linjc16/ctgov huggingface dataset:
Transvaginal Versus Transobturator Paravaginal Repair

Study Overview
=================
Brief Summary
-----------------
Clinical trial comparing the new technique for paravaginal repair versus the traditional technique

Detailed Description
-----------------
trial comparing the transobturator paravaginal repair versus the traditional technique

Official Title
-----------------
Transvaginal Versus Transobturator Paravaginal Repair Trial

Conditions
-----------------
Cystocele

Intervention / Treatment
-----------------
* Procedure: Transobturator Paravaginal Repair
* Procedure: traditional transvaginal Paravaginal Repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: paravaginal defect cystocele midline and paravaginal defect cystocele Exclusion Criteria: uterine descent previous cystocele surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transobturator arm<br>Transobturator Paravaginal Repair | Procedure: Transobturator Paravaginal Repair<br>* Transobturator application of sutures to the white line in cases needing paravaginal repair<br>|
| Experimental: Transvaginal arm<br>traditional transvaginal Paravaginal Repair | Procedure: traditional transvaginal Paravaginal Repair<br>* traditional transvaginal application of sutures to the white line<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative data | Operative time | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic organ prolapse quantification system | Evaluation of the postoperative degree of anterior vaginal wall descent | 3 month | 
| Operative Details | blood loss | 1 day |
Helicobacter Pylori Eradication and Irritable Bowel Syndrome: A Prospective Study

Study Overview
=================
Brief Summary
-----------------
H. Pylori is frequently observed in patients with irritable bowel syndrome(IBS). However, the effect of H. pylori eradication on IBS is not clear.

Detailed Description
-----------------
Patients with IBS symptoms using Rome IV criteria will be included. Testing for H. pylori will be done. Patients with H. pylori will receive triple therapy and followed after two weeks for eradication and assessment of IBS symptoms.

Official Title
-----------------
Effect of Helicobacter Pylori Eradication on Symptoms and Quality of Life of Irritable Bowel Syndrome: A Prospective Study

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: Triple therapy for H.pylori


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients newly diagnosed with IBS and H.pylori Exclusion Criteria: Patients received previous treatment of H.pylori Patients receiving treatment for IBS.
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
Interventional Model Description: Patients with IBS and have H. pylori
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with IBS<br>Patients with IBS and positive H. pylori. | Drug: Triple therapy for H.pylori<br>* Triple therapy of proton pump inhibitors, clarithromycin and metronidazole.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire for Rome IV criteria | Symptoms of IBS | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life questionnaire | Quality of life. | 2 weeks |
Excretion of Radiolabelled AZD0837

Study Overview
=================
Brief Summary
-----------------
This is an explorative study and the scientific question to be investigated in this study is if AZD0837 and/or its metabolites AR-H069927XX and AR-H067637XX and other unknown metabolites are excreted into the bile.

Official Title
-----------------
An Open, Single Centre Pharmacokinetic (Phase 1) Study of the Biliary Excretion of AZD0837 and Metabolites Following a Single Dose of [3H] AZD0837 Given in the Duodenum Via a Loc-I-Gut Catheter to Young Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD0837


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body mass index (BMI) between 19 to 30 kg/m2 and body weight between 50 to 100 kg inclusive Exclusion Criteria: Significant illness, trauma or surgical procedures. Clinically significant laboratory abnormalities. Clinically significant medical history.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD0837|Oral solution, dosing through the Loc-I-Gut catheter, single dose|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amounts of total radioactivity excreted in bile. Metabolic profile of AZD0837 excreted in bile and identification of previously unknown metabolites and the amounts of AZD0837, AR-H069927XX and AR-H067637XX in bile. |  | Frequent sampling through a Loc-I-Gut catheter for up to 3 hours post dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables of AZD0837, AR-H069927XX, and AR-H067637XX. |  | Frequent sampling during 24 hours. | 
| Adverse events, physical examination, safety laboratory variables, blood pressure, pulse and electrocardiography. |  | Some of the safety variables will be followed at each visit, some less frequent. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics
ONO-2952 Single-dose PET Study in Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the brain TSPO occupancy of ONO-2952 in healthy adult subjects after a single dose using [11C]PBR28 as a specific PET ligand for TSPO. The secondary objective is to evaluate the relationship between TSPO occupancy and the plasma concentration of ONO-2952 and to investigate the safety and tolerability of ONO-2952 in healthy subjects.

Official Title
-----------------
Open-Label, Single-Center, Single Dose Positron Emission Topography (PET) Using [11C]PBR28 to Evaluate Brain Translocator Protein 18KDa (TSPO) Occupancy of ONO-2952 in Healthy Adult Subjects

Conditions
-----------------
Healthy Adult Subjects

Intervention / Treatment
-----------------
* Drug: ONO-2952


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy non-smoking male or female subjects (18-55 inclusive) Body mass index (BMI) of 19-35 kg/m2 (inclusive) For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception Exclusion Criteria: History or presence of clinically significant disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br> | Drug: ONO-2952<br>* 1 mg to 200 mg QD at a single descending dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the brain TSPO occupancy of ONO-2952 in healthy adult subjects after a single dose using [11C]PBR28 as a specific PET ligand for TSPO |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the relationship between TSPO occupancy and the plasma concentration of ONO-2952 |  | 2 days | 
| To investigate the safety and tolerability of ONO-2952 in healthy adult subjects |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-2952, Healthy adult subjects, single doe, PET study, Safety, Tolerability
Human Chorionic Gonadotropin Supplementation Prior to In-vitro Fertilization Treatment in Poor Responders

Study Overview
=================
Brief Summary
-----------------
In an era of delayed fertility plans, there is increasing need for fertility treatment in older women with poor response. Human chorionic gonadotropin (hCG) supplementation prior to treatment, as a thecal stimulant, may improve folliculogenesis and ovarian response.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Ovitrelle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women >39 years on IVF treatment Exclusion Criteria: polycystic ovary syndrome Any allergy to injection of human chorionic gonadotropin before

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ovitrelle supplemantation<br>The women will be given 250 mcg of Ovitrelle prior to their IVF cycle | Drug: Ovitrelle<br>* One dose of Ovitrelle 250 mcg<br>|
| No Intervention: no Ovitrelle supplementation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of oocytes retrieved |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
in-vitro fertilization, poor responders, human chorionic gonadotropin, Fertility Agents, Female
A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding

Study Overview
=================
Brief Summary
-----------------
The study is designed to assess the efficacy and safety of famciclovir 250 mg twice a day (bid) suppressive treatment in men and women with herpes virus type 2 (HSV-2) infection, with and without a reported history of genital herpes and with or without herpes virus type 1 (HSV-1) seropositivity.

Official Title
-----------------
A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding

Conditions
-----------------
Genital Herpes

Intervention / Treatment
-----------------
* Drug: Famciclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or non-pregnant females at least 18 years of age with HSV-2 seropositive serology with or without history of clinically diagnosed recurrent genital herpes Exclusion Criteria: Pregnancy History of renal dysfunction Use of immunosuppressive therapy, including steroids (other than topical or inhaled), or use of probenecid Hypersensitivity to famciclovir, valacyclovir or drugs with similar chemical structure

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group 1. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients with a history of clinical genital herpes lesions |  |  | 
| Group 2. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients without a history of clinical genital herpes lesions |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of HSV DNA PCR positive days without lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions |  |  | 
| quantitative HSV DNA PCR, during the days with positive HSV-2 shedding. |  |  | 
| time to the first recurrence of genital herpes and number of genital herpes recurrence episodes |  |  | 
| oral HSV-1 and/or HSV-2 shedding in HSV-1 and HSV-2 seropositive patients |  |  | 
| reduction of HSV DNA PCR positive days with lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genital herpes, viral shedding, famciclovir, Symptomatic genital herpes, Asymptomatic genital herpes
Three-dimensional Assessment of Craniofacial Structures

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to reduce the radiation exposure in orthodontic patients by the use of a new imaging protocols based on non-ionizing orthodontic records (e.g. digital dental models, three-dimensional photograph) The first step in this process is to develop and validate an orthodontic analysis able to assess craniofacial proportions, dental, skeletal, and facial soft tissue. The investigators working hypothesis is that data from three-dimensional facial photographs and from digital dental casts can be registered accurately and consistently, and the diagnostic information about tooth position and facial soft-tissue derived from them are comparable to x-ray derived data

Official Title
-----------------
Assessment of Dental, Skeletal Pattern, and Soft Tissue Using Three-dimensional Images

Conditions
-----------------
Malocclusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full permanent dentition Complete set of digital orthodontic records Must be able to follow directions Exclusion Criteria: Incomplete orthodontic records
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 |
| --- | --- | --- |
| Assessment of dental and soft tissue position relative to cone-beam computed tomography (CBCT) |  | At the time of initial orthodontic records |
CARMEDAS: Cost-Effectiveness Analysis of Imaging Strategies in Symptomatic Carotid Stenosis

Study Overview
=================
Brief Summary
-----------------
PURPOSE: The purpose of this clinical trial is to study the cost-effectiveness ratios of diagnostic strategies for the imaging assessment of symptomatic carotid stenosis. MATERIALS AND METHODS: The diagnostic accuracies of Doppler ultrasound (DUS), contrast-enhanced magnetic resonance angiography (CEMRA) and computed tomography angiography (CTA) were compared with digital subtraction angiography (DSA) in a multicenter study (CARMEDAS; 206 patients assessable) and in a meta-analysis (for CEMRA and CTA). The direct costs of each imaging method were calculated in 2 university medical centers. Eight hypothetical models were studied with DUS considered as the first-line imaging method and either CEMRA or CTA or DSA as the second or third line method. The effectiveness criterion was the number of potential avoided strokes for each strategy and for 1000 patients.

Official Title
-----------------
Cost-Effectiveness Analysis of Imaging Strategies in Symptomatic Carotid Stenosis

Conditions
-----------------
Carotid Stenosis

Intervention / Treatment
-----------------
* Procedure: contrast-enhanced magnetic resonance angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Carotid artery stenosis > 50%

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: contrast-enhanced magnetic resonance angiography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the cost-effectiveness ratios of diagnostic strategies for the imaging assessment of symptomatic carotid stenosis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carotid artery stenosis, cost effectiveness, magnetic resonance angiography, computed tomography angiography, digital subtraction angiography
High-fat Yogurt and Plasma Lipids Profile

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to compare the effect of saturated fat intake from different source on cardiometabolic risk markers in healthy subjects. The main question it aims to answer are: -Does intake of saturated fat in the form of high-fat yogurt have a different effect on cardiometabolic risk factors than intake of the same amount from butter? In this study, in two periods of 4 weeks, the effect of receiving saturated fat from high-fat yogurt compared to receiving the same amount of saturated fat from butter and low-fat yogurt on the plasma concentration of lipids, cholesterol, insulin, and some inflammatory factors will be studied in healthy subjects.

Official Title
-----------------
Comparison of the Impact of Saturated Fat From High-fat Yogurt or Low-fat Yogurt and Butter on Cardiometabolic Risk Markers: a Randomized Cross-over Trial

Conditions
-----------------
Plasma Lipid Profile

Intervention / Treatment
-----------------
* Other: saturated fat intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy people who do not use lipid-lowering, blood pressure control or diabetes medications Exclusion Criteria: Taking supplements of omega-3 fatty acids, or antioxidants

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-fat yogurt<br>Daily consumption of 1-2 servings (based on daily calorie requirement) of high-fat yogurt | Other: saturated fat intake<br>* Intake of saturated fat from yogurt and animal butter daily for 4-week period<br>|
| Active Comparator: Low-fat yogurt and butter<br>Daily consumption of 1-2 servings of low-fat yogurt along with daily consumption of about 10 grams of animal butter | Other: saturated fat intake<br>* Intake of saturated fat from yogurt and animal butter daily for 4-week period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma lipid profile | Plasma concentrations of cholesterol, high-density lipoprotein cholesterol, Low-density lipoprotein cholesterol, and triglyceride | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic measures | Fasting plasma concentrations of glucose and insulin | 4 weeks |