bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY900014 Administered in Participants With Type 1 Diabetes Using an Insulin Pump
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro (Humalog)
Intervention description: Administered subcutaneously (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: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study will be conducted in participants with type 1 diabetes mellitus to investigate how
      the human body processes LY900014, a new blood sugar lowering insulin, and its effect on
      blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability
      will be documented. The study will last about 4 to 11 weeks for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants with Type 1 Diabetes Mellitus (T1DM) who are receiving
             insulin therapy via an approved insulin pump

          -  Have a screening body mass index (BMI) of greater than 18.5 to 33.0 kilograms per
             meter squared (kg/m²), inclusive

          -  Have medical and laboratory test results that are acceptable for the study

          -  Have had no episodes of severe hypoglycemia (requiring assistance in treatment by a
             second party) in the past 6 months

          -  Have venous access sufficient to allow for blood sampling

          -  Have provided written consent and are willing to follow study procedures and commit to
             the study duration

        Exclusion Criteria:

          -  Are currently participating or recently participated in a clinical trial or any other
             type of medical research judged to be incompatible with this study

          -  Had blood loss of more than 500 milliliters (mL) within the last month

          -  Have known allergies to LY900014, insulin lispro, related compounds or any components
             in the study drug formulations

          -  Have previously participated or withdrawn from this study

          -  Have or used to have health problems or medical test results that, in the opinion of
             the doctor, could make it unsafe to participate, or could interfere with understanding
             the results of the study
A Study of Lasmiditan in Healthy Chinese Participants
Condition: Healthy
Intervention: Lasmiditan; Placebo
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Lasmiditan
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: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study of lasmiditan in healthy Chinese participants. The purposes are:

        -  To evaluate the safety of lasmiditan

        -  To learn more about how the body processes lasmiditan

      The study will last up to 50 days for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy Chinese (all 4 biological grandparents and both biological parents
             to be of Chinese origin) males or females, as determined by medical history and
             physical examination

          -  Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter, inclusive

          -  Are able and willing to give signed informed consent

        Exclusion Criteria:

          -  Have known allergies to lasmiditan, related compounds or any components of the
             formulation

          -  Have an abnormal blood pressure and/or pulse rate as determined clinically significant
             by the investigator

          -  Have a history of, show evidence of, or are undergoing treatment for significant
             active neuropsychiatric disease (for example, manic depressive illness, schizophrenia,
             depression)

          -  Have a history of central nervous system (CNS) conditions such as strokes, transient
             ischemic attack, significant head trauma, CNS infections, migraines, brain surgery, or
             any other neurological conditions that, in the opinion of the investigator, increases
             the risk of participating in the study

          -  Regularly use known drugs of abuse and/or show positive findings on drug screening
Safety Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 & Piperaquine to Healthy Subjects
Condition: Healthy
Intervention: 100mg OZ439 single oral dose; Placebo; 300 mg OZ439 single oral dose; 160mg Piperaquine single oral dose; 480mg Piperaquine single oral dose; 1440mg Piperaquine single oral dose; 800 mg OZ439 single oral dose
Intervention description: 100mg OZ439 oral suspension single dose; Placebo; 300mg OZ439 oral suspension single dose; 160 mg Piperaquine tablet; 480 mg Piperaquine tablet; 1440 mg Piperaquine tablet; 800mg OZ439 oral suspension single dose
Intervention MeSH terms: Piperaquine; Artefenomel
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy; Volunteers

Summary:

      A Phase I Study to investigate the safety, tolerability & pharmacokinetics of co-administered
      single doses of OZ439 and Piperaquine to healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males & females, 18-55 years old

          -  BMI 18 to 30kg/m2; total body weight >50kg

          -  Healthy, determined by pre-study medical history, physical examination vital signs, 12
             Lead ECG

          -  Females of non-childbearing potential.

          -  Males must agree to use a double barrier method of contraception

          -  Lab tests at screening within the reference ranges

        Exclusion Criteria:

          -  Any condition that could affect drug absorption, e.g. gastrectomy, diarrhea

          -  Clinically relevant abnormalities in ECG

          -  Family history of sudden death or of congenital prolongation of QTc interval - History
             of symptomatic cardiac arrhythmias or with clinically relevant bradycardia

          -  Electrolyte disturbances

          -  History of drug or alcohol abuse, tobacco users

          -  Participation in evaluation of any drug for 3 months before the study

          -  Administration of ANY systemic medication/herbal product within 14 days of first dose
             of study drug.

          -  unaccustomed strenuous exercise within 7 days of any study visit

          -  Alcohol consumption within 24 hours of any study visit

          -  Consumption of any fruit juice or food containing grapefruit within 7 days

          -  Positive test for HIV-1, HBsAg or HCV

          -  Positive urine drug screen at Screening or admission

          -  Severe allergies/multiple drug allergies

          -  Volunteers who have donated blood or experienced significant blood loss within 90 days
             of screening

          -  Hemoglobin below lower limit of the reference range

          -  Clinically relevant abnormal lab values indicative of physical illness
Relative Drug Exposures Of Two Formulations of PF-02341066
Condition: Healthy
Intervention: PF-02341066; PF-02341066
Intervention description: A 250-mg single dose of PF-02341066 administered as 1 x 50-mg Powder-in-Capsule and 2 x 100-mg Powder-in-Capsules; A 250-mg single dose of PF-02341066 administered as 1 x 50-mg Immediate Release Tablet and 2 x 100-mg Immediate Release Tablets
Intervention MeSH terms: Crizotinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: bioavailability, capsule, tablet, healthy volunteer

Summary:

      The study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over,
      single-dose study employing administration of two PF-02341066 formulations in the fasted
      state to healthy adult volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female of non-childbearing potential subjects between the ages of
             18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities
             identified by a detailed medical history, full physical examination, including blood
             pressure and pulse rate measurement, 12-lead electrocardiogram(ECG) and clinical
             laboratory tests).

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at time of dosing).

          -  Treatment with an investigational drug within 30 days (or as determined by the local
             requirement, whichever is longer) or 5 half-lives preceding the first dose of study
             medication.

          -  Pregnant or nursing females; females of childbearing potential, including those with
             tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who
             are postmenopausal (defined as being amenorrheic for at least 2 years) must have
             confirmatory Follicle-stimulating hormone(FSH) test results at Screening.
Bioequivalence of TF3 and TF2 and Effect of Food on the PK of Tepotinib
Condition: Healthy
Intervention: Tepotinib TF2; Tepotinib TF3
Intervention description: Participants received a single oral dose of 500 mg Tepotinib TF2 under fasting or fed conditions in treatment period 1 or 2.; Participants received single oral dose of 500 mg (2 x 250 mg)Tepotinib TF3 under fasting or fed conditions in treatment period 1 or 2.
Intervention MeSH terms: Tepotinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tepotinib; Pharmacokinetics; Bioequivalence

Summary:

      The main purpose of the study was to demonstrate bioequivalence between the new tablet
      formulation (TF3, test treatment) and the tablet formulation used in clinical studies (TF2,
      reference treatment) and to investigate effect of food on pharmacokinetics (PK) of tepotinib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants of non-child bearing potential

          -  Body weight between 50 to 100 kilogram (kg)

          -  Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m^2)

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Participation in a clinical study within 60 days prior to first drug administration

          -  Whole blood donation or loss of greater than 450 milliliter (mL) within 60 days prior
             to first drug administration

          -  Any surgical or medical condition, or any other significant disease that could
             interfere with the study objectives, conduct, or evaluation

          -  Other protocol defined exclusion criteria could apply
Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.
Condition: Retinal Degeneration; Primary Open-angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Retinal Degeneration
Intervention: Intravitreal transplantation of mesenchymal stem cell; Culture and isolation of autologous bone-marrow mesenchymal stem cells
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 40 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      Bone marrow-derived mesenchymal stem cells (MSC) therapy is a promising treatment for several
      degenerative diseases, including retinopathies and glaucoma, however no previous safety study
      involving humans has been conducted. The objective of this study is to evaluate effects of
      autologous bone marrow-derived MSC transplantation in the worst eye of 10 patients with legal
      bilateral blindness due to glaucoma. Primary outcome are types and severity of adverse
      effects. Secondary outcomes are changes in visual field, visual acuity, optical coherence
      tomography, and retinal ganglion cells function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Advanced Bilateral Open-Angle Glaucoma;

          -  Best corrected visual acuity less than 0,1 in the better eye;

          -  Social and cognitive ability to participate.

        Exclusion Criteria:

          -  Severe systemic morbidities;

          -  Other ocular blind conditions associated;

          -  Impossibility in performing any of the proposed examinations.
Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers
Condition: Healthy
Intervention: ST-246; Placebo
Intervention description: 250 mg, 400 mg or 800 mg capsules given once daily for 21 days; Capsules to match experimental drug
Intervention MeSH terms: Tecovirimat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Volunteers

Summary:

      The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a
      single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30
      healthy, fed volunteers.
    

Eligibility criteria:

        Subject Inclusion Criteria:

          -  Healthy volunteers

          -  Ability to Consent

          -  Not taking any other medication

          -  Adequate venous access

          -  Using adequate birth control

        Subject Exclusion Criteria:

          -  Inability to swallow study medication.

          -  Pregnant or breastfeeding

          -  Received experimental drug within 30 days of study entry or will participate in any
             experimental study during the study period.

          -  Current drug abuse, alcohol abuse, or homelessness.

          -  Taking concomitant medication

          -  Lactose Intolerance

          -  Medical condition; e.g., asthma, diabetes, thyroid disease, angioedema, BMI >35 or
             <18, hypertension, bleeding disorder, malignancy, seizure, neutropenia, Hepatitis B or
             C, HIV or AIDS.

          -  Any condition, occupational reason or other responsibility that, in the judgment of
             the Investigator, would jeopardize the safety or rights of a volunteer, or render the
             subject unable to comply with the protocol
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults
Condition: HIV-1 Infection
Intervention: Lenacapavir; Placebo; B/F/TAF; TAF
Intervention description: Administered subcutaneously in the abdomen; Administered subcutaneously in the abdomen; 50/200/25 mg tablets administered orally once daily; Tablets administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are:

      Part A: To evaluate the short-term antiviral activity of lenacapavir (formerly GS-6207) with
      respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day
      10 compared to placebo in HIV-1 infected adults who are antiretroviral treatment naive or are
      experienced but capsid inhibitor (CAI) naive.

      Part B: To evaluate the short-term antiviral activity of tenofovir alafenamide (TAF) with
      respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day
      10 in HIV-1 infected adult subjects who are antiretroviral treatment naïve or are experienced
      but without resistance to TAF.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Plasma HIV-1 RNA ≥ 5,000 copies/mL but ≤ 400,000 copies/mL and CD4+ cell count > 200
             cells/mm^3

          -  Treatment naive or experienced but CAI (for Part A only) and integrase strand transfer
             inhibitor (INSTI) naïve, and have not received any antiretroviral therapy (ART) within
             12 weeks of screening

          -  Screening genotype report must show sensitivity to B/F/TAF to allow its initiation on
             Day 10

          -  Screening genotype report must show sensitivity to at least one agent in either
             non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI)
             class to allow its use as part of standard of care oral antiretroviral treatment in
             the future

          -  Have adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min)

          -  No clinically significant abnormalities in electrocardiography (ECG) at Screening

          -  Willing to initiate B/F/TAF on Day 10 after completion of all assessments

        Key Exclusion Criteria:

          -  Pregnant or lactating females

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of Two Formulations of Ixekizumab in Healthy Participants
Condition: Healthy
Intervention: Ixekizumab
Intervention description: Administered SC.
Intervention MeSH terms: Ixekizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare two different formulations of ixekizumab. One
      formulation (Reference) is approved by the Food and Drug Administration (FDA) and one
      formulation (Test) is not approved. This study will compare how much of each formulation gets
      into the blood stream. Information about any side effects that may occur will also be
      collected. The study will last up to about four months for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are healthy male or female participants, with chronic stable medical problems, that in
             the investigator's opinion will not place the subject at increased risk by
             participating in the study

        Exclusion Criteria:

          -  Have a significant history of, or current, cardiovascular, respiratory, hepatic,
             renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of
             the investigator poses an unacceptable risk to the participant if participating in the
             study

          -  Are allergic or hypersensitive to the study medicine

          -  Had a vaccination with a live vaccine within 12 months prior to the first check-in or
             intend to get a vaccine for tuberculosis within 12 months of completing treatment on
             this study

          -  Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other
             serious infection

          -  Show evidence of active or latent tuberculosis (TB)

          -  Presence of significant neuropsychiatric disorder or a recent history of depression

          -  Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion
             of the investigator, would pose an unacceptable risk to the participant
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
Condition: Respiratory Syncytial Virus
MeSH terms: Virus Diseases
Intervention: Placebo; MEDI8897 10 mg; MEDI8897 25 mg; MEDI8897 50 mg
Intervention description: Participants will receive placebo intramuscularly.; Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.; Participants will receive a single dose of MEDI8897 25 mg intramuscularly.; Participants will receive a single dose of MEDI8897 50 mg intramuscularly.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 151.0
Sex: All
Maximum age: 12 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Respiratory Syncytial Virus, RSV

Summary:

      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an
      extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to
      placebo when administered to healthy preterm infants.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Healthy infants born between 32 weeks 0 days and 34 weeks 6 days gestational age

          -  Infants who are entering their first RSV season at the time of screening

        Key Exclusion Criteria:

          -  Gestational age < 32 weeks 0 days and >34 weeks 6 days

          -  Meets AAP or other local criteria to receive commercial palivizumab

          -  Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or lower respiratory illness
             within 7 days prior to randomization

          -  Acute illness (defined as the presence of moderate or severe signs and symptoms) at
             the time of randomization

          -  Active RSV infection (a child with signs/symptoms of respiratory infection must have
             negative RSV testing) or known prior history of RSV infection

          -  Receipt of palivizumab or any RSV vaccine, including maternal RSV vaccination