ID

14235

Beschrijving

Low-Dose Opiate Therapy for Discomfort in Dementia (L-DOT); ODM derived from: https://clinicaltrials.gov/show/NCT00385684

Link

https://clinicaltrials.gov/show/NCT00385684

Trefwoorden

  1. 05-04-16 05-04-16 -
Geüploaded op

5 april 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Alzheimer Disease NCT00385684

    Eligibility Alzheimer Disease NCT00385684

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    55 years of age or older;
    Beschrijving

    age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    must have a diagnosis of dementia;
    Beschrijving

    dementia

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0497327
    advanced stage of dementia demonstrated by a score of 6 or greater on the functional assessment staging (fast) scale;
    Beschrijving

    dementia stage

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0743034
    unable to report pain in a reliable and consistent manner;
    Beschrijving

    pain

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0030193
    have a painad score of at least 2 on two consecutive assessments (separated by at least two days) or an average painad score of at least 2 on three consecutive assessments each separated by at least two days;
    Beschrijving

    painad score

    Datatype

    boolean

    the patient must have at least one medical condition associated with pain recorded on the cprs problem list.
    Beschrijving

    medical condition pain

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1405025
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    the existence of an effective analgesia treatment regimen;
    Beschrijving

    treatment regimen analgesia

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0040808
    UMLS CUI [1,2]
    C3202977
    pain treatment related to angina or pain judged to be related to angina;
    Beschrijving

    Pain management; pain angina

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0002766
    UMLS CUI [2,1]
    C0030193
    UMLS CUI [2,2]
    C0002962
    current pain treatment with opiates that cannot, in the opinion of the attending physician, be discontinued without placing the patient at risk for increased pain or opiate withdrawal;
    Beschrijving

    Compliance behavior pain therapy opiates

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0002766
    UMLS CUI [1,4]
    C0376196
    current pain treatment with tramadol that cannot, in the opinion of the attending physician, be discontinued;
    Beschrijving

    Pain management tramadol

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0002766
    UMLS CUI [1,2]
    C0040610
    presence of necessary drug therapy that is incompatible with or has potential for clinically significant drug interaction with either hydrocodone or acetaminophen;
    Beschrijving

    concomitant medication hydrocodone acetaminophen

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0020264
    UMLS CUI [1,3]
    C0000970
    a history of allergy, hypersensitivity, or intolerance to either hydrocodone or acetaminophen;
    Beschrijving

    hypersensitivity hydrocodone acetaminophen

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0020264
    UMLS CUI [1,3]
    C0000970
    constipation refractory to current treatment measures or a condition that would make constipation dangerous for the patient in the opinion of the attending physician;
    Beschrijving

    constipation

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009806
    the presence of liver disease, hepatic encephalopathy, or clinically significant elevation of liver function tests (lfts), as determined by the attending physician;
    Beschrijving

    liver disease; encephalopathy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023895
    UMLS CUI [2]
    C0085584
    the presence of renal failure, clinically significant renal insufficiency, or clinically significant elevations of serum bun or creatinine levels, as determined by the attending physician; or
    Beschrijving

    renal failure; serum creatinine levels

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1533077
    UMLS CUI [2]
    C0600061
    evidence, based on assessment by a geriatrician, that the apparent behavioral manifestations of discomfort are better explained by another problem (e.g., fever, infection, dehydration, delirium, psychosis)
    Beschrijving

    comorbidity infection fever; geriatrician

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C3714514
    UMLS CUI [1,3]
    C0015967
    UMLS CUI [2]
    C0586872

    Similar models

    Eligibility Alzheimer Disease NCT00385684

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    age
    Item
    55 years of age or older;
    boolean
    C0001779 (UMLS CUI [1])
    dementia
    Item
    must have a diagnosis of dementia;
    boolean
    C0497327 (UMLS CUI [1])
    dementia stage
    Item
    advanced stage of dementia demonstrated by a score of 6 or greater on the functional assessment staging (fast) scale;
    boolean
    C0743034 (UMLS CUI [1])
    pain
    Item
    unable to report pain in a reliable and consistent manner;
    boolean
    C0030193 (UMLS CUI [1])
    painad score
    Item
    have a painad score of at least 2 on two consecutive assessments (separated by at least two days) or an average painad score of at least 2 on three consecutive assessments each separated by at least two days;
    boolean
    medical condition pain
    Item
    the patient must have at least one medical condition associated with pain recorded on the cprs problem list.
    boolean
    C1405025 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    treatment regimen analgesia
    Item
    the existence of an effective analgesia treatment regimen;
    boolean
    C0040808 (UMLS CUI [1,1])
    C3202977 (UMLS CUI [1,2])
    Pain management; pain angina
    Item
    pain treatment related to angina or pain judged to be related to angina;
    boolean
    C0002766 (UMLS CUI [1])
    C0030193 (UMLS CUI [2,1])
    C0002962 (UMLS CUI [2,2])
    Compliance behavior pain therapy opiates
    Item
    current pain treatment with opiates that cannot, in the opinion of the attending physician, be discontinued without placing the patient at risk for increased pain or opiate withdrawal;
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0002766 (UMLS CUI [1,3])
    C0376196 (UMLS CUI [1,4])
    Pain management tramadol
    Item
    current pain treatment with tramadol that cannot, in the opinion of the attending physician, be discontinued;
    boolean
    C0002766 (UMLS CUI [1,1])
    C0040610 (UMLS CUI [1,2])
    concomitant medication hydrocodone acetaminophen
    Item
    presence of necessary drug therapy that is incompatible with or has potential for clinically significant drug interaction with either hydrocodone or acetaminophen;
    boolean
    C2347852 (UMLS CUI [1,1])
    C0020264 (UMLS CUI [1,2])
    C0000970 (UMLS CUI [1,3])
    hypersensitivity hydrocodone acetaminophen
    Item
    a history of allergy, hypersensitivity, or intolerance to either hydrocodone or acetaminophen;
    boolean
    C0020517 (UMLS CUI [1,1])
    C0020264 (UMLS CUI [1,2])
    C0000970 (UMLS CUI [1,3])
    constipation
    Item
    constipation refractory to current treatment measures or a condition that would make constipation dangerous for the patient in the opinion of the attending physician;
    boolean
    C0009806 (UMLS CUI [1])
    liver disease; encephalopathy
    Item
    the presence of liver disease, hepatic encephalopathy, or clinically significant elevation of liver function tests (lfts), as determined by the attending physician;
    boolean
    C0023895 (UMLS CUI [1])
    C0085584 (UMLS CUI [2])
    renal failure; serum creatinine levels
    Item
    the presence of renal failure, clinically significant renal insufficiency, or clinically significant elevations of serum bun or creatinine levels, as determined by the attending physician; or
    boolean
    C1533077 (UMLS CUI [1])
    C0600061 (UMLS CUI [2])
    comorbidity infection fever; geriatrician
    Item
    evidence, based on assessment by a geriatrician, that the apparent behavioral manifestations of discomfort are better explained by another problem (e.g., fever, infection, dehydration, delirium, psychosis)
    boolean
    C0009488 (UMLS CUI [1,1])
    C3714514 (UMLS CUI [1,2])
    C0015967 (UMLS CUI [1,3])
    C0586872 (UMLS CUI [2])

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