ID

5102

Description

ODM derived from http://clinicaltrials.gov/show/NCT01217528

Link

http://clinicaltrials.gov/show/NCT01217528

Keywords

Versions (2)
  1. 2/12/13 2/12/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
Uploaded on

April 19, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01217528 Cardiac Death

German English

Eligibility

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

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Approved indication for new ICD implantation for primary prevention of sudden cardiac death
Description

Approved indication for new ICD implantation for primary prevention of sudden cardiac death

Data type

boolean

Alias
UMLS CUI 2011AA
C0205540
SNOMED CT 2011_0131
9571008
UMLS CUI 2011AA
CL335836
UMLS CUI 2011AA
C0205314
SNOMED CT 2011_0131
7147002
UMLS CUI 2011AA
C0162589
SNOMED CT 2011_0131
72506001
UMLS CUI 2011AA
C0021107
SNOMED CT 2011_0131
71861002
LOINC Version 232
MTHU035917
UMLS CUI 2011AA
C0033144
SNOMED CT 2011_0131
315233008
UMLS CUI 2011AA
C0085298
SNOMED CT 2011_0131
95281009
MedDRA 14.1
10049418
CTCAE 1105E
E11171
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Written informed consent
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
HL7 V3 2006_05
WRITTEN
Exclusion Criteria
Description

Exclusion Criteria

ICD indication for secondary prevention reasons
Description

ICD indication for secondary prevention reasons

Data type

boolean

Alias
UMLS CUI 2011AA
C0162589
SNOMED CT 2011_0131
72506001
UMLS CUI 2011AA
CL335836
UMLS CUI 2011AA
C0679699
SNOMED CT 2011_0131
315234002
MedDRA 14.1
10067625
UMLS CUI 2011AA
C0392360
SNOMED CT 2011_0131
410666004 230165009
LOINC Version 232
MTHU008862
ICD indication for electrical disorders (i.e. long/short QT syndrome, Brugada syndrome etc...)
Description

ICD indication for electrical disorders (i.e. long/short QT syndrome, Brugada syndrome etc...)

Data type

boolean

Alias
UMLS CUI 2011AA
C0162589
SNOMED CT 2011_0131
72506001
UMLS CUI 2011AA
CL335836
UMLS CUI 2011AA
C0013790
SNOMED CT 2011_0131
258096005, 18213006
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0023976
SNOMED CT 2011_0131
9651007
MedDRA 14.1
10024803
ICD-10-CM Version 2010
I45.81
ICD-9-CM Version 2011
426.82
UMLS CUI 2011AA
C2348199
UMLS CUI 2011AA
C1142166
SNOMED CT 2011_0131
418818005
MedDRA 14.1
10059027
ICD change or upgrade
Description

ICD change or upgrade

Data type

boolean

Alias
UMLS CUI 2011AA
C0162589
SNOMED CT 2011_0131
72506001
UMLS CUI 2011AA
C0392747
SNOMED CT 2011_0131
243326001
UMLS CUI 2011AA
CL433422
Pregnancy, Gestation
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
Nonage
Description

Nonage

Data type

boolean

Alias
UMLS CUI 2011AA
C0026193
SNOMED CT 2011_0131
410599005
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patient is already participating to another study with active therapy arm
Description

Patient is already participating to another study with active therapy arm

Data type

boolean

Alias
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
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C1522541
Patient will most likely not be able to participate to the routine follow ups in the study center.
Description

Patient will most likely not be able to participate to the routine follow ups in the study center.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332148
SNOMED CT 2011_0131
2931005
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205547
SNOMED CT 2011_0131
50811001
UMLS CUI 2011AA
CL433109
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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 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Approved indication for new ICD implantation for primary prevention of sudden cardiac death
Item
Approved indication for new ICD implantation for primary prevention of sudden cardiac death
boolean
C0205540 (UMLS CUI 2011AA)
9571008 (SNOMED CT 2011_0131)
CL335836 (UMLS CUI 2011AA)
C0205314 (UMLS CUI 2011AA)
7147002 (SNOMED CT 2011_0131)
C0162589 (UMLS CUI 2011AA)
72506001 (SNOMED CT 2011_0131)
C0021107 (UMLS CUI 2011AA)
71861002 (SNOMED CT 2011_0131)
MTHU035917 (LOINC Version 232)
C0033144 (UMLS CUI 2011AA)
315233008 (SNOMED CT 2011_0131)
C0085298 (UMLS CUI 2011AA)
95281009 (SNOMED CT 2011_0131)
10049418 (MedDRA 14.1)
E11171 (CTCAE 1105E)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
Item Group
Exclusion Criteria
ICD indication for secondary prevention reasons
Item
ICD indication for secondary prevention reasons
boolean
C0162589 (UMLS CUI 2011AA)
72506001 (SNOMED CT 2011_0131)
CL335836 (UMLS CUI 2011AA)
C0679699 (UMLS CUI 2011AA)
315234002 (SNOMED CT 2011_0131)
10067625 (MedDRA 14.1)
C0392360 (UMLS CUI 2011AA)
410666004 230165009 (SNOMED CT 2011_0131)
MTHU008862 (LOINC Version 232)
ICD indication for electrical disorders (i.e. long/short QT syndrome, Brugada syndrome etc...)
Item
ICD indication for electrical disorders (i.e. long/short QT syndrome, Brugada syndrome etc...)
boolean
C0162589 (UMLS CUI 2011AA)
72506001 (SNOMED CT 2011_0131)
CL335836 (UMLS CUI 2011AA)
C0013790 (UMLS CUI 2011AA)
258096005, 18213006 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0023976 (UMLS CUI 2011AA)
9651007 (SNOMED CT 2011_0131)
10024803 (MedDRA 14.1)
I45.81 (ICD-10-CM Version 2010)
426.82 (ICD-9-CM Version 2011)
C2348199 (UMLS CUI 2011AA)
C1142166 (UMLS CUI 2011AA)
418818005 (SNOMED CT 2011_0131)
10059027 (MedDRA 14.1)
ICD change or upgrade
Item
ICD change or upgrade
boolean
C0162589 (UMLS CUI 2011AA)
72506001 (SNOMED CT 2011_0131)
C0392747 (UMLS CUI 2011AA)
243326001 (SNOMED CT 2011_0131)
CL433422 (UMLS CUI 2011AA)
Pregnancy
Item
Pregnancy, Gestation
boolean
C0549206 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
Nonage
Item
Nonage
boolean
C0026193 (UMLS CUI 2011AA)
410599005 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patient is already participating to another study with active therapy arm
Item
Patient is already participating to another study with active therapy arm
boolean
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)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1522541 (UMLS CUI 2011AA)
Patient will most likely not be able to participate to the routine follow ups in the study center.
Item
Patient will most likely not be able to participate to the routine follow ups in the study center.
boolean
C0332148 (UMLS CUI 2011AA)
2931005 (SNOMED CT 2011_0131)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205547 (UMLS CUI 2011AA)
50811001 (SNOMED CT 2011_0131)
CL433109 (UMLS CUI 2011AA)
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