linjc16/ctgov huggingface dataset:
Evaluation of Safety and Efficacy of Mersina, an Ayurvedic Formulation: A Double Blind, Placebo Controlled Study in Type 2 Diabetic Patients With Secondary Failure to Oral Drugs

Study Overview
=================
Brief Summary
-----------------
To determine the safety and efficacy of an Ayurvedic formulation, Mersina in type 2 diabetic patients with secondary failure to oral hypoglycemic agents, a randomized double blind, single centre, study of 3 months duration was carried out.

Official Title
-----------------
Evaluation of Safety and Efficacy of Mersina, an Ayurvedic Formulation: A Double Blind, Placebo Controlled Study in Type 2 Diabetic Patients With Secondary Failure to Oral Drugs

Conditions
-----------------
Antihyperglycemic Effect in Type 2 Diabetic Patients With Secondary Failure to Oral Hypoglycemic Agents

Intervention / Treatment
-----------------
* Drug: Mersina


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Secondary failure to Oral Hypoglycemic Agents was diagnosed if the patient had HbA1c levels > 8.5% even after supplementation of maximal dose of a combination of a sulphonylurea (15 mg glybenclamide or 160 mg gliclazide or 15 mg glipizide) and metformin 1500 mg/day. Exclusion Criteria: Patients with ketosis, diabetes related complications, hepatic or renal disease, pancreatitis, cardiac problems, uncontrolled hypertension, malnutrition and severe immune deficiency

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: CORN STARCH<br> | Drug: Mersina<br>* capsule, 3g/day, 3 months<br>|
| Active Comparator: Mersina, Diet and exercise<br> | Drug: Mersina<br>* capsule, 3g/day, 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antidiabetic activity |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in metabolic, insulin level, HbA1c,kidney and lipid profile |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ayurvedic formulation, type 2 diabetes mellitus, secondary failure to oral hypoglycemic agents, antidiabetic
Projected Peripheral Defocus Using a Wearable Device

Study Overview
=================
Brief Summary
-----------------
Acucela Inc. intends to develop a medical device to significantly halt or reverse myopic progression, which is a significant public health concern across the world, especially in Asian demographics. Acucela is working towards a spectacle-like device (eSPECs), which will have a clear zone for unimpeded central visual tasks and a periphery that provides defocus in order to alter retinal physiology leading to myopia regulation. This study will establish the changes seen during a proof-of-concept that projected defocus in the periphery utilizing a wearable device will stimulate physiological changes similar to those in the literature.

Official Title
-----------------
Effects of Projected Peripheral Defocus on Ocular Biometrics Using a Wearable Device

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)
* Device: No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spherical equivalent +2.00 to -4.00 diopters Refractive cylinder ≤ 0.75 diopters Visual acuity 20/20 -3 or better Exclusion Criteria: Pregnant or lactating Active ocular infection History of dry eye, strabismus, or amblyopia Previous or planned ocular surgery Use of medication known to affect vision or accommodation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Test Arm<br> | Device: Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)<br>* For the right/test eye, a defocused image is projected onto the peripheral retina while the subject views a distant, in-focus image<br>Device: No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)<br>* For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length (AL) | Change in AL from baseline in the test eye vs. control eye | 1 hour | 
| Choroidal thickness (CT) | Change in CT from baseline in the test eye vs. control eye | 1 hour |
The Effect of Fish Oil Supplementation on Vocal Performance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine if use of omega-3 PUFA supplement in combination with a singer's training regimen enhances training adaptations and body composition.

Official Title
-----------------
The Effect of Fish Oil Supplementation on Vocal Performance

Conditions
-----------------
Voice Range Profile, Reflux Symptom Index, Evaluation of Ability to Sing Easily, Body Composition

Intervention / Treatment
-----------------
* Dietary Supplement: omega-3 PUFA supplement
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Apparently healthy college vocal performers (male and female of all ethnicities) *Between the ages of 18-28 years Majoring in classical voice in the Baylor University School of Music or musical theatre in the Baylor University Department of Theatre Arts. Exclusion Criteria: Previously diagnosed with a voice disorder Vegans Smokers Allergic to fish, shellfish or safflower oil Have been taking daily FO n-3 supplement within the past three months, or any supplement known to effect muscle biology (e.g. creatine).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 28 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: omega-3 PUFA supplement<br>omega-3 PUFA supplement, 3.0 grams per day | Dietary Supplement: omega-3 PUFA supplement<br>* participants were instructed to take 3.0 grams per day of omega-3 PUFA supplement<br>|
| Placebo Comparator: placebo<br>safflower oil, 3.0 grams per day | Dietary Supplement: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Evaluation of Ability to Sing Easily | survey designed to aid in subject self-assessment | baseline and up to 11 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Voice Range Profile | known as a phonetogram, is a representation of a participants minimum and maximum intensity levels across vocal range | baseline and up to 11 weeks | 
| change in Body composition | height in cm, weight measured in kg. Bio-electrical impedance scale use to assess lean and body fat mass, measured in kg. Weight and height were combined to report BMI in kg/m^2 | baseline and up to 11 weeks |
Evaluation of a Disposable Sound Sensor for Recording Respiration During Sleep

Study Overview
=================
Brief Summary
-----------------
Split-night prospective monocentric study to evaluate, in real conditions, the effectiveness of a disposable tracheal sound sensor.

Official Title
-----------------
Evaluation of a Disposable Sound Sensor for Recording Respiration During Sleep

Conditions
-----------------
Sleep Apnea (Disorder)

Intervention / Treatment
-----------------
* Device: Sleep apnea diagnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected obstructive sleep apnea Exclusion Criteria: Lung infection Insomnia

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: Evaluation of a disposable sound sensor for recording respiration during sleep<br>PneaVoX sensor, CIDELEC | Device: Sleep apnea diagnosis<br>* Split-night<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyzable signal time | Percentage of the analyzable signal duration compared to the total recorded signal duration | One night |
Effect of Steroids on Cerebral Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if methylprednisolone is effective in reducing the cerebral inflammatory response after open heart surgery with cardiopulmonary bypass.

Detailed Description
-----------------
In a previous study we found that patients undergoing aortic valve surgery had elevated cerebrospinal inflammatory markers. In this study we aim to investigate if this inflammatory response can be reduced after treatment with steroids. 30 patients will be randomized to intraoperative treatment with either placebo or methylprednisolone 15mg/kg. CSF and blood will be collected the day before and the day after surgery, analyzed for markers of inflammation (IL-6, IL-8), neuronal damage (S-100) and blood brain barrier function (alb).

Official Title
-----------------
Effect of Steroids on Cerebrospinal Fluid Markers of Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement

Conditions
-----------------
Aortic Stenosis

Intervention / Treatment
-----------------
* Drug: Methylprednisolone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective aortic surgery +/- coronary artery bypass grafting (CABG) Exclusion Criteria: coagulopathy preoperative neurologic deficit uncontrolled hypertension

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylprednisolone<br>Methylprednisolone i.v. 15mg/kg x 1 intraoperative Aortic Valve Replacement | Drug: Methylprednisolone<br>* Methylprednisolone 15mg/kg<br>* Other names: Solu-Medrol;|
| Placebo Comparator: Placebo (NaCl)<br>Placebo i.v., x1, intraoperative Aortic Valve Replacement | Drug: Placebo<br>* Placebo<br>* Other names: Sodium Chloride;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb |  | 24h after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative/intraoperative insulin demand |  | 24h after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebrospinal fluid, inflammatory markers, heart surgery, neuronal damage, blood brain barrier
Sedative-Anxiolytic Effects on Simulated Driving Performance

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of anxiety drugs taken at night on the ability to drive a car the next day. Participants will receive alprazolam, placebo, or zolpidem at night before bed or in the morning before using a driving simulator to assess impairment.

Official Title
-----------------
Alprazolam and Simulated Driving Performance: Next Day Effects

Conditions
-----------------
Psychomotor Impairment

Intervention / Treatment
-----------------
* Drug: Alprazolam 2mg (2ALP/PLC)
* Drug: Alprazolam 1mg (1ALP/PLC)
* Drug: Alprazolam 0.5mg (0.5ALP/PLC)
* Drug: Zolpidem 10mg (ZOL/PLC)
* Drug: Placebo (PLC/PLC)
* Drug: Alprazolam 1mg (PLC/ALC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: valid driver's license english-speaking and literate Exclusion Criteria: using daily medication for chronic condition acute narrow angle glaucoma previous adverse experience with study drugs experiences motion sickness in response to driving simulator BMI > 30 women who are pregnant, lactating, or planning on becoming pregnant regular use of tobacco products current substance use disorder clinically significant ECG current ongoing psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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: All Participants<br>All participants received each intervention with alprazolam, zolpidem and placebo. | Drug: Alprazolam 2mg (2ALP/PLC)<br>* 2mg alprazolam administered at night, placebo administered in the morning.<br>Drug: Alprazolam 1mg (1ALP/PLC)<br>* 1mg alprazolam administered at night, placebo administered in the morning.<br>Drug: Alprazolam 0.5mg (0.5ALP/PLC)<br>* 0.5mg alprazolam administered at night, placebo administered in the morning.<br>Drug: Zolpidem 10mg (ZOL/PLC)<br>* 10mg alprazolam administered at night, placebo administered in the morning.<br>Drug: Placebo (PLC/PLC)<br>* Placebo administered at night, placebo administered in the morning.<br>Drug: Alprazolam 1mg (PLC/ALC)<br>* Placebo administered at night, 1mg alprazolam administered in the morning.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Deviation of Lane Position (SLDP) | Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane. | 16 hours |
Type 2 Diabetes and the Effect of Probiotics

Study Overview
=================
Brief Summary
-----------------
Insulin-resistance in type 2 diabetes is associated with chronic inflammation. Anti-inflammatory actions might increase sensitivity to insulin. Since some probiotics have anti-inflammatory properties, ingestion of the probiotic bacteria Lactobacillus Acidophilus NCFM might increase insulin-sensitivity. The inflammatory response to endotoxin injection and the insulin-sensitivity is examined before and after four weeks ingestion of probiotics.

Detailed Description
-----------------
Numerous studies have shown an association between insulin-resistance in type 2 diabetes and chronic low-grade inflammation. Some probiotics have an anti-inflammatory properties. Ingestion of probiotics might therefore, due to this property, increase sensitivity to insulin. In this study type 2 diabetics (N=24) and healthy control (N=24) are given the probiotic bacteria Lactobacillus Acidophilus NCFM for four weeks. The anti-inflammatory effect is examined by evaluating the inflammatory response (White blood cell count, plasma-cytokines) to an iv injection of endotoxin (0,3 ng/kg) before and after the intervention. Also the insulin-sensitivity is measured with an hyperinsulinemic euglycemic clamp before and after L. acidophilus NCFM.

Official Title
-----------------
Effect of Probiotics on Systemic Inflammation and Insulin Resistance in Type 2 Diabetics and Healthy Controls

Conditions
-----------------
Type 2 Diabetes, Healthy, Endotoxemia

Intervention / Treatment
-----------------
* Drug: Lactobacillus acidophilus NCFM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Type 2 diabetes Exclusion Criteria: Heart failure Lung disease Infections in the last two weeks before endotoxin injections. Treatment with antibiotics

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: Lactobacillus acidophilus NCFM|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin-resistance |  |  | 
| Change in inflammatory response to E. coli endotoxin injection |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, Probiotics, Insulin-resistance, Inflammation, Hyperinsulinemic euglycemic clamp, Endotoxin
EMERALD - AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the incidence and evolution over-time of co-morbidities in a general dual-chamber pacemaker population (n=2188 patients) through a 2 years follow-up.

Detailed Description
-----------------
The study will focus on the number of patients moving to persistent Atrial Fibrillation as a function of cumulative %Vp (< or >40%), in a general dual-chamber pacemaker population through a 2 year follow-up (n=2188). The same endpoint will be analyzed in sub populations (Sinus Node Disease and AVB) at 4 years follow up (n=4290).

Official Title
-----------------
AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients

Conditions
-----------------
Atrial Arrhythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patient implanted (primo-implant, replacement, upgrade) with dual chamber pacemaker from less than two months or implanted at inclusion. Exclusion Criteria: Contraindicated for cardiac pacing, according to the ESC and ACC/AHA/HRS guidelines Permanent or persistent atrial tachyarrhythmia

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 |
| --- | --- | --- |
| Atrial arrhythmias incidence | Two consecutive visits in which atrial fibrillation was present or - at least 22 hours of atrial fibrillation for at least 7 consecutive days or - at least 22 hours of atrial fibrillation per day for fewer than 7 consecutive days if an interruption by electrical or pharmacologic cardioversion occurred | 2 years | 
| % ventricular pacing | as measured in the device over the timeframe period | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reply, Symphony, Atrial arrhythmias, V pacing, Evaluate the incidence and evolution over-time of co-morbidities
The Effect of Education on Decreasing the Prevalence and Severity of Neck and Shoulder Pain

Study Overview
=================
Brief Summary
-----------------
Neck and shoulder pain (NSP) is fairly common among high school students in Korea. Presumably, the high prevalence of NSP in Korean adolescents is a consequence of an inappropriate static position for a prolonged period of time. We suspect that proper education and posture correction for Korean adolescents may decrease the prevalence or severity of NSP. Although several studies have focused on the etiology of NSP during adolescence, few studies have addressed the management or prevention of NSP in adolescents, despite its high prevalence in this age group. The aims of this prospective study was to identify the effects of education, in terms of recognition of this issue and posture correction, on prevalence and severity of NSP in Korean adolescents

Conditions
-----------------
Korean, Male, Adolescents

Intervention / Treatment
-----------------
* Behavioral: Education and posture correction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high school students Exclusion Criteria: deny to participate

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 19 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Korean Male Adolescents<br>students from two academic high schools | Behavioral: Education and posture correction<br>* a lecture concerning the fine posture for health and exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS score of neck and shoulder pain | numeric rating scale (NRS; range, 0-100)of neck and shoulder pain during the 1-week period preceding follow-up | 3 months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index (NDI) | Total NDI scores were interpreted as follows: 0-4, no disability; 5-14, mild disability; 15-24, moderate disability; 25-34, severe disability; >34, complete disability | 3 months later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Education, Neck pain, Shoulder pain, Prevalence, Associated factors, Students