ID

5084

Descrizione

ODM derived from http://clinicaltrials.gov/show/NCT01117441

collegamento

http://clinicaltrials.gov/show/NCT01117441

Keywords

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

17 aprile 2014

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility NCT01117441 Leukemia

Tedesco Inglese

Eligibility

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 1 Year to 18 Years
Descrizione

age 1 Year to 18 Years

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
newly diagnosed acute lymphoblastic leukemia
Descrizione

newly diagnosed acute lymphoblastic leukemia

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C2585997
SNOMED CT 2011_0131
441308009
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
no Ph+ (BCR/ABL or t(9;22)-positive) ALL
Descrizione

no Ph+ (BCR/ABL or t(9;22)-positive) ALL

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1960397
SNOMED CT 2011_0131
425688002
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL415097
UMLS CUI 2011AA
C0004891
SNOMED CT 2011_0131
56564003
LOINC Version 232
MTHU021298
UMLS CUI 2011AA
C1515809
no evidence of pregnancy or lactation period
Descrizione

no evidence of pregnancy or lactation period

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0332125
SNOMED CT 2011_0131
41647002
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C1948053
no participation in another clinical study
Descrizione

no participation in another clinical study

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
patient enrolled in a participating center
Descrizione

patient enrolled in a participating center

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205099
SNOMED CT 2011_0131
26216008
written informed consent
Descrizione

written informed consent

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
pre-treatment with cytostatic drugs
Descrizione

pre-treatment with cytostatic drugs

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C1882440
UMLS CUI 2011AA
C0010858
SNOMED CT 2011_0131
373221003
steroid pre-treatment with >= 1 mg/kg/d for > two weeks during the last month before diagnosis
Descrizione

steroid pre-treatment with >= 1 mg/kg/d for > two weeks during the last month before diagnosis

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
UMLS CUI 2011AA
C1882440
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
treatment started according to another protocol
Descrizione

treatment started according to another protocol

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1272689
SNOMED CT 2011_0131
385652002
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C2348563
underlying diseases that prohibit treatment according to the protocol
Descrizione

underlying diseases that prohibit treatment according to the protocol

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C1527178
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0683610
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C2348563
ALL diagnosed as second malignancy steroid pre-treatment with >= 1 mg/kg/d for more than two weeks during the last month before diagnosis
Descrizione

ALL diagnosed as second malignancy steroid pre-treatment with >= 1 mg/kg/d for more than two weeks during the last month before diagnosis

Tipo di dati

boolean

Alias
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
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0205436
SNOMED CT 2011_0131
81170007
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
UMLS CUI 2011AA
C1882440
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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
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 1 Year to 18 Years
Item
age 1 Year to 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
newly diagnosed acute lymphoblastic leukemia
Item
newly diagnosed acute lymphoblastic leukemia
boolean
C2585997 (UMLS CUI 2011AA)
441308009 (SNOMED CT 2011_0131)
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)
no Ph+ (BCR/ABL or t(9;22)-positive) ALL
Item
no Ph+ (BCR/ABL or t(9;22)-positive) ALL
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1960397 (UMLS CUI 2011AA)
425688002 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
CL415097 (UMLS CUI 2011AA)
C0004891 (UMLS CUI 2011AA)
56564003 (SNOMED CT 2011_0131)
MTHU021298 (LOINC Version 232)
C1515809 (UMLS CUI 2011AA)
no evidence of pregnancy or lactation period
Item
no evidence of pregnancy or lactation period
boolean
C0332125 (UMLS CUI 2011AA)
41647002 (SNOMED CT 2011_0131)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C1948053 (UMLS CUI 2011AA)
no participation in another clinical study
Item
no participation in another clinical study
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
patient enrolled in a participating center
Item
patient enrolled in a participating center
boolean
C1516879 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205099 (UMLS CUI 2011AA)
26216008 (SNOMED CT 2011_0131)
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
pre-treatment with cytostatic drugs
Item
pre-treatment with cytostatic drugs
boolean
C1882440 (UMLS CUI 2011AA)
C0010858 (UMLS CUI 2011AA)
373221003 (SNOMED CT 2011_0131)
steroid pre-treatment with >= 1 mg/kg/d for > two weeks during the last month before diagnosis
Item
steroid pre-treatment with >= 1 mg/kg/d for > two weeks during the last month before diagnosis
boolean
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
C1882440 (UMLS CUI 2011AA)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
treatment started according to another protocol
Item
treatment started according to another protocol
boolean
C0039798 (UMLS CUI 2011AA)
C1272689 (UMLS CUI 2011AA)
385652002 (SNOMED CT 2011_0131)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C2348563 (UMLS CUI 2011AA)
underlying diseases that prohibit treatment according to the protocol
Item
underlying diseases that prohibit treatment according to the protocol
boolean
C1527178 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0683610 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C2348563 (UMLS CUI 2011AA)
ALL diagnosed as second malignancy steroid pre-treatment with >= 1 mg/kg/d for more than two weeks during the last month before diagnosis
Item
ALL diagnosed as second malignancy steroid pre-treatment with >= 1 mg/kg/d for more than two weeks during the last month before diagnosis
boolean
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)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205436 (UMLS CUI 2011AA)
81170007 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
C1882440 (UMLS CUI 2011AA)
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