bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Aldosterone on Energy Starvation in Heart Failure
Condition: Heart Failure; Nonischemic Dilated Cardiomyopathy
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated; Starvation
Intervention: spironolactone
Intervention description: spironolactone 50 mg daily for 6 months
Intervention MeSH terms: Spironolactone
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: heart failure; positron emission tomography; magnetic resonance imaging; myocardial energetics; myocardial perfusion

Summary:

      We plan to study the concept of "energy starvation" in heart failure by evaluation of
      patients with nonischemic dilated cardiomyopathy (NIDCM) (heart failure with reduced heart
      pump function due to causes other than heart attack). We will use a combination of positron
      emission tomography and magnetic resonance imaging to study metabolism, anatomy, function,
      blood flow and efficiency, before and after 6 months' treatment with the drug spironolactone
      which blocks the deleterious effects of the hormone aldosterone on the myocardium (heart
      muscle).
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  Nonischemic dilated cardiomyopathy

          -  Left ventricular ejection fraction 35% or less

          -  Stable heart failure symptoms

          -  Able to undergo both positron emission tomography and magnetic resonance imaging with
             gadolinium

          -  Able to tolerate treatment with spironolactone

        Exclusion Criteria:

          -  Serum potassium >5.0

          -  Serum creatinine >2.5

          -  Contraindications to magnetic resonance imaging such as internal
             cardioverter-defibrillator.
Single-cell CBD Biomarkers of Inflammation Reduction in People Living With HIV
Condition: Chronic Inflammation
MeSH terms: Inflammation
Intervention: CBD oil
Intervention description: Each participant will be provided two 30mL(Milliliters) bottles (2000mg CBD per bottle) with a syringe dropper during their initial (baseline) visit with instructions to administer the solution under the tongue (0.5 cc ~1/2 dropper) twice per day (BID) 8-12 hours apart (morning and evening) at the prescribed daily dosage (63mg/day).
The investigators plan to collect samples from five patients over three time points: baseline (no CBD), and after one and two months of CBD-administration
Intervention MeSH terms: Cannabidiol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      People living with HIV (PLWH) are affected by comorbidities appearing to be strongly related
      to chronic inflammation, a condition characterizing PLWH.

      The investigators propose to study the effects of CBD on inflammation in PLWH, and establish
      the molecular role of different immune cells in this process. The investigators plan to use
      single cell RNA-sequencing (scRNAseq) to isolate CBD-specific cellular phenotypes from five
      persons with HIV who will provide blood samples before and after taking CBD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willingness to take CBD and to participate in follow up for two months

          -  Older than 21 and younger than 60

          -  Under antiretroviral therapy for 5+ years and suppressed viral load (CD4 count
             <350cells/ml)

        Exclusion Criteria:

          -  Conditions/medications that may impair the immune response, e.g., rheumatoid
             arthritis, cancer, diabetes, chronic infections, CAD (Cold agglutinin disease),
             cellulitis, autoimmune diseases such as lupus, sarcoidosis

          -  All medications that may affect inflammation such as aspirin, steroids, statins; CD4
             count <350cells/ml), pregnancy, and current marijuana or CBD use (urine drug screen)

          -  UF(University of Florida)/Shands staff and students will not be considered for
             enrollment
Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Fluticasone furoate and fexofenadine
Intervention description: Fluticasone furoate and fexofenadine
Intervention MeSH terms: Fluticasone; Xhance; Fexofenadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 1000.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: once daily; mountain cedar; fexofenadine; allergic rhinitis; fluticasone furoate

Summary:

      The primary objective of this study is to compare the nighttime symptom relief of fluticasone
      furoate nasal spray and oral fexofenadine
    

Eligibility criteria:

        Inclusion criteria:

          -  Informed consent.

          -  Outpatient.

          -  Females of child-bearing potential must use appropriate contraception.

          -  Diagnosis of seasonal allergic rhinitis to mountain cedar.

          -  Adequate exposure to allergen.

          -  Able to comply with study procedures.

          -  Literate.

        Exclusion criteria:

          -  Significant concomitant medical condition.

          -  Use of corticosteroids, allergy medications, or other medication that affect allergic
             rhinitis

          -  Positive pregnancy test.

          -  Allergy to any component of the investigational product.

          -  Tobacco use

          -  Contact lens use

          -  Has chickenpox or measles or recent exposure

          -  Other clinical trial drug exposure in last 30 days

          -  Affiliation with clinic site
Bupropion and Weight Control for Smoking Cessation - 1
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Bupropion; Placebo; weight concerns intervention; smoking cessation intervention
Intervention description: smoking cessation medication aid; A matched placebo pill; cognitive behavioral treatment to address weight concners; Cognitive behavioral intervention for smoking cessation
Intervention MeSH terms: Bupropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 349.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: smoking cessation; Women; bupropion; weight concerns; weight

Summary:

      The purpose of this study is to determine whether the addition of bupropion (Zyban) to
      cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smoke at least 10 cigarettes per day

          -  Report concern about cessation-related weight gain

          -  Motivated to quit smoking

        Exclusion Criteria:

          -  Currently pregnant, lactating, or no medically approved method of contraception

          -  Major medical problem

          -  History of seizure disorder or head injury

          -  Current or historical psychosis or bipolar disorder

          -  History of alcohol or substance abuse within previous year

          -  Current or historical eating disorder

          -  Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous
             month

          -  Multiple Drug Allergies

          -  Current major depressive disorder
The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Exenatide SC; Exenatide IV; Placebo SC; Exendin-9; Placebo IV
Intervention description: Exenatide 5-10 ug sc BID/10 days; 50 ng/min intravenously for 45 minutes on 2 out of 3 study visits separated by 5-10 days; Placebo sc BID/10days; Primed (6,000 pM/kg), continuous (600 pM/kg) intravenous infusion for 75 minutes on 1 out of 3 study visits.; Intravenous infusion for 45 minutes on 1 out of 3 visits
Intervention MeSH terms: Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 35 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Type 2 diabetes mellitus, Impaired glucose tolerance

Summary:

      The purpose of this investigation is to evaluate whether exenatide, a type 2 diabetes
      medication, will improve the function of the innermost part of the arterial wall called the
      endothelium after a fat-enriched meal and to determine how this occurs. The results of this
      study will help to determine and understand a novel action of this group of diabetes
      medications based on the action of naturally occuring gut substances called incretins. This
      may have a significant impact on cardiovascular health in patients with early and
      longstanding diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  US Veterans

          -  type 2 diabetes mellitus (T2D) diagnosed within 3 years with good glycemic control on
             diet, metformin, or sulfonylurea agents or combinations of these agents (HbA1c ≤8.0%)

          -  T2D diagnosed ≥ 5 years prior to study enrollment

          -  Impaired glucose tolerance

        Exclusion Criteria:

          -  T2D not meeting inclusion above criteria for duration of diabetes or HbA1c values

          -  known or suspected T1D (early onset age, low body mass index, lack of family history)

          -  TZD use in the prior 3 months

          -  prior regular use of insulin

          -  Creatinine >2.0 mg/dl or other laboratory or clinical evidence of kidney disease

          -  anemia

          -  known active liver disease or hepatic enzyme elevation two-and-a half times above
             normal

          -  acute bacterial or viral illness or evidence of other active infection in the past 4
             weeks

          -  stable or unstable angina or other major illness in the past 6 months

          -  Raynaud's disease or any rheumatic disease affecting fingers

          -  current regular use of anti-inflammatory medications or antioxidants, including over
             the counter medications and high dose salicylates (>1 g/day);

          -  subjects receiving lipid lowering or anti-hypertension medications must be on stable
             doses for at least 2 months prior to participation.
A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: Tadalafil
Intervention description: Administered orally
Intervention MeSH terms: Tadalafil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 635.0
Sex: Male
Minimum age: 22 Years
Maximum age: 69 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of the study drug,
      taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED).
      The study will last about up to 25 months for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a history of erectile dysfunction for at least 3 months.

          -  Are sexually active and willing to remain sexually active with the same female partner
             during the study.

          -  Are willing to have 4 or more attempts of sexual intercourse with female partner
             between screening and first treatment start day.

          -  Are willing to stay away from any other medicines that the participants were already
             taking for erectile dysfunction during this study period.

        Exclusion Criteria:

          -  Have erectile dysfunction, which is caused by any other primary sexual disorder.

          -  Have certain problems with kidneys, liver, heart, blood sugar levels, eyes, or central
             nervous system (study doctor will discuss with participants).

          -  Have a penis deformity or penile implant that in the opinion of the participants'
             doctor is significant.

          -  Have human immunodeficiency virus (HIV) infection.

          -  Are using certain kinds of medicines, which are not allowed in this study.

          -  Are allergic to tadalafil.

          -  Are planning to father a baby or are in a relationship with a pregnant partner.

          -  Are participating or discontinued participation in the past 30 days from any another
             clinical trial, which is not compatible with this trial.

          -  Have participated or discontinued from any other tadalafil clinical trial.

          -  Have a history of drug, alcohol, or substance abuse within the past 6 months.
A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]
Intervention description: 8 mg/kg iv every 4 weeks, 52 weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single arm study will assess the effect of RoActemra/Actemra (tocilizumab)
      on neutrophils and monitor safety and benefit-risk of RoActemra/Actemra treatment in patients
      with active rheumatoid arthritis who have an inadequate response to current biologic or
      non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive
      RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks, either as monotherapy or
      in combination with their current non-biologic DMARD. Anticipated time on study treatment is
      52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Moderate to severe active rheumatoid arthritis of >/= 6 months duration

          -  DAS28 >/= 3.2 at screening and baseline

          -  Inadequate response to biologic or non-biologic DMARDs

          -  Biologic DMARDs must be withdrawn (approximately 5 half-lives for the agent) before
             first dose of study drug

          -  If continuing on a non-biologic DMARD, dose should be stable for at least 8 weeks

          -  Oral corticosteroids must have been at stable dose for at least 25 out of 28 days
             prior to baseline

        Exclusion Criteria:

          -  Major surgery (including joint surgery) within 8 weeks prior to screening or not
             recovered from prior surgery

          -  Rheumatic autoimmune disease other then RA

          -  Functional class IV as defined by the American College of Rheumatology (ACR)
             classification

          -  Prior history of or current inflammatory joint disease other than RA

          -  Previous treatment with any cell-depleting therapies

          -  Intraarticular or parenteral corticosteroids within 4 weeks prior to baseline

          -  Active infection or history of recurrent infection

          -  Positive for HIV or hepatitis B or C

          -  History of or current primary or secondary immunodeficiency
IV Acetaminophen for Postoperative Analgesia
Condition: Postoperative Pain; Postoperative Nausea; Postoperative Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: IV Acetaminophen; Standard of Care
Intervention description: Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen; Standard of care pain management regimen, no IV Acetaminophen,
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: IV Acetaminophen; Laparoscopic cholecystectomy; Postoperative nausea; Postoperative vomiting

Summary:

      The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain
      management after laparoscopic cholecystectomy to determine if its use to supplement standard
      of care pain management decreases the incidence of post-operative nausea and vomiting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is undergoing pre-scheduled laparoscopic cholecystectomy;

          -  American Society of Anesthesiology patient classification status I-II

        Exclusion Criteria:

          -  Regular preoperative use of or opioids,

          -  Subjects admitted after surgery for postoperative complications other than
             postoperative pain or PONV.

          -  Subjects converted to open laparoscopic cholecystectomy

          -  Known allergy/hypersensitivity to acetaminophen

          -  Use of opioids prior to commencement of the study (<7 days)

          -  Patients with chronic pain conditions or disease requiring pain control

          -  Abnormal liver function

          -  Known or suspected alcohol, drug or opiate abuse or dependence

          -  Patients with a BMI of greater than 35

          -  Other physical, mental or medical conditions that could effect participation.

          -  Abnormal renal function; serum creatinine>2gm/dl
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE
Condition: HIV-1-infection
MeSH terms: Substance-Related Disorders
Intervention: Bictegravir/emtricitabine/tenofovir alafenamide
Intervention description: B/F/TAF single tablet formulation
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine tenofovir alafenamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Substance use

Summary:

      This study will evaluate the efficacy and safety of bictegravir/emtricitabine/tenofovir
      alafenamide (B/F/TAF) in HIV-1 infected patients who actively use illicit substances. The
      study will also evaluate retention in care and adherence to B/F/TAF by self-report and
      pharmacokinetic analysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented HIV-1 infection

          -  Treatment naive or experienced

          -  Self-reported illicit substance use or confirmed urine drug screen within past 6
             months of any of the following: cocaine, heroin, methamphetamine, MDMA, phencyclidine,
             ketamine, gamma hydroxybutyrate, cathiniones, or inappropriate prescription opiate,
             benzodiazepine or stimulant use (excluding nicotine, alcohol, marijuana for criteria)

          -  HIV RNA >1000 copies/mL

          -  Creatinine clearance > 30 mL/min (Cockroft-Gault)

          -  ALT and AST < 5 times the upper limit of normal

          -  Willing and able to provide written informed consent

        Exclusion Criteria:

          -  History of integrase or tenofovir related HIV resistance mutations

          -  Pregnancy

          -  Serious illness requiring systemic treatment and/or hospitalization within 30 days
             prior to study entry
Effect of Ketamine on Analgesia Post-Cardiac Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Normal Saline Flush, 0.9% Injectable Solution_#1; Ketamine Hydrochloride
Intervention description: Normal saline infusion mimicking infusion rate of ketamine for a given weight; Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ketamine; Cardiac surgery; Pain

Summary:

      Randomized, controlled, double-blind pilot study evaluating the effect of an intraoperative
      infusion of intravenous Ketamine on the quantity of opioid consumed postoperatively in
      coronary artery bypass surgery patients receiving a median sternotomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 years of age or older coming for coronary artery bypass surgery with a
             left ventricular ejection fraction over 50% and able to consent prior to surgery

        Exclusion Criteria:

          -  Minimally invasive cardiac surgery

          -  Preoperative opioid use

          -  Preoperative hepatic or renal dysfunction
Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers
Condition: Healthy
Intervention: Warfarin; Warfarin 5mg + Rosuvastatin 40 mg once daily (QD); Warfarin 5 mg + Pitavastatin 4mg once daily (QD)
Intervention description: Warfarin 5 mg once daily; Warfarin 5mg + Rosuvastatin 40 mg once daily (QD); Warfarin 5 mg + Pitavastatin 4mg
Intervention MeSH terms: Warfarin; Rosuvastatin Calcium; Pitavastatin
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Volunteers

Summary:

      This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug
      interaction study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a healthy adult male or female volunteer aged 18 to 45 years, inclusive

          -  Subject has a body mass index of 18 to 32 kg/m2, inclusive

          -  Subject is able and willing to abstain from alcohol, grapefruit, caffeine

          -  Subject has no clinically relevant abnormalities on the basis of medical history,
             physical examination, and vital signs

        Exclusion Criteria:

          -  Subject has clinically relevant out-of-range prothrombin time (PT), activated partial
             thromboplastin time, fibrinogen, protein C, or protein S

          -  Subject has abnormal prolongation of bleeding time at Screening

          -  Subject has hematuria on urinalysis

          -  Subject has personal or family history of coagulation or bleeding disorders