linjc16/ctgov huggingface dataset:
Endothelial Dysfunction and Coronary Artery Spasm

Study Overview
=================
Brief Summary
-----------------
Non-obstructive coronary artery disease (NOCAD) frequently accounts for myocardial ischemia in women. Endothelial dysfunction is a pathogenic factor in coronary spastic angina (CSA). CSA is an important cause of NOCAD diagnosed invasively by coronary angiography (CAG). Digital reactive hyperemia peripheral arterial tonometry (RH-PAT) provides noninvasive evaluation of endothelial dysfunction. The investigators hypothesized that the fingertip RH-PAT could predict the presence of CSA in women.

Detailed Description
-----------------
Outline of methods: RH-PAT was measured in women with chest pain prior to CAG. Coronary spasm was diagnosed by intra-coronary acetylcholine (ACh) provocation test. Using Flow-Wire, we assessed coronary endothelial function by coronary blood flow increase in response to ACh (ACh-CBF) and coronary flow reserve was assessed by adenosine (Ad-CFR).

Official Title
-----------------
Digital Tonometry for Measurement of Peripheral Artery Reactive Hyperemia as Non-invasive Test for Diagnosis of Coronary Artery Spasm

Conditions
-----------------
Coronary Vasospasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable post-menopausal women complaining angina-like chest pain Exclusion Criteria: Severe valvular disease Hypertrophic cardiomyopathy Severe peripheral artery disease Uncontrolled hypertension Severe collagen diseases Acute coronary syndrome

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Ischemic heart disease diagnosed by cardiac catheterization |  | From Aug 2006 to May 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Vasospasm, Endothelium, Vascular, Vasodilation, Hyperemia
A Non-Drug Study on the Relationship Between Exploratory Biomarkers and Functional Dimensions in Individuals With Autistic Disorder or Asperger's Syndrome

Study Overview
=================
Brief Summary
-----------------
This multi-center, non-drug study will explore the relationship between exploratory biomarkers and functional dimensions in male adult individuals with Autistic Disorder or Asperger's Syndrome and healthy volunteer controls. Subjects will undergo a number of assessments on study visit Day 1.

Official Title
-----------------
A Multi-center, Non-drug Study to Explore the Relationship Between Exploratory Biomarkers and Functional Dimensions in Individuals With Autistic Disorder or Asperger's Syndrome.

Conditions
-----------------
Healthy Volunteer, Autistic Disorder, Asperger's Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with Autistic Disorder or Asperger's Syndrome: Male adults, 18 to 45 years of age inclusive Diagnosis of Autistic Disorder or Asperger's Syndrome as defined by DSM-IV IQ >70 Body mass index (BMI) 18 to 35 kg/m2 Availability of a reliable caregiver, able and willing to provide information regarding the individual's behavior and symptoms Healthy controls: Healthy male adults, 18 to 45 years of age inclusive IQ >70 Body mass index (BMI) 18 to 30 kg/m2 Exclusion Criteria: General exclusion criteria: Positive test for drugs of abuse or alcohol Confirmed systolic blood pressure >140 or <90 mmHg, and diastolic blood pressure >90 or <50 mmHg Resting pulse rate >100 or <40 beats per minute Alcohol and/or substance abuse/dependence during the last 12 months Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study Additionally for individuals with Autistic Disorder or Asperger's Syndrome: History of epilepsy/seizure disorder (except simple febrile seizures) Significant disruptive, aggressive or self-injurious, or sexually inappropriate behavior during the last 3 months that in the opinion of the investigator might interfere with the conduct of the study Additionally for healthy controls: Clinically significant abnormalities in laboratory test results History of or current psychiatric, neurological disorder or pervasive developmental disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavior assessment ratings |  | approximately 5 months | 
| Cognition assessment ratings |  | approximately 5 months |
Taiwan Registry for Leadless Pacemaker

Study Overview
=================
Brief Summary
-----------------
Taiwan Registry for Leadless Pacemaker is a nationwide registry for leadless pacemaker performance in Taiwan.

Detailed Description
-----------------
The purpose of this registry is to investigate the safety and efficiency performance of the leadless pacemakers in Taiwan. The registry will collect all the information about the patient selection, implantation procedure, and follow up parameters of the leadless pacemakers to evaluate the real-world benefit specifically in Taiwan population.

Official Title
-----------------
Taiwan Registry for Leadless Pacemaker

Conditions
-----------------
Sick Sinus Syndrome, Atrioventricular Block

Intervention / Treatment
-----------------
* Device: Leadless Pacemaker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who had successfully received leadless pacemaker implantation The patients who attempt to receive leadless pacemaker implantation Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Leadless Pacemaker|Leadless pacemaker implantation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute complication | Any acute complication during procedure | On the 1 day of implant procedure | 
| Subacute complication | Any subacute complication, including pacemaker syndrome | within 3 month after implant procedure | 
| Leadless Pacemaker performance | The AV synchrony or pacemaker parameters | aroung 12 months after implant proceure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful implant | The attempts of deployment in one procedure | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leadless Pacemaker, Taiwan
Flu Vaccine Responses in the Setting of Melanoma Treatment

Study Overview
=================
Brief Summary
-----------------
Influenza vaccination is indicated for all adults, but the immunogenicity of vaccination has not been assessed in all situations. We are conducting a prospective unblinded study of influenza vaccine recipients.

Detailed Description
-----------------
Influenza vaccination is indicated for all adults, but the immunogenicity of vaccination has not been assessed in all situations. In particular, immune responses following influenza vaccination have not been studied in the setting of advanced melanoma and in the context of various anti-tumor treatments. In this study, we will look at the immune response of subjects receiving vaccination.

Official Title
-----------------
Influenza Vaccine Responses in the Setting of Melanoma Treatment

Conditions
-----------------
Viral Vaccines

Intervention / Treatment
-----------------
* Biological: Inactivated influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults capable of providing consent have a diagnosis of locally advanced or metastatic melanoma Exclusion Criteria: are allergic to influenza vaccination have received influenza vaccination within the past 6 months require prednisone, methotrexate, or other immunosuppressing medications have HIV infection have a history of solid organ or bone marrow transplant require combination immunotherapy are on other studies requiring blood draws that might exceed 450 mL total during the period of the influenza vaccine study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Influenza vaccination cohort<br>Subjects will receive one dose of seasonal quadrivalent inactivated influenza vaccine intramuscularly for standard of care for prevention of influenza infection. | Biological: Inactivated influenza vaccine<br>* One dose of quadrivalent inactivated influenza vaccine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutralizing antibody response | The neutralizing antibody titer will be assessed by measurement of the hemagglutinin-inhibition titer before and after influenza vaccination in order to determine the seroconversion rate. The late blood draw may occur between days 21-42 following vaccination. | 21-42 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza vaccine
Nutritional Quality of Egg Proteins and Effect on Satiety

Study Overview
=================
Brief Summary
-----------------
The project aims to precisely quantify the postprandial amino acid utilization of egg proteins in vivo in humans, and also to assess their satiating power, in relation with nutrient postprandial waves and incretin secretions. For that purpose, 2 independent studies are conducted. The first one is realized using stable isotopes on 8 volunteers ingesting an egg test meal. The second one is a cross over design performed on 30 volunteers to compare the satiating effect of 2 equivalent snacks: whole eggs or cottage cheese.

Conditions
-----------------
Physiology, Nutrition

Intervention / Treatment
-----------------
* Dietary Supplement: Egg snack
* Dietary Supplement: Cottage cheese


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers BMI between 18 and 25 Exclusion Criteria: Allergy to egg or milk protein Digestive or metabolic pathology Positiveness to HIV, Hepatitis B and C Smokers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Egg<br> | Dietary Supplement: Egg snack<br>* subject consume 4 cooked whole eggs, providing 380 kcal<br>|
| Experimental: Cottage cheese<br> | Dietary Supplement: Cottage cheese<br>* Subjects consume 200 g of cottage cheese, providing 380 kcal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| energy intake at lunch following the snack |  |  | 
| Dietary amino acid utilization | transfer of stables isotopes used as intrinsic markers of egg proteins to metabolic pools |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma incretin concentrations | insulin, glucagon, GLP-1, PYY, ghrelin, GIP |  | 
| postprandial nutrient waves | plasma glucose, cholesterol, triglyceride, urea |  | 
| neoglucogenesis | Endogenous production of glucose and contribution of dietary amino acids |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ingestive behavior
Functional Evaluation With Questionnaire in Patients Investigated for Suspected Peripheral Artery Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the routine faisibility of a questionnaire to estimate walking impairment(The WELCH questionnaire) in patients investigated for suspected PAD.

Detailed Description
-----------------
The WELCH and WIQ questionnaires are self completed by the patients and scored by the physician after self-completion.

Official Title
-----------------
Estimation de la capacité Fonctionnelle a la Marche Par Questionnaire Clinique Chez Des Patients adressés Pour Bilan artériel Des Membres inférieurs: Etude WELCH-bis

Conditions
-----------------
Peripheral Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sigjned consent for the data treatment as a database Exclusion Criteria: Non french native language age < 18 years old

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 |
| --- | --- |
| Investigation for lower limb arteries<br>Patients referred for investigation of assumed peripheral artery disease (PAD) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scoring of the WELCH. Percent scored questionnaires | Predetermined scored . Scoring is optional and compared to scoring of the WIQ | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral artery disease, claudication, walking, questionnaire
Diagnostic Accuracy to Detect Hemodynamically Significant Stenosis by Non-invasive SURECardio CT-FFR

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to determine the diagnostic accuracy of SURECardio CT-FFR to detect functionally significant coronary stenosis.

Detailed Description
-----------------
CT acquision and invasive FFR measurement is performed for each patients. The diagnostic accuracy of coronary CTA and SURECardio CT-FFR is investigated using Invasive FFR is used as the reference standard.

Official Title
-----------------
Clinical Trial for SURECardio CT-FFR

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: CT-FFR. CTA. FFR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected coronary artery disease hemodynamically stable condition Exclusion Criteria: hemodynamic instability atrial fibrillation morbid obesity (BMI≥40 kg/m2) previous stent implantation recent myocardial infarction (within 30 days) age <40 years renal insufficiency (eGFR <60mL/min/1.73m2) bronchospastic lung disease requiring long term steroid therapy

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| CT-FFR. CTA. FFR<br>59 patients with suspected CAD that have been scheduled for an interventional FFR study | Device: CT-FFR. CTA. FFR<br>* Study is to compare results of CT FFR against CTA and interventional FFR<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of SURECardio CT-FFR to detect functionally significant coronary stenosis |  | one day |
Forxiga HF General Drug Use-Results Study

Study Overview
=================
Brief Summary
-----------------
To capture safety when Forxiga is administered to patients with HF in clinical practice after launch.

Detailed Description
-----------------
The purpose of the study is to review the following points during use of Forxiga Tablets (hereinafter referred to as Forxiga) in the real world setting after launch. ADRs which are unexpected from the precautions for use Understanding of incidence of ADRs during use of Forxiga in the real world setting Factors possibly having an impact on the safety

Official Title
-----------------
Forxiga Tablets General Drug Use-Results Study in Patients With HF

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged more than 15 years Patients who have been prescribed Forxiga for the first time Exclusion Criteria: Patients with a history of hypersensitivity to any ingredients of this drug. Patients with severe ketosis, diabetic coma or precoma Patients with severe infections, before or after a surgery, or with serious trauma

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |
| frequency of adverse drug reactions (ADRs) | Development of ADRs by unexpected from Precautions for Use of Forxiga JPI, by SOC, by patient demography and by treatment | 1 year |
Evaluation of Pacemaker Algorithms to Avoid Unnecessary Right Ventricular Pacing

Study Overview
=================
Brief Summary
-----------------
Unnecessary right ventricular pacing has been shown to be detrimental in recipients of implantable pacemaker or defibrillators. The ADVANTAGE study evaluates the efficacy of two pacemaker based algorithms (atrioventricular hysteresis function versus mode switch to atrial pacing) to reduce right ventricular pacing.

Detailed Description
-----------------
Comparison of the effect of an atrioventricular hysteresis function with a mode switch to atrial pacing on the right ventricular pacing percentage in a multi-centre, prospective, randomized, single blinded, cross-over study.

Official Title
-----------------
AV-Hysteresis Versus Mode Switch to AAI (MVP) for the Avoidance of Unnecessary Right Ventricular Pacing

Conditions
-----------------
Pacemaker Implantation for Sinus Node Disease

Intervention / Treatment
-----------------
* Other: pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for the implantation of a dual-chamber pacemaker Exclusion Criteria: Persistent or permanent atrial tachyarrhythmias atrioventricular block 2nd or 3rd degree indication or the implantation of an defibrillator

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mode switch to atrial pacing<br> | Other: pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function<br> <br> |
| Active Comparator: atrioventricular hysteresis function<br> | Other: pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right ventricular pacing percentage |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BNP levels |  | 3 months |
Oxford Partial Knee Kinematics Gait Analysis Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the effect on gait of unicompartmental knee arthroplasty (UKA), using the Oxford Partial Knee, versus normal knee.

Official Title
-----------------
Investigation of Unicompartmental Knee Arthroplasty and Functional, Daily Activities: A Quantitative Assessment of Gait, Sit-to-Stand, and Stair Climbing

Conditions
-----------------
Medial Knee Compartment Arthritis

Intervention / Treatment
-----------------
* Device: Oxford Partial Knee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with medial knee compartment arthritis Exclusion Criteria: Patients with diagnoses other than osteoarthritis (i.e., rheumatoid arthritis, psoriatic arthritis, etc.) Patients with significant diseases of other joints of the lower extremity Patients with a diagnosed disorder with gait disturbance (e.g. lower extremity weakness, prior lower extremity arthrodesis, diagnosed movement disorders, etc.).

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Partial Knee Arthroplasty<br>Oxford Mobile Bearing Unicompartmental Knee Arthroplasties | Device: Oxford Partial Knee<br>* The Oxford partial knee contains tibial and medial components and a mobile meniscal bearing.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score (KSS) |  | up to 1 month pre-operatively and at 1 year post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion (ROM) |  | up to 1 month pre-operatively and at 1 year post operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
partial knee arthroplasty