ID
5028
Description
ODM derived from http://clinicaltrials.gov/show/NCT00882245
Link
http://clinicaltrials.gov/show/NCT00882245
Keywords
Versions (2)
- 12/9/13 12/9/13 - Martin Dugas
- 4/16/14 4/16/14 - Julian Varghese
Uploaded on
April 16, 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.
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 NCT00882245 Atopic Dermatitis
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Description
Subjects with current or recurrent disease (except AD) that could affect the site of application, the action, absorption or disposition of the investigational product, or clinical or laboratory assessments.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0521116
- SNOMED CT 2011_0131
- 15240007
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C0277556
- SNOMED CT 2011_0131
- 58184002
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0011615
- SNOMED CT 2011_0131
- 24079001
- MedDRA 14.1
- 10012438
- ICD-10-CM Version 2010
- L20.9
- UMLS CUI 2011AA
- C0392760
- SNOMED CT 2011_0131
- 247591002
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C0582103
- SNOMED CT 2011_0131
- 225886003
Description
Subjects who have medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0815173
- UMLS CUI 2011AA
- C0438215
- SNOMED CT 2011_0131
- 165346000
- MedDRA 14.1
- 10023547
- UMLS CUI 2011AA
- C0035647
- SNOMED CT 2011_0131
- 30207005
- HL7 V3 2006_05
- RSK
- UMLS CUI 2011AA
- C2348568
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C1533734
- SNOMED CT 2011_0131
- 416118004
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0459471
- SNOMED CT 2011_0131
- 280452008
- LOINC Version 232
- MTHU003869
- UMLS CUI 2011AA
- C0683954
Description
Subjects with any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible drug application sites which could impact the application of the test agent or confound the local assessments during this study.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0221258
- UMLS CUI 2011AA
- C2004491
- SNOMED CT 2011_0131
- 12402003
- ICD-10-CM Version 2010
- L90.5
- UMLS CUI 2011AA
- C0000925
- SNOMED CT 2011_0131
- 283396008
- UMLS CUI 2011AA
- C0009938
- SNOMED CT 2011_0131
- 125667009
- MedDRA 14.1
- 10050584
- ICD-10-CM Version 2010
- T14.8
- ICD-9-CM Version 2011
- 924.9
- CTCAE 1105E
- E11666
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0037284
- SNOMED CT 2011_0131
- 95324001
- MedDRA 14.1
- 10040882
- UMLS CUI 2011AA
- C2938993
- MedDRA 14.1
- 10070687
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0229986
- SNOMED CT 2011_0131
- 39801007
Description
Subjects with clinically significant renal and liver parameters, as defined as > 1.5 x creatinine and 3 x AST ULN (upper limit of normal) respectively.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0750502
- SNOMED CT 2011_0131
- 386134007
- UMLS CUI 2011AA
- C0022646
- SNOMED CT 2011_0131
- 64033007
- LOINC Version 232
- MTHU002935
- UMLS CUI 2011AA
- C0023884
- SNOMED CT 2011_0131
- 10200004
- LOINC Version 232
- MTHU002039
- UMLS CUI 2011AA
- C0449381
- SNOMED CT 2011_0131
- 252116004
- UMLS CUI 2011AA
- C0010294
- SNOMED CT 2011_0131
- 15373003
- MedDRA 14.1
- 10011358
- LOINC Version 232
- 38483-4
- UMLS CUI 2011AA
- C0004002
- SNOMED CT 2011_0131
- 26091008
- LOINC Version 232
- MTHU004883
- UMLS CUI 2011AA
- C1519815
Similar models
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
392521001 (SNOMED CT 2011_0131)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
225886003 (SNOMED CT 2011_0131)
C0559229 (UMLS CUI 2011AA)
281900007 (SNOMED CT 2011_0131)
15240007 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C2348568 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0459471 (UMLS CUI 2011AA)
280452008 (SNOMED CT 2011_0131)
MTHU003869 (LOINC Version 232)
C0683954 (UMLS CUI 2011AA)
C2004491 (UMLS CUI 2011AA)
12402003 (SNOMED CT 2011_0131)
L90.5 (ICD-10-CM Version 2010)
C0000925 (UMLS CUI 2011AA)
283396008 (SNOMED CT 2011_0131)
C0009938 (UMLS CUI 2011AA)
125667009 (SNOMED CT 2011_0131)
10050584 (MedDRA 14.1)
T14.8 (ICD-10-CM Version 2010)
924.9 (ICD-9-CM Version 2011)
E11666 (CTCAE 1105E)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0037284 (UMLS CUI 2011AA)
95324001 (SNOMED CT 2011_0131)
10040882 (MedDRA 14.1)
C2938993 (UMLS CUI 2011AA)
10070687 (MedDRA 14.1)
C0013227 (UMLS CUI 2011AA)
C0229986 (UMLS CUI 2011AA)
39801007 (SNOMED CT 2011_0131)
386134007 (SNOMED CT 2011_0131)
C0022646 (UMLS CUI 2011AA)
64033007 (SNOMED CT 2011_0131)
MTHU002935 (LOINC Version 232)
C0023884 (UMLS CUI 2011AA)
10200004 (SNOMED CT 2011_0131)
MTHU002039 (LOINC Version 232)
C0449381 (UMLS CUI 2011AA)
252116004 (SNOMED CT 2011_0131)
C0010294 (UMLS CUI 2011AA)
15373003 (SNOMED CT 2011_0131)
10011358 (MedDRA 14.1)
38483-4 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)