bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Intervention: whole liver lobe cTACE doxorubicin; superselective cTACE doxorubicin
Intervention description: Doxorubicin CTACE administered in a whole liver lobe manner.; Doxorubicin CTACE administered in a super-selective (close to the tumor) manner.
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients with primary and secondary liver cancer may participate in this study. The purpose
      is to perform an analysis of the effects of doxorubicin and its metabolite doxorubicinol on
      the body (doxorubicin pharmacokinetics ) after conventional transarterial chemoembolization
      (cTACE). cTACE is a procedure in which chemotherapy drugs are injected, followed by an
      injection of small beads to block the tumor-feeding arteries. Doxorubicin is a
      chemotherapeutic agent used in the cTACE procedure. This study will examine doxorubicin
      pharmacokinetics in patients who: 1) receive whole liver cTACE; and 2) receive
      super-selective CTACE (i.e., delivered in close proximity to the tumor).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 18 years.

          2. Histologically, cytologically, or radiologically confirmed liver dominant or liver
             only malignancy.

          3. Preserved liver function (Child-Pugh A-B class) without significant liver
             decompensation.

          4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at study entry.

          5. Measurable or evaluable disease that will be directly treated with intrahepatic
             therapy (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).

          6. Suitable for TACE based on blood parameters such as platelet count, bilirubin, and
             international normalized ratio.

          7. May be enrolled with a history of prior liver directed intra-arterial therapy if
             intra-arterial therapy to the target lesion occured > 1 year prior to enrollment date.
             Intra-arterial therapy to different targets within 1 year prior to enrollment date
             will not exclude subjects.

        Exclusion Criteria:

          1. Serum total bilirubin > 3.0 mg/dL

          2. Creatinine > 2.0 mg/dL

          3. Platelets < 50000/µL

          4. Complete portal vein thrombosis with reversal of flow

          5. Ascites (trace ascites on imaging is acceptable)
The Effect of Acute Lysine Administration on α-aminoadipic Acid (Sub-study)
Condition: Healthy
Intervention: C-13 labeled Lysine; Normal saline
Intervention description: Carbon-13 is a stable naturally occurring heavy isotope of carbon. Inclusion of a 13C label on lysine allows for subsequent differentiation between endogenous and exogenous lysine and 2-AAA for calculation of clearance and excretion of the lysine bolus.; Because patients will have multiple blood draws during the course of the study, subjects will have an IV placed to reduce the number of needle sticks. To keep the vein open for blood collections, we will infuse Normal (0.9%) Saline (NS) at a rate of approximately 10ml/hr in order to keep the line open.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This sub-study aims to assess the effect and breakdown of lysine administration, specifically
      examining whether it leads to increased plasma 2-AAA in healthy humans.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI 18 to <25 kg/m2

          -  Men and women ages 18-45 years

        Exclusion Criteria:

          -  Current use of prescription medications (apart from hormonal birth control)

          -  Current use of amino acid supplements (including branched-chain amino acids) or
             supplemental protein (habitual consumption of protein powder, bars, shakes), and
             unwilling to temporarily discontinue use (1 week prior to study visit)

          -  Individuals who currently use tobacco products or have done so in the previous 30 days

          -  Prior or current cardiovascular disease, renal disease, or liver disease

          -  Diabetes mellitus (taking insulin, other anti-diabetic agents, or diet-controlled)

          -  Atrial fibrillation

          -  Bleeding disorder or anemia

          -  Positive pregnancy test

          -  Women who are breastfeeding

          -  Participation in another clinical trial within the previous 6 weeks prior to the study
             visit

          -  Inability to provide written informed consent

          -  Inability to fast for 8 hours
Vaccine Therapy For Patients Being Considered For Organ Transplant Who Are at Risk For PTLD
Condition: Lymphoproliferative Disorder
MeSH terms: Lymphoproliferative Disorders
Intervention: Inactivated EBV-infected vaccine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Healthy volunteers: No
Keywords: post-transplant lymphoproliferative disorder

Summary:

      RATIONALE: Vaccines made from a person's white blood cells may help the body build an
      effective immune response.

      PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating
      patients who are being considered for solid organ transplant who are at risk for
      post-transplant lymphoproliferative disorder.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Being considered for a solid organ transplant

          -  At high risk for post-transplant lymphoproliferative disorder

        PATIENT CHARACTERISTICS:

          -  Body weight ≥ 25 kg

          -  Karnofsky performance status 50-100% OR

          -  Lansky performance status 50-100%

          -  Not pregnant

          -  Negative pregnancy test

          -  Fertile patients must use contraception during and for 2 months after completion of
             study treatment

          -  Hemoglobin ≥ 8 g/dL (erythropoietin allowed)

          -  No history of autoimmune disease, including any of the following:

               -  Systemic lupus erythematosus

               -  Sarcoidosis

               -  Rheumatoid arthritis

               -  Glomerulonephritis

               -  Vasculitis

          -  No primary immunodeficiency

          -  No HIV positivity

        PRIOR CONCURRENT THERAPY:

          -  No corticosteroids for 1 month before and for 1 month after the first study
             vaccination, except for the following:

               -  Physiologic steroid dosing (≤ 20 mg/day of prednisone or steroid equivalent) for
                  adrenal insufficiency

               -  Inhaled steroids
MEDI-573 in Combination With SOC in Unresectable or Metastatic HCC.
Condition: Unresectable or Metastatic Hepatocellular Carcinoma (HCC)
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: MEDI-573 (1 of 3 doses); Sorafenib
Intervention description: MEDI-573, a human immunoglobulin G2 lambda (IgG2λ) monoclonal antibody (MAb), is a dual-targeting human antibody that neutralizes insulin-like growth factor (IGF)-I and IGF-II ligands; Sorafenib is a tyrosine kinase inhibitor, anti-angiogenic, VEGF inhibitor
Intervention MeSH terms: Sorafenib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: HCC, liver cancer, hepatocellular carcinoma, MEDI-573, anti-IGF

Summary:

      A Phase 1b/2, open-label, randomized study to evaluate MEDI-573 in combination with standard
      of care in adult subjects with unresectable or metastatic hepatocellular carcinoma (HCC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years or minimum age of consent per local regulations at the time of
             screening

          -  Unresectable or metastatic hepatocellular carcinoma

          -  ECOG Performance Status ≤ 2

          -  Life expectancy of ≥ 3 months;

        Exclusion Criteria:

          -  Child-Pugh Score for Cirrhosis Mortality > 7 points

          -  Prior or current system anti-cancer therapy for HCC, including cytotoxic, biologic,
             targeted or experimental therapy

          -  Prior local treatment for HCC less than 4 weeks prior to initiating study treatment

          -  Active second malignancy

          -  Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to
             initiating study treatment

          -  Thrombotic or embolic events within 6 months prior to initiating study treatment

          -  Ongoing pancreatitis

          -  Uncontrolled or refractory ascites

          -  Evidence of ongoing spinal cord compression, known carcinomatous meningitis, or known
             leptomeningeal carcinomatosis

          -  Hepatic encephalopathy > Grade 1

          -  Active brain metastases with exceptions

          -  Poorly controlled diabetes mellitus

          -  Active coronary artery disease

          -  Uncontrolled hypertension
Study to Assess the Pharmacokinetics, Safety and Tolerability of Aztreonam-Avibactam in Healthy Chinese Participants.
Condition: Healthy
Intervention: Aztreonam-Avibactam
Intervention description: 500/167 mg ATM/AVI loading infusion, followed by 1500/500 mg ATM/AVI extended loading infusion, then 1500/500 mg ATM/AVI maintenance dose infusion every 6 hours
Intervention MeSH terms: Aztreonam; Avibactam
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: no clinically relevant abnormalities

Summary:

      A Phase 1, single center, single arm, open-label study to assess the PK, safety and
      tolerability of Aztreonam-Avibactam after single and repeated IV infusion of doses in healthy
      Chinese participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Chinese male and female participants

          -  No clinical relevant abnormalities

          -  willing and able to comply with all study procedures

          -  BMI:17.5-30.5

          -  Sign informed consent

        Exclusion Criteria:

          -  Any clinical significant illness

          -  History of alcohol abuse

          -  Use within 14 days prior the first study dose

          -  CL>80ml/min

          -  Abnormal vital signs, such 12-ECG, blood pressure and pulse rate

          -  Blood donation within 60days

          -  History of HIV, HBsAg, HBcAb, HCVAb

          -  Other medical or psychiatric may inappropriate for the study
Pharmacokinetics of Leptin Administration During Fasting
Condition: Energy Deficiency Due to Short-term Fasting
Intervention: r-metHuLeptin
Intervention description: r-metreleptin was given in 3 different dose in fed and fasting states
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: leptin; fasting; pharmacokinetics

Summary:

      The purpose of this study will be to determine the correct dose of leptin, a natural hormone
      secreted by the fat cells, to give to people when they are fasting and also to determine
      whether giving leptin to a person when he or she is fasting will reverse the changes in
      hormone levels that occur with fasting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy men with body mass indices (BMI) <25 kg/m2)

          -  overweight otherwise healthy men with BMI > 27 kg/m2

          -  healthy lean women with BMI<25 kg/m2

          -  overweight otherwise healthy women with BMI > 27 kg/m2

        Exclusion Criteria:

          -  history of any illness that may affect the concentrations of the hormones that will be
             studied (such as anemia, infectious diseases, renal or hepatic failure, diabetes
             mellitus, cancer, lymphoma, hypogonadism, malabsorption or malnourishment, hypo or
             hyperthyroidism, hypercortisolism, alcoholism or drug abuse, eating disorders)

          -  on medications known to affect the hormones to be measured in this study (such as
             glucocorticoids, anti-seizure medications or thyroid hormones)

          -  known history of anaphylaxis or anaphylactoid-like reactions or who have a known
             hypersensitivity to E. Coli derived proteins

          -  women who are breast feeding, pregnant, or wanting to become pregnant during the next
             6 months
Trial of Safety and Tolerability of Oral Verdinexor (KPT-335) in Healthy Adults
Condition: Healthy
Intervention: Verdinexor; Placebo
Intervention description: Participants received verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral; Participants received placebo matched to verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: KPT-335; Verdinexor; Karyopharm; First-in-Human; Adult Subjects

Summary:

      This is a randomized, double-blind, sequential, dose-escalation, Phase 1 trial to evaluate
      the safety and tolerability of verdinexor. Verdinexor or placebo will be given on Days 1 and
      3 to healthy adult participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be in good health as determined by the investigator, based on the
             medical history, ECG, physical examination, and safety laboratory tests at screening.

          -  Participants must be identified as a non-smoker at the screening visit (a non-smoker
             is defined as an individual who has abstained from smoking for at least 1 year prior
             to the screening visit and who has a ≤ 15 pack year history of lifetime cigarette
             use). A urine cotinine test will be performed at screening and at the time of clinic
             check-in prior to study drug treatment.

        Exclusion Criteria:

          -  The participant has any surgical or medical condition that potentially may alter the
             absorption, metabolism, or excretion of the study drug such as gastrectomy, Crohn's
             disease, or liver disease.

          -  The participant has a history of clinically significant allergies. Hay fever is
             allowed unless it is active or has required treatment within the previous 2 months.

          -  Presence of a chronic condition(s) with clinical or historical evidence of recent
             exacerbation, or other information to suggest non-control of such condition(s).

          -  History of alcohol abuse or drug addiction within 12 months of the screening visit.

          -  Any participant with active cataracts or medical history of cataracts.
A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo
Intervention description: subcutaneous, single dose 0.3 mg/kg; Subcutaneous normal saline single dose; Subcutaneous, single dose 1.0 mg/kg; Subcutaneous normal saline single dose; Subcutaneous single dose 3 mg/kg; Subcutaneous normal saline single dose; Subcutaneous single dose 6 mg/kg; Subcutaneous normal saline single dose; Intravenous infusion single dose 1 mg/kg; Intravenous infusion normal saline single dose; Subcutaneous injection multiple dose 75 mg (Days 1, 29 and 57); Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57); Subcutaneous injection multiple dose 150 mg (Days 1, 29 and 57); Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57); Subcutaneous injection multiple dose 250 mg (Days 1, 29 and 57); Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57); Subcutaneous injection multiple dose TBD mg (Days TBD); Subcutaneous injection normal saline multiple dose (Days TBD)
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: first in human; single dose; multiple dose; escalation; safety study; Type 2 Diabetes Mellitus

Summary:

      A first in human study to determine the safety, tolerability and pharmacokinetics of single
      and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women of non-childbearing potential with Type 2 Diabetes Mellitus

          -  Subjects on stable doses of metformin >/= 1500 mg daily (SAD cohorts) or >/= 1000 mg
             daily (MAD cohorts) x 30 days prior to screening

          -  HbA1c 7-10% (SAD Cohorts) or 6.5-10% (MAD cohorts) inclusive at screening

          -  Fasting C-peptide >1.12 ng/mL (SAD cohorts) or >/= 0.8 mg/mL (MAD cohorts) at
             screening

        Exclusion Criteria:

          -  History of Type 1 diabetes mellitus

          -  Evidence of diabetic complications with significant end-organ damage

          -  History of chronic pancreatitis or at high risk for pancreatitis

          -  Poorly controlled hypertension

          -  History of cardiovascular or cerebrovascular event or procedure
A Study of Two Formulations of LY3074828 in Healthy Participants
Condition: Healthy
Intervention: LY3074828; LY3074828; Auto-injector (AI); Prefilled syringe (PFS)
Intervention description: Administered SC; Administered SC; AI to administer LY3074828; PFS to administer LY3074828
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: 66.0
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 study will last about 12 weeks, not including screening.
    

Eligibility criteria:

        Inclusion Criteria: Healthy participants.

        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 8 weeks 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 severe 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
Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis
Condition: Japanese Patients With ALS
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Intervention: MT-1186
Intervention description: Suspension
Intervention MeSH terms: Edaravone
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Patients
      with Amyotrophic Lateral Sclerosis
    

Eligibility criteria:

        Inclusion Criteria:

        The key criteria are listed below.

          -  Patients aged between 20 and 75 years at the time of informed consent

          -  Japanese patients

          -  Among patients with ALS, those "Clinically definite ALS," "Clinically probable ALS" or
             "Clinically probable-laboratory-supported ALS" according to El Escorial Revised Airlie
             House criteria

          -  Patients who can consent to contraception

          -  Patients who have thoroughly understood the contents of the study and voluntarily
             provided written informed consent to participate in the study

        Exclusion Criteria:

        The key criteria are listed below.

          -  Patients in whom the possibility could not be ruled out that the current symptoms were
             symptoms of a disease requiring differential diagnosis, such as cervical spondylosis
             and multifocal motor neuropathy

          -  Patients undergoing treatment for malignancy

          -  Patients who have presence of clinically significant liver, heart, or renal disease
             requiring hospitalization (except ALS) and infections requiring antibiotics. Patients
             who have a problem in general condition and are judged ineligible by the Investigator

          -  Body mass index (BMI) of <18.0 or >30.0, or a body weight of <50 kg

          -  Patients judged by the investigator (or subinvestigator) to be unsuitable for the
             study for any other reason