linjc16/ctgov huggingface dataset:
Double-Blind Comparison Between Mitiglinide and Nateglinide in Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of Mitiglinide compared to Nateglinide for the treatment of type 2 diabetes.

Official Title
-----------------
Multicentre, Double-Dummy, Randomized, Double-Blind Comparison Between Mitiglinide and Nateglinide in the Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: Mitiglinide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes patients with inadequate control of blood glucose with diet and/or exercise therapy Exclusion Criteria: Type 1 diabetes patients Patients who require treatment with insulin Patients with severe diabetic complications (neuropathy, retinopathy or nephropathy) Patients with severe ketosis, diabetic coma or precoma Patients complicated with severe hepatic diseases Patients complicated with severe renal diseases Patients complicated with severe hypertension Patients complicated with severe cardiac disease Pregnant women or women possible to be pregnant, nursing women, or women who want to become pregnant during the study period

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: 2<br>Nateglinide 120 mg TID | Drug: Mitiglinide<br>* 10mg tablet, 10mg TID<br>* Other names: Glufast;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C (HbA1C) |  | -2, 0, 4, 8, 10, 12, 16, 20 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose level (FPG) |  | 0, 4, 8, 12, 16, 20 week | 
| Two-hour postprandial glucose level (PPG2) |  | 0, 12, 20 week | 
| One-hour postprandial glucose level (PPG1) |  | 0, 12, 20 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, rapid and short acting insulin secretagogue, α-glucosidase inhibitor, HbA1C, insulin
Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing

Study Overview
=================
Brief Summary
-----------------
This study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of the three following indications: sinus node dysfunction, atrial disease (or bradycardia/tachycardia) and atrio-ventricular paroxysmal block. In addition use and outcome of automatic functions will be evaluated.

Official Title
-----------------
Clinical Observations of Automatic Algorithms for Cardiac Pacing

Conditions
-----------------
Bradycardia, Sick Sinus Syndrome, Heart Block

Intervention / Treatment
-----------------
* Device: Insignia Ultra and Insignia AVT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dual chamber pacemaker (INSIGNIA ULTRA or AVT pacemaker), implant not older than 60 days, estimated life expectancy more than one year in case of associated illness, Age ≥ 18 years, signed patient information. Exclusion Criteria: Indication for conventional treatment with ventricular resynchronisation or by implantable defibrillator during inclusion, implanted for severe permanent AVB (AVB 2/1 and complete), PR > 250 ms, implant of the device older than 60 days before the inclusion date, Heart transplant foreseen within six months, unexplained syncope.

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

| Intervention/Treatment |
| --- |
|Device: Insignia Ultra and Insignia AVT|Regular AV-Delay increase to allow for intrinsic AV conduction, if present.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Atrio-ventricular hysteresis algorithm on percentage of Ventricular pacing | % Vp is compared between patients with atrio-ventricular hysteresis algorithm ON and OFF in patients with sino-atrial disease or paroxysmal AV block. | At 12 Months |
Feeling of Being in Control of One's Own Action

Study Overview
=================
Brief Summary
-----------------
The investigators aim is to understand the cognitive mechanisms that contribute to the emergence of delusions of control (the belief that one's own actions or thoughts are controlled by an external force). These symptoms are mainly encountered in patients with schizophrenia, and the investigators will distinguish patients with schizophrenia with or without this symptom together with patients with bipolar disorder. Based on the investigators previous studies, this project will help to determine the role of two elementary mechanisms in the ability to feel in control of voluntary actions: (1) the processing of the sensory consequences of action, and (2) the ability to build mental representations for sequenced actions.

Official Title
-----------------
Feeling of Being in Control of One's Own Action: Which Mechanisms in Healthy Volunteers and in Mental Diseases

Conditions
-----------------
Schizophrenia, Bipolar Disorders

Intervention / Treatment
-----------------
* Behavioral: Experimental psychology methods (computer tests)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with schizophrenia or bipolar disorders (criteria DSM IV) or healthy controls matched with patients on age, sex and education level 18-55 years old Exclusion Criteria: Past history affecting CNS Invalidating sensory disorders Intake of psychotropic drugs, except for patients Intake of benzodiazepines

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Healthy volunteers | Behavioral: Experimental psychology methods (computer tests)<br> <br> |
| Experimental: Arm 2<br>Schizophrenia with history of delusions of control | Behavioral: Experimental psychology methods (computer tests)<br> <br> |
| Experimental: Arm 3<br>Schizophrenia without history of delusions of control | Behavioral: Experimental psychology methods (computer tests)<br> <br> |
| Experimental: Arm 4<br>Bipolar disorders | Behavioral: Experimental psychology methods (computer tests)<br> <br> |
| Active Comparator: Arm 5<br>Matched healthy controls | Behavioral: Experimental psychology methods (computer tests)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Study of LBBP

Study Overview
=================
Brief Summary
-----------------
At present, cardiac pacing has been widely used in the treatment of bradyarrhythmias and heart failure, which can effectively improve the survival rate of patients. With the rapid development of technology, you can choose to pace the heart in different parts. The atrium can choose the right atrial appendage, the atrial septum and the right ventricular side wall. The right ventricle can choose to be paced in the His bundle, right ventricular apex and ventricular septal outflow tract. The right ventricle can choose the pacing positions including left bundle branch pacing and left ventricular pacing via coronary vein. There are few studies comparing the long-term efficacy and safety of different pacing programs in daily practice. This study is to observe the short-term and long-term effects and safety of different parts of cardiac pacing, and compare the advantages and disadvantages of different parts of cardiac pacing.

Official Title
-----------------
Study of the Efficacy and Safety of Cardiac Pacing of Different Sites

Conditions
-----------------
Bradyarrhythmias, Heart Failure

Intervention / Treatment
-----------------
* Procedure: pacemaker implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received pacemaker implantation in the Second Hospital of Zhejiang Medical University by Pan Xiaohong and other surgeons. Patients who have the ability to understand the test and can cooperate with investigators. Exclusion Criteria: Patients who unable to understand or unwilling to fill in informed consent forms or follow visitors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: pacemaker implantation|cardiac pacing has been widely used in the treatment of bradyarrhythmias and heart failure, which can effectively improve the survival rate of patients.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Cardiovascular death, myocardial infarction, and stroke events |  | 60 months |
Safety and Efficacy of AGN201781 in Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
This study will explore the safety and efficacy of AGN201781 in patients with postherpetic neuralgia or post-traumatic peripheral neuralgia

Conditions
-----------------
Neuralgia

Intervention / Treatment
-----------------
* Drug: AGN201781
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of postherpetic neuralgia or post-traumatic peripheral neuralgia Moderate or severe pain associated with postherpetic neuralgia or post-traumatic peripheral neuralgia Exclusion Criteria: Women of child-bearing potential Any other uncontrolled diseases

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGN201781<br>AGN201781 50 mg capsules three-time daily for 2 weeks | Drug: AGN201781<br>* AGN201781 50 mg capsules three-times daily for 2 weeks<br>|
| Placebo Comparator: Placebo<br>placebo 50 mg capsules three-times daily for 2 weeks | Drug: placebo<br>* placebo 50 mg capsules three-times daily for 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Daily Pain Score at Week 2 | Change from baseline in the daily-average-pain score at week 2. This was measured using a 11-point (0 to 10) scale where 0 represented no pain and 10 represented worst pain. Due to the low number of patients completing the treatment period of the study no analyses were performed | Baseline, Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Subject Global Impression of Change Score at Week 2 | Change from baseline in Subject Global Impression of Change score at week 2. The Subject Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale (1=very much improved to 7=very much worse). Due to low number of patients completing the treatment period of the study no analyses were performed. | Baseline, Week 2 |
Regional Anesthesia Database

Study Overview
=================
Brief Summary
-----------------
This is a quality assurance database to prospectively examine regional anesthesia outcomes at Toronto Western Hospital.

Official Title
-----------------
Regional Anesthesia Database

Conditions
-----------------
Regional Anesthesia

Intervention / Treatment
-----------------
* Procedure: Ultrasound guided blocks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Patients having regional anesthesia - Exclusion Criteria:Patients not having regional anesthesia -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Ultrasound guided blocks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
18F-NaF Uptake and Aortic Stenosis Progression

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate whether baseline 18F-sodium fluoride uptake activity at aortic valve could predict aortic stenosis progression in moderate aortic stenosis. Patients with moderate aortic stenosis are enrolled and underwent baseline evaluation including 18F-sodium fluoride PET/CT. After 1 year, all the participants underwent follow-up echocardiography. The study design is an observational trial. Primary endpoint was a change in mean pressure gradient along the aortic valve as assessed by echocardiography at 1 year. Secondary endpoints include changes in aortic valve area, and symptom occurrence.

Detailed Description
-----------------
Recent studies demonstrated 18F-sodium fluoride (NaF) uptake activity as a marker of early-stage calcification. Although valve calcification could be visualized either by echocardiography or coronary computed tomography, they only reflect the current burden of calcium deposit not the activity of calcium deposit. Limited studies exist regarding the usefulness of 18F-NaF uptake at aortic valve for prediction of stenosis progression. Patients with moderate aortic stenosis - diagnosed by echocardiography - will be enrolled. Enrolled participants will undergo baseline 18F-NaF PET/CT within 6 weeks of baseline echocardiography and followed up for 1 year. After 1 year, all the participants are required to evaluate the aortic stenosis progression by performing echocardiography. The objective of the study is to test whether baseline 18F-NaF uptake activity predict AS progression.

Official Title
-----------------
Clinical Value of 18F-sodium Fluoride Uptake at the Aortic Valve for Prediction of the Progression in Patients With Moderate Aortic Stenosis: a Prospective Study

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

Intervention / Treatment
-----------------
* Other: Imaging test: 18F-NaF PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 20 years old moderate aortic stenosis Exclusion Criteria: age < 20 yrs pregnant women

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Imaging test: 18F-NaF PET/CT|18F-NaF PET/CT as an imaging test|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean PG |  | AS severity progression after 1 year |
Prospective Evaluation of Predictors for Organ Failure Following Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Early organ failure occurs frequently and is difficult to predict. The study aims to define a predictive score for early transplant failure.

Detailed Description
-----------------
Patients will be monitored 7 days following liver transplantation, including clinical scores, clinical chemistry, ultrasound findings and indocyaninegreen-clearance.

Official Title
-----------------
Prospective Evaluation of Predictors for Organ Failure Following Liver Transplantation

Conditions
-----------------
Liver Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: orthotopic liver transplantation age > 18 years Exclusion Criteria: allergy to indocyangreen

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?
-----------------
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
-----------------
liver transplantation, organ failure, outcome
Prevention of Catheter-Associated Urinary Tract Infection in Incontinence and Reconstructive Pelvic Surgery Patients

Study Overview
=================
Brief Summary
-----------------
The study will assess the risk of catheter associated urinary tract infection in women undergoing incontinence or reconstructive pelvic surgery. Women will be given an antibiotic or placebo at the time of catheter removal. The investigators hypothesize that prophylactic antibiotics will reduce the rate of infection.

Official Title
-----------------
Prevention of Catheter-Associated Urinary Tract Infections in Patients Undergoing Incontinence and Reconstructive Pelvic Surgery: A Randomized Controlled Trial

Conditions
-----------------
Catheter-Associated Urinary Tract Infection

Intervention / Treatment
-----------------
* Drug: Bactrim
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Requires catheterization >24h hours following incontinence or pelvic reconstructive surgery Exclusion Criteria: Receipt of antibiotics for either prophylaxis or treatment of a known infection during the postoperative hospitalization Allergy to sulfonamides or trimethoprim Non-English speaking Pregnancy Breast feeding Severe renal impairment (creatinine clearance <30) Patients taking dofetilide, methenamine, procaine, warfarin, procainamide, methotrexate.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug<br> | Drug: Bactrim<br>* Bactrim DS BID for 3 days<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Corn starch capsules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Urinary Tract Infection | Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as >100,000 colony forming units/mL | 7 days following catheter removal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
catheter, urinary tract infection
Sleep Intervention for Kids and Parents: A Self-Management Pilot Study

Study Overview
=================
Brief Summary
-----------------
Behavioral intervention for 6-11 year children with persistent asthma and sleep disturbance and a parent with sleep disturbance.

Official Title
-----------------
Sleep Intervention for Kids and Parents (SKIP): A Self-Management Pilot Study

Conditions
-----------------
Sleep Disturbance, Asthma

Intervention / Treatment
-----------------
* Behavioral: Sleep Intervention for Kids and Parents (SKIP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (child): Children 6-11 years Child diagnosis of asthma with prescription for daily medication Able to understand English (child) Sleep disturbance per CSHQ (child >= 41) and/or < 9 hours of sleep per night Exclusion Criteria (child) Parent reported diagnosis of traumatic brain injury, developmental delay, autism spectrum disorder, attention deficit hyperactivity disorder (ADHD), obstructive sleep apnea, cancer Positive sleep related breathing disorder screening (obstructive sleep apnea screening) Inclusion Criteria (parent) 18 years or older Able to understand and read English Lives with child 50% of time or more Is child's legal guardian Has reliable access to internet >/= 5 on Pittsburgh Sleep Quality Index or <7 hours overnight reported sleep Exclusion Criteria (parent) Diagnosed obstructive sleep apnea or sleep disordered breathing Is a nightshift worker Uses sleep medication

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 11 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Dyadic intervention for school-age children and a parent
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SKIP Intervention<br> | Behavioral: Sleep Intervention for Kids and Parents (SKIP)<br>* Dyadic approach using self-efficacy theory to set goals, anticipate barriers, problem solve<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total sleep time | Actigraphy | 3 months post intervention (x 10 days of measurement) | 
| Sleep efficiency | Actigraphy | 3 months post intervention (x 10 days of measurement) | 
| Bedtime Consistency | Actigraphy | 3 months post intervention (x 10 days of measurement) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
School-age child