linjc16/ctgov huggingface dataset:
A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study in couples and to evaluate the safety of personal lubricant products.

Detailed Description
-----------------
Study to evaluate the safety of Class II personal lubricant devices.

Official Title
-----------------
A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions

Conditions
-----------------
Coitus

Intervention / Treatment
-----------------
* Device: PD-F-5254
* Device: 10855-096


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal, healthy males and females >18 years of age In committed heterosexual relationship for >6months On acceptable method of birth control Exclusion Criteria: Pregnant or breastfeeding Allergy to product ingredients Irritation or infection in genital area Unstable or uncontrolled medical condition

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MINE Alone<br>Female Personal Lubricant (PD-F-5254) | Device: PD-F-5254<br>* Female Personal Lubricant (MINE)<br>* Other names: K-Y;|
| Experimental: YOURS and MINE<br>Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254) | Device: PD-F-5254<br>* Female Personal Lubricant (MINE)<br>* Other names: K-Y;Device: 10855-096<br>* Male Personal Lubricant (YOURS)<br>* Other names: K-Y;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Showing Change From Baseline in Irritation Scores | Number of participants showing change in irritation scores based on physical examinations of both male and female subjects according to a 6-point scale, ranging from 0=Normal appearance, no irritation to 6 = Presence of Lesions | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Sensations Experienced by Male Subjects - Overall | Number of sensations experienced by male subjects, based on two applications of the investigational product. | 1 Week | 
| Number of Sensations Experienced by Female Subjects - Overall | Number of sensations experienced by female subjects, based on two applications of the product for each subject. | 1 Week |
Prevalence of Genetic Polymporphism on RNF213 rs112735431 Gene in Non-cardioemboli Ischemic Cerebrovascular Disease

Study Overview
=================
Brief Summary
-----------------
To explore the prevalence of genetic polymorphism on RNF213 rs112735431 gene in non-cardioembolic ischemic cerebrovascular disease in Thai patients.

Detailed Description
-----------------
This is an cross-sectional observational study in Chulalongkorn hospital, to determine the prevalence of genetic polymorphism on RNF213 rs112735431 gene in non-cardioembolic ischemic cerebrovascular disease. Patients who are potentially eligible for study participation will be identified through a chart review of patients who were admitted in Chulalongkorn Hospital for acute ischemic stroke treatment.

Official Title
-----------------
Prevalence of Genetic Polymporphism on RNF213 rs112735431 Gene in Non-cardioemboli Ischemic Cerebrovascular Disease: A Cross-sectional Study in Thai Patients

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Genetic: DNA sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nationality in Thailand Age equal or more than 18 years Clinical and imaging diagnosis of acute ischemic stroke Patient consent to participate in the research Exclusion Criteria: High risk for cardioembolic stroke by TOAST classification Contraindication for venipuncture Pregnancy or breast feeding patient History of head and neck radiation Down's syndrome Marfan syndrome Autoimmune disease such as SLE Ongoing malignancy or remission of malignancy less than 1year

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 |
| --- | --- |
| non embolic ischemic stroke<br>acute ischemic stroke from atherosclerosis or lacunar stroke | Genetic: DNA sequencing<br>* withdraw 3m blood from vein only once during the whole design to analyse on DNA sequencing on RNF213 rs112735431 Gene<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With RNF213 rs112735431 Gene polymorphism |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RNF213 rs112735431 Gene, Acute Non-embolic ischemic stroke
Istria County CPR Survival 2011-2017

Study Overview
=================
Brief Summary
-----------------
Analysis of factors that influence CPR survival of 1440 patients that were resuscitated in Istria County, Croatia between 2011-2017.

Detailed Description
-----------------
Survival status, duration to EMS arrival, level of education of initial CPR provider, initial monitored rhythm, cause of cardiac arrest, age, gender and time of year will be recorded and analyzed to determine which factors influence CPR survival.

Official Title
-----------------
Effect of Duration of EMS Teams' Arrival on CPR Survival in Istria County, Croatia, 2011.-2017.

Conditions
-----------------
Cardiopulmonary Resuscitation

Intervention / Treatment
-----------------
* Procedure: Cardiopulmonary resuscitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all adult patients that were resuscitated in Istria county because of out of hospital cardiac arrest (OHCA) Exclusion Criteria: minors

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients resuscitated in Istria county<br>Cardiopulmonary resuscitation performed for OHCA | Procedure: Cardiopulmonary resuscitation<br>* CPR performed because of out-of-hospital cardiac arrest<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival status | Documented as electrocardiographic and hemodynamic evidence of return of spontaneous circulation | At hospital admission |
Granulocyte-monocyte Apheresis in Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
BACKGROUND: Granulocyte-monocyte apheresis has been proposed for the treatment of ulcerative colitis, although is limited by costs and variability of results.

Official Title
-----------------
Granulocyte-monocyte Apheresis in Steroid-dependent, Azathioprine-intolerant/Resistant Moderate Ulcerative Colitis: a Prospective Multicentre Study

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Device: apheresis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate UC with steroid-dependence and azathioprine intolerance or resistance
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 |
| --- | --- |
| Other: apheresis<br>leukapheresis in ulcerative colitis | Device: apheresis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| steroid-free clinical remission |  | 3 months |
Impact of Continuous Positive Airway Pressure on the Treatment of Acute Asthma Exacerbation

Study Overview
=================
Brief Summary
-----------------
This current study aimed to demonstrate the effectiveness of the addition of CPAP to the current conventional therapy in terms of airway obstruction improvement in acute asthma patients.

Detailed Description
-----------------
Continuous positive airway pressure (CPAP) is widely used in providing ventilator support. However, its role in an acute asthmatic attack is uncertain. The purpose of this study was to compare the efficacy of CPAP when used in addition to conventional therapy with conventional therapy alone in the management of acute asthma exacerbation.

Official Title
-----------------
Impact of Continuous Positive Airway Pressure on the Treatment of Acute Asthma Exacerbation

Conditions
-----------------
Acute Asthma

Intervention / Treatment
-----------------
* Device: Continuous positive airway pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged over 18 years known asthmatic patients visiting ED with acute exacerbation had given their written informed consent. Exclusion Criteria: smoking history chronic obstructive pulmonary disease required intubation instability of hemodynamic or arrhythmia unable to perform PEFR facial abnormality pulmonary infiltration pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: NIPPV<br> | Device: Continuous positive airway pressure<br>* CPAP 8 cmH2O<br>* Other names: GoodKnight 420 G; Nellcor Puritan Bennett Inc.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| an improvement in PEFR, as % predicted |  | 75 mins | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchial disease, asthma, continuous positive airway pressure (CPAP), Bronchoconstriction
Fructo-oligosaccharides and Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
Fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the intestinal microbiota and particularly to stimulate the growth of Bifidobacteria. Imbalance of the intestinal microbiota such as reduction of Bifidobacteria is implicated in Irritable Bowel Syndrome (IBS). Thus the objective of the study is to evaluate the effect of fructo-oligosaccharides to improve IBS score and to explore which modifications of the microbiota are responsible of this improvement.

Official Title
-----------------
Effect of Dietary Supplementation With Fructo-oligosaccharides on Visceral Sensitivity and on Taxonomic and Functional Composition of Intestinal Microbiota of IBS Patients

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

Intervention / Treatment
-----------------
* Dietary Supplement: Fructo-oligosaccharides
* Dietary Supplement: Maltodextrins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IBS subjects according to Rome III criteria Incomfort below or equivalent to 30mmHg during Tensostat test between 18 and 60 years no antibiotic treatment for the last 2 months less than 20g of dietary fibres consummed per day no analgesic treatment no treatment for intestinal transit Exclusion Criteria: subjects suffering from diabetes, colic cancer, inflammatory bowel disease, dysthyroidy, Hirschprung disease, anorexia excessive consumption of alcohol or tobacco participating to another clinical study pregnant women antidepressor or anxiolytic treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fructo-oligosaccharides | Dietary Supplement: Fructo-oligosaccharides<br>* Dietary supplementation for 4 weeks<br>|
| Placebo Comparator: 2<br>Maltodextrins | Dietary Supplement: Maltodextrins<br>* Dietary supplementation for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rectal sensitivity |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| taxonomic composition of intestinal microbiota |  | 4 weeks |
Investigation of the Effect of Acupuncture Needling on Connective Tissue Using Ultrasound Elastography

Study Overview
=================
Brief Summary
-----------------
During acupuncture treatment, acupuncture needles are inserted and manipulated until a characteristic local tissue reaction termed de qi is observed. De qi can be perceived by the acupuncturist in the form of needle grasp, a mechanical gripping of the needle by the tissue. De qi is considered essential to the therapeutic effect of acupuncture. Therefore, the investigator proposes that understanding this local tissue reaction will lead to an understanding of how the therapeutic effect of acupuncture therapy arises. Specifically, it is hypothesized that needle manipulation causes winding of collagen and elastic fibers around the needle. This action induces tension in the collagen network surrounding the needling site and results in a mechanical signal that is transduced into local cells. The objective of the current work is to use ultrasound elastography, a recently developed ultrasound imaging technique, to visualize and quantify changes in the elastic properties of skin and subcutaneous tissue in 12 healthy human volunteers as a result of acupuncture needle manipulation.

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

Intervention / Treatment
-----------------
* Device: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Acupuncture|nan|

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
-----------------
elastic property of skin
Instrument Development of Screening Prediabetes Patients

Study Overview
=================
Brief Summary
-----------------
It will be more effective if we can work on the primary prevention for the high risk groups of diabetes and prediabetes such as the early detection.

Detailed Description
-----------------
During the past years, many efforts were put on the diagnosis and treatment of DM and its complications. It will be more effective if we can work on the primary prevention for the high risk groups of diabetes and prediabetes such as the early detection. As a first public health step, it is worthwhile to identify prediabetes people in community by screening program. Three thousand persons will be randomly selected from residents of Taichung city. All the participants will fulfill a structured questionnaire and 'Diabetes risk factor screening tool' which American Diabetes Association suggested in 2003. This project will estimate the prevalence of prediabetes in conventional hospital-base population as well as the validity of a screening questionnaire for prediabetes.

Official Title
-----------------
Instrument Development of Screening Prediabetes Patients

Conditions
-----------------
Prediabetic State

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Residents aged 40 and over of Taichung city, Taiwan in October, 2004. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
Steep Trendelenburg Positioning on Intra-Ocular Pressure During Surgery for Endometrial Robotics Versus Laparotomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess changes of intra-ocular pressure (IOP) and examine preoperative facts affecting IOP in endometrial cancer patients undergoing robotic hysterectomy compared to laparotomy.

Detailed Description
-----------------
All patients that are surgical candidates with endometrial cancer will be screened for this study. Two measurements from each eye will be taken in the following positions: awake at rest, supine before induction, after induction on anesthesia, after insufflation of abdomen with CO2 in supine position, in trendelenburg position, in deep trendelenburg position,at the end of procedure,prior to awakening in supine position and one last reading 45-60 min after awakening in supine position. The time, blood pressure, heart rate, peak airway pressure, plateau airway pressure, end tidal desflurane, end tidal CO2, total IV fluids administered, and blood loss.

Official Title
-----------------
Effects of Steep Trendelenburg Positioning on Intra-Ocular Pressure During Surgery For Endometrial Cancer: Robotics Versus Laparotomy

Conditions
-----------------
Intraocular Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Endometrial Cancer Surgery Exclusion Criteria: Not a surgical candidate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Endometrial Cancer Patients Hysterectomy Robotic Surgery | |
| 2<br>Endometrial Cancer Patient Hysterectomy Laparotomy Surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the changes in intra-ocular pressure and examine perioperative factors affecting IOP in endometrial cancer patients undergoing robotic hysterectomy compared to a laparotomy |  | 5years for enrollment completion |
Skin Incisions and Wound Complication Rates for C-sections in Obese Women

Study Overview
=================
Brief Summary
-----------------
It is the purpose of this study to evaluate the relationship between a low transverse, vertical midline, and supra-panicular high transverse skin incisions and the rate of wound complications in women with a BMI of 40 or greater undergoing a cesarean section for delivery. So far, the choice of incision for the morbidly obese is based only on case reports. No randomized controlled trials have been done up to date comparing these methods. It is our hope that a high transverse incision will have all of the benefits of a low transverse skin incision, with the added benefit of better exposure offered by a vertical midline incision, without the added increased risk of subjecting the woman to a vertical hysterotomy.

Official Title
-----------------
Randomized Controlled Trial of Wound Complication Rates Between Low Transverse, Midline Vertical, and High Transverse Skin Incisions in Women With a BMI of 40 or Above Undergoing a Cesarean Section for Delivery

Conditions
-----------------
Obesity, Infection; Cesarean Section, Surgical Wound

Intervention / Treatment
-----------------
* Procedure: Midline Vertical
* Procedure: High Transverse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pre-pregnancy BMI equal or greater than 40 Exclusion Criteria: prior cesarean section or laparotomy
Sexes Eligible for Study
-----------------
Female

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Low Transverse<br>Patients in this arm will undergo their cesarean section using the standard low transverse skin incision location | |
| Experimental: Midline Vertical<br>Patients in this arm will undergo their cesarean section using a midline vertical skin incision | Procedure: Midline Vertical<br>* Cesarean section performed using a midline vertical skin incision, located between the umbilicus and pubis<br>|
| Experimental: High Transverse<br>Patients in this arm will undergo their cesarean section using a high transverse skin incision, above the pannus | Procedure: High Transverse<br>* Cesarean section performed using a transverse skin incision located above the pannus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Complications |  | 6 months |