linjc16/ctgov huggingface dataset:
Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

Study Overview
=================
Brief Summary
-----------------
Heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic stomach contents move into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.

Official Title
-----------------
A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Lansoprazole 15 mg Once a Day in Frequent Heartburn

Conditions
-----------------
Heartburn

Intervention / Treatment
-----------------
* Drug: Lanzoprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Experiencing heartburn at least 2 days per week over the past month. Having heartburn that responds to heartburn medication. Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study. Exclusion Criteria: Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy). Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study. Other protocol-defined inclusion or exclusion criteria may apply

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that repeated daily doses of 15 mg of lansoprazole are effective in increasing the proportion of days with no heartburn during study treatment, when compared to placebo. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the proportion of nighttimes with no heartburn during 14 days of treatment in subjects receiving lansoprazole versus placebo |  |  | 
| To determine the proportion of subjects with no heartburn during day 1 in those receiving lansoprazole versus placebo |  |  | 
| Evaluation of lansoprazole safety. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heartburn, frequent heartburn, proton pump inhibitor, lansoprazole
Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery

Study Overview
=================
Brief Summary
-----------------
Preterm delivery accounts for about 10% of deliveries in France. Prematurity is the leading cause of perinatal morbidity and mortality in economically developed countries. Despite the development of therapeutics and paraclinic examinations, this rate of preterm delivery remains stable or even increases. The use of medically assisted procreation techniques alone can not explain this rate. The analysis of the electrical activity of the uterus (electrohysterograms) is a promising technique for early diagnosis of the risk of premature delivery, allowing better management of the patients. This study is part of a European theme to study risk factors for the prevention of prematurity.

Official Title
-----------------
Association Between Holter Electro Hysterogram (EHG) and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery

Conditions
-----------------
Preterm Birth

Intervention / Treatment
-----------------
* Other: Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients arriving at maternity emergency for threat of premature birth between 26 SA and 35 SA defined by uterine contractions and a cervical modification Patient affiliated to a social security scheme Exclusion Criteria: Patient minor, Associated Obstetric Pathology: Pre-Eclampsia, Premature Rupture of Membranes (RPM) Patient under tutelage or curatorship or deprived of public law

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 |
| --- | --- |
| Other: Patients with the diagnosis of threat of uterine delivery<br> | Other: Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization<br>* Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the electrical activity of the uterus (electro hysterogram) for the early diagnosis of the risk of preterm delivery |  | 15 days |
'Wristband Device for the Measurement of Intermittent Blood Pressure and Other Physiological Signals

Study Overview
=================
Brief Summary
-----------------
A wristband device intended for use as a standalone device, designed for the measurement of intermittent blood pressure, as well as other physiological signals. The device is intended to be worn in day to day life by individuals suffering from hypertension or other conditions where monitoring of blood pressure is of importance.

Detailed Description
-----------------
The device is intended to be worn on the wrist for intermittent measurements of vital signs such as HR, blood pressure, Skin temperature and activity. The use does not require any special action from the user apart form wearing the band on either their left or right wrist. The device applies no inflatable mechanics or moving parts. The waistband is watertight and can be worn as any type of bracelet all the time of most of the time. The study will focus on patients in intensive care or any other cardiology unit who are under continuous oversight of existing Invasive (A-line Gold Standard monitors

Official Title
-----------------
Non-invasive, Non-Oscillometric Blood Pressure Band

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written Institution approved Informed Consent Form (ICF) Male and Females over the age of 18 years Patients in intensive care or cardiology units who are under continuous oversight of existing Invasive (A-Line) Gold Standard monitors. Only subjects who are fitted with an invasive Arterial Line (A LINE) To the extent possible, individuals who have not been using medication 5 (five) hours prior to the test shall be classified as non-medicated subjects. Exclusion Criteria: Subject who are unable to provide consent Where it would be impractical or inconvenient or otherwise unfeasible to place to place a wristband and generate a signal. Subjects who are not fitted with, or not planned to be fitted with an A-Line during their stay in the hospital.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Monitoring | Wearing of a non invasive wristband to measure Blood Pressure | 30-60 seconds of a clean signal from the A-line monitor |
Association Between Levels of D-Dimer, Fibrinogen and PAI-1 in Elderly Patients With Infection and Occurrence of Cardio- and Cerebro-vascular Disease After Discharge

Study Overview
=================
Brief Summary
-----------------
The association between the levels of d-dimer, fibrinogen and PAI-1 in plasma of elderly patients admitted to internal medicine departments because of infection and the occurrence of cardio- and cerebro-vascular disease after discharge

Conditions
-----------------
Infection, Acute Coronary Syndrome, Cerebrovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute infection Exclusion Criteria: Anticoagulant therapy

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| thrombosis |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebro vascular event
Effects of Two Hypocaloric Diets on Weight Loss

Study Overview
=================
Brief Summary
-----------------
The investigators evaluated whether an energy-restricted protein diet with low glycaemic index carbohydrates and soluble fibers (LC-P-LGI) would be more effective than a conventional diet (LC-CONV) on weight-loss and related metabolic variables.

Detailed Description
-----------------
The subjects (9 men and 5 post-menopausal women) were randomly allocated, in a cross-over design, to two periods of 4 weeks of an energy restricted diet of 1200 kcal as either a conventional diet (LC- CONV) or a special energy restricted diet compensated by proteins (LC-P-LGI). The two nutritional periods were separated by a wash-out interval of 8 weeks. Before the start of the study, all subjects were instructed to maintain their usual lifestyle during the experimental period.Anthropometric parameters, glucose and lipid homeostasis and inflammatory markers were evaluated before and after each dietary period.Body fat and fat-free mass distributions were measured by a dual-energy X-ray absorptiometry (DXA, GE Lunar Prodigy Corporation, Madison, WI, USA) before and after each dietary period at the fasting state.

Official Title
-----------------
Effects of Two Hypocaloric Diets on Weight Loss and Inflammatory Markers

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

Intervention / Treatment
-----------------
* Other: LC-P-LGI diet
* Other: LC-CONV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 26 to 35 Kg/m2 25 to 60 years old non diabetic subjects Exclusion Criteria: SGOT and SGPT >2.5x the normal plasma glucose more than 1.26 g/l hepatic or renal or cardiac failure

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: LC-P-LGI diet|a hypocaloric diet low in lipids (25%) which is compensated by proteins (35%) with no change in carbohydrate content.|
|Other: LC-CONV|4-week CONV period consisted in the subjects' consumption of 1200 Kcal/ day (25% protein, 31% lipids, 44% carbohydrates).|

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
-----------------
obesity, dietary treatment, high protein diet, Low glycaemic index, adipocytes, fat mass, systemic inflammatory markers, improvement of complications, effect on weight loss
Clinical Study on Diagnostics and Outcome of Ruptures of the Subscapularis After Arthroscopic Refixation

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to optimize the diagnostics of subscapularis tendon tears and as the circumstances require to found a new classification. The prime objective is a comparison of the conclusive of the clinic check-up, the sonographic and magnetic resonance tomography findings. The secondary objective is to detect the correlation of the outcome with the age , the gender, the pathogenesis and attendant injuries.

Official Title
-----------------
Prospective Multicenter Trial on Diagnostics and Outcome of Ruptures of the Subscapularis After Arthroscopic Refixation

Conditions
-----------------
Subscapularis Tendon Rupture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients, who have turned 18 suspected subscapularis tendon rupture Exclusion Criteria: disability to understand the trial intraoperative intact supbscapularis tendon pre-surgical operation of the affected shoulder tumor infection

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subscapularis rupture<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder function (Constant Score) |  | 52 weeks post- operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strength | Strength will be measured by a special force sensor | 12 and 52 weeks post-operative | 
| Rerupture Rate | Sonographic investigation of rerupture rate | 12 and 52 weeks post-operative |
Effects of L-carnitine on Hypothyroidism

Study Overview
=================
Brief Summary
-----------------
L-carnitine and thyroid hormone tended to antagonize reciprocally in human body. Urinary excretion of L-carnitine decreased in hypothyroid patients, and levothyroxine supplementation increased excretion of L-carnitine. The investigators hypothesized that supplying L-carnitine to hypothyroid patients with fatigue symptom could improve the quality of life, and fatigue score in them. Therefore, the investigators planned to compare the efficacy of L-carnitine and placebo in hypothyroid patients who had taken levothyroxine.

Official Title
-----------------
Single-center, Randomized, Double-Blinded, Comparative Study of the Effectiveness of L-carnitine in Patients'Fatigue Degree Changing With Hypothyroidism Who Take Levothyroxine

Conditions
-----------------
Hypothyroidism

Intervention / Treatment
-----------------
* Drug: L-carnitine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of hypothyroidism with fatigue symptom Currently use of the same amount of levothyroxine over at least six months Normal serum free T4 level Exclusion Criteria: Current smoker Serum hemoglobin level of under 12mg/dL Clinical diagnosis of diabetes mellitus or fasting serum glucose level ≥ 126mg/dL or HbA1c level ≥ 6.5% History of significant heart failure History of large amount of alcohol consumption Uncontrolled hypertension (systolic blood pressure ≥ 160 millimeter of mercury (mmHg) or diastolic blood pressure ≥ 100 mmHg pregnant, or planning to be pregnant, or breast feeding women aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 times of normal limit serum Cr level > 2.0mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L-carnitine<br>L-carnitine 330mg, 3 tablet twice daily | Drug: L-carnitine<br> <br> |
| Placebo Comparator: Placebo<br>placebo drug, 3 tablet twice daily | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Severity scale | Change from Baseline in Fatigue severity scale at 12 weeks (scoring 'fatigue severity scale' at baseline and 12 weeks) | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wessely and Powell score | Change from Baseline in Wessely and Powell score at 12 weeks (scoring 'Wessely and Powell score' at baseline and 12 weeks) | baseline and 12 weeks |
Out-of Pocket Payments in Patients With Lymphedema

Study Overview
=================
Brief Summary
-----------------
Primary lymphedema is a chronic condition posing a high burden on patients. Clinical guidelines emphasize the role of compression therapy by prescription medical devices. Even in a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist due to the price and reimbursement setting processes. OOPP may threaten the equity of care and drive patients to forgo care. The investigators aim was to analyze the distributive effects of OOPP for primary lymphedema patients in France. A prospective, multicenter study will be conducted in France in 2015 on patients with primary lymphedema. Household ability to pay will be specified by net income and OOPP will be assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices, nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory and voluntary health insurance reimbursements will be considered. The investigators will combine concentration curves and concentration indices to assess the distributive effects.

Official Title
-----------------
Out-of Pocket Payments in Patients With Primary Lymphedema in France and Inequities of Access to Healthcare

Conditions
-----------------
Primary Lymphedema

Intervention / Treatment
-----------------
* Other: Out of pocket payments in patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient aged over six years, with primary lymphedema, regardless of the severity of the disease; Patient treated in one of the centres participating in the study; Patient (and her legal representative for minors) who gave her written consent [or did not refuse to participate, according to local Law]; Patient with Internet access and an active email address. Exclusion criteria: Patients with concomitant chronic venous insufficiency; Patient not covered by any health care insurance scheme; People protected under the law.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Out of pocket payments in patients|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean monthly out-of-pocket payment as assessed by an online self-questionnaire |  | 6 months |
Quantitative Genetic Analysis of Lipid Research Clinic Family Data

Study Overview
=================
Brief Summary
-----------------
To assess the mode of inheritance of familial combined hyperlipidemia and familial primary hypoalphalipoproteinemia and to resolve genetic and familial environmental effects on several phenotypes of importance to coronary heart disease.

Detailed Description
-----------------
BACKGROUND: Although coronary heart disease has long been known to aggregate in families, in 1986 little was known about the relative importance of genetic and environmental factors. This was partly due to the heterogeneous nature of the disease. Instead of analyzing complex endpoints, the tendency had been to focus on the individual risk factors or phenotypes. Plasma lipids and lipoproteins are heterogeneous risk factors that have been analyzed as subgroups from a genetic epidemiological perspective. Attention turned to the familial aggregation of risk factors, particularly the hyperlipidemias, hypertension, and diabetes. In 1971, the National Heart and Lung Institute began a series of epidemiologic studies at several North American sites under the Lipid Research Clinics Program. The Family Study was designed to investigate the familial association of blood lipids, lipoproteins, and dyslipoproteinemias. This study complemented and did not duplicate ongoing analysis of Lipid Research Clinics data. DESIGN NARRATIVE: The study addressed seven phenotypes, all derived from fasting blood samples: total cholesterol, total triglyceride, LDL-cholesterol, HDL-cholesterol, VLDL-cholesterol, uric acid, and glucose levels. The data had already been collected at Lipid Research Clinics in Cincinnati, Iowa, Oklahoma, Minneapolis, and Stanford. Univariate and bivariate segregation analysis were conducted on the mode of inheritance of familial combined hyperlipidemia and familial primary hypoalphalipoproteinemia. Path analysis was used to resolve cultural and biological inheritance for each phenotype within each clinic and for resolution of population heterogeneity among the five Lipid Research Clinics. A general bivariate path model was used to analyze the associations among the various phenotypes. General models were used to analyze temporal trends in family resemblance for the seven phenotypes. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

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

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 |
| --- | --- | --- |