ID

5148

Description

ODM derived from http://clinicaltrials.gov/show/NCT01410916

Link

http://clinicaltrials.gov/show/NCT01410916

Keywords

Versions (2)
  1. 4/17/13 4/17/13 - Martin Dugas
  2. 4/20/14 4/20/14 - Julian Varghese
Uploaded on

April 20, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01410916 Shiga-like Toxin-producing Escherichia Coli

German English

Eligibility

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

Inclusion Criteria

age at least 2 Months
Description

age at least 2 Months

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patient must be willing and able to give written informed consent/Assent.
Description

Patient must be willing and able to give written informed consent/Assent.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Adults, adolescents, or pediatric (>=2 months and >=5kg) patients
Description

Adults, adolescents, or pediatric (>=2 months and >=5kg) patients

Data type

boolean

Alias
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
UMLS CUI 2011AA
C0205653
SNOMED CT 2011_0131
133937008
UMLS CUI 2011AA
C1521725
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
Patient has been diagnosed with Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
Description

Patient has been diagnosed with Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0580794
SNOMED CT 2011_0131
116395006
UMLS CUI 2011AA
C0019061
SNOMED CT 2011_0131
111407006
MedDRA 14.1
10018932
ICD-10-CM Version 2010
D59.3
ICD-9-CM Version 2011
283.11
CTCAE 1105E
E10043
Exclusion Criteria
Description

Exclusion Criteria

Known complement regulatory mutation or family history of complement regulatory mutation
Description

Known complement regulatory mutation or family history of complement regulatory mutation

Data type

boolean

Alias
UMLS CUI 2011AA
C0312772
SNOMED CT 2011_0131
106194009
UMLS CUI 2011AA
C0026882
SNOMED CT 2011_0131
55446002
UMLS CUI 2011AA
C0241889
SNOMED CT 2011_0131
57177007
Unresolved systemic meningococcal disease
Description

Unresolved systemic meningococcal disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0443342
SNOMED CT 2011_0131
263921008
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0025303
SNOMED CT 2011_0131
23511006
MedDRA 14.1
10027274
ICD-10-CM Version 2010
A39.9
ICD-9-CM Version 2011
036.9
Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
Description

Hypersensitivity to eculizumab, to murine proteins or to one of the excipients

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C1541483
SNOMED CT 2011_0131
427429004
UMLS CUI 2011AA
C1334805
UMLS CUI 2011AA
C0015237
SNOMED CT 2011_0131
360215002
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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
age at least 2 Months
Item
age at least 2 Months
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patient must be willing and able to give written informed consent/Assent.
Item
Patient must be willing and able to give written informed consent/Assent.
boolean
C0021430 (UMLS CUI 2011AA)
Adults, adolescents, or pediatric (>=2 months and >=5kg) patients
Item
Adults, adolescents, or pediatric (>=2 months and >=5kg) patients
boolean
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
C0205653 (UMLS CUI 2011AA)
133937008 (SNOMED CT 2011_0131)
C1521725 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
Patient has been diagnosed with Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
Item
Patient has been diagnosed with Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0580794 (UMLS CUI 2011AA)
116395006 (SNOMED CT 2011_0131)
C0019061 (UMLS CUI 2011AA)
111407006 (SNOMED CT 2011_0131)
10018932 (MedDRA 14.1)
D59.3 (ICD-10-CM Version 2010)
283.11 (ICD-9-CM Version 2011)
E10043 (CTCAE 1105E)
Item Group
Exclusion Criteria
Known complement regulatory mutation or family history of complement regulatory mutation
Item
Known complement regulatory mutation or family history of complement regulatory mutation
boolean
C0312772 (UMLS CUI 2011AA)
106194009 (SNOMED CT 2011_0131)
C0026882 (UMLS CUI 2011AA)
55446002 (SNOMED CT 2011_0131)
C0241889 (UMLS CUI 2011AA)
57177007 (SNOMED CT 2011_0131)
Unresolved systemic meningococcal disease
Item
Unresolved systemic meningococcal disease
boolean
C0443342 (UMLS CUI 2011AA)
263921008 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0025303 (UMLS CUI 2011AA)
23511006 (SNOMED CT 2011_0131)
10027274 (MedDRA 14.1)
A39.9 (ICD-10-CM Version 2010)
036.9 (ICD-9-CM Version 2011)
Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
Item
Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1541483 (UMLS CUI 2011AA)
427429004 (SNOMED CT 2011_0131)
C1334805 (UMLS CUI 2011AA)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
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