linjc16/ctgov huggingface dataset:
HEALTHY (Health Education Adolescent Leadership Training to Help Youth) Leaders

Study Overview
=================
Brief Summary
-----------------
This project will measure baseline stress among a group of youth in foster and kinship care. The investigators will implement a pilot program to target stress reduction by using an evidence-based group therapy technique teaching mindfulness skills. The investigators hypothesize that the mindfulness skills will help youth to reduce stress, which will be measured using psychological and physiological techniques.

Conditions
-----------------
Stress

Intervention / Treatment
-----------------
* Behavioral: Mindfulness based stress reduction
* Behavioral: only pre and post evaluation measures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 14-21 years at time of intervention being offered, offered to youth in out of home care (e.g. foster and kinship care) Exclusion Criteria: severe developmental delay non English speaking, not in age range

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness Based Stress reduction<br>attending 10 weekly sessions and comprised of an eight week mindfulness intervention program, and completing pre- and postevaluation measures on the first and last sessions | Behavioral: Mindfulness based stress reduction<br>* an 8 week group intervention to teach mindfulness skills<br>|
| Placebo Comparator: No Mindfulness based intervention<br>completing only re- and post-evaluation measures on the first and last sessions | Behavioral: only pre and post evaluation measures<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17) | Self Administered questionnaire to assess level of stress at baseline and week 10. PSC-17 is a one page behavioral assessment tool that can be completed in <5 minutes and can assess the sub-domains of attention, externalizing problem and internalizing problems. Attention, externalizing and Internalizing domains are each scored on a scale from 0 (best) to 10 (worst), where a score >= 7 indicates stress. | Baseline and week 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
youth, Stress, mindfulness, foster care, stress reduction, high risk teens
Buprenorphine Detoxification With Two Types of Treatment. BBD III - 12

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate buprenorphine and behavioral treatment with and without contingent payment on compliance with naltrexone.

Official Title
-----------------
Buprenorphine Detoxification With Two Types of Treatment. BBD III

Conditions
-----------------
Opioid-Related Disorders

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Retention |  |  | 
| Weeks abstinent |  |  | 
| Weeks continuous abstinence |  |  | 
| Overall treatment outcome |  |  |
PET/CT: Role in Detecting Unknown Primary Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
Historically metastatic squamous cell carcinoma in a cervical lymph node from an occult primary malignancy of the head and neck was evaluated with panendoscopy and biopsies of high risk areas, such as the base of tongue, nasopharynx, and tonsils. This diagnostic protocol identifies the primary malignancy in about 50% of cases. In recent years, the availability of CT has slightly increased the detection rate to 65% when used as an adjunct to the traditional work-up. Studies using PET as an adjunct are conflicting with detection rates ranging up to 75%. Currently, no prospective study has analyzed the role of the PET-CT fusion in the work-up of an occult primary malignancy of the head and neck. This study will compare the detection rate of the traditional work-up to a new protocol involving a pre-operative diagnostic PET-CT.

Official Title
-----------------
The Clinical Utility of PET-CT in the Management of Squamous Cell Carcinoma of Neck Nodes With an Unknown Primary Malignancy.

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Other: PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old Biopsy proven SCC in a cervical lymph node Unknown primary cancer after: History, Physical exam, and office endoscopy by otolaryngologist Negative Chest X-Ray for malignancy Patient consent signed to undergo investigative protocol Exclusion Criteria: Un-fit for general anesthesia Unable to lie flat for 45 minutes Unable to fast for > 6 hours Unable to perform PET-CT (Obesity > 150kg) Pregnant Prior Head and Neck cancer Any invasive cancer (Non-Head and Neck) within the last 2 years

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>All patients have PET/CT and biopsies with the surgeon blinded to the result of PET/CT. Additional biopsies are performed (or not) after the surgeon has the PET/CT results revealed. | Other: PET/CT<br>* PET/CT is being performed on all patients in the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients where PET/CT resulted in a change in diagnosis |  | 2 weeks after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unknown primary, head and neck cancer, squamous cell carcinoma, Unknown primary head and neck cancer
Sitosterolemia Extension Study (0653-003)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This is an extension study for patients having unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study will evaluate the long term safety and the ability to lower cholesterol levels with an investigational drug.

Detailed Description
-----------------
The duration of treatment is 52 weeks.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK0653 When Added to Current Regimen in Patients With Homozygous Sitosterolemia - 1 Year Open-Label Extension

Conditions
-----------------
Lipid Metabolism, Inborn Errors, Heart Disease

Intervention / Treatment
-----------------
* Drug: MK0653, ezetimibe
* Drug: Comparator: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with elevated sitosterol levels while taking current medication Exclusion Criteria: Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0653, ezetimibe|nan|
|Drug: Comparator: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK0653 10 mg/day. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the percent change relative to baseline in LDL-C/plasma campesterol concentrations, and safety and tolerability after long-term treatment with MK0653 10 mg/day in patients with homozygous sitosterolemia |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Homozygous Sitosterolemia
Prevalence and Risk Factors of Erectile Dysfunction in Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The investigators evaluated 250 male, type 2 diabetic patients, aged 18-80 years. They will undergo IIEF (International Index of Erectile Function), SAS of Zung (self-rating anxiety state)and SDS of Zung (self-rating depression scale)questionnaires. The investigators will evaluate anthropometric and biochemical parameters, dysautonomic function index, IMT (Intima Media Thickness) index, and fundus oculi examen. Furthermore, the investigators will perform MNSI (Michigan Neuropathy Screening Instrument) and NDS (Neuropathy Disability Score)questionnaires.

Conditions
-----------------
Type 2 Diabetic Patients, Erectile Dysfunction

Intervention / Treatment
-----------------
* Other: type 2 diabetic patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes mellitus Exclusion Criteria: type 1 diabetes mellitus < 18 years old anatomic abnormalities of the penis patients taking erectile dysfunction therapy at the moment of the enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| type 2 diabetic patients<br>males; type 2 diabetic patients | Other: type 2 diabetic patients<br>* males; type 2 diabetic patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of erectile dysfunction |  | Baseline (time 0); 3 months; 6 months | 
| Description of erectile disfunction markers |  | Baseline (time 0); 3 months; 6 months | 
| Evaluation of diabetic neuropathy in patients with erectile dysfunction |  | Baseline (time 0); 3 months; 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metalloproteinases 2 and 9 |  | Baseline (time 0); 3 months; 6 months | 
| Insulin-sensitivity index (HOMA index) |  | Baseline (time 0); 3 months; 6 months | 
| Glycemic control |  | Baseline (time 0); 3 months; 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes mellitus, male, erectile dysfunction
Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single doses of BMS-686117

Official Title
-----------------
Randomized, Placebo-Controlled, Single-Dose, Crossover Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: BMS-686117
* Drug: Byetta
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Type 2 diabetes for ≥ 3 months treated with metformin, thiazolidinedione, or sulfonylurea (either monotherapy or combination) or diet alone (drug naïve) Fasting plasma glucose: 126 - 240 mg/dL Hemoglobin A1c: 6 - 10% Estimated CrCl ≥ 60 mL/min ALT ≤ 1.5 x ULN and total bilirubin ≤ 2 x ULN Stable and well controlled hypertension and/or dyslipidemia Concomitant medications used for hypertension and/or dyslipidemia, thyroid hormone replacement therapy and low dose aspirin will be allowed if stable for at least 6 weeks Exclusion Criteria: Women of childbearing potential Symptomatic diabetes with polyuria and/or polydipsia History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome History of renal disease including diabetic nephropathy

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: BMS-686117<br>* Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.<br>|
| Active Comparator: B<br> | Drug: Byetta<br>* Injection solution, Subcutaneous, 5 mcg, Once daily, Single dose.<br>|
| Placebo Comparator: C<br> | Drug: Placebo<br>* Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: incidence of adverse events |  | from subject enrollment to study discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters: Cmax, Tmax, AUC(0-24h), AUC(INF) and T-HALF |  | from pre-dose to 24 hrs post-dose | 
| PD Measures: Fasting and postprandial serum glucose (AUC), serum insulin, and plasma glucagon concentrations. Acetaminophen plasma concentrations will be measured after a single dose of acetaminophen |  | from pre-dose to 9 hrs post-dose |
Randomized Trial to Evaluate the Effectiveness of Nurse Case Management

Study Overview
=================
Brief Summary
-----------------
The management of high-risk pregnancies require substantial use of medical resources. Our goal is to determine the effectiveness of a nurse case management program in which case managers are assigned to patients with high-risk conditions. Our hypothesis is that women with diabetes in pregnancy or hypertension who are assigned a nurse case manager will have lower glucose levels and lower blood pressure levels

Detailed Description
-----------------
We will recruit 50 women for each arm of the study. We we conduct a stratified randomization (by disease) in which women are randomized to a nurse case manager who provides on-going face-to-face contact compared to women who are assigned to a case manager with telephone contact only.

Official Title
-----------------
Randomized Trial to Evaluate the Effectiveness of Nurse Case Management on High-Risk Pregnancy Outcomes

Conditions
-----------------
Type 2 Diabetes, Gestational Diabetes, Hypertension, Preterm Delivery

Intervention / Treatment
-----------------
* Behavioral: nurse case manager


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes, gestational diabetes, preterm labor, hypertensive disease Exclusion Criteria: No telephone; ability to provide consent; english-speaking

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: nurse case manager|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcomes measures are mean fasting glucose levels, mean systolic pressure and mean diastolic pressure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
randomized trial, diabetes, pregnancy
Renal Donor Comparison of Outcomes: Hand Assist Versus Laparoscopic Nephrectomy

Study Overview
=================
Brief Summary
-----------------
This study is designed to look at outcomes of patients who have undergone hand assisted laparoscopic donor nephrectomy versus totally laparoscopic donor nephrectomy.

Official Title
-----------------
Renal Donor Comparison of Outcomes: Hand Assist Versus Laparoscopic Nephrectomy

Conditions
-----------------
Living Renal Donor

Intervention / Treatment
-----------------
* Procedure: donor nephrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any person undergoing minimally invasive donor nephrectomy surgery at NewYork Hospital/Columbia. Exclusion Criteria: any person undergoing open donor nephrectomy surgery at NewYork Hospital/Columbia.

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

| Intervention/Treatment |
| --- |
|Procedure: donor nephrectomy|The objective of this protocol is to look at the outcomes of laparoscopic donor nephrectomy performed by using hand assisted (HA)or entirely laparoscopic (LDN) surgical techniques. To define the advantages of each technique, we will use records of patients who underwent laparoscopic live kidney donation with HALDN.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of postoperative comfort and hospital stay satisfaction with HALDN |  | 1 week | 
| Prevalence of postoperative comfort and hospital stay satisfaction with LDN |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hand assist, laparoscopy, renal donor, outcomes
The Cardiac Autonomic System Response to Activity and Cognitive Tasksinjury

Study Overview
=================
Brief Summary
-----------------
18 children post acquired brain injury and 18 typically developed controls matched for age and gender. All children aged 10-18 yrs who understand simple commands. Tools: Heart rate monitor Six minute walk test The behavior rating inventory Method: At the introductory visit the child will be asked to walk for six minutes, to sit and perform a cognitive test and then to walk on a treadmill for 5 seconds. At the second visit the child will be asked to go on the treadmill for 5 minutes and at the same time to perform the cognitive assignment; After a rest the child will be asked to walk on the treadmill for 5 minutes and at the end to perform the cognitive assignment .

Official Title
-----------------
The Cardiac Autonomic System Response to Activity and Cognitive Tasks in Children Post Acquired Brain

Conditions
-----------------
Brain Injuries

Intervention / Treatment
-----------------
* Other: cognitive and motor assignments


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 10-18 understand simple commands walk independently Exclusion Criteria: Canot understand simple commands

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: brain injury<br>children post brain injury | Other: cognitive and motor assignments<br>* walking on treadmill, performing cognitive assignment; and performing the cognitive assignment while walking .<br>|
| Active Comparator: controls<br>children typically developed age matched | Other: cognitive and motor assignments<br>* walking on treadmill, performing cognitive assignment; and performing the cognitive assignment while walking .<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  | 5 min | 
| Heart rate variability- time domain measures |  | 5 min | 
| Heart rate variability- frequency domain measures |  | 5 min |