linjc16/ctgov huggingface dataset:
The Registry Study to Compare the Cardiopulmonary Exercise Test Parameters Before and After Cardiac Rehabilitation in Patients With Chronic Total Occlusion of the Coronary Arteries

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to find strategy for treatment through comparing the cardiopulmonary exercise test parameters before and after cardiac rehabilitation in patients with chronic total occlusion of the coronary arteries.

Official Title
-----------------
The Registry Study to Compare the Cardiopulmonary Exercise Test Parameters Before and After Cardiac Rehabilitation in Patients With Chronic Total Occlusion of the Coronary Arteries

Conditions
-----------------
Coronary Artery Disease, Total Occlusion of Coronary Artery

Intervention / Treatment
-----------------
* Behavioral: cardiac rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 and more Chronic total occlusion of coronary artery disease Cardiac rehabilitation Exclusion Criteria: Not applicable

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: cardiac rehabilitation|cardiac rehabilitation in patients with chronic total occlusion of the coronary arteries.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 5 year | 
| Myocardial infarction |  | 5 year | 
| Repeat revascularization |  | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum rate of oxygen consumption | maximum rate of oxygen consumption as measured during incremental exercise, most typically on a motorized treadmill. | 5 year | 
| Respiratory exchange ratio |  | 5 year | 
| Maximal heart rate |  | 5 year | 
| Physical activity_METs | Physical activity is measured in metabolic equivalents (METs), which are multiples of the resting rate of O2 consumption. | 5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiopulmonary exercise test, chronic total occlusion, cardiac rehabilitation
Myocardial Deformation Imaging After Acute Alcohol Excess

Study Overview
=================
Brief Summary
-----------------
Background: Chronic excessive alcohol consumption leads to progressive and chronic cardiac dysfunction. In general, patients consuming alcohol more than five years are at risk for the development of dilated cardiomyopathy. As only few data about immediate changes in left ventricular function after acute excessive alcohol ingestion are available, this study sought to close this gap. Methods: 200 subjects (not used to alcohol, no cardiac disease) will be examined up to 12 hours after alcohol excess and after 4 weeks of complete alcohol abstinence. Echocardiography will performed at baseline and at follow-up regarding conventional parameter [as left ventricular ejection fraction (LVEF), transmitral early (E) and late (A) Doppler flow velocities, E/A ratio, deceleration time of E (DT) and isovolumic relaxation time (IVRT)] and myocardial deformation data [as layer specific global circumferential (endo GCS, mid GCS, epi GCS) and longitudinal (endo GLS, mid GLS, epi GLS) strain].

Official Title
-----------------
Detection of Early Changes in Left Ventricular Function by Myocardial Deformation Imaging After Acute Excessive Alcohol Ingestion

Conditions
-----------------
Myocardial Dysfunction

Intervention / Treatment
-----------------
* Other: routine treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects who are not used to alcohol subjets who had an excessive alcohol Ingestion up to 12 hours before echocardiography Exclusion Criteria: any heart disease subjects under 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: routine treatment|No intervention, only observation and describing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Dysfunction by echocardiographic parameters | Conventional echocardiographic parameters as left ventricular ejection fraction (measured in %) and volumes (measured in ml) and myocardial Deformation parameters as global and layer specific radial, longitudinal and circumferential strain (all measured in %) will be determined | At 4 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in echocardiographic parameters | These echocardiographic parameters will be determined at baseline and at 4 weeks follow up and the changes (assessed by percentage differences) will be given | from baseline to follow up at 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alcohol induced cardiomyopathy, myocardial deformation imaging
Iron Therapy in Erythropoietic Protoporphyria

Study Overview
=================
Brief Summary
-----------------
Giving oral iron to patients with erythropoietic protoporphyria (EPP) who is iron deficient is thought to be beneficial. This is, however, not well documented. The purpose of this study is to investigate the effect and safety of oral iron in patients with EPP who is taking iron tablets due to iron deficiency.

Official Title
-----------------
Oral Iron Therapy in Erythropoietic Protoporphyria

Conditions
-----------------
Iron-deficiency, Erythropoietic Protoporphyria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with EPP Taking standard dose of iron tablets due to iron deficiency Exclusion Criteria: Pregnant Lactating

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |
| Change in erythrocyte protoporphyrin concentration |  | Before treatment and after 6-8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin and iron parameters |  | Before treatment and after 6-8 weeks of treatment | 
| Adverse event |  | 6-8 weeks of treatment |
Validity of the MET-REPAIR Questionnaire

Study Overview
=================
Brief Summary
-----------------
MET-REPAIR CONVAL is an international cohort study to examine the ability of self-reported exercise capacity to predict perioperative cardiovascular events correcting for preoperative risk factors.

Official Title
-----------------
MET-REPAIR CONVAL: Concurrent Validity of the MET-REPAIR Questionnaire in German and of the Duke Activity Scale Index for Estimating Exercise Capacity Measured Using Exercise Testing

Conditions
-----------------
Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 45 years of age clinically indicated exercise testing signed written informed consent Exclusion Criteria: unable to complete the questionnaire unable to consent or unwilling to participate cancelled exercise

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| Cohort<br>Cohort Study correlating self reported exercise activity and spiroergometry results | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic equivalents (METs) | METs per spiroergometry; assessment at time of clinically mandated spiroergometry | at Baseline |
Dryvax Dilution-Prev Vacc Adults

Study Overview
=================
Brief Summary
-----------------
A double-blind, randomized, dose-response study of four dilutions of Dryvax in previously vaccinated adults in order to assess the clinical success rates, humoral responses, and virus-specific actifity of cytotoxi T cells and interferon-y producing T cells

Official Title
-----------------
A Double Blind, Randomized Dose Response Study of Dryvax Vaccine Against Smallpox in Previously Vaccinated Adults

Conditions
-----------------
Smallpox

Intervention / Treatment
-----------------
* Biological: Dryvax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For cohort E (never vaccinated): Aged 18-31; Never been vaccinated for smallpox. If female, not pregnant or lactating. Promise to use an effective method of birth control for 7 months after vaccination. Negative result on a test for HIV, AIDS, Hepatitis B and C. Acceptable as blood donors. For cohorts A, B, C, D (previously vaccinated): Aged 32 to 60 years; known history of smallpox vaccination with a typical vaccinia scar; no smallpox vaccination after 1971. Healthy adults (aged 18-60). Exclusion Criteria: Eczema or history of eczema, or other chronic skin disorder. Pregnancy or lactation. History of immunodeficiency, liver disease, severe kidney impairment, malignancy, HIV, Hepatitis B, or Hepatitis C. Household contact with persons who are under 12 months of age, pregnant or lactating, or have any of the specified diseases.

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Dryvax|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Knowledge, Attitude and Practice of Physicians Toward The Prescription of Proton Pump Inhibitors in Egypt

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify the knowledge , attitude and practice toward PPI use among doctors in Egypt

Detailed Description
-----------------
Proton pump inhibitors (PPIs) were developed in the '80s and their use has continuously grown. They represent the first choice in the treatment of acid-related diseases and are currently themost prescribed drugs in the world [1]. In addition, PPIs have become the 8th therapeutic class on the prescription list in 2013. This impacted on health care costs especially in the last decade: in 2010, USA paid $13.9 billion for PPIs [3]. Several studies described a range of adverse events related to longterm PPI use [5,6], some of them are related to increased gastric pH which could alter intestinal bacterial flora and drugs or electrolyteabsorption. Another issue is represented by potential pharmacological interactions between PPIs and other drugs, due to interference with liver metabolic systems, and competition for renal excretion [7-16]. The huge increase in PPI use cannot be justified only by increased prevalence of acid-related diseases or extension of therapeutic indications. Some studies have shown that PPIs are often over-administered in hospital setting, inappropriately prescribed at discharge and maintained by general practitioners (GPs) [1,17,18] A recent research showed that 86% of patients who were prescribed PPIs did not have appropriate indications in the general medical ward of a tertiary Jordanian hospital [2]. Another study showed that PPI were taken by 25.4% of the patients hospitalized in an internal medicine department of a tertiary Greek hospital, but as many as 81.2% of them had no indications [11]. However, the knowledge and practice of physicians in Egypt toward the use of PPI is not well studied.

Official Title
-----------------
Knowledge, Attitude and Practice of Physicians Toward The Prescription of Proton Pump Inhibitors in Egypt

Conditions
-----------------
Knowledge, Attitudes, Practice

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physicians dealing with PPI therapy in their specialty including general practitioners, gastroenterologists and non gastroenterologist (hepatologists, otolaryngolists, surgeons, anesthesiologists, pediatriticians and internal medicine physicians.) Who gave consent to participate at the beginning of the questionnaire. Exclusion Criteria: who refuse to gave consent to participate
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 |
| --- | --- | --- |
| five points likert-scale score being | 5 for 'completely agree', 4 for 'almost agree', 3 for 'indifferent', 2 for 'almost disagree', and 1 for 'completely disagree'. | one year |
Investigation of the Effect of E.-Coli-Nissle as Supporting Therapy to Standard Care of Diabetes Mellitus Type II

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to investigate the effect of e.-coli-nissle as supporting therapy to antidiabetic standard care in patients with diabetes mellitus type II

Official Title
-----------------
Pilot Study to Investigate the Effect of E-coli-nissle as Probiotic Adjuvant to Antidiabetic Standard Care in Patients With Diabetes Mellitus Type II

Conditions
-----------------
Diabetes Mellitus Type II

Intervention / Treatment
-----------------
* Drug: e.-coli-nissle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetes mellitus type 2; HbA1c >7 % (stable für 6 months, max. variation of 0,5%) stable oral antidiabetic therapy for 6 months with Metformin, Vildagliptin, Gliniden or without oral Antidiabetics age of 45 to <80 years (men and women) Exclusion Criteria: Myocardial infarction or stroke within the last 5 years Therapy with acarbose Acute peripheral arterial disease within the last 12 months Instable metabolic situation Uncontrolled hypertension Body-Mass-Index ≥ 35 kg/m² Smokers Daily consumption of probiotic food Malignant disease within the last 5 years Status post transplantation Immunosuppressive therapy within the last 3 months Therapy with antibiotics Macroalbuminuria Severe liver disease

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E.-coli-Nissle<br>10 patients will be enrolled Intervention: E.-coli-Nissle (Mutaflor), oral suspension Dose: 1 ml / day frequency: qd | Drug: e.-coli-nissle<br>* 1 ml qd for 24 weeks<br>* Other names: Mutaflor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in HbA1c levels |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in insulin resistance/secretion |  | 24 weeks | 
| change in lipid parameters |  | 24 weeks | 
| change in parameters of oxidative stress |  | 24 weeks | 
| change in gastrointestinal condition |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes
Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan and Atorvastatin in patients with hypertension and hyperlipidemia.

Official Title
-----------------
Efficacy and Safety of Coadministered Irbesartan and Atorvastatin in Patients With Hypertension and Hyperlipidemia

Conditions
-----------------
Hypertension, Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: Irbesartan/Atorvastatin A
* Drug: Irbesartan
* Drug: Atorvastatin A
* Drug: Placebo
* Drug: Irbesartan/Atorvastatin B
* Drug: Atorvastatin B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 19 and 75 years Signed informed consent Exclusion Criteria: At screening, SPB ≥ 180mmHg or DBP ≥ 110mmHg or LDL-C > 250mg/dL or TG ≥ 400mg/dL Has a history of hypersensitivity to Angiotensin Ⅱ receptor blocker or HMG-CoA reductase inhibitor or component of this drug Has a history of multi-drug allergy

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irbesartan/Atorvastatin A<br> | Drug: Irbesartan/Atorvastatin A<br>* once daily, P.O. 8week<br>* Other names: HCP0912 A;|
| Active Comparator: Irbesartan<br> | Drug: Irbesartan<br>* once daily, P.O. 8week<br>|
| Active Comparator: Atorvastatin A<br> | Drug: Atorvastatin A<br>* once daily, P.O. 8week<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* once daily, P.O. 8week<br>|
| Experimental: Irbesartan/Atorvastatin B<br> | Drug: Irbesartan/Atorvastatin B<br>* once daily, P.O. 8week<br>* Other names: HCP0912 B;|
| Active Comparator: Atorvastatin B<br> | Drug: Atorvastatin B<br>* once daily, P.O. 8week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 8 week in LDL-Cholesterol |  | baseline and 8 week | 
| Change from baseline to 8 week in Blood Pressure. |  | baseline and 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood pressure responder rate according to JNC VII Guideline. |  | week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irbesartan, Atorvastatin, Hypertension, Hyperlipidemia
A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects receiving chronic hemodialysis, and by subjects with normal kidney function. The removal rate of PF-00734200 by hemodialysis will be calculated. The safety and tolerability of PF-00734200 in subjects with various degrees of kidney function or undergoing chronic hemodialysis will be assessed.

Official Title
-----------------
A Phase 1, Open-Label Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PF-00734200 Administered To Subjects With Various Degrees Of Renal Impairment And Normal Renal Function

Conditions
-----------------
Renal Insufficiency, Chronic

Intervention / Treatment
-----------------
* Drug: PF-00734200


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must meet one of the following renal function categories Normal renal function Mild renal impairment Moderate renal impairment End stage renal disease requiring chronic hemodialysis Body mass index between approximately 18-40 kg/m2 inclusive, and a total body weight greater than 50 kg Subjects in the normal renal function category must be healthy and not receiving any chronic treatment with prescription or non-prescription medications Exclusion Criteria: Women who are pregnant, nursing or women of childbearing potential Subjects with acute renal disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 77 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-00734200<br> | Drug: PF-00734200<br>* The drug is administered as a single dose of four 5-mg tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve from time 0 until last observation (AUCtlast) |  | 3-6 days | 
| Maximum serum concentration (Cmax) |  | 3-6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC extrapolated to infinity (AUCinf) |  | 3-6 days | 
| Time of Cmax (Tmax) |  | 3-6 days | 
| Half life (T1/2) |  | 3-6 days | 
| Renal clearance (CLr) |  | 3-6 days | 
| Hemodialysis clearance (CLd) |  | 3 days |