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ID

16897

Description

Clozapine and Olanzapine Treatment of Aggression; ODM derived from: https://clinicaltrials.gov/show/NCT01123408

Lien

https://clinicaltrials.gov/show/NCT01123408

Mots-clés

  1. 13/08/2016 13/08/2016 -
Téléchargé le

13 août 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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    Eligibility Schizophrenia NCT01123408

    Eligibility Schizophrenia NCT01123408

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    age: 18 to 60 years.
    Description

    Age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    diagnosis of schizophrenia or schizoaffective disorder.
    Description

    Schizophrenia or schizoaffective disorder

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0036341 (Schizophrenia)
    SNOMED
    58214004
    LOINC
    MTHU020814
    UMLS CUI [2]
    C0036337 (Schizoaffective Disorder)
    SNOMED
    191567000
    aggression: one episode of physical assault directed at another person in the hospital and persistence of violence/hostility for two weeks, as evidenced by the presence of some other physical, verbal or property assault or hostility, which would result in a score of 4 or more on the positive and negative syndrome scale (panss) hostility item.
    Description

    Aggression and PANSS

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001807 (Aggressive behavior)
    SNOMED
    61372001
    LOINC
    LA30507-0
    UMLS CUI [2]
    C0451383 (Positive and negative syndrome scale)
    SNOMED
    273703003
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    patients who were hospitalized for more than a year
    Description

    Hospitalization

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    patients who had a history of nonresponse to clozapine, olanzapine or haloperidol (defined as a lack of improvement despite a contiguous adequate trial of medication)
    Description

    Nonresponse to clozapine, olanzapine or haloperidol

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C3845351 (Patient nonresponsive)
    LOINC
    LA6335-9
    UMLS CUI [1,2]
    C0009079 (clozapine)
    SNOMED
    96221003
    UMLS CUI [2,1]
    C3845351 (Patient nonresponsive)
    LOINC
    LA6335-9
    UMLS CUI [2,2]
    C0171023 (olanzapine)
    SNOMED
    108441004
    UMLS CUI [3,1]
    C3845351 (Patient nonresponsive)
    LOINC
    LA6335-9
    UMLS CUI [3,2]
    C0018546 (haloperidol)
    SNOMED
    10756001
    patients who had a history of clozapine, olanzapine, or haloperidol intolerance
    Description

    Intolerance to clozapine, olanzapine, or haloperidol

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1744706 (intolerance to substance)
    SNOMED
    782197009
    UMLS CUI [1,2]
    C0009079 (clozapine)
    SNOMED
    96221003
    UMLS CUI [2,1]
    C1744706 (intolerance to substance)
    SNOMED
    782197009
    UMLS CUI [2,2]
    C0171023 (olanzapine)
    SNOMED
    108441004
    UMLS CUI [3,1]
    C1744706 (intolerance to substance)
    SNOMED
    782197009
    UMLS CUI [3,2]
    C0018546 (haloperidol)
    SNOMED
    10756001
    patients who had medical conditions that would be adversely affected by any of these three medications.
    Description

    Comorbidity

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
    patients who received a depot antipsychotic within 30 days before randomization.
    Description

    Depot antipsychotic medication

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2585377 (Injection of depot antipsychotic agent)
    SNOMED
    440701009

    Similar models

    Eligibility Schizophrenia NCT01123408

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    age: 18 to 60 years.
    boolean
    C0001779 (UMLS CUI [1])
    Schizophrenia or schizoaffective disorder
    Item
    diagnosis of schizophrenia or schizoaffective disorder.
    boolean
    C0036341 (UMLS CUI [1])
    C0036337 (UMLS CUI [2])
    Aggression and PANSS
    Item
    aggression: one episode of physical assault directed at another person in the hospital and persistence of violence/hostility for two weeks, as evidenced by the presence of some other physical, verbal or property assault or hostility, which would result in a score of 4 or more on the positive and negative syndrome scale (panss) hostility item.
    boolean
    C0001807 (UMLS CUI [1])
    C0451383 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Hospitalization
    Item
    patients who were hospitalized for more than a year
    boolean
    C0019993 (UMLS CUI [1])
    Nonresponse to clozapine, olanzapine or haloperidol
    Item
    patients who had a history of nonresponse to clozapine, olanzapine or haloperidol (defined as a lack of improvement despite a contiguous adequate trial of medication)
    boolean
    C3845351 (UMLS CUI [1,1])
    C0009079 (UMLS CUI [1,2])
    C3845351 (UMLS CUI [2,1])
    C0171023 (UMLS CUI [2,2])
    C3845351 (UMLS CUI [3,1])
    C0018546 (UMLS CUI [3,2])
    Intolerance to clozapine, olanzapine, or haloperidol
    Item
    patients who had a history of clozapine, olanzapine, or haloperidol intolerance
    boolean
    C1744706 (UMLS CUI [1,1])
    C0009079 (UMLS CUI [1,2])
    C1744706 (UMLS CUI [2,1])
    C0171023 (UMLS CUI [2,2])
    C1744706 (UMLS CUI [3,1])
    C0018546 (UMLS CUI [3,2])
    Comorbidity
    Item
    patients who had medical conditions that would be adversely affected by any of these three medications.
    boolean
    C0009488 (UMLS CUI [1])
    Depot antipsychotic medication
    Item
    patients who received a depot antipsychotic within 30 days before randomization.
    boolean
    C2585377 (UMLS CUI [1])

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