linjc16/ctgov huggingface dataset:
Ventricular Rate Regularization for Improved Quality of Life in Patients With CHF and AF

Study Overview
=================
Brief Summary
-----------------
Single center investigator initiated sponsored by Guidant Boston Scientific Corp. to evaluate the benefit of ventricular rate regularization (VRR) in patients with congestive heart failure (CHF) and significant atrial fibrillation (AF) burden.

Official Title
-----------------
Randomized Study of Ventricular Rate Regularization for Improved Quality of Life in Patients With Congestive Heart Failure and Atrial Fibrillation.

Conditions
-----------------
Congestive Heart Failure, Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be between 18-85 years old Be willing and able to give informed consent Patient currently has a CRT-D or ICD with > 20% atrial fibrillation burden as recorded by defibrillator follow up report or a history of atrial fibrillation prior to implant. Patient has the ability to complete a Six minute walk test with the only limiting factors to be fatigue or shortness of breath. Exclusion Criteria: Expected mortality less than 6 months due to non-cardiac causes. Pregnant women. Creatinine greater than or equal to 2.5 mg/dl. Anemia (HCT less than 30) COPD causing significant dyspnea Orthopedic problems affecting 6 minute walk.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved quality of life, reduced emergency room visits and hospitalization for congestive heart failure symptoms. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICD, Atrial Fibrillation, BiV ICD, CHF, Congestive Heart Failure, AF
Effect of Active Release Technique and Abdominal Drawing-Maneuver on Pain and Quality of Life in Patients With Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
To determine the effect of active release technique and abdominal drawing in maneuver on pain and quality of life in patients of chronic low back pain.

Official Title
-----------------
Effect of Active Release Technique and Abdominal Drawing-Maneuver on Pain and Quality of Life in Patients With Chronic Low Back Pain

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Diagnostic Test: Active Release Technique
* Diagnostic Test: Abdominal Drawing-Maneuver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with hamstring tightness[9] Subjects with pain between 4 and 7cm on visual analogue scale[18]. Subjects having 20-40 age group are included in this study[11] Patients having pain for more than 3 month of mild-moderate intensity[9] Exclusion Criteria: Patients with any spine injury[11] Lumber intervertebral disc fracture[11] Patients having any surgical history of spine[11] Spinal stenosis[11]

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Release Technique<br>Using Active Release Technique | Diagnostic Test: Active Release Technique<br>* Using Active Release Technique<br>|
| Experimental: Abdominal Drawing-Maneuver<br>Using Abdominal Drawing-Maneuver Technique | Diagnostic Test: Abdominal Drawing-Maneuver<br>* Using Abdominal Drawing-Maneuver Technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal Drawing-Maneuver on Pain and Quality of Life in Patients With Chronic Low Back Pain | 11 participents with The Hot pack initially for 10 minutes then this group will receive abdominal drawing-in maneuver technique for 2 times in week of 10 session. SF-36 Questionnaire. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active Release Technique in Patients With Chronic Low Back Pain | 12 participents with The Hot pack initially for 10 minthen this group will receive active release technique 2 times in week of 10 session while other group will receive abdominal drawing-in maneuver technique for 2 times in week of 10 session. Visual analogue scale. | 6 Months |
Translation and Validation of a Disease-specific Questionnaire for Hirschsprung's Disease in Danish Patients

Study Overview
=================
Brief Summary
-----------------
The Hirschsprung and anorectal malformation quality of life (HAQL) questionnaire is a disease-specific quality of life questionnaire with 5 different elements (3 questionnaires for patients (categories: age 8-11, 12-16, and >17 years) and two questionnaires for parents of patients (categories: patients aged 8-11 and 12-16 years). In the first part of this study, the questionnaires will be translated via forward-backward-translation, culturally adapted and evaluated for content validity. In the second part of the study, the questionnaires will be validated in a cohort of all eligible Hirschsprung patients from Odense University Hospital from 1985-2014.

Official Title
-----------------
Translation and Validation of the Hirschsprung and Anorectal Malformation Quality of Life (HAQL) Questionnaire in a Danish Hirschsprung Population

Conditions
-----------------
Hirschsprung Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Hirschsprung's Disease between the years 1985-2014 Age > 7 years Good Danish comprehension Signed informed consent Exclusion Criteria: Inability to follow the procedures of the study, e.g. due to language problems, severe psychological disorders, dementia, etc.

Ages Eligible for Study
-----------------
Minimum Age: 8 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 |
| --- | --- | --- |
| Internal Consistency (IC) assessed by Cronbach's Alpha |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test-retest reliability assessed by intraclass-correlations coefficient |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Translation and validation, Hirschsprung Disease, Quality of Life
Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique

Study Overview
=================
Brief Summary
-----------------
Hypothesis of the study is that a modified and improved implantation protocol (regarding membranous septum length and implantation depth) will decrease the need for permanent pacemaker stimulation follow TAVR-procedures.

Detailed Description
-----------------
Project objectives or hypothesis Hypothesis of the study is that a modified and improved implantation protocol (regarding membranous septum length and implantation depth) will decrease the need for permanent pacemaker stimulation following TAVR-procedures. Patient profile and sample size The study cohort will comprise of patients referred to transcatheter aortic valve replacement. Patients will be prospectively and consecutively screened and enrolled at a tertiary high-volume center in Germany. TAVR will be performed according to a modified implantation technique regarding membranous septum length. Pacemaker rates will be analyzed and compared to a historical control. Taking into account a contemporary pacemaker rate of 15%, a reduction to 7% will require a sample size of 239 patients per group to achieve statistically significance (Chi-squared test, alpha 0.05, beta 0.80). Regarding the prospective cohort, interims analysis will be performed after each 10 TAVR procedures. In case a signal towards worse outcomes with the modified implantation technique will be observed, the institutional safety and endpoint adjudication committee will stop further execution of the study.

Official Title
-----------------
Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique

Conditions
-----------------
PM Implantation After TAVR

Intervention / Treatment
-----------------
* Procedure: TAVR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients referred to TAVR procedure due to severe aortic stenosis Exclusion Criteria: PM-implantation before TAVR Valve-in-valve procedures

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Cohort A<br>Historical cohort 2019 + 2020 | |
| Cohort B<br>Prospective study cohort 2020 + 2021 (TAVR implantation according new IFU) | Procedure: TAVR<br>* TAVR implantation in cusp overlay technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pacemaker implantation rate | Primary endpoint | Day 5 after TAVR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of paravalvular leak | Secondary endpoint | Day 5 after TAVR | 
| Number of patients alive | Secondary endpoint | 30 days |
FAST: Clinical Feasibility

Study Overview
=================
Brief Summary
-----------------
This study evaluates the clinical ease of use of the Femoral Antegrade Starting Tool (FAST).

Detailed Description
-----------------
The investigators will recruit 10 patients at Sunnybrook Health Sciences Centre that are scheduled to receive femoral antegrade intramedullary nailing to treat a femur fracture. This study evaluates the clinical ease of use of the Femoral Antegrade Starting Tool (FAST) device, and the surgical workflow during entry point selection and guidewire alignment for intramedullary nailing of femoral fractures. It is hypothesized that the usage of the tool will reduce surgery time and number of images required.

Official Title
-----------------
Femoral Antegrade Starting Tool (FAST): Clinical Feasibility Pilot Study

Conditions
-----------------
Femur Fracture

Intervention / Treatment
-----------------
* Device: FAST


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a femoral shaft fracture Undergoing anterograde intramedullary nailing procedure Exclusion Criteria: Femoral head or neck fractures
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FAST Patients<br>Patients at Sunnybrook Health Sciences Centre with femur fractures that will undergo a femoral antegrade intramedullary nailing procedure. | Device: FAST<br>* Orthopaedic surgeons will use the FAST device to facilitate entry point selection and alignment of a guidewire for intramedullary nailing of femoral shaft fractures.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Time | Time of the procedure from the initiation of the guidewire step (surgeon picking up the guidewire) to the removal of the FAST device following acceptable guidewire placement | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoroscopic Images | Number of fluoroscopic images used to obtain start point | 1 day | 
| Number of guidewire drilling attempts | Number of times the guidewire has been drilled into the bone to test the alignment. | 1 day |
Comparison of Hyperemic Efficacy Between Nicorandil and Adenosine for Fractional Flow Reserve (FFR) Measurement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of nicorandil in the achievement of maximal coronary hyperemia compared with adenosine.

Conditions
-----------------
Coronary Artery Disease, Myocardial Ischemia

Intervention / Treatment
-----------------
* Other: Maximal Hyperemia with Adenosine Followed by Nicorandil
* Other: Maximal Hyperemia with Nicorandil Followed by Adenosine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non -infarct related, patients with moderate coronary artery stenosis normal left ventricular ejection fraction on echocardiogram Exclusion Criteria: infarct-related arteries or clinically unstable state collateral blood flow to the target vessel is shown atrioventricular block on electrocardiogram reduced left ventricular ejection fraction (<50%) or left ventricular hypertrophy on echocardiogram contraindication of adenosine bronchial asthma
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adenosine Followed by Nicorandil<br> | Other: Maximal Hyperemia with Adenosine Followed by Nicorandil<br>* Firstly FFR was measured with intravenous adenosine infusion (140 μg•min-1•kg-1) via femoral vein or antecubital vein. Secondly with intracoronary adenosine bolus injection (80μg, 40μg to LCA and RCA, respectively). Lastly with intracoronary nicorandil bolus injection (1mg followed by 2mg).<br>|
| Experimental: Nicorandil Followed by Adenosine<br> | Other: Maximal Hyperemia with Nicorandil Followed by Adenosine<br>* Firstly FFR was measured with intracoronary nicorandil bolus injection (1mg followed by 2mg). Secondly with intravenous adenosine infusion (140 μg•min-1•kg-1) via femoral vein or antecubital vein. Lastly with intracoronary adenosine bolus injection (80μg, 40μg to LCA and RCA, respectively).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional Flow Reserve at Maximal Hyperemia |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Maximal Hyperemia |  | 1 day | 
| Changes in Heart Rate |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenosine, Nicorandil, Fractional Flow Reserve, Maximal Hyperemia
A Small Changes Weight Loss Program and Message Dissemination Via Facebook in Chicago's West Side

Study Overview
=================
Brief Summary
-----------------
African-American communities experience a greater burden of obesity-related diseases such as type 2 diabetes mellitus and cardiovascular disease and higher rates of obesity, compared to other race groups. There is a need for interventions that show promise in mitigating these disparities. The primary goal of this project is to pilot test whether an existing small-changes intervention for weight loss can be modified and delivered within the West Side ALIVE churches.

Official Title
-----------------
A Small Changes Weight Loss Program and Message Dissemination Via Facebook in Chicago's West Side

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Small changes weight loss program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 25-45 kg/m2 Age 18-75 Attend one of the West Side partnership churches at least 2 times per month Able to attend in-person meetings Willing to share their experiences on the West Side ALIVE Facebook page Exclusion Criteria: Blood pressure > 170/90 (self-report or during the WSA screening) Diabetes treated with insulin History of cancer within the past 5 years Pregnancy or breastfeeding in the last 6 months, planning to become pregnant in the next 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Core Participants Weight Loss Program<br>Small changes weight loss program | Behavioral: Small changes weight loss program<br>* This intervention uses a small-changes approach to calorie reduction (operationalized as 6 100-calories changes per day) along with increasing leisure-time physical activity and self-regulation strategies to produce weight loss. The intervention will be delivered via 12 face-to-face group sessions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Change from baseline using objectively measured body weight | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Change from baseline | 3 months | 
| Physical activity | Change from baseline in total minutes of MVPA assessed by accelerometer | 3 months | 
| Weight loss strategies | Change from baseline on self-reported use of weight loss strategies | 3 months | 
| Weight | Change from baseline using objectively measured body weight | 6 months | 
| HbA1c | Change from baseline using a point of care analyzer | 3 months |
Blood Pressure Variability in Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the evaluation and comparison of blood pressure variability indices and ambulatory arterial stiffness index obtained by ambulatory blood pressure monitoring as prognostic indicators in the functional outcome of acute ischemic stroke.

Detailed Description
-----------------
All consecutive patients admitted with acute (within 24 hours after stroke onset) ischemic stroke in three University Hospital of Northern and Central Greece will be included. Blood pressure measurements are being obtained with ambulatory 24-hour BP monitoring (ABPM) every 20 minutes within 24 hours of admission using automated oscillometric device (TM2430, A&D Company Ltd) during day-time (7:00-22:59) and night-time (23:00-6:59). Several clinical, laboratory and imaging parameters are prospectively registered. Also, patients' medical history, previous medical treatment and cardiovascular risk factors are registered. Functional outcome is assessed by the modified Rankin Scale score at 3 months. Also, stroke recurrence and cardiovascular and all-cause mortality will be assessed.

Official Title
-----------------
Comparison of Blood Pressure Variability Indices and Ambulatory Arterial Stiffness Index as Prognostic Indicators in the Medium Term Outcome of Acute Ischemic Stroke

Conditions
-----------------
Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute ischemic stroke Admission within 24 after the onset of symptoms Exclusion Criteria: Transient ischemic attack Intracerebral hemorrhage Subarachnoid hemorrhage Cerebral sinus venous thrombosis Stroke mimics Late admission (>24 hours after stroke onset)

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale Score (mRS) | Description (score) No symptoms at all (0) No significant disability despite symptoms; able to carry out all usual duties and activities (1) Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance (2) Moderate disability; requiring some help, but able to walk without assistance (3) Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance (4) Severe disability; bedridden, incontinent and requiring constant nursing care and attention(5) Dead (6) | Three months (90 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute ischemic stroke, Blood pressure variability, Ambulatory arterial stiffness index, Ambulatory blood pressure monitoring, Outcome
Evaluation of Furcal Perforation Repair in Primary Molars With MTA Versus Bioceramics (A Randomized Clinical Trial)

Study Overview
=================
Brief Summary
-----------------
Furcal perforation is one of the most challenging procedural accidents during pulpotomy of primary molars and should be sealed as soon as possible to prevent bacterial invasion at perforation site and subsequent tooth extraction. The aim of the study is to compare bioceramics versus MTA as root repair material for treatment of furcal perforation in primary molars

Official Title
-----------------
Evaluation of Furcal Perforation Repair in Primary Molars With MTA Versus Bioceramics

Conditions
-----------------
Iatrogenic Perforation of Primary Molars

Intervention / Treatment
-----------------
* Other: Bioceramics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Apparently healthy children aged from 4 to 7 years No history of spontaneous pain or swelling No signs or symptoms of irreversible pulpits or loss of vitality Absence of radicular or priapical lesions. Accidental furcal perforation should be immediate or mediate (within two weeks) perforation in primary molars. Exclusion Criteria: Children with systemic disease Presence of priapical lesions

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 7 Years

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mineral Trioxide Aggregate (MTA)<br>Root repair material | Other: Bioceramics<br>* root repair material<br>|
| Experimental: bioceramics<br>Root repair material | Other: Bioceramics<br>* root repair material<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical success | Visual oral examination | 9 months | 
| radiographic success | Radiolucency assessment (+/-) | 9 months |