linjc16/ctgov huggingface dataset:
The RECORD Asia-Pacific Atrial Fibrillation Registry

Study Overview
=================
Brief Summary
-----------------
The Primary objective of this registry is to assess the control of Atrial Fibrillation (AF) over one year in patients attending clinical or specialized practices. The Secondary objectives are: To describe key demographics and treatment features in AF patients visiting cardiologists in various countries in Asia-Pacific. To establish correlation between control of AF and clinical outcomes. To establish correlation between treatment strategies and AF control.

Official Title
-----------------
REgistry on Cardiac Rhythm disORDers in Asia-Pacific

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient presenting with either: History of atrial fibrillation diagnosed < 1 year by standard Electro-Cardiogram (ECG) or by ECG-Holter monitoring (treated or not or whatever rhythm at inclusion). New atrial fibrillation diagnosed by standard ECG or by ECG-Holter monitoring at inclusion visit. Patient eligible for a pharmacological treatment of AF (by rhythm or rate control agent). Exclusion Criteria: AF due to transient cause (thyrotoxicosis, alcohol intoxication, acute phase of myocardial infarction, pericarditis, myocarditis, electrocution, pulmonary embolism or other pulmonary disease, hydroelectrolytic disorder, metabolic disorder, etc.). Post cardiac surgery AF (≤3 months). Mentally disabled patients unable to understand or sign the written informed consent. Patients unable to comply with follow-up visits. Patients with pacemaker, Implantable Cardioverter Defibrillator (ICD). Patients scheduled for pulmonary vein ablation, AV node/His bundle ablation, or pacemaker implantation. Patient included in any clinical trial in the previous 3 months. Pregnant or breastfeeding women. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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 |
| --- | --- | --- |
| Rate of therapeutic success by patients in sinus rhythm or heart rate control at target (< 80 beats per minute at rest) |  | At 12 ± 3 months follow-up | 
| Comparison of clinical outcomes (Cardiovascular death, Stroke, Myocardial infarction, etc) for patients in rhythm versus rate control strategies |  | At 12 ± 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment effectiveness evaluated by the proportion of patients in sinus rhythm |  | At 1 year follow-up |
Oral Misoprostol Solution in Comparison to Vaginal Misoprostol in Induction of Labor

Study Overview
=================
Brief Summary
-----------------
Induction of labour at term is a common obstetric intervention. Induction of labour is the artificial initiation of labour before its spontaneous onset for the purpose of delivery of the fetoplacental unit using mechanical or pharmacological methods. To determine the effects of oral misoprostol solution compared to vaginal misoprostol in induction of labour.

Detailed Description
-----------------
Patients recruited in the study will be primigravida at term with obstetric or medical indication for labour induction. These patients will be either booked attending antenatal clinic referred for induction of labour or emergency admissions in labour room. A total of 100 women will be randomly selected for the study. I. Women will be given 20 ml (20 µg) of misoprostol solution orally every 2 hourly until adequate uterine contractions occurred (3 contractions per 10 min lasting 30-40 s). II. The induction regimen included application of Vagiprost 25 µg tablet in the posterior fornix of the vagina every 4 h (up to 6 doses) after determination of the Bishop score.

Official Title
-----------------
Oral Misoprostol Solution in Comparison to Vaginal Misoprostol in Induction of Labor

Conditions
-----------------
Normal Vaginal Delivery

Intervention / Treatment
-----------------
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primigravida or Primipara Pregnancy between 36 and 42 weeks of gestation. A live singleton fetus in cephalic presentation. No history of uterine surgery. Clinically adequate pelvis. Modified Bishop's score <5. Reactive Non stress test (NST) . Exclusion Criteria: •Known hypersensitivity or contraindications to oral misoprostol (uterine surgery). Any antenatal medical complications. A situation requiring LSCS (Maternal or Fetal) e.g:fetal distress Non-reactive NST. Patient's refusal to give consent
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral<br>patients undergoing induction of labour using misoprostol oral solution | Drug: Misoprostol<br>* induction of labor<br>|
| Experimental: vaginal<br>patients undergoing induction of labour using vaginal misoprostol | Drug: Misoprostol<br>* induction of labor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| •Induction-delivery time |  | 2 hours |
Aripiprazole in the Treatment of Bipolar Depression

Study Overview
=================
Brief Summary
-----------------
A systematic open-label prospective pilot study to assess aripirazole for acute bipolar depression, with a secondary assessment of longer-term mood stabilization.

Detailed Description
-----------------
Study is 6 weeks long with 7 clinical visits.

Official Title
-----------------
Phase 4 Study: An Open Prospective Study of the Safety and Effectiveness of Aripiprazole in the Treatment of Bipolar Depression

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV diagnosis of bipolar disorder, any subtype; MADRS >16; MRS < 10; not currently taking other mood stabilizers; women of reproductive potential must use an acceptable method of birth control Exclusion Criteria: Current substance abuse within past month; serious unstable medical condition; active suicidal ideation; pregnant, trying to become pregnant, or nursing; intent to continue or initiate herbal preparations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Aripiprazole in depression treatment<br> | Drug: Aripiprazole<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression state |  | 6 week study |
Cell-based Non-invasive Prenatal Testing as an Alternative to Invasive Chorionic Villus Sampling

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate cell-based non-invasive prenatal testing (cbNIPT) as an alternative to invasive chorionic villus sampling (CVS) in patients who achieve pregnancy following preimplantation genetic testing for hereditary disorders.

Detailed Description
-----------------
The study has three main objects: to evaluate the optimal time of blood sampling (gestational week 7-8 or 11-14) to evaluate whole genome amplification prior to genetic analysis og isolated fetal cells (only relevant for monogenic disorders) evaluating specificity and sensitivity compared to chorionic villus sampling

Official Title
-----------------
Cell-based Non-invasive Prenatal Testing - Evaluation of Time of Blood Sampling and Whole Genome Amplification Prior to Genetic Testing

Conditions
-----------------
Hereditary Diseases

Intervention / Treatment
-----------------
* Genetic: Whole genome amplification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy following preimplantation genetic testing Exclusion Criteria: None
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WGA<br>DNA from the cells are amplified by whole genome amplification prior to genetic testing. | Genetic: Whole genome amplification<br>* DNA is amplified by whole genome amplification<br>|
| No Intervention: No-WGA<br>DNA from the cells are tested directly without whole genome amplification | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the fetal cell yield when blood sampling is performed at Gestational weeks 7-8 compared to gestational weeks 11-14. | Evaluation of whether cbNIPT be performed in gestational week 7-8. | Within 2 years | 
| Percentage of test with an informative test result from genetic testing following whole genome amplification or direct testing without whole genome amplification. | Analysis of whether genetic testing on whole genome amplified material is inferior to genetic testing directly on DNA purified from single cells. | Within 2 years | 
| Specificity and sensitivity of single cell analysis. | Evaluation of the sensitivity and specificity of single cell analysis. | Within 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cell-based non-invasive prenatal testing, Hereditary disorders
A Randomized, Double-Blind, Placebo Controlled Study of l-Leucovorin in Combination With Trimethoprim / Sulfamethoxazole in the Therapy of Pneumocystis Carinii Pneumonia in Patients With the Acquired Immunodeficiency Syndrome

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate the effectiveness of l-leucovorin in preventing toxicity from high dose trimethoprim / sulfamethoxazole (TMP / SMX) used as a therapy for Pneumocystis carinii pneumonia (PCP) in patients with AIDS.

Official Title
-----------------
A Randomized, Double-Blind, Placebo Controlled Study of l-Leucovorin in Combination With Trimethoprim / Sulfamethoxazole in the Therapy of Pneumocystis Carinii Pneumonia in Patients With the Acquired Immunodeficiency Syndrome

Conditions
-----------------
Pneumonia, Pneumocystis Carinii, HIV Infections

Intervention / Treatment
-----------------
* Drug: Trimethoprim
* Drug: Sulfamethoxazole
* Drug: Leucovorin calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have the following: Diagnosis of PCP. Fit the CDC definition of AIDS. Be receiving intravenous or oral trimethoprim / sulfamethoxazole (Bactrim, Septra) in doses of = or > 15mg/kg/day of the trimethoprim component. Be receiving = or < 48 hours of trimethoprim / sulfamethoxazole (TMP / SMX) prior to randomization. Must sign informed consent in accordance with FDA guidelines. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Cannot take oral medications. Require continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone. Concurrent Medication: Excluded: Continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone. Patients with the following are excluded: Cannot take oral medications. Require continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone. Prior Medication: Excluded: > 48 hours of trimethoprim / sulfamethoxazole prior to randomization.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Trimethoprim|nan|
|Drug: Sulfamethoxazole|nan|
|Drug: Leucovorin calcium|nan|

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
-----------------
Trimethoprim-Sulfamethoxazole Combination, AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Acquired Immunodeficiency Syndrome
Brain Volumes of Very Low Birth Weight Infants Measured by Cranial Ultrasonography

Study Overview
=================
Brief Summary
-----------------
Neonatal cranial ultrasound (US) remains the method of choice to detect brain injury in high risk preterm infants on neonatal intensive care units (NICU). It is a non-invasive, inexpensive bedside tool and examinations can be repeated as often as necessary without major disturbance of vulnerable infants. The anterior and posterior fontanelles from excellent acoustic windows to examine the deep midline and periventricular regions of the brain.Some data demonstrated that cerebral palsy can be accurately predicted with US. However, cranial US is not very suitable for investigating cortical regions or structures in the posterior fossa. There is limited data for very preterm infants.The investigators aimed to measure ventricular index, cranial height, biparietal diameter and calculate brain volume in a huge number of infants.

Official Title
-----------------
Neonatal Cranial Ultrasonography for Measuring Brain Volumes of Very Low Birth Weight Infants

Conditions
-----------------
Infant, Premature

Intervention / Treatment
-----------------
* Device: Cranial ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: both gender <1500 gr <32 week- 1-28 days neonates Exclusion Criteria: Anomalies and no viability

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 40 Weeks

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cranial ultrasonography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurements of ventricular indexes of preterm infants | measuring distance with 2D USG | 12 months | 
| measurements of brain volumes of preterm infants | subtracting the ventricular volumes from the total brain volume measured with 2D | 12 months |
Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the study medication, brivaracetam, is tolerable and safe for patients with brain tumors.

Detailed Description
-----------------
In this study, subjects will receive usual treatment for their brain tumor. In addition, they will be given brivaracetam at a dose of 50 mg twice daily.

Official Title
-----------------
Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas

Conditions
-----------------
Brain Tumor

Intervention / Treatment
-----------------
* Drug: Brivaracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years with pathologic diagnosis of a supratentorial diffuse astrocytic or oligodendroglial tumor Patients must be able to provide informed consent Exclusion Criteria: A pre-existing seizure disorder or epilepsy syndrome prior to tumor diagnosis Active maintenance therapy with an antiepileptic seizure drug (AED) prior to diagnosis of tumor Patients who have experienced an epileptic seizure as the presenting symptom of their brain tumor Predicted life expectancy of less than 6 months from the time of screening Pregnancy Patients with clinically significant hepatic disease (elevated aminotransferases [bilirubin, alkaline phosphatase] > 3 times upper limit normal) Patients with stage 4 or greater renal disease (GFR <30 mL/min/1.73 m2) Patients who are unable to swallow a tablet Patients with active suicidal ideation or a history of suicide attempt or other serious psychiatric disorder having required hospitalization within the previous 2 years.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Brivaracetam at a dose of 50 mg twice daily for 6 months | Drug: Brivaracetam<br>* Dose of 50 mg twice daily for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Brivaracetam | Evaluate adverse events | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voluntariness for study participation | Number of people that declined to participate | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain Tumor, Brivaracetam, Epilepsy
Vitamin D Supplementation to Obese Chinese Males

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Oral Supplementation of Vitamin D can Reduce Hypersecretion of Parathyroid Hormone and Insulin Resistance in Obese Chinese Males. Protocol: Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) or eight weeks to the obese males compared with the normal-weight males. Index measures were conducted at baseline and endpoint.

Official Title
-----------------
Health Effect of Oral Vitamin D Supplementation on Obese Chinese Males

Conditions
-----------------
Obesity, Insulin Resistance

Intervention / Treatment
-----------------
* Dietary Supplement: Oral supplementation of vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body mass index (BMI) ≥ 28kg/m2 or 18.5 ≤ BMI < 24 (kg/m2) non vegetarian Han Chinese and did not smoke, drink, nor take vitamin D supplements for > 2 y fasting serum glucose < 7.0 mmol/L serum glucose of 2 hr after 75 g oral glucose loading < 11.1 mmol/L normal functioning of liver and kidney evaluated by alkaline phosphatase, aspartate aminotransferase, creatinine, and uric acid Exclusion Criteria: not match the above inclusion criteria diagnosed as having any organic diseases were excluded

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 66 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obese group<br>Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks. | Dietary Supplement: Oral supplementation of vitamin D<br>* Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) for eight weeks to the obese males compared with the normal-weight males. The chemical form of vitamin D is cholecalciferol capsuled as fine powder.<br>|
| Experimental: Normal-weight group<br>Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks. | Dietary Supplement: Oral supplementation of vitamin D<br>* Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) for eight weeks to the obese males compared with the normal-weight males. The chemical form of vitamin D is cholecalciferol capsuled as fine powder.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L) |  | Endpoint and baseline of the 8 weeks' trial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D,, Oral supplementation,, Obese males