linjc16/ctgov huggingface dataset:
Rhomboid Flap Versus Primary Closure After Excision of Sacrococcygeal Pilonidal Sinus. (A Prospective Randomized Study)

Study Overview
=================
Brief Summary
-----------------
To evaluate and compare between excision with primary closure of wound and excision with Rhomboid flap reconstruction in the treatment of pilonidal sinus as regard duration of operation, healing time, hospital stay, complications and recurrence rate.

Official Title
-----------------
Rhomboid Flap Versus Primary Closure

Conditions
-----------------
Evaluate and Compare Between Excision and Primary Closure Procedure and Rhomboid Flap Technique for the Treatment of Pilonidal Sinus, Duration of Operation,

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic pilonidal sinus Exclusion Criteria: pilonidal abcess

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 43 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pilonidal disease, natal cleft, limberg flap
Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) Assay

Study Overview
=================
Brief Summary
-----------------
Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.

Official Title
-----------------
Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) Assay

Conditions
-----------------
Sunscreen Agents

Intervention / Treatment
-----------------
* Drug: BAY 987519
* Drug: SPF 15 Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of an age of 18 to 70 years inclusive; Fitzpatrick Skin Type I, II and/or III for SPF testing; Good health as determined from the CRO Subject History Form (SHF); Signed and dated Informed Consent Form; Signed and dated Health Insurance Portability and Accountability Act (HIPAA) Form; An unambiguous minimal erythema dose (MED).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPF evaluation<br>Subjects with good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were included for SPF testing. | Drug: BAY 987519<br>* Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.<br>Drug: SPF 15 Control<br>* Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of 2 hours water resistant SPF | ISO/COLIPA Sun Protection FactorTest Method. | 16-24 h post exposure |
A Study of Pattern of Presentation of Pulmonary Tuberculosis Patients Undergoing Treatment at Assiut University Hospital

Study Overview
=================
Brief Summary
-----------------
The objective of the investigator's study is to detect the characteristics, pattern and outcome of pulmonary tuberculosis patients treated at Assiut University Hospital by collecting their demographic, clinical, laboratory and radiological data.

Detailed Description
-----------------
Tuberculosis (TB) is a problem of global importance, it is a medical, social and economic disaster of immense magnitude that is occurring over the world TB remains one of the major health risks associated with morbidity and mortality. Worldwide, about 10 million TB cases have been reported in 2017, and about 1.57 million cases have died The estimated global average risk of infection is 1%, implying approximately 38 million new infections per year among the previously uninfected population . In Egypt ,researchers have found evidences of tuberculosis in the Egyptian mummies dating from 3000 to 2400 Before Christ and WHO reported that TB is the most important public health problem after hepatitis C , TB disease can affect any organ, but most commonly occurs in the lungs (70%-80%). Pulmonary TB is the most important form of TB infection, because an infection of the lungs is highly contagious due to the mode of droplet transmission . Patients with TB usually manifest diverse signs and symptoms that vary with age, sex and the associated socio-environmental as well as host factors .

Official Title
-----------------
A Study of Pattern of Presentation of Pulmonary Tuberculosis Patients Undergoing Treatment at Assiut University Hospital

Conditions
-----------------
Pulmonary Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pulmonary tuberculosis adult patients (age ≥ 18 years) who will attend the outpatient clinic of Chest Department at Assiut University Hospital during 2019 - 2020. Exclusion Criteria: Patients less than 18 ys. loss of patient follow-up . extrapulmonary tuberculosis.

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 |
| --- | --- | --- |
| sputum smear conversion | type of positive sample (spontaneous sputum , induced sputum , bronchoalveolar lavage) , technique used for AFB detection (Ziehl - Neelsen (ZN) staining , GeneXpert , conventional TB culture , non-conventional culture ) | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sputum culture conversion | type of positive sample (spontaneous sputum , induced sputum , bronchoalveolar lavage) , technique used for AFB detection (Ziehl - Neelsen (ZN) staining , GeneXpert , conventional TB culture , non-conventional culture ) | baseline |
Epilepsy Impact Scale

Study Overview
=================
Brief Summary
-----------------
The investigators are developing a questionnaire that can quickly measure the impact that epilepsy has on a person's life. This questionnaire will be useful in following whether the impact of epilepsy increases, decreases or stays the same over time. The results also may point out areas that would benefit from discussion or attention in visits with your doctor.

Detailed Description
-----------------
The investigators have used a set of broad open-ended questions about the impact of epilepsy on a person's life to formulate a long list of questions to characterize the impact the seizures, medications, and comorbidities that you are having. In the future, this will be boiled down to a short list of questions.

Official Title
-----------------
Questionnaire Development for a Comprehensive Scale to Measure the Impact of Epilepsy on Life.

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Other: Interviews and questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or more. Patient has had at least 1 seizure in the past 365 days. Patient can speak and understand English. Exclusion Criteria: Patients suspected of having one of the imitators of epilepsy, for example, syncope, sleep disorder, psychogenic nonepileptic seizures, will be excluded, even if they also have epileptic seizures. Patients unwilling to spend the time doing the questionnaire.

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 |
| --- | --- |
| People with epilepsy<br>People with epilepsy who have have had at least one seizure in the prior year. | Other: Interviews and questionnaires<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of a concise question set |  | Up to 1 year for question set validation, data presentation within up to 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of subscales | Correlation of subscales of the study questionnaire with previously validated scales, including QoLiE-39, NHS Seizure Severity Scale, Liverpool side effects scale, Beck Depression Index | Up to 1.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epilepsy, quality of life, seizure severity, antiepileptic drug side effects, questionnaire, patient reported outcomes
Medical Abortion With Single Daily Dose of Misoprostol

Study Overview
=================
Brief Summary
-----------------
Medical abortion using multiple vs single daily dose of misoprostol in first trimester miscarriage.

Official Title
-----------------
Medical Abortion With Multiple vs Single Daily Dose of Misoprostol in First Trimester Miscarriage: A Randomized Clinical Trial.

Conditions
-----------------
Miscarriage

Intervention / Treatment
-----------------
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Maternal age more than 18 years old (age of legal consent). Gestational age less than 13 weeks. Hemoglobin >10 g/dL. BMI between 25 kg/m2 and 35 kg/m2. Missed abortion. Living fetus with multiple congenital malformations incompatible with life. Exclusion Criteria: Maternal age less than 18 years old. Gestational age more than 12 weeks. Hemoglobin <10 g/dL. Anencephaly. Fibroid uterus. BMI less than 25kg/m2 and more than 35kg/m2. Coagulopathy. History or evidence of adrenal pathology. Previous attempts for induction of abortion in the current pregnancy. Allergy to misoprostol or letrozole. Medical disorder that contraindicate induction of abortion (e.g. heart failure).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single daily dose<br> | Drug: Misoprostol<br>* Misoprostol<br>|
| Active Comparator: Multiple daily doses<br> | Drug: Misoprostol<br>* Misoprostol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete miscarriage | Assessed by trans-vaginal ultrasound where endometrial thickness less than 15 mm is considered complete miscarriage | one week |
Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)

Study Overview
=================
Brief Summary
-----------------
The primary objective was to assess the effect of SR141716 on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with or without comorbidities. The main secondary objectives were to assess the effect of SR141716 on lipid parameters (HDL-C, TG), glucose tolerance status, the rate of patients with metabolic syndrome, waist circumference, glycemic parameters.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing Effect and Safety of SR141716 in Obese Patients With or Without Comorbidities (RIO-Europe)

Conditions
-----------------
Obesity

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body mass index (BMI) e30 kg/m2 in patients with or without comorbidities, or BMI >27 kg/m2 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia. stable body weight (variation <5 kg within 3 months prior to screening visit); Exclusion Criteria: History of very low-calorie diet within 6 months prior to screening visit; or history of surgical procedures for body weight loss (eg, stomach stapling, bypass); Presence of any clinically significant psychiatric , neurological or endocrine disease Presence of treated or untreated type 1 or type 2 diabetes); SBP >165 mmHg and/or DBP >105 mmHg on 2 consecutive visits from the screening to the inclusion visit; History of myocardial infarction or unstable angina pectoris within 6 months prior to screening visit; and history of stroke within 6 months prior to screening visit; Administration of anti-obesity drugs or other drugs for body weight reduction within 3 months prior to screening visit; The investigator will evaluate whether there are other reasons why a patient may not participate.

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 |
| --- | --- | --- |
| change in body weight from baseline to 1 year. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL-C and TG from baseline to 1 year; ·patients (%) with improvement of glucose tolerance, patients (%) with NCEP-ATPIII metabolic syndrome at 1 year. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, risk factors
Fast Titration of Oral Appliance at Obstructive Sleep Apnea Syndrome (OSAS) Treatment

Study Overview
=================
Brief Summary
-----------------
The literature does not discuss if the fast oral appliance titration (30 days period) in Obstructive Sleep Apnea Syndrome (OSAS) treatment, may improve subjects quality of life in such brief period. Temporomandibular dysfunction-related (TMD) is one of the most important side effects observed in OSAS treatment with oral appliance. Since the effectiveness of mandibular exercises in the control of TMD pain has already been verified, it may play a fundamental role in the support of the fast oral appliance titration.

Official Title
-----------------
Evaluation of the Efficacy and Side Effects of Fast Mandibular Advancement With Oral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome

Conditions
-----------------
Obstructive Sleep Apnea Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI ≤ 35kg/m2 MILD TO MODERATE OSAS DIAGNOSIS ACCORDING TO THE AASM CRITERIA (2005) Negative TMD diagnosis (according to RDC/TMD) Exclusion Criteria: DENTAL CONDITIONS THAT CONTRAINDICATED THE ORAL APLLIANCE USAGE SLEEP DISORDERS OTHER THAN OSAS

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
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 |
| --- | --- |
| Fast Titration<br> | |
| Regular Titration<br> | |
| Fast Tritation Including Mandibular Exercises<br> | |
| Regular Tritation Including Mandibular Exercises<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
-----------------
Mandibular Advancement, Oral Appliance, TMD
DNA Methylation and 1-C Metabolism Nutrient Intake

Study Overview
=================
Brief Summary
-----------------
The present study used a sub-sample of the Melbourne Collaborative Cohort Study (MCCS) (Milne RL et al, Int J Epidemiol, 2017), who had valid data on dietary intakes (121-item food frequency questionnaire) and valid measures of DNA methylation using the HumanMethylation Infinium 450K Beadchip assay, or using LINE-1, Alu and Sat2 assays. The investigators studied the association between nutrients involved in one-carbon metabolism and DNA methylation in peripheral blood.

Official Title
-----------------
Dietary Intake of One-carbon Metabolism Nutrients and DNA Methylation in Peripheral Blood

Conditions
-----------------
DNA Methylation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Selected into one of six case-control studies nested in the Melbourne Collaborative Cohort Study Completed a 121-item Food Frequency Questionnaire Had a blood DNA sample with a measure of methylation Exclusion Criteria: Missing data in any of the outcome, exposure, or confounders (N=797 excluded)

Ages Eligible for Study
-----------------
Minimum Age: 27 Years
Maximum Age: 80 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood DNA methylation | Methylation of DNA from peripheral blood, HumanMethylation 450 Beadchip assay | 2014-2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood DNA methylation | Methylation of DNA from peripheral blood, LINE-1, Alu, Sat2 | 2014-2015 |
The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females

Study Overview
=================
Brief Summary
-----------------
The efficacy of Solifenacin Succinate 5 mg as adjuvant therapy and levofloxacin (500 mg) for short-term treatment to reduce symptoms in patients with symptomatic non complicated urinary tract infection in females.

Official Title
-----------------
The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Symptomatic Non-complicated Urinary Tract Infection in Females

Conditions
-----------------
Urinary Tract Infection

Intervention / Treatment
-----------------
* Drug: Levofloxacin
* Drug: Solifenacin succinate
* Drug: Placebo (for Solifenacin succinate)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: females (18-65 years old) dysuria in symptomatic non complicated urinary tract infection Exclusion Criteria: Pediatric Patients (< 18 years old) geriatric Patients (> 65 years old) pregnant Patients Patients with complicated urinary tract infection sexually transmitted infections Patients with pathological abnormalities in the urinary bladder, including stone/mass Catheter-mounted Neurological diseases/disorders patients with allergy/hypersensitivity with Levofloxacin/Solifenacin

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: levofloxacin and solifenacin succinate<br>Levofloxacin 500 mg tablet and solifenacin succinate 5 mg tablet by mouth once daily for 3 days | Drug: Levofloxacin<br> <br> * Other names: neslav;Drug: Solifenacin succinate<br> <br> |
| Active Comparator: levofloxacin and placebo<br>Levofloxacin 500 mg tablet and placebo (for solifenacin succinate) by mouth once daily for 3 days | Drug: Levofloxacin<br> <br> * Other names: neslav;Drug: Placebo (for Solifenacin succinate)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with storage symptoms |  | up to three days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
female, age 18-65 years, storage symptoms, clinical urinary tract infection, non complicated