linjc16/ctgov huggingface dataset:
VAST - Ventricular Arrhythmia Suppression Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of VAST is to determine whether the Rate Smoothing feature in Guidant's PRIZM/VITALITY-family ICDs has an effect on the incidence of ventricular tachyarrhythmias.

Official Title
-----------------
Ventricular Arrhythmia Suppression Trial

Conditions
-----------------
Tachycardia

Intervention / Treatment
-----------------
* Device: Implantable Cardioverter Defibrillator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who receive a commercially available Guidant PRIZM, PRIZM 2, or VITALITY AVT ICD Patients who sign and date a Patient Informed Consent prior to study enrollment Patients who remain in the clinical care of physicians of their implanting center Exclusion Criteria: Patients who have chronic atrial fibrillation. Paroxysms of AF are not an exclusion criterion, but the patient must be in normal sinus rhythm at the time of randomization. If history of AF is unknown or uncertain, or the patient was recently cardioverted, there must be at least 23 hours of normal sinus rhythm within the 24 hour period preceding randomization Patients who previously had an ICD Patients with current indications for cardiac resynchronization therapy with defibrillation (CRT-D) Patients whose life expectancy is less than 12 months due to other medical conditions Patients who are expected to receive a heart transplant during the duration of the study Patients who have or who are likely to receive a tricuspid or other valve prosthesis Patients who are currently enrolled in another investigational study of active medical therapy. Each instance should be brought to Guidant's Clinical Application Research Studies (CARS) group to determine eligibility Patients who are younger than 18 years of age Patients who are mentally incompetent and cannot give a Patient Informed Consent or participate in the study

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Implantable Cardioverter Defibrillator|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint for this study will be the number of episodes of ventricular tachyarrhythmia in each patient during each follow-up period (ON vs. OFF treatment). |  |  |
Ambulatory Parkinson's Disease Dyskinesia Monitor for Drug Therapy Titration

Study Overview
=================
Brief Summary
-----------------
The objective is to assess a compact, portable, wireless movement disorder system with continuous monitoring capabilities to detect and quantify the severity of levodopa-induced dyskinesia in Parkinson's disease.

Official Title
-----------------
Kinesia-D Phase II In-Clinic Continuous Assessment Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of idiopathic Parkinson's disease Clinical history of levodopa-induced dyskinesia 21 Years of age or older Stage 2 - 4 OFF-medication on the Hoehn and Yahr scale Exclusion Criteria: Dementia (determined by a neuropsychological assessment) Severe tremor unaffected by levodopa

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Parkinson's disease on levodopa<br>Individuals with Parkinson's disease who are taking levodopa to treat motor symptoms | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between motion sensor features and clinician-rated dyskinesia severity | Motor function (movement speed and magnitude measured with a motion sensor) will be collected for a period of 2 hours after taking normally prescribed dose of levodopa. | All data will be collected within a single session not to exceed 3 hours |
Early Indicators of Chronic Rejection in Lung Transplant

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to discover the different patterns of cytokine production in patients who may develop Bronchiolitis Obliterans Syndrome-0p (BOS-0p) which means ongoing rejection. This is an early indicator of chronic rejection in lung transplant recipients. These cytokines can be detected in the bronchoalveolar (lung) and tissue samples of lung transplant recipients.

Detailed Description
-----------------
Lung transplant recipients are routinely followed in clinic every three months after the first year post-transplant. Spirometry with measurement of FEV1, FVC and FEF25-75 are obtained at each visit. In addition, lung transplant recipients undergo surveillance bronchoscopy at one, three, six, nine and twelve months. All bronchoscopy specimens that are obtained for this study will be obtained during bronchoscopies that were scheduled per the physician caring for the patient. An extra 90 cc of sterile solution will be instilled into bronchus and two extra transbronchial biopsies will be performed in addition to the routine bronchoscopic procedure. Routinely, 4-8 transbronchial biopsy samples are obtained from the transplanted lung. Two specimens will be randomly selected for study and the rest will undergo routine histopathologic study. The study biopsies will be set aside and processed. The study visits for this research will occur at the same time as standard of care post transplant visits. We will collect subject's history,demographic of subject's transplant data,donor procurement information, physical exam information, pregnancy tests,blood test and spirometry results from the visits mentioned above.

Official Title
-----------------
Role of Inflammatory and Fibroproliferative Cytokines in the Pathogenesis of Bronchiolitis Obliterans Syndrome-OP in Lung Transplant Recipients.

Conditions
-----------------
Chronic Rejection in Lung Transplant, Cytokine Production in Bos Post Lung Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung transplant recipients between the ages of 18 and 65 years old All patients must be able to give written informed consent Exclusion Criteria: Lung transplant recipients who are unable to undergo bronchoscopy Lung transplant recipients who are unable to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| cytokines, chemokines and T cell subsets associated with BOS |  | 12/2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic rejection, lung transplant, cytokines, bos
Hemodynamic Effects on Cerebral Autoregulation in Acute Stroke

Study Overview
=================
Brief Summary
-----------------
This study investigates if there are hemodynamic alterations in acute stroke that predispose patients to impaired perfusion and regulation of cerebral blood flow. To test this, we will target recruitment of acute ischemic stroke patients who present to the ED within 12 hours of symptoms onset. Enrolled subjects will receive continuous noninvasive hemodynamic monitoring contemporaneous with measurements of cerebral blood flow velocities and cerebral oximetry.

Conditions
-----------------
Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected ischemic stroke within 12 hours of symptom onset NIHSS ≥ 4 Age 18 to 90 years Exclusion Criteria: Baseline modified Rankin Scale > 3 Pregnancy Intracranial hemorrhage on head CT Mechanical ventilation prior to enrollment Inadequate temporal windows for TCD analysis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Change in cerebral blood flow velocities | Cerebral flow velocities determined by bilateral MCA measurements by TCD | initial 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, transcranial doppler, cerebral blood flow, cardiac output, non-invasive hemodynamic monitoring
Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the therapeutic efficacy, safety and local tolerability of two different paracetamol-containing solutions in postoperative total hip replacement. They will be compared to placebo (a dummy treatment which contains no active ingredient).

Official Title
-----------------
Single-Dose Comparison of the Analgesic Efficacy, Safety and Tolerability of Two Paracetamol 1%-Containing Solutions and Placebo in a Post-Surgical Total Hip Replacement Model

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

Intervention / Treatment
-----------------
* Drug: Paracetamol (acetaminophen)
* Drug: Paracetamol 1% solution
* Drug: 0.9% sodium chloride solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I, II or III and scheduled for elective total hip replacement, using a standard approach and a cemented implant. Moderate or severe pain within 4 hours after stopping the PCA in the morning of the first post-operative day. Exclusion Criteria: Another acute or chronic painful physical condition Use of any other analgesics (within 24 hours), sedatives, or narcotic drugs as well as microsomal enzyme inducers Inability to use and understand Visual Analog Scale and Verbal Rating Score

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test drug<br> | Drug: Paracetamol 1% solution<br>* Four 100 mL, 15 min IV infusions at six hour intervals<br>|
| Active Comparator: Reference drug<br> | Drug: Paracetamol (acetaminophen)<br>* Four 100 mL, 15 min IV infusions at six hour intervals<br>* Other names: Perfalgan;|
| Placebo Comparator: Placebo<br> | Drug: 0.9% sodium chloride solution<br>* Four 100 mL, 15 min IV infusions at six hour intervals<br>* Other names: Normal saline solution;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of PCA-administered morphine consumed during first six hours of study drug treatment |  | 6 hours from first (of four) study drug doses | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, postoperative, replacement, total hip, total hip replacement, arthroplasty, replacement, hip
Assessment of the Patients of Emergency Consultation

Study Overview
=================
Brief Summary
-----------------
The demographic data, mortality rates and clinical diagnoses of the patients who were evaluated, intubated and interned to ICU by the anesthesiology department due to an urgent consultation call from the emergency department in 2010-2011. Primary outcome: an examination of demographic data, predicted mortality rates and the clinical diagnosis of the patients Secondary outcome: to determine the terminal cancer ratio Inclusion criteria: patients throughout the hole hospital whom was intubated by the anaesthesiology team due to an emergency consultation call Exclusion criteria: patients who refused treatment

Detailed Description
-----------------
The demographic data and findings completed in the Emergency Department were obtained from the patient cards and information related to existing diseases was obtained from the patient records for the cases included in the study. Predicted mortality values were calculated for each patient with Apache II and SAPS II values using the worst or most critical physiological and laboratory parameters in the first 24 hours in the Emergency Department.

Official Title
-----------------
The Demographics, Mortality and Clinical Diagnosis of the Patients Who Were Evaluated, Intubated and Interned to ICU by the Anesthesiology in 2010-2011

Conditions
-----------------
Demographics of Intubated Patients Due to an Urgent Call

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients throughout the hole hospital whom was intubated by the anaesthesiology team due to an urgent consultation call Exclusion criteria: patients who refused treatment
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 |
| --- | --- | --- |
| The evaluation of the terminal phase cancer ratio | To determine the ratio of patients with terminal phase cancer who were intubated and interned to the intensive care unit. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic data of urgent anaesthesiology consultations required intubation | The evaluation of the demographics, clinical diagnosis and the calculated values of APACHE II, SAPS II and predicted mortality of the patients who were intubated and interned to the ICU by anesthesiology department due to an urgent consultation call. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intubation, intensive care, withholding treatment, cancer, terminal care, APACHE
Recurrent Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the recurrence rates of atrial fibrillation that develops in the hospital following non cardiac procedures or surgeries or acute medical illnesses.

Detailed Description
-----------------
Eligible individuals with no previous history of atrial fibrillation or flutter who develop a limited episode of atrial fibrillation during a hospital stay for an acute medical illness or non-cardiothoracic surgery or procedure. Patients will be monitored for a period of 1 month using Medtronic SEEQ monitors for recurrence. Subjects will self assign to wear the SEEQ monitor or standard of care. Individuals with implanted cardiac devices capable of detecting atrial fibrillation will also be included.

Official Title
-----------------
Recurrent Atrial Fibrillation

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

Intervention / Treatment
-----------------
* Device: SEEQ monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Development of atrial fibrillation or flutter during a hospital stay following a non-cardiac procedure or acute medical illness CHADS2VASc score of 2 or more Exclusion Criteria: Prior history of atrial fibrillation of flutter Requiring ventilator support or in shock Acute decompensated heart failure or EF =/< 40% Greater than mild valvular heart disease Other structural heart disease such as more than mild LVH, constrictive or restrictive cardiomyopathy Hyperthyroidism uncontrolled at the time of diagnosis if known Pulmonary embolism that requires thrombolysis or resulted in shock Use of antiarrhythmic drugs (class I or III) at the time of discharge Cardiothoracic surgery in the last 6 months

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: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SEEQ monitor<br>Subjects will be monitored via use of the SEEQ monitor | Device: SEEQ monitor<br>* An external cardiac rhythm monitor<br>|
| No Intervention: Standard of care<br>Subjects will not wear the SEEQ monitor or may have a pre-existing implanted device capable of detecting atrial fibrillation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of atrial fibrillation | The rate of recurrence of atrial fibrillation will be compared to the recurrence noted in the standard of care arm. | 28 days |
A Study on Nutrition Support Therapy of Patients With Liver Failure

Study Overview
=================
Brief Summary
-----------------
This study is a Clinical trial to assess the efficacy of nutrition support therapy of patients with liver failure. Patients were randomized to one of 2 groups to receive different nutrition and energy support treatment.

Detailed Description
-----------------
Patients with liver failure (defined by APASL) induced by any precipitating factors were randomized to two groups; a treatment group and a control group. Participants in treatment group were provided with a standard hospital diet that provided 25-30 kcal/kg/day . Patients in control group receive diet guide

Official Title
-----------------
A Clinic Trail on Nutrition Support Therapy of Patients With Liver Failure

Conditions
-----------------
Nutrition

Intervention / Treatment
-----------------
* Dietary Supplement: standard hospital diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients from 18 to 65 years of age; Patient inclusion criteria: jaundice (serum total bilirubin ≥5 mg/dl) and coagulopathy (INR ≥ 1.5 or prothrombin activity ≥ 40 %), accompanied by ascites and/or encephalopathy within 4 weeks. Exclusion Criteria: Surgery with in 4 weeks three degree hepatoencephalopathy malignant tumors cardiac failure or respiratory failure liver transplantation within observing period -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: a treatment group<br>All study participants were provided with a standard hospital diet that provided B25-30 kcal/kg/day | Dietary Supplement: standard hospital diet<br>* patients were provided standard hospital diet that provided 25-30 kcal/kg/day<br>|
| No Intervention: control group<br>All study participants were not intervened with diet | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at 30 day | The percentage of death of liver failure patients at 4 weeks | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver transplant-free survival | survival rate on 4 weeks and 3 month | 3month | 
| Laboratory variables on serum biochemistry markers | Laboratory variables on serum lever of glutamic-pyruvic transaminase/glutamic oxalacetic transaminase/total bilirubin/ cholinesterase will be combined to report liver function | 3month | 
| Laboratory variables on fasting blood sugar | Laboratory variables on serum lever of fasting blood sugar | 3month |
An Injury Prevention Program for Professional Ballet

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the efficacy of an injury prevention program for professional ballet dancers.

Official Title
-----------------
An Injury Prevention Program for Professional Ballet: a Randomized Controlled Investigation

Conditions
-----------------
Accidents Sports, Injury Prevention

Intervention / Treatment
-----------------
* Behavioral: Injury Prevention Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Professional Ballet Dancer Willing to participate and undergo informed consent process Exclusion Criteria: Pregnant Women, non-English speaking subjects, or those who decline participation in the study.
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: Parallel Assignment
Interventional Model Description: 2 arm: randomized to injury prevention protocol or control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injury Prevention Program<br>Those allocated to the injury prevention program will be instructed on the program, the added exercises, and the additional time commitment. | Behavioral: Injury Prevention Program<br> <br> |
| No Intervention: Control<br>The control group will practice and perform with no change to pre-existing years' standard operating practice. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Injury | Number of injuries sustained and reported per subject during the 1 year study. Data will be aggregated according to arm of study to ascertain the rate of injury for each group. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Turn-out degrees | Turn-out degree values to measure flexibility and strength. Turnout is the sum of hip rotation, tibial torsion, and contributions from the foot. | 1 year | 
| Beighton | Beighton scale to ascertain generalized joint laxity. Maximum score of 9, minimum score of 0. | 1 year | 
| AOFAS ankle-hindfoot | American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score. 100 point total score. Instrument combines functional outcome and pain for subject's ankle or hindfoot. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
injury prevention program; professional ballet