linjc16/ctgov huggingface dataset:
Measuring Health Related Quality of Life in Veterans With Stroke

Study Overview
=================
Brief Summary
-----------------
Approximately 11,000 veterans annually are hospitalized with a newly acquired incident stroke. Based on American Heart Association ratios of stroke incidence and prevalence, up to 80,000 veterans may be stroke survivors. The assessment of outcomes in stroke survivors is important for clinical practice and research, yet there is no consensus on the best measures of stroke outcome in either clinical practice or research. We have developed a new stroke-specific outcome measure, the Stroke Impact Scale (SIS), to capture physical function and other dimensions of health-related quality of life.

Detailed Description
-----------------
Background: Approximately 11,000 veterans annually are hospitalized with a newly acquired incident stroke. Based on American Heart Association ratios of stroke incidence and prevalence, up to 80,000 veterans may be stroke survivors. The assessment of outcomes in stroke survivors is important for clinical practice and research, yet there is no consensus on the best measures of stroke outcome in either clinical practice or research. We have developed a new stroke-specific outcome measure, the Stroke Impact Scale (SIS), to capture physical function and other dimensions of health-related quality of life. Objectives: The major research questions in this investigation are: 1) Does the SIS have concurrent and discriminate validity in a veteran stroke population when compared to the FIM, Rankin, and the SF-36V? 2) What effect does mode of administration have on response rates, bias, data quality, reliability and validity, SIS domain scores, and cost of data collection? 3) What factors differentiate responders and non-responders? 4) Will the SIS scores predict health care costs and utilization? Methods: Using ICD-9 discharge codes and electronic medical records, patients were screened for a valid diagnosis of stroke. At three months post-stroke, patients were randomly assigned to receive a mailed SIS instrument or SIS via telephone interview. At four months post-stroke, all respondents were evaluated using the Functional Independence Measure and SF-36V by telephone. Status: Completed.

Official Title
-----------------
Measuring Health Related Quality of Life in Veterans With Stroke

Conditions
-----------------
Stroke, Quality of Life, Rehabilitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No exclusion criteria. Exclusion Criteria: No exclusion criteria.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease

Study Overview
=================
Brief Summary
-----------------
Clinical trial to evaluate the safety and efficacy of JP-1366 in patients with erosive gastroesophageal reflux disease

Official Title
-----------------
A Randomized, Double-blind, Active-controlled, Multi-center Phase II Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease

Conditions
-----------------
GERD

Intervention / Treatment
-----------------
* Drug: JP-1366
* Drug: JP-1366 placebo
* Drug: Esomeprazole 40mg
* Drug: Esomeprazole placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults between 19 and 75 years old based on the date of written agreement Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy Those who experienced symptoms of heartburn or acid reflux within the last 7 days Exclusion Criteria: Those who have undergone gastric acid suppression or gastric, esophageal surgery Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease Clinically significant abnormal laboratory values during screening

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>JP-1366 A mg | Drug: JP-1366<br>* JP-1366, QD<br>Drug: JP-1366 placebo<br>* JP-1366 placebo, QD<br>Drug: Esomeprazole placebo<br>* Esomeprazole placebo, QD<br>|
| Experimental: Group 2<br>JP-1366 B mg | Drug: JP-1366<br>* JP-1366, QD<br>Drug: JP-1366 placebo<br>* JP-1366 placebo, QD<br>Drug: Esomeprazole placebo<br>* Esomeprazole placebo, QD<br>|
| Experimental: Group 3<br>JP-1366 C mg | Drug: JP-1366<br>* JP-1366, QD<br>Drug: JP-1366 placebo<br>* JP-1366 placebo, QD<br>Drug: Esomeprazole placebo<br>* Esomeprazole placebo, QD<br>|
| Active Comparator: Goup 4<br>Esomeprazole 40 mg | Drug: JP-1366 placebo<br>* JP-1366 placebo, QD<br>Drug: Esomeprazole 40mg<br>* Esomeprazole 40mg, QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accumulated mucosal defect cure rate*(%) at Week 8 following study drug administration (%) | * Erosion recovered to normal mucous membrane on upper gastrointestinal endoscopy | 8 weeks |
Mobile Medically Supervised Patient Management in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the use, usability and feasibility of an Application (App) for patients with rheumatoid arthritis with diary functionalities, in patient-physician interaction.

Official Title
-----------------
Mobile Medically Supervised Patient Management in Rheumatoid Arthritis Patients Using DocuMed.rh and RheumaLive App

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Behavioral: RheumaLive App use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >= 18 years, owner of App capable device, RA, informed consent Exclusion Criteria: non German speaking, no App capable device available

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RheumaLive App use<br>RheumaLive App use and evaluation of feasibility | Behavioral: RheumaLive App use<br> <br> |
| RheumaLive App use & threshold values<br>RheumaLive App use and evaluation of feasibility | Behavioral: RheumaLive App use<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of use of the RheumaLive Application in patients with rheumatoid arthritis. | Evaluation of use by counting and by a patient paper-based questionnaire | baseline and change over up to nine months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison paper-based vs electronic PROM in the App - Differences of the scores | RADAI - Rheumatoid Arthritis Disease Activity Index and FFbH (Hannover Functional Ability Questionnaire ) / calculated HAQ (Health Assesment Questionnaire) | baseline and change after 3 months | 
| Evaluation of feasibility of the RheumaLive Application in patients with rheumatoid arthritis. | Evaluation of feasibility by a patient and a physician paper-based questionnaire | at 3 months from start and change over 6 more months | 
| Evaluation of usability of the RheumaLive Application in patients with rheumatoid arthritis. | Evaluation of usability by a patient paper-based questionnaire | at 3 months from start and change over 6 more months |
Non Alcoholic Fatty Liver Disease Influence of Statin Therapy

Study Overview
=================
Brief Summary
-----------------
Aim: To determine the prevalence of fatty liver in a cohort of patients hospitalized with chest pain in the Cardiology department. To assess the effect of statins on the prevalence of fatty liver by a cross sectional survey of patients hospitalized with chest pain.

Detailed Description
-----------------
Consecutive patients hospitalized with chest pain will be recruited at the cardiology department. Patients with an inflammatory condition, recent infection or history of alcoholism will be excluded. After signing an informed consent each patient will undergo an ultrasound examination for diagnosis of fatty liver. Information regarding BMI, hypertension and use of medications will be collected on each patient. Blood samples for fasting glucose, hemoglobin A1C, lipid profile, ESR, and CRP and liver function tests will be collected from each participant. Prevalence of fatty liver in patients who have been taking statins for 6 months or more statins will be compared to patients who have been taking statins for a lesser period and to those who do have not taken statins using a multivariate regression analysis. Serum samples will be frozen and kept for future ongoing research.

Conditions
-----------------
Non-alcoholic Fatty Liver Disease (NAFLD)

Intervention / Treatment
-----------------
* Procedure: Ultrasound to demonstrate existence of fatty liver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiology patient Age above 18 Exclusion Criteria: Age below 18

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Ultrasound to demonstrate existence of fatty liver|nan|

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
-----------------
fatty liver, statin, non-alcoholic
Validation of an Obstacle Course Used in Patients With Muscle Tightness

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to compare healthy patients versus patients with muscle tightness in their leg(s) after an acquired brain injury using walking trials time, a balance test, and foot pressure data. This data is obtained using foot pressure sensors, timers, and distance walked.

Detailed Description
-----------------
This study is being conducted to demonstrate the objective utility of the use of pedobarography as a tool to differentiate normal controls from people with spastic gait as well as having utility in objectification of treatment effect on level surfaces and on a ADA based obstacle course.

Official Title
-----------------
The Validation of a New Method to Evaluate the Effects of Chemoneurolytic Intervention on Balance and Community Ambulation in Spastic Hemiplegic Patients

Conditions
-----------------
Stroke, Traumatic Brain Injury, Multiple Sclerosis, Spasticity, Healthy Controls

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years of age Must wear shoe size 5½ - 11 US womens or size 6 - 13 US mens For treatment group be a clinical patient being treated for lower extremity spasticity Exclusion Criteria: Age matched controls must have no significant neurological or orthopedic disease that would effect their gait Clinical patients who are unable to walk for 1 minute

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ABI<br>Acquired brain injury with lower limb spasticity | |
| Healthy Controls<br>Age matched healthy controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the objective utility of the use of pedobarography to differentiate normal controls from people with spastic gait as well as having utility in objectification of treatment effect on level surfaces and on a ADA based obstacle course. |  | 4 months post acquired brain injury |
Testosterone and Alendronate in Hypogonadal Men

Study Overview
=================
Brief Summary
-----------------
This study will investigate the hypothesis that the combination of testosterone replacement and alendronate will improve bone density and parameters of bone quality more than either medication alone in older men with low testosterone levels and low bone density.

Official Title
-----------------
Testosterone and Alendronate in Hypogonadal Men

Conditions
-----------------
Hypogonadism, Osteopenia, Osteoporosis

Intervention / Treatment
-----------------
* Drug: Testosterone
* Drug: Alendronate
* Drug: Placebo Alendronate
* Drug: Placebo Testosterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male sex Age 60 or above Testosterone <300 ng/dL DXA T score < -1 OR FRAX Score of 3% or greater for hip fracture or 20% or greater for major osteoporotic fracture Exclusion Criteria: Significant liver or kidney disease Elevated prolactin level Abnormal TSH Abnormal 25-Vitamin D PSA > 2.5 History of malignancy Calcium > 10.6 Alkaline Phosphatase > 150 Fracture within the last 6 months History of acute urinary retention Hematocrit < 32% or > 50% Fracture within the past 6 months American Urological Association BPH symptom index > 21 Sleep apnea Abnormalities of the esophagus which delay esophageal emptying Significant cardiopulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 85 Years

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

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

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 |
| --- | --- |
| Placebo Comparator: Testosterone and Placebo Alendronate<br> | Drug: Testosterone<br>* Testosterone Gel (Fortesta) 40mg daily.<br>Drug: Placebo Alendronate<br>* A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.<br>|
| Placebo Comparator: Alendronate and Placebo Testosterone<br> | Drug: Alendronate<br>* Alendronate (Fosamax) 70mg every week.<br>Drug: Placebo Testosterone<br>* Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.<br>|
| Experimental: Testosterone and Alendronate<br> | Drug: Testosterone<br>* Testosterone Gel (Fortesta) 40mg daily.<br>Drug: Alendronate<br>* Alendronate (Fosamax) 70mg every week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Spine Bone Density From Baseline to 12 Months | Percent Change in Spine Bone Density from Baseline (month 0) to Month 12 | Baseline and 12 months |
Individual Differences in Diabetes Risk: Role of Slow WaveSleep

Study Overview
=================
Brief Summary
-----------------
This study will examine the relationship between the amount of slow wave sleep (deep sleep) and the ability of the body to bring the blood sugar level to a normal range after receiving glucose.

Official Title
-----------------
Ancillary Studies to Major Ongoing NIDDK Clinical Research Studies

Conditions
-----------------
Sleep, Diabetes

Intervention / Treatment
-----------------
* Behavioral: baseline study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers age 18-20 with a BMI < 27kg/m2 in women and < 28 kg/m2 in men with normal findings on clinical examination, routine laboratory tests and EKG only subjects who have regular life styles (no shift work, no travel across time zone during the previous 4 weeks) habitual bedtimes between 7.0-8.5 hours/night do not take medications will be recruited Exclusion Criteria: women taking hormonal contraceptive therapy and pregnant women will be excluded individuals with a history of psychiatric, endocrine, cardiac or sleep disorders will be excluded other exclusion criteria will be: tobacco use, habitual alcohol use of more than 1 drink per day, excessive caffeine intake of more than 300 mg per day

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 20 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 |
| --- | --- |
| control<br>normal healthy men and women | Behavioral: baseline study<br>* normal bedtimes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Slow Wave Activity determines insulin sensitivity. |  | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep, insulin, diabetes, determine association between sleep characteristics and diabetes risk
Foley Catheter Versus Dinoprostone Vaginal Insert for Induction of Labor in Parous Women at Term: A Randomized Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness and safety of transcervical foley catheter as compared to dinoprostone vaginal insertion for preinduction cervical ripening and labor induction in term parous women with unfavorable cervix.

Conditions
-----------------
Failed Induction of Labor

Intervention / Treatment
-----------------
* Device: Transcervical foley catheter
* Drug: Dinoprostone 10mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancy parous women gestational age >=37.0 weeks Bishop score <=5 intact amniotic membrane absence of labor live fetus with vertex presentation no previous uterine surgical procedure Exclusion Criteria: major congenital anomaly
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transcervical foley catheter<br> | Device: Transcervical foley catheter<br>* 16 French foley catheter insertion<br>|
| Active Comparator: Dinoprostone<br> | Drug: Dinoprostone 10mg<br>* Dinoprostone vaginal insertion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful labor induction | Successful labor induction is defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of >=4cm. | Twelve hours of initiating oxytocin on the first day of induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical change in the bishop scores and cervical lengths induced by transcervical foley catheter and dinoprostone vaginal insertion | Cervical change based on the bishop score and cervical length induced by cervical ripening methods(foley catheter balloon vs dinoprostone) Incidence of cesarean delivery Vaginal delivery with 24 hours of starting of induction The interval from start of oxytocin to delivery Incidence of admission to neonatal intensive care unit and uterine tachysystole | When transcervical foley catheter or dinoprostone was removed before adminitoring oxytocin | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor induction, transcervical foley catheter, dinoprostone, parous women
NIS-observe Treatment Efficacy in Maintaining Symptoms Control in Moderate/Severe Asthma With Symbicort SMART

Study Overview
=================
Brief Summary
-----------------
The primary objective of this non-interventional study is to evaluate efficacy of Symbicort® SMART treatment in adult patients with moderate to severe asthma using ACQ scores during 6 months period

Official Title
-----------------
SMART Way of Treating Asthma. Non-interventional Study to Evaluate Clinical Efficacy of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Patients With Moderate and Severe Asthma

Conditions
-----------------
Moderate/Severe Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients eligible for entry into study are the patients diagnosed with moderate to severe asthma, that the doctors have already decided to treat with Symbicort SMART within the last month, before inclusion in this program All eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme. Exclusion Criteria: All the patients who have a known hypersensitivity to Symbicort or any of its excipients will not be included in this study. As per valid Romanian SmPC, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Moderate and severe asthma patients stabilized on Symbicort SMART | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Questionnaire ACQ |  | 5 visits (V1-week 0, V2-week 4, V3-week 8, V4-week 16, V5-week 24) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma