bioihbjkbjnl/mcl2 huggingface dataset:
Guanfacine Immediate-release Electrocardiogram Results (QTc) Study
Condition: Healthy Volunteers
Intervention: immediate release guanfacine hydrochloride; moxifloxacin; Placebo
Intervention description: Subjects will receive 2x2mg immediate-release guanfacine on day 1. Subjects will receive 4x2mg immediate-release guanfacine on day 6.; Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6.; Subjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.
Intervention MeSH terms: Moxifloxacin; Guanfacine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: QT/QTc

Summary:

      To assess the effect of immediate-release guanfacine hydrochloride, administered at
      therapeutic and supratherapeutic doses, on QT/QTc in healthy normal males and females
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Normal Subjects
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
Condition: Nonalcoholic Steatohepatitis (NASH); Primary Sclerosing Cholangitis (PSC)
MeSH terms: Fatty Liver; Cholangitis; Non-alcoholic Fatty Liver Disease; Cholangitis, Sclerosing
Intervention: Cilofexor
Intervention description: Tablet(s) administered orally in a fed state on Day 1
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to evaluate the single-dose pharmacokinetics of
      cilofexor in adults with impaired hepatic function relative to matched, healthy controls with
      normal hepatic function.
    

Eligibility criteria:

        Key Inclusion Criteria:

        Cohort 1:

          -  Individuals with mildly impaired and normal hepatic function.

          -  Individuals with mild hepatic impairment must have a score of 5-6 on the
             Child-Pugh-Turcotte (CPT) classification at screening without evidence of worsening
             clinical and/or laboratory signs of hepatic impairment within 2 months prior or within
             the screening period.

        Cohort 2:

          -  Individuals with moderately impaired and normal hepatic function.

          -  Individuals with moderate hepatic impairment must have a score of 7-9 on the CPT
             classification at screening without evidence of worsening clinical and/or laboratory
             signs of hepatic impairment within 2 months prior or within the screening period.

        Cohort 3:

          -  Individuals with severely impaired and normal hepatic function.

          -  Individuals with severe hepatic impairment must have a score of 10-15 on the CPT
             classification at screening without evidence of worsening clinical and/or laboratory
             signs of hepatic impairment within 2 months prior or within the screening period.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Drug Interaction Study of Digoxin and BI 10773
Condition: Healthy
Intervention: Digoxin plus BI 10773; Digoxin
Intervention description: Digoxin 0.5 mg as single dose, BI 10773 medium dose once daily; Digoxin 0.5 mg as single dose
Intervention MeSH terms: Empagliflozin; Digoxin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study is to investigate the relative bioavailability of digoxin after
      concomitant multiple oral administration of BI 10773 and a single dose of digoxin in
      comparison to digoxin given alone to healthy male and female subjects.
    

Eligibility criteria:

        Inclusion criteria:

        -Healthy male and female subjects

        Exclusion criteria:

        -Any relevant deviation from healthy conditions
A Study of LY3202626 in Healthy Participants
Condition: Healthy
Intervention: LY3202626 (R-Fasting); LY3202626 (T1-Fasting); LY3202626 (T1-Fed)
Intervention description: Administered orally; Administered orally; Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purposes of this study are to determine:

        -  If there are any differences in the way LY3202626 is handled by the body when taken in
           two different forms

        -  Whether a high fat meal affects the way the body handles LY3202626

        -  How well tolerated LY3202626 is

      There are three (3) study periods for all participants. Participants will be admitted to the
      clinical research unit (CRU) each period and will be discharged from the CRU following the
      completion of 2 overnight stays and up to 36 hours after dosing with LY3202626.

      The study will last about 50 days, not including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined by medical history and physical
             examination

          -  Female participants must be of non-childbearing potential confirmed by medical history
             or menopause

          -  Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²)
             inclusive, at screening

        Exclusion Criteria:

          -  Are investigative site personnel directly affiliated with this study and their
             immediate families

          -  Are currently enrolled in a clinical trial involving an investigational product or any
             other type of medical research judged not to be scientifically or medically compatible
             with this study

          -  Have participated, within the last 30 days, in a clinical trial involving an
             investigational product. If the previous investigational product has a long half-life,
             3 months or 5 half-lives (whichever is longer) should have passed

          -  Have previously completed or withdrawn from this study or any other study
             investigating LY3202626, and have previously received the investigational product

          -  Have a history of or current cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders capable of
             significantly altering the absorption, metabolism, or elimination of drugs; of
             constituting a risk when taking the investigational product; or of interfering with
             the interpretation of data

          -  Have a history of head trauma with loss of consciousness within the last 5 years

          -  Have known or ongoing psychiatric disorders
The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream
Condition: Healthy Volunteers
Intervention: LY2409021; Gemfibrozil; Ketoconazole; Clarithromycin
Intervention MeSH terms: Clarithromycin; Ketoconazole; Gemfibrozil
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to examine the effect of gemfibrozil, ketoconazole, and
      clarithromycin on how much LY2409021 is found in the bloodstream and how long the body takes
      to get rid of it. The study is split into two parts, Part A and Part B. Participants in Part
      A are divided into two cohorts (groups). Each cohort will participate in two study periods.
      Period 1 involves a single dose of LY2409021. Period 2 involves either gemfibrozil or
      ketoconazole given daily for 21 days with LY2409021 given once on Day 4. Part A will last for
      51 days and will also involve screening within 27 days of the start of the study. Part B is
      only open to participants who successfully completed Part A of the study. Participants in
      Part B will receive clarithromycin given daily for 21 days with LY2409021 given once on Day
      4. Part B will last for 29 days and will also involve screening within 27 days of the start
      of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants are overtly healthy males or females, as determined by medical history
             and physical examination

          -  Participants have a body mass index (BMI) of 18.0 to 32.0 kilograms per meter squared
             (kg/m^2), inclusive, at screening

          -  Participants have a fasting blood glucose of 54 to 110 milligrams per deciliter
             (mg/dL) (3.0 to 6.1 micromoles per liter [mmol/L])

        Exclusion Criteria:

          -  Participants that have a contraindication to use of clarithromycin

          -  Participants that have a personal or family history of long QT syndrome

          -  Participants with a family history of sudden unexplained death or cardiac death in an
             immediate family member under 60 years of age

          -  Participants with a personal history of unexplained syncope within the last year

          -  Participants who have taken drugs or substances known to be an inducer or inhibitor of
             cytochrome P450 (CYP)3A4 or CYP2C8 or CYP2J2 (for example, St. John's wort, rifampin,
             ketoconazole, trimethoprim) within 30 days prior to the first dose
Ascending Single Doses of Erenumab (AMG 334) in Healthy Adults and Migraine Patients
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Erenumab; Placebo
Intervention description: Administered by subcutaneous injection or intravenous injection; Administered by subcutaneous injection or intravenous injection
Intervention MeSH terms: Erenumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Migraine

Summary:

      The primary purpose of this study is to determine whether erenumab is safe and well tolerated
      in healthy adults and migraine patients. As part of the secondary objectives, this study will
      be conducted to characterize the pharmacokinetic (PK) profile of erenumab after single
      subcutaneous (SC) or intravenous (IV) doses in healthy participants and migraine patients as
      well as to characterize the effect of erenumab on the capsaicin-induced increase in dermal
      blood flow after single SC or IV doses in healthy participants and migraine patients.
    

Eligibility criteria:

        Inclusion Criteria:

        - Healthy male and female subjects between 18 and 45 years of age, or male or female
        subjects with migraines between 18 and 55 years of age, inclusive, with no history or
        evidence of clinically relevant medical disorders as determined by the investigator in
        consultation with the Amgen physician;

        Exclusion Criteria:

        - History or evidence of clinically significant disorder (including psychiatric), condition
        or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to
        subject safety or interfere with the study evaluation, procedures, or completion;
A Study of Cabiralzumab Given by Itself or With Nivolumab in Advanced Cancer or Cancer That Has Spread
Condition: Advanced Malignancies
MeSH terms: Neoplasms
Intervention: Cabiralizumab; Nivolumab
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment will only in combination therapy arm.
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether an investigational immuno-therapy,
      cabiralizumab in combination with nivolumab, is safe and tolerable in the treatment of
      advanced malignancies.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Performance status 0-1

          -  Adequate organ function

          -  Cohort M1, 2 and C1: Measurable disease

          -  Cohort M1, M2 and C1: Subjects must have histologic or cytologic confirmation of an
             advanced (metastatic and/or unresectable) malignant solid tumor

          -  Cohort C2: Documented refractory or relapsed multiple myeloma

          -  Subjects must be refractory to or have relapsed after standard therapies, or have no
             known effective treatment

        Exclusion Criteria:

          -  Cohort M1, M2, and C1: Untreated or active central nervous system (CNS) or
             leptomeningeal metastases

          -  Cohort M1, M2, and C1: Subjects with hepatocellular carcinoma (HCC)

          -  Cohort C2: Subjects with solitary bone or extramedullary plasmacytoma as the only
             evidence of plasma cell dyscrasia

        Other protocol defined inclusion/exclusion criteria could apply
Assessment of the Effect of Empagliflozin (BI 10773) as Single Dose on the QT Interval in Healthy Female and Male Subjects
Condition: Healthy
Intervention: BI 10773 (low); Moxifloxacin; BI 10773 Placebo; BI 10773 (high)
Intervention description: single oral dose; single oral dose; 2 times single dose; single oral dose
Intervention MeSH terms: Empagliflozin; Moxifloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this study is to demonstrate that BI 10773 does not prolong the QT(c)
      interval more than placebo
    

Eligibility criteria:

        Inclusion criteria:

        healthy female and male subjects
ORAL T-6: Oral Androgens in Man-6
Condition: Contraception; Hypogonadism
MeSH terms: Hypogonadism
Intervention: Acyline; Testosterone; Finasteride
Intervention description: 300 mcg/kg; 24 hours after acyline administration on Day 2 "immediate release" Testosterone (T) 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.; 1 mg PO once daily [day -2 to day 12) 14 days total
Intervention MeSH terms: Methyltestosterone; Finasteride; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate; Acyline
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Male Contraception; Hypogonadism; Testosterone

Summary:

      We propose a study to determine the single-dose pharmacokinetics of these two novel
      formulations of testosterone in normal men with experimentally induced hypogonadism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  males between 18 to 50 years of age in good general health based on normal screening
             evaluation

          -  must agree not to participate in another research drug study during participation

          -  must agree to not donate blood during the study

          -  must be willing to comply with the study protocol and procedures

          -  must agree to use an acceptable form of contraception

          -  agrees to not take medications other than the study drugs for the duration of the
             study

        Exclusion Criteria:

          -  Subject in poor health, determined by medical history physical and lab results

          -  a known history or current use of alcohol, drug or steroid abuse and/or use of more
             than 3 alcohol beverages per day

          -  Participation in a long-term contraceptive study within the past two months

          -  History of bleeding disorders or current use of anti-coagulants

          -  History of sleep apnea and/or major psychiatric disorders
Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.
Condition: Healthy
Intervention: Rotigotine transdermal patch
Intervention description: Rotigotine 4.5mg/10cm^2 patch applied for 24 hours
Intervention MeSH terms: Rotigotine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rotigotine; Neupro®; Transdermal Patch

Summary:

      The major aim of this study is to investigate and compare the drug amount delivered to the
      body after sequential application of 2 rotigotine transdermal patches from 2 different
      manufacturing processes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy White, male volunteers between 18 and 55 years of age (inclusive).

          -  BMI between 19 and 28 kg/m² (inclusive).

        Exclusion Criteria:

          -  Previous participation in a clinical study with rotigotine

          -  History or current condition of epilepsy and/or seizures.

          -  Known clinically relevant allergy or known/suspected clinically relevant drug
             hypersensitivity.

          -  History of significant skin hypersensitivity to adhesives or other transdermal
             products or recently unresolved contact dermatitis.

          -  History or present condition of an atopic or eczematous dermatitis, psoriasis, and/or
             an active skin disease.

          -  Clinically relevant abnormality in physical examination, ECG, vital signs or safety
             laboratory examinations.

          -  Positive HIV, hepatitis B or C test or positive alcohol or drug test.

          -  Relevant hepatic or renal dysfunction

          -  Intake of medication that might interfere with the test drug within 2 weeks prior to
             dosing.

          -  Thickly hair-covered abdomen resulting in difficulties in finding appropriate patch
             application sites
MK-0941 Multiple Dose Study in Japanese Patients With Type 2 Diabetes (MK-0941-011).
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; MK-0941
Intervention description: Placebo tablets before every meal (q.a.c) Treatment period is 5 days.; MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The multiple dose study to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese Male or Female between 20 to 65 years of age

          -  Diagnosis of Type 2 Diabetes

          -  Patient being treated by diet and exercise alone

        Exclusion Criteria:

          -  Patient has a history of Type 1 Diabetes

          -  Patient is being treated with glaucoma medications

          -  Patient has donated blood or participated in another clinical study in the past 12
             weeks

          -  Patient is a regular user of any illicit drugs or has a history of drug, including
             alcohol, abuse
Florbetapir Calibration to the Centiloid Scale
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Florbetapir (18F); 11C-PiB
Intervention MeSH terms: Corticosterone
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission
      Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cognitively Normal Subjects

               -  Males or females ≥ 21 and ≤ 45 years of age

               -  Mini-mental state examination (MMSE) ≥ 29

          -  Clinically Diagnosed AD Subject

               -  Males or females ≥ 50 years of age

               -  Meet clinical criteria for dementia due to probable AD

               -  MMSE ≥ 16 and ≤ 26

          -  Possible AD Subject

               -  Males or females ≥ 50 years of age

               -  Meet clinical criteria for dementia due to possible AD

               -  MMSE ≥ 16 and ≤ 26

          -  MCI Subject

               -  Males or females ≥ 60 years of age with cognitive impairment (not dementia)

               -  MMSE >24 and <29

          -  At Risk Elderly Subject

               -  Cognitively normal males or females that are known ApoE4 carriers and ≥ 75 years
                  of age

               -  MMSE ≥ 27

        Exclusion Criteria:

          -  Have had or currently have a diagnosis of neurodegenerative disorders other than AD

          -  Have a current serious or unstable illness that could interfere with completion of the
             study

          -  Subject has a known brain lesion, pathology or traumatic brain injury

          -  Have received or participated in a trial with investigational medications in the past
             30 days

          -  Have had a radiopharmaceutical imaging or treatment procedure within 7 days of study
             imaging session

          -  Females of childbearing potential who are not surgically sterile, not refraining from
             sexual activity or not using reliable methods of contraception