linjc16/ctgov huggingface dataset:
Satisfaction and Long-term Anatomic Efficacy Study on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008

Study Overview
=================
Brief Summary
-----------------
Satisfaction and Long-term Anatomic Efficacy will be assessed on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008.

Detailed Description
-----------------
Satisfaction and Long-term Anatomic Efficacy will be assessed on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008.

Official Title
-----------------
Satisfaction and Long-term Anatomic Efficacy Study on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008

Conditions
-----------------
Genital Prolapse

Intervention / Treatment
-----------------
* Other: Satisfaction assessment
* Other: Quality of life
* Other: Gynecological assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who underwent a Richter intervention between 01/01/2008 and 31/12/2017 in the Gynecology Department of Foch Hospital Exclusion Criteria: None

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

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

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: Patients who had Richter intervention<br> | Other: Satisfaction assessment<br>* Patient will be asked to assess their satisfaction concerning the Richter procedure and its long term effect<br>Other: Quality of life<br>* The Quality of life will be assessed with 3 questionnaires (I-Qol / PISQ-12/PFDI-20)<br>Other: Gynecological assessment<br>* An optional gynecological consult is proposed to the patients to better estimate the gynecological long-term impact of the procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term satisfaction of the Richter procedure | It will be ask to the patients to evaluate their satisfaction of the procedure, base on a 4-answer scale (Not at all satisfied, Not very satisfied, Moderately satisfied, Fully satisfied) | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term anatomic impact of the procedure | An optional gynecological consult is proposed to the patients | 7 months | 
| Post-operative complications | Post-operative complications will be collected and compared to the anatomic impact of the procedure and the patient satisfaction | 7 months |
Feasibility and Acceptability of an Educational Intervention to Improve the Management of Depression in Primary Care.

Study Overview
=================
Brief Summary
-----------------
Qualitative study based on interviews and questionnaires with patients participating to an educational intervention to improve the management of depression in primary care. Objective is to assess feasibility and acceptability of an educational intervention to improve the management of depression in primary care To elaborate an educational program for the management of depression in primary care.

Detailed Description
-----------------
To assess feasibility and acceptability of an educational intervention to improve the management of depression in primary care To elaborate an educational program for the management of depression in primary care. And perspectives are to elaborate an educational intervention to care depression in primary care

Official Title
-----------------
Feasibility and Acceptability of an Educational Intervention to Improve the Management of Depression in Primary Care

Conditions
-----------------
Patients With Moderate Depression,, First or Second Episode

Intervention / Treatment
-----------------
* Behavioral: an educational intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18-65y moderate depression (CIM 10) first or second episode able to read and understand French language Exclusion Criteria: psychotic symptoms severe depression bipolar disorder suicide risk substance abuse

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental arm<br> | Behavioral: an educational intervention<br>* To elaborate an educational program for the management of depression in primary care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative study | It is a qualitative study based on interviews and questionnaires with patients participating to an educational intervention to improve the management of depression in primary care. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients, moderate depression
Realization of the Recommendation for Influenza Vaccination in Pregnant Women

Study Overview
=================
Brief Summary
-----------------
Introduction: In 2010, the vaccination recommendations for pregnant women against seasonal influenza were published by the German Standing Committee on Vaccination (STIKO). This work deals with the immunization coverage and the influencing factors. Method: A cross-sectional study was realized at two Level 1 perinatal centers in two German federal states during the influenza saisons 2012/2013 and 2013/2014. Pregnant women were interviewed by using a standardized and pre-tested questionnaire covering their knowledge about the influenza vaccination and other factors influencing the vaccination decision. Furthermore, data from the vaccination card and the pregnancy record booklet have been evaluated.

Official Title
-----------------
Women - Influencing Factors and Coverage Rate

Conditions
-----------------
Coverage Rate of Vaccination for Influenza

Intervention / Treatment
-----------------
* Behavioral: vaccination rate for influenza


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women older than 18 vaccination records signatetd letter of agreement Exclusion Criteria: younger than 18

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| vaccination rate- pregnant- influenca<br> | Behavioral: vaccination rate for influenza<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza Vaccination rate in Pregnant Women | The first aim of the study is check how many pregnant women are following the new german recommendation of influenza vaccination in pregnancy. | 02/12- 02/14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influencing factors on the Influenza vaccination rate | Second aim is to investigate the factors which are influencing the decission for or against the influenza vaccination in pregnancy. | 02/12- 02/14 |
Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid parameters in hypercholesterolemic patients on a stable dose of a statin.

Official Title
-----------------
An 8-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study in Hypercholesterolemic Patients to Determine the Efficacy and Safety of Combination Therapy With CI-1027 and a Statin

Conditions
-----------------
Hypercholesterolemia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and Females 18 to 65 years of age Baseline LDL-C ≥ 130 mg/dL (3.4 mmol/L) Exclusion Criteria: If female, postmenopausal or surgically menopausal Triglycerides (TG) >400 mg/dL Creatine phosphokinase (CPK) >3 × the upper limit of normal (ULN) Body Mass Index (BMI) >35 kg/m2 Uncontrolled diabetes mellitus (HbA1c >10%) Renal dysfunction (blood urea nitrogen [BUN] or creatinine >2 × ULN) Hepatic dysfunction (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 × ULN) Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous month

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo treatment on stable background statin therapy | Drug: Placebo<br> <br> |
| Experimental: Gemcabene 300 mg QD<br>Gemcabene (also known as CI-1027) treatment on stable background statin therapy | Drug: Gemcabene<br>* 1-300 mg tablet, QD, 56 days<br>|
| Experimental: Gemcabene 900 mg QD<br>Gemcabene (also known as CI-1027) treatment on stable background statin therapy | Drug: Gemcabene<br>* 3-300 mg tablets, QD, 56 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C - percent change from baseline at Week 8 |  | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma lipid levels - percent change from baseline at Week 8 | apolipoprotein B (apoB), total cholesterol (TC), C reactive protein (CRP), triglyceride (TG), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C) | 56 days | 
| Adverse Events |  | 56 days | 
| Clinical Laboratory |  | 56 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LDL-C, Lipid Regulator
Facilitating Completion of HPV Vaccination

Study Overview
=================
Brief Summary
-----------------
With the surge in use of electronic media among adolescents, a strategy that has been utilized to increase HPV4 uptake in girls has been reminder text messaging to their parents. To date, no published study has looked at the effectiveness of texting adolescents themselves (especially boys) rather than their parents OR compared texting to social network sites to increase HPV knowledge and uptake of HPV vaccination in boys. Interactive technology-based interventions targeted at youth are feasible in North Carolina for the following reasons: (1) through the NC Minors' Consent Law adolescents can consent to the prevention, diagnosis, and treatment of sexually transmitted diseases (N.C. Gen. Stat. § 90-21.5(a); and (2) many school based health centers can provide immunizations. Since HPV infection is a sexually transmitted infection, NC teens do not have to get consent for HPV prevention (i.e., vaccination). To optimize HPV vaccination in young people, especially males, communication strategies are needed to motivate adolescents to get themselves vaccinated. Texting has been demonstrated to be a feasible, popular, and effective method of sexual health promotion to young people with a relatively low withdrawal rate, positive feedback, and an observed improvement in sexual health knowledge and STI testing (12). Social media communication strategies are a new and potentially effective channel for communicating public health messages about HPV vaccine that are also likely to increase HPV initiation and completion among adolescent girls in addition to boys. According to the NC Immunization Registry, as of March 8, 2011, only 2% of boys ages 9-13 had received at least one dose of HPV vaccine. In the investigators continuity clinic less than 50 percent of adolescents are fully immunized. This project will identify social behavioral, emotional, and cognitive correlates and predictors that help explain why teens pursue, complete, and do not complete HPV vaccination, and develop a social media communication intervention collaboratively with teens to increase HPV vaccine initiation and completion.

Official Title
-----------------
Facilitating the Completion of the 3-Dose Series of HPV Vaccination in Males and Females

Conditions
-----------------
Adolescent Immunizations Among Clinic Population

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: incomplete immunization Exclusion Criteria: complete immunization

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 21 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 |
| --- | --- |
| Social media<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV vaccination uptake |  | 2 years |
Results of an Interferon-Gamma Release Assay After Treatment for Tuberculosis

Study Overview
=================
Brief Summary
-----------------
New blood tests have become available to detect either latent or active tuberculosis. These tests - which according to the CDC can replace the tuberculin skin test - measure the production of gamma-interferon (a cytokine) by peripheral lymphocytes (white cells) when exposed to antigens which are highly specific of mycobacterium tuberculosis (the bacteria responsible for tuberculosis). Our hypothesis was that the production of gamma-interferon would be much higher at the beginning of treatment than at the end, and that decline in gamma-interferon secretion could be an indicator of clinical response to treatment.

Detailed Description
-----------------
Patients either treated for active culture proven tuberculosis (TB) or having completed treatment during the preceding 6 months were recruited. Exclusion criteria were : HIV infection and previous TB. Interferon gamma release assay (T-SPOT.TB, Oxford Immunotec) was sampled during the 2 first weeks of treatment, at the end of treatment and 6 months later. T-SPOT.TB was analysed qualitatively (pos/neg) and quantitatively (Spot forming units: SFU) to determine if there was a higher rate of negative tests at the end of treatment and 6 months after treatment than initially. Paired samples were analysed to compare SFU counts between beginning of treatment and end of treatment, and SFU counts between end of treatment and 6 months later. Clinical response to treatment was recorded, as well as treatment failures and relapses.

Official Title
-----------------
Observational Study of Production of IFN-Gamma by Peripheral Lymphocytes in Response to Specific Antigens Before and After Treatment for Tuberculosis

Conditions
-----------------
Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: culture proven tuberculosis Exclusion Criteria: age < 18 prior tuberculosis HIV infection

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 |
| --- | --- | --- |
| Interferon gamma response to M. tuberculosis antigens by peripheral lymphocytes after treatment for tuberculosis |  | 12-18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tuberculosis, interferon gamma release assays, treatment
Balance in Patients After Surgery for Torn Meniscus

Study Overview
=================
Brief Summary
-----------------
The important role of the menisci in knee function and in preserving knee health has been shown in several studies. Additionally to principal functions of load transmission and shock absorption, meniscus contributes to knee joint proprioception and probably also to joint stability.Study about affect of meniscus injury on balance posture has not previously been published.Surgical practice is increasingly aimed at minimal resection of injured tissue, preserving a stable meniscal remnant with as much function as possible.The purpose of this study is to determine whether menisci surgery have any effects on relatively new postural control measures, in correlation with functional balance assessment. The second purpose is to establish the affect of different types of menisci surgery on balance impairment (meniscectomy vs tear repair), in correlation with a long-term outcome.

Official Title
-----------------
Functioning Balance in Patients After Surgery for Torn Meniscus: Meniscectomy vs Meniscal Repair; A Prospective Study

Conditions
-----------------
Torn Menisci

Intervention / Treatment
-----------------
* Procedure: meniscectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants have to be healthy people 18-40 years old After a traumatic event of only one knee Exclusion Criteria: Previous knee surgery OA per arthroscopy Neurological problem Any other orthopedic problem of lower limbs Systemic arthritic condition (RA, SLE etc.) Severe cognitive problem with restricted consent Pregnancy

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: meniscectomy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load

Study Overview
=================
Brief Summary
-----------------
Patients with chronic hepatitis B and treated with entecavir for over 6 months (with no previous other antiviral treatment) will be invited to participate in this study. They will be eligible if their liver tests are normal and their viral load is undetectable. Patients will be switched to lamivudine treatment to assess whether lamivudine can maintain adequate suppression of the hepatitis B virus after successful treatment with entecavir. Patients will be monitored closely after switching treatment at 1 months and then every 3 monthly. If there is any evidence of increase in viral load then patients will be given the option of changing back to entecavir.

Official Title
-----------------
Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load

Conditions
-----------------
Hepatitis B, Chronic

Intervention / Treatment
-----------------
* Drug: Entecavir
* Drug: Lamivudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic hepatitis B treated with entecavir for 6 months or more Normal ALT Undetectable HBV DNA by Roche Taqman PCR Assay No other previous therapy with nucleoside/nucleotide analogues Exclusion Criteria: Presence of other liver diseases including hepatitis C co-infection, autoimmune hepatitis , primary biliary cirrhosis, primary sclerosing cholangitis, alcoholic liver disease, and Wilson's disease History of hepatocellular carcinoma History of decompensated 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
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Entecavir<br>Ongoing entecavir 0.5mg daily | Drug: Entecavir<br>* Entecavir 0.5mg orally daily<br>* Other names: Baraclude;|
| Active Comparator: Lamivudine<br>Switch to lamivudine 100mg daily | Drug: Lamivudine<br>* Lamivudine 100mg orally, daily<br>* Other names: Zeffix;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the efficacy of lamivudine therapy in patients with prior entecavir treatment with undetectable viral load |  | 96 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the chance of lamivudine resistance in patients with prior entecavir treatment with undetectable viral load |  | 96 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
entecavir, lamivudine, sequential therapy