linjc16/ctgov huggingface dataset:
Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess the effect of rimonabant compared to placebo on weight loss over a period of 6 months when prescribed with a mild hypocaloric diet in obese patients with binge eating disorder. The secondary objectives are: to assess the effect of rimonabant on the number of binge episodes per week, to assess the effect of rimonabant on eating behavior using the Binge Eating Scale (BES) and Three Factor Eating Questionnaire (TFEQ), to evaluate the safety and tolerability of rimonabant over a period of 6 months.

Official Title
-----------------
A Randomized, Double-Bind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study to Assess Efficacy and Safety of Rimonabant 20 mg Versus Placebo on Weight Loss and Frequency of Binge Episodes in Obese Patients With Food Craving

Conditions
-----------------
Obesity, Eating Disorders

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI) ≥30 to ≤45 kg/m² Diagnosis of eating disorder using The Questionnaire on Eating and Weight Patterns (QEWP-R) for diagnosing Eating Behaviors Exclusion Criteria: History of surgical procedures for weight loss Treatment with anti-obesity drugs within 3 months prior to screening visit Presence or history of Diagnostic and Statistical Manual of Mental Disorders (4th edition)(DSM IV) bulimia or anorexia nervosa The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight from baseline to Day 180 visit |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: binge eating episodes, BES score, TFEQ dimensions, waist circumference, Body Mass Index |  |  | 
| Safety: clinical examination, vital signs, adverse events, Hospital Anxiety and Depression (HAD) scale |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
binge eating, eating disorders, obesity
TWO DİFFERENT ELECTROSURGERY DEVICES AS MONOPOLAR HOOC AND PLASMAKINETIC BIPOLAR SPATULA EFFECTIVENESS DURING COLPOTOMY

Study Overview
=================
Brief Summary
-----------------
WE DECIDED TO COMPARE TWO DIFFERENT ELECTROSURGERY DEVİCES TO PROVIDE COLPOTOMY. ONE OF THEM İS MONOPOLAR HOOC, THE OTHER DEVİCE İS PLASMAKİNETİC BİPOLAR SPATULA. WE WİLL RANDOMİSE PATİENTS FİRSTLY THEN COMPARE THE RESULTS SUCH, VAGİNAL DEHİSSENS, COLPOTOMY DURATİON, AMOUNT OF MIST DURING COLPOTOMY, AMOUNT OF BLEEDİNG.

Detailed Description
-----------------
COLPOTOMY IS A PROCESS DURING TOTAL LAPAROSCOPIC HYSTERECTOMY. WE CAN USE EİTHER ELECTROSURGERY INSTRUMENTS TO PROVIDE COLPOTOMY. IN OUR TRIAL WE WİLL RANDOMİSE PATİENTS FİRSTLY THEN COMPARE THE RESULTS SUCH, VAGİNAL DEHİSSENS, COLPOTOMY DURATİON, AMOUNT OF MIST DURING COLPOTOMY, AMOUNT OF BLEEDİNG.

Official Title
-----------------
THE EFFECTIVENESS OF MONOPOLAR HOOC VERSUS PLASMAKINETIC BİPOLAR SPATULA USAGE DURING COLPOTOMY PROCESS IN PATIENTS UNDERGOİNG TOTAL LAPAROSCOPIC HYSTERECTOMY

Conditions
-----------------
Uterine Fibroid, Ovary Cyst, Endometrial Hyperplasia, Cervical Dysplasia

Intervention / Treatment
-----------------
* Device: MONOPOLAR HOOC
* Device: PLASMAKINETIC BIPOLAR SPATULA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: APPROPIATE FOR TOTAL LAPAROSCOPIC HYSTERECTOMY Exclusion Criteria: MALIGNANCY

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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: Crossover Assignment
Interventional Model Description: MONOPOLAR HOOC VERSUS PLASMAKINETIC BIPOLAR SPATULA USAGE DURING COLPOTOMY
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MONOPOLAR HOOC<br>COLPOTOMY WITH USAGE MONOPOLAR HOOC | Device: MONOPOLAR HOOC<br>* COLPOTOMY WITH MONOPOLAR HOOC<br>|
| Active Comparator: PLASMAKINETIK BIPOLAR SPATULA<br>COLPOTOMY WITH USAGE MONOPOLAR HOOC | Device: PLASMAKINETIC BIPOLAR SPATULA<br>* COLPOTOMY WITH BIPOLAR SPATULA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAGINAL DEHISSENS | AFTER LAPAROSCOPIC HYSTERECTOMY TWO DIFFERENT ELECTROSURGERY DEVICES RESULTS | 0 DAY-365 DAYS |
For a Better Interpretation of Quality of Life Scores of Kidney Transplant Patients: Determination of the Minimum Significant Change RetransQol

Study Overview
=================
Brief Summary
-----------------
The project team developped and validated a French patient-based health-related quality of life instrument in kidney transplant: the QoL Retrans. The aim of the study is to determine the minimum significant change of the valdiated tool: ReTransQol

Conditions
-----------------
Kidneys Transplantation

Intervention / Treatment
-----------------
* Behavioral: Answering specific quality of life questionnaire in kidneys transplantation population


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a transplant kidney Exclusion Criteria: Patient not able to answer survey

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

| Intervention/Treatment |
| --- |
|Behavioral: Answering specific quality of life questionnaire in kidneys transplantation population|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of change in quality of life in kidneys transplantation patients using ReTransQol |  | 1 year |
Tea Tree Oil in the Treatment of Chronic Blepharitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine: The prevalence of Demodex sp. in chronic blepharitis. The efficacy of the treatment of topical Tree Tea Oil in chronic blepharitis for Demodex sp.

Detailed Description
-----------------
Patients with clinical diagnosis of chronic blepharitis were included in this study. A check list of symptoms and an ophthalmologic examination including best corrected visual acuity and biomicroscopy were performed. Under a slit lamp visualization, three lashes with cylindrical dandruff of each eyelid were epilated by fine forceps. The lashes were immersed in fluorescein dye and examined under a light microscope at a 20-times magnification. The mites were detected based on its morphological characteristics and movement. The patients with chronic blepharitis who had Demodex were randomly divided in two groups. The treatment group was prescribed lid hygiene with Tea Tree Oil shampoo 0.25% and ointment 5% daily and Tea Tree Oil oily solution 50% once a week - produced by Ophthalmos, São Paulo. The control group used the same posology of placebo similar products. After six weeks, all subjects underwent the initial clinical and laboratory examination. The symptoms and the quantity of mites (mites/eye) were compared before and after the treatment in both groups.

Official Title
-----------------
Tea Tree Oil in the Treatment of Chronic Blepharitis

Conditions
-----------------
Blepharitis

Intervention / Treatment
-----------------
* Drug: Tea Tree Oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Blepharitis with out treatment previously Exclusion Criteria: Patients under 18 y.o. Pregnant woman Others Ocular Surface Disease (Severe Dry Eye, Lagoftalmo, Entropium, Ectropium)

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: Tea Tree Oil|Tea Tree Oil shampoo 0.25% and ointment 5% daily and Tea Tree Oil oily solution 50% once a week for six weeks|

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
-----------------
Tea Tree Oil, Chronic Blepharitis
Market Research - Acceptability Trial for a New PKU Amino Acid Based Protein Substitute

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with PKU.

Official Title
-----------------
Market Research - Acceptability Trial for a New PKU Amino Acid Based Protein Substitute (Dr Schär Medical Nutrition - Mevalia Amino Acids) Mevalia PKU Motion 10 - Tropical or Red Fruits Mevalia PKU Motion 20 - Tropical or Red Fruits

Conditions
-----------------
PKU, Phenylketonurias, Inborn Errors of Metabolism, Metabolic Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Motion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of PKU or PKU variant requiring a phenylalanine-free protein substitute Subjects who are already taking a phenylalanine-free protein substitute and are willing to try the study product for 7 days Patients aged 3 years of age to adulthood Written informed consent obtained from parental caregiver Exclusion Criteria: Presence of serious concurrent illness Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study. Any patients having taken antibiotics over the previous 2 weeks leading up to the study. Patients less than 3 years of age.

Ages Eligible for Study
-----------------
Minimum Age: 3 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PKU Motion<br>amino acid based protein substitute | Dietary Supplement: Motion<br>* Amino acid based protein substitute<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal tolerance | Questionnaire detailing any GI symptoms, severity and change from usual • The collection of daily data about the gastro-intestinal tolerance of the protein substitute. | 7 days | 
| Product compliance | Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount. | 7 days | 
| Product palatability | Questionnaire data captured to evaluate taste | 7 days | 
| Product acceptability | Brief tick-box questionnaire on overall liking and acceptability of product | 7 days |
GBE Deficiency (GSD IV and APBD) Natural History Study

Study Overview
=================
Brief Summary
-----------------
Collection and review of clinical information related to glycogen branching enzyme (GBE) deficiency, diagnosed as Glycogen Storage Disease Type IV (GSD IV) or Adult Polyglucosan Body Disease (APBD generated during clinic visits.

Detailed Description
-----------------
This natural history study will serve as a repository of clinical, laboratory, and biochemical information on individuals with GBE deficiency, diagnosed as either GSD IV or APBD. This information will allow a more definitive description of GBE deficiency to be developed, which will permit development of treatment strategies for this disease. Duke will be the only site where this study takes place. However, since this is a rare disorder, participants who receive care for GBE deficiency at other institutions will be included. We will collect retrospective data from patient charts on diagnosed individuals, as far back as necessary to capture the clinical course of the disorder. Prospective data collected from patient charts after enrollment will be captured as well. Participant's medical records will be continually reviewed for the duration of the study. Data will be collected from medical records and will only pertain to clinically relevant information, including, but not limited to: demographic and diagnostic information, tissue biopsy results, medical and family history, review of systems, imaging studies, results of liver, muscle, and nerve function testing, and urine and blood laboratory results.

Official Title
-----------------
GBE Deficiency (GSD IV and APBD) Natural History Study

Conditions
-----------------
Glycogen Storage Disease Type IV, Adult Polyglucosan Body Disease, GSD4, GSD IV, APBD

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Diagnosis of GSD IV or APBD via: Two variants in the GBE1 gene Deficient GBE activity in liver, muscle, skin fibroblast or other tissue One variant in GBE1 gene with evidence of disease that is pathogenic, per the clinician Able to provide informed consent for self (adults) or affected individual (minor or adults with a legally authorized representative) Able to provide consent for release of medical records Pregnant women with a diagnosis of GSD IV or APBD will be included Histology as confirmed by clinician

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|This is an observational study that consists of data abstraction from patient medical records.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of disease |  | Duration of study, approximately 10 years |
Dose-Escalating Study of Propiverine Hydrochloride in Children Suffering From Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
The open-label dose-escalating two-centre study was designed to assess the pharmacokinetics as well as safety, tolerability and efficacy parameters of propiverine in patients 5-10 years of age suffering from frequency-urgency-syndrome and urinary incontinence indicative of detrusor overactivity (overactive bladder) for determination of the recommended dose in children.

Official Title
-----------------
Dose-Escalating Study of Propiverine Hydrochloride (Mictonetten®) in Children Suffering From Frequency-Urgency-Syndrome and Urinary Incontinence Indicative of Detrusor Overactivity (Overactive Bladder)

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: propiverine hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Micturition Frequency ≥6 micturitions during awake period Urge Incontinence Episodes ≥1/week Urgency Episodes ≥1/day Main Exclusion Criteria: Contraindication to anticholinergic therapy Repeated measurement of Post Void Residual ≥20 mL Nocturnal Enuresis Clinically significant cardiovascular, hepatic, renal, gastrointestinal or hematological disease, psychiatric disorder or diabetes insipidus Anatomical abnormalities of the urinary tract

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 10 Years

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

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

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

Design Details

Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: propiverine hydrochloride<br> | Drug: propiverine hydrochloride<br>* coated tablets containing 5 mg consecutive dose escalation of 5 mg, 10 mg or 15 mg propiverine b.i.d.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters of propiverine and its main metabolite propiverine N-oxide at steady state: Ctrough, Cmax, Tmax, AUC0-8h. Children were separated into 3 groups. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of propiverine. Efficacy: Changes from baseline: voiding frequency, incontinence and urgency episodes,voided volume. Safety: Post Void Residual (PVR),adverse events,laboratory values (urine, blood), ECG. |  | two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
propiverine, anticholinergics, urinary incontinence, overactive bladder, children, dose-finding in children aged 5-10 years
Blood Glucose Testing and You

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the difference between self-reported, estimated blood glucose level versus blood glucose levels measured with a Blood Glucose Meter.

Official Title
-----------------
Blood Glucose Testing and You

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Other: Blood Glucose meter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, 18 years of age and above Type 2 diabetes Able to speak, read, and understand English Willing to complete all study procedures Exclusion Criteria: Type 1 diabetes Currently a user of continuous glucose monitoring system Currently pregnant Hemophilia or any other bleeding disorder Employee of competitive medical device company Cognitive disorder or other condition which, in the opinion of the investigator (or designee), would put the person at risk or seriously compromise the integrity of the study

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: People with type 2 diabetes<br>People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on a Blood Glucose meter, subjects were informed of their BG value. | Other: Blood Glucose meter<br>* Staff tested subject Blood Glucose using a Blood Glucose meter.<br>* Other names: Contour® Blood Glucose Meter;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose | The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are > +/-20% different than meter BG values when samples have BG >=75mg/dL or > +/- 15mg/dL different than meter BG values when samples have BG <75mg/dL, as measured by fingerstick CONTOUR®. | 1 visit 15-20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose | The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are > +/-15% different than meter BG values when samples have BG >=100 mg/dL or > +/- 15 mg/dL different than meter BG values when samples have BG <100 mg/dL, as measured by fingerstick CONTOUR®. | 1 visit 15-20 minutes |