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43316

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT01369342

Link

http://clinicaltrials.gov/show/NCT01369342

Stichworte

Versionen (2)
  1. 11.04.13 11.04.13 - Martin Dugas
  2. 20.09.21 20.09.21 -
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20. September 2021

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    Eligibility NCT01369342 Crohn's Disease

    Deutsch Englisch

    Eligibility

    1 Formulare  
    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    age at least 18 Years
    Beschreibung

    age at least 18 Years

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy
    Beschreibung

    Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0010346
    SNOMED CT 2011_0131
    34000006
    MedDRA 14.1
    10011401
    ICD-10-CM Version 2010
    K50.9
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0009319
    SNOMED CT 2011_0131
    64226004
    MedDRA 14.1
    10009887
    ICD-10-CM Version 2010
    K52.9
    CTCAE 1105E
    E10521
    UMLS CUI 2011AA
    C0020877
    SNOMED CT 2011_0131
    52457000
    MedDRA 14.1
    10021312
    ICD-10-CM Version 2010
    K52.9
    UMLS CUI 2011AA
    C0949272
    MedDRA 14.1
    10062647
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    C0043299
    SNOMED CT 2011_0131
    363680008
    ICD-9-CM Version 2011
    87
    UMLS CUI 2011AA
    C0344441
    MedDRA 14.1
    10062005
    LOINC Version 232
    MTHU010496
    UMLS CUI 2011AA
    C0014245
    SNOMED CT 2011_0131
    423827005
    MedDRA 14.1
    10014805
    LOINC Version 232
    MTHU008659
    Have active Crohn's disease, defined as a baseline Crohn Disease Activity Index (CDAI) score of >= 220 and <= 450, with confirmation of active inflammation
    Beschreibung

    Have active Crohn's disease, defined as a baseline Crohn Disease Activity Index (CDAI) score of >= 220 and <= 450, with confirmation of active inflammation

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205177
    SNOMED CT 2011_0131
    55561003
    UMLS CUI 2011AA
    C0010346
    SNOMED CT 2011_0131
    34000006
    MedDRA 14.1
    10011401
    ICD-10-CM Version 2010
    K50.9
    UMLS CUI 2011AA
    C1704788
    UMLS CUI 2011AA
    C1442488
    UMLS CUI 2011AA
    C0451071
    SNOMED CT 2011_0131
    273364009
    UMLS CUI 2011AA
    C0449820
    SNOMED CT 2011_0131
    246262008
    LOINC Version 232
    MTHU024701
    UMLS CUI 2011AA
    C0205177
    SNOMED CT 2011_0131
    55561003
    UMLS CUI 2011AA
    C0021368
    SNOMED CT 2011_0131
    23583003
    MedDRA 14.1
    10061218
    Has failed conventional therapy as demonstrated by having received corticosteroids and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is corticosteroid dependent or has had a history of corticosteroid dependency AND Has not previously demonstrated failure of or intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria
    Beschreibung

    Has failed conventional therapy as demonstrated by having received corticosteroids and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is corticosteroid dependent or has had a history of corticosteroid dependency AND Has not previously demonstrated failure of or intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0231175
    UMLS CUI 2011AA
    CL429695
    UMLS CUI 2011AA
    C0001617
    SNOMED CT 2011_0131
    79440004
    UMLS CUI 2011AA
    C1527392
    SNOMED CT 2011_0131
    108940007
    UMLS CUI 2011AA
    C0004482
    SNOMED CT 2011_0131
    372574004
    LOINC Version 232
    MTHU006794
    UMLS CUI 2011AA
    C0025677
    SNOMED CT 2011_0131
    387381009
    LOINC Version 232
    MTHU005020
    UMLS CUI 2011AA
    C0000618
    SNOMED CT 2011_0131
    386835005
    LOINC Version 232
    MTHU002562
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0162643
    MedDRA 14.1
    10066901
    UMLS CUI 2011AA
    C1456820
    SNOMED CT 2011_0131
    39525005
    LOINC Version 232
    MTHU004497
    UMLS CUI 2011AA
    C0243076
    UMLS CUI 2011AA
    C0666743
    SNOMED CT 2011_0131
    386891004
    LOINC Version 232
    MTHU018219
    UMLS CUI 2011AA
    C1122087
    SNOMED CT 2011_0131
    407317001
    UMLS CUI 2011AA
    C1172157
    SNOMED CT 2011_0131
    430307008
    Have screening laboratory test results within protocol-specified parameters
    Beschreibung

    Have screening laboratory test results within protocol-specified parameters

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1409616
    UMLS CUI 2011AA
    C0587081
    SNOMED CT 2011_0131
    118246004
    UMLS CUI 2011AA
    C0332285
    SNOMED CT 2011_0131
    18720000
    UMLS CUI 2011AA
    C2348563
    UMLS CUI 2011AA
    C0205369
    SNOMED CT 2011_0131
    69658003
    UMLS CUI 2011AA
    C0449381
    SNOMED CT 2011_0131
    252116004
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Patients who have had any kind of bowel resection within 6 months
    Beschreibung

    Patients who have had any kind of bowel resection within 6 months

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1514756
    UMLS CUI 2011AA
    CL407060
    UMLS CUI 2011AA
    C1706124
    UMLS CUI 2011AA
    C0741614
    MedDRA 14.1
    10067878
    Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent
    Beschreibung

    Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0549206
    MedDRA 14.1
    10036586
    UMLS CUI 2011AA
    C0032992
    SNOMED CT 2011_0131
    169565003
    UMLS CUI 2011AA
    C0025266
    SNOMED CT 2011_0131
    339947000
    UMLS CUI 2011AA
    C0043210
    SNOMED CT 2011_0131
    224526002
    Patients who have received infliximab, adalimumab or certolizumab pegol < = 8 weeks before the first administration of study drug
    Beschreibung

    Patients who have received infliximab, adalimumab or certolizumab pegol < = 8 weeks before the first administration of study drug

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1514756
    UMLS CUI 2011AA
    C0666743
    SNOMED CT 2011_0131
    386891004
    LOINC Version 232
    MTHU018219
    UMLS CUI 2011AA
    C1122087
    SNOMED CT 2011_0131
    407317001
    UMLS CUI 2011AA
    C1172157
    SNOMED CT 2011_0131
    430307008
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C1533734
    SNOMED CT 2011_0131
    416118004
    UMLS CUI 2011AA
    C0304229
    SNOMED CT 2011_0131
    902003
    Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug
    Beschreibung

    Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0009566
    SNOMED CT 2011_0131
    116223007
    LOINC Version 232
    MTHU008883
    UMLS CUI 2011AA
    C0010346
    SNOMED CT 2011_0131
    34000006
    MedDRA 14.1
    10011401
    ICD-10-CM Version 2010
    K50.9
    UMLS CUI 2011AA
    C1299586
    SNOMED CT 2011_0131
    52925006
    UMLS CUI 2011AA
    C1516048
    UMLS CUI 2011AA
    C0871261
    UMLS CUI 2011AA
    C0304229
    SNOMED CT 2011_0131
    902003
    Patients with a history of or ongoing chronic or recurrent infectious disease
    Beschreibung

    Patients with a history of or ongoing chronic or recurrent infectious disease

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0151317
    SNOMED CT 2011_0131
    177010002
    UMLS CUI 2011AA
    CL429630
    UMLS CUI 2011AA
    C0009450
    SNOMED CT 2011_0131
    40733004
    MedDRA 14.1
    10021881
    LOINC Version 232
    MTHU034915
    ICD-9-CM Version 2011
    136.9
    Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)
    Beschreibung

    Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205156
    SNOMED CT 2011_0131
    9130008
    UMLS CUI 2011AA
    C1514756
    UMLS CUI 2011AA
    C0005515
    UMLS CUI 2011AA
    C1521840
    UMLS CUI 2011AA
    C0123759
    SNOMED CT 2011_0131
    6411000
    LOINC Version 232
    MTHU003527
    UMLS CUI 2011AA
    C0963088
    UMLS CUI 2011AA
    C0332257
    SNOMED CT 2011_0131
    55919000
    UMLS CUI 2011AA
    C1608841
    SNOMED CT 2011_0131
    443644001
    UMLS CUI 2011AA
    C2744325
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    Ähnliche Modelle

    Eligibility

    1 Formulare
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Inclusion Criteria
    age at least 18 Years
    Item
    age at least 18 Years
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy
    Item
    Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy
    boolean
    C0010346 (UMLS CUI 2011AA)
    34000006 (SNOMED CT 2011_0131)
    10011401 (MedDRA 14.1)
    K50.9 (ICD-10-CM Version 2010)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0009319 (UMLS CUI 2011AA)
    64226004 (SNOMED CT 2011_0131)
    10009887 (MedDRA 14.1)
    K52.9 (ICD-10-CM Version 2010)
    E10521 (CTCAE 1105E)
    C0020877 (UMLS CUI 2011AA)
    52457000 (SNOMED CT 2011_0131)
    10021312 (MedDRA 14.1)
    K52.9 (ICD-10-CM Version 2010)
    C0949272 (UMLS CUI 2011AA)
    10062647 (MedDRA 14.1)
    C0750484 (UMLS CUI 2011AA)
    C0043299 (UMLS CUI 2011AA)
    363680008 (SNOMED CT 2011_0131)
    87 (ICD-9-CM Version 2011)
    C0344441 (UMLS CUI 2011AA)
    10062005 (MedDRA 14.1)
    MTHU010496 (LOINC Version 232)
    C0014245 (UMLS CUI 2011AA)
    423827005 (SNOMED CT 2011_0131)
    10014805 (MedDRA 14.1)
    MTHU008659 (LOINC Version 232)
    Have active Crohn's disease, defined as a baseline Crohn Disease Activity Index (CDAI) score of >= 220 and <= 450, with confirmation of active inflammation
    Item
    Have active Crohn's disease, defined as a baseline Crohn Disease Activity Index (CDAI) score of >= 220 and <= 450, with confirmation of active inflammation
    boolean
    C0205177 (UMLS CUI 2011AA)
    55561003 (SNOMED CT 2011_0131)
    C0010346 (UMLS CUI 2011AA)
    34000006 (SNOMED CT 2011_0131)
    10011401 (MedDRA 14.1)
    K50.9 (ICD-10-CM Version 2010)
    C1704788 (UMLS CUI 2011AA)
    C1442488 (UMLS CUI 2011AA)
    C0451071 (UMLS CUI 2011AA)
    273364009 (SNOMED CT 2011_0131)
    C0449820 (UMLS CUI 2011AA)
    246262008 (SNOMED CT 2011_0131)
    MTHU024701 (LOINC Version 232)
    C0205177 (UMLS CUI 2011AA)
    55561003 (SNOMED CT 2011_0131)
    C0021368 (UMLS CUI 2011AA)
    23583003 (SNOMED CT 2011_0131)
    10061218 (MedDRA 14.1)
    Has failed conventional therapy as demonstrated by having received corticosteroids and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is corticosteroid dependent or has had a history of corticosteroid dependency AND Has not previously demonstrated failure of or intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria
    Item
    Has failed conventional therapy as demonstrated by having received corticosteroids and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is corticosteroid dependent or has had a history of corticosteroid dependency AND Has not previously demonstrated failure of or intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria
    boolean
    C0231175 (UMLS CUI 2011AA)
    CL429695 (UMLS CUI 2011AA)
    C0001617 (UMLS CUI 2011AA)
    79440004 (SNOMED CT 2011_0131)
    C1527392 (UMLS CUI 2011AA)
    108940007 (SNOMED CT 2011_0131)
    C0004482 (UMLS CUI 2011AA)
    372574004 (SNOMED CT 2011_0131)
    MTHU006794 (LOINC Version 232)
    C0025677 (UMLS CUI 2011AA)
    387381009 (SNOMED CT 2011_0131)
    MTHU005020 (LOINC Version 232)
    C0000618 (UMLS CUI 2011AA)
    386835005 (SNOMED CT 2011_0131)
    MTHU002562 (LOINC Version 232)
    C1518422 (UMLS CUI 2011AA)
    C0162643 (UMLS CUI 2011AA)
    10066901 (MedDRA 14.1)
    C1456820 (UMLS CUI 2011AA)
    39525005 (SNOMED CT 2011_0131)
    MTHU004497 (LOINC Version 232)
    C0243076 (UMLS CUI 2011AA)
    C0666743 (UMLS CUI 2011AA)
    386891004 (SNOMED CT 2011_0131)
    MTHU018219 (LOINC Version 232)
    C1122087 (UMLS CUI 2011AA)
    407317001 (SNOMED CT 2011_0131)
    C1172157 (UMLS CUI 2011AA)
    430307008 (SNOMED CT 2011_0131)
    Have screening laboratory test results within protocol-specified parameters
    Item
    Have screening laboratory test results within protocol-specified parameters
    boolean
    C1409616 (UMLS CUI 2011AA)
    C0587081 (UMLS CUI 2011AA)
    118246004 (SNOMED CT 2011_0131)
    C0332285 (UMLS CUI 2011AA)
    18720000 (SNOMED CT 2011_0131)
    C2348563 (UMLS CUI 2011AA)
    C0205369 (UMLS CUI 2011AA)
    69658003 (SNOMED CT 2011_0131)
    C0449381 (UMLS CUI 2011AA)
    252116004 (SNOMED CT 2011_0131)
    Item Group
    Exclusion Criteria
    Patients who have had any kind of bowel resection within 6 months
    Item
    Patients who have had any kind of bowel resection within 6 months
    boolean
    C1514756 (UMLS CUI 2011AA)
    CL407060 (UMLS CUI 2011AA)
    C1706124 (UMLS CUI 2011AA)
    C0741614 (UMLS CUI 2011AA)
    10067878 (MedDRA 14.1)
    Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent
    Item
    Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent
    boolean
    C0549206 (UMLS CUI 2011AA)
    10036586 (MedDRA 14.1)
    C0032992 (UMLS CUI 2011AA)
    169565003 (SNOMED CT 2011_0131)
    C0025266 (UMLS CUI 2011AA)
    339947000 (SNOMED CT 2011_0131)
    C0043210 (UMLS CUI 2011AA)
    224526002 (SNOMED CT 2011_0131)
    Patients who have received infliximab, adalimumab or certolizumab pegol < = 8 weeks before the first administration of study drug
    Item
    Patients who have received infliximab, adalimumab or certolizumab pegol < = 8 weeks before the first administration of study drug
    boolean
    C1514756 (UMLS CUI 2011AA)
    C0666743 (UMLS CUI 2011AA)
    386891004 (SNOMED CT 2011_0131)
    MTHU018219 (LOINC Version 232)
    C1122087 (UMLS CUI 2011AA)
    407317001 (SNOMED CT 2011_0131)
    C1172157 (UMLS CUI 2011AA)
    430307008 (SNOMED CT 2011_0131)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C1533734 (UMLS CUI 2011AA)
    416118004 (SNOMED CT 2011_0131)
    C0304229 (UMLS CUI 2011AA)
    902003 (SNOMED CT 2011_0131)
    Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug
    Item
    Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug
    boolean
    C0009566 (UMLS CUI 2011AA)
    116223007 (SNOMED CT 2011_0131)
    MTHU008883 (LOINC Version 232)
    C0010346 (UMLS CUI 2011AA)
    34000006 (SNOMED CT 2011_0131)
    10011401 (MedDRA 14.1)
    K50.9 (ICD-10-CM Version 2010)
    C1299586 (UMLS CUI 2011AA)
    52925006 (SNOMED CT 2011_0131)
    C1516048 (UMLS CUI 2011AA)
    C0871261 (UMLS CUI 2011AA)
    C0304229 (UMLS CUI 2011AA)
    902003 (SNOMED CT 2011_0131)
    Patients with a history of or ongoing chronic or recurrent infectious disease
    Item
    Patients with a history of or ongoing chronic or recurrent infectious disease
    boolean
    C0151317 (UMLS CUI 2011AA)
    177010002 (SNOMED CT 2011_0131)
    CL429630 (UMLS CUI 2011AA)
    C0009450 (UMLS CUI 2011AA)
    40733004 (SNOMED CT 2011_0131)
    10021881 (MedDRA 14.1)
    MTHU034915 (LOINC Version 232)
    136.9 (ICD-9-CM Version 2011)
    Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)
    Item
    Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)
    boolean
    C0205156 (UMLS CUI 2011AA)
    9130008 (SNOMED CT 2011_0131)
    C1514756 (UMLS CUI 2011AA)
    C0005515 (UMLS CUI 2011AA)
    C1521840 (UMLS CUI 2011AA)
    C0123759 (UMLS CUI 2011AA)
    6411000 (SNOMED CT 2011_0131)
    MTHU003527 (LOINC Version 232)
    C0963088 (UMLS CUI 2011AA)
    C0332257 (UMLS CUI 2011AA)
    55919000 (SNOMED CT 2011_0131)
    C1608841 (UMLS CUI 2011AA)
    443644001 (SNOMED CT 2011_0131)
    C2744325 (UMLS CUI 2011AA)
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