linjc16/ctgov huggingface dataset:
Induction of Drug Metabolism: In Vivo Comparison of Carbamazepine and Oxcarbazepine.

Study Overview
=================
Brief Summary
-----------------
This is a study of the possible effect of two antiepileptic drug on enzymes in the liver that metabolizes a number of drugs. It is a well know fact that carbamazepine induces some of these enzymes and this may reduce the effect of concomitantly administered drugs. Clinical observations suggest that oxcarbazepine does not induce these enzymes to the same degree. This study directly compares the ability of these two drugs to induce the cytochrome P450 3A4 enzyme, in healthy volunteers using a well defined biomarker reaction of a specific enzyme activity. It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine.

Official Title
-----------------
Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4.

Conditions
-----------------
Metabolic Clearance Rate

Intervention / Treatment
-----------------
* Drug: carbamazepine oxcarbazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI < 30 Non smoker No signs or symptoms of disease by routine laboratory analysis, ECG and physical examination (general appearance assessment; pulmonal and cardiac stetoscopy; abdominal palpation) Informed consent Exclusion Criteria: signs or symptoms of disease by routine laboratory analysis, ECG and physical examination mental disease participation in another clinical trial involving drugs with 3 months of randomization donation of more than 500 mL blood within 3 months of randomization intake of more than 21 alcohol equivanlents (one normal strength beer contain one alcohol equivalent)per week

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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: carbamazepine oxcarbazepine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Formation clearance of 3-hydroxyquinidine |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CYP3A4, Induction, Oxcarbazepine, Carbamazepine, Quinidine, Human, In vivo
Olympus - 19-gauge Needle

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test whether the 19-gauge needle can collect more tissue and get better sampling during a bronchoscopy procedure.

Official Title
-----------------
A Pilot Study Evaluating the Performance of 19-gauge Needles in Testing Molecular Markers in Samples Obtained Via Endobronchial Ultrasound Guided Needle Aspiration of Lymph Nodes in Patients With Lung Cancer

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with known or suspected lung cancer with mediastinal adenopathy as defined by a mediastinal lymph node >0.5 cm in short axis on EBUS or any lymph node with uptake on FDG-PET scan that is higher than background PET activity. Participants must lack bleeding disorders Exclusion Criteria: Subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary) Subjects on anticoagulation (other than Aspirin) whom cannot have their anticoagulation held for the procedure due to other clinical reasons (i.e. recent cardiac stent placement).

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Molecular marker test | Descriptive statistics will be used to calculate the success rate of the procedure in successful performance of molecular marker testing | Day of Procedure |
A Long-Term Safety Study of ALKS 5461

Study Overview
=================
Brief Summary
-----------------
This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.

Official Title
-----------------
A Phase 3 Multicenter Study of the Long-Term Safety and Tolerability of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults Who Have an Inadequate Response to Antidepressant Therapy (the FORWARD-2 Study)

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: ALKS 5461


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Agree to use an approved method of contraception for the duration of the study Have the potential to safely benefit from the administration of ALKS 5461 Have a diagnosis of major depressive disorder (MDD) Additional criteria may apply Exclusion Criteria: Have a positive test for drugs of abuse Currently pregnant or breastfeeding Have a current primary Axis-I disorder other than MDD Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days Have received electroconvulsive therapy treatment within the last 2 years, or received more than 1 course of electroconvulsive treatment during their lifetime Have attempted suicide within the past 2 years Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone) Have had a significant blood loss or blood donation within the past 60 days Additional criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: ALKS 5461<br> | Drug: ALKS 5461<br>* Sublingual tablet, taken daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Up to 56 weeks |
Explanted Lung Tissues With Pulmonary Fibrosis

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to use the tissues from the explanted lungs in order to better study the cause of pulmonary fibrosis at a cellular level.

Detailed Description
-----------------
Pulmonary Fibrosis involves scarring of the lung. Gradually, the air sacs of the lungs become replaced by fibrotic tissue. The most current thinking is that the fibrotic process is a reaction to tiny injury to the lung. When the scar forms, the tissue becomes thicker causing a permanent loss of the tissue's ability to carry oxygen into the bloodstream. We need to obtain lung tissue from patients without pulmonary fibrosis and compare it to lung tissue from patients with pulmonary fibrosis.

Official Title
-----------------
Utilization of Explanted Lungs for Isolation of Tissue Samples and Primary Cell Lines to Study Pulmonary Fibrosis

Conditions
-----------------
Pulmonary Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients awaiting lung transplant Exclusion Criteria: all who will not give consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| assess fibroblasts and cytokines associated with pulmonary fibrosis |  | 12/2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
explanted lungs, pulmonary fibrosis
Cytogenetic Analysis of Bone Marrow Specimen Prior to High Dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease

Study Overview
=================
Brief Summary
-----------------
Cytogenetic Analysis of Bone Marrow Specimen Prior to High Dose Chemotherapy and Autologous Stem Cell Transplantation in Patients with Non-Hodgkin's Lymphoma or Hodgkin's Disease

Conditions
-----------------
Lymphoma, Non-Hodgkin, Hodgkin Disease

Intervention / Treatment
-----------------
* Procedure: Cytogenetic Analysis of Bone Marrow Specimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Non-Hodgkin's Lymphoma or Hodgkin's Disease
Sexes Eligible for Study
-----------------
All

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

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

| Intervention/Treatment |
| --- |
|Procedure: Cytogenetic Analysis of Bone Marrow Specimen|Cytogenetic Analysis of BM Specimen|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cytogenetic Analysis of Bone Marrow Specimen in Non-Hodgkin's Lymphoma or Hodgkin's Disease
Study of Improving Insulin Sensitivity by Electroacupuncture Therapy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to find out whether the hypoglycemic and improving insulin resistance effect will appear or not, when EA applying on specific acupoints of NIDDM patients.

Detailed Description
-----------------
Some previous animal model studies reveal that electroacupuncture (EA) applying on specific acupoints, such as Zhongwan and Zusanli acupoint, can reduce plasma glucose levels and encourage insulin secretion, even improve insulin resistance. In this study, we want to observe these results on type II diabetic patients who have been diagnosed in five years under a study design of randomized control trial (RCT) to obtain evidence on clinical. We undertook a randomized, single blind and sham group controlled study to evaluate the effect of EA with a frequency in 15 Hz and fixed intensity (10 mA) on human Zusanli acupoint. A total of 26 newly diagnostic type II diabetic patients are enrolled in this study. They are randomly divided into 2 groups. There are 13 patients in the experimental group (EG) with EA treatment, and the other 13 patients are divided into control group (CG) with sham treatment. The main outcome is the changes of laboratory parameters between before and 30 minutes after the test.

Official Title
-----------------
Study of Improving Insulin Sensitivity by Combined Both Electroacupuncture and Drug Therapy

Conditions
-----------------
Diabetes Mellitus, Type 2, Insulin Resistance

Intervention / Treatment
-----------------
* Device: electroacupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed NIDDM patient within 5 years age between 30 to 65 years old controlled BP below 140/90 mmHg oral hypoglycemic agent (OHA) therapy with Gliclazide twice per day. Exclusion Criteria: disorders of hemostasis patient had received insulin therapy severe disease such as CVA, CAD within 6 months Arrhythmia history and on pacemaker.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: electroacupuncture|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemic activity, plasma insulin level, HOMA index |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride, cholesterol, free fatty acid |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
electroacupuncture, plasma glucose, plasma insulin
The Role of Nebulized Budesonide in the Treatment of Acute Exacerbations of COPD

Study Overview
=================
Brief Summary
-----------------
This study was designed to evaluate the hypothesis that nebulized budesonide) might be an alternative to systemic corticosteroids (SC) in the treatment of patients with acute exacerbations of COPD (AECOPD).

Detailed Description
-----------------
Patients, hospitalized with AECOPD, were randomized into three groups. Group I received only bronchodilator treatment (BDT), Group II received SC (40 mg prednisolon) plus BDT, and Group III received nebulized budesonide (NB)(1500 mcg qid) plus BDT. Improvement rates in multiple parameters during 10-day hospitalization, and acute exacerbation and re-hospitalization rates within one-month after discharge were compared between the groups.

Conditions
-----------------
COPD Acute Exacerbation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients who were admitted to our pulmonary department for an acute exacerbation were prospectively enrolled in the study Exclusion Criteria: COPD patients hospitalized with specific reasons like pneumonia, pulmonary emboli, congestive heart failure, pneumothorax etc. as the cause of acute exacerbation, or patients with risk of imminent respiratory failure requiring mechanical ventilation or direct admission to the ICU were excluded.

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?
-----------------
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
-----------------
COPD, nebulized budesonide, systemic corticosteroids
A Comparison of Factors of Symptoms Generation and Evaluation of Role of Biofeedback in Patients With Different Types of Functional Esophageal Disorders (Functional Heartburn and Functional Chest Pain)

Study Overview
=================
Brief Summary
-----------------
There is supposed that patients with functional esophageal disorders such as functional heartburns and functional chest pain have common underlying mechanisms of symptom generation. These include esophageal dysmotility, non-acidic gastro-esophageal reflux, duodeno-gastro-esophageal reflux, esophageal hypersensitivity, and psychological comorbidity. The treatment of these patients is the growing challenge in the primary care medicine and in the gastroenterological practice. It was postulated that functional disorders of the esophagus are the main reason for PPI failure in patients with heartburn. The aim of the study is to evaluate the role of biofeedback in the treatment of patients with functional chest pain and functional heartburns.

Conditions
-----------------
Chest Pain, Heartburn

Intervention / Treatment
-----------------
* Behavioral: Biofeedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women ages 18-75. Willing to participate and sign an inform consent. Having heartburns, acid regurgitations and/or chest pain at least twice a week for at least 3 months. Ability to stop anti-acid and anti-pain medications for at least two weeks. Exclusion Criteria: History of upper gastrointestinal surgery. Concomitant diseases that may affect esophageal perception (diabetes mellitus, neuropathy). Concomitant medications that may affect esophageal perception (anti-inflammatory, anti-depressants drugs). Pregnancy. Severe conditions such as cardiac failure, renal failure and other that may be contraindication for upper endoscopy. Erosive esophagitis on upper endoscopy or pathological result of ambulatory 24-hour pH monitoring.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Biofeedback|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
-----------------
Patients with functional chest pain and functional heartburns
Is Regional Anesthesia of the Hip Preferable Over Traditional Analgesia in the Acute Stage of the Management of Patients With a Fracture of the Hip

Study Overview
=================
Brief Summary
-----------------
The main hypothesis of the study is that anaesthesia of the hip using infiltration with a local anesthetic solution is preferable over traditional analgesia with oral opioid medications in the acute stage of the management of patients with a fracture of the hip. To study the hypothesis the investigators designed a prospective randomised study where patients are assigned in two groups, the first receiving local hip anesthesia and the other placebo treatment. Both groups are eligible to use of standard oral pain treatment. Effect of analgesia as well as medical complications will be recorded.

Conditions
-----------------
Hip Fractures

Intervention / Treatment
-----------------
* Drug: Ropivacaine
* Drug: Natrium chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fracture of the hip Exclusion Criteria: multiple fractures, delay (more than 12 hours) from the time of injury until admission to the hospital, local infections, hypersensitivity to local analgetics, cognitive impairment

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ropivacaine<br> | Drug: Ropivacaine<br>* Local injection (fascia iliaca block) using 150 mg ropivacaine<br>* Other names: Narop;|
| Placebo Comparator: Natrium chloride<br> | Drug: Natrium chloride<br>* Placebo injection of Natrium chloride solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| medical complications (Number of participants that develop pressure ulcers, number of participants that develop pneumonia) |  | under hospitalization (expected average of 10 days) |
Clinical, Molecular and Physiopathological Study of Cohen Syndrome and Cohen-like Syndromes

Study Overview
=================
Brief Summary
-----------------
This project will make it possible to better understand the natural history of Cohen Syndrom and the phenotypes associated with mutations in the VPS13B gene, to improve the therapeutic management of patients. It will also provide a better description of Cohen-like syndrome for genetic counselling for the families concerned.

Conditions
-----------------
Cohen Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting Cohen syndrome and two VPS13B mutations who accept a clinical evaluation, and to provide at least one blood sample Patients presenting the diagnostic criteria of Cohen syndrome, but without a VPS13B mutation Patients presenting neutropenia or pigmentary retinopathy and at least one of the following signs, after exclusion of any other syndrome: mental retardation, microcephaly, truncal obesity Exclusion Criteria: - Patients who do not meet the clinical and/or molecular criteria Patients who do not wish to provide a blood sample for question 1, Patients who have not provided written informed consent, Pregnant or breast-feeding women, Persons not covered by National Health Insurance and persons under guardianship or in prison.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| - Patients presenting Cohen syndrome and two VPS13B mutations<br> | |
| Patients presenting Cohen syndrome without a VPS13B mutation<br> | |
| Patients presenting neutropenia<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spectrum of mutations VPS13B |  | baseline |