linjc16/ctgov huggingface dataset:
Angina in Non Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
Many patients undergoing coronary angiography are found to have no significant coronary artery disease (CAD) despite angina equivalent symptoms and/or electrocardiographic abnormalities suggestive of myocardial ischemia. The aim of this study is to systematically assess patients with angina equivalent symptoms despite normal coronary angiograms and to evaluate their symptoms according to a defined algorithm.

Detailed Description
-----------------
All consecutive patients who had coronary angiography at the Luzerner Kantonsspital between July 1st 1996 and July 31st 2008 and who had no significant coronary stenoses (no coronary stenoses ≥ 50%) were recruited for this study. Patients are extensively examined during angiography using acetylcholine infusion and fast atrial pacing. According to the result of the additional invasive examination (vasospasm, vasoconstriction, vasodilation; symptoms during examination) a distinct diagnosis is attributed to the patients (small vessel disease, vasospastic disease, hypertensive heart disease, rhythm disorder, or extracardiac thoracic pain including pulmonary hypertension). Patients are followed-up after 10 years and prognosis of these patients is assessed (including mortality, cardiovascular events, re-angiography, functional status after 10 years).

Official Title
-----------------
Invasive Findings in Patients With Angina Equivalent Symptoms But No Coronary Artery Disease; Results From the Heart Quest Cohort Study

Conditions
-----------------
Angina Pectoris, Microvascular Angina, Angina Pectoris, Variant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coronary angiography at the Luzerner Kantonsspital between July 1st 1996 and July 31st 2008 No significant coronary stenoses (no coronary stenoses ≥ 50%) Exclusion Criteria: Severe valvular heart disease Severe congestive heart failure
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 |
| --- | --- | --- |
| Cause of angina equivalent symptoms in patients with no coronary artery disease |  | One day | 
| Prognosis of patients with angina equivalent symptoms and normal coronary arteries |  | 10 years after baseline assessment |
A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal cancer improve outcomes without causing significant side effects.

Detailed Description
-----------------
Primary Outcome measures are 3-year locoregional control, progression-free and overall survival rates. Secondary outcome measures are toxicities scores up to 3 months after surgery (acute) and greater than 3 months after surgery (late). Data collected at 3-6 month intervals for 30 months

Official Title
-----------------
A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer

Conditions
-----------------
Malignant Rectal Neoplasm, Recurrent Tumor

Intervention / Treatment
-----------------
* Radiation: intraoperative radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: locally advanced or recurrent rectal cancer suitable for radical surgery but at high risk of positive resection margins, no evidence of metastasis, age greater than 18 years, histologically confirmed adenocarcinoma, ECOG performance status <2. Informed consent Exclusion Criteria: unresectable pelvic disease distant metastasis significant co-morbidities

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: intraoperative radiotherapy<br> | Radiation: intraoperative radiotherapy<br>* intraoperative radiotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical outcomes | locoregional control, progression-free and overall survival rates. | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicities | Toxicity score criteria defined by Intraoperative Radiation Therapy Working Group Criteria | 3-6 monthly up to 30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraoperative radiotherapy
AZD8529 Single Ascending Dose Study in Healthy Japanese Subjects

Study Overview
=================
Brief Summary
-----------------
This is a Phase I, double-blind, placebo-controlled, randomised within each dose group, single ascending dose study, with the objective to assess the safety, tolerability and pharmacokinetic profile of AZD8529 in healthy Japanese subjects.

Official Title
-----------------
A Phase I, Single-Centre, Randomised, Double-Blind, Placebo Controlled Single-Ascending Dose, Study to Assess the Safety, Tolerability, Pharmacokinetics of AZD8529 in Healthy Male Japanese Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD8529
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male Japanese subjects aged 20 to 45 years (inclusive) Have a body mass index (BMI) between 18 and 27 kg/m 2 (inclusive) and weigh at least 50 kg.least 50 kg. Exclusion Criteria: History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study. Any clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, haematology or urinalysis as judged by the Investigator and/or Sponsor. Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD8529<br>* Oral<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To asses the safety:Adverse events, vital signs, physical examinations, telemetry, dECGs, clinical chemistry and haematology labs including testosterone, prolactin, LH, FSH and TSH, and urinalysis. |  | From screening period to follow-up, 42 days (maiximum). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetics of AZD8529 in plasma and urine. |  | Blood and urine sampling from pre-dose until 12 days post dose. | 
| To collect and store DNA for future exploratory research |  | One blood sampling after randomisation. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I, Japanese healthy volunteer, AZD8529
Burden of Invasive Group B Streptococcal (GBS) Disease in Young Infants in China

Study Overview
=================
Brief Summary
-----------------
Evaluate the burden of invasive group B streptococcal (GBS) disease in young infants (up to 90 days of age) in China, in terms of incidence, case fatality rate and serotype distribution

Official Title
-----------------
Burden of Invasive Group B Streptococcal (GBS) Disease in Young Infants in China: Incidence, Case Fatality Rate and Serotype Distribution

Conditions
-----------------
Invasive Group B Streptococcal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive culture for GBS from one or more of the following normally sterile sites: blood, cerebrospinal fluid (CSF), pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, joint fluid, suprapubic bladder aspiration or internal body site (e.g., lymph node, brain). ≤90 days old at the time of GBS confirmation. Voluntary written informed consent provided. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Maximum Age: 90 Days

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 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of group B streptococcal (GBS) disease |  | From birth to 90 days of age | 
| Case Fatality Rate of GBS disease |  | From birth to 90 days of age | 
| GBS serotype distribution |  | From birth to 90 days of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Group B streptococcus, Incidence, Case fatality rate, Serotype distribution
Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the long-term safety, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a gating or residual function mutation (F/G and F/RF genotypes).

Official Title
-----------------
A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: ELX/TEZ/IVA
* Drug: IVA


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Completed study drug treatment in parent study (VX18-445-104); or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study Key Exclusion Criteria: History of study drug intolerance in parent study Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Triple Combination Arm<br>Subjects will receive ELX/TEZ/IVA TC in the morning and IVA as mono tablet in the evening. | Drug: ELX/TEZ/IVA<br>* Fixed-dose combination (FDC) tablet for oral administration.<br>* Other names: elexacaftor/tezacaftor/ivacaftor;Drug: IVA<br>* 150-mg tablet for oral administration.<br>* Other names: ivacaftor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as assessed by number of subjects with adverse events (AEs) and serious adverse events (SAEs) |  | From Baseline up to Week 100 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in percent predicted forced expiratory volume in 1 second (ppFEV1) |  | From Baseline up to Week 96 | 
| Absolute change in sweat chloride (SwCl) |  | From Baseline up to Week 96 | 
| Absolute change in body mass index (BMI) |  | From Baseline up to Week 96 | 
| Absolute change in BMI z-score |  | From Baseline up to Week 96 | 
| Absolute change in body weight |  | From Baseline up to Week 96 | 
| Absolute change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain score |  | From Baseline up to Week 96 |
Long-term Prognosis of Patients With Sepsis After Immunotherapy

Study Overview
=================
Brief Summary
-----------------
Current clinical studies of thymosin α1 for sepsis have focused on short-term outcomes (28-day or 90-day mortality), and lack of clinical data on long-term outcomes (3 year mortality) of patients with sepsis after immunotherapy. Based on the preliminary clinical study (NCT02867267), this study will conduct long-term follow-up for sepsis patients to provide data support for the long-term prognosis of immunotherapy.

Official Title
-----------------
Long-term Prognosis After Thymosin Alpha 1 Treatment in Patients With Sepsis: A Multicenter Cohort Study

Conditions
-----------------
Long-term Effects of Thymosin Alpha 1 Treatment

Intervention / Treatment
-----------------
* Drug: Thymosin Alpha1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sepsis patients in the TESTS study Patients who discharged from hospital after recovery Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| thymosin α1 group<br>The patient was treated with thymosin α1 in sepsis | Drug: Thymosin Alpha1<br>* Drug interventions have been done in previous clinical studies<br>|
| placebo group<br>The patient was treated without thymosin α1 in sepsis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| three years mortality | Mortality rate of patients treated with thymosin α1 or placebo within 3 years | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate of sepsis | Percentage of recurrent sepsis within 5 years of discharge sepsis patients | 5 years | 
| one year mortality | Mortality rate of patients treated with thymosin α1 or placebo within 1 year | 1 year | 
| Five years mortality | Mortality rate of patients treated with thymosin α1 or placebo within 5 years | 5 years | 
| short form 36 questionnaire | Quality of life of sepsis patients after 1 year of thymosin α1 or placebo treatment | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
long-term, thymosin alpha 1, sepsis, immunotherapy
Homocysteine in Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the relation between high homocysteine levels and increased incidence of acute coronary syndrome in young patients

Detailed Description
-----------------
Cross sectional study to: assess homocysteine level in young adult patients presenting with acute coronary syndrome

Official Title
-----------------
Serum Homocysteine Level in the Setting of Acute Coronary Syndrome in Young Adult Patients

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: Homocysteine level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - The patients who presented in the hospital with chest pain consistent with acute coronary syndrome with any of the following features: Electrocardiogram (ECG) changes: ST elevation ST depression T wave inversion recent left bundle branch block Troponin T elevation (Norma value < 0.06) 2- Age: -Between 18- 40 years (Group A) - Age > 40 years (Group B) Exclusion Criteria: Chest pain not consistent with acute coronary syndrome Chronic kidney disease (CKD) Rheumatic heart disease (RHD) Congenital heart disease Anemia Cancer

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Homocysteine level|diagnostic test|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary care unit admission with acute coronary syndrome | Acute coronary syndrome hospitalization and cardiovascular deathes and estimated hazard ratios (HR) by use of multivariable Cox regression models | From date of randomization up to 1 month |
Vascular Inflammation Stratified by Body Size Phenotype

Study Overview
=================
Brief Summary
-----------------
Vascular Inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18FDG-PET is a promising novel tool for identifying and quantifying vascular inflammation within atherosclerotic plaque Recently, unique subsets of obese individuals, such as metabolically obese but normal weight (MONW) and metabolically healthy obese (MHO), have been getting an attention Therefore, the purpose of this study is to examine the relationship of vascular inflammation,measured by FDG-PET, with various body sized phenotypes

Conditions
-----------------
Atherosclerosis, Obesity, Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy patients for visiting routine medical check in our clinic Exclusion Criteria: history of CVD (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization) stage 2 hypertension (resting blood pressure, ≥160/100 mmHg) history of inflammatory conditions that affect the study results taking medications that might affect inflammatory status, including steroid and non-steroidal anti-inflammatory drug within 6 months or malignancy or severe renal or hepatic disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| max TBR values stratified by the four body size phenotypes |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Framingham risk scores according to the four body size phenotypes |  | 12 weeks |
Fetal Anomalies Scan at the Time of Nuchal Translucency Study

Study Overview
=================
Brief Summary
-----------------
Purpose: Fetal anomalies scan at the time of Nuchal Translucency (NT) study.

Detailed Description
-----------------
Prospective study of patients at 12-14 weeks gestation that are coming for NT examination is conducted. Meticulous ultrasound examination will be done to the fetuses using trans vaginal and transabdominal techniques. The patients will receive only the NT information. Only in cases of detection of severe fetal anomalies the patient will get the information of the examination and counseling according to the findings. All patients will be asked to provide information of the 15 weeks early comprehensive ultrasound examination. The NT examination will be compared to the 15 weeks ultrasound. All patients will be asked to give information after delivery of the baby's health condition.

Official Title
-----------------
Fetal Anomalies Scan at the Time of Nuchal Translucency Study

Conditions
-----------------
Fetal Anomalies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women at 12-14 weeks Exclusion Criteria: -
Sexes Eligible for Study
-----------------
Female

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

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
-----------------
Fetal anomalies scan at the time of NT study
Decompression Intervention of Variceal Rebleeding Trial (DIVERT)

Study Overview
=================
Brief Summary
-----------------
The Decompression Intervention of Variceal Rebleeding Trial (DIVERT) is a multi-center prospective randomized clinical trial comparing the radiologic procedure of transjugular intrahepatic portal-systemic shunt (TIPS) with the surgical procedure of distal splenorenal shunt (DSRS) for variceal bleeding in patients with Child's Class A and B cirrhosis. This is recognized nationally and internationally as the study that will answer the question as to which of these is the best treatment for decompression of varices in patients who have failed endoscopic and pharmacologic therapy.

Official Title
-----------------
Decompression Intervention of Variceal Rebleeding Trial

Conditions
-----------------
Esophageal and Gastric Varices, Liver Cirrhosis

Intervention / Treatment
-----------------
* Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)
* Procedure: Distal Splenorenal Shunt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Variceal bleeding secondary to cirrhosis and portal hypertension Child's Class A or B cirrhosis of any etiology Patients who have failed endoscopic therapy (sclerotherapy or banding) of varices; or patients who are not candidates for endoscopic therapy Exclusion Criteria: Prior shunt procedure Portal vein thrombosis Polycystic liver disease Intractable ascites Prior organ transplant Any medical intractable disease

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)|nan|
|Procedure: Distal Splenorenal Shunt|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
-----------------
TIPS, DSRS, Varices, Variceal bleeding, Splenorenal Shunt, Transjugular Intrahepatic Portosystemic Shunt, Cirrhosis, Portal hypertension, Liver disease