linjc16/ctgov huggingface dataset:
Comparison of Coronary Xience V and the Cypher Select+ Stents in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
In stent neointimal hyperplasia may be less in the Cypher select plus stent compared to the Xience V stent in diabetic patients.

Official Title
-----------------
A Danish Prospective Randomized Multicenter Comparison of the Xience V and the Cypher Select+ Stents in Unselective Patients With Diabetes Mellitus. An Intravascular Ultrasound Study.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Cypher Select plus
* Device: Xience V stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All diabetic patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centres in Denmark (Gentofte, Rigshospitalet, Odense, Skejby, Aalborg) can be included in the study. Exclusion Criteria: The patient will not participate The patient participates in other randomised stent studies Expected survival < 1 year Allergy to Aspirin, Clopidogrel or Ticlopidine Allergy to Sirolimus or ABT-578

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Cypher Select plus stent | Device: Cypher Select plus<br>* Drug eluting stent<br>|
| Active Comparator: 2<br>Xience V stent | Device: Xience V stent<br>* Drug eluting stent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In stent neointimal hyperplasia |  | Within 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-stent remodeling - Edge response to Cypher Select plus and Xience V stent - Malapposition - Angiographic late lumen loss |  | Within 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug eluting stent, Diabetics, Intravascular ultrasound, Pathophysiologic (neointimal hyperplasia and peri-stent remodeling)
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 187004 CL

Study Overview
=================
Brief Summary
-----------------
To investigate safety, tolerability, pharmacokinetics including dose proportionality, and pharmacodynamics of BI 187004 CL within a predefined dose range

Official Title
-----------------
A Randomised, Double-blind, Placebo-controlled Trial in Healthy Volunteers to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of 2.5 mg to 360 mg of BI 187004 CL

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

Intervention / Treatment
-----------------
* Drug: Placebo to BI 187004 CL
* Drug: BI 187004 CL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy male subjects overweight or obese Exclusion criteria: 1. Any relevant deviation from healthy conditions

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 187004 CL<br>1 single dose per subject as oral solution | Drug: BI 187004 CL<br>* 1 single dose per subject as oral solution<br>|
| Placebo Comparator: Placebo to BI 187004 CL<br>1 single dose per subject as oral solution | Drug: Placebo to BI 187004 CL<br>* 1 single dose per subject as oral solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events |  | up to 15 days postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum measured concentration of the analyte in plasma) |  | up to 96 hours postdose | 
| AUC0-8 (area under the concentration-time curve of the in plasma over the time interval from 0 extrapolated to infinity) |  | up to 96 hours postdose | 
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) |  | up to 96 hours postdose |
A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Shoulder Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic shoulder osteoarthritis (OA). Patients will be given Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the 3 month follow up period.

Conditions
-----------------
Osteoarthritis, Musculoskeletal Diseases

Intervention / Treatment
-----------------
* Device: Synvisc (hylan G-F 20)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic OA pain of shoulder (gleno-humeral) Exclusion Criteria: Patients with current or prior conditions or treatment that would impede measurement of efficacy or safety

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Synvisc (hylan G-F 20)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis of the shoulder, Musculoskeletal
Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System

Study Overview
=================
Brief Summary
-----------------
The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System & Trivium 3D Spinal Deformity Correction System.

Detailed Description
-----------------
The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System & Trivium 3D Spinal Deformity Correction System. We have extended the study tol collect further outcomes data at the 12 month time point.

Official Title
-----------------
A Post Market Surveillance Validation to Evaluate the Effectiveness of the Following System: Polaris Deformity Spinal System

Conditions
-----------------
Spinal Deformity

Intervention / Treatment
-----------------
* Procedure: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 200 subjects at 10 clinical centers. All subjects undergoing spinal fusion surgery between the levels of T1- Ilium (Thoracic 1 to Ilium) All subjects are skeletally mature with spinal deformity. Risser score must be ≥ 3. Subjects or their representative must be willing and able to give informed consent and assent (if applicable). Subjects who do not meet any of the following contraindications: spinal infection or inflammation, morbid obesity, mental illness, alcoholism, drug abuse, pregnancy, metal sensitivity, foreign body sensitivity, patients with inadequate tissue coverage over the operative site, open wounds local to the operative area, any case not described in the specific indications Exclusion Criteria: Any subject who does not meet the inclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Surgery|All subjects will have spinal surgery between the levels of T1 and Ilium using the Polaris Deformity Spinal System|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of Deformity Correction | The primary outcome measure for this trial will be the percentage of subjects who have maintained their degree of deformity correction within 10% from immediate post-op to the 6 month follow-up visit. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased Operative Time | Comparison of Operative times vs. literature | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
scoliosis, kyphosis, spinal deformity, curvature, lordosis
Perioperative Cardiac Troponin Levels in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
This study will determine the extent of high-sensitivity cardiac troponin (hs-cTn) release in patients without cardiac risk factors undergoing extremity orthopedic surgery. This study will provide important evidence on how to interpret postoperative cardiac troponin elevations.

Official Title
-----------------
Perioperative High-sensitivity Cardiac Troponin Levels in Healthy Adults Undergoing Elective Trauma Surgery

Conditions
-----------------
Extremity Orthopedic Surgery

Intervention / Treatment
-----------------
* Procedure: Extremity orthopedic or trauma surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-35 years Extremity orthopedic or trauma surgery: leg, hip, arm, shoulder. Planned overnight hospital admission No cardiac risk factors (Lee's Revised Cardiac Risk Index Class 1) American Society of Anesthesiologists (ASA) physical status I-II Exclusion Criteria: Any history or symptoms of cardiac disease Kidney or liver disease Recent or current trauma to the trunk or head Persons with increased vulnerability (e.g. cognitive limitations, prisoners,…) Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| Adults without cardiac disease<br>Extremity orthopedic or trauma surgery | Procedure: Extremity orthopedic or trauma surgery<br>* hip, leg, shoulder, arm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative change of high-sensitivity cardiac troponin plasma level | 3 samples: Preoperative, POD 0, and POD 1 | 24 hours preoperatively to postoperative day (POD) 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak high-sensitivity cardiac troponin plasma level | 3 samples: Preoperative, POD 0, and POD 1 | 24 hours preoperatively to POD 1 | 
| Incidence rate of high-sensitivity cardiac troponin plasma level elevation | 3 samples: Preoperative, POD 0, and POD 1 | 24 hours preoperatively to POD 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Troponin, Perioperative Period, surgery
Treatment of Hyperhidrosis With Oxybutynin

Study Overview
=================
Brief Summary
-----------------
Evaluation of the effectiveness of oxybutynin in hyperhidrosis

Official Title
-----------------
Treatment of Hyperhidrosis With Oxybutynin: a Randomized Controlled Double Blind Against Placebo

Conditions
-----------------
Hyperhidrosis

Intervention / Treatment
-----------------
* Drug: Oxybutynin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 years Patient affiliated to social security or beneficiary of such a regime Patient able to consent Patient with hyperhidrosis, generalized or localized (palmar, plantar, axillary) and whose score HDSS (Hyperidrosis Disease Severity Scale) is greater than two. Exclusion Criteria: Age less than 18 years Patient who can't be followed Patient participating in another clinical trial Pregnant Woman breastfeeding Hypersensitivity to oxybutynin or any of the excipients Risk of urinary retention related disorders uretroprostatiques Intestinal obstruction Toxic megacolon Intestinal atony Severe Ulcerative Colitis Myasthenia Closure glaucoma the anterior chamber angle or slightly deep

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: oxybutynin<br>Oxybutynin was done at 2.5 mg/day from day 1 to day 4, then at 5 mg/day from day 5 to day 7 and at 7.5 mg/day from day 8 to the end of the 6 weeks. | Drug: Oxybutynin<br>* Oxybutynin is started at a dose of 2.5 mg / day and increased gradually until an effective dose without exceed 7.5 mg / day up to 6 weeks.<br>|
| Placebo Comparator: Placebo<br>Placebo was done at 2.5 mg/day from day 1 to day 4, then at 5 mg/day from day 5 to day 7 and at 7.5 mg/day from day 8 to the end of the 6 weeks. | Drug: Placebo<br>* Placebo is started at a dose of 2.5 mg / day and increased gradually until an effective dose without exceed 7.5 mg / day up to 6 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effectiveness of oxybutynin in hyperhidrosis | Two scales are used for this evaluation (Hyperhydrosis Disease Severity Scale and Dermatology Life Quality Index ) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation of treatment in this indication | Number of Participants with Adverse Events will be followed. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyperhidrosis, oxybutynin
H+ Mobilization With Dialysate Bicarbonate Variation

Study Overview
=================
Brief Summary
-----------------
The aims of the proposed studies are first to delineate the physiological response of End Stage Kidney Disease (ESKD) patients to exposure to a bath [HCO3-] of 35 mEq/L and an [acetate] of 4 mEq/L, and second, to determine whether reducing bath [HCO3-] will have the expected effect of decreasing or abolishing stimulation of organic acid production. A secondary endpoint will be whether the patients tolerate such a reduction and its impact on pre-dialysis blood [HCO3-]. If the outcome is positive in both regards, future studies will measure well-being and outcomes with reduced bath [HCO3-].

Official Title
-----------------
H+ Mobilization With Dialysate Bicarbonate Variation

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Device: variation in dialysis bicarbonate
* Dietary Supplement: Zone Perfect bar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be 18 years or older, Have been on dialysis for at least 1 year, Be stable on treatment (i.e., without frequent changes in their dialysis prescription, or recent hospitalizations), Be reasonably nourished (serum albumin > 3.5 g/dl and not currently receiving oral nutritional supplement through DCI). Self-reported urine output of <200 cc/day Functioning arteriovenous fistulas or grafts for dialysis access Currently dialyzing at a dialysate [HCO3-] of 33-37 mEq/L. Exclusion Criteria: Pregnancy, Acute illnesses of any kind, Hospitalization in the prior 3 months (except for vascular access related), Significant congestive heart failure, liver or lung failure. Pre-dialysis blood [HCO3-] <19 mEq/L) (to reduce the risk of metabolic acidosis )

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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bicarb Variation<br>Variation in dialysis bicarbonate, lowered to 30 mEq/L for week 2 of 3 | Device: variation in dialysis bicarbonate<br>* 35 mEq/L dialysate bicarbonate for one week, followed by 30 mEq/L for one week, followed by 35mEq/L for one week with nutritional supplement during dialysis<br>Dietary Supplement: Zone Perfect bar<br>* 16g protein supplement given during first 30 mins of dialysis on last testing day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate levels | 7 tests conducted through the dialysis treatment after the long interdialytic interval | through study completion, a period of 3 weeks | 
| H+ mobilization | 7 tests conducted through the dialysis treatment after the long interdialytic interval | through study completion, a period of 3 weeks |
The Value of Narrow Band Imaging in Stratifying Patients for Endoscopic Resection or Surgery

Study Overview
=================
Brief Summary
-----------------
Magnification narrow band imaging (NBI) can make accurate evaluation in in predicting of invasive depth of colorectal neoplasia.

Detailed Description
-----------------
NBI could be used in stratifying patients for endoscopic resection or surgery and got an accurate evaluation.

Official Title
-----------------
The Value of NBI in Stratifying Patients for Endoscopic Resection or Surgery

Conditions
-----------------
Colorectal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients with more than one lesion ≧6mm Exclusion Criteria: Patients with chronic inflammatory bowel disease, advanced cancer, insufficient bowel preparation, familial adenomatous polyposis (FAP) Lesions ≦ 5mm and submucosal tumor (SMT).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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
-----------------
narrow band imaging（NBI）, colorectal lesions, predicting histology
The Effects of a Results Management System on Physician Awareness of Post-Discharge Test Results

Study Overview
=================
Brief Summary
-----------------
This project aims to define the problem of results that return after patient discharge and to study the implementation of an Electronic Medical Record (EMR)-based system for tracking these results.

Detailed Description
-----------------
The transfer of care at hospital discharge is complex and requires the transmission of large amounts of data between inpatient physicians (hospitalists) and outpatient physicians (PCPs), including information about pending tests. Frequently, laboratory and radiology tests are not finalized until after a patient is discharged, and when the responsibility for these pending results is not clearly defined, they can be missed. Our project aims to define the problem of these post-discharge results and to study the implementation of an EMR-based system (Hospitalist Results Manager, HRM) for tracking these results on the hospitalist services at Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH). The project consists of two phases: a cross-sectional study before intervention to define the epidemiology of post-discharge results, and a randomized trial of HRM to determine its effect on physician awareness of these results.

Official Title
-----------------
The Effects of a Results Management System on Physician Awareness of Post-Discharge Laboratory and Radiology Results

Conditions
-----------------
Healthy, Medical Record Systems, Computerized

Intervention / Treatment
-----------------
* Behavioral: Hospitalists Results Manager


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted under enrolled study Attendings at the two study locations Patient had test result finalized after discharge and prior to subsequent admission Exclusion Criteria: Test result noted in discharge summary Test result not clinically actionable

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Hospitalists Results Manager|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
-----------------
Electronic Medical Record, Electronic Results Tracking, Patient Safety, Post-Discharge Test Results