bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Boceprevir
Intervention description: Single dose of boceprevir powder prior to breakfast in a dosing vehicle of chocolate pudding (i.e., a mousse or custard), apple sauce, Nutella, fruit pudding such as strawberry, cherry, or raspberry pudding, or yogurt or a similar semi-solid product into which the boceprevir powder can be evenly stirred
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir
      following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented chronic hepatitis C (CHC) genotype 1 infection

          -  Treatment naïve or failed previous interferon/ribavirin therapy (≥12 uninterrupted
             weeks)

          -  Weigh between 10 kg to 90 kg inclusive at screening and baseline (Day -1).

          -  Body Mass Index (BMI) from the 5th to the 95th percentile for the participant's age
             and gender, inclusive, per tables from the Center for Disease Control and Prevention,
             USA

          -  Use of acceptable methods of contraception for at least 3 months prior to baseline and
             continue on study

        Exclusion Criteria:

          -  Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg
             positive).

          -  Treatment with ribavirin within 90 days, or any interferon-alfa within 30 days

          -  Discontinued from interferon treatment due to adverse events

          -  Currently receiving antiviral/immunomodulating therapy for hepatitis C

          -  Prior treatment with an HCV protease inhibitor

          -  Prior treatment with any known hepatotoxic agent (including herbal remedies)

          -  Use of investigational drugs within 30 days of enrollment into study

          -  Evidence of de-compensated liver disease including, but not limited to, a history or
             presence of clinical ascites, bleeding varices, or hepatic encephalopathy.

          -  Substance abuse (including but not limited to alcohol abuse, illicit drugs,

        inhalational drugs, marijuana use, etc) any time prior to entry into the study

          -  Any surgical or medical condition which might significantly alter the absorption,
             distribution, metabolism or excretion of any drug.

          -  Pregnant or breastfeeding female

          -  Meeting any of the laboratory exclusion criteria
The Effects of LY2409021 on the Liver
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; LY2409021
Intervention description: Administered orally; Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 30.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study that involves multiple doses of study drug (60 mg of LY2409021, 15 mg of
      LY2409021 or placebo) taken as capsules by mouth on a daily basis for 28 days. This study
      will image the liver using magnetic resonance imaging (MRI) and magnetic resonance
      spectroscopy (MRS) in healthy participants and in participants with type 2 diabetes mellitus,
      when they take LY2409021 to see if liver changes happen at the same time as changes in blood
      tests. This study is approximately 11 weeks long, not including screening. A screening
      appointment is required within 28 days prior to the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

        For all participants:

          -  Must be a male, or a female who cannot become pregnant, and who is either a healthy
             participant, or who has type 2 diabetes

          -  Must have a body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m^2)
             if a healthy participant, or a BMI of 18.5 to 35.0 kg/m^2 if diabetic

        For participants with type 2 diabetes mellitus (T2DM):

        - On diet and exercise treatment, or taking metformin

        Exclusion Criteria:

        For all participants:

          -  Have signs or symptoms of liver disease

          -  Are infected with hepatitis B or hepatitis C

          -  Have donated more than 450 mL of blood in the last 3 months or if have donated any
             blood in the last month

          -  Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while
             at the clinic

          -  Have had surgery with metallic clips, staples or stents, or have had a cardiac
             pacemaker (or other surgical implants) inserted in any part of the body, or have fear
             of enclosed spaces or have symptoms that prevent them from being sent for an magnetic
             resonance imaging (MRI) scan

        For participants with T2DM:

        - Are using insulin
Topical Bethanechol for Improvement of Esophageal Dysmotility
Condition: Esophageal Dysmotility
MeSH terms: Esophageal Motility Disorders; Esophageal Spasm, Diffuse
Intervention: Bethanechol
Intervention description: Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled.
Intervention MeSH terms: Bethanechol
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: IEM

Summary:

      The purpose of this research project is to determine the effect of a drug called bethanechol
      on swallowing function in patients with Ineffective Esophageal Motility (IEM). This drug is
      FDA approved for use in treating other conditions, but not for the treatment of IEM. There is
      currently no approved therapy for the treatment of IEM. This information is important for the
      possible development of new ways of treating patients with IEM and for the effectiveness of
      topically applied Bethanechol on patients with IEM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any adult patient treated at the Medical College of Georgia, with severe IEM as
             defined using current criteria: esophageal contraction amplitude <30 mmHg either 5 or
             10 cm above the lower esophageal sphincter, in 50% or more of saline swallows.

        Exclusion Criteria:

          -  Patients with severe comorbidities (including uncontrolled hypertension, severe
             coronary artery disease, and uncontrolled diabetes) will be specifically excluded from
             the study.

          -  Additionally, the use of bethanechol (as well as all other muscarinic receptor
             agonists) is contraindicated in patients with asthma, coronary insufficiency, peptic
             ulcers, Parkinson's disease, seizure disorder, recent gastrointestinal surgery, and
             hyperthyroidism. As such any patient with these disorders will be specifically
             excluded from this study.

          -  Women of childbearing age will also be specifically excluded (Bethanechol is listed as
             a pregnancy class C drug).
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
Condition: Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency
MeSH terms: Urinary Bladder, Overactive
Intervention: fesoterodine; fesoterodine; fesoterodine; fesoterodine; fesoterodine; fesoterodine
Intervention description: single dose of beads in capsule; single dose of beads in capsule; single dose of beads in capsule; single dose of beads in capsule; single dose of tablet; single dose of beads in capsule
Intervention MeSH terms: Fesoterodine
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: BIOAVAILABILITY; FOOD EFFECT

Summary:

      This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female subjects between the ages of 18 and 55 years

        Exclusion Criteria:

          -  Evidence or history of clinically significant disease
Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate)
Condition: Healthy
Intervention: Fenofibric Acid (Fibricor™) 105 mg Tablet; Fenofibrate (Tricor®) 145 mg Tablet
Intervention description: 1 x 105 mg fenofibric acid (Fibricor™) tablet administered after an overnight fast of at least 10 hours; 1 x 145 mg Fenofibrate (Tricor®) tablet administered after an overnight fast of at least 10 hours
Intervention MeSH terms: Fenofibrate; Fenofibric acid
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy; pharmacokinetics; therapeutic equivalency; fasting; procetofen; fenofibric acid

Summary:

      This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145
      mg fenofibrate tablets in healthy volunteers under fasting conditions. A secondary objective
      is to characterize the pharmacokinetic profile of fenofibric acid when administered as a
      single 105 mg dose to healthy volunteers in a fasted state. Safety and tolerability of this
      regimen will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-45 years of age

          -  Non-smoking

          -  Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive
             measures)

          -  Body mass index (BMI) less than 30

          -  Medically healthy on the basis of medical history and physical examination

          -  Hemoglobin > or = to 12g/dL

          -  Completion of the screening process within 28 days prior to dosing

          -  Provision of voluntary written informed consent

        Exclusion Criteria:

          -  Recent participation (within 28 days) in other research studies

          -  Recent significant blood donation or plasma donation

          -  Pregnant or lactating

          -  Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HbsAg), or hepatitis C virus (HCV)

          -  Recent (2-year) history or evidence of alcoholism or drug abuse

          -  History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or
             biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic,
             dermatologic, neurologic, or psychiatric disease

          -  Subjects who have used any drugs or substances known to inhibit or induce cytochrome
             (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose
             and throughout the study

          -  Drug allergies to fenofibrate (fenofibric acid)
A Study of Nasal Glucagon in Participants With Type 1 Diabetes Mellitus
Condition: Hypoglycemia; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Intervention: Nasal Glucagon; Intramuscular Glucagon
Intervention description: Administered nasally; Administered IM
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare a needle-free treatment of hypoglycemia with nasal
      glucagon (study drug) to a marketed glucagon administered by the intramuscular (IM) route, in
      participants with type 1 diabetes mellitus (T1DM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 2 years and receiving daily
             insulin since the time of diagnosis

        Exclusion Criteria:

          -  Have a history of hypersensitivity to glucagon or any related products or severe
             hypersensitivity reactions (such as angioedema) to any drugs

          -  Have a history of pheochromocytoma (that is, adrenal gland tumor) or insulinoma

          -  Occurrence of an episode of severe hypoglycemia (defined as requiring the assistance
             of another person in the 1 month prior to enrolling in the study)

          -  Have a history of epilepsy or seizure disorder

          -  Are women who are pregnant or lactating

          -  Have, except for the current regimen of insulin therapy and concomitant medication,
             regular use of or intended use of any over-the-counter or prescription medications or
             nutritional supplements that treat hyperglycemia or insulin resistance or that promote
             weight loss within 14 days before dosing

          -  Daily use of systemic beta-blocker, indomethacin, warfarin or anticholinergic drugs

          -  Require daily insulin treatment greater than (>)1.5 unit/kilograms (U/kg)/body weight
A Method to Evaluate Glucose-Dependent Insulin Secretion in Healthy Males (MK-0431-179)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: sitagliptin; Comparator: Placebo
Intervention description: Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.; Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the effect of a single dose of sitagliptin on glucose dependent
      insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG)
      procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is an Asian Indian male between 18 to 45 years of age

          -  Subject is in good health

          -  Subject is a nonsmoker or has not used nicotine-containing products for six months

          -  Subject is willing to avoid strenuous activity

        Exclusion Criteria:

          -  Subject has a history of stroke, seizures, or major neurological disorders

          -  Subject has irritable bowel disease or recurrent nausea, vomiting, diarrhea, or
             abdominal pain

          -  Subject has a history of high blood pressure requiring treatment

          -  Subject has history of cancer

          -  Subject has a history of diabetes
Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together
Condition: Healthy
Intervention: Empagliflozin; Metformin; Empagliflozin; Empagliflozin/Metformin; Metformin; Empagliflozin/Metformin; Empagliflozin; Metformin; Empagliflozin/Metformin
Intervention description: medium dose oral administration; oral administration; low dose of Empagliflozin oral administration; low dose of Empagliflozin; oral administration; medium dose of Empagliflozin oral administration; medium dose oral administration; oral administration; medium dose of Empagliflozin oral administration
Intervention MeSH terms: Metformin; Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two
      strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and
      bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets
      empagliflozin and metformin under fed conditions (Part II).
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male and female subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
Bioequivalence of Azathioprine Suspension 10 mg/mL (Jayempi) Versus Azathioprine Tablet 50mg (Imurek®)
Condition: Therapeutic Equivalency
Intervention: Azathioprine 50Mg Tab; Azathioprine 10mg/mL oral suspension
Intervention description: tablet; oral suspension
Intervention MeSH terms: Azathioprine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A single center, single dose, open-label, randomized, two period crossover study to assess
      the bioequivalence of an oral azathioprine suspension 10 mg/mL (Jayempi™) versus oral
      azathioprine tablet 50mg (Imurek®, Aspen Pharma Trading Limited, Dublin, Ireland.) in at
      least 30 healthy adult subjects under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Volunteers.

          -  No significant medical history or conditions that may interfere with the study.

          -  Adequate contraception.

        Exclusion Criteria:

          -  Volunteers who may be likely to have the inherited mutated NUDT15.

          -  Subjects with a deficient, low or intermediate TPMT enzyme activity.

          -  Disease that may interfere with the safety of the participant or the study outcome
             measures.

          -  Participants who want to procreate in the next 6 months.
A Study to Investigate the Influence of Hepatic Impairment on MK-8189 Treatment (MK-8189-012)
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Intervention: MK-8189
Intervention description: Administered at a dose of 4 mg via oral tablet
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the pharmacokinetics (PK) of MK-8189 in participants
      with moderate hepatic impairment (based on the Child-Pugh classification) to healthy
      participants. This is Part 1 of the study; following review of the safety and PK data from
      Part 1, a decision will be made as to whether Part 2 of the study will be initiated. If done,
      Part 2 of the study will compare the PK of MK-8189 in participants with mild hepatic
      impairment to healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is a continuous non-smoker or moderate smoker (of fewer than 20 cigarettes/day or
             equivalent)

          -  Female participant is not pregnant or breastfeeding and is not woman of childbearing
             potential (WOCBP) or is a WOCBP using contraception or abstinent from heterosexual
             intercourse during the intervention period and for at least 14 days after the last
             dose of study intervention

          -  (For hepatically impaired participants) Has a diagnosis of chronic (>6 months), stable
             (no acute episodes within the previous 2 months due to deterioration in hepatic
             function) hepatic impairment

        Exclusion Criteria:

          -  Has a history of clinically significant endocrine, gastrointestinal, cardiovascular,
             hematological, hepatic, immunological, renal, respiratory, genitourinary or major
             neurological abnormalities or diseases

          -  Has a history of cancer; exceptions include (1) adequately treated non-melanomatous
             skin carcinoma or carcinoma in situ of the cervix, (2) other successfully treated
             malignancies

          -  Has a history of significant multiple and/or severe allergies or has had significant
             intolerability to prescription or non-prescription drugs or food

          -  Is positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)

          -  Has had major surgery or lost 1 unit of blood within 4 weeks prior to prestudy visit

          -  Consumes greater than 3 glasses of alcoholic beverages per day

          -  Consumes greater than 6 servings (1 serving is ~120 mg of caffeine) caffeinated
             beverages per day

          -  (For hepatically impaired participants) Is taking medications to treat chronic medical
             conditions and has not been on a stable regimen for at least 1 month and/or is unable
             to withhold the use of the medications during study