ID

5117

Description

ODM derived from http://clinicaltrials.gov/show/NCT01282645

Link

http://clinicaltrials.gov/show/NCT01282645

Keywords

Versions (2)
  1. 2/22/13 2/22/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
Uploaded on

April 19, 2014

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT01282645 E04.525.190

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
Cranial Defects
Description

Cranial Defects

Data type

boolean

Alias
UMLS CUI 2011AA
C3163632
UMLS CUI 2011AA
C1457869
SNOMED CT 2011_0131
6920004
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Received a Synthes PSI made of PEEK intended for replacement of bony voids in the cranial/craniofacial skeleton at least 24 months before inclusion in the study
Description

Received a Synthes PSI made of PEEK intended for replacement of bony voids in the cranial/craniofacial skeleton at least 24 months before inclusion in the study

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1552740
HL7 V3 2006_05
INSTANCE
UMLS CUI 2011AA
C0021102
SNOMED CT 2011_0131
40388003
UMLS CUI 2011AA
C0084113
UMLS CUI 2011AA
C0559956
SNOMED CT 2011_0131
282089006
UMLS CUI 2011AA
C0262950
SNOMED CT 2011_0131
272673000
LOINC Version 232
MTHU011886
UMLS CUI 2011AA
C1510420
SNOMED CT 2011_0131
2483006
UMLS CUI 2011AA
C0037303
SNOMED CT 2011_0131
89546000
LOINC Version 232
MTHU003024
UMLS CUI 2011AA
C0596392
UMLS CUI 2011AA
C0816871
Ability to obtain written informed consent from the recipient or the recipient's legal guardian
Description

Ability to obtain written informed consent from the recipient or the recipient's legal guardian

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C1301820
SNOMED CT 2011_0131
398092000
UMLS CUI 2011AA
C1576874
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0021430
UMLS CUI 2011AA
C1709854
UMLS CUI 2011AA
C0023226
SNOMED CT 2011_0131
58626002
LOINC Version 232
MTHU020628
Ability to comply with the procedures described in the protocol, including responding to simple questionnaires either by the recipient in person or by a next relative (spouse, parent) who lives with the recipient
Description

Ability to comply with the procedures described in the protocol, including responding to simple questionnaires either by the recipient in person or by a next relative (spouse, parent) who lives with the recipient

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0525058
UMLS CUI 2011AA
C1706817
UMLS CUI 2011AA
C0034394
UMLS CUI 2011AA
C1709854
UMLS CUI 2011AA
C0080103
SNOMED CT 2011_0131
125677006
Exclusion Criteria
Description

Exclusion Criteria

Patient was contraindicated to receive a PSI made of PEEK at the time of implantation
Description

Patient was contraindicated to receive a PSI made of PEEK at the time of implantation

Data type

boolean

Alias
UMLS CUI 2011AA
C1444657
SNOMED CT 2011_0131
410536001
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1552740
HL7 V3 2006_05
INSTANCE
UMLS CUI 2011AA
C0021102
SNOMED CT 2011_0131
40388003
UMLS CUI 2011AA
C0084113
Back to the top of the page

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)
Cranial Defects
Item
Cranial Defects
boolean
C3163632 (UMLS CUI 2011AA)
C1457869 (UMLS CUI 2011AA)
6920004 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Received a Synthes PSI made of PEEK intended for replacement of bony voids in the cranial/craniofacial skeleton at least 24 months before inclusion in the study
Item
Received a Synthes PSI made of PEEK intended for replacement of bony voids in the cranial/craniofacial skeleton at least 24 months before inclusion in the study
boolean
C1514756 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1552740 (UMLS CUI 2011AA)
INSTANCE (HL7 V3 2006_05)
C0021102 (UMLS CUI 2011AA)
40388003 (SNOMED CT 2011_0131)
C0084113 (UMLS CUI 2011AA)
C0559956 (UMLS CUI 2011AA)
282089006 (SNOMED CT 2011_0131)
C0262950 (UMLS CUI 2011AA)
272673000 (SNOMED CT 2011_0131)
MTHU011886 (LOINC Version 232)
C1510420 (UMLS CUI 2011AA)
2483006 (SNOMED CT 2011_0131)
C0037303 (UMLS CUI 2011AA)
89546000 (SNOMED CT 2011_0131)
MTHU003024 (LOINC Version 232)
C0596392 (UMLS CUI 2011AA)
C0816871 (UMLS CUI 2011AA)
Ability to obtain written informed consent from the recipient or the recipient's legal guardian
Item
Ability to obtain written informed consent from the recipient or the recipient's legal guardian
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1301820 (UMLS CUI 2011AA)
398092000 (SNOMED CT 2011_0131)
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
C1709854 (UMLS CUI 2011AA)
C0023226 (UMLS CUI 2011AA)
58626002 (SNOMED CT 2011_0131)
MTHU020628 (LOINC Version 232)
Ability to comply with the procedures described in the protocol, including responding to simple questionnaires either by the recipient in person or by a next relative (spouse, parent) who lives with the recipient
Item
Ability to comply with the procedures described in the protocol, including responding to simple questionnaires either by the recipient in person or by a next relative (spouse, parent) who lives with the recipient
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
C1706817 (UMLS CUI 2011AA)
C0034394 (UMLS CUI 2011AA)
C1709854 (UMLS CUI 2011AA)
C0080103 (UMLS CUI 2011AA)
125677006 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
Patient was contraindicated to receive a PSI made of PEEK at the time of implantation
Item
Patient was contraindicated to receive a PSI made of PEEK at the time of implantation
boolean
C1444657 (UMLS CUI 2011AA)
410536001 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1552740 (UMLS CUI 2011AA)
INSTANCE (HL7 V3 2006_05)
C0021102 (UMLS CUI 2011AA)
40388003 (SNOMED CT 2011_0131)
C0084113 (UMLS CUI 2011AA)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial