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ID

4441

Description

ODM derived from http://clinicaltrials.gov/show/NCT00684619

Link

http://clinicaltrials.gov/show/NCT00684619

Keywords

Versions (1)
  1. 12/9/13 12/9/13 - Martin Dugas
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December 9, 2013

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Creative Commons BY 4.0
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    Eligibility NCT00684619 T-ALL, T-NHL (Lymphoblastic)

    German English

    Eligibility

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425202
    age at least 18 Years
    Description

    age at least 18 Years

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    T-ALL, T-NHL
    Description

    T-ALL, T-NHL

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1961099
    SNOMED CT 2011_0131
    277575008
    MedDRA 14.1
    10042987
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0079772
    SNOMED CT 2011_0131
    109978004
    MedDRA 14.1
    10042971
    cytological treatment failure / relapse
    Description

    cytological treatment failure / relapse

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205471
    SNOMED CT 2011_0131
    40413002
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0231174
    SNOMED CT 2011_0131
    76797004
    UMLS CUI 2011AA
    C0277556
    SNOMED CT 2011_0131
    58184002
    molecular treatment failure / relapse
    Description

    molecular treatment failure / relapse

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    CL414625
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0231174
    SNOMED CT 2011_0131
    76797004
    UMLS CUI 2011AA
    C0277556
    SNOMED CT 2011_0131
    58184002
    no promising therapy alternatives with approved medication available
    Description

    no promising therapy alternatives with approved medication available

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1555307
    HL7 V3 2006_05
    PRMS
    UMLS CUI 2011AA
    C0554849
    SNOMED CT 2011_0131
    309846006
    UMLS CUI 2011AA
    C1523987
    UMLS CUI 2011AA
    C1706842
    UMLS CUI 2011AA
    C0013227
    no CNS-manifestation, requiring intrathecal therapy or CNS-radiation
    Description

    no CNS-manifestation, requiring intrathecal therapy or CNS-radiation

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C1269563
    SNOMED CT 2011_0131
    278199004
    UMLS CUI 2011AA
    C0205319
    SNOMED CT 2011_0131
    250255003
    UMLS CUI 2011AA
    C1514873
    UMLS CUI 2011AA
    C0205527
    SNOMED CT 2011_0131
    72607000
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C1269563
    SNOMED CT 2011_0131
    278199004
    UMLS CUI 2011AA
    C0851346
    SNOMED CT 2011_0131
    82107009
    LOINC Version 232
    MTHU026213
    no convulsive disease or neurotoxicity > grade III in patients history
    Description

    no convulsive disease or neurotoxicity > grade III in patients history

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0234972
    MedDRA 14.1
    10010924
    ICD-10-CM Version 2010
    R56.9
    UMLS CUI 2011AA
    C0235032
    SNOMED CT 2011_0131
    19466003
    MedDRA 14.1
    10029350
    UMLS CUI 2011AA
    CL384738
    UMLS CUI 2011AA
    C0450094
    UMLS CUI 2011AA
    C0679831
    LOINC Version 232
    MTHU016351
    written informed consent
    Description

    written informed consent

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1576874
    HL7 V3 2006_05
    WRITTEN
    UMLS CUI 2011AA
    C0021430
    no cytostatic therapy in the last 10 days
    Description

    no cytostatic therapy in the last 10 days

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0010858
    SNOMED CT 2011_0131
    373221003
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C1517741
    UMLS CUI 2011AA
    C0205456
    SNOMED CT 2011_0131
    3445001
    UMLS CUI 2011AA
    C0439228
    SNOMED CT 2011_0131
    258703001
    HL7 V3 2006_05
    D
    no pregnancy or breastfeeding
    Description

    no pregnancy or breastfeeding

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0032961
    SNOMED CT 2011_0131
    289908002
    MedDRA 14.1
    10036556
    LOINC Version 232
    MTHU035048
    UMLS CUI 2011AA
    C0006147
    MedDRA 14.1
    10006247
    Contraception, Birth control
    Description

    effective contraception

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0700589
    SNOMED CT 2011_0131
    146680009
    MedDRA 14.1
    10010808
    recovery of toxicities of previous chemotherapy - except leukemia-related changes like bone marrow suppression or pathological transaminases in liver manifestation
    Description

    recovery of toxicities of previous chemotherapy - except leukemia-related changes like bone marrow suppression or pathological transaminases in liver manifestation

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C2004454
    UMLS CUI 2011AA
    C0040539
    UMLS CUI 2011AA
    C1514457
    UMLS CUI 2011AA
    C1554961
    HL7 V3 2006_05
    E
    UMLS CUI 2011AA
    C0023418
    SNOMED CT 2011_0131
    93143009
    MedDRA 14.1
    10024288
    ICD-10-CM Version 2010
    C95.9
    ICD-9-CM Version 2011
    208.9
    UMLS CUI 2011AA
    C0445223
    SNOMED CT 2011_0131
    262094002
    UMLS CUI 2011AA
    C0392747
    SNOMED CT 2011_0131
    243326001
    UMLS CUI 2011AA
    C0280962
    UMLS CUI 2011AA
    C1521733
    SNOMED CT 2011_0131
    29458008
    UMLS CUI 2011AA
    C0002594
    SNOMED CT 2011_0131
    130093006
    UMLS CUI 2011AA
    C0023884
    SNOMED CT 2011_0131
    10200004
    LOINC Version 232
    MTHU002039
    UMLS CUI 2011AA
    C0205319
    SNOMED CT 2011_0131
    250255003
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425201
    Severe psychiatric illness
    Description

    Severe psychiatric illness

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205082
    SNOMED CT 2011_0131
    24484000
    UMLS CUI 2011AA
    C0004936
    SNOMED CT 2011_0131
    74732009
    MedDRA 14.1
    10037174
    ICD-10-CM Version 2010
    F99
    ICD-9-CM Version 2011
    290-319.99
    uncontrolled or severe cardiac disease or infection
    Description

    uncontrolled or severe cardiac disease or infection

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205318
    SNOMED CT 2011_0131
    19032002
    UMLS CUI 2011AA
    C0205082
    SNOMED CT 2011_0131
    24484000
    UMLS CUI 2011AA
    C0018799
    SNOMED CT 2011_0131
    56265001
    MedDRA 14.1
    10061024
    UMLS CUI 2011AA
    C1096253
    MedDRA 14.1
    10054212
    active secondary neoplasms - except skin cancer (no melanoma)
    Description

    active secondary neoplasms - except skin cancer (no melanoma)

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205177
    SNOMED CT 2011_0131
    55561003
    UMLS CUI 2011AA
    C2939419
    SNOMED CT 2011_0131
    128462008
    MedDRA 14.1
    10061289
    UMLS CUI 2011AA
    C1554961
    HL7 V3 2006_05
    E
    UMLS CUI 2011AA
    C0699893
    MedDRA 14.1
    10040810
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    Similar models

    Eligibility

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion Criteria
    CL425202 (UMLS CUI 2011AA)
    age at least 18 Years
    Item
    age at least 18 Years
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    T-ALL, T-NHL
    Item
    T-ALL, T-NHL
    boolean
    C1961099 (UMLS CUI 2011AA)
    277575008 (SNOMED CT 2011_0131)
    10042987 (MedDRA 14.1)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0079772 (UMLS CUI 2011AA)
    109978004 (SNOMED CT 2011_0131)
    10042971 (MedDRA 14.1)
    cytological treatment failure / relapse
    Item
    cytological treatment failure / relapse
    boolean
    C0205471 (UMLS CUI 2011AA)
    40413002 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    C0231174 (UMLS CUI 2011AA)
    76797004 (SNOMED CT 2011_0131)
    C0277556 (UMLS CUI 2011AA)
    58184002 (SNOMED CT 2011_0131)
    molecular treatment failure / relapse
    Item
    molecular treatment failure / relapse
    boolean
    CL414625 (UMLS CUI 2011AA)
    C0039798 (UMLS CUI 2011AA)
    C0231174 (UMLS CUI 2011AA)
    76797004 (SNOMED CT 2011_0131)
    C0277556 (UMLS CUI 2011AA)
    58184002 (SNOMED CT 2011_0131)
    no promising therapy alternatives with approved medication available
    Item
    no promising therapy alternatives with approved medication available
    boolean
    C1555307 (UMLS CUI 2011AA)
    PRMS (HL7 V3 2006_05)
    C0554849 (UMLS CUI 2011AA)
    309846006 (SNOMED CT 2011_0131)
    C1523987 (UMLS CUI 2011AA)
    C1706842 (UMLS CUI 2011AA)
    C0013227 (UMLS CUI 2011AA)
    no CNS-manifestation, requiring intrathecal therapy or CNS-radiation
    Item
    no CNS-manifestation, requiring intrathecal therapy or CNS-radiation
    boolean
    C1518422 (UMLS CUI 2011AA)
    C1269563 (UMLS CUI 2011AA)
    278199004 (SNOMED CT 2011_0131)
    C0205319 (UMLS CUI 2011AA)
    250255003 (SNOMED CT 2011_0131)
    C1514873 (UMLS CUI 2011AA)
    C0205527 (UMLS CUI 2011AA)
    72607000 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    C1269563 (UMLS CUI 2011AA)
    278199004 (SNOMED CT 2011_0131)
    C0851346 (UMLS CUI 2011AA)
    82107009 (SNOMED CT 2011_0131)
    MTHU026213 (LOINC Version 232)
    no convulsive disease or neurotoxicity > grade III in patients history
    Item
    no convulsive disease or neurotoxicity > grade III in patients history
    boolean
    C1518422 (UMLS CUI 2011AA)
    C0234972 (UMLS CUI 2011AA)
    10010924 (MedDRA 14.1)
    R56.9 (ICD-10-CM Version 2010)
    C0235032 (UMLS CUI 2011AA)
    19466003 (SNOMED CT 2011_0131)
    10029350 (MedDRA 14.1)
    CL384738 (UMLS CUI 2011AA)
    C0450094 (UMLS CUI 2011AA)
    C0679831 (UMLS CUI 2011AA)
    MTHU016351 (LOINC Version 232)
    written informed consent
    Item
    written informed consent
    boolean
    C1576874 (UMLS CUI 2011AA)
    WRITTEN (HL7 V3 2006_05)
    C0021430 (UMLS CUI 2011AA)
    no cytostatic therapy in the last 10 days
    Item
    no cytostatic therapy in the last 10 days
    boolean
    C1518422 (UMLS CUI 2011AA)
    C0010858 (UMLS CUI 2011AA)
    373221003 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    C1517741 (UMLS CUI 2011AA)
    C0205456 (UMLS CUI 2011AA)
    3445001 (SNOMED CT 2011_0131)
    C0439228 (UMLS CUI 2011AA)
    258703001 (SNOMED CT 2011_0131)
    D (HL7 V3 2006_05)
    no pregnancy or breastfeeding
    Item
    no pregnancy or breastfeeding
    boolean
    C1518422 (UMLS CUI 2011AA)
    C0032961 (UMLS CUI 2011AA)
    289908002 (SNOMED CT 2011_0131)
    10036556 (MedDRA 14.1)
    MTHU035048 (LOINC Version 232)
    C0006147 (UMLS CUI 2011AA)
    10006247 (MedDRA 14.1)
    effective contraception
    Item
    Contraception, Birth control
    boolean
    C0700589 (UMLS CUI 2011AA)
    146680009 (SNOMED CT 2011_0131)
    10010808 (MedDRA 14.1)
    recovery of toxicities of previous chemotherapy - except leukemia-related changes like bone marrow suppression or pathological transaminases in liver manifestation
    Item
    recovery of toxicities of previous chemotherapy - except leukemia-related changes like bone marrow suppression or pathological transaminases in liver manifestation
    boolean
    C2004454 (UMLS CUI 2011AA)
    C0040539 (UMLS CUI 2011AA)
    C1514457 (UMLS CUI 2011AA)
    C1554961 (UMLS CUI 2011AA)
    E (HL7 V3 2006_05)
    C0023418 (UMLS CUI 2011AA)
    93143009 (SNOMED CT 2011_0131)
    10024288 (MedDRA 14.1)
    C95.9 (ICD-10-CM Version 2010)
    208.9 (ICD-9-CM Version 2011)
    C0445223 (UMLS CUI 2011AA)
    262094002 (SNOMED CT 2011_0131)
    C0392747 (UMLS CUI 2011AA)
    243326001 (SNOMED CT 2011_0131)
    C0280962 (UMLS CUI 2011AA)
    C1521733 (UMLS CUI 2011AA)
    29458008 (SNOMED CT 2011_0131)
    C0002594 (UMLS CUI 2011AA)
    130093006 (SNOMED CT 2011_0131)
    C0023884 (UMLS CUI 2011AA)
    10200004 (SNOMED CT 2011_0131)
    MTHU002039 (LOINC Version 232)
    C0205319 (UMLS CUI 2011AA)
    250255003 (SNOMED CT 2011_0131)
    Item Group
    Exclusion Criteria
    CL425201 (UMLS CUI 2011AA)
    Severe psychiatric illness
    Item
    Severe psychiatric illness
    boolean
    C0205082 (UMLS CUI 2011AA)
    24484000 (SNOMED CT 2011_0131)
    C0004936 (UMLS CUI 2011AA)
    74732009 (SNOMED CT 2011_0131)
    10037174 (MedDRA 14.1)
    F99 (ICD-10-CM Version 2010)
    290-319.99 (ICD-9-CM Version 2011)
    uncontrolled or severe cardiac disease or infection
    Item
    uncontrolled or severe cardiac disease or infection
    boolean
    C0205318 (UMLS CUI 2011AA)
    19032002 (SNOMED CT 2011_0131)
    C0205082 (UMLS CUI 2011AA)
    24484000 (SNOMED CT 2011_0131)
    C0018799 (UMLS CUI 2011AA)
    56265001 (SNOMED CT 2011_0131)
    10061024 (MedDRA 14.1)
    C1096253 (UMLS CUI 2011AA)
    10054212 (MedDRA 14.1)
    active secondary neoplasms - except skin cancer (no melanoma)
    Item
    active secondary neoplasms - except skin cancer (no melanoma)
    boolean
    C0205177 (UMLS CUI 2011AA)
    55561003 (SNOMED CT 2011_0131)
    C2939419 (UMLS CUI 2011AA)
    128462008 (SNOMED CT 2011_0131)
    10061289 (MedDRA 14.1)
    C1554961 (UMLS CUI 2011AA)
    E (HL7 V3 2006_05)
    C0699893 (UMLS CUI 2011AA)
    10040810 (MedDRA 14.1)
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