bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy
Condition: Healthy Participants; Narcolepsy
MeSH terms: Narcolepsy
Intervention: TAK-925; Placebo
Intervention description: TAK-925; TAK-925 Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy adult participants and Healthy elderly participants:

        • Participant weighs at least 50 kg (Healthy adults participants) / 40 kilogram (kg)
        (Healthy elderly participants) and has a body mass index (BMI) from 18.5 to 30 kilogram per
        square meter (kg/m^2), inclusive at Screening.

        Narcolepsy participants:

          -  Participants weighs at least 40 kg inclusive at Screening (>=50 kg is required for
             Cohort B4).

          -  A diagnosis of narcolepsy, as defined by the International Classification of Sleep
             Disorders, Third Edition (ICSD-3).

          -  At Day -1, Epworth sleepiness scale (ESS) score >=10

        Exclusion Criteria:

        All Participants:

          -  Participants consume excessive amounts, defined as greater than 6 servings (1 serving
             is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy
             drinks, or other caffeinated beverages per day.

          -  Participants have a moderate to severe substance use disorder.

          -  Participants have a risk of suicide according to endorsement of item 4 or 5 with
             Screening/Baseline visit C-SSRS (Columbia Suicide Severity Rating Scale) or has made a
             suicide attempt in the previous 6 months.

          -  Participants have a lifetime history of major psychiatric disorder, such as bipolar
             disorder or schizophrenia.

          -  Participants experienced sleep wake cycle disturbance with external factors such as
             irregular work hours.
Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Intervention: PF-05230907
Intervention description: PF-05230907 IV bolus injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: safety, maximum tolerated dose, modified continual reassessment method, intracerebral, hemorrhage, hematoma

Summary:

      This study employs a modified continual reassessment method (mCRM) design to estimate the
      maximum tolerated dose (MTD) of PF-05230907, defined as a target toxicity rate of 15% based
      on treatment emergent thromboembolic and/or ischemic events (TIEs). The mCRM design utilizes
      Bayesian methodology to continuously learn the dose-toxicity relationship, which is
      characterized by a parametric model.

      Subjects with a diagnosis of ICH (determined by computed tomography) will be enrolled in
      cohorts of 3. The total length of time planned for study participation is approximately 3
      months; 6.0 hours for screening, a single dose administration with a 4-day minimum hospital
      confinement period and follow-up visits through Day 91.

      Severity of adverse events (AEs) and serious adverse events (SAEs) will be graded according
      to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
      version 4.03. All subjects who receive PF-05230907 are evaluable for TIEs. The determination
      of MTD using mCRM modeling will be based on TIEs which occur through 7 days post-dose (Day
      8).
    

Eligibility criteria:

        Inclusion Criteria:

          -  ICH as documented by CT scan within 6.0 hours of symptom onset

          -  Baseline ICH volume > 5mL and < 60 mL

        Exclusion Criteria:

          -  Deep coma (Glasgow Coma Scale < 6)

          -  Modified Rankin Score > 3 prior to ICH onset

          -  Known history of schemic, vaso-occlusive or thrombotic events within 6 months prior to
             screening

          -  Known prothrombotic disorders

          -  Known secondary ICH related to aneurysm, arteriovenous malformation, subarachnoid
             hemorrhage, trauma, or other causes. CT angiography, MR, or other diagnostic studies
             obtained as part of the standard of care may be used to assess eligibility.

          -  Known use of oral anticoagulant(s)

          -  Known use of low-molecular weight heparin or heparin
A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: PF-06755992; PF-06755990; TDS-IM Electroporation Device; Tremelimumab; PF-06801591; PF-06753512
Intervention description: PF-06755992 will be administered on Day 1 of Cycles 1 and 2.; PF-06755990 will be administered using a device on Day 29, 57 and 85 of each cycle.; TDS-IM electroporation device and associated supplies will be used for PF-06755990 administration; PF-06753388 will be administered every 28 days.; PF-06801591 will be administered every 28 days.; Combination of adenovirus (AdC68) + plasmid DNA (pDNA) + tremelimumab
Intervention MeSH terms: Tremelimumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses
      of a vaccine-based immunotherapy regimen for patients with prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological diagnosis of prostate cancer

          -  Adequate bone marrow, kidney and liver function

          -  Hormone sensitive relapsing prostate cancer after definitive local therapy
             (biochemical relapse) OR

          -  Failed prior therapy with a novel hormone (e.g. enzalutamide, abiraterone) with
             documented progressive disease (post-novel hormone therapy CRPC)

        Exclusion Criteria:

          -  ECOG performance status greater than or equal to 2

          -  Concurrent immunotherapy for prostate cancer

          -  History of or active autoimmune disorders (including but not limited to: myasthenia
             gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic
             lupus erythematosus, scleroderma) and other conditions that disorganize or alter the
             immune system.

          -  History of inflammatory bowel disease.

          -  Current use of any implanted electronic stimulation device

          -  For biochemically relapsed patients, no concurrent use of ADT or orchiectomy and no
             known prior or current evidence of any metastatic involvement of distant organs

          -  For post-novel hormone patients, no concurrent treatment with a secondary hormone
             (e.g. enzalutamide, abiraterone), no metastasis to the liver or brain
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-954 in Healthy Adult Participants
Condition: Healthy Volunteers
Intervention: TAK-954; TAK-954 Placebo
Intervention description: TAK-954 infusion administered intravenously.; TAK-954 placebo-matching infusion intravenous.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and PK of single ascending
      intravenous doses of TAK-954.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=)
             32 kilogram per square meter (kg/m^2), weighing >=50 kilogram (kg) at screening.

          2. Medically healthy with no clinically significant medical history, physical
             examination, laboratory profiles, vital signs, orthostatic vital signs, or ECGs, as
             deemed by the Investigator or designee.

          3. Continuous non-smoker who has not used nicotine-containing products for at least 3
             months prior to the first dose and throughout the study, based on participant
             self-reporting.

        Exclusion Criteria:

          1. History or presence of alcoholism or drug abuse within the past 2 years prior to the
             first dosing.

          2. Has infrequent bowel movements (less than approximately once per day) within 30 days
             prior to first dosing.

          3. Recent history of abnormal bowel movements, such as diarrhea, loose stools, or
             constipation, within 2 weeks of first dosing.
A Study of LY3337641 in Japanese and Caucasian Healthy Participants
Condition: Healthy
Intervention: LY3337641; Placebo
Intervention description: Administered orally.; Administered orally.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to evaluate the safety and tolerability of LY3337641 in
      healthy Japanese and Caucasian participants. The study will also investigate how the body
      processes LY3337641 and the effect of LY3337641 on the body. The study will last up to 4
      weeks for each participant. Screening may occur within 28 days prior to first dose of study
      drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy Japanese or Caucasian

          -  Body mass index (BMI) 18.0 - 32.0 kilograms per square meter (kg/m²)

        Exclusion Criteria:

          -  Are currently enrolled in a clinical trial involving an investigational product or
             off-label use of a drug or device or are concurrently enrolled in any other type of
             medical research judged not to be scientifically or medically compatible with this
             study

          -  Have participated, within the last 30 days, in a clinical trial involving an
             investigational product. If the previous investigational product has a long half-life,
             3 months or 5 half-lives (whichever is longer, if known) should have passed

          -  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 or
             affects or confounds the QTc analysis or have Fridericia-corrected QT interval (QTcF)
             >450 milliseconds (msec) for males and >470 msec for females

          -  Have had symptomatic herpes zoster within 3 months of screening

          -  Have active or latent tuberculosis (TB) based on a positive medical history,
             examination, and/or TB test results.

          -  Have received live vaccine(s) within 1 month of screening or intend to during the
             study

          -  Are immunocompromised

          -  Have a history of constipation or have had acute constipation within 3 weeks prior to
             admission
A Study of LY3832479 (LY-CoV016) in Healthy Participants
Condition: Healthy
Intervention: LY3832479; Placebo
Intervention description: Administered IV.; Administered IV.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to learn more about the safety of LY3832479 and any side
      effects that might be associated with it. Blood tests will be done to measure how much
      LY3832479 is in the bloodstream and how long it takes the body to eliminate it. Participation
      could last up to 16 weeks and may include up to 10 visits to the study center.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy as determined by medical evaluation including medical history and
             physical examination

        Exclusion Criteria:

          -  Test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

          -  Pregnant women and women of childbearing potential

          -  Have a history or presence of cardiovascular (including hypertension), respiratory,
             hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
             that, in the opinion of the investigator, are capable of significantly altering the
             absorption, metabolism, or elimination of drugs, or of constituting a risk while
             taking the investigational product, or of interfering with the interpretation of data

          -  Have participated in a clinical study involving an investigational product, with last
             dose within the past 30 days or 5 half-lives (whichever is longer) prior to dosing
Safety and Tolerability of the Ophthalmic Solution PRO-156 in Ophthalmologically Healthy Volunteers.
Condition: Healthy
Intervention: PRO-156
Intervention description: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.
Intervention MeSH terms: Ketorolac
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate safety and tolerability of the ophthalmic solution
      PRO-156 over the ocular surface of ophthalmologically healthy volunteers
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female.

          -  Age between 18 and 40 years old at screening visit.

          -  Signed informed consent

        Exclusion Criteria:

          -  Patient with one blind eye.

          -  Any ocular or systemic condition.

          -  Visual acuity of 20/100 in any eye.

          -  Use of ocular or systemic medication.

          -  Contraindications or sensitivity to any component of the study treatment.

          -  Contact lens users.

          -  Ocular surgery within the past 3 months..

          -  Pregnant, nursing or childbearing potential women who were not using effective
             contraception.

          -  Participation in any studies of investigational drugs within 90 days previous to the
             inclusion.
A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors
Condition: Pediatric Solid Tumor; Refractory Tumor; Recurrent Tumor; CNS Malignancies
MeSH terms: Neoplasms; Recurrence
Intervention: Ramucirumab
Intervention description: Administered IV
Intervention MeSH terms: Ramucirumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 12 Months
Maximum age: 21 Years
Healthy volunteers: No
Keywords: relapsed pediatric solid tumors; unspecified childhood solid tumor; brain and central nervous system tumors

Summary:

      The main purpose of this study is to evaluate the safety of the study drug known as
      ramucirumab in children with recurrent or refractory solid tumors including central nervous
      system (CNS) tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Part A: participants with recurrent or refractory non-CNS solid tumors

          -  Part B: participants with recurrent or refractory CNS tumors

          -  Measurable or evaluable disease

          -  No other therapeutic options

          -  Performance Status: Karnofsky ≥50% for participants >16 years and Lansky ≥50 for
             participants ≤16 years

        Exclusion Criteria:

          -  Active or recent history of serious bleeding events

          -  Active or recent history of gastrointestinal perforations, ulcers, fistulas or
             abscesses

          -  Active or recent history of hypertensive crisis or hypertensive encephalopathy

          -  Active non-healing wound or bone fracture

          -  History of solid organ transplant
A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis
Condition: Adult Onset Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: VIB4920; Placebo
Intervention description: Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.; Participants will receive a single IV dose of placebo matched to VIB4920 Q2W from Day 1 up to 12 weeks.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: MEDI4920, VIB4920, CD40L, RA, rheumatoid arthritis

Summary:

      The purpose of this study is to determine whether VIB4920 (formerly MEDI4920) is safe and
      well tolerated in participants with adult-onset rheumatoid arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult-onset rheumatoid arthritis

          -  swollen and tender joints

        Exclusion Criteria:

          -  venous thromboembolism or arterial thrombosis

          -  pregnant or breastfeeding

          -  positive hepatitis B, hepatitis C, and human immunodeficiency virus infection

          -  active or untreated latent tuberculosis
Staccato Loxapine Pulmonary Safety in Healthy Volunteers
Condition: Healthy
Intervention: Inhaled Placebo; Inhaled Loxapine
Intervention description: Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
Intervention MeSH terms: Loxapine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy volunteers

Summary:

      The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato
      Loxapine within a day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  nonsmoker subjects in good general health with normal spirometry at screening AND
             baseline

        Exclusion Criteria:

          -  history of asthma, COPD, or any other acute or chronic pulmonary disease or
             bronchodilator use
A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants
Condition: Healthy
Intervention: Lasmiditan; Placebo; Diphenhydramine
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Diphenhydramine; Promethazine; Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the effect of lasmiditan on simulated driving
      performance in healthy participants. Participants are expected to complete each of four study
      periods, which will last a total of about 10 days. During this time, participants will remain
      in the clinical research unit. Screening must be completed within 28 days before the start of
      the study. Follow-up will be completed about one week after discharge.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined through medical history and
             physical examination.

          -  Possess a valid driver's license and is an active driver at screening. Driven a
             minimum of 8,000 miles (about 13,000 kilometers) per year for the preceding 3 years.

          -  Have a score of <10 on the Epworth Sleepiness Scale.

        Exclusion Criteria:

          -  Have a history within 3 months of admission, or current treatment for, a sleeping
             disorder (including excessive snoring, obstructive sleep apnea), or a chronic painful
             condition that interferes with the subject's sleep.

          -  Have a history of difficulty either falling asleep or staying asleep in the previous 3
             months of admission that is considered clinically significant by the investigator.

          -  Are expected to use any other medication or dietary supplement to promote sleep
             including over the-counter sleep medications, during their participation in the study.

          -  Have traveled across 2 or more time zones (transmeridian travel) in the past 2 weeks
             prior to randomization.

          -  Have worked in a night shift in the past 2 weeks prior to randomization.

          -  Show a history of central nervous system (CNS) conditions such as strokes, transient
             ischemic attacks, significant head trauma, seizures, CNS infections, migraine, brain
             surgery, or any other neurological conditions that, in the opinion of the
             investigator, increase the risk of participating in the study.

          -  Show evidence of significant active neuropsychiatric disease (e.g., manic depressive
             illness, schizophrenia, depression) considered as clinically significant by the
             investigator.