bioihbjkbjnl/mcl2 huggingface dataset:
Fed 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 30 minutes after the initiation of a standard breakfast.; 1 x 145 mg Fenofibrate (Tricor®) tablet administered 30 minutes after the start of a standard breakfast.
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

Summary:

      This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145
      mg fenofibrate tablets in healthy volunteers when administered following a breakfast of
      standard composition. 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)
Health Service Intervention for the Improvement of Access and Adherence to Colorectal Cancer Screening
Condition: Colorectal Carcinoma
MeSH terms: Colorectal Neoplasms
Intervention: Community Health Service; Survey Administration
Intervention description: Receive Witness CARES services; Ancillary studies
Phase: Phase 1
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 183.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This phase I study investigates how well a health service program called Witness CARES
      Services works in increasing access and adherence to colorectal cancer screening in patients
      who have not undergone a colorectal screening in the past year. Providing patients with
      navigational and screening services via Witness CARES Services may improve access to and
      adherence levels of colorectal screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who are non-adherent to CRC screening over the past year (i.e., no stool
             testing in past 11 months or colonoscopy for over 9 years)

          -  Medicaid or Medicaid/Medicare subscribers

          -  Uninsured patients may be included from Mercy Comprehensive Care Center (MCCC), but
             will only be eligible for services to obtain fecal immunochemical tests (FIT) through
             the New York State (NYS) Cancer Services Program

        Exclusion Criteria:

          -  Any participants from the lists of gaps in care clients from insurance or primary care
             practices who report having had a colonoscopy in the past 9 years (or having positive
             findings such as polyps, 5 years) or having completed some type of fecal test for CRC
             will be excluded

          -  Participants under 50 will be excluded unless they have been deemed high risk by their
             physician, and have a prescription for CRC screening

          -  Participants symptomatic for CRC will be excluded from the study
Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled Prucalopride Succinate in Volunteers
Condition: Healthy
Intervention: Radiolabeled Prucalopride Succinate
Intervention description: A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
Intervention MeSH terms: Prucalopride
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Phase I study to evaluate the excretion of radioactivity, the metabolic profile,
      pharmacokinetics, safety and tolerability following a single oral administration of [14C]
      Prucalopride Succinate in healthy male volunteers aged 18 to 50 years (inclusive).The purpose
      of this study is to investigate how and how quickly Prucalopride Succinate or its break down
      products are excreted by analysing blood, faeces and urine samples collected during the
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males aged between 18 and 50 years, inclusive

          -  Body mass index (BMI) of ≥18 and ≤30 kg/m2

          -  No more than 2 bowel movements per day or fewer than 3 bowel movement per week

          -  Provision of signed and dated, written informed consent prior to any study specific
             procedures

        Exclusion Criteria:

          -  Have participated in a [14C]-study within the last 6 months.

          -  Exposure to clinically significant radiation within 12 months prior to dose (for
             example, serial X-ray or computed tomography scans, barium meal, current employment in
             a job requiring radiation exposure monitoring).

          -  Male subjects who consume more than 21 units of alcohol per week or 3 units per day.
A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects
Condition: Diabetes Mellitus
Intervention: LY2963016; Lantus
Intervention description: Administered subcutaneously; Administered subcutaneously
Intervention MeSH terms: Insulin Glargine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of
      LY2963016 compared to those of basal insulin. The study will also gather information on the
      safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females

          -  Have a body mass index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m^2)

          -  Are nonsmokers

          -  Have normal blood pressure and pulse rate

          -  Have an electrocardiogram (ECG) considered as within normal limits

          -  Have clinical laboratory test results within normal reference range

        Exclusion Criteria:

          -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical
             trial involving an investigational drug or device

          -  Have known allergies to insulin or its excipients

          -  Have significant history of or current cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders

          -  Show evidence of significant active neuropsychiatric disease

          -  Have a history of first-degree relatives known to have diabetes mellitus

          -  Have a fasting venous blood glucose >6.0 millimoles per liter (mmol/L)

          -  Intend to use over-the-counter or prescription medication

          -  Have donated or had a blood loss of 450 milliliters (mL) or more in the past 3 months

          -  Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14
             units per week (females)
Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: MDV3100
Intervention description: 4 x 40 mg capsules, orally, once per day
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate cancer; docetaxel; MDV3100; enzalutamide; Xtandi

Summary:

      The purpose of this study is to determine the safety of MDV3100 given in combination with
      Docetaxel in men with advanced prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide informed consent;

          -  Men, 18 years of age or older;

          -  Histologically or cytologically confirmed adenocarcinoma of the prostate;

          -  Ongoing androgen deprivation therapy

        Exclusion Criteria:

          -  Severe concurrent disease;

          -  Known or suspected brain metastasis;

          -  History of another malignancy within the previous 5 years;

          -  Prior treatment with docetaxel-based chemotherapy
A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of TAK-079 in Healthy Participants
Condition: Autoimmune Disease
MeSH terms: Autoimmune Diseases
Intervention: TAK-079; Placebo to TAK-079
Intervention description: TAK-079 solution; Placebo to TAK-079 solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to characterize the pharmacokinetic and safety and tolerability
      profile of TAK-079 following a single intravenous (IV) infusion or subcutaneous (SC)
      administration at escalating dose levels in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a healthy male or female with no child bearing potential who is 18 to 55 years of
             age inclusive.

          2. The subject weighs at least 70 kilogram (kg) for cohort 1 and subsequent cohorts 50 kg
             (110.2 lb) and less than 100 kg (220.5 lb) and has a body mass index (BMI) range of
             18.5 to 30 kilogram per square meter (kg/m^2), inclusive at Screening Visit 1.

          3. A male participant who is non-sterilized and sexually active with a female partner of
             childbearing potential agrees to use adequate contraception from signing of informed
             consent throughout the duration of the study and for 6 months after last dose of study
             medication.

        Exclusion Criteria:

          1. Has received any investigational compound within the last 3 months or 5*T1/2 of the
             investigational compound,whichever is longer, prior to the day of study medication
             (Day 1).

          2. Has received any live vaccinations, within the last 3 months prior to Screening or is
             expected to receive any vaccinations during the study or for 1 month after the Day 78
             Study Exit visit.

          3. Has received any other biologic medical products at any time in the past.

          4. Has a positive drug or alcohol screening result, or a history of drug or alcohol
             abuse.

          5. Has a positive test result for hepatitis or human immunodeficiency virus antibody.

          6. Has any signs of an acute infection or history of frequent or chronic infection, or
             herpes zoster.

          7. Has active or latent tuberculosis (TB)

          8. Considered unfit for the study by the Principal Investigator.
Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products
Condition: Pharmacodynamics
Intervention: Generic clopidogrel product Apolets®; Original clopidogrel product Plavix®
Intervention description: Clopidogrel 75 mg once daily for 7 days
Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7; Clopidogrel 75 mg once daily for 7 days
Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
Intervention MeSH terms: Clopidogrel
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Clopidogrel; Platelet inhibition; Platelet aggregation

Summary:

      The purpose of this study is to compare the pharmacodynamic effect of clopidogrel on the
      platelet inhibition and the pharmacokinetic profiles of clopidogrel carboxylic acid
      metabolite between generic and reference clopidogrel products in Thai healthy volunteers
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age between 18 and 45 years

          -  Body mass index between 18-25 kg/m2

          -  No clinically significant abnormalities, as confirmed on medical history; detailed
             physical examination; clinical laboratory analysis (blood hematology, biochemistry,
             prothrombin time, bleeding time, and urinalysis)

        Exclusion Criteria:

          -  An allergy to any drug; and/or a history of drug and/or alcohol abuse.

          -  Subjects who had donated blood within 3 months prior to the start of this study or had
             participated in another investigational drug study within 3 months prior to the start
             of this study

          -  Participating subjects were instructed to abstain from the use of any drugs for at
             least 2 weeks before and throughout the study.
A Study of Multiple Doses of LY2922470 in Participants With Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; LY2922470
Intervention description: Administered orally as capsules; Administered orally as capsules
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to determine the safety of LY2922470, taken as oral
      capsules, once or twice daily for approximately 28 days, in participants with diabetes. It
      also aims to determine how long the drug stays in the body and how it affects blood sugar
      levels. A screening appointment is required within 28 days before the start of the study and
      a follow up appointment is required approximately 14 days after the last study dose is taken.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be a male, or a female who cannot become pregnant, and who has type 2 diabetes

          -  Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6.5% and less
             than or equal to 11% at screening

          -  Do not have any change to their diabetes treatment (exercise with or without
             metformin) for at least 4 weeks prior to screening

          -  Have a screening body mass index (BMI) of 18.0 to 45.0 kilograms per square meter
             (kg/m^2)

          -  Have blood pressure, pulse rate, blood and urine laboratory test results acceptable
             for the study

        Exclusion Criteria:

          -  Are currently participating in another clinical study or completed one in the last 30
             days

          -  Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or
             have any medical problems which may cause an increased risk during the study

          -  Have electrocardiogram (ECG) readings that are not suitable for the study

          -  Are infected with hepatitis B or hepatitis C

          -  Are infected with human immunodeficiency virus (HIV)

          -  Have donated blood equal to or more than 500 mL within 56 days before the first dose
             of drug or have donated plasma within 7 days before the first dose or provided any
             blood donation within the last month from screening
EASI Access II --- Follow-up Study to the EASI Access Trial
Condition: Disaster Medicine; Difficult Intravenous Access; Dehydration
MeSH terms: Dehydration
Intervention: Human recombinant hyaluronidase (HRH); Enzymatically Augmented Subcutaneous Infusion (EASI) line placement
Intervention description: 150u HRH administered via EASI access line, prior to infusion of 250 D5W (5% dextrose in water); Subjects will under placement of an EASI line. This entails placement of a small (20-gauge) catheter in the upper back, in the subcutaneous space.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Disaster; Mass casualty incident; Prehospital; Rehydration; Intravascular access

Summary:

      Test whether Basic Life Support (BLS) providers can successfully place Enzymatically
      Augmented Subcutaneous Infusion (EASI) Access lines for subcutaneous infusion, and
      characterize intravascular absorption of EASI-administered (tracer-labelled) glucose (D5W).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be at least 18 years of age and have none of the following conditions:

               -  pregnancy (negative urine pregnancy test to be performed before study
                  participation),

               -  diabetes, or coagulopathic (including taking any anticoagulants);

          -  Subjects cannot be taking steroids or other immunosuppressants.

          -  Because of the potential for reduced hyaluronidase effectiveness, the study excludes
             patients taking more than 80 mg daily aspirin, as well as any patients taking ACTH,
             antihistamines, or estrogen other than in oral contraceptive preparations.

          -  Subjects will not be required to fast before the study, but will not allowed to eat or
             drink during the EASI infusion or the phlebotomy sampling time frame.
Experimental Gene Transfer Procedure to Treat Alpha 1-Antitrypsin (AAT) Deficiency
Condition: Alpha 1-Antitrypsin Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency
Intervention: rAAV1-CB-hAAT
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gene Transfer Techniques; Gene Therapy; AAV; AAT; Phase I; Intramuscular transfer

Summary:

      Individuals with a deficiency of the alpha 1-antitrypsin (AAT) protein are at risk for
      developing emphysema and liver damage. Researchers have developed a way to introduce normal
      AAT genes into muscle cells with the expectation that the AAT protein may be produced at
      normal levels. This study will evaluate the safety of the experimental gene transfer
      procedure in individuals with AAT deficiency. The study will also determine what dose may be
      required to achieve normal levels of AAT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with AAT deficiency

          -  Forced expiratory volume in one second (FEV1) greater than 24% of predicted value
             (post bronchodilator)

          -  Willing to discontinue AAT protein replacement 4 weeks (Group 1) and 8 weeks (Groups 2
             and 3) prior to study entry, and to resume 11 weeks after rAAV1-CB-hAAT has been
             administered

          -  Willing to discontinue aspirin, aspirin-containing products, and other drugs that may
             alter platelet function 7 days prior to study entry, and to resume 24 hours after
             rAAV1-CB-hAAT has been administered

          -  Willing to use contraception throughout the study

        Exclusion Criteria:

          -  Required antibiotic therapy for a respiratory infection in the 28 days prior to
             rAAV1-CB-hAAT administration

          -  Required oral or systemic corticosteroids in the 28 days prior to rAAV1-CB-hAAT
             administration

          -  Liver disease

          -  Currently receiving or has received an investigational study agent in the 30 days
             prior to study entry

          -  Received gene transfer agents in the 6 months prior to study entry

          -  Currently smokes cigarettes or uses illegal drugs

          -  History of immune response to human AAT replacement

          -  History of platelet dysfunction

          -  Abnormal ECG, heart disease, pulmonary edema, or embolism in the 6 months prior to
             study entry

          -  Current or recent facial or chest trauma that makes it medically impossible to perform
             pulmonary function tests (PFTs)

          -  Any other medical condition that the investigator deems unsuitable for study
             participation

          -  Pregnant or breastfeeding