0 Bedömningar

ID

4885

Beskrivning

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

Länk

http://clinicaltrials.gov/show/NCT00296309

Nyckelord

  1. 2012-03-06 2012-03-06 -
  2. 2014-04-13 2014-04-13 - Julian Varghese
Uppladdad den

13 april 2014

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility NCT00296309 Kidney Transplantation

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Age 60 Years and older
    Beskrivning

    Age

    Datatyp

    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.
    Beskrivning

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

    Datatyp

    boolean

    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Patient has an immunological high risk
    Beskrivning

    immunological high risk

    Datatyp

    boolean

    Cold ischemia time greater than 30 hours
    Beskrivning

    Cold ischemia time >30 hours

    Datatyp

    boolean

    Patient has significant liver disease
    Beskrivning

    significant liver disease

    Datatyp

    boolean

    Patient is allergic or intolerant to study medication
    Beskrivning

    allergy or intolerance to study medication

    Datatyp

    boolean

    Patient or donor is known to be HIV positive.
    Beskrivning

    Patient or donor is HIV positive

    Datatyp

    boolean

    Patient with malignancy or history of malignancy
    Beskrivning

    malignancy or history of malignancy

    Datatyp

    boolean

    Patient has significant, uncontrolled concomitant infections
    Beskrivning

    significant, un-controlled concomitant infections

    Datatyp

    boolean

    Medical Concepts
    Beskrivning

    Medical Concepts

    Age
    Beskrivning

    Age

    Datatyp

    integer

    Alias
    UMLS CUI
    C0001779
    SNOMED CT 2010_0731
    397669002
    disorder
    Beskrivning

    Disease

    Datatyp

    string

    Alias
    UMLS CUI
    C0012634
    SNOMED CT 2010_0731
    64572001
    Renal Disease, End-Stage
    Beskrivning

    End stage kidney disease

    Datatyp

    string

    Alias
    UMLS CUI
    C1261469
    SNOMED CT 2010_0731
    46177005
    ICD-9-CM Version 2011
    585.6
    Renal transplant
    Beskrivning

    Kidney Transplantation

    Datatyp

    string

    Alias
    UMLS CUI
    C0022671
    SNOMED CT 2010_0731
    70536003
    MedDRA 13.1
    10038533
    ICD-9-CM Version 2011
    55.6
    retransplantation
    Beskrivning

    retransplantation

    Datatyp

    string

    Alias
    UMLS CUI
    C0597409
    Structure of transplanted kidney
    Beskrivning

    Transplanted kidney

    Datatyp

    string

    Alias
    UMLS CUI
    C1261317
    SNOMED CT 2010_0731
    70948008
    LOINC Version 232
    MTHU017667
    Live donor
    Beskrivning

    Living Donors

    Datatyp

    string

    Alias
    UMLS CUI
    C0348050
    SNOMED CT 2010_0731
    105456007
    Donor person
    Beskrivning

    Donor

    Datatyp

    string

    Alias
    UMLS CUI
    C0013018
    Human leukocyte antigen
    Beskrivning

    HLA Antigens

    Datatyp

    string

    Alias
    UMLS CUI
    C0019721
    SNOMED CT 2010_0731
    47038001
    LOINC Version 232
    MTHU018438
    ABO blood group antigen system
    Beskrivning

    ABO blood group system

    Datatyp

    string

    Alias
    UMLS CUI
    C0000778
    SNOMED CT 2010_0731
    63915006
    LOINC Version 232
    MTHU004899
    Immunological Risk Factors
    Beskrivning

    Immunological Risk Factors

    Datatyp

    string

    Alias
    UMLS CUI
    CL365957
    Cold Ischemic Time
    Beskrivning

    Cold Ischemia Time

    Datatyp

    string

    Alias
    UMLS CUI
    C1563922
    LOINC Version 232
    MTHU020173
    Liver diseases
    Beskrivning

    Liver disorder

    Datatyp

    string

    Alias
    UMLS CUI
    C0023895
    SNOMED CT 2010_0731
    235856003
    MedDRA 13.1
    10024670
    ICD-10-CM Version 2010
    K76.9
    ICD-9-CM Version 2011
    573.9
    Drug intolerance
    Beskrivning

    Drug intolerance

    Datatyp

    string

    Alias
    UMLS CUI
    C0277585
    SNOMED CT 2010_0731
    59037007
    MedDRA 13.1
    10061822
    HL7 V3 02-34
    DINT
    HIV Seropositivity
    Beskrivning

    HIV positive

    Datatyp

    string

    Alias
    UMLS CUI
    C0019699
    SNOMED CT 2010_0731
    165816005
    MedDRA 13.1
    10020188
    ICD-10-CM Version 2010
    Z21
    Malignant Neoplasms
    Beskrivning

    Cancer

    Datatyp

    string

    Alias
    UMLS CUI
    C0006826
    SNOMED CT 2010_0731
    363346000
    MedDRA 13.1
    10028997
    LOINC Version 232
    MTHU010328
    ICD-10-CM Version 2010
    C00-C96
    Infection
    Beskrivning

    Infection

    Datatyp

    string

    Alias
    UMLS CUI
    C0009450
    SNOMED CT 2010_0731
    257551009
    MedDRA 13.1
    10021789

    Similar models

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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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