linjc16/ctgov huggingface dataset:
Safety and Efficacy of Empagliflozin (BI 10773) in Type 1 Diabetes Mellitus Patients With or Without Renal Hyperfiltration

Study Overview
=================
Brief Summary
-----------------
This open-label study aims to evaluate the impact of BI 10773 treatment on glomerular filtration rate under controlled conditions of euglycaemia and hyperglycaemia in subjects with type 1 diabetes mellitus with or without renal hyperfiltration and to characterize the safety and efficacy of BI 10773 25 mg QD as add-on therapy to insulin in these subjects.

Official Title
-----------------
An Open-label 8-week Adjunctive-to-insulin and Renal Mechanistic Pilot Trial of BI 10773 in Type 1 Diabetes Mellitus (the ATIRMA Trial)

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: BI 10773


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male or female subjects 18 years of age or older diagnosed with type 1 diabetes mellitus Glycated hemoglobin (HbA1C) of 6.5% to 11.0% and an estimated glomerular filtration rate (eGFR) greater or equal to 60 ml/min/1.73m² at screening Subjects must be either experienced insulin pump users or be on multiple daily injections of any type of insulin Exclusion criteria: Evidence of macroalbuminuria or leukocyte positive urinalysis at screening Any concomitant medication known to interfere with renin-angiotensin-aldosterone system (RAAS) activity or treatment with any other drugs to reduce blood glucose other than insulin History of macrovascular disease or any other disease which would interfere with trial participation or any ongoing clinical condition that would jeopardize subject safety or study compliance based on investigator judgement

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 10773<br>Oral once daily | Drug: BI 10773<br>* Oral once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glomerular Filtration Rate (GFR) After 8 Weeks of Treatment With Empagliflozin Under Controlled Conditions of Euglycaemia and Hyperglycaemia | The primary endpoint is change in glomerular filtration rate (GFR) after 8 weeks of treatment with empagliflozin under controlled conditions of euglycaemia and hyperglycaemia | Baseline and 8 weeks |
Association Between Arterial Wall Uptake of Fluorodeoxyglucose on PET Imaging and sRAGE

Study Overview
=================
Brief Summary
-----------------
Arteriosclerosis is a dynamic inflammatory disorder. Recently, FDG-PET CT is emerging diagnostic tool of non-invasive technique to detect vulnerable atherosclerotic plaque. And there are arising evidence that sRAGE(soluble Receptor for Advanced glycation End Product) is correlated with metabolic risk. So the investigators will investigate association between sRAGE and FDG-PET uptake in large artery in healthy patient.

Official Title
-----------------
Association Between Arterial Wall Uptake of Fluorodeoxyglucose on PET Imaging and sRAGE

Conditions
-----------------
sRAGE Level, SUV and TBR Levels in FDG PET

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis od type 2 DM Exclusion Criteria: Type 1 DM Gestational Diabetes Severe Liver or Renal disease Diagnosis of cancer Trauma Acute infection or inflammatory disease Acute vasculitis or history of vasculitis Pregnant or Lactating women Dyslipidemia(active state) Cardiovascular disease or history of CVD Chronic obstructive pulmonary disease Any patient by judge of investigator

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 |
| --- | --- |
| Type 2 DM, Healthy control<br>Type 2 DM patients are treating in the Diabetic Clinic of Korea university Guro hospital, and their age- and sex-matched healthy controls are underwent a routine health checkup at Korea university Guro hospital. | |
| Type 2 DM, Heatlhy control<br> | |

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
-----------------
sRAGE, SUV, TBR, FDG PET CT, Type 2 DM
Evaluation of a Telehealth Lifestyle Management Program to Improve Healthy Behaviors Post Head Injury

Study Overview
=================
Brief Summary
-----------------
Interventions to help individuals with traumatic brain injury manage their healthy lifestyle behaviors have been limited. Thus, the goal of this project is to evaluate the efficacy of a telehealth lifestyle program on reductions in weight and improvements in health behaviors/lifestyle choices.

Official Title
-----------------
Evaluation of Telehealth Lifestyle Program for Persons With Traumatic Brain Injury: Objective 2

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Behavioral: Lifestyle
* Behavioral: Health Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 19 years or older English speaking sustained a moderate or severe TBI (as defined by a period of confusion after the injury of more than 24 hours) overweight or obese as defined by a BMI score of ≥ 25 kg/m2 1-year or greater post-injury not currently enrolled in a weight loss program or receiving weight loss medication regular access to a computer/laptop with internet capability which allows internet and telephone access simultaneously if person with TBI who meets criteria 1-7 but does not cook, shop, and/or prepare meals independently, he or she must have a non-paid, study partner willing to participate in the study. Exclusion Criteria:1 pregnant or planning to become pregnant in the next 7 months concurrent medical condition for which changes in exercise or diet would be contraindicated severe hearing or visual impairment significant psychiatric disorder, such as schizophrenia or bipolar disorder (those with depression or anxiety will not be excluded) unable to communicate significant cognitive impairment and without a study partner, and/or person with TBI who does not cook, shop, and/or prepare meals independently who does not have a non-paid, study partner willing to participate in the study currently enrolled in an organized weight loss program has lost > 10% of body weight over the past 6 months history of an eating disorder

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Treatment Condition<br>Telehealth Lifestyle Program | Behavioral: Lifestyle<br> <br> |
| Sham Comparator: Attention Control Condition<br>Health Education Program | Behavioral: Health Education<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) scores |  | Changes in baseline and post-program BMI scores at 7-months |
The Effect of Music on Surgical Skill in the Setting of Simulated Intraocular Surgery

Study Overview
=================
Brief Summary
-----------------
Music is commonly heard in operating room. The goal of this study is to measure the effect of music on surgical performance using a intraocular surgery simulator. The music chosen is Sonata for 2 pianos D-440 from Mozart. The participants will complete 2 tasks on the simulator, both with and without music, in a randomized sequence. The results will be subtracted from the simulator and analyzed.

Official Title
-----------------
The Effect of Music on Surgical Skill in the Setting of Simulated Intraocular Surgery

Conditions
-----------------
Surgical Performance

Intervention / Treatment
-----------------
* Behavioral: Music - Mozart's sonata for 2 pianos in D-440


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ophthalmology residents at Laval University Ophthalmologist at Centre Hospitalier Universitaire de Québec Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exposure to music<br>The participants in this groups will have to complete the tasks on the intraocular surgery simulator while listening to Mozart's sonata for 2 pianos in D-440 | Behavioral: Music - Mozart's sonata for 2 pianos in D-440<br> <br> |
| No Intervention: No exposure<br>The participants in this groups will have to complete the tasks on the intraocular surgery simulator in silence | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Task score | The participants will perform tasks on a simulator on three separate days. The outcome will be measured at each of these visits. | Assessed up to 12 weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete the task | The participants will perform tasks on a simulator on three separate days. The outcome will be measured at each of these visits. | Assessed up to 12 weeks after randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Simulator, Music, Mozart Effect
Effect of Portion Size Over 5 Days in Preschool Children

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators varied the portion size of all meals served during two 5-day periods. During one period, baseline amounts of all foods and beverages were served, and during the other, the portion size of all items was increased by 50%. The primary aim of the study is to determine the effect of varying the portion size of foods and beverages served over 5 days on energy intake in preschool children.

Conditions
-----------------
Feeding Behavior

Intervention / Treatment
-----------------
* Other: Food and Beverage Portion Size


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Attending one of the designated childcare centers Exclusion Criteria: Food Allergies Food Restrictions Health Issues that Preclude Participation Not available for duration of the study

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100% Portion Size<br>100% Food and Beverage Portion Size | Other: Food and Beverage Portion Size<br>* Variations of Food and Beverage Portion Size (100% Baseline portions and increased 50% for 150% portions)<br>|
| Experimental: 150% Portion Size<br>150% Food and Beverage Portion Size | Other: Food and Beverage Portion Size<br>* Variations of Food and Beverage Portion Size (100% Baseline portions and increased 50% for 150% portions)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Food and Beverage Intake by Energy | Differences between 100% and 150% portion size conditions in energy intake (kcal) determined from weighed intakes of food and beverages | Days 1-5 in Periods 1 and 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Food and Beverage Intake by Energy Density | Differences between 100% and 150% portion size conditions in daily energy density (kcal/g) determined from weighed intakes of food and beverages | Days 1-5 in Periods 1 and 2 | 
| Differences in Food and Beverage Intake by Weight | Differences between 100% and 150% portion size conditions in daily weighed intake of food and beverages (g) | Days 1-5 in Periods 1 and 2 |
Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the efficacy of endovascular treatment (balloon angioplasty and/or stenting) for the improvement of clinical symptoms in multiple sclerosis patients.

Detailed Description
-----------------
The aim of this study is to assess the efficacy of endovascular treatment (balloon angioplasty and/or stenting) for the improvement of clinical symptoms in multiple sclerosis patients measured by Extended Disability Severity Score (EDSS), Multiple Sclerosis Impact Scale-29 (MSIS-29), Fatigue Severity Scale (FSS) and heat intolerance

Official Title
-----------------
Endovascular Correction of Chronic Cerebrospinal Venous Insufficiency (CCSVI) and Evaluation of Influence of These Treatments on the Symptoms of Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Procedure: balloon angioplasty and/or stenting
* Procedure: balloon angioplasty and/or stenting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with clinically defined multiple sclerosis Exclusion Criteria: contraindication for endovascular procedure performed in local anesthesia
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balloon angioplasty and/or stenting<br>Balloon angioplasty and/or stenting of stenosed internal jugular vein and/or azygous vein and/or brachiocephalic vein | Procedure: balloon angioplasty and/or stenting<br>* balloon angioplasty and/or stenting of internal jugular veins and/or azygous vein and/or brachiocephalic veins<br>Procedure: balloon angioplasty and/or stenting<br>* balloon angioplasty and/or stenting of extracranial vein draining the central nervous system, on condition that such outflow pathology has been confirmed using catheter venography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical symptoms of multiple sclerosis measured by Extended Disability Severity Score (EDSS), Multiple Sclerosis Impact Scale-29 (MSIS-29), Fatigue Severity Scale (FSS) and heat intolerance |  | 6 months after the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple sclerosis, venous insufficiency
Microvascular Ultrasonographic Imaging for the Detection of Early Stage Epithelial Ovarian Carcinoma

Study Overview
=================
Brief Summary
-----------------
In the United States, ovarian cancer is the fifth most common cancer to develop in women and causes more deaths than all other gynecologic malignancies combined. Because of the difficulties in detecting early stage ovarian cancer, 75% of women continue to be diagnosed with advanced stage disease (stage III or IV). The National Ovarian Cancer Early Detection Program (NOCEDP) as part of the National Cancer Institute's Early Detection Research Network (EDRN) is committed to the development of effective means for the accurate detection of early stage ovarian cancer. The last decade has seen rapid technological advances in diagnostic ultrasonography with the recent development of three-dimensional imaging. Initial studies suggest that these new technologies improve upon the diagnostic accuracy of two-dimensional transvaginal imaging in the differentiation between benign and malignant pathology. This improved diagnostic accuracy may promote improved patient care by separating complex benign masses from ovarian cancer therefore facilitating appropriate treatment.

Official Title
-----------------
Microvascular Ultrasonographic Imaging for the Detection of Early Stage Epithelial Ovarian Carcinoma

Conditions
-----------------
Ovarian Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women must be greater than 21 years of age Women must have a complex adnexal mass (as defined per ultrasound) which requires surgical intervention Exclusion Criteria: Known or suspected hypersensitivity to blood, blood products, or albumin. Known history of congenital heart defect that creates a bi-directional or right-to-left shunt. Known history of severe emphysema or a history of pulmonary emboli. known history of severe pulmonary hypertension (systolic pulmonary artery pressures > 90 mmHg).

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

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

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
-----------------
Women with ultrasound defined complex pelvic masses
Electrophysiological Comparison of mAP and mADM Using EMG

Study Overview
=================
Brief Summary
-----------------
The primary aim of this clinical investigation is to examine a prototype of a quantitative monitoring instrument that will meet most, if not all, of the clinical requirements.

Detailed Description
-----------------
This is a blinded, single-center, prospective study in patients during surgery, requiring use of neuromuscular blockade. Neurostimulation will be used to monitor objective responses, as per current clinical routine. Data collection of Tetragraph EMG responses will be unavailable to the clinician for clinical decision-making, as per current clinical routine, but will be stored on the interfaced SD card.

Official Title
-----------------
Electrophysiological Comparison of mAP and mADM Using EMG

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Device: TetraGraph


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age 18 years or older. American Society of Anesthesiology (ASA) physical status I-III criteria (Table I). Subject has provided verbal consent BMI <39 Exclusion Criteria Presence of an underlying neuromuscular disease. Presence of renal or hepatic disease. Subject has open skin sores in the locations needed for electrode application (forearms). Patients on oral anticholinesterase, anti-seizure medications, and magnesium sulfate.

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

| Intervention/Treatment |
| --- |
|Device: TetraGraph|The TetraGraph is a dedicated neuromuscular stimulator / recorder intended to evoke, record, and analyze muscle action potentials during surgical procedures|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary performance assessment of TetraGraph device | Agreement between the mAP and mADM EMG based TOF ratios | Duration of surgery | 
| Primary performance assessment of TetraGraph device | Agreement between the mAP and mADM EMG based TOF counts | Duration of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary performance assessment of TetraGraph device | Correlation between stimulation current and T1 twitch height in the two muscles | Duration of surgery | 
| Secondary performance assessment of TetraGraph device | Comparison of EMG to the quantitative AMG monitor | Duration of surgery |