bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY2969822 in Healthy Participants
Condition: Healthy Volunteers
Intervention: LY2969822; Placebo
Intervention description: Capsules administered orally; Capsules administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 99.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate how safe LY2969822 (study drug) is and whether it
      causes any side effects. The study will also measure how much of the study drug gets into the
      blood stream and how long it takes the body to get rid of the study drug. This is the first
      time that this study drug is being given to participants. This study is for research purposes
      only and is not intended to treat any medical condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male participants must agree to use a reliable method of birth control in addition to
             having their partner use another method for the duration of the study and for 3 months
             after the last dose of LY2969822

          -  Female participants must not be of child-bearing potential

          -  Participants have a body mass index (BMI) of 18.5 to 29.9 kilogram per meter square
             (kg/m^2), inclusive, at screening

        Exclusion Criteria:

          -  Have participated, within the last 30 days (prior to first dose in this study), in a
             clinical trial involving an investigational product

          -  Have a significant history of or current cardiovascular, respiratory, hepatic, renal,
             gastrointestinal (GI), 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

          -  Intended use of over-the-counter medication within 14 days prior to dosing or during
             the study with the exception of vitamins and mineral supplements or occasional
             paracetamol or acetaminophen

          -  Intended use of herbal supplements or prescription medications, other than stable
             doses of thyroid or estrogen hormone replacement, within 14 days prior to dosing or
             during the study
Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Subjects
Condition: Healthy
Intervention: metformin; empagliflozin/metformin; empagliflozin
Intervention description: single dose of metformin given as tablets; Single dose empagliflozin/metformin given as fixed-dose combination tablet; single dose of empagliflozin given as tablet
Intervention MeSH terms: Metformin; Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose
      combination (FDC) tablet containing empagliflozin and metformin extended release compared to
      the free combination of empagliflozin and metformin extended release under fed conditions.
    

Eligibility criteria:

        Inclusion criteria:

        - Healthy male and female subjects

        Exclusion criteria:

        - Any relevant deviation from healthy condition.
Drug-Drug Interaction Study Between Colchicine and Atorvastatin
Condition: Healthy
Intervention: Colchicine; Atorvastatin; Colchicine
Intervention description: A single dose of 0.6 mg colchicine administered alone in the morning on Day 1.; Atorvastatin (1 x 40 mg tablet) administered once daily on Days 15-28.; A single dose of 0.6 mg colchicine administered with a single dose of 40 mg atorvastatin in the morning on Day 28 after an overnight fast.
Intervention MeSH terms: Colchicine; Atorvastatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pharmacokinetics

Summary:

      Colchicine is a substrate for cytochrome P450 3A4 (CYP3A4). In-vitro studies have indicated
      that the ortho-and para-hydroxylated metabolites of atorvastatin may be CYP3A4/5 competitive
      and mechanism-based inhibitors (MBI). This study will evaluate the effect of multiple doses
      of atorvastatin on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A
      secondary objective is to evaluate the safety and tolerability of this regimen in healthy
      volunteers. All study subjects will be monitored for adverse events throughout the study
      period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-45 years of age

          -  Non-smoking and non-pregnant (post-menopausal, surgically sterile or using effective
             contraceptive measures)

          -  Body mass index (BMI) greater than or equal to 18 and less than or equal to 32,
             inclusive

          -  Hemoglobin greater than or equal to 11.5g/dL

        Exclusion Criteria:

          -  Recent participation (within 28 days) in other research studies

          -  Recent significant blood donation or plasma donation

          -  Pregnant or lactating

          -  Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HbsAg), or hepatitis C virus (HCV)

          -  Recent (2-year) history or evidence of alcoholism or drug abuse

          -  History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or
             biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic,
             dermatologic, neurologic, or psychiatric disease

          -  Subjects who have used any drugs or substances known to inhibit or induce cytochrome
             (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose
             and throughout the study

          -  Drug allergies to colchicine or atorvastatin or any other HMG-CoA reductase inhibitor
             agents (i.e. simvastatin, lovastatin, rosuvastatin, fluvastatin, and pravastatin)
A Study of Nivolumab Safety and Pharmacokinetics in Patients With Severe Sepsis or Septic Shock.
Condition: Severe Sepsis
MeSH terms: Sepsis; Toxemia
Intervention: Nivolumab
Intervention description: Specified dose on specified days
Intervention MeSH terms: Nivolumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to evaluate the safety, tolerability and pharmacokinetics of Nivolumab in
      participants with severe sepsis or septic shock.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Men and women ages ≥ 18 years old

          -  Documented or suspected infection

          -  Severe sepsis or septic shock for at least 24 hours

          -  Sepsis-induced immunosuppression

          -  In Intensive Care Unit (ICU) with no plans to discharge in next 24 hours

        Exclusion Criteria:

          -  Previous episode of severe sepsis or septic shock with ICU admission during the
             current hospitalization

          -  Autoimmune disease

          -  Organ or bone marrow transplant

          -  Cancer treatment in the past 6 weeks

          -  Human immunodeficiency virus (HIV) infection and not on therapy prior to this episode
             of sepsis; hepatitis C virus(HCV) infection and still has virus (not cured); Chronic
             hepatitis B virus (HBV) infection and not on treatment

        Other protocol defined inclusion/exclusion criteria could apply
A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants
Condition: Healthy Participants
Intervention: Sotorasib
Intervention description: Oral tablet
Intervention MeSH terms: Sotorasib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sotorasib; AMG 510; Bioequivalence

Summary:

      The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose
      A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8
      tablets (reference).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male participants or female participants, between 18 and 60 years of age
             (inclusive), at the time of Screening.

          -  Body mass index, between 18 and 30 kg/m^2 (inclusive), at the time of Screening.

          -  Females of nonchildbearing potential.

        Exclusion Criteria:

          -  Inability to swallow oral medication or history of malabsorption syndrome.

          -  History of hypersensitivity, intolerance, or allergy to any drug compound, food, or
             other substance, unless approved by the Investigator (or designee) and in consultation
             with the Sponsor.

          -  Poor peripheral venous access.

          -  History or evidence, at Screening or Check in, of clinically significant disorder,
             condition, or disease, including history of myolysis, not otherwise excluded that, in
             the opinion of the Investigator (or designee), would pose a risk to participant safety
             or interfere with the study evaluation, procedures, or completion.
A Study of Ramucirumab (LY3009806) in Healthy Participants
Condition: Healthy
Intervention: Ramucirumab - IV; Placebo - IV; Ramucirumab - SC; Placebo - SC
Intervention description: Administered IV.; Administered IV.; Administered SC.; Administered SC.
Intervention MeSH terms: Ramucirumab; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates a new formulation of ramucirumab, a drug approved for several types of
      cancer.

      In this study of healthy participants, a small amount of ramucirumab will be given by
      injection either into a vein or just under the skin. Study doctors will measure the amount of
      ramucirumab in the bloodstream.

      Side effects and tolerability will be documented. The study will last for about 16 weeks for
      each participant, including screening and follow up. Screening is required within 28 days
      prior to entering the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy male or a female (not pregnant and agreeable to take birth control
             measures until study completion)

          -  Have a body weight greater than or equal to (≥)70 kilograms (kg) and body mass index
             (BMI) of 18 to 32 kilogram per square meter (kg/m ²), inclusive

          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine
             laboratory test results that are acceptable for the study

        Exclusion Criteria:

          -  Are currently participating in or completed a clinical trial within the last 30 days
             or any other type of medical research judged to be incompatible with this study

          -  Have previously participated or withdrawn from this study

          -  Have or used to have health problems or laboratory test results or ECG readings that,
             in the opinion of the doctor, could make it unsafe to participate, or could interfere
             with understanding the results of the study

          -  Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study
             screening
Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs
Condition: Crohn's Disease; Ileitis; Ileo-colonic and Colonic Crohn's Disease; Granulomatous Colitis; Regional Enteritis; Ulcerative Colitis
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Enteritis; Ileitis; Ulcer
Intervention: lumbar puncture; lumbar puncture
Intervention description: 2 lumbar punctures prior to treatment; study drug 225mg SC once a month X 3 doses.; 1 lumbar puncture before and after 3 doses; study drug 225mg SC once a month X 3 doses.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Crohn's disease lumbar puncture anti-MAdCAM monoclonal antibody PF-00547659 Ulcerative Colitis

Summary:

      Study is designed to show a lack of effect on white blood cells circulating in the spinal
      fluid.
    

Eligibility criteria:

        Inclusion Criteria:

          -  males and females >=18 and =<75 years

          -  For CD subjects: hsCRP > 5 mg/L and Harvey-Bradshaw Index > 8 OR when HBI cannot be
             determined (ie if stoma is present) or hsCRP < 5mg/L then: active lesions on
             colonoscopy or flexible sigmoidoscopy or active Crohn's disease on CT or MR
             enterography

          -  For UC subjects: diagnosis of UC > 3 months; must have endoscopy to confirm active
             disease during screening; total mayo score of 6 to 12 points and moderate to severe
             disease on endoscopy

        Exclusion Criteria:

          -  Pregnancy or breastfeeding

          -  TB or active enteric infections

          -  Entero vesicular fistulae

          -  Prior use of natalizumab or vedolizumab

          -  Right or left heart failure including symptomatic diastolic dysfunction or unexplained
             elevation of troponin I (>0.05 ng/mL)
A Study of 2 Different Formulations of Insulin Lispro in Healthy Participants
Condition: Healthy Volunteers
Intervention: Insulin Lispro
Intervention description: LY275585 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: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study involves 4 injections of insulin lispro and its purpose is to:

        -  Determine if 2 formulations of insulin lispro are treated by the body in a similar way.

        -  Compare how the 2 formulations of insulin lispro affect blood sugar level.

        -  Determine the safety of each insulin lispro formulations and any side effects that might
           be associated with them when given to healthy participants. The study is expected to
           last up to approximately 9 weeks for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are healthy males or females

          -  Body mass index (BMI) between 18.5 and 29.9 kilogram per meter squared (kg/m^2)

          -  Are nonsmokers

          -  Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and
             clinical laboratory test results within normal reference range at screening.

        Exclusion Criteria:

          -  History of first-degree relatives known to have diabetes mellitus

          -  Evidence of significant active neuropsychiatric disease

          -  Evidence of an acute infection with fever or infectious disease

          -  Intend to use over-the-counter or prescription medication (apart from vitamin/mineral
             supplements, occasional paracetamol, or birth control methods).

          -  Have used systemic glucocorticoids within 3 months prior to entry into the study.

          -  Have donated blood of 1 unit or more within the last 3 months prior to study entry

          -  Excessive alcohol intake

          -  Have a fasting venous blood glucose (fasting blood glucose [FBG], plasma) >6
             millimoles per liter (mmol/L) at screening

          -  Have positive hepatitis B surface antigen.
Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours
Condition: Advanced Solid Tumours
MeSH terms: Neoplasms
Intervention: PG545
Intervention description: PG545 Lyophilized Powder for Subcutaneous Injection. Patients will be dosed once weekly until they exhibit disease progression, are discontinued for reasons of tolerability, or the study reaches its defined end-point. This study is a dose escalation study with doses of 25 mg to 500 mg planned.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PG545; Phase I; Progen; antimetastatic; antiangiogenic; advanced cancer patients; solid tumors; solid tumours

Summary:

      This first-in-human study aims to establish the maximum tolerated dose of PG545 and to
      evaluate its safety in subjects with advanced solid tumours. In addition the study will
      explore whether PG545 exposure results in changes to chemicals produced by the body that are
      associated with cancer growth and spread.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >=18 years.

          -  Histological or cytological documentation of non hematologic, malignant solid tumour.

          -  Have failed at least one previous therapeutic regimen.

          -  Measurable disease according to RECIST 1.1.

          -  Life expectancy >= 12 weeks

          -  ECOG Performance Status of 0 or 1

          -  Written, signed and dated informed consent

          -  Able and willing to meet all protocol-required treatments, investigations and visits.

          -  Have adequate organ function

        Exclusion Criteria:

          -  Clinically significant non-malignant disease.

          -  Active CNS metastases.

          -  Subjects with uncontrolled diabetes.

          -  History of clinically significant adverse drug reaction to heparin or other
             anti-coagulant agents

          -  History of immune-mediated thrombocytopaenia or other platelet abnormalities or other
             hereditary or acquired coagulopathies.

          -  Concomitant use of aspirin (> 150 mg/day), NSAIDs (except COX-2 selective inhibitors),
             vitamin K antagonists (other than low-dose prophylactic use), heparin within two weeks
             prior to randomisation, or other anti-platelet drugs.

          -  History of severe allergic, anaphylactic or other significant adverse reaction to
             radiographic contrast media

          -  Known seropositivity to the human immunodeficiency virus (HIV)

          -  Women who are pregnant or breast-feeding.

          -  Women of child-bearing potential and male subjects who are partners of women of
             childbearing potential who are unable or unwilling to practice a highly effective
             means of contraception.

          -  Active substance abuse

          -  Subjects who have received an investigational agent within 28 days prior to Cycle 1
             Day 1.
Phase 1 Oral Solution Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects
Condition: Healthy Volunteers
Intervention: Apixaban
Intervention MeSH terms: Apixaban
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the bioavailability of Apixaban solution administered
      through NGT and washed with Dextrose 5% in water (D5W) or infant formula relative to Apixaban
      solution administered orally in healthy subjects
    

Eligibility criteria:

        Inclusion Criteria:

        - Healthy subjects as determined by no clinically significant deviation from normal in
        medical history, physical examination, ECGs, and clinical laboratory determinations

        Exclusion Criteria:

          -  Any significant acute or chronic medical illness

          -  Any history or evidence of abnormal bleeding or coagulation disorders, intracranial
             hemorrhage, or abnormal bleeding (including heavy menstrual bleeding that has resulted
             in anemia within the past 1 year) or coagulation disorders in a first degree relative
Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®
Condition: Leucocytosis
MeSH terms: Leukocytosis
Intervention: Leucostim®; Neupogen®
Intervention description: Leucostim® is filgrastim biosimilar.
Intervention MeSH terms: Lenograstim
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: neutrophil count; filgrastim; granulocyte colony-stimulating factor

Summary:

      BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety
      of single-injection of Leucostim® to healthy volunteers compared to Neupogen®
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent.

          -  Male gender.

          -  Age between 18 and 45 years.

          -  Normal body mass index.

          -  Verified diagnosis "healthy", established according to the anamnesis, physical
             examination and laboratory findings.

          -  Absence of alcohol or drug abuse.

        Exclusion Criteria:

          -  History of use of filgrastim.

          -  Allergy to any components of study drugs.

          -  Acute hemorrhage, donation of blood / plasma or blood transfusions during last 2
             months prior to enrollment in the study, history of chronic bleeding.

          -  Surgical interventions during last 30 days prior to screening or planed surgical
             intervention during the study.

          -  Any diseases that could interfere with pharmacokinetics of filgrastim, including
             chronic liver, liver or blood diseases, diseases of cardiovascular, lung and
             neuroendocrine systems.

          -  Fever with body temperature higher than 40°С.