linjc16/ctgov huggingface dataset:
Effects of Pioglitazone in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
Insulin resistance is often complicated with hypertension. AGE and inflammation play important roles in insulin resistance. Some studies reported that pioglitazone, insulin sensitizer, is effective for patients with insulin resistance, however, the mechanisms are still unclear. The aim of this study to evaluate the effect of pioglitazone compared with glimepiride on AGE, inflammatory cytokines and cardiac markers (BNP and echo) in hypertensive patients during oral glucose tolerance test.

Official Title
-----------------
Effects of Pioglitazone and Glimepiride in Hypertensive Patients - Relationship With AGE, Inflammatory Cytokines and Cardiac Markers -

Conditions
-----------------
Hypertension, Insulin Resistance

Intervention / Treatment
-----------------
* Drug: Pioglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertension with insulin resistance Exclusion Criteria: Chronic systolic heart failure, ACS

Ages Eligible for Study
-----------------
Minimum 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glymepiride<br> | Drug: Pioglitazone<br>* pioglitazone (15mg) once a day for 24 weeks<br>* Other names: actos;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| advanced glycation end-product (AGE) |  | 24 weeks | 
| inflammatory cytokines (TNF-alfa, IL-6 and MCP-1) |  | 24 weeks | 
| cardiac function (echo and BNP) |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, insulin resistance, oral glucose tolerance test, AGE, inflammatory cytokine
Lead Registry for Optim Leads

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multi-center, actively monitored, long term data collection registry. Any Patient that receives a market released St. Jude Medical (SJM) Optim lead and a compatible market released cardia rhythm management (CRM) implantable pulse generator is eligible for enrollment into the registry.

Detailed Description
-----------------
Patients are enrolled in the registry up to 180 days post implantation of an Optim lead. Patients with Optim™ ICD leads and Quicksite®/Quickflex®/Quickflex® µ/Quartet® LV leads are followed indefinitely following enrollment. Patients with other Optim leads are followed for a period of 60 months after Optim™ lead implantation. The follow-up plan for this registry is based on the established follow-up practices currently used by each of the respective registry centers. Patients are followed according to the center's standard follow-up schedule. At each office/clinic follow-up visit standard electrical measurements are collected. During system revision in a patient with either Optim™ ICD leads, Quicksite®, Quickflex®, Quickflex® µ or Quartet® LV lead, cinefluoroscopy (AP, LAO 45° or the best possible LAO view, RAO 45° or the best possible RAO view) should be performed at specific study sites. If cinefluoroscopy or chest X-ray is performed according to the site's standard of care then copies of those should be submitted.

Official Title
-----------------
Optim Lead Insulation Material Registry

Conditions
-----------------
Optim Lead Insulation Related Adverse Events

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a standard indication for a CRM implantable pulse generator. Patient receives a market released SJM Optim lead at implant. Patient receives a market released CRM implantable pulse generator at implant. Patient is willing to provide authorization for registry participation. Complete device implant information, including any Optim lead related adverse event is available Exclusion Criteria: Patient has medical conditions or related factors that would prevent or limit participation (including mechanical tricuspid valves, tricuspid valvular disease, and candidacy for heart transplants within 6 months). Patient is < 18 years of age. Patient has a life expectancy of < 2 years (malignancies)

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Optim Leads<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival from insulation related adverse events |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Optim, Insulation
Green Tea Consumption and Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
To examine the prospective association of green tea consumption to the incidence and mortality of coronary heart disease (CHD) using multivariate analysis while controlling for the potential confounding effects of cholesterol, triglycerides, glucose and dietary nutrients.

Detailed Description
-----------------
BACKGROUND: Both in vivo and in vitro experiments have show that flavonoids, antioxidants which are rich in green tea, are potentially as beneficial as vitamin E, beta-carotene and vitamin C in reducing the risk of cardiovascular disease. Thus, the possible preventive effects of green tea on CHD have begun to raise research interests in green tea sufficiently to inquire about its beneficial effects formally in humans. However, few epidemiologic studies have been carried out to directly examine the effects of green tea on CHD. The Honolulu Heart Program (HHP) is a 30 year longitudinal study of CHD and stroke among 8,006 Japanese American men living on Oahu Hawaii. Until the end of 1992, 1,888 men from this cohort were defined as having incident CHD; this includes 396 deaths due to CHD. The baseline examination for the HHP was conducted during 1965-68. A comprehensive physical examination and 24 hour dietary recall interview were administered. Within the original cohort more than 75 percent men reported to have drunk green tea daily. The amount consumed per day varied considerably from low to high doses. The high prevalence of green tea consumption coupled with dose information (i.e low, moderate and high consumption) provides good opportunities to examine the relationships of green tea consumption and CHD. DESIGN NARRATIVE: The study uses the Honolulu Heart Program data to examine the prospective association of green tea consumption to the incidence and mortality of CHD using multivariate analysis while controlling for the potential confounding effects of cholesterol, triglycerides, glucose and dietary nutrients. 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, Coronary Disease, Heart Diseases

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 |
| --- | --- | --- |
The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis

Study Overview
=================
Brief Summary
-----------------
The study will investigate if Anakinra can ameliorate allergic contact dermatitis in participants with known nickel allergy

Official Title
-----------------
The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis: A Randomized Controlled Trial With Anakinra vs. Placebo

Conditions
-----------------
Allergic Contact Dermatitis

Intervention / Treatment
-----------------
* Drug: Anakinra
* Drug: Sodium Chloride 9mg/ml Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged at least eighteen years old. Able to provide written informed consent. Have a medical diagnosis of nickel allergy with at least a +2 reaction on the ICDRG scoring system when challenged with nickel. Fitzpatrick skin type 1-4. Able to speak and understand Danish. Exclusion Criteria: Received any topical immunomodulating or immunosuppresive treatment on the lower back two weeks prior, or applied crème/lotion on the lower back 24 hours prior to day 0. Received systemic immunomodulating or immunosuppressive treatment four weeks prior to day 0. Any skin lesions at the area of interest such as nevi, scar tissue or pigment changes. Dermatitis and/or infection. Recent (3 months or less) administration of a live virus vaccine. Women of childbearing potential who are not taking adequate contraception or who are pregnant, plan to become pregnant during the study duration or lactating. Taking part in any other intervention study. Has any other condition which would, in the Investigator's opinion, deem the patient unsuitable for participation in the study (e.g. condition requiring long term or frequent oral steroid use). Presence of any condition or use of any medication which precludes the use of the study drug. Allergy to any of the ingredients in the drug.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anakinra<br> | Drug: Anakinra<br>* 100 mg Anakinra injections s.c.<br>|
| Placebo Comparator: Placebo<br> | Drug: Sodium Chloride 9mg/ml Injection<br>* 9 mg Sodium Chloride injections s.c.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical reaction | Number of participants with a lower clinical icdrg scoring in the active treatment group compared to placebo | 2 months |
Epidemiology of Pain in the Delivery Room

Study Overview
=================
Brief Summary
-----------------
The nociceptif system of the newborn child is functional from 22 to 23 weeks of pregnancy. During the delivery the baby is exposed to multiple exterior factors and he is capable to memorize the pain .Recent epidemiologic studies showed that the coverage of pain was insuffcient and also an increase of analgesic means. Normally the pain coverage have to be managed and group every painful gesture. In fact all these recommandations are not followed by medical team. The aim of the study is to evaluate the prevalence of this type of pain as to set up an adequate coverage.

Official Title
-----------------
Epidemiology of New Born Child Pain in the Delivery Room

Conditions
-----------------
New Born Child Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborn child been born after 24 weeks amenorrheas undergoing a painful gesture in delivery room Exclusion Criteria: Newborn child been born in palliative care non francophone parents

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 5 Days

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 |
| --- | --- | --- |
| Evaluation of prevalence of the newborn child 's pain in delivery room | Counting the number of painful gesture (injection,blood test...) | Day 1 |
A Multicenter Survey of the Indications for Esophagogastroduodenoscopy (EGD)

Study Overview
=================
Brief Summary
-----------------
Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology diseases. The investigators want to find which symptoms can support for positive endoscopic findings through this multicenter study.

Detailed Description
-----------------
Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology diseases. And there are indications for EGD. Here, investigators want to find which symptoms can strongly support for positive endoscopy findings. So, investigators design the study to record the symptoms in detail and diagnosis, and then analysis symptoms and the rate of endoscopic findings.

Official Title
-----------------
Children's Hospital of Fudan University

Conditions
-----------------
Digestive System Abnormalities, Endoscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All of the patients need esophagogastroduodenoscopic procedures Exclusion Criteria: Patients whose parents reject to provide information for study

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 17 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 |
| --- | --- | --- |
| Quantities of every indications for esophagogastroduodenoscopic procedures collected from questionaire finished by clinical doctor | Indications for esophagogastroduodenoscopic procedures were collected through questionaire, including abdominal pain, vomiting, and so on. | from August 15th to October 15th in 2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophagogastroduodenoscopy, Paediatric
A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine bioequivalence of amodiaquine suspension ( Pfizer) and the WHO approved reference product Flavoquine® tablet ( Sanofi Aventis).

Official Title
-----------------
A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects

Conditions
-----------------
Falciparum Malaria

Intervention / Treatment
-----------------
* Drug: Flavoquine®, Camoquin® Suspension
* Drug: Flavoquine®, Camoquin® Suspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight >45 kg (99 lbs). An informed consent document signed and dated by the subject or a legally acceptable representative. Exclusion Criteria: A history of drug induced agranulocytosis and history of liver and hematological problems while taking amodiaquine. Any condition possibly affecting drug absorption (eg, gastrectomy). A positive urine drug screen.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1 (19 subjects)<br>Period 1: treatment A (15.3 mL (50 mg/5 mL) AQ suspension (Pfizer); test treatment. Period 2: treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis); reference treatment). | Drug: Flavoquine®, Camoquin® Suspension<br>* Treatment A 15.3 mL (50 mg/5 mL) AQ suspension single dose. Treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis) single dose.<br>* Other names: amodiaquine;|
| Experimental: Sequence 2 (19 subjects)<br>Period 1: treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis Period 2: treatment A (15.3 mL (50 mg/5 mL) AQ suspension (Pfizer); test treatment | Drug: Flavoquine®, Camoquin® Suspension<br>* Treatment A 15.3 mL (50 mg/5 mL) AQ suspension single dose. Treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis) single dose.<br>* Other names: amodiaquine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, AUCtlast and AUCinf for amodiaquine. |  | end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax and AUC72 for DesethylAQ |  | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amodiaquine suspension, Flavoquine tablets, Bioequivalence study
Sympathetic Innervation of the Heart and Cardiac Resynchronization Therapy(CRT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether baseline sympathetic innervation in patients with chronic heart failure (CHF) is predictive for response to cardiac resynchronization therapy (CRT). And to assess whether response to CRT coincides with restoration of regional sympathetic innervation.

Official Title
-----------------
Identification of the Role of Sympathetic Innervation in Heart Failure Patients Treated With Cardiac Resynchronization Therapy. A Pilot Study

Conditions
-----------------
Sympathetic Innervation, Chronic Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for CRT Stable optimal medication Non ischemic cardiomyopathy Exclusion Criteria: Age less then 18 years Previous CRT Clinically relevant valvular heart disease or coronary artery disease Acute or chronic infection Untreated clinical hypo- or hyperthyroidism or < 3 months euthyroidism Uncontrolled hypertension, defined as a systolic blood pressure > 160 mm Hg and/or a diastolic blood pressure > 95 mm Hg A concurrent medical condition (i.e. alcohol or drug abuse or a severe progressive extra cardiac disease or M. Parkinson) or is unlikely to comply with the protocol Participation to a previous protocol involving radioactivity in the past year Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| sympathetic innervation in patients with chronic heart failure (CHF) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NYHA class Echocardiographic parameters: LVEDD, LVESD, LVEF, LVESV,IVMD, and septal to lateral delay Hospitalization for heart failure Maximal oxygen consumption NT pro-BNP changes |  | 6 months |
Breast Milk Composition and HIV-exposed/Unexposed Early Infant Growth and Infectious Disease Events

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand how breast milk may protect infants from infection and promote favorable immunological, growth and development outcomes. By following mothers and their infants, we will evaluate the important interactions between infant immune responses and infectious disease events in relation to breast milk composition and feeding patterns. Our aim is to identify a set of predictive factors corresponding to healthy early infant growth and development in this setting in Northern Tanzania.

Conditions
-----------------
HIV, Malnutrition, Cryptosporidiosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent provided by mothers, and parental consent on behalf of their infants Confirmed maternal HIV status (HIV-1, HIV-2 or HIV-Dual seropositive or HIV-seronegative) Stated intention to remain in the clinic catchment area ≥6 months post-partum Singleton birth Exclusion Criteria: None
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 |
| --- | --- |
| HIV+ and HIV- mothers and their infants<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast milk composition |  | Up to 6 months post-partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant anthropometric measures |  | Up to 6 months of age | 
| Infant infectious disease events |  | Up to 6 months of age |