linjc16/ctgov huggingface dataset:
Registry for Mitral Valve Surgery at Department of Cardiac Surgery University Hospital of Basel/ Switzerland

Study Overview
=================
Brief Summary
-----------------
A registry is installed to collect (pre-, intra- and postoperative) data on patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009. Retrospective data (since 2009) as well as prospective data are included in this ongoing registry to analyse the development of mitral valve surgery at the Department of Cardiac Surgery University Hospital of Basel/ Switzerland.

Official Title
-----------------
Registry for Mitral Valve Surgery at Department of Cardiac Surgery University Hospital of Basel/ Switzerland

Conditions
-----------------
Mitral Valve Disease, Mitral Valve Surgery

Intervention / Treatment
-----------------
* Procedure: mitral valve surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009 Exclusion Criteria: - patients refusing consent for data use
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: mitral valve surgery|pre-, intra- and postoperative data on patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between technique of mitral valve surgery and postoperative mitral valve pressure gradient | correlation between technique of mitral valve surgery and postoperative mitral valve pressure gradient | 4 weeks post surgery |
Evaluation of Heart Function in Breast Cancer Patients Using Trastuzumab

Study Overview
=================
Brief Summary
-----------------
By dynamically observing the changes of echocardiogram and biomarkers in breast cancer patients using trastuzumab, evaluate the effect of trastuzumab on cardiac function; determine the sensitivity of echocardiography and biomarker indicators And specificity, explore effective and specific early warning indicators, and provide technical support for the evaluation of the cardiac safety of anti-tumor drugs.

Detailed Description
-----------------
Thirty female breast cancer patients using trastuzumab, collected demographic and clinical information of all patients before chemotherapy, performed echocardiography (conventional echocardiography, three-dimensional spot tracking technology), and collected blood samples to detect plasma biology Markers (TnT, BNP, GDF-15, topoisomerase), follow-up echocardiography and biomarkers at 1 month, 3 months and 6 months after chemotherapy.

Official Title
-----------------
Evaluation of Heart Function in Breast Cancer Patients Using Trastuzumab

Conditions
-----------------
Cardiotoxicity, Antitumor Drugs, Breast Cancer, Trastuzumab

Intervention / Treatment
-----------------
* Drug: Trastuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with breast cancer (18-70 years old) Patients who are planning to undergo trastuzumab for the first time Exclusion Criteria: Organic heart disease such as coronary heart disease, heart valve disease, cardiomyopathy liver and kidney failure severe cerebrovascular disease chronic obstructive pulmonary disease rheumatic immune system disease other tumors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with breast cancer using trastuzumab<br> | Drug: Trastuzumab<br>* 30 female breast cancer patients using trastuzumab, collected demographic and clinical information of all patients before chemotherapy, performed echocardiography (conventional echocardiography, three-dimensional spot tracking technology), and collected blood samples to detect plasma biology Markers (TnT, BNP, GDF-15, topoisomerase<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time ending | 180 days after chemotherapy | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac safety, Antitumor drugs, Breast Cancer, Trastuzumab
Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Injection the day before surgery of 90 mg of Lanreotide LP sub-cutaneously or placebo. Evaluation of the lymphorrhea in the 2 arms of the study

Detailed Description
-----------------
Patients will be recruited among patient refered to our department for a breast cancer and needing an axillary dissection. Enrolled patients will have an injection of Lanreotide or placebo the day before surgery when they arrive in their room. The quantity of lymph in axillary drain will by daily noted until day 4. The patient will be evaluated at D15, D30 and M6 for pain, lymphocele and adverse events. Data will be compared in the 2 groups.

Official Title
-----------------
Evaluation of the Efficacity of Lanreotide LP 90 mg to Minimized the Lymphorrhea Post Axillary Lymphadenectomy in Breast Cancer

Conditions
-----------------
Lymphocele

Intervention / Treatment
-----------------
* Drug: Lanreotide LP 90
* Drug: Placebo lanreotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient (> 18 years), Patient undergoing an axillary lymphadenectomy for breast cancer Patient giving her agreement after being informed Exclusion Criteria: Patients that don't understand the trial Type 2 diabetic patients Cyclosporine treatment Biliary lithiasis Pregnancy or breast feeding Allergic reaction to Lanréotide or same class treatments Patient included in another trial within the last 30 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lanreotide LP 90 | Drug: Lanreotide LP 90<br>* Lanreotide LP 90<br>|
| Placebo Comparator: 2<br> | Drug: Placebo lanreotide<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of lymph collected by the drain |  | D4 post operativly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of lymphocele |  | D15, D30 and M6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Axillary lymphocele breast cancer
An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in the United States of America (USA). The aim of the study is to assess longitudinal variation of immune biomarkers in subjects at risk for development of type 1 diabetes (T1D).

Official Title
-----------------
The Longitudinal Diabetes Biomarker Study: An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Other: No treatment given


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with general good health as judged by the investigator Participant tested positive at above or equal to 99th percentile for one or more of three islet antibodies (GAD (glutamic acid decarboxylase), IA2 (islet antigen-2), IAA (insulin autoantibody)) Exclusion Criteria: Any chronic disorder (diabetes at enrolment) or severe disease which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol Female of child-bearing potential who is pregnant, breast-feeding, or intends to become pregnant

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br> | Other: No treatment given<br>* The participants will not receive any treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluctuation in islet autoantibodies titers |  | One-two years dependent on sampling frequency | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluctuation in islet autoantibody isotypes |  | One-two years dependent on sampling frequency | 
| Fluctuation in T-cell specificity profiling (mainly for CD8 (cluster of differentiation 8) T-cells) |  | One-two years dependent on sampling frequency |
Medtronic HAMMOCK Post Approval Study

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to satisfy the post-CE approval requirement.

Official Title
-----------------
Medtronic Hancock II® and Mosaic Mitral and Aortic Valves: A Study to Observe the Effects of the Stent Material Change to PEEK Post Approval Study (HAMMOCK PAS)

Conditions
-----------------
Heart Valve Diseases

Intervention / Treatment
-----------------
* Device: Mosaic model 305, model 310, and ultra model 305


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who require aortic or mitral valve replacement of their native valve. Subject is geographically stable and willing to return to the implanting site for all follow-up visits. Subject is of legal age to provide informed consent in the country where they enroll in the study. Subject has been adequately informed of risks and requirements of the study and is willing and able to provide informed consent for participation in the clinical study. Exclusion Criteria: Subject requires concomitant replacement of the aortic and mitral valves. Subject requires a replacement of a previously implanted prosthetic aortic or mitral valve. Subject requires a Bentall procedure for replacement of aortic valve or aortic root.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary cohort<br>Subjects requiring aortic or mitral valve replacement | Device: Mosaic model 305, model 310, and ultra model 305<br>* Aortic or mitral valve replacement<br>* Other names: Hancock II model T505, model T510, and ultra model T505;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deaths, re-interventions, explants | Related to valve | 1 year post implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically acceptable hemodynamic performance | Related to valve | (at discharge (or 30 days), 1 year and annually thereafter through 3 years) | 
| New York Heart Association Functional Classification | Related to valve | 1 year and annually thereafter through 3 years |
Molecular Epidemiology of Myocardial Infarction and Stroke in Older Adults - Ancillary to CHS

Study Overview
=================
Brief Summary
-----------------
To investigation the association of thrombosis and inflammation genes with sub-clinical cardiovascular disease and with incident myocardial infarction and stroke in older adults.

Detailed Description
-----------------
DESIGN NARRATIVE: The study represents a collaborative effort among investigators of the Cardiovascular Health Research Unit, Department of Genome Sciences at the University of Washington (UW), and the multi-center Cardiovascular Health Study (CHS), including the CHS Blood Laboratory at the University of Vermont. The study links advances in thrombosis and inflammation biology, large-scale human genomics, and population and statistical genetics, with the unique resources of CHS, a large, bi-racial cohort of older adults. In older men and women without clinically apparent vascular disease, carotid intimal-medial thickness or IMT (a measure of subclinical atherosclerosis), C-reactive protein (a sensitive marker of inflammation), and D-dimer (a global marker of activation of the hemostatic system) predict subsequent clinical events such as myocardial infarction (MI) and stroke. While the therapeutic benefits of thrombolytic therapy and aspirin suggest a major role for clotting and inflammation in the etiology of coronary disease and stroke, the genetic determinants of these risk factors, which are also influenced by traditional lifestyle risk factors such as smoking and obesity, remain largely unexplored in older adults. The setting for this study is the Cardiovascular Health Study, a cohort study of 5888 older adults designed to assess risk factors for stroke and coronary disease. Data on traditional risk factors, on measures of subclinical disease, and cardiovascular events are available to the ancillary study. By integrating recent clinical and experimental data on age-related and vascular bed-specific regulation of blood coagulation, and incorporating complete human genomic DNA sequence variation data from the NHLBI-funded UW Program for Genomic Applications, the investigators will evaluate thoroughly the association of thrombosis and inflammation genes with (1) carotid IMT, CRP, and D-dimer levels measured at baseline and (2) incident MI and stroke in adults >65 years old followed for up to 12 years.

Conditions
-----------------
Coronary Disease, Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
Effects of Acarbose on Endothelial Function After a Mixed Meal in Newly Diagnosed Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Endothelial dysfunction (ED) has been suggested as a possible causal link between postprandial hyperglycemia and cardiovascular events in patients with type 2 diabetes. Recent trials demonstrated a reduction of cardiovascular events by treatment with the alpha glucosidase inhibitor acarbose - a drug which mainly reduces postprandial glucose excursions. We were interested whether patients with newly diagnosed type 2 diabetes showed postprandial ED and if so whether acarbose was able to improve this condition.

Conditions
-----------------
Type 2 Diabetes

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 35-75 years type 2 diabetes (newly diagnosed) well glycemic control (HbA1c </= 8.1) leucocyte count > 6.2 or hs CrP > 1 Exclusion Criteria: hs CrP > 10 type 1 diabetes previous treatment with antidiabetic drugs

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>20 weeks of treatment with acarbose (100 mg t.i.d.) | Drug: acarbose<br>* 100 mg (tablets) t.i.d.<br>|
| Placebo Comparator: 2<br>20 weeks of treatment with placebo (one tablet t.i.d.) | Drug: placebo<br>* one tablet t.i.d.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| forearm blood flow assessed by forearm occlusion plethysmography after a mixed meal |  | at baseline and after 20 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| forearm blood flow assessed by forearm occlusion plethysmography in the fasting state, plasma glucose excursion in response to the mixed meal, insulin levels in response to the mixed meal, triglyceride levels in response to the mixed meal |  | at baseline and after 20 weeks of treatment |
Evaluation of a Novel Method of Contrast Volume Quantification - AVERT PLUS 2.0

Study Overview
=================
Brief Summary
-----------------
Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during angiographic procedures. This will be a first in man prospective observational study of the accuracy of this system to quantify contrast volume used during clinically indicated angiography in the cardiac catheterization laboratory.

Detailed Description
-----------------
Research Design: The AVERT PLUS is an FDA 510K cleared device which consists of 1) a contrast delivery modulator designed to reduce unnecessary contract dye delivery to the patient during angiography (coronary or peripheral) and 2) a concomitant contrast monitoring system to precisely measure contrast volume delivered to the patient. This will be a first in man prospective observational study of the accuracy of this system to quantify contrast volume used during clinically indicated angiography in the cardiac catheterization laboratory.

Official Title
-----------------
Evaluation of a Novel Method of Contrast Volume Quantification - AVERT PLUS 2.0

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Device: AVERT PLUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing clinically indicated coronary or peripheral angiography Exclusion Criteria: None

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 |
| --- | --- |
| AVERT PLUS<br>The AVERT PLUS will be used on the first 10 patients enrolled in the study. The AVERT PLUS is a contrast monitoring system which is used to precisely measure the volume of contrast delivered to the patient. | Device: AVERT PLUS<br> <br> |
| Non device group<br>The second group of 10 patients will undergo the scheduled angiography using the standard method of measuring contrast dye delivery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observational study of the accuracy of the AVERT PLUS CM system to quantify contrast volume during a clinically indicated procedure. | The fluid volume of contrast media used during the angiography procedure will be measured in milliliters. | The total volume of contrast received by the subject will be measured at the conclusion of the angiography procedure, procedure duration from 30 minutes to 4 hours dependent on patient's clinical status; no further measurements thereafter. |
Endosleeve in Adolescents

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators assess the safety and efficacy of endoscopic sleeve gastroplasty in adolescents with obesity.

Detailed Description
-----------------
Endoscopic bariatric therapy (EBT) is an emerging, rapidly evolving field that aims to serve as a middle ground between safe, albeit poorly effective medical weight loss strategies and drastic but effective bariatric surgery. Endoscopic sleeve gastroplasty (ESG) is a procedure that restricts the stomach to a sleeve-like configuration by utilizing full-thickness sutures that plicate the greater curvature of the stomach. Emerging data from adult populations shows an acceptable safety, tolerability and efficacy profile. Based on analysis that confirmed the safety and efficacy of ESG in adult patients who undergo the procedure under a standardized protocol and clinical care pathway, the investigators planned to study its effects on adolescents in a specialized center that offers surgical, endoscopic, and medical management of obesity under a standardized protocol and care pathway.

Official Title
-----------------
Safety and Efficacy of Endoscopic Sleeve Gastroplasty in Obese Children and Adolescents

Conditions
-----------------
Obesity, Childhood

Intervention / Treatment
-----------------
* Procedure: Endoscopic Sleeve Gastroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI that is >120% of the 95th percentile for age and gender Written informed assent/consent, with concomitant parental consent for patients aged ≤17 years Exclusion Criteria: Age <10 years Age >21 years Presence of large hiatal hernia Previous gastric surgery Cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 21 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: Adolescent Endosleeve<br>Patients who will undergo endoscopic sleeve gastroplasty | Procedure: Endoscopic Sleeve Gastroplasty<br>* Endoscopic full-thickness suture system to plicate the greater curvature of the stomach<br>* Other names: Endosleeve;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | % total weight loss | One year | 
| Adverse events | Adverse events, including hospitalization, or unplanned intervention | One year |