bioihbjkbjnl/mcl2 huggingface dataset:
Entospletinib (ENTO) as Monotherapy and in Combination With Chemotherapy in Japanese Adults
Condition: Hematologic Malignancy; Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Neoplasms; Hematologic Neoplasms
Intervention: Entospletinib; Daunorubicin; Cytarabine
Intervention description: 400 mg (2 × 200 mg tablets) orally twice daily; 60 mg/m^2 administered intravenously daily on Days 1 to 3 of each 28-day induction cycle; 100 mg/m^2 intravenous administration twice daily on Days 1 to 7 of each 28-day induction cycle
Hi-DAC: 3 g/m^2 IV administration twice daily on days 1, 3, and 5 (≤ 60 years of age) or 1 g/m^2 IV administration once daily on Days 1 to 5 (> 60 years of age) of each 28-day post-remission cycle
Intervention MeSH terms: Cytarabine; Daunorubicin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsed or Refractory Hematologic Malignancy; Previously untreated AML

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of
      entospletinib (ENTO) monotherapy and in combination with chemotherapy in Japanese
      participants.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  ENTO monotherapy (Group A): relapsed or refractory hematologic malignancies by World
             Health Organisation (WHO) criteria and who are not eligible to receive standard of
             care

          -  ENTO + cytarabine + daunorubicin (Group B): previously untreated AML by WHO criteria,
             who are deemed fit for cytarabine and daunorubicin (7+3) induction chemotherapy and
             are able to undergo up to 2 cycles of induction chemotherapy, as determined by the
             treating physician

          -  Must have been born in Japan and must not have lived outside of Japan for a period > 1
             year in the 5 years prior to Day 1 of study treatment

          -  Must be able to confirm the Japanese origin of their maternal and paternal ancestry

        Key Exclusion Criteria:

          -  Known active central nervous system or leptomeningeal leukemic involvement

          -  Ongoing liver injury, or known infection with chronic active hepatitis C virus (HCV)
             or chronic active hepatitis B virus (HBV)

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
A Study of LY3337641 in Healthy Participants
Condition: Healthy
Intervention: Reference Formulation (R); LY3337641 (T1); LY3337641 (T2)
Intervention description: Administered PO; 20 mg PO; 20 mg PO
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purposes of this study are to determine:

        -  If there are any differences in the amount of LY3337641 in the blood/body when it is
           taken in different formulations. A total of 3 different formulations of LY3337641 are
           being tested.

        -  How a high-fat meal affects the amount of LY3337641 in the blood/body.

        -  How safe and well tolerated LY3337641 is.

      The study has four periods. Individuals will participate in all four periods. Each period
      will include 4 overnight stays (5 days) in the Clinical Research Unit (CRU).

      This study is expected to last up to 8 weeks. This includes the initial screening period, the
      study or dosing period, and the follow up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined by medical history and physical
             examination

          -  Have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²)
             inclusive

          -  Have clinical laboratory test results within normal reference range for the population
             or investigative site

          -  Are able and willing to give signed informed consent

        Exclusion Criteria:

          -  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) should have passed

          -  Have significant history of or current cardiovascular, dermatological (such as eczema,
             psoriasis, and acne), respiratory, hepatic, renal, gastrointestinal (cholecystectomy
             is not acceptable), endocrine, 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 used or intend to use over-the-counter or prescription medication, including
             herbal medications, within 14 days prior to planned dosing

          -  In the opinion of the investigator or sponsor, are unsuitable for inclusion in the
             study
Ketamine as an Adjunctive Therapy for Major Depression
Condition: Major Depressive Episode; Unipolar Depression; Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Ketamine; Midazolam
Intervention description: A sub-anaesthetic dose of ketamine will be administered in four infusions, each one week apart.; A sub-anaesthetic dose of midazolam will be administered in four infusions, each one week apart.
Intervention MeSH terms: Midazolam; Ketamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ketamine; glutamate

Summary:

      Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam as an
      adjunctive therapy for depression. The main purpose of the pilot study is to assess trial
      processes to help inform a future definitive trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥18 years old

          -  Hamilton Rating Scale for Depression-24 item version (HRSD-24) score of ≥21

          -  Voluntary admission for treatment of an acute depressive episode

          -  Meet Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition (DSM-V)
             criteria for a major depressive disorder (MDD) and bipolar affective disorder (current
             episode depression)

        Exclusion Criteria:

          -  Current involuntary admission

          -  Medical condition rendering unfit for ketamine/midazolam

          -  Active suicidal intention

          -  Dementia

          -  History of Axis 1 diagnosis other than major depression

          -  Electroconvulsive Therapy (ECT) administered within the last two months

          -  Alcohol/substance dependence in previous six-months

          -  Pregnancy or inability to confirm use of adequate contraception during the trial

          -  Breastfeeding women
A Study of the Cardiac Effects of ALXN1840 in Healthy Adults
Condition: Healthy
Intervention: ALXN1840; Placebo; Moxifloxacin
Intervention description: ALXN1840 (120 milligrams) will be administered orally (supratherapeutic dose).; Placebo will be administered orally.; Moxifloxacin (400 milligrams) will be administered orally.
Intervention MeSH terms: Moxifloxacin; Tetrathiomolybdate; Choline
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a 3-treatment, 3-period, 6-sequence, crossover study in healthy adults.
Masking: Double (Participant, Care Provider)
Masking description: This study will employ a double-blind study design. The ALXN1840 and matching placebo will be identical in appearance and will be administered in a double-blind manner.
Moxifloxacin will not be blinded.
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Electrocardiogram; Cardiac Repolarization; ALXN1840; Optimized QT Correction; QT Interval Correction; Thorough QT; QT Correction by Fridericia; Individual QT Correction; Wilson Disease

Summary:

      This study will evaluate the effect of a supratherapeutic dose of ALXN1840 on the heart rate
      (HR)-corrected QT interval (QTc) in healthy adult participants. Moxifloxacin will be used as
      the active control.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Nonsmoker.

          2. Body weight at least 60 kilograms (kg) for males or 52 kg for females and body mass
             index ≥18.0 and ≤30.0 kg/meter squared.

          3. Willing and able to follow protocol-specified contraception requirements.

          4. Participant has no clinically significant history or presence of ECG findings.

        Exclusion Criteria:

          1. History or presence of clinical and/or lab disorders.

          2. Lymphoma, leukemia, or any malignancy within the past 5 years, or breast cancer within
             the past 10 years.

          3. Participant has abnormal blood pressure, defined as a supine blood pressure <90/50
             millimeters of mercury (mm Hg) or >140/90 mm Hg.

          4. Serum potassium, calcium, or magnesium levels outside the normal range.

          5. Serum copper and/or ceruloplasmin values below the lower limit of normal at Screening.

          6. Female participant has hemoglobin <10.8 grams/deciliter (g/dL) and male participant
             has hemoglobin <12.5 g/dL.

          7. Clinically significant multiple or severe allergies.

          8. Alanine aminotransferase, aspartate aminotransferase, serum creatinine, or total
             bilirubin greater than upper limit of normal (with the exception of Gilbert's
             syndrome).
A Drug-drug Interaction Study With Risdiplam Multiple Dose and Midazolam in Healthy Participants
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal
Intervention: Risdiplam; Midazolam
Intervention description: Part 1: a dose of 5 milligram (mg) risdiplam QD ; Part 2: precise dose will be based on Part 1 results; single dose administration of 2 mg midazolam
Intervention MeSH terms: Midazolam; Risdiplam
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This will be a Phase I, 2-part, open-label, non-randomized study to investigate the safety,
      tolerability, and pharmacokinetics (PK) of a multiple-dosing regimen of risdiplam (Part 1)
      and the effect of risdiplam on the PK of midazolam (Part 2) following oral administration in
      healthy adult male and female participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants as defined by the Investigator

          -  A body mass index (BMI) of 18.0 to 32.0 kg/m2

          -  Use of adequate contraception methods during the treatment period and until 4 months
             after last study drug administration. Males must refrain from donating sperm during
             this same period

          -  Willingness and ability to complete all aspects of the study

        Exclusion Criteria:

          -  Concomitant disease or condition that could interfere with, or treatment of which
             might interfere with, the conduct of the study

          -  History or evidence of any medical condition potentially altering the absorption,
             metabolism, or elimination of drugs

          -  Surgical history of the GI tract affecting gastric motility or altering the GI tract

          -  History or presence of clinically significant ECG abnormalities or cardiovascular
             disease

          -  History of malignancy in the past 5 years

          -  Positive result on human immunodeficiency virus (HIV)-1, HIV-2, hepatitis B virus, or
             hepatitis C virus

          -  Donation of blood or blood products for transfusion

          -  Participation in an investigational drug medicinal product or medical device study
             within 90 days prior to Screening

          -  Any clinically significant history of hypersensitivity or allergic reactions

          -  History of hypersensitivity to midazolam or any other benzodiazepine or its
             formulation ingredients

        For Part 2 participants:

        - History of acute angle glaucoma
A Study of Dulaglutide in Healthy Participants
Condition: Healthy
Intervention: Dulaglutide (Reference); Dulaglutide (Test)
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Dulaglutide; Immunoglobulin Fc Fragments
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate a new formulation of dulaglutide (study drug)
      administered under the skin as one injection using a single dose pen compared to three
      injections using a pre filled syringe.

      This study will evaluate how much of the study drug enters the body and how long it takes the
      body to get rid of it. Information about any side effects that may occur will also be
      collected.

      The study will last about 84 days, including screening and will require overnight stays in
      the clinical research unit (CRU).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy as determined by medical history and physical examination at time of
             screening

          -  Have a body mass index of greater than or equal to (≥) 23 kilograms per meter squared
             (kg/m²) inclusive

        Exclusion Criteria:

          -  Have known allergies to dulaglutide, glucagon-like peptide-1 (GLP-1) related
             compounds, or any components of the formulation

          -  Have family history of medullary thyroid cancer (MTC) or a genetic condition that
             predisposes to MTC

          -  Have a history or presence of pancreatitis (history of chronic pancreatitis or
             idiopathic acute pancreatitis) or gastrointestinal disorder (e.g., relevant esophageal
             reflux or gall bladder disease) or any gastrointestinal disease which impacts gastric
             emptying (e.g., gastric bypass surgery, pyloric stenosis, with the exception of
             appendectomy) or could be aggravated by GLP-1 analogs
A Study to Evaluate the Bioequivalence of Single Oral Dose of Esomeprazole Capsule and Tablet Formulation in Healthy Participants
Condition: Healthy Participants
Intervention: Esomeprazole Capsule; Esomeprazole Tablet
Intervention description: Esomeprazole Capsule; Esomeprazole Tablet
Intervention MeSH terms: Esomeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 52.0
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 determine the bioequivalence of esomeprazole 40 milligram
      (mg) tablets and capsules.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a healthy adult male or female participant.

          2. Is aged 18 to 55 years, inclusive, at the time of informed consent and first study
             medication dose.

          3. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 18.5 to 30
             kilogram per square meter (kg/m^2), inclusive at Screening and Day -1.

        Exclusion Criteria:

          1. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary,
             hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other
             abnormality, which may impact the ability of the participant to participate or
             potentially confound the study results. It is the responsibility of the investigator
             to assess the clinical significance; however, consultation with the Takeda Medical
             Monitor may be warranted.

          2. Has a history of significant gastro intestinal (GI) disorders manifested with
             persistent, chronic or intermittent nausea, vomiting, diarrhea, or has a current or
             recent (within 6 months) GI disease that would influence the absorption of drugs
             (example, a history of malabsorption, severe esophageal reflux, peptic ulcer disease
             or erosive esophagitis), or any gastrointestinal-related surgical intervention..

          3. Has a known hypersensitivity to any component of the formulation of esomeprazole
             capsules or tablets or compounds with the same mechanism of action (dexlansoprazole,
             lansoprazole, omeprazole, rabeprazole, pantoprazole), or related compounds.
Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers
Condition: Healthy Adult Volunteers
Intervention: Drug: OP0201; Drug: Placebo
Intervention description: Drug OP0201; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety and tolerability of two dose levels of
      OP0201 and placebo, when administered intranasally in healthy adults subjects.
    

Eligibility criteria:

        Inclusion Criteria includes but is not limited to:

          1. Body mass index of 18 to 30 kg/m2 (inclusive) and a minimum body weight of 50 kg at
             Screening.

          2. Able and willing to follow study instructions (including compliance with daily study
             treatment administration) and likely to complete all required study visits as assessed
             by the Investigator's judgement.

          3. Female subjects must agree to use an acceptable method of contraception (for pregnancy
             considerations and contraceptive requirements).

          4. Female subjects who are of childbearing potential must have a negative urine pregnancy
             test result at Screening and Day -1 prior to randomization.

          5. Male subjects must agree to use contraception

          6. Subjects must agree to refrain from immersing their head fully under water (eg,
             swimming, diving) from the time of signed informed consent until after the study exit
             visit.

          7. Physiologic tympanogram classified as Type A (normal) by the Investigator or designee.

        Exclusion Criteria includes but is not limited to:

          1. History or presence of significant medical condition or a clinically significant
             abnormal finding, as determined by the Investigator.

          2. Presence of a clinically significant abnormal olfactory test finding at Screening
             defined as a total UPSIT score <35 (for females) and <34 (for males).

          3. Clinically significant ear disorder/disease currently or within 6 weeks prior to
             Screening.

          4. History of tympanostomy tubes in one or both ears within 1 year prior to Screening.

          5. Upper respiratory tract infection or pharyngitis currently or within 6 weeks prior to
             Screening.

          6. Allergy or sinus conditions (eg, sinusitis, non-specific nasal inflammation) currently
             or within 6 weeks prior to Screening.

          7. Clinically relevant blockage of one or both nasal passages, in the Investigator's
             opinion.

          8. Gastroesophageal reflux disease currently or within 6 weeks prior to Screening.
A Study of Mirikizumab (LY3074828) in Healthy Participants
Condition: Healthy
Intervention: Mirikizumab - IV; Mirikizumab - SC; Placebo - IV; Placebo - SC
Intervention description: Administered IV; Administered SC; Administered IV; Administered SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to explore the safety and tolerability of mirikizumab in
      healthy Japanese and Caucasian participants. The study will also estimate how much
      mirikizumab gets into the blood stream and how long it takes the body to remove it. The study
      is expected to last about 16 weeks for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined by medical history and physical
             examination.

          -  Are first generation Japanese or are Caucasian.

          -  Have a body mass index (BMI) of 18.0 kilograms per square meter (kg/m2) to 32.0 kg/m2,
             inclusive, at screening.

          -  Have a body weight of 40.0 kg or higher for Cohorts 1, 2, 3 and 4, and 48.0 kg or
             higher for Cohort 5 and 6.

        Exclusion Criteria:

          -  Have had symptomatic herpes zoster within 3 months of screening.

          -  Show evidence of active or latent tuberculosis (TB), as documented by medical history
             and examination, chest x-rays (posterior anterior and lateral), and TB testing.

          -  Have received live vaccine(s) within 1 month of screening or intend to during the
             study.

          -  Are immunocompromised.

          -  Have received treatment with biologic agents (such as monoclonal antibodies, including
             marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.