linjc16/ctgov huggingface dataset:
Stem Cells and Resynchronization Cardiac

Study Overview
=================
Brief Summary
-----------------
Same patients with dilated myocardiopathies with large areas of fibrosis has not been as successful after Cardiac Resynchronization Therapy, for Heart Failure patients in functional class III or IV. Therefore the investigators have decided to associate the Stem-Cell implant with Cardiac Resynchronization Therapy in these patients.

Detailed Description
-----------------
About 120cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution the mononuclear cells are injected into the cardiac muscles with fibroses area through 20 shots.This procedure is indicated for patients with cardiac ischemia and left ventricular dysfunction(desynchrony), on whom all the others known therapies have failed.

Official Title
-----------------
Stem-Cells and Heart Failure in Several Ethiologies. Alternative Indication With Cardiac Resynchronization

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

Intervention / Treatment
-----------------
* Procedure: Pacing and Stem Cells Implantations.
* Procedure: Pacing and Stem Cells Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Dilated Cardiomyopathy Heart Failure Optimized Therapeutics Ventricular Desynchrony Functional Class III or IV Ejection Fraction(Echo/ Sympson) < 35%

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pacing and Stem Cells Implantations.|Implantation of Cardiac Ressyncrhonization combined with the implantation of Stem Cells Hematopoietics.|
|Procedure: Pacing and Stem Cells Implantation|Pacing and Stem Cells Implantation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ejection Fraction(EF)-(Eco- Sympson):It is the comparison of these measurements between late pre and post operative. NYHA: Comparison of these measurements between late pre and post operative. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ejection Fraction (Echo/Sympson) and functional class(NYHA). |  | 24 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Resynchronization, Dilated Cardiomyopathy, Stem Cells Therapy, Heart Failure, Stem Cells/Cardiac Pacing, Artificial
Women Health Cohort for Breast, Bone and Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
A single center cohort which enrolled women who performed mammography, bone densitometry (DEXA), and coronary CT angiography in Seoul National University Bundang Hospital from March 2011 to February 2013.

Detailed Description
-----------------
To evaluate whether bone mineral density and breast arterial calcification can predict coronary artery disease in women older than 40 years

Official Title
-----------------
Women Health Cohort for Breast, Bone and Coronary Artery Disease

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

Intervention / Treatment
-----------------
* Diagnostic Test: Coronary CT angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women (≥ 40 years) who performed mammography, bone DEXA, and coronary CT angiography at health promotion center of Seoul National University Bundang Hospital. Exclusion Criteria: Women who have history of breast surgery or intervention Women who have history of myocardial infarction or revascularization Too poor image quality of coronary CT angiography for interpretation Renal dysfunction with serum creatinine ≥ 1.4mg/dL

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Coronary CT angiography|Presence of coronary plaques Characteristic of coronary plaques|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of coronary plaque | Any coronary plaque in coronary CT angiography | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of coronary plaque | Plaque characteristics (fibrosis, calcification, lipid, thrombosis) in coronary CT angiography | 5 years | 
| Major adverse cardiovascular events | Cardiac death, nonfatal myocardial infarction, ischemic stroke, coronary revascularization | 5 years |
PHARMO Institute Seroquel Safety Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to study specific outcomes of interest in users of quetiapine compared with all other atypical antipsychotics and specifically olanzapine and risperidone. The outcomes of interest are all-cause mortality, failed suicide attempts, extrapyramidal symptoms, diabetes mellitus, hypothyroidism, acute myocardial infarction and stroke. This retrospective cohort study is based on population-based record linkage system (PHARMO RLS) capturing about 2.5 millions residents in the Netherlands.

Official Title
-----------------
Seroquel Safety Study

Conditions
-----------------
Schizophrenia, Major Depressive Disorder, Bipolar Disorder, Generalized Anxiety Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Episode of new use of atypical antipsychotics in naïve (not used antipsychotic drugs for a year) users of antipsychotics. Exclusion Criteria: less than a year of recorded history before the cohort entry date use of multiple antipsychotics concomitantly duration and dose of the antipsychotic drug cannot be determined

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 |
| --- | --- |
| Quetiapine<br>Quetipine users | |
| All other atypical antipsychotics<br>All other atypical antipsychotics users | |
| Risperidone<br>Risperidone users | |
| Olanzapine<br>Olanzapine users | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The outcomes of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine vs corresponding incidence rates in users of comparison drugs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atypical antipsychotics, quetiapine
Transcranial Magnetic Stimulation in Treatment of Attention Deficit/Hyperactivity Disorders

Study Overview
=================
Brief Summary
-----------------
ADHD is one of the most common psychiatric disorders. While most of the attention is directed towards youth, 60% continue to suffer symptoms into adult life. Current treatment is effective, but 30% suffer side effects that lowers QOL, and 20% are non-responders. Known mechanism of pathophysiology includes hypoactive dopaminergic system, especially at right PFC. It is this study hypothesis that by stimulating the right PFC by TMS, it will be possible to alleviate ADHD symptoms. A 10 sessions of treatment will by applied on a randomly allocated group of patients, diagnosed with ADHD, in a 2:1 ratio: The first group will receive an actual TMS treatment, and the second group will receive a sham treatment. Improvement of objective and subjective ADHD scale will be examined.

Official Title
-----------------
Transcranial Magnetic Stimulation of the Pre-Frontal Cortex in the Treatment of Attention Deficit/Hyperactivity Disorders: A Randomized, Controlled, Double Blind Study.

Conditions
-----------------
Attention Deficit/Hyperactivity Disorder

Intervention / Treatment
-----------------
* Device: Transcranial Magnetic Stimulation (Magstim, Rapid)
* Other: Placebo Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-50 Established diagnosis of ADHD No C/I for TMS Has signed an informed consent form Exclusion Criteria: Major Psychiatric disorders (Psychotic or Affective) Active use of drugs (4 weeks prior to participation) Neurologic disorder such as Epilepsy. No use of stimulants during the previous 7 days

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 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 |
| --- | --- |
| Active Comparator: Treatment Group<br> | Device: Transcranial Magnetic Stimulation (Magstim, Rapid)<br>* Superficial rTMS, directed at right PFC, power of 100% of MT, 10Hz for 4 seconds, intervals of 30 seconds, 42 trains.<br>* Other names: Transcranial Magnetic Stimulation;|
| Sham Comparator: Sham group<br>Sham TMS coil (same noise, minimal magnetic field) | Other: Placebo Treatment<br>* Sham coil (minimal magnetic field, same noise and feeling)<br>* Other names: Sham;|

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
-----------------
ADHD, Attention Deficit/Hyperactivity Disorder, TMS, Transcranial Magnetic Stimulation
B7 Coreceptor Molecules in Hyper IgD Syndrome Form of Mevalonate Kinase Deficiency

Study Overview
=================
Brief Summary
-----------------
The hyper IgD syndrome (HIDS) is an inflammatory disease caused by mevalonate kinase deficiency. There is no cure, and available treatments of HIDS febrile episodes have shown limited clinical efficacy. The development of effective interventions for HIDS is limited by our poor understanding of the disease. The goal of the study is to better characterize the inflammatory response during HIDS episodes and to determine the relationship between this response and blood and urine markers of mevalonate kinase deficiency. This knowledge will help us learn more about the cause of the disease and should lead to the identification of new disease biomarkers that can be used to evaluate clinical efficacy in future therapeutic trials. The primary hypothesis is that the costimulatory B7 glycoprotein abnormalities identified in the murine MKD model will be recapitulated in sera obtained from human HIDS patients, either before, during or after febrile episodes. The secondary hypothesis is that B7 glycoprotein molecule levels will correlate with clinical symptomatic severity score, other known biomarkers of HIDS, markers of inflammation and or markers of isoprenoid metabolism.

Official Title
-----------------
B7 Coreceptor Molecules as Clinically-Relevant Surrogate Biomarkers in the Hyper IgD Syndrome (HIDS) Form of Mevalonate Kinase Deficiency (MKD)

Conditions
-----------------
Hyper IgD Syndrome, Mevalonate Kinase Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any race or ethnicity diagnosed with HIDS Exclusion Criteria: parents' inability to donate blood currently having cancer, renal failure, diabetes, liver disease, thyroid diseases, major infectious diseases or immunodeficiency pregnancy inability to provide consent

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyper IgD Syndrome (HIDS), Mevalonate Kinase Deficiency (MKD)
Vaginal Microbiota as a Decisive Factor in Vaginal Prosthetic Surgery

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of vaginal microbiota in the post-operative course of patient operated for genital prolapse with vaginal mesh with or without mesh related complication

Detailed Description
-----------------
We propose to collect vaginal specimens to obtain exfoliated mucosal cells from women who had vaginal mesh implantation for POP complicated by mesh erosion into the vagina (cases). We aim to recruit women who will receive exactly the same clinical investigations (outlined below), follow up and management. Samples from patients without complications after mesh surgery will be used as controls since there are ethical difficulties in obtaining cold-cup swabs from 'normal' women and cystoscopy for conditions other than OAB or USI in premenopausal women is rare. Both cases and controls will be identified by the urogynaecology team based on surgical outcome reports and follow-up documentation. Cases and controls will be invited to participate by the research team. Relevant members of the research team (Dr Nikolaus Veit-Rubin, Pr Renaud DeTayrac, and Mr Vikram Khullar) have extensive experience in urogynaecological investigation and pelvic floor assessment. Cases and controls will be provided with an information leaflet about the study and will be asked to sign informed consent for the biopsies and a high vaginal swab will be taken. Consent will be taken either a trained member of the urogynaecology team. All participants will complete the 'P-QoL Questionnaire for symptoms relative to POP. Clinical assessment will include a comprehensive relevant past medical history, calculation of BMI, urinalysis, standardized POP-Q Quantification and abdominal examination. Specimens collected to be analysed will be a high vaginal swab following fully informed written consent. The specimens of Vaginal swab will be processed to extract and purify the DNA and then the exact bacterial genomic make up will be sequenced and analysed to identify the exact species of bacteria within the samples. Further detailed protocol of the mentioned procedures is outlined in the attached protocol.

Conditions
-----------------
Pelvic Organ Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females aged 18 and over who have consented for vaginal mesh surgery for pelvic organ prolapse at the the Nîmes University Hospital, France Exclusion Criteria: Pregnant or breast feeding Unwilling or unable to complete questionnaire or give valid consent.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota diversity (Shannon's H index) |  | Day 0 |
Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure

Study Overview
=================
Brief Summary
-----------------
Different doses of relaxin will be compared to placebo to determine efficacy and safety for the treatment of patients hospitalized with acute heart failure

Detailed Description
-----------------
This is an international, randomized, double-blind, placebo-controlled, Phase II/III trial of intravenous recombinant relaxin for the treatment of signs and symptoms in patients hospitalized for acute decompensated heart failure. The Phase II pilot study has completed; the Phase III main portion of the trial is ongoing.

Official Title
-----------------
A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure

Conditions
-----------------
Heart Failure, Congestive

Intervention / Treatment
-----------------
* Drug: Relaxin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized for acute heart failure Dyspnea at rest or with minimal exertion Pulmonary congestion Able to provide informed consent Systolic blood pressure > 125 mmHg Impaired renal function defined as an eGFR of 30-75 mL/min/1.73m2 Exclusion Criteria: Use of other IV therapies for acute heart failure Fever or sepsis Recent major neurologic event Recent major surgery Recent acute coronary syndrome Other recent investigational drug use

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 |
| --- | --- |
| Placebo Comparator: Placebo<br>48 hour iv infusion of placebo | Drug: Placebo<br>* Intravenous infusion for 48 h<br>|
| Experimental: Relaxin<br>48 hour iv infusion of relaxin at 30 ug/kg/day | Drug: Relaxin<br>* Intravenous infusion for 48 h at 30 ug/kg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of dyspnea in acute heart failure |  | Up to day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days alive and out of hospital |  | Up to day 60 | 
| CV death or rehospitalization due to heart failure or renal failure |  | Up to day 60 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, Renal dysfunction, Relaxin, Vasodilator
Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision

Study Overview
=================
Brief Summary
-----------------
There is no theoretical or practical reason why non-medical personnel such as nurses could not be trained to perform diagnostic colonoscopy with comparable proficiency as medical endoscopists. Nurse endoscopists have been widely accepted in the United Kingdom for the past 15 years as a valuable resource to cope with the increasing demand for endoscopic service, in particular diagnostic colonoscopy for colorectal screening. A pilot study performed in Hong Kong in 2008 has shown that endoscopy nurses can be trained to perform diagnostic endoscopy safely and reliably. This study aims to demonstrate that properly trained nurse endoscopists have a comparable proficiency in performing colonoscopy procedures as their medical counterparts.

Official Title
-----------------
Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision: A Randomized Controlled Study in Asia (NE Study)

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

Intervention / Treatment
-----------------
* Procedure: Colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Subjects receiving screening colonoscopy 2. Age ≥ 18 3. Informed consent Exclusion Criteria: 1. Subjects have undergone colonoscopy in the past 5 years 2. Patients with prior colorectal surgery 3. Subjects with a personal history of inflammatory bowel disease, colon adenoma or cancer or family history of Familial Adenomatous Polyposis or Familial non-polyposis syndrome 4. Pregnant or lactating women 5. Lack of 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nurse endoscopists<br>Colonoscopy performed by nurse endoscopists supervised by senior medical endoscopists | Procedure: Colonoscopy<br> <br> |
| Active Comparator: Medical endoscopists<br>Colonoscopy performed by senior medical endoscopists | Procedure: Colonoscopy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate |  | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cecal intubation RATE |  | Up to 3 months | 
| Withdrawal time |  | Up to 3 months | 
| Complication rate |  | Up to 3 months | 
| Patients pain score |  | Up to 3 months | 
| Patients overall satisfactory score |  | Up to 3 months | 
| Cecal intubation TIME |  | up to 3 months |