bioihbjkbjnl/mcl2 huggingface dataset:
Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Omeprazole; Placebo oral tablet; Gliclazide
Intervention description: Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.; Placebo will be administered orally once daily for 5 days in one of the two treatment periods.; Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5.
Intervention MeSH terms: Gliclazide; Omeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Proton pump inhibitors (PPIs) are treatment of choice for different gastrointestinal
      disorders common in type 2 diabetes. Sulfonylureas (SUs) are anti-diabetes agents
      particularly widely used in developing countries. Gliclazide, a recommended SU drug, is
      metabolised in part by CYP2C19, the main enzyme responsible for the PPI metabolism.

      A randomised, placebo-controlled, two-sequence, two-period crossover study will be performed
      to explore whether gliclazide pharmacokinetics (PK) and pharmacodynamics (PD) are altered
      upon co-administration with omeprazole. Sixteen healthy volunteers, CYP2C19
      extensive/ultrarapid metabolisers (EM/UM), will receive placebo or omeprazole alone for 4
      days, and concomitantly with single dose of gliclazide on day 5. Plasma concentration of
      gliclazide will be measured for 24 hours, and plasma glucose and insulin levels up to 12
      hours after gliclazide administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men

          -  Age 18-30 years

          -  Non-smokers

          -  CYP2C19 extensive/ultrarapid metabolisers

        Exclusion Criteria:

          -  medical history of hepatic, renal, gastrointestinal and hematologic disease or any
             acute or chronic disease, or drug allergy to sulfonylureas or PPIs or history of drug
             abuse

          -  abnormalities in physical examination, ECG and routine clinical laboratory tests
             (including fasting blood glucose concentration)

          -  medication use during the 14 days prior and during the study period

          -  grapefruit, grapefruit juice, alcohol, beverages or food containing methylxanthines
             use during 72 h prior and during the study period
Phase 1 Clinical Trial MPC-2130 Treatment of Blood Cancers / Refractory Cancer
Condition: Cancer
MeSH terms: Hematologic Neoplasms
Intervention: MPC-2130
Intervention description: MPC-2130 10 mg/mL administered by intravenous infusion over 1-2 hours
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oncology; Cancer; Blood Cancers

Summary:

      Phase 1 Open-label treatment with MPC-2130 for subjects with refractory cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be capable of understanding the informed consent form (ICF) and complying with the
             protocol, and must sign the ICF prior to the performance of any study related
             procedures;

          2. Have cancer that is nonresponsive despite prior treatment with current standard of
             care regimens or for whom there are no available effective therapies;

          3. Have measurable or evaluable neoplastic disease;

          4. Be greater than or equal to age 18;

          5. Have and ECOG Performance Status score of less than or equal to 2;

          6. Have adequate organ function defined by:

               1. Liver function tests (AST & ALT) less than or equal to 3 times the upper limit of
                  normal (ULN);

               2. Bilirubin less than or equal to 1.5 X ULN;

               3. Serum Creatinine less than or equal to 1.5 X ULN;

               4. Hemoglobin greater than or equal to 8.0 g/dL;

          7. Have recovered or stabilized from clinically significant toxicities of prior
             chemotherapy, surgery, or radiotherapy;

          8. Have left ventricular ejection fraction (LVEF) of greater than or equal to 45% by
             multiple gated acquisition (MUGA) scan or echocardiogram.

        Exclusion Criteria:

          1. Have had a prior serious, uncontrollable hypersensitivity reaction to Cremophor EL;

          2. Be pregnant or lactating (women of childbearing potential must use appropriate birth
             control (abstinence, barrier methods, oral contraceptives and/or intrauterine devices)
             during the entire duration of the study, or the patient must be surgically sterile
             (with documentation in the patient's medical records);

          3. Receive any other anticancer treatment or investigational therapy within 14 days prior
             to day 1; or within 6 weeks after prior mitomycin C or nitrosourea. Patients with
             advanced prostate cancer may continue to receive leutinizing hormone-releasing hormone
             (LHRH) therapy while in this study;

          4. Have previously enrolled in this trial. -
Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Intervention: PF-05230907
Intervention description: PF-05230907 IV bolus injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: safety, maximum tolerated dose, modified continual reassessment method, intracerebral, hemorrhage, hematoma

Summary:

      This study employs a modified continual reassessment method (mCRM) design to estimate the
      maximum tolerated dose (MTD) of PF-05230907, defined as a target toxicity rate of 15% based
      on treatment emergent thromboembolic and/or ischemic events (TIEs). The mCRM design utilizes
      Bayesian methodology to continuously learn the dose-toxicity relationship, which is
      characterized by a parametric model.

      Subjects with a diagnosis of ICH (determined by computed tomography) will be enrolled in
      cohorts of 3. The total length of time planned for study participation is approximately 3
      months; 6.0 hours for screening, a single dose administration with a 4-day minimum hospital
      confinement period and follow-up visits through Day 91.

      Severity of adverse events (AEs) and serious adverse events (SAEs) will be graded according
      to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
      version 4.03. All subjects who receive PF-05230907 are evaluable for TIEs. The determination
      of MTD using mCRM modeling will be based on TIEs which occur through 7 days post-dose (Day
      8).
    

Eligibility criteria:

        Inclusion Criteria:

          -  ICH as documented by CT scan within 6.0 hours of symptom onset

          -  Baseline ICH volume > 5mL and < 60 mL

        Exclusion Criteria:

          -  Deep coma (Glasgow Coma Scale < 6)

          -  Modified Rankin Score > 3 prior to ICH onset

          -  Known history of schemic, vaso-occlusive or thrombotic events within 6 months prior to
             screening

          -  Known prothrombotic disorders

          -  Known secondary ICH related to aneurysm, arteriovenous malformation, subarachnoid
             hemorrhage, trauma, or other causes. CT angiography, MR, or other diagnostic studies
             obtained as part of the standard of care may be used to assess eligibility.

          -  Known use of oral anticoagulant(s)

          -  Known use of low-molecular weight heparin or heparin
A Study of LY2928057 in Hemodialysis Participants
Condition: Renal Insufficiency, Chronic; Kidney Disease, Chronic
MeSH terms: Kidney Diseases; Renal Insufficiency; Renal Insufficiency, Chronic
Intervention: LY2928057; Placebo
Intervention description: Administered intravenously; Administered intravenously
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety of LY2928057 and how LY2928057 affects hemoglobin in
      hemodialysis participants. This study will involve multiple doses of LY2928057 given during a
      6 week period either after a participant discontinues or reduces treatment to stimulate red
      blood cells. This study will last up to 26 weeks for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants having end-stage renal disease (ESRD), have received an erythropoiesis
             stimulating agent (ESA) at least weekly for 2 weeks prior to screening, and have been
             receiving adequate maintenance hemodialysis (3 times weekly) for at least 12 weeks
             prior to screening (that is, an approximate Kt/V greater than 1.1 (K equals dialyzer
             clearance of urea, t equals dialysis duration time, V equals volume of distribution of
             urea, which is approximately equal to the participant's total body water) based on the
             clinical judgment of participant's nephrologist and investigator and who are willing
             to stop (Parts A and B) or reduce (Part C) their stable ESA dose from the week of
             randomization until completion of the 6-week treatment period (unless rescue therapy
             is needed)

          -  Have a hemoglobin value (taken prior to dialysis if taken on a dialysis day) greater
             than or equal to 9.5 grams per deciLiter (g/dL) and less than or equal to 12.5 g/dL at
             screening

          -  Have a body mass index (BMI) of 18.5 to 45 kilograms per square meter (kg/m^2)
             inclusive at screening

          -  Have a transferrin saturation (TSat) greater than or equality to 15 percent and
             ferritin greater than 40 nanograms per milliliter (ng/mL) at screening

        Exclusion Criteria:

          -  Any cause of anemia other than renal disease

          -  A history of hyporesponsiveness to ESA
A Study of Evacetrapib and Rifampin in Healthy Participants
Condition: Healthy Volunteers
Intervention: Evacetrapib; Rifampin
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Rifampin; Evacetrapib
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
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to determine how much evacetrapib gets into the blood
      stream and how long it takes the body to get rid of it when given with rifampin. The safety
      and tolerability of the two drugs, given together, will also be evaluated. The study will
      also look at blood cholesterol levels and levels of a hormone called cortisol before and
      after taking rifampin. Information about any side effects that may occur will also be
      collected.

      For each participant, this study will include 2 periods in fixed order. The study will last
      approximately 29 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy males and females (of non child-bearing potential)

          -  Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2), inclusive, at
             screening

        Exclusion Criteria:

          -  Have known allergies to evacetrapib, rifampin, related compounds or any components of
             either formulation, or history of significant allergic disease as determined by the
             investigator
Enhancing Participation In the Community by Improving Wheelchair Skills: Phase 2
Condition: Older Adult Manual Wheelchair Users
Intervention: EPIC WheelS
Intervention description: EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
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: 50 Years
Healthy volunteers: No
Keywords: Mobility Impairment; Manual Wheelchair; Older Adults

Summary:

      The purpose of this project is to conduct a pilot study of the EPIC WheelS wheelchair skills
      home training program for older adults in preparation for a third phase feasibility study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least 50 years old

          -  live in the community within metropolitan Winnipeg

          -  self-propel a MWC (Manual Wheelchair) at least 1 hour per day

          -  use their MWC for mobility outside of the home

          -  have used a MWC for less than 2 years

        Exclusion Criteria:

          -  cannot communicate and complete study questionnaires in English

          -  anticipate a health condition that contraindicates wheelchair training
Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin
Condition: Pre-diabetes
MeSH terms: Prediabetic State
Intervention: (+)-Epicatechin
Intervention description: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy or pre-diabetic based on medical history

          -  Male or female

          -  Must be 21 to 75 years of age (inclusive)

          -  Able to give informed consent to the procedures

          -  If female, must be either postmenopausal or test negative for pregnancy at screening
             and on the day of the procedure. Women on estrogen therapy will be included.

          -  If of childbearing potential, must practice and be willing to continue to practice
             appropriate birth control during the entire duration of the study

          -  Medication use stable for 4 weeks

          -  Body Mass Index (BMI) > 27 kg/m^2

          -  Definition of pre-diabetes: impaired fasting glucose (IFG, fasting glucose = 100-125
             mg/dL) and elevated HbA1c (5.7-6.4%), each in the absence of other risk factors for
             diabetes

        Exclusion Criteria:

          -  Type 2 diabetes

          -  Pregnancy

          -  Younger than 21 or older than 75 years of age

          -  Clinically significant abnormalities in liver or kidney function (>3x ULN), determined
             in the last 6 months by a certified clinical laboratory

          -  Recent MI or stroke (within 6 months of screening)

          -  Blood pressure (BP) >160 mmHg Systolic and >100 mmHg Diastolic

          -  Medications - thiazolidinediones, any steroids, anti-depressants, weight loss drugs

          -  Other diseases, besides type 2 diabetes, influencing carbohydrate metabolism
Minimally Invasive Sensing of Beta-lactam Antibiotics
Condition: Healthy Volunteers
Intervention: Phenoxymethyl Penicillin; Microneedle array
Intervention description: Phenoxymethylpenicillin tablets, 500mg every six hours for six doses, starting the day before study; The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed.
Intervention MeSH terms: Penicillins; Penicillin V
Phase: Phase 1
Study type: Interventional
Primary purpose: Device Feasibility
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics; Penicillin V; Penicillins; Proof of Concept Study; Clinical Trial, Phase I; Microneedle array

Summary:

      This study is an in-house feasibility study of a microneedle biosensor developed within
      Imperial College London.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult >18 years old

          -  Healthy with no evidence of active infection

          -  Previously received penicillin with no adverse effects

        Exclusion Criteria:

          -  High risk of skin soft tissue infection or local skin and soft tissue infection near
             sensor site

          -  Previous history of allergies to adhesive strips or active dermatitis

          -  Penicillin allergy or previous adverse event whilst receiving penicillin

          -  Anaemia on screening bloods (defined as haemoglobin <13 g/dL in males and <12 g/dL in
             females)
Effect of Antacid on Bioavailability of Febuxostat After Administration of a Febuxostat 80 mg Extended-Release Capsule
Condition: Healthy Volunteers
Intervention: Febuxostat XR; Maalox Advance Regular Strength liquid
Intervention description: Febuxostat extended-release (XR) capsules; Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent
Intervention MeSH terms: Febuxostat
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: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the effect of antacid administration, and its timing,
      on the bioavailability of a single dose of febuxostat extended-release (XR) 80 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a healthy adult male or female aged 18 to 55 years, inclusive, by check-in (Day-1
             of Period 1)

          2. Weighs at least 50 kg (110 pounds), and has a body mass index (BMI) between 18.0
             kg/m^2 to 30 kg/m^2, inclusive at Screening.

          3. Has estimated glomerular filtration rate ≥90 mL/min

        Exclusion Criteria:

        Any participant who meets any of the following criteria will not qualify for entry into the
        study:

          1. Has received any investigational compound within 30 days prior to the first dose of
             study medication.

          2. Has received febuxostat in a previous clinical study or as a therapeutic agent.

          3. Has a known hypersensitivity to any xanthine oxidase inhibitor, xanthine compounds or
             any component of the formulation of febuxostat tablets (see Package Insert) or to
             caffeine.

          4. Has a known hypersensitivity to aluminum, magnesium hydroxide, or any component of the
             formulation of antacid (Maalox Advanced Regular Strength or equivalent) (see Package
             Insert).

          5. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
             abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain
             from alcohol and drugs throughout the study. If female, the participant is pregnant or
             lactating or intending to become pregnant before, during, or within 30 days after
             participating in this study; or intending to donate ova during such time period.

          6. Has current or recent (within 6 months) gastrointestinal disease that would be
             expected to influence the absorption of drugs (ie, a history of malabsorption,
             esophageal reflux, peptic ulcer disease, erosive esophagitis frequent [more than once
             per week] occurrence of heartburn, or any surgical intervention [eg,
             cholecystectomy]).
A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas
Condition: Glioma
MeSH terms: Glioma
Intervention: capecitabine [Xeloda]
Intervention description: 500mg/m2 po bid (starting dose)
Intervention MeSH terms: Capecitabine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 3 Years
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities,
      of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed
      diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered
      twice daily, at a starting dose of 500mg/m2 bid, beginning within 24 hours of the start of
      radiation therapy. Subsequent dose escalations will be in increments of 30%, using a standard
      dose escalation schema. Post-radiation therapy with Xeloda will continue after a 2 week
      break. The anticipated time on study treatment is 3-12 months, and the target sample size
      will not exceed 30 evaluable patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients >=3 and <=21 years of age;

          -  newly diagnosed non-disseminated brainstem glioma or non-disseminated high grade
             glioma;

          -  Karnofsky (if >16 years) or Lansky (if < 16 years) Performance Scale of >=50%;

          -  adequate organ function.

        Exclusion Criteria:

          -  previous chemotherapy, radiation therapy, immunotherapy or bone marrow transplant;

          -  uncontrolled infection;

          -  known DPD deficiency.