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ID

14568

Beskrivning

Choline Magnesium Trisalicylate and Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02144675

Länk

https://clinicaltrials.gov/show/NCT02144675

Nyckelord

  1. 2016-04-21 2016-04-21 -
Uppladdad den

21 april 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT02144675

    Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT02144675

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patients must have a diagnosis of non-m3 aml (patients with m3 subtype are excluded); determination of the presence of cytogenetic abnormalities will be by standard cytogenetics +/- fluorescent-in-situ (fish) studies; additional molecular analyses for nucleophosmin (npm) mutation and fms-related tyrosine kinase 3 (flt3) internal tandem duplication will be obtained as a part of standard care by institutional procedures
    Beskrivning

    aml

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    leukemic blast count > 1500/mm^3 of peripheral blood
    Beskrivning

    leukemic blast count

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2697913 (Leukemic Blast Count)
    patients must have an eastern cooperative oncology group (ecog) performance status =< 3
    Beskrivning

    eastern cooperative oncology group (ecog) performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    total bilirubin < 2 times the institutional upper limit of normal (uln)
    Beskrivning

    total bilirubin

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201913 (Bilirubin, total measurement)
    SNOMED
    359986008
    aspartate aminotransferase (ast) (serum glutamic oxaloacetic transaminase [sgot]) < 3 times the institutional uln
    Beskrivning

    aspartate aminotransferase

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201899 (Aspartate aminotransferase measurement)
    SNOMED
    45896001
    serum creatinine < 1.5 times the institutional uln
    Beskrivning

    serum creatinine

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    multi gated acquisition scan (muga) or echocardiogram with left ventricular ejection fraction (lvef) > 50%
    Beskrivning

    Left ventricular ejection fraction

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0428772 (Left ventricular ejection fraction)
    SNOMED
    250908004
    women of childbearing potential must have a negative pregnancy test
    Beskrivning

    negative pregnancy test

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0427780 (Pregnancy test negative)
    SNOMED
    250425007
    no uncontrolled psychiatric illness that the principal investigator feels will compromise obtaining informed consent from a patient
    Beskrivning

    psychiatric illness

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    patient must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines; patients who do not provide informed consent will not be eligible for the study
    Beskrivning

    informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    any coexisting medical condition or medications precluding full compliance with any of the arms of the study
    Beskrivning

    Protocol Compliance

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058 (Protocol Compliance)
    UMLS CUI [1,2]
    C0009488 (Comorbidity)
    allergies to any investigational drugs and/or to the chemotherapeutic agents
    Beskrivning

    allergies to any investigational drugs

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0729502 (Chemotherapeutic agent)
    allergies to any non-steroidal anti-inflammatory drugs (nsaids)/salicylates (e.g., aspirin)
    Beskrivning

    allergies to any non-steroidal anti-inflammatory drugs

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0003211 (Anti-Inflammatory Agents, Non-Steroidal)
    SNOMED
    16403005
    endoscopically documented upper or lower gastrointestinal (gi) related hemorrhage within last 6 months; also, patients with a clinical diagnosis of gi bleeding requiring blood transfusions will be excluded
    Beskrivning

    gastrointestinal hemorrhage

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0017181 (Gastrointestinal Hemorrhage)
    SNOMED
    74474003
    LOINC
    LP209002-7

    Similar models

    Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT02144675

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    aml
    Item
    patients must have a diagnosis of non-m3 aml (patients with m3 subtype are excluded); determination of the presence of cytogenetic abnormalities will be by standard cytogenetics +/- fluorescent-in-situ (fish) studies; additional molecular analyses for nucleophosmin (npm) mutation and fms-related tyrosine kinase 3 (flt3) internal tandem duplication will be obtained as a part of standard care by institutional procedures
    boolean
    C0023467 (UMLS CUI [1])
    leukemic blast count
    Item
    leukemic blast count > 1500/mm^3 of peripheral blood
    boolean
    C2697913 (UMLS CUI [1])
    eastern cooperative oncology group (ecog) performance status
    Item
    patients must have an eastern cooperative oncology group (ecog) performance status =< 3
    boolean
    C1520224 (UMLS CUI [1])
    total bilirubin
    Item
    total bilirubin < 2 times the institutional upper limit of normal (uln)
    boolean
    C0201913 (UMLS CUI [1])
    aspartate aminotransferase
    Item
    aspartate aminotransferase (ast) (serum glutamic oxaloacetic transaminase [sgot]) < 3 times the institutional uln
    boolean
    C0201899 (UMLS CUI [1])
    serum creatinine
    Item
    serum creatinine < 1.5 times the institutional uln
    boolean
    C0201976 (UMLS CUI [1])
    Left ventricular ejection fraction
    Item
    multi gated acquisition scan (muga) or echocardiogram with left ventricular ejection fraction (lvef) > 50%
    boolean
    C0428772 (UMLS CUI [1])
    negative pregnancy test
    Item
    women of childbearing potential must have a negative pregnancy test
    boolean
    C0427780 (UMLS CUI [1])
    psychiatric illness
    Item
    no uncontrolled psychiatric illness that the principal investigator feels will compromise obtaining informed consent from a patient
    boolean
    C0004936 (UMLS CUI [1])
    informed consent
    Item
    patient must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines; patients who do not provide informed consent will not be eligible for the study
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Protocol Compliance
    Item
    any coexisting medical condition or medications precluding full compliance with any of the arms of the study
    boolean
    C0525058 (UMLS CUI [1,1])
    C0009488 (UMLS CUI [1,2])
    allergies to any investigational drugs
    Item
    allergies to any investigational drugs and/or to the chemotherapeutic agents
    boolean
    C0020517 (UMLS CUI [1,1])
    C0729502 (UMLS CUI [1,2])
    allergies to any non-steroidal anti-inflammatory drugs
    Item
    allergies to any non-steroidal anti-inflammatory drugs (nsaids)/salicylates (e.g., aspirin)
    boolean
    C0020517 (UMLS CUI [1,1])
    C0003211 (UMLS CUI [1,2])
    gastrointestinal hemorrhage
    Item
    endoscopically documented upper or lower gastrointestinal (gi) related hemorrhage within last 6 months; also, patients with a clinical diagnosis of gi bleeding requiring blood transfusions will be excluded
    boolean
    C0017181 (UMLS CUI [1])

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