bioihbjkbjnl/mcl2 huggingface dataset:
Aspirin and Plavix Following Coronary Artery Bypass Grafting
Condition: Coronary Graft Patency
Intervention: clopidogrel; sugar pill; Aspirin
Intervention description: clopidogrel 75mg daily by mouth daily for 12 months; sugar pill by mouth daily for 12 months; aspirin 81 mg daily by mouth for 12 months ( Standard of care in both arms)
Intervention MeSH terms: Aspirin; Clopidogrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: aspirin; clopidogrel; coronary artery bypass graft; Plavix

Summary:

      The design of the study will be randomized, double blind trial, which will examine the
      effects of addition of clopidogrel to current guideline recommended background therapy on
      lowering the incidence of graft stenosis after coronary artery bypass grafting compared to
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing coronary artery bypass grafting, with or without cardiopulmonary
             bypass

          -  Age ≥ 18

        Exclusion Criteria:

          -  Left ventricle ejection fraction <30%

          -  Emergency surgery

          -  Valve surgery

          -  Redo CABG

          -  Postoperative cardiogenic shock for more than 48 hours

          -  Postoperative bleeding or cardiac tamponade

          -  More than 24 hours postoperative intubation course

          -  Requirement of postoperative anticoagulation

          -  Serum creatinine >1.4

          -  Contraindication to use of postoperative coronary CT scan

          -  Allergy or contraindication to aspirin or clopidogrel

          -  Inability to provide informed consent

          -  Pregnant or breast feeding females
Memantine and Postoperative Pain
Condition: Pain
Intervention: Memantine; Placebo
Intervention description: 20 mg, BID; BID
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 77.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Memantine is associated with improvement in pain relief after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male

          -  Age 18 to 75 years old

        Exclusion Criteria:

          -  Chronic pain conditions or taking regular analgesics

          -  Taking psychotropic medications

          -  Parkinson's disease

          -  Narrow-angle glaucoma

          -  Known gastroduodenal ulcer

          -  History of seizure disorder

          -  Renal insufficiency, as defined by serum creatinine greater than 2 mg/dL

          -  Liver disease, including liver failure, cirrhosis, or acute hepatitis

          -  Significant coronary vascular disease or cardiac conduction system disease, as noted
             by ECG or history of cardiac symptoms, or cardiac ejection fraction less than 30%

          -  American Society of Anesthesiologists (ASA) score of 4 or higher

          -  Allergy to ketorolac or memantine
The Effect of BEPREVE 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Refresh Tears 0.5% Lubricant Eye Drops; Bepreve 1.5% Ophthalmic Solution
Intervention MeSH terms: Ophthalmic Solutions; Lubricant Eye Drops
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Allergic; conjunctivitis; Allergic conjunctivitis

Summary:

      The purpose of this study is to compare the effect of Bepreve® with an artificial-tear eye
      drop on the quality of your tears.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Are male or female at least 18 years of age who are diagnosed with allergic
             conjunctivitis.

          2. Have documented positive skin prick puncture test to at least one (1) seasonal
             allergen (e.g., grasses, trees, weeds, or other allergens) within two (2) years of
             Visit 1.

          3. Agree not to have any other ocular drops in study eyes within 2 days prior to the
             initiation of dosing with the test article or throughout the duration of the study.

          4. Have a Best Corrected Visual Acuity of 20/200 or better in either eye.

          5. Are willing/able to follow instructions from the study investigator and his/her staff.

          6. Be willing/able to return for all required study visits, to follow instructions from
             the study investigator and his/her staff.

          7. Are able to self-administer test article (or have a caregiver available to instill all
             doses of test article).

          8. Have signed informed consent approved by Institutional Review Board or Independent
             Ethics Committee.

        Exclusion Criteria:

          1. Have known hypersensitivity to either BEPREVE™ or REFRESH TEARS® or to any component
             of the test article (including "procedural" medications such as anesthetic and/or
             fluorescein drops, dilating drops, etc.).

          2. Have active corneal pathology noted in the study eye at the screening visit. Active
             corneal pathology is defined as corneal pathology that is non-stable, or greater than
             mild, or will compromise assessment of the safety or efficacy of treatment.

          3. Have used topical, ocular, inhaled or systemic steroids within 14 days prior to
             screening.

          4. Have a history of abuse of alcohol/drugs within six months prior to the screening
             visit.

          5. Are pregnant or nursing/lactating.

          6. Have participated in any other study of an investigational drug or device within 30
             days prior to randomization.
Ranolazine for the Treatment of Chest Pain in HCM Patients
Condition: Hypertrophic Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Intervention: Ranolazine
Intervention MeSH terms: Ranolazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chest pain; dyspnea

Summary:

      The purpose of RHYME is to evaluate the safety and efficacy of ranolazine in Hypertrophic
      Cardiomypathy patients with chest pain or dyspnea despite treatment with standard medical
      therapy. This is a small, pilot, open-label (non-randomized) study of an approved drug for
      the treatment of angina in a novel patient population (adult patient population with
      hypertrophic cardiomyopathy).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older

          -  Left Ventricle wall thickness >/= 15mm in the absence of other condition causing
             hypertrophy

          -  Baseline Angina/Shortness of Breath Frequency of > 2 episodes per week

          -  Willing to provide informed consent

        Exclusion Criteria:

          -  Severe stenotic valvular disease

          -  Severe valvular regurgitation except mitral regurgitation due to systolic anterior
             motion

          -  Significant (>60% stenosis) coronary artery disease

          -  Acute coronary syndrome within 30 days

          -  Severe heart failure defined as LV systolic dysfunction with Ejection Fraction <40% or
             NYHA class 4 symptoms

          -  Severe renal impairment (glomerular filtration rate, <30 mL/min/1.73 m2)

          -  Moderate-severe hepatic impairment (Child-Pugh classes B and C)

          -  Hospitalization for cardiac reason within 3 months of enrollment

          -  Anticipated changes to treatment of HCM within study period, including medications,
             device implantation, or septal reduction therapies

          -  Concomitant use of ketoconazole, macrolide antibiotics, and HIV protease inhibitors

          -  Active myocarditis, pericarditis, or restrictive cardiomyopathy

          -  Non-cardiac terminal illness with expected survival less than 6 months

          -  Women who are of childbearing potential

          -  Inability to perform or adhere to study protocol
Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery
Condition: Post Operative Pain; Nausea
MeSH terms: Pain, Postoperative
Intervention: Dexamethasone 8mg iv x1; placebo
Intervention description: Dexamethasone 8mg iv x1; 2 ml normal saline IV x1
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to determine the opiate sparing effects of intravenously
      administered dexamethasone in outpatient knee surgery. Dexamethasone is a glucocorticoid with
      well known antiemetic effects. However, the analgesic effects of dexamethasone have not been
      adequately researched. Following surgery, patients are typically discharged home with PO
      opiates to manage post-operative pain. The investigators believe that by using VAS (Visual
      Analog Scale) for Pain the investigators can show that a single dose of dexamethasone can
      reduce pain scales and opiate consumption post-operatively, on Post Operative Day (POD 1)
      when compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients undergoing ambulatory knee arthroscopy surgery

          -  Must provide phone contact number and agree to phone followup on post operative day 1

        Exclusion Criteria:

          -  Patients with major systemic disease

          -  Allergy or intolerance to study drug
Combining Placing a Synera Patch With Propofol/Lidocaine Mixture to Decrease Pain With IV Propofol Injection
Condition: Pain on IV Injection of Propofol.
Intervention: Lidocaine/tetracaine transdermal patch; Saline; Lidocaine
Intervention description: All patients in arm 1 and arm 2 will receive the Synera Patch.; Patients in arm 2 will receive Saline with the Propofol.; Patients in arm 1 will receive Lidocaine with the Propofol.
Intervention MeSH terms: Lidocaine; Tetracaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main objective is to evaluate if combining placing the Synera patch and using Propofol
      /Lidocaine mixture will further decrease the pain associated with the IV injection of
      Propofol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Children 6-17 yrs.

          -  Scheduled to receive general anesthesia for an elective procedure.

          -  ASA classification 1-2

        Exclusion Criteria:

          -  Children with Skin disease and/or Skin infections.

          -  Allergy to Propofol, Lidocaine or tetracaine.
A Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity
Condition: Renal Transplant Rejection
Intervention: Prograf; Neoral
Intervention description: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID; Cyclosporine (Neoral) starting dose 3mg/kg PO BID
Intervention MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Kidney Transplantation; Immunosuppression

Summary:

      This study aims to compare outcomes in renal transplant recipients in the hispanic population
      based on their immunosuppressant regimens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cadaveric or Living Donors

          -  18 years old or greater

          -  Primary renal transplants

          -  Hispanic ethnicity

        Exclusion Criteria:

          -  Prior renal transplant

          -  Multi-organ transplant

          -  Recipient with history of Diabetes Mellitus

          -  PRA > 20%

          -  Cold Ischemia Time > 24 hours
Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™
Condition: Tetanus; Poliomyelitis; Haemophilus Influenzae Type b; Acellular Pertussis; Diphtheria; Hepatitis B; Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
MeSH terms: Influenza, Human; Hepatitis B; Tetanus; Diphtheria; Poliomyelitis; Tetany
Intervention: Blood Sampling
Intervention description: A blood sample will be taken at 5 years of age, after vaccination in the primary study.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 5 Years
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Infanrix-IPV/Hib; Long-term follow up; Persistence; Infanrix hexa

Summary:

      The aim of this study is to assess antibody persistence in infants who received three doses
      of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11
      months of age in study NCT00307034.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who had received 3 doses of Infanrix hexa™ or Infanrix-IPV/Hib™ in study
             NCT00307034.

          -  Subjects who the investigator believes that parent(s)/Legally Acceptable
             Representative(s) LAR(s) can and will comply with the requirements of the protocol.

          -  A male or female subject aged 5 years at the time of study entry.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Child in care.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product.

          -  Use of any investigational or non-registered product within 30 days prior to blood
             sampling.

          -  Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis
             B, and Hib vaccination or disease since the study NCT00307034, with the exception of
             hepatitis B vaccination in the DTPa-IPV/Hib group.

          -  Administration of immunoglobulins and/or any blood products within the 3 months prior
             to blood sampling.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Family history of congenital or hereditary immunodeficiency.
Effects of Low Sodium Intake on the Anti-proteinuric Efficacy in Hypertensive Patient With Olmesartan
Condition: Hypertension; Chronic Kidney Disease; Microalbuminuria
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypertension
Intervention: Intensive education of low salt diet
Intervention description: For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.
Intervention MeSH terms: Angiotensin II
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 269.0
Sex: All
Minimum age: 19 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: hypertension; Chronic kidney disease; albuminuria; low salt diet; Angiotensin II receptor blocker

Summary:

      Purpose of this study

        1. Intensive education for low salt diet will be enhance the anti-proteinuric effect of
           Olmesartan, a popular anti-hypertensive drug of angiotensin II receptor blocker, in
           Koreans compared to conventional prescription of medication.

        2. Intensive education for low salt diet will decrease the amount of 24 hour-urine sodium
           excretion compared to control group, effectively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 19 years or more and 75 years or less

          -  Hypertension patients: Patients whose blood pressure is 140/90mmHg and over, patients
             is newly diagnosed with hypertension or is prescribed antihypertensive medications.

          -  Hypertensive patients verified 2 times or more of albuminuria 30 mg/g cr or more in a
             spot urine sample with interval of 1 week or more in recent 6 months

          -  Estimated glomerular filtration rate (GFR) by Modification of Diet in Renal Disease
             (MDRD) equation 30 ml/min/1.73 m2 or more

          -  Patients who give written consent to this study by oneself

        Exclusion Criteria:

          -  Blood pressure more than 160/100 mmHg

          -  Pregnant

          -  Serum potassium level more than 5.5 mEq/L at screening period

          -  Patients with malignancy, acute cerebral infarction, acute myocardial infarction,
             unstable angina, percutaneous coronary arterial intervention (PCI), or coronary artery
             bypass graft (CABG) in recent 6 months

          -  Patients with diabetes mellitus

          -  Patients who have an allergy to Olmesartan

          -  Patients who were involved in other clinical trial in recent 1 month or are
             participated in screening period

          -  Patients taking medication(s) of corticosteroid or immunosuppressant in a screening
             period
The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation
Condition: Fontan Circulation
Intervention: Sildenafil; Placebo; Sildenafil 2; Placebo 2
Intervention description: oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will be randomized to receive Sildenafil first and then crossed over to receive the opposite intervention, placebo.; Patient will receive a look-alike placebo. Enrolled patients will be randomized to receive Placebo first and then crossed over to receive the opposite intervention, Sildenafil.; oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will receive Sildenafil, the crossed over intervention from their initial intervention (Placebo).; Patient will receive a look-alike placebo. Enrolled patients will receive Placebo, the crossed over intervention from their initial intervention (Sildenafil).
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fontan; sildenafil; exercise capacity; Patients with Fontan Circulation

Summary:

      The study will test the hypothesis that a single dose of sildenafil can increase the exercise
      capacity of pediatric patients with a Fontan Circulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 6-17 years

          -  Male or female

          -  Possess Fontan Circulation

        Exclusion Criteria:

          -  Severe heart failure (New York Heart Ass. functional class IV)

          -  Evidence of Fontan pathway obstruction

          -  History of exercise-induced severe arrhythmias

          -  Pregnancy (known or suspected)

          -  Orthopedic limitations that prevent ambulation on a treadmill

          -  Use of nitroglycerin

          -  Herbal medications
Does Rosuvastatin Delay Progression of Atherosclerosis in HIV
Condition: HIV; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis
Intervention: Rosuvastatin; Placebo
Intervention description: encapsulated tablet 20mg daily; Placebo arm included to maintain blinding
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: HIV; Cardiovascular disease; Inflammation; Statin

Summary:

      This study is a randomised double blind placebo controlled trial comparing Rosuvastatin with
      placebo in HIV positive people who are at intermediate cardiovascular risk.

      It is possible that HIV positive people will receive a greater benefit from statins because
      of their higher baseline levels of inflammation. Current Australian guidelines recommend
      initiation of statin therapy on the basis of cholesterol level and the presence of other risk
      factors for heart disease (such as diabetes) but do not take into account whether a patient
      is infected with HIV. This study aims to determine what benefit HIV infected people will
      receive from starting statin therapy earlier then currently recommended.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Moderate cardiovascular disease (CVD) risk, (10-15% 10 year risk of CVD)

          -  HIV positive

          -  Stable combination anti-retroviral therapy (cART) with plasma HIV viral load
             <200copies/ml for ≥ 6 months

        Exclusion Criteria:

          -  Recommended use of lipid lowering therapy according to Australian guidelines

          -  Prior use of statin, fibrate, ezetimibe within the last six months

          -  Contraindication to statin use