bioihbjkbjnl/mcl2 huggingface dataset:
Dapagliflozin Effects on Epicardial Fat
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Metformin; Placebo
Intervention description: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.; 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL; Placebo pill taken once daily to mimic Dapagliflozin
Intervention MeSH terms: Metformin; Dapagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: epicardial fat; diabetes; dapagliflozin

Summary:

      The purpose of this research study is to learn about the effect of Dapagliflozin (Farxiga) on
      the fat of the heart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes, as defined by ADA criteria

          -  HbA1c < 8% measured at least 1 week prior to the study

          -  BMI ≥27 kg/m2

          -  Pre-treatment with Metformin as monotherapy

          -  Age > 18 and < 65 years old

          -  Normal and stable hemodynamic status

        Exclusion Criteria:

          -  Known contra-indications to Farxiga, in accordance with risks and safety information
             included in the latest updated Prescribing Information

          -  Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria

          -  Insulin dependent or treated type 2 diabetes

          -  Current use of other SGLT2 inhibitors, Glucagon Like Peptide -1 (GLP- 1) analogs or
             Dipeptidyl Peptidase 4 (DPP4) inhibitors

          -  Glomerular Filtration Rate (GFR) < 60 mL/min/1.73 m2

          -  Signs or symptoms of hypovolemia

          -  Patients with poor glycemic control (HbA1c ≥ 8%) will be excluded to maximize
             long-term patient retention without need

          -  History of diabetes ketoacidosis

          -  Patients with active bladder cancer or with a prior history of bladder cancer

          -  Acute or chronic infective, including genital mycotic infections

          -  Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart
             failure

          -  Clinical or laboratory evidences of chronic active liver diseases

          -  Acute or chronic infective diseases

          -  Cancer or chemotherapy

          -  Current use of systemic corticosteroids or in the 3 months prior this study

          -  Known or suspected allergy to Dapagliflozin, excipients, or related products

          -  Pregnant, breast-feeding or the intention of becoming pregnant

          -  Females of childbearing potential who are not using adequate contraceptive methods
Pneumococcal Vaccines in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: PCV13; PPSV23
Intervention description: Single 0.5 ml dose of PCV13 administered via intramuscular injection; Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 19 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Vaccine; Pneumococcal; Pneumonia

Summary:

      Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine
      if they are given Prevnar initially.
    

Eligibility criteria:

        Inclusion Criteria:

        - Diagnosis of asthma

        Exclusion Criteria:

          -  Research exemption requested

          -  History of PCV-13 vaccination

          -  History of cochlear implant

          -  Cerebrospinal Fluid (CSF) leak

          -  Congestive Heart Failure (CHF)

          -  Diabetes Mellitus (DM)

          -  Chronic Kidney Disease (CKD)

          -  Human Immunodeficiency Virus (HIV)

          -  Common Variable Immune Deficiency (CVID)

          -  Patients who have received the PPSV23 vaccine in the last 5 years

          -  Women who are pregnant will also be excluded from the study by performing 2 point of
             care urine pregnancy tests ( prior to vaccinations)
Evaluation of Intravenous and Intraperitoneal Pharmacokinetics of Dalbavancin in Peritoneal Dialysis Patients
Condition: Infectious Peritonitis
MeSH terms: Peritonitis
Intervention: Dalbavancin via Intravenous Administration; Dalbavancin via Intraperitoneal Administration
Intervention description: Patients will undergo plasma fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.; Patients will undergo peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.
Intervention MeSH terms: Dalbavancin; Teicoplanin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the pharmacokinetic properties of dalbavancin when administered as
      an intravenous infusion and instilled into the peritoneal space in patients who are
      undergoing peritoneal dialysis. The patients will receive intravenous dalbavancin followed by
      intensive plasma and peritoneal dialyses fluid sampling. Following a washout phase, the
      patients will then receive dalbavancin instilled into their peritoneal space followed by the
      same intensive plasma and peritoneal dialyses fluid sampling.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 to ≤89 years of age

          -  Actively receiving chronic peritoneal dialysis

          -  Ability and willingness to provide written informed consent

        Exclusion Criteria:

          -  Patients currently receiving antimicrobial therapy or have received antibiotic therapy
             within 14 days prior to study

          -  Patients with known hypersensitivity reactions to dalbavancin or other glycopeptides

          -  Prisoners

          -  Pregnant or breastfeeding women

          -  Decisionally challenged patients
Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors
Condition: Previously Treated PH + CML
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
Intervention: Bosutinib
Intervention description: 100 mg and 500 mg tablets, once daily dosage up to 4 years duration
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 163.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bosutinib; Chronic Myeloid Leukemia; CML; Leukemia; Myelogenous; Chronic; BC-ABL Positive

Summary:

      The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to
      the European Medicines Agency in providing additional safety and efficacy data in
      approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with
      high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase
      patients in the fourth or later line treatment setting (i.e., after treatment with at least 3
      other Tyrosine Kinase Inhibitors).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed Philadelphia Chromosome positive Chronic Myeloid Leukemia or Confirmed
             BCR-ABL1 (Abelson-break point cluster) Positive if Philadelphia Chromosome negative
             Chronic Myeloid Leukemia (from initial diagnosis).

          -  Prior treatment with 1 or more tyrosine kinase inhibitor drugs (imatinib, dasatinib
             and/or nilotinib) for Philadelphia Chromosome positive Chronic Myeloid Leukemia (CML).

          -  Any Chronic Myeloid Leukemia disease phase, as long as the patient is unable to
             receive treatment with imatinib, dasatinib and/or nilotinib for any reason.

        Exclusion Criteria:

          -  Participation in any other clinical studies involving investigational drug(s) within
             14 days or within 3 half-lives of drug levels in blood (whichever is longer) prior to
             the first dose of bosutinib.

          -  Prior treatment with bosutinib.

          -  Prior treatment with ponatinib.

          -  Known T315I or V299L mutation.
Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Ceftazidime/avibactam
Intervention description: Ceftazidime/avibactam 2.5gm iv q8h for 3 doses
Intervention MeSH terms: Ceftazidime; Avibactam; Avibactam, ceftazidime drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pharmacokinetics; ceftazidime/avibactam

Summary:

      The purpose of this research study is to characterize the pharmacokinetics of intravenous
      ceftazidime/avibactam in patients with Cystic Fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of CF based on positive sweat chloride or know CF mutation

          -  Age > 17 years

          -  Able to spontaneously expectorate sputum

        Exclusion Criteria:

          -  Any clinically significant laboratory abnormality

          -  Presence of an ongoing acute pulmonary exacerbation

          -  Pregnancy

          -  Serious past allergy to a beta-lactam antibiotic
Long-Duration Stimulant Treatment Study of ADHD in Young Children
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: B-MPH
Intervention description: Dosage form is a 20 mg capsule to be given once daily in the morning for 30 days
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 4 Years
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ADHD; Attention-deficit/hyperactivity disorder (ADHD)

Summary:

      This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in
      4-to-5-year olds.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Parents/guardians and children must speak English and/or Spanish; parents/guardians
             must sign consent form; children must verbally assent.

          2. Boys and girls from 4-5 years old (inclusive) at screening.

          3. Children who meet the DSM-IV criteria for a primary diagnosis of ADHD (combined or
             hyperactive subtype), with symptoms present for at least 9 months.

          4. Children who demonstrate adequate need for treatment due to ADHD symptom-severity and
             clinical impairment.

          5. Children with IQ of at least 70 confirmed by valid IQ test.

          6. Children who are in educational settings (pre-school, kindergarten, or elementary
             school program) with at least 8 same-age peers for at least two half days weekly.

          7. Parents and children who can attend weekly study visits.

          8. Children who are naïve to ADHD medications; received ADHD medications in the past but
             are not currently treated; or on ADHD medications but finding them inconvenient (due
             to short duration of action) or not very helpful

        Exclusion Criteria:

          1. Children and parents/guardians who do not understand or cannot follow necessary
             instructions; children and parents who are unwilling to comply with study procedures
             or cooperate with child psychiatrist.

          2. Children taking excluded medications.

          3. Children with history of intolerance to MPH/stimulant medications or no response to
             adequate stimulant trials.

          4. Children with current adjustment disorder, autism, psychosis, bipolar disorder,
             significant suicidality, or other psychiatric disorders.

          5. Children with history of physical, sexual, or emotional abuse, which lead to a
             significant impact on the clinical presentation and potentially some ADHD symptoms.

          6. Children with screening abnormalities deemed clinically significant by child
             psychiatrist.
Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO
Condition: Extracorporeal Membrane Oxygenation Complication; Pediatric ALL; Anticoagulants
Intervention: Bivalirudin; Unfractionated heparin
Intervention description: Continuous infusion; Continuous infusion
Intervention MeSH terms: Heparin; Calcium heparin; Bivalirudin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 1 Day
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a
      single pediatric Level 1 trauma center. The patients will be randomized into two arms; one
      arm will receive unfractionated heparin and the other arm will receive bivalirudin. There
      will be 15 patients in each arm for a total of 30 patients.

      Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 1 day to less than 18 years

          -  Cared for in the pediatric intensive care unit or pediatric cardiac intensive care
             unit

          -  receiving venovenous or venoarterial ECMO

        Exclusion Criteria:

          -  Patients with known or suspected heparin induced thrombocytopenia prior to consent

          -  Patients with hepatic failure defined as coagulopathy with elevated transaminases more
             than three times normal values

          -  Patients with plan to decannulate from ECMO within 48 hours

          -  Known or suspected pregnant women

          -  Previous enrollment in this study

          -  Primary language spoken that is not English or Spanish
Comparison of Blood Pressure Medications on Metabolism
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Intervention: carvedilol; metoprolol
Intervention description: variable; variable
Intervention MeSH terms: Metoprolol; Carvedilol
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: diabetes blood pressure oxidative stress

Summary:

      The purpose of this study is to determine if there are differences, (benefits) between
      carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes.
      Specifically we will be looking at differences in blood pressure and blood sugar control,
      endothelial function, inflammation, oxidative stress and coagulation.

      Subjects will be randomized to one of the two beta-blockers and followed for 5 months. Each
      subject will undergo 4 inpatient studies where an oral glucose tolerance test will be done,
      Inflammatory and oxidative stress markers will be measured. Endothelial function will be
      measured using brachial artery ultrasound and laser skin Doppler
    

Eligibility criteria:

        Inclusion Criteria:

          -  not enrolling

        Exclusion Criteria:

          -  not enrolling
Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis
Condition: Muscle Cramp; Cirrhosis
MeSH terms: Muscle Cramp; Liver Cirrhosis; Spasm; Fibrosis
Intervention: Vitamin E; Ropinirole; Muscle cramp survey
Intervention description: Patients will take 400 IU vitamin E nightly for 3 months.; Patients will take 0.5mg ropinirole nightly for 3 months.; Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.
Intervention MeSH terms: Vitamin E; Ropinirole
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigator's aim is to compare the efficacy of Ropinirole (Requip) to vitamin E in the
      treatment of muscle cramps in cirrhotic patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients at least 18 years of age in the Vanderbilt Medical Center Hepatology Practice

          -  diagnosis of cirrhosis

          -  Self report regular muscle cramping

        Exclusion Criteria:

          -  Patients without cirrhosis

          -  Patients under the age of 18

          -  Pregnant women
Gastric Acid Suppression and Probiotic Colonization
Condition: Probiotics
Intervention: Omeprazole; VSL #3; Placebo
Intervention description: Proton pump inhibitor (PPI) that suppresses gastric acid secretion; Probiotics; Placebo to match omeprazole
Intervention MeSH terms: Omeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Probiotics are over-the-counter dietary products with microorganisms that are generally
      consumed for health benefit. However, the durability of these microorganisms is unclear,
      particularly when they pass through the highly acidic environment of the stomach. We will
      test the colonization of these microorganisms among individuals who consume probiotics with
      and without acid suppression therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteers ages 18 years and ≤ 75 years.

          -  Able to visit the study Doctor's office 3 times, answer 3 questionnaires, and provide
             stools and blood samples.

        Exclusion Criteria:

          -  Gastric cancer, Barrett's esophagus cancer, any gastrointestinal condition, or soy or
             gluten sensitivity

          -  Previous abdominal surgery

          -  Currently pregnant or nursing

          -  Had H. Pylori Infection

          -  Diagnosed with any chronic medical condition other than hypertension or hyperlipidemia

          -  Currently consuming herbs or probiotics
Do Angiotensin Receptor Blockers Mitigate Progression to Acute Respiratory Distress Syndrome With SARS-CoV-2 Infection
Condition: SARS-CoV Infection
MeSH terms: Infections; Communicable Diseases; COVID-19; Severe Acute Respiratory Syndrome
Intervention: Losartan
Intervention description: Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days. Upon the treating clinician's discretion, losartan may be continued beyond 10 days for non-COVID-19 indications.
Intervention MeSH terms: Losartan
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized into one of two groups: Standard of Care or Standard of Care plus an ARB.
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronavirus; Angiotensin receptor blocker; SARS-CoV-2; COVID-19

Summary:

      The purpose of this research is to identify whether or not Angiotensin Receptor Blockers
      (ARB) can halt the progression to respiratory failure requiring transfer into the intensive
      care unit (ICU), as well as halt mechanical ventilation in subjects with mild to moderate
      hypoxia due to the corona virus that causes COVID-19. Based on previous animal studies, the
      researchers hypothesize that the addition of an ARB is beneficial in abating acute lung
      injury in subjects in early stages of SARS-CoV-2 viral induced hypoxia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed COVID-19 positive test result

          -  Mild to moderate respiratory symptoms of COVID-19.

          -  Systolic blood pressure ≥ 105 mmHg.

          -  Screen within 3 days of a positive COVID-19 test.

          -  Age ≥18 years old.

          -  Access to a phone in the hospital room or an electronic device that is capable of
             receiving phone or video calls.

          -  Able to read/write/speak English or Spanish fluently.

          -  Subjects must have the capacity to provide consent or an appropriate LAR to provide
             informed consent.

          -  Negative pregnancy test for women of childbearing potential and subject is randomized
             to the study arm.

        Exclusion Criteria:

          -  Severe allergy to any ARB or ACE-inhibitor, including angioedema

          -  In the intensive care unit at screening.

          -  Home meds include any kind of ACE inhibitor or ARB

          -  Acute Kidney Injury (50% reduction in GFR from baseline at admission to any time
             during treatment in the study treatment arm)

          -  Hyperkalemia >5.0 mmol/L at baseline or any time during treatment in the study
             treatment arm

          -  Creatinine Clearance < 30 ml/min at baseline or any time during treatment in the study
             treatment arm