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ID

4280

Descrizione

ODM derived from http://clinicaltrials.gov/show/NCT00729235

collegamento

http://clinicaltrials.gov/show/NCT00729235

Keywords

versioni (3)
  1. 06/12/13 06/12/13 - Martin Dugas
  2. 16/04/14 16/04/14 - Julian Varghese
  3. 20/09/21 20/09/21 -
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6 dicembre 2013

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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    Eligibility NCT00729235 Biventricular Tachycardias

    Tedesco Inglese

    Eligibility

    1 moduli  
    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Descrizione

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202
    Alter mindestens 18 Jahre
    Descrizione

    age at least 18 Years

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Biventricular Tachycardias
    Descrizione

    Biventricular Tachycardias

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0042514
    SNOMED CT 2011_0131
    25569003
    MedDRA 14.1
    10047302
    ICD-10-CM Version 2010
    I47.2
    CTCAE 1105E
    E10239
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    Patient has been prescribed the implantation or replacement of a CRT-ICD system accordingly to the relevant currently-approved ACC/AHA15 (August 2005, Appendix § M.10) or ESC 16 (Update 2005, Appendix § M.11) guidelines or any relevant currently-approved local guidelines for the implantation or replacement of CRT-ICD.
    Descrizione

    Patient has been prescribed the implantation or replacement of a CRT-ICD system accordingly to the relevant currently-approved ACC/AHA15 (August 2005, Appendix § M.10) or ESC 16 (Update 2005, Appendix § M.11) guidelines or any relevant currently-approved local guidelines for the implantation or replacement of CRT-ICD.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0033080
    SNOMED CT 2011_0131
    16076005
    UMLS CUI 2011AA
    C0021107
    SNOMED CT 2011_0131
    71861002
    LOINC Version 232
    MTHU035917
    UMLS CUI 2011AA
    C0559956
    SNOMED CT 2011_0131
    282089006
    UMLS CUI 2011AA
    C2936377
    UMLS CUI 2011AA
    C0162589
    SNOMED CT 2011_0131
    72506001
    UMLS CUI 2011AA
    C0680240
    UMLS CUI 2011AA
    C0205540
    SNOMED CT 2011_0131
    9571008
    UMLS CUI 2011AA
    C0220845
    Patient's Signature on Informed Consent Form
    Descrizione

    Patient has signed a consent form after he/she received the appropriate and mandatory information.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C2348583
    Ausschlusskriterien
    Descrizione

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    Clinical history of symptomatic or not symptomatic slow VT
    Descrizione

    Clinical history of symptomatic or not symptomatic slow VT

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0078888
    SNOMED CT 2011_0131
    61277005
    MedDRA 14.1
    10049003
    permanentes Vorhofflimmern
    Descrizione

    Permanent Atrial Fibrillation (AF)

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C2586056
    SNOMED CT 2011_0131
    440028005
    MedDRA 14.1
    10071668
    Any contraindication to the implant or replacement of CRT-ICD
    Descrizione

    Any contraindication to the implant or replacement of CRT-ICD

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C1301624
    SNOMED CT 2011_0131
    397745006
    UMLS CUI 2011AA
    C0021107
    SNOMED CT 2011_0131
    71861002
    LOINC Version 232
    MTHU035917
    UMLS CUI 2011AA
    C0559956
    SNOMED CT 2011_0131
    282089006
    UMLS CUI 2011AA
    C2936377
    UMLS CUI 2011AA
    C0162589
    SNOMED CT 2011_0131
    72506001
    Pt is unable to attend the scheduled f-up visits at the implanting Centre
    Descrizione

    Pt is unable to attend the scheduled f-up visits at the implanting Centre

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    UMLS CUI 2011AA
    C1299582
    SNOMED CT 2011_0131
    371151008
    UMLS CUI 2011AA
    C1321605
    SNOMED CT 2011_0131
    405078008
    UMLS CUI 2011AA
    C0086960
    UMLS CUI 2011AA
    C0589121
    SNOMED CT 2011_0131
    185389009
    Pt is already included in another ongoing clinical study
    Descrizione

    Pt is already included in another ongoing clinical study

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0679823
    HL7 V3 2006_05
    PART
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0750536
    UMLS CUI 2011AA
    C0008972
    Pt is unable to understand the objectives of the ITAC04 study
    Descrizione

    Pt is unable to understand the objectives of the ITAC04 study

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C1299582
    SNOMED CT 2011_0131
    371151008
    UMLS CUI 2011AA
    C0162340
    SNOMED CT 2011_0131
    66216009
    UMLS CUI 2011AA
    C0681832
    Pt refuses to cooperate
    Descrizione

    Pt refuses to cooperate

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0392337
    UMLS CUI 2011AA
    C2733540
    SNOMED CT 2011_0131
    443390004
    Pt is unable or refuses to provide informed consent
    Descrizione

    Pt is unable or refuses to provide informed consent

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C1299582
    SNOMED CT 2011_0131
    371151008
    UMLS CUI 2011AA
    C2733540
    SNOMED CT 2011_0131
    443390004
    UMLS CUI 2011AA
    C0184704
    SNOMED CT 2011_0131
    55149002
    Minderjähriger
    Descrizione

    Pt is minor (less than 18-year old)

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0026193
    SNOMED CT 2011_0131
    410599005
    Pt has life expectancy of less than 1 year
    Descrizione

    Pt has life expectancy of less than 1 year

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0023671
    LOINC Version 232
    LP75025-4
    UMLS CUI 2011AA
    C0439092
    SNOMED CT 2011_0131
    276139006
    HL7 V3 2006_05
    LT
    UMLS CUI 2011AA
    C0205447
    SNOMED CT 2011_0131
    38112003
    UMLS CUI 2011AA
    C0439234
    SNOMED CT 2011_0131
    258707000
    HL7 V3 2006_05
    Y
    Pt is pregnant.
    Descrizione

    Pt is pregnant.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    UMLS CUI 2011AA
    C0549206
    MedDRA 14.1
    10036586
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    Similar models

    Eligibility

    1 moduli
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Einschlusskriterien
    CL425202 (UMLS CUI 2011AA)
    age at least 18 Years
    Item
    Alter mindestens 18 Jahre
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Biventricular Tachycardias
    Item
    Biventricular Tachycardias
    boolean
    C0042514 (UMLS CUI 2011AA)
    25569003 (SNOMED CT 2011_0131)
    10047302 (MedDRA 14.1)
    I47.2 (ICD-10-CM Version 2010)
    E10239 (CTCAE 1105E)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    Patient has been prescribed the implantation or replacement of a CRT-ICD system accordingly to the relevant currently-approved ACC/AHA15 (August 2005, Appendix § M.10) or ESC 16 (Update 2005, Appendix § M.11) guidelines or any relevant currently-approved local guidelines for the implantation or replacement of CRT-ICD.
    Item
    Patient has been prescribed the implantation or replacement of a CRT-ICD system accordingly to the relevant currently-approved ACC/AHA15 (August 2005, Appendix § M.10) or ESC 16 (Update 2005, Appendix § M.11) guidelines or any relevant currently-approved local guidelines for the implantation or replacement of CRT-ICD.
    boolean
    C0033080 (UMLS CUI 2011AA)
    16076005 (SNOMED CT 2011_0131)
    C0021107 (UMLS CUI 2011AA)
    71861002 (SNOMED CT 2011_0131)
    MTHU035917 (LOINC Version 232)
    C0559956 (UMLS CUI 2011AA)
    282089006 (SNOMED CT 2011_0131)
    C2936377 (UMLS CUI 2011AA)
    C0162589 (UMLS CUI 2011AA)
    72506001 (SNOMED CT 2011_0131)
    C0680240 (UMLS CUI 2011AA)
    C0205540 (UMLS CUI 2011AA)
    9571008 (SNOMED CT 2011_0131)
    C0220845 (UMLS CUI 2011AA)
    Patient has signed a consent form after he/she received the appropriate and mandatory information.
    Item
    Patient's Signature on Informed Consent Form
    boolean
    C2348583 (UMLS CUI 2011AA)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    Clinical history of symptomatic or not symptomatic slow VT
    Item
    Clinical history of symptomatic or not symptomatic slow VT
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0078888 (UMLS CUI 2011AA)
    61277005 (SNOMED CT 2011_0131)
    10049003 (MedDRA 14.1)
    Permanent Atrial Fibrillation (AF)
    Item
    permanentes Vorhofflimmern
    boolean
    C2586056 (UMLS CUI 2011AA)
    440028005 (SNOMED CT 2011_0131)
    10071668 (MedDRA 14.1)
    Any contraindication to the implant or replacement of CRT-ICD
    Item
    Any contraindication to the implant or replacement of CRT-ICD
    boolean
    C1301624 (UMLS CUI 2011AA)
    397745006 (SNOMED CT 2011_0131)
    C0021107 (UMLS CUI 2011AA)
    71861002 (SNOMED CT 2011_0131)
    MTHU035917 (LOINC Version 232)
    C0559956 (UMLS CUI 2011AA)
    282089006 (SNOMED CT 2011_0131)
    C2936377 (UMLS CUI 2011AA)
    C0162589 (UMLS CUI 2011AA)
    72506001 (SNOMED CT 2011_0131)
    Pt is unable to attend the scheduled f-up visits at the implanting Centre
    Item
    Pt is unable to attend the scheduled f-up visits at the implanting Centre
    boolean
    C0030705 (UMLS CUI 2011AA)
    116154003 (SNOMED CT 2011_0131)
    C1299582 (UMLS CUI 2011AA)
    371151008 (SNOMED CT 2011_0131)
    C1321605 (UMLS CUI 2011AA)
    405078008 (SNOMED CT 2011_0131)
    C0086960 (UMLS CUI 2011AA)
    C0589121 (UMLS CUI 2011AA)
    185389009 (SNOMED CT 2011_0131)
    Pt is already included in another ongoing clinical study
    Item
    Pt is already included in another ongoing clinical study
    boolean
    C0679823 (UMLS CUI 2011AA)
    PART (HL7 V3 2006_05)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0750536 (UMLS CUI 2011AA)
    C0008972 (UMLS CUI 2011AA)
    Pt is unable to understand the objectives of the ITAC04 study
    Item
    Pt is unable to understand the objectives of the ITAC04 study
    boolean
    C1299582 (UMLS CUI 2011AA)
    371151008 (SNOMED CT 2011_0131)
    C0162340 (UMLS CUI 2011AA)
    66216009 (SNOMED CT 2011_0131)
    C0681832 (UMLS CUI 2011AA)
    Pt refuses to cooperate
    Item
    Pt refuses to cooperate
    boolean
    C0392337 (UMLS CUI 2011AA)
    C2733540 (UMLS CUI 2011AA)
    443390004 (SNOMED CT 2011_0131)
    Pt is unable or refuses to provide informed consent
    Item
    Pt is unable or refuses to provide informed consent
    boolean
    C1299582 (UMLS CUI 2011AA)
    371151008 (SNOMED CT 2011_0131)
    C2733540 (UMLS CUI 2011AA)
    443390004 (SNOMED CT 2011_0131)
    C0184704 (UMLS CUI 2011AA)
    55149002 (SNOMED CT 2011_0131)
    Pt is minor (less than 18-year old)
    Item
    Minderjähriger
    boolean
    C0026193 (UMLS CUI 2011AA)
    410599005 (SNOMED CT 2011_0131)
    Pt has life expectancy of less than 1 year
    Item
    Pt has life expectancy of less than 1 year
    boolean
    C0023671 (UMLS CUI 2011AA)
    LP75025-4 (LOINC Version 232)
    C0439092 (UMLS CUI 2011AA)
    276139006 (SNOMED CT 2011_0131)
    LT (HL7 V3 2006_05)
    C0205447 (UMLS CUI 2011AA)
    38112003 (SNOMED CT 2011_0131)
    C0439234 (UMLS CUI 2011AA)
    258707000 (SNOMED CT 2011_0131)
    Y (HL7 V3 2006_05)
    Pt is pregnant.
    Item
    Pt is pregnant.
    boolean
    C0030705 (UMLS CUI 2011AA)
    116154003 (SNOMED CT 2011_0131)
    C0549206 (UMLS CUI 2011AA)
    10036586 (MedDRA 14.1)
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