bioihbjkbjnl/mcl2 huggingface dataset:
Multiple Ascending Dose Study of AMG 598 in Adults With Obesity
Condition: Obesity
MeSH terms: Obesity
Intervention: AMG 598; Placebo; Liraglutide
Intervention description: AMG 598 administered by subcutaneous injection; Placebo matching to AMG 598 administered by subcutaneous injection; Liraglutide administered by subcutaneous injection. The starting dose is 0.6 mg/day, and increased by 0.6 mg/day dose increment every 7 days, up to the full dosage of 3.0 mg/day by week 5.
Intervention MeSH terms: Liraglutide
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-blind study
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The main objective of this study is to assess the safety and tolerability of multiple doses
      of AMG 598 administered alone or in combination with liraglutide in adults with obesity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women with ages between 18 and 65 years old, inclusive, at time of signing
             consent

          -  Body mass index (BMI) between greater than or equal to 30.0 kg/m^2 and less than or
             equal to 40.0 kg/m^2 at screening

          -  Except for obesity, otherwise healthy or medically stable per protocol

          -  Have a stable body weight defined as less than 5 kg self-reported change during the
             previous 8 weeks prior to screening

          -  Other Inclusion criteria may apply

          -  Stable on liraglutide, depending on cohort

        Exclusion Criteria:

          -  History or clinical evidence of diabetes

          -  Inadequate organ function at screening

          -  Currently receiving treatment in another investigational device or drug study

          -  Women who are pregnant/lactating/breastfeeding or who plan to become
             pregnant/breastfeed while on study through 5 months after receiving the last dose of
             investigational product

          -  History or evidence of a clinically significant disorder, condition or disease that
             would pose a risk to subject safety or interfere with the study evaluation, procedures
             or completion

          -  A family or personal history of medullary thyroid carcinoma or multiple endocrine
             neoplasia type 2; a personal history of non-familial medullary thyroid carcinoma;
             confirmed chronic pancreatitis or idiopathic acute pancreatitis, or gallbladder
             disease (ie, cholelithiasis or cholecystitis) not treated with cholecystectomy, for
             cohorts receiving liraglutide

          -  History of major depressive disorder

          -  Other Exclusion criteria may apply
Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Intervention: BMS-790052; Ortho Tri-Cyclen®
Intervention description: Tablets, Oral, 60 mg, once daily, 10 days; Tablets, Oral, once daily, 78 days
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 1
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the effect of BMS-790052 on the pharmacokinetics of
      Ortho Tri-Cyclen® in healthy female subjects.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Healthy female subjects, 18-45 years, BMI 18-32 kg/m².

          -  Must be using an adequate method of contraception to avoid pregnancy throughout the
             study.

        Key Exclusion Criteria:

          -  Abnormal Pap smear within 1 yr of dosing, and abnormal menstrual cycle during the 3
             months prior to enrollment.

          -  Any significant or chronic uncontrolled medical illness.
A Study of LY2835219 in Participants With Cancer
Condition: Neoplasm; Neoplasm Metastasis
MeSH terms: Neoplasms; Neoplasm Metastasis
Intervention: Abemaciclib; Clarithromycin
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Clarithromycin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: advanced cancer; metastatic cancer

Summary:

      The purpose of this study is to assess how the body handles Abemaciclib when it is given with
      another drug called clarithromycin. The study doctor will measure the amount of Abemaciclib
      that is absorbed into the blood stream and the time that it takes to remove Abemaciclib from
      the body. The safety and tolerability of these drugs will be studied.

      Each participant will complete 2 study periods in fixed order. After screening, Period 1 will
      last approximately 8 days and Period 2 will last approximately 15 days. Participants who
      complete Period 2 may continue to receive Abemaciclib in 28-day cycles until discontinuation
      criteria are met.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histological or cytological evidence of cancer (solid tumors) that is advanced
             and/or metastatic

          -  Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG)
             scale

        Exclusion Criteria:

          -  No symptomatic central nervous system (CNS) malignancy or metastasis
A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro; Insulin Aspart; Insulin Aspart
Intervention description: Administered SC; Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Two forms of insulin lispro (LY900014 and Humalog®) and two forms of insulin aspart
      (NovoRapid® and Fiasp®) will be given to trial participants with diabetes mellitus type 1 by
      injection under the skin. The study will assess how fast the active ingredient (insulin
      lispro or insulin aspart) gets into the blood stream and how long it takes the body to remove
      it. A test meal will be given to trial participants to assess the course of the blood sugar
      lowering effect of the investigational products. The safety and tolerability of LY900014 will
      also be assessed. Screening is required within 14 days prior to the lead in. For each
      participant, the study will last up to 91 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1
             year

          -  Have a body mass index (BMI) of 18.5 to 35.0 kilogram per meter square (kg/m²)

          -  Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)

          -  Have had no episodes of severe hypoglycaemia in the last 6 months

        Exclusion Criteria:

        - Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal,
        endocrine (apart from T1DM), hematological, or neurological disorders capable of
        significantly altering the absorption, metabolism or elimination of drugs; of constituting
        a risk when taking the investigational product; or of interfering with the interpretation
        of data
Use of Ranibizumab to Treat Rubeosis in Diabetics Prior to Cataract Surgery
Condition: Rubeosis Iridis; Proliferative Diabetic Retinopathy
MeSH terms: Cataract; Retinal Diseases; Diabetic Retinopathy
Intervention: Ranibizumab
Intervention description: Intravitreally administered 0.5mg ranibizumab, 3 doses administered monthly.
Intervention MeSH terms: Ranibizumab
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: Rubeosis; Neovascularization of iris; Proliferative diabetic retinopathy; PDR; Cataract

Summary:

      The purpose of this study was to determine the safety of ranibizumab: a) as a surgical
      adjunct during cataract surgery in subjects with proliferative diabetic retinopathy (PDR)
      induced rubeosis and, b) in treatment of proliferative diabetic retinopathy (PDR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or over

          -  Subjects with diabetes mellitus

          -  Subjects with proliferative diabetic retinopathy induced rubeosis

          -  Be willing to undergo cataract surgery

          -  HgbA1c level < 12%

        Exclusion Criteria:

          -  History of glaucoma surgery

          -  Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis

          -  Intraocular surgery in the study eye within 60 days preceding Day 0

          -  History of prior pars plana vitrectomy in the study eye

          -  Positive pregnancy test

          -  HbA1c >12
PK Study of PT003 and PT001 in Japanese Healthy Subjects
Condition: COPD
Intervention: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1; Glycopyrronium and Formoterol Fumarate (GFF) Dose 2; Glycopyrronium (GP) Dose 1; Glycopyrronium (GP) Dose 2
Intervention description: Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID); Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID); Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID); Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)
Intervention MeSH terms: Glycopyrrolate; Formoterol Fumarate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Japanese Healthy Volunteers

Summary:

      A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over,
      Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the
      Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.
    

Eligibility criteria:

        Inclusion Criteria:

        Informed Consent Form (ICF) prior to any study related procedures

          -  Male and female first generation Japanese subjects 18 to 45 years, inclusive

          -  Good general health

          -  Medically acceptable contraception for women of child-bearing potential and males with
             female partners of childbearing potential

          -  Clinical labs within normal ranges or determined to be not clinically significant by
             the Investigator

        Exclusion Criteria:

          -  Pregnancy, nursing female subjects, or subjects trying to conceive

          -  Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic,
             pulmonary, hematological, psychiatric, or other medical illness that would interfere
             with participation in this study

          -  History of ECG abnormalities

          -  Cancer not in complete remission for at least 5 years

          -  Clinically significant, symptomatic prostatic hypertrophy

          -  Male subjects with a trans-urethral resection of the prostate or full resection of the
             prostate within 6 months prior to Screening

          -  Clinically significant bladder neck obstruction or urinary retention

          -  Inadequately treated glaucoma

          -  History of an allergic reaction or hypersensitivity to any drug or to any component of
             the formulations used in this study

          -  Subjects with pre-existing anemia and/or iron deficiency
Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis
Condition: Peritoneal Dialysis-associated Peritonitis
MeSH terms: Peritonitis
Intervention: Vancomycin
Intervention description: Vancomycin one-time 20 mg/kg intraperitoneal dose.
Intervention MeSH terms: Vancomycin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Vancomycin; Pharmacokinetics; Pharmacodynamics; Automated Peritoneal Dialysis

Summary:

      Vancomycin is the most commonly used empiric treatment for infectious peritonitis in patients
      on peritoneal dialysis. Current dosing and monitoring for safety and efficacy is empiric,
      especially for those on rapid-cycling modalities. The goal of this study is to understand the
      pharmacokinetics of vancomycin in patients on rapid-cycling peritoneal dialysis modalities in
      order to derive an optimal dosing regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male or females between 18 - 85 years old

          -  Stabilized on a PD regimen for > 3 months prior to study initiation

        Exclusion Criteria:

          -  Clinically significant disease unrelated to renal impairment or deemed unfit by the
             investigator

          -  Allergy or hypersensitivity to vancomycin or icodextrin-containing dialysis solution

          -  Active peritonitis infection

          -  Previous intraperitoneal antibiotic treatment within 2 months

          -  Previous intravenous vancomycin treatment within 2 months

          -  Hemoglobin < 9 g/dL

          -  Pregnant or breast-feeding women
Demonstration of Bioequivalence of Empagliflozin and Metformin Given in One Tablet Compared to the Intake of Single Tablets
Condition: Healthy
Intervention: Empagliflozin; Empagliflozin + Metformin; Metformin; Metformin; Empagliflozin + Metformin; Empagliflozin
Intervention description: empagliflozin tablets and metformin tablet; fixed dose combination tablet (low); empagliflozin tablets and metformin tablet; empagliflozin tablet and metformin tablet; fixed dose combination tablet (low); empagliflozin tablet and metformin 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: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial is to establish bioequivalence of two FDC tablets and the
      single tablets when administered together after a high fat high caloric meal.
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male and female subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in Postmenopausal Women With Low Bone Mineral Density (BMD)
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic
Intervention: abaloparatide-sMTS
Intervention description: Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto an sMTS array for transdermal administration of abaloparatide.
Intervention MeSH terms: Abaloparatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Female
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: postmenopausal osteoporosis; transdermal delivery; microstructure patch; abaloparatide

Summary:

      This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS
      by participants with low BMD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal for at least 2 years

          -  BMD T-score based on the female reference range <-1.0 and >-5.0 at the lumbar spine
             (L1-L4) or hip (femoral neck or total hip) by dual energy X-ray absorptiometry (DXA)

          -  Good general health as determined by medical history and physical exam (including
             vital signs, and has a body mass index up to 33 kilograms/square meter (kg/m^2)

          -  Laboratory tests within the normal range including serum calcium (albumin-corrected),
             intact parathyroid hormone (PTH), serum phosphorus, alkaline phosphatase, and thyroid
             stimulating hormone

          -  Serum 25-hydroxyvitamin D values ≥ 20 nanograms per milliliter (ng/mL)

        Exclusion Criteria:

          -  History of prior external beam or implant radiation therapy involving the skeleton,
             other than radioiodine

          -  History of bone disorders other than postmenopausal osteoporosis (such as Paget's
             disease)

          -  History of cancer within the last 5 years (with the exception of basal cell or
             squamous cancer of the skin)

          -  History of Cushing's disease, hypo or hyperparathyroidism, or malabsorptive syndromes
             within the past year

          -  Prior treatment with PTH, PTH-related peptide-derived drugs, or bone anabolic
             steroids, including abaloparatide, teriparatide, or PTH (1-84)

          -  Prior treatment with intravenous bisphosphonates at any time or oral bisphosphonates
             within the past year (12 months). Participants who have received a short course of
             oral bisphosphonate therapy (3 months or less) may be enrolled as long as the
             treatment occurred 6 or more months prior to enrollment

          -  Prior treatment with an investigational drug or device within the past 3 months or 5
             half-lives of the investigational drug, whichever is longer
Study of the Bioequivalence of the 20% and 30% Etoricoxib Tablet Formulations (0663-070)
Condition: Pain
Intervention: etoricoxib; Comparator: etoricoxib
Intervention description: Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods.; Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.
Intervention MeSH terms: Etoricoxib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will establish the bioequivalence of the 20%, milled, roller compaction final
      market image (FMI) etoricoxib tablets and 30% unmilled, roller compaction (UMC) etoricoxib
      tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is in good health

          -  Subject agrees to follow the study guidelines

        Exclusion Criteria:

          -  Subject is a smoker

          -  Subject has a history of adverse reactions caused by NSAIDs or allergies/intolerance
             to NSAIDs

          -  Subject is in a situation or has a condition/disease which may interfere with optimal
             participation in the study
Dose Escalation Study With MK-2206 in Patients With Locally Advanced or Metastatic Solid Tumors (MK-2206-002)
Condition: Locally Advanced Tumors; Metastatic Solid Tumors; Cancer; Neoplasms
MeSH terms: Neoplasms
Intervention: MK-2206
Intervention description: MK-2206 administered as an oral formulation in rising dose levels on a QOD schedule (30 mg, 60 mg, 75 mg, and 90 mg) or QW schedule (90 mg, 135 mg, 200 mg, 250 mg, and 300 mg) in repeating 4 week cycles, depending upon allocation.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to investigate the Dose Limiting Toxicities (DLTs),
      pharmacokinetics (PK), and pharmacodynamics (PD) of MK-2206 administered orally to
      participants with advanced solid tumors. The preliminary efficacy of MK-2206 will also be
      investigated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have confirmed locally advanced or metastatic solid tumors that have
             failed to respond to standard therapy, have gotten worse or have come back after
             existing therapy

          -  Has normal organ function; is no greater than 2 on the ECOG Performance Scale

          -  Has a negative blood or urine pregnancy test within 72 hours of receiving the first
             dose of study drug if participant is female

          -  Is able to swallow capsules and has no surgical or bodily condition that will prevent
             the patient from swallowing and absorbing oral medications on an ongoing basis

        Exclusion Criteria:

          -  Participant has had chemotherapy, radiotherapy, biological therapy or surgery within 4
             weeks of starting the study and has not recovered from adverse events caused by the
             treatment

          -  Is currently participating or has participated in a study with an investigational
             compound or device within 30 days

          -  Has a primary central nervous system tumor

          -  Has a history or current evidence of heart disease, slow heart rate or untreated high
             blood pressure

          -  Is a known diabetic who is taking insulin or oral antidiabetic therapy

          -  Is pregnant or breastfeeding or planning to become pregnant during the study

          -  Is HIV-positive

          -  Has known history of Hepatitis B or C or active Hepatitis A

          -  Is receiving treatment with oral corticosteroids