ID

5050

Description

ODM derived from http://clinicaltrials.gov/show/NCT00927836

Link

http://clinicaltrials.gov/show/NCT00927836

Keywords

Versions (2)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
Uploaded on

April 17, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00927836 Acute Ischemic Stroke

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 85 Years
Description

age 18 Years to 85 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
diagnosis of acute ischemic stroke with an onset within 9 hours prior to start of study agent administration
Description

diagnosis of acute ischemic stroke with an onset within 9 hours prior to start of study agent administration

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0948008
SNOMED CT 2011_0131
422504002
MedDRA 14.1
10055221
UMLS CUI 2011AA
C0332162
SNOMED CT 2011_0131
77374008
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
ischemic stroke in the MCA territory confirmed by MRI (diffusion)
Description

ischemic stroke in the MCA territory confirmed by MRI (diffusion)

Data type

boolean

Alias
UMLS CUI 2011AA
C0948008
SNOMED CT 2011_0131
422504002
MedDRA 14.1
10055221
UMLS CUI 2011AA
C1269012
SNOMED CT 2011_0131
181312002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
lesion size on DWI >=15 ccm
Description

lesion size on DWI >=15 ccm

Data type

boolean

Alias
UMLS CUI 2011AA
C0449453
SNOMED CT 2011_0131
246116008
UMLS CUI 2011AA
CL382559
written informed consent
Description

written informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
prior to current stroke: inability to walk or to lead an independent life
Description

prior to current stroke: inability to walk or to lead an independent life

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
UMLS CUI 2011AA
C0560046
SNOMED CT 2011_0131
282145008
MedDRA 14.1
10049278
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0085862
LOINC Version 232
MTHU013536
UMLS CUI 2011AA
C0376558
LOINC Version 232
MTHU029989
life expectancy <= 6 months
Description

life expectancy <= 6 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
LOINC Version 232
LP75025-4
UMLS CUI 2011AA
C0439090
SNOMED CT 2011_0131
276137008
HL7 V3 2006_05
LE
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
stupor or coma
Description

stupor or coma

Data type

boolean

Alias
UMLS CUI 2011AA
C0085628
SNOMED CT 2011_0131
89458003
MedDRA 14.1
10042264
ICD-10-CM Version 2010
R40.1
UMLS CUI 2011AA
C0009421
SNOMED CT 2011_0131
371632003
MedDRA 14.1
10010071
LOINC Version 232
MTHU020645
ICD-10-CM Version 2010
R40.20
ICD-9-CM Version 2011
780.01
Lacunar infarction
Description

lacunar infarct

Data type

boolean

Alias
UMLS CUI 2011AA
C0333559
SNOMED CT 2011_0131
81037000
MedDRA 14.1
10051078
Intracerebral hemorrhage (ICH)
Description

any evidence of ICH

Data type

boolean

Alias
UMLS CUI 2011AA
C2937358
SNOMED CT 2011_0131
274100004
MedDRA 14.1
10008111
ICD-9-CM Version 2011
431
Malignant Hypertension
Description

malignant hypertension

Data type

boolean

Alias
UMLS CUI 2011AA
C0020540
SNOMED CT 2011_0131
70272006
MedDRA 14.1
10025600
presence of history of active malignancies
Description

presence of history of active malignancies

Data type

boolean

Alias
UMLS CUI 2011AA
C0006826
platelet count <100/nl at randomization
Description

platelet count <100/nl at randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
UMLS CUI 2011AA
C0034656
leukocyte count >20/nl at randomization
Description

leukocyte count >20/nl at randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
UMLS CUI 2011AA
C0034656
Congenital neutropenia
Description

congenital neutropenia

Data type

boolean

Alias
UMLS CUI 2011AA
C0340970
SNOMED CT 2011_0131
89655007
MedDRA 14.1
10069819
ICD-10-CM Version 2010
D70.0
ICD-9-CM Version 2011
288.01
pregnant or lactating women
Description

pregnant or lactating women

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 85 Years
Item
age 18 Years to 85 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
diagnosis of acute ischemic stroke with an onset within 9 hours prior to start of study agent administration
Item
diagnosis of acute ischemic stroke with an onset within 9 hours prior to start of study agent administration
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0948008 (UMLS CUI 2011AA)
422504002 (SNOMED CT 2011_0131)
10055221 (MedDRA 14.1)
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
ischemic stroke in the MCA territory confirmed by MRI (diffusion)
Item
ischemic stroke in the MCA territory confirmed by MRI (diffusion)
boolean
C0948008 (UMLS CUI 2011AA)
422504002 (SNOMED CT 2011_0131)
10055221 (MedDRA 14.1)
C1269012 (UMLS CUI 2011AA)
181312002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
lesion size on DWI >=15 ccm
Item
lesion size on DWI >=15 ccm
boolean
C0449453 (UMLS CUI 2011AA)
246116008 (SNOMED CT 2011_0131)
CL382559 (UMLS CUI 2011AA)
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
prior to current stroke: inability to walk or to lead an independent life
Item
prior to current stroke: inability to walk or to lead an independent life
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0560046 (UMLS CUI 2011AA)
282145008 (SNOMED CT 2011_0131)
10049278 (MedDRA 14.1)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0085862 (UMLS CUI 2011AA)
MTHU013536 (LOINC Version 232)
C0376558 (UMLS CUI 2011AA)
MTHU029989 (LOINC Version 232)
life expectancy <= 6 months
Item
life expectancy <= 6 months
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439090 (UMLS CUI 2011AA)
276137008 (SNOMED CT 2011_0131)
LE (HL7 V3 2006_05)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
stupor or coma
Item
stupor or coma
boolean
C0085628 (UMLS CUI 2011AA)
89458003 (SNOMED CT 2011_0131)
10042264 (MedDRA 14.1)
R40.1 (ICD-10-CM Version 2010)
C0009421 (UMLS CUI 2011AA)
371632003 (SNOMED CT 2011_0131)
10010071 (MedDRA 14.1)
MTHU020645 (LOINC Version 232)
R40.20 (ICD-10-CM Version 2010)
780.01 (ICD-9-CM Version 2011)
lacunar infarct
Item
Lacunar infarction
boolean
C0333559 (UMLS CUI 2011AA)
81037000 (SNOMED CT 2011_0131)
10051078 (MedDRA 14.1)
any evidence of ICH
Item
Intracerebral hemorrhage (ICH)
boolean
C2937358 (UMLS CUI 2011AA)
274100004 (SNOMED CT 2011_0131)
10008111 (MedDRA 14.1)
431 (ICD-9-CM Version 2011)
malignant hypertension
Item
Malignant Hypertension
boolean
C0020540 (UMLS CUI 2011AA)
70272006 (SNOMED CT 2011_0131)
10025600 (MedDRA 14.1)
presence of history of active malignancies
Item
presence of history of active malignancies
boolean
C0006826 (UMLS CUI 2011AA)
platelet count <100/nl at randomization
Item
platelet count <100/nl at randomization
boolean
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C0034656 (UMLS CUI 2011AA)
leukocyte count >20/nl at randomization
Item
leukocyte count >20/nl at randomization
boolean
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
C0034656 (UMLS CUI 2011AA)
congenital neutropenia
Item
Congenital neutropenia
boolean
C0340970 (UMLS CUI 2011AA)
89655007 (SNOMED CT 2011_0131)
10069819 (MedDRA 14.1)
D70.0 (ICD-10-CM Version 2010)
288.01 (ICD-9-CM Version 2011)
pregnant or lactating women
Item
pregnant or lactating women
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
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