bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Metformin IR (glucophage); Saxagliptin + Metformin IR (FDC)
Intervention description: Tablet, Oral, 2.5 mg, Once Daily, 1 week; Tablets, Oral, 1000 mg, Once Daily, 1 week; Tablet, Oral, Saxagliptin 2.5 mg + metformin IR 1000 mg, Once Daily, 1 Week
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 19 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To demonstrate bioequivalence of a 2.5 mg saxagliptin/1000 mg metformin (glucophage)
      immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet
      and 1000 mg metformin IR tablet co-administered to healthy subjects in a fasted and in a fed
      state.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ages 19 to 45 inclusive

          -  Healthy subjects as determined by no clinically significant deviation from normal in
             medical history, physical examination, electrocardiograms (ECGs), and clinical
             laboratory determinations

          -  Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2

        Exclusion Criteria:

          -  Women of child-bearing potential (WOCBP) who are unwilling or unable to use acceptable
             barrier methods (condoms and spermicides) to avoid pregnancy for the entire study
             period and for up to 8 weeks after the last dose of investigational product

          -  Any significant acute or chronic medical illness

          -  Current or recent (within 3 months) gastrointestinal disease

          -  Any major surgery within 4 weeks of study drug administration

          -  History of allergy to Dipeptidyl peptidase 4 (DPP4) inhibitor or related compounds

          -  History of allergy or intolerance to metformin or other similar acting agents

          -  Prior exposure to saxagliptin

          -  Prior exposure to metformin within 3 months of study drug administration

          -  Estimated creatinine clearance (Clcr) of < 80ml/min using the Cockcroft Gault formula
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers
Condition: Healthy
Intervention: Placebo; intact ALO-02 60 mg/7.2 mg; crushed ALO-02 60 mg/7.2 mg; crushed oxycodone IR 60 mg; crushed ALO-02 40 mg/4.8 mg; crushed oxycodone IR 40 mg
Intervention description: Placebo solution + Placebo ALO-02 (intact); Placebo solution + ALO-02 60 mg/7.2 mg (intact); crushed ALO-02 60 mg/7.2 mg in solution + placebo ALO-02 (intact); crushed oxycodone immediate-release (IR) 60 mg in solution + placebo ALO-02 (intact); crushed ALO-02 40 mg/4.8 mg in solution + placebo ALO-02 (intact); crushed oxycodone immediate-release (IR) 40 mg in solution + placebo ALO-02 (intact)
Intervention MeSH terms: Naltrexone; Oxycodone
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Relative abuse potential study; oxycodone; nalteone; Opioid-related disorders; drug abusers; Chronic pain

Summary:

      The main purpose of this study is to determine if oxycodone and naltrexone combination
      capsules (ALO-02) have the potential to be abused.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects.

          -  Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic
             purposes on at least 10 occassions within the last year before Screening Visit, and at
             least once in 8 weeks before the Screening Visit.

        Exclusion Criteria:

          -  Diagnosis of substance and/or alcohol dependence.

          -  Subject has participated in, is currently participating in, or is seeking treatment
             for substance and/or alcohol related disorder.

          -  History of sleep apnea.

          -  Positive urine drug screen (UDS) for other that marijuana.

          -  Positive for Hepatitis B or C and HIV on Screening.
Safety and Tolerability of Odanacatib (0822-059)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Odanacatib; Comparator: Placebo
Intervention description: Oral doses of Odanacatib 50 mg administered once weekly for 4 consecutive weeks; Oral Placebo tablet administered once weekly for 4 consecutive weeks
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 45 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will test the weighted average inhibition of u-NTx/Cre (aminoterminal crosslinked
      telopeptide of Type 1 collagen) and AUC (0-168 hours) of Odanacatib
    

Eligibility criteria:

        Inclusion Criteria:

          -  male subject between the ages of 50 and 75 years; post menopausal female subjects
             between the ages of 45 and 75 years

          -  Subject is in good general health

          -  Subject has no evidence of metabolic bone disorder other than osteopenia or
             osteoporosis

          -  Subject is a non-smoker

        Exclusion Criteria:

          -  Subject works night shift and is unable to avoid nightshift work during the study

          -  Subject has had major surgery, donated blood or participated in another
             investigational study with in the past 4 weeks

          -  Subject has a history of stroke, chronic seizures, or major neurological disease

          -  Subject has a history of cancer

          -  Subject consumes excessive amounts of alcohol or caffeine
Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects
Condition: Healthy
Intervention: RPH-104; Sodium chloride Sterile Injection 0.9% w/v
Intervention description: Anti-IL-1 Mab; Sterile saline solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: safety; tolerability; RPH-104; RPH104; Anti-IL1 beta; Anti-IL1

Summary:

      The purpose of this first in human study is to evaluate the safety and tolerability of
      RPH-104 in humans.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects.

          -  Male or female subjects between 18 and 35 years old (inclusive).

          -  Subject who has normal body weight as determined by a body mass index (BMI) of between
             18 kg/m² and 30 kg/m² (inclusive) and within a body weight of ≥50kg and ≤120kg.

        Exclusion Criteria:

          -  Subject who has a history or presence of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrinological, dermatological, neurological, psychiatric, and
             hematological or immunological disorder(s), and/or any condition that could constitute
             a potential safety risk factor or could alter the absorption, distribution, metabolism
             or elimination of the study drugs.

          -  Subject who has positive immunoglobulin-M (IgM) antibodies against Epstein-Barr virus
             (EBV)-viral capsid antigen (VCA) (IgM-anti-EBV-VCA) and Cytomegalovirus (CMV).

          -  Subject who has a positive Quantiferon TB-Gold (TB) test

          -  Subject who is positive to Human Immunodeficiency Virus-1/2 antibody (HIV-1/2Ab).

          -  Subject who has serum hepatitis, or is a carrier of the Hepatitis B surface antigen
             (HBsAg), or is Hepatitis C virus antibody (HCV-Ab) positive.
A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects
Condition: Healthy Adult Male
Intervention: (14C)-OPC-61815
Intervention description: On the morning of Day 1, all subjects will receive a single IV infusion of (14C) OPC-61815
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Male
Minimum age: 35 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      -  To determine the mass balance of totalradioactivity following a single IV infusionof
           (14C)-OPC-61815.

        -  To determine routes and rates of elimination of total radioactivity following a single
           IV infusion of (14C)-OPC-61815

        -  To assess the PK of total radioactivity in plasma and whole blood following a single IV
           infusion of (14C)-OPC-61815

        -  To assess the PK of OPC-61815 free form and OPC-41061 in plasma following a single IV
           infusion of (14C)-OPC-61815
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects between 35 and 55 years of age, inclusive; hold a valid Japanese
             passport and be first generation Japanese, defined as the subject, the subject's
             biological parent, and all of the subject's biological grandparents being of exclusive
             Japanese descent, have been born in Japan, and not lived outside of Japan for more
             than 5 years; with a body mass index between 18.5 and 28.0 kg/m2, inclusive, and a
             total body weight between 50 and 100 kg, inclusive; in good health, determined by no
             clinically significant findings from medical history, physical examination, 12-lead
             electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations
             at Screening and Check in as assessed by the investigator (or designee); and have a
             history of a minimum of 1 bowel movement per day.

        Exclusion Criteria:

          -  History of stomach or intestinal surgery or resection that would potentially alter
             absorption and/or excretion; poor peripheral venous access; participation in a
             clinical trial involving administration of an investigational drug in the past 90 days
             prior to dosing; subjects with exposure to significant diagnostic or therapeutic
             radiation or current employment in a job requiring radiation exposure monitoring
             within 12 months prior to Check-in; subjects who have participated in any clinical
             trial involving a radiolabeled investigational drug within 12 months prior to
             Check-in.
A Study To Assess The Safety And Tolerability Of Different Doses Of PF-06444753 And PF-06444752 In Subjects With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: IGE-1; IGE-2; Saline
Intervention description: Intramuscular, multiple dose; Intramuscular, multiple dose; Saline (0.9% sodium chloride)
Intervention MeSH terms: Immunoglobulin E
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 190.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccines; Phase 1; Allergic Rhinitis

Summary:

      The purpose of this study is to assess the safety and tolerability of different doses of
      PF-06444753 and PF-06444752 in subjects with allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, males or females of non-child bearing potential, who are between 18 and 55
             years, inclusive,

          -  Intermittent or persistent allergic rhinitis that is associated with perennial or
             seasonal allergen reactivity at screening as determined by a positive specific IgE
             level ≥1 KU/L to at least one of the following common allergens: dust mite
             (Dermatophagoides farinae or Dermatophagoides pteronyssinus), cat, dog, mold
             (Alternaria), Bermuda grass, common ragweed, oak, Timothy grass or elm.

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic
             disease that may compromise their ability to safely participate in the study.

          -  Evidence or history of clinically significant pulmonary disease (including allergic
             and non-allergic asthma, chronic obstructive pulmonary disease [COPD], cystic
             fibrosis, bronchiectasis, chronic bronchitis, emphysema, tuberculosis, pulmonary
             fibrosis, pulmonary hypertension, or others).

          -  Evidence or history of clinically significant autoimmune disease (including rheumatoid
             arthritis, systemic lupus erythematosus, ulcerative colitis, or others).
Study of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Quizartinib; Cytarabine; Idarubicin; Daunorubicin
Intervention description: [Induction period, Cycle 1] Once-daily repeated oral administration Day 8 to Day 21.
[Induction period, Cycle 2] Once-daily repeated oral administration Day 6 to Day 19.
[Consolidation period] Once-daily repeated oral administration Day 6 to Day 19.; [Induction period, Cycle 1] Once-daily intravenous injection of 100 mg/m^2 cytarabine on Day 1 to 7.
[Induction period, Cycle 2] Once-daily intravenous injection of 100 mg/m^2 cytarabine on Day 1 to 5.
[Consolidation period] Twice-daily intravenous injection of 3.0 g/m^2 cytarabine at 12-hour intervals on Days 1, 3, and 5.; Either Idarubicin or Daunorubicin will be used [Induction period, Cycle 1] Once-daily intravenous injection of 12 mg/m^2 idarubicin on Day 1 to 3.
[Induction period, Cycle 2] Once-daily intravenous injection of 12 mg/m^2 idarubicin on Day 1 and 2.; Either Idarubicin or Daunorubicin will be used [Induction period, Cycle 1] Once-daily intravenous injection of 60mg/m^2 daunorubicin on Day 1 to 3.
[Induction period, Cycle 2] Once-daily intravenous injection of 60mg/m^2 daunorubicin on Day 1 and 2.
Intervention MeSH terms: Cytarabine; Daunorubicin; Idarubicin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: AML; phase 1; hematology; malignancy; newly diagnosed

Summary:

      This is a phase 1b, dose escalation, study of quizartinib to evaluate the safety profile, the
      pharmacokinetics, and the recommended dose of quizartinib for subsequent clinical studies of
      the combination of quizartinib and induction and consolidation chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No prior treatment for AML (including quizartinib)

          -  ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 to 2

        Exclusion Criteria:

          -  Diagnosis of acute promyelocytic leukemia

          -  Active acute or chronic systemic fungal, bacterial, or viral infection not well
             controlled by antifungal, antibacterial or antiviral therapy.
A Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 Tablet Formulation
Condition: Healthy Volunteers
Intervention: TAK-831
Intervention description: TAK-831 film-coated tablet.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to determine the pharmacokinetic (PK) of a single oral dose of
      TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK
      of a single oral dose of TAK-831 400 mg when administered as tablet formulation in healthy
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Weighs greater than or equal to (>=) 45 kilogram (kg) and has a body mass index (BMI)
        between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive at Screening.

        Exclusion Criteria:

          1. Has received TAK-831 in a previous clinical study.

          2. Has poor peripheral venous access.

          3. Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including
             plasmapheresis), or had a transfusion of any blood product within 45 days prior to
             first dose of study drug.

          4. Has any dietary restrictions or preferences that may interfere with the conduct of the
             study.
Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites Deliver Equivalent Drug Amount to the Body
Condition: Healthy Volunteers
Intervention: rotigotine transdermal patch (Neupro®)
Intervention description: Rotigotine 4.5 mg/10 cm^2 patch applied for 24 hours
Intervention MeSH terms: Rotigotine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rotigotine; Neupro®

Summary:

      The major aim of this study is to investigate and compare the drug amount delivered to the
      body after sequential application of 2 rotigotine transdermal patches from 2 different
      manufacturing sites.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy, white, male volunteers between 18 and 55 years of age (inclusive)

          -  BMI between 19 and 28 kg/m² (inclusive)

        Exclusion Criteria:

          -  previous participation in a clinical study with Rotigotine

          -  history or current condition of epilepsy and/or seizures

          -  known clinically relevant allergy or known/suspected clinically relevant drug
             hypersensitivity

          -  history of significant skin hypersensitivity to adhesives or other transdermal
             products or recently unresolved contact dermatitis

          -  history or present condition of an atopic or eczematous dermatitis, psoriasis, and/or
             an active skin disease

          -  clinically relevant abnormality in physical examination, ECG, vital signs or safety
             laboratory examinations

          -  positive HIV, hepatitis B or C test or positive alcohol or drug test

          -  relevant hepatic or renal dysfunction

          -  intake of medication that might interfere with the test drug within 2 weeks prior to
             dosing

          -  thickly hair-covered abdomen resulting in difficulties in finding appropriate patch
             application sites
Regional Anesthesia for Sickle Cell Crisis Using Ultrasound in The Emergency Department: Phase I
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell; Emergencies
Intervention: Femoral Nerve Block
Intervention description: Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sickle Cell Disease; Pain; Vasoocclusion; Nerve Block; Regional Anesthesia

Summary:

      The hypothesis of this study is:

      Femoral nerve blocks can feasibly be performed on patients with Sickle Cell Disease and
      painful crisis in the Emergency Department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or above

          -  Documented SCD: HbSS, HbSC, HbSβ0Thal, HbSβ+Thal

          -  Rapid onset of acute pain consistent with VOC

          -  Pain in at least one lower extremity

          -  Pain requiring admission to the hospital

          -  Cognitive ability to report pain on a 0-10 NRS

        Exclusion Criteria:

          -  Primary admitting diagnosis other than VOC

          -  Contraindication to femoral nerve block

          -  Pregnant
Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors
Condition: Malignant Central Nervous System Neoplasm; Metastatic Malignant Neoplasm in the Central Nervous System
MeSH terms: Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: Gadolinium; Hyperpolarized Carbon C 13 Pyruvate; Magnetic Resonance Imaging; Magnetic Resonance Spectroscopic Imaging
Intervention description: gadolinium enhanced MRI; Given IV; Undergo MRI; Undergo MRSI
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This early phase I trial studies how well hyperpolarized carbon C 13 pyruvate magnetic
      resonance imaging works in detecting lactate and bicarbonate in participants with central
      nervous system tumors. Hyperpolarized carbon C 13 pyruvate magnetic resonance imaging may be
      used to measure the metabolic state of malignant brain tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a known diagnosis of central nervous system (CNS) malignancy, including
             metastases, with known enhancement on magnetic resonance (MR) who are otherwise
             eligible to undergo MRI

          -  Glomerular filtration rate (GFR) > 30 ml/min

          -  No allergy to gadolinium

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Refusal to have an IV placed for injection

          -  Acute major illness (e.g., unstable angina, etc.) or other condition that makes
             participation unsafe, per the investigator?s judgement

          -  Total bilirubin > 1.5 x upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 x ULN

          -  Gamma-glutamyltransferase (GGT) > 2.5 x ULN

          -  Pregnant or breast-feeding

          -  Cardiovascular risk, including:

               -  Poorly controlled hypertension, defined as either systolic > 170 or diastolic >
                  110

               -  Congestive heart failure

               -  Myocardial infarction within the past year

               -  QT prolongation, defined as pretreatment corrected QT interval (QTc) > 440 msec
                  in males or > 460 msec in females