linjc16/ctgov huggingface dataset:
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III) - 3

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the clinical efficacy of the buprenorphine/naloxone combination tablet to methadone for opioid maintenance treatment.

Detailed Description
-----------------
S/A brief Summary for the Public

Official Title
-----------------
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III

Conditions
-----------------
Heroin Dependence, Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Opioid-Related Disorders


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals must be at least 18 years of age, currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency. Exclusion Criteria: Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Opioid-Related Disorders|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Retention |  |  | 
| Opioid agonist rating |  |  | 
| Opioid antagonist rating |  |  | 
| Compliance |  |  | 
| Medication identification |  |  | 
| Addiction Severity Index (ASI) Composite Score Rating |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drug dependence
Effects of Clopidogrel and Clarithromycin on the Oral Disposition of Sibutramine in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy subjects

Detailed Description
-----------------
1. Plasma concentrations of sibutramine and its two active metabolites after single oral dose of sibutramine were determined in Korean healthy male subjects with different CYP2B6 genotypes (CYP2B6*1/*1, *1/*6 and *6/*6), either alone or after four-day pretreatment with clopidogrel or clarithromycin.

Official Title
-----------------
Effects of Clopidogrel and Clarithromycin on the Disposition of Sibutramine and Its Active Metabolites M1 and M2 in Relation to CYP2B6*6 Polymorphism

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Sibutramine-clopidogrel
* Drug: sibutramine-Clarithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must be healthy volunteer Exclusion Criteria: must not be under 18 years old

Ages Eligible for Study
-----------------
Minimum Age: 19 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sibutramine-clopidogrel<br>sibutramine-clopidogrel | Drug: Sibutramine-clopidogrel<br>* Sibutramine-clopidogrel<br>|
| Active Comparator: sibutramine-clarithromycin<br>sibutramine-clarithromycin | Drug: sibutramine-Clarithromycin<br>* sibutramine-Clarithromycin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effects of clopidogrel and clarithromycin on the disposition of sibutramine | the effects of clopidogrel and clarithromycin on the disposition of sibutramine and its two active metabolites M1 and M2 in vivo in relation to CYP2B6*6 genetic polymorphism have been evaluated in Korean healthy subjects. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clarithromycin, sibutramine, clopidogrel
Pilot Study Evaluating the Toray Satake Balloon Thermal Ablation System for Treatment of Paroxysmal Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect preliminary safety and effectiveness data evaluating the Toray Satake Balloon Thermal Ablation System (TSB)to treat subjects with symptomatic paroxysmal atrial fibrillation that is resistant to antiarrhythmic drug therapy.

Official Title
-----------------
A Pilot Study Evaluating the Safety and Effectiveness of the Toray Satake Balloon Thermal Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

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

Intervention / Treatment
-----------------
* Device: Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of recurrent symptomatic paroxysmal atrial fibrillation ≥2 Symptomatic atrial fibrillation episodes At least 1 paroxysmal atrial fibrillation episode documented by an ECG or device recording system in the 6 months prior to enrollment AND At least 1 additional (for a total of ≥2) paroxysmal atrial fibrillation episode documented by an ECG or device recording system, OR, at a minimum, a physician's note indicating recurrent symptomatic atrial fibrillation No episode >7 days Failed to respond to or is intolerant of ≥1 Class I, II, III or IV antiarrhythmic drug Able and willing to provide informed consent and Health Insurance Privacy and Portability Act (HIPAA) authorization Able and willing to meet all study requirements, including attending all post-ablation procedure assessments and visits Exclusion Criteria: Left atrium ≥50 mm Chronically used amiodarone in the 3 months prior to enrollment Previous left atrial ablation or surgical treatment for atrial fibrillation Left ventricular ejection fraction (LVEF) <35 % New York Heart Association (NYHA) Class III or IV heart failure History of myocardial infarction (MI) or unstable angina in the 6 months prior to enrollment Multiple other exclusion criteria to establish overall good health and likely study compliance

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ablation<br> | Device: Ablation<br> <br> * Other names: Toray Satake Balloon Thermal Ablation System;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of major complications |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paroxysmal Atrial Fibrillation, Catheter Ablation, Ablation Techniques
Desensitization of Renal Transplant Candidates

Study Overview
=================
Brief Summary
-----------------
Trial of the use of Myfortic to reduce anti-HLA alloantibody in patients waiting for renal transplantation.

Detailed Description
-----------------
Pre-formed HLA antibodies prevent renal transplantation because of the risk of hyperacute rejection. We propose a prospective study evaluating the efficacy of Enteric Coated Mycophenolate Sodium (Myfortic) in decreasing the titers of anti-HLA alloantibodies in patients awaiting kidney transplantation. Myfortic is an immunosuppressant that inhibits the proliferation of B and T cells by blocking the enzyme inosine monophosphate dehydrogenase. We will attempt to determine whether a 6-week course of Myfortic adequately decreases the antibody reactivity to a level compatible with transplantation.

Official Title
-----------------
Desensitization of Renal Transplant Candidates

Conditions
-----------------
End Stage Renal Disease, Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Myfortic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients on the deceased donor kidney transplant waiting list with panel reactive antibodies >50% and living donor waiting list patients who have a history of a positive crossmatch (donor-specific antibodies) will be eligible for the study. Exclusion Criteria: Any subjects not meeting the Inclusion Criteria Subjects unable to attend weekly clinic visits for six weeks Inability to tolerate Myfortic

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>This is a single arm, interventional trial. | Drug: Myfortic<br>* Myfortic 360mg PO BID for six weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in antibody reactivity |  | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CBC and CMP values </> 2 times normal |  | six weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal, Transplant, PRA
Women's Health Habits Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomized trial is to test the effectiveness of screening and brief intervention for risk drinking by nonpregnant women with specific medical problems exacerbated by excessive alcohol consumption. The medical problems are female factor infertility, hypertension, diabetes, and osteoporosis, conditions that are costly to treat and difficult to manage. Just as pregnant women are thought to be highly motivated to modify their alcohol consumption, so women with specific medical problems worsened by alcohol intake are an appropriate group to receive a brief intervention.

Official Title
-----------------
Screening and Brief Intervention for Problem Drinking Women

Conditions
-----------------
Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility

Intervention / Treatment
-----------------
* Behavioral: Brief Intervention
* Behavioral: Diagnostic assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - 1. has diabetes, hypertension, osteoporosis, or infertility 2. Not currently receiving treatment for alcohol or drug problems or substance related medical illness 3. Not currently experiencing physical dependence on alcohol, requiring medically supervised detoxification 4. Not currently abusing or physically dependent on opiates, cocaine, or other illicit drugs 5. Not currently pregnant. Subjects with infertility may become pregnant during the course of the study. 6. Not currently nursing. 7. Able to complete study measures. Exclusion Criteria: Alcohol screen negative or drinks within NIAAA sensible drinking limits for women Does not agree to randomization and study terms

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Diagnostic assessment with brief intervention and 3, 6, and 12 month follow-up | Behavioral: Brief Intervention<br>* Diagnostic assessment followed by a single session Brief Intervention with 3, 6, and 12 month follow-up<br>|
| Active Comparator: 2<br>Diagnostic assessment with 12 month follow-up | Behavioral: Diagnostic assessment<br>* Single session diagnostic assessment with 12 month followup<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drinking outcome |  | 12 months post enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Risk drinking, Women, Medical problems
Determination of Optimal Mask Ventilation Mode in Pediatrics Using Real-time Ultrasonography

Study Overview
=================
Brief Summary
-----------------
The peak inspiratory pressure during face mask ventilation for general anesthesia is closely correlated with gastric insufflation. High pressure increases the amount of air in stomach and low pressure could decrease the tidal volume, therefore ideal pressure means the pressure guarantee adequate ventilation with minimal gastric insufflation. The aim of this study is finding the proper pressure and mode of face mask ventilation in pediatric patients.

Official Title
-----------------
Determination of Optimal Mask Ventilation Mode in Pediatrics Using Real-time Ultrasonography

Conditions
-----------------
Ultrasound, Ventilator Lung

Intervention / Treatment
-----------------
* Other: Peep 5cmH2O
* Other: Peak inspiratory pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The ASA class I,II and 1-5 years pediatric patients need general anesthesia Exclusion Criteria: Oropharyngeal or facial pathology accompanied Obese (BMI > 30 kg/m2) GI tract obstruction

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 5 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: P12<br> | Other: Peak inspiratory pressure<br>* Face mask ventilation with peak inspiratory pressure according to the group P12 means face mask ventilation with peak inspiratory pressure 12cmH2O without PEEP.<br>|
| Active Comparator: P7+5<br> | Other: Peep 5cmH2O<br>* Face mask ventilation with peak inspiratory pressure according to the group P7+5 means face mask ventilation with peak inspiratory pressure 7cmH2O plus PEEP 5 cmH2O.<br>* Other names: Peak inspiratory pressure;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of atelectasis | After intubation, confirming endotracheal intubation, the ventilator is connected and turned on. | 1min after ventilator-on | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of gastric insufflation |  | During face mask ventilation |
Abciximab i.v. Versus i.c. in Primary PCI Patients With STEMI

Study Overview
=================
Brief Summary
-----------------
Randomized comparison of abciximab i.v. versus i.c. in patients with STEMI undergoing primary PCI. The hypothesis is, that higher concentration of abciximab i.c. leads to improved epicardial flow, perfusion, reduction of no-reflow, reduction in infarct size and subsequently better outcome.

Official Title
-----------------
Randomized Comparison of Abciximab i.v. Versus i.c. in Primary PCI Patients With STEMI and Effects on Infarct Size and Microvascular Obstruction

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Abciximab i.v.
* Drug: Abciximab i.c.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical symptoms: Angina < 12 h persistent Angina > 30 min. ECG-Criteria: ST-elevation > 1mm in ≥ 2 extremity leads ST-elevation > 2mm in ≥ 2 contiguous anterior leads Informed consent Exclusion Criteria: No consent Pregnancy Allergy against abciximab, ASA or heparin Active peptic ulcus ventriculi or duodeni Active non-superficial bleeding Major surgical intervention, intracerebral interventions, puncture central artery < 4 weeks Active internal bleeding Cerebrovascular complications < 2 years Known coagulation disorders, thrombocytopenia Arteriovenous malformations or aneurysms Severe Liver or renal dysfunction Severe untreated hypertension Active vasculitis Previous thrombolysis < 12 h

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Abciximab i.v.|nan|
|Drug: Abciximab i.c.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size and microvascular obstruction assessed by MRI |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ST-segment resolution, TIMI-Flow, TIMI blush grade, ejection fraction, left ventricular volumes, clinical outcome (MACE) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
STEMI, infarct size, primary PCI, no-reflow, ST-elevation myocardial infarction
Intestinal Microflora in Lung Cancer After Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Probiotics modulate the gut microflora and immune status in lung cancer who need chemotherapy.

Detailed Description
-----------------
Chemotherapy destroys the intestinal mucosal barrier, affects intestinal flora, causing bacterial translocation, infection and other complications. Probiotics may restore the intestinal immunity, mucosal barrier and nutrient absorption.

Official Title
-----------------
Intestinal Microflora in Lung Cancer After Chemotherapy

Conditions
-----------------
Lung Cancer, Effects of Chemotherapy, Tumor Immunity, Malnutrition

Intervention / Treatment
-----------------
* Drug: Probiotics
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for chemotherapy of lung cancer Exclusion Criteria: Antibiotic, probiotic or prebiotic usage within 1month Other malignancy History of abdominal surgery Pregnant or breast-feeding (for females) Impaired liver or renal function Diabetes, thyroid disorder, coagulopathy or bleeding disorders, mental disorder

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Microbial composition using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks | Drug: Probiotics<br>* Microbial composition using probiotic<br>* Other names: containing clostridium butyricum;|
| Placebo Comparator: Placebo<br>Microbiota modulation using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks | Drug: placebo<br>* Microbiota modulation using placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composition of Microorganisms in stool after probiotic intervention | Primary coordination of fecal samples' 16s(%) rDNA will be compared between two groups using Braycurtis distance based Primary coordination analysis(PCoA) | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and severity of Adverse effects during Chemotherapy |  | 2 months | 
| The change of immunity and nutrition index |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gut microflora, Lung cancer, Chemotherapy, Immunity, Nutrition
REgistry of MisOprostol 200 µg Vaginal dElivery System

Study Overview
=================
Brief Summary
-----------------
The design of the study is post-marketing, observational, multi-centre and open-label. The study does not provide treatment; only patients to whom misoprostol 200 µg vaginal delivery system (VDS) is prescribed may be included. All directions for medication usage and patient monitoring are solely at the discretion of the investigator in accordance with their usual practice and must be consistent with the Dutch prescribing information of misoprostol 200 µg VDS. No other (invasive) study-related interventions or measurements are done, other than the procedures routinely performed during induction of labour. No effort is expected from the study subjects. 150 patients from 20 Dutch centres will be included.

Conditions
-----------------
Induction of Labour

Intervention / Treatment
-----------------
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of induction of labour in women with an unfavourable cervix, from 36 weeks gestation, in whom induction is clinically indicated Decision made to prescribe misoprostol 200 µg VDS according to Summary of Product Characteristics (SmPC) Willingness and ability to provide written informed consent Exclusion Criteria: Misoprostol 200 µg VDS is contraindicated according to the SmPC
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Misoprostol 200 µg VDS<br>At the discretion of the investigator in accordance with their usual practice and consistent with the Dutch prescribing information. | Drug: Misoprostol<br> <br> * Other names: Misodel®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to vaginal delivery of the neonate in hours |  | From insertion until vaginal delivery |