bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-Pamiparib in Participants With Advanced Cancer
Condition: Advanced Solid Tumors
Intervention: [14C]-pamiparib
Intervention description: During the treatment phase, pamiparib 60 mg administered orally twice daily
Intervention MeSH terms: Pamiparib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label study, in participants with advanced and/or metastatic solid tumors,
      which consists of 2 parts: a research phase (inpatient) and a treatment phase. The research
      phase (Part 1) of the study will assess the disposition of a single oral dose of
      [14C]-pamiparib. In the treatment phase (Part 2) participants will be allowed to have
      continued access to pamiparib.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Histologically and/or cytologically confirmed advanced or metastatic solid tumor that
             has progressed after treatment with approved therapies for which there are no standard
             therapies available

          2. A total body weight between 50 and 100 kg, inclusive at Screening

          3. Measurable disease by CT/MRI

          4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

          5. Adequate organ function

        Key Exclusion Criteria:

          1. Clinically significant cardiovascular disease

          2. Have a previous complete gastric resection, chronic diarrhea, active inflammatory
             gastrointestinal disease, or any other disease causing malabsorption syndrome.

          3. Poor peripheral venous access

          4. Major surgical procedure, open biopsy, or significant traumatic injury ≤ 2 weeks prior
             to Day 1, or anticipation of need for major surgical procedure during the course of
             the study

          5. Use or have anticipated need for food or drugs known to be strong or moderate CYP3A
             inhibitors or strong CYP3A inducers

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells ( LCs); Standard of care
Intervention description: Patients receive CT7/MAGE-A3/WT1 mRNA-electroporated autologous Langerhans-type dendritic cells ID on days 12, 30, and 90 after autologous stem cell transplant. Patients on the vaccine arm of the study will receive a total of 3 vaccinations, comprising a primary immunization on day +12 after ASCT followed by two boosters at days +30 and +90. Vaccines will be dosed at 9x10^6 LCs per vaccine x 3.; No vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CT7; MAGE-A3; WT1 mRNA-electroporated Autologous Langerhans; vaccine; Autologous Stem Cell Transplantation; 13-009

Summary:

      The purpose of this study is to see if the investigator can help the immune system to work
      against myeloma.

      This study will see if a vaccine made with altered dendritic cells will make T cells work
      against tumor cells. The stem cells collected for the transplant will also be used to grow
      dendritic cells in the lab. The dendritic cells will carry the antigens. These cells then
      will be injected under the skin. The investigators will do lab studies before and after the
      vaccination to find out if the vaccine is working.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic multiple myeloma, ISS stages I-III, within 12 months of starting therapy.

          -  Completion of induction therapy with Very Good Partial Response (VGPR), or better, by
             International Myeloma Working Group (IMWG) criteria.

          -  Deemed eligible for ASCT by standard institutional criteria.

          -  Age ≥18 years.

          -  Documentation of CT7, MAGE-A3, or WT1 expression in the bone marrow and/or bone marrow
             aspirate.

        Exclusion Criteria:

          -  Prior autologous or allogeneic SCT.

          -  Previous immunization against CT7, MAGE-A3, other cancer-testis antigens, or WT1.

          -  Known immunodeficiency, HIV positivity, hepatitis B, or hepatitis C.

          -  History of autoimmune disease (e.g., rheumatoid arthritis, SLE), other than vitiligo,
             diabetes, or treated thyroiditis, which are allowed.

          -  History of severe allergic reactions to vaccines or unknown allergens.

          -  Participation in any other clinical trial involving another investigational agent
             within 4 weeks prior to first immunization.

          -  Lenalidomide-related toxicities before ASCT necessitating its discontinuation as part
             of treatment.
A Study of Two Different Formulations of LY3074828 in Healthy Participants
Condition: Healthy
Intervention: LY3074828
Intervention description: Administered SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to look at the amount of the study drug, LY3074828, that gets
      into the blood stream and how long it takes the body to get rid of LY3074828 when given as
      different formulations. The tolerability of LY3074828 will also be evaluated and information
      about any side effects experienced will be collected.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be approximately 13 weeks, not including
      screening.
    

Eligibility criteria:

        Inclusion Criteria:

        Exclusion Criteria:

          -  Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and
             14 units/week (females)

          -  Must not show evidence of active or latent tuberculosis (TB)

          -  Must not have received live vaccine(s) (including attenuated live vaccines and those
             administered intranasally) within 1 month of screening, or intend to during the study

          -  Must not have been treated with steroids within 1 month of screening, or intend to
             during the study

          -  Must not be immunocompromised

          -  Must not have received treatment with biologic agents (e.g. monoclonal antibodies,
             including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior
             to Day 1

          -  Must not have significant allergies to humanised monoclonal antibodies

          -  Must not have clinically significant multiple or severe drug allergies, or intolerance
             to topical corticosteroids, or sever post treatment hypersensitivity reactions

          -  Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except
             for basal cell or squamous epithelial carcinomas of the skin that have been resected
             with no evidence of metastatic disease for 3 years

          -  Must not have had breast cancer within the past 10 years
Amendment of rTSST-1 Variant Vaccine Phase 1 Clinical Trial
Condition: Toxic-Shock Syndrome; Sepsis
MeSH terms: Shock, Septic; Shock
Intervention: rTSST-1 Variant Candidate Vaccine
Intervention description: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Toxic Shock Syndrome (TSS) a severe condition with high morbidity and mortality results from
      the hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen
      toxins are the main causative agents. Toxic shock syndrome toxin (TSST-1) being responsible
      for almost all of menstruation associated and more than 50% of all other cases. There is no
      specific therapy. The Phase I study BioMed0713 demonstrated the safety and tolerability of
      the BioMed recombinant toxic shock syndrome toxin (rTSST-1) Variant Vaccine in healthy
      adults.

      The aim of this amendment is to demonstrate prolonged safety of the BioMed rTSST-1 Variant
      Vaccine and to assess persistence of antibodies generated in participants. The second aim of
      the study is to assess boosterability of the BioMed rTSST-1 Variant Vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male and female

          -  18 - 64 years

          -  written informed consent

          -  physical exam: no abnormal findings unless considered irrelevant by the investigator

          -  uneventful medical history

          -  females: adequate contraception

        Exclusion Criteria:

          -  pregnancy

          -  positive virology markers at first screening

          -  signs and symptoms of relevant autoimmunity
Study of LC23-1306 in Healthy Male Subjects
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Intervention: LC23-1306; placebo; Ticagrelor
Intervention description: LC23-1306 10, 30, 100, 200, 400, 600 mg Placebo 10, 30, 100, 200, 400, 600 mg; LC23-1306 placebo; Ticagrelor 90mg
Intervention MeSH terms: Ticagrelor; Platelet Aggregation Inhibitors
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 113.0
Sex: Male
Minimum age: 20 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: phase1; healthy subjects; antiplatelet agent

Summary:

      This will be a dose block-randomized, double-blind, active and placebo controlled, single and
      multiple dosing, dose-escalation study to evaluate tolerability, safety and
      pharmacokinetic/pharmacodynamic characteristics. Adverse events, physical examinations, vital
      signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and
      serial blood samples and urine collections for pharmacokinetic and pharmacodynamic
      evaluations will be conducted at specified time points.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male subjects between the ages of 20 and 50 years at screening

          2. Subjects with Body Mass Index (BMI) between 18.0 (inclusive) and 27.0 kg/m2
             (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive).
             BMI (kg/m2) = body weight (kg)/ {height (m)}2.

          3. Subject is informed of the investigational nature of this study and voluntarily agrees
             to participate in this study and signs an Institutional Review Board (IRB) - approved
             informed consent prior to performing any of the screening procedures.

          4. Findings within the range of clinical acceptability in medical history and physical
             examination, and laboratory results within the laboratory reference ranges for the
             relevant laboratory tests
Drug-interaction Trial in Healthy Subjects With Oral Administration of Empagliflozin (BI 10773), Rifampicin and Probenecid
Condition: Healthy
Intervention: Probenecid; Rifampicin; Empagliflozin; Empagliflozin; Rifampicin; Probenecid; Empagliflozin (BI 10773)
Intervention description: Probenecid; Rifampicin; BI Drug; BI Drug; Rifampicin; Probenecid; BI Drug
Intervention MeSH terms: Empagliflozin; Rifampin; Probenecid
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: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objectives of the trial are to investigate the effect of concurrent administration of
      rifampicin and probenecid on the pharmacokinetics of empagliflozin.
    

Eligibility criteria:

        Inclusion criteria:

        1. healthy male and female subjects

        Exclusion criteria:

        1. any relevant deviation from healthy conditions
An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode
Condition: Herpes Labialis
MeSH terms: Herpes Labialis
Intervention: Acyclovir patch; Placebo patch
Intervention description: Patch containing acyclovir; Patch without acyclovir
Intervention MeSH terms: Acyclovir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cold sore

Summary:

      This study will treat approximately 24 participants who experience cold sores. Patches will
      be applied to the cold sore for up to ten days, and the symptoms will be measured during
      daily clinic visits using non-invasive measurement techniques.
    

Eligibility criteria:

        Participants who are susceptible to cold sores that reactivate when exposed to ultraviolet
        (UV) light
Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD9291 in Volunteers
Condition: Healthy Volunteers
Intervention: AZD9291
Intervention description: Volunteer will receive a single oral dose of 20 mg [14C]-AZD9291 as a solution on Day 1
Intervention MeSH terms: Osimertinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Male
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Phase I, healthy, pharmacokinetics, Mass balance

Summary:

      Study to evaluate the pharmacokinetic and Mass Balance of single dose [14C] AZD9291 in
      healthy male volunteers
    

Eligibility criteria:

        Inclusion Criteria:

        1, Volunteers must be willing to use reliable methods of contraception (condom and
        spermicide), even if their partners are postmenopausal, surgically sterile, or using an
        effective hormonal method of contraception or intrauterine coil. 2. In addition, volunteers
        must agree to continue to take similar contraceptive precautions until 6 months after the
        last administration of AZD9291 and avoid procreative sex as well as sperm donation for 6
        months.

        Exclusion Criteria: 1, Any clinically relevant abnormalities in physical examination, vital
        signs, hematology,clinical chemistry, urinalysis or ECG at baseline in the opinion of the
        investigator. 2. Radiation exposure from clinical studies, including that from the present
        study, excluding background radiation but including diagnostic X-rays and other medical
        exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. -
A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: alendronate sodium (+) cholecalciferol; Comparator: alendronate; Comparator: cholecalciferol (Vitamin D)
Intervention description: A single dose tablet of 70 mg alendronate/2800 IU (international unit) vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.; A single dose table of 70 mg alendronate in one treatment period of each sequence. There will be a 12 day interval between each treatment period.; A single dose tablet of 2800 IU vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.
Intervention MeSH terms: Vitamin D; Cholecalciferol; Alendronate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 244.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the bioequivalence of alendronate in combination with vitamin D
      (cholecalciferol) compared to alendronate alone and the bioequivalence of vitamin D in
      combination with alendronate compared to vitamin D alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or nonpregnant female age 18 to 65 years

          -  Female of childbearing potential on appropriate method of contraception and not
             nursing

          -  BMI (body mass index) less than or equal to 30 kg/m2

          -  Subject is in good health

          -  Willing to limit direct sunlight and apply sunscreen if in the sun more than 1 hour

        Exclusion Criteria:

          -  mental or legal incapacitation

          -  received bisphosphonate treatment within 3 months of screening

          -  unable to sit or stand upright for at least 2 hours
Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: MK-0873 Patch; MK-0873 Cream; Placebo Patch; Placebo Cream; Plain patch
Intervention description: MK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873; MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873; Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches; Placebo cream matching MK-0873 0.05%, 0.5%, or 2%; Plain patch containing no MK-0873 or placebo
Intervention MeSH terms: MK 0873
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the incidence of erythema and other local cutaneous irritation after
      administration of MK-0873 by patch or cream formulation in healthy participants and
      participants with mild psoriasis. Part I and Part II in healthy participants will be
      initiated prior to Part III in psoriasis participants. The primary hypotheses of the study
      are: 1) that MK-0873 is safe and well tolerated in healthy participants and participants with
      psoriasis and 2) that the maximum plasma concentration of MK-0873 is <20 nM in healthy
      participants and participants with psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

        Part I, II and III:

          -  Female participants of reproductive potential must test negative for pregnancy and
             agree to use two acceptable methods of birth control;

          -  In good general health;

          -  Nonsmoker;

        Part III only:

          -  Has diagnosis of plaque-type psoriasis, and has lesions covering at least 3% of total
             body surface area;

        Exclusion Criteria:

        Part I, II and III:

          -  Has a history of stroke, chronic seizures or major neurological disease;

          -  Has a history of cancer;

          -  Is a nursing mother;

        Part III only:

          -  Has nonplaque forms of psoriasis;

          -  Has current drug-induced psoriasis;

          -  Has received phototherapy, systemic medications/treatments, or used topical medication
             that could affect psoriasis;

          -  Has used any systemic immunosuppressants or biologics within the past 4 weeks.
Bexagliflozin Drug/Drug Interaction Study With Digoxin
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Bexagliflozin; Digoxin
Intervention description: Bexagliflozin tablets, 20 mg; 2 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
Intervention MeSH terms: Bexagliflozin; Digoxin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to examine the drug-drug interaction in your body when given the
      study drug, bexagliflozin, with the heart failure medication digoxin. The study will evaluate
      whether bexagliflozin effects the amount of digoxin in your blood and how safe the study drug
      is and how well the study drug is tolerated when taken with digoxin.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects with body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2

          2. Subjects who are non-smokers for at least 6 months prior to first dose

          3. Subjects who are willing to use an adequate form of birth control during the study and
             for 30 days after discharge from clinic

        Exclusion Criteria:

          1. Subjects with a clinically significant history of allergy to drugs or latex

          2. Subjects with a history of alcohol or drug dependence in the past 12 months

          3. Subjects who have donated a significant amount of blood in the past 2 months

          4. Subjects who have taken an investigational drug in the past 30 days or 7 half-lives of
             the investigational drug, whichever is longer

          5. Subjects who had previously received digoxin or drugs of the same class, or SGLT2
             inhibitors, in the past 3 months