bioihbjkbjnl/mcl2 huggingface dataset:
THE EFFECT OF CYP3A5 GENOTYPE ON THE PHARMACOKINETICS OF MARAVIROC
Condition: Healthy Subjects
Intervention: Maraviroc (Part 1); Maraviroc (Part 2); Darunavir/cobicistat (Part 2)
Intervention description: 300 mg twice daily x 5 days; 150 mg once daily x 10 days; 800/150 mg once daily x 10 days
Intervention MeSH terms: Maraviroc; Darunavir; Cobicistat; Cobicistat mixture with darunavir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Maraviroc, CYP3A5, pharmacokinetics, pharmacogenomics

Summary:

      This will be an open-label, parallel group, multiple dose study in approximately 48 healthy
      male or female subjects of African American and Caucasian self-reported race, to assess the
      effect of CYP3A5 genotype on the PK of MVC and CYP3A5-derived metabolites. Maraviroc and
      CYP3A5-derived metabolite PK will also be compared between African-Americans and Caucasians
      in subjects carrying two copies of the dysfunctional CYP3A5 alleles (*3, *6, and/or *7).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

          -  Healthy female subjects and/or male subjects of African-American/Black or Caucasian
             race

        Exclusion Criteria:

          -  History of regular alcohol consumption exceeding 7 drinks/week for females or 14
             drinks/week for males

          -  Treatment with an investigational drug within 30 days

          -  Screening supine blood pressure <90 or >/=140 mm Hg (systolic) or <60 or >/= 90 mm Hg
             (diastolic), following at least 5 minutes of supine rest

          -  Use of prescription or nonprescription drugs and dietary supplements within 7 days or
             5 half-lives (whichever is longer) prior to the first dose of study medication.

          -  Use of tobacco- or nicotine-containing products in excess of the equivalent of 5
             cigarettes per day

          -  Subjects who have a CYP3A4*22 allele and/or have a SLCO1B1 *5 or *15 allele
IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With IMCY-0098 or Placebo
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Intervention: IMCY-0098 or placebo
Intervention description: Long-term follow-up
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Long-term follow-up (LTFU), no study treatment administered.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Treatment or Placebo
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 31 Years
Healthy volunteers: No

Summary:

      This study is the follow-up of study IMCY-T1D 001 (EudraCT: 2016-003514-27, NCT03272269) in
      which patients with recent onset T1D have been treated with IMCY-0098 or placebo.

      At the end of the primary 6 month study, patients will be proposed to enter this follow-up
      study to evaluate up to 12 months (V3 - Week 48) the safety, the immune responses and the
      clinical parameters.

      The study involves a follow-up of 6 months after the end of the initial participation to the
      IMCY-T1D-001 study. Subjects will undergo visits at 24 weeks, 36 weeks and 48 weeks post
      first study product administration in study IMCY-T1D-001.

      For each patient, the study comprises a total of 3 visits occurring over a period of
      approximately 24 weeks (from study entry). The patients will undergo planned assessments and
      procedures as outlined in the table of study procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients who were treated with IMCY-0098 or placebo in the IMCY-T1D-001 clinical
             trial who are willing to participate to this long-term follow-up study.

        Exclusion criteria:

          -  Ongoing pregnancy or lactation

          -  History of or current malignancy (except excised basal cell skin cancer)

          -  Primary or secondary immune deficiency disorders

          -  Human Immunodeficiency virus (HIV) infection.

          -  Ongoing treatment with immunosuppressive agents with the exception of topical or intra
             nasal corticosteroids.

          -  Treatment with an investigational drug within the past 3 months
Multiple Dose Study Of PF-05231023 In Adult Subjects Who Have Poor Lipid Control With And Without Type 2 Diabetes Mellitus
Condition: Diabetes Melliuts, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; 25 mg PF-05231023; 50 mg PF-05231023; 100 mg PF-05231023; 150 mg PF-05231023
Intervention description: 0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), once a week for 4 weeks; 25 mg IV once a week for 4 weeks; 50 mg IV once a week for 4 weeks; 100 mg IV once a week for 4 weeks; 150 mg IV once a week for 4 weeks
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 107.0
Sex: All
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Type 2 diabetes; safety; multiple dose; intravenous

Summary:

      This is a trial in obese subjects who have poor lipid control with and without Type 2
      diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple doses of
      PF-05231023
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects of non-childbearing potential between the ages of 30 and 70
             years with and without a diagnosis of Type 2 diabetes mellitus (according to the
             American Diabetes Association guidelines).

          -  Subjects with poor lipid control as confirmed by laboratory tests.

          -  BMI of 30 to 40 Kg/m2 and a total body weight of >50 kg (110 lbs).

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease (including drug allergies, but excluding asymptomatic, seasonal
             allergies at time of dosing).

          -  Levels of blood enzymes indicating pancreatitis or elevated liver function enzymes
             outside of the laboratory's reference range as confirmed by laboratory tests.

          -  Subjects with Type 1 Diabetes Mellitus.
A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Brodalumab
Intervention description: Brodalumab is a large molecule for the treatment of inflammatory diseases
Intervention MeSH terms: Brodalumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single dose of
      Brodalumab vs. two doses of Brodalumab
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy males and females with a BMI between 18.0 and 30.0 kg/m2, inclusive. Females
             must be of non-reproductive potential

        Exclusion Criteria:

          -  no history or evidence of clinically significant disorder that would pose a risk to
             subject safety or interfere with study evaluation, procedures, or completion.
Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab
Condition: Lymphoma, B-Cell
MeSH terms: Lymphoma; Lymphoma, B-Cell
Intervention: Inotuzumab Ozogamicin (CMC-544); Rituximab (Rituxan)
Intervention description: 1.8 mg/m2, IV on day 2 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.; 375 mg/m2, IV on day 1 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.
Intervention MeSH terms: Rituximab; Inotuzumab Ozogamicin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: B-cell Non-Hodgkin's Lymphoma; NHL

Summary:

      To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544)
      in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  CD20 and CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.

          -  Prior therapy must have contained at least one dose of Rituximab therapy. Patients can
             not be refractory to Rituximab (refractory = PD under treatment or within 6 month

          -  Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.

          -  Patients must not have received previous radioimmunotherapy.

          -  Patients tolerant to Rituximab.

          -  Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth
             factors (except erythropoietin), or investigational agents within 28 days before first
             dose of test article.

        Exclusion Criteria:

          -  Candidate for potentially curative therapies

          -  Subjects must not have received previous radioimmunotherapy.

          -  Subjects with autologous hematopoietic stem cell transplant within the last 6 months
A Study of LY2334737 in Participants With Cancer That is Advanced and/or Has Spread
Condition: Malignant Solid Tumor; Solid Tumor; Metastatic Tumor
MeSH terms: Neoplasms; Neoplasm Metastasis
Intervention: LY2334737
Intervention description: Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate two different dosing regimens of LY2334737 in
      participants with cancer that is advanced and/or has spread to other parts of the body.
      Information about side effects will be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of advanced and/or metastatic cancer (including lymphoma) for which no
             treatment of higher priority exists

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

          -  Estimated life expectancy of more than 12 weeks

          -  Have discontinued all previous therapies for cancer for at least 30 days (6 weeks for
             mitomycin-C or nitrosoureas) and recovered from acute effects of therapy

          -  Have discontinued radiotherapy more than one week before enrolling in the study and
             have recovered from the acute effects of therapy

          -  Have adequate organ function

          -  Follow your doctor's directions and live close enough to the study site so you can
             continue to go to the clinic for follow-up

          -  Are willing and able to swallow capsules and follow study procedures

          -  Have given written informed consent prior to any study-specific procedures

          -  Males and females with reproductive potential should use medically approved
             contraceptive precautions during the study and for 6 months following the last dose of
             study drug

          -  Females with child-bearing potential must have had a negative urine or serum pregnancy
             test 7 days prior to the first dose of study drug

        Exclusion Criteria:

          -  Have gastrointestinal diseases or prior surgery that may interfere with the absorption
             of medication taken by mouth

          -  Females who are pregnant or lactating

          -  Symptomatic central nervous system malignancy or metastasis

          -  Known positive test results in human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HBSAg), or hepatitis C antibodies (HCAb)

          -  Liver cirrhosis or chronic hepatitis

          -  Acute or chronic leukemia

          -  Are currently receiving treatment with valproic acid (VPA) and its derivatives, or if
             you have a history of intolerance to VPA

          -  Known hypersensitivity to gemcitabine
A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
Condition: Type 2 Diabetes Mellitus
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: TA-7284 Low; TA-7284 High
Intervention description: Low; High
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 40 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: TA-7284; JNJ-28431754; Canagliflozin; Renal Impairment; Sodium Glucose Co-transporter2 (SGLT2) inhibitor

Summary:

      The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with
      type 2 diabetes mellitus who have moderate renal impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with type 2 diabetes mellitus in stable condition who have normal renal
             function or moderate renal impairment

          -  Body mass index of ≥18.5 kg/m2 and ≤39.9 kg/m2 at screening

          -  HbA1c of ≥6.5% and ≤10.5% at screening

        Exclusion Criteria:

          -  Type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder,
             secondary diabetes mellitus

          -  Past or current history of severe diabetic complications

          -  Patients requiring insulin therapy

          -  History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese Subjects
Condition: Obesity
Intervention: Liraglutide; Placebo
Intervention description: Liraglutide; Placebo
Intervention MeSH terms: Liraglutide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This will be a randomized, double blind, placebo controlled, 2 arm, parallel group,
      methodology study to assess the effect of 6 weeks of liraglutide administration on food
      intake in obese subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and female subjects;

          -  Body Mass Index 30-40 kg/m2;

        Exclusion Criteria:

          -  Evidence of history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease (including drug allergises, but excluding untreated, asymptomatic,
             seasonal allergies at time of dosing)
Investigation of Faldaprevir Effect on Pharmacokinetics of Raltegravir
Condition: Healthy
Intervention: Raltegravir; Raltegravir; Faldaprevir
Intervention description: low dose oral administration; low dose oral administration; medium dose oral administration
Intervention MeSH terms: Raltegravir Potassium
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial is to investigate effect of faldaprevir on steady state
      pharmacokinetics of raltegravir.

      The assessment of safety and tolerability will be an additional objective of this trial.
    

Eligibility criteria:

        Inclusion criteria:

        1. healthy male subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
Cognitive Health Promotion Project in the Community
Condition: Alteration of Cognitive Function; Dietary Modification
Intervention: Lifestyle Counseling Usual Care; Lifestyle Counseling Telephone, Bimonth; Lifestyle Counseling Telephone, Month; Lifestyle Counseling Visit, Bimonth; Lifestyle Counseling Visit, Reward
Intervention description: Usual care participants in the group A received no additional services.; Participants in the group B received bimonthly telephonic care management based on manual.; Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.; Participants in the group D received health educator-initiated visit counseling bimonthly.; Participants in the group E received health educator-initiated visit counseling bimonthly and reward.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1115.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: MMSE; activity

Summary:

      This study was based on baseline data derived from a large prospective study called the Suwon
      Project (SP), a cohort comprising random clustering samples of elderly people, all of whom
      are ethnic Koreans aged over 60 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  more than 60 years old

        Exclusion Criteria:

          -  those with a history of significant hearing or visual impairment that rendered
             participation in the interview difficult

          -  those with a history of neurological disorders (e.g., stroke, Parkinson's disease, or
             active epilepsy)

          -  those with psychiatric illness (e.g., schizophrenia, mental retardation, severe
             depression, or mania)

          -  those taking psychotropic medications, or those with significant alcohol and other
             substance abuse.
A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK0941; Comparator: Placebo
Intervention description: MK0941 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day; Placebo 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in
      patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily
      MK-0941 in subjects with T2DM with or without adequate control on metformin will be
      sufficiently safe and well tolerated to permit continued clinical investigation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Nonsmoking Male or Female (of non-child bearing potential)

          -  Diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or with
             less than 3 oral anti-hyperglycemic agents

          -  Panel E only (MK0941 60 mg before 2 meals each day): diagnosis of Type 2 Diabetes and
             is on a dose of metformin of greater than or equal to 1500 mg for 8 weeks or more

        Exclusion Criteria:

          -  Subject is on insulin or a peroxisome proliferator-activated receptor (PPAR) agonist

          -  Subject is on 3 or more oral anti-diabetes medications

          -  Subject has a history of type 1 diabetes

          -  Subject has a diagnosis of glaucoma or is blind

          -  Subject has had trauma to one or both eyes
A Study of Lasmiditan in Healthy Participants When Co-administered With Topiramate
Condition: Healthy
Intervention: Lasmiditan; Placebo; Topiramate
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Topiramate; Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will assess the safety, tolerability and blood concentrations of lasmiditan and
      topiramate together compared to lasmiditan and topiramate separately. Information about any
      side effects that may occur will be collected.

      Participants will be admitted to the Clinical Research Unit (CRU) one day prior to the start
      of the study and will remain through Day 14.

      This study is expected to last approximately 25 days, not including screening. Screening is
      required within 28 days prior to the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are healthy males or females (of non-child bearing potential), as determined by
             medical history and physical examination

          -  Have a body mass index of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive

        Exclusion Criteria:

          -  Have known allergies to lasmiditan, topiramate, related compounds or any components of
             the formulation of lasmiditan or topiramate

          -  Have an abnormal supine blood pressure, defined as systolic blood pressure less than
             (<) 90 or great (>) 140 millimeters of mercury (mmHg) or diastolic blood pressure <60
             or >90 mmHg at screening

          -  Have known or ongoing psychiatric disorders considered clinically significant by the
             investigator or demonstrate suicidal ideation on the Columbia Suicide Severity Rating
             Scale (C-SSRS)

          -  Have a clinically significant abnormality in the neurological examination

          -  Have current or a history of orthostatic hypotension (>20-mmHg drop in systolic blood
             pressure, or >10-mmHg drop in diastolic blood pressure) with or without dizziness
             and/or syncope at screening or admission to the Clinical Research Unit (CRU) upon
             repeat testing

          -  Have an estimated glomerular filtration rate using Modification of Diet in Renal
             Disease <60 milliliter per minute (mL/min) per 1.73 meter squared (m²)

          -  Have a history of glaucoma

          -  Have a history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose
             malabsorption