linjc16/ctgov huggingface dataset:
Efficacy of Oral Ivabradine in Patients Presenting With NSTEMI

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the beneficial effect of heart rate reduction of oral ivabradine in patients presenting with non ST-segment elevation myocardial infarction (NSTEMI) during acute stage post percutaneous coronary intervention versus conventional treatment. Materials and methods: A total of 100 patients admitted to the emergency department, National Heart Institute, Cairo, Egypt were randomized into two groups as follows: Group A: 50 patients with NSTEMI treated with ivabradine (5mg twice daily) in addition to the conventional treatment; Group B: 50 patients with NSTEMI treated with the conventional treatment only. Demographic data, detailed history, clinical examination, chest pain onset, blood pressure, heart rate (HR), temperature and respiratory rate, electrocardiogram (ECG) as well as echocardiography and laboratory investigations were recorded. Patients were monitored for a period of 3-5 days (acute stage).

Official Title
-----------------
The Efficacy of Oral Ivabradine in Patients Presenting With Acute Non ST-segment Elevation Myocardial Infarction (NSTEMI): Interventional Randomized Parallel Study

Conditions
-----------------
NSTEMI

Intervention / Treatment
-----------------
* Drug: Ivabradine
* Drug: Conventional Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with NSTEMI with normal sinus rhythm and heart rate (HR) more than 70 beats per minute (bpm) and systolic blood pressure (SBP) >90 mm Hg undergoing PCI Exclusion Criteria: Patients needing urgent cardiac surgery, IV inotropic agents or had a HR less than 60 bpm without any medication.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A Ivabradine Group<br> | Drug: Ivabradine<br>* Ivabradine (5mg twice daily)<br>|
| Active Comparator: Group B Control Group<br> | Drug: Ivabradine<br>* Ivabradine (5mg twice daily)<br>Drug: Conventional Treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Heart Rate Reduction | acute stage post percutaneous coronary intervention (3-5 days) |
Symbicort Single Inhaler Therapy for Asthma in a General Practice Setting

Study Overview
=================
Brief Summary
-----------------
The primary objective is to compare the effects of Symbicort SiT and treatment according to NHG-guidelines on bronchial hyperresponsiveness in asthmatic patients, as measured by PD20 histamine, and to validate the Bronchial Hyperresponsiveness Questionnaire (BHQ).

Official Title
-----------------
Effects of Symbicort Single Inhaler Therapy on Bronchial Hyper Responsiveness, Asthma Control and Safety in Mild to Moderate Asthmatics in General Practice, Compared to Usual Care Therapy

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

Intervention / Treatment
-----------------
* Drug: budesonide/formoterol Turbuhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of mild to moderate asthma, FEV1 ³ 60% of predicted normal values pre-bronchodilator, daily use of inhaled GCS during the last 3 months Exclusion Criteria: Regular need of >4 inhalations of a short-acting b2-agonist/day, known or suspected hypersensitivity to any of the investigational drugs or inhaled lactose, use of any b-blocking agent, having smoked ³10 pack-years

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: budesonide/formoterol Turbuhaler|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PD20 histamine |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of asthma-control days, time to first mild asthma exacerbation, number of mild asthma exacerbation days, asthma symptom scores (day and night), FEV1, PEF (morning and evening), Number of inhalations with iGCS and mean dose of iGCS |  |  |
Comparison of Intraoperative Warming Devices

Study Overview
=================
Brief Summary
-----------------
The sublingual (under the tongue) core temperature within 10 minutes of arrival in the post anesthesia care unit (PACU) for patients warmed with the Dynatherm vitalHeat2 (VH2) System under general anesthesia for total knee arthroplasty will be equivalent to that of patients warmed with the Arizant Bair Hugger System.

Official Title
-----------------
Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHeat™ Temperature Management System (vH2) and the Arizant Bair Hugger System

Conditions
-----------------
Total Knee Arthroplasty

Intervention / Treatment
-----------------
* Device: VH2
* Device: Bair Hugger


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Initial total knee arthroplasty. Expected duration of surgery at least 2 hours. General anesthesia. American Society of Anesthesiologists (ASA) classification I-III. Age >= 18 years. Exclusion Criteria: Skin abrasion at the device application site. History of peripheral vascular disease. History of allergic skin conditions of the upper extremities. History of malignant hyperthermia.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VH2<br>Dynatherm vitalHeat2 (VH2) temperature management system. | Device: VH2<br>* Dynatherm vitalHeat2 (VH2) temperature management system.<br>|
| Active Comparator: Bair Hugger<br>Arizant Bair Hugger temperature management system. | Device: Bair Hugger<br>* Arizant Bair Hugger temperature management system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sublingual Temperature. |  | Within 10 minutes of arrival in PACU |
MultiPoint Pacing Programming Guided by Noninvasive Hemodynamics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate noninvasive hemodynamics with MultiPoint™ Pacing (MPP) and biventricular (BiV) pacing under various vector combinations and paced delays in patients receiving cardiac resynchronization therapy (CRT).

Official Title
-----------------
Noninvasive Hemodynamics for MultiPoint(TM) Pacing Programming in Cardiac Resynchronization Therapy Patients

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: CRT with MultiPoint Pacing
* Procedure: Hemodynamic measurements for CRT device programming


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be scheduled to undergo de novo implant of a St. Jude Medical CRT-D system Be in NYHA II or III functional class with approved standard indication by ESC/EHRA Guidelines Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule Exclusion Criteria: Have persistent or permanent atrial fibrillation Have a recent myocardial infarction within 40 days prior to enrollment Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 12 months Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months prior to enrollment Have had intravenous inotropic support in the last 30 days Be scheduled or considered for heart transplantation over the next 12 months Be less than 18 years of age Be pregnant or plan to become pregnant over the next 12 months

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MultiPoint Pacing<br>CRT with MultiPoint Pacing | Device: CRT with MultiPoint Pacing<br> <br> Procedure: Hemodynamic measurements for CRT device programming<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure changes in hemodynamics during BiV pacing and MPP |  | up to 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| echocardiographic changes to MPP programming guided by noninvasive hemodynamic measurements | End systolic volume will be assessed at 6-month follow-up visit and compared to that of baseline. | 6 months |
Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial Amputees

Study Overview
=================
Brief Summary
-----------------
The aim of this work was to test the Echelon foot efficiency to offer enhanced safety, comfort and function over a wide range of walking surfaces, inclines and stairs, thereby improving the quality of life for amputees. Ten individuals with a unilateral trans- tibial amputation will participate in two test sessions- one while using their own prosthetic foot, the other while using the Echelon foot.

Official Title
-----------------
Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial

Conditions
-----------------
Unilateral Trans Tibial Amputation

Intervention / Treatment
-----------------
* Device: Echelon foot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ten individuals with a unilateral trans tibial amputation due to trauma. Walking at list one year from the end of their gait training. Mobility status is 3 or 4. Exclusion Criteria: Bilateral amputation. Injury of the sound limb that compromises the gait of the amputee.

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

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

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

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: Echelon<br> | Device: Echelon foot<br>* One Echelon foot for each subject, for a period of a month.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| While using the Echelon foot the amputees will present lower internal mechanical strain in the soft tissue of the stump while standing on a 10 degrees platform. |  | Beginning of the trial and one month after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Using the Echelon foot the Kinematic of level ground walking and climbing up and down stairs will be closer to normal curves. |  | At the beginning of the trial and one month later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Unilateral trans-tibial amputees
A Study to Collect Survival Data on Patients Previously Enrolled in Abraxane Pancreatic Cancer Study CA046.

Study Overview
=================
Brief Summary
-----------------
A study to collect survival data on patients previously enrolled in Abraxane pancreatic cancer study CA046.

Detailed Description
-----------------
A study to collect survival status of CA046 subjects who were know to be alive at the last report of vital status for CA046 - approximate timeframe - end of March, 2013. Once consent is given, on a quarterly basis, information on status will be collected to include: Vital Status Date of disease progression Subsequent anticancer therapy for pancreatic adenocarcinoma

Official Title
-----------------
MPACT Extension Study: Multicenter, Survival Data Collection in Subjects Previously Enrolled in Protocol CA046

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: ABI-007


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have been enrolled in the CA046 study Must have been living at the time of the last survival follow-up (approximate timeframe - end of March, 2013) Must understand and be able to give informed consent (if a subject is deceased, proper legal consent (ie, next of kin, legal representative) will be obtained prior to collection of data) Exclusion Criteria: Consent refused for any reason
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients previously enrolled in study CA046<br>No intervention is being given in this extension study which is gathering survival information on participants of study NCT 00844649 (Celgene study CA046) who were known to be alive as of March 2013) | Drug: ABI-007<br>* No intervention is being given in this extension study which is gathering survival information on participants of study NCT 00844649 (Celgene study CA046) who were known to be alive as of March 2013)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Number of participants who survive | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression | Date of disease progression and subsequent anticancer therapy for pancreatic adenocarcinoma other than that already recorded for subject while enrolled in CA046 | up to 3 years |
Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications.

Official Title
-----------------
Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery

Conditions
-----------------
Post-operative Pain

Intervention / Treatment
-----------------
* Drug: Cannabidiol Oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Requiring shoulder arthroscopic surgery for soft tissue pathology Able to complete surveys and follow-up visits Exclusion Criteria: Younger than 18 years of age Shoulder dislocation, fracture, previous surgery, coexisting extremity pathology, pregnancy.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Opioid standard of care: Tramadol 50 mg PO PRN #30, Hydrocodone/Acetaminophen 5/325 PO PRN #30 | |
| Experimental: Cannabidiol Oil 100 mg<br>CBD 100 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op | Drug: Cannabidiol Oil<br>* Subjects will self-administer CBD sublingually.<br>|
| Experimental: Cannabidiol Oil 200 mg<br>CBD 200 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op | Drug: Cannabidiol Oil<br>* Subjects will self-administer CBD sublingually.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | Numerical Pain Scale (NRS): 0 being no pain, 10 being the worst pain imaginable. Higher scores are worse outcomes. | 30 days post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality | Insomnia Severity Index | 30 days preoperatively leading up to surgery then 30 days postoperatively as well. Outcomes will be collected from surgery to 6 weeks postoperatively. |
Time to Defibrillation Using Automated External Defibrillators by Pediatric Residents in Simulated Cardiac Arrests

Study Overview
=================
Brief Summary
-----------------
Automated external defibrillators have improved survival for adult in hospital cardiac arrest. Automated external defibrillators are approved for children aged 1 year and older for out of hospital cardiac arrests. It is unknown whether automated external defibrillators have a role for in hospital pediatric cardiac arrests. The purpose of study is to compare the management of cardiac rhythm disorders by pediatric residents using an automated external defibrillator versus a standard defibrillator in simulated pediatric cardiac arrests. It is our hypothesis that residents using an automated external defibrillator will have a shorter time to defibrillation.

Official Title
-----------------
Defibrillation by Automated External Defibrillators Versus Manual Defibrillators in Simulated Pediatric In-Hospital Cardiac Arrests: A Prospective Randomized Controlled Trial of Pediatric Residents

Conditions
-----------------
Pediatric Residents

Intervention / Treatment
-----------------
* Device: Automated external defibrillator
* Device: Manual defibrillator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric resident at Baylor College of Medicine Exclusion Criteria: Not a pediatric resident at Baylor College of Medicine
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 |
| --- | --- |
| Experimental: 1<br>Pediatric residents randomized to having an automated external defibrillator | Device: Automated external defibrillator<br>* Residents randomized to this group had an automated external defibrillator available for the simulated cardiac arrest. The automated external defibrillator did not actually discharge energy into the simulated patient<br>|
| Active Comparator: 2<br>Pediatric residents randomized to having a manual defibrillator | Device: Manual defibrillator<br>* Residents randomized to this group had a manual defibrillator available for the simulated cardiac arrest. The defibrillator did not actually discharge energy into the simulated patient.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to defibrillation |  | Within 5 minutes of the start of the simulated cardiac arrest | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Automated External Defibrillator, Resuscitation, Pediatric
A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)

Study Overview
=================
Brief Summary
-----------------
One objective of this study is to determine the levels of markers of inflammation on the eyelid margin of subjects with blepharoconjunctivitis and compare them with those of healthy volunteers. Another objective is to determine in subjects with blepharoconjunctivitis the effect of azithromycin ophthalmic solution, 1 % on markers of inflammation of lid margins and conjunctivae and on signs and symptoms of blepharoconjunctivitis.

Official Title
-----------------
A Single-Center, Open-Label Study to Characterize Eyelid Margin Erythema, Markers of Clinical Inflammation and Levels of Inflammatory Mediators in the Lid Margins and Conjunctivae of Untreated Healthy Volunteers and Subjects Diagnosed With Posterior Blepharoconjunctivitis Following Dosing With Azithromycin Ophthalmic Solution, 1% for Four Weeks

Conditions
-----------------
Posterior Blepharoconjunctivitis

Intervention / Treatment
-----------------
* Drug: Azithromycin ophthalmic solution, 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a current diagnosis of posterior blepharoconjunctivitis in both eyes (except for healthy volunteers) Have a Best Corrected Visual Acuity (BCVA), using corrective lenses if necessary, in both eyes of at least +0.7 LogMAR If female, are non-pregnant or non-lactating Exclusion Criteria: Have anterior blepharitis Have lid structural abnormalities Have had penetrating intraocular surgery in the past 90 days or require penetrating intraocular surgery during the study Unable to withhold the use of contact lenses within 3 days prior to Visit 1 during the study Have been diagnosed with ongoing glaucoma Have a serious medical condition which could confound study assessments

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azithromycin ophthalmic solution, 1%<br> | Drug: Azithromycin ophthalmic solution, 1%<br>* 1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of investigator-rated scores for eyelid margin erythema |  | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of investigator-rated scores of blepharoconjunctivitis signs |  | Weeks 2, 4, 6, 8 | 
| Change from baseline of subject-rated scores of blepharoconjunctivitis symptoms |  | Weeks 2, 4, 6, 8 |