bioihbjkbjnl/mcl2 huggingface dataset:
High Dose Vitamin C in Cardiac Surgery Patients
Condition: Disorder of Vitamin C; Atrial Fibrillation; Complications Due to Coronary Artery Bypass Graft; Heart Valve Disease
MeSH terms: Atrial Fibrillation; Heart Valve Diseases
Intervention: Ascorbic Acid; Placebo
Intervention description: Comparing safety and efficacy of IV Vitamin C in CABG patients; Placebo intervention
Intervention MeSH terms: Ascorbic Acid
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Vitamin C; Coronary Artery Bypass Grafting; Atrial Fibrillation; Cardiac Valve Repair

Summary:

      Coronary artery bypass grafting (CABG) is the most common procedure performed by cardiac
      surgeons. Post-operative atrial fibrillation (AF) is the most common adverse event following
      CABG, experienced in 20-50% of patients; the highest incidence of AF occurs by the third
      post-operative day. Reduction of AF by various drugs is moderately effective, but involves
      either rate control with beta blockers or rate conversion with amiodarone after the
      myocardial damage processes initiating AF have already occurred. Decreasing the incidence of
      post-operative AF, and hence the morbidity and mortality of high-risk CABG patients, could be
      more fruitfully approached by targeting the upstream combined processes of inflammation and
      coagulation activation induced by the surgical insult and associated ischemia-reperfusion
      (I/R). We propose that cell damage induced by oxidative stress and I/R injury could be
      prevented and/or inhibited by antioxidant supplementation. Specifically the investigators
      hypothesize that high-dose intravenous (IV) vitamin C supplementation will ameliorate ROS and
      therefore damp down upstream inflammatory processes, leading to a reduction of downstream
      adverse events with demonstrable links to inflammation processes, such as AF.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Scheduled for elective non-emergent valve repair or replacement, or multi-vessel CABG
             surgery

          -  No known coagulopathy prior to surgery

        Exclusion Criteria:

          -  Emergency cardiac surgery

          -  Ejection fraction < 35%

          -  Presence of autoimmune disease or currently receiving immunosuppressant therapy

          -  History of renal calculi

          -  Renal dysfunction (pre-operative creatinine clearance < 40 mL/min, or serum creatinine
             greater than 1.8 mg/dl)

          -  Known bleeding diathesis

          -  Active infection, cancer or tumor

          -  Prior history of atrial fibrillation

          -  Single CABG procedure (one involved coronary vessel)

          -  Prisoner

          -  Pregnant
A Study of the Cardiac Effects of ALXN1840 in Healthy Adults
Condition: Healthy
Intervention: ALXN1840; Placebo; Moxifloxacin
Intervention description: ALXN1840 (120 milligrams) will be administered orally (supratherapeutic dose).; Placebo will be administered orally.; Moxifloxacin (400 milligrams) will be administered orally.
Intervention MeSH terms: Moxifloxacin; Tetrathiomolybdate; Choline
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a 3-treatment, 3-period, 6-sequence, crossover study in healthy adults.
Masking: Double (Participant, Care Provider)
Masking description: This study will employ a double-blind study design. The ALXN1840 and matching placebo will be identical in appearance and will be administered in a double-blind manner.
Moxifloxacin will not be blinded.
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Electrocardiogram; Cardiac Repolarization; ALXN1840; Optimized QT Correction; QT Interval Correction; Thorough QT; QT Correction by Fridericia; Individual QT Correction; Wilson Disease

Summary:

      This study will evaluate the effect of a supratherapeutic dose of ALXN1840 on the heart rate
      (HR)-corrected QT interval (QTc) in healthy adult participants. Moxifloxacin will be used as
      the active control.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Nonsmoker.

          2. Body weight at least 60 kilograms (kg) for males or 52 kg for females and body mass
             index ≥18.0 and ≤30.0 kg/meter squared.

          3. Willing and able to follow protocol-specified contraception requirements.

          4. Participant has no clinically significant history or presence of ECG findings.

        Exclusion Criteria:

          1. History or presence of clinical and/or lab disorders.

          2. Lymphoma, leukemia, or any malignancy within the past 5 years, or breast cancer within
             the past 10 years.

          3. Participant has abnormal blood pressure, defined as a supine blood pressure <90/50
             millimeters of mercury (mm Hg) or >140/90 mm Hg.

          4. Serum potassium, calcium, or magnesium levels outside the normal range.

          5. Serum copper and/or ceruloplasmin values below the lower limit of normal at Screening.

          6. Female participant has hemoglobin <10.8 grams/deciliter (g/dL) and male participant
             has hemoglobin <12.5 g/dL.

          7. Clinically significant multiple or severe allergies.

          8. Alanine aminotransferase, aspartate aminotransferase, serum creatinine, or total
             bilirubin greater than upper limit of normal (with the exception of Gilbert's
             syndrome).
Comparison of Intravenous Adenosine Infusion With Regadenoson Bolus for Inducing Maximal Coronary Hyperemia
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Hyperemia
Intervention: adenosine; regadenoson
Intervention description: Measuring FFR and Coronary Flow Reserve after administration of IV adenosine 140 mcg/kg/min for 2 minutes.; Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds.
Intervention MeSH terms: Adenosine; Regadenoson
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fractional flow reserve; adenosine; regadenoson

Summary:

      The purpose of this study is to determine if regadenoson is as safe and effective as
      adenosine when used in the cardiac catheterization lab during measurement of coronary flow
      reserve and fractional flow reserve. The study hypothesis is the assessment of Fractional
      Flow Reserve (FFR) in the catheterization lab can be performed with equivalent accuracy when
      hyperemia is induced with IV Regadenoson compared with IV Adenosine without compromising
      patient safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female patients greater than 18 years old (If female, pt. must be
             post-menopausal, surgically sterile, or be non-pregnant as determined by a negative
             urine or serum beta human chorionic gonadotropin (B-HCG) pregnancy test within 24
             hours prior to enrollment.

          -  Provided written consent approved by Institutional Review Board and provided Health
             Insurance Portability and Accountability Act (HIPAA) authorization

          -  Have at least one coronary stenosis (greater or equal to 40% but less than 70&
             narrowing by visual inspection) and technically accessible coronary artery into which
             the pressure wire may be introduced.

        Exclusion Criteria:

          -  ST elevation myocardial infarction

          -  Cardiogenic shock

          -  Pregnancy

          -  Total vessel occlusion

          -  Extremely tortuous coronary arteries

          -  Second and third degree heart block without pacemaker

          -  Severe chronic obstructive pulmonary disease and active bronchospasm

          -  Less than age 18 years

          -  Have received theophylline, aminophylline, pentoxifylline or dipyridamole within 12
             hours of FFR measurement.

          -  Has severe 3 vessel disease defined by >80% luminal narrowing by visual inspection

          -  Known hypersensitivity to adenosine or regadenoson

          -  Recent uncontrolled ventricular arrhythmia

          -  History of greater than Type I atrioventricular block, symptomatic resting
             bradycardia, sick sinus syndrome (without permanent pacemaker)

          -  History of heart transplantation
Co-Administration Of Methotrexate And CP-690,550
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CP-690,550 (tofacitinib); Methotrexate (MTX)
Intervention description: CP-690,550 30 mg q12h for 5 days; individual dose of methotrexate (stably dosed)
Intervention MeSH terms: Methotrexate; Tofacitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Pharmacokinetics; oral JAK inhibitor; methotrexate (MTX); rheumatoid arthritis (RA)

Summary:

      This study was designed to estimate the effects of methotrexate (MTX) on the pharmacokinetics
      (PK) of CP-690,550 when administered to subjects with rheumatoid arthritis (RA), to estimate
      the effects of CP-690,550 on the PK of MTX and to evaluate the short-term safety and
      tolerability of co-administration of CP-690,550 and MTX.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults diagnosed with moderate to severe RA (Rheumatoid Arthritis)

          -  Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.

          -  Treatment with an oral stable weekly dose of Methotrexate (MTX) (15-25 mg/week,
             administered as a single dose [SD]) for a minimum of 4 doses (4 weeks)

        Exclusion Criteria:

          -  Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White
             blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count
             <100 x 109/L

          -  Evidence or history of clinically significant infections within the past 6 months (eg,
             those requiring hospitalization, requiring parenteral antimicrobial therapy, or those
             with recurrent oral or genital herpes, recurrent herpes zoster, or any infection
             otherwise judged by the investigator to have the potential for exacerbation by
             participation in the trial.

          -  Total bilirubin, AST (aspartate aminotransferase) or ALT (alanine aminotransferase)
             more than 1.2 times the upper limit of normal at the Screening visit, or a history of
             clinically significant elevated liver function tests (LFTs) while on current MTX dose
             or chronic liver disease, recent or active hepatitis.
Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia
Condition: Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: PF-04950615 (RN316); PF-04950615 (RN316); PF-04950615 (RN316); PF-04950615 (RN316); PF-04950615 (RN316)
Intervention description: Infusion every week; Infusion every week; Infusion every week; Infusion every week; Infusion every week
Intervention MeSH terms: Bococizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hypercholesterolemia; Dyslipidemia; LDL; High Cholesterol; Japanese Volunteers; PF-04950615; RN316

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of repeated
      doses of PF-04950615 (RN316) in study volunteers with hypercholesterolemia. PF-04950615 is an
      investigational drug that is currently being studied as a lipid lowering agent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  LDL-C must be greater or equal to 130 mg/dl

          -  BMI must be between 18.5 and 40 kg/m2

          -  Japanese volunteers must have 4 Japanese grand parents born in Japan

        Exclusion Criteria:

          -  History of cardiovascular or cerebrovascular event during the past year.

          -  Poorly controlled type 1 or type 2 diabetes mellitus

          -  Subjects who have taken lipid lowering therapies within the last 3 months of
             screening.
Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT
Condition: Cholestasis; Primary Sclerosing Cholangitis; Primary Biliary Cirrhosis
MeSH terms: Cholangitis; Cholestasis; Cholangitis, Sclerosing; Liver Cirrhosis, Biliary
Intervention: 11C-CSar; ICG
Intervention description: PET/CT recording with bile acid tracer 11C-cholylsarcosine used to evaluate the transport of bile acids.; Infusion of indocyanine green prior and during the PET/CT scanning with the bile tracer 11C-CSar.
Intervention MeSH terms: Cholylsarcosine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      We wish to develop a protocol for PET/CT examination of humans using the bile acid tracer
      11C-cholylsarcosine. This is done by a series of PET/CT examinations of healthy humans and
      patients with cholestatic disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with cholestatic disorders and healthy subjects

        Exclusion Criteria:

          -  Body weight above 110 kg (catheterization problematic).

          -  Diabetes

          -  Pregnant or breast feeding women.
A Study of Evacetrapib in Healthy Female Participants
Condition: Healthy Volunteers
Intervention: Ortho-Cyclen; Evacetrapib
Intervention description: Oral administration; Oral administration
Intervention MeSH terms: Moxifloxacin; Evacetrapib; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the effects of evacetrapib on oral contraceptives
      (Ortho-Cyclen®) when given to healthy female participants. The amount of female hormones
      found in the blood will be measured and compared when taken alone and when taken with
      evaceptrapib. Each woman will participate in two study periods. Information about any side
      effects that may occur will also be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are pre-menopausal females, and who are healthy as determined by medical history and
             physical examination

          -  Have a body mass index of 18 to 30 kilograms per square meter (kg/m^2)

        Exclusion Criteria:

          -  Have known allergies to evacetrapib and Ortho-Cyclen (ethinyl estradiol and
             norgestimate), related compounds or any components of the formulation

          -  Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) that,
             in the opinion of the investigator, increases the risks associated with participating
             in the study

          -  Regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening

          -  Have taken injectable contraceptives within 12 months prior to the first dose of the
             lead-in period or topical controlled delivery contraceptives (patch) for 3 months
             prior to the first dose of the lead-in period

          -  Use of any tobacco- or nicotine-containing products within 6 months prior to the
             lead-in phase and during the study
2-Week Study In People With Nonalcoholic Fatty Liver Disease
Condition: Non-alcoholic Steatohepatitis; Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Placebo; PF-06865571; PF-06865571
Intervention description: tablet, 0 mg, 14 days, every 12 hours; tablet, 50 mg, 14 days, every 12 hours; tablet, 300 mg, 14 days, every 12 hours
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      2-week study in people with nonalcoholic fatty liver disease. Study drug at 1 of 2 doses, or
      placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging
      procedures will be performed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  controlled attenuation parameter greater than or equal to 260 dB/m via FibroScan

          -  liver fat greater than or equal to 6% via MRI

        Exclusion Criteria:

          -  Chronic liver disease

          -  Type 2 diabetes requiring drug treatment

          -  Unable to undergo MRI

          -  History of heart attack or stroke
Evaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: CLP; Spironolactone
Intervention description: Oral administration; oral administration
Intervention MeSH terms: Spironolactone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effects of CLP, with and without
      spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic
      kidney disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heart failure with New York Heart Association (NYHA) Classification II or III

          -  Chronic kidney disease

          -  Cardiac ejection fraction <40%

          -  On heart failure therapy including an ACEI or ARB, and a BB

          -  Willing to understand and comply with study procedures and provide written informed
             consent.

        Exclusion Criteria:

          -  Hospitalization within 4 weeks of baseline visit

          -  History or presence of gastrointestinal conditions such as severe constipation or
             gastrointestinal tract strictures

          -  Current or anticipated dialysis during study

          -  In the investigator's judgment, any cardiovascular, renal, hepatic, endocrine,
             gastrointestinal, neurological, or other disease or condition that makes the subject's
             study participation unsafe

          -  Drug or alcohol abuse
Melatonin Postoperative Sleep Study in Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Melatonin; Placebo; Questionnaire
Intervention description: 0.15 mg/kg by mouth (PO) Daily; Two, three, or four starch tablet or capsules before bed; Sleep study surveys, two per day completed each evening, lasting 10 minutes
Intervention MeSH terms: Melatonin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Breast Cancer; Sleep; Melatonin; Placebo; Survey; Postoperative Srejic Sleep SAT Survey

Summary:

      Primary Objective:

      To evaluate the impact of postoperative exogenous nocturnal melatonin supplementation on the
      early regulation of the sleep-wake cycle and its clinical impact (subjective improvement of
      the quality of sleep and reduction of cardiopulmonary events) during the first postoperative
      week following anesthesia and surgery in older breast cancer patients receiving a unilateral
      segmental mastectomy with or without intraoperative lymph node mapping, sentinel node biopsy
      and axillary node dissection.

      Secondary Objective:

      To collect data and validate the Postoperative Srejic Sleep SAT Survey Questionnaire (SAT
      implies relative subjective satisfaction of the patient's sleep in a scaled score out of 100
      with 100 being the highest degree of satisfaction).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Breast cancer patients having a unilateral segmental mastectomy, with or without
             intraoperative lymph node mapping, sentinel node biopsy, and axillary node dissection

          2. Ages >= 40 years

          3. American Society of Anesthesiology (ASA) physical status classification of
             preoperative functioning) 1-4 levels are acceptable

          4. Willing and able to give written informed consent

          5. Willing and able to complete questionnaires

          6. Not currently taking benzodiazepine medication for insomnia.

        Exclusion Criteria:

          1. Autoimmune diseases: rheumatoid arthritis, systemic lupus, or other collagen vascular
             disease

          2. Alcoholics

          3. Seizure disorder

          4. Thyroid disease

          5. Pregnant or lactating patients (effects not known in pregnancy)

          6. Renal/hepatic failure (if ood urea nitrogen (BUN) or creatinine (Cr) >2.5* Upper limit
             of normal (ULN); Bili or aspartate aminotransferase (AST) or alanine aminotransferase
             (ALT)>2.5* ULN)

          7. Dementia/poor compliance

          8. Manic/psychotic patients

          9. Children/adults under 40 yrs

         10. Movement disorders (ex. restless leg syndrome)

         11. Tremor disorder (ex. parkinsonism)

         12. Chronic benzodiazepine use for sleep (>4 times per week )

         13. Designated preop medications including melatonin for sleep