bioihbjkbjnl/mcl2 huggingface dataset:
E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
Condition: Peripheral T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Intervention: denileukin diftitox (E7777)
Intervention description: E7777 will be administered by intravenous (IV) infusion for 5 days from Day 1 through 5 of each cycle (21 days/cycle) with 8 cycles in maximum for E7777 alone therapy. E7777 dose will be escalated from 6 micro-g/kg/day to 12, 15 and then to 18 in a stepwise fashion.
Intervention MeSH terms: Denileukin diftitox
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Neoplasms; Neoplasms by Histologic Type; Lymphoma; Non-Hodgkin; T- Cell; Lymphatic Diseases; Lymphoproliferative Disorders; lmmune System Diseases; lmmunoproliferative Disorders

Summary:

      The purpose of this Phase 1 study is to determine the maximum tolerated dose (MTD) through
      observation of dose limiting toxicity (DLT), which is in advance defined, in patients with
      peripheral or cutaneous T-cell lymphoma.
    

Eligibility criteria:

        lnclusion Criteria:

          -  Male and female patients 20 to less than 80 years of age at the time of informed
             consent

          -  Patients histologically or cytologically diagnosed to have peripheral T -cell lymphoma

          -  Patients with a history of chemotherapy (including PUVA and retinoid) that resulted in
             relapse, recurrence and treatment resistance (just for the administration of E7777
             alone)

          -  Patients subject to CHOP therapy and without a history of prior treatment with
             anthracycline or anthraquinone anticancer drugs (just for the administration of E7777
             in combination with CHOP therapy)

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

          -  No carry-over of beneficial or adverse effects of the prior treatment that may affect
             the safety evaluation of the investigational drug (excluding Grade 1 neuropathy and
             alopecia)

        Exclusion Criteria:

          -  Brain metastasis with clinical symptoms which requires treatment

          -  Serious systemic infection requiring intensive treatment

          -  Serious complications or histories

          -  History of hypersensitivity to protein therapeutics

          -  Known to be positive for HIV antibody, HCV antibody, or HBs antigen

          -  History of malignancy other than peripheral T-cell lymphoma and less than five years
             have elapsed since the last remission

          -  Patients who have undergone allogeneic hematopoietic stem cell transplantation

          -  Patients with a relapse within 6 months after autologous hematopoietic stem-cell
             transplantation
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
Condition: Nonalcoholic Steatohepatitis (NASH); Primary Sclerosing Cholangitis (PSC)
MeSH terms: Fatty Liver; Cholangitis; Non-alcoholic Fatty Liver Disease; Cholangitis, Sclerosing
Intervention: Cilofexor
Intervention description: Tablet(s) administered orally in a fed state on Day 1
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to evaluate the single-dose pharmacokinetics of
      cilofexor in adults with impaired hepatic function relative to matched, healthy controls with
      normal hepatic function.
    

Eligibility criteria:

        Key Inclusion Criteria:

        Cohort 1:

          -  Individuals with mildly impaired and normal hepatic function.

          -  Individuals with mild hepatic impairment must have a score of 5-6 on the
             Child-Pugh-Turcotte (CPT) classification at screening without evidence of worsening
             clinical and/or laboratory signs of hepatic impairment within 2 months prior or within
             the screening period.

        Cohort 2:

          -  Individuals with moderately impaired and normal hepatic function.

          -  Individuals with moderate hepatic impairment must have a score of 7-9 on the CPT
             classification at screening without evidence of worsening clinical and/or laboratory
             signs of hepatic impairment within 2 months prior or within the screening period.

        Cohort 3:

          -  Individuals with severely impaired and normal hepatic function.

          -  Individuals with severe hepatic impairment must have a score of 10-15 on the CPT
             classification at screening without evidence of worsening clinical and/or laboratory
             signs of hepatic impairment within 2 months prior or within the screening period.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects
Condition: Healthy
Intervention: SB2; EU Remicade; US Remicade
Intervention description: IV infusion; IV infusion; IV infusion
Intervention MeSH terms: Infliximab
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 159.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics

Summary:

      The purpose of this study is to compare the pharmacokinetics, safety, tolerability and
      immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy female subjects of non-childbearing potential and healthy male subjects

          -  Have a body weight between 60.0 and 94.9 kg and a body mass index between 20.0 and
             29.9 kg/m², inclusive.

        Exclusion Criteria:

          -  history and/or current presence of clinical significant atopic allergy,
             hypersensitivity or allergic reactions, also including known or suspected clinically
             relevant drug hypersensitivity to any components of the test and reference IP
             formulation or comparable drugs.

          -  active or latent Tuberculosis or who have a history of Tuberculosis.

          -  history of invasive systemic fungal infections or other opportunistic infections

          -  systemic or local infection, a known risk for developing sepsis and/or known active
             inflammatory process

          -  serious infection associated with hospitalisation and/or which required intravenous
             antibiotics

          -  history of and/or current cardiac disease

          -  have received live vaccine(s) within 30 days prior to Screening or who will require
             live vaccine(s) between Screening and the final study visit.

          -  Intake medication with a half-life > 24 h within 1 month or 10 half-lives of the
             medication prior to the administration of investigational product.
Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: enzalutamide; anastrozole; exemestane; fulvestrant; enzalutamide; exemestane
Intervention description: 80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.; 1 mg/day; The exemestane dose is 25mg daily.; 500 mg every 28 days; 160 mg (4 capsules) taken orally daily.; The exemestane dose is 50 mg daily.
Intervention MeSH terms: Fulvestrant; Anastrozole; Exemestane
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 101.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: enzalutamide; MDV3100; breast cancer

Summary:

      The purpose of this study is to determine the safety, tolerability and pharmacokinetics of
      enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in
      patients with incurable breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed breast cancer with accompanying pathology report;

          -  Submit unstained representative tumor specimen, either as a paraffin block (preferred)
             or ≥ 10 unstained slides

          -  Received at least 2 lines of systemic therapy in the advanced setting (for
             enzalutamide alone arm only);

          -  Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1;

          -  Estimated life expectancy of at least 3 months

        Exclusion Criteria:

          -  Severe concurrent disease, infection, or comorbidity that, in the judgment of the
             Investigator, would make the patient inappropriate for enrollment;

          -  Pregnant or lactating;

          -  Known or suspected brain metastasis or leptomeningeal disease;

          -  History of another malignancy within the previous 5 years other than curatively
             treated in situ carcinomas;

          -  For patients who are enrolled to receive enzalutamide plus anastrozole or exemestane
             or fulvestrant must not have received tamoxifen or any medication known to be a potent
             CYP3A4 inducer or inhibitor.
Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
Condition: Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL)
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Acalabrutinib
Intervention MeSH terms: Acalabrutinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma; Diffuse Large B-Cell Lymphoma; de Novo Activated B-cell (ABC); de Novo Activated B-cell; ABC DLBCL; DLBCL; Lymphoma; B-Cell; Immunoproliferative Disorders; Immune System Diseases; Bruton's tyrosine kinase

Summary:

      To characterize the safety profile of acalabrutinib in subjects with relapsed or refractory
      de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age.

          -  Pathologically confirmed de novo ABC DLBCL

          -  Relapsed or refractory disease

          -  Subjects must have ≥ 1 measurable disease sites

        Exclusion Criteria:

          -  A life-threatening illness, medical condition or organ system dysfunction which, in
             the investigator's opinion, could compromise the subject's safety, interfere with the
             absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk

          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
             congestive heart failure, or myocardial infarction within 6 months of screening, or
             any Class 3 or 4 cardiac disease as defined by the New York Heart Association
             Functional Classification, or LVEF < 50%

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel or ulcerative colitis, symptomatic
             inflammatory bowel disease, or partial or complete bowel obstruction.

          -  Breast feeding or pregnant
A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients
Condition: Pharmacokinetics of Avycaz in ICU Patients
MeSH terms: Critical Illness
Intervention: Ceftazidime/avibactam
Intervention description: Ceftazadime/avibactam dosing in ICU patients
Intervention MeSH terms: Ceftazidime; Avibactam; Avibactam, ceftazidime drug combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to analyze the PK/PD of AvyCaz in critically ill patients in the
      Intensive Care Unit (12). This study will include medical and post-surgical patients who
      develop an infection where Avycaz can be utilized. Since these patients will have variable PK
      parameters, the investigators will also analyze (time-kill) these serum concentrations (ex
      vivo) against relevant clinical isolates (e.g. GNR with ESBL or KPC) from the ICU to
      determine microbiologic activity of Avycaz in critically ill patients with variable
      characteristics. Monte-Carlo simulations will also be conducted against clinical ICU isolates
      (JMI labs) to help determine appropriate dosing schedules based upon these PK parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥18y/o) patients with a medical or post-surgical infection such as skin/soft
             tissue infections, urinary infections, IA infections and pneumonia (including VAP)

          -  Patients requiring intensive care (critically ill patients) in the med/surg ICU
             (APACHE II score ≥ 15)

          -  Patients prescribed Avycaz for their infection will receive FDA recommended dosages
             and times of administration

          -  Written informed consent

        Exclusion Criteria:

          -  Pregnant Patients, patients older than 90 y/o, those with CrCl < 30 mL/min, patients
             with a BMI > 45 Kg/m2, patients unable to provide serum samples, and those with the
             risk of imminent death during the study
A Phase 1 Study of Continuous Intravenous L-citrulline During Sickle Cell Pain Crisis or Acute Chest Syndrome
Condition: Sickle Cell Disease
MeSH terms: Acute Chest Syndrome; Anemia, Sickle Cell
Intervention: Intravenous citrulline
Intervention description: Intravenous citrulline at a bolus dose of 20 mg/kg over 5 minutes and then continuous at a rate of 7 mg/kg/hour for the next 23 hours for the first 7 participants, and depending on safety and pharmacokinetic profile, increase or decrease the continuous rate to 9 or 5 mg/kg/hour for the next 7 participants.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 6 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: sickle cell disease; citrulline

Summary:

      Sickle cell disease is a genetic red blood cell disorder characterized by vaso-occlusion from
      sickling of red blood cells, that can lead to pain or organ complications such as acute chest
      syndrome. Sickle cell disease is associated with low amounts of nitric oxide, a compound
      important for dilating the blood vessel wall. Citrulline is a substance that is known to
      increase nitric oxide. The goal of this Phase I study are to find the highest safe dose of
      continuous IV citrulline that can be given to individuals with sickle cell disease
      experiencing a sickle cell pain crisis or acute chest syndrome without causing severe side
      effects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Sickle cell disease genotypes (HbSS, HbS/β0-thalassemia, HbS/β+-thalassemia, HbSC)

          2. Ages 6 to 50 years old

          3. Patients with sickle cell disease aged 6 to 50 years old Presence of sickle cell pain
             crisis defined by the presence of pain requiring hospitalization and parental opioid
             therapy

          4. Presence of acute chest syndrome defined by the presence of a new CXR infiltrate and
             any one of the following respiratory symptoms of fever, shortness of breath, wheezing,
             chest pain, cough or new onset hypoxia.

        Exclusion Criteria:

          1. Presence of any other complication related to sickle cell disease requiring
             hospitalization such as splenic sequestration, hepatic sequestration, stroke,
             avascular necrosis of the hip/shoulder, acute priapism, etc.

          2. Severe anemia (hemoglobin < 5g/dL)

          3. History of red blood cell transfusion within the last 30 days

          4. Systemic steroid therapy within the last 48 hours

          5. Pregnant (as confirmed by a negative urine pregnancy test) or lactating female

          6. Alanine/aspartate transferase >2x upper limit of normal laboratory range for age.

          7. Subject has the following serum creatinine:

               -  Age 6 to 13 years > 0.9 mg/dL

               -  Age 14-17 years 1.0 mg/dL

               -  Age 18 years >1.5mg/dL

          8. Patients with an inability to give consent will be excluded
Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of Tolbutamide
Condition: Healthy Volunteers
Intervention: Ritlecitinib; Tolbutamide
Intervention description: Ritlecitinib 200 mg provided as four 50 mg oral capsules; Tolbutamide 500 mg provided as one 500 mg oral tablet
Intervention MeSH terms: Tolbutamide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pharmacokinetics (PK)

Summary:

      This is a Phase 1, 2-period, multiple-dose, open-label, single fixed sequence study of the
      effect of ritlecitinib on tolbutamide pharmacokinetics in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and/or female participants who are healthy as determined by medical evaluation
             including medical history, full physical examination (including BP and pulse rate
             measurements), clinical laboratory tests, and 12-lead ECG.

          -  BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

        Exclusion Criteria:

          -  Past/present clinically significant hematological, renal, endocrine, pulmonary, GI,
             CV, hepatic, psychiatric, neurological, dermatological or allergic disease (including
             drug allergies).

          -  Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

          -  Infection with hepatitis B or C viruses.

          -  Participants with any of the following acute or chronic infections or infection
             history: any infection requiring treatment within 2 weeks prior to the start of study
             participation; any infection requiring hospitalization or parenteral antimicrobial
             therapy within 60 days of the first dose of investigational product; any infection
             judged to be an opportunistic infection or clinically significant within the past 6
             months of the first dose of investigational product; known active or history of
             recurrent bacterial, viral, fungal, mycobacterial or other infections; history of
             recurrent localized dermatomal herpes zoster, or history of disseminated (single
             episode) herpes simplex or disseminated herpes zoster.

          -  History of any lymphoproliferative disorder such as EBV related lymphoproliferative
             disorder, history of lymphoma, history of leukemia, or signs or symptoms suggestive of
             current lymphatic or lymphoid disease.

          -  Known presence or a history of malignancy other than a successfully treated or excised
             non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in
             situ.
Mood Effects of Serotonin Agonists Extended
Condition: Healthy
Intervention: Placebo; Serotonin agonist - 13ug; Serotonin agonist - 26ug
Intervention description: Drug will be administered in solution form; 13ug lysergic acid diethylamide; 26ug lysergic acid diethylamide
Intervention MeSH terms: Serotonin; Serotonin Receptor Agonists
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In this study we are examining the effects of repeated very low doses of serotonin agonists
      on mood individuals with negative mood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English fluency

          -  High school level education

          -  BMI between 19 and 30

        Exclusion Criteria:

          -  Diagnosed medical condition

          -  women who are nursing, pregnant, or plan to become pregnant within 3 months

          -  History of psychotic disorder or family history of psychotic disorder
A Study of LY3185643 and rGlucagon in Healthy Participants
Condition: Healthy
Intervention: LY3185643; rGlucagon
Intervention description: Administered SC; Administered SC
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine how the body handles LY3185643 and rGlucagon and
      what effects LY3185643 and rGlucagon have on the body. This study will also help to determine
      if LY3185643 is safe and well-tolerated.

      This study will last at least 35 days, not including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy as determined by medical history and physical examination

          -  Body mass index of 18.0 to 30.0 kilograms per square meter (kg/m²)

        Exclusion Criteria:

          -  Have participated, within the last 30 days, in a clinical trial involving an
             investigational product

          -  Known allergies to LY3185643 or rGlucagon, related compounds, or any components of the
             formulation

          -  History or electrocardiogram (ECG) evidence of heart block, or any abnormality in the
             12-lead ECG

          -  Abnormal blood pressure

          -  History of recurring symptomatic postural hypotension irrespective of the decrease in
             blood pressure, or asymptomatic postural hypotension at screening as defined as a
             decrease in systolic blood pressure greater than or equal to (≥) 20 millimeter of
             Mercury (mm Hg) within 3 minutes when changing from supine to standing position

          -  History of vasovagal response such as fainting

          -  History of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal,
             endocrine, hematological, or neurological disorders capable of significantly altering
             the absorption, metabolism, or elimination of drugs; of constituting a risk when
             taking the investigational product; or of interfering with the interpretation of data

          -  History of/current insulinoma and/or pheochromocytoma

          -  Have used systemic glucocorticoids within 3 months before entry into the study