linjc16/ctgov huggingface dataset:
Combining Behavioral Treatment With Agonist Maintenance - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether the community reinforcement approach (CRA) plus contingency management (CM) is more effective overall than CRA only in reducing illicit opioid and cocaine use during agonist maintenance treatment and at 3 and 6 month follow-up after completion of study protocol, and to compare the efficacy of maintenance on buprenorphine to methadone when maintenance is combined with CRA only or CRA plus CM.

Official Title
-----------------
Combining Behavioral Treatment With Agonist Maintenance

Conditions
-----------------
Cocaine-Related Disorders, Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine
* Drug: methadone


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Methadone + CM (contingency management) | Drug: methadone<br>* medication and behavioral<br>|
| Experimental: 2<br>methadone + VC (voucher control) | Drug: methadone<br>* medication and behavioral<br>|
| Experimental: 3<br>Buprenorphine + CM | Drug: Buprenorphine<br>* Medication and Behavioral<br>|
| Experimental: 4<br>Buprenorphine + VC | Drug: Buprenorphine<br>* Medication and Behavioral<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression |  | 24 weeks | 
| Withdrawal symptoms |  |  | 
| Opioid and cocaine use |  |  | 
| Social and psychological functioning |  |  | 
| AIDS risk behavior |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cocaine-Related Disorders, Opioid-Related Disorders, Substance-Related Disorders
Non Invasive External Monitoring in Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
This is a single center, non randomized study to gather data to correlate physiological signals with the patient's fluid status during fluid removal in hemodialysis.

Detailed Description
-----------------
Patients undergoing hemodialysis will be monitored with the study device . The collected information will be correlated with fluid loss.

Official Title
-----------------
Fluid Removal During Adherent Renal Monitoring

Conditions
-----------------
Kidney Failure

Intervention / Treatment
-----------------
* Device: AVIVO™ Mobile Patient Management System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is female or male, 18 years of age or older Undergoing hemodialysis for fluid removal Exclusion Criteria: Is participating in another clinical study that may confound the results of this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dialysis<br> | Device: AVIVO™ Mobile Patient Management System<br>* Non Invasive monitoring device<br>* Other names: Diuretics- oral or IV;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Tissue Repository for Studies of Myasthenia Gravis

Study Overview
=================
Brief Summary
-----------------
This is a study during which the investigators collect plasma and cells from patients with myasthenia gravis for the purpose of finding new antibodies.

Detailed Description
-----------------
This is a bio-specimen collection study. The investigators will collect plasma and peripheral lymphocytes. Plasma will be collected either when the patient undergoes plasma exchange, a decision independent of this study, or through a scheduled blood draw. Patient plasma will be screened for novel antibodies which may cause myasthenia gravis. Subjects that are found to be positive for candidate antigens for myasthenia gravis will have a clinical evaluation which will consist of several disease rating scales will be performed (QMG score, MG-composite, Myasthenia Gravis Foundation of America (MGFA) clinical classification, MG-Quality of Life (QOL)15, MGFA Therapy Status).

Official Title
-----------------
Tissue Repository for Studies of Myasthenia Gravis

Conditions
-----------------
Myasthenia Gravis

Intervention / Treatment
-----------------
* Other: No interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older. Clinical Diagnosis of MG with supporting evidence either from antibody testing, repetitive nerve stimulations study (RNS) or Single Fiber Electromyography (EMG) (SFEMG). Exclusion Criteria: Significant medical condition that would make participation in diagnostic and research part of evaluation impossible or risky. Acute or unstable medical condition. Inability to provide informed consent, either directly or via appointed power of attorney. Unwillingness to consent for collection of biological samples or their cryopreservation. Unable to provide evidence of previous antibody testing or neurophysiology confirming the diagnosis of Myasthenia Gravis. Any bleeding disorder that would prevent or present any danger during blood extraction.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Myasthenia Positive Antibodies<br>Patients with Acetyl choline receptor (AChR) or muscle-specific kinase (MuSK) Positive Myasthenia | Other: No interventions<br> <br> |
| Myasthenia Double Negative<br>Patients without AChR or MuSK antibodies | Other: No interventions<br> <br> |
| Normal Controls<br>Patients without myasthenia | Other: No interventions<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of New Antibodies in Myasthenia Gravis assessed by enzyme-linked immunosorbent assay (ELISA) |  | Up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myasthenia Gravis
A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The Purpose of a randomized, double-blind, placebo-controlled, single-dose, dose-escalation clinical trial is to explore investigate the safety, tolerability, pharmacokinetics, and food effect of PMK-S005 after oral administration in healthy male volunteers.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers

Conditions
-----------------
Gastritis, Gastric Ulcer

Intervention / Treatment
-----------------
* Drug: PMK-S005


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 20 year ≤ age ≤ 40 year. Weight ≥ 55kg, IBW ±20%. Patients with normal hematology, biochemistry, urinary result. Patients who have not congenital or chronic disease. Provision of written informed consent voluntarily. Exclusion Criteria: Patients having known hypersensitivity to any component of the study drug. Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system. Patients with any gastrointestinal disorders. Systolic blood pressure ≥ 150 or ≤ 90 mmHg, Diasolic blood pressure ≥ 95 or ≤ 50 mmHg. Drug abuser, alcoholic. Patients taking ETC medication within 14 days, OTC within 7 days. Patients taking other investigational product within 60 days prior to the participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PMK-S005<br> | Drug: PMK-S005<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product. Before and after physical examination Before and after bital Sign: blood pressure, pulse rate, temperature. Before and after 12-ECG: ventricular rate (/min), PR interval (msec), QRS duration (msec), QT/QTc interval (msec. Lab: hematologic examination, blood coagulation examination,urine examination | 8day | 
| Pharmacokinetics | Blood evaluation variables: Cmax, AUCt (t=48 h), AUC∞, tmax, CL/F, t1/2. Urine evaluation variables: Aet (t=48 h), Ae∞, urine recovery | 8day |
Myocardial Function of the Setonis Aortic Valve Before and Beyond Valve Replacement

Study Overview
=================
Brief Summary
-----------------
Study the consequences on heart muscle of the stenosis aortic valve before and after the replacement procedure, the repercussion on heart. Study the impact on the heart of sick valve can affect on well-being and prognosis in the year following the surgery.

Official Title
-----------------
Myocardial Function of the Setonis Aortic Valve Before and Beyond Valve

Conditions
-----------------
Myocardial Function of the Stenosis Aortic Valve Before and Beyond Valve Replacement

Intervention / Treatment
-----------------
* Procedure: stenosis aortic valve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: major patient freely accepting to participate in the study non-opposition signed aortic surface <1cm² or <0.6cm² / m² of indication surgical restraint oriented to short interventional management surgical term LVEF Left ventricular ejection fraction> 50% In the subgroup MRI-fibrosis, absence of indication for performing MRI Exclusion Criteria: patient under guardianship, curatorship or safeguard of justice minor patient pregnant woman patient with significant polyvalvulopathy for which it is from the start programmed more than aortic valve replacement patient with severe coronary artery disease requiring revascularization allergy to the contrast product

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Echocardiography<br> | Procedure: stenosis aortic valve<br>* The exams to be realized : a clinical examination with blood pressure a 12-lead surface electrocardiogram a standard biological assessment including NTproBNP (Brain Natriuretic Peptide) Transthoracic echocardiography at baseline and 12 months after the aortic valve intervention on the (according to recommendations) a cardiac MRI looking for fibrosis myocardial<br>|
| MRI Fibrosis<br> | Procedure: stenosis aortic valve<br>* The exams to be realized : a clinical examination with blood pressure a 12-lead surface electrocardiogram a standard biological assessment including NTproBNP (Brain Natriuretic Peptide) Transthoracic echocardiography at baseline and 12 months after the aortic valve intervention on the (according to recommendations) a cardiac MRI looking for fibrosis myocardial<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is a composite endpoint: all-cause death, cardiovascular hospitalization: cardiac decompensation, atrial fibrillation within 12 months of surgical or percutaneous aortic valve replacement. |  | 1 day of inclusion |
Pseudoexfoliation and Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Background: Pseudoexfoliation (PEX) is characterised by the deposition of fibrillar material in an eye structures and many other parts of the body including kidneys and blood vessels. As both PEX and chronic kidney disease (CKD) are associated with oxidative stress and endothelial dysfunction we studied if the risk of PEX was increased in patients with CKD. Methods: Patients over age 40 with the diagnosis of CKD were included in the study. Chronic kidney disease was diagnosed as decreased glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m². Study groups were arranged as group 1 consisting of HD receiving patients, group 2 consisting of stage 1-4 CKD patients and group 3 consisting of patients with normal kidney functions (control group). Demographic properties and the rate of PEX were evaluated and compaired between the groups.

Official Title
-----------------
The Relationship Between Pseudoexfoliation and Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with chronic kidney disease stage 1-5 Exclusion Criteria: History of eye trauma or surgery

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dialysis patients<br>Patients with stage 5 chronic kidney disease undergoing haemodialysis | |
| Chronic kidney disease patients<br>Stage 1-4 Chronic kidney disease patients | |
| Control group<br>Patients with normal renal functions | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalance of pseudoexfoliation in patients with chronic kidney disease |  | 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pseudoexfoliation, chronic kidney disease
Effects of Atazanavir Treatment on Type 2 Diabetes Mellitus Related Endothelial Dysfunction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether atazanavir use is of influence on the endothelial dysfunction associated with type 2 diabetes mellitus.

Official Title
-----------------
Influence of Atazanavir Treatment on Endothelial Dysfunction, Vascular Inflammation and Heme Oxygenase Activity in Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus Related Endothelial Dysfunction

Intervention / Treatment
-----------------
* Drug: placebo + atazanavir
* Drug: atazanavir + placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (most important): 18 - 70 years type 2 diabetes mellitus treated with diet, oral medication and/or insulin BMI of 18 to 35 determinants of renal and hepatic function within twice the upper limit of normal range, abnormalities in lipid profile permitted Exclusion Criteria (most important): history of smoking within past year history of or current abuse of drugs, alcohol or solvents current use of antihypertensive, cardiac or other vasoactive medication clinical evidence of cardiac or pulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Placebo treatment first, atazanavir treatment second | Drug: placebo + atazanavir<br>* Placebo treatment first, atazanavir treatment second 4 day treatment<br>|
| Experimental: 2<br>Atazanavir treatment first, placebo treatment second | Drug: atazanavir + placebo<br>* Atazanavir treatment first, placebo treatment second 4 day treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acetylcholine induced vasodilation |  | following a 4 day treatment with either placebo or atazanavir | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heme oxygenase expression and activity |  | following a 4 day treatment with either placebo or atazanavir | 
| assessment of vascular inflammation by determination of adhesion molecule levels |  | following a 4 day treatment with either placebo or atazanavir |
Effects of Chronic Leucine Supplemetion on Glucose Homeostasis, Body Compositin, Muscle Mass and Strength of Healthy and Young Subjects

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the effects of chronic leucine supplemetion on glucose homeostasis, body compositin, muscle mass and strength of healthy and young subjects

Official Title
-----------------
Effects of Chronic Leucine Supplemetion on Glucose Homeostasis, Body Compositin, Muscle Mass and Strength of Healthy and Young Subjects: a Randomized, Double-blind, and Placebo Controlled Trial

Conditions
-----------------
Effect of Chronic Leucine Supplementation on Glucose Homeostasis, Lipid Profile, Body Composition, and Muscle Mass and Strenght

Intervention / Treatment
-----------------
* Dietary Supplement: Leucine
* Dietary Supplement: Alanine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-smokers; Healthy; Non-users of dietary supplements and drugs Not engaged in any regular physical activity program Exclusion Criteria: Vegetarians

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leucine<br> | Dietary Supplement: Leucine<br>* 7,2 g/day during 3 months<br>|
| Placebo Comparator: Alanine<br> | Dietary Supplement: Alanine<br>* 7,2 g/day during 3 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strenght |  | 3 months | 
| Body composition |  | 3 months | 
| Muscle cross-sectional area |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose homeostasis |  | 3 months | 
| Lipid profile |  | 3 months | 
| Systemic inflammation |  | 3 months |
Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus placebo in patients with bipolar depression.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Aripiprazole
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
ages 18-65 Men and women, who have experienced a prior manic episode that required hospitalization, and now meet criteria for a major depressive episode.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1<br> | Drug: Aripiprazole<br>* Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.<br>* Other names: Abilify;|
| Placebo Comparator: A2<br> | Drug: Placebo<br>* Tablets, Oral, 0 mg, Once daily, 8 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on a depression rating scale at endpoint |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate and Clinical Global Impression scale at endpoint |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar 1 Disorder, depressed