bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY2484595 on the Electrical Activity of the Heart
Condition: Healthy Volunteers
Intervention: LY2484595; Placebo; Moxifloxacin
Intervention description: Administered orally once daily for 10 days.; Administered orally once daily for 10 days.; Single dose administered orally.
Intervention MeSH terms: Moxifloxacin; Evacetrapib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the effect on the electrical activity of the heart
      as measured by an electrocardiogram (ECG) after dosing with 10 days of LY2484595 compared to
      10 days of placebo in relation to a single dose of moxifloxacin. Information about any side
      effects that occur will also be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males and females

          -  Body mass index (BMI) of 18.5 to 29 kilograms per square meter (kg/m²)

          -  Reliable and willing to be available for the duration of the study and are willing to
             follow study procedures

          -  Provided written informed consent

        Exclusion Criteria:

          -  Known allergies to LY2484595 or moxifloxacin

          -  Personal or family history of long QT syndrome, heart failure, or low blood potassium
             (hypokalemia) a family history of sudden death, or unexplained syncope within the last
             year

          -  Positive findings on urinary drug screening

          -  Cigarette smokers
Effect of Delivery Route on PK of Sufentanil NanoTab
Condition: Pharmacokinetics
Intervention: Treatment A: Sufentanil IV; Treatment B: Sufentanil NanoTab Sublingual; Treatment C: Sufentanil NanoTab Buccal; Treatment D: Sufentanil NanoTab Oral
Intervention description: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV); Single Sufentanil NanoTab 15 mcg given sublingually (SL); Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU); Single Sufentanil NanoTab 15 mcg swallowed (PO)
Intervention MeSH terms: Sufentanil; Dsuvia
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pharmacokinetics; area under curve; time to maximum concentration

Summary:

      Determine whether the amount of drug absorbed is different if the tablet is placed under the
      tongue, placed between the cheek and gum, or swallowed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  body mass index 18 - 30

        Exclusion Criteria:

          -  pregnant females

          -  smokers

          -  pulmonary disease

          -  sleep apnea
Co-Administration of MK-4618 With Antihypertensive Agents (MK-4618-010)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: MK-4618; Placebo for MK-4618; Metoprolol; Amlodipine
Intervention description: Once daily oral dose of MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7; Once daily oral dose of placebo for MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7; Previously prescribed daily dose of open-label metoprolol for the duration of the study; Previously prescribed daily dose of open-label amlodipine for the duration of the study
Intervention MeSH terms: Metoprolol; Amlodipine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and tolerability of MK-4618 when coadministered with
      antihypertensive agents and will evaluate changes in blood pressure following
      co-administration of MK-4618 with a beta blocker and a vasodilator. The primary hypothesis of
      the study is that MK-4618 does not result in a clinically meaningful change in systolic blood
      pressure relative to placebo when co-administered with a beta-blocker or with amlodipine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female not of childbearing potential

          -  Not a nursing mother

          -  Must be on stable dose of a beta blocker (Panel A only) or amlodipine (Panel B only)
             for the treatment of hypertension for at least 6 weeks prior to enrollment. Must take
             the designated daily dose of metoprolol or amlodipine for the duration of the study

          -  In good health other than hypertension

          -  Nonsmoker

          -  Participant has a resting systolic blood pressure <150 and >95 mmHg and a diastolic
             blood pressure <95 and >75 mmHg at prestudy clinical evaluation

        Exclusion Criteria:

          -  Any illness that might confound the results of the study or pose a risk by
             participation

          -  History of orthostatic hypotension (decrease in blood pressure upon standing
             accompanied by symptoms of lightheadedness or dizziness)

          -  History of cancer, excepting certain skin or cervical cancers or cancers that were
             treated successfully 10 or more years prior to screening

          -  Condition for which there is a warning, contraindication, or precaution against the
             use of extended release metoprolol (Panel A) or amlodipine (Panel B)

          -  Consumes excessive amounts of alcohol or caffeine daily

          -  Has multiple and/or severe allergies (including latex allergy) or has had an
             anaphylactic reaction or significant intolerance to drugs or food

          -  Uses illicit drugs or has a history of drug abuse
A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants
Condition: Healthy Volunteers
Intervention: TAK-831 T2; TAK-831 T3
Intervention description: TAK-831 T2 Tablets.; TAK-831 T3 Tablets.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to assess the oral BA of TAK-831 T3 tablet formulation relative
      to TAK-831 T2 tablet formulation under fasting conditions and to assess the effect of food on
      the pharmacokinetics (PK) of TAK-831 T3 tablet formulation.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Body mass index (BMI) greater than or equal to (>=) 18.0 and less than (<) 30.0 kilogram
        per square meter (kg/m^2), at Screening.

        Exclusion Criteria:

          1. History or presence of alcoholism or drug abuse within the past 2 years prior to the
             first dosing.

          2. Smokes more than 20 cigarettes or equivalent per day within 3 months prior to the
             first dose and is unwilling to discontinue use of any tobacco- or nicotine-containing
             products during the confinement period(s) of the study.

          3. Has been on a diet incompatible with the on-study diet, in the opinion of the
             Investigator or designee, within the 30 days prior to the first dosing and throughout
             the study.

          4. Is lactose intolerant or unable/unwilling to eat the high-fat breakfast.

          5. Donation of blood or significant blood loss within 56 days prior to the first dosing.
Taste Assessment Study of SHP429 in Healthy Adult Subjects
Condition: Healthy
Intervention: Mesalamine
Intervention MeSH terms: Mesalamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the palatability of SHP429 capsule contents delivered
      via 3 means of administration (sprinkled on yogurt, sprinkled on applesauce, and emptied into
      a cup and administered with water).
    

Eligibility criteria:

        Inclusion Criteria:

          -  normal, healthy, adult male and female volunteers, without evidence of active or
             chronic disease
A Study of Pertuzumab With Erlotinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib; Pertuzumab
Intervention description: Erlotinib will be administered as oral tablets.; Pertuzumab will be administered as intravenous (IV) infusion.
Intervention MeSH terms: Erlotinib Hydrochloride; Pertuzumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Squamous

Summary:

      This study will assess the safety and tolerability, and make a preliminary assessment of
      activity, of a combination of pertuzumab and erlotinib in patients with locally advanced or
      metastatic non-small cell lung cancer (NSCLC) who have failed on at least one prior
      chemotherapy regimen. The anticipated time on study treatment is until disease progression or
      unacceptable toxicity, and the target sample size is less than 100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients greater than or equal to 18 years of age

          -  Histological confirmation of non-small cell lung cancer (NSCLC)

          -  Locally advanced or metastatic disease

          -  Failure of at least one prior regimen of standard chemotherapy for locally advanced or
             metastatic disease

          -  Life expectancy of more than or equal to 12 weeks

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

          -  Baseline Left Ventricular Ejection Fraction (LVEF) of greater than or equal to 50%

          -  A negative pregnancy test one week prior to treatment and willingness to use
             contraception among women of childbearing potential

          -  Availability of histological Formalin-Fixed, Paraffin-Embedded (FFPE) tumor tissue

        Exclusion Criteria:

          -  Prior chemotherapy, radiotherapy or immunotherapy within 4 weeks of study Day -8

          -  Prior treatment with any agent which targets growth factors or their receptors

          -  Patients who have not recovered from the acute reversible effects of chemotherapy and
             radiotherapy

          -  History of clinically significant cardiovascular disease

          -  History or evidence of central nervous system metastases

          -  Treatment with any investigational drug within 28 days of the start of the study (day
             -8)

          -  Prior cumulative doxorubicin dose of more than 360 mg/m2 or the equivalent
Trial of Safety and Tolerability of Oral Verdinexor (KPT-335) in Healthy Adults
Condition: Healthy
Intervention: Verdinexor; Placebo
Intervention description: Participants received verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral; Participants received placebo matched to verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: KPT-335; Verdinexor; Karyopharm; First-in-Human; Adult Subjects

Summary:

      This is a randomized, double-blind, sequential, dose-escalation, Phase 1 trial to evaluate
      the safety and tolerability of verdinexor. Verdinexor or placebo will be given on Days 1 and
      3 to healthy adult participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be in good health as determined by the investigator, based on the
             medical history, ECG, physical examination, and safety laboratory tests at screening.

          -  Participants must be identified as a non-smoker at the screening visit (a non-smoker
             is defined as an individual who has abstained from smoking for at least 1 year prior
             to the screening visit and who has a ≤ 15 pack year history of lifetime cigarette
             use). A urine cotinine test will be performed at screening and at the time of clinic
             check-in prior to study drug treatment.

        Exclusion Criteria:

          -  The participant has any surgical or medical condition that potentially may alter the
             absorption, metabolism, or excretion of the study drug such as gastrectomy, Crohn's
             disease, or liver disease.

          -  The participant has a history of clinically significant allergies. Hay fever is
             allowed unless it is active or has required treatment within the previous 2 months.

          -  Presence of a chronic condition(s) with clinical or historical evidence of recent
             exacerbation, or other information to suggest non-control of such condition(s).

          -  History of alcohol abuse or drug addiction within 12 months of the screening visit.

          -  Any participant with active cataracts or medical history of cataracts.
Taste and Palatability of Orfadin Suspension
Condition: Hereditary Tyrosinemia, Type I
MeSH terms: Tyrosinemias
Intervention: Nitisinone
Intervention description: Oral suspension
Intervention MeSH terms: Nitisinone
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: 1 Month
Maximum age: 17 Years
Healthy volunteers: No
Keywords: nitisinone; Orfadin; suspension; taste; acceptability

Summary:

      The purpose of this study is to verify that pediatric patients, especially those who are not
      old enough to swallow capsules, accept the taste and palatability of a new suspension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with HT-1 currently managed on Orfadin (nitisinone) capsules.

          -  Age from 1 month to less than 18 years.

          -  Signed informed consent.

        Exclusion Criteria:

          -  Any medical condition which in the opinion of the investigator makes the subject
             unsuitable for inclusion.

          -  Enrollment in another concurrent clinical study, or intake of an investigational
             medicinal product (IMP), within one month prior to inclusion in this study.

          -  Foreseeable inability to cooperate with given instructions or study procedures.
Phase I Biomarker Study (BMS-936558)
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: BMS-936558 (Anti-PD-1); BMS-936558 (Anti-PD-1); BMS-936558 (Anti-PD-1)
Intervention description: Solution, Intravenous infusion, 0.3 mg/kg, Every 3 weeks, Indefinitely depending on response; Solution, Intravenous infusion, 2 mg/kg, Every 3 weeks, Indefinitely depending on response; Solution, Intravenous infusion, 10 mg/kg, Every 3 weeks, Indefinitely depending on response
Intervention MeSH terms: Nivolumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the pharmacodynamic and biologic properties of
      BMS-936558 in subjects with metastatic renal cell carcinoma.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Women and men ≥ 18 years of age.

          -  Histologic confirmation of renal cell carcinoma with a clear cell component.

          -  Measurable disease as defined by Response Evaluation Criteria in Solid Tumors
             (RECIST).

          -  Tumor sites that can be accessed for repeat biopsies at acceptable clinical risk.

          -  Previously treated subjects must have failed at least 1 prior anti-angiogenic agent
             and can have a maximum of 3 prior systemic treatments for renal cell cancer.

          -  Subjects in the treatment naive arm cannot have received prior systemic therapy for
             their renal cell carcinoma.

        Exclusion Criteria:

          -  Active or progressing brain metastases.

          -  Active concomitant.

          -  Active or history of autoimmune disease.

          -  Active use of systemic corticosteroids.

          -  Prior therapy with Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4), anti
             Programmed death-1 (anti-PD1), anti Programmed death ligand 1 (anti-PD-L1), anti
             Programmed death ligand 2 (anti-PD-L2), anti-CD137, anti-CD40, anti-OX40 antibodies.
Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium
Condition: Sinusitis
MeSH terms: Sinusitis
Intervention: SinuSys Dilation System
Intervention description: Sinuplasty
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess safety and performance of the SinuSys Dilation System
      for dilation of the maxillary sinus ostium.
    

Eligibility criteria:

        Inclusion Criteria:

        -Diagnosis of chronic maxillary sinusitis

        Exclusion Criteria:

          -  Previous antrostomy

          -  Sinonasal tumours

          -  Cystic fibrosis

          -  History of facial trauma that distorts sinus anatomy and precludes access to the
             maxillary sinus

          -  Pregnant or breastfeeding females

          -  Currently participating in another drug or device study
A Study of LY3143753 and LY3185643 in Healthy Participants
Condition: Healthy
Intervention: LY3143753 (Part A); LY3185643 (Part B); Placebo (Part A and Part B); rGlucagon (Part B)
Intervention description: Administered via SC injection; Administered via SC injection; Administered via SC injection; Administered via SC injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study involves a single dose of LY3143753 or LY3185643, given as an injection into the
      abdomen. The study will evaluate the effects of the LY3143753 or LY3185643 on your body. The
      study is approximately 12 weeks for each participant, not including screening. Screening is
      required within 28 days prior to the start of the study. This study involves Part A
      (LY3143753) and Part B (LY3185643). Participants may only enroll in one part and at one dose
      level.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy males or females

          -  Are reliable and willing to make themselves available for the duration of the study
             and are willing to follow study procedures

        Exclusion Criteria:

          -  Are investigator site personnel directly affiliated with this study and their
             immediate families

          -  Are currently enrolled in a clinical trial involving an investigational product (IP)
             or off-label use of a drug or device

          -  Have participated, within the last 3 months, in a clinical trial

          -  Have known or ongoing psychiatric disorders

          -  Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
             HIV antibodies

          -  Show evidence of hepatitis C and/or positive hepatitis C antibody

          -  Show evidence of hepatitis B and/or positive hepatitis B surface antigen

          -  History of/current phaeochromocytoma

          -  History of/current insulinoma
Dose Escalation Study of Nintedanib (BIBF 1120) in Japanese Patients With Hepatocellular Carcinoma
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Nintedanib high dose; Nintedanib low dose; Nintedanib medium dose; Nintedanib medium dose; Nintedanib high dose
Intervention description: twice daily oral dosing; twice daily oral dosing; twice daily oral dosing; twice daily oral dosing; twice daily oral dosing
Intervention MeSH terms: Nintedanib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The aim of the study is to investigate the safety, tolerability, efficacy and
      pharmacokinetics (PK) for Japanese hepatocellular carcinoma which are not amenable to
      curative surgery or loco regional therapy
    

Eligibility criteria:

        Inclusion criteria:

          1. Histologically/cytologically confirmed hepatocellular carcinoma not amenable to
             curative surgery or loco-regional therapy

          2. Age 20 years or older

          3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1

          4. Child-Pugh score of 7 or less

          5. Life expectancy more than 3 months

          6. Time interval from last loco-regional therapy more than 4 weeks

          7. Written informed consent in accordance with good clinical practice (GCP)

        Exclusion criteria:

          1. More than one line of prior systemic therapy for metastatic/unresectable
             hepatocellular carcinoma (HCC)

          2. Fibrolamellar HCC

          3. Uncontrolled or refractory ascites

          4. Inadequate organ function

          5. Variceal bleeding within 6 months or the presence of inappropriate varices

          6. History of major thrombotic (except portal vein thrombosis) or clinically relevant
             major bleeding event in the past 6 months

          7. Major surgery within 4 weeks

          8. Known inherited predisposition to bleeding or thrombosis

          9. Significant cardiovascular diseases