linjc16/ctgov huggingface dataset:
Effect of Aldosterone Blockade on Arterial Compliance

Study Overview
=================
Brief Summary
-----------------
The present study investigated the long-term (12 months) effect of spironolactone treatment on glucose homeostasis, metabolic parameters and vascular properties.

Official Title
-----------------
Effect of Aldosterone Blockade on Metabolic Parameters and Arterial Compliance

Conditions
-----------------
Arterial Stiffness, Arterial Elasticity

Intervention / Treatment
-----------------
* Drug: Spironolactone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. patients with type 2 diabetes mellitus Exclusion Criteria: history of unstable angina, myocardial infarction (MI), cerebrovascular accident (CVA) major surgery within the six months preceding entrance to the study unbalanced endocrine disease any disease that might affect absorption of medications plasma creatinine >2.5 mg/dl elevation of liver enzymes to more that twice the upper normal limit plasma potassium levels >5.5 mg/dl

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aldosteron blokade, Arterial stiffness, Glucose homeostasis<br> | Drug: Spironolactone<br>* Spironolactone orally, at a dose of 50 mg/day for 12 months<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
-----------------
Aldosterone Blockade, Arterial elasticity, Glycemic control
Efficiency of the Imaging Strategy for the Management of Suspected Covid-19

Study Overview
=================
Brief Summary
-----------------
Emergency departments have been placed at the heart of the patient triage strategy during the COVID-19 epidemic. In the absence of scientific knowledge on the most efficient strategy to put in place in emergency structures, the centers have proposed very heterogeneous protocols resulting from collaboration with local radiology and virology teams. While the pandemic in France appears to be currently under control, it is important to assess the sorting strategies put in place to deal with a new epidemic.

Official Title
-----------------
Efficiency of the Imaging Strategy for the Management of Suspected Covid-19

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥18 years old) Subject treated in the emergency rooms of participating centers for suspicion of COVID-19 presenting with fever> 38 ° and / or respiratory signs (dyspnea, cough, sputum) and / or other symptoms suggestive of COVID-19 (diarrhea , confusion ...) and / or people over 85 or living in an institution during the study period from March 9 to May 8, 2020 Subject affiliated to a social health insurance protection scheme Subject not having expressed their opposition, after information, to the reuse of their data for the purposes of this research Exclusion criteria: Subject having expressed opposition to participating in the study Subject under guardianship or guardianship Subject under safeguard of justice

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| A retrospective study of the imaging strategy for the management of suspected Covid-19 |  | Files analysed retrospectively from March 09, 2020 to May 08, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, SARS-COV-2, Dyspnea, Cough, Sputum, Diarrhea, Confusion
Cardiac Perfusion and Metabolism With [11C] Acetate PET/CT is Associated With Hematopoietic System Activation in Acute Decompensated Heart Failure: An Imaging Sub-study

Study Overview
=================
Brief Summary
-----------------
The purpose of this sub-study is to use positron emission tomography and computed tomography imaging (PET/CT) with an investigational drug called [11C] acetate to see if inflammation in patients with acute decompensated heart failure (ADHF) can cause changes in blood flow and oxygen use in the heart. This study may help physicians better understand how to treat patients diagnosed with ADHF in the future.

Official Title
-----------------
Cardiac Perfusion and Metabolism With [11C] Acetate PET/CT is Associated With Hematopoietic System Activation in Acute Decompensated Heart Failure: An Imaging Sub-study

Conditions
-----------------
Acute Decompensated Heart Failure

Intervention / Treatment
-----------------
* Drug: Cardiac Perfusion and Metabolism with [11C] Acetate PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age. Enrollment in the UAB CMC-ADHF study under the separate UAB approved research protocol (IRB-300000114, PI Rajapreyar) Negative urine or serum β-hCG test within 48 hours of [11C] acetate administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing. Exclusion Criteria: Inability to provide informed consent Pregnancy Inability to lie still for the imaging study Weight exceeding the weight limit of the PET imaging table (500 pounds).

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with acute decompensated systolic and diastolic heart<br> | Drug: Cardiac Perfusion and Metabolism with [11C] Acetate PET/CT<br>* A rest and stress imaging study will be conducted on the PET/CT scanner with [11C] Acetate.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation in patients with acute decompensated heart failure (ADHF) will be measured with rest-stress [11C] acetate PET/CT to see if the inflammation can cause changes in the blood flow and oxygen use in the heart. |  | 3 years |
Study of Brain Control of Movement

Study Overview
=================
Brief Summary
-----------------
This study will use transcranial magnetic stimulation to examine how the brain controls movement by sending messages to the spinal cord and muscles and what goes wrong with this process in disease. Normal healthy volunteers between the ages of 18 and 65 years may be eligible to participate. In transcranial magnetic stimulation, an insulated wire coil is placed on the subject's scalp or skin. Brief electrical currents are passed through the coil, creating magnetic pulses that stimulate the brain. During the stimulation, participants will be asked to tense certain muscles slightly or perform other simple actions. The electrical activity of the muscle will be recorded on a computer through electrodes applied to the skin over the muscle. In most cases, the study will last less than 3 hours.

Detailed Description
-----------------
The purpose of this study is to investigate the influence of voluntary inhibition of movement, using either negative motor imagery or Go/NoGo reaction task, on cortical inhibitory mechanisms. Intracortical inhibition (ICI) and silent period (SP) are two major cortical inhibitory mechanisms demonstrated by transcranial magnetic stimulation (TMS). Alterations in these inhibitory mechanisms have been extensively studied in various situations, but the influence of voluntary inhibition has not been elucidated yet. In normal volunteers, therefore, we plan to determine if voluntary inhibition of movement influences these cortical inhibitory mechanisms. The primary outcome measures would be any changes in motor evoked potential (MEP) size and intracortical inhibition (ICI) parameters.

Official Title
-----------------
Effect of Volitional Inhibition on Cortical Inhibitory Mechanisms

Conditions
-----------------
Healthy, Movement Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Volunteers who are greater than or equal to 18 years old. Subjects must not have any medico-surgical illness. Subjects must not have neurological illness. Subjects must not have psychiatric illness. Subjects must not be taking any medication with potential influence on nervous system function. Subjects must not have a pacemaker. Subjects must not have an implanted medical pump. Subjects must not have a metal plate or a metal object in the skull or eye. Subjects must not have a history of seizure disorder.
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transcranial Magnetic Stimulation, Motor Cortex, Motor Imagery, Reaction Time, Cerebral Inhibition, Healthy Volunteer, Normal Control
Prevention of Graft Reinfection After Liver Transplantation With Anti HCV Monoclonal Antibodies Identified in Chronically Infected Patients or in Patients With Resolved Hepatitis C

Study Overview
=================
Brief Summary
-----------------
End stage HCV-related cirrhosis has become a major indication for liver transplantation (LT). Unfortunately, recurrence of HCV infection on the liver graft occurs in almost all patients following transplantation and causes a persistent infection that leads to chronic hepatitis and cirrhosis in a significant proportion of patients. To date there is no effective way to prevent HCV reinfection of the liver graft in the early phase after transplantation. . Early passive immunotherapy with neutralizing antibodies against HCV should be considered for preventing reinfection of liver transplanted patients associated with HCV. This approach is well established in the case of patients undergoing liver transplantation for chronic hepatitis B virus infection. Our purpose is to produce neutralizing monoclonal antibodies to prevent reinfection of the liver graft.

Official Title
-----------------
Prevention of Graft Reinfection After Liver Transplantation for HCV Related End-stage Liver Disease . Study of Humoral Anti-HCV Response

Conditions
-----------------
Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health insurance Resolved HCV infection ( HCV RNA negative since more then 6 months ) -HCV chronically infected ( RNA positive ) Anti- HCV antibodies positive Volunteers and informed patients Exclusion Criteria: Immunosuppression HBV or HIV infection Pregnancy Breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| 1<br>patients with resolved infection | |
| 2<br>chronically infected patients | |

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
-----------------
Hepatitis C, liver transplantation, antibodies mediated neutralization, monoclonal antibodies
Performance Evaluation of the Micromedic CD24 in Vitro Diagnostic Assay

Study Overview
=================
Brief Summary
-----------------
This study is aimed to evaluate the performance of the Micromedic CD24 assay in identifying colorectal adenoma using Western blot and ELISA assays. These assays are designed to detect CD24 protein in peripheral blood leukocytes (PBL). Elevated levels of CD24 may be indicative of colorectal adenoma (inclusive of optically detectable early adenoma to late adenoma, and cancer).

Official Title
-----------------
Performance Evaluation of the Micromedic CD24 Western Blot and ELISA in Vitro Diagnostic Assay

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Other: blood-sample based diagnostic assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 50 years old and above Subject is asymptomatic and referred for regular recommended screening colonoscopy or subject is referred due to suspicion of colon cancer, prior to beginning of any treatment (enriched population) Subject signed the informed consent Exclusion Criteria: Subject has been previously diagnosed with any type of cancer Subject has been previously diagnosed with a colorectal abnormality such as colorectal adenoma, hyperplastic polyp or carcinoma Blood sample was not collected on the day of colonoscopy and prior to colonoscopy Subject has first degree family history of colorectal cancer Subject has active infection or inflammation as determined clinically at screening Subject is currently taking medications related to the previous exclusion criteria Subject has participated in, or is participating in, any investigational drug or device study within 30 days prior the date of colonoscopy and any additional study required test Pregnant or lactating woman

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: blood-sample based diagnostic assay|A blood sample will be used in a Western blot and ELISA assay to determine CD24 levels|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonoscopy and CD24 assay correlation |  | 12 months |
Acid Production in Dental Plaque After Exposure to Probiotic Bacteria

Study Overview
=================
Brief Summary
-----------------
The increasing interest in probiotic lactobacilli in health maintenance has raised the question of potential risks. One possible side effect could be an increased acidogenicity in dental plaque. The aim of this study was to investigate the effect of probiotic lactobacilli on plaque lactic acid (LA) production in vitro and in vivo. Methods. subjects (n=18) were given lozenges with probiotic lactobacilli (L. reuteri DSM 17938 and ATCC PTA 5289) or placebo for two weeks in a double-blinded, randomized cross-over trial. The concentration of LA in supragingival plaque samples was determined at baseline and after 2 weeks. Salivary counts of mutans streptococci (MS) and lactobacilli were estimated with chair-side methods.

Conditions
-----------------
Caries

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic Lactobacilli reuteri
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate to high counts of salivary mutans streptococci (>104 CFU) as estimated with the Dentocult SM chair-side test, no visible open caries lesions or periodontal disease, Exclusion Criteria: smokers, ingestion of probiotic bacteria within the last two months, ingestion of antibiotics within the last two months

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L. reuteri (DSM 17938 and ATCC PTA 5289; 1x108 CFU<br>2 tablets a day for 2 weeks | Dietary Supplement: Probiotic Lactobacilli reuteri<br> <br> |
| Placebo Comparator: Sugar pill<br>2 tablets a day for 2 weeks | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acid production in plaque after exposure to probiotic bacteria |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acid producton in plaque after in vitro exposure to probiotic bacteria |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caries, probiotic bacteria
The Prevention of Postoperative Epidural Catheter Migration: a Comparison of Three Types of Dressing

Study Overview
=================
Brief Summary
-----------------
Three types of dressing will be compared to prevent postoperative epidural catheter migration. Patients will be randomised to have a Tegaderm dressing, an Epi-fix dressing or a Lockit-Plus dressing to secure the epidural catheter for postoperative analgesia. The length of the epidural catheter visible at the patient's skin surface will be recorded after insertion and every day until removal. The integrity of the dressing and problems with analgesia will also be recorded.

Official Title
-----------------
The Prevention of Postoperative Epidural Catheter Migration: a Comparison of Three Types of Dressing

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Device: Tegaderm dressing
* Device: Epi-Fix dressing
* Device: Lockit-Plus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who receive a lumbar epidural catheter for patient controlled analgesia will be included after informed consent 18 years or older Exclusion Criteria: Patients who did not sign an informed consent

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Tegaderm dressing | Device: Tegaderm dressing<br>* Tegaderm dressing is used to secure the epidural catheter for postoperative analgesia<br>|
| Active Comparator: 2<br>Epi-Fix dressing | Device: Epi-Fix dressing<br>* Epi-Fix dressing is used to secure the epidural catheter for postoperative analgesia<br>|
| Active Comparator: 3<br>Lockit-Plus dressing | Device: Lockit-Plus<br>* Lockit-Plus dressing is used to secure the epidural catheter for postoperative analgesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidural catheter migration from insertion till removal |  | Until removal of the epidural catheter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Problems of analgesia during Patient Controlled Epidural Analgesia |  | Until removal of the epidural catheter | 
| Body Mass Index |  | Until removal of the epidural catheter | 
| The integrity of the dressing |  | Until removal of the epidural catheter | 
| The comfort of the dressing |  | Until removal of the epidural catheter |
Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.

Study Overview
=================
Brief Summary
-----------------
The  CirB-RNA  cohort aims to create a biological collection associated with clinical and biological data from patients with hepatitis B infection. This project is part of a much larger program that aims to characterize and quantify circulating viral RNAs as a possible new biomarker of hepatitis B functional cure.

Official Title
-----------------
Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults patients and minor children over 6 years of age (in Lyon) with acute or chronic hepatitis B or presenting with HBsAg loss (with/without HBs seroconversion). (Co-infected patients with HDV and/or HCV and/or HIV are eligible) Patients requiring blood sampling for medical care at the time of the medical appointment. Informed patients who do not refuse to participate. Persons not affiliated to a social security scheme and persons receiving medical assistance from the state may be asked to participate in the study Exclusion Criteria: Patients participating at the time of the inclusion to an interventional trial evaluating a drug likely to interfere with this study. Persons deprived of their liberty by a judicial or administrative decision Adults who are subject to a legal protection measure Children less than 6 years old (in Lyon)

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

| Intervention/Treatment |
| --- |
|Other: Blood sampling|Blood sampling at each clinical follow-up visit.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of plot samples collected | The aim of this study is the constitution of a cohort with biological collection associated with clinical and biological data Data and samples will be collected at each follow-up visit until end of project (longitudinal study). This cohort is the first step of a research program and will be use in further study which are part of this research program. All studies of this research program aim to improve knowledge about hepatitis B, develop and validate a new biomarker of hepatitis B cure. | maximum 46 months |