linjc16/ctgov huggingface dataset:
Registry Study on Drug Therapy and Clinical Outcomes in Patients With Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
Registry Study on Drug Therapy and Clinical Outcomes in Patients With Acute Coronary Syndrome

Official Title
-----------------
Registry Study on Drug Therapy and Clinical Outcomes in Patients With Acute Coronary Syndrome

Conditions
-----------------
Drug Therapy, Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent has been signed. Patients diagnosed in our hospital with acute coronary syndrome. Age ≥18. Life expectancy ≥12 months. Exclusion Criteria: Severe lack of important information such as history of previous medication, history of previous disease, history of surgery. Pregnant and lactating women. Mental disorders, or inability to communicate effectively with researchers, or failure to comply with research protocols.

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 |
| --- | --- | --- |
| main adverse cardiovascular and cerebrovascular events (MACCE) | MACCE will be defined as all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI), and ischemic-driven revascularization. | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug reaction | Adverse drug reaction will be defined as any adverse reactions in the patients. | up to 5 years |
Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)

Study Overview
=================
Brief Summary
-----------------
Hypertension is a major risk factor for stroke and cardiovascular mortality. Catheter- based renal denervation causes substantial and sustained blood- pressure reduction in patients with resistant hypertension. The purpose of RENSYMPIS is to study the effects of renal denervation on: Cardiovascular function Metabolic factors Inflammatory and endocrine factors Coagulation Sleep

Conditions
-----------------
Resistant Hypertension

Intervention / Treatment
-----------------
* Procedure: Renal Denervation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resistant Hypertension (systolic blood pressure >160mmHg and 3 or more antihypertensive agents in use) Age 30- 69 years Written informed consent Exclusion Criteria: Secondary hypertension Pseudohypertension Pregnancy Renal insufficiency (GFR <45ml/min) Clinically significant stenotic valvular disease Oral anticoagulation CCS III-IV symptoms or CABG/PCI in previous 6 months Prior stroke Contrast agent allergy inappropriate renal artery anatomy (< 4mm diameter, < 20mm length)

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 69 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Renal denervation<br>Patients are randomized to renal denervation | Procedure: Renal Denervation<br>* Sympathetic renal denervation via renal arteries<br>|
| No Intervention: Optimization of medical therapy<br>Antihypertensive treatment is optimized | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Office blood pressure |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory blood pressure |  | 2 years | 
| Insulin resistance |  | 2 years | 
| Endothelial function |  | 2 years |
The V-Tachogram:Decreasing Ventricular Arrythmias When Injecting Contrast in the Left Ventricle

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if increasing the linear rise rate of injection of x-ray contrast in the heart during left ventriculograms(part of a cardiac Catheterization procedure) will decrease the incidence of arrythmias and improve image quality?

Detailed Description
-----------------
The LV angiogram is performed frequently as part of the cardiac catheterization procedure. It is done by injecting a bolus of x-ray contrast into the ventricle through a pigtail catheter over a short period of time and observing the heart as it is pumped out. This provides information on regional wall motion abnormalities, ejection fraction, and mitral regurgitation. A common occurrence when performing a LV angio is frequent PVC's or V-tach during the injection, it has been suggested that ectopic's occurs about 54% of the time and that interpretability was limited 30% of the time(3) This is rarely serious and subsides at the end of the injection but the irregularity of the contractions does affect the diagnostic quality of the exam. In an attempt to decrease the incidence of ventricular ectopic's during the LV angiogram Contrast injections with a greater linear rise increasing the injection duration to at least ½ the flow rate, greater than previous settings should decrease the tension and the contrast jets coming out of the catheter, decreasing the fling of the catheter at the initiation of the injection. Whether this affects the quality of the angiogram with a pig tail vs. a straight catheter will also need to be considered?

Conditions
-----------------
Ventricular Arrythmias

Intervention / Treatment
-----------------
* Procedure: lv injection of contrast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only ventriculograms that the operator deems necessary for the booked procedure will be considered. Only operators agreeing to the for mentioned settings will participate in the study. Patients will be randomized consecutively and should conclude in 3 to 4 weeks. Exclusion Criteria: Patients with aortic valve disease, a-fib, and frequent benign ectopic beats and patients unable to follow instructions to stop breathing will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: lv injection of contrast|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
-----------------
arrythmias
SALTO - Symbicort Single Inhaler Therapy Use in Adolescent Adults and Adults With Persistent Asthma

Study Overview
=================
Brief Summary
-----------------
The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adolescent and adult patients with persistent asthma.

Official Title
-----------------
A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbohaler 160/4.5 μg, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26-week, Randomised, Open-label, Parallel-group, Multi-centre Study (SALTO)

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Budesonide/formoterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum of 3 months documented history of asthma, diagnosed according to the American Thoracic Society (ATS) definition. Prescribed inhaled GCS at a dose of ≥320 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1. Exclusion Criteria: Use of any b-blocking agent, including eye-drops. Use of oral GCS as maintenance treatment. Known or suspected hypersensitivity to study therapy or excipients. A history of smoking ≥ 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).

Ages Eligible for Study
-----------------
Minimum Age: 12 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Budesonide/formoterol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first severe asthma exacerbation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of severe asthma exacerbations |  |  | 
| Mean use of as-needed medication |  |  | 
| Prescribed asthma medication |  |  | 
| Peak Expiratory Flow (PEF) |  |  |
Efficacy, Safety and Adherence of Patients Infected With Hepatitis C Virus in Retreat With INFERGEN (Interferon Alfacon1)

Study Overview
=================
Brief Summary
-----------------
This is a Phase 4, descriptive, observational, open, prospective study of patients who their doctor prescribes INFERGEN for clinical practice. No medication was provided by the sponsor. The planned observation time is 48 weeks and 24 weeks of follow-up. Each investigator participating in this registry will employ his or her discretion and standard clinical practice to determine when to see the patient in the clinic, how to manage the patient's drug regimen, and how best to monitor the patient's response and tolerance to therapy.

Conditions
-----------------
Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing to consent to data being collected Considered by the investigator as an appropriate patient for treatment with INFERGEN in retreatment.

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 |
| --- | --- | --- |
| Incidence of SVR | •Determine the incidence of SVR, defined as undetectable HCV RNA measured 24 weeks after therapy ends, associated with prescribed, therapy with Infergen® (Interferon alfacon 1) in patients chronically infected with HCV, in retreatment. | 24 weeks post end of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile | •Capture of defined adverse events (AEs),dose changes or cessation, and adherence to the prescribed dose of Infergen and other prescribed therapies over the course of treatment | Treatment weeks 4, 12, 24,32, 40, 48, and Follow-Up weeks 4 and 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, Retreatment, Failures, Infergen, Interferon Alfacon-1
Association Between Sagittal Patellar Offset and Anterior Knee Pain in Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The aim of this study to evaluate whether the position of the sagittal patellar offset is a predictive factor for anterior knee pain in subjects having undergone bilateral multiradius total knee replacement.

Detailed Description
-----------------
A prospective, observational study. A total of to 80 subjects requiring bilateral multiradius knee arthroplasty will be enrolled. Anterior femoral offset, femoral diameter and patellar offset will be measured by orthopaedic surgeons. In addition, Visual Analogue Scale Score, Oxford Knee Score, WOMAC, SF12 and SF36 will be evaluated postoperative in patients long-term follow up to see if there is a relationship between anterior femoral offset and anterior knee pain.In the direct lateral knee joint radiograph, the distance between the two parallel axis extending from both cortices of the femur is measured as femoral diameter.The remaining length between the anterior axis and the maximum peak at the anterior of the prosthesis is considered as an anterior femoral offset[1]. Sagittal patellar offset defined by us as the ratio of the anterior femoral offset to the remaining distance between the maximum anterior point of the patella and the posterior vertex in the direct lateral knee joint radiography.

Official Title
-----------------
Association Between Sagittal Patellar Offset and Anterior Knee Pain After Multiradius Total Knee Replacement.

Conditions
-----------------
Primary Gonarthrosis, Bilateral, Knee Osteoarthritis, Knee Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 50 years of age with primary severe gonarthrosis who will undergo total knee replacement Exclusion Criteria: Patients with severe gonarthrosis, with a history of malignancy, with severe extraarticular deformity, with posttraumatic and septic arthritis sequel

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| anterior patellar offset ratio | The distance between the anterior cortex of the femur and the maximum peak at the anterior of the prosthesis is considered as an anterior femoral offset[1].Sagittal patellar offset defined by us as the ratio of the anterior femoral offset to the remaining distance between the maximum anterior point of the patella and the posterior vertex in the direct lateral knee joint radiography. | minimum 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total knee arthroplasty, anterior knee pain, sagittal patellar offset
Comparison of Lung Administration With Three Different Nebulizer

Study Overview
=================
Brief Summary
-----------------
Comparison between three modalities of nebulization.

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Device: Jet Nebulizer
* Device: Trunk Mask Nebulizer
* Device: Aerobika Nebulizer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Subjects Exclusion Criteria: Pulmonary disease Cardiac disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jet Nebulizer<br>Nebulization with a jet nebulizer and a classic mask | Device: Jet Nebulizer<br> <br> |
| Experimental: Trunk Mask Nebulizer<br>Nebulization with a je nebulizer and a trunk mask | Device: Trunk Mask Nebulizer<br> <br> |
| Experimental: Aerobika Nebulizer<br>Nebulization with an Aerobika | Device: Aerobika Nebulizer<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung deposition by urinary measure |  | 10 minutes |
Self-Management in Stroke Survivors

Study Overview
=================
Brief Summary
-----------------
This is a feasibility study of using health-IT to promote self-management of risk factors in stroke survivors.

Official Title
-----------------
Promoting Self-Management in Stroke Survivors Using Health IT

Conditions
-----------------
Stroke, Hypertension

Intervention / Treatment
-----------------
* Other: Self-Management / MTM using Health IT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Stroke Survivors and their caregivers English speaking History of hypertension Exclusion Criteria: -Cannot use the health-IT system

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Management / MTM via Health IT<br>Stroke survivors are trained to measure and enter BP into an online health management tool | Other: Self-Management / MTM using Health IT<br> <br> |
| No Intervention: Usual Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of blood pressure control into guideline recommended ranges | The American Heart Association/American Stroke Association (AHA/ASA) have cited the JNC-7 in their guidelines to define normal blood pressure as < 120/80. We will use these guidelines and examine rates (percentage of subjects) of blood pressure control in intervention vs. usual care group. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Compliance | Percent of subjects who have discontinued one or more of the blood pressure medications on their own (i.e. without medical direction) in the intervention vs. usual care group. | 3 months | 
| Use of online tool | Ease of online health management tool use will be operationalized as the percent of subjects in the intervention group who measure their BP and enter it online at least 75% of the study period, 50% of the study period and those with 25% or less of the study period. | 3 months |
Comparison of Usual Care and Distraction (Tablet) in Children 3-5 Years Old

Study Overview
=================
Brief Summary
-----------------
Randomized control trial comparing usual care and distraction (tablet) on anxiety and length of stay between in children 3-5 years old

Detailed Description
-----------------
Two group RCT comparing usual care and distraction (tablet) on preoperative anxiety and length of stay in preschool children.

Official Title
-----------------
Comparison of Usual Care and Distraction (Tablet) on Anxiety and Length of Stay Between in Children 3-5 Years Old

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Behavioral: Distraction
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3-5 year old children Scheduled for elective surgery American Society of Anesthesiologists physical status classification system: I - II Exclusion Criteria: Children younger than 3 or older than 6 Allergy to midazolam Cognitive or developmental delays American Society of Anesthesiologists physical status classification system: III - VI Anesthesia provider determines child is not eligible Children that are transferred to ICU after surgery

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 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
Interventional Model Description: Group 1: usual care Group 2: distraction
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>Usual care (midazolam) is administered pre-operatively | Other: Usual care<br>* Anxiolytic ordered by anesthesiologist is usual care<br>* Other names: Anxiolytic per anesthesia;|
| Experimental: Distraction<br>Distraction (interactive tablet) is given to children pre-operatively | Behavioral: Distraction<br>* Distraction (interactive tablet)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Pre-operative anxiety measured by the modified Yale Preoperative Anxiety Scale; scores range 23-100 with higher scores indicating greater levels of anxiety. A categorical variable was created using a cut-off score of 30 or more to indicate anxiety. Scores less than 30 indicate no anxiety. | Pre-operative |
SPOT Vision Screening

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to determine if the Welch-Allyn Spot Vision Screener (SPOT) is effective at detecting various risk factors for poor vision in developmentally delayed children. These children have a higher percentage of vision disorders than the average population. The SPOT screen itself takes about six seconds to complete. It produces a photograph of the eye and a print out with amount of hyperopia, myopia, astigmatism and pupil size. The subject will have three SPOT screens around the time of their standard of care eye exam. The data obtained from the three SPOT screens will be compared among themselves for accuracy and to the findings of the clinical eye exam.

Official Title
-----------------
Accuracy of Welch Allyn Spot™ Vision Screener to Detect Amblyogenic Factors in Developmentally Delayed Children

Conditions
-----------------
Vision Disorders

Intervention / Treatment
-----------------
* Diagnostic Test: Welch-Allyn Spot Vision Screener


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: child over 4 months of age social, behavioral, physical, or other handicap unable to complete age-appropriate vision screening Exclusion Criteria: glaucoma post intraocular surgery microphthalmia other serious eye disorder inability to complete SPOT screener

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Welch-Allyn Spot Vision Screener|photograph of the eye|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the SPOT will be effective in screening for amblyogenic risk factors | the Spot has a sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) necessary to appropriately perform visual triage in developmentally delayed children | 12 months |