bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Tamiflu
Intervention description: 10 doses over 5 or 6 days of which the first 5 or 6 doses must be intravenous, up to 5 days (10 doses) of additional intravenously or oral treatment if virus shedding continues at day 6
Intervention MeSH terms: Oseltamivir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Maximum age: 365 Days
Healthy volunteers: No

Summary:

      This open-label study will assess the pharmacokinetics and safety of oseltamivir [Tamiflu] in
      3 cohorts of infants, aged 0-30 days, 31-90 days and 91-<365 days with influenza infection.
      Patients will receive 10 doses of intravenous oseltamivir [Tamiflu] therapy over 5 or 6 days.
      Optional oral therapy with oseltamivir [Tamiflu] may be considered following the intravenous
      dose associated with pharmacokinetic blood sampling. Evidence of continued virus shedding at
      day 6 can allow for up to 5 additional days (10 doses) of oral or intravenous administration.
      Anticipated time on study drug is 5-11 days. Target sample size is <50 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infant patients

          -  Date of birth to date of enrollment is <1 year

          -  Diagnosis of influenza

          -  Duration of influenza symptoms </=96 hours prior to first dose

          -  - Parent/guardian willing to have patient receive intravenous therapy for 3 or 4 days
             (5 or 6 doses of study drug)

        Exclusion Criteria:

          -  Date of conception to date of birth + date of birth to enrollment is <36 weeks

          -  Creatinine clearance <30 mL/min/1.73m2

          -  Patients receiving any form of renal replacement therapy at baseline

          -  Clinical evidence of severe hepatic decompensation at the time of enrollment

          -  Patients taking probenecid medication within 1 week prior to study day 1 or during the
             study
A Safety Study of LY2886721 Single Doses in Healthy Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: LY2886721; Placebo
Intervention description: Oral capsules; Oral capsules
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of
      LY2886721 single doses, how the body handles the drug, and the drug's effect on the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men and nonchild-bearing potential women

          -  20 years or older

          -  Body mass index between 18-32 kilograms per square meter (kg/m^2)

        Exclusion Criteria:

          -  Taking over-the-counter or prescription medication with the exception of vitamins or
             minerals or stable doses of thyroid or estrogen hormone replacement

          -  Smoke more than 10 cigarettes per day
A Dose Escalation, Dose Expansion Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, in Subjects With Advanced Tumors.
Condition: Cancer
Intervention: MEDI-575
Intervention description: MEDI-575 as an IV infusion
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Evaluate the safety, tolerability and the tolerated maximum dose of MEDI-575 in adult
      subjects with advanced solid tumors refractory to standard therapy or for which no standard
      therapy exists.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed advanced solid tumor for which no curative or standard
             therapies exist

          -  Karnofsky performance status of ≥ 60

          -  Life expectancy of >12 weeks

          -  Adequate hematologic and organ function

          -  Negative serum pregnancy test (women only)

          -  Two methods of birth control for female participants of child-bearing potential or
             male participants with their female partners of child-bearing potential

        Exclusion Criteria:

          -  Prior chemotherapy or investigational treatment within 4 weeks of study drug
             administration

          -  Prior biological or immunological treatment within 6 weeks of study drug
             administration

          -  Concurrent therapy for of cancer

          -  Major surgery within four weeks or minor surgery within two weeks of study drug
             administration

          -  History of diabetes or current treatment for diabetes

          -  New York Heart Association ≥ Grade 2 congestive heart failure

          -  History of myocardial infarction, unstable angina, transient ischemic attack or stroke
             within the previous 6 months prior to study entry

          -  History of other invasive malignancy within 5 years (exceptions are cervical carcinoma
             in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the
             breast that are surgically cured)

          -  Significant active infection

          -  Known brain metastases

          -  Pregnancy or lactation or plans to become pregnant while on study

          -  Clinically significant abnormality on ECG
Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults
Condition: Pneumococcal Vaccines
MeSH terms: Pneumonia; Pneumonia, Pneumococcal
Intervention: Placebo; SPWCV+Alum 100 mcg; SPWCV+Alum 600 mcg; SPWCV+Alum 300 mcg
Intervention description: 3 cohorts of normal saline injection; 3 injections 28 days apart; 3 injections 28 days apart; 3 injections 28 days apart
Intervention MeSH terms: Aluminum sulfate
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine
      (SPWCV) given with alum is safe and well tolerated by healthy adults.
    

Eligibility criteria:

        Inclusion Criteria, Healthy adults:

          -  If female, not breastfeeding, not pregnant, not planning pregnancy during study
             period), and willing to consistently use an adequate method of contraception and have
             repeated pregnancy tests.

          -  In good health with normal laboratory results

          -  Willing to comply with study restrictions, study schedule, and can be reliably
             contacted

        Exclusion Criteria:

          -  Currently consumes alcohol in excess of 2 drinks per day for men or 1 drink per day
             for women.

          -  current use or likely requirement for medications with potential for liver injury or
             effect immune system

          -  History of event or condition such as anaphylaxis, severe allergic reactions, serious
             reactions to any vaccines, or other events that might increase risk of reaction to an
             investigational disease

          -  History of diabetes, cancer, autoimmune or immunosuppressive disease or chronic such
             as HIV, Hepatitis B or C
A Study of Prasugrel in Healthy Participants
Condition: Healthy Volunteers
Intervention: Prasugrel ODT1 - Tablet; Prasugrel ODT2 - Tablet; Prasugrel ODT2 - Suspension
Intervention description: Administered orally as tablet.; Administered orally as tablet.; Administered orally as suspension.
Intervention MeSH terms: Prasugrel Hydrochloride
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the amount of drug available in the body when given
      to healthy participants as two different formulations with or without a meal. In addition,
      this study will evaluate how much of the drug gets into the blood stream and how long the
      body takes to get rid of it. Information about any side effects that may occur will also be
      collected. Each participant will receive a total of five different treatments. Each treatment
      is given by mouth, once a day. The treatment period lasts for five consecutive days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m^2)

        Exclusion Criteria:

          -  No known allergies to Prasugrel or related compound

          -  No regular alcohol intake greater than 21 units per week for males or 14 units per
             week for females
An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants
Condition: Sepsis
Intervention: Daptomycin
Intervention description: single dose of 6 mg/kg of daptomycin
Intervention MeSH terms: Daptomycin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 48 Hours
Maximum age: 120 Days
Healthy volunteers: No
Keywords: Infants; Daptomycin

Summary:

      This is a safety and pharmacokinetic study of single-dose daptomycin in infants > 48 hours
      and < 120 days of age with suspected systemic infections. The investigators will enroll a
      total of 24 infants in 4 gestational age/postnatal age cohorts. Interim analyses will be
      performed after 3 infants are enrolled in each cohort. The investigators anticipate that 6
      mg/kg of daptomycin will yield an AUC <740 mch*hr/mL.
    

Eligibility criteria:

        Inclusion Criteria:

          1. > 48 hours and <120 days of age at the time of daptomycin administration

          2. Sufficient venous access to permit administration of study medication

          3. Suspected to have systemic infection and appropriate cultures (blood +/- urine/CSF)
             are obtained within 72 hours of study entry

          4. Availability and willingness of the parent/legally authorized representative to
             provide written informed consent

        Exclusion Criteria:

          1. History of anaphylaxis attributed to daptomycin

          2. Previous participation in the study

          3. Exposure to daptomycin in the month prior to the study

          4. Serum creatinine >1.0 mg/dL

          5. Concomitant administration of tobramycin
Phase I Imaging Study Evaluating Gem/Cis or Gem/Carbo for Participants With Non-Small Cell Lung Cancer (MK-0000-083 AM3)
Condition: Carcinoma; Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Comparator: CT or MRI and FDG-PET; Gemcitabine and Cisplatin or Gemcitabine and Carboplatin
Intervention description: Participants have 4 computed tomography (CT) or magnetic resonance imaging (MRI) scans at screening, baseline, at the end of each treatment cycle (day 21 and day 42.) They also have FDG-PET scans, 2 at Baseline and one at the end of each treatment cycle.; Gemcitabine administered intravenously at a dose of 1000-1250 mg/m^2 on Day 1 and Day 8 of each cycle; Cisplatin administered intravenously at a dose of 60-85 mg/m^2 or Carboplatin at a dose of 4-6 Area Under the Curve (AUC) on Day 1 of each cycle. Two cycles are given 3 weeks apart.
Intervention MeSH terms: Carboplatin; Gemcitabine
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will use imaging to look at tumor response to combination chemotherapy of
      gemcitabine (Gem) and cisplatin (Cis) or gemcitabine and carboplatin (Carbo) in non small
      cell lung cancer (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has histologically or cytopathologically confirmed metastatic or locally advanced
             stage IIIB/IV Non-small cell lung cancer (NSCLC)

          -  Has measurable disease

          -  Has not been previously treated with surgery (involving the thorax), radiation (unless
             it was for a metastatic site), or chemotherapy for NSCLC

          -  Is 18 years of age or older

          -  Has a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale

          -  Women of childbearing potential have a negative pregnancy test

        Exclusion Criteria:

          -  Is participating in or has participated in a study with an investigational compound or
             device within 30 days or 5 half-lives of the start of treatment

          -  Has untreated brain metastases related to their NSCLC or carcinomatous meningitis

          -  Abuses drugs or alcohol

          -  Is pregnant or breastfeeding

          -  Is Human Immunodeficiency Virus (HIV) positive

          -  Has active viral hepatitis

          -  Has hearing loss

          -  Has poorly controlled diabetes mellitus

          -  Is allergic to gemcitabine, cisplatin or carboplatin
Comparison Bioequivalence Study: Pre-filled Syringe (Reference) Versus Auto-injection Device (Test)
Condition: Healthy
Intervention: Certolizumab pegol; Certolizumab pegol
Intervention description: Auto-injection device (test) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections; Pre-filled syringe (reference) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: certolizumab pegol; Cimzia; bioequivalence; Comparison Bioequivalence Study

Summary:

      To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x
      200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an
      auto-injection device (test).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 18-55 years.

          -  A Body mass Index (BMI) of 18 to 28 kg/m

          -  Good physical and mental health status determined on the basis of the medical history
             and a general clinical examination

          -  Electrocardiogram and clinical laboratory tests interpreted as "normal"

          -  QuantiFERON-TB test negative

          -  female subjects: medically accepted method of contraception

        Exclusion Criteria:

          -  prohibited concomitant medication

          -  administered vaccines and immunoglobulins in the month preceding the certolizumab
             pegol injection

          -  history of significant disease, allergies

          -  history of drug and/or alcohol abuse

          -  hepatic enzyme inducing drug within 2 months before study drug administration

          -  any drugs having influence of the immune response and antibiotic in the month
             preceding the inclusion

          -  known to be intolerant to PEG

          -  previously received certolizumab pegol

          -  previously received an antibody product within 5-half lives of the antibody or within
             3 months of the start of the study

          -  history of tuberculosis

          -  have serum hepatitis or is carrier of the Hepatitis B surface antigen (HBs Ag), or
             Hepatitis C antibody or who is HIV positive
The Effects of Smell on Mood and Physical Responses
Condition: Stress; Anxiety; Depression
MeSH terms: Depression
Intervention: Exposure to relaxant and stimulant odors
Intervention description: A yellow-tinted cotton ball containing 100 ml of the essential oil or distilled water was taped between the nose and upper lip on top of a piece of surgical tape; use of the barrier tape avoided percutaneous absorption . This method provided continuous and uniform exposure across subjects that would not have been possible with ambient room inhalation, and helped maintain experimenter blindness.
Intervention MeSH terms: Central Nervous System Stimulants
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 44 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Aromatherapy; Smell

Summary:

      The purpose of this study is to examine the body's response to relaxing and stimulating
      fragrances commonly used in aromatherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults with a normal sense of smell

        Exclusion Criteria:

          -  Treatment with medication that has immunological or endocrinological consequences

          -  Chronic health problems that affect immune or endocrine systems

          -  Allergy to perfume or cosmetics

          -  Problems with sense of smell

          -  Respiratory problems

          -  Smoker

          -  Current active asthma

          -  Use of psychoactive drugs or mood-altering medication

          -  History of anxiety disorder, major depression, bipolar disorder, schizophrenia, or
             other psychotic disorders

          -  History of chest pain or ventricular fibrillation
A Study of Lasmiditan in Healthy Japanese and Caucasian 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: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 27.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to evaluate the safety and tolerability of lasmiditan in
      healthy Japanese and Caucasian participants. The study will also investigate how much
      lasmiditan gets into the bloodstream and how long it takes the body to get rid of lasmiditan
      when given to Japanese and Caucasians. The study will last up to 47 days for each
      participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy Japanese (first generation) or Caucasian males or females, as
             determined by medical history and physical examination

          -  Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

        Exclusion Criteria:

          -  Have known allergies to lasmiditan, related compounds or any components of the
             formulation of lasmiditan

          -  Have previously received the investigational product in this study, withdrawn from
             this study, or received lasmiditan in any other study investigating lasmiditan

          -  Have an abnormal supine blood pressure at screening.

          -  Have a history of syncope, presyncope, uncontrolled vertigo, postural dizziness, or a
             risk of falls, as judged to be clinically significant by the investigator, or have
             orthostatic decreases in supine blood pressure of >20 millimeters of mercury (mmHg),
             or have orthostatic decreases in diastolic blood pressure of >10 mmHg at screening.

          -  Are women who are pregnant, lactating, or have a positive pregnancy test at screening
             or admission to the clinical research unit (CRU)

          -  Have donated blood of more than 500 milliliters (mL) within 1 month prior to screening
Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061)
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Comparator: sitagliptin phosphate; Comparator: pioglitazone; Comparator: placebo to pioglitazone; Comparator: placebo to sitagliptin
Intervention description: sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily.; pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.; pioglitazone 30 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.; sitagliptin phosphate 100 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
Intervention MeSH terms: Pioglitazone; Sitagliptin Phosphate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 211.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus (T2DM)

Summary:

      A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin
      alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who
      have inadequate glycemic (blood sugar) control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has type 2 diabetes mellitus

          -  Male

          -  Female that is highly unlikely to become pregnant

          -  Patient is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7-10%) or on
             oral single AHA or low-dose combination therapy (A1C 6.5-9.0%)

        Exclusion Criteria:

          -  Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis

          -  Patient has required insulin therapy within the past 12 weeks

          -  Patient is on or has been taking a Peroxisome Proliferator-Activated Receptor-gamma
             (PPAR -gamma) agent (i.e. Thiazolidinediones [TZDs]) within the prior 12 weeks of the
             screening visit.