linjc16/ctgov huggingface dataset:
Diet, Exercise and Cardiovascular Health Among Ethnic Children

Study Overview
=================
Brief Summary
-----------------
To document the patterns of influence or socialization from parents to children in regard to the transmission of cardiovascular disease risk related behaviors such as diet and physical activity.

Detailed Description
-----------------
BACKGROUND: While much of the research in heart disease prevention has focused on relationships among cardiovascular disease risk factors, cardiovascular disease morbidity and mortality, there is a growing recognition of the importance of various health behaviors, such as what people eat, how much they exercise, if they smoke, their habitual approach to life including Type A behavior. Many of these risk related behaviors are correlated with the various cardiovascular disease risks. This study determined differences in social influence patterns in regard to diet and exercise between obese and non-obese families, and the impact on the obesity, dietary and exercise habits, and risk factors of children beginning at three to four years of age until seven to eight years. DESIGN NARRATIVE: This prospective, longitudinal study collected data on the twelve cohorts of families. Blood pressures, resting pulse, height, weight, skinfolds, plasma cholesterol fractions and Type A behavior data were collected on the children at five times over the course of five years. During the four years between each of the clinic measurements, observational data were collected on the diet and exercise habits of the children. At the time of clinic assessment, clinic data were also collected on the parents of the children and self report data on the parents' diet, exercise habits, and other psychosocial variables. Two substudies were also conducted. The first assessed energy expenditure levels of children in the three age groups of 3-4 years, 5-6 years, and 7-8 years and the three body types of lean, average, and obese in 12 different activities. The second substudy assessed the accuracy of mothers' 24-hour recall of the diet and exercise behaviors of their 3-4 year old children as compared to observational data on the same behaviors.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
SEBBIN Round, Anatomical and Biconvex Gluteal Implants

Study Overview
=================
Brief Summary
-----------------
This study is part of the clinical evaluation of SEBBIN silicone gel-filled gluteal implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.

Official Title
-----------------
Prospective Observational Study About SEBBIN Gluteal Implants

Conditions
-----------------
Complication, Prosthesis Durability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient is a man or a woman ≥ 18 years old at the time of inclusion. The patient is planned for a unilateral or bilateral gluteal implant placement with SEBBIN implants as per investigator decision The patient has been informed of the study, has read the patient informed consent and provided consent for the study in writing. Exclusion Criteria: Patient implanted with silicone implants somewhere else in the body. Patient candidate for implantation with custom-designed implants. Participation in another interventional clinical study (participation into an observational study is permitted) with a medicinal product or a medical device in the 30 days prior to enrolment.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate |  | At 10 years of follow-up |
Glucose Metabolism and Quality of Life in Healthy Women

Study Overview
=================
Brief Summary
-----------------
Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. Women with PCOS often have problems with fertility, unwanted hair growth, and irregular menstrual cycle. PCOS is associated with obesity, changes in glucose metabolism and low quality of life. In the present study, hormonal profile, glucose metabolism, adrenal functon, androgen levels, cortisol metabolism, anflammatory response, ovarian morphology, body composition, pfysical activity and quality of life is studied in 40 healthy women. The results will be compared with results from studies on women with PCOS in order to investigate any differences in these parametres.

Official Title
-----------------
Glucose Metabolism, Adrenal Function, Cortisol Metabolism, Body Composition Physical Activity, and Quality of Life in Healthy Women

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy No medications regular menstrual cycle no hair growth problems BMI 18-35 kg/m2 Exclusion Criteria: medication diabetes mellitus signs of PCOS BMI < 18 or > 35

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Controls<br>Healthy control women | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of androgens | Level of testosterone and sexual hormone binding globuline in blood samples | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life measured by validated questionnaires | Baseline | 
| Body composition | Body composition measured by full body DXA-scan with estimates on lean body mass and fat mass | baseline | 
| Bone density | Bone density measured by DXA scan of hip and wrist | baseline | 
| Glucose tolerance | Glucose tolerance measured by 5 hour oral glucose tolerance test with blood glucose measurements for 5 hours after oral intake of 75 g glucose | 5 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy women, Quality of life, Glucose metabolism, Adrenal reactivity, Physical activity, Body Composition
Bioequivalency Study of Meloxicam Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane Laboratories' Meloxicam tablets, 15 mg, to Mobic® Tablets, 15 mg (Boehringer Ingelheim) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 15 mg Meloxicam Tablets Under Fasting Conditions

Conditions
-----------------
Inflammation

Intervention / Treatment
-----------------
* Drug: Meloxicam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Meloxicam or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Fourteen day washout | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti-inflammatory
Use of Synvisc® in Knee Osteoarthritis - Survey on Practice

Study Overview
=================
Brief Summary
-----------------
Study of prescription methods in everyday medical practice, tolerance profile and effect of Synvisc® until six months of follow-up.

Official Title
-----------------
Use of SYNVISC in Knee Osteoarthritis. Survey on Practice. U.S.A.G.E Pratique

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

Intervention / Treatment
-----------------
* Drug: Synvisc®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: not applicable Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Synvisc®<br> | Drug: Synvisc®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical symptoms | assessed via questionnaire | up to 6 months | 
| Amount of medication consumed |  | up to 6 months | 
| Patient satisfaction on a 4-point verbal rating scale |  | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | up to 6 months |
Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions

Study Overview
=================
Brief Summary
-----------------
There is a pressing need to find effective strategies for the prevention of contrast induced nephropathy in patients with advanced renal dysfunction. The current study was designed to assess the efficacy of a new protocol for preventing contrast induced nephropathy in patients with advanced renal dysfunction undergoing coronary interventions

Official Title
-----------------
The Efficacy of a New Protocol for Preventing Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions

Conditions
-----------------
Kidney Disease, Chronic, Ischemic Heart Disease

Intervention / Treatment
-----------------
* Procedure: Percutaneous coronary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with estimated glomerular filtration rate<45ml/min undergoing coronary angiography due to one of the following indications in accordance with the 2014 guidelines: Elective coronary angiography due to symptoms suggestive for angina with a positive non-invasive ischemia assessment of ≥10% of left ventricle. Non ST-elevation acute coronary syndrome with a GRACE score>110 Exclusion Criteria: Patients on dialysis or those planned for dialysis in the next 3 months. Patients with ST-elevation myocardial infarction No symptoms or signs of heart failure Treatment with IV diuretics during the 48 hours prior to enrolment Patients with acute renal failure (Creatinine raise of at least 0.3mg/dl from )baseline Patients post coronary artery bypass surgery

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coronary angiography<br>Patients undergoing coronary angio with or without percutaneous coronary intervention using a new protocol designed to minimize the exposure to contrast medium | Procedure: Percutaneous coronary intervention<br>* Patients planned for coronary angiography or percutaneous coronary intervention will be managed using a protocol that allows us to use minimal volumes of contrast dye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in glomerular filtration rate following coronary angiography or intervention | Significant changes are defined as a reduction ≥25% in glomerular filtration rate | 24 and 48 hours post procedure |
The Early and Late Contribution of Fasting and Postprandial Triglycerides on Newborn Subcutaneous and Intrahepatic Fat in Pregnancy

Study Overview
=================
Brief Summary
-----------------
This study plans to learn more about how triglyceride levels in pregnancy affect newborn fat mass. Obesity in pregnancy, in the absence of gestational diabetes, is now the most common cause of large-for-gestational-age infants and increased newborn fat mass. Previous data supports the idea that maternal triglycerides, not glucose, are the strongest predictor of both total newborn fat mass and liver fat. In this study, mothers will monitor triglyceride and glucose levels at specific points in pregnancy using point-of-care meters at home. Two weeks after birth, infants will have total fat measured by air-displacement plethysmography (PEAPOD) and liver fat measures by Magnetic Resonance Spectroscopy (MRS). The central hypothesis is that in obesity, fasting triglycerides and postprandial triglycerides will predict newborn fat mass in a free-living environment.

Official Title
-----------------
The Early and Late Contribution of Fasting and Postprandial Triglycerides on Newborn Subcutaneous and Intrahepatic Fat in Pregnancy

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women less than 16 weeks gestational age Between the ages of 21-39 years Pre-pregnancy BMI 28-39 kg/m2 Exclusion Criteria Pre-gestational diabetes or prediabetes History of gestational diabetes History of pre-eclampsia, spontaneous pre-term delivery, or gestational hypertension <34wks Tobacco or illicit substance use Chronic steroid use

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 39 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 |
| --- | --- | --- |
| Newborn Fat Mass | Newborn fat mass measured by air displacement plethysmography (PeaPod) | 7-14 days after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newborn Intrahepatic Fat | Newborn intrahepatic fat measured by Magnetic Resonance Spectroscopy (MRS) | 7-14 days after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Triglycerides, Glucose, Adiposity, Air displacement plethysmography, Continuous glucose monitoring
Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, 3-period crossover phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on febuxostat pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of febuxostat on tranilast PK and PD as measured by reduction in serum uric acid levels.

Official Title
-----------------
A Randomized, Double-Blind, Crossover, Pharmacodynamic and Pharmacokinetic Drug Interaction Study of Tranilast in Combination With Febuxostat Compared With Tranilast Alone and Febuxostat Alone in Healthy Subjects With Hyperuricemia

Conditions
-----------------
Gout, Hyperuricemia

Intervention / Treatment
-----------------
* Drug: Tranilast
* Drug: Febuxostat
* Drug: Combination - Tranilast and Febuxostat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, aged 18 to 70 Subjects with hyperuricemia who are otherwise healthy Exclusion Criteria: Pregnant or nursing Known history of gout Clinically significant infection at Screening Known sensitivity to tranilast or febuxostat

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranilast<br>Tranilast tablets | Drug: Tranilast<br>* Tranilast tablets, 300 mg, QD<br>|
| Active Comparator: Febuxostat<br>Febuxostat tablets | Drug: Febuxostat<br>* Febuxostat Tablets, 40 mg, QD<br>* Other names: Uloric;|
| Experimental: Combination<br>Tranilast plus febuxostat | Drug: Combination - Tranilast and Febuxostat<br>* Tranilast, 300 mg QD; Febuxostat, 40 mg QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean decrease in serum uric acid levels |  | Seven days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, febuxostat and combination |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gout, Hyperuricemia
Depot Disulfiram for AIDS and ARC

Study Overview
=================
Brief Summary
-----------------
To assess the safety and efficacy of depot disulfiram as a new treatment for AIDS and AIDS related complex.

Official Title
-----------------
Depot Disulfiram for AIDS and ARC

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

Intervention / Treatment
-----------------
* Drug: Disulfiram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have a positive diagnosis of AIDS or AIDS related complex (ARC) according to the CDC criteria. Also patient must be: Able to understand the study. Strongly motivated to participate in the study, and willing to comply with all the conditions specified in the informed consent forms. Ambulatory and able to maintain an independent life outside the hospital. Free of clinically significant organic disease affecting neurologic, hepatic, renal, and clinical status. Patients must be free of clinically significant organic disease affecting neurologic, hepatic, renal, and clinical status. Patients must be free of clinically significant organic disease affecting neurologic, hepatic, renal, and clinical status. History of alcohol abuse.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Disulfiram|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
-----------------
Delayed-Action Preparations, Disulfiram, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
Diagnostic Pilot Study of Dual Energy Absorptiometry in the Detection of Osteopenia or Osteoporosis in Patients With Thalassemia Major

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the frequency and severity of osteopenia and osteoporosis in patients with thalassemia major who undergo dual energy x-ray absorptiometry, and correlate these findings with other relevant endocrinologic measurements.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients undergo dual energy x-ray absorptiometry for bone density measurements, height (sitting and standing) and weight measurements, comprehensive endocrinologic examination, and assessment of the severity of iron overload at baseline, and then at years 1 and 2.

Conditions
-----------------
Osteoporosis, Thalassemia Major, Osteopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Diagnosis of thalassemia major with iron overload Not pregnant Negative pregnancy test

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
disease-related problem/condition, genetic diseases and dysmorphic syndromes, hematologic disorders, osteoporosis, rare disease, thalassemia major