linjc16/ctgov huggingface dataset:
Reducing Pediatric Obesity Through After-school Programs

Study Overview
=================
Brief Summary
-----------------
This study will assess the impact of a national, community-based after-school program promoting physical activity (America SCORES) on obesity, fitness and important cardiovascular risk factors among minority children. The investigators central hypothesis is that established community-based programs, such as America SCORES, can reduce obesity and cardiovascular risk among participants. The 1-year study followed 158 children from 6 public schools, 3 of which were randomized to have SCORES and 3 to usual care after-school program. Primary outcomes are change in body mass index (BMI), physical activity (measured by accelerometer), and fitness (aerobic capacity assessed with the 20-meter shuttle test). Cardiovascular outcomes include blood pressure, body composition (assessed using bioelectrical impedance) and waist circumference. The investigators will also measure academic outcomes.

Detailed Description
-----------------
Baseline measures were collected in September 2009; midpoint measures were collected in January 2010; and final measures were collected in May 2010. Repeated measures analyses will compare trajectories for BMI, physical activity, and fitness between students in the SCORES and the usual care arms.

Official Title
-----------------
Reducing Pediatric Obesity Through After-school Programs

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: America SCORES, Bay Area


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3rd-5th grade student enrolled in after-school program in San Francisco Unified School District Exclusion Criteria: Uncontrolled asthma Unable to participate in moderate physical activity

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCORES<br>America SCORES, Bay Area, after-school program | Behavioral: America SCORES, Bay Area<br>* After-school program promoting physical activity via soccer 3 days/week<br>|
| No Intervention: Usual care<br>Standard after-school programming | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI z-score |  | Baseline (0 months) and 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Aerobic capacity |  | Baseline and 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, minority, child, physical fitness, school, physical activity
Hepatic Mitochondrial Function in Sepsis

Study Overview
=================
Brief Summary
-----------------
Multi-organ failure due to sepsis is a major cause of death in critically ill patients. But the mechanisms leading to this condition are not fully understood. Mitochondrial dysfunction has been shown in skeletal muscle of critically ill septic patients. Liver is very important in sepsis as it is responsible of the synthesis of several inflammatory proteins. Moreover hepatic failure is associated to a bad outcome. The aim of this study is to evaluate the hepatic mitochondrial function in sepsis.

Official Title
-----------------
Evaluation of Hepatic Mitochondrial Function in Sepsis

Conditions
-----------------
Sepsis, Peritonitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Septic group : Peritonitis patients needing surgery Non septic group : Patients needing hepatic surgery Exclusion Criteria: No liver biopsy performed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Control<br>Non septic patients needing hepatic surgery | |
| Sepsis<br>Septic patients needing surgery for peritonitis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitochondrial complex activities |  | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of adenine nucleotides |  | during surgery | 
| Quantification of oxidative stress markers |  | during surgery | 
| Correlation between SOFA score and mitochondrial complex activities |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sepsis, Peritonitis, Mitochondria, Liver
Hemi-Gland Cryoablation for Prostate Cancer at UCLA

Study Overview
=================
Brief Summary
-----------------
This is a prospective data collection of men who are electing to undergo prostate hemi-gland cryoablation. The purpose of this observational research study is to investigate the localized treatment of prostate cancer using hemi-gland cryoablation. UCLA patients undergoing hemi-gland cryoablation are a unique cohort compared to prior research because all patients at UCLA have had a pre-treatment multi-parametric MRI and Ultrasound fusion targeted biopsy; they will be followed in a similar fashion. This results in more precise assessment of a target region of cancer for ablation which may, in turn, result in improved clinical outcomes.

Official Title
-----------------
Cryoablation: An Observational Study of Hemi-Gland Cryoablation Outcomes for Prostate Cancer at University of California at Los Angeles (UCLA)

Conditions
-----------------
Prostate Cancer, Prostate Adenocarcinoma, Prostate Disease

Intervention / Treatment
-----------------
* Device: Hemigland Cryoablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has undergone or has elected to undergo hemi-gland cryoablation at UCLA Low or intermediate risk prostate cancer (Gleason ≤ 7) or select high-risk patients (Gleason 8 prostate cancer). Prostate volume of ≤ 70 cc Ability to complete informed consent form Exclusion criteria: Medical contraindication to follow-up multi-parametric magnetic resonance imaging (mpMRI) or prostate biopsy Patients unable to tolerate general or regional anesthesia.
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hemigland Cryoablation|Hemigland cryoablation for the treatment of prostate cancer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response to Cancer Treatment | Our primary endpoint will be a patient's clinical response to cancer treatment, specifically, the degree of prostate cancer on a post-treatment fusion biopsy compared to pre-treatment. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Assessment - Urinary Function | Comparison of urinary function pre- and post-treatment will be obtained using the International Prostate Symptom Score (IPSS) and the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaires to report combined overall urinary function assessments. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, cryoablation
Evia/Entovis HF-T Master Study

Study Overview
=================
Brief Summary
-----------------
The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and efficacy of these pacemakers. In particular, the left ventricular (LV) capture control feature is evaluated, which automatically measures the LV pacing threshold and subsequently adjusts the pacing output.

Official Title
-----------------
Master Study of the Evia/Entovis HF-T Pacemaker

Conditions
-----------------
Indication for Cardiac Resynchronization Therapy (CRT)

Intervention / Treatment
-----------------
* Device: Evia/Entovis HF-T pacemaker for CRT therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Standard indication for CRT therapy Legal capacity and ability to consent Signed patient informed consent Exclusion Criteria: Contraindication for CRT therapy ICD indication Age < 18 years Pregnant or breast-feeding woman Cardiac surgery planned within the next 6 months Life expectancy of less than 6 months Participating in another clinical study of an investigational cardiac drug or device

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 |
| --- | --- |
| CRT pacemaker implantation<br> | Device: Evia/Entovis HF-T pacemaker for CRT therapy<br>* Implantation of CRT pacemaker and standard follow-ups at pre-hospital discharge, and after 1, 3 and 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Serious Adverse Device Effect (SADE) free rate | While the investigator is asked to record all adverse events throughout the study, only the number of SADEs possibly or securely related to a device deficiency will be the basis for the calculation of the SADE free rate: (1-number of SADE divided by number of patients)%. | Until 3 month follow-up | 
| Efficacy of the left ventricular capture control feature (focus on threshold measurements) | Absolute difference between the triggered automatic and manual pacing threshold in the left ventricle is smaller than 0.3 Volt. | At pre-hospital discharge, 1 and 3 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the left ventricular capture control feature (focus on pulse amplitude adjustment) | Rate of appropriate adjustment of the left ventricular (LV) pulse amplitude by the LV capture control feature is greater than 90%. | 1 and 3 month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pacemaker therapy, Cardiac resynchronisation therapy (CRT)
PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study

Study Overview
=================
Brief Summary
-----------------
The PING-EP study is designed to evaluate electrode properties on phrenic nerve stimulation (PNS) in coronary sinus using a commercially available diagnostic electrophysiology catheter.

Official Title
-----------------
PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: diagnostic electrophysiology catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is indicated for a cardiac resynchronization therapy-pacemaker or defibrillator (CRT-P/CRT-D) implant, for an upgrading from a previously implanted single/dual chamber pacemaker/implantable cardioverter (ICD) or for system revision requiring repositioning of the transvenous left ventricular (LV) lead Patient has signed and dated the study-specific Patient Informed Consent form Subject is at least 18 years of age Exclusion Criteria: Patient has a previous LV lead implanted not requiring repositioning Pregnant woman Patient is enrolled or planning to participate in any concurrent study, which would confound the results of this trial as determined by Medtronic, during the course of this clinical 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: diagnostic electrophysiology catheter|electrical measurements through a diagnostic electrophysiology catheter|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of electrode property on phrenic nerve stimulation (PNS) | Effect of electrode property on PNS in the cardiac veins | at implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of electrode configuration on phrenic nerve stimulation (PNS) |  | at implant | 
| Electrode polarity effect on phrenic nerve stimulation (PNS) |  | at implant | 
| Effect of electrode property on sensing (r-wave amplitude) |  | at implant | 
| Incidence of phrenic nerve stimulation (PNS) in the cardiac veins | Incidence of PNS occurrence in different locations in the cardiac vein | at implant |
French Prospective Anterior Cruciate Ligament Reconstruction Cohort Study (FAST)

Study Overview
=================
Brief Summary
-----------------
In this study we will examine patients who have undergone anterior cruciate and/or posterior cruciate ligament and/or multi ligaments reconstruction to determine the rate of re-injury, contralateral tear and functional outcomes at least two years after surgery.

Detailed Description
-----------------
The purpose of this study is to identify the rate of re tear two year after ligament reconstruction of the knee. The second objective is to assess the osteoarthritis of the knee at 20 years follow-up.

Official Title
-----------------
Prospective Follow-up Study of Patients Undergoing Knee Ligament Surgery

Conditions
-----------------
Rupture of Anterior Cruciate Ligament, Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Ligament of the knee reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One ligament or multi-ligaments tear of the knee Surgery reconstruction with any technique Exclusion Criteria: Patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 7 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Ligament of the knee reconstruction|Reconstruction of ligaments of the knee by autografts|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of re-tear |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Knee Documentation Committee score |  | 2 years | 
| Lyshom score |  | 2 years | 
| Tegner score |  | 2 years | 
| Knee injury and Osteoarthritis Outcome Score |  | 2 years | 
| joint line space measurement on comparative standard radiograph at 30 degree of flexion before surgery and at the final follow-up (Schuss view) |  | 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anterior Cruciate Ligament, Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament
Outcome Analysis of the Oxford Partial Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Prospectively monitor the patients receiving the Oxford Partial knee arthroplasty

Detailed Description
-----------------
Utilization of systematic outcome measurements and specific designated time frames to monitor patient satisfactions will assist in analysing this type of prosthesis and the post operative period. Data collected will be added to the compiled information from previous studies in relation to the Oxford knee.

Official Title
-----------------
Outcome Analysis of the Oxford Partial Knee Arthroplasty

Conditions
-----------------
Knee Arthroplasty

Intervention / Treatment
-----------------
* Device: Oxford Partial Knee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient Suitable for Knee Replacement Exclusion Criteria:
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: 1<br> | Device: Oxford Partial Knee<br>* Oxford Partial Knee<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC, SF12, oxford Knee,KSCRS |  | 3weeks, 3months,6months, yearly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay |  | Postop | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee Replacement
Bifeprunox in the Treatment of Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia.

Official Title
-----------------
A Randomized, Double-Blind, Olanzapine-Referenced, Parallel-Group Safety and Efficacy Study of Flexible Doses of Bifeprunox in the Long-term Treatment of Schizpohrenia (Extension of S1543003)

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: bifeprunox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of schizophrenia understand nature of study able to be managed in out-patient setting for long-term bifeprunox treatment Exclusion Criteria: current primary diagnosis other than schizophrenia suicide risk diagnosis or history of substance abuse uncontrolled hypertension

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bifeprunox|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
-----------------
double-blind study in the treatment of schizophrenia
A Study of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2

Study Overview
=================
Brief Summary
-----------------
To evaluate the prevention of SARS-COV-2 infection after administration of DWJ1248 in person who contact from COVID-19 confirmed patient compared to the placebo.

Official Title
-----------------
A Randomized Double-blinded Controlled Clinical Trial of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2

Conditions
-----------------
Covid19, SARS-COV-2 Infection

Intervention / Treatment
-----------------
* Drug: DWJ1248
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over the age of 19 as of the signed date in written consent Subjects in self-quarantine who contact from COVID-19 confirmed patient Subjects who have COVID-19 negative RT-PCR result Subjects with no symptoms of COVID-19 Exclusion Criteria: Subjects who cannot orally administer the investigational products Subjects who need administration of immunosuppressants Subjects who are allergic or sensitive to investigational products or its ingredients Subjects who have a history of drug and/or alcohol abuse within 12 months before screening Subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Experimental: DWJ1248<br>Camostat mesilate 200mg | Drug: DWJ1248<br>* Orally, 1 tablet of DWJ1248 TID, up to 14 days<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Orally, 1 tablet of placebo TID, up to 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with COVID-19 | positive result in RT-PCR test | Up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with hospitalization | hospitalization due to COVID-19 | Days 3, 7, 14, and 28 | 
| Percentage of subjects who experience intensive care unit (ICU) | ICU requirement due to COVID-19 | Days 3, 7, 14, and 28 |