linjc16/ctgov huggingface dataset:
Femoral vs Radial Approach and MRI Evaluation of Strokes

Study Overview
=================
Brief Summary
-----------------
Symptomatic cerebral infarction following cardiac catheterization is rare but silent brain injury could occur at an unexpectedly high rate. One study has found that up to 22% of patients with severe aortic stenosis who have undergone retrograde catheterization of the valve can be identified as having new ischemic lesions as detected by diffusion-weighted (DW) magnetic resonance imaging (MRI). During cardiac catheterization, cerebral microembolism as detected by TCD has frequently been observed, but whether it is clinically relevant remains unknown . However, recent studies have suggested that some of these microemboli could be responsible for acute brain injury, as documented by DW MRI. Indeed the high sensitivity of DW MRI suggests that this technique could allow an improved estimate of cerebral ischemic events associated with cardiovascular-catheter procedures. We therefore decided to perform DW MRI before and after cardiac catheterization to prospectively assess both clinically silent and apparent cerebral embolisms for the first time in a multicenter trial. Furthermore, a randomization between radial and femoral access will allow assessment of risk of silent brain injury associated with the different vascular access sites.

Official Title
-----------------
Silent Cerebral Infarction After Heart Catheterization: A Randomized Comparison of Radial and Femoral Arterial Access.

Conditions
-----------------
Aortic Stenosis

Intervention / Treatment
-----------------
* Behavioral: vascular access site


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with significant aortic valve stenosis before planned surgery. Exclusion Criteria: Contraindication to MRI or inability to give written informed 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Radial access | Behavioral: vascular access site<br>* Randomized vascular access site<br>|
| 2<br>Femoral access | Behavioral: vascular access site<br>* Randomized vascular access site<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
-----------------
aortic stenosis, radial, femoral, vascular access site, embolism, cerebral, MRI, stroke
Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee

Study Overview
=================
Brief Summary
-----------------
This is a phase III, multicentre, randomized, double blind, parallel-group, pilot study designed to compare a long term (12 weeks) versus a short term (2 weeks) treatment with celecoxib 200 mg/die in treatment and prevention of new flare in patients with osteoarthritis of the knee.

Official Title
-----------------
Protocol For A Multicentre, Double Blind, Parallel Group Pilot Study To Compare Celecoxib Long Term Vs Celecoxib Short Term Therapy In Treatment And Prevention Of New Flare In Patients With Osteoarthritis Of The Knee

Conditions
-----------------
Osteoarthritis,Knee

Intervention / Treatment
-----------------
* Drug: Celebrex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of OA of the knee according to the ACR Classification Criteria for osteoarthritis; patients in flare Exclusion Criteria: any concomitant inflammatory rheumatic condition which may interfere with the assessment of OA clinical or radiological evidence of chondrocalcinosis

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Celebrex|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time elapsing between the last drug administration and a new flare, if any, occurring within a 12 months FU and proportion pts with a new flare |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flare intensity WOMAC OA index Psycho-affective Index Pt's assessment of OA pain (VAS) Pt's & Physician's global assessment disease severity Incidence of total AEs Incidence of GI AEs: Incidence of changes in: hematology, renal function, liver function |  |  |
Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Pediatric Patients With Mild Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
A study to compare the safety and efficacy of Protopic and Elidel in treating mild Atopic Dermatitis in pediatric patients

Official Title
-----------------
A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Pediatric Patients With Mild Atopic Dermatitis

Conditions
-----------------
Dermatitis, Atopic

Intervention / Treatment
-----------------
* Drug: tacrolimus ointment
* Drug: pimecrolimus cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a diagnosis of Atopic Dermatitis rated mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area, and the maximum of 20% of the body surface area If female, and of childbearing potential, patient has a negative pregnancy test and agrees to practice effective birth control during the study Exclusion Criteria: Patient has a skin disorder other than Atopic Dermatitis in the areas to be treated Patient has extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters Patient has clinically infected Atopic Dermatitis at baseline Patient is likely to require systemic corticosteroids, or the patient is likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug Patient has a known hypersensitivity to macrolides or any excipient of either study medication Patient has a chronic condition which is either not stable or not well controlled Patient is pregnant or breast feeding an infant

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: tacrolimus ointment<br>* topical<br>* Other names: FK506 ointment;|
| Active Comparator: 2<br> | Drug: pimecrolimus cream<br>* topical<br>* Other names: Elidel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Eczema Area and Severity Index (EASI) |  | 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Atopic Dermatitis Assessment (IGADA) |  | 6 Weeks | 
| Patient's evaluation of itch |  | 6 Weeks | 
| Body surface area affected |  | 6 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mild Atopic Dermatitis, Protopic, Pediatric
Personalized Lifestyle Intervention and Weight Control

Study Overview
=================
Brief Summary
-----------------
This trial aims to investigate whether tailored lifestyle consultation through SNP testing leads to more effective weight loss among overweight or obese individuals compared to general lifestyle guidance for weight control.

Official Title
-----------------
Personalized Lifestyle Intervention Based on SNP Testing and Weight Control

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

Intervention / Treatment
-----------------
* Behavioral: personalized lifestyle intervention
* Behavioral: general lifestyle intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: overweight or obese individuals Exclusion Criteria: a past history of bariatric surgery or eating disorders currently pregnant or planning a pregnancy within 2 years

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: personalized lifestyle intervention<br>to provide personalized lifestyle guidance for weight loss through SNP testing | Behavioral: personalized lifestyle intervention<br>* Based on genotype of SNPs potentially relevant to weight control, tailored lifestyle guidance to facilitate weight loss will be provided.<br>|
| Active Comparator: general lifestyle intervention<br>to provide general lifestyle guidance for weight loss | Behavioral: general lifestyle intervention<br>* Regardless of individuals' genetic make-up, general lifestyle guidance to facilitate weight loss will be provided.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight change (kg) | change in weight from the time of randomization | at six months, 1 year, and 2 years after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| waist circumference (cm) | change in waist circumference from the time of randomization | at six months, 1 year, and 2 years after randomization |
Follow up of Patients After Oral Immunotherapy for Cow's Milk, Eggs and Peanuts

Study Overview
=================
Brief Summary
-----------------
Food allergy is a potentially life threatening condition. The current practice consists of elimination diet and injectable epinephrine in case of a reaction. Recently, oral immunotherapy has emerged as a treatment for food allergy in milk eggs and peanuts. We conduct an oral immunotherapy program with  500 patients so far. In this study we intent to follow patients who completed the program and assess their allergy status and quality of life.

Detailed Description
-----------------
Food allergy is a potentially life threatening condition. The current practice consists of elimination diet and injectable epinephrine in case of a reaction. Recently, oral immunotherapy (OIT) has emerged as an treatment for food allergy in milk eggs and peanuts. Since 4/2010,a clinical OIT program for milk eggs and peanuts is performed at the Institute fir Allergy Asthma and Immunology at Assaf Harofeh Medical Center with  500 patients so far. Patients with IgE-mediated food allergy that are >4 years old are eligible. In this study we intent to follow patients who completed the program. Patients will fill a questionnaire regarding current consumption of the allergenic food, adverse reactions experienced and treatments required including the use of EpiPen. Patients underwent skim prick tests (SPT) for the allergenic food prior to initiation and treatment and will undergo SPT again upon entering the study. Blood tests for IgE, IGG4, basophil activation and cytokines will be obtained. Patients who are not consuming the allergenic food regularly will undergo an oral food challenge in clinic.

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Dietary Supplement: Allergenic food


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>4 years old IgE mediated allergy to milk eggs or peanuts Completion of OIT >6 months ago Exclusion Criteria: Non approval to participate

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 40 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 |
| --- | --- |
| Completed OIT<br>Patients who completed OIT >6 months prior to enrollment | Dietary Supplement: Allergenic food<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergenic food consumption questionnaire |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
food, consumption
Evaluation of the Contribution of the Ultrasound Tracking and the Positioning of the Distal End During the Implantation of Implantable Chamber or Long-lasting Venous Catheter

Study Overview
=================
Brief Summary
-----------------
Given the increase in the number of PAC implants or long-term catheters, and the ease of access to cardiac ultrasound in the operating theaters, the investigator thought to use ultrasound to PAC or long-term catheters. The investigator considers cardiac echocardiography through its costal pathway to locate the correct positioning of the distal end of the catheter in a manner equivalent to the scopic locating with all the side effects of the irradiation and with Equivalent efficiency

Official Title
-----------------
Evaluation of the Contribution of the Ultrasound Tracking and the Positioning of the Distal End During the Implantation of Implantable Chamber or Long-lasting Venous Catheter

Conditions
-----------------
Echocardiography, Implantable Chamber

Intervention / Treatment
-----------------
* Other: Adult patients who are candidates for a CAP or long-term central catheter placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients are candidates for a long-term CAP or central catheter placement. Benefiting from sedation or general anesthesia. Exclusion Criteria: Patient aged <18 years. Pregnant woman. Lack of anesthesiologist with knowledge of ultrasound. Site of femoral puncture

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients applying for CAP or long-term central catheter<br> | Other: Adult patients who are candidates for a CAP or long-term central catheter placement<br>* Evaluate the feasibility of finding the correct positioning of the distal end of the PAC or of the long-term catheter by cardiac ultrasound in comparison with the brightness scopy, reference method.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Good positioning of the distal end of the catheter by ETT, without repositioning following the scopy |  | 1 day |
Reserpine for the Treatment of Cocaine Dependence - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of reserpine for the treatment of cocaine dependence.

Detailed Description
-----------------
To assess the efficacy and safety of reserpine in reducing cocaine use in subjects with cocaine dependence. This is a double-blind, placebo-controlled, parallel-group design with a 2 week baseline period.

Official Title
-----------------
Phase 2, Double-Blind, Placebo-Controlled Trial of Reserpine for the Treatment of Cocaine Dependence

Conditions
-----------------
Cocaine-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Reserpine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 yrs of age; DSM-4 diagnosis of cocaine dependence; treatment seeking individuals; have the ability to understand and provide written informed consent; females of child bearing potential using appropriate birth control method Exclusion Criteria: Additional criteria available during screening at the site.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Reserpine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine use |  |  | 
| Addiction severity |  |  | 
| Cocaine withdrawal |  |  | 
| Adverse events |  |  | 
| Clinical improvement |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Evaluation of Patient and Lesion Specific Prognostic Factors for Standard Radioimmunotherapy

Study Overview
=================
Brief Summary
-----------------
MERIT-NHL as an addendum to the International Registry of Radioimmunotherapy (RIT registry) pooling clinical data of patients who suffered from a non-Hodgkin´s lymphoma also includes the documentation of the respective FDG-PET and CT-image files in an online archive. Based on these documented clinical and imaging data, the MERIT study group centrally performs an intra- as well as interindividual evaluation of follicular CD20+ lymphoma lesions before and after radioimmunotherapy. According to this, the aim of the MERIT-NHL study is to prospectively identify yet unknown patient- and lesion specific prognostic factors predicting patient´s outcome in line with the therapeutic modality radioimmunotherapy.

Official Title
-----------------
Multicenter Prospective Evaluation of Patient- and Lesion Specific Prognostic Factors for Standard RadioImmunoTherapy With 90-Yttrium-labeled Anti-CD20 in Follicular Non-Hodgkin´s Lymphoma

Conditions
-----------------
Follicular Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: standard radioimmunotherapy with 90-yttrium-labeled anti-CD20-antibodies in treatment of relapsed and/or refractory follicular NHL or partial remission after induction chemotherapy finding of at least one image-guided measurable lymphoma lesion existence of FDG-PET- and CT-image data of at most 8 weeks before treatment signed patient´s agreement for RIT registry and MERIT-NHL Exclusion Criteria: other therapy modalities than standard radioimmunotherapy (e.g. consolidation) solely CNS-lymphoma or primary effusion lymphoma

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 |
| --- | --- | --- |
| Evaluation of patient- and lesion specific prognostic factors of radioimmunotherapy |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of diagnostical relevance of FDG-PET- and CT-image data findings in staging and re-staging of follicular non-Hodgkin´s lymphoma as well as in documentation of patient´s outcome after standard radioimmunotherapy |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radioimmunotherapy, follicular non-Hodgkin´s lymphoma, FDG-PET, prognostic factors, multicenter study
The Use of Statins for Myocardial Death Prevention

Study Overview
=================
Brief Summary
-----------------
The administration of high dose HMG-CoA reductase inhibitors (Statins) to patients with acute ST-elevation MI (hypoxia/ischemia) who are treated with primary PCI (reoxygenation/ reperfusion) will protect their cardiomyocytes from death and thus preserve LV ejection fraction.

Official Title
-----------------
The Use of Statins for Myocardial Death Prevention: From Cell to Bedside

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients suffering from acute ST elevation resulting from myocardial infarction, Killip Classification 1 and 2 will be included at-random to either group. Included subjects should be able to give their informed consent to participate in this study. Exclusion Criteria: The impossibility to give the required informed consent. Known allergy to Atorvastatin. Base line serum creatinine of 1.4 mg/dL. Killip Classification 3 and 4. Persisting vomiting. History of previous liver disease. History of previous muscle disease or rabdomyolisis. Treated already with high dose atorvastatin Non Compliance.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 90 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin 80 mg<br> | Drug: Atorvastatin<br>* Oral Atorvastatin<br>|
| Experimental: Atorvastatin 10 mg<br> | Drug: Atorvastatin<br>* Oral Atorvastatin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart EcoCardiography and specific laboratory tests |  | Base line, second day and 60 days after myocardial infarction | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute ST Elevation Myocardial Infarction