linjc16/ctgov huggingface dataset:
Wide Area Circular Ablation Versus Extra-wide Area Circular Ablation in Persistent Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Ablation of atrial fibrillation is an established method for treatment of subjects with atrial fibrillation with goal of restoration of sinus rhythm. Among different methods, wide area circular ablation (WACA) is shown to provide the same results with fewer complications. This project will compare WACA with extra-wide area circular ablation (E-WACA) in subjects who are considered for ablation of atrial fibrillation.

Official Title
-----------------
Comparison of Wide Area Circular Ablation With Extra-wide Area Circular Ablation in Subjects With Persistent Atrial Fibrillation, a Randomized Study

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

Intervention / Treatment
-----------------
* Procedure: Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects with symptomatic persistent atrial fibrillation who are scheduled for clinically indicated ablation of AF. Exclusion Criteria: Subjects younger than 18 year of age. Subjects who are pregnant. Subjects who are unable to provide consent.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: WACA<br>wide area circular ablation | Procedure: Ablation<br> <br> |
| Active Comparator: EWACA<br>extra-wide area circular ablation | Procedure: Ablation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the achievement of sinus rhythm in subjects undergoing ablation of atrial fibrillation using WACA compared to E-WACA. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ii. To compare the time to reoccurrence of atrial fibrillation, atrial flutter and/or atrial tachycardia in subjects undergoing ablation of atrial fibrillation using WACA compared to E-WACA. |  | 1 year |
Prognostic Significance of the Baroreflex Sensitivity Changes After Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
After acute stroke, baroreflex sensitivity (BRS) is impaired. This impaired acute stage BRS has been reported to be predictive of worsen outcome years after stroke in general. However, it is not very clear if the impaired acute stroke BRS would actually persist months after the acute stage. It is also not clear that such change, if any, would correlate with the functional outcome or prognosis after stroke. The trial is to investigate the longitudinal time course of BRS after ischemic stroke up to the 6th month post stroke and to see if there is any correlation of the changes in BRS with the functional outcome parameters using NIHSS and mRS scores throughout this period.

Official Title
-----------------
Noninvasive Study of the Time Course of Baroreflex Sensitivity 6-Month After Acute Ischemic Stroke and the Relation of Its Changes With Post Stroke Prognosis

Conditions
-----------------
Cerebrovascular Accident, Baroreflexes, Autonomic Nervous System Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Baroreflex sensitivity can be done within 72 hours of onset of acute ischemic stroke 50-80 years old Must have either brain CT or brain MRI done Exclusion Criteria: NIHSS score > 10 Patient could not cooperate Unstable vital sign Atrial fibrillation Transient ischemic attack patient Diabetic patient Impaired renal function (Cr > 2.26 mg/dl) Unstable angina, acute myocardiac infarction, cardiomyopathy patients Patient who has known autonomic dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ischemic stroke, Baroreflex sensitivity, Prognosis, Cardiovascular autonomic regulation
Retrospective Observational Trial on Reasons for Withdraw of Adjuvant Tamoxifen in Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Retrospective observational trial on reasons for withdraw of Adjuvant Tamoxifen in Breast Cancer patients

Official Title
-----------------
Retrospective Observational Trial on Reasons for Withdraw of Adjuvant Tamoxifen in Breast Cancer Patients

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast Ca Patients with surgery and withdraw of adjuvant treatment with Tamoxifen for Tam related AEs Documented reasons for treatment withdrawal Exclusion Criteria: enrollment in other studies treatment withdraw for other causes than Tam related AEs
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Post menopausal women treated with adjuvant TAM for breast cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of withdraw from adjuvant Tamoxifen due to Tam related AEs |  | January 2003-December 2004 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Types of TAM related AE |  | January 2003-December 2004 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Adjuvant TAM, post-menopausal, women
A Study of Azacitidine in Participants With International Prognostic Scoring System (IPSS) Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS), or Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and effectiveness in the real-world setting among participants who are treated with Azacitidine in accordance with the China Product Label.

Detailed Description
-----------------
This study will have participants both enrolled retrospectively and prospectively for azacitidine (AZA) treatment.

Official Title
-----------------
A Prospective/Retrospective Non-Interventional Study of Vidaza® (Azacitidine) in Patients With International Prognostic Scoring System (IPSS) Intermediate-2 and High-risk Myelodysplastic Syndromes, or Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia With 20-30% Blasts and Multi-lineage Dysplasia in China

Conditions
-----------------
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of intermediate-2/ high-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML) with 20-30% bone marrow blasts and multi-lineage dysplasia Initiated azacitidine (AZA) treatment per approved China Product Label after April 2017 Exclusion Criteria: Contraindicated for the use of AZA according to China Product Label Simultaneously participating in a treatment intervention study Other protocol-defined inclusion/exclusion criteria 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospectively enrolled cohort<br>Participants who initiate Azacitidine (AZA) before enrollment | |
| Prospectively enrolled cohort<br>Participants who initiate AZA initiation at enrollment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Up to 12 Months | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 12 Months | 
| Incidence of Adverse Drug Reactions (ADRs) |  | Up to 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Overall response rate (ORR) defined as the proportion of participants who achieved best response of superior to stable disease |  | Up to 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myelodysplastic syndromes (MDS), Azacitidine (AZA), Chronic myelomonocytic leukemia (CMML), Acute myeloid leukemia (AML)
Changes in the Permeability of the Blood Brain Barrier and Intestinal Barrier in Humans During Conditions of Stress and Immune Activation: in Vivo Studies

Study Overview
=================
Brief Summary
-----------------
The relevance of BBB and IB permeability changes as a major precipitating cause for cognitive and digestive dysfunction in the military stress setting.

Conditions
-----------------
Combat Training Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male troops (aged 18-50 yrs) scheduled to be engaged in a protracted multi-day stressful field exercises. Exclusion Criteria: Significantly systemic disease, including cardiovascular, psychiatric, neurological (including polyneuropathies) and endocrine disease including diabetes mellitus. No written informed consent obtained from subject.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with combat training stress<br> | |
| without combat training stress<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study to Assess the Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study was designed to directly assess the effects of vildagliptin on gastric emptying in people with type 2 diabetes.

Official Title
-----------------
A Double-blind, Crossover, Placebo-Controlled, Multiple-dose Study to Evaluate the Effects of Vildagliptin on Gastric Emptying, Gastric Volume and Satiety in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: Vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with type 2 diabetes for at least 6 months Blood glucose criteria must be met BMI in the range 22-40 Exclusion Criteria: History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes Use of thiazolidinediones or need for insulin within 3 months prior to screening Significant concomitant diseases or complications of diabetes High fasting triglycerides as defined by the protocol Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on gastric emptying |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on gastric volume |  |  | 
| Effect on satiety |  |  | 
| Effect on endogenous glucose appearance, glucose appearance and glucose disposal |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vildagliptin, Type 2 diabetes
Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Failing on OADs

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in North America. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving glycaemic targets on OADs (oral anti-diabetic drugs).

Official Title
-----------------
NovoMix® 30 (Biphasic Insulin Aspart 70/30) Titrate-to-target: An Observational Study of the Efficacy of NovoMix® 30 in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus for at least 12 months HbA1c between 7.5-14.5% (inclusive) at screening Insulin naïve An antidiabetic regimen that has been stable for at least 3 months prior to screening An antidiabetic regimen that includes a minimum of 2 OADs Exclusion Criteria: Use of any insulin preparations within the past 6 months Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIAsp 30<br> | Drug: biphasic insulin aspart 30<br>* Dose individually adjusted. Administered once daily for 16 weeks. If HbA1c after 16 weeks of treatment is above 7.0%, insulin is administered twice daily for additional 16 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving HbA1c (glycosylated haemoglobin A1c) below 7.0% |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  |  | 
| Total number of hypoglycemic events |  |  | 
| Adverse events |  |  |
Spirituality, Religiosity, and Immune Functioning

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether religiosity and spirituality are related to immune functioning, as measured by interleukin-6 blood plasma level, among terminally ill cancer patients.

Conditions
-----------------
Cancer, Depression, Dying Process

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Inpatient at Calvary Hospital Diagnosis of terminal cancer Score of 20 or above on Mini-Mental State Exam Exclusion criteria: Presence of a psychiatric disorder that would preclude the production of meaningful data

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spirituality, religiosity, immune functioning, psychoneuroimmunology, cytokines, cancer, death, depression
Austrian COVID-19 Registry

Study Overview
=================
Brief Summary
-----------------
The AGMT_COVID-19 Registry is designed as multicenter observational cohort of patients, that are tested positive for SARS-CoV-2. Data will be collected from all sites in Austria willing to participate. Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF.

Detailed Description
-----------------
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease was first identified at the end of 2019 in Wuhan, the capital of Hubei province in central China, and has since spread globally. There are currently no authorised vaccines or treatments in the EU (European Union) to prevent or treat novel coronavirus disease (COVID-19) specifically or any other coronaviruses. The AGMT_COVID-19 Registry is designed as multicenter observational cohort of patients, that are tested positive for SARS-CoV-2. Data will be collected from all sites in Austria willing to participate. Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF. Treatment indication, the decision to offer treatment, treatment choice, dose, schedule and dose reductions/escalations, and response assessments shall be exclusively based on the risk/benefit estimation of the treating physician.

Official Title
-----------------
Austrian COVID-19 Registry (AGMT_COVID-19)

Conditions
-----------------
Infectious Disease, COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >=18 years Positive test for SARS-CoV-2 Exclusion Criteria: Due to the non-interventional design of the registry there are no specific exclusion criteria.

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 |
| --- | --- | --- |
| Documentation of natural course and the therapeutic landscape of patients with COVID-19. | Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF. Treatment indication, the decision to offer treatment, treatment choice, dose, schedule and dose reductions/escalations, and response assessments shall be exclusively based on the risk/benefit estimation of the treating physician. | 2 years |
Efficacy of Low Dose Levothyroxine During Pregnancy

Study Overview
=================
Brief Summary
-----------------
the effect using low dose levo thyroxine in pregnant females with TSH level more than 2.5 mU/L in the first trimester on pregnancy outcome

Detailed Description
-----------------
the study aim to detect the effect of low dose levothyroxine 50 ug on pregnant females and compare it with others receiving placebo

Official Title
-----------------
Efficacy of Low Dose Levothyroxine During Pregnancy

Conditions
-----------------
Euthyroid Females

Intervention / Treatment
-----------------
* Drug: levothyroxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: females with TSH more than 2.5 mU/L and less than 4 mU/L after biochemical diagnosis of pregnancy. Exclusion Criteria: associated endocrinopathies (PCO/ DM/ hyperprolactinemia ) associated medical condition (HTN/ chronic kidney disease. history of recurrent pregnancy loss

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: levothyroxine<br>100 pregnant female with TSH of> 2.5 mU/L but less than 4 mU/L after biochemical diagnosis of pregnancy will receive 50 ug of levothyroxine (eltroxin 50) aspen,Egypt throughout the pregnancy | Drug: levothyroxin<br>* 90 female received levothroxine<br>|
| No Intervention: control<br>100 pregnant female with TSH of> 2.5 mU/L but less than 4 mU/L after biochemical diagnosis of pregnancy will not receive any drug throughout the pregnancy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1st trimester miscarriage | 1st trimester spontaneous or missed abortion | during 1st 13 weeks of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse pregnancy outcome | 2nd trimesteric missed or spontaneous abortion ,gestational hypertension,preeclampsia, anemia, abruptio placenta premature delivery , fetal growth restriction, low birth weight | last 26 week of gestation |