bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability
Condition: Advanced Solid Malignancy,; Safety and Tolerability,; Pharmacokinetics, Pharmacodynamics,; Tumour Response,
MeSH terms: Neoplasms
Intervention: AZD5363; AZD5363
Intervention description: Oral AZD5363 twice daily, 4 days on 3 days off: tablet formulation for one week, followed by two weeks with capsule formulation.; Oral AZD5363 twice daily, 4 days on 3 days off, tablet formulation. On day 4 AZD5363 tablet without food. On day 11 AZD5363 tablet with food.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Advanced solid malignancy, AZD5363,; food effect,; formulation comparison

Summary:

      Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure,
      Safety and Tolerability
    

Eligibility criteria:

        Inclusion Criteria: -

          -  Aged at least 18 years

          -  The presence of a solid, malignant tumour, excluding lymphoma, that is resistance to
             standard therapies or for which no standard therapies exist

          -  The presence of at least one lesion that can be accurately assessed at baseline by
             Computerised Tomography (CT), Magnetic Resonance Imaging (MRI) or plain X-ray and is
             suitable for repeated assessment

          -  Estimated life expectancy of more than 12 weeks

        Exclusion Criteria: -

          -  Clinically significant abnormalities of glucose metabolism

          -  Spinal cord compression or brain metastases unless asymptomatic, treated and stable
             (not requiring steroids)

          -  Evidence of severe or uncontrolled systemic diseases, including active bleeding
             diatheses or active infections including hepatitis B, C and Human Immunodeficiency
             Virus (HIV)

          -  Evidence of clinically significant cardiac abnormalities, uncontrolled hypotension,
             left ventricular ejection fraction below the lower limit of normal for the site or
             experience of significant cardiac interventional procedures

          -  A bad reaction to AZD5363 or any drugs similar to it in structure or class
Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects
Condition: Healthy
Intervention: SB8; EU sourced Avastin®; US Sourced Avastin®
Intervention description: SB8, proposed bevacizumab biosimilar; EU sourced Avastin® (bevacizumab, Roche Registration Ltd.); US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)
Intervention MeSH terms: Bevacizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 119.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of
      Bevacizumab
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects

          -  Have body weight between 65.0-90.0 kg (inclusive) and body mass index between
             20.0-29.9 kg/m2 (inclusive)

        Exclusion Criteria:

          -  Have a history of hypersensitivity or allergic reactions to bevacizumab or to any of
             the excipients

          -  Have a history of and/or current clinically significant gastrointestinal, renal,
             hepatic, cardiovascular, haematological, pulmonary, neurologic, metabolic,
             psychiatric, or allergic disease excluding mild asymptomatic seasonal allergies

          -  Have a history of arterial thromboembolic events including cerebrovascular accidents,
             transient ischaemic attacks, and myocardial infarction

          -  Have a history of and/or current cardiac disease

          -  Have previously been exposed to vascular endothelial growth factor (VEGF) antibody,
             any other antibody, or protein targeting the VEGF receptor

          -  Have a history of cancer including lymphoma, leukaemia, and skin cancer.

          -  Have received live vaccine(s) within 30 days prior to Screening visit or who will
             require a vaccine(s) between Screening and the end of study visit

          -  Have taken medication with a half-life of > 24 hours within 30 days or 10 half-lives
             of the medication prior to the IP administration
Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze
Condition: Osteosarcoma; Leukemia; Lymphoma
MeSH terms: Osteosarcoma
Intervention: glucarpidase, high-dose methotrexate, leucovorin; high-dose methotrexate, leucovorin
Intervention description: single intravenous dose; standard of care, leucovorin every 6 hours
Intervention MeSH terms: Leucovorin; Methotrexate; Levoleucovorin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Healthy volunteers: No
Keywords: high dose methotrexate; Voraxaze; leucovorin; delayed elimination; methotrexate toxicity; rescue; renal insufficiency

Summary:

      The purpose of this study is to investigate whether the administration of Voraxaze reduces
      exposure to leucovorin and its active metabolite to below the level achieved in patients who
      have not received Voraxaze.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receiving High-dose methotrexate (HDMTX) with or without risk of methotrexate (MTX)
             toxicity, impaired renal function, and delayed MTX elimination

          -  Require intravenous leucovorin

        Exclusion Criteria:

          -  Arm A only: allergic reactions to lactose

          -  Arm A only: hereditary fructose or galactose intolerance

          -  Arm B only: delayed elimination of MTX
Pharmacokinetics of Co-administration of Seretide 250 Diskus (HCP0910) and Spiriva Capsule for Inhalation (HGP1011)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: HCP0910 and HGP1011
Intervention description: Inhalation of HCP0910 (Seretide 250 diskus (Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 72.5 mcg)) and HGP1011 (Spiriva capsule for inhalation (Micronized Tiotropium Bromide Monohydrate 22.5 mcg))
Intervention MeSH terms: Fluticasone; Tiotropium Bromide; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Screening
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Male
Minimum age: 19 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This pilot study was designed to evaluate the pharmacokinetic characteristics of fluticasone,
      salmeterol, and tiotropium after co-administration of HCP 0910 (Seretide 250 diskus) and
      HGP1011 (Spiriva capsule for inhalation) which are prescribed concomitantly for the patients
      with chronic obstructive pulmonary disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age between 19 to 45, healthy male subjects (at screening)

          -  Body weight between 55kg - 90kg, BMI (Body Mass Index) between 18.0 - 27.0

          -  Volunteer who totally understands the progress of this clinical trials, make decision
             by his free will, and signed a consent

        Exclusion Criteria:

          -  Volunteer who has past or present history of any diseases such as liver including
             hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine,
             hematooncology, cardiology, mental disorder

          -  Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction

          -  Subject who already participated in other trials in 3 months

          -  Subject who had whole blood donation in 2 months, or component blood donation in 1
             months or transfusion
A Study of Japanese Rheumatoid Arthritis Participants
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: LY2127399
Intervention description: Administered subcutaneously every 4 weeks for 48 weeks
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and tolerability of 48 weeks
      subcutaneous (SC) dosing with LY2127399 for participants who have participated in a prior
      LY2127399 clinical study. At the end of the 48-week treatment period, participants will
      participate in a 24-week follow-up period. Additional follow up after Week 72 may continue to
      assess B-cell recovery.
    

Eligibility criteria:

        Inclusion criteria

          -  Have given written informed consent

          -  Women must not be pregnant, breastfeeding or be at risk to become pregnant during
             study participation

          -  Must have completed treatment and 12 week follow up period in prior LY2127399 study
             NCT01253226 [Study H9B-JE-BCDK (BCDK)]

        Exclusion criteria

          -  Have had any safety event during the previous LY2127399 (BCDK) study that participants
             participated in

          -  Have received, during previous study (BCDK), any drugs prohibited in the study
             protocol which includes unapproved drugs, live vaccines, or any biologic or
             non-biologic disease-modifying anti-rheumatic drug (DMARD) except for, methotrexate
             (MTX), hydroxychloroquine, sulfasalazine or bucillamine
A Study of Tirzepatide at Different Injection Sites in Participants With Different Body Sizes
Condition: Healthy
Intervention: Tirzepatide
Intervention description: Tirzepatide administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the amount of tirzepatide that gets into the blood
      stream and how long it takes the body to get rid of it, when injected under the skin of the
      upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and
      females with different body sizes. The tolerability of tirzepatide will be evaluated and
      information about any side effects experienced will be collected. For each participant, the
      study will last about 20 weeks, including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males or females of nonchildbearing potential as determined by medical
             history, physical examination, and other screening procedures

          -  Are between the body mass index (BMI) of 18.5 and 45.0 kilograms per meter squared
             (kg/m²), inclusive, at screening

          -  Are agreeable to receiving study treatment by injections under the skin

        Exclusion Criteria:

          -  Have known allergies to tirzepatide or related compounds

          -  Have a personal or family history of medullary thyroid carcinoma or have multiple
             endocrine neoplasia syndrome type 2

          -  Have a history or presence of pancreatitis (history of chronic pancreatitis or
             idiopathic acute pancreatitis), elevation in serum amylase or lipase or
             gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder
             disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery,
             pyloric stenosis, with the exception of appendectomy) or could be aggravated by
             glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors

          -  Have a prior history of malignant disease(s) in the past 5 years prior to screening

          -  Smoke more than the equivalent of 10 cigarettes per day

          -  Is a known user of drugs of abuse
A Study of Evacetrapib and Digoxin in Healthy Participants
Condition: Healthy Volunteers
Intervention: Evacetrapib; Digoxin
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Digoxin; Evacetrapib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to determine how much digoxin gets into the blood stream
      and how long it takes the body to get rid of it when given with the study drug evacetrapib.
      This study will also look at the effect of evacetrapib on the removal of digoxin from the
      body by the kidneys. Information about any side effects that may occur will be collected.
      This study will last approximately 33 days for each participant, not including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy males and females (of non-childbearing potential)

          -  Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)

          -  Normal renal function

        Exclusion Criteria:

          -  Participants who currently smoke or use tobacco or nicotine products
Phase I Combination Ixabepilone + Cisplatin
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Ixabepilone; Cisplatin; Ixabepilone; Cisplatin
Intervention description: Escalation: Solution, intravenous (IV), 32-40 mg/m2, every 3 weeks, approximately 6 months; Escalation: Solution, IV, 60-100 mg/m2, every 3 weeks, approximately 6 months; Expansion: Solution, IV, 32 mg/m2, every 3 weeks, approximately 6 months; Expansion: Solution, IV, 60-80 mg/m2, every 3 weeks, approximately 6 months
Intervention MeSH terms: Cisplatin; Epothilones
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Cancer (NSCLC)

Summary:

      The purpose of this study is to determine the highest dose of ixabepilone that can be given
      safely with cisplatin without causing severe or life-threatening side effects and for some
      patients with non-small cell lung cancer, the effects (good or bad) on your cancer will also
      be studied
    

Eligibility criteria:

        Escalation Phase Subjects: Primary solid tumor not curable by local measures such as
        surgery, radiation

        Inclusion Criteria:

          -  Men and women age ≥ 18

        Exclusion:

          -  More than 2 prior chemotherapy containing regimens for metastatic disease

          -  No prior exposure to cisplatin or ixabepilone

        Expansion Phase Subjects: Advanced Non-small cell lung cancer

        Inclusion Criteria:

          -  Men and women age ≥ 18

        Exclusion:

          -  No prior chemotherapy-containing regimen for metastatic disease

          -  No prior exposure to cisplatin or ixabepilone
Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)
Condition: Corneal Neovascularization
MeSH terms: Corneal Neovascularization; Neovascularization, Pathologic
Intervention: Ranibizumab
Intervention description: 10 Patients will receive treatment (Ranibizumab)
Intervention MeSH terms: Ranibizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effectiveness and safety of ranibizumab
      (Lucentis) in treatment of corneal neovascularization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide written informed consent and comply with study assessments for the
             full duration of the study

          -  Age > 18 years old

          -  Patients with superficial or deep corneal neovascularization that extends farther than
             2 mm from the limbus

        Exclusion Criteria:

          -  Has received investigational therapy within 60 days prior to study entry

          -  Has received treatment with anti-VEGF agents (intraocular or systemic) within 45 days
             of study entry

          -  Concurrent use of systemic anti-VEGF agents

          -  Full thickness or lamellar keratoplasty within 90 days prior to study entry

          -  Ocular surface reconstruction within 90 days prior to study entry

          -  Other ocular surgeries within 90 days prior to study entry

          -  Corneal or ocular surface infection within 90 days prior to study entry

          -  Ocular or periocular malignancy

          -  Contact lens (excluding bandage contact lens) within 30 days prior to study entry

          -  Persistent epithelial defect (>1mm2 and ≥14 days duration) within 30 days prior to
             study entry

          -  Systemic, intravitreal, or periocular steroids within 30 days prior to study entry

          -  Change in dose/frequency of topical steroids and/or NSAIDs within 30 days prior to
             study entry

          -  Hypertension: systolic BP > 150 or diastolic BP > 90

          -  History of thromboembolic event within 6 months prior to study entry

          -  Current diagnosis of diabetes, Pregnancy (positive pregnancy test) or lactation

          -  Premenopausal women not using adequate contraception (The following are considered
             effective means of contraception: surgical sterilization or use of oral
             contraceptives, barrier contraception with either a condom or diaphragm in conjunction
             with spermicidal gel, an IUD, or contraceptive hormone implant or patch)

          -  Participation in another simultaneous medical investigation or trial.
A Study of Evacetrapib (LY2484595) in Healthy Participants
Condition: Healthy Volunteers
Intervention: Evacetrapib
Intervention description: Administered orally
Intervention MeSH terms: Evacetrapib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to measure and compare the amounts of the study drug evacetrapib
      found in the blood after taking two different formulations. The study has 3 periods.
      Participants will take each formulation by mouth at least once. A minimum of 14 days will
      pass between study drug doses. The safety and tolerability of the study drug will also be
      examined. Information about any side effects that may occur will also be collected. This
      study will last approximately 6 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male participants who agree to use a reliable method of birth control and not donate
             sperm during the study and for 90 days after study completion

          -  Female participants who are not of child-bearing potential due to surgical
             sterilization confirmed by medical history or menopause

          -  Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)

          -  Are reliable and willing to make themselves available for the duration of the study
             and are willing to follow study procedures

        Exclusion Criteria:

          -  Are currently enrolled in or have completed or discontinued within the last 30 days
             from a clinical trial involving an investigational product

          -  Have known allergies to evacetrapib, related compounds or any components of the
             formulation, or history of significant allergic disease as determined by the
             investigator

          -  Have a history or presence of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders

          -  Regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening

          -  Are women who are pregnant or lactating

          -  Have used or intend to use over-the-counter or prescription medications (including
             vitamins/mineral supplements, herbal medicine) 14 days prior to enrollment and during
             the study

          -  Have donated blood of more than 500 milliliters (mL) within the last month

          -  Have an average weekly alcohol intake that exceeds 21 units per week (for males) and
             14 units per week (for females) or are unwilling to stop alcohol consumption 48 hours
             prior to each dose and while resident at the Clinical Research Unit (CRU)

          -  Currently smoke or use tobacco or nicotine products