ID

5028

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT00882245

Länk

http://clinicaltrials.gov/show/NCT00882245

Nyckelord

Versioner (2)
  1. 2013-12-09 2013-12-09 - Martin Dugas
  2. 2014-04-16 2014-04-16 - Julian Varghese
Uppladdad den

16 april 2014

DOI

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Licens

Creative Commons BY 4.0
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Eligibility NCT00882245 Atopic Dermatitis

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beskrivning

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter mindestens 18 Jahre
Beskrivning

age at least 18 Years

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Subjects with a history of AD
Beskrivning

Subjects with a history of AD

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0011615
SNOMED CT 2011_0131
24079001
MedDRA 14.1
10012438
ICD-10-CM Version 2010
L20.9
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Written and dated informed consent
Beskrivning

Written and dated informed consent

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0021430
Satisfactory medical assessment with no clinical relevant abnormalities.
Beskrivning

Satisfactory medical assessment with no clinical relevant abnormalities.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
UMLS CUI 2011AA
C0559229
SNOMED CT 2011_0131
281900007
Ausschlusskriterien
Beskrivning

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
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.
Beskrivning

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.

Datatyp

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
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.
Beskrivning

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.

Datatyp

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
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.
Beskrivning

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.

Datatyp

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
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.
Beskrivning

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.

Datatyp

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
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Subjects with a history of AD
Item
Subjects with a history of AD
boolean
CL421546 (UMLS CUI 2011AA)
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)
Written and dated informed consent
Item
Written and dated informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Satisfactory medical assessment with no clinical relevant abnormalities.
Item
Satisfactory medical assessment with no clinical relevant abnormalities.
boolean
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
C0559229 (UMLS CUI 2011AA)
281900007 (SNOMED CT 2011_0131)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
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.
Item
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.
boolean
C0521116 (UMLS CUI 2011AA)
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)
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.
Item
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.
boolean
C0815173 (UMLS CUI 2011AA)
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)
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.
Item
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.
boolean
C0221258 (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)
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.
Item
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.
boolean
C0750502 (UMLS CUI 2011AA)
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)
Tillbaka till toppen 

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