0 Bedömningar

ID

4866

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT00214578

Länk

http://clinicaltrials.gov/show/NCT00214578

Nyckelord

  1. 2011-12-27 2011-12-27 -
  2. 2014-04-13 2014-04-13 - Julian Varghese
Uppladdad den

13 april 2014

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility NCT00214578 Schizophrenia

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alter 18 bis 65 Jahre
    Beskrivning

    Age

    Datatyp

    boolean

    In- or outpatients with schizophrenia, 18-65 years old, requiring a change in treatment due to insufficient efficacy or tolerability and giving signed informed consent.
    Beskrivning

    Schizophrenia requiring a change in treatment

    Datatyp

    boolean

    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Known diabetes mellitus, high HbA1c, fasting plasma glucose and/or high 2h glucose-OGTT
    Beskrivning

    Diabetes mellitus

    Datatyp

    boolean

    Previous use of atypicals (3 months) or other medications that might influence glucose metabolism
    Beskrivning

    Other medications

    Datatyp

    boolean

    Contraindications or non-responsiveness for any of the treatments or other safety issues
    Beskrivning

    Contraindications

    Datatyp

    boolean

    Expected non-compliance to treatment and/or study procedures
    Beskrivning

    Non-Compliance

    Datatyp

    boolean

    Medical Concepts
    Beskrivning

    Medical Concepts

    Alter
    Beskrivning

    Age

    Datatyp

    string

    Alias
    UMLS CUI
    C0001779
    SNOMED CT 2010_0731
    102518004
    Diagnose
    Beskrivning

    Diagnosis

    Datatyp

    string

    Alias
    UMLS CUI
    C0011900
    SNOMED CT 2010_0731
    439401001
    LOINC Version 232
    MTHU008876
    Schizophrenie
    Beskrivning

    Schizophrenia

    Datatyp

    string

    Alias
    UMLS CUI
    C0036341
    SNOMED CT 2010_0731
    58214004
    MedDRA 13.1
    10039626
    LOINC Version 232
    MTHU020814
    ICD-10-CM Version 2010
    F20
    ICD-9-CM Version 2011
    295
    Änderung der Therapie
    Beskrivning

    Treatment changed

    Datatyp

    string

    Alias
    UMLS CUI
    C2919691
    SNOMED CT 2010_0731
    445528004
    Effectiveness
    Beskrivning

    Efficacy

    Datatyp

    string

    Alias
    UMLS CUI
    C1280519
    SNOMED CT 2010_0731
    255403003
    Einverständniserklärung
    Beskrivning

    Informed Consent

    Datatyp

    string

    Alias
    UMLS CUI
    C0021430
    Diabetes mellitus
    Beskrivning

    Diabetes mellitus

    Datatyp

    string

    Alias
    UMLS CUI
    C0011849
    SNOMED CT 2010_0731
    191044006
    HbA1c
    Beskrivning

    Glycosylated hemoglobin A

    Datatyp

    string

    Alias
    UMLS CUI
    C0019018
    SNOMED CT 2010_0731
    33601001
    LOINC Version 232
    MTHU018890
    Oraler Glukose-Toleranztest
    Beskrivning

    Oral Glucose Tolerance

    Datatyp

    string

    Alias
    UMLS CUI
    C0029161
    Nüchternblutzucker im Plasma
    Beskrivning

    Plasma fasting glucose measurement

    Datatyp

    string

    Alias
    UMLS CUI
    C0583513
    SNOMED CT 2010_0731
    167096006
    Medikation
    Beskrivning

    Pharmaceutical Preparations

    Datatyp

    string

    Alias
    UMLS CUI
    C0013227
    Treatment noncompliance
    Beskrivning

    Treatment noncompliance

    Datatyp

    string

    Alias
    UMLS CUI
    C0376405
    MedDRA 13.1
    10049414

    Similar models

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Age
    Item
    Alter 18 bis 65 Jahre
    boolean
    Schizophrenia requiring a change in treatment
    Item
    In- or outpatients with schizophrenia, 18-65 years old, requiring a change in treatment due to insufficient efficacy or tolerability and giving signed informed consent.
    boolean
    Diabetes mellitus
    Item
    Known diabetes mellitus, high HbA1c, fasting plasma glucose and/or high 2h glucose-OGTT
    boolean
    Other medications
    Item
    Previous use of atypicals (3 months) or other medications that might influence glucose metabolism
    boolean
    Contraindications
    Item
    Contraindications or non-responsiveness for any of the treatments or other safety issues
    boolean
    Non-Compliance
    Item
    Expected non-compliance to treatment and/or study procedures
    boolean
    Age
    Item
    Alter
    string
    C0001779 (UMLS CUI)
    102518004 (SNOMED CT 2010_0731)
    Diagnosis
    Item
    Diagnose
    string
    C0011900 (UMLS CUI)
    439401001 (SNOMED CT 2010_0731)
    MTHU008876 (LOINC Version 232)
    Schizophrenia
    Item
    Schizophrenie
    string
    C0036341 (UMLS CUI)
    58214004 (SNOMED CT 2010_0731)
    10039626 (MedDRA 13.1)
    MTHU020814 (LOINC Version 232)
    F20 (ICD-10-CM Version 2010)
    295 (ICD-9-CM Version 2011)
    Treatment changed
    Item
    Änderung der Therapie
    string
    C2919691 (UMLS CUI)
    445528004 (SNOMED CT 2010_0731)
    Efficacy
    Item
    Effectiveness
    string
    C1280519 (UMLS CUI)
    255403003 (SNOMED CT 2010_0731)
    Informed Consent
    Item
    Einverständniserklärung
    string
    C0021430 (UMLS CUI)
    Diabetes mellitus
    Item
    Diabetes mellitus
    string
    C0011849 (UMLS CUI)
    191044006 (SNOMED CT 2010_0731)
    Glycosylated hemoglobin A
    Item
    HbA1c
    string
    C0019018 (UMLS CUI)
    33601001 (SNOMED CT 2010_0731)
    MTHU018890 (LOINC Version 232)
    Oral Glucose Tolerance
    Item
    Oraler Glukose-Toleranztest
    string
    C0029161 (UMLS CUI)
    Plasma fasting glucose measurement
    Item
    Nüchternblutzucker im Plasma
    string
    C0583513 (UMLS CUI)
    167096006 (SNOMED CT 2010_0731)
    Pharmaceutical Preparations
    Item
    Medikation
    string
    C0013227 (UMLS CUI)
    Treatment noncompliance
    Item
    Treatment noncompliance
    string
    C0376405 (UMLS CUI)
    10049414 (MedDRA 13.1)

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