bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Brexpiprazole Orally Disintegrating Tablets (ODT) 2mg
Condition: Healthy Adult Male
Intervention: Brexpiprazole ODT 2mg with water; Brexpiprazole ODT 2mg without water; Brexpiprazole conventional tablet 2mg
Intervention description: Brexpiprazole ODT 2mg is administered with water.; Brexpiprazole ODT 2mg is administered without water.; Brexpiprazole conventional tablet 2mg is administered with water.
Intervention MeSH terms: Brexpiprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Male
Minimum age: 20 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the bioequivalence of brexpiprazole ODT 2 mg and brexpiprazole conventional
      tablet 2 mg
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Japanese males

          -  BMI ［body weight in kg /(height in m)2］ of at least 18.5 kg/m2 and less than 25.0
             kg/m2 (as a result of at the screening examination)

          -  Capable of providing written informed consent prior to initiation of any trial-related
             procedures, and able, in the opinion of the investigator, to comply with all
             requirements of the trial

        Exclusion Criteria:

          -  Clinically significant abnormality at the time of screening (eg, significant deviation
             from reference ranges) or in medical history that, in the opinion of investigator,
             subinvestigator, or sponsor may place the subject at risk or interfere with outcome
             variables such as drug absorption, distribution, metabolism, and excretion

          -  History of serious mental disorder

          -  History of drug or alcohol abuse within 2 years prior to screening

          -  History of any significant drug allergy

          -  Use of another investigational drug within 120 days prior to the first administration
             of IMP

          -  Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange
             products, Star fruit, or Star fruit products within 72 hours prior to the first
             administration of IMP or consumption of alcohol within 72 hours prior to
             administration of IMP

          -  Use of prescription, over-the-counter (OTC), or herbal medication, or vitamin
             supplements, or consumption of food or beverages containing St. John's Wort within 14
             days prior to the first administration of IMP, or use of antibiotics within 30 days
             prior to the first administration of IMP

          -  History of major surgery of the digestive tract (excluding appendectomy)

          -  Any subject who, in the judgement of the investigator or subinvestigator, should not
             participate in the trial
Safety and Efficacy Study of Peripheral Blood Mononucleated Cells for Treatment of Liver Cirrhosis
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Intervention: G-colony stimulating factor; Infusion of the mobilized monocyte cells
Intervention description: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm.; G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.
Intervention MeSH terms: Lenograstim
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      The investigators aim to investigate the safety and efficacy of peripheral blood monocyte for
      the treatment of patients with advanced liver cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 20 =< Age < 80

          2. Advanced liver cirrhosis with Child-Pugh score 8 or 9 (including patients who have no
             radiologic evidence of remnant HCC for more than 2 years after treatment)

        Exclusion Criteria:

          1. HBsAg-positive

          2. Active status of hepatocellular carcinoma (HCC) (except patients who have no
             radiologic evidence of remnant HCC for more than 2 years after treatment)

          3. History of hemochromatosis and/or autoimmune hepatitis

          4. Pregnant women or lactating women

          5. Hemoglobin < 8g/dL (male), 7.5g/dL (female) or white blood cell (WBC) <1,500 mm3 or
             Neutrophils <500/mm3 or platelet count <50,000/mm3

          6. Serum creatinine> 1.5 x normal upper limit or creatinine clearance <60 ml/min

          7. Presence of signs of malignant tumors or tumor suspected symptoms, or history of
             malignant tumors with recurrence rate greater than 20% within two years

          8. Gastrointestinal bleeding within the last 3 months or if there is a history of
             spontaneous bacterial peritonitis

          9. Presence of portal vein thrombosis

         10. Presence of acute infections
Distribution of Neutrophils in Bronchial Mucosal Tissue in Asthma Patients Before and After 4 Weeks Treatment With AZD 5069
Condition: Asthma
MeSH terms: Asthma
Intervention: AZD5069
Intervention description: oral BD administration of 45 mg AZD5069
Phase: Phase 1
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Asthma

Summary:

      Distribution of neutrophils in bronchial mucosal tissue in asthma patients before and after 4
      wk treatment with AZD 5069
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients of Caucasian origin, aged between 18 to 65 years, inclusive,
             at the time informed consent is obtained.

          2. Physician based (according to GINA 2011) diagnosis of asthma for at least 6 months
             prior to the date informed consent is obtained and confirmed by 1 of the detailed
             respiratory criteria stated in the CSP

          3. Morning prebronchodilator (ie, after abstinence from short-acting and long-acting
             ß-agonist treatment for ≥ 6 and ≥ 12 hours, respectively) FEV1 of ≥70% of predicted
             normal (PN) for age, sex and height at enrolment

          4. Increased number of neutrophils in induced sputum samples at baseline, with a relative
             neutrophil count of ≥ 50% of total sputum cell count

          5. Physician prescribed daily use of medium or high dose ICS (≥ fluticasone 250 μg to ≤
             1.000 µg or the equivalent daily, as defined in GINA 2011; see CSP Appendix E) plus
             LABA.

        Exclusion Criteria:

          1. History of clinically relevant allergies or idiosyncrasies to AZD5069 or other
             investigational CXCR2 antagonists, or any inactive ingredient(s) of the IMP, or
             tool-substances (eg, salbutamol, local anaesthetics) used for the purpose of this
             study

          2. History of severe asthma exacerbation requiring hospitalization within the last 12
             months before screening.

          3. Asthma exacerbation requiring a treatment course of systemic (ie, oral or parenteral)
             corticosteroids within the 3 months before screening or ≥ 3 courses within the last 12
             months before screening.

          4. Moderate to severe airflow limitation (FEV1 <70% PN)

          5. Any chronic lower respiratory disease other than asthma (see CSP for details) that, as
             judged by the Investigator or Medical Monitor, would interfere with the evaluation of
             the IMP or interpretation of patient safety or study results.

             -
Study Of PF-00562271, Including Patients With Pancreatic, Head And Neck, Prostatic Neoplasms
Condition: Head and Neck Neoplasm; Prostatic Neoplasm; Pancreatic Neoplasm
MeSH terms: Neoplasms; Prostatic Neoplasms; Pancreatic Neoplasms; Head and Neck Neoplasms
Intervention: PF00562271; PF00562271; PF00562271; PF00562271
Intervention description: 125 mg twice daily [BID] with food, tablet; 125 mg BID with food, tablet; 125 mg BID with food, tablet; 125 mg BID with food, tablet
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic Neoplasm; Head and Neck neoplasm; Prostatic neoplasms; Focal Adhesion Kinase; Phase 1; Pharmacodynamics; FDG-PET

Summary:

      Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase
      (FAK) inhibitor PF-00562271 in patients with positive Positron Emission Tomography [PET]
      scans due to advanced non-hematologic malignancies, including pancreatic, head and neck, and
      prostatic neoplasms, and patients with other malignancies appropriate for serial biopsy.
      Screening consists of a Fluorodeoxyglucose Positron Emission Tomography [FDG-PET] and tumor
      imaging, medical history, physical examination, Eastern Cooperative Oncology Group [ECOG]
      performance status, blood draws, a pregnancy test for female patients of childbearing
      potential. Treatment consists of PF00562271 tablets continued until progression of disease,
      unacceptable toxicity, or patient request. Evaluations for bioactivity are measured by serial
      FDG-PET and blood tests for biomarkers related to FAK and PYK2 kinase activities.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pancreatic, head and neck, and prostatic neoplasms, and patients with non-hematologic
             malignancies who have tumor appropriate for serial biopsy.

          -  Adequate organ function, including bilirubin less than 1.5 x ULN, and [Eastern
             Cooperative Oncology Group] ECOG performance status of 0-2.

        Exclusion Criteria:

          -  Clinically significant gastrointestinal abnormalities, requirement for systemic
             anticoagulants or potent CYP 3A4 inhibitors, and history of clinically significant
             cardiac or pulmonary disorders.
Early Airway Response to Allergen in Asthmatics (MK-0000-176)
Condition: Asthma
MeSH terms: Asthma
Intervention: Nedocromil; Comparator: Montelukast; Comparator: Mometasone; Placebo
Intervention description: Nedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge; Montelukast single 10 mg tablet administered 2 hours prior to allergen challenge; Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge; Mometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet
Intervention MeSH terms: Mometasone Furoate; Nedocromil; Montelukast
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study will assess the Early Airway Response (EAR) associated change in forced expiratory
      volume in one second (FEV1) and plasma 9α-11ß-PGF2 ('9P') after single dose pretreatment of
      nedocromil, montelukast, and mometasone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of mild to moderate Asthma

          -  In good general health (except for asthma)

          -  Stable and free of respiratory infection

          -  Nonsmoker

          -  Females highly unlikely to conceive (surgically sterilized, postmenopausal, or agrees
             to use 2 acceptable methods of birth control)

        Exclusion Criteria:

          -  Nursing mother

          -  Recent or ongoing upper or lower respiratory tract infection

          -  Unable to refrain from or anticipates the use of any prescription and non-prescription
             drugs

          -  Consumes excessive amounts of alcohol or caffeine

          -  History of stroke, chronic seizures, or major neurological disorder

          -  History of cancer

          -  Received a vaccination within the past 3 weeks
A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults
Condition: Healthy
Intervention: ALXN1840 Enteric-coated Tablet; ALXN1840 Non-coated Capsule; Omeprazole
Intervention description: ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1.; ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.; Omeprazole (20 milligrams) was administered orally as a delayed-release capsule in the morning of Days -5 to -1 and at Hour -1 on Day 1.
Intervention MeSH terms: Molybdenum; Tetrathiomolybdate; Choline; Omeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ALXN1840; WTX101; Omeprazole

Summary:

      This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover
      study evaluating the PK of single doses of WTX101 in healthy participants based on the
      measurement of plasma total Mo concentration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-smoker

          -  Medically healthy with no clinically significant laboratory profiles, vital signs, or
             electrocardiograms.

          -  Body mass index ≥ 18 and ≤ 32.0 kilograms/meter squared.

          -  Willing and able to adhere to contraception requirements.

        Exclusion Criteria:

          -  Participant was mentally or legally incapacitated

          -  History or presence of clinically significant medical or psychiatric condition or
             disease.

          -  History of any illness that might have interfered with drug absorption.

          -  History or presence of hypersensitivity or idiosyncratic reaction to the study
             medications, study medication excipients.

          -  History or presence of alcoholism or drug abuse.

          -  Female participants who were pregnant or lactating.

          -  Positive results at screening for human immunodeficiency virus, hepatitis B surface
             antigen, or hepatitis C virus.

          -  Serum ceruloplasmin and copper values outside of the normal range at screening.

          -  On a diet incompatible with the on-study diet within the 28 days prior to the first
             ALXN1840 dose and throughout the study; unable to consume the contents of a high-fat
             breakfast.

          -  Participation in a previous clinical trial with ALXN1840.
Drug Interaction Study With Rifampicin and Afatinib
Condition: Healthy
Intervention: Afatinib; Afatinib; Rifampicin
Intervention description: single dose; single dose; multiple doses
Intervention MeSH terms: Rifampin; Afatinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the current study is to investigate the effect of the P-gp inducer
      rifampicin on the pharmacokinetics (PK) of afatinib in healthy male volunteers
    

Eligibility criteria:

        Inclusion criteria:

        Healthy male volunteers

        Exclusion criteria:

        Any relevant deviations from healthy conditions
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785)
Condition: Postmenopausal; Osteopenia
MeSH terms: Bone Diseases, Metabolic
Intervention: Romosozumab; Placebo
Intervention description: Administered by subcutaneous injection; Administered by subcutaneous injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study was to assess the safety, tolerability, and
      immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations
      in healthy men and postmenopausal women with low bone mass.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males and females between 45 to 80 years of age

          -  Postmenopausal females

          -  Low bone mineral density, defined by bone mineral density (BMD) T-scores between -1.0
             and -2.5, inclusive, for the lumbar spine [L1-L4] or total evaluable vertebrae [if
             fewer than L1-L4] or total hip)

          -  25-hydroxyvitamin D ≥ 20 ng/mL

          -  Weight ≤ 98 kg (216 lb) and/or height ≤ 196 cm (77 in)

        Exclusion Criteria:

          -  Osteoporosis defined by bone mineral density (BMD) T-scores < -2.5 for the lumbar
             spine (L1-L4) or total evaluable vertebrae (if fewer than L1-L4) or total hip

          -  Diagnosed with any condition that would affect bone metabolism

          -  Previous exposure to AMG 785
Tobacco Tactics Website for Veteran Smokers
Condition: Smoking
Intervention: Tobacco Tactics website
Intervention description: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers
Phase: Phase 1
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Smoking Cessation; Internet; Intervention Studies; Health Services Accessibility

Summary:

      The purpose of this study is to develop an evidence-based Tobacco Tactics website tailored to
      veterans based on an intervention tested in the VA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Veteran,

          -  Screen Positive for Current Smoking,

          -  Greater than 18 Years of Age,

          -  Access to the Internet

        Exclusion Criteria:

          -  Non-English Speaking,

          -  Have Unstable Physical or Psychiatric/Mental Conditions
A Study In Japanese Healthy Male Volunteers To Investigate The Safety, Tolerability And Pharmacokinetics Of PF-02341066
Condition: Healthy
Intervention: PF-02341066; PF-02341066; PF-02341066
Intervention description: Cohort 1: a 150 mg single dose of PF-02341066 administered as 1 x 50 mg IRT and 1 x 100 mg IRT.; Cohort 2: a 250 mg single dose of PF-02341066 administered as 1 x 50 mg IRT and 2 x 100 mg IRTs.; Cohort 3: a 400 mg single dose of PF-02341066 administered as 4 x 100 mg IRTs.
Intervention MeSH terms: Crizotinib
Phase: Phase 1
Study type: Interventional
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Male
Minimum age: 20 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PK profile in Japanese healthy male volunteers

Summary:

      The purpose of this study is to investigate the pharmacokinetics of single doses of
      PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male
      volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects, inclusive (Healthy is defined as no clinically relevant
             abnormalities identified by a detailed medical history, full physical examination,
             including blood pressure and pulse rate measurement, 12-lead ECG and clinical
             laboratory tests).

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg

        Exclusion Criteria:

          -  Subjects who are smoking,

          -  Subjects with evidence of disease,

          -  Subjects with conditions affecting absorption,

          -  Subjects with treatment with other investigational drug within 30 days,

          -  Subjects with history of regular alcohol consumption,

          -  Subjects with use of prescription, nonprescription drugs and dietary supplement within
             28 days,

          -  Subjects with blood donation of approximately 400 mL within 3 months or 200 mL within
             1 month prior to dosing
Drug-Drug Interaction Study Between Colchicine and Cyclosporine
Condition: Pharmacokinetics; Healthy
Intervention: Colchicine; Cyclosporine; Colchicine
Intervention description: A single dose of 0.6 mg colchicine administered alone at 7:15 a.m. on Day 1 after an overnight fast of at least 10 hours.; A single dose of 100 mg cyclosporine administered with colchicine at 7:15 a.m. on Day 15 after an overnight fast of at least 10 hours.; A single dose of 0.6 mg colchicine administered with cyclosporine at 7:15 a.m. on Day 15 after an overnight fast of at least 10 hours.
Intervention MeSH terms: Cyclosporine; Colchicine; Cyclosporins
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy; adult; colchicine; cyclosporine; blood levels over time

Summary:

      Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp).
      Cyclosporine is a potent inhibitor of both CYP3A4 and P-gp. This study will evaluate the
      effect of single-dose cyclosporine on the pharmacokinetic profile of a single 0.6 mg dose of
      colchicine. A secondary objective is to evaluate the safety and tolerability of this regimen
      in healthy volunteers. All study subjects will be monitored for adverse events throughout the
      study period
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-45 years of age, non-smoking and non-pregnant (post-menopausal,
             surgically sterile or using effective contraceptive measures) with a body mass index
             (BMI) greater than or equal to 18 and less than or equal to 32, inclusive.

        Exclusion Criteria:

          -  Recent participation (within 28 days) in other research studies

          -  Recent significant blood donation or plasma donation

          -  Pregnant or lactating

          -  Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HbsAg), or hepatitis C virus (HCV)

          -  Recent (2-year) history or evidence of alcoholism or drug abuse

          -  History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or
             biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic,
             dermatologic, neurologic, or psychiatric disease

          -  Subjects who have used any drugs or substances known to inhibit or induce cytochrome
             (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose
             and throughout the study

          -  Drug allergies to colchicine or cyclosporine