linjc16/ctgov huggingface dataset:
A Study To Assess GW677954 Used In Combination With Insulin In Subjects Who Have Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Many drugs used for the treatment of Type 2 Diabetes Mellitus cause the body to retain water. This study will assess whether or not GW677954 causes the body to retain fluid.

Official Title
-----------------
A Randomized, Double-blind, Parallel, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of Oral GW677954 Capsules (15 mg) in Combination With Insulin in Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Insulin
* Drug: Oral GW677954 Capsules (15 mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Have been diagnosed by a doctor with Type 2 Diabetes Mellitus at least 3 months before Screening Have a body mass index within range 25 to 40.0kg/m2 inclusive Females who meet above criteria must be physiologically incapable of becoming pregnant (ie., surgically sterilized, or post-menopausal per protocol definition) Exclusion criteria: Significant weight loss or gain in the 3 months before screening Have used insulin to treat hyperglycemia within 3 months before screening Have a history of fluid retention Have uncontrolled high blood pressure Have liver disease Take loop diuretics (water pills), certain blood thinners, and/or St. Johns Wort. - Have or have had certain kinds of cancer

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insulin|nan|
|Drug: Oral GW677954 Capsules (15 mg)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in fluid related parameters as measured by hematocrit and hemoglobin levels and body weight |  | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety/tolerability, as measured by adverse events, clinical laboratory, edema & glycemic measures, ophthalmic assessments; & changes in weight, waist & hip circumference |  | up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin, NaBr, Sodium Bromide, DEXA Deuterium, Total Body Water, D2O, GW677954, Randomized Withdrawal, T2DM
Diagnostic and Evaluation of Hepato-pancreatico-biliary Disease With MRI

Study Overview
=================
Brief Summary
-----------------
This is a retrospective review of images from patient data. There is no recruitment necessary for this study. Research Question: Can advanced multiparametric MRI techniques improve the detection and characterization of focal and diffuse liver disease, accurately assess treatment response and predict patient outcomes based on longitudinal monitoring? Hypotheses: Advanced multiparametric MRI techniques improve the detection, characterization and response assessment of focal and diffuse liver disease and can predict serious liver related outcomes.

Official Title
-----------------
Diagnostik Und Evaluierung Hepato-pankreatiko-biliärer Erkrankungen Mittels Morphologischer Und Funktioneller Magnetresonanztomographie

Conditions
-----------------
Liver Diseases, Pancreas Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspicion for or diagnosed focal and/or diffuse liver or pancreatic disease who underwent MRI of the abdomen. 18 years of age and older. Exclusion Criteria: Age less than 18 years. Lack of MRI of the abdomen. Inadequate image quality. Documented rejection to participate in research studies

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liver disease<br> | Diagnostic Test: Magnetic resonance imaging<br>* Advanced multiparametric MRI techniques to diagnose hepatic and pancreatic disease<br>|
| Pancreatic disease<br> | Diagnostic Test: Magnetic resonance imaging<br>* Advanced multiparametric MRI techniques to diagnose hepatic and pancreatic disease<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathology findings in focal and/or diffuse liver disease | Pathology findings in focal and/or diffuse liver disease | 1 year | 
| Pathology findings in focal and/or diffuse pancreatic disease | Pathology findings in focal and/or diffuse pancreatic disease | 1 year |
Incontinence Management System ICU Field Evaluation

Study Overview
=================
Brief Summary
-----------------
The objective of this Field Evaluation is to assess usage and satisfaction associated with the Hill-Rom Incontinence Management System.

Official Title
-----------------
Hill-Rom Incontinence Management System ICU Field Evaluation

Conditions
-----------------
Urinary Incontinence, Fecal Incontinence

Intervention / Treatment
-----------------
* Device: Incontinence Management System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with urinary, fecal, or dual incontinence who are ≥ 18 years old The patient, or the patient's legal authorized representative (LAR), is willing and able to provide written informed consent Exclusion Criteria: - Patients that are considered to be near death or require palliative care

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: Incontinence Management system<br> | Device: Incontinence Management System<br>* Incontinence detection device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Staff satisfaction surveys on product performance | Following product use, staff can complete an optional, Likert scale survey | Through study completion, an average of 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient exposure time following an incontinence event |  | Through study completion, an average of 4 months |
Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
This study is being done to determine if the use of double strength cranberry juice in daily diet will improve endothelial function.

Detailed Description
-----------------
Study participants will be randomized assigned to drink either placebo (a drink that looks and tastes like cranberry juice, but does not contain cranberry juice) or a double strength Ocean Spray light cranberry juice cocktail for four months.

Official Title
-----------------
Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease

Conditions
-----------------
Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects over the age of 18 years old with known or suspected cardiovascular disease including documented CAD by cardiac catheterization, and multiple cardiovascular risk factors will be included, regardless of severity of endothelial dysfunction or previous history of cardiovascular events. Subjects with no known history of cardiac disease will also be eligible to participate. Subjects must demonstrate endothelial dysfunction via the RH-PAT test (an RH-PAT score of less than 2.0) to continue participating in this study. Exclusion Criteria: Patients will be excluded if they have confounding factors including, but not limited to, history of renal or liver failure, or relevant food allergies (cranberries, etc.).

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Bottle number 615<br>Patients are randomized to either Bottle number 615 or Bottle number 429 (actual product vs. placebo). This is a blinded study. | |
| Bottle number 429<br>Patients are randomized to either Bottle number 615 or Bottle number 429 (actual product vs. placebo). This is a blinded study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The current study was designed to test the hypothesis that the chronic administration of supplementation with double-strength cranberry juice will improve peripheral endothelial dysfunction. |  | baseline and 4 months post | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The current study was also designed to test the acute effect of double-strength cranberry juice on endothelial function. |  | 45 mins post consumption |
Characterization of Cardiac Hemodynamics During MultiSite Pacing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of MultiPoint Pacing (MPP) on cardiac hemodynamics assessed by pressure-volume loop during MPP at implant. NYHA functional class assessment and echocardiographic measurements are performed at 3 months and 12 months post-implant to characterize long-term effect of MPP.

Official Title
-----------------
Characterization of Cardiac Hemodynamics by Pressure-Volume Loop Analysis During MultiPoint Pacing

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be scheduled to undergo implant of a St Jude Medical CRT-D system with approved standard indication by ESC/EHRA Guidelines Be in sinus rhythm at the time of enrollment Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule Exclusion Criteria: Exhibit Cheyne-Stokes respiration Have persistent or permanent atrial fibrillation Have complete heart block Be in NYHA IV functional class Have a recent myocardial infarction within 40 days prior to enrollment Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months Have had a recent CVA or TIA within 3 months prior to enrollment Have had intravenous inotropic support in the last 30 days Be less than 18 years of age Be pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| MulitPoint Pacing<br> | |
| BiV Conventional<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Within-patient differences in PV loop-based hemodynamic parameters (dP/dtMax, stroke work, stroke volume, ejection fraction) |  | At implant |
Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 10% Phenylephrine

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to quantify eyelid position changes in tested and opposite eyes in ptosis patients submitted to 1, 2 or 4 drops of 10% phenylephrine in one eye. The secondary objective is to correlate the eye dominance, severity and laterality of ptosis with eyelid position changes in these 3 groups.

Detailed Description
-----------------
This is a prospective observational study conducted in involutional ptosis patients, which will be submitted to instillation of a single drop of 10% phenylephrine in one eye(Group 1), 2 drops (G2) or 4 drops ( G3). Video camera will record the images of both eyes before and after drug application at 3, 10, 15 and 30 minutes. The images will be edited to analyze upper and lower lid height.

Official Title
-----------------
Comparative Study of Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 1, 2 or 4 Drops of 10% Phenylephrine

Conditions
-----------------
Blepharoptosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Involutional blepharoptosis Upper Margin-reflex distance less or equal 2.0mm Good fixation and collaboration Exclusion Criteria: Previous eyelid surgeries Use of adrenergic or sympathicomimetics drugs Myopathies Thyroid orbitopathy Non-controlled cardiovascular disease
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients submitted to application of 1 drop of 10% phenylephrine | |
| 2<br>Patients submitted to application of 2 drops of 10% phenylephrine | |
| 3<br>Patients submitted to application of 4 drops of 10% phenylephrine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper lid height before and after phenylephrine test lower lid height before and after phenylephrine test |  | 3, 10, 15 and 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scobee test to detect eye dominance |  | 15 minutes before 10% phenylephrine instillation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adrenergic alpha-agonists, phenylephrine, drug effects, diagnostic use
Rate Control in Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Rate control in atrial fibrillation is a usual battle in emergency departments. Oral medications have a natural superiority to intravenous ones because they are easy-to-use and decrease the workload in busy emergency departments. This study wants to find an effective oral medication for rate control in rapid ventricular response atrial fibrillation. Propranolol and Metoprolol, Diltiazem and Verapamil are compared in patients with a stable hemodynamic status.

Official Title
-----------------
Oral Propranolol, Diltiazem, Metoprolol and Verapamil in Atrial Fibrillation Rate Control in Patients With Stable Hemodynamic Status

Conditions
-----------------
Rapid Ventricular Response Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Propranolol
* Drug: Metoprolol
* Drug: Verapamil
* Drug: Diltiazem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 18 years old Stability in hemodynamic Exclusion Criteria: Systolic blood pressure less than 90 mm Hg Altered mental status attributable to rapid ventricular response atrial fibrillation Acute pulmonary edema attributable to rapid ventricular response atrial fibrillation Chest pain attributable to rapid ventricular response atrial fibrillation Allergy to Propranolol or Metoprolol or Verapamil or Diltiazem History of asthma

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metoprolol Per Oral<br>50 mg Metoprolol | Drug: Metoprolol<br> <br> * Other names: Metoral;|
| Experimental: Verapamil<br>40 mg Verapamil Per Oral | Drug: Verapamil<br> <br> |
| Experimental: Propranolol<br>40 mg Propranolol Per Oral | Drug: Propranolol<br> <br> * Other names: Inderal;|
| Experimental: Diltiazem<br>60 mg Diltiazem Per Oral | Drug: Diltiazem<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate less than 100 per minute | Ventricular rate less than 100 per minute after 1 hour of per oral medication administration | In 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drugs adverse effects | Drugs adverse effects seen in patients in 2 hours after per oral medication administration | 2 hours | 
| Unstability in hemodynamic | Hemodynamic instability (systolic blood pressure less than 90 mmHg, loss of consciousness, pulmonary edema, chest pain) | 2 hours |
A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the pharmacokinetics and safety of a controlled release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR) pitavastatin in healthy adult volunteers.

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: A: NK-104-CR 8 mg
* Drug: B: Pitavastatin IR 4 mg
* Drug: C: Pitavastatin IR 8 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject provides written informed consent before any study-specific evaluation is performed. Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive. Subject has no clinically significant abnormalities on the basis of medical history, physical examination findings, or vital sign measurements, as judged by the Investigator. Subject is able and willing to comply with the protocol and study procedures. Exclusion Criteria: Subject is a woman who is pregnant or breastfeeding. Subject has clinically relevant abnormalities in the screening or check-in assessments. Subject has received an investigational drug within 30 days before the first dose of study drug.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- |
| Experimental: NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg)<br> | Drug: A: NK-104-CR 8 mg<br>* NK-104-CR 8 mg (Controlled Release single 8-mg tablet)<br>Drug: B: Pitavastatin IR 4 mg<br>* Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet)<br>Drug: C: Pitavastatin IR 8 mg<br>* Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)<br>|
| Experimental: Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg)<br> | Drug: A: NK-104-CR 8 mg<br>* NK-104-CR 8 mg (Controlled Release single 8-mg tablet)<br>Drug: B: Pitavastatin IR 4 mg<br>* Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet)<br>Drug: C: Pitavastatin IR 8 mg<br>* Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)<br>|
| Experimental: Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg)<br> | Drug: A: NK-104-CR 8 mg<br>* NK-104-CR 8 mg (Controlled Release single 8-mg tablet)<br>Drug: B: Pitavastatin IR 4 mg<br>* Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet)<br>Drug: C: Pitavastatin IR 8 mg<br>* Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve | Area Under the Curve 0 to tau | 0 to 48 hours |