bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Lasmiditan in Healthy Participants
Condition: Healthy
Intervention: Lasmiditan; Placebo
Intervention description: Oral administration; Oral administration
Intervention MeSH terms: Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2 Groups: Group 1 - Double-blind Randomized 2-Period Crossover, Group 2 - Open-label single dose
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to look at the amount of study drug that gets into the blood
      stream and how long it takes the body to get rid of it by comparing the results of healthy
      elderly participants to those of healthy young participants. The tolerability of the study
      drug will be evaluated. Information about any side effects that may occur will also be
      collected.

      This study will last up to approximately 19 days, not including screening. This study
      requires either one (Group 2) or two (Group 1) stays at the clinic each of at least four
      days/three nights. Participants will return for a follow-up seven days after last dose of
      study drug. Screening is required within 28 days prior to Day 1.

      This study is for research purposes only and is not intended to treat any medical condition.
    

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 19 to 35 kilograms per meter squared (kg/m²)
             inclusive, at the time of screening.

        Exclusion Criteria:

          -  Have known allergies to lasmiditan, related compounds or any components of the
             formulation.

          -  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.

          -  Show evidence of active renal disease or estimated glomerular filtration rate (eGFR)
             less than 60 milliliter per minute (mL/min) per 1.73 m².

          -  Show evidence of or positive serology for human immunodeficiency virus (HIV)
             infection, hepatitis B or C.

          -  Are women with a positive pregnancy test or women who are lactating.

          -  Have a clinically significant abnormality in the neurological examination.

          -  Have a history of syncope, presyncopy, uncontrolled vertigo, postural dizziness, or at
             risk for falls, as judged to be clinically significant by the investigator.

          -  Have orthostatic hypotension with or without dizziness and/or syncope at screening or
             Day -1 upon repeat testing, or a history of it.
A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients
Condition: Pharmacokinetics of Avycaz in ICU Patients
MeSH terms: Critical Illness
Intervention: Ceftazidime/avibactam
Intervention description: Ceftazadime/avibactam dosing in ICU patients
Intervention MeSH terms: Ceftazidime; Avibactam; Avibactam, ceftazidime drug combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to analyze the PK/PD of AvyCaz in critically ill patients in the
      Intensive Care Unit (12). This study will include medical and post-surgical patients who
      develop an infection where Avycaz can be utilized. Since these patients will have variable PK
      parameters, the investigators will also analyze (time-kill) these serum concentrations (ex
      vivo) against relevant clinical isolates (e.g. GNR with ESBL or KPC) from the ICU to
      determine microbiologic activity of Avycaz in critically ill patients with variable
      characteristics. Monte-Carlo simulations will also be conducted against clinical ICU isolates
      (JMI labs) to help determine appropriate dosing schedules based upon these PK parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥18y/o) patients with a medical or post-surgical infection such as skin/soft
             tissue infections, urinary infections, IA infections and pneumonia (including VAP)

          -  Patients requiring intensive care (critically ill patients) in the med/surg ICU
             (APACHE II score ≥ 15)

          -  Patients prescribed Avycaz for their infection will receive FDA recommended dosages
             and times of administration

          -  Written informed consent

        Exclusion Criteria:

          -  Pregnant Patients, patients older than 90 y/o, those with CrCl < 30 mL/min, patients
             with a BMI > 45 Kg/m2, patients unable to provide serum samples, and those with the
             risk of imminent death during the study
Pharmacokinetic Interaction Between SSP-004184 (SPD602) and Midazolam in Healthy Adult Subjects
Condition: Healthy
Intervention: Midazolam; SSP-004184SS
Intervention MeSH terms: Midazolam
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 and Midazolam in
      Healthy Adult Subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal healthy male and female volunteers between the ages of 18 and 65, inclusive

          -  Serum ferritin, hemoglobin and erythrocyte indices within normal range

        Exclusion Criteria:

          -  Evidence of any active or chronic disease
Study of Pembrolizumab (MK-3475) in Participants With Advanced Non-small Cell Lung Cancer (MK-3475-025/KEYNOTE-025)
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pembrolizumab
Intervention description: Intravenous infusion
Intervention MeSH terms: Pembrolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: PD1; PD-1; PDL1; PD-L1

Summary:

      This study is being done to evaluate the safety and efficacy of pembrolizumab (MK-3475) in
      participants with advanced non-small cell lung cancer (NSCLC) tumors that are positive for
      programmed cell death ligand 1 (PD-L1): the hypothesis is that treatment with pembrolizumab
      will result in a clinically meaningful Overall Response Rate (ORR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of non-small cell lung cancer
             (NSCLC) that is PD-L1 positive per central laboratory review

          -  At least one measurable lesion

          -  Radiographic progression of NSCLC after treatment with a platinum-containing doublet
             for Stage IIIB/IV or recurrent disease

          -  Eastern Cooperative Oncology Group (ECOG) Performance Scale 0 or 1

          -  Adequate organ function

        Exclusion Criteria:

          -  Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks
             of the first dose of trial treatment

          -  Systemic steroid therapy within 3 days prior to the first dose of trial treatment or
             any other form of immunosuppressive medication

          -  Expected to require any other form of systemic or localized antineoplastic therapy
             while on trial

          -  History of prior malignancy, with the exception of basal cell carcinoma of the skin,
             superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer

          -  Active central nervous system (CNS) metastases and/or carcinomatous meningitis

          -  Active autoimmune disease or documented history of autoimmune disease or syndrome that
             requires systemic steroids or immunosuppressive agents

          -  Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic
             T-lymphocyte-associated antigen-4 (CTLA-4) antibody

          -  Concurrent or past history of interstitial lung disease

          -  Pregnant or breast-feeding, or expecting to conceive or father children within the
             projected duration of the study, starting with screening visit through 120 days after
             the last dose of pembrolizumab
PENTA15: Pharmacokinetic Study of Once Versus Twice Daily Abacavir in HIV-1 Infected Children Aged 3 to <36 Months
Condition: HIV Infection
MeSH terms: Infections
Intervention: Intervention 1: PK assessment while on Twice Daily Abacavir; Intervention 2: PK assessment while on Once Daily Abacavir
Intervention description: Week 0; Week 4
Intervention MeSH terms: Abacavir; Dideoxynucleosides
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 3 Months
Maximum age: 36 Months
Healthy volunteers: No
Keywords: HIV; Abacavir; Lamivudine; Pharmacokinetics

Summary:

      To compare the plasma pharmacokinetic (PK) parameters of q24h versus q12h dosing of abacavir
      in HIV-1-infected infants and children aged 3 months to 36 months

      The secondary objectives of PENTA15 were:

      To compare the plasma PK parameters of q24h versus q12h dosing of lamivudine in
      HIV-1-infected infants and children aged 3 months to 36 months who were receiving lamivudine
      in combination with abacavir

      To compare age-related differences in the PK parameters of q24h versus q12h dosing of
      abacavir and lamivudine infants and children in 3 age groups (≥3 to <12 months, ≥12 to <24
      months and ≥24 to <36 months)

      To describe child and family acceptability of and adherence to q24h compared to q12h dosage
      regimens of abacavir and lamivudine
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants and children with confirmed presence of HIV-1 infection

          -  Infants and children aged 3 to <36 months

          -  Parents/guardians able and willing to give written, informed consent

          -  Currently on combination ART including Abacavir (ABC) oral solution with or without
             Lamivudine (3TC) oral solution, for at least 12 weeks and expected to stay on this
             regimen for at least a further 12 weeks.

          -  HIV-1 RNA viral load either;

               -  suppressed HIV-1 RNA viral load (i.e. <400 copies/ml)

               -  non-suppressed, but low, HIV-1 RNA viral load (i.e. 400-20 000 copies/ml). The
                  non-suppressed children should have had a stable or decreasing HIV-1 RNA viral
                  load prior to study entry and should be considered to be still gaining benefit
                  from the current regimen

          -  Stable or rising CD4+ cell percent prior to study entry and should not be expected to
             fall within the next 12 weeks.

        Exclusion Criteria:

          -  Intercurrent illness

          -  Receiving concomitant therapy except prophylactic antibiotics

          -  Abnormal renal or liver function (grade 3 or above)
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
Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Comparator: sitagliptin phosphate; Comparator: placebo (unspecified)
Intervention description: Sitagliptin tablet 100 mg, administered once daily before the morning meal.; Matching placebo tablet, administered once daily before the morning meal.
Intervention MeSH terms: Sitagliptin Phosphate
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: 30 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A clinical study to determine the safety, efficacy and the way sitagliptin works in patients
      with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has type 2 diabetes mellitus

          -  Males

          -  Females who are highly unlikely to become pregnant

          -  Participants poorly controlled without taking any, or taking one or two oral
             antidiabetic medications

        Exclusion Criteria:

          -  Participant has a history of type 1 diabetes mellitus or history of ketoacidosis

          -  Participant required insulin therapy within the prior 8 weeks

          -  Participant is on or has been taking TZDs such as Actos® (pioglitazone) or Avandia®
             (rosiglitazone) within the prior 12 weeks of the screening visit
Topical Avastin for Treatment of Corneal Neovascularization
Condition: Corneal Neovascularization
MeSH terms: Corneal Neovascularization; Neovascularization, Pathologic
Intervention: Topical Avastin 1%
Intervention description: Avastin (bevacizumab) 1%
Intervention MeSH terms: Bevacizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effectiveness and safety of Topical Bevacizumab
      (Avastin) for treatment of corneal neovascularization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, at least 18 years of age

          -  Clinical stable corneal neovascularization (as defined above)

          -  Ability to understand and provide informed consent to participate in this study and
             willingness to follow study instructions and likely to complete all required visits.

          -  All female patients of childbearing potential will be excluded. A female is considered
             to be of childbearing potential unless she is postmenopausal and without menses for 12
             months or without a uterus and/or both ovaries.

        Exclusion Criteria:

          -  Current or recent (≤ 1 month) systemic corticosteroid therapy or periocular
             corticosteroid injections to the study eye

          -  Current or recent (≤ 3 months) intravitreal drug injection to the study eye; recent (≤
             1 month) change in dose and frequency of topical steroids and/or non-steroidal
             anti-inflammatory agents

          -  Uncontrolled hypertension defined as systolic blood pressure of ≥ 150 mmHg or
             diastolic blood pressure of ≥ 90 mmHg; history of a thromboembolic event, including
             myocardial infarction or cerebral vascular accident

          -  Patients age 75 or older; history of renal abnormalities

          -  Recent (≤ 3 months ) or planned surgery

          -  History of coagulation abnormalities, including end stage liver disease or current
             anticoagulation medication other than aspirin (warfarin, heparin, enoxaparin, or
             similar anticoagulant agent)

          -  All female patients of childbearing potential (a female is considered to be of
             childbearing potential unless she is postmenopausal and without menses for 12 months
             or without a uterus and/or both ovaries)

          -  Any condition (including language barrier) that precludes patient's ability to comply
             with study requirements including completion of study
A Study of LY2940680 in Healthy Participants
Condition: Healthy Volunteers
Intervention: [^14C]-LY2940680
Intervention description: Administered as solution by mouth
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a single dose study of radiolabelled LY2940680 taken by mouth in healthy participants
      to study how the body absorbs and removes LY2940680 from the blood. This study is for
      research purposes only and is not intended to treat any medical condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy sterile males or surgically sterile females or postmenopausal
             females, as determined by medical history and laboratory assessments

          -  Have a body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m^2),
             inclusive

        Exclusion Criteria:

          -  Regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening

          -  Have consumed herbal supplements, grapefruit juice, grapefruits, grapefruit containing
             products, Seville orange juice, Seville oranges, star fruit, or star fruit juice
             within 7 days prior to dosing or intend to consume during the study

          -  Have donated blood of more than 500 milliliters (mL) within the last month

          -  Have participated in a [^14C]-study within the last 6 months prior to admission for
             this study

          -  Exposure to significant radiation within 12 months prior to dose (for example, serial
             X-ray or computed tomography scans, barium meal, current employment in a job requiring
             radiation exposure monitoring)

          -  Have a pattern less than once per 2 days to expel feces from the bowel through the
             rectum or acute constipation within 3 weeks of the day prior to dose
Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects
Condition: Healthy Adult Subjects
Intervention: MT-1186; MCI-186
Intervention description: Oral suspension; Intravenous formulation
Intervention MeSH terms: Edaravone
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate the single-dose bioequivalence of oral suspension and intravenous (IV)
      formulation of edaravone in the fasting state in healthy adult subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult male or female volunteers

          -  Japanese

          -  Subjects aged between 20 and 45 years at the time of informed consent

          -  Subjects who have thoroughly understood the contents of the study and voluntarily
             provided written informed consent to participate in the study

        Exclusion Criteria: Additional screening criteria check may apply for qualification:

          -  Subjects with a current or previous history of cardiac, hepatic, renal,
             gastrointestinal, respiratory, psychiatric/nervous, hematopoietic, or endocrine
             diseases, and those whom the investigator (or subinvestigator) deems unsuitable for
             the study

          -  Body mass index (BMI) of <18.0 or >30.0, or body weight of <50 kg (BMI formula: body
             weight [kg]/height [m]2, rounded to one decimal place)

          -  Subjects who have undergone any surgery known to affect the gastrointestinal
             absorption of drugs

          -  Female subjects who do not agree to use an effective method of contraception from
             screening or 2 weeks before the start of investigational product administration,
             whichever comes earlier, to 14 days after the completion (or discontinuation) of
             investigational product administration. Male subjects who do not agree to use an
             effective method of contraception from the start of investigational product
             administration to 14 days after the completion (or discontinuation) of investigational
             product administration

          -  Subjects who have previously received edaravone

          -  Subjects who have participated in another clinical study and received an
             investigational product within 12 weeks before providing informed consent