0 Bedömningar

ID

18688

Beskrivning

A Single-Blind Placebo Run-in Study of Duloxetine for Activity-Limiting Osteoarthritis Pain; ODM derived from: https://clinicaltrials.gov/show/NCT00609557

Länk

https://clinicaltrials.gov/show/NCT00609557

Nyckelord

  1. 2016-11-16 2016-11-16 -
Uppladdad den

16 november 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :


    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

    Eligibility Osteoarthritis NCT00609557

    Eligibility Osteoarthritis NCT00609557

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    age 50-80
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    physician diagnosis of oa in hip, knee or spine.
    Beskrivning

    Osteoarthritis of hip | Osteoarthritis, Knee | Osteoarthritis, Spine

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0029410
    UMLS CUI [2]
    C0409959
    UMLS CUI [3]
    C2350242
    significant activity limitation due to pain for at least one month on the western ontario and mcmasters university osteoarthritis index (womac) and average pain >5/10 on brief pain inventory despite adequate treatment with acetaminophen or nsaids. [this will identify an oa group with significant psychological distress and a desire for treatment.]
    Beskrivning

    Activity Limitation Significant Due to Pain | WOMAC osteoarthritis index | BPI - Pain on the Average | Acetaminophen | Anti-Inflammatory Agents, Non-Steroidal | Psychological distress Significant

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0026606
    UMLS CUI [1,2]
    C0449295
    UMLS CUI [1,3]
    C0750502
    UMLS CUI [1,4]
    C0678226
    UMLS CUI [1,5]
    C0030193
    UMLS CUI [2]
    C3472647
    UMLS CUI [3]
    C3639289
    UMLS CUI [4]
    C0000970
    UMLS CUI [5]
    C0003211
    UMLS CUI [6,1]
    C0815107
    UMLS CUI [6,2]
    C0750502
    depression status is not restricted, but will be monitored with prime-md interview and the scl-20. we anticipate depressive symptoms will be common in this population due to the above requirement for activity limitation.
    Beskrivning

    Depressive disorder Status Restricted | PRIME-MD Interview Monitoring | Symptom checklist Depression scale | Depressive Symptoms

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0011581
    UMLS CUI [1,2]
    C0449438
    UMLS CUI [1,3]
    C0443288
    UMLS CUI [2,1]
    C2982364
    UMLS CUI [2,2]
    C0683518
    UMLS CUI [2,3]
    C1516647
    UMLS CUI [3,1]
    C0451524
    UMLS CUI [3,2]
    C0679604
    UMLS CUI [4]
    C0086132
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    cannot read and write english
    Beskrivning

    Able to read English Language | Able to write English Language

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0586740
    UMLS CUI [1,2]
    C0376245
    UMLS CUI [2,1]
    C0584993
    UMLS CUI [2,2]
    C0376245
    significant cognitive impairment
    Beskrivning

    Impaired cognition Significant

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0338656
    UMLS CUI [1,2]
    C0750502
    history of psychosis or mania
    Beskrivning

    Psychotic Disorders | Manic Disorder

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0033975
    UMLS CUI [2]
    C0024713
    current suicidal ideation
    Beskrivning

    Feeling suicidal

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0424000
    current substance abuse or dependence
    Beskrivning

    Substance Use Disorders | Substance Dependence

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    UMLS CUI [2]
    C0038580
    current use of opioids or any antidepressant medication
    Beskrivning

    Opioids | Antidepressive Agents

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0242402
    UMLS CUI [2]
    C0003289
    use of investigational drug within the past month
    Beskrivning

    Investigational New Drugs

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0013230

    Similar models

    Eligibility Osteoarthritis NCT00609557

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    age 50-80
    boolean
    C0001779 (UMLS CUI [1])
    Osteoarthritis of hip | Osteoarthritis, Knee | Osteoarthritis, Spine
    Item
    physician diagnosis of oa in hip, knee or spine.
    boolean
    C0029410 (UMLS CUI [1])
    C0409959 (UMLS CUI [2])
    C2350242 (UMLS CUI [3])
    Activity Limitation Significant Due to Pain | WOMAC osteoarthritis index | BPI - Pain on the Average | Acetaminophen | Anti-Inflammatory Agents, Non-Steroidal | Psychological distress Significant
    Item
    significant activity limitation due to pain for at least one month on the western ontario and mcmasters university osteoarthritis index (womac) and average pain >5/10 on brief pain inventory despite adequate treatment with acetaminophen or nsaids. [this will identify an oa group with significant psychological distress and a desire for treatment.]
    boolean
    C0026606 (UMLS CUI [1,1])
    C0449295 (UMLS CUI [1,2])
    C0750502 (UMLS CUI [1,3])
    C0678226 (UMLS CUI [1,4])
    C0030193 (UMLS CUI [1,5])
    C3472647 (UMLS CUI [2])
    C3639289 (UMLS CUI [3])
    C0000970 (UMLS CUI [4])
    C0003211 (UMLS CUI [5])
    C0815107 (UMLS CUI [6,1])
    C0750502 (UMLS CUI [6,2])
    Depressive disorder Status Restricted | PRIME-MD Interview Monitoring | Symptom checklist Depression scale | Depressive Symptoms
    Item
    depression status is not restricted, but will be monitored with prime-md interview and the scl-20. we anticipate depressive symptoms will be common in this population due to the above requirement for activity limitation.
    boolean
    C0011581 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    C0443288 (UMLS CUI [1,3])
    C2982364 (UMLS CUI [2,1])
    C0683518 (UMLS CUI [2,2])
    C1516647 (UMLS CUI [2,3])
    C0451524 (UMLS CUI [3,1])
    C0679604 (UMLS CUI [3,2])
    C0086132 (UMLS CUI [4])
    Item Group
    C0680251 (UMLS CUI)
    Able to read English Language | Able to write English Language
    Item
    cannot read and write english
    boolean
    C0586740 (UMLS CUI [1,1])
    C0376245 (UMLS CUI [1,2])
    C0584993 (UMLS CUI [2,1])
    C0376245 (UMLS CUI [2,2])
    Impaired cognition Significant
    Item
    significant cognitive impairment
    boolean
    C0338656 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    Psychotic Disorders | Manic Disorder
    Item
    history of psychosis or mania
    boolean
    C0033975 (UMLS CUI [1])
    C0024713 (UMLS CUI [2])
    Feeling suicidal
    Item
    current suicidal ideation
    boolean
    C0424000 (UMLS CUI [1])
    Substance Use Disorders | Substance Dependence
    Item
    current substance abuse or dependence
    boolean
    C0038586 (UMLS CUI [1])
    C0038580 (UMLS CUI [2])
    Opioids | Antidepressive Agents
    Item
    current use of opioids or any antidepressant medication
    boolean
    C0242402 (UMLS CUI [1])
    C0003289 (UMLS CUI [2])
    Investigational New Drugs
    Item
    use of investigational drug within the past month
    boolean
    C0013230 (UMLS CUI [1])

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial