linjc16/ctgov huggingface dataset:
Influence of Resident's Degree of Formation on the Quality of Care Delivered to the Patients.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluation the influence of the resident in anesthesiology's degree of formation on the quality of care delivered to the patient.

Detailed Description
-----------------
The aim of this study is to evaluation the influence of the resident in anesthesiology's degree of formation on the quality of care delivered to the patient. To perform it, the investigators will enrolled all of the patients scheduled for an axillary plexus anesthesia technique in the Clinique Saint-Luc of Bouge in September 2018 (end of formation for the residents in anesthesia) and compare the patient's degree of satisfaction with the patients scheduled for the same kind of anesthesia on October and November 2018 (begin of formation for the residents in anesthesia).

Official Title
-----------------
Influence of Resident's Degree of Formation on the Quality of Care Delivered to the Patients.

Conditions
-----------------
Anesthesia Complication

Intervention / Treatment
-----------------
* Biological: Axillary Plexus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients scheduled for hand surgery under axillary plexus Exclusion Criteria: Patient's refusal

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| End of training<br>Anesthesia residents at the end of their training who will realize axillary plexus. The satisfaction of the patient will be registered. | Biological: Axillary Plexus<br>* Axillary plexus anesthesia technique for hand surgery<br>|
| Begin of training<br>Anesthesia residents at the begin of their training who will realize axillary plexus. The satisfaction of the patient will be registered. | Biological: Axillary Plexus<br>* Axillary plexus anesthesia technique for hand surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction (Likert's scale) | Patient satisfaction after the completion of axillary plexus (satisfaction will be studied with a Lickert's scale). This scale will examine the patient's satisfaction in a scale ranging from 0 (worse satisfaction) to 5 (best satisfaction). | 1 day |
Development of a Face Valid Executive Functioning Task

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a task to measure executive thinking skills that can be performed in a laboratory setting, but has clear parallels to the thinking demands of real life situations, and can be administered to patients such as those with Parkinson's who have difficulty moving.

Official Title
-----------------
Development of a Face Valid Executive Functioning Task

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Brief Inclusion Criteria Parkinson's Disease (PD) group: Must have definite PD have clear benefit from levodopa Brief Exclusion Criteria PD Group and Control: Hx of stroke Head injury Visual loss

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinson's Disease<br>Meets criteria for definite Parkinson's Disease | |
| Healthy Controls<br>- Must be in good health | |

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
-----------------
Parkinson's Disease
Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During Ureteroscopy

Study Overview
=================
Brief Summary
-----------------
A prospective study comparing different laser settings used for stone fragmentation during ureteroscopy

Detailed Description
-----------------
Two groups prospectively randomized for different laser settings during ureteroscopy one aimed for stone dusting, the other for stone fragmentation and basket extraction of fragments

Official Title
-----------------
Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During

Conditions
-----------------
Ureterolithiasis, Nephrolithiasis

Intervention / Treatment
-----------------
* Device: Ureteroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are planned for ureteroscopy \ retrograde intra renal surgery (RIRS) for stone treatment Exclusion Criteria: known ureteral stricture severe immune deficiency patients after urinary diversion surgery patients with single \ ectopic\ implanted kidney double collecting system severe thrombocytopenia patients taking anticoagulant drugs that cannot be stooped before the operation

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low energy high frequency<br>Ureteroscopy with laser settings of low energy & high frequency with aim of stone dusting | Device: Ureteroscopy<br>* Ureteroscopy with laser stone fragmentation<br>|
| Active Comparator: High energy low frequency<br>Ureteroscopy with laser settings of low energy high frequency with aim of stone fragmentation and basket extraction of fragments | Device: Ureteroscopy<br>* Ureteroscopy with laser stone fragmentation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of operation |  | Immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ureteroscopy
Mason Heart Study With MCG

Study Overview
=================
Brief Summary
-----------------
Heart disease is the number one cause of death in the United States, with over 650,000 deaths in 2019 alone. Many healthy individuals possess key risk factors for heart disease which include but are not limited to high blood pressure, high cholesterol, family history of heart disease, and diabetes. The Mason Heart Study-MCG (MHS-MCG) registry is designed to collect magnetocardiography (MCG) scans on a select group of healthy volunteers who work for the city of Mason, OH, with and without cardiac symptoms, illnesses, and/or risk factors. CardioFlux is used as a noninvasive MCG tool that analyzes and records the magnetic fields of the heart to detect various forms of heart disease. There will be a 12-month duration of the study where we propose to collect screening data from approximately 250 volunteers who present to the Genetesis facility for a 5-minute CardioFlux MCG scan. The volunteers will be contacted at intervals over a 1-year period for follow-up data and may choose whether or not they would like to provide follow-up data or participate in another scan.

Official Title
-----------------
Mason Heart Study With Magnetocardiography

Conditions
-----------------
Acute Myocardial Injuries

Intervention / Treatment
-----------------
* Device: CardioFlux


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. ≥ 18 years of age at the time of enrollment. Exclusion Criteria: < 18 years of age Patients unable to fit into device Non-ambulatory patients Positive response on CardioFlux Pre-Screening Form Patients with claustrophobia or unable to lie supine for 5 minutes Pregnant women Poor candidate for follow-up (e.g. no access to phone) Prisoners

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: CardioFlux|Non-invasive screening for ACS|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| specificity and accuracy statistics | analyzing the specificity and accuracy of CardioFlux | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ischemia, acute myocardial injuries, CardioFlux, Cardiovascular disease, MCG
Cleveland Kids Run

Study Overview
=================
Brief Summary
-----------------
A 12 month long program focused on making good food choices and exercise directed at 8-12 year olds and their caregivers. The program will consist of monthly educational meetings each teaching a new nutritional and exercise concept. Children will be given weekly exercise schedules and their adherence to the program will be assessed. The study will culminate with an annual children's race in May.

Official Title
-----------------
Adherence to a Running and Nutrition Program in Children Aged 8-12 Years: A Pilot Study

Conditions
-----------------
Childhood Obesity

Intervention / Treatment
-----------------
* Behavioral: Excercise and Nutrition Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be aged 8-12 years old and enrolled in kindergarten through 6th grade in a Cleveland Public School Participants must have at least a B-average or equivalent in the prior academic year Participants must have at least one part or guardian who is able to accompany the participant during exercise and educational sessions Participants must be willing to participate in the Rite Aid Cleveland Marathon Ringling Bros. and Barnum & Bailey Red Nose Run® at the end of the study Exclusion Criteria: Children who are younger than 8 years or older than 12 years Children whose parents who are unable or unwilling to provide informed consent, Children whose parents are are illiterate or non-English speaking or reading Children whose parents are unable or unwilling to accompany them to educational and exercise sessions Children with a medical condition that prevents them from unmonitored exercise Children who have not maintained an equivalent of a B-average in the prior academic year

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Excercise and Nutrition Program<br>Children and their care givers will receive 5 lectures on nutrition and exercise and will be given a weekly running program. At the end of the study children will be encouraged to participate in an annual 0.25-0.5 mile race. | Behavioral: Excercise and Nutrition Program<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to program | number of subjects who participate in race | 12 months |
A Study to Evaluate the Safety of Adjuvant Treatment With Exemestane Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to give access to postmenopausal women with estrogen sensitive primary breast cancer to exemestane for the adjuvant treatment of breast cancer after the use of tamoxifen and to collect all serious adverse events.

Official Title
-----------------
A Phase 4, Open-Label Exemestane Adjuvant Safety Surveillance Program: Adjuvant Exemestane (Aromasin) Treatment Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer (IES Inclusion Criteria)

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: exemestane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal patients Patients with early breast cancer after adequate loco-regional treatment and eventual adjuvant chemotherapy, treated with tamoxifen for 2-3 years OR treated with tamoxifen for 2-3 years and consecutive exemestane treatment, provided the total duration of endocrine treatment is less than 5 years Estrogen receptor positive breast cancer patients Patients who remain free from disease following treatment with tamoxifen Exclusion Criteria: Patients taking other drugs for the adjuvant treatment of breast cancer Patients taking hormone replacement therapy Donation of blood or blood products for transfusion during the 30 days prior to initiation of treatment with study drug, at any time during the program or 30 days after completion of treatment
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exemestane group<br> | Drug: exemestane<br>* Exemestane 25 mg oral tablet once daily for a maximum of 3 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess for serious adverse events |  | Months 3, 6, 12, 18, 24, and 30; Follow-up visit 28 days posttreatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Surveillance Program |  | Duration of trial |
Study of the Blood Concentrations of Two Formulations of REGN2222 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Primary Objective: Determine blood concentrations of two formulations of REGN2222 Secondary Objective: Assess safety and tolerability of REGN2222

Official Title
-----------------
A Randomized, Open-Label, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of a Single Intramuscular (IM) Injection of REGN2222 Produced by 2 Different Cell Lines in Healthy Adult Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: REGN2222


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Healthy man or woman aged 18 to 60 years Body weight between 50.0 kg and 95.0 kg, inclusive Willing and able to comply with clinic visits and study-related procedures Provide signed informed consent Key Exclusion Criteria: Hemoglobin not within normal limits Positive drug and alcohol screen test results at screening visits 1 and 2 Participation in any clinical research study that evaluated another investigational drug or therapy within 30 days or at least 5 half-lives, whichever is longer, of the investigational drug, prior to the screening visit Pregnant or breastfeeding women, and women of childbearing potential Sexually active men who are unwilling to practice adequate contraception during the study

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reference Drug<br>REGN2222 Reference Formulation | Drug: REGN2222<br> <br> |
| Experimental: Test Drug<br>REGN2222 Test Formulation | Drug: REGN2222<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum REGN2222 concentration-time curve (AUC) |  | Day 1 to Day 148 (end of study) | 
| Peak REGN2222 concentration (Cmax) |  | Day 1 to Day 148 (end of study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent adverse events (TEAEs) from baseline to the end of the study |  | Day 1 to Day 148 (end of study) | 
| Presence or absence of anti-drug antibody (ADA) |  | Day 1 to Day 148 (end of study) |
Effects of Birth Weight on Anterior Eye Segment Measurements in Full-Term Children by Galilei Dual-Scheimpflug Analyzer

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effects of birth weight (BW) on ocular anterior segment parameters in preschool children using the Galilei Dual-Sheimpflug Analyzer (GD-SA). Children were measured by GD-SA and relationships between all anterior segment parameters obtained by this device and birth weight were analyzed.

Detailed Description
-----------------
Preschoolers, who were born heavier, had thicker cornea and lens, longer axial length, and flatter corneal curve. The thicknesses and axial curves of central cornea within 7mm may be particularly associated with BW.

Official Title
-----------------
Effects of Birth Weight on Anterior Eye Segment Measurements in Full-Term Children by Galilei Dual-Scheimpflug Analyzer

Conditions
-----------------
Birth Weight

Intervention / Treatment
-----------------
* Device: Galilei Dual-Scheimpflug Analyzer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 3- 6 years; birth weight >2,500 g; gestational age (i.e., the period of time between the first day of the mother's last menstrual period and birth) >37 weeks; visual acuity >0.8 (in decimals); no history of any systemic or ocular diseases; no history of previous ocular surgeries; no retinopathy of prematurity; no current medications; and no retinal or optic disc abnormalities on fundoscopy. Exclusion Criteria: ages <3 >6 years; birth weight <2,500 g; gestational age (i.e., the period of time between the first day of the mother's last menstrual period and birth) <37 weeks; visual acuity <0.8 (in decimals); history of any systemic or ocular diseases; history of previous ocular surgeries; retinopathy of prematurity; current medications; and retinal or optic disc abnormalities on fundoscopy.

Ages Eligible for Study
-----------------
Minimum Age: 30 Months
Maximum Age: 80 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Birth Weight<br> | Device: Galilei Dual-Scheimpflug Analyzer<br>* Measuring of Anterior Segment by Galilei Dual-Scheimpflug Analyzer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurements of anterior segment parameters in Full-Term Children by Galilei Dual-Scheimpflug Analyzer | Corneal parameters, anterior chamber parameters and lens thickness were measured by Galilei Dual-Scheimpflug Analyzer in healthy preschool children. | 1 day |
A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and efficacy of ONO-4641 in patients with relapsing-remitting multiple sclerosis over a 26-week treatment period.

Official Title
-----------------
A Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis

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

Intervention / Treatment
-----------------
* Drug: ONO-4641
* Drug: ONO-4641
* Drug: ONO-4641
* Drug: ONO-4641 placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male or female aged 18-55 years inclusive at screening Patients who have a definite diagnosis of relapsing-remitting Multiple Sclerosis Exclusion Criteria: Multiple Sclerosis course other than relapsing-remitting multiple sclerosis History of malignancy History of clinically significant chronic disease of the immune system (other than Multiple Sclerosis) Inability to undergo Gd-enhanced MRI scans Diagnosis of diabetes mellitus (type I or type II)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: E1<br> | Drug: ONO-4641<br>* 0.15 mg once per day for 26 weeks<br>|
| Experimental: E2<br> | Drug: ONO-4641<br>* 0.1 mg once per day for 26 weeks<br>|
| Experimental: E3<br> | Drug: ONO-4641<br>* 0.05 mg once per day for 26 weeks<br>|
| Placebo Comparator: P<br> | Drug: ONO-4641 placebo<br>* Placebo once per day for 26 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks. |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total volume of Gd-enhanced lesions |  | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, ONO-4641