bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Effect of Food on Pharmacokinetics of Total EPA and Total DHA of AZD0585 in Healthy Male Japanese Subjects
Condition: Healthy
Intervention: AZD0585
Intervention description: Following an overnight fast of at least 10 hours, a single dose of 4 g AZD0585 will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: the effect of food timing on PK; the effect of food timing on Safety and Tolerability; AZD0585; Japanese

Summary:

      The purpose of this study is to assess the effect of food timing on pharmacokinetics (PK) of
      AZD0585 and the effect of food timing on tolerability and safety of AZD0585 in healthy male
      Japanese subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Japanese male, 20 to 45 years of age (inclusive).

          -  Body mass index (BMI) ≥ 18.5 and ≤ 25 (kg/m2).

          -  Medically healthy with clinically insignificant screening results (e.g., laboratory
             profiles, medical histories, ECGs, physical findings). Hemoglobin level must be ≥ the
             lower limit of study centre reference range. 12-Lead ECG with QT interval corrected
             for heart rate using Fridericia's formula (QTcF) should be > 340 msec and < 450 msec.

          -  No habitual use of drug(s) and tobacco/nicotine-containing products for a minimum of 3
             months prior to first dosing.

          -  Subjects must be willing and able to give written informed consent by signing an
             Institutional Review Board (IRB)-approved Informed Consent Form prior to admission to
             this study and follow the restrictions and procedures outlined for the study.

        Exclusion Criteria:

          -  Past history of psychological or physical disorder which may affect the objectives of
             this study, in the opinion of the PI.

          -  An individual who has abnormal laboratory values (ie, suggesting hepatic, renal,
             cardiovascular or endocrine disorders or diabetes mellitus), or an inappropriate
             current or past medical history for participation based on the decision of the PI.

          -  A history or presence of significant cardiovascular, pulmonary, hepatic, renal,
             haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or
             psychiatric disease.

          -  Had used fish oil, other EPA- and/or DHA-containing supplements within 2 months prior
             to first admission day.

          -  Have serum (or plasma) EPA and/or DHA concentrations exceeding the upper limit of
             reference range for the "fatty acids profile, four-fraction" test, determined at Visit
             1.
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Bictegravir (GS-9883) in Human Immunodeficiency Virus (HIV)-1 Infected Participants
Condition: HIV-1 Infection
Intervention: Bictegravir; Placebo
Intervention description: Bictegravir tablet(s) administered orally once daily; Placebo to match bictegravir administered orally once daily
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HIV-1 Infected; Adults; Treatment Naive

Summary:

      The primary objective of the study is to investigate the short-term antiviral potency of
      bictegravir at multiple doses in antiretroviral (ART) treatment-naive adult participants and
      participants who are ART-experienced but integrase strand transfer inhibitor (INSTI) naive.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  No current or prior anti-HIV treatment, including ART medications received for
             prevention (preexposure prophylaxis [PrEP]), or postexposure prophylaxis (PEP) within
             12 weeks of screening

          -  Plasma HIV-1 ribonucleic acid (RNA) ≥ 10,000 copies/mL but ≤ 400,000 copies/mL at
             screening

          -  Cluster of differentiation 4+ (CD4+) cell count > 200 cells/mm^3

        Key Exclusion Criteria:

          -  Anticipated to start HIV-1 therapy during the study period

          -  Active participation in another study of investigational or approved ART agents

          -  A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within
             the 30 days prior to screening

          -  Participants with positive hepatitis C antibody at screening

          -  Chronic hepatitis B virus (HBV) infection

          -  Active, serious infections (other than HIV-1 infection) requiring parenteral
             antibiotic or antifungal therapy within 42 days prior to Day 1 (baseline)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of E7080 in Subjects With Solid Tumor
Condition: Cancer
Intervention: E7080
Intervention description: This arm will be a dose-escalation evaluation of 9-18 subjects to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle). Administration of the study drug can continue until subjects meet discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent.
Intervention MeSH terms: Lenvatinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Cancer

Summary:

      The purpose of this study is to investigate the tolerability and safety of E7080 up to 24 mg
      when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1
      cycle) in subjects with solid tumors
    

Eligibility criteria:

        Inclusion Criteria

          -  Subjects with histologically and/or cytologically diagnosis of solid tumor

          -  Subjects with solid tumor which is resistant to standard anti-tumor therapies, or
             which no appropriate treatment is available

          -  Subjects whose toxicity of previous treatment has recovered to Grade 1 or lower
             toxicity (except for alopecia)

          -  Subjects who completed previous anti-tumor therapy before at least 4 weeks

          -  Subjects who are 20 years or older

          -  Subjects with 0 to 1 of Performance Status

          -  Subjects agree to be hospitalized for DLT observation

          -  Subjects with adequate organ functions

          -  Males and females of childbearing potential must agree to use appropriate
             contraception from the agreement to 30 days after study drug administration.

          -  Agree to participate in this study in writing based on voluntary will

        Exclusion Criteria

          -  Subjects with brain metastasis accompanying clinical symptoms or requiring treatment

          -  Subjects with the severe complication or disease history

          -  Subjects unable to take oral medication.

          -  Subjects being treated with drugs that strongly inhibit or induce CYP3A4 and that may
             be possibly used during this study.

          -  Scheduled for surgery during the projected course of the study.

          -  Positive for human immunodeficiency virus (HIV antibody) test or positive for
             hepatitis B surface (HBs antigen) or hepatitis C (HCV antibody) by serum test.

          -  Subjects who in the view of the investigator are not able to comply with this protocol
             because of psychiatric or physical diseases including alcoholism or drug addict

          -  Pregnant or nursing subjects

          -  Subjects who are participating in another clinical trial.
Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis
Condition: Thrombosis; Heparin-induced Thrombocytopenia
MeSH terms: Thrombosis; Thrombocytopenia
Intervention: Fondaparinux
Intervention description: Fondaparinux 0.1 mg/kg (up to 7.5 mg max initial dose) once daily for up to 21 days.
Intervention MeSH terms: PENTA; Fondaparinux
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: fondaparinux; thrombosis; heparin-induced thrombocytopenia; pediatrics

Summary:

      This study will evaluate the use of a blood thinner, fondaparinux, which is approved for use
      in adults (not in children) in a children aged 1-18 years. Subject with a blood clot
      (thrombosis) or heparin-induced thrombocytopenia who need to be on a blood thinner will be
      eligible to participate. Subjects will receive a once daily dose of fondaparinux followed by
      blood tests at 2, 4, 12, and 24 hours after the first dose in order to determine the proper
      dose for this age group. The hypothesis is that children receiving fondaparinux will be able
      to receive a once daily dose. The currently available alternative agent, enoxaparin, needs to
      be given twice daily. In addition, an evaluation of the safety of this medication will be
      made by assessing for side effects, especially bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children between 1 year and 18 years of age.

          -  The presence of documented venous or arterial thrombosis confirmed by diagnostic
             imaging.

          -  Weight greater than 8.3 kg.

          -  Signed informed consent/assent.

        Exclusion Criteria:

          -  Patients with active bleeding.

          -  Patients with planned invasive procedures less than 2 weeks from the time of
             enrollment.

          -  Patients with a contraindication to anticoagulation.

          -  Patients receiving thrombolytic agents.

          -  Patients with an INR>1.5 or an activated partial thromboplastin time (PTT)>40 seconds.

          -  Patients with a creatinine level above 1.2 times the upper limit of normal expected
             for age.

          -  Children <1 year of age.
Harnessing the Power of Technology: MOMBA for Postpartum Smoking
Condition: Smoking Cessation
Intervention: MoMba Live Long app & Sensordrone™ carbon-monoxide sensor; Office contingency management; Sensordrone™ carbon-monoxide sensor; MoMba Live Long Smartphone application
Intervention description: MoMba Live Long application & Sensordrone™ carbon-monoxide sensor to deliver contingency management remotely; A control group which will receive financial incentives at an in-person office/clinic visit based on expired CO levels obtained through the piCO sensor.; A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.; The MoMba Live Long app provides an interface for the Sensordrone which allows participants to complete a breath test and see results of smoking status. The app verifies the user is correctly taking the tests by recording pictures using the front facing camera as well as recording audio to verify that the participants where exhaling while taking the test. The app also provided a platform for social interaction based on a previous system where app users can interact with each other and provide support during the quitting process.
Intervention MeSH terms: Carbon Monoxide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tobacco cessation

Summary:

      Through a smartphone platform, financial incentives for smoking abstinence in postpartum
      women can be delivered remotely, thus minimizing the need for participants to come to the
      office to receive traditional contingency management.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who are over the age of 18

          -  Speak English

          -  Second or third trimester of pregnancy

          -  Smoking in the third trimester of pregnancy

          -  No complicating general medical or psychiatric conditions (including marijuana use).

        Exclusion Criteria:

          -  Receiving other smoking cessation medication

          -  Planning to move out of New Haven in the next 15 months

          -  Actively suicidal, psychotic or unable to provide informed consent
Study Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: PF-04937319 once-daily; PF-04937319 split-dose; Sitagliptin once-daily
Intervention description: Tablets, 300 mg once-daily with breakfast, 14-days; tablets, 150 mg with breakfast plus 100 mg with lunch, 14-days; tablets, 100 mg once-daily with breakfast, 14-days
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Phase 1b; type 2 diabetes; metformin background; PF-04937319

Summary:

      Study B1621019 will assess efficacy and safety of two different dosing regimens of an
      investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients
      with type 2 diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with type 2 diabetes, on background metformin therapy either alone or with 1
             other oral anti-diabetic agent (excluding Actos)

        Exclusion Criteria:

          -  Patients with cardiovascular event within 6-months of screening

          -  Patients with diabetic complications

          -  Female subjects who are pregnant or planning to become pregnant

          -  Subjects with unstable medical conditions (eg, hypertension)
Speech Recognition Training in Children With Hearing Loss
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Intervention: clEAR auditory training
Intervention description: Children play auditory brain training computer games
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Within subjects A1 - A2 - B1 - B2 design
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 8 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Auditory training; Children with hearing loss

Summary:

      clEAR's auditory brain training has been shown to be effective in improving childrens'
      abilities to recognize the speech of generic talkers in a laboratory setting. In the proposed
      research, the researchers will build upon these results and assess the extent to which
      auditory brain training delivered via the web enhances children's abilities to recognize the
      speech of a potential classroom teacher and diminishes their communication challenges that
      are associated with significant hearing loss. First, investigators will conduct focus groups
      with children who have undergone training with the research version of clEAR's pediatric
      games, then they will recode the games from LabView to Java Script, making changes in the
      games in response to the focus group comments, and finally, they will collect data from 20
      children to assess whether web-based auditory brain training improves their abilities to
      recognize the speech of their (hypothetical) upcoming school year's classroom teacher.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children with moderate to severe hearing loss.

        Exclusion Criteria:

          -  Must be native English speakers
Bioequivalence of 5 Tablets of 100 mg Versus 2 Tablets of 250 mg TF3 of Tepotinib
Condition: Healthy
Intervention: Tepotinib 100 mg; Tepotinib 250 mg
Intervention description: Participants received a single oral dose of test treatment of tepotinib TF3 (5 * 100 mg) in either treatment period 1 or 2.; Participants received a single oral dose of reference treatment of tepotinib TF3 (2 * 250 mg) in either treatment period 1 or 2.
Intervention MeSH terms: Tepotinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tepotinib; Bioequivalence; Pharmacokinetics

Summary:

      This study investigated the bioequivalence of the 100 milligrams (mg) and 250 mg dose
      strengths of tepotinib tablet formulation 3 (TF3) when administered at the same dose under
      fasted condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants of non-child bearing potential

          -  Body weight between 50 to 100 kilogram (kg)

          -  Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m^2)

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Participation in a clinical study within 60 days prior to first drug administration

          -  Whole blood donation or loss of greater than 450 milliliter (mL) within 60 days prior
             to first drug administration

          -  Any surgical or medical condition, or any other significant disease that could
             interfere with the study objectives, conduct, or evaluation

          -  Other protocol defined exclusion criteria could apply
N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19)
Condition: Coronavirus; Covid19
MeSH terms: COVID-19; Coronavirus Infections
Intervention: N-acetyl glucosamine (NAG); Control
Intervention description: Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.; Patients do not receive treatment with N-Acetylglucosamine. They may receive other treatments at the discretion of the treating physician, as with the treatment group.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: N-acetyl glucosamine

Summary:

      This study examines the efficacy of N-acetylglucosamine (NAG) in treating patients with novel
      coronavirus (COVID-19) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥18 years old

          -  Treated with N-acetyl glucosamine (NAG) as first-line treatment

          -  Present with coronavirus disease 2019 (COVID-19) symptoms (including but not limited
             to fever, cough, shortness of breath, sore throat, nasal congestion, malaise,
             headache, muscle pain, loss of taste and/or smell, diarrhea, and vomiting)

          -  Clinically diagnosed with COVID-19 by reverse transcription polymerase chain reaction
             (RT-PCR)

          -  No intubation prior to hospitalization and enrollment in the current study.

        Exclusion Criteria:

          -  <18 years old upon admission

          -  Allergy to NAG

          -  Allergy to shellfish

          -  Currently taking warfarin

          -  Currently pregnant or lactating
The Effect of Omeprazole on the Pharmacokinetics of Dasatinib in Healthy Subjects
Condition: Healthy
Intervention: Dasatinib + Omeprazole
Intervention description: Tablet/Capsule, Oral, (Dasatinib 100 mg)/(Omeprazole 40 mg), once daily, 7 days
Intervention MeSH terms: Dasatinib; Omeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Subjects

Summary:

      The purpose of this study is to assess the effect of omeprazole on the pharmacokinetics of
      dasatinib in healthy subjects and to assess the safety and tolerability of a single dose of
      dasatinib before and after 5 days of dosing with omeprazole in healthy subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects as determined by medical history, physical examination, ECGs, and
             clinical laboratory determinations

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Prior exposure to dasatinib