linjc16/ctgov huggingface dataset:
Evaluation of the Improvement of Primary Prevention in Ischemic Cardiomyopathy Patients Using New Screening and Referring System (Advance-ICM)

Study Overview
=================
Brief Summary
-----------------
The patients who undergo ICD(implantable cardioverter defibrillator) implantation for the primary prevention of sudden cardiac death with severe LV(left ventricle) dysfunction (ejection fraction ≤ 40%) by ICM(idiopathic cardiomyopathy). Indications for ICD implantation for primary prevention in accordance with 2016 revised Korean indication guideline on ICD implantation FU LVEF(Left Ventricular Ejection Fraction) ≤ 30% (at least 40 days post-myocardial infarction) FU LVEF 31 35%, NYHA(the New York Heart Association) class II, III (at least 40 days post-myocardial infarction) FU LVEF ≤ 40%, NSVT(non-sustained ventricular tachycardia) (Holter), inducible VF(ventricular flutter) or sustained VT(ventricular tachycardia) at electrophysiological study (at least 40 days post-myocardial infarction)

Official Title
-----------------
Evaluation of the Improvement of Primary Prevention in Ischemic Cardiomyopathy Patients Using New Screening and Referring System (Advance-ICM)

Conditions
-----------------
Ischemic Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 years Patients eligible for the indications for ICD implantation for primary prevention indication in accordance with 2016 revised Korean indication guideline on ICD implantation Patients should be managed by non-EP physician Patients who are willing to sign the informed consent Patients who are willing to receive the implantation and post-operative follow-up Exclusion Criteria: Malignant tumor Life expectancy < 12 months Patients unable or unwilling to cooperate in the study procedures

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| new screening and referring system of ICD<br>Non-randomized, non-blinded, multi-center study receiving new screening and referring system of ICD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of the quality of care in patients with ICM | the rate of device therapy(ICD or CRT-D(Cardiac Resynchronization Therapy-Device)) | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of the cardiovascular outcome of patients | Cardiovascular outcome (cardiovascular death, Non-cardiovascular death) | 3 years | 
| Improvement of the cardiovascular outcome of patients | Pattern of arrhythmia measured by EKG or echocardiography | 3 years |
Stressor-evoked Brain and Cardiovascular Responses to Acute Psychological Stress

Study Overview
=================
Brief Summary
-----------------
The present study will examine the relationship between metabolically excessive cardiovascular and neural responses to acute psychological stress using a cross-sectional approach.

Detailed Description
-----------------
All participants in this study will undergo an acute psychological stress paradigm, there will be no randomization or assignment since all participants will complete the same tasks. Sample size was calculated based off of recent papers examining multivariate pattern brain responses predicting cardiovascular responses to stress.

Official Title
-----------------
Stressor-evoked Brain and Cardiovascular Responses to Acute Psychological Stress

Conditions
-----------------
Acute Psychological Stress

Intervention / Treatment
-----------------
* Other: Acute psychological stress


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-30 years old Exclusion Criteria: Chronic medical or neurological condition Pregnant Current illness or infection Any condition that would prohibit engaging in physical exercise Any metal implants in body Claustrophobia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute psychological stress<br>Participants will undergo an acute psychological stress task that has been shown to elicit neural, cardiovascular, and psychological (feelings of stressfulness) responses. | Other: Acute psychological stress<br>* Participants will undergo an acute psychological stress task that has been shown to elicit neural, cardiovascular, and psychological (feelings of stressfulness) responses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen consumption |  | 20 minutes | 
| Heart rate (bpm) measured by electrocardiogram |  | 20 minutes | 
| Neural activity measured by fMRI |  | 20 minutes | 
| Additional heart rate |  | 20 minutes |
Acute Kidney Attack in Severe Traumatized Patients

Study Overview
=================
Brief Summary
-----------------
Acute Kidney Injury (AKI) is a common complication of severe traumatized patients. The diagnosis is often delayed. The Nephrocheck® test allows an earlier assessment of renal stress. The objective of our study is to determine the incidence of risk of AKI in severe traumatized patients within the first 24 hours after their admission to our trauma center. The risk of AKI is defined by a NephroCheck® test >0.3

Official Title
-----------------
Evaluation of the Incidence of Acute Kidney Attack by Dosing Nephrocheck® in Severe Traumatized Patients

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

Intervention / Treatment
-----------------
* Biological: Nephrocheck test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years trauma patients with ISS ≥15 patient admitted to the resuscitation bay of Edouard Herriot Hospital Exclusion Criteria: anuric patient opposition of the patient (or a trusted person) to participate pregnant or lactating woman age <18 years

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 |
| --- | --- |
| Severe traumatized patients<br>Severe traumatized patients with an Index Severity Score (ISS) ≥ 15 admitted to the trauma center of Edouard Herriot Hospital. | Biological: Nephrocheck test<br>* Nephrocheck® measurement on urine sample at different timepoints.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of patients with Nephrocheck score > 0,3 | Incidence of severe traumatized patient at risk of AKI as defined by Nephrocheck test score > 0,3 within the first 24 hours after admission | Up to 24 hours after trauma |
Choroidal and Retinal Thickness Following Strabismus Surgery

Study Overview
=================
Brief Summary
-----------------
Prospective study, conducted at Tanta University Ophthalmology Department Measurement of macular and choroidal thickness before and after strabismus surgery

Detailed Description
-----------------
This is a prospective study and will be conducted in Tanta University hospital Duration: February 2020 till May 2020 and may be extended The study will include 30 patients who suffer from esotropia or exotropia, inferior oblique (IO) over-action with or without any other type of horizontal deviation Pre-operative measurement of the macular and choroidal thickness by Enhanced Depth Imaging Optical Coherence Tomography (EDI-OCT). Post-operative measurement: First day, first week, one month then 3 months.

Official Title
-----------------
Effect of Strabismus Surgery on Macular and Subfoveal Choroidal Thickness Assessed by Spectral Domain Optical Coherence Tomography

Conditions
-----------------
Strabismus, Retinal Thickening

Intervention / Treatment
-----------------
* Procedure: Strabismus surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No prior history of ocular surgery or trauma Normal ocular examination findings No medical or family history of retinal disease, glaucoma or diabetes mellitus. Exclusion Criteria: Patients with orbital and/or craniofacial abnormalities Patients with sensory or restrictive strabismus or neurological disease Preoperative retinal or macular pathology Patient who is unable to cooperate to do OCT scanning

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 40 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 |
| --- | --- |
| Horizontal muscle surgery<br>Patients suffering from esotropia or exotropia, will have medial/lateral rectus recession/resection | Procedure: Strabismus surgery<br>* Resection or recession of the medial or lateral rectus muscle, or inferior oblique myectomy<br>|
| Patients with Inferior Oblique Overaction<br>Will undergo inferior Oblique Myectomy | Procedure: Strabismus surgery<br>* Resection or recession of the medial or lateral rectus muscle, or inferior oblique myectomy<br>|
| Patients with combined horizontal and oblique muscle surgery<br>Having combined surgery | Procedure: Strabismus surgery<br>* Resection or recession of the medial or lateral rectus muscle, or inferior oblique myectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choroidal and retinal thickness change after strabismus surgery | Measured by Spectral Domain Optical coherence tomography | preoperative, 1st week, 1st month, and 3 months |
Immunglobulin M Enriched Intra Venous Immunoglobulin (IVIG) Therapy in Adult Respiratory Distress Syndrom (ARDS) Patients

Study Overview
=================
Brief Summary
-----------------
57 patients with Adult Respiratory Distress Syndrome (ARDS) requiring Extracorporeal membrane oxygenation (ECMO) therapy were analyzed retrospectively. 28 patients had received immunglobulin M-enriched immunoglobulin therapy (IVIG); 29 patients did not receive IVIG therapy. These patients were analyzed regarding length of stay in intensive care unit (LOS ICU), length of stay (LOS) in hospital and regarding mortality.

Detailed Description
-----------------
57 patients with ARDS requiring ECMO therapy were analyzed retrospectively. 28 patients had received IgM-enriched immunoglobulin therapy (IVIG); 29 patients did not receive IVIG therapy. Patient characteristics, like Acute Physiology And Chronic Health Evaluation (APACHE) and Sepsis-related organ failure assessment (SAPS) Score, preexisting diseases, origin of infection, duration of ECMO therapy were analyzed in these patients. These patients were further analyzed regarding LOS ICU, LOS in hospital and regarding mortality.

Official Title
-----------------
Intravenous Immunoglobulin Therapy in ARDS Patients With Extracorporeal Membrane Oxygenation (ECMO) Therapy

Conditions
-----------------
Respiratory Distress Syndrome, Adult, Septic Shock

Intervention / Treatment
-----------------
* Drug: IgM enriched Immunoglobulins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All data available ARDS with ECMO therapy Exclusion Criteria: Data missing
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IgM enriched Immunoglobulins<br>ARDS patients with septic shock requiring ECMO therapy were treated for 3 days by IgM-enriched Immunoglobulin | Drug: IgM enriched Immunoglobulins<br>* Treatment for 3 days<br>* Other names: Pentaglobin, Biotest Pharma GmbH Germany; Code 170a/90;|
| Control<br>ARDS patients with septic shock requiring ECMO therapy were NOT treated by IgM-enriched Immunoglobulin | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death during ICU therapy | during ICU treatment, up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lengh of stay (LOS ICU) | lengh of stay on ICU in days | up to 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVIG, ARDS, ECMO
EU: A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
The primary objective of this program is to provide Daclatasvir in combination with Sofosbuvir with or without Ribavirin to subjects with chronic Hepatitis C who are at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options.

Official Title
-----------------
A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C

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

Intervention / Treatment
-----------------
* Drug: Daclatasvir
* Drug: Sofosbuvir
* Drug: Ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
This program is conducted in the EU (Germany, Austria, Norway, The Netherlands, Sweden and United Kingdom only) For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Patients chronically infected with Hepatitis C Patients at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options Exclusion Criteria: Patients who are <18 years old Patients who have contraindications to either Daclatasvir (DCV) or Sofosbuvir (SOF) Patients who are pregnant Creatinine clearance (CrCl) ≤ 30 mL/min (as estimated by Cockcroft and Gault formula) Patients who are pregnant or Women of Child Bearing Potential who are not using required contraception

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 |
| --- |
|Drug: Daclatasvir|nan|
|Drug: Sofosbuvir|nan|
|Drug: Ribavirin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Innovative Modalities for Restoring Upper Limb Function Post Stroke

Study Overview
=================
Brief Summary
-----------------
PURPOSE. After stroke many patients are unable to engage in normal upper limb functional activities, which may restrict them from participation in meaningful life roles. For many, conventional rehabilitation does not restore upper limb function to a useful level. The purpose of this research is to investigate the benefits of three promising motor learning interventions: focused intensive, motor learning (FIML); 2) robotics and motor learning (ROB-ML); and 3) functional neuromuscular stimulation and motor learning (FNS-ML).

Official Title
-----------------
Innovative Modalities for Restoring Upper Limb Function Post Stroke

Conditions
-----------------
Cerebrovascular Accident

Intervention / Treatment
-----------------
* Other: Motor Learning
* Other: Robotics
* Other: surface FES


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >1 year post stroke no acute, uncontrolled medical condition single stroke Exclusion Criteria: pacemaker other neurological condition more than one stroke

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motor Learning<br>subjects are provided with intensive motor learning training of the upper limb | Other: Motor Learning<br>* training of the hemiplegic upper limb with motor learning<br>|
| Experimental: Robotics and Motor Learning<br>subject are provided with intensive motor learning and robotics training of the upper limb | Other: Motor Learning<br>* training of the hemiplegic upper limb with motor learning<br>Other: Robotics<br>* subjects perform training of hemiplegic arm using an upper extremity robot<br>|
| Experimental: Motor learning and FES<br>subjects are provided with intensive motor learning and surface FES (Functional Electrical Stimulation) of the upper limb | Other: Motor Learning<br>* training of the hemiplegic upper limb with motor learning<br>Other: surface FES<br>* subjects are provided with surface FES to the hemiplegic upper limb<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl Meyer | impairment measure of coordination of the upper limb | after 12 weeks of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, electric stimulation, robotics, motor learning
Treatment of Refractory Urinary Retention Secondary to Benign Prostatic Hyperplasia (BPH) With Dual Five Alpha Reductase Inhibition Combined With an Alpha Blocker

Study Overview
=================
Brief Summary
-----------------
To determine whether the addition of a dual Five Alpha Reductase Inhitor (Dutasteride) will alleviate urinary retention secondary to BPH in who have failed a voiding trial without a catheter. Following treatment with an Alpha Blocker alone.

Official Title
-----------------
Phase 4 Study of Dual Five Alpha Reductase Inhibition Combined With Alpha Blockade in Men With Refractory Urinary Retention Secondary to BPH

Conditions
-----------------
Urinary Retention, Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: Dutasteride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males betewen the ages of 50 and 90 years of age.Written informed consent. Men with acute urinary retention attributed to bladder outlet obstruction caused by BPH, who have failed atleast 1 week trial of alpha blocker treatment. PSA level equal to or greater than 1.5ng/ml and equal to or less than 15 ng/ml. Exclusion Criteria: Urinary retention attributed to a neurogenic or myogenic bladder dysfunction. Use of psychotrophic medications. Use of antichollinergic medications. Prostate cancer. Allery to five alpha reductase inhibitors. Prior prostate surgery. Urethral stricture. Bladder calculi. Invasive bladder cancer. Inability to understand or agree with the requirements of the study. Any investigational drug received within 30 days prior of study entry.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Male

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: Dutasteride|Patients will continue on their alpha blocker in addition to Dutasteride 0.5mg daily for a maximum of 3 months|

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
-----------------
Urinary retention secondary to benign prostatic hyperplasia
A Study to Examine the Human Papillomavirus Types Exposure in Women From Southern Africa and Brasil

Study Overview
=================
Brief Summary
-----------------
This is a study to determine what Human Papillomavirus HIV seropositive women in Botswana, South Africa and Brasil have been exposed to during their life. The Human Papillomavirus causes cervical cancer. Different types are more likely to lead to cancer than other types. A vaccine has been made to fight infection against HPV 16 and 18 which has been shown to cause cervical cancer in America and Europe. What HPV type cause cancer in other countries is not as well studied. Hypothesis HPV serology will demonstrate that exposure to each HPV type in Gardisil (6,11,16,18) will be <50% in HIV seropositive women in resource limited countries.

Detailed Description
-----------------
Plasma from HIV seropositive women will be taken and sent to MERCK in the USA to evaluate what the antibody titers of HPV 6,11,16 and 18. .

Official Title
-----------------
A Pilot Observational Study to Determine the Prevalence of HPV Serology in HIV Seropositive Women From Subsaharan Africa and Brasil

Conditions
-----------------
HIV, HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV seropositive women 18 years of age and older Consent signed per local IRB requirement Exclusion Criteria: Can not give blood

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>HIV seropositive women from an HIV Antiretroviral therapy clinic in Johannesburg South Africa | |
| 2<br>A cohort of HIV seropositive women from Gabarone Botswana | |
| 3<br>A cohort of HIV seropositive women from Rio De Janeiro Brasil | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the seroprevalence of HPV types 6,11,16,18 in HIV serOpositive women for Botswana, South Africa and Brazil |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPV