linjc16/ctgov huggingface dataset:
Acupuncture for Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
Little is known about acupuncture's efficacy for Irritable Bowel Syndrome (IBS). This trial uses a manualized acupuncture treatment format that closely follows clinical practice and allows flexibility in designing individualized treatments. In addition, a second parallel qualitative study will follow a subgroup of patients throughout the trial to explore the relationships between patients' interpretations and understandings (what anthropologists call meaning) of irritable bowel and their response to treatment. Cortisol levels (an important stress hormone) will also be assessed. This will be a 3-arm trial: Active acupuncture, placebo acupuncture, and wait list.

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Device: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of Irritable Bowel Syndrome based on Rome II criteria, including at least 12 weeks of abdominal discomfort or pain in the last 12 months with at least 2 of the following features: Relief with defecation Onset associated with a change in stool frequency Onset associated with a change in form/appearance of stool Exclusion criteria: History of severe or intractable IBS, defined as continuous, unremitting and several abdominal pain greater than 12 hours/day Previous acupuncture treatment Concurrent diagnosis of any bowel disturbance that would interfere with the assessment or safety of the study History of laxative abuse Previous abdominal surgery (uncomplicated appendectomy, hysterectomy or cholecystectomy at least 6 months prior to entry acceptable) History of metabolic or inflammatory disease that may affect bowel motility, eg.g., inflammatory bowel disease, diabetes mellitus, sarcoidosis Other significant illness as determined by Investigator History of drug or alcohol abuse w/in 2 years; Insufficient knowledge of English to complete self-assessments to participate in study

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Acupuncture|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
-----------------
Irritable Bowel Syndrome, Acupuncture
PGx Study to Develop and Validate the Predictive Warfarin Dosing Algorithm for Personalized Warfarin Pharmacotherapy

Study Overview
=================
Brief Summary
-----------------
To develop and validate the predictive warfarin dosing algorithm.

Detailed Description
-----------------
This study aims to develop and validate the predictive warfarin dosing algorithm for personalized warfarin pharmacotherapy in Korean patients.

Official Title
-----------------
Warfarin Dosing Algorithm for Personalized Warfarin Pharmacotherapy in Korean Patients

Conditions
-----------------
Heart Valve Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patients taking warfarin Exclusion Criteria: noncompliance

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| To Develop and Validate the Predictive Warfarin Dosing Algorithm |  | 1 year |
Healthy Volunteer Study

Study Overview
=================
Brief Summary
-----------------
The study will recruit healthy volunteers to undergo the iontophoresis procedure using the Acclarent Iontophoresis System with Headset.

Official Title
-----------------
Performance of the Iontophoresis System With Headset in Healthy Volunteers

Conditions
-----------------
Anesthesia of Tympanic Membrane

Intervention / Treatment
-----------------
* Device: Iontophoresis System with Headset


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 2 years old Exclusion Criteria: Pregnant or lactating females Subject with a history of sensitivity or reaction to lidocaine, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution Significant atrophic or perforated tympanic membrane Otitis externa Damaged or denuded skin in the auditory canal Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.) Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anesthetization<br> | Device: Iontophoresis System with Headset<br>* Iontophoresis of an anesthesia solution to the tympanic membrane using the Acclarent Iontophoresis System with Headset<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores on visual analog scale |  | Day 1 |
General Practitioners' Felt With Their Patients' Death (REGIDAQ)

Study Overview
=================
Brief Summary
-----------------
Very few studies are dealing with the way general practitioners feel the death of their patients. Main studies about that subject are qualitative. It needs quantitative studies to analyse how is felt general practitioners' patients' death. This is an epidemiologic quantitative cross-sectional study. The Studied population is the whole of the general practitioners of the region Nouvelle-Aquitaine. The primary endpoint is the percentage of the general practitioners which have hard time living with their patients' death. The secondary endpoints are to evaluate the general practitioners' help needing after their patients' death, to evaluate the personal and professional impact of the patient's death, the percentage of general practitioners using chemical aid after their patients' death and to determinate the existence of support facilities to help general practitioners to stand patients' death. The results of that study could help general practitioners to improve their medical practice in the patient's death situation.

Official Title
-----------------
General Practitioners' Felt With Their Patients' Death (REGIDAQ)

Conditions
-----------------
Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General practitioners from the Nouvelle-Aquitaine region. Exclusive or joint exercise of general medicine. None retired Exclusion Criteria: Retired patricians Students, Residents General practitioners from another region General practitioners with no general medicine activity
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 |
| --- | --- | --- |
| percentage of hard time living | percentage of general practitioners which have hard time living with their patients' death | 2 months (End of study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of help needing | percentage of general practitioners which need help after their patients' death | 2 months (End of study) | 
| percentage of personal impact | percentage of general practitioners which have a personal impact when their patient's death | 2 months (End of study) | 
| percentage of professional impact | percentage of general practitioners witch have a professional impact when the patient's death | 2 months (End of study) | 
| percentage of chemical aid using | percentage of general practitioners using chemical aid after their patients' death | 2 months (End of study) | 
| support facilities | Determinate the existence of support facilities to help general practitioners to stand patients' death | 2 months (End of study) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
General practice, death, bereavement
A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) with Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking Lamivudine.

Official Title
-----------------
A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: telbivudine or lamivudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Hepatitis B, documented by Clinical history compatible with chronic HBV Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding Patient is co infected with hepatitis C virus (HCV), hepatitis D virus (HDV), HIV-1 or HIV-2. Patient previously received lamivudine or an investigational anti-HBV nucleoside or nucleotide analog at any time Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study Other protocol defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 Years

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

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: telbivudine or lamivudine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy endpoint: therapeutic response, defined as reduction of serum HBV DNA to below 5 log10 copies/mL, coupled with normalization of serum alanine aminotransferase levels OR loss of detectable serum HBeAg. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy endpoints: Improvement of liver histology, serum HBV DNA changes, normalization of serum alanine aminotransferase levels, HBeAg and HBsAg loss and seroconversion. |  |  |
IMMunological resPonse Assessment afteR Acute iSchemic Stroke Treated With Endovascular Therapy (IMPRESS)

Study Overview
=================
Brief Summary
-----------------
IMPRESS study aims to describe the immuno-inflammatory and thrombo-inflammatory profiles during the first 24/36 hours of treatment of patients suffering from AIC treated with TM, and to study the possible impact of these profiles on the functional prognosis at 3 months of AIC treatment.

Official Title
-----------------
IMMunological resPonse Assessment afteR Acute iSchemic Stroke Treated With Endovascular Therapy

Conditions
-----------------
Ischemic Stroke, Thrombectomy

Intervention / Treatment
-----------------
* Other: Prospective patient


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presenting an acute ischemic stroke for which treatment by mechanical thrombectomy is indicated according to European and North American recommendations (associated or not with intravenous thrombolysis) Exclusion Criteria: Intracranial haemorrhage associated with acute ischemic stroke on initial imaging Contraindication or non-indication to a mechanic thrombectomy Immunosuppressive treatment or corticosteroid therapy on admission of the patient Pre-existing neurological disability limiting the neurological assessment to 3 months (mRS>2 on admission) Dementia known and diagnosed pre-existing at acute ischemic stroke Pregnant or breastfeeding woman

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Prospective patient|The immuno-inflammatory and thrombo-inflammatory profiles will be evaluated at inclusion, and at 24 hours +/- 12 hours of the reperfusion treatment.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immuno-inflammatory and thrombo-inflammatory profiles in patients suffering from AIC and treated with mechanical Thrombectomie. | Blood plasma collected from patients at inclusion, and at 24 hours +/- 12 hours of the reperfusion treatment will be used to discover and validate panels of inflammatory biomarkers that are predictive of therapeutic response. The biomarkers will be measured using a multiplex preconfigured panels for inflammatory biomarkers. | 21 months |
Postprandial VLDL-TG Metabolism

Study Overview
=================
Brief Summary
-----------------
In thise study, we aim to determine the effect of meal fat on VLDL-TG kinetics in type 2 diabetic and healthy subjects matched for BMI in order to elucidate the potential pathophysiological differences in VLDL-TG FA channeling towards oxidation and storage in abdominal and leg subcutaneous adipose tissue. Specifically, we want to measure, by way of fat and muscle biopsies, the quantitative postprandial storage of VLDL-TG FA's in skeletal muscle and adipose tissue in relation to a series of tissue specific proteins and enzymes that might be involved in regulating skeletal muscle and adipose tissue FA storage.

Official Title
-----------------
Postprandial VLDL-TG Metabolism

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written consent Exclusion Criteria: Known diseases Alcohol abuse Smoker Regular use of medicine

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 diabetic men<br> | |
| Age- and weight-matched controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VLDL-TG storage in adipose tissue |  | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18F-THA fractional storage |  | 6 Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VLDL-TG kinetics, Obesity, Postprandial state
Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of multiple doses of DVS SR and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.

Official Title
-----------------
A Randomized, Open-Label, Cross-Over Drug Interaction Study to Evaluate the Effects of Desvenlafaxine (DVS SR) and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: desvenlafaxine SR
* Drug: desipramine
* Drug: paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women between 18 to 55 years of age Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs, and 12-lead electrocardiogram (ECG) History of being a nonsmoker for at least 1 year Other inclusions apply. Exclusion Criteria: Presence or history of any disorder or significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, or neurologic condition, and any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure) or psychiatric disease Known or suspected alcohol abuse or consumption of more than 2 standard units per day within the past 6 months Use of any over-the-counter, prescription, hormonal therapy or investigational medications within 30 days of study day-1 until the end of the study Other exclusions apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: desvenlafaxine SR|nan|
|Drug: desipramine|nan|
|Drug: paroxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of the study is to evaluate the effects of multiple doses of DVS SR and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Subjects, Major Depressive Disorder, Depression
The Efficacy and Safety of Ramosetron in Patients Undergoing Off Pump Coronary Artery Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of ramosetron on corrected QT interval in patients undergoing off pump coronary artery bypass surgery.

Official Title
-----------------
The Efficacy and Safety of Ramosetron in Patients Undergoing Off Pump Coronary Artery Bypass Surgery

Conditions
-----------------
Coronary Artery Bypass Graft Triple Vessel, Hypotension

Intervention / Treatment
-----------------
* Drug: Ramosetron
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective off-pump coronary artery bypass graft surgery Exclusion Criteria: Emergency operation preoperative use of any inotropics or mechanical assist device severe liver disease (>Child class II) dialysis dependent renal failure Left ventricular ejection fraction <30 % Combined major surgery like carotid endarterectomy Previous allergy history to any 5-hydroxytryptamine type 3 (5-HT3) antagonist Preoperative QT prolongation ( 500 >msec) or arrhythmia

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ramosetron<br>Intravenous administration of ramosetron 0.3 mg before the induction of general anesthesia | Drug: Ramosetron<br>* 0.3 mg IV as bolus before induction of general anesthesia<br>* Other names: Nasea;|
| Placebo Comparator: Control<br>Intravenous administration of 2ml normal saline before the induction of general anesthesia | Drug: Normal saline<br>* 2 ml normal saline as bolus before induction of general anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corrected QT interval (QTc interval) | at 1,2,3,5,10,15,30,45,60,90,120,240 minutes after ramosetron injection, at the time of operation end, ICU 12hour | up to 240 minutes after induction of general anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypotension or bradycardia during the peri-induction period and the coronary anastomosis period |  | up to 240 minutes after induction of general anesthesia | 
| incidence of postoperative atrial fibrillation |  | during the hospital stay (from ICU admission to hospital discharge, average of 1 week) |