linjc16/ctgov huggingface dataset:
Effects of Limicol on LDL-cholesterol

Study Overview
=================
Brief Summary
-----------------
The principal objective of this study is to investigate the effects of a novel food supplement (Limicol) on LDL-cholesterol levels in healthy subjects with moderate hypercholesterolemia.

Official Title
-----------------
Study of the Effects of Limicol (a Food Supplement) on LDL-cholesterol in Moderate Hypercholesterolemia Subjects

Conditions
-----------------
Hypercholesteremia

Intervention / Treatment
-----------------
* Dietary Supplement: Limicol
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: About 18 to 55 years (inclusive) Subject has a stable weight for at least three months before the start of the study Subject able and willing to comply with the protocol and agreeing to give their consent in writing Subject affiliated with a social security scheme Subject willing to be included in the national register of volunteers who lend themselves to biomedical research

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Limicol<br> | Dietary Supplement: Limicol<br>* 3 tablets / day during 4 months<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* 3 tablets / day during 4 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in blood LDL-cholesterol levels at 4 months |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in blood Vit. C, Vit. E, polyphenols and MDA levels at 4 months |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delivery of Health Care, Cholesterol, LDL-cholesterol, Coronary artery disease, Red yeast rice, Plants extract, Cholesterol excess
Safety and Efficacy of MBI 226 2.5% and 5.0% Topical Acne Solutions in the Treatment of Acne

Study Overview
=================
Brief Summary
-----------------
This study investigates the safety and efficacy of MBI 226 2.5% and 5.0% Acne Solutions, applied topically for six weeks, in the treatment of acne.

Official Title
-----------------
Phase II, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of MBI 226 2.5% and 5.0% Acne Solutions Applied Topically for 6 Weeks to Subjects With Acne Vulgaris

Conditions
-----------------
Acne Vulgaris, Acne, Propionibacterium Acnes

Intervention / Treatment
-----------------
* Drug: MBI 226 Acne Solutions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, ages 13 and up, exhibiting high levels of facial P. acnes Presence of inflammatory and non-inflammatory lesions Exclusion Criteria: Acne conglobata, acne fulminans, or secondary acne (chlorine, drug-induced acne, etc.) Active facial cysts

Ages Eligible for Study
-----------------
Minimum Age: 13 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: MBI 226 Acne Solutions|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - percent change in inflammatory, non-inflammatory, and total acne lesion counts over entire study and dichotomized Global Severity Assessment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - percent change in lesion counts after  2 and  4 weeks |  |  | 
| - Global Severity Assessment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acne, acne vulgaris, MBI 226, Propionibacterium acnes, lesion counts, lesions, inflammatory, non-inflammatory, topical
Preop Conformal Radiotherapy - Prostate

Study Overview
=================
Brief Summary
-----------------
Radical prostatectomy and radical radiation therapy remain the standard treatment approaches for patients with clinically localized prostate cancer (T1, T2).Radical prostatectomy is most effective when the disease is organ confined at the time of surgery. However, in many series up to 60% of patients have positive resection margins at the time of surgery and there is evidence to suggest that these patients may not be curable by surgery alone. A number of preoperative clinical variables including clinical stage, serum Prostate Specific Antigen (PSA) and Gleason scorea re helpful in determining the probability of finding organ confined disease at the time of syrgery.

Official Title
-----------------
A Pilot Study of Pre-Operative Conformal Radiotherapy in Patients With Radical Prostatectomy

Conditions
-----------------
Prostatic Neoplasm

Intervention / Treatment
-----------------
* Procedure: Pre-Operative Conformal Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Histologically confirmed carcinoma of the prostate High risk localized disease defined as clinical T1 or T2 plus [ (i) Gleason ¡Ý7, PSA>10 ng/ml and <35 ng/ml OR (ii) PSA >15 ng/ml and less <35 ng/ml (any Gleason) ] No evidence of pelvic lymph node metastases on CT scan within 4 months of surgery No evidence of distant metastases on bone scan within 4 months of surgery No contraindication to pelvic radiation therapy

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- |
|Procedure: Pre-Operative Conformal Radiotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To document the feasibility of pre-operative conformal radiation therapy in patients undergoing radical prostatectomy for localized prostate cancer who are at high risk for having local extra-prostatic disease at time of surgery. |  |  |
Information During Maternity

Study Overview
=================
Brief Summary
-----------------
During the pregnancy , it's now compulsary for the doctors to inform pregnant women and the couple about the medical, non medical informations and explain the physiological changes . As usual, medical staff and doctors explain and inform by oral and with a booklet patient. In order to cluster and make more accessible these informations, the maternity team of GHPSJ has developed an application on smartphone . If this application has been evaluated on his contents and accordance to recommendations, there is no evaluation about the satisfaction of patient. The aim is to study the impact of this kind of application on pregnant women satisfaction.

Official Title
-----------------
Information During Maternity

Conditions
-----------------
Pregnancy Related

Intervention / Treatment
-----------------
* Other: application on smarthphone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: single pregnancy delivery at 37 weeks of amenhorrhea age > 18 with an email address Exclusion Criteria: refusing participation foetal pathology

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

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

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

| Intervention/Treatment |
| --- |
|Other: application on smarthphone|application on smarthphone|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction score |  | 9 months |
Transversus Abdominis Plane Block In Children

Study Overview
=================
Brief Summary
-----------------
Aim of this study; Intra-operative anesthesia and analgesia effects of Transversus Abdominis Plane Block supported by ketamine sedation only.

Official Title
-----------------
Effect of Ultrasonography Guided Transversus Abdominis Plane Block to Intraoperative Anesthesia in Children: Randomized Controlled Study

Conditions
-----------------
Intra-operative Anesthesia

Intervention / Treatment
-----------------
* Drug: ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II To undergo elective lower abdominal surgery between 2-6 years old Exclusion Criteria: Patients with psychiatric disease Patients whose weight is more than 40 kg Patients with cardiac-pulmonary-neurological disease Patients with bleeding disorder Patients with infection or scar on the injection area Patients with known allergies to local anesthetics

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: block and ketamine<br>Transversus Abdominis Plane block after ketamine atropine induction and continued with ketamine only in anesthesia | Drug: ketamine<br> <br> |
| Active Comparator: ketamine atropine; laryngeal mask<br>After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane MAC and oxygen / air mixture and applied Transversus Abdominis Plane block. | Drug: ketamine<br> <br> |
| Active Comparator: control group<br>After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane MAC and oxygen / air mixture and Non-block, postoperative analgesia with paracetamol IV | Drug: ketamine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the amount of anesthetic drug which was used |  | two hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative visual analogue scale |  | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intra-operative anesthesia, Pediatric patient, Transversus Abdominis Plane Block
Multicentric, Transversal, Descriptive, Epidemiological Study on the Management of Asthma in Asthmatic Middle East Adult Population

Study Overview
=================
Brief Summary
-----------------
Descriptive study on the management of asthma in asthmatic Middle East adult population : Algeria,Egypt, Irak,Iran, Jordan, Koweit, Lebanon, Qatar,Saudi,Tunisia, UAE

Detailed Description
-----------------
Multicentric, transversal, descriptive, epidemiological study, conducted in a random sample of general practitioner and medical specialist (Pulmonologist and/or allergologist) in the public and the private sector.

Official Title
-----------------
Evaluation of aSthma Management in Middle EAst Adult Population

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, 18 years of age and older. Asthmatic since at least one year before inclusion. Patient's informed consent obtained. Exclusion Criteria: Patient concurrently participating to another study. Patient with concomitant pulmonary disease. Patient with psychiatric disorders. Patient consulting for an asthma attack

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 130 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 |
| --- | --- |
| 8645 asthmatic patients<br>Men and women, 18 years of age and older. Asthmatic since at least one year before inclusion. Patient's informed consent obtained. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control | Daytime symptoms Limitation of activities Nocturnal symptoms / awakening Need for reliever /rescue treatment Lung function (PEF or FEV) | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| general and sociodemographic patient's characteristics | sex, age, BMI, educational level, occupation, comorbidities, smoking status, and social security coverage. | up to 1 year | 
| Identify predictive factors of asthma control, | such as age, sex, BMI, smoking status, adherence to treatment, asthma history, comorbidity. | UP to 1 year | 
| asthma control level | Asthma control test questionnaire : activities at work,breathless,asthma symptoms (wheezing, coughing, chest tightness, shortness of breath;use of rescue inhaler or taken a nebulizer treatment ,asthma assessment | Up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma control
E-NOSE for Breath Gas Analysis Under Microgravity Conditions

Study Overview
=================
Brief Summary
-----------------
The main goal of the study is demonstrate that e-Nose system function is not altered in weightlessness and more specifically that gas concentration measurements are the same in weightlessness and normal gravity.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Other: measurement of the concentration of C02, CO and NH4, 3 exhaled gas with E-Nose system
* Other: Parabolic flight


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers (men or women) Aged from 20 to 65 Affiliated to a French Social Security system or, for people living abroad, holding a European Health Insurance Card (EHIC) Who accepted to take part in the study Who has given their written stated consent Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection Exclusion Criteria: Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: gas concentration<br>Gaz concentration of C02, CO and NH4, 3 exhaled in weightlessness and normal gravity. | Other: measurement of the concentration of C02, CO and NH4, 3 exhaled gas with E-Nose system<br> <br> Other: Parabolic flight<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The judgment criteria are the concentration of C02, CO and NH4, 3 exhaled gas |  | baseline |
A Clinical Study Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris.

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: IDP-110
* Drug: Clindamycin
* Drug: Benzoyl peroxide
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of inflammatory and non-inflammatory lesions Exclusion Criteria: Dermatological conditions of the face other than acne that could interfere with clinical evaluations Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: IDP-110<br>* Topical application for 12 weeks<br>|
| Active Comparator: 2<br> | Drug: Clindamycin<br>* Topical application for 12 weeks<br>|
| Active Comparator: 3<br> | Drug: Benzoyl peroxide<br>* Topical application for 12 weeks<br>|
| Placebo Comparator: 4<br> | Drug: Vehicle<br>* Topical application for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in number of lesions |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in global severity |  | 12 weeks |
Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Atrial Fibrillation (AF) is one of the most common postoperative complications after coronary artery bypass grafting (CABG). Postoperative AF produces a substantial impact on hospital resources with an estimated annual expenditure of over $1 billion. This includes the cost of pharmacological treatment and the cost of the increased length of stay. The incidence of AF is about 30-40% in CABG patients and increases with age of the patient. As the average age of the patient that undergoes CABG surgery is increasing, it is critical to find a way to prevent or reduce the incidence of this complication. We propose a prospective, randomized, controlled study to determine the role of pulmonary vein isolation by bipolar ablation in the prevention or reduction of postoperative AF. The block- randomization plan will be used to maintain balance of the study and control arms throughout the study.

Official Title
-----------------
Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation

Conditions
-----------------
Postoperative Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Isolation of pulmonary veins with Bipolar radiofrequency ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who require an isolated elective CABG surgery on CPB. Both male and female patients of age 18 years to 90 years. Exclusion Criteria: Pre existing atrial fibrillation or history of previous atrial fibrillation. Inability to provide informed consent. Pregnant or nursing patients. Reoperative sternotomy Emergency CABG surgery.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary Vein isolation<br>Patients in this arm will receive pulmonary vein isolation during surgery | Procedure: Isolation of pulmonary veins with Bipolar radiofrequency ablation<br> <br> |
| No Intervention: Standard of care<br>Subjects in this arm will receive standard of care and no pulmonary vein isolation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced incidence of Postoperative Atrial fibrillation |  | 12 hours |
Economisation of Whipple Resection Using an Ultrasonic Dissection Device

Study Overview
=================
Brief Summary
-----------------
Including 150 randomised patient, the studies aim is to determine whether an economisation and/or improvement in terms of operating time, drainage fluid, blood loss, time of hospitalisation can be found using an ultrasonic dissection device versus traditional surgical methods such as stitches an ligations.The study is performed for patients undergoing partial pancreatoduodenectomy.

Official Title
-----------------
Economisation of Preparation by Using an Ultrasonic Dissection Device in Partial Pancreatoduodenectomy

Conditions
-----------------
Resectable Pancreatic Head Neoplasm, Resectable Periampullary Neoplasm, Chronic Pancreatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: resectable tumor Exclusion Criteria: palliative resection

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 |
| --- | --- |
| Group A<br>Preparation with Harmonic WAVE | |
| Group B<br>Preparation with conventional modalities | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total operation time | Measurement of time regarding incision-closure-time | end of operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative blood loss |  | end of operation | 
| number of transfusions |  | within the first 24 hours perioperatively | 
| hospitalization time |  | end of hospitalization | 
| resulting cost reduction |  | end of hospitalization | 
| pancreatic fistula |  | within the first 5 days postoperatively | 
| postoperative intervention | Postoperative interventions due complications, e.g. pancreatic fistula | end of hospitalization |