linjc16/ctgov huggingface dataset:
Combined Intensive and Conventional Exercise on Nonalcoholic Fatty Liver Disease (NAFLD)

Study Overview
=================
Brief Summary
-----------------
The prevalence of NAFLD is 50-70% in obese people. A decrease of calorie intake and increase of physical activity are recommended as an effective approach for the prevention and treatment of NAFLD. However, the exercise model for NAFLD intervention is understudied. In the present study we aim to compare the effect of intensive and conventional exercise interventions on NAFLD.

Official Title
-----------------
Combined Intensive and Conventional Exercise Intervention of Nonalcoholic Fatty Liver Disease

Conditions
-----------------
Non-alcoholic Fatty Liver Disease (NAFLD)

Intervention / Treatment
-----------------
* Other: Intensive exercise
* Other: Conventional exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects with NAFLD determined by MRS ; Age 40-65 years old; Waist circumference> 90cm for men and > 85cm for women.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive exercise<br>The subjects receive an intensive exercise for 6 months and a subsequent conventional exercise for another 6 months. | Other: Intensive exercise<br>* Subjects conduct an aerobic exercise at 65-80% maximum oxygen consumption for 30 minutes each day, five days a week, totally for 6 months.Subsequently, moderate physical activity(3.0-6.0 MET s) at 150 min/wk for 6 months.<br>|
| No Intervention: Lifestyle counseling<br>Subjects receive a general lifestyle counseling for 12 months | |
| Experimental: Regular exercise<br>Subjects receive conventional exercise for 12 months | Other: Conventional exercise<br>* Subjects receive moderate physical activity(3.0-6.0 MET s) at 150 min/wk(30 min per day, five days a week) for 12 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of intrahepatic triglyceride contents |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of body weight |  | 12 months | 
| Change of waist circumference |  | 12 months | 
| Change of body fat |  | 12 months | 
| Change of abdominal fat |  | 12 montshs | 
| Change of carotid intima-media thickness |  | 12 months | 
| Change of cardiovascular risk factors (Blood pressure, lipids, glucose) |  | 12 months | 
| Change of insulin resistance |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NAFLD, exercise, hepatic triglycerides
Clinical Rescue Protocol - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to detect increasing medication dose results in heroin cessation for patients still using, to determine if decreasing medication dose in patients unable to tolerate medication dose increases retention, and to determine if blood levels of methadone or buprenorphine correlate with clinical response.

Official Title
-----------------
Clinical Rescue Protocol

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F ages 21-50. Opiate dependence according to DSM-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

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
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention |  |  | 
| Opiate use |  |  | 
| Opiate craving |  |  | 
| Adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opioid
Has Pulmonary Rehabilitation a Positive Impact on Sleep Quality in Patients Suffering From COPD ?

Study Overview
=================
Brief Summary
-----------------
The purpose of our study is to assess the impact of pulmonary rehabilitation on objective sleep quality in COPD patients.

Detailed Description
-----------------
COPD patients suffer from bad sleep quality. About 27 -50% are suffering from insomnia, and respiratory related symptoms are also inducing sleep disturbances. Recently, a correlation between altered sleep quality and low activity levels have been shown in this population. In primary insomnia, it is well established that physical activity has a positive impact on sleep quality. The purpose of our study is to assess the impact of pulmonary rehabilitation on objective sleep quality in COPD patients.

Official Title
-----------------
Has Pulmonary Rehabilitation a Positive Impact on Sleep Quality in Patients Suffering From Chronic Obstructive Pulmonary Disease?

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Other: pulmonary rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients able to walk and cycle Exclusion Criteria: Shift work orthopedic diseases of limbs

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD patients following a pulmonary rehabilitation program<br>COPD patients following a pulmonary rehabilitation program | Other: pulmonary rehabilitation<br>* a pulmonary rehabilitation program of 30 sessions, (3X1h/ week), will be followed by the COPD patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep efficiency | sleep efficiency assessed by actigraphy | 3 +/- 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| steps | number of steps walked daily assessed by actigraphy | 3 +/- 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, pulmonary rehabilitation, insomnia, sleep quality, physical activity
Brain Imaging Study of F17464

Study Overview
=================
Brief Summary
-----------------
Assess the binding rate of F17464 to cerebral receptors in healthy volunteers.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: F17464


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male healthy volunteers Exclusion Criteria: Presence or positive history of severe medical illness or psychiatric conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: Tested product<br> | Drug: F17464<br>* Single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binding rate to cerebral receptors | by brain imaging | up to 29 hours |
How to Test Success of a Renal Denervation

Study Overview
=================
Brief Summary
-----------------
The study aimed to assess the success of a clinically indicated renal denervation by different tests and correlate the results of the tests with the clinical outcome.

Detailed Description
-----------------
We aim to test the response to adenosine infusion, cold pressure test, flow mediated dilation of renal artery before and after a clinical indicated renal denervation. Renal Denervation is not a study intervention

Official Title
-----------------
Testing Effectiveness of Renal Denervation in Patients With Therapy-resistant Hypertension

Conditions
-----------------
Hypertension, Resistant to Conventional Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients 18 years to 85 years of age, with a diagnosis of re-sistant hypertension (office sitting blood pressure >140/90 mmHg and 24-hour blood pressure >130/80 mmHg in patients treated with at least three antihypertensive drugs including a diuretic) and a clinical indication for a renal denervation. Exclusion Criteria: Secondary cause of hypertension Anatomical contraindication to renal denervation (renal artery diameter less than 4 mm or more than 8 mm), multiple renal artery, length to bifurcation less than 2 cm Heart failure (normal ejection fractions on echocardiography and no clinical signs and symptoms of heart failure). Alcohol or drug abuse, Malignancy (unless healed or remission > 5 years) Pregnancy Know allergy to contrast medium Participation in another study within the last month

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Response to adenosine infusion, cold pressure test, flow mediated dilation of renal artery before and 1 year after renal denervation B | Changes in blood pressure and heart rate, in renal artery diameter and flow during adenosine infusion before and 1 year after renal denervation | chronic | 
| lood pressure (office and 24-hour blood pressure), laboratory parameter before and 12 months after catheter-based renal denrevation |  | chronic | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure (office and 24-hour blood pressure), laboratory parameter before and 1, 3, 6 months after catheter-based | Blood pressure (office and 24-hour blood pressure), laboratory parameter before and 1, 3, 6 months after catheter-based | chronic |
Serum MIF in Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
Acute kidney injury (AKI) is a common complication in critical care patients. Currently no parameters are available for early prognosis of AKI. Macrophage migration inhibitory factor (MIF) has been associated with AKI in clinical studies. The aim of this study is to evaluate the time course of MIF concentrations in patients with AKI.

Official Title
-----------------
Macrophage Migration Inhibitory Factor in the Serum of Critically Ill Patients as an Early Marker for Acute Kidney Injury

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

Intervention / Treatment
-----------------
* Other: Blood draw for measurement of MIF


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Age < 18 years and > 80 years Patients with chronic dialysis Patients with continuous hemodialysis, hemofiltration or hemodiafiltration within 4 weeks prior to the study Patients with an expected length of ICU stay shorter than 3 days Patients with a low probability of surviving the first 2 days after ICU admission Pregnancy and nursing

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| AKI<br>Patients developing AKI during the ICU stay | Other: Blood draw for measurement of MIF<br>* Observational study, no intervention<br>|
| No AKI<br>Matched controls not developing AKI during the ICU stay | Other: Blood draw for measurement of MIF<br>* Observational study, no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macrophage migration inhibitory factor |  | Up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine |  | Up to 14 days |
MPI Predicts Outcome of CRC Elderly Patients (MPI=MULTIDIMENSIONAL PROGNOSTIC INDEX; CRC=COLORECTAL CANCER)

Study Overview
=================
Brief Summary
-----------------
Patients aged ≥75 year scheduled for CRC surgery were studied (104 cases) and variables associated with major postoperative complications / mortality were evaluated. The importance of this report is that MPI-score resulted strongly associated with major complications and it was a primary component of an individual prediction model.

Detailed Description
-----------------
Patients aged ≥75 year scheduled for CRC surgery were studied (104 cases) and variables associated with major postoperative complications / mortality were evaluated. The MPI (multidimensional prognostic index)-score resulted strongly associated with major complications. also, it was a primary component of an individual prediction model (LASSO model).

Official Title
-----------------
Multidimensional Prognostic Index (MPI) Score Has the Major Impact on Outcome Prediction in Elderly Surgical Patients With Colorectal Cancer: the Fragis Study

Conditions
-----------------
Colorectal Cancer, Fragility, Elderly

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All CRC patients aged ≥75 years, who were scheduled for elective surgery and able to express their consent to treatment, were considered. Exclusion Criteria: emergency surgery; patients aged <75 years; patients unable to sign informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: surgery|colectomy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MPI and major morbidity | The primary goal of the FRAGIS (Frailty Assessment by Geriatric Investigation in Surgery) study was to evaluate the association between the MPI score and the occurrence of major postoperative complications within 30 days of CRC surgery. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of complication | The secondary goal was to develop a model to predict the individual risk of postoperative complications, allowing the appropriate patient selection for surgery. | 90 days |
Treatment of Upper Ureteric Stones

Study Overview
=================
Brief Summary
-----------------
This study will be conducted to compare the success and complication rates of ureteroscopy, and shockwaves lithotripsy for treatment of upper ureteric stones ≤1 cm.

Detailed Description
-----------------
This study will be conducted to compare the success and complication rates of Flexible, Semi-rigid URS, and SWL approaches for proximal ureteric stones with size ≤1 cm.

Official Title
-----------------
A Comparison Between Flexible Ureteroscopy, Semirigid Ureteroscopy and Extracorporeal Shockwaves Lithotripsy (SWL) in The Management of Proximal Ureteric Stones. A Randomized Controlled Trial

Conditions
-----------------
Ureteric Stones

Intervention / Treatment
-----------------
* Procedure: SWL
* Procedure: Semirigid URS
* Procedure: Flexible URS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radio-opaque stones less than or equal 1 cm Exclusion Criteria: Active UTI Coagulopathy Pregnancy Ureteric stricture

Ages Eligible for Study
-----------------
Minimum Age: 14 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extracorporeal Shockwaves<br>Patients in this arm will undergo SWL | Procedure: SWL<br>* Patients in this arm will undergo SWL<br>|
| Active Comparator: Semirigid URS<br>Patients in this arm will undergo Semirigid Ureteroscopy | Procedure: Semirigid URS<br>* Patients in this arm will undergo semirigid URS<br>|
| Active Comparator: Flexible URS<br>Patients in this arm will undergo Flexible Ureteroscopy | Procedure: Flexible URS<br>* Patients in this arm will undergo Flexible URS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate | The stone free rate will be evaluated with non-contrast CT | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Complications will be classified according to modified Clavien Dindo | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ureteral stones, ureter, ureteroscopy, flexible, SWL
Droxidopa in Treating Patients With Neurogenic Hypotension

Study Overview
=================
Brief Summary
-----------------
Please note that the continuation study can be found at http://clinicaltrials.gov/show/NCT00633880. RATIONALE: Neurogenic hypotension is a fall in blood pressure that occurs when one moves from a lying down to a standing position or after eating a meal. It causes one to feel dizzy, light headed, and weak. Neurogenic hypotension is caused by a problem in the part of the nervous system that controls such functions as heart rate and blood pressure. Droxidopa, a drug that may increase blood pressure, may be an effective treatment for neurogenic hypotension. PURPOSE: Clinical trial to study the effectiveness of droxidopa in treating patients who have neurogenic hypotension.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive escalating doses of droxidopa or placebo for 7-14 days. Patients undergo blood pressure measurements hourly in both supine and standing positions.

Official Title
-----------------
Study of Droxidopa in Patients With Neurologic Hypotension

Conditions
-----------------
Shy-Drager Syndrome, Orthostatic Hypotension

Intervention / Treatment
-----------------
* Drug: droxidopa


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Orthostatic hypotension due to autonomic nervous system failure Fall in systolic blood pressure (supine to standing) of at least 20 mm Hg and diastolic blood pressure of at least 15 mm Hg AND Symptoms of hypotension such as dizziness, light-headedness, unsteadiness, dimming or blurred vision History of syncope or near-syncope --Prior/Concurrent Therapy-- Endocrine therapy: No concurrent adrenergics Concurrent fludrocortisone allowed Other: Concurrent indomethacin, support garments, and high salt diets allowed

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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
-----------------
rare disease, Shy-Drager Syndrome, cardiovascular and respiratory diseases, neurologic and psychiatric disorders, orthostatic hypotension