bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Evacetrapib (LY2484595) in Participants With Severe Renal Impairment and in Healthy Participants
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: Evacetrapib
Intervention MeSH terms: Evacetrapib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to measure how much of the study drug, evacetrapib, enters the
      blood stream and how long it takes the body to dispose of the study drug when given to
      participants with severe renal (kidney) impairment compared to participants with normal renal
      (kidney) function. This study will last approximately 8 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants are not of child-bearing potential

          -  Have a body mass index of 18 to 40 kilograms per square meter (kg/m^2)

          -  Participants with normal renal function - healthy as determined by medical history,
             physical examination, and other screening procedures, with normal renal function
             (assessed by estimated creatinine clearance [CLcr] greater than or equal to 90
             milliliters per minute [mL/min] at screening)

          -  Participants with severe renal impairment - estimated CLcr less than 30 mL/min at
             screening and are not undergoing hemodialysis

        Exclusion Criteria:

          -  Have a history or presence of 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 study medication; or of interfering with the
             interpretation of data

          -  Participants who are unwilling to comply with the dietary requirements/restrictions
             during the study

          -  Hemoglobin less than 9 grams/deciliter (g/dL) or significant active hematological
             disease from causes other than underlying renal disease
A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets
Condition: Healthy Participants
Intervention: Sotorasib
Intervention description: Oral Tablet
Intervention MeSH terms: Sotorasib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 146.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sotorasib; AMG 510

Summary:

      The primary objective of the study is to compare the pharmacokinetics (PK) of sotorasib
      administered orally as 1 tablet under fasted conditions to sotorasib administered orally as 2
      tablets under fasted conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male participants or female participants, between 18 and 60 years of age
             (inclusive), at the time of Screening.

          -  Body mass index, between 18 and 30 kg/m^2 (inclusive), at the time of Screening.

          -  Females of nonchildbearing potential.

        Exclusion Criteria:

          -  Inability to swallow oral medication or history of malabsorption syndrome.

          -  History of hypersensitivity, intolerance, or allergy to any drug compound, food, or
             other substance, unless approved by the Investigator (or designee) and in consultation
             with the Sponsor.

          -  Poor peripheral venous access.

          -  History or evidence, at Screening or Check in, of clinically significant disorder,
             condition, or disease, including history of myolysis, not otherwise excluded that, in
             the opinion of the Investigator (or designee), would pose a risk to participants
             safety or interfere with the study evaluation, procedures, or completion.
A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions
Condition: Healthy
Intervention: sertraline hydrochloride; sertraline hydrochloride
Intervention description: 50 mg capsule, single-dose; 50 mg tablet, single-dose
Intervention MeSH terms: Sertraline
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: bioequivalence study; sertraline 50 mg; capsules vs tablets

Summary:

      This study is designed to determine differences in drug exposure in subjects after being
      administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after
      administering 50 mg capsules of sertraline hydrochloride under fasted (nonfed) conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive
             (Healthy is defined as no clinically relevant abnormalities identified by a detailed
             medical history, full physical examination, including blood pressure and pulse rate
             measurement, 12-lead ECG and clinical laboratory tests).

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 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 untreated, asymptomatic,
             seasonal allergies at time of dosing).

          -  Any condition possibly affecting drug absorption (eg, gastrectomy)
A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: oseltamivir [Tamiflu]
Intervention description: 5-day course (10 doses), intravenous administration, may be switched to oral administration at the discretion of the investigator; up to 5 additional days of treatment possible.
Intervention MeSH terms: Oseltamivir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 1 Year
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of
      intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2
      years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10
      doses). For patients whose conditions no longer merit continued iv dosing, therapy may be
      switched to oral Tamiflu to complete their prescribed course of treatment. If medically
      necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days.
      Anticipated time on study treatment is 5 to 10 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  children, 1-12 years of age

          -  diagnosis of influenza

          -  duration of influenza symptoms </=96 hours prior to first dose of study drug

        Exclusion Criteria:

          -  evidence of severe hepatic decompensation

          -  patients taking probenecid within 1 week prior to first dose of study drug
Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: losartan potassium (+) hydrochlorothiazide (HCTZ); losartan potassium; hydrochlorothiazide (HCTZ)
Intervention description: Single dose losartan 100 mg/HCTZ 12.5 mg combination tablet in one of two treatment periods.; Single dose losartan 100 mg tablet in one of two treatment periods.; Single dose HCTZ 12.5 mg capsule in one of two treatment periods.
Intervention MeSH terms: Losartan; Hydrochlorothiazide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ)
      combination tablet and coadministration of losartan and hydrochlorothiazide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a healthy male or female between the ages of 18 and 45 years of age

          -  Subject does not smoke

        Exclusion Criteria:

          -  Subject has a history of any illness that might pose additional risk to participation
             or confound the results of the study

          -  Subject has a history of hepatitis B or C or significant drug allergies
Phase I Study of OPB-51602 in Patients With Hematologic Malignancies
Condition: Multiple Myeloma; Non-Hodgkin Lymphoma; Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Multiple Myeloma; Leukemia, Myeloid, Acute; Lymphoma, Non-Hodgkin; Hematologic Neoplasms; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Intervention: OPB-51602
Intervention description: once daily during the treatment period
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: multiple myeloma [MM]; non-Hodgkin lymphoma [NHL]; acute myeloid leukemia [AML]; acute lymphoid leukemia [ALL]; chronic myeloid leukemia [CML]

Summary:

      To determine the maximum tolerated dose (MTD) of OPB-51602
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with a confirmed diagnosis of MM, NHL, AML, ALL or CML.

          2. Patients who are responsive or have relapsed following standard treatment

          3. Patients capable of providing written informed consent

          4. Japanese patients age 20 to 75 years (inclusive) at time of informed consent

          5. ECOG performance status score of 0-1

          6. Life expectancy of at least 3 months

          7. Adequate vital organ function

          8. Patients who, together with their partner, are willing and capable of using an
             appropriate method of contraception throughout the trial period and until at least 12
             weeks after final IMP administration

        Exclusion Criteria:

          1. Patients with other primary malignant tumors

          2. Symptomatic CNS involvement

          3. Ongoing or active infection, or complication that is not controllable by medication or
             other means

          4. Complication of uncontrolled cardiac disease

          5. Female patients who are pregnant, possibly pregnant, or lactating, or who wish to
             become pregnant during the study period

          6. Patients who have received another study drug, or who have received chemotherapy,
             immunotherapy, cytokine therapy, surgery, or radiotherapy for treatment of the primary
             disease, within 4 weeks prior to enrollment
Phase I Study of Dalotuzumab (MK-0646) in Combination With Cetuximab and Irinotecan in Participants With Colorectal Cancer (MK-0646-016)
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Dalotuzumab 10 mg/kg; Cetuximab; Irinotecan; Dalotuzumab 15/7.5 mg/kg
Intervention description: Dalotuzumab at 10 mg/kg was intravenously administered once weekly; Following pre-treatment with a histamine-receptor antagonist, Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2, followed by subsequent once weekly intravenous infusions of 250 mg/m^2; Irinotecan was administered with an intravenous infusion of 150 mg/m^2, once every other week for 42 days; Dalotuzumab was intravenously administered, with the first infusion of 15 mg/kg, followed by subsequent infusions of 7.5 mg/kg
Intervention MeSH terms: Irinotecan; Cetuximab; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purposes of this study were to assess the safety, tolerability, pharmacokinetic
      interactions, and the Human Anti-Human Antibody of dalotuzumab in combination with cetuximab
      and irinotecan in participants with advanced or metastatic colorectal cancer in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is 20 years of Age or older

          -  Has a histologically or cytologically confirmed colorectal cancer

          -  Has previously failed both Irinotecan and Oxaliplatin containing regimens and should
             have progressed on or within 3 months of completing their last line of therapy with
             objective radiological evidence of progression as verified by previous radiologic
             scans

          -  Must have adequate organ function

        Exclusion Criteria:

          -  Has had chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to
             initial dosing on this study or whose toxicities from agents administrated 4 weeks
             earlier have not resolved to at least grade 1 or baseline

          -  Has experienced intolerable toxicity to Irinotecan therapy

          -  Has prior exposure to insulin-like growth factor 1 receptor (IGF-1R) inhibitors or
             epidermal growth factor receptor (EGFR) inhibitors (e.g. Cetuximab)

          -  Is concurrently using growth hormone (GH), Or GH inhibitors
A Study of Different Particle Sizes of Evacetrapib in Healthy Participants
Condition: Healthy
Intervention: Evacetrapib
Intervention description: administered orally
Intervention MeSH terms: Evacetrapib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine if there is any difference in the way the body
      handles 3 types of evacetrapib tablets with different particle sizes. Information about any
      side effects will also be collected. This study will consist of 3 study periods. Participants
      will be dosed 3 times during the entire study. Each study period will consist of an inpatient
      stay for 3 days - the day before dosing (Day -1), dosing day (Day 1) and the day after dosing
      (Day 2). Then participants will be asked to return to the clinical research unit (CRU) daily
      for outpatient appointments up to Day 8. The overall length of this study is about 7 weeks
      from first dose to end of study. Screening will take place within 28 days prior to the first
      dose of evacetrapib and follow-up will take place 21 days after the last dose of evacetrapib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy participants of non-child bearing potential

          -  Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)

          -  Must be willing to make oneself available for the whole study and be willing to follow
             study procedures

        Exclusion Criteria:

          -  Have known allergies to evacetrapib, compounds or components related to this drug, or
             have a history of significant allergic reactions of another origin.
Exposure Therapy for Veterans With PTSD and Panic Attacks (Phase 1)
Condition: PTSD; Panic Attacks
MeSH terms: Panic Disorder
Intervention: Multiple Channel Exposure Therapy- Veterans
Intervention description: Individual therapy design completed over a 12-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      To evaluate the feasibility, acceptability and effectiveness of Multiple Channel Exposure
      Therapy-Veterans (MCET-V) as a treatment for returning service members with comorbid
      posttraumatic stress disorder (PTSD) and panic disorder (PD) in two phases. The first phase
      of the study will examine the feasibility and acceptability of MCET-V.
    

Eligibility criteria:

        Inclusion Criteria:

          -  being a veteran of any era;

          -  being enrolled in the Trauma Recovery Program (TRP) at the Michael E. DeBakey Veterans
             Affairs Medical Center (MEDVAMC), with a current diagnosis of PTSD and PD;

          -  being stable on psychotropic medication for 4 weeks before study participation; and

          -  being at least 18 years of age.

        Exclusion Criteria:

          -  active substance dependence, or bipolar or psychotic disorders;

          -  severe depression and active suicidal ideation and intent (based on Structured
             Clinical Interview for DSM-IV disorders [SCID-IV] & Beck Depression Inventory-2nd
             edition [BDI-II]);

          -  cognitive impairment as indicated by the St. Louis University Mental Status exam
             (SLUMS); and

          -  veterans currently receiving psychosocial treatment specifically targeting PTSD or
             panic symptoms.
Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment
Condition: Hepatitis C
MeSH terms: Hepatitis C
Intervention: Daclatasvir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the effect of renal function impairment on the single
      dose pharmacokinetics of Daclatasvir.
    

Eligibility criteria:

        Inclusion Criteria:

        - Meet renal function criteria in one of four categories

        Exclusion Criteria:

        - Unstable or uncontrolled medical conditions
A Brief Study To Evaluate The Safety, Tolerability, And Blood Levels Of Multiple Doses Of PF-044467943 Or Placebo In Combination With Donepezil In Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: PF-04447943; Placebo
Intervention description: 25 mg of PF-04447943 orally every 12 hours for 7 days; 25 mg matching placebo to PF-04447943 orally every 12 hours for 7 days
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: phase 1 Alzheimer's disease donepezil

Summary:

      The purpose of the study is to evaluate the safety of PF-04447943 when given in combination
      with donepezil in subjects who have Alzheimer's Disease. The study will also evaluate the
      absorption and distribution of both PF-04447943 and donepezil.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have Alzheimer's dementia with a Mini Mental State Examination score
             between 18-26, inclusive.

          -  Subjects must have a reliable caregiver.

          -  Subjects must be on Aricept

          -  Memantine is allowed if subjects are on a stable dose

          -  Subjects must be in reasonably good health, based on medical history, physical
             examination, vital signs, and ECG, with no serious or unstable disease within the past
             3 months.

        Exclusion Criteria:

          -  Subjects with clinically significant heart disease cannot participate.

          -  Subjects with a past or current history of seizures cannot participate.
Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655)
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Intervention: PegIFN-2b (Sylatron®)
Intervention description: Single 4.5 μg/kg dose
Intervention MeSH terms: Peginterferon alfa-2b
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b
      (Sylatron®) in healthy participants to that in participants with moderate to severe
      impairment of kidney function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index (BMI) between 19 to 40 kg/m^2, inclusive

          -  Moderate renal impairment and severe renal impairment and/or end-stage renal disease
             (ESRD) who may require hemodialysis and normal renal function

          -  Free of any clinically significant disease (except those related to renal disease and
             comorbid conditions) that requires a physician's care and would interfere with the
             study

          -  Females of reproductive potential must have used a medically accepted method of
             contraception for three months prior to screening and must agree to use an accepted
             contraceptive method during and for two months following the study

          -  Males must agree to use a medically accepted method of contraception during the trial
             and for 3 months after the study

        Exclusion Criteria:

          -  Pregnant, intend to become pregnant, or breastfeeding

          -  Surgical or medical condition which might significantly alter the absorption,
             distribution, metabolism or excretion of any drug

          -  History of any infectious disease within 4 weeks prior to study drug administration
             that affects ability to participate in the study

          -  Positive for hepatitis B surface antigen, and/or for human immunodeficiency virus
             (HIV) antibodies. Healthy participants positive for hepatitis C antibodies

          -  Previously received PegIntron®, Sylatron®, and/or Pegasys

          -  More than 10 cigarettes or equivalent tobacco use per day

          -  History of malignancy

          -  Hypothyroidism or hyperthyroidism

          -  History of depression requiring treatment with psychotherapy or medication

          -  History of suicidality or at risk of self-harm or harm to others

          -  History of autoimmune disorder requiring medical therapy

          -  Immune mediated renal insufficiency

          -  Removal of a kidney (healthy participants) or functioning renal transplant
             (participants with renal impairment)