linjc16/ctgov huggingface dataset:
Effect of Rifampin on Bosutinib When Both Are Given to Healthy People

Study Overview
=================
Brief Summary
-----------------
Study to examine whether rifampin has an effect on the pharmacokinetics of bosutinib.

Official Title
-----------------
A Study to Examine the Potential Effect of Rifampin on the Pharmacokinetics of Bosutinib When Administered Concomitantly to Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Bosutinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men age 18-50 Healthy women of nonchildbearing potential, age 18-50

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Bosutinib | Drug: Bosutinib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (plasma concentrations) |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy subjects
Intestinal Microbiome and Chronic Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
The aim is to examine the role of intestinal microbiota in the pathogenesis of chronic inflammatory bowel diseases (IBD)

Detailed Description
-----------------
IBD patients to whom colonoscopy is performed will be recruited. Mucosal specimens from large intestine and terminal ileum will be collected as well as stool specimens. The microbiota will be analyzed at the microbiology laboratory and the results will be correlated with endoscopical, laboratory and histopathological findings.

Official Title
-----------------
The Role of Intestinal Microbiome ih the Pathogenesis and Course of Chronic Inflammatory Bowel Diseases

Conditions
-----------------
Colitis

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IBD Exclusion Criteria: patient refusal to participate

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

| Intervention/Treatment |
| --- |
|Other: Observational|Blood, stool ja biopsy specimens|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of microbiome in chronic inflammatory bowel disease |  | 5 yrs |
Japan Morning Surge-1 Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether strict blood pressure (BP) control by doxazosin using home BP monitoring, especially targeting the morning BP level, can reduce hypertensive target organ damage.

Detailed Description
-----------------
Morning blood pressure may play an important role in the pathogenesis of hypertensive target organ damage. Increased sympathetic nerve activity is reported to be one of the mechanisms of morning hypertension; however, there are no available data that show whether strict home blood pressure control, especially in the morning period, can reduce target organ damage.We will evaluate whether strict morning blood pressure control by sympathetic nervous system blockade using an alfa-blocker, doxazosin, and with the addition of a beta-blocker if needed, can reduce hypertensive target organ damage.

Official Title
-----------------
The Effects of Controlling Morning Hypertension on Target Organ Damage With Adrenergic Blockers, Based on Self-Measured Morning Blood Pressure Readings

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Doxazosin (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morning systolic blood pressure >135 mmHg in a sitting position at home while on stable antihypertensive medication for at least 3 months Exclusion Criteria: History of heart failure Presence of orthostatic hypotension, dementia, malignancy and chronic inflammatory disease Taking an alfa-blocker or beta-blocker Atrial fibrillation or atrial flutter

Ages Eligible for Study
-----------------
Minimum Age: 0 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

| Intervention/Treatment |
| --- |
|Drug: Doxazosin (drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain natriuretic peptide and the urinary albumin excretion/creatinine ratio at 6 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Morning hypertension
The Health Burden of Primary Biliary Cirrhosis (PBC) in Switzerland

Study Overview
=================
Brief Summary
-----------------
PBC is a rare, autoimmune, cholestatic liver disease with genetic and environmental pathogenetic factors. Data about epidemiology of PBC in Switzerland are completely lacking. Epidemiology can be a powerful tool in yielding important clues as to burden and etiology of diseases. In addition, the investigators study will be the first one carried out in the country on PBC, and therefore will raise disease awareness and create a network.

Official Title
-----------------
The Health Burden of Primary Biliary Cirrhosis (PBC) in Switzerland

Conditions
-----------------
Primary Biliary Cirrhosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PBC patients living in Switzerland Exclusion Criteria: -

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 |
| --- | --- | --- |
| Prevalence of PBC in Switzerland |  | from 1.1.2005 until 31.12.2015 |
RYGB AL 150cm BPL 100cm vs RYGB AL 100cc BPL 150cm

Study Overview
=================
Brief Summary
-----------------
A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized according the limb lengths: Group 1: Alimentary limb (AL) 150cm and biliopancreatic limb (BPL) 100cm Group 2: AL 100cm and BPL 150cm Weight loss will be evaluated 1 year after surgery

Detailed Description
-----------------
A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized according the limb lengths: Group 1: Alimentary limb 150cm and biliopancreatic limb 100cm Group 2: Alimentary limb 100cm and biliopancreatic limb 150cm Weight loss will be evaluated 1 year after surgery

Official Title
-----------------
Ponderal Outcomes After Roux-en-Y Gastric Bypass With Alimentary Limb (AL) of 150cm and Biliopancreatic Limb (BPL) of 100cm vs AL 100cm and BPL 150cm

Conditions
-----------------
Weight Loss

Intervention / Treatment
-----------------
* Procedure: AL 150 BPL100
* Procedure: AL 100 BPL 150


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 40 Kg/m2 BMI > 35 Kg/m2, associated with obesity-related comorbidities Patients undergoing Roux-en-Y gastric bypass as bariatric procedure Exclusion Criteria: Patients undergoing Roux-en-Y gastric bypass as revisional procedure Patients lost to follow-up

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AL150 BPL100<br>Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb | Procedure: AL 150 BPL100<br>* Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb<br>|
| Experimental: AL100 BPL150<br>Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb | Procedure: AL 100 BPL 150<br>* Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Weight loss will be assessed 1 year after surgery | 1 year after surgery |
Effect of Dexmedetomidine and Propofol on Regional Cerebral Tissue Oxygen Saturation

Study Overview
=================
Brief Summary
-----------------
50 patients divided into 2 groups .Group I Dexmedetomidine infusion. Group II with Propofol infusion

Detailed Description
-----------------
: 50 patients anticipated for open heart surgeries were encompassed in the study. Patients were divided into 2 groups, group P (receiving propofol) and group D (receiving dexmedetomidine) during CPB. Both groups were studied for variations in right and left rScO2 as well as postoperative cognitive dysfunction using the Mini Mental State Examination Score (MMSE) test.

Official Title
-----------------
The Effect of Continuous Propofol Versus Dexmedetomidine Infusion on Regional Cerebral Tissue Oxygen Saturation During Cardiopulmonary Bypass

Conditions
-----------------
Regional Cerebral Tissue Oxygen Saturation

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine Hydrochloride 0.1 MG/ML
* Drug: Propofol 10 MG/ML


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing valve surgeries Patients undergoing on pump coronary artery bypass grafting surgeries Exclusion Criteria: emergency cases, patients with cervical spine pathology (cervical stenosis, cervical disc herniation, carotid stenosis), patients with cerebral pathology (cerebral strokes, ischemic attacks), patients with Mini Mental State Examination Score (MMSE) of 23 or less, complicated cases with prolongation of the cardiopulmonary bypass period, patients needing moderate hypothermia

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>Infusion of dexmedetomidine | Drug: Dexmedetomidine Hydrochloride 0.1 MG/ML<br>* Dexmedetomidine Hydrochloride 0.1 MG/ML infusion at 0.2-0.7 mcg/kg/min<br>|
| Active Comparator: Propofol<br>Propofol infusion | Drug: Propofol 10 MG/ML<br>* Propofol 10 MG/ML infusion at 0.3 -4 mg/kg/h<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive function assessment | Mini Mental State Examination Score (MMSE) test to assess orientation to time and place with ability to speak, think and draw. with highest ability 32 and lowest o | 24 hours postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral oxygen saturation, cardiopulmonary bypass, dexmedetomidine, propofol
Phase III Trial of Vinflunine Plus Best Supportive Care vs. Best Supportive Care in Patients With Transitional Cell Carcinoma (TCC) of the Urothelial Tract

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to learn if patients who receive vinflunine plus best supportive care live longer than patients who receive best supportive care alone. This study will also investigate patient benefit, safety and whether or not vinflunine shrinks or slows the growth of the cancer.

Official Title
-----------------
Prospective, Randomized Phase III Trial of I.V. Vinflunine Plus Best Supportive Care as Second Line Therapy Versus Best Supportive Care After a Platinum-containing Regimen, in Patients With Advanced Transitional Cell Carcinoma of Urothelial Tract

Conditions
-----------------
Transitional Cell Carcinoma of the Urothelial Tract, Bladder Cancer, Bladder Neoplasms

Intervention / Treatment
-----------------
* Drug: vinflunine and best supportive care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bladder cancer Progressed after 1st line platinum-chemotherapy >= 18 years old Adequate hematologic, hepatic & renal function Exclusion Criteria: CNS disease Moderate neuropathy More than 1 previous chemotherapy

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: vinflunine and best supportive care<br>* solution for injection, IV, 280/320 mg/m2, every 3 wks variable duration<br>|
| No Intervention: 2<br>best supportive care for 18 week duration | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of Overall Survival after Randomization |  | 30-March-07 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient benefit |  | 30-Mar-07 | 
| safety |  | 30-Mar-2007 | 
| response rate |  | throughout the study | 
| time to response |  | upon occurrence | 
| response duration |  | throughout the study | 
| progression free survival |  | throughout the study |
Magnesium and Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
Objective : to test the BP lowering-effect of oral magnesium supplementation, as magnesium chloride (MgCl2) solution, 2.5 g daily, in uncomplicated hypertensive type 2 diabetic subjects with decreased serum magnesium levels Design : Randomised double blind placebo controlled trial. Setting : Outpatients with type 2 diabetes from Durango, city in northern Mexico Subjects : 82 subjects between 40 and 75 years of age with type 2 diabetes serum magnesium deficiency and uncomplicated hypertension. Interventions : During 4 months the intervention group received 2.5 gr of magnesium chloride (50 ml of a solution containing 50 gr of MgCl2 by 1000 ml of solution ). Controls received inert placebo. Main outcome measure: Change in blood pressure. Increase of serum magnesium Secondary outcomes measures: Changes in lipid profile

Official Title
-----------------
Hypomagnesemia as a Risk Factor for Development of Metabolic Syndrome

Conditions
-----------------
Diabetes Mellitus, High Blood Pressure, Hypomagnesemia

Intervention / Treatment
-----------------
* Dietary Supplement: Magnesium chloride
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Decreased serum magnesium levels Uncomplicated hypertension 40 and 75 years of age Men and Women Exclusion Criteria: Chronic diarrhea Alcohol intake (equal or more than 30 g per day) Use of diuretics and/or calcium antagonists drugs Previous oral magnesium supplementation Ischemic diseases; AND Reduced renal function

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Magnesium chloride | Dietary Supplement: Magnesium chloride<br>* Subjects in the intervention group received 2.5 gr of MgCl2 daily during 4 months, from a solution solution containing 50 gr of MgCl2 by 1000 ml.<br>|
| Placebo Comparator: 2<br>Placebo | Other: Placebo<br>* Subjects in the control group received inert placebo once per day during 4 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the systolic and diastolic blood pressures |  | 2 y | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average increase of serum magnesium levels Changes in lipid profile |  | 2 y | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Hypertension, Hypomagnesemia
Health-economic Evaulation of Interventional Pain Mangement

Study Overview
=================
Brief Summary
-----------------
To establish the cost per QALY (Quality Adjusted life Years) gained all patients that are referred to a specialized interventional pain clinic are assessed by Euroqol EQ-5D to measure the health-related quality of life at the first visit and then during the following year. Quality of life is calculated from EQ-5D by using hte TTO-validated UK-value set. With this and calculations of the cost we will be able to calculate the cost per QALY-gained which makes it possible to compare interventional pain managment to other treatments for pain patients.

Official Title
-----------------
Health-economic Evaluation of Interventional Pain Management Among Patients With Chronic Pain

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Other: Radio-frequency dennervation of facet joint
* Other: Diagnostic nerve-blocks performed under direct x-ray vision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 99 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 |
| --- | --- |
| Chronic pain associated to facet-joints<br>Patients where the pain can be localized to the facet joints. | Other: Radio-frequency dennervation of facet joint<br> <br> |
| Chronic pain of other origin<br>Patients with pain that can not be localized to facet joints. | Other: Diagnostic nerve-blocks performed under direct x-ray vision<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality Adjusted Life gained | QALY is calculated from the EQ-5D value using the TTO-validated UK value set accoring to ordinary health-economic evaluations. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost per QALY gained | The cost per QALY gained is calculated according to normal health-economic evaluation models. | 1 year |
Cardiovascular Autonomic Control Evaluation Through Cardiac Frequency Variability in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
Analyzing cardiovascular evaluation measures in the multidisciplinary and in the conventional treatment of hypertensive patients will provide better parameters for comparing the two approaches.

Official Title
-----------------
Cardiovascular Autonomic Control Evaluation Through Cardiac Frequency Variability in Hypertensive Patients Subjected to Distinct Interventions: Clinical Trial

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Other: Multidisciplinary assistance
* Other: Conventional treatment and follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 18 years of age Diagnosis of primary hypertension Exclusion Criteria: Neurological condition Cardiac condition Renal condition Congenital conditions Previous myocardial revascularization surgery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Group<br>Conventional treatment and follow up | Other: Conventional treatment and follow up<br>* Assistance was effected by physician and nurse and consisted about adapting to the drug<br>|
| Experimental: Multidisciplinary Group<br>Multidisciplinary assistance | Other: Multidisciplinary assistance<br>* Multidisciplinary group assistance was effected every two months by all professionals (physician, nurse, dietitian, physiotherapist and psychologist) and consisted in orientations and mechanisms to medication and non-pharmacological adherence (lifestyle changes).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Cardiac Frequency Variability at 1 year |  | Measured at the first appointment and 1 year later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Systolic and Diastolic Blood pressure |  | Measured at the first appointment and 1 year later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Frequency Variability, multidisciplinary care, clinical trial