bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence of Azathioprine Suspension 10 mg/mL (Jayempi) Versus Azathioprine Tablet 50mg (Imurek®)
Condition: Therapeutic Equivalency
Intervention: Azathioprine 50Mg Tab; Azathioprine 10mg/mL oral suspension
Intervention description: tablet; oral suspension
Intervention MeSH terms: Azathioprine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A single center, single dose, open-label, randomized, two period crossover study to assess
      the bioequivalence of an oral azathioprine suspension 10 mg/mL (Jayempi™) versus oral
      azathioprine tablet 50mg (Imurek®, Aspen Pharma Trading Limited, Dublin, Ireland.) in at
      least 30 healthy adult subjects under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Volunteers.

          -  No significant medical history or conditions that may interfere with the study.

          -  Adequate contraception.

        Exclusion Criteria:

          -  Volunteers who may be likely to have the inherited mutated NUDT15.

          -  Subjects with a deficient, low or intermediate TPMT enzyme activity.

          -  Disease that may interfere with the safety of the participant or the study outcome
             measures.

          -  Participants who want to procreate in the next 6 months.
Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis
Condition: Peritoneal Dialysis-associated Peritonitis
MeSH terms: Peritonitis
Intervention: Vancomycin
Intervention description: Vancomycin one-time 20 mg/kg intraperitoneal dose.
Intervention MeSH terms: Vancomycin
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
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Vancomycin; Pharmacokinetics; Pharmacodynamics; Automated Peritoneal Dialysis

Summary:

      Vancomycin is the most commonly used empiric treatment for infectious peritonitis in patients
      on peritoneal dialysis. Current dosing and monitoring for safety and efficacy is empiric,
      especially for those on rapid-cycling modalities. The goal of this study is to understand the
      pharmacokinetics of vancomycin in patients on rapid-cycling peritoneal dialysis modalities in
      order to derive an optimal dosing regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male or females between 18 - 85 years old

          -  Stabilized on a PD regimen for > 3 months prior to study initiation

        Exclusion Criteria:

          -  Clinically significant disease unrelated to renal impairment or deemed unfit by the
             investigator

          -  Allergy or hypersensitivity to vancomycin or icodextrin-containing dialysis solution

          -  Active peritonitis infection

          -  Previous intraperitoneal antibiotic treatment within 2 months

          -  Previous intravenous vancomycin treatment within 2 months

          -  Hemoglobin < 9 g/dL

          -  Pregnant or breast-feeding women
Phase 1b Study of Weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Carfilzomib; Lenalidomide; Dexamethasone
Intervention description: Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.; Administered orally once daily on days 1-21 of each 28-day cycle.; Administered by mouth or IV at 40 mg on days 1, 8, and 15 of each 28-day cycle and on day 22 of cycles 1 to 8.
Intervention MeSH terms: Dexamethasone; Lenalidomide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the safety, tolerability and activity of a once-weekly
      regimen of carfilzomib in combination with lenalidomide and dexamethasone for the treatment
      of multiple myeloma.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Newly diagnosed or relapsed multiple myeloma

          2. Measureable disease by serum M protein, or urine M protein, or serum free light chain
             (SFLC) and an abnormal serum kappa lambda ratio (for subjects without detectable serum
             or urine M-protein), or serum quantitative immunoglobulin A (glgA) (for immunoglobulin
             (Ig) A subjects whose disease can only be reliable measured by qlgA).

          3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2

          4. Left ventricular ejection fraction (LVEF) ≥ 40%

        Key Exclusion Criteria:

          1. Waldenström macroglobulinemia

          2. For newly diagnosed multiple myeloma: multiple myeloma of IgM subtype

          3. For relapsed disease:

               1. If treated with a lenalidomide and dexamethasone combination, progression during
                  the first 3 months after initiating treatment.

               2. Any progression during treatment if the lenalidomide and dexamethasone regimen
                  was the most recent line of therapy.

               3. Any prior treatment with carfilzomib

          4. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and
             skin changes)

          5. Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard
             differential)

          6. Myelodysplastic syndrome

          7. Amyloidosis

          8. Prior treatment with carfilzomib or oprozomib
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.
A Study in Healthy Men to Test Whether Four Capsules of 25 mg Nintedanib Are Taken up in the Body in the Same Way as One 100 mg Capsule
Condition: Healthy
Intervention: nintedanib 25 mg; nintedanib 100 mg
Intervention description: soft gelatin capsule; soft gelatin capsule
Intervention MeSH terms: Nintedanib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main objective of this trial is to investigate the relative bioavailability of 100 mg
      nintedanib given as four capsules of 25 mg nintedanib compared with one capsule of 100 mg
      nintedanib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects according to the assessment of the investigator, as based on a
             complete medical history including a physical examination, vital signs (blood pressure
             (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests

          -  Age of 18 to 55 years (inclusive)

          -  Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)

          -  Signed and dated written informed consent prior to admission to the study, in
             accordance with Good Clinical Practice (GCP) and local legislation

        Exclusion Criteria:

          -  Any finding in the medical examination (including BP, PR or ECG) deviating from normal
             and assessed as clinically relevant by the investigator

          -  Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,
             diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the
             range of 45 to 90 bpm

          -  Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          -  Any evidence of a concomitant disease assessed as clinically relevant by the
             investigator

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          -  Cholecystectomy or other surgery of the gastrointestinal tract that could interfere
             with the pharmacokinetics of the trial medication (except appendectomy or simple
             hernia repair)

          -  Diseases of the central nervous system (including but not limited to any kind of
             seizures or stroke), and other relevant neurological or psychiatric disorders

          -  History of relevant orthostatic hypotension, fainting spells, or blackouts Further
             exclusion criteria apply.
Study of an Experimental New Drug, PPARγ Agonist Taken by Mouth by Participants With Advanced or Metastatic Cancer
Condition: Neoplasm
Intervention: CS-7017
Intervention description: CS-7017 0.05mg and 1.0mg tablets
Intervention MeSH terms: Efatutazone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PPARγ agonist; advanced or metastatic malignancies; Tumor; Cancer

Summary:

      An open-label, Phase I, dose escalation study of CS-7017 administered by mouth in sequential
      cohorts of 3 to 6 participants with advanced or metastatic malignancies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically diagnosed advanced or metastatic malignancy that is
             refractory to, not curable with, or not eligible for standard treatment(s).

          -  18 years or older

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.

          -  Resolution of any toxic effects of prior therapy (except alopecia) to National Cancer
             Institute Common Terminology Criteria for Adverse Events v3.0 grade less than or equal
             to 1.

          -  Adequate organ and bone marrow function.

          -  Willing to use effective contraceptive while on treatment through at least 3 months
             thereafter.

          -  Negative pregnancy test for females of childbearing potential.

          -  Echocardiogram with ejection fraction within normal range.

        Exclusion Criteria:

          -  Anticipation of need for a major surgical procedure or radiation therapy during the
             study.

          -  Treatment with chemotherapy, hormonal therapy, other thiazolidinediones, radiotherapy,
             minor surgery, or any investigational agent within 4 weeks (6 weeks for nitrosoureas,
             mitomycin C, immunotherapy, biological therapy, or major surgery) of study treatment
             start.

          -  Participants with clinically significant pleural or pericardial effusion (participants
             with minimal pleural effusion may be eligible at the Investigator's discretion).

          -  Clinically significant active infection, which requires antibiotic therapy, or human
             immunodeficiency virus (HIV)-positive participants receiving antiretroviral therapy.
Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
Condition: Candida Infection; Premature Infant
MeSH terms: Candidiasis
Intervention: Medium-Chain Triglyceride (MCT) Oil
Intervention description: Infants receive 0.5 ml/oz of MCT oil to their prescribed feedings for 21 days or until hospital discharge.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Maximum age: 6 Months
Healthy volunteers: No

Summary:

      This study evaluates whether adding a dietary supplement similar to coconut oil (MCT oil) to
      feedings in premature infants will reduce the amount of yeast (Candida) detectable in their
      stool. Infants who have Candida in their stool are eligible to participate. Half of the
      enrolled infants will have additional MCT oil added to their feedings and half will not.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premature infant admitted to the Neonatal Intensive Care Unit at Women & Infants
             Hospital

          -  Receiving full enteral feeds of either preterm or transitional formula or fortified
             breast milk

          -  Anticipated to have a minimum stay of two weeks

        Exclusion Criteria:

          -  Prior exposure to antifungal drugs
Effect of Tepotinib on PK of CYP3A Substrate Midazolam
Condition: Healthy
Intervention: Midazolam; Tepotinib
Intervention description: Participant received single oral dose of 7.5 mg midazolam tablet on Day 1 of treatment period 1 and Day 11 in treatment period 2.; Participants received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 in treatment period 2.
Intervention MeSH terms: Tepotinib; Midazolam
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Sequential Assignment
Intervention model description: This is a single sequence cross-over trial.
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 44 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tepotinib; Midazolam; Cytochrome P450; Pharmacokinetics

Summary:

      The study investigated the effect of tepotinib on the pharmacokinetics (PK) of the Cytochrome
      P450 (CYP) 3A substrate midazolam determined from concentrations of midazolam and its main
      metabolite 1-hydroxymidazolam in healthy participants.
    

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
A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Ixekizumab
Intervention description: Administered as subcutaneous (SC) injection
Intervention MeSH terms: Ixekizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to research how much ixekizumab enters the bloodstream and how
      long the body takes to get rid of the drug and the safety of ixekizumab and any side effects
      that might be associated with it. The study has two parts: A single-dose part and
      multiple-dose part. The single dose part of this study will last up to 24 weeks, including
      the screening period. The multiple dose part of this study will last up to 32 weeks including
      the screening period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged ≥18 years.

          -  Diagnosis of chronic plaque psoriasis for ≥6 months before baseline.

          -  Candidates for phototherapy and/or systemic therapy.

          -  ≥10% body surface area (BSA) involvement at screening and baseline.

          -  static Physician's Global Assessment (sPGA) score ≥3, and Psoriasis Area and Severity
             Index (PASI) score ≥12 at screening and baseline.

        Exclusion Criteria:

          -  Clinically significant flare of psoriasis during the 12 weeks before baseline.

          -  Systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks. prior to
             baseline or topical psoriasis treatment or medicated shampoo within 2 weeks prior to
             baseline .

          -  Current or recent use of any biologic agent within the required washout periods.

          -  Clinical evidence or suspicion of active tuberculosis or previously had evidence of
             active tuberculosis and did not receive appropriate and documented treatment.
PD-1 Knockout Engineered T Cells for Metastatic Non-small Cell Lung Cancer
Condition: Metastatic Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Cyclophosphamide; PD-1 Knockout T Cells
Intervention description: To deplete Tregs before collecting peripheral blood; Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment
Intervention MeSH terms: Cyclophosphamide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: lung cancer; immune checkpoint; PD-1; CRISPR; autologous cell infusion

Summary:

      This study will evaluate the safety of PD-1 knockout engineered T cells in treating
      metastatic non-small cell lung cancer. Blood samples will also be collected for research
      purposes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically verified stage IV non-small cell lung cancer with measurable lesions
             (On CT: longest diameter of tumoral lesion >=10 mm, shorted diameter of lymph node
             >=15 mm; measurable lesions should not have been irradiated)

          -  Progressed after all standard treatment

          -  Performance score: 0-1

          -  Expected life span: >= 6 months

          -  Toxicities from prior treatment has resolved. Washout period is 4 weeks for
             chemotherapy, and 2 weeks for targeted therapy

          -  Major organs function normally

          -  Women at pregnant ages should be under contraception

          -  Willing and able to provide informed consent

        Exclusion Criteria:

          -  Pathology is mixed type

          -  Emergent treatment of tumor emergency is needed

          -  Poor vasculature

          -  Coagulopathy, or ongoing thrombolytics and/or anticoagulation

          -  Blood-borne infectious disease, e.g. hepatitis B

          -  History of mandatory custody because of psychosis or other psychological disease
             inappropriate for treatment deemed by treating physician

          -  With other immune diseases, or chronic use of immunosuppressants or steroids

          -  Compliance cannot be expected

          -  Other conditions requiring exclusion deemed by physician