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ID

12649

Beschreibung

Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia; ODM derived from: https://clinicaltrials.gov/show/NCT01949129

Link

https://clinicaltrials.gov/show/NCT01949129

Stichworte

  1. 07.12.15 07.12.15 -
Hochgeladen am

7. Dezember 2015

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Acute Lymphoblastic Leukaemia NCT01949129

    Eligibility Acute Lymphoblastic Leukaemia NCT01949129

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patients with all (except for patients with b-all) who fulfil the following criteria:
    Beschreibung

    patients with all

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0027651 (Neoplasms)
    SNOMED
    108369006
    age at time of screening less than 18 years
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    indication for allogeneic hsct
    Beschreibung

    indication for allogeneic hsct

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0472699 (Hemopoietic stem cell transplant)
    SNOMED
    234336002
    complete remission (cr) before hsct
    Beschreibung

    complete remission (cr) before hsct

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0677874 (In complete remission)
    SNOMED
    103338009
    UMLS CUI [1,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [1,3]
    C2242529 (Allogeneic Stem Cell Transplantation)
    written consent of the parents (legal guardian) and, if necessary, the minor patient via "informed consent form"
    Beschreibung

    written consent of the parents (legal guardian) and, if necessary, the minor patient via "informed consent form"

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    UMLS CUI [2]
    C0030551 (parent)
    SNOMED
    40683002
    LOINC
    LA30680-5
    UMLS CUI [3]
    C0026193 (Minor (person))
    no pregnancy
    Beschreibung

    no pregnancy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0232973 (Not pregnant (finding))
    SNOMED
    60001007
    LOINC
    LA26683-5
    no secondary malignancy
    Beschreibung

    no secondary malignancy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3266877 (Secondary Malignant Neoplasm)
    no previous hsct
    Beschreibung

    previous hsct

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205156 (Previous)
    SNOMED
    9130008
    LOINC
    LP21061-4
    UMLS CUI [1,2]
    C2242529 (Allogeneic Stem Cell Transplantation)
    hsct is performed in a study participating centre
    Beschreibung

    hsct is performed in a study participating centre

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0472699 (Hemopoietic stem cell transplant)
    SNOMED
    234336002
    UMLS CUI [2]
    C2347449 (Participating Clinical Study Organization)
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    patients who do not fulfil the inclusion criteria
    Beschreibung

    patients who do not fulfil the inclusion criteria

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1512693 (Inclusion)
    non hodgkin-lymphoma
    Beschreibung

    non hodgkin-lymphoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0024305 (Lymphoma, Non-Hodgkin)
    SNOMED
    1929004
    all with extramedullary involvement with indication for tbi
    Beschreibung

    all with extramedullary involvement with indication for tbi

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1868812 (Leukaemic infiltration extramedullary)
    cns involvement at the timepoint of screening
    Beschreibung

    cns involvement

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0449389 (CNS involvement status)
    SNOMED
    260766009
    trisomy 21
    Beschreibung

    trisomy 21

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3537167 (Trisomy 21)
    LOINC
    LP19800-9
    the whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
    Beschreibung

    informed consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    no consent is given for saving and propagation of anonymous medical data for study reasons
    Beschreibung

    no consent is given for saving and propagation of anonymous medical data for study reasons

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    severe concomitant disease that does not allow treatment according to the protocol at the investigators discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
    Beschreibung

    severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [3]
    C0009488 (Comorbidity)
    karnofsky / lansky score < 50
    Beschreibung

    karnofsky / lansky score < 50

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1522275 (Lansky Play-Performance Status)
    UMLS CUI [2]
    C0206065 (Karnofsky Performance Status)
    SNOMED
    273546003
    LOINC
    LP267177-6
    subjects unwilling or unable to comply with the study procedures
    Beschreibung

    subjects unwilling or unable to comply with the study procedures

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008

    Ähnliche Modelle

    Eligibility Acute Lymphoblastic Leukaemia NCT01949129

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    patients with all
    Item
    patients with all (except for patients with b-all) who fulfil the following criteria:
    boolean
    C0027651 (UMLS CUI [1])
    Age
    Item
    age at time of screening less than 18 years
    boolean
    C0001779 (UMLS CUI [1])
    indication for allogeneic hsct
    Item
    indication for allogeneic hsct
    boolean
    C0472699 (UMLS CUI [1])
    complete remission (cr) before hsct
    Item
    complete remission (cr) before hsct
    boolean
    C0677874 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C2242529 (UMLS CUI [1,3])
    written consent of the parents (legal guardian) and, if necessary, the minor patient via "informed consent form"
    Item
    written consent of the parents (legal guardian) and, if necessary, the minor patient via "informed consent form"
    boolean
    C0021430 (UMLS CUI [1])
    C0030551 (UMLS CUI [2])
    C0026193 (UMLS CUI [3])
    no pregnancy
    Item
    no pregnancy
    boolean
    C0232973 (UMLS CUI [1])
    no secondary malignancy
    Item
    no secondary malignancy
    boolean
    C3266877 (UMLS CUI [1])
    previous hsct
    Item
    no previous hsct
    boolean
    C0205156 (UMLS CUI [1,1])
    C2242529 (UMLS CUI [1,2])
    hsct is performed in a study participating centre
    Item
    hsct is performed in a study participating centre
    boolean
    C0472699 (UMLS CUI [1])
    C2347449 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    patients who do not fulfil the inclusion criteria
    Item
    patients who do not fulfil the inclusion criteria
    boolean
    C1512693 (UMLS CUI [1])
    non hodgkin-lymphoma
    Item
    non hodgkin-lymphoma
    boolean
    C0024305 (UMLS CUI [1])
    all with extramedullary involvement with indication for tbi
    Item
    all with extramedullary involvement with indication for tbi
    boolean
    C1868812 (UMLS CUI [1])
    cns involvement
    Item
    cns involvement at the timepoint of screening
    boolean
    C0449389 (UMLS CUI [1])
    trisomy 21
    Item
    trisomy 21
    boolean
    C3537167 (UMLS CUI [1])
    informed consent
    Item
    the whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
    boolean
    C0021430 (UMLS CUI [1])
    no consent is given for saving and propagation of anonymous medical data for study reasons
    Item
    no consent is given for saving and propagation of anonymous medical data for study reasons
    boolean
    C0021430 (UMLS CUI [1])
    severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion
    Item
    severe concomitant disease that does not allow treatment according to the protocol at the investigators discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
    boolean
    C1321605 (UMLS CUI [1])
    C0439801 (UMLS CUI [2])
    C0009488 (UMLS CUI [3])
    karnofsky / lansky score < 50
    Item
    karnofsky / lansky score < 50
    boolean
    C1522275 (UMLS CUI [1])
    C0206065 (UMLS CUI [2])
    subjects unwilling or unable to comply with the study procedures
    Item
    subjects unwilling or unable to comply with the study procedures
    boolean
    C1321605 (UMLS CUI [1])

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