linjc16/ctgov huggingface dataset:
Genetics, Metabolism and Weight Loss in Older, Obese Veterans

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine whether sequence variation in the lipoprotein lipase (LPQ) gene affects the amount of weight loss and metabolic responses during a hypocaloric diet treatment for overweight and obese (BMI=25-35 kg/m2), older (50-65 yrs), sedentary veterans.

Detailed Description
-----------------
Veterans who are 50-65 yrs, non-smoking, sedentary and weight stable with a BMI between 25-35 kg/m2 (120-150% desirable body weight) are recruited and screened via telephone, medical history, and physical exam. Exclusion criteria are: diabetes, hypertriglyceridemia (>400 mg/dl), history of cancer or myocardial infarction, clinical depression, renal, liver or hematologic disease, and medications that affect glucose or lipid metabolism (thiazides, estrogen replacement, beta-blockers). Changes in total and visceral body fat are measured by dual x-ray absorptiometry and computerized tomography, resting energy expenditure and fat oxidation rate by indirect calorimetry, and lipoprotein lipids by enzymatic assay. Glucose tolerance is assessed during a three-hour oral glucose tolerance test with measurement of glucose- and insulin levels every 30 minutes. LPL activity is measured in 3050mg pieces of subcutaneous abdominal and gluteal adipose tissue.

Official Title
-----------------
Genetics, Metabolism and Weight Loss in Older, Obese Veterans

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

Intervention / Treatment
-----------------
* Behavioral: Weight Loss


Participation Criteria
=================
Eligibility Criteria
-----------------
50-65 yrs, non-smoking, sedentary and weight stable with a BMI between 25-35 kg/m2 (120-150% desirable body weight) are recruited and screened via telephone, medical history, and physical exam. Exclusion criteria: Diabetes, Hypertriglyceridemia (>400 mg/dl), History of cancer or myocardial infarction, Clinical depression, Renal, liver or hematologic disease, and Medications that affect glucose or lipid metabolism (thiazides, estrogen replacement, beta-blockers).

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Non-Randomized
Intervention Model: Single Group Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Weight Loss|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
-----------------
Behavioral, Weight Loss, Genetics, Lipoprotein lipase, Visceral fat, Lipoprotein
Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients

Study Overview
=================
Brief Summary
-----------------
AIR STUDY TITLE: Anti-Ischemic effects of Abciximab(Reopro) PATIENT POPULATION: Patients undergoing PCI(an interventional procedure placing a small stent/metallic tube to keep a narrowed artery in your heart open) and either on a stable statin dose or not on a statin. Statin= cholesterol lowering drug(ie, lipitor, zocor). INTERVENTION: Heparin vs. heparin + abciximab during PCI PURPOSE: Measure the effects of abciximab on special healing blood stem cells (EPC's-Endothelial Progenitor Cells), on inflammation, on oxidative stress and on microvascular blood flow. PATIENT ASSESSMENT: 50ccs blood draw on day 1(from sheath), day 2 ,day 7 and day 28. Measurement of blood flow in selected suitable patients 10 minute questionnaire before discharge and on visit on day 28.

Official Title
-----------------
Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients (AIR)

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Abciximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have either: clinical history of anginal symptoms or positive stress test or in stent restenosis Have an angiographic >70% coronary artery stenosis that will be treated with coronary angioplasty or stenting procedure For at least four weeks prior to the procedure have been on, no Hmgcoa- reductase inhibitor or a stable statin dose negative pregnancy test are able to give informed consent Exclusion Criteria: Coronary intervention within four weeks prior to enrollment. Treatment with abciximab antagonist within four weeks. treatment with thrombolytic therapy within 48 hours MI within 2 months. recent infections general anesthesia within 3 months. renal failure

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 |
| --- |
|Drug: Abciximab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pilot Study to Assess Feasibility, Reliability and Validity of the e-SSRS-IVR

Study Overview
=================
Brief Summary
-----------------
The proposed study is designed to evaluate the clinical contents of the e-SSRS-IVR with respect to 1.the intent of the instrument (assess face and content validity), 2. system validation with respect to programming integrity, 3. implementation feasibility in clinical ill and healthy patient populations, and 4. criterion/predictive validity to discriminate patient population with known clinical status differences.

Official Title
-----------------
Pilot Study to Assess Feasibility, Reliability and Validity of the e-SSRS-IVR

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking adults, able/willing to read and provide written consent Exclusion Criteria: Dementia, delirium, psychosis or deafness. Control subjects will be excluded for any MINI lifetime MDD or dysthymia diagnosis of a DSM-IV disorder except for specific phobia or dependence on nicotine and caffeine. Inpatients not admitted with suicidal ideations

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospital Patients/Hospital Employees<br> | |
| Hospital employees<br>A group of 10 hospital employees used as baseline | |

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
-----------------
Evaluate the clinical content of the e-SSRS-IVR
Effect of Clitoris Location on Orgasm

Study Overview
=================
Brief Summary
-----------------
Topography and location of clitoris and its parts may affect the orgasm

Detailed Description
-----------------
Orgasm measurement via Orgasm domain of Female Sexual Function Index, clitoris volume, suprapubic angle, urethra-levator gap, suburethral triangle area measurement could made using 4 D transperineal ultrasonography. Clitoris fourchette distance, clitoris perineal body distance, clitoris urethra distance could made with special compasses.

Official Title
-----------------
Effect of Clitoris Topography on Orgasm

Conditions
-----------------
Sexual Dysfunction

Intervention / Treatment
-----------------
* Other: Orgasm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sexually active women between 18 and 50 years old BMI below 40 kg/m2 Exclusion Criteria: BMI over 40 mhg/m2, Women younger than 18 years old Virgins No active sexual intercourse, women with Handicapped to get lithotomy position Active vulvar and vaginal infection Psychiatric diseases Drug usage that may cause sexual dysfunction, menopause.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low orgasm<br>Female Sexual Function Index orgasm score below 3.6 | Other: Orgasm<br>* clitoris volume, suprapubic angle, urethra-levator gap, suburethral triangle area measurement could made using 4 D transperineal ultrasonography. Clitoris fourchette distance, clitoris perineal body distance, clitoris urethra distance could made with special compasses. Female Sexual Function Index orgasm domain score<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| orgasm score |  | 12 weeks |
Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors

Study Overview
=================
Brief Summary
-----------------
Pancreatic cancer is among the most serious human neoplasia and the most difficult to treat. Most patients present at diagnosis a non resectable, locally advanced or metastatic disease, with a median survival of 12 month. The aim of this study is the identification of diagnosis biomarkers, predictive of the therapeutic response. This project investigate the use of molecular analyses applied to pancreatic tumor cells collected by microbiopsy under ultrasound-endoscopy, and blood cells.

Official Title
-----------------
Research for Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors - PACAomics / IPC 2011-004

Conditions
-----------------
Pancreatic Tumor

Intervention / Treatment
-----------------
* Procedure: suspected pancreatic tumor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspicion of pancreatic adenocarcinoma Patient > 18 years old Social Security affiliation Signed informed consent Exclusion Criteria: Patient in emergency situation Major person being the object of a legal protective measure or unable to express its 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: suspected pancreatic tumor<br>Realization of pancreatic tumor biopsy and blood samples | Procedure: suspected pancreatic tumor<br>* Realization of pancreatic surgery to obtain tumor biopsy and blood samples to realize biomarkers analyses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers | Genomics, transcriptomics and proteomics analyses to determine presence or absence of biomarkers | within twenty four hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histology | To determine the histologic characteristics of the pancreatic tumor | within twenty four hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic tumor
Exercise During Pregnancy and Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on urinary incontinence.

Official Title
-----------------
Effect of Physical Exercise Program During Pregnancy on Urinary Incontinence

Conditions
-----------------
Pregnancy, Healthy

Intervention / Treatment
-----------------
* Behavioral: Supervised physical exercise program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy pregnant women Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Pregnant women receiving usual care and participating in supervised physical exercise program. | Behavioral: Supervised physical exercise program<br>* Supervised physical conditioning program of two 60-minutes sessions per week during pregnancy, developed from gestational week 20 to 38. Each session consists of 25-30 minutes of cardiovascular exercise,15 minutes of strengthening exercises, 5 minutes of coordination and balance exercises and 10 minutes of pelvic floor muscles training.<br>|
| No Intervention: Control group<br>Pregnant women that are receiving usual care but are not participating in supervised physical exercise program. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary incontinence | Urinary incontinence was measured by the International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF). | Gestational week 36-38 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Physical exercise, Urinary incontinence
GM-CSF in Patients With Pulmonary Alveolar Proteinosis

Study Overview
=================
Brief Summary
-----------------
This is a study to determine the efficacy and safety of granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim) administered subcutaneously to patients with pulmonary alveolar proteinosis (PAP).

Detailed Description
-----------------
PAP is a rare lung disease characterized by accumulation of surfactant phospholipids and proteins within the lungs. There is no specific pharmacologic therapy for PAP and the current practice of lung lavage under general anesthesia is invasive and has limitations. Although it is unknown if the anti GM-CSF antibody is related to the disease pathogenesis, observations suggest a role for GM-CSF in lung homeostasis as well as in the pathogenesis of PAP. Patients will receive subcutaneous GM-CSF or placebo once a day and will be followed on an outpatient basis at 2 weeks, and 1, 2, 3, 4, 5 and 6 months after initiation of therapy. Clinical response will determine dosing schedule and will be evaluated by symptom scores, gas exchange data, and chest radiographs. Completion date provided represents the completion date of the grant per OOPD records

Official Title
-----------------
Trial of GM-CSF for Alveolar Proteinosis

Conditions
-----------------
Pulmonary Alveolar Proteinosis

Intervention / Treatment
-----------------
* Drug: GM-CSF (granulocyte-macrophage colony-stimulating factor, sargramostim)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of primary or idiopathic PAP Creatinine no greater than 2 mg/dL Bilirubin no greater than 2 mg/dL Liver enzymes no greater than 3 times normal Women must use an effective method of contraception, be post menopausal, or be surgically sterilized Exclusion criteria: Active respiratory infection Active cardiovascular disease (e.g., cardiogenic pulmonary edema) Underlying myeloproliferative disorder or leukemia Other secondary cause of PAP (e.g., occupational exposure to silica or HIV with PCP) At increased risk of side effects from GM-CSF therapy (i.e., rheumatoid arthritis, immune thrombocytopenia, or autoimmune thyroiditis) Previous therapy with GM-CSF Pregnant or nursing Significant renal or liver 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GM-CSF (granulocyte-macrophage colony-stimulating factor, sargramostim)|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
-----------------
Sargramostim, Injections, Subcutaneous
The Impact of Preemptive Epidural Analgesia on Acute Postoperative Pain in Pediatric Orthopedic Surgery

Study Overview
=================
Brief Summary
-----------------
Management of postoperative pain is critical in the pediatric patients, however, safe and effective analgesia for pediatric surgical patients remains a challenge. Preemptive analgesia is based on preventing a prolonged change in central nervous system function by blocking afferent input before the surgical stimulation may evoke central sensitization and aggravate amplification and prolongation of postoperative pain. However, the clinical efficacy of preemptive analgesia is still controversial. In this study, the investigators aim to assess the impact of preemptive epidural analgesia on postoperative pain in pediatric patients for corrective osteotomy of the lower extremities expecting severe postoperative pain.

Conditions
-----------------
Pediatric Surgical Patients, Preemptive Epidural Analgesia

Intervention / Treatment
-----------------
* Procedure: 0.2 ml/kg of 0.2% ropivacaine
* Procedure: 0.2mg/kg of Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients (3-12 years of age) scheduled for corrective osteotomy of the lower extremities ASA class I and II Exclusion Criteria: Coagulopathy Neurological disease Allergy to local anesthetics or contraindication to use of ropivacaine Infection at the site of epidural catheter insertion

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preemptive group<br>Group who will be received ropivacaine bolus and continous infusion 5 minutes before skin incision. | Procedure: 0.2 ml/kg of 0.2% ropivacaine<br>* In the preemptive group, 5 minutes before skin incision, the epidural catheter is dosed with 0.2 ml/kg of 0.2% ropivacaine, followed by continuous infusion of 5 minutes before skin incision at 0.2 ml/kg/h.<br>|
| Placebo Comparator: saline group<br>Group who will be received saline bolus and continous infusion 5 minutes before skin incision | Procedure: 0.2mg/kg of Normal Saline<br>* In the saline group, 5 minutes before skin incision, the epidural catheter is dosed with 0.2 ml/kg of normal saline, followed by continuous infusion of 5 minutes before skin incision at 0.2 ml/kg/h.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FLACC scale score (Face, Legs, Activity, Cry, Consolability) |  | 0-6 hours after the operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
child, analgesia, epidural, pain, postoperative, orthopedics
Physical Activity Counseling During Pulmonary Rehabilitation

Study Overview
=================
Brief Summary
-----------------
This randomized controlled trial will assess the effect of adding intensive physical activity counseling to an outpatient pulmonary rehabilitation program. Counseling including real-time feedback on daily activities from an activity monitor will be offered to improve participation in physical activities in daily life during and after an outpatient pulmonary rehabilitation program.

Official Title
-----------------
Physical Activity Counseling During Pulmonary Rehabilitation: Does it Improve Daily Physical Activity Levels

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Behavioral: physical activity counseling program
* Behavioral: sham counseling program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spirometry-proven COPD Referred for 6-month outpatient pulmonary rehabilitation program Exclusion Criteria: Orthopedic problems impairing daily activities Progressive neurological or neuromuscular disorders Psychiatric or cognitive disorders Patients on the waiting list for lung transplantation
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: physical activity counseling program<br> <br> |
| Sham Comparator: 2<br> | Behavioral: sham counseling program<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking time in daily life and the amount of time spent in moderate intense activities |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, physical activity, pulmonary rehabilitation, counseling