linjc16/ctgov huggingface dataset:
Efficacy and Safety of Rimonabant as an Aid to Maintenance of Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The primary study objective is to evaluate the efficacy of 2 dose levels of rimonabant (5 mg and 20 mg) for the maintenance of abstinence from smoking. Secondary objectives are to evaluate the effect of rimonabant on craving and weight, the clinical and biological safety of 2 doses of rimonabant rimonabant during a 12-month treatment period and to evaluate the pharmacokinetics of the drug.

Official Title
-----------------
Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5 mg/Day or 20 mg/Day, Versus Placebo, as an Aid to Maintenance of Smoking Cessation (1-Year Treatment, 1-Year Follow-up)

Conditions
-----------------
Maintenance of Smoking Cessation

Intervention / Treatment
-----------------
* Drug: rimonabant (SR141716)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Smokers smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale Exclusion Criteria: non tobacco cigarettes consumption chronic use of marijuana pregnancy, breastfeeding any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug Concomitant use of drugs as an aid to smoking cessation or that might induce weight change

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

| Intervention/Treatment |
| --- |
|Drug: rimonabant (SR141716)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to smoking relapse from the point of re-randomization (Week 10) through Week 32 |  |  | 
| Smoking relapse defined as: any 7 or more consecutive days of smoking (even a puff) or any 2 consecutive days of smoking 5 or more cigarettes per day |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Time to smoking relapse from Week 10 to Week 52, craving, body weight change in abstainers, lipid parameters |  |  | 
| Safety data |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abstinence, maintenance
Descriptive Study of a Cohort of Orbital Solitary Fibrous Tumors

Study Overview
=================
Brief Summary
-----------------
Orbital solitary fibrous tumors are rare tumors with an intermediate potential of malignancy. Orbital solitary fibrous tumors' prognostic criteria are still poorly understood. Some patients with orbital solitary fibrous tumors have been treated at the Adolphe de Rothschild Foundation Hospital. This cohort will be studied to describe the recurrence rate and to identify predictive factors of recurrence or metastasis.

Official Title
-----------------
Orbital Solitary Fibrous Tumors: Description of a Case Series and Study of the Recurrence Rate

Conditions
-----------------
Orbital Tumor

Intervention / Treatment
-----------------
* Other: Phone call


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated at the Adolphe de Rothschild foundation hospital for an orbital solitary fibrous tumor between 01/01/2014 and 09/30/2020 Exclusion Criteria: Opposition of the patient (or of the relative if the patient is deceased) Patients benefiting from a legal protection measure Pregnant or breastfeeding woman

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- | --- |
| Patients with Orbital Solitary Fibrous Tumors<br> | Other: Phone call<br>* Patients will be asked to complete a questionnaire via a phone call<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Population characteristics | descriptive statistics of each variable: age, sex, symptoms, duration of symptoms | inclusion | 
| Medical history | descriptive statistics of each variable: history of previous biopsy or excision, previous intraoperative data,previous pathological data | inclusion | 
| Radiological lesion features | descriptive statistics of each variable: laterality, orbital location, size and characteristics on preoperative orbital imaging | inclusion | 
| Pathological lesion characteristics | descriptive statistics of each variable: presence of necrosis, presence of epithelioid morphology of these cells, presence of cellular atypia, description of the mitotic index, immunohistochemical study, proliferation factor | inclusion | 
| Intraoperative data | descriptive statistics of each variable: complete or incomplete surgical removal, surgical removal 'in toto' or by fragments | inclusion |
Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel Versus Conventional Method in Day Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to compare between the safety and efficacy of the harmonic shears and the commonly used clip technique in achieving safe closure and division of the cystic duct in the laparoscopic cholecystectomy in day surgery setting

Official Title
-----------------
Comparative Study Between Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel Versus Conventional Method in Day Surgery: a Prospective Randomized Study

Conditions
-----------------
Cholelithiasis

Intervention / Treatment
-----------------
* Procedure: Harmonic scalpel
* Procedure: Traditional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic Cholelithiasis Age under 65 yr old BMI under 35 ASA I or II Exclusion Criteria: Acute cholecystitis Suspect of common bile duct stones

Ages Eligible for Study
-----------------
Maximum Age: 65 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 |
| --- | --- |
| clipless<br>laparoscopic cholecystectomy performed by harmonic scalpel with closure and division of the cystic duct only by the device | Procedure: Harmonic scalpel<br>* The Cholecystectomy is performed using only Harmonic Scalpel to mobilize the Cholecystis and to close the cystic duct and the cystic artery<br>|
| traditional<br>laparoscopic cholecystectomy performed by harmonic scalpel with closure of the cystic duct only by titanium clip | Procedure: Traditional<br>* The cholecystectomy is performed using Harmonic Scalpel to mobilize the cholecystis and the cystic duct and the cystic artery are closed by titanium clips<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness closure of the cystic duct | the effectiveness closure of the cystic duct is assessed on the presence or not of cystic duct bile leak | at 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complication | the presence of postoperative complication is investigated | 1 month | 
| efficacy and safety of the use of harmonic scalpel performing cholecystectomy | the efficacy and safety of the use of harmonic scalpel performing cholecystectomy is assessed by evaluating the operative time, the presence of major or minor intraoperative complication and the postoperative complication. | 24 hours |
Bedrest, Feeding Pattern, and Insulin Sensitivity

Study Overview
=================
Brief Summary
-----------------
In the present study, the investigators will assess the impact of two different feeding patterns (continuous vs intermittent) on insulin sensitivity and muscle mass following bedrest.

Detailed Description
-----------------
In the present study, the investigators will assess the impact of two different feeding patterns on insulin sensitivity and muscle mass following bedrest. Healthy, young males will be fed in a continuous (no breaks in food supply) or intermittent (in boluses throughout the day) manner.

Official Title
-----------------
The Impact of Continuous Versus Intermittent Feeding on Changes in Insulin Sensitivity During Bed-rest

Conditions
-----------------
Atrophy, Disuse, Insulin Resistance

Intervention / Treatment
-----------------
* Other: Intermittent feeding pattern
* Other: Continuous feeding pattern


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 18.5 and 35 Recreationally active Exclusion Criteria: Type 2 diabetes Performing progressive resistance training in 6 months prior to study Back/knee/leg problems Hypertension Use of certain anticoagulants All co morbidities interacting with mobility and muscle metabolism of the lower limbs Blood donation in past 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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: Intermittent feeding<br>Intermittent feeding pattern throughout the bedrest period, with 4 boluses per day | Other: Intermittent feeding pattern<br>* Intermittent feeding<br>|
| Experimental: Continuous feeding<br>Continuous feeding pattern throughout the bedrest period, with 4 boluses per day, without breaks in food supply. | Other: Continuous feeding pattern<br>* Continuous feeding<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin sensitivity (measured as glucose infusion rate during hyperinsulinaemic-euglycaemic clamp) |  | 7 days bedrest | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle mass (measured as upper leg muscle cross-sectional area with CT scan) | Via single-slice CT scan | 7 days bedrest | 
| Change in lean tissue (measured via DEXA scan) | Via DEXA | 7 days bedrest |
Post Cond No Reflow

Study Overview
=================
Brief Summary
-----------------
After having shown that postconditioning allowed a significant 36% reduction of infarct size as assessed by blood levels of myocardial enzymes in acute myocardial patients, the investigators objective is to assess the effect of postconditioning in acute myocardial infarction (AMI) patients on microvascular obstruction lesions defined by cardiac MRI images.

Official Title
-----------------
The POSTCONDITIONING and THE NO REFLOW Phenomenon in Acute Myocardial Infarction

Conditions
-----------------
Myocardial Reperfusion Injury

Intervention / Treatment
-----------------
* Procedure: postconditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years old, Male or female, Presenting first myocardial infarction, with the beginning of pains < 12 hours, Requiring a revascularisation by primary angioplasty or  rescue  (after failure of thrombolysis) on IVA or RCA (not CA). Artery guilty with TIMI flow = 0 Exclusion Criteria: cardiac arrest before the angioplasty, Cardiogenic shock Occlusion of the artery circumflex responsible for the infarction Magnetic resonance imaging: contre indication

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>22 controls patients without post conditionment | |
| Experimental: Intervention<br>22 posconditioned patients | Procedure: postconditioning<br>* Direct postconditioning (brief repeated cycle of 4 occlusion and desocclusion of the initially occluded culprit coronary artery) after primary direct stenting.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of the area of microvascular obstruction | Extent of the area of microvascular obstruction defined on post-gadolinium CMR images realized 48-72 hours after admission in each group | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of the myocardial infarction | Size of the myocardial infarction defined on post-gadolinium CMR images realized 48-72 hours after admission in each group. | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial infarction, Postconditioning, Microvascular obstruction, No reflow, MRI
Gut Hormone Profiling in Obese Patients With Type 2 Diabetes (MK-0000-134)

Study Overview
=================
Brief Summary
-----------------
This study will examine changes in various gut-derived hormones in obese type 2 diabetic patients before and after elective bariatric surgery.

Official Title
-----------------
Gut Hormone Profiling in Peripheral Blood After Bariatric Surgery in Obese Patients With Type 2 Diabetes

Conditions
-----------------
Obesity, Morbid, Diabetes Mellitus Type 2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented type 2 diabetes with total disease duration ≤10 years BMI of at least 35 kg/m^2 Patient is a surgical candidate for either RYGBP, GBS or vertical sleeve gastrectomy (VSG) Exclusion Criteria: Any illness that might confound the results of the study or pose additional risk to the patient by participation History of stroke, seizures, or other major neurological disorder History of cancer Patient uses or has used any medication that can alter body weight Patient is unwilling or unable to follow study procedures

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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>Participants having elective Roux-en-Y gastric bypass surgery (RYGBP) | |
| 2<br>Participants having elective gastric banding surgery (GB) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in PYY (Peptide YY) measured by ELISA 4 weeks after RYGBP |  | Baseline and Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in PYY measured by dMS 4 weeks after RYGBP |  | Baseline and week 4 |
Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Conventional rehabilitation after total hip arthroplasty (THA) does not seem to restore muscular strength or walking speed. Three-5 years after surgery patients are still not fully rehabilitated. This study evaluates the effects of maximal strength training on the muscular strength in leg press and abduction in patients undergoing THA. Aim of the study is to increase the patients physical function through evidence-based rehabilitation in clinical practice, with gradually less supervision.

Official Title
-----------------
Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty: Implementing Evidence Based Rehabilitation Into Clinical Practice, and the Influence of Supervised Training

Conditions
-----------------
Muscle Weakness

Intervention / Treatment
-----------------
* Behavioral: Maximal strength training
* Behavioral: conventional rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled for total hip arthroplasty (THA) living nearby Trondheim diagnosis of primary osteoarthritis as the main cause for elective THA ASA score of I-III (stable) Exclusion Criteria: muscular or skeletal disease which might influence the training and/or physical testing performance communication difficulties postoperatively discharged to a rehabilitation institution THA in the bilateral hip that is not fully rehabilitated.
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: Maximal strength training<br>Maximal strength training supervised by a physiotherapist | Behavioral: Maximal strength training<br> <br> |
| Active Comparator: Control<br>Conventional rehabilitation supervised by a physiotherapist | Behavioral: conventional rehabilitation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscular strength | leg press (kg), abduction (kg) | 3 months | 
| Muscular strength | leg press (kg), abduction (kg) | 6 months | 
| muscular strength | leg press (kg), abduction (kg) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function | Harris hip score, 6 min walking test | up to 1 year | 
| Bone mineral density | Dual X-ray absorptiometry (DXA) | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resistance training, Arthroplasty, Replacement, Hip, Professional-Patient Relations, Evidence-based practice
Stem Cell Therapy in Limb Girdle Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to study the effect of stem cell therapy on the course of the disease in patients with Limb Girdle Muscular Dystrophy.

Official Title
-----------------
The Role of Cell Therapy in Modifying the Course of Limb Girdle Muscular Dystrophy- A Longitudinal 5-year Study

Conditions
-----------------
Limb Girdle Muscular Dystrophy

Intervention / Treatment
-----------------
* Biological: Autologous bone marrow mononuclear cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males and females age group of 15 years and above limb girdle muscular dystrophy diagnosed on the basis of clinical presentation Electromyographic and Nerve Conduction velocity findings Exclusion Criteria: presence of respiratory distress presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus malignancies acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction < 30% pregnancy or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 15 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem Cells<br>autologous bone marrow mononuclear cell transplantation | Biological: Autologous bone marrow mononuclear cell transplantation<br>* bone marrow derived mononuclear cells are administered intrathecally and intramuscularly in limb girdle muscular dystrophy patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence Measure |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manual Muscle Testing |  | 6 months |
Results of CRS and Debulking in PMP Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to compare debulking surgery and cytoreductive surgery in patients with Pseudomyxoma Peritonei with respect to efficacy and safety.

Official Title
-----------------
Comparison Between Cyotreductive Surgery and Debulking Surgery in Patients With Pseudomyxoma Peritonei

Conditions
-----------------
Pseudomyxoma Peritonei

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with radiology histopathology finding of Pseudomyxoma Peritonei Exclusion Criteria: Preformance status WHO >2 and histopathology shows other origin then Pseudomyxoma Peritonei

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Overall survival | from treatment and forward |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity and mortality | mortality is messured during the first 90 postoperative days and morbidity during hospital stay. | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pseudomyxoma Peritonei, Cytoreductive surgery, Debulking surgery, Intraperitoneal chemotherapy