linjc16/ctgov huggingface dataset:
Black Pooling Project

Study Overview
=================
Brief Summary
-----------------
To conduct a person-level meta-analysis by pooling 9 United States studies with both black and white cohorts.

Detailed Description
-----------------
BACKGROUND: Over the last three decades a sustained and marked decline in death rates from coronary heart disease (CHD) has occurred for all major demographic groups of the US population. Recently, however, the decline has proceeded less rapidly in blacks than in whites, and in women than men. These trends have focused further attention on possible heterogeneity in the risk factor patterns among the demographic sub-groups. As is well recognized, the knowledge on CHD risk factors and statistical models used to predict personal risk of CHD have been based on studies among white populations. In some epidemiological studies with samples from black populations, large variation in the effect of specific factors has been noted. Given the small sample of blacks under investigation, however, low statistical power exists for many of the black-white comparisons. The fundamental obstacle to progress in this area remains the absence of the cohorts of sufficient size that is representative of all four major groups. Hence, a strong rationale exists to undertake a pooling project to clarify a set of important unanswered questions in cardiovascular disease epidemiology. DESIGN NARRATIVE: Person-level meta-analysis will be conducted by pooling 9 large United States epidemiologic studies with both black and white samples: the First National Health and Nutrition Examination Survey (NHANES I) Epidemiological Follow-up Study, the NHANES II Mortality Follow-up Study, the Charleston Heart Study, the Evans County Heart Study, the Chicago Heart Association Detection Project in Industry, the Atherosclerosis Risk in Communities Study (ARIC), the Follow-up Study of the screenees for the Multiple Risk Factors Intervention Trial (MRFIT), the Follow-up Study of the participants from the MRFIT, and the Follow-up Study of the participants from the Hypertension Detection and Follow-up Program (HDFP). Black-white comparison will be performed on the CHD incidence and mortality, exposure-outcome relationship, patterns of co-morbidity (or coexistence of risk factors) and population attributable risk. Multivariate risk functions will also be examined in blacks and whites in the three contexts: ordering risk, magnitude of relative risks, and estimation of absolute risk.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases

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

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Retrospective Study of Incidence and Etiology of Reoperation After Primary Augmentation With Natrelle® Breast Implants

Study Overview
=================
Brief Summary
-----------------
Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)

Official Title
-----------------
Retrospective Multi-centre, Post-marketing Study to Evaluate the Incidence and Aetiology of Reoperations With Allergan Natrelle® Breast Implants in Primary Augmentation (RANBI)

Conditions
-----------------
Breast Implantation

Intervention / Treatment
-----------------
* Device: BIOCELL™ Textured 410 Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary breast augmentation (either bilateral or unilateral) operated on by the investigating surgeon with an infra-mammary approach 410 cohesive BIOCELL™ textured device (Truform 2 & 3 only) has been implanted Primary breast augmentation 3 to 10 years prior to data collection Submuscular/dual plane or subglandular implant placement Exclusion Criteria: Breast augmentation for Poland Syndrome or amastia Breast reconstruction following mastectomy Revision or secondary breast reconstruction Non 410 device at initial breast augmentation Women subsequently diagnosed with fibrocystic disease considered to be pre-malignant Procedures of the breast not related to the primary breast augmentation (e.g. excision of skin lesions) Axillary or peri-areolar approach Glandular mastopexy augmentation (skin excision only)

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Natrelle BIOCELL™ Textured 410 Implant<br>Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation. | Device: BIOCELL™ Textured 410 Implant<br>* Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant | Data were retrospectively collected on the percentage of subjects who had a first reoperation following previous breast augmentation with a BIOCELL™ Textured 410 Implant. | 3 to 10 years |
A Study on the Possible Health Effects of Lean Fish, Fatty Fish and Lean Meat Intake in Non-obese Adults

Study Overview
=================
Brief Summary
-----------------
This study is a pilot study to investigate whether intake of lean or fatty fish, or lean meat would affect parameters related to health in healthy non-obese adults, and will serve as basis for future calculation of group sizes in coming studies. Participants consumed 750g/week of fillets of fish or meat for 4 weeks. Hypothesis: High intake of either lean or fatty fish will not affect serum concentrations of lipids and inflammatory markers as well as improve glucose tolerance during the 4 week intervention period when compared to lean meat intake.

Conditions
-----------------
Metabolic Disorders, Obesity

Intervention / Treatment
-----------------
* Other: Lean fish
* Other: Fatty fish
* Other: Lean meat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults non-obese healthy Exclusion Criteria: diabetes diagnosed diseases of the intestine or cardiovacular system

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lean fish<br> | Other: Lean fish<br>* Participants consumed 150g of lean fish, five times per week for 4 weeks<br>|
| Experimental: Fatty fish<br> | Other: Fatty fish<br>* Participants consumed 150g of fatty fish, five times per week for 4 weeks<br>|
| Experimental: Lean meat<br> | Other: Lean meat<br>* Participants consumed 150g of lean meat, five times per week for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in metabolic parameters (lipids, glucose, inflammatory markers) measured in serum |  | Endpoint after 4 weeks intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight |  | Endpoint after 4 weeks intervention |
Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair

Study Overview
=================
Brief Summary
-----------------
Today Endoscopic repair of recurrent Tracheesophageal fistula (TEF) is a safe procedure. Using Trichlosiacetic acid 50% (TCA) for endoscopic aplication of the fistula was reported with a good results ( 4 cases). There were no serious advers effects. The investigators want to use also TCA 50% for endoscopic repair in children with recurrent TEF.

Detailed Description
-----------------
Today Endoscopic repair of recurrent Tracheesophageal fistula (TEF) is a safe procedure. Using Trichlosiacetic acid 50% (TCA) for endoscopic aplication of the fistula was reported with a good results ( 4 cases). There were no serious advers effects. We want to use also TCA 50% for endoscopic repair in children with recurrent TEF.

Official Title
-----------------
Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair

Conditions
-----------------
Tracheo Esophageal Fistula

Intervention / Treatment
-----------------
* Procedure: Endoscopic repair of recurrent TEF by trichloroacetic acid aplications


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children age 1 month- 20 years old with recurrent TEF. Failure of surgical repair.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 20 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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic repair of recurrent TEF by trichloroacetic acid aplications|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure of the fistula | Closure of the fistula |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical and pulmonary improvment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
We will treat children age 1 month to 20 years with recurrent TEF after surgical failure
A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and immunogenicity of different combinations of influenza vaccine in healthy young children.

Official Title
-----------------
A Phase Ib, Randomized, Observer-Blind, Multicenter, Factorial-Design Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Injections of Trivalent Inactivated Influenza Vaccine With or Without a Second Influenza B Strain in Combination With or Without One of Three Different Doses of Adjuvant in Healthy Children, Aged 6 to <36 Months

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Adjuvanted and un-adjuvanted influenza vaccines


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children of 6 month to <36 month of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator. Exclusion Criteria: History of serious disease. History of serious reaction following administration of vaccine or hypersensitivity to vaccine components. Known or suspected impairment/alteration of immune function.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 35 Months

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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Adjuvanted and un-adjuvanted influenza vaccines<br>* 16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment. |  | 50 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strain-specific influenza antibody titers will be used to assess Immunogenicity |  | 50 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza, Flu, Vaccine, Adjuvant
Comparison of Vascular Effects After Therapy With Irbesartan and Atorvastatin.

Study Overview
=================
Brief Summary
-----------------
Vascular responses to angiotensin II and histamine are compared before and after 30 days of systemic treatment with either irbesartan 150 mg or atorvastatin 20 mg.

Detailed Description
-----------------
Vascular responses to angiotensin II and histamine are compared before and after 30 days of systemic treatment with either irbesartan 150 mg or atorvastatin 20 mg.

Official Title
-----------------
Characterization of Local Vascular Effects of Angiotensin II and Histamine After Treatment With Irbesartan and Atorvastatin.

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: atorvastatin
* Drug: irbesartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects no relevant disease amendment: hypercholesterolaemic subjects Exclusion Criteria: any relevant disease

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

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

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: atorvastatin|nan|
|Drug: irbesartan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vascular responses after treatment. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
venoconstriction, venodilation, pleiotropic effects
Atorvastatin/CoenzymeQ10 in Congestive Heart Failure

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the effect of addition of combination of Atorvastatin/CoenzymeQ10 to standard congestive heart failure (CHF) treatment versus addition of Atorvastatin alone on CHF outcomes.

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

Intervention / Treatment
-----------------
* Drug: Atorvastatin
* Drug: Coenzyme Q10
* Drug: placebo for coenzyme Q10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented Congestive hear failure Ejection Fraction less than 40 percent Compensated heart failure without hospital admission during previous three months No change in type and dose of medications in the last months New York Heart Association Function Class 2 to 4 Exclusion Criteria: Acute coronary syndrome developing in the last month Active myocarditis Active pericarditis Uncontrolled hypertension Hepatic failure(Child B,C) Pulmonary failure Renal failure Heart failure with KILLIP classification 3 and 4
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coenzyme Q10 & Atorvastatin<br>10 mg Atorvastatin daily plus 100 mg Coenzyme Q10 pearl supplement twice daily for four months. | Drug: Atorvastatin<br> <br> Drug: Coenzyme Q10<br> <br> |
| Active Comparator: Atorvastatin & placebo<br>10 mg Atorvastatin daily and the placebo of Coenzyme Q10 pearl for four months. | Drug: Atorvastatin<br> <br> Drug: placebo for coenzyme Q10<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiac Ejection Fraction (EF) | For the determination of change in EF,cardiac EF was determined two times . Baseline :at the beginning of study(before intervention) and the second time after 4 months(after intervention). | Baseline for the first time and after 4 months for the second time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in New York Heart Association Function Class | For the determination of change in New York Heart Association Function Class.it was determined two times .Baseline:at the beginning of study(before intervention)and the second time after 4 months(after intervention). | Baseline for the first time and after 4 months for the second time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coenzyme Q10, Atorvastatin, clinical trial, congestive heart failure
Low-dose Peg-interferon Plus Ribavirin (IFN/RBV) for Prevention of Hepatocellular Carcinoma (HCC) Recurrence in Patients Who Had Surgery to Remove Primary HCC

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether low-dose peg-interferon plus ribavirin therapy is effective in the prevention of hepatocellular carcinoma (HCC) in patients who had the curative resection of primary HCC.

Official Title
-----------------
Phase 4 Study of Peg-interferon Plus Ribavirin Therapy for Prevention of Hepatocellular Carcinoma

Conditions
-----------------
Hepatitis C, Chronic

Intervention / Treatment
-----------------
* Drug: interferon-alfa-2b and ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Hepatocellular carcinoma due to Chronic Hepatitis C Virus Infection. Must be treated with curative treatment for primary tumor using either surgical resection or radiofrequency ablation therapy Exclusion Criteria: No recurrence of hepatocellular carcinoma 3 months after the primary treatment Renal dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: interferon<br> | Drug: interferon-alfa-2b and ribavirin<br>* Interferon, pnce per week plus daily ribavirin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse effect of interferon |  | During the treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatocellular carcinoma
Companion Dog & Loneliness in Elderly Persons

Study Overview
=================
Brief Summary
-----------------
Elderly may have problems to create personal connections or to have physical activities in their day- to - day life; loneliness and social isolation may increase fragility in this population. Companion dog presence favours social relations, affective feelings and physical exercises. On the other hand dog presence raises risk of falling and has a cost for its owner. This project seeks to assess positive impacts of companion dog presence in elderly living at home. This transdisciplinar study (general practionners, veterinarians, dog instructors, nurses, researchers) evaluates loneliness and social isolation between elderly with or without a companion dog at home. Objective:To Evaluate the link between companion dog presence and loneliness in elderly persons living at home Method: An Observational, multicentric, transversal, national, comparative study (elderly with companion dog vs elderly without a dog). 200 subjects needed

Official Title
-----------------
Companion Dog Impact on Loneliness and Social Link in Elderly Persons (≥ 75 Years Old) Living at Home : a Comparative Transversal Study

Conditions
-----------------
Elderly, Companion Dog, Home Based, Loneliness

Intervention / Treatment
-----------------
* Other: dog presence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: person aged ≥ 75years old living at home Exclusion Criteria: bedridden person person accompanied by any animal, other than a dog EPHAD based (establishments providing care for the dependent elderly) comprehension or reading difficulties in french affecting study participation and scales assessment cognitive, mental ou psychic disorders person under legal protection

Ages Eligible for Study
-----------------
Minimum Age: 75 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 |
| --- | --- |
| Elderly with a companion dog<br>elderly living at home with a dog consulting his family doctor | Other: dog presence<br>* This project seeks to assess positive impacts of companion dog presence in elderly living at home ; to assess loneliness and isolement between eldlery with a companion dog and without, at home<br>|
| Elderly without a companion dog<br>elderly living at home without a dog consulting his family doctor | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of loneliness using Jong Gierveld scale (11items). | emotional dimension (6items) social dimension (5items) | 5 to 10 days after inclusion visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| social isolation | Social Network Index french version (http://dx.doi.org/10.13072/midss.464) | 5 to 10 days after inclusion visit |