linjc16/ctgov huggingface dataset:
Islet Transplantation in Type 1 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
Our hypothesis is that a successful clinical islet transplant program can be established at the University of Wisconsin using a steroid -free, sirolimus- and low dose tacrolimus - based immunosuppressive drug regimen (Edmonton protocol). We intend to answer the following research questions: 1) will treatment of islet transplant recipients with thiazolidinediones (i.e. pioglitazone) enhance post-transplant islet function and reduce the number of islets necessary to achieve adequate metabolic control? 2) which type 1 diabetic patients are optimal candidates for islet transplantation (i.e. islet transplant alone or islet after kidney transplantation)? 3) Can cadaver donor pancreases, which are ordinarily discarded and not used for pancreas transplantation be used for islet transplantation?

Official Title
-----------------
Islet Transplantation in Type 1 Diabetic Patients Using a Steroid-free Immunosuppression Protocol and Thiazolidinedione Insulin Sensitizers

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Drug: Thiazolidinedione


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 16 Type I insulin-dependent diabetic subjects ages 18-60,(8 who have received a prior kidney or liver transplant and have stable renal function, and 8 who have labile glucose regulation and who have failed a trial of intensive exogenous insulin therapy and who have preserved native renal function) Exclusion Criteria: untreated proliferative diabetic retinopathy; HgbA1C >12%; creatinine clearance < 80 ml/minute or macroalbuminuria > 0.3 gm/24 hrs; presence of panel reactive antibodies >20%

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Thiazolidinedione therapy | Drug: Thiazolidinedione<br>* Thiazolidinedione vs. no intervention with standard immunosuppression using Edmonton Protocol<br>|
| No Intervention: 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of islets necessary to achieve adequate metabolic control |  | 5 years | 
| post-transplant islet function |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suitability of cadaver donor pancreases for islet transplantation |  | 5 years |
Study of NTBC for Tyrosinemia I

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Assess the safety and efficacy of NTBC in children with tyrosinemia I. II. Evaluate the effects of NTBC on survival, rate of neurologic crises, improvement in renal tubular damage, reduction in the need for liver transplantation, and reduction in the development of hepatocarcinoma in these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients are stratified according to age at onset of symptoms (0-2 months vs 2-6 months vs greater than 6 months). Patients receive oral NTBC twice a day. Treatment continues in the absence of unacceptable toxicity. Patients are followed once a month for 6 months, then every 3 months thereafter. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Tyrosinemia I

Intervention / Treatment
-----------------
* Drug: NTBC


Participation Criteria
=================
Eligibility Criteria
-----------------
Confirmed diagnosis of tyrosinemia Detected through newborn screening before the onset of symptoms OR Diagnosed on the basis of symptoms (liver disease, neurological crises, growth failure) and succinylacetone in urine or blood and/or fumarylacetoacetate dehydratase deficiency in cultured fibroblasts or liver biopsy

Ages Eligible for Study
-----------------
Maximum Age: 17 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: NTBC|nan|

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
-----------------
inborn errors of metabolism, rare disease, tyrosinemia I
Cohort Study of HIV-1 Incidence Among Clients of the Thai Red Cross AIDS Research Center, Bangkok, Thailand

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess populations in Thailand at high risk for HIV-1 infection for potential efficacy trials of candidate HIV vaccines to include: assess incidence of HIV-1 and volunteer retention describe early viral load and CD4 counts assess participant willingness to participate in HIV vaccine efficacy trials and other HIV prevention trials describe volunteer risk behavior

Detailed Description
-----------------
Prospective cohort study of HIV-negative participants who will receive voluntary counseling and testing (VCT) for HIV-antibody in conjunction with questionnaires on risk behavior, willingness to participate in HIV vaccine trials and other HIV prevention trials at 4 month intervals for a period of 1 year. This study will follow 1000 HIV-negative volunteers with an expected minimum of 15-20 incident HIV-infections based on a minimum incidence rate of 1.5/100 person-years. Weighted incidence estimates will be calculated with exact 95% confidence intervals.

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman aged 18-50 years Willing to provide location or contact information and allow contact Thai citizenship as identified by Thai National Identification card Ability and willingness to provide consent Availability for follow-up for the planned study duration Exclusion Criteria: Persons who have a history of a medical or psychiatric disorder, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent Persons who are known to be HIV-positive

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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 |
| --- | --- | --- |
| number of HIV-1 infections per 100 person-years |  | 5 years | 
| Lost to follow-up on an annual basis (10% or better) |  | 5 years | 
| Post-infection viral load and CD4 count |  | 5 years | 
| Willingness to participate in HIV vaccine and prevention trials |  | 5 years | 
| Risk behavior by questionnaire |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV-1 prevalence |  | 5 years | 
| HIV-1 genotype distribution |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-negative, male and female clients, ages 18-50 years, seeking HIV counseling, testing at TRCARC
Measuring Head Control Change With 2D Video Analysis After Utilization of Headpod in Children With Poor Head Control

Study Overview
=================
Brief Summary
-----------------
Inclusion Criteria: children ages 2 to 14 years with poor head control and non progressive diagnoses. Exclusion criteria: significant change of status i.e. prolonged hospitalization, surgery; inability to tolerate using Headpod. Requires use of Headpod 3x per day for minimum of 15 minutes each time over a 6 month period. Log must be kept documenting usage of the Headpod. Video will be taken to document changes.

Detailed Description
-----------------
Requires usage of the Headpod 3x per day for a minimum of 15 minutes each time. Usage required for 6 month period. Log must be kept documenting usage of the Headpod. Video will be taken on initial trial use, 1 week post trial use, at 3 months post utilization of the Headpod and at 6 months post utilization of the Headpod.

Official Title
-----------------
Measuring Head Control Changes With 2d Video Analysis After Utilization of the Headpod in Children With Cerebral Palsy and Poor Head Control

Conditions
-----------------
To Determine Efficacy of the Headpod, Cerebral Palsy

Intervention / Treatment
-----------------
* Device: Headpod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non progressive diagnoses with poor head control Exclusion Criteria: recent prolonged hospitalization; surgery, inability to tolerate wearing the Headpod

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 14 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
Interventional Model Description: Quasi-experimental, one-way repeated measures design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Headed utilization<br>Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time; | Device: Headpod<br>* Adaptive equipment to assist with active head movements<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Head Holding Active Time From Baseline to 6 Months | Active time in seconds holding head upright | baseline to 6 months |
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to a 10% hypersensitivity response was considered acceptable.

Official Title
-----------------
Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) Open Label, Normal Volunteer Study

Conditions
-----------------
Drug Hypersensitivity

Intervention / Treatment
-----------------
* Drug: Vitrase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Agreed to avoid disallowed meds Exclusion Criteria: Known hypersensitivity to hyaluronidase and/or bee sting Previous known exposure to ovine hyaluronidase or bovine hyaluronidase Atopic individuals assessed by medical history Topical/inhaled/systemic corticosteroids within 30 days Concurrent use of antihistamines or anti-inflammatory during study Active or chronic disease likely to affect immune function History of alcohol/drug abuse within 6 months

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitrase<br>A single intradermal dose of 4.5 USP units of Vitrase at one site and the same volume of saline at a distant site for comparative control. | Drug: Vitrase<br> <br> * Other names: ovine hyaluronidase;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypersensitivity | Incidence of hypersensitivity to Vitrase following a single intradermal injection of 4.5 USP units Vitrase. | 1-2 days |
Enhancing Motivation To Quit Smoking In Smokers With Serious Mental Illness

Study Overview
=================
Brief Summary
-----------------
This project will assess the utility of a brief motivational intervention to engage smokers with schizophrenia in treatment for tobacco dependence treatment. It is hypothesized that a brief motivational intervention will be more effective in engaging smokers with schizophrenia to tobacco dependence treatment than an educational intervention. The educational intervention will increase the likelihood to reducing cigarette intake and/or attending tobacco dependence treatment by teaching subjects about the negative effects of smoking and the success of tobacco dependence treatment. The motivational intervention will increase the likelihood to reducing cigarette intake and/or attending tobacco dependence treatment by increasing subjects' motivation to change by presenting objective and personalized information regarding their smoking behaviors in a non-judgmental and supportive manner.

Detailed Description
-----------------
See Brief Summary above.

Official Title
-----------------
Enhancing Motivation To Quit Smoking In Smokers With Serious Mental Illness

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Behavioral: Motivational Interviewing
* Behavioral: Psychoeducation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current smokers must be over the age of 18, Must have a diagnosis of schizophrenia or schizoaffective disorder Must smoke at least 10 cigarettes per day Must be capable of giving informed consent as measured by Folstein Mini Mental Status Exam of at least 22 Exclusion Criteria: •Those unable to give informed consent.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interviewing<br>Motivational Interviewing | Behavioral: Motivational Interviewing<br>* Motivational Interviewing<br>|
| Active Comparator: Psychoeducation<br>Psychoeducation | Behavioral: Psychoeducation<br>* Psychoeducation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance at first smoking cessation session |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarettes per day |  | 1-Month Follow Up |
Exercise for Patients With Renal Cell Cancer Receiving Sunitinib

Study Overview
=================
Brief Summary
-----------------
In this randomized, controlled trial the investigators evaluate the effects of an exercise program lasting for 12 weeks on the physical performance, the cardiovascular function (24h blood pressure, rest blood pressure and hear function) and the fatigue and mood of patients with renal cell carcinoma undergoing a therapy with Sunitinib.

Official Title
-----------------
Effects of Physical Activity on the Endothelial and Cardiac Function of Patients With Renal Cell Carcinoma Receiving a Thyrosine Kinase Inhibitor (Sunitinib)

Conditions
-----------------
Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Other: Endurance exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 75 years Understanding of written German Treatment with Sunitinib Ability to walk Exclusion Criteria: Cardiovascular, pulmonary or osteoarticular disease which can be aggravated by exercise BMI < 18 or > 30

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Exercise | Other: Endurance exercise<br>* Endurance exercise, 3 times weekly for 35-45 minutes, 12 weeks.<br>|
| No Intervention: 2<br>No structured exercise program | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2max |  | 12 weeks | 
| Systolic and diastolic blood pressure (24 h) |  | 12 weeks | 
| Depression score |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, renal cell carcinoma, fatigue, exercise
Fitness and Daily Function in Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the impact of aerobic fitness on the ability of able and disabled older adults to perform daily functional activities. Subjects are tested in their oxygen use patterns as they perform a series of functional tasks (such as walking on stairs) and following a 24-week training program focused on improving the ability to perform daily tasks likely requiring aerobic fitness (such as walking on stairs).

Official Title
-----------------
Oxygen Kinetics, Mobility Task Performance, and Task Training in Older Adults

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Behavioral: Task specific endurance training
* Behavioral: Tai Chi


Participation Criteria
=================
Eligibility Criteria
-----------------
Both healthy and self-reported mobility-impaired older adults

Ages Eligible for Study
-----------------
Minimum 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Task specific endurance training|nan|
|Behavioral: Tai Chi|nan|

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
-----------------
Rehabilitation, exercise test, aging
A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-219)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of osteoarthritis of the knee.

Detailed Description
-----------------
The duration of treatment is 6 weeks.

Official Title
-----------------
A Randomized, Placebo-Controlled, Parallel-Group, Double -Blind Study to Evaluate the Safety and Efficacy of Rofecoxib 12.5 mg and Celecoxib 200 mg in Patients With Osteoarthritis of the Knee

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: MK0966, rofecoxib
* Drug: Comparator: celecoxib, placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoarthritis of the knee which requires treatment with medication for pain relief Exclusion Criteria: Any known allergy to the study drug

Ages Eligible for Study
-----------------
Minimum Age: 40 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

| Intervention/Treatment |
| --- |
|Drug: MK0966, rofecoxib|nan|
|Drug: Comparator: celecoxib, placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteoarthritis (OA) of the knee as measured by Patient Global Assessment of Response to Therapy (PGART) and WOMAC VA 3.0 over 6 weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OA of the knee as measured by PGART over 6 wks of treatment. |  |  | 
| WOMAC Question #1 over 6 wks of treatment. |  |  |