linjc16/ctgov huggingface dataset:
Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This study was conducted to assess the bioequivalence of the ezetimibe tablet to Ezetrol ® in healthy Chinese volunteers and estimate the pharmacokinetic proﬁles of ezetimibe tablet.

Official Title
-----------------
Study on the Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Conditions
-----------------
Hyperlipidemias

Intervention / Treatment
-----------------
* Drug: ezetimibe tablet
* Drug: ezetimibe tablet(Ezetrol ®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects ≥18 years of age The body mass index is in the range of 18.0-26.0 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg. Serum total cholesterol was between 2.9 and 5.0mmol/L (not including critical value). Exclusion Criteria: any medical history of cardiovascular, digestive, respiratory, nervous or ematological diseases hepatic/renal impairment abnormal vital signs drug or alcohol abuse smoking ≥5 cigarettes per day , donation(≥300ml) o enrollment in other clinical trials during the 3 months prior to screening allergic to ezetimibe or its excipients any use of other prescription drugs or vitamins or caffeine/xanthine-rich beverages 48h prior to taking medication lactating or pregnant women

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ezetimibe tablet<br>ezetimibe tablet test formulation at a single dose of 10 mg | Drug: ezetimibe tablet<br>* The subjects randomly received single oral administration of ezetimibe tablet 10 mg<br>|
| Active Comparator: ezetimibe tablet(Ezetrol ®)<br>ezetimibe tablet reference formulation at a single dose of 10 mg | Drug: ezetimibe tablet(Ezetrol ®)<br>* The subjects randomly received single oral administration of ezetimibe tablet (Ezetrol ®) 10 mg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) Peak Plasma Concentration (Cmax) | Peak Plasma Concentration (Cmax) Evaluation of Peak Plasma Concentration (Cmax) | 80 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC)0-t | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t | 80 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ezetimibe Tablet, Bioequivalence, Pharmacokinetics
Nerve Access Tool Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the ability of the nerve access tool to facilitate nerve stimulation lead placement.

Official Title
-----------------
A Prospective, Non Randomized, Single-center, Non-blinded Feasibility Study Examining the Use of a Nerve Access Tool

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

Intervention / Treatment
-----------------
* Device: Facilitate nerve stimulation lead placement with the nerve access tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is equal to or greater than 18 years of age Subject has a diagnosis of cystocele with planned surgical repair Subject has no known deficit of the nerve Subject is willing and able to provide written informed consent and HIPAA authorization to participate by signing the Informed Consent/Health Insurance Portability and Accountability Act Form after a full explanation of the nature and purpose of this study Subject is willing and able to comply with the study protocol Exclusion Criteria: Subject has known neurological abnormalities of the nerve Subject has a known allergy to the tool or neurostimulation lead components Subject is pregnant or lactating

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Research Arm<br>Facilitate nerve stimulation lead placement with the nerve access tool | Device: Facilitate nerve stimulation lead placement with the nerve access tool<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyography Response |  | Implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
The focus of the study is to assess the ability of the nerve access tool to facilitate nerve lead placement
Effects of Probiotic Capsules in Promoting Fat Excretion by Human Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the efficacy of 2 capsules (500 mg per capsule, 1000 mg per day) of Grape King Probiotic Capsules per day in promoting fat excretion in obese patients by clinical human food test.

Detailed Description
-----------------
This experiment is carried out in a controlled manner. Before the subjects enter the research experiment, they need to follow their original lifestyle. The habits of maintaining a constant body weight for more than 2 weeks before the test, such as calorie balance in the diet and the amount of activity. Then enter the test to carry out the evaluation test of probiotics to the end. 60 subjects were randomized, 20 to placebo and 40 to probiotics. The subjects took two capsules of Grape King probiotics daily, a total of 1000 mg. Continue to take it for 4 weeks, and perform blood routine tests. Body composition detection, waist and hip circumference measurement, related index analysis and 24-hour dietary questionnaires, gut health questionnaires and stool samples were collected and analyzed for 4 weeks before and after treatment.

Official Title
-----------------
Effects of Grape King Bio Probiotic Capsules in Promoting Fat Excretion by Human Trial

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

Intervention / Treatment
-----------------
* Dietary Supplement: probiotics
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female participants aged 20-40 years old body mass index in 25-27 kg/m2 body fat > 25% for men and > 30% for women Exclusion Criteria: cancer, chronic heart disease, use drugs which pharmacological effects may affect immunity having systemic infections using probiotics.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>Probiotic capsules, 500 mg each, two daily for a total of 1000 mg for 4 weeks | Dietary Supplement: probiotics<br>* Eat a capsule for once, and twice a day<br>|
| Placebo Comparator: Placebo<br>The placebo capsules had the same composition as the experimental capsules, except that they did not contain probiotics, and should be used for 4 weeks. | Dietary Supplement: placebo<br>* Eat a capsule for once, and twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline fecel lipid weight at week 4 | Compared the difference of fecel lipid weight level between the week 4 and 0 | Week0, Week4 |
Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma

Study Overview
=================
Brief Summary
-----------------
This study is a preliminary proof of efficacy study of AIN457 in patients with bronchial asthma that is poorly controlled with the current standard of care.

Official Title
-----------------
A Randomized, Double-blind, Placebo Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous Administration of Secukinumab (AIN457) in Patients With Asthma Not Adequately Controlled With Inhaled Corticosteroids and Long Acting Beta-agonists.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: AIN457 (secukinumab)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with asthma >1 year duration diagnosed according to the GINA guidelines (GINA 2010). Daily treatment with > 1000μg beclomethasone dipropionate or equivalent, plus a long acting beta agonist for ≥ 3 months prior to Day 1, that has been stable for at least 4 weeks prior to screening. Asthma which is not adequately controlled on current treatment Peripheral blood eosinophil count < 400/μl at screening Exclusion Criteria: Women of child-bearing potential unwilling to use effective contraception during the study and for 16 weeks after stopping treatment. Use of other investigational drugs at the time of screening, or within 30 days of screening. Smokers

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIN457<br>AIN457 10 mg/kg | Drug: AIN457 (secukinumab)<br>* Secukinumab intravenous injection<br>|
| Placebo Comparator: Placebo<br>Placebo intravenous injection | Drug: Placebo<br>* Placebo intravenous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score | The ACQ scores range from 0 to 6 with lower scores reflecting better asthma control. Without loss of generality, as Day 85 minus baseline (Visit 3) so that improvements in asthma control translate to negative change scores. | Baseline and 85 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Secukinumab, Therapeutic Uses, Respiratory, Lung, Pulmonary, inhaled, corticosteroids
Behavioral Lifestyle Intervention Study (BLIS) in Patients With Type 2 Diabetes in UAE: A Randomized Controlled Trial in Real Life Setting

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to develop a behavioral lifestyle intervention and evaluate its effectiveness in improving the glycemic control in patients with type 2 diabetes in real life setting. This is because ambiguity still exists on the effectiveness of behavioral lifestyle interventions in routine clinical practice despite of the efficacy of large randomized controlled trials, suggesting the need for more research in this area.

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Behvarioal lifestyle modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females or males. Type 2 diabetes. BMI (kg/ m²) ≥ 25. Age 18-60 years old. HbA1c > 7%. Exclusion Criteria: major physical activity disability that restricts participation in moderate physical activity. serious heart condition like heart failure, heart attack, stroke within the last 3 months. participating in a weight management or lifestyle program. presence of proliferative retinopathy or kidney failure.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavrioal Lifestyle modification<br> | Behavioral: Behvarioal lifestyle modification<br>* A six months behavioral lifestyle program composed of 8 sessions; 4 individual consultations and 4 telephonic calls. The cognitive behavior theory (CBT) is the underpinning theory for the lifestyle intervention; hence CBT behavioral strategies like self monitoring and goal setting are used to improve compliance to healthy lifestyle practices<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c% |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 6 months | 
| Body composition analysis |  | 6 months | 
| Lipid profile ( serum cholesterol, LDL, HDL, triglycerides) |  | 6 months | 
| Blood presssure (systolic and diastolic) |  | 6 months | 
| carbohydrates intake in grams |  | 6 months | 
| physical exercise in minutes per day |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive behavior therapy, Lifestyle modification, HbA1c, Carbohydrates
Pentraxin-3 in Chronic Renal Failure

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to measure Pentraxin-3 levels in patients on hemodialysis, peritoneal dialysis and those in the pre-dialysis period; and to compare these groups with the control group; so as to investigate the eligibility of it as a reliable marker of inflammation; relationship with other inflammatory markers and carotis intima media thickness.

Detailed Description
-----------------
The investigators planned to involve four group of patients: Hemodialysis, peritoneal dialysis, pre-dialysis and the control group; with about 25 patients planned to be involved in each group. The laboratory parameters to be measured are Pentraxin-3, C-reactive protein (CRP), high sensitive CRP, fibrinogen and interleukin-6. Concomitantly, carotis intima media thickness will be measured in the radiology clinic. Statistical analysis will be carried on by Statistical Package for Social Sciences (SPSS) for Windows 13.0. The variables acting on the inflammatory parameters and the correlation between them and carotis intima media thickness will be studied.

Official Title
-----------------
The Role Pentraxin-3 in the Inflammatory Process in Chronic Renal Failure, and the Association With Other Inflammatory Parameters

Conditions
-----------------
Inflammation, Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To give informed consent Hemodialysis or peritoneal dialysis for more than 3 months Creatinin clearance less than 30 ml/min for the pre-dialysis group Exclusion Criteria: Not to give informed concent Active infection within the last 3 months Known chronic inflammatory disease

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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 |
| --- | --- |
| Hemodialysis group<br>Patients on chronic hemodialysis program | |
| Peritoneal dialysis group<br>Patients on chronic peritoneal dialysis program | |
| Pre-dialysis group<br>Patients with chronic kidney disease stage-4 | |
| Control group<br>Healthy subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pentraxin-3 level | Pentraxin-3 level will be compared with other inflammatory markers. | Five months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotis intima media thickness | Correlation of Pentraxin-3 and carotis intima media thickness | Five months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, peritoneal dialysis, chronic kidney disease, inflammation, carotis intima media thickness
Small Bowel Motility in Patients With Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
Several studies using intestinal manometry have reported alterations in small bowel motility in patients with systemic sclerosis. Our aim is to apply endoluminal image analysis to stratify the intestinal motor dysfunction in these patients can be assessed by non-invasive techniques. Consecutive patients with systemic sclerosis referred to our institution will be prospectively investigated using automated non-invasive techniques developed in our laboratory. Intraluminal images of the gut were obtained by capsule endoscopy. Endoluminal image analysis will be performed with original, previously validated programs based on computer vision and machine learning techniques.

Official Title
-----------------
Intestinal Dysmotility in Patients With Functional Digestive Symptoms

Conditions
-----------------
System Sclerosis

Intervention / Treatment
-----------------
* Diagnostic Test: Endoluminal image analysis by capsule endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systemic sclerosis diagnosed by ACR criteria Exclusion Criteria: Lung transplantation End stage kidney disease

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systemic sclerosis<br> | Diagnostic Test: Endoluminal image analysis by capsule endoscopy<br>* Studies will be performed after discontinuation of medications that could affect gastrointestinal motility for at least 48 hours and overnight fast. Endoluminal images were obtained with the Pillcam capsule (Pillcam SB3 video capsule; Medtronic). Images will be obtained at a fixed 2 per second rate and recorded for a total of 8 hours with the subjects lying comfortably on a hospital bed and the trunk raised 30° above horizontal. Forty-five minutes after gastric exit, participants will be instructed to ingest a liquid meal (Ensure HN; Abbott; 300 mL,1 Kcal/mL). Endoluminal images of the small bowel will be analyzed with a computer program specifically developed in our laboratory for the evaluation of intestinal motility. This previously validated program is based on computer vision techniques, which allow the detection and quantification of contractile and non-contractile patterns characterizing small bowel motility.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motility index score |  | 8 hours |
Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
Comparison of Ultrasonic Cardiac Output Monitor (USCOM) system with Fick and thermodilution methods during right heart catheterization in patients with pulmonary hypertension.

Official Title
-----------------
Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Device: Ultrasonic Cardiac Output Monitor (USCOM) system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age > 18 years Diagnosis of Group 1 or Group 4 PAH based on PAPm > 25 mmHg, PAWP <15 mmHg, PVR >3 WU and consistent clinical history. Note: for logistical reasons, patients at high suspicion for Group 1 or Group 4 PAH will sign informed consent to have the USCOM system applied during right heart catheterization before the procedure; if it is found that the patient does not meet the definition of Group 1 or Group 4 PAH during right heart catheterization, he/she will be excluded. Willingness and ability to comply with study procedures. No known hypersensitivity to the components of USCOM electrodes Exclusion criteria: Unwillingness to sign informed consent or inability or unwillingness to comply with study procedures Evidence of postcapillary pulmonary hypertension on right heart catheterization

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: USCOM<br> | Device: Ultrasonic Cardiac Output Monitor (USCOM) system<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output measurement correlation at baseline | Correlation between cardiac output measurement between USCOM system and Fick and thermodilution methods of cardiac output measurement (standard of care) | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output measurement correlation after vasodilator testing | Correlation between cardiac output measurement between USCOM system and Fick and thermodilution methods of cardiac output measurement (standard of care) after vasodilator trial testing | 30 minutes |