bioihbjkbjnl/mcl2 huggingface dataset:
A Study of [14 C]-Pevonedistat in Participants With Advanced Solid Tumors
Condition: Advanced Solid Tumors, Neoplasms, Advanced Solid
MeSH terms: Neoplasms
Intervention: Pevonedistat; [14C]-Pevonedistat; Docetaxel; Carboplatin; Paclitaxel
Intervention description: Pevonedistat intravenous infusion.; [14C]-Pevonedistat intravenous infusion.; Docetaxel intravenous infusion.; Carboplatin intravenous infusion.; Paclitaxel intravenous infusion.
Intervention MeSH terms: Paclitaxel; Docetaxel; Carboplatin; Pevonedistat
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the mass balance (that is, cumulative excretion of
      total radioactivity [TRA] in urine and feces) and to characterize the pharmacokinetics (PK)
      of pevonedistat in whole blood, plasma, and urine, and of TRA in plasma and whole blood
      following a single 1-hour infusion of 25 milligram per square meter (mg/m^2)
      [14C]-pevonedistat intravenous (IV) solution containing approximately 60 to 85 microcurie
      (mCi) (approximately 2.22-3.145 megabecquerel [MBq]) of TRA in participants with advanced
      solid tumors in Part A.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a histologically or cytologically confirmed metastatic or locally advanced and
             incurable solid tumor that is felt to be appropriate for treatment with one of the 2
             chemotherapy regimens in Part B of this study (carboplatin+paclitaxel or docetaxel),
             or have progressed despite prior standard therapy, or for whom conventional therapy is
             not considered effective. The tumor must be radiographically or clinically evaluable
             and/or measurable.

          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

          3. Expected survival longer than 3 months from enrollment in the study.

          4. Recovered (that is, less than or equal to [<=] Grade 1 toxicity) from the effects of
             prior antineoplastic therapy.

        Exclusion Criteria:

          1. Has irregular defecation patterns (less than 1 defecation per 2 days or excessive
             diarrhea) and/or has a history of changes in bowel habits with daily routine or
             environment changes.

          2. Prior treatment with radiation therapy involving greater than or equal to (>=) 25% of
             the hematopoietically active bone marrow.
Oral Abuse Potential Study of Nalbuphine
Condition: Nalbuphine; Opioid Abuse
MeSH terms: Opioid-Related Disorders
Intervention: Nalbuphine HCl solution; Placebo solution
Intervention description: nalbuphine solution administered at various strengths; Placebo
Intervention MeSH terms: Nalbuphine; Pharmaceutical Solutions
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-dose, randomized, double-blind, active- and placebo-controlled, double-dummy, 2-part, 7-way crossover study.
Part A: Dose selection phase Part B: Treatment Periods 1-7
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: For each dosing cohort, an unblinded statistician, not otherwise involved in the study, will prepare a list of subject randomization numbers. These randomization numbers will be used to prepare individual subject doses. Sealed qualification code break envelopes will be available for each subject in case of emergency.
Upon completion of each cohort of subjects, the randomization codes for the completed subjects will be unblinded by the CRU pharmacy. After unblinding, the safety data will be reviewed to determine if dosing can proceed for the next planned dosing cohort,
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nalbuphine; abuse potential

Summary:

      The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid
      drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no
      active drug ingredients). The amount of nalbuphine levels in the blood will also be measured
      and the safety of the study drugs will be evaluated.

      This study has 2 parts: Part A and Part B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female subjects 18 to 55 years of age

          -  Current opioid users who have used opioids for recreational (non-therapeutic) purposes

        Exclusion Criteria:

          -  Self-reported substance or alcohol dependence (excluding nicotine and caffeine)

          -  Heavy smoker (≥ 20 cigarettes per day) and/or who is unable to abstain from smoking
             for at least 8 hours during the in clinic periods.

          -  History or presence of clinically significant abnormality as assessed by physical
             examination, medical history, ECGs, vital signs, or laboratory values.

          -  History or presence of any clinically significant illness

          -  History of major mental illness that may affect the ability of the subject to
             participate in the study.
A Study of LY900014 in Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY900014; Insulin Lispro
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in
      participants with type 2 diabetes mellitus. The study will be conducted in participants with
      type 2 diabetes on insulin injection therapy to investigate how the body processes LY900014
      and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog).

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be between 3 and 8 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are male or female participants with Type 2 Diabetes Mellitus (T2DM) for at least 1
             year

          -  Have a body mass index (BMI) of 18.5 to 35.0 kilogram per meter square (kg/m²)

          -  Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)

          -  Have had no episodes of severe hypoglycaemia in the last 6 months

        Exclusion Criteria:

          -  Have a history or current cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine (apart from T2DM), 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 renal impairment

          -  Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg
             vein thrombosis in first-degree relatives

          -  Have proliferative retinopathy or maculopathy and/or severe neuropathy
Four Arm Food Effect Study of Fenofibric Acid Tablets
Condition: Healthy
Intervention: Fenofibric Acid 105 mg Tablet; Fenofibric Acid 105 mg Tablet; Fenofibric Acid 105 mg Tablet; Fenofibric Acid 105 mg Tablet
Intervention description: One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.; One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast; One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.; One 105 mg tablet administered after an overnight fast of at least 10 hours.
Intervention MeSH terms: Fenofibric acid; Fenofibrate
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pharmacokinetics

Summary:

      The primary objective of this study is to characterize the single-dose pharmacokinetic
      profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat
      compositions on the rate and extent of absorption. Additionally, the safety and tolerability
      of this dose and regimen of fenofibric acid will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults between the ages of 18 and 45

          -  Non-smoking

          -  Non-pregnant (post-menopausal, surgically sterile, or using effective contraceptive
             measures)

          -  Body mass index (BMI) less than 30

          -  Medically healthy on the basis of medical history and physical examination

          -  Hemoglobin > or = to 12g/dL

          -  Completion of the screening process within 28 days prior to dosing

          -  Provision of voluntary written informed consent

        Exclusion Criteria:

          -  Recent participation (within 28 days) in other research studies

          -  Recent significant blood donation or plasma donation

          -  Pregnant or lactating

          -  Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HbsAg), or hepatitis C virus (HCV)

          -  Recent (2-year) history or evidence of alcoholism or drug abuse

          -  History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or
             biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic,
             dermatologic, neurologic, or psychiatric disease

          -  Subjects who have used any drugs or substances known to inhibit or induce cytochrome
             (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose
             and throughout the study

          -  Drug allergies to fenofibric acid
Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: rLP2086 vaccine or control; rLP2086 vaccine or control; rLP2086 vaccine or control; rLP2086 vaccine or control
Intervention description: intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months; intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months; intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months; intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and tolerability of an investigational
      meningococcal B rLP2086 vaccine in healthy adults.
    

Eligibility criteria:

        Inclusion Criteria:

        A subject must meet the following inclusion criteria at screening (visit 1) and at
        randomization (visit 2) to be considered for enrollment in the study:

          -  Male or female subjects between the ages of 18 and 40.

          -  Healthy male or female subjects as determined by medical history, physical
             examination, and judgment of the investigator.

          -  Male or female subject who is considered biologically capable of having children must
             agree to commit to the use of a reliable method of birth control for the duration of
             the study and for 30 days after early discontinuation. A subject is still biologically
             capable of having children, even if he or she is using contraceptives or if his or her
             sexual partner is sterile or using contraceptives.

        In addition a subject must meet the following inclusion criteria at randomization (visit 2)
        to be considered for enrollment in the study. The referred blood and urinalysis tests
        (inclusion criterion 5) will be performed on a blood and urine sample taken at visit 1:

          -  Female subjects of childbearing potential with a negative urine pregnancy test prior
             to study drug administration. Note: this criterion will apply to each vaccination
             visit and to the last study visit.

          -  Laboratory blood and urinalysis tests results within the per-protocol normal ranges.

          -  Able to be contacted by telephone during the study period. Note: this criterion will
             apply to each study visit.

        Exclusion Criteria:

        None
Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease
Condition: End-Stage Renal Disease; Hemodialysis
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Intervention: CP-690,550
Intervention description: CP-690,550 10 mg oral powder for constitution
Intervention MeSH terms: Tofacitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: CP-690; 550; pharmacokinetics; end-stage renal disease

Summary:

      There were 2 study periods in this study. In the Period 1, CP-690,550 was to be administered
      approximately 1 to 2 hours following hemodialysis. If significant non-renal clearance of the
      drug occurred such that dialyzability of CP-690,550 could not be assessed in Period 1, a
      second period (Period 2) will be conducted. In Period 2, a single dose of drug will be
      administered approximately 4 hours prior to hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with end-stage renal disease

          -  Subjects need hemodialysis 3 times weekly

        Exclusion Criteria:

          -  Subjects with evidence or history of clinically significant disease, excluding those
             common for subjects with End-Stage Renal Disease (ESRD).

          -  Subjects with any condition possibly affecting drug absorption.

          -  Subjects with malignancies with the exception of adequately treated basal cell
             carcinoma of the skin.
A Phase 1, Dose-escalation Study of MEDI-551 in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies
Condition: Blood Cancer; Advanced B Cell Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms
Intervention: MEDI-551
Intervention description: MEDI-551 will be administered by intravenous infusion at dose of 2, 4 or 8 mg/kg once per week on Days 1 and 8 in the first cycle and then once every 28 days at the start of each subsequent cycle
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 20 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Phase I; advanced; B cell malignancies; dose escalation; CD19; Japanese

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of MEDI-551 in
      Japanese patients with relapsed or refractory advanced B-cell malignancies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese men or women at least 20 years of age

          -  Histologically confirmed CLL (excluding small lymphocytic lymphoma (SLL)), DLBCL, FL,
             or MM.

          -  Karnofsky Performance Status ≥70;

          -  Life expectancy of ≥12 weeks

        Exclusion Criteria:

          -  Any available standard line of therapy known to be life-prolonging or life-saving

          -  Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy
             for treatment of cancer

          -  Previous therapy directed against CD19, such as monoclonal antibodies or MAb
             conjugates
Two Devices for Reflex Voiding Following Spinal Cord Injury
Condition: Spinal Cord Injury; Urinary Incontinence
MeSH terms: Spinal Cord Injuries; Urinary Incontinence
Intervention: Vibrator; Anal dilator
Intervention description: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction; A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter. An anal dilator is being conduced with the balloon
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Male
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: electric stimulation; urethral obstruction; urodynamics; urology

Summary:

      The purpose of this investigation is to evaluate methods in spinal cord injured individuals
      to improve reflex urination. Anal dilation will be investigated to reduce high urethral
      resistance and a vibrator on the patient's bottom will be tested to induce more sustained
      bladder contractions for better bladder emptying.
    

Eligibility criteria:

        Inclusion Criteria:

        Male Veterans using Hines VA Hospital SCI Service that have upper motor neuron injuries

        Exclusion Criteria:

          -  Can voluntarily control their urination

          -  Surgically removed external urethral sphincter in men or replaced bladder

          -  Any implanted devices in the lower urinary tract

          -  Female

          -  Urinary tract infection in the prior 3 months or untreated urinary tract infection, or
             bladder pathology such as a tumor or stones

          -  History of autonomic dysreflexia

          -  Anal inflammation or pathology

          -  Use of Indwelling (Foley) catheter as the primary method of bladder management; note
             patients will be included if they only occasionally use a Foley catheters; for
             example, during traveling

          -  Not under 18 or over 70 years old and in good health

          -  Less than 3-months after injury and before the return of bladder reflexes

          -  Lower motor neuron spinal cord injury

          -  Not competent to understand the study and the consent and willing to participate in
             study.
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Fimasartan; Rosuvastatin; Fimasartan + Rosuvastatin
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Male
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fimasartan

Summary:

      The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and
      rosuvastatin when coadministered or administered alone as a single dose or as multiple doses
      to healthy male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Caucasian male 19-55 years of age.

          2. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.

          3. Medically healthy with no clinically significant medical history.

          4. Understands the study procedures in the Informed consent form (ICF), and be willing
             and able to comply with the protocol.

        Exclusion Criteria:

          1. History or presence of clinically significant medical or psychiatric condition or
             disease.

          2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B
             surface antigen (HBsAg) or hepatitis C virus (HCV).

          3. Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at
             screening.

          4. Plasma donation within 7 days prior to the first dose of study drug.

          5. Participation in another clinical trial within 28 days prior to the first dose of
             study drug(s).
Investigate the Safety and Tolerability of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies
Condition: Cancer; Advanced Solid Malignancies
MeSH terms: Neoplasms
Intervention: olaparib
Intervention description: tablet oral
Intervention MeSH terms: Olaparib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 20 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Cancer; Tumour; Solid Malignancies

Summary:

      The objective of this study will be to investigate the safety and tolerability of olaparib
      tablet when given orally to Japanese patients with advanced solid malignancies. In addition,
      the pharmacokinetic profile, MTD (if possible) and efficacy of olaparib will be investigated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects diagnosed with advanced solid malignancies who are refractory to standard
             therapies or for which no standard therapy exists.

          -  Subjects who have overall good overall general condition.

          -  Subjects who agree to hospitalisation from starting olaparib to multiple dose period
             at day 15.

          -  Evidence of non-childbearing status for women of childbearing potential, or
             postmenopausal status.

          -  Subjects who have at least one lesion (measurable and/or non-measurable) that can be
             accurately assessed by CT/MRI at baseline and follow up visits

        Exclusion Criteria:

          -  Subjects who received any previous treatment with a PARP (poly adenosine
             diphosphate-ribose polymerase) inhibitor, including olaparib.

          -  Subjects receiving inhibitors of CYP3A4 (cytochrome P450 3A4).

          -  Subjects with symptomatic uncontrolled brain metastases.

          -  Subjects with myelodysplastic syndrome/acute myeloid leukaemia.

          -  Subjects with a known hypersensitivity to olaparib or any of the excipients of the
             product.