bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED)
Condition: Primary Hypercholesterolemia; Mixed Hyperlipidemia
MeSH terms: Hyperlipidemia, Familial Combined; Hypercholesterolemia; Hyperlipidemias
Intervention: niacin (+) laropiprant; Comparator: aspirin; Comparator: clopidogrel; Comparator: laropiprant; Comparator: placebo
Intervention description: open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets; 81 mg oral tablet once daily for 7 days; 75 mg oral tablet once daily for 7 days; 40 mg oral tablet once daily for 7 days; placebo oral tablet once daily for 7 days
Intervention MeSH terms: Aspirin; Niacin; Clopidogrel
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a 3-period study. Periods 1 and 2 will evaluate the effects of multiple doses of
      laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in
      combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3
      will be open-label and will evaluate single dose pharmacokinetics of nicotinic acid and
      laropiprant components of Tredaptive.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has primary hypercholesterolemia or mixed dyslipidemia (high cholesterol)

          -  Participant is a non-smoker

        Exclusion Criteria:

          -  Participant has a history of chronic seizures

          -  Participant has a history of cancer

          -  Participant has a history of stomach or intestinal ulcers or any history of GI
             bleeding

          -  Participant has had major surgery, donated blood or participated in another
             investigational study in the past 4 weeks
Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Plitidepsin; Bortezomib; Dexamethasone
Intervention MeSH terms: Dexamethasone; Bortezomib
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: multiple myeloma; plitidepsin; APLIDIN

Summary:

      Study of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in
      Combination with Bortezomib and Dexamethasone in Patients with Relapsed and/or Refractory
      Multiple Myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years.

          -  Prior autologous transplantation (HSCT) patients are allowed.

          -  Patients must have received at least one previous treatment line of induction,
             chemotherapy, chemotherapy and transplantation or previous treatment with bortezomib
             or another proteasome drug

        Exclusion Criteria:

          -  Previous treatment with plitidepsin.

          -  Active or metastatic primary malignancy other than MM.

          -  Serious concomitant systemic disorders

          -  History of hypersensitivity reactions to bortezomib, polyoxyl 35 castor oil or
             mannitol

          -  Neuropathy

          -  Pregnant and/or lactating women

          -  HIV infection

          -  Active hepatitis B or C virus infection.

          -  Treatment with any Investigational Medicinal Product (IMP) in the 30 days before
             inclusion in the study

          -  Plasma cell leukemia at the time of study entry

          -  Contraindication for the use of steroids
Multiple Dose Study Of PF-05231023 In Obese Adult Subjects
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Placebo; 100 mg PF-05231023
Intervention description: 0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), twice a week for 4 weeks.; 100 mg IV infusion twice a week for 4 weeks
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: T2DM; obesity; safety; multiple dose; intravenous

Summary:

      This is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and
      pharmacodynamics of multiple doses of PF-05231023.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects of non-childbearing potential between the ages of 21 and 70.

          -  Subjects with a BMI of 30 to 45.4 kg/m2 and total body weight >110 lbs.

        Exclusion Criteria:

          -  Recent (6 months) unstable concurrent disease.

          -  History of allergic disease or drug allergies.

          -  Any condition affecting food consumption or absorption.
Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: empagliflozin medium dose; empagliflozin high dose; empagliflozin low dose
Intervention MeSH terms: Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the
      safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18
      years with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion criteria:

          -  Children and adolescents with type 2 diabetes mellitus

          -  Insufficient glycaemic control (HbA1c <=10.5%) despite diet and exercise and/or
             metformin and/or stable basal or MDI insulin

          -  Negative for Islet Cell Antigen and Glutamic Acid Decarboxylase autoantibodies and
             fasting C-peptide levels >= 0.85 ng/ml

          -  BMI > 50th percentile for age and sex

        Exclusion criteria:

          -  Uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (> 13.3 mmol/l)

          -  History of acute metabolic decompensation such as diabetic ketoacidosis within 3
             months before the screening visit with the exception of acute de-compensation at the
             time of type 2 diabetes diagnosis

          -  Treatment with weight reduction medications within 4 weeks before randomisation
A Study of LY2835219 in Healthy Participants
Condition: Healthy Volunteers
Intervention: LY2835219
Intervention description: Administered orally.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days
      apart. One dose will be given with a standard meal, one dose with a high-fat meal and one
      dose without food. The study will evaluate the effects of the standard and high-fat meals on
      how much drug gets into the bloodstream. Side effects will be documented. This study is
      approximately 43 days, not including screening. Screening is required within 28 days prior to
      the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy sterile males or surgically sterile or postmenopausal females

          -  Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2),
             inclusive, at screening

          -  Are able to eat a high-fat, high-calorie meal

        Exclusion Criteria:

          -  Participated in a clinical trial involving investigational product within 30 days

          -  Abnormal blood pressure

          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
             investigator, increases the risks associated with participating in the study

          -  Have donated blood of more than 500 milliliter (mL) within the last month

          -  Show evidence of human immunodeficiency virus, hepatitis B or hepatitis C
A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: PRM-151; Placebo
Intervention description: Intravenous PRM-151 administered over 30 minutes on study days 1, 3, 5, 8, and 15 at doses of 1.0, 5.0, or 10.0 mg/kg.; Intravenous 0.9% normal saline administered over 30 minutes on study days 1, 3, 5, 8, and 15.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: pulmonary, fibrosis

Summary:

      The aims of the study are to assess safety, tolerability, the pharmacokinetic profile, and
      the pharmacodynamic profile of multiple doses of PRM-151 administered IV to IPF patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women of non-childbearing potential aged 40 to 80 years at screening.

          -  Diagnosis of idiopathic pulmonary fibrosis (IPF) as determined by high resolution
             computerized tomography (HRCT) and pulmonary function tests.

        Exclusion Criteria:

          -  History or presence of connective tissue disorder, tuberculosis (TB), cystic fibrosis,
             sarcoidosis, amyloidosis or other pulmonary disease except idiopathic pulmonary
             fibrosis (IPF).

          -  History or presence of chronic pulmonary obstructive disease, severe pulmonary
             hypertension, drug-induced pulmonary toxicity, other forms of idiopathic pneumonia, or
             interstitial lung diseases associated with environmental exposure medication or
             systemic disease.

          -  High resolution computerized tomography (HRCT) findings inconsistent with idiopathic
             pulmonary fibrosis(IPF).
A Single Dose Study of MK-8266 (MK-8266-001)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: MK-8266 0.1 mg; MK-8266 1.0 mg; Placebo
Intervention description: Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form. Participants will fast for 8 hours prior to dosing. There will be at least a 7- day washout period between doses for any given participant. Some participants will receive study drug with food.; MK-8266 1.0 mg oral capsule. Participants will fast for 8 hours prior to dosing. There will be at least a 7- day washout period between doses for any given participant.; Placebo to match MK-8266 0.1 or 1.0 mg. Participants will fast for 8 hours prior to dosing. There will be at least a 7- day washout period between doses for any given participant.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A three panel study, to determine if MK-8266 given as a single dose is sufficiently safe and
      well tolerated. Panel A and B will consist of healthy young males and Panel C will consist of
      subjects with mild to moderate hypertension. The primary hypotheses for the study are that
      MK-8266 given as single doses is sufficiently safe and well tolerated to permit continued
      clinical investigation in healthy young male volunteers and male participants with
      mild-to-moderate hypertension and that in males with mild to moderate hypertension, at a
      single oral dose of MK-8266 that is sufficiently safe and well-tolerated, postdose mean
      time-weighted average across 24 hours of aortic augmentation index (TWA0-12hrs AIx) is
      reduced compared to placebo. A mean decrease of ≥ 5 percentage points is considered
      clinically meaningful.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For Panel A and B Participant is a healthy male between 18 to 45 years of age. For
             Panel C Participant is a male with essential hypertension between 18 to 55 years of
             age

          -  A non-smoker

        Exclusion Criteria:

          -  Has a history of stroke, chronic seizure or major neurological disorder

          -  Has a disability that can interfere with rising from a sitting position to the
             standing position

          -  Has a personal of family history of bleeding or clotting disorders

          -  Has a history of cancer

          -  Is unable to refrain from or anticipates the use of any prescription or
             nonprescription drug during the study

          -  Consumes excessive amounts of caffeine or alcohol

          -  Has had major surgery, donated blood or participated in another investigational study
             in the past 4 weeks
BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: vemurafenib
Intervention description: Cohort 1 (participants >=45 kg): starting dose level 720mg; next dose level 960 mg Cohort 2 (participants <45 kg): starting dose 480 mg
Intervention MeSH terms: Vemurafenib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail
      extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy
      of vemurafenib (RO5185426) in pediatric participants (aged 12 through 17) with newly
      diagnosed or recurrent surgically incurable and unresectable Stage IIIC or Stage IV melanoma
      harboring BRAFV600 mutations. Participants will receive vemurafenib orally twice daily until
      disease progression or unacceptable toxicity occurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric participants, 12 to 17 years of age inclusive

          -  Histologically confirmed surgically incurable and unresectable Stage IIIC or Stage IV
             (AJCC) melanoma

          -  Positive proto-oncogene B-Raf (BRAF) mutation result (Cobas 4800 BRAF V600 Mutation
             Test)

          -  Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
             criteria

          -  Performance status: Karnofsky (for participants >/= 16 years of age) or Lansky (for
             participants < 16 years of age) score of >/= 60

          -  Adequate bone marrow, liver and renal function

          -  Participants must have fully recovered from the acute toxic effects of all prior
             therapy prior to first administration of study drug

        Exclusion Criteria:

          -  Active or untreated central nervous system (CNS) lesions

          -  History of or known spinal cord compression or carcinomatous meningitis

          -  Anticipated or ongoing administration of anti-cancer therapies other than those
             administered in this study

          -  Previous malignancy within the past 5 years except for basal or squamous cell
             carcinoma of the skin, melanoma in-situ, and carcinoma in-situ of the cervix

          -  Previous treatment with selective/specific BRAF or Methyl Ethyl Ketone (MEK) inhibitor
             (previous treatment with sorafenib is allowed)

          -  Any previous treatment with study drug (RO5185426) or participation in a clinical
             trial that includes RO5185426

          -  Pregnant or lactating females

          -  Known human immunodeficiency virus (HIV) positivity or acquired immune deficiency
             syndrome (AIDS)-related illness, active hepatitis B virus, or active hepatitis C virus
A Drug-Drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants
Condition: Healthy
Intervention: Lanabecestat; Simvastatin; Midazolam; Midazolam; Donepezil; Lanabecestat
Intervention description: 50 mg lanabecestat will be administered orally as 1 × 50-mg tablet; 20 mg simvastatin will be administered orally as 1 × 20-mg tablet; 500 mcg midazolam will be administered orally as 0.25 mL of 2-mg/mL syrup; 250 mcg midazolam will be administered intravenous (IV) as 0.25 mL of 1-mg/mL injection solution; 5 mg donepezil will be administered orally as 1 × 5-mg tablet; 50 mg lanabecestat will be administered orally as 1 × 50-mg tablet
Intervention MeSH terms: Midazolam; Donepezil; Simvastatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to study the effect of lanabecestat on how the body absorbs and
      processes 3 other medications, midazolam, simvastatin and donepezil and how these 3
      medications affect lanabecestat when they are taken together. This study is in 2 cohorts,
      Cohort A is approximately 44 days long and Cohort B about 70 days only. The screening visit
      is required within 30 days prior to the start on the study
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy and either sterile or, male and prepared to use an approved method of
             contraception

          -  Have a body mass index (BMI) at screening of 19.0 to 32.0 kilogram per square meter
             (kg/m^2)

        Exclusion Criteria:

          -  History of any clinically significant disease or disorder which, in the opinion of the
             Investigator, may put the subject at risk because of participation in the study, may
             influence the results, or may limit the subject's ability to participate in the study

          -  History or presence of gastrointestinal, hepatic or renal disease or any other
             condition known to interfere with absorption, distribution, metabolism or excretion of
             drugs

          -  History of previous or ongoing psychiatric disease/condition
Study to Evaluate the Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers
Condition: Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer
Intervention: KITE-439; Cyclophosphamide; Fludarabine; Interleukin-2
Intervention description: A single infusion of E7 TCR T cells (KITE-439).; Administered intravenously.; Administered intravenously.; Administered subcutaneously.
Intervention MeSH terms: Cyclophosphamide; Fludarabine; Interleukin-2
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study has 2 parts: Phase 1A and Phase 1B. The primary objectives of Phase 1A are to
      evaluate the safety of KITE-439 and to determine a recommended Phase 1B dose. The primary
      objective of Phase 1B is to estimate the efficacy of KITE-439 in adults who are human
      leukocyte antigen (HLA)-A*02:01+ and have relapsed/refractory human papillomavirus (HPV)16+
      cancers.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Advanced cancer defined as relapsed or refractory disease after at least 1 line of
             therapy that included systemic chemotherapy and that is not amenable to definitive
             locoregional therapy

          -  HPV16+ tumor as confirmed by the central laboratory

          -  HLA type is HLA-A*02:01+ per local assessment

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

        Key Exclusion Criteria:

          -  Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for
             management

               -  Note: Simple urinary tract infection (UTI) and uncomplicated bacterial
                  pharyngitis are permitted if responding to active treatment and after
                  consultation with the Kite medical monitor

          -  Primary immunodeficiency

          -  History of autoimmune disease (eg, Crohns, rheumatoid arthritis, systemic lupus)
             resulting in end organ injury or requiring systemic immunosuppression/systemic disease
             modifying agents within the last 2 years prior to enrollment

          -  Known history of infection with human immunodeficiency virus (HIV), hepatitis B (HBsAg
             positive), or hepatitis C (anti-HCV positive). A history of treated hepatitis B or
             hepatitis C is permitted if the viral load is undetectable per quantitative polymerase
             chain reaction (qPCR) and/or nucleic acid testing

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.