linjc16/ctgov huggingface dataset:
Phase 2, Multi-Center Trial of Modafinil for Methamphetamine Dependence

Study Overview
=================
Brief Summary
-----------------
The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.

Detailed Description
-----------------
To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects with methamphetamine dependence. It is hypothesized that modafinil, compared to placebo, will be associated with an increase in the number of methamphetamine non-use weeks over time as measured by quantitative urine analysis for methamphetamine.

Official Title
-----------------
Phase2, Double-blind, Placebo-controlled Trial of Modafinil for the Treatment of Methamphetamine Dependence

Conditions
-----------------
Methamphetamine Dependence

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be between the ages of 18 and 65 Methamphetamine dependent as defined by DSM-IV criteria Must be in good general heath with a history of methamphetamine use at screening Must be able to provide written informed consent If female and of child bearing potential, must agree to use birth control. Exclusion Criteria: Please contact site for more information

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

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

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 |
| --- | --- |
| Active Comparator: Modafinil<br>Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks | Drug: Modafinil<br>* 200 mg or 400 mg /daily<br>|
| Placebo Comparator: Placebo<br>Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks | Drug: Placebo<br>* Placebo / daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence (Week 1 - 12) | Number of participant who abstained from methamphetamine from weeks 1 through 12 | Weeks 1 - 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Craving | Number of subjects with 21 or more consecutive days of abstinence | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Methamphetamine Dependence
Implementation of A Patient Centered Self-Management Program for Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Translational study based on the American Association of Diabetes Educators 7 behaviors to manage Type 2 diabetes

Detailed Description
-----------------
The Primary Investigator will meet with patients that attend routine visits for Diabetes 2 in the primary care office on a monthly basis to set behavior goals. Behavior goals will be set by patient's choice of 4 out of 7 of the AADE7 recommendations. The goals are health eating, being active, monitoring,taking medications, problem solving, healthy coping, and reducing risk. Once the goal is chosen, the PI and patient will make a plan to address the goals on a monthly basis for four months. There will be pre and post questionnaires that will evaluate diabetes knowledge and self-efficacy. There will also be a pre and post measure of the patient's Hemoglobin A1c which is a measurement that helps determine the extent of glycemic control over a three-month period. The goal of the study is to determine if translation of the AADE7 behavioral goals into the primary care setting will make a difference in diabetes knowledge, self efficacy, and Hemoglobin A1c.

Official Title
-----------------
Implementation of A Patient Centered Self-Management Program for Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Education of goal setting and achievement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 with Hemoglobin A1c 7 mmol/mol or higher will be included in the study Patients willing to attend minimum of 4 monthly appointments for diabetes treatment Patients who give written consent to participate Exclusion Criteria: Patients below age 18, children are not treated in the facility for type 2 diabetes Patients who attend less than 4 monthly appointments for diabetes, Patients who do no give written consent to participate

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Life style changes<br>Pre and post after education intervention Education program | Behavioral: Education of goal setting and achievement<br>* Education of American Association of Diabetes Educations 7 behavioral goals and how to achieve them<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | Pre and Post Differences | 4 months |
The Effects of Butyrate Enemas on Visceral Perception

Study Overview
=================
Brief Summary
-----------------
During this double blind, placebo controlled, randomised cross over study, healthy volunteers received an enema once daily for one week containing either placebo (saline), 50mM butyrate or 100mM of butyrate. Before and directly after each test period a barostat protocol was performed to measure parameters for visceral perception.

Official Title
-----------------
The Effects of Butyrate Enemas on Visceral Perception

Conditions
-----------------
Visceral (Hyper)Sensitivity

Intervention / Treatment
-----------------
* Drug: Butyrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy Exclusion Criteria: age, under 18 or over 65 use of pre- or probiotics during study and 3 months previous to study previous bowel complaints gastrointestinal disease or abdominal surgery

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>enemas, once daily, containing saline | Drug: Butyrate<br> <br> |
| Experimental: 2<br>enemas, once daily, containing 50mM butyrate | Drug: Butyrate<br> <br> |
| Experimental: 3<br>enemas, once daily, containing 100mM butyrate | Drug: Butyrate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
butyrate, visceral perception, compliance
New Thyroid Fine Needle Aspiration Biopsy Apparatus

Study Overview
=================
Brief Summary
-----------------
Evaluation of the effectivity of the new thyroid fine needle aspiration biopsy (FNAB) apparatus of which patented from Turkish Patent Institute.

Detailed Description
-----------------
The author group of this investigation produced a new thyroid fine needle aspiration biopsy (FNAB) apparatus and patented it from Turkish patent Institute. FNAB indicated nodular goitre patients are the subjects of this research. First, the investigators will perform standart FNAB after this procedure will perform FNAB with new apparatus. The investigators will evaluate the aspirates according to number of cells and malignity ratio of cells.

Official Title
-----------------
New Thyroid Fine Needle Biopsy Apparatus

Conditions
-----------------
Thyroid Cancer

Intervention / Treatment
-----------------
* Procedure: biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fine needle aspiration biopsy indicated noduler goiter patients Exclusion Criteria: diffuse goiter

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: single group<br>FNAB will be perform first with standart technique and after with new FNAB apparatus | Procedure: biopsy<br>* fnab<br>* Other names: fnab;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of cells | number of aspirated cells will be compared | 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| type of cells | type (benign, suspect, malign) of cells will be compared | 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
new, thyroid, fine, needle, aspiration, biopsy, technique
Pre-Approval Access Single Patient Request for Talquetamab in Relapsed or Refractory Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The purpose of this pre-approval access program is to provide talquetamab for the treatment of participants with relapsed or refractory multiple myeloma.

Official Title
-----------------
Pre-Approval Access Single Patient Request Treatment for Talquetamab for Treating Physician Use in Relapsed or Refractory Multiple Myeloma

Conditions
-----------------
Relapsed or Refractory Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Talquetamab


Participation Criteria
=================

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


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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Talquetamab|Talquetamab will be administered subcutaneously (SC).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Dose-finding Trial of HCD122 in Patients With Chronic Lymphocytic Leukemia (CLL) That is Relapsed or Non-responsive to Prior Fludaribine Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with chronic lymphocytic leukemia who are relapsed after receiving prior treatment.

Official Title
-----------------
An Open-label,Multi-center, Phase l/ll Study of Anti-CD40 Monoclonal Antibody (HCD122) Administered Intravenously to Subjects With Advanced Chronic Lymphocytic Leukemia That is Refractory or Relapsed After at Least One Previous Fludarabine-containing Chemotherapy Regimen

Conditions
-----------------
Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: HCD122


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of CLL requiring treatment Refractory or relapsed disease Prior treatment with fludarabine Male or Female >18 years of age Exclusion Criteria: Treatment with rituximab within 90 days and alemtuzumab or any monoclonal antibody within 6 months. Clinically significant cardiac dysfunction or other significant organ dysfunction Additional eligibility criteria apply that will be reviewed with potential study subjects at the site.

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCD122<br> | Drug: HCD122<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine the maximum tolerated dose (MTD) |  | between study Day 1 and study Day 50 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to characterize safety and tolerability of HCD122 at each dose level in dose escalation patients |  | between study Day 1 and study termination | 
| To characterize pharmacokinetics of HCD122 at each dose level in dose escalation patients |  | between study Day 1 and study termination | 
| To characterize peripheral blood CD40 occupancy on CD5/CD19 (CLL) cells and CD5/CD19 cell depletion activity (pharmacodynamics) of HCD122 at each dose level in dose escalation patients |  | between study Day 1 and study termination | 
| To assess preliminary anti-tumor activity of HCD122 in dose escalation patients |  | between study Day 1 and study termination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphocytic Leukemia
Robots for Stroke Survivors

Study Overview
=================
Brief Summary
-----------------
The investigators are looking for individuals who have suffered a stroke to participate in an experiment examining the use of robotics in rehabilitation. They are trying to develop a robotic environment for hands after having had a stroke. Participants will interact with up to two small robots and a visual display. The experiment involves minimal risk and may involve testing sessions over multiple weeks. Subjects must be at least 1 year post-stroke and have difficulty picking up small objects. For more information, contact: Bambi Brewer, CMU Ph.D. Student, 412-241-9423 or bambi@andrew.cmu.edu.

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Procedure: Participants will interact with up to two small robots and a visual display


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 1 year post-stroke Difficulty picking up small objects

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Participants will interact with up to two small robots and a visual display|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Emergence of the COVID 19 Epidemic in the City of Nice

Study Overview
=================
Brief Summary
-----------------
Descriptive analysis of the appearance of the first cases of COVID 19 diagnosed in the city of Nice. Analysis of the association of socio-demographic factors with the viremia attack rate according to the district of residence.

Official Title
-----------------
Socio-demographic Factors and Emergence of the COVID 19 Epidemic in the City of Nice in 2020

Conditions
-----------------
COVID

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People resident in city of Nice at the COVID diagnosis
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attack rate | Diagnosed cases of COVID 19 divided by the population by district and multiplied by 100,000 | 1 month |
Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of reducing HIV transmission among sero-discordant couples by applying comprehensive intervention components.

Detailed Description
-----------------
A cluster-randomized controlled trial was carried out in forty counties from 16 cities. The strategy of Social Marketing was applied to influence sero-discordant couples' behavioral changes including safer sexual intercourses, regular HIV testing for the negative partners, antiretroviral therapy initiation.

Official Title
-----------------
A Cluster-randomized Controlled Trial of Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Behavioral: comprehensive intervention components


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Couples are required to have a stable relationship and live together in the last 3 months; Older than 18 years and younger than 60 years; without regard to CD4 count; Open cohort(any newly diagnosed serodiscordant couples who are eligible for treatment will be included during the study period). Exclusion Criteria: Couples are not have a stable relationship or do not live together in the last 3 months; Younger than 18 years old.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>comprehensive intervention components | Behavioral: comprehensive intervention components<br>* ART promotion, Couple testing and consulting promotion, and Condom use promotion<br>|
| No Intervention: Usual<br>According the National HIV Antiretroviral treatment Guideline, provide treatment referrals for those treatment-eligible HIV-positive patients. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV seroconversion rate of HIV negatives among HIV serodiscordant couples |  | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of HIV positives receiving ART among HIV serodiscordant couples |  | up to 2 years | 
| The incidence rate of AIDS-related diseases of HIV positives among serodiscordant couples |  | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, serodiscordant couples HIV sero-conversion, anti-retroviral therapy, intervention
The SOLACE-AU Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to observe the safety, efficacy and cost effectiveness of the Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.

Detailed Description
-----------------
This is a multi-centre, prospective, consecutively enrolled, non-randomized clinical trial. The comparatator group will consist of subjects undergoing surgical aortic valve replacement in Cohort A of the PARTNER II Trial [NCT01314313].

Official Title
-----------------
A Multicentre, Non-Randomised Controlled Study of the Safety, Performance, Quality of Life and Cost Effectiveness Outcomes of the Edwards SAPIEN XT™ Transcatheter Heart Valve in an Australian Population

Conditions
-----------------
Severe, Symptomatic Aortic Stenosis

Intervention / Treatment
-----------------
* Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 70 years STS Score > 4 Heart team agrees on eligibility including assessment that TAVR or AVR is appropriate Exclusion Criteria: Age <70 years Evidence of an acute myocardial infarction ≤ 30 days Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified Stroke or transient ischemic attack (TIA) within 6 months of the procedure

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>SAPIEN XT™ valve with the NovaFlex and NovaFlex+ delivery systems. | Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis<br>* Operable subjects<br>* Other names: Implantation of the Transcatheter Aortic Valve Prosthesis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VARC-2 Composite Safety Endpoint | The primary endpoint is a VARC-2 Composite. It comprises of All cause mortality All stroke Life-threatening bleeding Acute kidney injury - Stage 3 (including renal replacement therapy) Coronary artery obstruction requiring intervention Major vascular complications Valve related dysfunction (requiring repeat procedure) A composite endpoint is an endpoint that is a combination of multiple components. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cause Mortality |  | 30 days | 
| All Cause Mortality |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic Stenosis, Transfemoral, Transcatheter Heart Valve