.
* Asplenia or functional asplenia;
* Platelet disorder or other bleeding disorder that may cause intramuscular injection contraindication;
* Faint with needles in intramuscular administration group;
* Immunosuppressive medication, anti-allergic, cytotoxic therapy, inhaled corticosteroids (excluding surface corticosteroid therapy for acute non-complicated dermatitis) in the last 6 months;
* Prior administration of blood products in last 4 months;
* Other vaccination(s) or investigational drugs within 1 month before study onset;
* Prior administration of live attenuated vaccine within 1 month before study onset;
* Prior administration of subunit or inactivated vaccine within 14 days before study onset;
* Current anti-tuberculosis therapy;
* Woman is pregnant or lactating, positive urine pregnancy test or plan to become pregnant during the next 8 months;
* Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives or informed consent (i.e. medical, psychological, social or other conditions, etc.).
Exclusion Criteria for the second vaccination:
* Severe allergic reaction after the first dose of vaccination;
* Severe adverse reactions causally related to the first vaccination;
* For those newly discovered or newly occured after the first vaccination that does not meet the first-dose selection criteria or meets the first-dose exclusion criteria, the investigator will determine whether to continue participating in the study;
* Other reasons for exclusion as deemed by the investigator.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT04552366 | {
"brief_title": "A Clinical Trial of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults",
"conditions": [
"COVID-19"
],
"interventions": [
"Biological: Ad5-nCoV"
],
"location_countries": [
"China"
],
"nct_id": "NCT04552366",
"official_title": "A Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults Aged 18 Years and Older",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-31",
"study_completion_date(actual)": "2021-04-30",
"study_start_date(actual)": "2020-09-29"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-24",
"last_updated_that_met_qc_criteria": "2020-09-16",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-17",
"first_submitted": "2020-09-15",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
To characterize pharmacokinetic profile of test product compared to that of the corresponding reference product in adult patients, who are diagnosed to have Chronic Myeloid Leukemia \& Gastrointestinal Stromal Tumor under Fed Conditions.
Detailed Description
To characterize pharmacokinetic profile of Imatinib Mesylate tablets EQ 400 mg base of Amneal Pharmaceuticals LLC, compared to that of the reference product - GLEEVEC® (imatinib mesylate) tablets 400 mg in adult patients, who are diagnosed to have CML or GIST and are presently receiving stable dose of imatinib mesylate tablets 400 mg, and assess their bioequivalence.
#Intervention
- DRUG : Imatinib Mesylate Tablets, 400 mg
- Brown, oval, scored, film coated, beveled edge tablet. Debossed with AN on scored side and 795 on the other side.
- DRUG : Imatinib Mesylate Tablets, 400 mg
- Very dark yellow to brownish orange, film-coated tablets, ovaloid, biconvex with bevelled edges, debossed with '400' on one side with score on the other side, and 'SL' on each side of the score.
- Other Names :
- Gleevec | #Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 55 (both inclusive) and either sex
* Diagnosed case of Philadelphia chromosome positive (Ph+) CML patients in chronic phase or GIST and presently being treated with imatinib 400 mg tablets.
* Willing to give written informed consent for participation in the study as well as willing and able to comply with study visit schedule and other protocol requirements.
* Female patients of child bearing potential (except for those who have completed one year since menopause or have gone through hysterectomy or bilateral tubal ligation) must have negative serum pregnancy test at the screening, negative urine pregnancy test on check in to housing, must be non-lactating at screening and must agree to use effective contraception (barrier or hormonal) for the study period.
Exclusion Criteria:
* History of hypersensitivity to imatinib mesylate or to any of the excipients as judged by investigator.
* Patient of CML receiving treatment in Myeloid Blast Crisis or Accelerated Phase
* Abnormal laboratory results as below:
* History of a heart failure, renal insufficiency, hypereosinophilic syndrome (HES), myelodysplastic syndrome (MDS)/ myeloproliferative disease (MPD) or acute systemic mastocytosis (ASM).
* History of therapy with any of the following as per timelines before randomization: inducers of CYP3A4 activity and inhibitors of CYP3A4 activity, within 14 days, investigational product/device within last one month
* Alcohol or any drug dependence within past one year.
* Blood donation/loss exceeding 200 ml within last 60 days.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT02103322 | {
"brief_title": "Comparative Bioequivalence Study in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions",
"conditions": [
"Chronic Myeloid Leukemia",
"Gastrointestinal Stromal Tumor"
],
"interventions": [
"Drug: Imatinib Mesylate Tablets, 400 mg"
],
"location_countries": [
"India"
],
"nct_id": "NCT02103322",
"official_title": "A Randomized, Open Label, Two-Treatment, Multiple Dose, Steady State, Two-period, Cross-over, Multi-Centre Comparative Bioequivalence Study of Imatinib Mesylate Tablet 400 mg of Amneal Pharmaceuticals, USA With GLEEVEC® (Imatinib Mesylate) Tablets 400 mg Distributed by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-03",
"study_completion_date(actual)": "2014-06",
"study_start_date(actual)": "2014-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-06-27",
"last_updated_that_met_qc_criteria": "2014-04-01",
"last_verified": "2014-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-04-03",
"first_submitted": "2014-04-01",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to determine whether Vitamin B12,B6 and Folic Acid are effective with antipsychotic medication in the treatment of First Episode Psychosis.The B-complex Vitamins' homocysteine lowering properties may have an effect on cognition and symptoms. We are examining changes in symptoms and cognition over a 3 month period.
Detailed Description
The core rationale of this study will be to prospectively investigate whether Vitamin B12, B6 and Folic Acid and the associated lowering of homocysteine levels will improve and /or protect cognitive functioning in a cohort of 120 first episode psychosis patients.
This is a randomized, double blind placebo controlled add on standard therapy trial with vitamin B12, B6 and folic acid, in young patients between 15-25 presenting to ORYGEN Youth Health with a first psychotic episode . Vitamins (B12 , B6 and Folate) will be compared with placebo added to standard treatment for a period of 12 weeks in a double blind fashion. Primary outcome measures will be psychopathology and cognition (CogState and MATRICS). Secondary outcome measures will be tolerability and safety measures (drop-out rates, general side effect scale (UKU).
Patients who give informed consent will be randomised to receive treatment with vitamin (5 mg folic acid, 0.4 mg B12, and 50 mg B6) daily or placebo for 12 weeks.
Patients will be randomised by a dynamic randomisation method called minimization which allocates patients to treatment group by checking the allocation of similar patients already randomised, and allocating the next treatment group 'live' to best balance the treatment groups across all stratification variables. The minimization will be carried out by the NHMRC clinical trials centre in Sydney , and the patient will be randomized to either placebo or vitamin. Each patient will collect their tablets from the clinical trials pharmacy. The Clinical Trials Pharmacy will dispense either vitamin or placebo. All study personnel and participants will be blinded to treatment assignment for the duration of the study. To enhance the quality of measurement (and increase the power of the study by avoiding dilution of effect) adherence to medication will be measured electronically with electronic pill caps (Medication Event Monitoring System VI, ARRDEX Ltd). This will allow us to assess actual pharmacological exposure in an objective manner.
#Intervention
- DRUG : Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg | #Eligibility Criteria:
Inclusion Criteria:
* Male and females
* Between 15 and 25 years
* First Episode Psychosis
* 3 months of treatment
* Attending ORYGEN Youth Health, a geographical based catchment area service for young people aged between 15 and 25
Exclusion Criteria:
* Untreated B12 deficiency or untreated pernicious anaemia
* Patients on multi-vitamins, single B6, or folic acid, unless willing to discontinue and take study supplement
* Chronic haemolytic states such as thalassaemia major or sickle-cell anaemia
* Hypersensitivity to folic acid
* Organic disorders presenting with a psychotic syndrome (e.g. brain tumour, temporal lobe epilepsy, HIV encephalopathy)
* Mental retardation (unable and/or unlikely to give appropriate information of symptomatology or side-effects (IQ approximately lower than 70)
* History of clinically significant physical illness (e.g. terminal cancer, renal dialysis)
* History of brain surgery
* History of brain infarction
* Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception
Sex :
ALL
Ages :
- Minimum Age : 15 Years
- Maximum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT00202280 | {
"brief_title": "Efficacy of Treating First Episode Psychosis With Folic Acid,B12 and B6 in Addition to Antipsychotic Medication",
"conditions": [
"First Episode Psychosis"
],
"interventions": [
"Drug: Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg"
],
"location_countries": [
"Australia"
],
"nct_id": "NCT00202280",
"official_title": "VIP (Vitamins In Psychosis) Study. A Randomized Double Blind Placebo Controlled Trial of the Effects of Vitamin B12, B6 and Folic Acid Augmentation on Cognition and Symptoms in Early Psychosis.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-09",
"study_completion_date(actual)": "2009-06",
"study_start_date(actual)": "2004-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-11-20",
"last_updated_that_met_qc_criteria": "2005-09-14",
"last_verified": "2015-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-20",
"first_submitted": "2005-09-14",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This will be a single-centre, open label trial to determine the safety and feasibility of CHMI model using Plasmodium falciparum-infected cryopreserved erythrocytes administered to healthy Tanzanian adults with varying prior exposure to P. falciparum.
Detailed Description
This study will be a single-centre controlled human malaria infection study using adults with varying degrees of prior exposure to P. falciparum. The study will take place at Bagamoyo Clinical Trail Facility of the Ifakara Health Institute, located in Bagamoyo town (about 60 km north of Dar es Salaam).
Twelve healthy male adults aged 18 to 35 years will be recruited into two cohorts of high and low previous exposure consisting of 6 volunteers each as determined by anti-schizont antibody levels. Up to 5 back-up volunteers will be also be recruited and may take the place of another volunteer should they withdraw or become ineligible prior to challenge.
Participants will be infected via IV administration of Plasmodium falciparum-infected human erythrocytes of the chloroquine-susceptible 3D7 strain. Participants will then be closely monitored in a clinical trial facility for a maximum of 31 (28 days plus 3 days of treatment with anti-malarial drugs) days while undergoing frequent clinical and laboratory assessment. Volunteers who do not reach malaria treatment criteria as per protocol at day 28 (C+28) will be treated presumptively with antimalarial medications (ALU + a single low dose primaquine) under direct observation and will be discharged upon completion of treatment and on discretion of the study clinician.
Identifying data will not be included on any trial documentation (other than signed consent) and participants will be referred to by the trial study ID number. The study will be funded primarily by EDCTP grant supporting the evaluation of Multi-Stage Malaria Vaccine.
#Intervention
- BIOLOGICAL : P. falciparum infected erythrocytes
- Chloroquine sensitive P. falciparum 3D7-infected red blood cells, thawed and prepared under strict aseptic conditions, will be used as a challenge agent. | #Eligibility Criteria:
Inclusion Criteria:
* Volunteer being adult male aged >= 18 and <= 35 years, and in good health.
* Volunteer a resident in Bagamoyo town or rural areas of Bagamoyo district for the past 6 months
* Able and willing to complete the informed consent process conducted in English
* Volunteer has adequate understanding of the procedures of the study and is able and willing (in the investigator's opinion) to comply with all study requirements.
* Volunteer is willing to complete an informed consent questionnaire and is able to answer all questions correctly in a maximum of two attempts.
* Volunteer is able to communicate well with the investigator and is willing to be monitored in an inpatient setting for 28 days after challenge with infected erythrocytes.
* The volunteer agrees to refrain from blood donation throughout the study period.
* Volunteer agrees to refrain from intensive physical exercise (disproportionate to the volunteer's usual daily activity or exercise routine) during the malaria challenge period.
* Volunteer has signed written informed consent to participate in the trial.
Exclusion Criteria:
* Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, gastrointestinal, renal, hepatic, neurological, dermatological (e.g. psoriasis, contact dermatitis etc.), allergy, endocrine, malignant, haematological, infectious, immunodeficient, psychiatric and other disorders, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results.
* A heightened risk of cardiovascular disease, as determined by: an estimated ten-year risk of fatal cardiovascular disease of >=5% at screening, as determined by the Systematic Coronary Risk Evaluation (SCORE); history, or evidence at screening, of clinically significant arrhythmia, prolonged QT-interval or other clinically relevant ECG abnormalities; or a positive family history of cardiac events in 1st or 2nd degree relatives <50 years.
* Body mass index (BMI) of <18 or >30 Kg/m2
* A medical history of functional asplenia.
* History of epilepsy in the period of five years prior to study onset, even if no longer on medication.
* Confirmed parasite positive by PCR a day before challenge i.e., at C-1.
* Screening tests positive for Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)
* Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or other immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral antihistamines exempted) or expected use of such during the study period
* Any recent or current systemic therapy with an antibiotic or drug with potential antimalarial activity (chloroquine, doxycycline, tetracycline, piperaquine, benzodiazepine, flunarizine, fluoxetine, tetracycline, azithromycin, clindamycin, erythromycin, hydroxychloroquine, etc.) (allowable time frame for use at the Investigator's discretion).
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
* Any history of treatment for severe psychiatric disease by a psychiatrist in the past year.
* History of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset.
* Previous participation in any malaria investigational product study (allowable time frame for use at the Investigator's discretion)
* Known hypersensitivity to or contra-indications (including co-medication) for use of chloroquine, artemether-lumefantrine, Primaquine or history of severe (allergic) reactions to blood transfusion.
* Participation in any other clinical study in the 30 days prior to the start of the study or during the study period.
* Being an employee or relative of an employee of Ifakara Health Institute.
* Any other condition or situation that would, in the opinion of the investigator, place the volunteer at an unacceptable risk of injury or render the volunteer unable to meet the requirements of the protocol.
Exclusion criteria on day of challenge:
* Acute disease, defined as moderate or severe illness with or without fever
* 2. Current COVID-19 infection, defined as ongoing symptoms with positive COVID-19 PCR or rapid antigen test taken during current illness or positive COVID-19 PCR or rapid antigen test within preceding 7 days without symptoms.
* History of close contact with COVID-19 confirmed case within preceding 14 days
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT04788862 | {
"brief_title": "A Study of Blood-stage Controlled Human Plasmodium Falciparum Malaria Infection in Tanzania",
"conditions": [
"Malaria",
"Plasmodium Falciparum"
],
"interventions": [
"Biological: P. falciparum infected erythrocytes"
],
"location_countries": [
"Tanzania"
],
"nct_id": "NCT04788862",
"official_title": "Open Label Trial to Establish a Blood-stage Controlled Human Malaria Infection Model and Determine Its Safety in Healthy Tanzanian Adults With Varying Prior Exposure to P. Falciparum",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-02-24",
"study_completion_date(actual)": "2023-02-24",
"study_start_date(actual)": "2022-07-18"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-24",
"last_updated_that_met_qc_criteria": "2021-03-04",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-03-09",
"first_submitted": "2021-02-25",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
In this study, the effects of 6-week telerehabilitation-based Pain Neuroscience Education and exercise training in participants with Non-specific Chronic Neck Pain will be investigated.
Detailed Description
Neck pain is a general health problem that is very common in society and affects daily life activities by causing disability. Non-specific chronic neck pain is defined as 'continuous neck pain that persists for 12 weeks or longer beyond the healing process without any known specific pathology. Chronic pain is considered to be a complex problem in which cognitive and emotional factors, as well as biological factors, significantly affect the perception of pain. In the last decade, a patient education model that educates people about the neurobiology and neurophysiology of pain has been recognized as an intriguing approach to the management of chronic pain. Pain Neuroscience Education (PNE) is a patient education approach that explains in detail the neurobiology, neurophysiology of pain, and the processing of pain by the nervous system in the management of chronic pain. In the literature, there is evidence supporting the use of PNE in reducing pain and disability and overcoming the psychosocial factors of chronic pain.
While the Covid-19 pandemic has made telerehabilitation applications widespread, it has also shown us its necessity, but until now, no study in which Pain Neuroscience Education was carried out with the telerehabilitation method has been found in the literature.
This study aimed to perform Pain Neuroscience Education with the telerehabilitation method on patients with non-specific chronic neck pain and to examine the effects on pain-related factors, disability, and quality of life.
It has been shown that the long-term results of the use of PNE in addition to physiotherapy are more effective in reducing pain and disability. It has been reported that progressive submaximal exercise program including cervicothoracic strengthening, endurance, flexibility, and coordination exercises has positive effects on chronic neck pain, related disability, quality of life and mood. In this study, in addition to telerehabilitation-based PNE, progressive submaximal exercise program will also be given to the participants through telerehabilitation.
#Intervention
- OTHER : Pain Neuroscience Education
- Pain Neuroscience Education (PNE) is a patient education approach that explains in detail the neurobiology, neurophysiology of pain, and the processing of pain by the nervous system in the management of chronic pain.
- OTHER : Progressive submaximal exercise program
- It has been shown that the long-term results of the use of PNE in addition to physiotherapy are more effective in reducing pain and disability. It has been reported that progressive submaximal exercise program including cervicothoracic strengthening, endurance, flexibility, and coordination exercises has positive effects on chronic neck pain, related disability, quality of life and mood. | #Eligibility Criteria:
Inclusion Criteria:
* Being between the ages of 18 <= age <= 55
* History of neck pain lasting at least three months
* Agreeing to participate in the study
* Being able to read and write Turkish
* Having a computer or tablet and an active internet connection at home
* To be able to use a computer, tablet and internet at a level to participate in video conference or to have a relative who can help in this regard.
Exclusion Criteria:
* History of spinal surgery
* Traumatic cervical injuries
* Serious comorbidities (neurological, neuromuscular, cardiological, psychiatric)
* Tumor conditions
* Having vision and hearing problems
* Cognitive problems
* Receiving physiotherapy for neck and/or low back pain in the last 6 months
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT05249517 | {
"brief_title": "Telerehabilitation Based Pain Neuroscience Education on Patients With Non-specific Chronic Neck Pain",
"conditions": [
"Neck Pain"
],
"interventions": [
"Other: Progressive submaximal exercise program",
"Other: Pain Neuroscience Education"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05249517",
"official_title": "Telerehabilitation Based Pain Neuroscience Education on Patients With Non-specific Chronic Neck Pain: A Double-Blinded Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-09-08",
"study_completion_date(actual)": "2022-12-08",
"study_start_date(actual)": "2022-02-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-02-15",
"last_updated_that_met_qc_criteria": "2022-02-10",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-02-21",
"first_submitted": "2022-01-12",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to evaluate whether early life natural exposure to fatty acid affects the AD risk.
Detailed Description
The prevalence of Allergic Diseases (AD) is rising dramatically worldwide especially in more industrialized countries during the past two decades, representing a substantial disease burden of individuals and health service cost. Early life nutritional exposures could modify the gene expression and susceptibility of allergic diseases (AD), yet the effects of early life polyunsaturated fatty acids (PUFA) and ruminant trans fatty acids (R-TFA) on AD remain unclear.Therefore,the investigators performed the meta-analysis and systematic review to evaluate whether early life natural exposure to PUFA and R-TFA affects the AD risk.
#Intervention
- OTHER : PUFA and R-TFA
- PUFA and R-TFA exposure were assessed mainly from maternal dietary, blood sample or breast milk. Exposure period was restricted to early life. Dietary PUFA and R-TFA were measured by food-frequency questionnaire (FFQ) or diet history questionnaire (DHQ). The profile of PUFA and R-TFA in the blood sample and breast milk were examined by using gas chromatography | #Eligibility Criteria:
Inclusion Criteria:
* Studies needed to provide endpoints of AD, and risk estimates [odds risk (OR), relative risk (RR) or hazard ratio (HR)] for PUFA or R-TFA as the exposure. We included English language articles only, while scanned titles /abstracts of non-English language articles to evaluate agreement with the results published in English.
Exclusion Criteria:
* Studies were excluded if they didn't report the profile of PUFA or R-TFA, or if they targeted participants with medical condition.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT03344783 | {
"brief_title": "The Effects of Early Life PUFA and R-TFA on AD: A Systematic Review and Meta-analysis",
"conditions": [
"Allergic Disorder"
],
"interventions": [
"Other: PUFA and R-TFA"
],
"location_countries": [
"China"
],
"nct_id": "NCT03344783",
"official_title": "The Effects of Early Life Polyunsaturated Fatty Acids and Ruminant Trans Fatty Acids on Allergic Diseases: A Systematic Review and Meta-analysis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-06-20",
"study_completion_date(actual)": "2017-10-10",
"study_start_date(actual)": "2017-03-15"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-11-17",
"last_updated_that_met_qc_criteria": "2017-11-13",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-17",
"first_submitted": "2017-11-07",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
H7N9 viruses have caused a recent outbreak of severe illness in humans in China. The purpose of this study is to evaluate the safety and immune response of an H7N9 A/Anhui/13 ca influenza virus vaccine followed by an inactivated subvirion H7N9 vaccine at varying intervals.
Detailed Description
H7N9 avian influenza (AI) viruses have been responsible for a recent outbreak of illness in humans in China, which was associated with severe respiratory illnesses resulting in acute respiratory distress syndrome (ARDS) and intensive care unit (ICU) admissions. The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a live attenuated H7N9 A/Anhui/13 cold adapted (ca) influenza virus vaccine followed by a boost with an inactivated subvirion H7N9 vaccine at varying intervals.
This study will enroll participants into five cohorts. Participants in Cohorts 1, 2, 3, and 4 will be admitted to an isolation unit on Study Day -2. On Study Day 0, participants will receive one dose of the H7N9 A/Anhui/13 ca influenza virus vaccine via a nose spray device. While in the isolation unit, participants will undergo a physical examination and nasal wash each day, and a blood collection on select days. Participants will remain in the isolation unit for at least 9 days after receiving the vaccine, but possibly longer, depending on their test results.
Participants in Cohorts 1 and 2 will return to the isolation unit 4 to 8 weeks after receiving the first vaccine (at approximately Day 28). They will receive the second dose of the H7N9 A/Anhui/13 ca influenza virus vaccine and repeat all of the same procedures that occurred after the first vaccination.
Participants will then receive one dose of the inactivated subvirion H7N9 vaccine 1 month (Cohort 1) or 2 months (Cohort 2) after receiving the second vaccine.
Participants in Cohorts 3 and 4 will receive the inactivated subvirion H7N9 vaccine either 1 month (Cohort 4) or 2 months (Cohort 3) after receiving one dose of the live attenuated vaccine. For Cohorts 1-4, participants study visits will occur 7, 14, 28, and 90 days after receiving the vaccine and will include a medical history review, physical examination, and blood collection at select visits.
Participants in Cohort 5 will receive one dose of the inactivated subvirion H7N9 vaccine at Day 0 and one dose at Day 28. Study visits will occur on Days 0, 7, 28, 35, 42, 56, and 118, and will include blood collections and physical examinations. Participants in Cohort 5 will not be admitted to the isolation unit.
#Intervention
- BIOLOGICAL : H7N9 A/Anhui/13 ca influenza virus vaccine
- Participants will receive approximately 10\^7.0 fluorescent focus units (FFU) of the vaccine; the vaccine will be administered with a nose spray device.
- BIOLOGICAL : Inactivated subvirion H7N9 vaccine
- Participants will receive a dose of 30 mcg of the vaccine; the vaccine will be administered as an injection. | #Eligibility Criteria:
Inclusion Criteria:
* Adult males and non-pregnant females between 18 years and 49 years, inclusive. Children will not be recruited or enrolled in this study because they are not in the apparent risk group, for safety considerations, and because of the need for isolation.
* General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
* Agree to storage of blood specimens for future research
* Available for the duration of the trial
* Willingness to participate in the study as evidenced by signing the informed consent document
* Female participants of childbearing potential must agree to use effective birth control methods for the duration of the study (for example, pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; intrauterine device; abstinence from heterosexual intercourse; surgical sterilization). All female participants will be considered being of childbearing potential except those who have undergone hysterectomy and those in whom menopause occurred at least 1 year prior to the study.
Exclusion Criteria:
* Pregnancy, as determined by a positive human choriogonadotropin (beta-HCG) test
* Currently breastfeeding
* Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urine testing
* Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
* Previous enrollment in an H7 influenza vaccine trial or in any study of an avian influenza vaccine
* Seropositive to the H7N9 influenza A virus (serum HAI titer greater than 1:8)
* Positive urine drug toxicology test indicating narcotic use/dependency
* Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
* Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
* History of anaphylaxis
* Allergy to oseltamivir as determined by participant report
* Current diagnosis of asthma or reactive airway disease (within the past 2 years)
* History of Guillain-Barré Syndrome
* Positive enzyme-linked immunosorbent assay (ELISA) and confirmatory test (e.g., Western blot or HIV-1/HIV-2 differentiation assay) for human immunodeficiency virus-1 (HIV-1)
* Positive ELISA and confirmatory test (e.g., recombinant immunoblot assay) for hepatitis C virus (HCV)
* Positive hepatitis B virus surface antigen (HBsAg) by ELISA
* Known immunodeficiency syndrome
* Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination
* Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study vaccination
* History of asplenia
* Body mass index (BMI) greater than 40
* Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination
* Current smoker unwilling to stop smoking for the duration of the study. More information on this criterion is available in the protocol.
* Travel to the Southern Hemisphere within 14 days prior to study vaccination
* Travel on a cruise ship within 14 days prior to study vaccination
* Receipt of another investigational vaccine or drug within 30 days prior to study vaccination
* History of hypersensitivity to any component of the investigational product including egg or egg protein, or serious, life threatening, or severe reactions to previous influenza vaccinations
* Individuals who use intranasal medications chronically
* Receipt of antiviral therapy or antiviral agents within 48 hours prior to receipt of investigational product
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 49 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT02151344 | {
"brief_title": "Evaluating the Safety and Immune Response to a Live H7N9 Influenza Virus Vaccine Followed by an Inactivated H7N9 Influenza Virus Vaccine, Given at Varying Intervals",
"conditions": [
"Influenza A Virus, H7N9 Subtype"
],
"interventions": [
"Biological: Inactivated subvirion H7N9 vaccine",
"Biological: H7N9 A/Anhui/13 ca influenza virus vaccine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02151344",
"official_title": "Phase 1 Evaluation of the Optimal Interval Between Priming With a Live Influenza A Vaccine H7N9 (6-2) AA ca Recombinant (A/Anhui/1/2013 (H7N9) x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H7N9 Disease Followed by Boost With a Non-adjuvanted Inactivated H7N9 Influenza Vaccine",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-02",
"study_completion_date(actual)": "2015-02",
"study_start_date(actual)": "2014-05"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-03-30",
"last_updated_that_met_qc_criteria": "2014-05-28",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-05-30",
"first_submitted": "2014-05-28",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Coronavirus 2019 (COVID-19) infection is associated with higher morbidity and mortality in adult patients on dialysis, and kidney transplant recipients (KTRs). Although children had lower morbidity and mortality, KTRs are more vulnerable than healthy children.
It has already known that the general immune responses to vaccines, which are currently in practice (attenuated, conjugated, or recombinant) were lower than healthy controls in children and adolescents on dialysis and with a kidney transplantation. Uremic milieu and immunosuppressive drugs are the factors causing impaired immune response in this group of patients. The new mRNA vaccine technology is used worldwide including children and adolescents during the pandemic. Studies have demonstrated lower immune response to new SARS-CoV-2 mRNA vaccine in adult KTRs. However, there is limited data about vaccine-induced immune response in children and adolescent with renal replacement therapy.
The aim of this study was to assess immune response to SARS-CoV-2 mRNA BNT162b2 and its clinical and laboratory correlates in children and adolescent KTRs. Humoral immune response was assessed by anti-SARS-CoV-2 immunoglobulin G (Anti-S IgG) and its clinical correlate neutralizing antibody (nAb). Cellular immune response was assessed with SARS-CoV-2 specific Interferon ɣ release assay (IGRA).
Detailed Description
This is a prospective, multicenter case-control study performed between September 2021 and March 2022 in the Pediatric Nephrology Units of IU- Cerrahpaşa School of Medicine, Memorial Hospital, Marmara University School of Medicine, IU- Istanbul School of Medicine, Medeniyet University School of Medicine, and Istinye University School of Medicine. The control group has consisted of age and gender comparable 19 healthy children without any acute infection or chronic disease, who were admitted to Cerrahpasa School of Medicine, Pediatric out-patient unit for routine control.
When permitted by local guidelines, children and adolescents who were over 12 years old were notified of vaccine eligibility and encouraged to schedule an appointment. The SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®) administered to all participants by intramuscular route in the deltoid region. At least one month after the second dose of the vaccine, serum samples and whole blood samples were collected from all patients and controls, to analyze the humoral and cellular immune response to the vaccine. All samples were stored at -20 ◦C until testing. SARS-CoV-2 PCR test results were recorded retrospectively to determine natural infection.
#Intervention
- BIOLOGICAL : SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®)
- When permitted by local guidelines, children and adolescents who were over 12 years old were notified of vaccine eligibility and encouraged to schedule an appointment | #Eligibility Criteria:
Inclusion Criteria:
* 12 <= age <= 21 year-old chronic kidney diseases and dialysis patients
Exclusion Criteria:
* Patients with primary immune deficiencies and not vaccinated with SARS-CoV-2 mRNA BNT162b2 vaccine
* Patients who did not completed 2 series of SARS-CoV-2 mRNA BNT162b2 vaccine
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT05465863 | {
"brief_title": "Humoral and Cellular İmmune Response to SARS-CoV-2 mRNA BNT162b2 Vaccine in Children With Chronic Kidney Diseases",
"conditions": [
"Chronic Kidney Disease 5D",
"Chronic Kidney Disease 5T"
],
"interventions": [
"Biological: SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®)"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05465863",
"official_title": "Humoral and Cellular İmmune Response to SARS-CoV-2 mRNA BNT162b2 Vaccine in Pediatric Kidney Transplant Recipients Compared to Dialysis Patients and Healthy Children",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-02-01",
"study_completion_date(actual)": "2022-03-01",
"study_start_date(actual)": "2021-09-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-07-20",
"last_updated_that_met_qc_criteria": "2022-07-19",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-07-20",
"first_submitted": "2022-07-19",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This pilot study will evaluate home vision testing using a mobile medical application in participants with diabetic macular edema (DME) or neovascular age-related macula degeneration (nAMD) who receive intravitreal ranibizumab therapy. In the main, decentralized study, participants will be recruited via digital media, advocacy groups, or through their own ophthalmologist. The traditional substudy will evaluate the association between visual acuity and anatomical markers of disease status determined using clinical 'gold standard' assessments (certified Early Treatment Diabetic Retinopathy Study \[ETDRS\] protocol visual acuity and macula optical coherence tomography \[OCT\]) and the results of home vision testing using the myVisionTrack\^TM (mVT) application.
#Intervention
- OTHER : Ranibizumab
- Ranibizumab administered as part of standard-of-care | #Eligibility Criteria:
Inclusion Criteria:
* DME or active nAMD in at least one eye
* Current treatment with intravitreal ranibizumab therapy, with evaluations planned every 4 to 8 weeks
* Access to an approved mobile device with a data plan or WiFi internet access
Exclusion Criteria:
* Any other eye condition causing eye disease that limits vision and cannot be corrected, other than DME or nAMD
* Dementia or other neurologic or psychological limitation that would prevent the participant from performing regular self-testing of visual function
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02420132 | {
"brief_title": "Study to Evaluate Home Vision Testing in Participants Who Receive Ranibizumab (Lucentis®)",
"conditions": [
"Macular Edema",
"Macular Degeneration"
],
"interventions": [
"Other: Ranibizumab"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02420132",
"official_title": "Decentralized Pilot Study to Evaluate MyVisionTrack^TM Home Vision Testing in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration Currently Receiving Intravitreal Lucentis® Therapy.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-08-25",
"study_completion_date(actual)": "2016-08-25",
"study_start_date(actual)": "2015-04-20"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-06-10",
"last_updated_that_met_qc_criteria": "2015-04-14",
"last_verified": "2019-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-04-17",
"first_submitted": "2015-04-14",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
To assess the long-term safety and effectiveness of Nephoxil® for the treatment of hyperphosphatemia in patients with ESRD undergoing dialysis.
Detailed Description
This study is an open-label, prospective, long term, Phase IV study to assess the safety and efficacy of Nephoxil® in subjects with ESRD on dialysis.
#Intervention
- DRUG : Ferric Citrate
- Ferric citrate will be provided as a 500mg capsule. All intervention doses will be based on serum phosphorus levels.
- Other Names :
- Nephoxil® Capsules | #Eligibility Criteria:
Inclusion Criteria:
* Is ≧ 18 years on the day of signing informed consent or other age required by local regulation
* Willing and able to provide written informed consent
* ESRD patients who is undergoing hemodialysis 3 times per week and is considered necessary to receive medication for hyperphosphatemia by his/her treating physician
* Serum ferritin <1000 ng/mL and transferrin saturation (TSAT) < 50% at the Enrollment Visit
* Women of child-bearing potential (WOCBP [defined as women <= 50 years with a history of amenorrhea for < 12 months prior to study entry]) who is willing to use an effective form of contraception during study participation
Exclusion Criteria:
* Has any known contraindication to ferric citrate according to locally approved prescribing information, include but not limited to the following criteria:
i. Is allergic to ferric citrate ii. Has hypophosphatemia iii. Has hemochromatosis or iron overload syndromes iv. Has active severe GI disorders
* Has parathyroidectomy (PTx) or percutaneous ethanol injection therapy (PEIT) within 3 months prior to Enrollment Visit or serum calcium < 7 mg/dL at the Enrollment Visit
* Has participated in another interventional study for any investigational agent or device within 30 days prior to enrollment
* Is currently pregnant or breastfeeding
* Other unstable medical condition or psychiatric conditions that is considered unsuitable for this study per Investigator's clinical judgment
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03256838 | {
"brief_title": "Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis",
"conditions": [
"Kidney Failure, Chronic",
"End-stage Renal Disease",
"Phosphorus Metabolism Disorders",
"Hyperphosphatemia"
],
"interventions": [
"Drug: Ferric Citrate"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT03256838",
"official_title": "A Long-Term, Open-Label, Prospective Phase IV Study to Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12-31",
"study_completion_date(actual)": "2019-05-31",
"study_start_date(actual)": "2017-04-12"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-13",
"last_updated_that_met_qc_criteria": "2017-08-20",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-22",
"first_submitted": "2017-07-24",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Cardiovascular (CV) disease is the leading cause of death in Canada. Fifty percent of all Tc-99m used in nuclear medicine is for the diagnosis of coronary artery disease (CAD) with SPECT myocardial perfusion imaging (MPI). The reduced supply of Tc-99m requires other tracers to be investigated. Tl-201 SPECT is available but generally accepted to be inferior to Tc-99m. Rubidium (Rb-82), a nonreactor produced tracer, is believed to have superior accuracy compared to Tc-99m and Tl-201 SPECT, with 5-20 times lower radiation dose. In the U.S. Rb-82 generators have been FDA-approved since 1989 and are used increasingly for CAD diagnosis, but are still considered investigational in Canada.
Objectives: To demonstrate that Rb-82 PET MPI is i) an accurate, cost-effective alternative to Tc-99m; ii) superior to Tl-201; iii) can be implemented in multiple Canadian centres for the diagnosis and management of CAD. Short term clinical outcomes of Rb-82 will be evaluated and compared to Tc-99m and Tl-201 SPECT MPI across Canadian imaging centres.
Plan: Rb-ARMI is an innovative multidisciplinary, multi-centre imaging research initiative that builds on existing collaborative networks and Canadian industry partnership (DRAXIMAGE). Rb PET will be implemented, standardized and validated in 4 overlapping phases over 2 years, at 10 Canadian Centres.
Impact: This project meets the expected goal to 'lead to clinical trial applications and clinical validation studies which compare novel radiolabeled probes with those in current practice', and to 'bring a new radiopharmaceutical to the clinic' within a short time frame. Increased use of Rb-82 PET MPI has the potential to reduce the demand for Tc-99m by 10-40%, effectively increasing the available supply for other procedures, and improving the standard of care for many Canadians at risk of heart disease.
Detailed Description
Rationale: Cardiovascular (CV) disease is the leading cause of death in Canada. Half of all the Tc-99m used in nuclear medicine is for the diagnosis of coronary artery disease (CAD) with SPECT myocardial perfusion imaging (MPI). The reduced supply of Tc-99m requires other tracers to be investigated. While Tl-201 SPECT is available, it is generally accepted to be inferior to the Tc-99m tracers; low specificity may prompt further testing and increase costs. Rubidium (Rb-82) PET MPI is believed to have superior accuracy compared to Tc-99m and Tl-201, and 5-20 times lower radiation dose. Rb-82 is produced in a generator from the cyclotron-produced (non-reactor) parent isotope Sr-82. In the U.S. Rb-82 generators have been FDA-approved since 1989. Rb-82 PET MPI has been reimbursed in the U.S. since 1995 and is used increasingly for CAD diagnosis, but is still considered investigational in Canada.
Objectives: Primary: To demonstrate that Rb-82 PET MPI is i) an accurate alternative to Tc-99m SPECT;ii) is superior to Tl-201; iii) can be implemented in multiple Canadian centres for diagnosis and management of CAD. Secondary: To evaluate short-term clinical outcomes and cost-effectiveness of Rb-82 PET MPI for diagnosis and management of CAD compared i) to Tc-99m and Tl-201 MPI and ii) across imaging centres.
Hypotheses: 1: Rubidium MPI can be standardized with highly repeatable interpretation across multiple Canadian centres, using current 3D PET and 3D PET/CT imaging technology.
2-A: Rubidium PET MPI has superior accuracy compared to Tl-201 SPECT MPI, using invasive coronary angiography (ICA) as the gold-standard for diagnosis of CAD. (reference centre A - Ottawa) 2-B: Rubidium PET MPI has comparable accuracy to Tc-99m SPECT MPI. (reference centre B - Quebec) 3: Rubidium PET MPI has similar (non-inferior) accuracy across additional Canadian imaging centres compared to the primary imaging centres 4-A: Rubidium PET MPI is cost-effective compared to Tc-99m and Tl-201 SPECT MPI in the diagnosis and management of CAD, in terms of tracer costs and down-stream resource utilization such as ICA.
4-B: Rubidium PET MPI improves short-term clinical outcomes measured at 6 months, compared to Tc-99m or Tl-201 SPECT MPI in the management of CAD, in terms of adverse cardiac events including cardiac death, nonfatal MI, late revascularization and cardiac hospitalization. 4-C: Site-specific attributes will impact resource utilization and local Rb-82 PET costs.
Research Plan: Rb-ARMI is an innovative multidisciplinary, multi-centre imaging research initiative that builds on existing collaborative networks (ICT, IMAGE-HF, CAIN, CADRE) and Canadian industry partnership (DRAXIMAGE). Rb-82 PET will be implemented, standardized and validated in 4 overlapping phases over 2 years, in up to 10 centres across Canada, including Ottawa, Quebec City, Montreal, Sherbrooke, Toronto, Hamilton, London, Thunder Bay, Halifax, and Edmonton.
Phase 1 is a knowledge translation and standardization phase (0-6 months). Qualifying scans using cardiac phantoms will be performed to standardize imaging protocols across centres. Site training and co-reading of an initial series of scans from each centre will be performed by the reference site (Ottawa), to confirm low inter-operator variability (≤5%) in interpretation (sum stress score and sum difference score).
Phase 2 is a matched-cohort comparative accuracy study (months 3-20). In the reference centres, pre-test likelihood ± extent of CAD will be assessed in patients referred for assessment of ischemia (N=200) undergoing dipyridamole Rb-82 PET MPI and coronary angiography (ICA) within 6 months. These patients will be used to identify a matched group undergoing Tl-201 SPECT to compare accuracy in 2A. A similar study will be performed to compare Rb-82 PET with Tc-99m SPECT MPI in centre B (the site most ready to start Rb-82 PET MPI) using the same propensity-matched cohort design in 2B. All 800 angiography studies (+600 in phase 3) will be co-read by the core lab in Montreal.
Phase 3 tests whether the implementation of Rb-82 PET across the additional imaging centres in Canada can achieve comparable accuracy, again using ICA as the gold-standard in N=600 patients (months 4-20).
Phase 4 is a cost-effectiveness study to evaluate short-term resource utilization (RU), cost and outcomes at 6-month follow-up for: Rb-82 PET vs SPECT MPI (centres A and B) in 4A and 4B (N=1000); Rb-82 PET in additional Canadian sites vs the primary centres in 4C (N=1000). RU will be measured during follow up and unit costs estimated. Analysis will estimate incremental costs associated with each of the outcomes within the composite endpoint, as well as costs associated specifically with the imaging and subsequent diagnostic tests. Cost-effectiveness analysis will be undertaken in accordance with Canadian guidelines for economic evaluations. Database review, follow-up completion, data analysis and manuscript preparation will be completed in the final 6 months of the study.
Impact: The project meets the expected goal of the RFA to 'lead to clinical trial applications and clinical validation studies which compare novel radiolabeled probes with those in current practice', and to 'bring a new radiopharmaceutical to the clinic' within a short time frame. Increased use of Rb-82 PET MPI has the potential to reduce the demand for Tc-99m by 10-40%, effectively increasing the available supply for other procedures, and improving the standard of care for many Canadians at risk of heart disease.
#Intervention
- OTHER : Myocardial perfusion imaging using Rb-82 PET or Tc-99m or Tl SPECT
- Patients will undergo a clinically indicated PET Rb-82 myocardial perfusion scan for diagnosis or risk stratification of CAD. This cohort will be matched to the SPECT perfusion database. | #Eligibility Criteria:
Inclusion Criteria:
* patients referred for myocardial perfusion imaging for diagnosis and/or risk stratification for CAD
* male or female
* 18 years or older
* having given informed consent
Exclusion Criteria:
* contraindications to dipyridamole radionuclide imaging including
* severe reactive airway disease
* <3 days post MI/acute coronary syndrome (ACS) presentation
* unstable crescendo angina
* high grade atrio-ventricular (AV) block
* allergy to dipyridamole or theophyllines
* caffeine within 24 hours
* theophyllines within 48 hours
* severe claustrophobia
* patients who may be pregnant
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01128023 | {
"brief_title": "Rubidium-82 - An Alternative Radiopharmaceutical for Myocardial Imaging(Rb-ARMI)",
"conditions": [
"Coronary Artery Disease"
],
"interventions": [
"Other: Myocardial perfusion imaging using Rb-82 PET or Tc-99m or Tl SPECT"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT01128023",
"official_title": "Rubidium-82 - An Alternative Radiopharmaceutical for Myocardial Imaging(Rb-ARMI)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12-31",
"study_completion_date(actual)": "2018-12-31",
"study_start_date(actual)": "2010-04"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-11-21",
"last_updated_that_met_qc_criteria": "2010-05-19",
"last_verified": "2019-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-05-21",
"first_submitted": "2010-05-05",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to determine if patients are able to self-rate their physical abilities and how these ratings compare to the ratings of their health-care provider.
Detailed Description
The Karnofsky Performance Scale (KPS) is a highly validated and essential measuring tool across the cancer population. The scale relates to purely physical ability and covers 11 stages, ranging from normal health to death, with each stage scored as a percentage. The score is determined by the health-care provider and is based on observation and narrative patient descriptions. The purpose of this study is to compare the scores rated by the health-care provider to the scores that patients assign to themselves.
#Intervention
- OTHER : Karnofsky Performance Status Score
- Karnofsky Performance Status scores will be independently completed by both the patient and their health-care provider at each routine clinic visit.
- Other Names :
- Performance Status Scale | #Eligibility Criteria:
Inclusion Criteria:
* Patients with a diagnosis of brain or spinal tumor.
* Receiving medical care under the supervision of the Principal Investigator.
* Written informed consent.
Exclusion Criteria:
None.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00735111 | {
"brief_title": "Do Self-Rated Performance Status Scores Correlate With Health-Care-Provider-Scores?",
"conditions": [
"Cancer"
],
"interventions": [
"Other: Karnofsky Performance Status Score"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00735111",
"official_title": "Do Self-Rated Karnofsky Performance Status (KPS) Scores Correlate With Health-Care-Provider-Rated Scores?",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-11",
"study_completion_date(actual)": "2011-11",
"study_start_date(actual)": "2008-02"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-01-17",
"last_updated_that_met_qc_criteria": "2008-08-13",
"last_verified": "2013-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-08-14",
"first_submitted": "2008-08-13",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study aims at investigating handwashing behavior during COVID-19 pandemic. It was hypothesized that social-cognitive and emotional predictors as well as COVID-19 morbidity and mortality rates within the country would be associated with handwashing behavior in the general population of adults in 14 countries.
Detailed Description
This observational study aims at testing the adherence to handwashing guidelines (the World Health Organization, WHO, 2020) at two measurement points, spanning 1 month. Adults from the general population in 14 countries (Poland, Australia, Canada, China, France, Gambia, Germany, Israel, Italy, Malaysia, Portugal, Romania, Singapore, Switzerland) will provide self-report data on handwashing behavior and its social-cognitive predictors (perceived effectiveness of handwashing, risk perception, outcome expectancy, self-efficacy, intention, planning, and action control), anxiety, as well as COVID-19 morbidity and mortality rates within the country.
#Intervention
- OTHER : No intervention
- Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country | #Eligibility Criteria:
Inclusion Criteria:
* adults (from general population) who provided informed consent to participate
Exclusion Criteria:
* younger than <18 years
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT04367337 | {
"brief_title": "Health Behavior Change During COVID-19 Pandemic",
"conditions": [
"Health Behavior"
],
"interventions": [
"Other: No intervention"
],
"location_countries": [
"France",
"Israel",
"Gambia",
"China",
"Poland",
"Germany",
"Portugal",
"Singapore",
"Romania",
"Canada",
"Malaysia",
"Australia",
"Switzerland",
"Italy"
],
"nct_id": "NCT04367337",
"official_title": "Health Behavior Change During COVID-19 Pandemic: the Focus on Handwashing",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-09-24",
"study_completion_date(actual)": "2020-09-24",
"study_start_date(actual)": "2020-03-25"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-08-10",
"last_updated_that_met_qc_criteria": "2020-04-28",
"last_verified": "2020-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-04-29",
"first_submitted": "2020-04-28",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Investigational drug AMG 714 will be given to 66 subjects with moderate to severe psoriasis to study safety, pharmacokinetics, and efficacy. Dose levels include 150mg and 300mg and will be given to each subject for a total of 6 doses. Each dose for each subject will be given once every 2 weeks. Subjects will followed for up to 300 days post the first dose of AMG 714.
#Intervention
- DRUG : AMG 714
- Dosing Regimen is 6 Doses over 3 Months | #Eligibility Criteria:
Inclusion Criteria:
* Active but clinically stable, plaque psoriasis.
* Psoriasis involving greater than or equal to 10% of the body surface area
* A minimum PASI score of 10 obtained during the screening period.
* Received at least one previous phototherapy or systemic psoriasis therapy or have been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
* At least 18 years.
* Heterosexually active men and women must be willing to practice an effective method of contraception (as outlined in section 6.7) as determined by the investigator and sponsor for the duration of the study. This includes any washout period and the follow-up period.
* ALT and AST less than or equal to 2 x the upper limit of normal; hemoglobin greater than or equal to 10 g/dL (greater than or equal to 100 g/L in SI units); platelet count greater than or equal to 125,000 mm3 (greater than or equal to 125 x109/L in SI units); white blood cell count greater than or equal to 3,500 cells/mm3 (greater than or equal to 3.5 x109/L in SI units); serum creatinine less than or equal to 2 mg/dL (less than or equal to 177 μmol/L in SI units).
* Negative for HIV antibodies, hepatitis B surface antigen, and hepatitis C antibodies.
* Capable of understanding and giving written, voluntary informed consent before study screening.
Exclusion Criteria:
* Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
* Evidence of skin conditions (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis.
* Clinically significant adverse event, infection, or laboratory toxicity, at the time of the screening visit or between the screening visit and study drug initiation that in the opinion of Amgen or the Investigator would preclude participation in the study.
* Clinically significant infection less than or equal to 30 days before the screening visit that in the opinion of Amgen or the Investigator would preclude participation in the study.
* Known positive tuberculin skin test (if not treated with appropriate chemoprophylaxis) or recent (within 6 months) exposure to a patient with active tuberculosis.
* Any other known infectious process that would, in the investigator's discretion, interfere with the subject's ability to participate in the study.
* Significant concurrent medical conditions at the time of screening, including:
* Uncontrolled hypertension (defined as screening systolic blood pressure measurement of greater than 160 mm Hg or a screening diastolic blood pressure of greater than 100 mm Hg) confirmed by 2 separate measurements during the screening visit
* Myocardial infarction less than or equal to 52 weeks before the screening visit
* Unstable angina pectoris
* Congestive heart failure
* Steroid or oxygen dependent chronic obstructive pulmonary disease
* Diagnosis of multiple sclerosis or any other demyelinating disease
* Inadequately controlled diabetes mellitus, defined by glycohemoglobin greater than 7.0 at screening
* History of cancer (other than resected and surgically cured cervical cancer, cutaneous basal cell, squamous cell carcinoma) less than or equal to 5 years before the administration of first dose of investigational product
* Open cutaneous ulcers
* Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject.
* Any evidence during screening of cutaneous basal or squamous cell carcinoma, or melanoma.
* Current or history of psychiatric disease that would interfere with the ability to comply with the study protocol or give informed consent.
* History of alcohol or drug abuse that would interfere with the ability to comply with the study protocol.
* Previous receipt of etanercept or any other anti-TNF agent(s), alefacept, efalizumab, or other investigational biologic agent for psoriasis.
* Receipt of any investigational product(s) less than or equal to 30 days before the first dose of investigational product in this study.
* PUVA therapy less than or equal to 30 days before the first dose of investigational product.
* UVA therapy less than or equal to 14 days before the first dose of investigational product.
* UVB therapy less than or equal to 30 days before the first dose of investigational product.
* Receipt of any other systemic psoriasis therapy or oral or parenteral corticosteroids less than or equal to 14 days before the first dose of investigational product.
* Topical steroids, topical vitamin A or D analog preparations or anthralin less than or equal to 14 days before the first dose of investigational product (exception - topical steroids at no higher than moderate strength, according to the package insert, are permitted on the scalp, axillae, and groin).
* Topical cyclosporin or calcineurin inhibitors such as pimecrolimus (Elidel) and tacrolimus (Protopic) less than or equal to 14 days before the first dose of investigational product.
* Intravenous or oral calcineurin inhibitors such as tacrolimus (Prograf) less than or equal to 30 days before the first dose of investigational product.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00443326 | {
"brief_title": "AMG 714 20060349 Multiple Dose Study in Moderate to Severe Psoriasis Subjects",
"conditions": [
"Psoriasis"
],
"interventions": [
"Drug: AMG 714"
],
"location_countries": null,
"nct_id": "NCT00443326",
"official_title": "A Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of AMG 714 After Multiple Dose Administration in Subjects With Moderate to Severe Psoriasis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-12",
"study_completion_date(actual)": "2010-05",
"study_start_date(actual)": "2007-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-01-20",
"last_updated_that_met_qc_criteria": "2007-03-01",
"last_verified": "2015-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-03-05",
"first_submitted": "2007-03-01",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
An important cognitive bias in many emotional disorders, particularly obsessive-compulsive disorder (OCD), is thought-action fusion (TAF). TAF describes the bias to interpret the presence of unwanted mental intrusions as morally equivalent to acting on them (TAF-M), and/or increasing the likelihood of the feared consequence occurring to either oneself (TAF-LS) or others (TAF-LO). The present study is designed to test the feasibility of a single session computerized cognitive bias modification for interpretations (CBM-I) to reduce TAF among individuals who reported obsessional intrusions. Participants will be randomized to (a) the TAF-incongruent condition (TAF-INC), designed to decrease TAF linked to obsessional thoughts, to (b) the TAF-congruent condition (TAF-CON), designed to render TAF-like interpretation of obsessional thoughts unchallenged, or to (c) a Stress Management Psychoeducation (SMP) condition, designed to provide information about stress reduction, but not target TAF directly.
Detailed Description
Individuals who display at least mild obsessional and TAF symptoms will be invited to the current study. Participants will be randomized to one of the three interpretation training conditions: an TAF-INC, TAF-CON, or SMP. Before and after the training, participants will complete some self-report questionnaires and clinician administered measures. The computerized training will provide statements intended to activate the mechanisms involved in thought-action-fusion (TAF), which will almost always produce a negative outcome interpretation. It is hypothesized that through TAF-INC participants will learn alternative, more neutral, ways of interpreting the thoughts and lower the subject's TAF. The TAF-CON condition will receive the same statements as TAF-INC, but TAF-CON is designed to leave the interpretation of the scenarios unchallenged. The study will also include another comparison condition, SMP, to test if TAF-INC outperforms not only TAF-CON, but also stress reduction techniques provided in empirically supported psychological treatment. The SMP training will be similar in procedure and structure to the other two conditions, but it will provide psychoeducation about stress and stress management techniques.
#Intervention
- OTHER : Cognitive Bias Modification
- There is support that CBM-I may work through the process of cognitive restructuring, and specifically, threat reappraisal. Threat appraisal is a tendency to overestimate the likelihood of harm (i.e., likelihood bias) and/or the negative consequences of anticipated harm (i.e., Clark \& Beck, 2010), producing avoidance, thus interfering with effectively reappraising threat, thereby creating a vicious cycle (Beck et al., 1985; Clark \& Beck, 2010). CBM-I procedures ensure that an interpretation bias is triggered by the ambiguous scenarios, and participants are then guided to solve the key word in accordance with a healthy response (Grey \& Mathews, 2000). The observed effects of CBM-I may stem from active generation of benign or positive meanings in response to ambiguous situations, where threats were previously interpreted (Beadel et al., 2014).
- Other Names :
- Interpretation Training | #Eligibility Criteria:
Inclusion Criteria:
* UWM undergraduates who were at least 18 years who (i) score of at least 1 [A Little (Distressed or Bothered)] on the OCI-R obsessing subscale, and (ii) at least one TAFS item scored 3 (Agree) or 4 (Agree Strongly) were be eligible to participate in the study. A score of 1 or higher on the obsessing subscale of the OCI-R indicates the presence of obsessional intrusions, and was used as a cutoff in previous research (Siwiec et al., 2017). A score of 3 or above on an item of the TAFS indicates the participant agrees with and holds some pronounced TAF bias.
Exclusion Criteria:
* Individuals whose primary language is not English will not be included in the study. Assessment and training programs are all written in English (we are not able to present a version in another language) - it is important for participants to understand subtlety of slightly varying vignettes in the training program.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT03921255 | {
"brief_title": "Cognitive Bias Modification for Thought-Action Fusion",
"conditions": [
"Obsessive-Compulsive Disorder"
],
"interventions": [
"Other: Cognitive Bias Modification"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03921255",
"official_title": "Developing Interpretation Training for Modifying Thought Action Fusion Associated With Obsessive-compulsive Symptoms",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-31",
"study_completion_date(actual)": "2019-12-31",
"study_start_date(actual)": "2016-04-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-01-24",
"last_updated_that_met_qc_criteria": "2019-04-16",
"last_verified": "2022-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-04-19",
"first_submitted": "2019-03-10",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
To compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in Superficial femoropopliteal artery (SFA )and/or Proximal Popliteal Artery in Peripheral Artery Disease (PAD) patients with Rutherford class 2-4.
Detailed Description
This study is a prospective, multi-center 1:1 randomized trial. Patients will be stratified according to lesion length (≤ 10 cm/ \> 10 cm and \< 20 cm / \> 20 cm and ≤ 30 cm). Each strata will include approximately 138 patients.
The trial is to investigate the safety and efficacy of the Ranger™ Drug Coated Balloon in comparison to the IN.PACT™ Drug Coated Balloon in patients with symptomatic femoropopliteal artery disease.
All enrolled subjects will be followed through to 24 months to assess the incidence of restenosis by ultrasound and major adverse events (MAE). Follow-up visits occur at 1, 6, 12 and 24-month intervals per local standard of care. Telephone follow-up visits will occur at 36, 48 and 60 month.
Up to 414 patients will be enrolled at approximately 10-18 sites in Germany for comparison between the following two groups:
Treatment with the Ranger™ Paclitaxel Coated Balloon Catheter (Boston Scientific Corporation, Natick, MA, USA) vs. the IN.PACT™ Drug Eluting Balloon (Medtronic Inc., Minneapolis, MI, USA).
#Intervention
- DEVICE : Ranger Drug Eluting Balloon
- Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries
- DEVICE : In Pact Drug Eluting Balloon
- Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries | #Eligibility Criteria:
Inclusion Criteria:
* Subject age >= 18
* Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing Rutherford category 2 <= age <= 4.
* Subject has a de novo or restenotic lesion with >= 70% stenosis documented angiographically and no prior stent in the target lesion.
* Target lesion length is <= 30cm
* Target lesion is at least 1cm below the origin of the profunda femoris and does not exceed the medial femoral epicondyle.
* Multiple lesions with max. 3cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion. Total lesion length should not exceed 30 cm.
* Reference vessel diameter (RVD) >= 4 mm and <= 6.5 mm by visual estimation.
* Patency of at least one (1) infrapopliteal artery to the ankle (< 50% diameter stenosis) in continuity with the native femoropopliteal artery.
* A guidewire has successfully traversed the target treatment segment.
Exclusion Criteria:
* Failure to successfully cross the target lesion
* Angiographic evidence of severe calcification
* Presence of fresh thrombus in the lesion.
* Presence of aneurysm in the target vessel/s
* Presence of a stent in the target lesion
* Prior vascular surgery of the target lesion.
* Stroke or heart attack within 3 months prior to enrollment
* Any surgical procedure or intervention performed within 30 days prior to or post index procedure
* Superficial femoropopliteal Artery or Proximal popliteal artery disease in the opposite leg that requires treatment at the index procedure
* Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices
* Enrolled in another investigational drug, device or biologic study
* Life expectancy of less than one year
* Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
* Rutherford classification of 0, 1, 5 or 6.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02701543 | {
"brief_title": "Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease",
"conditions": [
"Peripheral Artery Disease"
],
"interventions": [
"Device: In Pact Drug Eluting Balloon",
"Device: Ranger Drug Eluting Balloon"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT02701543",
"official_title": "Prospective, Randomized, Multi-Center Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease With the Ranger Paclitaxel Coated PTA Balloon Catheter (Study Arm) Versus the IN.PACT Drug Eluting Balloon (Control Arm)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10",
"study_completion_date(actual)": "2023-12",
"study_start_date(actual)": "2015-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-12-20",
"last_updated_that_met_qc_criteria": "2016-03-02",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-03-08",
"first_submitted": "2016-01-19",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The aim of this work was to reduce the bleeding risk during thrombolysis using the viscoelastic blood coagulation tests.
Detailed Description
Patient data The patients' age, body measurements, general and coagulation-related medical history, SARS-COV2 status, APACHE-II, frailty score will be recorded.
Sampling times and examinations
The following considerations will be taken into account in the course of examining and providing care to the patients:
Imaging procedures:
CT angiography of the chest To confirm embolism and the results of lysis 12 to 24 hours after it is completed mandatory Echocardiography Right ventricle diameter mandatory views to be recorded: TAPSE mandatory parasternal longitudinal section IVC minimum and maximum diameter mandatory parasternal basal cross-section extent of tricuspid regurgitation mandatory apical 4 chamber estimated APsys mandatory subcostal 4 chamber D sign? mandatory IVC McConnel sign? optional 60/60 sign optional right heart thrombus optional Tricuspid annulus with reduced S' (\<9.5 cm/s) tissue doppler optional Lower limb Doppler ultrasound Search for the origin of thromboembolism, preferably prior to lysis optional Table 2: Summary of the imaging procedures required for the study The condition for enrolment into the study is PE confirmed by CT angiography of the chest, with haemodynamic impact confirmed by echocardiography; the recording of the test in the IMPAX system is also a requirement. To assess the effectiveness of thrombolysis, echocardiography must be repeated after the lysis is completed, and then 12 to 24 hours later; the same is true for long-term follow-up.
Blood analyses:
Laboratory tests blood type + antibody screening mandatory blood count mandatory INR mandatory aPTI mandatory D-dimer mandatory fibrinogen mandatory Troponin T mandatory NT-proBNP mandatory creatinine mandatory urea mandatory electrolytes (Na+; K+; Ca2+ (t/ion); Mg2+; Cl-, phosphate) mandatory liver function (AST, ALT, LDH) mandatory Blood gases pH; pO2; pCO2 mandatory HCO3-; BE mandatory hgb mandatory Na+; K+; Ca2+; Cl- mandatory blood glucose mandatory lactate mandatory
Table 3: Summary of the laboratory and point-of-care blood tests required for the study The above lab parameters are planned to be obtained upon enrolment of a patient. Also, in addition to regular blood gas testing during the treatment, targeted testing for coagulation parameters and factors might be necessary.
Invasive interventions:
Arterial cannulation invasive pressure monitoring; pressurised infusion without heparin! mandatory PVC at least one, but preferably two, minimum G18 mandatory CVC only if vasopressor must be delivered; giving dobutamine to increase inotropy is not in itself an indication for a CVC! optional bladder catheter indication should be considered; if in doubt, should be inserted before the start of lysis optional endotracheal tube only for an indication not associated with pulmonary embolism optional Table 4: Considerations for the invasive interventions required for the study
Study phase and follow-up The study period is expected to last from 1 October 2021 to 31 December 2024. Follow-up (subject to a separate consent from the patients) will take place 1, 3 and 12 months after the thrombolysis and is planned to include quality of life questionnaires (EuroQOL -5D-5L), assessment of physical capacity (6MW, or, if unfeasible, Timed Up\&Go test), echocardiography, ClotPro and blood gas testing.
Methodology and organisation of the study Potential recruits are the patients of Semmelweis University with relevant impact on circulation (high-risk or intermediate to high-risk categories), whose PE is confirmed by CT angiography of the chest. Patients may come from the Emergency Care Unit or may be hospitalised patients from another department. The patient will then be admitted to the Anaesthesiology and Intensive Therapy Clinic and receive care there until stabilised.
Instable patients who are enrolled will all be administered a fixed dose (100 mg/h) (see the section 'Inclusion criteria'). High risk or intermediate-high risk patients who can be stabilised will be randomised and then receive either a fixed dose (100 mg/2h) or a ClotPro-controlled variable dose of thrombolytic treatment.
Coagulation tests
ClotPro tests are planned before and regularly after the start of treatment: EX, IN, FIB, TPA, AP, RVV and ECA tests will be required.
Statistical methods Statistical analyses will be performed by Social Sciences software (SPSS; SPSS Inc, Chicago, Illinois, USA).
Continuous and discrete variables will be analysed by independent samples t tests (two categories) and one-way analyses of variance (one-way ANOVA; more categories), respectively. Two continuous variables will be compared by Spearman's rank correlation test. Discrete variables will be tested by Pearson's Chi squared test. Ordinary variables will be compared by Mann-Whitney U test or Kruskal-Wallis test. For multivariate analyses, logistic regression models will be generated.
Significance level will be set to 5% (p ≤ 0.05).
#Intervention
- DRUG : Alteplase Injectable Product
- The 2019 ESC guideline for the diagnosis and management of acute pulmonary embolism (PE) recommended thrombolytic therapy only in high-risk PE cases because of the bleeding risk. The most often used drug for thrombolysis is the rtPA and the recommended dose is 100 mg over two hours. According to the literature, the risk of major haemorrhage is 10-13% and fatal or intracranial bleeding is 1.7-3.6% among patients receiving thrombolysis. | #Eligibility Criteria:
Inclusion Criteria:
* Pulmonary embolism confirmed by CT angiography of the chest, and planned systemic thrombolysis, taking into account the following:
* For indications based on circulatory collapse or circulatory instability that persists despite circulatory support, a fixed dose will be delivered, preferably with coagulation monitoring. The rtPA dose is 0.6 mg/kg over 15 minutes (with a maximum dose of 50 mg) for circulatory collapse, and 100 mg over 2 hours for circulatory instability that persists despite circulatory support.
* Otherwise, a regime relevant to our study is followed in the following cases in the individuals randomised to the study treatment group:
* Haemodynamic instability resolved through inotropic and/or vasopressor therapy, or
* In the event of right heart strain confirmed by echocardiography, and elevated cardiac biomarker (hs Troponin-T/NT-proBNP) in a haemodynamically stable patient, the regime to be followed will be determined by the monitoring results.
Exclusion criteria:
* Failure to obtain informed consent from the patient (or from the closest relative of an incapacitated patient).
* Coagulation tests included in the study protocol cannot be performed for any technical reason or samples cannot be collected.
* Patients <18 years at the onset of pulmonary embolism.
* Pregnancy.
* The following risk factors are known or currently present in the patient:
* Haemorrhagic stroke at any time in the medical history
* Major trauma or head injury within the last three weeks
* Incorrigible bleeding abnormality
* Active bleeding that cannot be attenuated
* Therapy refractory hypertension
* Infective endocarditis
* Patients lacking legal competence and the guardian or closest relative cannot be contacted.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT06667882 | {
"brief_title": "Safe Delivery of Thrombolytic Treatment for Pulmonary Embolism Using ClotPro® Viscoelastic Tests",
"conditions": [
"Pulmonary Embolism Subacute Massive",
"Complication of Treatment",
"Fibrinolysis; Hemorrhage"
],
"interventions": [
"Drug: Alteplase Injectable Product"
],
"location_countries": [
"Hungary"
],
"nct_id": "NCT06667882",
"official_title": "Safe Delivery of Thrombolytic Treatment for Pulmonary Embolism Using ClotPro® Viscoelastic Tests",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-10-24",
"study_completion_date(actual)": "2024-10-24",
"study_start_date(actual)": "2021-12-17"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-31",
"last_updated_that_met_qc_criteria": "2024-10-30",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-10-31",
"first_submitted": "2024-10-24",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The primary aim of the 'Sensing Atrial High Rate Episodes with DX System in Implantable Cardioverter Defibrillators Trial' (SENSE Trial) is to assess the efficacy of a implantable cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles in detecting atrial high rate episodes.
The study hypothesis is that an ICD system with a lead with dedicated atrial sensing dipoles will have a diagnostic yield comparable to that of a standard dual chamber ICD system and superior to that of a standard single chamber ICD system.
Detailed Description
The SENSE Trial is designed to study the efficacy of the DX System in detection of atrial high rate episodes (AHREs) in subjects with no prior history of atrial fibrillation. The DX System, or 'DX,' consists of a Biotronik DX ICD, and the Biotronik Linox Smart S DX lead which is an FDA approved ICD system that incorporates use of an implantable cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles.
The SENSE Trial will be conducted at 8-12 U.S. sites. The lead coordinating site will be at Weill Cornell Medical College. Subjects will be followed for 1 year to assess for the primary endpoints of the trial.
#Intervention
- DEVICE : ICD with DX system
- Implantable cardioverter defibrillator (ICD) system implantation with single lead with ventricular sensing and pacing and defibrillation combined with dedicated atrial sensing dipole.
- Other Names :
- Biotronik Ilesto 7 VR-T ICD, Biotronik Lumax Smart S DX ICD lead, Future FDA-approved Biotronik DX-capable ICD and leads | #Eligibility Criteria:
Inclusion Criteria:
* Fulfills standard indications for ICD implantation
* Subject or legally authorized representative can provide written authorization per institutional requirements
* Subject is intended to be implanted with a complete Biotronik DX system (consisting of a Biotronik Ilesto 7 VR-T DX ICD or any future FDA approved Lumax VR-T DX ICD, and the Biotronik Linox Smart S DX lead), or has been implanted with a complete Biotronik DX system no more than 30 days prior to the date of consent
* Able to comply with Home Monitoring
Exclusion Criteria:
* Subject has prior diagnosis of atrial fibrillation or atrial flutter
* Subject has need for atrial pacing
* Subject unwilling or unable to give informed consent or participate in follow-up
* Subject is unable to comply with Home Monitoring
* Subject is pregnant
* Subject has less than one year estimated life expectancy
* Subject was implanted with a cardiac device capable of detecting AHREs prior to implantation of the Biotronik DX system
* Subject was implanted with Biotronik DX system and had an AHRE detection before enrollment
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02186704 | {
"brief_title": "Sensing Atrial High Rate Episodes With Implantable Cardioverter-Defibrillators Trial (The SENSE Trial)",
"conditions": [
"Atrial Fibrillation"
],
"interventions": [
"Device: ICD with DX system"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02186704",
"official_title": "Sensing Atrial High Rate Episodes With DX System in Implantable Cardioverter Defibrillators Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-03",
"study_completion_date(actual)": "2018-07",
"study_start_date(actual)": "2014-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-08-28",
"last_updated_that_met_qc_criteria": "2014-07-09",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-07-10",
"first_submitted": "2014-07-07",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The intent of this study is to demonstrate that single doses of the Final Market Image (FMI) ezetimibe/atorvastatin 10mg/10mg and 10mg/80mg fixed dose combination (FDC) tablets are bioequivalent to the same doses of ezetimibe (ZETIA®) and atorvastatin (LIPITOR®) that are coadministered as individual tablets in healthy adults.
#Intervention
- DRUG : Ezetimibe
- Ezetimibe 10mg tablet given orally after an overnight fast (at least 10 hours).
- Other Names :
- Zetia
- DRUG : Ezetimibe/atorvastatin 10mg/10mg FDC
- Ezetimibe/atorvastatin 10mg/10mg FDC tablet given orally after an overnight fast (at least 10 hours).
- Other Names :
- SCH 900068
- DRUG : Atorvastatin 10mg
- Atorvastatin 10mg given orally after an overnight fast (at least 10 hours).
- Other Names :
- Lipitor
- DRUG : Atorvastatin 80mg
- Atorvastatin 80mg tablet given orally after an overnight fast (at least 10 hours).
- Other Names :
- Lipitor
- DRUG : Ezetimibe/atorvastatin 10mg/80mg FDC
- Ezetimibe/atorvastatin 10mg/80mg FDC tablet given orally after an overnight fast (at least 10 hours).
- Other Names :
- SCH 900068 | #Eligibility Criteria:
Inclusion Criteria
* Healthy adult males and females age 18 <= age <= 55 years
* Body mass index (BMI) between 18 <= age <= 35 kg/m^2
* Clinical laboratory tests (complete blood count, blood chemistry, and urinalysis), electrocardiogram, and vital signs must be within normal limits
* Must agree to refrain from consumption of red wine, grapefruit, and grapefruit-containing products, orange and apple juices, and orange- and apple-containing products from beginning approximately 2 weeks prior to administration of the initial dose of study drug, throughout the study (including the washout interval between treatment periods), and until the poststudy visit
Exclusion Criteria
* Female subjects who are pregnant, intend to become pregnant (within 3 months of ending the study), or are nursing/breastfeeding.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
* History of any infectious disease within 4 weeks prior to drug administration
* Have demonstrated allergic reactions or hypersensitivities or intolerance to atorvastatin or other 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, ezetimibe, or any component/excipient of the study drug or other food, drug, atopic reactions or asthmatic episodes which, in the opinion of the investigator and sponsor, interfere with their ability to participate in the trial.
* Have a history of prior myopathy or abnormality in liver function studies with statin therapy.
* Are positive for hepatitis B surface antigen, hepatitis C antibodies, or HIV.
* Have donated blood in the past 60 days
* Consume excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT01236430 | {
"brief_title": "A Study to Determine the Bioequivalence of SCH 900068 Compared to Marketed Products (Protocol No. P07551)",
"conditions": [
"Hyperlipidemia"
],
"interventions": [
"Drug: Ezetimibe/atorvastatin 10mg/10mg FDC",
"Drug: Atorvastatin 80mg",
"Drug: Ezetimibe",
"Drug: Atorvastatin 10mg",
"Drug: Ezetimibe/atorvastatin 10mg/80mg FDC"
],
"location_countries": null,
"nct_id": "NCT01236430",
"official_title": "A Study to Evaluate the Definitive Bioequivalence of SCH 900068 With Marketed Products (Protocol No. P07551)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-11",
"study_completion_date(actual)": "2012-02",
"study_start_date(actual)": "2011-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-02-16",
"last_updated_that_met_qc_criteria": "2010-11-05",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-11-07",
"first_submitted": "2010-11-05",
"first_submitted_that_met_qc_criteria": null
}
}
} |
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