bioihbjkbjnl/mcl2 huggingface dataset:
A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
Condition: Healthy
MeSH terms: Malnutrition
Intervention: CL-108; Vicoprofen; Ultracet; Phenergan
Intervention description: Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth; Hydrocodone Bitartrate and Ibuprofen 7.5 mg/200 mg single dose tablet by mouth; Tramadol HCl/acetaminophen 37.5 mg/325 mg single dose tablet by mouth; Phenergan (Promethazine HCl, USP) 12.5 mg single dose tablet by mouth
Intervention MeSH terms: Promethazine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Plasma concentration; Time to plasma concentration; Elimination rate constant; Elimination half life; Area under the curve

Summary:

      This study will compare the relative bioavailability of hydrocodone, acetaminophen, and
      promethazine in CL-108 (hydrocodone 7.5mg/ acetaminophen 325 mg/ promethazine 12.5 mg)
      manufactured by Charleston Laboratories, Inc. to hydrocodone in Vicoprofen (hydrocodone 7.5
      mg /ibuprofen 200 mg), promethazine 12.5 mg, and acetaminophen in Ultracet (tramadol HCl 37.5
      mg/acetaminophen 325 mg) under fasted and fed conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Subject's body mass index (BMI) must be between 18 and 30kg/m2 (inclusive), and
             subject must weigh a minimum of 50 kg (110lb)

          -  Abide by study restrictions

          -  Acceptable birth control measures

          -  Ability to attend all study visits

          -  Vital signs as per protocol

          -  Willing to consume high calorie meals within designated time frame

        Exclusion Criteria:

          -  Clinically significant medical history

          -  Clinically significant abnormal findings

          -  History or presence of allergic or adverse response to hydrocodone,
             ibuprofen,acetaminophen, any non-steroidal anti-inflammatory drugs (NSAIDs),
             promethazine, or related drugs.

          -  Has smoked or used tobacco products within 60 days prior to the first dose of study
             medication

          -  Has donated blood or plasma within 30 days prior to the first dose of study medication

          -  Has participated in another clinical trial (randomized subjects only) within 30 days
             prior to the first dose of study medication.
A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: peginterferon alfa-2a [Pegasys]; tenofovir
Intervention description: 360 micrograms sc/week for 2 weeks; 300mg po daily for 2 weeks
Intervention MeSH terms: Tenofovir; Peginterferon alfa-2a
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This open-label, randomized, parallel-arm study will assess the early immunologic response in
      treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment
      with Pegasys or tenofovir or Pegasys plus tenofovir. Patients will be randomized to one of 4
      cohorts to receive either Pegasys (360mcg subcutaneously weekly) or tenofovir (300mg orally
      daily) or both or no treatment for 2 weeks. After 2 weeks on study treatment, patients may
      opt to receive standard of care treatment with Pegasys. Target sample size is <50.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male adults of Southeast and/or East Asian origin, 18-55 years of age

          -  HBeAg-positive chronic hepatitis B

          -  detectable HBV DNA

        Exclusion Criteria:

          -  prior antiviral therapy for chronic hepatitis B

          -  evidence of bridging fibrosis, cirrhosis or decompensated liver disease

          -  positive test at screening for HAV (IgM), HCV, HDV or HIV

          -  history or evidence of medical condition associated with chronic liver disease

          -  antineoplastic or immunomodulatory treatment </=6 months prior to first dose of study
             drug
A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: PF06263276; Vehicle; 2%Tofacitinib Ointment; Vehicle; Daivonex; Daivonex Ointment
Intervention description: 4% PF 06263276 solution Daily dosage: approximately 8 mg PF 06263276 QD; Active ingredient-free vehicle to 4% solution; Daily Dosage: approximately 4 mg tofacitinib; Active ingredient-free vehicle to 2% Ointment; Daivonex solution (50 ug/ml Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg; Daivonex ointment (50 ug/g Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg
Intervention MeSH terms: Calcitriol; Calcipotriene; Tofacitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriasis; plaque; vulgaris; phase 1; randomized; double-blind; topical; safety

Summary:

      This is a vehicle and comparator controlled Proof of Mechanism (PoM) trial to evaluate the
      effect on psoriasis disease activity and safety of topically applied PF 06263276 in subjects
      with psoriasis vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female subjects age 18 years and older, 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 or clinical laboratory tests.

          -  Subjects with psoriasis vulgaris in a chronic stable phase and with a plaque area of
             mild to moderate severity sufficient for six treatment fields located in up to three
             plaque areas.

          -  The target lesion(s) should be on the trunk or extremities (excluding palms/soles).
             Psoriatic lesions on the knees or elbows are not to be used as a target lesion.

        Exclusion Criteria:

          -  Subjects with psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica,
             psoriasis arthropathica and pustular psoriasis.

          -  Treatment with any systemic medications which in the opinion of the investigator might
             counter or influence the trial aim (including anti psoriasis medications, eg,
             corticosteroids, cytostatics or retinoids) or medications which are known to provoke
             or aggravate psoriasis (eg, beta blocker, anti malarial drugs, lithium) or
             phototherapy/psoralen+UVA (PUVA) within 4 weeks preceding the treatment phase of the
             trial and during the trial.

          -  Treatment with any locally acting medications (including anti-psoriasis medications
             like vitamin D analogues, dithranol) within 4 weeks of the treatment phase.
A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Participants With Renal Insufficiency (MK-0941-015-02)
Condition: Type 2 Diabetes
MeSH terms: Renal Insufficiency
Intervention: MK-0941 20 mg; MK-0941 5 mg
Intervention description: Two 10-mg tablets of MK-0941 administered as a single oral dose.; MK-0941 administered as one single 5-mg tablet.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will assess the pharmacokinetics of MK-0941 in participants with varying degrees
      of renal insufficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or nonpregnant female age 18 to 75 years

          -  Female of childbearing potential on appropriate method of contraception

          -  Body mass index (BMI) less than or equal to 40 kg/m2

          -  Participant is in good health

          -  Participant diagnosed with Type 2 Diabetes

          -  Participant agrees to follow smoking restrictions

          -  Willing to follow the study diet restrictions

        Exclusion Criteria:

          -  Mental or legal incapacitation

          -  Participant has had kidney removed

          -  History of Type 1 diabetes

          -  History of stroke, chronic seizures or major neurological disorder

          -  History of neoplastic disease

          -  Nursing mother

          -  Consumes greater than 4 glasses of alcoholic beverages per day

          -  Consumes greater than 6 servings of caffeinated beverages per day

          -  Participant has had surgery or donated 1 unit of blood within 1 month of screening

          -  Participant has history of recent eye infection within 2 weeks of study drug
             administration

          -  Clinically diagnosed with glaucoma or blindness

          -  Has trauma to one or both eyes
Study Of Axitinib In Combination With Cisplatin And Capecitabine In Patients With Advanced Gastric Cancer
Condition: Stomach Neoplasms; Advanced Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: axitinib; capecitabine; cisplatin
Intervention description: Twice daily oral dose of axitinib continuously depending upon side effects observed. Starting dose is 5mg twice daily. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.; Given orally twice daily for 14 days followed by 7 days of drug free period. Starting dose is 1000mg/m^2 twice daily. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.; Given through a vein on Day 1 of every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. The starting dose is 80 mg/m^2 on day 1.
Intervention MeSH terms: Capecitabine; Axitinib
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: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safe and tolerable dose of axitinib given
      together with cisplatin and capecitabine 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 of stage IV

          -  adequate blood chemistry, blood counts and kidney function

          -  willing to participate to study requirements and 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 Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz
Condition: Healthy
Intervention: efavirenz; fenofibric acid 105 mg
Intervention description: 600 mg; fenofibric acid 105 mg
Intervention MeSH terms: Efavirenz; Fenofibric acid
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Efavirenz is predominantly metabolized by cytochrome P450 (CYP) 2B6. Fenofibric Acid is an
      inhibitor of CYP2B6. This study will evaluate the effect of multiple doses of fenofibric acid
      at steady-state on the pharmacokinetics of single-dose efavirenz in healthy adult subjects.
    

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 or equal to 18 and less than or equal to 32kg/m2, hemoglobin >12 g/dL.

        Exclusion Criteria:

          -  recent participation (within past month) 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, psychiatric disease or active sexually transmitted 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 or sensitivities to efavirenz, fenofibrate, fenofibric acid or any
             component of the two formulations

          -  Subjects who have had a tattoo or body piercing within 30 days prior to administration
             of study medication
A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.
Condition: Breast Cancer; Non-small Cell Lung Cancer; Non-Hodgkins Lymphoma
MeSH terms: Carcinoma, Non-Small-Cell Lung; Lymphoma, Non-Hodgkin
Intervention: Vinorelbine Tartrate
Intervention description: Subjects received one dose each of ANX-530 and NAVELBINE, each providing 30 mg/m2 vinorelbine. Study drugs will be infused into an arm vein over ten minutes.
Intervention MeSH terms: Vinorelbine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study was a randomized, single dose crossover comparison of the investigational product
      with a Reference Product (vinorelbine tartrate injection, NAVELBINE®). The primary objective
      was to demonstrate the equivalence of ANX-530 and the Reference Product, NAVELBINE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years.

          -  Advanced cancer potentially sensitive to vinorelbine:

          -  Breast cancer.

          -  Stage 3 or 4 non-small cell lung cancer.

          -  Non-Hodgkins lymphoma.

          -  Cancer of other histologic type, sensitive to vinca alkaloids.

          -  Rare tumor type with no standard treatment, for which single agent vinorelbine is
             appropriate therapy.

          -  Failure of standard treatment(s) of the tumor.

          -  Life expectancy of at least three months.

          -  ECOG performance level 0-2 or Karnofsky score 100-70.

          -  Hematological and serum chemistry results with defined ranges.

          -  Willingness and ability to provide written informed consent.

        Exclusion Criteria:

          -  Pregnancy or lactation. In a woman of childbearing potential, a positive pregnancy
             test result, no pregnancy test result, or no use of reliable contraception, at
             baseline. A postmenopausal woman will be considered to be of childbearing potential
             until there has been amenorrhea for at least 12 consecutive months.

          -  Previous treatment with vinorelbine or mitomycin.

          -  Any history suggesting or demonstrating resistance to, lack of response to, or
             intolerance of any prior vinca alkaloid treatment.

          -  Active infection.

          -  Prior anticancer therapy completed within four weeks prior to the first day of study
             treatment.

          -  Failure to have recovered from any toxicity of previous cancer treatment (patients
             with alopecia will not be excluded).

          -  Participation in another experimental drug study within four weeks prior to the first
             day of study treatment.

          -  Requirement for any concomitant chemotherapeutic agent other than the study
             medication.

          -  Any investigator judgment that the individual would not be an appropriate study
             subject.
Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years
Condition: H7N9 Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Intervention: H7N9c low dose with adjuvant; H7N9c medium dose with adjuvant; H7N9c high dose with adjuvant; H7N9c high dose without adjuvant
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 402.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza, H7N9, Vaccine

Summary:

      Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults
      between the ages of 18 years and 65 years.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy adult subject ages 18-64 years.

          2. Individuals willing to provide written informed consent

          3. Individuals in good health.

          4. Individuals who can comply with study procedures and follow-up.

        Exclusion Criteria:

          1. Individuals with history of cognitive or behavioral impairment or psychiatric disease,

          2. Individuals unable to understand and follow study procedures,

          3. History of significant illness,

          4. History of chronic medical condition or progressive disease,

          5. Allergy to any vaccine component or adverse event related to a vaccine component,

          6. Impairment/alteration of the immune system,

          7. Presence of progressive or severe neurological disorder,

          8. Pregnant or breast-feeding,

          9. Female of Child-bearing potential unwilling to use acceptable method of birth control,

         10. Presence of medically significant cancer,

         11. Receipt of investigational product within 30 day prior to entry into the study,

         12. History of previous or suspected illness from avian flu caused by H7N9 virus,

         13. History of H7 vaccination,

         14. Body temperature of greater than or equal to 38.0°C (100.4◦F) and/or acute illness
             within 3 days of intended study vaccination,

         15. Receipt of any flu vaccination 2 weeks before study entry or 4 weeks after study
             vaccination,

         16. Receipt of any vaccination 2 weeks before study entry or 4 weeks after study
             vaccination,

         17. History of drug or alcohol abuse within the past 2 years,

         18. Body Mass Index (BMI) greater than or equal to 35kg/m2,

         19. Individuals conducting the study or their immediate family members.
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (5mg/1000mg) Extended Release in Healthy Subjects
Condition: Healthy
Intervention: Linagliptin/Metformin ER FDC; Linagliptin; Metformin ER
Intervention description: 1x Linagliptin/Metformin FDC tablet; 1x Linagliptin tablet; 2x Metformin ER tablets
Intervention MeSH terms: Metformin; Linagliptin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose
      combination (FDC) tablet containing linagliptin and metformin extended release compared to
      the free combination of linagliptin and metformin extended release, both under fed and fasted
      conditions.
    

Eligibility criteria:

        Inclusion criteria:

        - Healthy male or female subjects

        Exclusion criteria:

        - Any relevant deviation from healthy condition
Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis
Condition: Japanese Patients With ALS
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Intervention: MT-1186
Intervention description: Suspension
Intervention MeSH terms: Edaravone
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Patients
      with Amyotrophic Lateral Sclerosis
    

Eligibility criteria:

        Inclusion Criteria:

        The key criteria are listed below.

          -  Patients aged between 20 and 75 years at the time of informed consent

          -  Japanese patients

          -  Among patients with ALS, those "Clinically definite ALS," "Clinically probable ALS" or
             "Clinically probable-laboratory-supported ALS" according to El Escorial Revised Airlie
             House criteria

          -  Patients who can consent to contraception

          -  Patients who have thoroughly understood the contents of the study and voluntarily
             provided written informed consent to participate in the study

        Exclusion Criteria:

        The key criteria are listed below.

          -  Patients in whom the possibility could not be ruled out that the current symptoms were
             symptoms of a disease requiring differential diagnosis, such as cervical spondylosis
             and multifocal motor neuropathy

          -  Patients undergoing treatment for malignancy

          -  Patients who have presence of clinically significant liver, heart, or renal disease
             requiring hospitalization (except ALS) and infections requiring antibiotics. Patients
             who have a problem in general condition and are judged ineligible by the Investigator

          -  Body mass index (BMI) of <18.0 or >30.0, or a body weight of <50 kg

          -  Patients judged by the investigator (or subinvestigator) to be unsuitable for the
             study for any other reason