bioihbjkbjnl/mcl2 huggingface dataset:
HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Recurrence
Intervention: HER-2 pulsed Dendritic Cell Vaccine
Intervention description: 6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Invasive Breast Cancer; Breast Cancer; Immunotherapy; Vaccine; Dendritic Cell

Summary:

      The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1
      vaccine in high risk HER-2 high and intermediate expression breast cancers. Participants will
      have HER-2 driven IBC at least Stage IIIA with N2 following chemotherapy with/without
      trastuzumab or recurrence exclusive of new primary tumor but rendered NED. Mammogram,
      laboratory studies, CT, and leukapheresis will be performed, in addition to vaccine
      administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women over Age 18 years.

          -  Potential participants with Invasive Breast Cancer at least Stage IIIA, greater than
             or equal to N2 (>4 positive nodes) or have recurrent metastatic breast cancer rendered
             NED by any means that are classic HER-2 3+ 30%, 2+ IHC and FISH positive or HER-2 2+
             FISH negative, that have completed chemotherapy and/or trastuzumab and are within 1
             year from their last treatment and have no evidence of disease.

          -  Deemed to require anti-estrogen therapy for treatment of their breast cancer can
             continue anti-estrogen therapy during vaccinations.

          -  Women of childbearing age with a negative pregnancy test documented prior to
             enrollment.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.

          -  Willing to use birth control if necessary.

          -  Have voluntarily signed a written Informed Consent in accordance with institutional
             policies after its contents have been fully explained to them.

        Exclusion Criteria:

          -  Pregnant or lactating.

          -  Positive for positive HIV or hepatitis C at baseline.

          -  Patients with coagulopathies, including thrombocytopenia with platelet count less than
             75,000, INR greater than 1.5 and partial thromboplastin time greater than 50 sec.

          -  Major cardiac illness MUGA less than 50% EF.

          -  Pre-existing medical illnesses or medications which might interfere with the study as
             determined by Principal Investigator (PI).
Extended Administration of Polyethylene Glycol (PEG) Interferon Alfa-2b in Participants With Solid Tumors (C/I97-349/MK-4031-009)
Condition: Neoplasms
Intervention: PEG Interferon Alfa-2b; Acetaminophen
Intervention description: Participants receive PEG interferon alfa-2b administered by SC injection, in doses ranging from 0.75 mcg/kg OW up to 7.5 mcg/kg OW, for up to 40 weeks of treatment.; Participants receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and continue acetaminophen 500 to 1000 mg after administration every 4 to 6 hours as needed. The total daily dose of acetaminophen should not exceed 3000 mg.
Intervention MeSH terms: Acetaminophen; Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study is an extension study to base study protocol C/I97-188 (MK-4031-006). Its primary
      purpose is to assess the safety and tolerability of extended administration of polyethylene
      glycol (PEG) interferon alfa-2b in participants with solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Had a response of stable disease or better in PEG interferon alfa-2b base study
             C/I97-188 (MK-4031-006).

          -  Has a Performance Status of 0 (normal activity), 1 (symptoms, but fully ambulatory),
             or 2 (symptomatic, but in bed <50% of the day).

          -  Is enrolled within two weeks of completing their last dose of PEG Interferon alfa-2b
             on the previous study and has not have received any other therapy during this period.

        Exclusion Criteria:

          -  Discontinued prior to completing PEG interferon alfa-2b base study C/I97-188
             (MK-4031-006).

          -  Is pregnant or nursing.
Relative Bioavailability of Ibuprofen From a Single Fixed Dose Combination Tablet of Ibuprofen and Caffeine Compared to Single Tablets of Ibuprofen and Ibuprofen Lysinate
Condition: Healthy
Intervention: Ibuprofen+caffeine FDC; Ibuprofen (Nurofen Immedia®); Ibuprofen (Brufen®)
Intervention description: oral dose; oral dose; oral dose
Intervention MeSH terms: Ibuprofen; Caffeine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the relative bioavailability of ibuprofen from a (FDC) film-coated tablet of
      ibuprofen and caffeine vs. a tablet of ibuprofen (Brufen®) and a tablet of ibuprofen lysinate
      (Nurofen Immedia®).
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male and female subjects

          -  Age 18 to 50 years

          -  Body mass index (BMI) 18.5 to 29.9 kg/m2

          -  Subjects must be able to understand and comply with study requirements

        Exclusion criteria:

        - Any relevant deviation from healthy conditions
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects
Condition: Healthy
Intervention: MT-6345; MT-6345 Placebo
Intervention description: MT-6345; MT-6345 Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to Investigate the Safety, Tolerability and Pharmacokinetics of
      MT-6345 in Healthy Subjects.
    

Eligibility criteria:

        Inclusion Criteria:

        Additional screening criteria check may apply for qualification:

          -  Able to provide written informed consent to participate in this study after reading
             the participant information sheet and Informed Consent Form (ICF), and after having
             the opportunity to discuss the study with the Investigator or designee.

          -  Healthy and free from clinically significant illness or disease as determined by
             medical history, physical examination, laboratory and other tests at Screening and Day
             -1.

          -  A body weight of ≥60 kg for males and ≥50 kg for females and a body mass index (BMI)
             (Quetelet index) ranging from 18 to 30.0 kg/m2 inclusive at Screening and Day -1.

          -  In the Investigator's opinion, subject is able to understand the nature of the study
             and any risks involved in participation, and willing to cooperate and comply with the
             Protocol restrictions and requirements.

        Exclusion Criteria:

        Additional screening criteria check may apply for qualification:

          -  Subjects with clinically significant (in the opinion of the Investigator) endocrine,
             thyroid, hepatic, respiratory, gastrointestinal, neurological, renal, cardiovascular
             disease, or history (within the last 5 years) of any significant psychiatric/psychotic
             illness disorder (including anxiety, depression and reactive depression).

          -  Female subjects who are pregnant (positive pregnancy test at Screening or Day -1) or
             lactating.

          -  Having previously received MT-6345 as part of this study.

          -  Clinically relevant abnormal medical history, physical findings or laboratory values
             at Screening or Day -1 that could interfere with the objectives of the study or the
             safety of the subject, as judged by the Investigator.

          -  Subjects who test positive for hepatitis B surface antigen, hepatitis B core antibody,
             hepatitis C antibody, human immunodeficiency virus (HIV)-1 or HIV-2 antibodies at
             Screening.
A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting
Condition: Hepatitis B Virus
MeSH terms: Hepatitis B; Hepatitis
Intervention: Baraclude
Intervention description: Specified dose on specified day
Intervention MeSH terms: Entecavir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com.

          -  Participants with chronic hepatitis B (CHB) (excluding participants with a
             superinfection) who have been confirmed to have CHB.

          -  Participants who are being treated with 0.5 mg daily Baraclude for a minimum of 10
             consecutive days prior to the study enrollment.

          -  Body mass index (BMI) of 18.5 to 30 kg/m2 (BMI = body weight [kg]/height [m]2)

        Exclusion Criteria:

          -  Current or recent (within 3 months of Baraclude administration) gastrointestinal
             disease that could impact upon the absorption of study drug.

          -  Any gastrointestinal surgery that could impact upon the absorption of study drug.

          -  Donation of blood to a blood bank or in a clinical study (except a screening visit)
             within 4 weeks of study drug administration (within 2 weeks for plasma only).

        Other protocol defined inclusion/exclusion criteria could apply.
Drug Interaction Study of Saxagliptin in Combination With Dapagliflozin in Healthy Participants
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Dapagliflozin
Intervention MeSH terms: Dapagliflozin; Saxagliptin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate whether the pharmacokinetics (body
      concentrations/metabolism of the drug) of Saxagliptin and Dapagliflozin are affected when
      they are administered together
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects as determined by no clinically significant deviation from normal in
             medical history, Physical Examination, vital signs, 12-lead ECG, and clinical
             laboratory determinations

          -  Body mass index (BMI) of 18 to 30 kg/m2

          -  Men and women, ages 18 to 45 years

          -  Women of childbearing potential must use acceptable methods of highly effective birth
             control

        Exclusion Criteria:

          -  History of chronic or recurrent urinary tract infection for females

          -  History of allergies or adverse reactions to Dipeptidyl peptidase-IV (DPP4) or
             Sodium-glucose transporter type 2 (SGLT2) inhibitors

          -  Any significant acute or chronic medical illness

          -  Current or recent gastrointestinal disease

          -  Any major surgery within 4 weeks of study drug administration

          -  Prior exposure to saxagliptin or dapagliflozin or related drugs
A Multiple Dose Study of LY3023703 in Healthy Participants
Condition: Healthy Volunteers
Intervention: Placebo; LY3023703; Celecoxib
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Celecoxib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study of LY3023703 in healthy participants. The purposes of this study are to look
      at safety, how well the study drug is tolerated, how much of the study drug gets into the
      blood stream and how long it takes the body to remove the study drug. The effects of
      LY3023703 on blood pressure after 28 days of dosing will be studied. Information about any
      side effects that occur will be collected. The study is expected to last 21 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy individuals based on the history and physical examinations as
             determined by the investigator

          -  Are normotensive (defined as supine systolic blood pressure [BP] less than 140
             millimeters of mercury [mm Hg] and diastolic BP less than 90 mm Hg without the use of
             any antihypertensives) or results that are judged to be not clinically significant by
             the investigator

        Exclusion Criteria:

          -  Have presence of clinically significant active bleeding or history of bleeding
             diathesis at the time of screening

          -  Have presence of active peptic ulcer disease, gastro-intestinal (GI) bleeding, chronic
             gastritis, inflammatory bowel disease, or chronic diarrhea

          -  Have evidence of other chronic liver disease

          -  Have any use of nonsteroidal anti-inflammatory drugs (NSAIDs), celecoxib, aspirin, or
             acetaminophen (at doses greater than 1 gram per day [g/day] within 14 days of
             admission

          -  Have greater than 1 plus pretibial pitting edema or 2 plus ankle or pedal edema
Phase I Study of MK-1496 in Patients With Advanced Solid Tumor (MK-1496-002 AM 4)(COMPLETED)
Condition: Neoplasms; Malignant
Intervention: MK-1496; MK-1496
Intervention description: MK-1496 (20 to 120 mg), orally, administered on Day 1 of each 21-day cycle; MK-1496 (20 to 120 mg), orally, administered on Days 1 and 3 each week for 3 weeks (Days 1, 3, 8, 10, 15 and 17) of each 28-day cycle
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study determines recommended clinical dose, to evaluate the safety, tolerability and
      pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors
      who have failed standard therapy or for whom no standard therapy exists, in two dosing
      schedules in Japan.
    

Eligibility criteria:

        Inclusion Criteria

          -  Participant must have a histologically-confirmed metastatic or locally advanced solid
             tumor that has failed to respond to standard therapy, progressed despite standard
             therapy, or for which standard therapy does not exist.

          -  Participant must have Performance Status 0 or 1.

          -  Participant must have adequate organ function.

        Exclusion Criteria

          -  Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks
             (6 weeks for nitrosoureas or mitomycin C) prior to registration.

          -  Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and
             incomplete 1 cycle treatment are not considered as 1 regimen).

          -  Participant has known hypersensitivity to the components of study drug or its analogs.

          -  Participant has had prescription or non-prescription drugs or other products known to
             be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of
             CYP3A4 with narrow therapeutic window.
Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
Condition: Evaluate PK Profile
Intervention: nirsevimab; Placebo
Intervention description: Drug: injection, a single fixed IM dose on day 1 only.; Placebo: injection, 0.9% (w/v) saline, a single fixed IM dose on day 1 only.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PK; safety; tolerability; Nirsevimab; healthy Chinese Adults; Respiratory Syncytial Viral (RSV)

Summary:

      The purpose of this study is to evaluate the Pharmacokinetics, Safety, Tolerability of
      Nirsevimab in Healthy Chinese Adults.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 to 45 years

          2. Weight ≥ 45 kg and ≤ 110 kg and Body Mass Index of 19 to 26 kg/m2

          3. Healthy Chinese subjects (both male and female)

          4. Normotensive

          5. Normal electrocardiogram (ECG) within 28 days prior to Day 1

        Exclusion Criteria:

          1. Acute illness at study entry (pre-dose on Day 1)

          2. Fever ≥99.5°F (37.5°C) on day of dosing

          3. Any drug therapy within 14 days prior to Day 1 (except contraceptives).

          4. Receipt of immunoglobulin or blood products within 6 months prior to study entry.

          5. Receipt of any investigational drug therapy within 120 days prior to investigational
             product dosing or planned to receive any investigational drug therapy within 150 days
             after investigational product dosing.

          6. Previous receipt of any marketed or investigational mAb.

          7. Previous vaccination against RSV.

          8. History of immunodeficiency or receipt of immunosuppressive medications during the
             prior year.

          9. History of asthma.

         10. History of autoimmune disorder.

         11. Evidence of any systemic disease on physical examination.

         12. Evidence of infection with hepatitis A, B, or C virus, syphilis, or human
             immunodeficiency virus.

         13. Any clinically significant abnormal laboratory assessments at screening.

         14. Pregnant or nursing mother.

         15. Alcohol or drug abuse
Relative Bioavailability of Single Dose Empagliflozin (BI 10773) When Co-administered With Multiple Doses of 600 mg Gemfibrozil Compared to Single Dose Treatment With Empagliflozin (BI 10773) When Given Alone in Healthy Volunteers
Condition: Healthy
Intervention: BI 10773; Gemfibrozil; BI 10773
Intervention description: 1 tablet single dose BI 10773 in the morning; Gemfibrozil 600 mg bid for 5 days; 1 tablet single dose BI 10773 in the morning
Intervention MeSH terms: Empagliflozin; Gemfibrozil
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
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

Summary:

      To investigate the relative bioavailability of BI 10773 following coadministration with 600
      mg gemfibrozil bid dosed to steady-state in comparison to BI 10773 when given alone.
    

Eligibility criteria:

        Inclusion criteria:

        - Healthy male and female subjects

        Exclusion criteria:

        - Any finding of the medical examination (including Blood Pressure, Pulse Rate and
        Electrocardiogram) deviating from normal and of clinical relevance
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED)
Condition: Type 2 Diabetes
Intervention: MK8245; Comparator: Placebo
Intervention description: MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken.; MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A 2-period crossover study to assess the safety, tolerability and glucose-lowering effects of
      MK8245.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a diagnosis of Type 2 Diabetes and is being treated with diet and exercise
             alone or a single oral anti-hyperglycemic agent

          -  Subject is willing to follow the weight-maintaining diet and exercise program or
             equivalent beginning 4 weeks before receiving study drug, throughout the study and
             until the post study visit

          -  Subject has been a nonsmoker and/or has not used nicotine-containing products for at
             least approximately 6 months

        Exclusion Criteria:

          -  Subject has a history of stroke, chronic seizures, or major neurological disorder

          -  Subject has a history of neoplastic disease (except non-melanomatous skin carcinoma,
             carcinoma in situ of the cervix, other malignancies successfully treated at least 10
             years prior to screening, or malignancies deemed highly unlikely to recur.)

          -  Subject has a history of Type 1 Diabetes Mellitus and/or history of ketoacidosis

          -  Subject has a history of contact lens use within approximately the previous 6 months

          -  Subject has been diagnosed with dry eye syndrome

          -  Subject has used lipid-lowering therapies in the past 3 months (Subjects on a stable
             monotherapy dose of statins may be included)

          -  Subject has had major surgery, donated or lost 1 unit of blood or participated in
             another investigational study within 4 weeks of starting in the study