bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy, Safety And Tolerability Of PF-06743649 In Gout Subjects.
Condition: Gout
MeSH terms: Gout
Intervention: PF-06743649; Placebo; PF-06743649; Placebo
Intervention description: Daily dosing (dose level 1) tablet for 14 days; Daily dosing (tablet) for 14 days; Daily dosing (dose level 2) tablet(s) for 14 days; Daily dosing (tablets) for 14 days
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Hyperuricemia; gout; serum uric acid

Summary:

      The purpose of the study is to assess the effect of PF-06743649 in lowering serum uric acid
      in subjects suffering from gout following 14 days of dosing, as well as assessing safety and
      tolerability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject meets the diagnosis of gout as per the American Rheumatism Association
             Criteria for the Classification of acute Arthritis of Primary Gout.

          -  Subjects taking urate lowering therapy at the time of screening must be willing to
             discontinue their prior urate lowering therapy from the time of Screening Visit 1
             until completion of the study period Day 16.

          -  Subjects taking urate lowering therapy at the time of screening must have a serum
             urate level of >= 8.0 mg/dL at time of the second screening visit.

          -  Subjects NOT taking urate lowering therapy at the time of screening must have a serum
             urate level of >= 8.0 mg/dL at both screening visits 1 and 2.

        Exclusion Criteria:

          -  Positive medical history or current evidence of medical or psychiatric
             condition/disease, or ECG or laboratory abnormality that may increase the risk
             associated with study participation or investigational product administration or may
             interfere with the interpretation of study results and, in the judgment of the
             Investigator, would make the subject inappropriate for entry into this study.

          -  Chronic kidney disease classified as moderate or severe (Clinical Practice Guideline,
             National Kidney Foundation)12; with GFR < 60 mL/min/1.73m2 calculated by the
             Cockcroft-Gault equation.

          -  Subjects with current tophaceous gout.

          -  Gout flare that has not resolved for at least 2 weeks prior to randomization.
Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects
Condition: Healthy Volunteers
Intervention: Linezolid; Linezolid
Intervention description: Linezolid OS 600 MG
Linezolid Tablet 600 MG; Linezolid Tablet 600 MG
Linezolid OS 600 MG
Intervention MeSH terms: Linezolid
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bio-equivalence; Linezolid OS; Linezolid tablet

Summary:

      The purpose of this study is to estimate the bioequivalence comparing Linezolid 600 MG Oral
      Suspension with 600 MG tablet in Chinese healthy male subjects. This study data will be used
      to support Linezolid OS NDA in China.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteers.

          -  18-40 years old, male.

          -  BMI 19-24kg/m2.

        Exclusion Criteria:

          -  Alcohol, drug, smoke user.

          -  Sensitive to oxazolidinones antibiotics class drug or heparin.

          -  Severe medical or psychiatric condition or laboratory abnormality.

          -  Blood donation.

          -  12-ECG abnormal.

          -  Treatment with study drug; clinically significant.
Relative Bioavailability of of Olodaterol and Ketoconazole
Condition: Healthy; Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: BI 1744; BI 1744; Ketoconazole; Ketoconazole
Intervention description: 10 mcg solution for oral inhalation; 10 mcg solution for oral inhalation; 400 mg tablet; 400 mg tablet
Intervention MeSH terms: Ketoconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This clinical trial is intended to investigate a possible effect of the p-gp inhibitor
      ketoconazole on the bioavailability of olodaterol
    

Eligibility criteria:

        Inclusion criteria Healthy male and female volunteers

        Exclusion criteria
Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies
Condition: B-cell Malignancies
MeSH terms: Neoplasms
Intervention: Zanubrutinib; Fluconazole; Diltiazem; Voriconazole; Clarithromycin
Intervention description: Capsules administered at a dose and frequency as specified in the treatment arm; Capsules administered at a dose and frequency as specified in the treatment arm; Capsules administered at a dose and frequency as specified in the treatment arm; Capsules administered at a dose and frequency as specified in the treatment arm; Capsules administered at a dose and frequency as specified in the treatment arm
Intervention MeSH terms: Clarithromycin; Fluconazole; Voriconazole; Zanubrutinib; Diltiazem
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study was to assess the steady-state zanubrutinib
      pharmacokinetics (PK) when co-administered with moderate and strong cytochrome P450 family 3
      subfamily A (CYP3A) inhibitors.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Histologically or cytologically confirmed CLL/SLL, MCL, WM, or MZL.

          2. Relapsed or refractory disease after at least 1 prior line of systemic therapy.
             Participants with MZL are required to have failed an anti-CD20 monoclonal
             antibody-containing chemotherapy regimen.

          3. Baseline Eastern Cooperative Oncology Group performance status of 0 to 1.

          4. Meet protocol guidelines for adequate bone marrow, kidney, liver, and cardiac
             function.

        Key Exclusion Criteria:

          1. Requirement of chronic treatment with strong and moderate CYP3A inhibitors or inducers
             or with drugs that are not allowed to be used in combination with diltiazem,
             clarithromycin, fluconazole, or voriconazole.

          2. History of stroke or intracranial hemorrhage (within 6 months of treatment start).

          3. Known hypersensitivity or contraindication to zanubrutinib, diltiazem, clarithromycin,
             fluconazole, or voriconazole.

          4. Prior exposure to zanubrutinib or other Bruton tyrosine kinase inhibitor

          5. Unable to swallow capsules or disease significantly affecting gastrointestinal
             function such as malabsorption syndrome, resection of the stomach or small bowel,
             bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or
             complete bowel obstruction.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
The Effect of OASIS Ultra on Critical Sized Wound Healing
Condition: Traumatic Wound; Infective Wound; Iatrogenic Critical Sized Wound Defects; Wound Healing
MeSH terms: Wounds and Injuries
Intervention: OASIS Ultra; Wound VAC Standard Therapy
Intervention description: Porcine derived intestinal submucosa; Negative pressure wound device aka wound VAC will be placed on the standard therapy half of the wound
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: OASIS
Masking: Single (Participant)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: OASIS ultra; faster healing time; better healing quality; standard of care

Summary:

      The aim of this study is to evaluate the speed and quality with which OASIS® Ultra
      (Healthpoint Biotherapeutics; Fort Worth, Texas) increases wound healing in the critical
      sized defect. The investigators intend on confirming the histological composition of the
      dermal substitute in order to delineate the amount of cellular recruitment, collagen
      deposition and neovascularization present compared with control wounds. The investigators
      hypothesize that OASIS® Ultra will provide a faster healing time as well as the
      re-establishment of a dermis for further skin graft application. The investigators anticipate
      that our study will define parameters for the application of OASIS® Ultra as well as
      potentially demonstrating the advantages in healing time, healed wound quality and hospital
      stay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  all patients >18 years

          -  traumatic, infective or iatrogenic critical sized wound defects (50 sq cm or greater)

          -  quantitative wound culture < 105.

        Exclusion Criteria:

          -  Wounds that cannot have a negative pressure wound device applied due to anatomical
             difficulty (i.e. proximity to perineum/anus) or exposed arteries/veins.

          -  Patients who are DNR/DNI

          -  Patients who are hemodynamically unstable or requiring pressors

          -  Patients that are immunodeficient or immunocompromised (ie HIV)

          -  Patients that have any allergy to porcine products

          -  Patients that have a religious or ethical necessity to avoid porcine products

          -  Patients whose wounds are derived from extension of mitotic lesions (ie ulcerative
             squamous cell carcinoma)

          -  Patients whose wounds are expected to heal in less than seven days or be ready for
             skin grafting in less than seven days with standard therapy

          -  Patients with full thickness burns

          -  Patients with wound surface area of <50 sq cm

          -  Pregnant patients (as confirmed by serum or urinary beta-Human Chorionic Gonadotrophin
             sampling or by History).
A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects
Condition: Healthy
Intervention: 4mg fesoterodine; 8mg fesoterodine; alprazolam 1mg; Placebo
Intervention description: 4mg tablet once daily for 6 days; 4mg tablet once daily for 3 days followed by 8mg tablet once daily for 3 days; 1mg tablet once on last day of treatment period at clinic; Placebo tablet for fesoterodine once daily for 6 days and placebo tablet for alprazolam once on last day of treatment period at clinic
Intervention MeSH terms: Alprazolam; Fesoterodine
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 65 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study is designed to evaluate elements of cognitive function in subjects receiving either
      fesoterodine or alprazolam.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult healthy volunteers 65 years and over with minimum MMSE of 26

        Exclusion Criteria:

          -  Prohibited concomitant medications

          -  Confounding medical conditions

          -  Clinically significant comorbid diseases

          -  Hypersensitivity or contraindications to fesoterodine or active control
Safety and Tolerability of the D1 Dopamine Receptor Antagonist Ecopipam in Patients With Lesch-Nyhan Disease
Condition: Lesch-Nyhan Disease
MeSH terms: Lesch-Nyhan Syndrome; Self-Injurious Behavior
Intervention: Ecopipam
Intervention description: Tablets, once daily, for two weeks up to 200 mg/day
Intervention MeSH terms: Ecopipam
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Male
Minimum age: 6 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Ecopipam; Lesch-Nyhan Disease; Safety; Self-Injurious Behavior

Summary:

      The purpose of this study is to determine the effects of ecopipam in patients with
      Lesch-Nyhan Disease (LND). Ecopipam specifically blocks the actions of one chemical in the
      brain that helps nerves talk to one another; ecopipam does this by stopping the chemical
      (dopamine) from binding to one of its family of receptors (i.e, the D1 family). LND is a very
      rare genetic disease. The sponsor is doing this study to find out what side effects ecopipam
      causes in LND patients, and whether ecopipam may be able to relieve the self-injurious
      behaviors seen in these patients.
    

Eligibility criteria:

        Inclusion Criteria

          -  Diagnosis of Lesch-Nyhan disease with moderate to severe Self- Injurious Behavior and
             are routinely restrained

          -  Male - 6 years of age and above

          -  Body weight greater than or equal to 44 pounds

        Exclusion Criteria:

          -  Taking Neuroleptic or Dopamine Depleting medications

          -  Currently treated with medications for depression or seizures

          -  Impaired renal function

          -  Medical conditions that may interfere with completing the study
Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Intervention: 5-fluorouracil; cisplatin; sunitinib malate
Intervention description: 5- fluorouracil is given as 4000 mg/m^2 total dose over 96 hr continuous infusion of a 21 day chemotherapy cycle. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.; Cisplatin is given 80 mg/m^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.; sunitinib is given orally 37.5mg /day for 14 days followed by 7 days of drug free period. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
Intervention MeSH terms: Fluorouracil; Sunitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safe and tolerable dose of sunitinib when given
      together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have
      not received prior chemotherapy for their advanced cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  confirmed diagnosis of stomach cancer

          -  advanced stomach cancer stage IV

          -  adequate blood chemistry, blood counts and kidney function

          -  willing to participate to study requirements and to sign an informed consent document

        Exclusion Criteria:

          -  prior chemotherapy for stomach cancer in its advanced stage

          -  excessive toxicities related to prior therapies

          -  pregnant or breastfeeding patients
A Multiple-dose Study of LY3031207 in Healthy Participants
Condition: Healthy Volunteers
Intervention: Placebo; LY3031207; Celecoxib; Simvastatin
Intervention description: Capsules administered orally; Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Celecoxib; Simvastatin; LY3031207
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purposes of this study are to look at safety, how well the study drug is tolerated, how
      much of the study drug gets into the blood stream, and how long it takes the body to get rid
      of it when given to healthy Japanese and non-Japanese participants as multiple doses. In
      addition, effects of 28-day oral dosing of LY3031207 on the amount of a cholesterol-lowering
      drug (simvastatin) that gets into the blood stream and how long the body takes to get rid of
      it will be determined. The effects of LY3031207 after single and 28-day dosing on blood
      pressure will also be studied. Information about any side effects that may occur will be
      collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy individuals based on the history and physical examinations as
             determined by the investigator, including first generation Japanese

          -  Body mass index between 17.0 and 32.0 kilograms per square meter (kg/m^2), inclusive

        Exclusion Criteria:

          -  Have known allergies to LY3031207 or any components of the formulation, simvastatin or
             related compounds (other 3-Hydroxy-3-Methyl-Glutaryl-CoA [HMG CoA] reductase
             inhibitors), celecoxib, or sulfonamides. Participants with known aspirin allergy or
             allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) should also be
             excluded
Study Evaluating HKI-272 in Tumors
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: neratinib
Intervention description: HKI-272
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: This trial was an open-label, phase 1, ascending single and multiple oral dose study of HKI-272 administered to subjects with erbB-2- or erbB-1-positive tumors. Each subject participated in only 1 dose group and received a single dose of test article, followed by a 1-week observation period, and then received the test article administered once daily by mouth for up to 6 months (6 cycles). Daily dose administration could continue beyond 6 cycles at the same dose level if HKI-272 was well tolerated and there was no evidence of progressive disease.
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tumors; Neratinib; HKI-272; Nerlynx

Summary:

      The purpose of this study is to evaluate the safety and tolerability as well as find the
      maximum tolerated dose (MTD) for HKI-272. In addition, this study will examine the effects of
      the study drug on your tumor, and how your body uses and eliminates HKI-272.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Her2/neu or Her1/EGFR positive cancer

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

          -  Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)

        Exclusion Criteria:

          -  Prior treatment with anthracyclines with a cumulative dose of doxorubicin or
             equivalent of greater than 300 mg/m^2

          -  Patients with significant cardiac risk factors

          -  Active central nervous system metastasis
A Study to Assess the Bioequivalence of Aprepitant and Fosaprepitant and the Effect of Food on Aprepitant Bioavailability (0869-165)
Condition: Chemotherapy-Induced Nausea and Vomiting
MeSH terms: Vomiting
Intervention: aprepitant 165 mg; Comparator: aprepitant 185 mg; Comparator: fosaprepitant 150 mg; Comparator: aprepitant with food
Intervention description: Single dose of aprepitant 165 mg tablet in the fasted state during treatment period 1,2, or 3.; Single dose of aprepitant 185 mg tablet in the fasted state during treatment period 1, 2, or 3.; Single dose of fosaprepitant 150 mg intravenous infusion in the fasted state during treatment period 1,2, or 3.; Single dose of aprepitant 165 mg or 185 mg tablet in the fed state during treatment period 4.
Intervention MeSH terms: Aprepitant; Fosaprepitant
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will assess the bioequivalence of single oral doses of aprepitant (MK0869) to a
      single intravenous infusion of fosaprepitant (MK0517) and also determine the effect of food
      on the bioavailability of oral aprepitant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is in good health

          -  Subject is a nonsmoker

          -  Subject is willing to comply with the study restrictions

        Exclusion Criteria:

          -  Subject has a history of any illness that might confound the results of the study or
             might make participation in the study unsafe

          -  Subject has a history of stroke, seizures, or major neurological disorder

          -  Subject has a history of cancer

          -  Subject consumes more than two alcoholic drinks per day

          -  Subject consumes more than three caffeinated beverages daily