0 Ratings

ID

4885

Description

ODM derived from http://clinicaltrials.gov/show/NCT00296309

Link

http://clinicaltrials.gov/show/NCT00296309

Keywords

  1. 3/6/12 3/6/12 -
  2. 4/13/14 4/13/14 - Julian Varghese
Uploaded on

April 13, 2014

DOI

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License

Creative Commons BY 4.0

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    Eligibility NCT00296309 Kidney Transplantation

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Description

    Inclusion Criteria

    Age 60 Years and older
    Description

    Age

    Data type

    boolean

    Patients with end stage kidney disease who are suitable candidates for primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible ABO blood type can be included.
    Description

    Patients with end stage kidney disease. Patients receiving a kidney transplant with compatible ABO blood type.

    Data type

    boolean

    Exclusion Criteria
    Description

    Exclusion Criteria

    Patient has an immunological high risk
    Description

    immunological high risk

    Data type

    boolean

    Cold ischemia time greater than 30 hours
    Description

    Cold ischemia time >30 hours

    Data type

    boolean

    Patient has significant liver disease
    Description

    significant liver disease

    Data type

    boolean

    Patient is allergic or intolerant to study medication
    Description

    allergy or intolerance to study medication

    Data type

    boolean

    Patient or donor is known to be HIV positive.
    Description

    Patient or donor is HIV positive

    Data type

    boolean

    Patient with malignancy or history of malignancy
    Description

    malignancy or history of malignancy

    Data type

    boolean

    Patient has significant, uncontrolled concomitant infections
    Description

    significant, un-controlled concomitant infections

    Data type

    boolean

    Medical Concepts
    Description

    Medical Concepts

    Age
    Description

    Age

    Data type

    integer

    Alias
    UMLS CUI
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    SNOMED CT 2010_0731
    397669002 (undefined)
    disorder
    Description

    Disease

    Data type

    string

    Alias
    UMLS CUI
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    SNOMED CT 2010_0731
    64572001 (undefined)
    Renal Disease, End-Stage
    Description

    End stage kidney disease

    Data type

    string

    Alias
    UMLS CUI
    C1261469 (undefined)
    SNOMED CT 2010_0731
    46177005 (undefined)
    ICD-9-CM Version 2011
    585.6 (undefined)
    Renal transplant
    Description

    Kidney Transplantation

    Data type

    string

    Alias
    UMLS CUI
    C0022671 (Kidney Transplantation)
    SNOMED
    70536003
    SNOMED CT 2010_0731
    70536003 (undefined)
    MedDRA 13.1
    10038533 (undefined)
    ICD-9-CM Version 2011
    55.6 (undefined)
    retransplantation
    Description

    retransplantation

    Data type

    string

    Alias
    UMLS CUI
    C0597409 (retransplantation)
    Structure of transplanted kidney
    Description

    Transplanted kidney

    Data type

    string

    Alias
    UMLS CUI
    C1261317 (Transplanted kidney)
    SNOMED
    70948008
    LOINC
    LP208026-7
    SNOMED CT 2010_0731
    70948008 (undefined)
    LOINC Version 232
    MTHU017667 (undefined)
    Live donor
    Description

    Living Donors

    Data type

    string

    Alias
    UMLS CUI
    C0348050 (Living Donors)
    SNOMED
    105456007
    SNOMED CT 2010_0731
    105456007 (undefined)
    Donor person
    Description

    Donor

    Data type

    string

    Alias
    UMLS CUI
    C0013018 (Donor person)
    Human leukocyte antigen
    Description

    HLA Antigens

    Data type

    string

    Alias
    UMLS CUI
    C0019721 (HLA Antigens)
    SNOMED
    47038001
    LOINC
    LP57611-3
    SNOMED CT 2010_0731
    47038001 (undefined)
    LOINC Version 232
    MTHU018438 (undefined)
    ABO blood group antigen system
    Description

    ABO blood group system

    Data type

    string

    Alias
    UMLS CUI
    C0000778 (ABO blood group system)
    SNOMED
    63915006
    LOINC
    LP17806-8
    SNOMED CT 2010_0731
    63915006 (undefined)
    LOINC Version 232
    MTHU004899 (undefined)
    Immunological Risk Factors
    Description

    Immunological Risk Factors

    Data type

    string

    Alias
    UMLS CUI
    CL365957 (undefined)
    Cold Ischemic Time
    Description

    Cold Ischemia Time

    Data type

    string

    Alias
    UMLS CUI
    C1563922 (Cold Ischemia Time)
    LOINC Version 232
    MTHU020173 (undefined)
    Liver diseases
    Description

    Liver disorder

    Data type

    string

    Alias
    UMLS CUI
    C0023895 (Liver diseases)
    SNOMED
    235856003
    LOINC
    LA17774-3
    SNOMED CT 2010_0731
    235856003 (undefined)
    MedDRA 13.1
    10024670 (undefined)
    ICD-10-CM Version 2010
    K76.9 (undefined)
    ICD-9-CM Version 2011
    573.9 (undefined)
    Drug intolerance
    Description

    Drug intolerance

    Data type

    string

    Alias
    UMLS CUI
    C0277585 (Intolerance to drug)
    SNOMED
    59037007
    SNOMED CT 2010_0731
    59037007 (undefined)
    MedDRA 13.1
    10061822 (undefined)
    HL7 V3 02-34
    DINT (undefined)
    HIV Seropositivity
    Description

    HIV positive

    Data type

    string

    Alias
    UMLS CUI
    C0019699 (HIV Seropositivity)
    SNOMED
    165816005
    SNOMED CT 2010_0731
    165816005 (undefined)
    MedDRA 13.1
    10020188 (undefined)
    ICD-10-CM Version 2010
    Z21 (undefined)
    Malignant Neoplasms
    Description

    Cancer

    Data type

    string

    Alias
    UMLS CUI
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    SNOMED CT 2010_0731
    363346000 (undefined)
    MedDRA 13.1
    10028997 (undefined)
    LOINC Version 232
    MTHU010328 (undefined)
    ICD-10-CM Version 2010
    C00-C96 (undefined)
    Infection
    Description

    Infection

    Data type

    string

    Alias
    UMLS CUI
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    SNOMED CT 2010_0731
    257551009 (undefined)
    MedDRA 13.1
    10021789 (undefined)

    Similar models

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion Criteria
    Age
    Item
    Age 60 Years and older
    boolean
    Patients with end stage kidney disease. Patients receiving a kidney transplant with compatible ABO blood type.
    Item
    Patients with end stage kidney disease who are suitable candidates for primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible ABO blood type can be included.
    boolean
    Item Group
    Exclusion Criteria
    immunological high risk
    Item
    Patient has an immunological high risk
    boolean
    Cold ischemia time >30 hours
    Item
    Cold ischemia time greater than 30 hours
    boolean
    significant liver disease
    Item
    Patient has significant liver disease
    boolean
    allergy or intolerance to study medication
    Item
    Patient is allergic or intolerant to study medication
    boolean
    Patient or donor is HIV positive
    Item
    Patient or donor is known to be HIV positive.
    boolean
    malignancy or history of malignancy
    Item
    Patient with malignancy or history of malignancy
    boolean
    significant, un-controlled concomitant infections
    Item
    Patient has significant, uncontrolled concomitant infections
    boolean
    Item Group
    Medical Concepts
    Age
    Item
    Age
    integer
    C0001779 (UMLS CUI)
    397669002 (SNOMED CT 2010_0731)
    Disease
    Item
    disorder
    string
    C0012634 (UMLS CUI)
    64572001 (SNOMED CT 2010_0731)
    End stage kidney disease
    Item
    Renal Disease, End-Stage
    string
    C1261469 (UMLS CUI)
    46177005 (SNOMED CT 2010_0731)
    585.6 (ICD-9-CM Version 2011)
    Kidney Transplantation
    Item
    Renal transplant
    string
    C0022671 (UMLS CUI)
    70536003 (SNOMED CT 2010_0731)
    10038533 (MedDRA 13.1)
    55.6 (ICD-9-CM Version 2011)
    retransplantation
    Item
    retransplantation
    string
    C0597409 (UMLS CUI)
    Transplanted kidney
    Item
    Structure of transplanted kidney
    string
    C1261317 (UMLS CUI)
    70948008 (SNOMED CT 2010_0731)
    MTHU017667 (LOINC Version 232)
    Living Donors
    Item
    Live donor
    string
    C0348050 (UMLS CUI)
    105456007 (SNOMED CT 2010_0731)
    Donor
    Item
    Donor person
    string
    C0013018 (UMLS CUI)
    HLA Antigens
    Item
    Human leukocyte antigen
    string
    C0019721 (UMLS CUI)
    47038001 (SNOMED CT 2010_0731)
    MTHU018438 (LOINC Version 232)
    ABO blood group system
    Item
    ABO blood group antigen system
    string
    C0000778 (UMLS CUI)
    63915006 (SNOMED CT 2010_0731)
    MTHU004899 (LOINC Version 232)
    Immunological Risk Factors
    Item
    Immunological Risk Factors
    string
    CL365957 (UMLS CUI)
    Cold Ischemia Time
    Item
    Cold Ischemic Time
    string
    C1563922 (UMLS CUI)
    MTHU020173 (LOINC Version 232)
    Liver disorder
    Item
    Liver diseases
    string
    C0023895 (UMLS CUI)
    235856003 (SNOMED CT 2010_0731)
    10024670 (MedDRA 13.1)
    K76.9 (ICD-10-CM Version 2010)
    573.9 (ICD-9-CM Version 2011)
    Drug intolerance
    Item
    Drug intolerance
    string
    C0277585 (UMLS CUI)
    59037007 (SNOMED CT 2010_0731)
    10061822 (MedDRA 13.1)
    DINT (HL7 V3 02-34)
    HIV positive
    Item
    HIV Seropositivity
    string
    C0019699 (UMLS CUI)
    165816005 (SNOMED CT 2010_0731)
    10020188 (MedDRA 13.1)
    Z21 (ICD-10-CM Version 2010)
    Cancer
    Item
    Malignant Neoplasms
    string
    C0006826 (UMLS CUI)
    363346000 (SNOMED CT 2010_0731)
    10028997 (MedDRA 13.1)
    MTHU010328 (LOINC Version 232)
    C00-C96 (ICD-10-CM Version 2010)
    Infection
    Item
    Infection
    string
    C0009450 (UMLS CUI)
    257551009 (SNOMED CT 2010_0731)
    10021789 (MedDRA 13.1)

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