ID

43437

Description

ODM derived from http://clinicaltrials.gov/show/NCT00749723

Link

http://clinicaltrials.gov/show/NCT00749723

Keywords

  1. 12/6/13 12/6/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility DRKS00003778 NCT00749723 Recurrent Brain Tumors

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Description

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter 3 Monate bis 30 Jahre
Description

age 3 Months to 30 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Histologically confirmed Medulloblastoma, cerebral PNET or Ependymoma
Description

Histologically confirmed Medulloblastoma, cerebral PNET or Ependymoma

Data type

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0025149
SNOMED CT 2011_0131
443333004
MedDRA 14.1
10027107
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0751675
UMLS CUI 2011AA
C0014474
SNOMED CT 2011_0131
443643007
MedDRA 14.1
10014967
Refractory or relapsed disease
Description

Refractory or relapsed disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0205269
SNOMED CT 2011_0131
20646008
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
Measurable disease by MRI or detection of tumor cells in cerebrospinal fluid
Description

Measurable disease by MRI or detection of tumor cells in cerebrospinal fluid

Data type

boolean

Alias
UMLS CUI 2011AA
C1513040
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
C1511790
UMLS CUI 2011AA
C0597032
SNOMED CT 2011_0131
252987004
UMLS CUI 2011AA
C0007806
SNOMED CT 2011_0131
65216001
LOINC Version 232
MTHU001311
HL7 V3 2006_05
CSF
Performance status ECOG >= 3 or Karnofsky Status >= 40%
Description

Performance status ECOG >= 3 or Karnofsky Status >= 40%

Data type

boolean

Alias
UMLS CUI 2011AA
C1828127
SNOMED CT 2011_0131
424122007
UMLS CUI 2011AA
C0206065
SNOMED CT 2011_0131
273546003
Life expectancy >= 8 weeks
Description

Life expectancy >= 8 weeks

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
Absolute leukocyte count >= 2.0 x 10^9 /l
Description

Absolute leukocyte count >= 2.0 x 10^9 /l

Data type

boolean

Alias
UMLS CUI 2011AA
C0205344
SNOMED CT 2011_0131
56136002
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
Hämoglobin, Hb
Description

Hemoglobin >= 10g/dl

Data type

boolean

Alias
UMLS CUI 2011AA
C0518015
MedDRA 14.1
10018876
Thrombozyten
Description

Platelet count >= 70 x 10^9/l

Data type

boolean

Alias
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
Creatinine no greater than 1.5 times UNL
Description

Creatinine no greater than 1.5 times UNL

Data type

boolean

Alias
UMLS CUI 2011AA
C0010294
SNOMED CT 2011_0131
15373003
MedDRA 14.1
10011358
LOINC Version 232
38483-4
UMLS CUI 2011AA
C1519815
No overt renal disease
Description

No overt renal disease

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
Bilirubin < 2.5 times UNL
Description

Bilirubin < 2.5 times UNL

Data type

boolean

Alias
UMLS CUI 2011AA
C1278039
AST and ALT < 5 times UNL
Description

AST and ALT < 5 times UNL

Data type

boolean

Alias
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C1519815
No overt hepatic disease
Description

No overt hepatic disease

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
No overt pulmonary disease
Description

No overt pulmonary disease

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0024115
SNOMED CT 2011_0131
19829001
MedDRA 14.1
10025082
ICD-10-CM Version 2010
J98.4
No overt cardiovascular disease
Description

No overt cardiovascular disease

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
Not pregnant or nursing
Description

Not pregnant or nursing

Data type

boolean

Alias
UMLS CUI 2011AA
C0232973
SNOMED CT 2011_0131
60001007
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
negativer Schwangerschaftstest
Description

Negative pregnancy test

Data type

boolean

Alias
UMLS CUI 2011AA
C0427780
SNOMED CT 2011_0131
250425007
MedDRA 14.1
10036574
Fertile patients must use effective contraception
Description

Fertile patients must use effective contraception

Data type

boolean

Alias
UMLS CUI 2011AA
CL426012
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
No uncontrolled infection prior concurrent therapy
Description

No uncontrolled infection prior concurrent therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0009429
> 2 weeks since prior systemic chemotherapy
Description

> 2 weeks since prior systemic chemotherapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C1514457
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
> 4 weeks since prior radiotherapy
Description

> 4 weeks since prior radiotherapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
No other concurrent anticancer or experimental drugs
Description

No other concurrent anticancer or experimental drugs

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C0003392
SNOMED CT 2011_0131
372688009
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
Examination of lumbar CSF
Description

Examination of lumbar CSF

Data type

boolean

Alias
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
UMLS CUI 2011AA
C0024090
SNOMED CT 2011_0131
264082005
UMLS CUI 2011AA
C0007806
SNOMED CT 2011_0131
65216001
LOINC Version 232
MTHU001311
HL7 V3 2006_05
CSF
Cranial and spinal MRI within 14 days prior to start of treatment
Description

Cranial and spinal MRI within 14 days prior to start of treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0037303
SNOMED CT 2011_0131
89546000
LOINC Version 232
MTHU003024
UMLS CUI 2011AA
C0521329
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
CL414705
UMLS CUI 2011AA
C0039798

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age 3 Months to 30 Years
Item
Alter 3 Monate bis 30 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Histologically confirmed Medulloblastoma, cerebral PNET or Ependymoma
Item
Histologically confirmed Medulloblastoma, cerebral PNET or Ependymoma
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0025149 (UMLS CUI 2011AA)
443333004 (SNOMED CT 2011_0131)
10027107 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0751675 (UMLS CUI 2011AA)
C0014474 (UMLS CUI 2011AA)
443643007 (SNOMED CT 2011_0131)
10014967 (MedDRA 14.1)
Refractory or relapsed disease
Item
Refractory or relapsed disease
boolean
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
Measurable disease by MRI or detection of tumor cells in cerebrospinal fluid
Item
Measurable disease by MRI or detection of tumor cells in cerebrospinal fluid
boolean
C1513040 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C1511790 (UMLS CUI 2011AA)
C0597032 (UMLS CUI 2011AA)
252987004 (SNOMED CT 2011_0131)
C0007806 (UMLS CUI 2011AA)
65216001 (SNOMED CT 2011_0131)
MTHU001311 (LOINC Version 232)
CSF (HL7 V3 2006_05)
Performance status ECOG >= 3 or Karnofsky Status >= 40%
Item
Performance status ECOG >= 3 or Karnofsky Status >= 40%
boolean
C1828127 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
C0206065 (UMLS CUI 2011AA)
273546003 (SNOMED CT 2011_0131)
Life expectancy >= 8 weeks
Item
Life expectancy >= 8 weeks
boolean
C0023671 (UMLS CUI 2011AA)
Absolute leukocyte count >= 2.0 x 10^9 /l
Item
Absolute leukocyte count >= 2.0 x 10^9 /l
boolean
C0205344 (UMLS CUI 2011AA)
56136002 (SNOMED CT 2011_0131)
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
Hemoglobin >= 10g/dl
Item
Hämoglobin, Hb
boolean
C0518015 (UMLS CUI 2011AA)
10018876 (MedDRA 14.1)
Platelet count >= 70 x 10^9/l
Item
Thrombozyten
boolean
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
Creatinine no greater than 1.5 times UNL
Item
Creatinine no greater than 1.5 times UNL
boolean
C0010294 (UMLS CUI 2011AA)
15373003 (SNOMED CT 2011_0131)
10011358 (MedDRA 14.1)
38483-4 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
No overt renal disease
Item
No overt renal disease
boolean
C1518422 (UMLS CUI 2011AA)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
Bilirubin < 2.5 times UNL
Item
Bilirubin < 2.5 times UNL
boolean
C1278039 (UMLS CUI 2011AA)
AST and ALT < 5 times UNL
Item
AST and ALT < 5 times UNL
boolean
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
No overt hepatic disease
Item
No overt hepatic disease
boolean
C1518422 (UMLS CUI 2011AA)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
No overt pulmonary disease
Item
No overt pulmonary disease
boolean
C1518422 (UMLS CUI 2011AA)
C0024115 (UMLS CUI 2011AA)
19829001 (SNOMED CT 2011_0131)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
No overt cardiovascular disease
Item
No overt cardiovascular disease
boolean
C1518422 (UMLS CUI 2011AA)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
Not pregnant or nursing
Item
Not pregnant or nursing
boolean
C0232973 (UMLS CUI 2011AA)
60001007 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Negative pregnancy test
Item
negativer Schwangerschaftstest
boolean
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
Fertile patients must use effective contraception
Item
Fertile patients must use effective contraception
boolean
CL426012 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
No uncontrolled infection prior concurrent therapy
Item
No uncontrolled infection prior concurrent therapy
boolean
C1518422 (UMLS CUI 2011AA)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0009429 (UMLS CUI 2011AA)
> 2 weeks since prior systemic chemotherapy
Item
> 2 weeks since prior systemic chemotherapy
boolean
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C1514457 (UMLS CUI 2011AA)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
> 4 weeks since prior radiotherapy
Item
> 4 weeks since prior radiotherapy
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
No other concurrent anticancer or experimental drugs
Item
No other concurrent anticancer or experimental drugs
boolean
C1518422 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0003392 (UMLS CUI 2011AA)
372688009 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Examination of lumbar CSF
Item
Examination of lumbar CSF
boolean
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
C0024090 (UMLS CUI 2011AA)
264082005 (SNOMED CT 2011_0131)
C0007806 (UMLS CUI 2011AA)
65216001 (SNOMED CT 2011_0131)
MTHU001311 (LOINC Version 232)
CSF (HL7 V3 2006_05)
Cranial and spinal MRI within 14 days prior to start of treatment
Item
Cranial and spinal MRI within 14 days prior to start of treatment
boolean
C0037303 (UMLS CUI 2011AA)
89546000 (SNOMED CT 2011_0131)
MTHU003024 (LOINC Version 232)
C0521329 (UMLS CUI 2011AA)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
CL414705 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)

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