bioihbjkbjnl/mcl2 huggingface dataset:
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 LY3015014 in Otherwise Healthy Participants With High Low-density Lipoprotein (LDL) Cholesterol
Condition: Healthy Volunteers
Intervention: LY3015014; Placebo
Intervention description: Administered SC; Administered SC
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: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a phase 1 study in otherwise healthy participants with high LDL cholesterol.
      Following multiple doses of LY3015014, the safety and tolerability of the drug, how the body
      handles the drug, and the drug's effect on the body will be evaluated. Participants will
      participate in the study for approximately 3 months not including screening. Screening is
      required within 42 days prior to the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be healthy males or females without childbearing potential as
             determined by medical history and physical examination, including first-generation
             Japanese participants

          -  Have body mass indexes of 18 to 35 kilograms per meter square (kg/m^2), inclusive, at
             screening

          -  Have screening low-density lipoprotein cholesterol (LDL-C) of between 100 and 180
             milligrams per deciliter (mg/dL), inclusive

        Exclusion Criteria:

          -  Have known allergies to compounds related to LY3015014 or any components of the
             formulation or known clinically significant hypersensitivity to biologic agents

          -  Have a history of atopy, significant allergies to humanized monoclonal antibodies,
             clinically significant multiple or severe drug allergies, intolerance to topical
             corticosteroids, or severe posttreatment hypersensitivity reactions [including but not
             limited to erythema multiforme major, linear immunoglobulin (Ig)A dermatosis, toxic
             epidermal necrolysis, or exfoliative dermatitis)

          -  Have significant history of or current 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

          -  Have received any vaccine(s) within 1 month of LY3015014 dosing or intend to do so
             during the study

          -  Have received treatment with biologic agents (such as monoclonal antibodies) within 3
             months or 5 half-lives (whichever is longer) prior to dosing
Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors
Condition: Neoplasms; Malignant Carcinoma
Intervention: Neratinib; Temsirolimus
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neratinib; solid tumors; phase 1; dose finding study; HKI-272; Nerlynx; Temsirolimus; PB-272

Summary:

      The primary purpose of this study is to identify the maximum tolerated dose(s) (MTD) of
      neratinib in combination with temsirolimus in subjects with solid tumors. This study will
      also include a preliminary evaluation of efficacy, and assessment of pharmacokinetic (PK)
      parameters of the combination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic diagnosis of advanced or metastatic solid tumor.

          -  Measurable disease per Response Criteria in Solid Tumors (RECIST criteria).

          -  Incurable cancer, with disease progression following at least 1 conventional or
             standard therapy for locally advanced or metastatic disease.

          -  Negative pregnancy test for women of child bearing potential.

        Exclusion Criteria:

          -  Chronic treatment with corticosteroids.

          -  Primary central nervous system (CNS) tumors and active metastases.

          -  Presence of clinically significant or uncontrolled cardiac disease.

          -  Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major
             symptom.

          -  Symptomatic or prior history of non-infectious interstitial pneumonitis.
Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: JTT-662; Placebo
Intervention description: Active drug tablets containing JTT-662; Placebo tablets matching in appearance to the active drug tablets
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: JTT-662; Diabetes; Safety; Tolerability; Pharmacokinetics; Pharmacodynamics

Summary:

      This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      JTT-662 administered once daily for 28 days in subjects with Type 2 diabetes mellitus (T2DM)
      who are receiving metformin monotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of T2DM for at least 12 weeks prior to the Screening Visit

          -  Currently treated with a stable oral dose of metformin monotherapy for at least 12
             weeks prior to the Screening Visit and until Day -3

          -  Have a glycosylated hemoglobin (HbA1c) value of between 6.5% and 10.0% at the
             Screening Visit

          -  Have a fasting plasma glucose (FPG) value of no more than 280 mg/dL at the Screening
             Visit and on Day -3

          -  Body Mass Index (BMI) of 25 to 40 kg/m2 (inclusive)

        Exclusion Criteria:

          -  Known medical history or presence of Type 1 diabetes mellitus, Maturity Onset Diabetes
             of the Young or secondary forms of diabetes

          -  Known medical history or presence of diabetic complications

          -  Have taken anti-diabetic medications (other than metformin) or medications that act
             mainly in the gastrointestinal tract (e.g., orlistat, acarbose) within 12 weeks prior
             to the Screening Visit or from the Screening Visit to Day -3

          -  Have uncontrolled hypertension (systolic blood pressure of at least 160 mmHg or
             diastolic blood pressure of at least 95 mmHg) at the Screening Visit

          -  Have impaired renal function (estimated glomerular filtration rate (eGFR) <60
             mL/min/1.73 m2)
A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib
Condition: Healthy, Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Intervention: Palbociclib 75 mg Capsule
Intervention description: Single oral 75 mg dose of palbociclib followed by serial PK sampling up to 192 hours post-dose (up to 120 hours post-dose for the healthy volunteer cohort).
Intervention MeSH terms: Palbociclib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Palbociclib, PD-0332991, Hepatic Impairment

Summary:

      This is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of
      palbociclib administered to healthy volunteers, and subjects with mild, moderate, and
      severely impaired hepatic function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index (BMI) of 18 to 40 kg/m2; and a total body weight >50 kg (110 lbs)

          -  Evidence of a personally signed and dated informed consent document indicating that
             the subject has been informed of all pertinent aspects of the study

          -  Subjects who are willing and able to comply with all scheduled visits, treatment plan,
             laboratory tests, and other study procedures

        Exclusion Criteria:

          -  Any condition possibly affecting drug absorption (eg, gastrectomy)

          -  A positive urine drug screen

          -  Pregnant female subjects; breastfeeding female subjects; female subjects of
             childbearing potential; male subjects with partners currently pregnant; male subjects
             of childbearing potential who are unwilling or unable to use a highly effective method
             of contraception for the duration of the study and for 90 days after the last dose of
             investigational product

          -  History of sensitivity to heparin or heparin-induced thrombocytopenia

          -  Blood donation of approximately 1 pint (500 mL) or more within 56 days prior to dosing

          -  Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol

          -  Use of tobacco or nicotine products in excess of 5 cigarettes per day (or equivalent)

          -  History of sensitivity to palbociclib
Cardiac Safety Evaluation of P03277
Condition: Healthy Volunteers
Intervention: P03277 0.1 mmol/kg; Moxifloxacin 400mg; NaCl 0.9%; P03277 0.3 mmol/kg
Intervention description: Single intravenous bolus injection at 2 mL/sec; One tablet per os; Single intravenous bolus injection at 2 mL/sec; Single intravenous bolus injection at 2 mL/sec
Intervention MeSH terms: Moxifloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Williams design for a 4*4 cross over
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Gadolinium-based contrast agent; Cardiac safety; ECG; Gadopiclenol

Summary:

      The study is a Phase I, Single center, Randomized, Cross-over Double-blind Placebo-controlled
      and Open-label Positive-controlled (moxifloxacin) in healthy volunteers.

      The primary objective is to assess the cardiac safety after administration of P03277 to 48
      healthy volunteers at dose of 0.1 mmol/kg (anticipated clinical dose) and 0.3 mmol/kg
      (supra-clinical dose) by evaluating the QT and QTc intervals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject assessed as healthy by a comprehensive clinical assessment (detailed medical
             history and complete physical examination)

          -  Subject with a Body Mass Index (BMI) > 19 kg/m² and < 28 kg/m² and a weight at least
             of 40 kg for female and 50 kg for male and at maximum of 100 kg

        Exclusion Criteria:

        -
Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Intervention: Ceftobiprole medocaril
Intervention description: Ceftobiprole medocaril was administered as a single intravenous infusion, with a bodyweight-adjusted volume, at a constant rate over 4 hours. The ceftobiprole dose was 7.5 mg/kg, which corresponds to 10.0 mg ceftobiprole medocaril.
Intervention MeSH terms: Ceftobiprole; Ceftobiprole medocaril; Cephalosporins
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Maximum age: 3 Months
Healthy volunteers: No

Summary:

      This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in
      neonates and infants aged ≤ 3 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Neonates and infants ≤3 months, with gestational age ≥28 weeks

          -  Documented or presumed (or at risk of) bacterial infections, and currently receiving
             antibiotic treatment

          -  Expected to survive beyond the first 7 days after enrollment

          -  Sufficient vascular access to receive study drug, and to allow blood sampling at a
             site separate from the study drug infusion site

          -  Parent's / legally acceptable representative's informed consent to participate in the
             study

        Exclusion Criteria:

          -  Major birth defect or malformation syndrome

          -  Proven presence of an immunodeficiency

          -  HIV or other congenital viral or fungal infection

          -  Significant laboratory abnormalities including: hematocrit <20%; absolute neutrophil
             count <0.5x10⁹/L; platelet count < 50x10⁹/L; alanine aminotransferase or aspartate
             aminotransferase >3 times the age-specific upper limit of normal

          -  Impaired renal function or known significant renal disease

          -  Any condition which would make the subject or caregiver, in the opinion of the
             investigator, unsuitable for the study
A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Lasmiditan
Intervention description: Administered orally.
Intervention MeSH terms: Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of the study is the measure the levels of lasmiditan in the body of children aged
      6 to 17 with migraine. The study also will also examine the safety and tolerability of
      lasmiditan in children aged 6 to 17 with migraine.

      The study will last about 6 weeks, and includes 4 visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have a history of migraine headaches for more than 6 months

          -  Participants must have a history of 2 to 15 migraine headaches per month in the past 2
             months

          -  Participants must weigh between 15 and 55 kilograms (kg)

          -  Participants must not have a migraine headache on the day of lasmiditan administration

        Exclusion Criteria:

          -  Participants must not be pregnant or nursing

          -  Participants must not have any acute, serious, or unstable medical condition

               -  Participants must not be actively suicidal or at significant risk for suicide, in
                  the opinion of the investigator

          -  Participants must not be on a medicine that acts in the brain and spinal cord
A Study of LY3025876 in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: LY3025876; Placebo
Intervention description: Given as a subcutaneous injection; Given as a subcutaneous injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 41.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This trial is conducted in Singapore. The aim of this trial is to evaluate the safety and
      tolerability of the study drug in healthy people and investigate how much of the study drug
      gets into the blood stream and how long it takes the body to get rid of it. Information about
      any side effects that may occur will also be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be either a healthy male or a healthy female who cannot become pregnant

          -  Have a body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m^2),
             inclusive, at screening

        Exclusion Criteria:

          -  Are allergic to LY3025876 or related compounds

          -  Have a history of significant disease that may affect the actions of drugs or may pose
             a risk when taking the study medication

          -  Have a history of developing allergies, asthma, severe drug allergies (symptoms
             including, but not limited to, itching, red rashes, sores on the skin, scaling and
             shedding of skin), allergies or reactions to more than one drug, or have had bad
             reactions to skin creams containing corticosteroids. Corticosteroids are mainly used
             to control inflammation.
Staccato Prochlorperazine Single Dose PK Study
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Prochlorperazine 0.5 mg IV over 5 sec; Inhaled prochlorperazine 0.625 mg; Inhaled prochlorperazine 1.25 mg; Inhaled prochlorperazine 2.5 mg; Inhaled prochlorperazine 5 mg; Inhaled prochlorperazine 10 mg; Inhaled placebo; Prochlorperazine 10 mg IV over 5 sec
Intervention description: IV Prochlorperazine for bioavailability; Inhaled Staccato Prochlorperazine 0.625 mg; Inhaled Staccato Prochlorperazine 1.25 mg; Inhaled Staccato Prochlorperazine 2.5 mg; InhaledStaccato Prochlorperazine 5 mg; InhaledStaccato Prochlorperazine 10 mg; Inhaled Staccato Placebo (0 mg); Prochlorperazine 10 mg IV over 5 sec for patient qualification
Intervention MeSH terms: Prochlorperazine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Stage 1: open-label, single-dose stage with 3 treatment periods divided into 2 phases Stage 2: double-blind, placebo-controlled, dose-escalation treatment period
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Stage 2 was a double-blind, placebo-controlled, 4 step dose-escalation trial
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Migraine, Prochlorperazine aerosol

Summary:

      The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of
      inhaled prochlorperazine
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be male or female subjects between the ages 18 to 45 years, inclusive in
             good general health as determined by medical history, physical examination, 12-lead
             ECG, spirometry, blood chemistry profile, hematology, urinalysis and in the opinion of
             the Principal Investigator.

        Exclusion Criteria:

          -  Subjects with a known history of allergy or intolerance to phenothiazines or related
             drugs or who have any disease, by history, physical examination, or laboratory
             abnormalities that in the investigator's opinion, would present undue risk to the
             subject, or may confound the interpretation of study results.
Bioavailability of Doravirine (MK-1439) Experimental Nano Formulations in Healthy Adults (MK-1439-046)
Condition: Human Immunodeficiency Virus-1 (HIV-1)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: Treatment A: Doravirine 100 mg film coated tablet; Treatment B: Doravirine 150 mg tablet (40% drug loaded granule); Treatment C: Doravirine 150 mg tablet (30% drug loaded granule); Treatment D: Doravirine 150 mg tablet (50% drug loaded granule); Treatment E: Doravirine 100 mg tablet (30% drug loaded granule)
Intervention description: Single doravirine 100 mg film coated tablet administered orally at the start of Period 2; Single doravirine NF Type 1 dose (150 mg tablet [40% drug loaded granule]) administered orally at the start of Period 1; Single doravirine NF Type 2 dose (150 mg tablet [30% drug loaded granule])administered orally at the start of Period 3; Single doravirine NF Type 3 dose (150 mg tablet [50% drug loaded granule])administered orally at the start of Period 4; Single doravirine NF Type 4 dose (100 mg tablet [30% drug loaded granule]) administered orally at the start of Period 5
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study aims to evaluate and compare the relative bioavailability of different doravirine
      (MK-1439) experimental nano formulations (NFs) with that of a doravirine film coated tablet.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy participants

          -  have been a non-smoker and/or have not used nicotine or nicotine-containing products
             for at least approximately 3 months

        Exclusion Criteria:

          -  is a pregnant or a nursing female

          -  has a history of stroke, chronic seizures or major neurological disorder

          -  has a history of clinically significant endocrine, gastrointestinal, cardiovascular,
             hematological, hepatic, immunological, renal, respiratory, or genitourinary
             abnormalities or diseases

          -  has a history of neoplastic disease (including leukemia, lymphoma, malignant
             melanoma), or myeloproliferative disease