linjc16/ctgov huggingface dataset:
Effects of Chocolate on Coronary Vasomotion in Patients After Heart Transplantation

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to investigate whether the ingestion of a flavonoid-rich dark chocolate compared to flavonoid-free placebo chocolate will improve coronary vasomotion in heart transplanted patients.

Detailed Description
-----------------
Dark chocolate contains a high amount of flavonoids. Flavonoids hold the possibilities to improve oxidative stress and hence the possibility to improve endothelium-dependent coronary vasomotion, which is a powerful surrogate for clinical prognosis. Coronary atherosclerosis is promoted by impaired endothelial function and increased platelet activation. High oxidative stress and reduced antioxidant defenses play a crucial role in the pathogenesis of atherosclerosis, in particular in transplanted hearts. The aim of the present study is to investigate whether the ingestion of a flavonoid-rich dark chocolate compared to flavonoid-free placebo chocolate will improve coronary vasomotion in heart transplanted patients.

Conditions
-----------------
Heart Transplantation

Intervention / Treatment
-----------------
* Other: Dark chocolate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients after heart transplantation not requiring immediate coronary intervention Age 20 - 80 Written obtained informed consent Exclusion Criteria: Heart failure (acute or chronic >NYHA II) Ventricular tachy-arrythmias or AV-Block >I° Renal insufficiency (>200 μmol/l) or liver disease (ALT or AST >150 IU) Symptomatic hypotension, hypertension >160/100mmHg Known allergy to compounds dark chocolate Acute infectious disease Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn) Participation in another study within the last month Concomitant vitamin supplements

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Dark chocolate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

Study Overview
=================
Brief Summary
-----------------
This study is a prospective registry of patients undergoing endoscopic suturing and/or clip placement at our institution to assess the efficacy and safety of endoscopic tissue apposition. 1.1 Hypothesis: Endoscopic tissue apposition is efficacious and safe in the practice of gastrointestinal endoscopy. 1.2 Aims: To prospectively evaluate the efficacy and safety of Endoscopic Tissue Apposition in the practice of gastrointestinal endoscopy.

Official Title
-----------------
Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

Conditions
-----------------
Endoscopic Tissue Apposition, Endoscopic Suturing, Endoscopic Clipping, Bariatric Endoscopy, Transoral Outlet Reduction, Endoscopic Sleeve Gastroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients>18 years of age undergoing endoscopy for any of the following indications: Indications for Tissue Apposition: Closure of perforations Closure of full thickness defects created during endoscopic full thickness resection Closure of defects after endoscopic submucosal dissection and endoscopic mucosal resection Closure of mucosotomy after Peroral Endoscopic Myotomy (POEM) Stent fixation Closure of fistulas Natural Orifice Transluminal Endoscopic Surgery defect closures Post-bariatric surgery gastrojejunal anastomosis and gastric pouch revision (transoral outlet repair) Primary endoscopic sleeve gastroplasty Exclusion Criteria: Patients unable or unwilling to provide consent Pregnant patients Coagulation disorders (INR >1.8, platelet <50,000) GI Bleeding Hemodynamic instability Enrollment in another device or drug study that may confound the results

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- | --- |
| Technical and clinical success in endoscopic tissue apposition | Successful completion of endoscopic suturing/clipping and measured as clinical symptom improvement as well as objective evidence of resolution / improvement of underlying pathology / confirmed with radiologic contrast studies as needed.. | From baseline to one year | 
| Adverse Events | Based on ASGE criteria | From baseline to one year |
Impact of Polymorphism on Pulmonary Pressure in Subjects With Pulmonary Hypertension of Different Cause

Study Overview
=================
Brief Summary
-----------------
Pulmonary Hypertension (PH) is a disease that is characterized by vasoconstriction of small vessels of the lung. Many cases do have proliferation of endothelial cells within these vessels. A possible influence of polymorphisms of genes relevant for inflammatory and endothelial processes is suspected. Especially patients with chronic heart failure can develope PH. The reasons therefore are lacking. The researchers investigate different polymorphism and the influence of these on pulmonary artery pressure (measured invasively) in patients with congestive heart failure (CHF) and patients with primary pulmonary hypertension.

Detailed Description
-----------------
The study consists of 3 arms-patients with CHF and PH, patients with CHF without PH and patients without CHF and PH. The PH measurement is due to routine catheterization, thereafter we measure different vasoactive polymorphism.

Official Title
-----------------
Impact of Different Genetic Polymorphism on the Pulmonary Pressure in Patients With Pulmonary Hypertension of Different Cause With Special Focus on Patients With Chronic Heart Failure

Conditions
-----------------
Congestive Heart Failure, Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CHF with or without pulmonary hypertension or patients with normal LVEF and pulmonary hypertension right heart catheterization due to routine informed consent Exclusion Criteria: no right heart catheterization no informed consent elevated pulmonary pressure due to valve diseases or congenital heart 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CHF with elevated PAP<br>CHF patients (LVEF > 35%) with elevated mean pulmonary pressure( > 20 mmHg ) measured by pa catheter | |
| CHF patient without elevated PAP<br>CHF patients (LVEF > 35%) with normal mean pulmonary pressure | |
| Normal EF with elevated PAP<br>Patients with normal LVEF < 60% with elevated mean pulmonary pressure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of the Expression of Glu 298ASP Polymorphism with pulmonary pressure |  | Dec. 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of G308A TNF alpha polymorphism within the different groups |  | Dec. 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eNOS Polymorphism, TNF alpha polymorphism, pulmonary pressure, polymorphism of vasoactive substances
A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Negative for Hepatitis B e Antigen

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to assess the safety and effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B infection who are hepatitis B e antigen negative.

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: Entecavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Male and female subjects =/> 16 years of age (or minimum age required in a given country) with history of chronic hepatitis B infection; HBeAg negative, anti-HBeAb positive; Absence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV); Absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease; Less than 12 weeks prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., adefovir, famciclovir and lamivudine)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Biomarker Study in Samples From Patients With Malignant Rhabdoid Tumor of the Kidney or Atypical Teratoid Rhabdoid Tumor

Study Overview
=================
Brief Summary
-----------------
This research trial studies biomarkers in samples from patients with rhabdoid tumor of the kidney and atypical teratoid rhabdoid tumor. Studying biomarkers of tissue samples from patients with cancer in the laboratory may help doctors learn more about changes the occur in DNA and identify biomarkers related to cancer.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To determine if there are molecular differences between rhabdoid tumor of the kidney (RTK) and the atypical teratoid rhabdoid tumor (ATRT). OUTLINE: Archived tumor tissue samples are analyzed for gene expression profile and microRNA profile.

Official Title
-----------------
Gene Expression (GE) and MicroRNA (MIRNA) Expression Profiles of Malignant Rhabdoid Tumors (MRT) of the Kidney (RTK) and Atypical Teratoid Rhabdoid Tumor (ATRT)

Conditions
-----------------
Childhood Atypical Teratoid/Rhabdoid Tumor, Rhabdoid Tumor of the Kidney

Intervention / Treatment
-----------------
* Other: Laboratory Biomarker Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Samples of RTK and ATRT provided by the Children?s Oncology Group (COG)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-Correlative (gene expression profile, miRNA profile)<br>Archived tumor tissue samples are analyzed for gene expression profile and microRNA profile. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular differences between RTK and the ATRT |  | Up to 3 months |
Pneumonia Due to Stenotrophomonas Maltophilia in ICUs

Study Overview
=================
Brief Summary
-----------------
Pneumonia is a major cause of ICU admission, or may complicate ICU course. Among the causative pathogens, Stenotrophomonas Maltophilia is a rare pathogen, but affects usually patients with chronic pulmonary co-morbidities, or with long duration of mechanical ventilation and multiples treatment with broad spectrum antimicrobial therapy. However, there are only a paucity of data regarding epidemiology, impact and outcome of Pneumonia due to Stenotrophomonas Maltophilia in critically ill patients. Primary objective was to study factors associated with mortality in case of Pneumonia due to Stenotrophomonas Maltophilia. Secondary objectives were to describe factors associated with morbidity of Pneumonia due to Stenotrophomonas Maltophilia (duration of mechanical ventilation, ICU length of stay), and to report the characteristics of critically ill patients presenting Pneumonia due to Stenotrophomonas Maltophilia.

Official Title
-----------------
Pneumonia Due to Stenotrophomonas Maltophilia in Intensive Care Units: a Multicentre Retrospective Study

Conditions
-----------------
Pneumonia, Ventilator-Associated, Stenotrophomonas Infection, Critical Illness, Pneumonia, Bacterial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years Documented Stenotrophomonas maltophilia pneumonia: Clinical suspicion (≥ two criteria including: fever> 38.5°C, leukocytosis > 10^9/L or leukopenia < 4.10^8/L, purulent tracheobronchial secretions and a new or persistent infiltrate on chest radiography). Documented Stenotrophomonas maltophilia positive quantitative culture of a respiratory sample: bronchoalveolar lavage fluid (significant threshold, >10^4cfu/ml) or plugged telescopic catheter (significant threshold, >10^3cfu/ml) or quantitative endotracheal aspirate (significant threshold, >10^6cfu/ml). 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure | Treatment failure is defined as composite of death and recurrence of pneumonia due to Stenotrophomonas Maltophilia within 30 days of the first episode | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of mechanical ventilation | Number of days under mechanical ventilation | Day 30 | 
| Recurrence of pneumonia due to Stenotrophomonas Maltophilia | New onset of pneumonia due to Stenotrophomonas Maltophilia | Day 30 | 
| Mortality |  | Day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stenotrophomonas maltophilia, Pneumonia, Intensive Care Unit
Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions

Detailed Description
-----------------
To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg after a single oral dose administration in healthy volunteers under fasting conditions

Official Title
-----------------
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions

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

Intervention / Treatment
-----------------
* Drug: Sarpogrelate HCL 300mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, non-smoking, male and female subjects, 19 years of age or older BMI ≥ 18.0 and ≤ 30.0 kg/m2. Females who participate in this study will be of childbearing or non- childbearing potential Exclusion Criteria: Know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anpl-one SR Tab. 300mg<br>a single oral dose administration in healthy volunteers under fasting condition | Drug: Sarpogrelate HCL 300mg<br>* a single oral dose administration in healthy volunteers under fasting condition<br>|
| Active Comparator: Sarpodipil SR Tab. 300mg<br>a single oral dose administration in healthy volunteers under fasting condition | Drug: Sarpogrelate HCL 300mg<br>* a single oral dose administration in healthy volunteers under fasting condition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration | Maximum Plasma Concentration | 0 24hours | 
| Area under the plasma concentration versus time curve | Area under the plasma concentration versus time curve | 0 24hours |
Femoral Block With or Without Ropivacaine for Analgesia After Total Knee Replacement (TKR)

Study Overview
=================
Brief Summary
-----------------
Total knee replacement is a painful procedure. Many solutions have been proposed to diminish the post-operative doses of narcotics, including nerve blocks. The purpose of the study is to compare if the adjunction of intra-articular ropivacaine to a femoral block is more effective on narcotics consumption than the block alone after TKR.

Official Title
-----------------
A Randomized Trial Comparing the Efficacy on Post-operative Analgesia of Intra-articular Ropivacaine Added to a Femoral Block After Total Knee Replacement

Conditions
-----------------
Total Knee Replacement

Intervention / Treatment
-----------------
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary total knee replacement Age > 18 years old Accept the study Exclusion Criteria: Revision surgery Use of anticoagulants drugs Neurologic disorder Unable to sign consent form

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine + femoral block<br>After the surgery is proceeded and after the closure of the joint capsule, 20 cc of ropivacaine 0.5% is inserted intra-articular through a catheter. | Drug: Ropivacaine<br>* 0.5% intra-articular ropivacaïne (20cc)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic consumption per 24 hours after surgery (mg/kg) |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score at 24 hours |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TKR, Femoral block, Ropivacaïne, intra-articular ropivacaïne, post-operative analgesia
Hyperglycaemia and Hyperlactataemia in Patients With Severe Acute Brain Injury

Study Overview
=================
Brief Summary
-----------------
This is an observational study of patients with severe acute brain injury, which aims to characterize the development of hyperglycaemia and hyperlactataemia and the influence of these markers on clinical outcome. Additionally, in a subgroup of patients undergoing advanced multimodal neuromonitoring on either clinical or research indication, the relationship between hyperglycaemia and brain glucose levels as well as systemic and microdialysis lactate will be examined.

Official Title
-----------------
Hyperglycaemia and Hyperlactataemia in Patients With Severe Acute Brain Injury in the Intensive Care Unit - a Prospective, Observational Cohort Study

Conditions
-----------------
Acute Brain Injury, Hyperglycemia, Hyperlactatemia

Intervention / Treatment
-----------------
* Other: Sampling of blood and cerebrospinal fluid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Admission to the neurointensive care unit at Rigshospitalet Diagnosis of acute brain injury categorised as TBI, SAH, ICH, ischaemic stroke, or other conditions Exclusion Criteria: Brain death before inclusion Closest relatives do not understand written and spoken Danish or English

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: Sampling of blood and cerebrospinal fluid|Blood HbA1c, insulin, C-peptide and IL-6 measured at admission. Glucose and lactate measured every 4 hours during intensive care stay. Daily sampling of CSV analysed for glucose and lactate in patients with EVD.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome at 6 months as evaluated by the modified Rankin Scale. | Modified Rankin Scale ranges from 0-6, where 0 is the best and 6 is the worst outcome. | 6 months after admission. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality at 6 months (dichotomous). |  | 6 months after admission. | 
| Length of stay in the neuro-ICU (continuous). |  | Day of discharge, typically 1-30 days after admission. |