Information:
Error:
ID
5082
Description
ODM derived from http://clinicaltrials.gov/show/NCT01095926
Link
http://clinicaltrials.gov/show/NCT01095926
Keywords
Versions (2)
- 12/6/13 12/6/13 - Martin Dugas
- 4/17/14 4/17/14 - Julian Varghese
Uploaded on
April 17, 2014
DOI
To request one please log in.
License
Creative Commons BY 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Eligibility DRKS00003787 NCT01095926 Wilms Tumor
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Similar models
Eligibility
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
age up to 17 Years
Item
age up to 17 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
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)
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)
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 performance status (assessment scale)
boolean
C0206065 (UMLS CUI 2011AA)
273546003 (SNOMED CT 2011_0131)
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)
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)
prior cardiac problems
Item
prior cardiac problems
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0262402 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0262402 (UMLS CUI 2011AA)