0 Ratings
ID

5155

Description

ODM derived from http://clinicaltrials.gov/show/NCT00321620

Link

http://clinicaltrials.gov/show/NCT00321620

Keywords

Versions (5)
  1. 3/20/12 3/20/12 -
  2. 3/20/12 3/20/12 -
  3. 4/14/14 4/14/14 - Julian Varghese
  4. 4/20/14 4/20/14 - Julian Varghese
  5. 9/20/21 9/20/21 -
Uploaded on

April 20, 2014

DOI

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License

Creative Commons BY 4.0
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    Eligibility DRKS00009676 NCT00321620 Bone Metastases

    German English

    Eligibility

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

    Inclusion Criteria

    Age 18 Years and older
    Description

    age >=18 Years

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Men >/= 18 years of age with histologically confirmed prostate cancer
    Description

    Men >/= 18 years of age with histologically confirmed prostate cancer

    Data type

    boolean

    Alias
    UMLS CUI 1
    C0001779
    UMLS CUI 2
    C0024554
    UMLS CUI 3
    C0279882
    Radiographic evidence of at least one bone metastasis
    Description

    Radiographic evidence of at least one bone metastasis

    Data type

    boolean

    Alias
    UMLS CUI 1
    C0153690
    SNOMED CT 1
    94222008
    MedDRA 14.1
    10055101
    ICD-10-CM Version 2010
    C79.51
    ICD-9-CM Version 2011
    198.5
    UMLS CUI 2
    C0444708
    SNOMED CT 2
    258106000
    UMLS CUI 3
    C0332120
    SNOMED CT 3
    18669006
    Failure of at least one hormonal therapy as evidenced by a rising PSA
    Description

    Failure of at least one hormonal therapy as evidenced by a rising PSA

    Data type

    boolean

    Alias
    UMLS CUI 1
    C0231174
    SNOMED CT 1
    76797004
    UMLS CUI 2
    C0279025
    SNOMED CT 2
    169413002
    MedDRA 14.1
    10065646
    UMLS CUI 3
    C0332120
    SNOMED CT 3
    18669006
    UMLS CUI 4
    C0138741
    SNOMED CT 4
    102687007
    LOINC Version 232
    MTHU001466
    Serum testosterone level of <50 ng/dL
    Description

    Serum testosterone level of <50 ng/dL

    Data type

    boolean

    Alias
    UMLS CUI 1
    C0857983
    MedDRA 1
    10040411
    UMLS CUI 2
    C0428413
    SNOMED CT 2
    270973006
    MedDRA 2
    10040409
    ECOG performance 0,1 or 2
    Description

    ECOG <= 2

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1520224
    SNOMED CT 2011_0131
    424122007
    Adequate organ function
    Description

    Adequate organ function

    Data type

    boolean

    Alias
    UMLS CUI 1
    C0205411
    SNOMED CT 2011_0131
    88323005
    UMLS CUI 2
    C0678852
    Exclusion Criteria
    Description

    Exclusion Criteria

    Current or prior IV bisphosphonate administration
    Description

    Current or prior IV bisphosphonate administration

    Data type

    boolean

    Alias
    UMLS CUI 1
    C0521116
    SNOMED CT 1
    15240007
    UMLS CUI 2
    C0332152
    SNOMED 2
    288556008
    UMLS CUI 3
    C0013125
    UMLS CUI 4
    C0012544
    SNOMED CT 3
    372907000
    Current or prior oral bisphosphonates for bone mets
    Description

    Current or prior oral bisphosphonates for bone mets

    Data type

    boolean

    Alias
    UMLS CUI 1
    C0521116
    SNOMED CT 1
    15240007
    UMLS CUI 2
    C0332152
    SNOMED CT 2
    288556008
    UMLS CUI 3
    C1527415
    SNOMED CT 3
    26643006
    HL7 V3 2006_05
    _OralRoute
    UMLS CUI 4
    C0012544
    SNOMED CT 4
    372907000
    UMLS CUI 5
    C0153690
    SNOMED CT 5
    94222008
    MedDRA 14.1
    10055101
    ICD-10-CM Version 2010
    C79.51
    ICD-9-CM Version 2011
    198.5
    life expectancy <6 months
    Description

    life expectancy of less than 6 months

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0023671
    LOINC Version 232
    MTHU032184
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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
    age >=18 Years
    Item
    Age 18 Years and older
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Men >/= 18 years of age with histologically confirmed prostate cancer
    Item
    Men >/= 18 years of age with histologically confirmed prostate cancer
    boolean
    C0001779 (UMLS CUI 1)
    C0024554 (UMLS CUI 2)
    C0279882 (UMLS CUI 3)
    Radiographic evidence of at least one bone metastasis
    Item
    Radiographic evidence of at least one bone metastasis
    boolean
    C0153690 (UMLS CUI 1)
    94222008 (SNOMED CT 1)
    10055101 (MedDRA 14.1)
    C79.51 (ICD-10-CM Version 2010)
    198.5 (ICD-9-CM Version 2011)
    C0444708 (UMLS CUI 2)
    258106000 (SNOMED CT 2)
    C0332120 (UMLS CUI 3)
    18669006 (SNOMED CT 3)
    Failure of at least one hormonal therapy as evidenced by a rising PSA
    Item
    Failure of at least one hormonal therapy as evidenced by a rising PSA
    boolean
    C0231174 (UMLS CUI 1)
    76797004 (SNOMED CT 1)
    C0279025 (UMLS CUI 2)
    169413002 (SNOMED CT 2)
    10065646 (MedDRA 14.1)
    C0332120 (UMLS CUI 3)
    18669006 (SNOMED CT 3)
    C0138741 (UMLS CUI 4)
    102687007 (SNOMED CT 4)
    MTHU001466 (LOINC Version 232)
    Serum testosterone level of <50 ng/dL
    Item
    Serum testosterone level of <50 ng/dL
    boolean
    C0857983 (UMLS CUI 1)
    10040411 (MedDRA 1)
    C0428413 (UMLS CUI 2)
    270973006 (SNOMED CT 2)
    10040409 (MedDRA 2)
    ECOG <= 2
    Item
    ECOG performance 0,1 or 2
    boolean
    C1520224 (UMLS CUI 2011AA)
    424122007 (SNOMED CT 2011_0131)
    Adequate organ function
    Item
    Adequate organ function
    boolean
    C0205411 (UMLS CUI 1)
    88323005 (SNOMED CT 2011_0131)
    C0678852 (UMLS CUI 2)
    Item Group
    Exclusion Criteria
    Current or prior IV bisphosphonate administration
    Item
    Current or prior IV bisphosphonate administration
    boolean
    C0521116 (UMLS CUI 1)
    15240007 (SNOMED CT 1)
    C0332152 (UMLS CUI 2)
    288556008 (SNOMED 2)
    C0013125 (UMLS CUI 3)
    C0012544 (UMLS CUI 4)
    372907000 (SNOMED CT 3)
    Current or prior oral bisphosphonates for bone mets
    Item
    Current or prior oral bisphosphonates for bone mets
    boolean
    C0521116 (UMLS CUI 1)
    15240007 (SNOMED CT 1)
    C0332152 (UMLS CUI 2)
    288556008 (SNOMED CT 2)
    C1527415 (UMLS CUI 3)
    26643006 (SNOMED CT 3)
    _OralRoute (HL7 V3 2006_05)
    C0012544 (UMLS CUI 4)
    372907000 (SNOMED CT 4)
    C0153690 (UMLS CUI 5)
    94222008 (SNOMED CT 5)
    10055101 (MedDRA 14.1)
    C79.51 (ICD-10-CM Version 2010)
    198.5 (ICD-9-CM Version 2011)
    life expectancy of less than 6 months
    Item
    life expectancy <6 months
    boolean
    C0023671 (UMLS CUI 2011AA)
    MTHU032184 (LOINC Version 232)
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