linjc16/ctgov huggingface dataset:
Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)

Study Overview
=================
Brief Summary
-----------------
In the present application, we propose to refine and extend current insight into AAF mechanism and therapy by examining the importance of pharmacologic RAAS inhibition, ACE genotype, and their interaction in secondary AF prevention. We have 3 specific aims: To confirm that RAAS inhibition therapy reduces the incidence of AF recurrence. To test the hypothesis that the incidence of AF recurrence in the absence of RAAS inhibition therapy is higher among patients with the D allele. To explore the hypothesis that RAAS inhibition therapy is more effective for preventing AF recurrence in patients with the DD genotype than in those with DI or II genotypes.

Official Title
-----------------
Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: no drug
* Drug: start cozaar
* Drug: continue cozaar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be in atrial fibrillation confirmed by 12 lead EKG. blood pressure > 90 mmHg Patient without cardiopulmonary symptoms 18+ years of age Exclusion Criteria: Contraindiction to warfarin Recent (within 6 months) MI or cardiac revascularization Recent (within 6 months) CVA or TIA NYHA Class IV CHF Active thyroid disease Major hepatic dysfunction Renal dysfunction (>2 mg/dL) Hyperkalemia (>4.6 mEq/L) Hyponatremia (<130 mEq/L) Currently taking a Vaughn-Williams Type I or III antiarrhythmic drug History of ARB intolerance Contraindication to ARB therapy Pregnancy Female of childbearing age Age < 18 years of age Inability to give informed consent Other medical conditions calling 1 year survival into question

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A Group 1 no drug<br>Patients who have not taken ACE/ARB, randomized to no drug. | Other: no drug<br>* none, no drug<br>|
| Experimental: A Group 2<br>Patients who have not taken ACE/ARB, randomized to take cozaar. | Drug: start cozaar<br>* start cozaar<br>|
| Experimental: B<br>Patients currently taking ACE/ARB will have their prescription changed to cozaar. | Drug: continue cozaar<br>* continue cozaar<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF burden |  | 1 year |
The Eosinophils Percentage Predicts In-hospital Major Adverse Cardiac Events in STEMI Patients After PCI

Study Overview
=================
Brief Summary
-----------------
Eosinophils (EOS) in peripheral blood are significantly decreased in ST-segment elevation myocardial infarction (STEMI) and the reduced EOS indicates severe myocardial damage. Whether EOS is a good predictor for in-hospital major adverse cardiac events (MACEs) of patients with ST-segment elevation myocardial infarction remains unknown. The aims of this study was to evaluate prognostic role of EOS for in-hospital MACEs in STEMI patients who have undergone primary percutaneous coronary intervention (PCI)

Detailed Description
-----------------
The investigators retrospectively analyzed the clinical data of 518 patients with STEMI after PCI. MACEs were defined as cardiac arrest, cardiac rapture, malignant arrhythmia and cardiac death. The receiver operating characteristic (ROC) curves were used to demonstrate the prognostic value of EOS% in in-hospital MACEs. All patients were divided into 2 groups according to the best cut-off EOS% value, including reduced EOS% group and control group. Cox regression analyses and KM survival curve were used to calculate the correlated between EOS with in-hospital MACEs.

Official Title
-----------------
The Eosinophils Percentage Predicts In-hospital Major Adverse Cardiac Events in Patients With ST-elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention

Conditions
-----------------
ST Elevation Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with STEMI who underwent PCI within 12 hours from symptom onset Patients from whom informed consent has been properly obtained in writing prior to start of the trial. Exclusion Criteria: Patients with previous myocardial infarction, congenital heart disease Patients with liver disease, and renal failure Patients with immunologic disease, malignant tumors, pregnancy, infection caused by various pathogens, chronic inflammatory disease, trauma.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| major adverse cardiac events | the relationship between reduced eosinophils percentage and in-hospital MACE | The median time of 7 days |
A Study Pilot About the Contribution of Pleuropulmonary Echography Iin Acute Bronchiolitis Among Infants

Study Overview
=================
Brief Summary
-----------------
Pleuropulmonary echography remains an almost non-existent tool in routine pediatric practice. Our study is part of a desire to develop its use in pediatrics, in particular for the diagnosis of acute bacterial pneumonitis associated with acute bronchiolitis among infants.

Official Title
-----------------
A Study Pilot About the Contribution of Pleuropulmonary Echography Iin Acute Bronchiolitis Among Infants

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Device: Pleuropulmonary echography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants aged <= 2 years old Medical diagnosis of acute bronchiolitis requiring hospitalization in the pediatric departments of the Besançon University Hospital No opposition from the parents for performing the pleuropulmonary echography. Exclusion Criteria: Children aged > 2 years old Infants aged < 2 years old consultant in pediatric emergencies for acute bronchiolitis without subsequent hospitalization. Previous chronic lung disease (including pulmonary bronchodysplasia), unoperated congenital heart disease or neuromuscular disease.

Ages Eligible for Study
-----------------
Maximum Age: 2 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: Pleuropulmonary echography<br> | Device: Pleuropulmonary echography<br>* Pleuropulmonary echography is performed, in addition of the chest X-ray already performed in routine care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between PleuroPulmonary Echography [PPE] and pulmonary radiography | Comparative analysis between PPE and chest/pulmonary radiography (gold standard) for the diagnosis of bacterial pneumonitis associated with acute bronchiolitis in infants. | Day 1 |
Reuptake of an E-Learning Programme in General Practice

Study Overview
=================
Brief Summary
-----------------
The evaluate the use and diffusion of an E-learning programme in Diagnostic Evaluation of Dementia among General Practitioners (GPs) in Denmark. The hypothesis are: The GPs do not use the guided instructions The GPs using the programme are more frequently younger GPs. GPs working in rural areas will use the programme more frequently

Detailed Description
-----------------
In a period from november 2006 to may 2007 all log files of those GPs who log on to the E-learning programme are kept by the Danish Medical Association. They are handed over to the principal investigator in an anonymous form.

Official Title
-----------------
The Use and Diffusion of an E-learning Programme in Diagnostic Evaluation of Dementia Among General Practitioners in Denmark

Conditions
-----------------
Education, Dementia

Participation Criteria
=================
Eligibility Criteria
-----------------
GPs stopping working as GPs in study period

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

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
-----------------
Heading Health Plan Implementation, Computer-Assisted Instruction, General Practice, Dementia
Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers

Study Overview
=================
Brief Summary
-----------------
To investigate the safety and tolerability of Xerecept during and following a 24-hour intravenous administration to healthy Japanese to healthy Japanese and Caucasian subjects To compare the PK profile of hCRF during and following a 24-hour intravenous Xerecept administration between healthy Japanese and Caucasian subjects

Detailed Description
-----------------
none needed

Official Title
-----------------
A Phase 1,Dose Escalation Study to Compare the Safety, Tolerability,Pharmacokinetic and Pharmacodynamic Profiles of the 24-hour Intravenous Administration of Xerecept in Healthy Japanese and Caucasian Adult Volunteers

Conditions
-----------------
Edema

Intervention / Treatment
-----------------
* Drug: Xerecept 1.0
* Drug: Xerecept 2.0
* Drug: Xerecept 3.0


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female Japanese subjects who are citizens of Japan Healthy male and female Caucasian subjects Age range 20-45 years BMI >19 and <27 kg/m squared Exclusion Criteria: Female subjects must not be pregnant at the time of study and use adequate birth control methods before,during and 4 weeks after the study Subjects must be negative for HCV and HIV Subjects must have negative urine tests for drugs of abuse and alcohol at screening Subjects must not have any clinically significant medical conditions

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Xerecept 1.0<br>1.0 ug/kg/hr hCRF -24 hour IV infusion | Drug: Xerecept 1.0<br>* 24 hour infusion<br>* Other names: 1.0 ug/kg/hr;|
| Active Comparator: Xerecept 2.0<br>2.0 ug/kg/hr-24 hour IV infusion | Drug: Xerecept 2.0<br>* 24 hour infusion<br>* Other names: 2.0 ug/kg/hr;|
| Active Comparator: Xerecept 3.0<br>3.0 ug/kg/hr-24 hour infusion | Drug: Xerecept 3.0<br>* 24 hour infusion<br>* Other names: 3.0 ug/kg/hr;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and severity of AEs Clinical laboratory tests( chemistry,hematology,urinalysis) Physical exam and vital signs ECG AUC, Tmax Cmax Terminal half life AUC for cortisol concentration |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Xerecept, Pharmacokinetics, Japanese versus Caucasians
Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet

Study Overview
=================
Brief Summary
-----------------
This study seeks to determine whether the Lactic Acid blood level in a critically ill patient must be drawn with a non-tourniquet venipuncture. The null hypothesis is that there is no significant difference in Lactic Acid blood level in critically ill patients in a sample taken from either with a tourniquet or a non-tourniquet veni-puncture. Monitoring of Lactic acid level is helpful in both identifying potentially serious ill patients as well as identifying in the ICU patients with high morbidity and mortality. When a patient arrives to an Emergency Department and that patient is hypotensive (BP less than or equal to 90 systolic), the nursing staff often starts an IV and if possible draws the patient's initial blood tests off that first IV site; or if the patient has had an IV started in the field by EMS, the nursing staff will draw blood from another site using a tourniquet. This initial work up by the nursing staff takes 15 -20 minutes before a physician may see the patient. Since the present standard Lactic Acid test must be drawn either by arterial puncture or venipuncture without a tourniquet, this test is rarely done as part of their (the RNs) initial blood draws. This simple impediment of needing to repeat the venipuncture without a tourniquet, especially in patients who often have venous access difficulty, delays the identification of appropriate patients for early and aggressive management- particularly those with sepsis. Our hypothesis is that this requirement for a non-tourniquet blood draw is unnecessary.

Official Title
-----------------
Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet

Conditions
-----------------
Hypotension, Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blood pressure systolic of 90 or less Non pregnant by history Exclusion Criteria: Pregnant by history Comfort care only

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- | --- |
| Lacid<br>Hypotensive, non pregnant by history, non comfort care Emergency Department patients. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in hypotensive patients between the use of a tourniquet and non tourniquet sampling for Lactic Acid level. |  | At the initial evaluation of the patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lactic acid, hypotension, sepsis
Effects of Physical Activity on the Brain in Parkinson's Disease (PD)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate whether exercise improves cognitive and motor functions in Parkinson's disease. To test this hypothesis, the researchers study general brain functions in subjects with PD during a 6-months exercise program.

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Behavioral: stationary bike exercise
* Behavioral: aerobic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: UPDRS <15 L-DOPA responsive <5 yrs since diagnosis Exclusion Criteria: severe other diseases MMSE < 26 treatment with psychiatric medication

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stationary bike exercise<br>6 months of exercise (60% of anaerobic threshold) | Behavioral: stationary bike exercise<br> <br> |
| Placebo Comparator: aerobic<br>6 months of exercise <30% anaerobic threshold | Behavioral: aerobic<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS motor score |  | Prior to intervention and after 6 months of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional/Structural brain changes |  | Prior to intervention and after 6 months of intervention | 
| Plasma biomarkers |  | Prior to intervention and after 6 months of intervention | 
| Cognitive Function based on neuropsychological test-performance |  | Prior to intervention and after 6 months of intervention |
Sleep Disturbances and Pulmonary Artery/Aorta Diameter in Scleroderma Patient

Study Overview
=================
Brief Summary
-----------------
To determine sleep disturbance, pulmonary function test, 6 minute walk, echocardiogram abnormality, arterial blood gas, ventilation/perfusion scan of the chest in Scleroderma patient with Pulmonary Hypertension.

Detailed Description
-----------------
As above

Official Title
-----------------
Sleep Disturbances and Pulmonary Artery/Aorta Diameter in Scleroderma Patient

Conditions
-----------------
Scleroderma, Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must have Scleroderma Exclusion Criteria: Patients who do not have Scleroderma

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?
-----------------
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
-----------------
Scleroderma, Pulmonary Hypertension
Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of tocilizumab vs placebo, in combination with stable, ongoing therapy, with regard to reduction in signs and symptoms in patients with moderate to severe active RA and inadequate response to current DMARD treatment

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and the Safety During Treatment With Tocilizumab vs Placebo in Combination With Traditional DMARD Therapy in Patients With Moderate to Severe Active RA and an Inadequate Response to Current DMARD Therapy

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: tocilizumab
* Drug: DMARDs
* Drug: Placebo
* Drug: DMARDs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >= 18 years of age Active RA of > 6monts duration Received permitted DMARDs each at a stable dose for at least 8 weeks Exclusion Criteria: Rheumatic autoimmune disease other than RA Significant systemic involvement secondary to RA ALT or AST > ULNⅹ1.5 Platelet count < 100,000/mm3 Hemoglobin < 8.5 g/dL White blood cells < 3,000/mm3 Absolute neutrophil count < 2,000/mm3 Absolute lymphocyte count < 500/mm3

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: Tocilizumab 8mg/kg+DMARDs<br> | Drug: tocilizumab<br>* intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks<br>Drug: DMARDs<br>* Methotrexate(MTX) and/or 1 DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)<br>|
| Placebo Comparator: Placebo+DMARDs<br> | Drug: Placebo<br>* intravenously over 1 hour infusion every 4weeks<br>Drug: DMARDs<br>* Methotrexate(MTX) and/or 1 DMARDs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with ACR20 responses | Proportion of patients with ACR20 responses at post therapy | 24weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with ACR50 and ACR70 responses at post therapy |  | 24weeks | 
| Change of DAS28, HAQ, individual parameter in ACR core set, hemoglobin |  | 24weeks |
A Study to Evaluate the Efficacy and Safety of Eplerenone in the Treatment of Hypertension in Children.

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy, safety, and toleration of eplerenone in the treatment of children aged 6 to 16 years with high blood pressure. The study will last approximately 10 weeks and about 320 patients will participate.

Official Title
-----------------
Peds I (Pediatric Eplerenone Development Study I): A Randomized, Double-Blind, Placebo Withdrawal, Parallel Group, Dose-Response Study To Evaluate The Efficacy And Safety Of Eplerenone In The Treatment Of Hypertension In Children

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Eplerenone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6-16 years old male and female Systolic blood pressure greater than or equal to the 95th percentile for age, gender, and height, measured on at least 3 separate occasions Exclusion Criteria: K/DOQI classification of stages of chronic kidney disease equal to or greater than 3 Serum or whole blood potassium > 5.5 mEq/L

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of eplerenone in children |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of eplerenone in hypertensive children |  |  |