bioihbjkbjnl/mcl2 huggingface dataset:
A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus
Condition: Non-alcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; PF-06835919; PF-06835919
Intervention description: Placebo; 150 mg once daily; 300 mg once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Non-alcoholic steatohepatitis; Type 2 Diabetes Mellitus

Summary:

      This is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis
      and Type 2 Diabetes Mellitis on stable dose of metformin monotherapy. Participants will be
      treated for 16 weeks with placebo or 1 of 2 doses of investigational product to determine the
      effect on liver fat, HbA1c, safety, tolerability and pharmacodynamics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males, or females of nonchildbearing potential

          -  18 to 70 years of age

          -  Type 2 Diabetes Mellitus

          -  Liver fat >/=8% by MRI-PDFF

          -  On stable dose of metformin monotherapy for at least 2 months (at a dose of at least
             500 mg daily)

        Exclusion Criteria:

          -  History of other liver disease

          -  Unable to have an MRI performed

          -  Significant weight loss in the previous month and/or participant in current weight
             loss program

          -  History of diabetic complications with end-organ damage
Intraoperative Amiodarone to Prevent Atrial Fibrillation in Lung Transplant Patients
Condition: Atrial Fibrillation; Lung Transplant; Complications
MeSH terms: Atrial Fibrillation
Intervention: Amiodarone with CoSeal; CO2 driver
Intervention description: CoSeal Surgical Sealant (Baxter Healthcare) consist of 2 formulations of synthetic polyethylene glycols, a dilute hydrogen chloride solution along with a sodium phosphate/sodium carbonate solution. These separate solutions are mixed at the time of application to form a hydrogel. Amiodarone hydrochloride powder (1mg/kg) will be mixed with CoSeal at the time of application to form an amiodarone containing hydrogel. The dosing of amiodarone is based on previous study using amiodarone hydrogel in post-operative coronary artery bypass patients [8]. This hydrogel will be delivered utilizing a CO2 driver along the pulmonary vein and arterial anastomoses, and to the surface right and left atria.; The amiodarone hydrogel will be delivered utilizing a CO2 driver along the pulmonary vein and arterial anastomoses, and to the surface right and left atria.
Intervention MeSH terms: Amiodarone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will prospectively evaluate the use of an amiodarone releasing hydrogel applied to
      the pulmonary veins and atria at the time of lung transplantation. This study will include
      patients undergoing lung transplantation at Jewish Hospital, Louisville KY. The prospective
      group will be compared to historical controls from the same institution. Investigators will
      access medical records and database entries for those patients undergoing lung
      transplantation after January 1st 2005 in order to obtain matched controls for analysis.
      Informed consent will be obtained from the prospective cohort prior to patient enrollment.
      This pilot study will be used to obtain preliminary data in order to proceed with a larger
      randomized control trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject or legal representative has signed Informed Consent Form (ICF)

          -  Undergoing lung transplant at the Jewish Hospital

          -  Age ≥ 18 years

          -  Subjects willing and able to comply with the follow up requirements of the study

        Exclusion Criteria:

          -  Patients with previous history of atrial fibrillation.

          -  Patients with previously documented allergy or adverse reaction to amiodarone.

          -  Patients with previous ablation for atrial fibrillation

          -  Patients with an implantable pacemaker.
Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants
Condition: Ureaplasma Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Ureaplasma Infections
Intervention: Azithromycin; Placebo
Intervention description: Azithromycin intravenous 20 mg/kg every 24 h x 3 days; D5W
Intervention MeSH terms: Azithromycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 2 Hours
Maximum age: 72 Hours
Healthy volunteers: No
Keywords: Ureaplasma parvum; Ureaplasma urealyticum; prematurity; bronchopulmonary dysplasia; azithromycin

Summary:

      The purpose of this study is to determine whether intravenous azithromycin is effective in
      eradicating Ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks
      gestation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gestational age 24 weeks 0 days-28weeks 6 days by best obstetrical estimate

          -  <72 h age

          -  Positive pressure ventilation for at least 1 hour duration during the first 72 hours
             of life

          -  Presence of indwelling intravenous line for drug administration

        Exclusion Criteria:

          -  Any patient judged to be non-viable or for whom withdrawal of life support is planned

          -  Patients with major lethal congenital anomalies

          -  Triplets or higher order multiples

          -  Patients delivered for maternal indications (low risk of Ureaplasma colonization)

          -  Patients with EKG QT interval corrected for heart rate (Qtc) ≥ 450 ms

          -  Patients with significant hepatic impairment (direct bilirubin >1.5 mg/dL)

          -  Patients exposed to other systemic macrolide

          -  Patients with clinically suspected Ureaplasma central nervous system (CNS) infection
             or other confirmed bacterial/viral infection

          -  Patients participating in other clinical trials involving investigational products.
Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Overweight; Syndrome
Intervention: LIK066; Placebo
Intervention description: LIK066 tablets for oral administration; Placebo tablets matching LIK066 tablets, for oral administration
Intervention MeSH terms: Licogliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 29.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Polycystic ovary syndrome; PCOS; hyperandrogenism; insulin resistance; overweight; obesity

Summary:

      The purpose of the study was to evaluate whether LIK066 can be developed for the treatment of
      polycystic ovary syndrome (PCOS) in overweight and obese women.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  PCOS (diagnosed as clinical or biochemical hyperandrogenism, amenorrhea or
             oligomenorrhea and exclusion of other causes of hyperandrogenism.

          -  Overweight/obese female subjects with BMI of 28 - 45 kg/m^2, inclusive, and stable
             weight +/- 3 kg over previous 3 months

          -  Subjects must use non-hormonal methods of contraception during the study.

        Key Exclusion Criteria:

          -  Subjects with exogenous causes of hirsutism

          -  Menstruation in the 30 days prior to screening or treatment

          -  Pregnant or nursing (lactating) women

          -  Use of prohibited medications

          -  Preexisting medical condition which may significantly alter the absorption,
             metabolism, or excretion of the study drug, or which may jeopardize the subject in
             case of participation in the study
Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure With Reduced Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-REDUCED)
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Vericiguat (BAY1021189) (1.25 mg); Vericiguat (BAY1021189) (5 mg); Placebo
Intervention description: 1.25 mg BAY1021189 tablets; 5 mg BAY1021189 tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 456.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Worsening Heart Failure; Heart Failure with Reduced Ejection Fraction

Summary:

      Objective of the study is to find the optimal dose of the once daily oral soluble guanylate
      cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard
      therapy for heart failure with reduced ejection fraction (HFrEF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous
             diuretic treatment for HF without hospitalization) with initiation of study treatment
             after clinical stabilization

          -  Left ventricular ejection fraction (LVEF) <45% by echocardiography at randomization

        Exclusion Criteria:

          -  Intravenous inotropes at any time after hospitalization
Blood Lipopolysaccharide (LPS) Rifaximin Study
Condition: Obese; Insulin Resistance; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Insulin Resistance
Intervention: Rifaximin SSD; Placebo
Intervention description: Study Drug dosing will be 80 mg SSD once daily; 80 mg placebo once daily
Intervention MeSH terms: Rifaximin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 35 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: obese; insulin resistance; metabolic syndrome

Summary:

      Metabolic syndrome is a condition involving elevated levels of fat in the blood, a tendency
      towards diabetes, hypertension, and too much fat around the abdomen (an increased waistline).
      Individuals with metabolic syndrome often have impaired glucose tolerance, which is a
      condition where blood sugar is normal when fasting (before eating), but is too high after
      drinking a sugary drink. This is due to an abnormality in the body's sensitivity to insulin
      (insulin resistance), which is due in part to an inability of the muscle to take up glucose.

      People with metabolic syndrome have inflammation in their fat tissue and in their blood
      stream, and the changes in the level of inflammatory chemicals produced by cells in your fat
      tissues will be studied. One possible source of the inflammation may be the bacteria in the
      intestine. When individuals eat fatty foods, some of the bacterial products become attached
      to the fat in their blood and then get directed to fat tissue. The investigators wish to
      determine whether individuals have an excessive amount of inflammation in their fat tissues,
      and whether this inflammation comes from the bacteria in their intestines. To determine this,
      the investigators wish to treat individuals with an antibiotic that reduces the bacteria in
      their intestines and in their blood, and determine whether this reduces their overall level
      of inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese

          -  Insulin resistance or metabolic syndrome

          -  Body Mass Index between 27 and 45

          -  Waist circumference >40" (M) or >35" (F)

          -  Impaired glucose tolerance (IGT)

          -  Normal glucose tolerance (NGT) with at least three features of MetS

          -  A1C <6.5

          -  Blood pressure 130/85

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Recent or unstable cardiovascular disease

          -  cancer,

          -  Renal insufficiency (GFR<30)

          -  Steroid use

          -  chronic inflammatory conditions

          -  Anticoagulant use

          -  Lipodystrophy

          -  Irritable Bowel Syndrome

          -  Allergy to local anesthetic

          -  Lactose intolerance
BLI4700-202: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
Condition: Colonoscopy
Intervention: BLI4700
Intervention description: BLI4700 Bowel Preparation (Investigational Regimen)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel
      preparation prior to colonoscopy in adult patients.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted
             indication.

          2. At least 18 years of age

          3. If female, and of child-bearing potential, is using an acceptable form of birth
             control.

          4. Negative urine pregnancy test at screening, if applicable

          5. In the Investigator's judgment, subject is mentally competent to provide informed
             consent to participate in the study

        Primary Exclusion Criteria:

          1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal
             obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.

          2. Subjects who had previous significant gastrointestinal surgeries.

          3. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with
             clinically significant electrolyte abnormalities based on Visit 1 laboratory results.

          4. Subjects with a prior history of renal, liver or cardiac insufficiency

          5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

          6. Subjects undergoing colonoscopy for foreign body removal and/or decompression.

          7. Subjects who are pregnant or lactating, or intending to become pregnant during the
             study.

          8. Subjects of childbearing potential who refuse a pregnancy test.

          9. Subjects allergic to any preparation components.

         10. Subjects who, in the opinion of the Investigator, should not be included in the study
             for any reason, including inability to follow study procedures.

         11. Subjects who have participated in an investigational surgical, drug, or device study
             within the past 30 days.
Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of Resveratrol, a Plant Polyphenol, for COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Resveratrol; Vitamin D3
Intervention description: Resveratrol vs placebo given for 15 days.; Vitamin D3 100,000 IU given on day one.
Intervention MeSH terms: Vitamin D; Cholecalciferol; Resveratrol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 105.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Coronavirus; SARS-CoV-2; COVID; Vitamin D3; Cholecalciferol; Supplement; Polyphenol; Resveratrol; Stilbene; phytoalexin

Summary:

      Resveratrol is a plant polyphenol (that is sold commercially as a supplement) that might help
      fight coronavirus as well as help protect the body from the effects of disease (COVID-19)
      caused by the infection. In this proof-of-concept pilot study we will compare the effects of
      resveratrol to placebo to assess the safety of the resveratrol and explore effectiveness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients who test positive for infection with SARS-CoV-2.

          -  Age ≥45 years

          -  Mild COVID-19 based on World Health Organization (WHO) Baseline Severity
             Categorization

          -  Symptom duration ≤ 10 days, or <72 hours of new respiratory symptoms.

          -  Patient must have access to the internet or a smartphone to complete surveys.

          -  English-speaking patients

        Exclusion Criteria:

          -  Diagnosed or suspected cognitive impairment that would prevent the patient from
             cooperating with study procedures, as judged by the screening clinician

          -  Asymptomatic patients (e.g. patients who were screened without symptoms but tested
             positive)

          -  Known or suspected liver disease or Hepatitis C

          -  Known kidney disease with estimate Glomerular Filtration Rate (eGFR) <60

          -  Patients on warfarin, Novel Oral Anticoagulants (NOACs), HIV Protease Inhibitors,
             immunosuppressants, hydroxychloroquine/chloroquine, and other medication with a narrow
             therapeutic window.

          -  Allergy to grapes or rice.

          -  Co-morbidities with a high likelihood of hospitalization within 30 days (e.g., current
             cancer treatment, severe Chronic Obstructive Pulmonary Disease (COPD) or Congestive
             Heart Failure (CHF))

          -  Currently pregnant

          -  Hospitalization
Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.
Condition: Hyperuricemia
MeSH terms: Hyperuricemia
Intervention: Wu Ling San; Yin-Chen Wu Ling San; Placebo
Intervention description: assigned to Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Wu Ling San for a period of 4 weeks.; assigned to Yin-Chen Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Yin-Chen Wu Ling San for a period of 4 weeks.; 1/10 Wu Ling San assigned to Placebo (n =20) and were instructed to take 4.5 gm 2 times per day of Placebo for a period of 4 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To testify the efficacy and safety of traditional Chinese formulae, "Wu-Ling San" and
      "Yin-Chen Wu-Ling San" for patients with hyperuricemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  serum uric acid > 8 mg/dL

        Exclusion Criteria:

          -  1. gout attack within 2 weeks before baseline 2. drug for control urine acid must be
             stable dose within 2 weeks before baseline
             (e.g.allopurinol、benzbromarone、probenecid、sulfinpyrazone) 3. subject taking the drug
             involved azathioprine、aspirin (>325
             mg)、atorvastatin、fenofibrate、losartan、thiazide、systemic corticosteroid、estrogen、oral
             contraceptive pills 4. serum creatinine > 3.0 mg/dL 5. GPT > 100 mg/dL 6. Pregnant or
             breast-feeding women 7. Chemotherapy or radiation therapy in cancer patients
Sildenafil for Swimming-Induced Pulmonary Edema (SIPE) Prevention
Condition: Edema, Pulmonary; Immersion; Diving
MeSH terms: Pulmonary Edema; Edema
Intervention: Sildenafil Citrate; Placebo Oral Tablet
Intervention description: Oral sildenafil, 50 mg; Placebo
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double blind, randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Placebo controlled
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This trial is testing the effectiveness of a single oral dose of sildenafil (50 mg) taken 1
      hour before a provocative event on the subsequent development of swimming-induced pulmonary
      edema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteers between 18 and 45 years

          -  History of swimming-induced pulmonary edema

        Exclusion Criteria:

          -  Pregnant women

          -  Significant heart valve disease

          -  Cardiomyopathy

          -  Uncontrolled hypertension

          -  Coronary artery disease

          -  Obstructive lung disease

          -  VO2max <25 mL/kg as estimated by the University of Houston Non-Exercise Test

          -  Previous adverse reaction to sildenafil

          -  Use of antihypertensives or other drugs that are known to interact adversely with
             sildenafil (e.g. nitrates, alpha adrenergic blockers)