linjc16/ctgov huggingface dataset:
Prevalence and Prognostic Value of Unrecognized Myocardial Injury in Stable Coronary Artery Disease (PUMI)

Study Overview
=================
Brief Summary
-----------------
This study includes patients with stable coronary artery disease without previously known myocardial infarction, and investigates the prevalence of clinically unrecognized myocardial damage and its prognostic implication.

Detailed Description
-----------------
A substantial portion of all myocardial infarctions are not clinically recognized, but the myocardial damage can be recognized afterwards e g by magnetic resonance imaging (MRI). This study includes patients with stable coronary artery disease without previously known myocardial infarction, and investigates the prevalence of clinically unrecognised myocardial damage (UMI), and the prognostic value of UMI regarding new cardiac events. In a subset of the patients, the biologic intra-individual variability of troponin and other biochemical markers will be investigated (substudy protocol).

Official Title
-----------------
Prevalence and Prognostic Value of Unrecognised Myocardial Injury in Stable Coronary Artery Disease (PUMI)- a Multicenter, Observational Cohort Study.

Conditions
-----------------
Stable Angina Pectoris

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptoms of stable angina pectoris according to the treating physician scheduled for coronary angiography written informed consent Exclusion Criteria: pathological Q-wave in the 12-lead resting ECG known previous myocardial infarction previous PCI (percutaneous coronary intervention) or CABG (coronary artery bypass graft) history of congestive heart failure anything that contraindicates a MRI investigation (e.g. pacemaker, claustrophobia, intracranial clips) lack of suitability for participation in the trial, for any reason, as judged by the Investigator.
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 |
| --- | --- | --- |
| Cardiac events defined as a composite of death, resuscitated cardiac arrest, spontaneous acute myocardial infarction and hospitalisation for congestive heart failure or unstable angina. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of unrecognized myocardial infarction |  | Baseline | 
| Size and localisation of unrecognized myocardial infarction |  | Baseline | 
| Degree and localization of artherosclerotic lesions at a coronary angiogram |  | Baseline | 
| Procedure related acute myocardial infarction |  | 5 years | 
| Left ventricular mass and dimensions, levels of troponin and other biochemical markers, electrocardiography (ECG), anthropometric data |  | Baseline | 
| Long-term mortality, cardiac mortality and incidence of acute myocardial infarction |  | 5 years |
Physiologic Effect of Topical Nitroglycerin on Microcirculation Capacity in Patients With Circulatory Shock.

Study Overview
=================
Brief Summary
-----------------
This is an open-label, single center, trial that will enroll up to 25 participants with circulatory shock after cardiac surgery. Participants will be administered a topical sublingual nitroglycerin solution and assessed for changes microcirculatory blood flow using incident dark field microscopy.

Official Title
-----------------
Trial of a Topical Nitroglycerin Challenge to Detect Reversible Microcirculatory Dysfunction in Patients With Circulatory Shock.

Conditions
-----------------
Circulatory Shock, Cardiovascular Shock

Intervention / Treatment
-----------------
* Drug: Nitroglycerin Topical Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients receiving elective CABG or valvular surgery requiring cardiopulmonary bypass Receiving postoperative catecholamine therapy to maintain a MAP > 65mmHg, cardiac index > 2 despite initial fluid resuscitation Invasive hemodynamic monitoring Exclusion Criteria: Surgical hemorrhage Unable to tolerate sublingual microcirculatory flow imaging Known intolerance or allergy to nitroglycerin Inadequate microcirculation imaging (based on Massey Score)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Topical nitroglycerin<br>A topical nitroglycerin solution will be applied to the area of interest | Drug: Nitroglycerin Topical Product<br>* Topical nitroglycerin solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfused vessel density |  | 3-30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red blood cell velocity |  | 3-30 minutes | 
| Hemodynamics |  | 3-30 minutes |
SAKK - a Trial to Evaluate Antitumor Efficacy of Faslodex® After Aromatase Inhibitor Failure in Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to assess the activity of fulvestrant in postmenopausal women with advanced breast cancer failing treatment with non-steroidal or steroidal aromatase inhibitors by estimating the Clinical Benefit Rate

Official Title
-----------------
An Open, Multicenter Phase II Trial Evaluating the Antitumour Efficacy of Faslodex® (Fulvestrant) in Postmenopausal Women With Advanced Breast Cancer Failing Non-Steroidal or Steroidal Aromatase Inhibitors

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: Fulvestrant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological/cytological confirmation of breast cancer progression under treatment with an aromatase inhibitor At least one measurable or non-measurable lesion Exclusion Criteria: Prior treatment for breast cancer with more than 2 different hormonal agents More than 1 chemotherapy for advanced disease Presence of life-threatening metastatic visceral disease
Sexes Eligible for Study
-----------------
Female

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Benefit Rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of clinical benefit |  |  | 
| Time to progression |  |  | 
| Duration of response |  |  | 
| Time to treatment failure |  |  | 
| Safety and tolerability |  |  | 
| 6. clinical benefit rate according to HER2/neu status |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, fulvestrant, Faslodex, hormonotherapy, aromatase inhibitor failure, Advanced breast cancer
Compliance With LDL-Lowering Therapy (Study P05467)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This observational study is being conducted in patients receiving statin treatment as secondary prevention of coronary heart disease under the current standard of care in compliance with European guidelines. The purpose of the study is to evaluate the percentage of these patients that reach target LDL levels. Additionally this study will measure the patient's compliance to treatment as assessed by counting the returned tablets. Both assessments will be made at visits conducted 6-8 weeks after the first visit and 28-32 weeks after the first visit.

Official Title
-----------------
Compliance With LDL-Lowering Therapy For Secondary Prevention of Coronary Heart Disease in Real Life Practice

Conditions
-----------------
Coronary Heart Disease, Hypercholesterolemia, Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: Statin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: willingness to participate in the study 18 years of age or more clinically established cardiovascular disease to be considered as patients in secondary prevention prior therapy with any statin without achieving goal (2.5 mmol/L of LDL cholesterol) at last lipid check performed 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 |
| --- | --- |
| Patients with coronary heart disease<br>Patients being treated with a statin for secondary prevention of coronary heart disease | Drug: Statin<br>* Statin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients reaching target LDL levels |  | 6-8 weeks after first visit and 28-32 weeks after first visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure patient compliance to treatment as assessed by counting returned tablets |  | 6-8 weeks after first visit and 28-32 weeks after first visit |
Hemoglobin Concentration in Patients With an Acute Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of hemoglobin concentrations and red cell transfusion thresholds in patients with an Acute Respiratory Distress Syndrome (ARDS) admitted to an ARDS-center of a German university hospital.

Detailed Description
-----------------
Transfusion of packed red blood cells is a common procedure in critically ill patients. In recent years it has been shown that for many patient populations a restrictive transfusion strategy is not inferior compared to a liberal transfusion strategy with regard to overall outcome. So far it is unclear whether patients with an ARDS should receive blood transfusions according to a restrictive or liberal transfusion strategy. Besides pulmonary gar exchange and cardiac output, the hemoglobin concentration is an important determinant for oxygen delivery. The aim of this retrospective observational study is to analyze if low levels of hemoglobin/a restrictive transfusion strategy and are associated with a different mortality compared to higher levels of hemoglobin/a liberal transfusion strategy in patients with an ARDS.

Official Title
-----------------
Hemoglobin Concentration in Patients With an Acute Respiratory Distress Syndrome

Conditions
-----------------
ARDS, Human

Intervention / Treatment
-----------------
* Other: Blood transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients with ARDS Admission to the Charité ARDS center Exclusion Criteria: All patients <18 years at the time of admission All patients with ARDS not admitted to the Charité ARDS center

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Blood transfusion|Observational post-ad-hoc design to compare patients admitted with an ARDS and separated into different groups according to their mean hemoglobin concentration during their stay on the intensive care unit. Approximately 1000 adult patients admitted from 2007 to 2018 to the Charite ARDS center will be enrolled in the study. They are followed up until their discharge from the ICU. [Time Frame: 01/2007 - 12/2018]|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality of patients with ARDS at 28 days according to transfusion threshold | 01/2007 - 12/2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure-free days composites | Failure-free days composites according to transfusion threshold | 01/2007 - 12/2018 |
Home-based Kidney Care in Native Americans of New Mexico (HBKC) - Enhancement: COVID-19 Study

Study Overview
=================
Brief Summary
-----------------
Novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) OR COVID-19 related Addition: The aim of this addition activity is to track the impact of the COVID-19 epidemic on participants with diabetes and chronic kidney disease (CKD). Investigators have modified the original HBKC Study protocol to expand data currently collected from study participants to include data in the following domains linked to the COVID-19 epidemic: symptoms of COVID-19 disease, access to healthcare, and impact on health related behaviors (such as medication adherence, physical activity, dietary behaviors, smoking, and alcohol use).

Detailed Description
-----------------
Investigators will administer a survey by phone or mail to all participants screened for diabetes and chronic kidney disease in the original HBKC study protocol. The survey will address to the following aims: Aim 1. Develop a phone-based and or mail based survey to understand the impact of COVID19 on patient-reported outcomes for adults with diabetes and CKD. Aim 2. Test the feasibility and acceptability of this phone-based and or mail based survey in the HBKC cohort.

Official Title
-----------------
Home-based Kidney Care in Native Americans of New Mexico (HBKC) - COVID-19 Related Disruption in Health and Health Care

Conditions
-----------------
CKD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willingness to participate in the phone-based and or mail based survey. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with problems in their health care due to COVID-19 related isolation | Document COVID-19 disruptions in normal health care check-ups, transportation, economic status, and access to food and water. | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD, Diabetes, Ameircan Indians, COVID-19,
Effect of Lactobacillus Rhamnosus on Serum Uremic Toxins in Hemodialysis

Study Overview
=================
Brief Summary
-----------------
Uremic toxins such as p-cresol and phenol are suggested to be associated with higher mortality in hemodialysis patients. The aim of this study was to investigate the effects of probiotics on serum p-cresol level in hemodialysis patients.

Detailed Description
-----------------
Overall, 42 hemodialysis patients (10 women and 32 men) were divided randomly into the Lactobacillus rhamnosus group (21 patients) and the placebo group (21 patients).

Official Title
-----------------
Effect of Lactobacillus Rhamnosus on Serum Uremic Toxins (Phenol and P-Cresol ) in Hemodialysis Patients: A Double Blind Randomized Clinical Trial

Conditions
-----------------
Hemodialysis Complication

Intervention / Treatment
-----------------
* Dietary Supplement: Lactobacillus rhamnosus
* Drug: Placebo - Cap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:• Age more than 20 years Acceptable performance of alimentary system Ability to drink at least 200 ml of water per day No history of being allergic to fungi and yeast Absence of acute medical illness life expectancy more than 3 months Accept and sign the consent Exclusion Criteria: Patient's unwillingness to participate in the study History of smoking, peritoneal dialysis (PD) or previous kidney transplantation Lactation or pregnancy Drug history including antibiotics, prebiotics, probiotics, herbal drugs, psychedelic drugs, flavors.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Lactobacillus rhamnosus<br>received daily one capsule containing 1.6*107 CFU of Lactobacillus Rhamnosus | Dietary Supplement: Lactobacillus rhamnosus<br>* daily one capsule containing 1.6*107 CFU of Lactobacillus Rhamnosus prepared by Tabriz Nutrition Research Center from yogurt and cheese of different farms located in the suburbs Heris, after meal for 28 days<br>|
| Placebo Comparator: Placebo<br>received one placebo capsule per day Infant formula after meal for 28 days | Drug: Placebo - Cap<br>* daily one capsule of placebo<br>* Other names: placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre- and post-treatment p-cresol levels |  | 4 weeks |
Partial Breast Irradiation With Multi-Catheter Brachytherapy for pT1-2pN0 Breast Cancer After Breast Conserving Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether accelerated partial breast irradiation (APBI) with multi-catheter brachytherapy is safe and effective.

Official Title
-----------------
Partial Breast Irradiation With Multi-Catheter Brachytherapy for pT1-2pN0 Breast Cancer After Breast Conserving Surgery

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

Intervention / Treatment
-----------------
* Procedure: Accelerated partial breast irradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pT1/2 (≤ 3 cm) pN0 or pN1 mi M0 and no contralateral BC Clear margins (≥ 2 mm) Age ≥ 35 years ER and/or PR positive Exclusion Criteria: Multifocality or Multicentricity EIC Lymphovascular invasion Poorly differentiated tumors Diffuse microcalcifications

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APBI<br>Accelerated Partial Breast Irradiation with interstitial Brachytherapy | Procedure: Accelerated partial breast irradiation<br> <br> |

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
-----------------
accelerated partial breast irradiation, multicatheter brachytherapy, high dose rate brachytherapy, pulsed dose rate brachytherapy
A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney

Study Overview
=================
Brief Summary
-----------------
Kidney obstruction might be caused by a stone in the urinary tract. In case of accompanying fever or renal failure, an urgent drainage might be needed. This can be done either by placing an ureteral stent or a nephrotomy tube. Only limited number of studies examined the question which of the two is preferred. A debate exist regarding the effectiveness of each procedure to improve symptoms, renal function and treating an infection. Our goal is to resolve this debate and to state whether one way is preferred on the other.

Conditions
-----------------
Kidney Disease

Intervention / Treatment
-----------------
* Device: nephrostomy tube and ureteral stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient suffering from obstructed kidney by a stone and at least one of these situations: fever (above 38c) A rise in creatine to above 1.5 Pain resistent to multiple analgetic treatments Exclusion Criteria: Patients with medical condition that prevent the use of one of the procedures

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: nephrostomy tube and ureteral stent|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preferred, procedure, drainage, obstructed, kidney, stone