linjc16/ctgov huggingface dataset:
Moisturizing Effect of Two Dexpanthenol Formulations

Study Overview
=================
Brief Summary
-----------------
The study focuses to prove the equivalent moisturizing effect of two different Dexpanthenol formulations

Official Title
-----------------
Evaluation of the Moisturizing Effect of Bepanthen Burn Relief Foam Spray New Formula Versus Bepanthen Burn Relief Foam Spray (Current Formula). Equivalence Trial. Intra-individual Design.

Conditions
-----------------
Skin Abnormalities

Intervention / Treatment
-----------------
* Drug: Dexpanthenol foam spray, new formulation
* Drug: Dexpanthenol foam spray, old formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Phototype: I to IV according to Fitzpatrick scale Subjects with dry skin on their forearms Exclusion Criteria: Pregnant or nursing women Subjects registered as being in exclusion period in the French Health Minister file of subjects Subjects with hypersensitivity to one of the test products

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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: Arm 1<br> | Drug: Dexpanthenol foam spray, new formulation<br>* 2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter<br>|
| Active Comparator: Arm 2<br> | Drug: Dexpanthenol foam spray, old formulation<br>* 2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve (AUC) of the cutaneous hydration rate measured with corneometer between T0 and T5h |  | 0 min, 15 min, 30 min, 1h, 2h, 3h, 5h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cutaneous hydration rate |  | 15 min, 30 min, 1h, 2h, 3h, 5h | 
| Incidence of Adverse Events |  | FPFV - LPLV | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry skin, Dexpanthenol, Moisturizing effect
Carotid Atherosclerosis and Vascular Events in People With Diabetes

Study Overview
=================
Brief Summary
-----------------
Diabetes is a risk factor for carotid atherosclerotic whose progression is associated with an increased risk of vascular events. Investigators assessed prospectively by arterial duplex ultrasonography the progression of carotid atherosclerosis in a cohort of people with diabetes to assess the importance of progression and to analyze the impact of this progression on vascular events. The main hypothesis is that people with carotid atherosclerosis progression are at higher risk of vascular events than those without any progression.

Official Title
-----------------
Progression of Carotid Atherosclerosis and Vascular Events in People With Diabetes: A Prospective Cohort Study

Conditions
-----------------
Carotid Atherosclerosis

Intervention / Treatment
-----------------
* Other: carotid assesment by duplex ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 ans Diabetes Carotid duplex ultrasonography in 2012 Exclusion Criteria: None

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 |
| --- | --- |
| diabetic patients with carotid assessment<br>Patients with diabetes and a carotid assessment by duplex ultrasonography in 2012 in a monocentric diabetic unit | Other: carotid assesment by duplex ultrasonography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of vascular events between day one and the last day of follow-up reviewed by patient examination | Vascular events include ischemic myocardial events, ischemic cerebrovascular events, lower limb ischemia, arterial revascularization procedure | Day of the last assessment of carotid atherosclerosis by duplex ultrasonography (between 01/2014 and 09/2016) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of carotid atherosclerosis progression measured by duplex ultrasonography in percentage of stenosis | At each visit, carotid arteries were examined by duplex ultrasonography. The most severe lesion for each patient was selected. Results were classified in three Strandness categories: normal (no atherosclerotic lesions), stenosis < 50% (systolic ratio Internal Carotid Artery (ICA)/Common Carotid Artery (CCA) < 2) and stenosis ≥ 50% (systolic ratio ICA/CCA ≥ 2). A progression was the move to a higher category. | Day of the last assessment of carotid atherosclerosis by duplex ultrasonography between 01/2014 and 09/2016. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carotid atherosclerosis, duplex ultrasonography, diabetes, vascular events
An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the distribution and spread of four different vehicle formulations in the vagina. In-vivo data will be obtained regarding each vehicle formulation at various time points after insertion of the gel into the vagina.

Official Title
-----------------
An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina: Candidate Formulations

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Vehicle gel formulations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 45 year old women non-pregnant healthy Exclusion Criteria: abnormal finding on pelvic exam pregnant or breastfeeding allergy to intravaginal products history of claustrophobia

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vehicle gel formulations|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI evaluation of gel formulation distribution in vagina |  |  | 
| Total linear distance in mm covered by gel |  |  | 
| Surface area actually covered by gel (mm) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Seronegativity, HIV
Duration of Immobilization After Rotator Cuff Repair: Its Clinical Impact

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the immobilization period is helpful for the better healing of repaired rotator cuff. The investigators hypothesis is that the longer immobilization after rotator cuff repair will help the healing of rotator cuff.

Official Title
-----------------
Prolonged Versus Conventional Immobilization After Arthroscopic Repair for Medium to Large Size Rotator Cuff Tear. A Prospective Randomized Controlled Trial

Conditions
-----------------
Rotator Cuff Tear

Intervention / Treatment
-----------------
* Procedure: Immobilization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medium to large sized cuff tear (2-4 cm) Yes subscapular partial fraying or longitudinal split side to side Yes acromioplasty Yes AC arthritis with mumford procedure Yes biceps tenotomy or tenodesis Exclusion Criteria: No arthritic changes of glenohumeral joint No combined infection No mini-open procedures No complete subscapularis tear No incomplete repair No small tears or side to side repairs without anchors No pregnancy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Immobilization|compared the healing status for 8 weeks of immobilization with the conventional 4 weeks of immobilization after rotator cuff repair|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| repair integrity analysis using postoperative MRI |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeons' score |  | 2 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medium to large tear, rotator cuff tear, arthroscopic repair, repair integrity, immobilization
Medical Safety Huddles - a Multi-site QI Project

Study Overview
=================
Brief Summary
-----------------
This quality improvement project will implement and evaluate the impact of physician-specific huddles, termed medical safety huddles on patient safety within four programs/sites at Sinai Health Systems, St. John's Rehab (Sunnybrook) and University Health Network.

Official Title
-----------------
Medical Safety Huddles - a Multi-site QI (Quality Improvement) Project

Conditions
-----------------
Patient Safety

Intervention / Treatment
-----------------
* Other: Implementing medical safety huddles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Any staff physicians, residents or medical students working at the four programs/sites Exclusion criteria: None
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: Sequential Assignment
Interventional Model Description: The multi-centre QI project will use a stepped wedge cluster randomized design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Medical Safety Huddles - Pre-implementation<br> | |
| Experimental: Medical Safety Huddles - Post-implementation<br> | Other: Implementing medical safety huddles<br>* These short, virtual huddles are led by a huddle leader and occur on a weekly or once every two week basis. Each site will be adapting the Medical Safety Huddles for their context and workflow to specifically engage physicians.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | We will examine whether the huddles impact the frequency and severity of adverse events experienced by patients. We will also determine if the huddles specifically impact certain types of adverse events in terms of frequency and severity. We will also perform analysis specific for each program/site. | 19 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Process measure - Attendance rate | The number of physicians attending each huddle will be monitored to ensure the fidelity of implementation | 15 months | 
| Process measure - Safety issues | The type and number of safety issues brought up during huddles will be monitored on a monthly basis to ensure the fidelity of implementation | 15 months | 
| Process measure - Actions taken to address safety issues | The number of actions taken to address safety issues will be monitored on a monthly basis to ensure the fidelity of implementation | 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality Improvement, Patient Safety, Physician Engagement, Huddles
Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.

Official Title
-----------------
MK0928 Phase II Sleep Laboratory Study - Primary Insomnia

Conditions
-----------------
Primary Insomnia

Intervention / Treatment
-----------------
* Drug: MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose)
* Drug: Placebo / Duration of Treatment: 2 days for screening period


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of primary insomnia Exclusion Criteria: Patients with an active psychiatric disorder other than primary insomnia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose)|nan|
|Drug: Placebo / Duration of Treatment: 2 days for screening period|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of total sleep time over 2 nights. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of other PSG sleep parameters over 2 nights, mean of subjective sleep parameters, and exploratory residual effect. |  |  |
Preoperative Gabapentine for Carpal Tunnel

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the postoperative analgesic effect of preoperative gabapentine for carpal tunnel syndrome surgery.

Detailed Description
-----------------
There was studied 40 patients. Group 1 patients received 600 mg of gabapentin 1 hour before surgery; G2 received placebo 1 hour before surgery. Anesthesia was regional intravenous block. Postoperative analgesia when needed was with acetaminophen. If needed was administered codeine. The evaluation of neuropathic pain was made by DN4 questionnaire. Pain intensity was assessed by numeric scale at block and after 30min, 1h, 2h, 2wk, 4wk, 6m. It was noted the duration of analgesia, and the amount of acetaminophen and codeine. The statistical program used for analysis of the results was the Instat Graph

Official Title
-----------------
Effect of Preoperative Gabapentine for Carpal Tunnel Syndrome

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Drug: Gabapentine
* Other: Sugar pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: carpal tunnel syndrome Exclusion Criteria: disorientation, psychiatric disease, myocardial ischemia, hypertension, arrhythmia, another pain syndrome, drug user, and pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: preoperative gabapentine,<br>Gabapentine | Drug: Gabapentine<br>* Gabapentine 600 mg 01 dose<br>* Other names: Anticonvulsant;|
| Placebo Comparator: sugar pill<br>Placebo group | Other: Sugar pill<br>* Sugar pill 01 dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Pain | Numerical score from 0 to 10 scale: Minimum value= zero (means no pain) and Maximum value= 10 (more intense pain) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gabapentine, postoperative pain
Hemodynamic Changes in Off-pump Coronary Artery Bypass Grafting

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the positioning and stabilization of different cardiac walls performed during off-pump coronary artery bypass grafting (CABG) may have dissimilar impact on hemodynamics. The objective is to evaluate hemodynamics during distal coronary anastomoses in different cardiac walls.

Detailed Description
-----------------
Twenty patients undergoing off-pump CABG monitored with pulmonary artery catheter and esophageal doppler will be enrolled. Patients with a left ventricular ejection fraction <50%, age >80 yr, creatinine >1.4 mg/dl, reoperation, valvular heart disease or chronic obstructive pulmonary disease were excluded Data will be collected after volemic and hemodynamic adjustments, after heart positioning and establishment of a suction stabilizer and before its removal in anterior, lateral or posterior wall artery anastomosis. Data was compared by means of two-way repeated measures ANOVA.

Official Title
-----------------
Hemodynamic Changes in Off-pump Coronary Artery Bypass Grafting

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal left ventricular function Minimal to moderate surgical risk according to criteria proposed by Higgins et al. (JAMA. 1992 May 6;267(17):2344-8) Exclusion Criteria: Patients with a left ventricular ejection fraction <50%, Age >80 yr Creatinine >1.4 mg/dl Reoperation Valvular heart disease Chronic obstructive pulmonary disease High surgical risk according to criteria proposed by Higgins et al. (JAMA. 1992 May 6;267(17):2344-8)

Ages Eligible for Study
-----------------
Maximum Age: 80 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 |
| --- | --- |
| Off-Pump<br>Patients with coronary artery disease undergoing elective off-pump CABG | |

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
-----------------
OPCAB, pulmonary artery catheter, esophageal doppler, hemodynamics
A Longitudinal Study in 1st Degree Relatives of Parkinson's Disease (PD) Patients

Study Overview
=================
Brief Summary
-----------------
This is a longitudinal study in healthy 1st degree relatives of patients with Parkinson's Disease (PD) carriers of a genetic mutation in genes that are known to increase the risk for PD. The purpose of this study is to explore the association between genetic mutations in the known genes and early preclinical symptoms such as motor, sensory, autonomic, behavioral and cognitive functions.

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Other: neurological examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy 1ST degree relatives of PD patients with known genotype that participated in an earlier genetic study at the sourasky medical center. Exclusion Criteria: subjects with cognitive decline by the parameters defined in DSM- IV subjects with psychiatric disorder subjects unable to sign a consent form

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 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 |
| --- | --- |
| healthy relatives<br>healthy 1st degree relatives of PD patients | Other: neurological examination<br>* motor and cognitive functions<br>|

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
-----------------
healthy 1st degree relatives of pd patients