0 Évaluations
ID

5082

Description

ODM derived from http://clinicaltrials.gov/show/NCT01095926

Lien

http://clinicaltrials.gov/show/NCT01095926

Mots-clés

Versions (2)
  1. 06/12/2013 06/12/2013 - Martin Dugas
  2. 17/04/2014 17/04/2014 - Julian Varghese
Téléchargé le

17 avril 2014

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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    Eligibility DRKS00003787 NCT01095926 Wilms Tumor

    Allemand Anglais

    Eligibility

    1 Formulaires  
    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Description

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202
    Alter bis zu 17 Jahre
    Description

    age up to 17 Years

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    plan to receive at least two cycles of doxorubicin
    Description

    plan to receive at least two cycles of doxorubicin

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C1301732
    SNOMED CT 2011_0131
    397943006
    UMLS CUI 2011AA
    C0439091
    SNOMED CT 2011_0131
    276138003
    HL7 V3 2006_05
    GE
    UMLS CUI 2011AA
    C0205448
    SNOMED CT 2011_0131
    19338005
    UMLS CUI 2011AA
    C0439596
    SNOMED CT 2011_0131
    44180009
    UMLS CUI 2011AA
    C0013089
    SNOMED CT 2011_0131
    68444001
    LOINC Version 232
    MTHU004184
    must be enrolled in a national or European protocol for treatment of Wilms Tumours, Neuroblastoma, Soft tissue sarcoma, Ewing Sarcoma or Acute lymphoblastic leukaemia and must be treated with doxorubicin according to that protocol Or Patients < 3 years enrolled or listed in any national or European study protocol for any paediatric malignancy. Treatment with doxorubicin has to be according to that protocol.
    Description

    must be enrolled in a national or European protocol for treatment of Wilms Tumours, Neuroblastoma, Soft tissue sarcoma, Ewing Sarcoma or Acute lymphoblastic leukaemia and must be treated with doxorubicin according to that protocol Or Patients < 3 years enrolled or listed in any national or European study protocol for any paediatric malignancy. Treatment with doxorubicin has to be according to that protocol.

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C1516879
    UMLS CUI 2011AA
    CL415062
    UMLS CUI 2011AA
    C1535514
    SNOMED CT 2011_0131
    414152003
    HL7 V3 2006_05
    2108-9
    UMLS CUI 2011AA
    C0040808
    UMLS CUI 2011AA
    CL343552
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0027819
    SNOMED CT 2011_0131
    432328008
    MedDRA 14.1
    10029260
    UMLS CUI 2011AA
    CL353068
    SNOMED CT 2011_0131
    2424003
    UMLS CUI 2011AA
    C0553580
    SNOMED CT 2011_0131
    76909002
    MedDRA 14.1
    10015560
    UMLS CUI 2011AA
    C0023449
    SNOMED CT 2011_0131
    91857003, 128822004
    MedDRA 14.1
    10060390
    ICD-10-CM Version 2010
    C91.0
    ICD-9-CM Version 2011
    204.0
    UMLS CUI 2011AA
    C1368871
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0013089
    SNOMED CT 2011_0131
    68444001
    LOINC Version 232
    MTHU004184
    Parents or legal representative(s) must provide written informed consent to participate in the trial according to national regulations. Patients that are able to understand should provide assent to participate in the trial.
    Description

    Parents or legal representative(s) must provide written informed consent to participate in the trial according to national regulations. Patients that are able to understand should provide assent to participate in the trial.

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0021430
    Life expectancy of at least 3 month
    Description

    Life expectancy of at least 3 month

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0023671
    Karnofsky
    Description

    Karnofsky performance status of >= 70%

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0206065
    SNOMED CT 2011_0131
    273546003
    Additional blood withdrawal is acceptable for the patient. The decision is left to the investigator
    Description

    Additional blood withdrawal is acceptable for the patient. The decision is left to the investigator

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C1524062
    LOINC Version 232
    MTHU013802
    UMLS CUI 2011AA
    C0005834
    SNOMED CT 2011_0131
    82078001
    UMLS CUI 2011AA
    C1879533
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    Ausschlusskriterien
    Description

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    prior cardiac problems
    Description

    prior cardiac problems

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C0262402
    Retour au début de la page

    Similar models

    Eligibility

    1 Formulaires
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Einschlusskriterien
    CL425202 (UMLS CUI 2011AA)
    age up to 17 Years
    Item
    Alter bis zu 17 Jahre
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    plan to receive at least two cycles of doxorubicin
    Item
    plan to receive at least two cycles of doxorubicin
    boolean
    C1301732 (UMLS CUI 2011AA)
    397943006 (SNOMED CT 2011_0131)
    C0439091 (UMLS CUI 2011AA)
    276138003 (SNOMED CT 2011_0131)
    GE (HL7 V3 2006_05)
    C0205448 (UMLS CUI 2011AA)
    19338005 (SNOMED CT 2011_0131)
    C0439596 (UMLS CUI 2011AA)
    44180009 (SNOMED CT 2011_0131)
    C0013089 (UMLS CUI 2011AA)
    68444001 (SNOMED CT 2011_0131)
    MTHU004184 (LOINC Version 232)
    must be enrolled in a national or European protocol for treatment of Wilms Tumours, Neuroblastoma, Soft tissue sarcoma, Ewing Sarcoma or Acute lymphoblastic leukaemia and must be treated with doxorubicin according to that protocol Or Patients < 3 years enrolled or listed in any national or European study protocol for any paediatric malignancy. Treatment with doxorubicin has to be according to that protocol.
    Item
    must be enrolled in a national or European protocol for treatment of Wilms Tumours, Neuroblastoma, Soft tissue sarcoma, Ewing Sarcoma or Acute lymphoblastic leukaemia and must be treated with doxorubicin according to that protocol Or Patients < 3 years enrolled or listed in any national or European study protocol for any paediatric malignancy. Treatment with doxorubicin has to be according to that protocol.
    boolean
    C1516879 (UMLS CUI 2011AA)
    CL415062 (UMLS CUI 2011AA)
    C1535514 (UMLS CUI 2011AA)
    414152003 (SNOMED CT 2011_0131)
    2108-9 (HL7 V3 2006_05)
    C0040808 (UMLS CUI 2011AA)
    CL343552 (UMLS CUI 2011AA)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0027819 (UMLS CUI 2011AA)
    432328008 (SNOMED CT 2011_0131)
    10029260 (MedDRA 14.1)
    CL353068 (UMLS CUI 2011AA)
    2424003 (SNOMED CT 2011_0131)
    C0553580 (UMLS CUI 2011AA)
    76909002 (SNOMED CT 2011_0131)
    10015560 (MedDRA 14.1)
    C0023449 (UMLS CUI 2011AA)
    91857003, 128822004 (SNOMED CT 2011_0131)
    10060390 (MedDRA 14.1)
    C91.0 (ICD-10-CM Version 2010)
    204.0 (ICD-9-CM Version 2011)
    C1368871 (UMLS CUI 2011AA)
    C0039798 (UMLS CUI 2011AA)
    C0013089 (UMLS CUI 2011AA)
    68444001 (SNOMED CT 2011_0131)
    MTHU004184 (LOINC Version 232)
    Parents or legal representative(s) must provide written informed consent to participate in the trial according to national regulations. Patients that are able to understand should provide assent to participate in the trial.
    Item
    Parents or legal representative(s) must provide written informed consent to participate in the trial according to national regulations. Patients that are able to understand should provide assent to participate in the trial.
    boolean
    C0021430 (UMLS CUI 2011AA)
    Life expectancy of at least 3 month
    Item
    Life expectancy of at least 3 month
    boolean
    C0023671 (UMLS CUI 2011AA)
    Karnofsky performance status of >= 70%
    Item
    Karnofsky
    boolean
    C0206065 (UMLS CUI 2011AA)
    273546003 (SNOMED CT 2011_0131)
    Additional blood withdrawal is acceptable for the patient. The decision is left to the investigator
    Item
    Additional blood withdrawal is acceptable for the patient. The decision is left to the investigator
    boolean
    C1524062 (UMLS CUI 2011AA)
    MTHU013802 (LOINC Version 232)
    C0005834 (UMLS CUI 2011AA)
    82078001 (SNOMED CT 2011_0131)
    C1879533 (UMLS CUI 2011AA)
    C0030705 (UMLS CUI 2011AA)
    116154003 (SNOMED CT 2011_0131)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    prior cardiac problems
    Item
    prior cardiac problems
    boolean
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C0262402 (UMLS CUI 2011AA)
    Retour au début de la page 

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