linjc16/ctgov huggingface dataset:
The Effect of Erythropoietin at the Time of Reperfusion in Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of intravenous human recombinant erythropoietin on the reperfusion injury at primary percutaneous coronary intervention in patients with acute myocardial infarction.

Official Title
-----------------
Phase 4 Study of the Effect of Human Recombinant Erythropoietin at the Time of Reperfusion in Patients With Acute Myocardial Infarction

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: human recombinant erythropoietin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute myocardial infarction <12hr Age >18yrs First myocardial infarction culprit lesion : proximal to mid left anterior descending artery Baseline coronary flow : TIMI Grade 0 1 Exclusion Criteria: Patients with previous myocardial infarction History of thrombotic complication History of cerebral infarction Uncontrolled hypertension Increased hemoglobin level >17g/dL Patients with mechanical valve Cardiogenic shock

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: PCI only<br>primary PCI only | |
| Experimental: EPO<br> | Drug: human recombinant erythropoietin<br>* intravenous bolus injection of EPO (50unit/kg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine kinase (CK), creatinine kinase-MB (CK-MB) |  | 4hr, 8hr, 12hr, 24hr, 48hr, 72hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size assessed by cardiac MRI |  | day 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
erythropoietin
Sunlight Exposure and Vitamin D in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the amount of sunlight exposure and vitamin D status of adolescent schoolchildren in each season throughout the year.

Official Title
-----------------
Sunlight Exposure and Vitamin D Status of Children in the UK

Conditions
-----------------
Healthy Schoolchildren

Intervention / Treatment
-----------------
* Other: None - observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy school children aged 12-15 years White Caucasian Male or female Exclusion Criteria: History of photosensitivity disorder

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 15 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 |
| --- | --- |
| Healthy volunteers<br>Healthy adolescents aged 12-15 years | Other: None - observational study<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration of 25-hydroxyvitamin D |  | Approximately every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of sunlight exposure received | Exposure to sunlight over 7 consecutive days is measured using polysulphone badges with one badge for weekdays and a second badge for the weekend. | Approx every 3 months | 
| Dietary intake of vitamin D | Intake of foods containing vitamin D is recorded for a one week period and the average daily intake determined. | Approximately every 3 months |
The Long-term Clinical Outcomes and Patterns of Transfusion in PCI Patients: Retrospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
A nationwide retrospective cohort study. To investigate the long-term patterns of transfusion and clinical outcomes of patients undergoing PCI.

Detailed Description
-----------------
A nationwide retrospective cohort study. Transfusion after PCI may increase a risk, but the long term effects after red blood cell transfusion is known. Longitudinal data is collected from administrative claims in the National Healthcare Insurance Service of Korea. All Korean patient date undergoing PCI inserting stent from January 1, 2011 to December 31, 2011 is extracted. Clinical outcomes until December 31, 2016 is investigated. Primary outcome is the incidence density of red blood cell transfusion. Secondary outcomes are the association of transfusion with major adverse clinical event (MACE) consisting all-cause death, revascularization, critically ill cardiovascular status, or stroke. Incidence density and time-dependent Cox proportional hazard regression is statistically analyzed.

Official Title
-----------------
The Five-year Pattern of Red Blood Cell Transfusion and Clinical Outcome in Patients Undergoing Percutaneous Coronary Intervention: A Korean Nationwide Longitudinal Cohort Study

Conditions
-----------------
Erythrocyte Transfusion, Percutaneous Coronary Intervention, Revascularization

Intervention / Treatment
-----------------
* Procedure: No intervention is required due to retrospective observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Korean patients undergoing PCI using stent from January 1, 2011 to December 31, 2011 Exclusion Criteria: Patients without any stent insertion
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: No intervention is required due to retrospective observational study|Red blood cell transfusion on or after percutaneous coronary intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence density of transfusion | 5-year incidence density of red blood cell transfusion | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence density of MACE | 5-year incidence densities of a major adverse clinical event (MACE) consisting of all-cause death, revascularization, critically ill cardiovascular status, and stroke | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCI, Transfusion, Percutaneous Coronary Intervention
A Study of Dasatinib to See How Liver Impaired and Healthy Subjects Process and React to the Study Drug

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate how a person with liver impairment processes and reacts to the study drug. Information about any side effects that may occur will also be collected.

Official Title
-----------------
Single-Dose Pharmacokinetics of Dasatinib in Subjects With Hepatic Impairment Compared to Healthy Adult Subjects

Conditions
-----------------
Liver Diseases

Intervention / Treatment
-----------------
* Drug: Dasatinib
* Drug: Dasatinib
* Drug: Dasatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - All subjects: Male and females ≥18 years old Women must be of non-childbearing potential Adequate hematologic and renal function BMI 18-35 kg/m2 Inclusion Criteria - Liver Impaired subjects: Subjects must have stable liver impairment diagnosed with standard classification - Child Pugh Exclusion Criteria - All subjects: Inability to swallow or absorb oral medication Uncontrolled medical disorder or infection Use of CYP3A4 inhibitors/inducers or drugs with risk of Torsades de Pointes Uncontrolled or Significant cardiovascular disease Any significant bleeding disorder Female subjects of childbearing potential Male subjects unwilling to use an effective method of contraception throughout the conduct of the study and for 2 months thereafter

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| A<br> | Drug: Dasatinib<br>* Tablets, Oral, 50 mg, once daily, for one day<br>* Other names: Sprycel;|
| B<br> | Drug: Dasatinib<br>* Tablets, Oral, 20 mg, once daily for one day<br>* Other names: Sprycel;|
| C<br> | Drug: Dasatinib<br>* Tablets, Oral, 70 mg, once daily for one day<br>* Other names: Sprycel;|

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
-----------------
hepatically impaired
Robot Assisted Radical Prostatecomy and Positional Injury

Study Overview
=================
Brief Summary
-----------------
Although a condition for surgery, robotic interventions applied with steep Trendelenburg-lithotomy (ST-L) position may cause positional injury and peripheral neuropathy if good position is not achieved on the operating table. This study will be a 7-year retrospective examination of postoperative positional injury (PPI) in patients undergoing robot-assisted radical prostatectomy (RARP) for prostate diagnosis.

Detailed Description
-----------------
Patients who underwent RARP between 2008-2014 will be evaluate. Patients with known peripheral neuropathy, lumbar-cervical discopathy, or history of orthopaedic surgery or trauma will exclude. The demographic data of patients, ASA, Charlson Comorbidity Index (CMI), Body Mass Index (BMI), operating time (OT) and Trendelenburg time (TT) will obtain from patient records. Patients will be questioned as to whether or not PPI had developed, if so, in which extremity, in what form (sensory-motor), duration, whether or not a doctor had been consulted, if so, what treatment had been given and whether or not the PPI had continued.

Official Title
-----------------
Robot Assisted Radical Prostatecomy and Positional Injury; 8 Years Survey

Conditions
-----------------
Peripheral Nerve Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing robot-assisted radical prostatectomy (RARP) for prostate diagnosis. Exclusion Criteria: Patients with known peripheral neuropathy, Lumbar-cervical discopathy, History of orthopaedic surgery or Trauma were excluded

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| retrospective examination of postoperative positional injury (PPI) in patients undergoing robot-assisted radical prostatectomy (RARP) for prostate diagnosis | The ST-L position carries high risk in terms of PPI, especially when lengthy surgery is planned and the risk could be increased in patients with high BMI. | 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Robotic Surgical Procedures, Trendelenburg Position
The Impact of Obesity on Maternal and Perinatal Outcomes

Study Overview
=================
Brief Summary
-----------------
Body Mass Index is an index that is commonly used to classify underweight, overweight and obesity in adults. It is defined as the weight in kilograms divided by the square of the height in meters.The growing epidemic of obesity in our society has become a major public health issue where the proportion of overweight and obese among women aged 15-59 have increased from 68 percent in 2008 to 76 percent in 2015

Official Title
-----------------
The Impact of Obesity on Maternal and Perinatal Outcomes; Analytic Cross Sectional Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women single fetus gestational age >28weeks Exclusion Criteria: patient refusal multifetal pregnancy Medical illness prior to pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| obese<br>Body mass index >30 Kilogram/m2 | |
| non-obese<br>Body mass index <30 Kilogram/m2 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of preeclampsia in both groups | The number of women who develop hypertension with proteinuria in pregnancy | 24 hours |
Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This study will evaluate long-term safety of etanercept with or without other DMARDs in children with polyarticular course or systemic juvenile rheumatoid arthritis (JRA) compared to a cohort of subjects with polyarticular or systemic JRA receiving methotrexate with or without other DMARDs.

Official Title
-----------------
Phase IV Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis

Conditions
-----------------
Juvenile Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Enbrel®


Participation Criteria
=================
Eligibility Criteria
-----------------
JRA by American College of Rheumatology (ACR) criteria - Active joints - Initiate etanercept alone, etanercept plus methotrexate or other DMARDs, methotrexate alone, or methotrexate with other DMARDs within 6 months of entry into Registry Polyarticular or systemic RA in 3 or more joints at start of treatment

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum 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 |
| --- | --- |
| Methotrexate group<br>Includes subjects being treated with methotrexate alone or in combination with other DMARDs with the exception of etanercept. | Drug: Enbrel®<br>* Etanercept alone, etanercept plus methotrexate or other DMARDs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event rates and severity |  | 36 months of observation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth data and Tanner scores |  | 36 months of observation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
JRA, Registry
A Study Of A New Medicine (GW679769) For The Treatment Of Social Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the safety and efficacy of GW679769 and paroxetine in subjects with Social Anxiety Disorder

Official Title
-----------------
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects With Social Anxiety Disorder

Conditions
-----------------
Social Anxiety Disorder, Anxiety Disorders

Intervention / Treatment
-----------------
* Drug: paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Generalized Social Anxiety Disorder as the primary diagnosis. If female, must commit to consistent and correct use of an acceptable method of birth control. Exclusion Criteria: Patients with any other psychiatric disorder as a primary diagnosis or within 6 months prior to screening. Patients with Body Dysmophic Disorder, Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder. Patients who pose a current suicidal or homicidal risk or have made a suicide attempt within the past 6 months or have ever been homicidal. Patients who have a positive urine test at screen for illegal drug use and/or a history of substance abuse or dependence (alcohol or drugs) within the past 12 months. Patients with an unstable medical disorder. Female patients who are pregnant, lactating, or planning to become pregnant during a specified time during the study. Patients who are taking other psychoactive medications.

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure will be the change from baseline in the Liebowitz Social Anxiety Scale (LSAS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measures include the change from baseline in the following scales: the Clinical Global Impression-Global Improvement, the Clinical Global Impression -Severity of Illness, and the Sheehan Disability Scale. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Social Anxiety Disorder, Anxiety, Psychiatry
Effect of Liraglutide on Pulsatile Insulin Secretion in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to assess the effect of NNC 90-1170 (liraglutide) on pulsatile insulin secretion and insulin secretion after a standard meal in subjects with type 2 diabetes.

Official Title
-----------------
Effect of NNC90-1170 on Pulsatile Insulin Secretion in Type 2 Diabetic Patients. A Double-blind, Placebo-controlled, Randomised, Single-dose, Cross-over Trial

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: liraglutide
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with type 2 diabetes, either newly diagnosed with at least two months of diet treatment, or in current OHA (oral hypoglycaemic agent) treatment with stable dose for at least six months BMI (Body Mass Index) between 24 and 35 kg/m^2 (both inclusive) Fasting plasma glucose between 6 and 15 mmol/l (both inclusive) Anti-GAD (glutamic acid decarboxylase) negative Exclusion Criteria: Known or suspected allergy to trial product or related products Receipt of any investigational drug within three months prior to this trial Recurrent severe hypoglycaemia as judged by the investigator Cardiac disease or any clinically significant abnormal ECG (electrocardiogram) Use of any drug (except oral hypoglycaemic agents (OHAs)) which in the investigator's opinion could interfere with the blood glucose level (i.e., insulin, systemic corticosteroids, thiazides) Liver or renal disease

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC 90-1170<br> | Drug: liraglutide<br>* A single dose injected subcutaneously (under the skin)<br>* Other names: NNC 90-1170;|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* A single dose injected subcutaneously (under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin secretory burst mass |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin secretory pulse mass, amplitude, frequency and regularity |  |  | 
| Insulin secretion |  |  | 
| Glucagon response |  |  | 
| Gastric emptying rate |  |  | 
| Adverse events |  |  |