linjc16/ctgov huggingface dataset:
Comparison Study of Drugs for Symptom Control and Complication Prevention of Atrial Fibrillation (AF) (Code-AF Trial)

Study Overview
=================
Brief Summary
-----------------
This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is all patients with atrial fibrillation who visit hospital. The purpose is to analyze complication, composite outcome (all cause mortality, hospitalization, the incidence of stroke, heart failure and cardiovascular event (MACE)) according to the 1) the use of anti-arrhythmic drugs (AADs), 2) use of medication for rate control (beta blocker, calcium channel blocker and digoxin) and 3) use of anticoagulation agents (warfarin, coumadin, an NOAC)

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with atrial fibrillation patients with age more than 19 patients who agree with study inclusion Exclusion Criteria: patients who do not agree with study inclusion patients with age less than 19 Pregnancy, Breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Code-AF registry<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | 3 years | 
| number of hospitalization by heart failure |  | 3 years | 
| number of recurrent stroke |  | 3 years | 
| number of cardiovascular events |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, anti arrhythmic drug, NOAC, warfarin, coumadin
Long Term Open Follow-up With H376/95 vs. Warfarin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate tolerability of long-term treatment with ximelagatran compared to standard treatment with warfarin.

Official Title
-----------------
Long-Term Treatment With the Oral Direct Thrombin Inhibitor Ximelagatran, Compared to Warfarin, as Stroke Prophylaxis in Patients With Atrial Fibrillation. A Long Term Follow-Up Study

Conditions
-----------------
Stroke Prevention in Patients With Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: EXANTA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent. Completion of the study SH-TPA-0002, history of chronic atrial fibrillation (i.e. rapidly beating heart), at least one risk factor for stroke (e.g. high blood pressure, age over 65, previous stroke or similar attack, diabetes or coronary heart disease) Exclusion Criteria: Conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: EXANTA|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events, with special regard to bleeding, thromboembolic events and discontinuation of treatment. |  |  |
Host Immune Response to Novel RNA COVID-19 Vaccination

Study Overview
=================
Brief Summary
-----------------
To determine the antibody response level in patients with cancer to the COVID-19 vaccination.

Official Title
-----------------
Host Immune Response to Novel RNA COVID-19 Vaccination in Patients With Cancer (CTMS# 21-0012)

Conditions
-----------------
COVID-19 Vaccine, Cancer

Intervention / Treatment
-----------------
* Biological: COVID-19 Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Must be eligible to receive the COVID19 vaccination by standard and current CDC guidelines. This includes all RNA vaccinations grant EUA status by the FDA Diagnosed with any malignancy within the last 5 years, with the exception of early-stage squamous cell skin cancer, early-stage basal cell skin carcinoma and noninvasive pathology such as DCIS (Ductal Carcinoma in-situ) Able to provide informed consent Patients can be on any form of treatment (including clinical trials) and at any stage (including remission) in their cancer therapy plan - including chemotherapy, immunotherapy, targeted therapy, hormonal therapy, radiation, palliative care or observation. Exclusion Criteria: Previously documented COVID infection Previously enrolled in a vaccination trial and either still blinded or known to receive the vaccination. (Those patients on a trial but known to receive a placebo dose are eligible to enroll) Contraindication to the vaccination based on current CDC guideline such as know allergic reactions that increase risk of having an allergic reaction to a COVID RNA vaccination. This includes but is not limited to: Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol [PEG]) Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG) Pregnant or breastfeeding Unable to comply with study related procedures as determined by the study team.

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 |
| --- | --- |
| Prospective - Cancer Patients that have received COVID-19 Vaccination<br> | Biological: COVID-19 Vaccine<br>* COVID-19 Vaccine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response level in patients with cancer to the COVID-19 vaccination. | Antibody response change over time | Pre dose on day 1 (baseline), pre dose on day 21, day 35, 6 months, 12 month and 18 months |
Effects of Exercise on Patients With Hemiparetic Stroke

Study Overview
=================
Brief Summary
-----------------
This randomized trial investigates the hypothesis that regular aerobic exercise training using a task specific gait training modality will improve cardiovascular fitness, functional mobility, and reduce risk factors for recurrent cardiovascular events in chronic hemiparetic stroke patients, when compared to matched controls performing just stretching.

Detailed Description
-----------------
The aims are to determine whether 6 months progressive graded treadmill training: 1) improves cardiovascular fitness levels and reduces the excessive energy demands of hemiparetic gait, as defined by oxygen consumption levels based on open circuit spirometry during peak and submaximal exercise ambulation tasks; 2) increases free living physical activity measured by portable kinematic recording devices and quantitative in vivo determination of energy expenditure using stable isotopes; and, 3) improves the cardiovascular-metabolic risk factor profile including measures of key endogenous fibrinolysis regulatory enzymes [plasma tissue plasminogen activator (t-PA) and its main circulating inhibitor (PAI-1)], fasting lipoprotein lipid profiles, blood pressure, and oral glucose tolerance and insulin responses. Measurements of body composition at baseline and after training will further determine the effects of aerobic exercise training on muscle mass and central obesity.

Official Title
-----------------
Effects of Exercise on Patients With Hemiparetic Stroke

Conditions
-----------------
Stroke, Hemiplegia, Cardiovascular Disease

Intervention / Treatment
-----------------
* Procedure: Treadmill Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Males or Females Ages 40 yrs to 80 yrs who are chronic hemiparetic stroke patients.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Treadmill Exercise|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
-----------------
Cerebrovascular Disorders, Exercise, Rehabilitation
Sofia hCG FIA Field Study

Study Overview
=================
Brief Summary
-----------------
The objective of this field study is to demonstrate the clinical performance of the Sofia hCG FIA Test, using urine specimens from females of childbearing age.

Detailed Description
-----------------
Subjects presenting for pregnancy testing will provide urine specimens that will be tested with the Sofia hCG FIA test and the comparator pregnancy test that will detect levels of hCG of 20mIU as positive for pregnancy.

Official Title
-----------------
Sofia hCG FIA Field Study

Conditions
-----------------
Pregnancy, Early Detection

Intervention / Treatment
-----------------
* Device: Sofia hCG FIA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects of childbearing age, who are being screened for pregnancy and who have signed the informed consent Exclusion Criteria: Subject is post-menopausal. Subject within the past six weeks has experienced any of the following: delivered a newborn; had an abortion or a natural termination (miscarriage); or, received hCG supplements. Subject has had a hysterectomy. Unable to understand and consent to participation.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Sofia hCG FIA|Qualitative detection via immunofluorescence technology of increased level of hCG present in urine.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of presence of hCG in urine | Clinical performance will be based on comparison of Sofia hCG FIA test results to those obtained from an FDA-cleared hCG test. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, hCG
Intraobserver and Interobserver Reproducibility on Hip Clinical Assessment

Study Overview
=================
Brief Summary
-----------------
The functional assessment of the hip joint is complex and challenging. Reproducible measures are necessary to identify changes in the structures and functionality of the hip joint over time and to evaluate the outcomes of treatments. A systematic evaluation process is critical to evidence-based practice. However, there are few studies investigating the reproducibility of these measures such as muscle strength, range of motion (ROM) and hip functionality in healthy subjects.

Detailed Description
-----------------
Twenty subjects were randomized in two different days: (1) First evaluation of muscle strength, range of motion and single-leg squat performed by the evaluator 1; (2) Repeat the first evaluation with 3 different evaluators

Official Title
-----------------
Intraobserver and Interobserver Reproducibility on Hip Clinical Assessment

Conditions
-----------------
Hip Joint

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No complaints of pain or knowledge of hip pathology Subjects willing to enroll Exclusion Criteria: Subjects reporting that they can not perform the tests due to pain With previous surgery of the hip or pelvis; Diabetes Mellitus; Neuromuscular or neurological diseases; Cardiovascular diseases that prevent the realization of maximum voluntary effort; Subjects presenting positive hip clinical tests

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip muscle strength | Measured with isometric hand hel dynamometry | Day 1 (evaluator 1) and after 4 days of rest repeat measures on day 2 with 3 different evaluators | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip range of motion | Measured with goniometer | Day 1 (evaluator 1) and after 4 days of rest repeat measures on day 2 with 3 different evaluators |
Study on Musculoskeletal Disorders in Spanish Pianist

Study Overview
=================
Brief Summary
-----------------
Background: musculoskeletal disorders related to instrumental practice (TMRPI) affect many pianists. Objectives: to know the prevalence of TMRPI in the population of Spanish pianists and its relationship with gender, age, physical activity, number of years playing the piano and the number of hours per week. Design: transversal study based on a survey that included 30 volunteers of both genders, aged between 17 and 65, who played the piano for at least 2 years. Method. due to the absence of specific questionnaires for pianist populations on MMRPI, a questionnaire was conducted combining a validated questionnaire on MMR, the Nordic Musculoskeletal Questionnaire (NMQ) with an ad hoc questionnaire created specifically for this study

Official Title
-----------------
Transversal Observational Study on Musculoskeletal Disorders in Spanish Pianist

Conditions
-----------------
Musculoskeletal Diseases

Intervention / Treatment
-----------------
* Other: SURVEY


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 16 years old at least 2 years playing piano Exclusion Criteria: Traumatism

Ages Eligible for Study
-----------------
Minimum Age: 16 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

| Intervention/Treatment |
| --- |
|Other: SURVEY|Pain survey on pianists|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessed by VAS Scale | Pain assessed by VAS Scale | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| YEARS | Incidence of pain over years of practice | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
assessments, pain, physical therapy specialty, musics
Hemodynamic Monitoring During Abdominal Aortic Surgery

Study Overview
=================
Brief Summary
-----------------
This trial investigates the ability of our istitutional algorithm in maintaining a safe hemodynamics during abdominal aorta open surgery, in terms of limitation of intraoperative hypotension incidence

Detailed Description
-----------------
The present trial includes patients submitted to abdominal aorta open surgery. This type of procedure is very challenging for the hemodynamic management because of the operation per se (during which the surgeon clamp and unclamp the aorta with very significant hemodynamic variations) and because of the altered tone of the vessels due to the general vascular disease such a type of patients is suffering from. The aim of this study is to verify if the incidence of intraoperative hypotension in terms of severity, lasting and number of episodes, may be reduced by the application of a protocol of hemodynamic management. Primary endpoint: Global time spent in hypotension <10%. Secondary Endpoints: Time Weighted Average (TWA) of Area Under the Threshold <0.4 mmHg Incidence of hypotensive events/patient < 8 (including the expected hypotensive events due to the aortic clamping and unclamping)

Official Title
-----------------
INTRAOPERATIVE HEMODYNAMIC MANAGEMENT IN ABDOMINAL AORTIC SURGERY GUIDED BY HYPOTENSION PREDICTION INDEX (HPI) - HEMAS Trial

Conditions
-----------------
Hemodynamic Instability

Intervention / Treatment
-----------------
* Other: Intraoperative fluids and vasoactive drugs management protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults patients undergoing abdominal aorta open surgical repair Exclusion Criteria: Emergent/urgent operation Age <18 years Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Intraoperative fluids and vasoactive drugs management protocol|Limitation of hypotensive events during open surgery for abdominal aorta repair|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global time spent in hypotension <10% | Hypotension=mean arterial pressure <65 mmHg for at least 1 minute | Intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Weighted Average (TWA) of Area Under the Threshold <0.4 mmHg | The severity of hypotension during the whole intraoperative surgery | Intraoperative period | 
| Incidence of hypotensive events/patient < 8 | including the expected hypotensive events due to the aortic clamping and unclamping | Intraoperative period |
Adapt and Incorporate dDPP Into Clinical Workflows

Study Overview
=================
Brief Summary
-----------------
This observational study will seek to adapt a digital diabetes prevention program (dDPP) tool suite into clinical workflows. This tool pushes key dDPP data elements (e.g. weight and daily step count) directly into EHR workflows of primary care to enhance patient engagement. It seeks to determine the impact of combining adapted visualizations and summaries of key dDPP data elements directly into the EHR with automated notifications and messaging designed to enhance patient engagement in the dDPP. The study will involve provider workflow analysis based on observation and facilitated group tool adaptation sessions.

Detailed Description
-----------------
Primary objective: to examine the impact of the dDPP tool suite on the EHR and clinical workflows, and identify optimization opportunities. Secondary objective: to assess the usability of the proposed dDPP tool suite in clinical practice.

Official Title
-----------------
An Observational Study to Adapt a Digital Diabetes Prevention Program (dDPP) and Incorporate it Into the Clinical Workflows.

Conditions
-----------------
Physician-Patient Relations, Nurse-Patient Relations

Intervention / Treatment
-----------------
* Other: Digital Diabetes Prevention Program (dDPP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physicians Nurses Practice assistants Health coaches Population health managers Patient navigators Exclusion Criteria: Practices will be ineligible for participation if they treat fewer than 100 adults with prediabetes.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Clinicians<br>Five practices will be selected from NYULH ambulatory practice sites to represent the spectrum of provider settings within the system. These sites will be the clinical partners for the adaptation of the dDPP tool suite | Other: Digital Diabetes Prevention Program (dDPP)<br>* dDPP tool suite to integrate with the EHR and clinical workflows<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability will be assessed using a 5-point Likert scale | 5 point likert scale is measured on a 5 point scale, 1 being very unsatisfied and 5 being very satisfied. Higher scores mean more usability | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physicians, Nurses, Practice assistants, Health coaches, Population health managers, Patient navigators