bioihbjkbjnl/mcl2 huggingface dataset:
Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors
Condition: Cancer; Refractory Solid Tumor
MeSH terms: Neoplasms
Intervention: Cetuximab + Irinotecan; Cetuximab + Irinotecan
Intervention description: Intravenous (IV) cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; irinotecan was administered at a dose of 16 or 20 mg/m2 or per dose escalation, administered x5 days x2 weeks, separated by 2 days off, every 21 days.; Intravenous (IV) cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; irinotecan was administered at a dose of 20 mg/m2 or per dose escalation, administered x5 days x2 weeks, separated by 2 days off, every 21 days.
Intervention MeSH terms: Irinotecan; Cetuximab
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to establish the maximum tolerated dose and
      recommended Phase II dose of Erbitux™ in combination with Irinotecan in pediatric and
      adolescent patients with refractory solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of a solid tumor which has
             progressed on, or following standard therapy, or for which no standard effective
             therapy is known.

          -  Children age 1-18 years.

        Exclusion Criteria:

          -  Presence of active infection.

          -  Requirement to receive concurrent chemotherapy immunotherapy, radiotherapy, or any
             other investigational drug while on study.

          -  Inadequate bone marrow, hepatic, or renal function.
Vitamin D Supplementation in Crohn's Patients
Condition: Inflammatory Bowel Disease
MeSH terms: Inflammatory Bowel Diseases
Intervention: Vitamin D
Intervention description: Oral supplementation daily with up to 5000 IU over 6 months.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Crohn's; vitamin D

Summary:

      The purpose of this study is to determine the effect of vitamin D supplementation in Crohn's
      disease patients. Patients will be evaluated for increases in circulating vitamin D levels
      and effects on health benefits including improved bone markers, Crohn's disease activity
      scores, and inflammatory markers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18-70 years of age with mild to moderate Crohn's disease who are not on
             active steroid treatment and who do not have ostomies.

        Exclusion Criteria:

          -  Patients with ulcerative colitis or other bowel conditions which are not Crohn's.

          -  Patients with ostomies.

          -  Those currently using supplemental vitamin D in excess of the amount in one
             multivitamin per day.

          -  Regular tanning bed users.

          -  Persons who report more than moderate alcohol consumption ( > 1 drink/day for women >
             2 for men).

          -  Pregnant or lactating women or women planning a pregnancy during the study time frame.

          -  Regular users of medications which may interfere with assessment of study outcomes .

          -  Those who cannot understand written or spoken English .

          -  Individuals under medical psychiatric care.
Middle School to High School Transition Project: Depression and Substance Abuse Prevention
Condition: Depression; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Depression; Depressive Disorder
Intervention: CAST-T/HSTS; Brief Intervention
Intervention description: Skills training small group.; Assessment of needs and referral to services as needed.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 497.0
Sex: All
Minimum age: 12 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adolescent; Substance Abuse; At-risk

Summary:

      This study will implement a school-based program to prevent depression, academic failure, and
      substance use in at-risk adolescents transitioning from middle school to high school.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At-risk for substance abuse, academic failure, and depression

          -  Enrolled in eighth grade in Seattle Public Schools

          -  English-speaking

        Exclusion Criteria:

          -  Score above the clinical cutoff on the Youth Self Report Aggressive subscale
Flortaucipir 18F PET Imaging in BIOCARD Study
Condition: Cognitive Decline
MeSH terms: Cognitive Dysfunction
Intervention: Flortaucipir F18; Brain PET scan
Intervention description: 370 megabecquerel (MBq)(10 millicurie [mCi]) single dose; positron emission tomography (PET) scan of the brain
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to assess the imaging characteristics of Flortaucipir (18F-AV-1451) in
      subjects who participated in the Biomarkers of Cognitive Decline Among Normal Individuals
      (BIOCARD) study at Johns Hopkins University.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females that have provided consent and are currently enrolled in BIOCARD
             study

          -  Ability to tolerate PET scan procedures

          -  Ability to provide informed consent for study procedures

        Exclusion Criteria:

          -  Has condition(s) that could augment risk to participant or compromise ability to
             tolerate experimental procedures or interfere with analysis of the study data as
             determined by the investigator

          -  Has a history of risk factors for Torsades de Pointes or taking medications known to
             cause QT prolongation.

          -  Has electrocardiogram acquired prior to initial flortaucipir scan that clinically
             contradicts subject's participation in the study as determined by the investigator.
             Bazett's corrected QT (QTcB) interval must be assessed and not exceed accepted values
             (458 msec in males, 474 msec in females).

          -  Females of childbearing potential who are not surgically sterile, not refraining from
             sexual activity, or not using reliable contraceptive methods.

          -  Has hypersensitivity to flortaucipir

          -  Has a currently clinically significant infectious disease, endocrine/metabolic
             disease, pulmonary/renal/hepatic impairment, or cancer that could impact study
             participation or scan results in the opinion of the investigator.

          -  Has a non-study related radiopharmaceutical imaging/treatment procedure within seven
             days prior to flortaucipir imaging visit.

          -  Is unsuitable for a study of this type in the opinion of the investigator.
A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: AR-C165395XX; Placebo
Intervention description: Oral dose of AR-C165395XX (tablets); Oral dose of placebo for AR-C165395XX (tablets)
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: patients; glycaemic control on metformin

Summary:

      A study to assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated
      Doses for 3 days in Subjects with Type 2 Diabetes Mellitus
    

Eligibility criteria:

        Inclusion Criteria

          -  Provision of informed consent

          -  Male or female of non-childbearing potential (postmenopausal, and/or have undergone
             hysterectomy and/or bilateral oophorectomy or salpingectomy/tubal ligation) aged ≥18.

          -  Patients with HbA1c ≥7.5 but ≤11% at enrolment visit (Visit 1)

          -  ody mass index >19 to <38 kg/m2

          -  he fasting plasma glucose should be in the range of 3-14 mmol/L (54-252 mg/dL,
             nclusive) on the morning of Visit 1.

          -  Clinical diagnosis of type 2 diabetes mellitus

          -  Metformin as only anti-diabetic treatment, at least for the last 3 months

        Exclusion Criteria:

          -  History or sign of any clinically significant disease or disorder which, in the
             opinion f the investigator, may either put the subject at risk because of
             participation in the sudy, or influence the results or the subject's ability to
             participate in the study

          -  Any clinically significant abnormalities in clinical chemistry, haematology or
             urinalysis results as judged by the investigator

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory results
             >3x upper level of normal range (ULN) Clinical diagnosis of Type 1 diabetes mellitus
             and/or history of diabetic ketoacidosis or positive Glutamic Acid Decarboxylase
             Autoantibodies test (GAD antibodies test).

          -  Patients treated with single Insulin therapy within the last 3 months
A Study of LY2835219 in Healthy Participants
Condition: Healthy Volunteers
Intervention: LY2835219; Rifampin
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Rifampin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of this two-period study is to compare how much of the study drug gets into the blood
      stream when it is given as a single oral dose and when it is given as a single oral dose in
      combination with rifampin (a Food and Drug Administration [FDA] approved antibiotic that is
      used to treat tuberculosis, a bacterial infection that mainly affects the lungs, and other
      infections). Each participant will complete both study periods.

      The study will last about 34 days. Screening is required within 28 days before study drug is
      given.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy sterile males or surgically sterile females or postmenopausal females

          -  Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2)

        Exclusion Criteria:

          -  Have participated in a clinical trial involving investigational product within the
             last 30 days

          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
             investigator, increases the risks associated with participating in the study

          -  Have an abnormal blood pressure

          -  Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C

          -  Have donated blood of more than 500 milliliters (mL) within the last month

          -  Have used or intend to use over-the-counter or prescription medication including
             herbal medications within 7 days prior to dosing or during the study
Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Intervention: PF-05221304
Intervention description: 25 mg dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Hepatic impairment PK study
    

Eligibility criteria:

        Key Exclusion Criteria:

        All subjects -

          -  Adults <18 years of age and >70 years of age

          -  BMI < 17.5 and > 35.4 kg/m2

          -  HIV positive

          -  Conditions that affect drug absorption

          -  Positive breath alcohol test

        Healthy/ those without hepatic impairment -

          -  Known or suspected hepatic impairment

          -  Evidence of Hepatitis B or C

          -  On any chronic medications

        Those with varying degrees of hepatic impairment -

          -  Not meeting Classification A, B, or C of hepatic impairment based on Child-Pugh
             Classification

          -  Evidence of Hepatic carcinoma or hepatorenal syndrome or limited predicted life
             expectancy

          -  Recent GI bleed

          -  Moderate or severe renal impairment

          -  Hepatic encephalopathy Grade 3 or higher
A Trial of Habit Formation Theory for Exercise in Older Adults
Condition: Sedentary Behavior; Aging; Activity, Motor; Behavior, Health
Intervention: Goal setting; Action Planning; Self-monitoring of behavior; Behavioral Practice/Rehearsal; Habit Formation
Intervention description: Goal setting: set or agree on a goal defined in terms of behavior to be achieved.; Action planning: prompt detailed planning of performance of behavior (must include a setting [walking to the mailbox], frequency, duration, and intensity.; Self-Monitoring of behavior: establish a method for person to monitor and record their number of steps based on their Fitbit.; Behavioral rehearsal: prompt practice or rehearsal of walking one or more times in a context when the performance may not be necessary, in order to increase habit and skill.; Prompt rehearsal & repetition of walking 2,000 steps or more in the same context repeatedly so that the context elicits the behavior.
Phase: Phase 1
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 45 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Habit Formation; Physical Activity; Behavior Change; Virtual; Personalized Trial; Personalized; Feasibility

Summary:

      This personalized trial will evaluate the effects of five behavioral change techniques (BCTs)
      described in Habit Formation Theory (Goal setting, Action Planning, Self-Monitoring,
      Behavioral Practice/Rehearsal and Habit Formation) delivered by text message to enhance
      low-intensity walking by 2,000 more steps per day/5 days per week in healthy Northwell
      employees aged 45-75 years old.
    

Eligibility criteria:

        Inclusion Criteria:

        Men and women who:

          -  Age 45 - 75 years old of age

          -  Fluent in English

          -  Employed in the Northwell Health system

          -  Community-dwelling

          -  Report they are in good general health, walk regularly and have never been informed by
             a clinician that it was not advisable/safe to participate in a low-intensity walking
             program

          -  Owns and can regularly access a smartphone capable of receiving text messages

          -  Owns and can regularly access an e-mail account

        Exclusion Criteria for Factors that May Limit Adherence to Interventions or Affect Conduct
        of the Trial

          -  < 45 years old or > 75 years old

          -  Unable to speak/comprehend English

          -  Not employed in Northwell Health system

          -  Have self-reported poor health, limited mobility and/or have been advised by a
             clinician not to increase their low-intensity walking

          -  Pregnancy

          -  Previous diagnosis of a serious mental health condition or psychiatric disorder, such
             as bipolar disorder
A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs
Condition: Healthy
Intervention: Sumatriptan
Intervention description: injection
Intervention MeSH terms: Sumatriptan
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: sumatriptan; Intraject; Local Site Reactions

Summary:

      Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled
      with 6 mg sumatriptan. Healthy Individuals will be enrolled for a series of 3 injections over
      2 days. Assessment of Local Site Signs will be recorded for up to 5 days, as needed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects of child-bearing potential must agree to use acceptable birth control

          -  Have abdominal or thigh injection sites that have sufficient subcutaneous tissue for
             needle-free injection

          -  Fluent in the spoken and written English language

          -  Provide written informed consent to participate in the study and be willing to comply
             with the study procedures

          -  Non-tobacco user for at least 12 months prior to screening (all types of tobacco,
             including cigars)

        Exclusion Criteria:

          -  A history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral
             vascular syndromes including ischemic or vasospastic coronary artery disease

          -  Other significant underlying cardiovascular diseases including uncontrolled
             hypertension

          -  Hemiplegic or basilar migraine

          -  A history or diagnosis of severe hepatic or renal impairment

          -  A history of epilepsy or seizure or other serious neurologic condition

          -  A history of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its
             components or similar drugs

          -  A history of scleroderma (systemic sclerosis) or any skin condition that may adversely
             affect the injection or absorption of subcutaneously administered medications

          -  Tattoos, birthmarks or other significant skin discoloration in the thigh or abdominal
             area that are large enough to restrict injection site selection and/or evaluation

          -  Pregnancy or breast-feeding

          -  Have participated in a clinical trial or receipt of an experimental therapy within 30
             days prior to dosing
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