bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers
Condition: Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer
Intervention: KITE-439; Cyclophosphamide; Fludarabine; Interleukin-2
Intervention description: A single infusion of E7 TCR T cells (KITE-439).; Administered intravenously.; Administered intravenously.; Administered subcutaneously.
Intervention MeSH terms: Cyclophosphamide; Fludarabine; Interleukin-2
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study has 2 parts: Phase 1A and Phase 1B. The primary objectives of Phase 1A are to
      evaluate the safety of KITE-439 and to determine a recommended Phase 1B dose. The primary
      objective of Phase 1B is to estimate the efficacy of KITE-439 in adults who are human
      leukocyte antigen (HLA)-A*02:01+ and have relapsed/refractory human papillomavirus (HPV)16+
      cancers.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Advanced cancer defined as relapsed or refractory disease after at least 1 line of
             therapy that included systemic chemotherapy and that is not amenable to definitive
             locoregional therapy

          -  HPV16+ tumor as confirmed by the central laboratory

          -  HLA type is HLA-A*02:01+ per local assessment

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

        Key Exclusion Criteria:

          -  Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for
             management

               -  Note: Simple urinary tract infection (UTI) and uncomplicated bacterial
                  pharyngitis are permitted if responding to active treatment and after
                  consultation with the Kite medical monitor

          -  Primary immunodeficiency

          -  History of autoimmune disease (eg, Crohns, rheumatoid arthritis, systemic lupus)
             resulting in end organ injury or requiring systemic immunosuppression/systemic disease
             modifying agents within the last 2 years prior to enrollment

          -  Known history of infection with human immunodeficiency virus (HIV), hepatitis B (HBsAg
             positive), or hepatitis C (anti-HCV positive). A history of treated hepatitis B or
             hepatitis C is permitted if the viral load is undetectable per quantitative polymerase
             chain reaction (qPCR) and/or nucleic acid testing

        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.
Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Omeprazole; Placebo oral tablet; Gliclazide
Intervention description: Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.; Placebo will be administered orally once daily for 5 days in one of the two treatment periods.; Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5.
Intervention MeSH terms: Gliclazide; Omeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Proton pump inhibitors (PPIs) are treatment of choice for different gastrointestinal
      disorders common in type 2 diabetes. Sulfonylureas (SUs) are anti-diabetes agents
      particularly widely used in developing countries. Gliclazide, a recommended SU drug, is
      metabolised in part by CYP2C19, the main enzyme responsible for the PPI metabolism.

      A randomised, placebo-controlled, two-sequence, two-period crossover study will be performed
      to explore whether gliclazide pharmacokinetics (PK) and pharmacodynamics (PD) are altered
      upon co-administration with omeprazole. Sixteen healthy volunteers, CYP2C19
      extensive/ultrarapid metabolisers (EM/UM), will receive placebo or omeprazole alone for 4
      days, and concomitantly with single dose of gliclazide on day 5. Plasma concentration of
      gliclazide will be measured for 24 hours, and plasma glucose and insulin levels up to 12
      hours after gliclazide administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men

          -  Age 18-30 years

          -  Non-smokers

          -  CYP2C19 extensive/ultrarapid metabolisers

        Exclusion Criteria:

          -  medical history of hepatic, renal, gastrointestinal and hematologic disease or any
             acute or chronic disease, or drug allergy to sulfonylureas or PPIs or history of drug
             abuse

          -  abnormalities in physical examination, ECG and routine clinical laboratory tests
             (including fasting blood glucose concentration)

          -  medication use during the 14 days prior and during the study period

          -  grapefruit, grapefruit juice, alcohol, beverages or food containing methylxanthines
             use during 72 h prior and during the study period
INSORB Versus Subcuticular Sutures at Cesarean Section
Condition: Cesarean Section; Pregnancy
Intervention: Insorb absorbable staples; Absorbable sutures
Intervention description: Placement of Insorb absorbable staples at cesarean section; placement of absorbable sutures at cesarean section
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 187.0
Sex: Female
Minimum age: 16 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: cesarean section; insorb staples; absorbable staples; transverse skin incision

Summary:

      The proposed study is a randomized controlled trial with two arms. All patients admitted to
      Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered
      entry into our study. Once the patient is enrolled, and if she undergoes a cesarean section,
      the patient will be randomized at time of cesarean section to receive skin closure by either
      the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture as is the
      standard practice. Both an observer scar assessment score (OSAS) and patient scar assessment
      score (PSAS) will be obtained during this visit. The patient will then be contacted by
      telephone by a study member 3 months after her surgery for a brief survey (same PSAS survey)
      assessing her satisfaction with the resulting scar.
    

Eligibility criteria:

        Inclusion Criteria:

          -  cesarean section via transverse skin incision informed consent

        Exclusion Criteria:

          -  vertical skin incision
A Study of Ixekizumab in Healthy Participants
Condition: Healthy
Intervention: Ixekizumab
Intervention description: Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare three different formulations of ixekizumab. One
      formulation (Reference) has been approved by the Food and Drug Administration (FDA) and two
      formulations (Test 1 and Test 2) have not been approved. This study will compare how much of
      each of the three formulations get into the blood stream. Information about any side effects
      that may occur will also be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male participant or female participant who agree to not become pregnant

          -  Are male participant or female participants with chronic stable medical problems, that
             in the investigator's opinion will not place the subject at increased risk by
             participating in the study

        Exclusion Criteria:

          -  Have a significant history of, or current, cardiovascular, respiratory, hepatic,
             renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of
             the investigator poses an unacceptable risk to the participant if participating in the
             study

          -  Are allergic or hypersensitive to the study medicine

          -  Had a vaccination with a live vaccine within 12 months prior to the first check-in or
             intend to get a vaccine for tuberculosis within 12 months of completing treatment on
             this study

          -  Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other
             serious infection

          -  Show evidence of active or latent tuberculosis (TB)

          -  Presence of significant neuropsychiatric disorder or a recent history of depression

          -  Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion
             of the investigator would pose an unacceptable risk to the participant, if
             participating in the study
4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; PF-06882961; PF-06882961; PF-06882961; PF-06882961; PF-06882961; PF-06882961; PF-06882961; PF-06882961
Intervention description: Tablet, 0 mg, twice daily, 28 days; Tablet, 15 mg twice daily, 28 days; Tablet, 50 mg twice daily, 28 days; Tablet, 150 mg twice daily, 28 days; Tablet, 300 mg twice daily, 28 days; Tablet, dose TBD, twice daily, Cohort 5, 28 days; Tablet, dose TBD, twice daily, Cohort 6, 28 days; Tablet, dose TBD, twice daily, Cohort 7, 28 days; Tablet, dose TBD, twice daily, Cohort 8, 28 days
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Type 2 diabetes mellitus

Summary:

      This is a dose-escalating study in patients with Type 2 diabetes on metformin. Participants
      will receive an investigational product or placebo for 28 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes treated with a stable dose of metformin at least 500 mg

          -  HbA1c value between 7.0 and 10.5%

        Exclusion Criteria:

        - Type 1 diabetes or secondary forms of diabetes
Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults
Condition: Healthy
Intervention: ALXN1840
Intervention description: Participants received ALXN1840 at Hour 0 on Day 1 of the dosing period.
Intervention MeSH terms: Tetrathiomolybdate; Choline
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ALXN1840; Enteric-coated tablet; Pharmacokinetics; Pharmacodynamics; Healthy

Summary:

      To assess the relative bioavailability of ALXN1840 administered orally as a single
      enteric-coated (EC) tablet (reference, Treatment A) versus three EC tablets (test, Treatment
      B).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight ≤ 100 kilograms (kg) and body mass index within the range 18-25 kg/meter
             squared, inclusive, at Screening.

          -  Negative serum pregnancy test at Screening and Day -1 for all women of childbearing
             potential.

          -  Willing to adhere to contraception requirements.

          -  Satisfactory medical assessment with no clinically significant or relevant
             abnormalities.

        Exclusion Criteria:

          -  Current or recurrent/chronic disease

          -  Positive test for hepatitis B surface antigen or human immunodeficiency virus antibody
             at Screening.

          -  Acute or chronic hepatitis C virus infection.

          -  History of hypersensitivity to ALXN1840 or its excipients or any significant allergic
             reaction.

          -  Use of prescription medications (excluding oral contraceptives) within 14 days prior
             to dosing on Day 1, except with prior approval of the Sponsor.

          -  Participation (that is, last protocol-required study visit) in a clinical study within
             90 days before initiation of dosing on Day 1.

          -  Serum ceruloplasmin value outside of the normal range at Screening

          -  Female participants who were breastfeeding.

          -  Prior exposure to ALXN1840.

          -  Major surgery or hospitalization within 90 days prior to dosing on Day 1.
Drug-Drug Interaction Study Assessing Effect of Carbamazepine on PF-07321332 Boosted With Ritonavir
Condition: Healthy Participant
Intervention: PF-07321332/ritonavir; Carbamazepine; PF 07321332/ritonavir
Intervention description: PF-07321332/ritonavir administered orally as a single dose on Day 1, Period 1; In Period 2, Days 1-3, participants will receive low-dose of carbamazepine twice daily (BID), then a titrated mid-dose of carbamazepine BID on Days 4-7, and finally maintaining carbamazepine at the high-dose on Days 8-15.; In Period 2, Day 14, participants will receive a single dose of PF-07321332/ritonavir orally.
Intervention MeSH terms: Ritonavir; Nirmatrelvir; Carbamazepine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a Phase 1, fixed sequence, 2-period study to estimate the effect of a strong CYP3A4 inducer, carbamazepine, on the PK of PF-07321332 and ritonavir in healthy participants. A total of approximately 12 healthy male and/or female participants will be enrolled into the study.
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug-drug interaction; Carbamazepine; CYP3A4 inducer

Summary:

      This is a drug-drug interaction study to assess the effects of a single dose of
      PF-07321332/ritonavir after multiple dose administrations of carbamazepine. Pharmacokinetic
      (PK) will be evaluated for PF-07321332 and ritonavir. Carbamazepine is being utilized as a
      cytochrome P450 3A4 (CYP3A4) inducer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female participants of childbearing potential must have a negative (urine or serum)
             pregnancy test.

          2. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

        Exclusion Criteria:

          1. Positive test reverse-transcriptase polymerase chain reaction (RT-PCR) result for
             SARS-CoV-2 infection at the time of Screening or Day -1.

          2. Subjects shown to carry or be positive for human leukocyte antigen (HLA)-B*1502 and
             HLA-A*3101

          3. Participants taking monoamine oxidase inhibitors (MAOIs) should discontinue MAOI for a
             minimum of 14 days prior to dosing in the current study.

          4. Hormonal methods of contraception (including oral and transdermal contraceptives,
             injectable progesterone, vaginal ring, and postcoital contraceptive methods) and
             hormone replacement therapy must have been discontinued at least 28 days prior to the
             first dose of investigational product. Depo Provera must be discontinued at least 6
             months prior to the first dose of study treatment.
Study of the JAK Inhibitor Ruxolitinib Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF)
Condition: Myelofibrosis
MeSH terms: Primary Myelofibrosis; Polycythemia
Intervention: Ruxolitinib
Intervention description: Starting dose of ruxolitinib for cohort 1 in dose escalation phase - 5mg twice a day (BID)
Doses will be increased a total of approximately 5mg for successive dosing cohorts based on baseline platelet count
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase IB, open-label, dose-finding study of the JAK 1 and 2 inhibitor ruxolitinib
      in patients with myelofibrosis (MF). The study consists of two periods: the core study
      period, comprising the dose escalation stage and the safety extension phase up to Week 24,
      then the extension study period beyond Week 24 and up to 3 years, to further characterize the
      safety and efficacy of ruxolitinib in this patient population. The dose escalation phase will
      enroll successive cohorts of patients who receive increasing doses of ruxolitinib until the
      maximum safe starting dose (MSSD) is determined. In the safety expansion phase, additional
      patients will be treated with ruxolitinib at the MSSD defined during dose escalation. The
      primary objective is to establish the MSSD of ruxolitinib in patients with MF and starting
      platelet counts < 100 x 10 ^9/L
    

Eligibility criteria:

        Inclusion Criteria:

          -  Require treatment for MF and classified at least as intermediate risk level 1 defined
             by the International Working Group.

          -  Platelet count < 100x10 ^9/L at screening or at Study Day 1.

        Exclusion Criteria:

          -  Received platelet transfusion within 14 days prior to Screening evaluations.