bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults
Condition: Healthy Male Adults
Intervention: ASC-01; Aripiprazole and sertraline
Intervention description: Aripiprazole 3 mg/sertraline 100 mg combination drug; Aripiprazole 3 mg and sertraline 100 mg
Intervention MeSH terms: Aripiprazole; Sertraline
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: Male
Minimum age: 20 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the bioequivalence of aripiprazole between administration of one ASC-01 tablet
      (aripiprazole 3 mg/sertraline 100 mg combination drug) and concomitant administration of one
      aripiprazole 3-mg tablet and two sertraline 50-mg tablets (Cohort 1).

      To investigate food effect on plasma pharmacokinetics of aripiprazole and sertraline by
      single oral administration of ASC-01 under a fasting or fed condition (Cohort 2).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subject at the age between 20 and 40 at the time of informed consent

          -  Subject has a body mass index (BMI = body weight [kg]/height [m]2) of ≥18.5 and <25.0
             kg/m2 at screening

          -  Subject is providing consent for participation in this trial in writing prior to the
             start of the procedures related to this trial, and judged by the investigator or
             subinvestigator to be capable of observing procedures in this trial.

        Exclusion Criteria:

          -  Subject has a clinically significant abnormality in physical findings at screening or
             in medical history that in the investigator's or subinvestigator's opinion may place
             the subject at risk or interfere with outcome variables including drug absorption,
             distribution, metabolism, and excretion.

          -  Subject is judged by the investigator or subinvestigator to be inappropriate for
             participation in this trial.
Safety and Immunogenicity Study of V710 Lyophilized Formulation (V710-004)
Condition: Healthy
Intervention: Comparator: V710; Comparator: placebo
Intervention description: Single dose V710 (60 Mcg/0.5 mL) by intramuscular injection.; Single dose of buffered saline placebo (0.5 mL) by intramuscular injection.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: study in healthy subjects

Summary:

      This study is being performed to evaluate a single 60 Mcg dose of lyophilized formulation of
      Merck Staphylococcus aureus vaccine (V710) in healthy subjects. This study is intended to
      provide necessary safety and immunogenicity data for the lyophilized formulation of V710
      prior to its subsequent evaluation in patients at risk for developing serious S. aureus
      infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 80 years of age

          -  Good physical health based upon medical history and physical examination

          -  Willing and able to participate in the entire study duration

          -  Female subject with a negative urine pregnancy test immediately prior to study
             vaccination

        Exclusion Criteria:

          -  Chronic skin infections or a chronic skin condition (e.g. psoriasis)

          -  Serious S. aureus infection in the last 12 months

          -  Allergy to aluminum-containing substance taken in the body or to any other vaccine
             component

          -  Oral temperature equal to or greater than 100.4ºF (38.0ºC), within the past 2 days

          -  Participation in a prior V710 vaccine clinical study

          -  Participation in any other clinical study in the past 4 weeks, or during the 3-month
             study duration
Study to Assess the Safety of AZD1480 in Patients With Myeloproliferative Diseases
Condition: Primary Myelofibrosis (PMF); Post-Polycythaemia Vera; Essential Thrombocythaemia Myelofibrosis
MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Polycythemia; Thrombocytosis; Thrombocythemia, Essential
Intervention: AZD1480
Intervention description: Oral capsule 2.5 mg, 10 mg and 40 mg
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 25 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Primary Myelofibrosis (PMF); Post-Polycythaemia Vera/Essential Thrombocythaemia Myelofibrosis (Post-PV/ET MF); Myeloproliferative diseases; Phase I; Phase II; Bone marrow

Summary:

      This study is being conducted to test study drug AZD1480 to see how it may work to treat
      myeloproliferative diseases. The main purpose of this study is to determine the safety and
      tolerability of AZD1480. This is the first time the drug has been given to humans and is
      classed as a first time in man study. Its main purpose is to establish a safe dosage of the
      drug and provide additional information on any potential side effects this drug may cause.
      The study will also assess the blood levels and action of AZD1480 in the body over a period
      of time and will indicate whether the drug has a therapeutic effect on myeloproliferative
      diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with myelofibrosis requiring therapy

          -  Evidence of post-menopausal status or sterile

          -  ECOG Performance Status </=2

        Exclusion Criteria:

          -  Prior therapy with any JAK2 medications

          -  Significant lung disorder or lung disease

          -  Previous radiation therapy to chest wall or chest infection requiring antibiotic
             treatment within 28 days before study screening

          -  Eye disease of the cornea

          -  Patients requiring oxygen supplementation

          -  Ejection fraction <45% (ECHO/MUGA) or significant pulmonary hypertension >40 mm Hg (by
             Echo/Doppler)

          -  Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) <70% predicted or >130%
             predicted

          -  Diffusing capacity of the Lung for Carbon Monoxide (DLCO) corrected for hemoglobin
             <60% predicted, oxygen saturation <88% at rest or after a 6-minute flat walk, without
             supplemental oxygen

          -  Chest infection requiring antibiotics within 7 days of the first dose of
             Investigational product.
Intravenous N-acetylcysteine for the Treatment of Gaucher's Disease and Parkinson's Disease
Condition: Parkinson's Disease; Gaucher's Disease
MeSH terms: Parkinson Disease; Gaucher Disease
Intervention: N-acetylcysteine
Intervention description: Single, intravenous administration of N-acetylcysteine
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Parkinson's disease; Gaucher's disease; Control

Summary:

      The investigators are interested in determining if the investigators are able to detect
      changes in brain chemistry using Magnetic Resonance Spectroscopy (MRS) in individuals with
      Parkinson's disease (PD), those with Gaucher's disease (GD), and those without neurological
      disorders (healthy controls) when they are given the antioxidant N-acetylcysteine (NAC). This
      study will combine information from a medical history, a physical examination and disease
      rating scales with results obtained using MRS brain scans and pharmacokinetic studies from
      blood samples. This research will require 1 visit that will require about 4 to 5 hours of
      time. During this study, participants will provide their medical history, be examined and
      undergo a rating scale for about one hour; the brain scan and pharmacokinetic studies will
      require 1.5-2 hours of time; in total the study will take about 4-5 hours.
    

Eligibility criteria:

        Inclusion Criteria:

          1. All participants must be 18 years or older.

          2. All enrollees must understand and cooperate with requirements of the study in the
             opinion of the investigators and must be able to provide written informed consent.

          3. Individuals with medically stable Parkinson's disease (in the opinion of the
             investigator).

          4. All participants must not have taken antioxidants coenzyme Q-10, vitamin C, or vitamin
             E for 3 weeks prior to the study.

          5. Absence of dementia in all subjects, as determined by pre-scanning cognitive
             assessment.

          6. Control subjects who are able to undergo MRS

        Exclusion Criteria:

          1. Inability to undergo MRI scanning without sedation

          2. Medically unstable conditions in any group as determined by the investigators

          3. Pregnant or lactating or those women of child-bearing age that are not using
             acceptable forms of contraception

          4. Diagnosis of asthma that is presently being treated with ANY medication, or past
             history of asthma/bronchospasm resulting in an emergency room visit, hospitalization
             or treatment

          5. Unable to adhere to study protocol for whatever reason
A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid Tumors
Condition: Tumors
MeSH terms: 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 was an open-label, phase 1, ascending single and multiple oral dose study of neratinib administered to subjects with advanced solid tumors. Each subject participated in only 1 dose group and received a single dose of neratinib. This was followed by a 1-week observation period, and the subject then received neratinib administered as a continual oral daily dose for up to 6 months (6 cycles). Daily dose administration could continue beyond 6 cycles at the same dose level after consultation with the sponsor if neratinib was well tolerated and there was no evidence of progressive disease.
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Advanced Malignant Solid Tumors; HKI-272; Neratinib; Nerlynx

Summary:

      The purpose of this study is to assess the tolerability and safety of HKI-272, and to
      determine the maximum dose that can safety be given. The secondary purpose of this study is
      to determine how the body uses and gets rid of HKI-272 and to assess whether HKI-272 is
      effective for the treatment of advanced solid tumors.
    

Eligibility criteria:

        Inclusion criteria

          1. Diagnosis of metastatic or advanced cancer that has failed standard effective therapy

          2. Life expectancy of at least 12 weeks and adequate performance status

          3. Adequate bone marrow, kidney and liver function

          4. Willingness of male and female subjects who are not surgically sterile or
             post-menopausal to use adequate methods of birth control

        Exclusion Criteria

          1. Any anticancer chemotherapy, radiotherapy immunotherapy or investigational agents
             within 4 weeks of first dose of HKI-272

          2. Inadequate cardiac function

          3. Surgery within 2 weeks of first dose of HKI-272

          4. Active central nervous system metastases (i.e., symptomatic, required use of
             corticosteroids and/or progressive growth)

          5. Significant gastrointestinal disorder with diarrhea as a major symptom

          6. Pregnant or breast feeding women
A Study of LY3337641 in Healthy Participants
Condition: Healthy
Intervention: Reference Formulation (R); LY3337641 (T1); LY3337641 (T2)
Intervention description: Administered PO; 20 mg PO; 20 mg PO
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purposes of this study are to determine:

        -  If there are any differences in the amount of LY3337641 in the blood/body when it is
           taken in different formulations. A total of 3 different formulations of LY3337641 are
           being tested.

        -  How a high-fat meal affects the amount of LY3337641 in the blood/body.

        -  How safe and well tolerated LY3337641 is.

      The study has four periods. Individuals will participate in all four periods. Each period
      will include 4 overnight stays (5 days) in the Clinical Research Unit (CRU).

      This study is expected to last up to 8 weeks. This includes the initial screening period, the
      study or dosing period, and the follow up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined by medical history and physical
             examination

          -  Have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²)
             inclusive

          -  Have clinical laboratory test results within normal reference range for the population
             or investigative site

          -  Are able and willing to give signed informed consent

        Exclusion Criteria:

          -  Have participated, within the last 30 days, in a clinical trial involving an
             investigational product. If the previous investigational product has a long half-life,
             3 months or 5 half-lives (whichever is longer) should have passed

          -  Have significant history of or current cardiovascular, dermatological (such as eczema,
             psoriasis, and acne), respiratory, hepatic, renal, gastrointestinal (cholecystectomy
             is not acceptable), endocrine, 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

          -  Have used or intend to use over-the-counter or prescription medication, including
             herbal medications, within 14 days prior to planned dosing

          -  In the opinion of the investigator or sponsor, are unsuitable for inclusion in the
             study
Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Intervention: 19 injections; sodium chloride 0.9% solution
Intervention description: Subjects will receive 19 injections in randomised order of which 13 will be in the abdomen and 6 in the thighs. Out of the 19 injections, 2 are needle insertions only. The remaining 17 injections represent different combinations of injection speed and volume of sodium chloride 0.9% solution for injection. The order of the injection speed and volume combinations will be blinded for the subject and the pain will be evaluated by the subject on a VAS (Visual Analogue Scale).; Solution for injection.
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe. The aim of this trial is to assess and describe the pain
      in relation to subcutaneous (under the skin) injection of different combinations of injection
      speed and volume with respect to acceptance of the injection pain and backflow.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities.

          -  Type 1 or type 2 diabetes

          -  Daily injection(s) with anti-diabetic drug (insulin or Glucagon like Peptide-1 (GLP-1)
             analogues) via pen-injector or vial/syringe for more than 6 months

          -  Body mass index (BMI) between 18.5 and 30.0 kg/m^2 (both included)

          -  Caucasians

        Exclusion Criteria:

          -  Known or suspected hypersensitivity to needle, ink ball pen or other that are in
             contact with the injection area during the clinical visit

          -  Previous participation in this trial. Participation is defined as: screened

          -  Receipt of any investigational medicinal product that can influence pain perception
             within 14 days before screening

          -  Injection of more than 40 units of insulin per injection

          -  Continuous Subcutaneous Insulin Infusion use within the last 6 months

          -  Continuous Glucose Monitoring use within the last 6 months

          -  Intake of any pain-relieving or analgesic within the last week (excluding low dose
             aspirin in cardio vascular prophylactic doses)

          -  Known active or in-active skin disease in the injection area or that may affect pain
             perception

          -  Anti-coagulant treatment within the last month (low dose of aspirin in cardiovascular
             prophylactic doses is allowed. However, not on the day of the injections)
A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Ixekizumab
Intervention description: Administered as subcutaneous (SC) injection
Intervention MeSH terms: Ixekizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to research how much ixekizumab enters the bloodstream and how
      long the body takes to get rid of the drug and the safety of ixekizumab and any side effects
      that might be associated with it. The study has two parts: A single-dose part and
      multiple-dose part. The single dose part of this study will last up to 24 weeks, including
      the screening period. The multiple dose part of this study will last up to 32 weeks including
      the screening period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged ≥18 years.

          -  Diagnosis of chronic plaque psoriasis for ≥6 months before baseline.

          -  Candidates for phototherapy and/or systemic therapy.

          -  ≥10% body surface area (BSA) involvement at screening and baseline.

          -  static Physician's Global Assessment (sPGA) score ≥3, and Psoriasis Area and Severity
             Index (PASI) score ≥12 at screening and baseline.

        Exclusion Criteria:

          -  Clinically significant flare of psoriasis during the 12 weeks before baseline.

          -  Systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks. prior to
             baseline or topical psoriasis treatment or medicated shampoo within 2 weeks prior to
             baseline .

          -  Current or recent use of any biologic agent within the required washout periods.

          -  Clinical evidence or suspicion of active tuberculosis or previously had evidence of
             active tuberculosis and did not receive appropriate and documented treatment.
Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Intervention: pravastatin
Intervention description: A single 10 mg dose of pravastatin will be administered 3 mL blood samples for pravastatin Pharmacokinetic evaluations will be collected at 0.5, 1, 2, 3, 4, 6, and 8 hours. 5 mL blood samples for pravastatin PK and laboratory evaluations will be drawn at pre-dose and 24 hours.
Vital Signs and Physical Exams will also be done throughout the study
Intervention MeSH terms: Pravastatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 12 Months
Maximum age: 18 Years
Healthy volunteers: No
Keywords: pravastatin, peritoneal dialysis, pediatric patients

Summary:

      Many children with end stage renal disease develop hyperlipidemia. HMG-CoA
      (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors, such as pravastatin, are
      typical treatments for hyperlipidemia. However, we do not know how pravastatin is metabolized
      in patients on dialysis. This study is designed to provide preliminary pharmacokinetic data
      for pravastatin in pediatric patients on peritoneal dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients from 12 months to 18 years of age.

          2. Patients with end stage renal disease who receive continuous cycling peritoneal
             dialysis.

          3. signed informed consent

          4. Physical exam demonstrates no abnormalities that would make this study medically
             hazardous to the subject.

             -

        Exclusion Criteria:

          1. Any clinically significant unstable medical condition or chronic disease other than
             those associated with ESRD.

          2. Any clinically significant illness within 10 days or receiving single-sdoe of study
             medication

          3. History of rhabdomyolysis

          4. Clinically significant liver disease or history of malabsorption or previous
             gastrointestinal surgery that could effect drug absorption or metabolism.

          5. Clinical laboratory abnormalities: Aspartate aminotransferase (AST), Alanine
             Aminotransferase (ALT), Creatine phosphokinase(CPK) > 2.5 times upper limit of normal;
             hemoglobin < 8.5 g.dL.

          6. Known hypersensitivity to pravastatin

          7. Unwilling to have blood samples drawn

          8. Has taken a HMG-CoA reductase inhibitor in the last week -