ID

4322

Descrizione

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

collegamento

http://clinicaltrials.gov/show/NCT01095926

Keywords

versioni (2)
  1. 06/12/13 06/12/13 - Martin Dugas
  2. 17/04/14 17/04/14 - Julian Varghese
Caricato su

6 dicembre 2013

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT01095926 Wilms Tumor

Tedesco Inglese

Eligibility

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Descrizione

Einschlusskriterien

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

age up to 17 Years

Tipo di dati

boolean

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

plan to receive at least two cycles of doxorubicin

Tipo di dati

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.
Descrizione

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.

Tipo di dati

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.
Descrizione

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.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0030551
SNOMED CT 2011_0131
40683002
HL7 V3 2006_05
PARNT
UMLS CUI 2011AA
C0030701
UMLS CUI 2011AA
C1576874
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0021430
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1273101
SNOMED CT 2011_0131
395659009
UMLS CUI 2011AA
C1883385
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Life expectancy of at least 3 month
Descrizione

Life expectancy of at least 3 month

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0023671
LOINC Version 232
LP75025-4
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Karnofsky
Descrizione

Karnofsky performance status of >= 70%

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
prior cardiac problems
Descrizione

prior cardiac problems

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0262402
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Similar models

Eligibility

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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
C0030551 (UMLS CUI 2011AA)
40683002 (SNOMED CT 2011_0131)
PARNT (HL7 V3 2006_05)
C0030701 (UMLS CUI 2011AA)
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1273101 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C1883385 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Life expectancy of at least 3 month
Item
Life expectancy of at least 3 month
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
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)
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