ID

44598

Description

ODM derived from http://clinicaltrials.gov/show/NCT01033097

Link

http://clinicaltrials.gov/show/NCT01033097

Keywords

Versions (3)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01033097 Atopic Dermatitis

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 45 Years
Description

age 18 Years to 45 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Male and female atopic dermatitis patients,18 to 45 years of age inclusive, who fulfill the following criteria:
Description

Male and female atopic dermatitis patients,18 to 45 years of age inclusive, who fulfill the following criteria:

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
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
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
CL414621
Requirement of systemic therapy
Description

Requirement of systemic therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1515119
Itch VAS score > 50 mm
Description

Itch VAS score > 50 mm

Data type

boolean

Alias
UMLS CUI 2011AA
C0033774
SNOMED CT 2011_0131
418363000
MedDRA 14.1
10037087
ICD-10-CM Version 2010
L29
ICD-9-CM Version 2011
698.9
CTCAE 1105E
E13686
UMLS CUI 2011AA
C0042815
SNOMED CT 2011_0131
273903006
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
EASI score > 8
Description

EASI score > 8

Data type

boolean

Alias
UMLS CUI 2011AA
C0013595
SNOMED CT 2011_0131
43116000
MedDRA 14.1
10014184
ICD-10-CM Version 2010
L30.9
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
UMLS CUI 2011AA
C0439793
SNOMED CT 2011_0131
246112005
UMLS CUI 2011AA
C0918012
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Pregnant or breastfeeding women. Women of child-bearing potential or men who are not willing to follow the restrictions in inclusion criteria 3 and 4, respectively, are not allowed in the study.
Description

Pregnant or breastfeeding women. Women of child-bearing potential or men who are not willing to follow the restrictions in inclusion criteria 3 and 4, respectively, are not allowed in the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0025266
SNOMED CT 2011_0131
339947000
UMLS CUI 2011AA
C0558080
SNOMED CT 2011_0131
225465005
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
CL425202
Any systemic immunosuppressive treatment and/or phototherapy within 4 weeks prior to the first dosing.
Description

Any systemic immunosuppressive treatment and/or phototherapy within 4 weeks prior to the first dosing.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
UMLS CUI 2011AA
C0031765
SNOMED CT 2011_0131
31394004
MedDRA 14.1
10063925
Any topical or oral treatment for atopic dermatitis within 2 weeks prior to the first dosing. Use of any topical or systemic treatment for atopic dermatitis (with the exception of emollients prescribed by the Investigator) will not be allowed during the study period.
Description

Any topical or oral treatment for atopic dermatitis within 2 weeks prior to the first dosing. Use of any topical or systemic treatment for atopic dermatitis (with the exception of emollients prescribed by the Investigator) will not be allowed during the study period.

Data type

boolean

Alias
UMLS CUI 2011AA
C0150349
SNOMED CT 2011_0131
386439008
UMLS CUI 2011AA
C1515119
UMLS CUI 2011AA
C1273553
SNOMED CT 2011_0131
394899003
UMLS CUI 2011AA
C0011615
SNOMED CT 2011_0131
24079001
MedDRA 14.1
10012438
ICD-10-CM Version 2010
L20.9
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0013983
SNOMED CT 2011_0131
373380003
UMLS CUI 2011AA
C0033080
SNOMED CT 2011_0131
16076005
UMLS CUI 2011AA
CL102947
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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
CL425202 (UMLS CUI 2011AA)
age 18 Years to 45 Years
Item
age 18 Years to 45 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Male and female atopic dermatitis patients,18 to 45 years of age inclusive, who fulfill the following criteria:
Item
Male and female atopic dermatitis patients,18 to 45 years of age inclusive, who fulfill the following criteria:
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
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)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Requirement of systemic therapy
Item
Requirement of systemic therapy
boolean
C1515119 (UMLS CUI 2011AA)
Itch VAS score > 50 mm
Item
Itch VAS score > 50 mm
boolean
C0033774 (UMLS CUI 2011AA)
418363000 (SNOMED CT 2011_0131)
10037087 (MedDRA 14.1)
L29 (ICD-10-CM Version 2010)
698.9 (ICD-9-CM Version 2011)
E13686 (CTCAE 1105E)
C0042815 (UMLS CUI 2011AA)
273903006 (SNOMED CT 2011_0131)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
EASI score > 8
Item
EASI score > 8
boolean
C0013595 (UMLS CUI 2011AA)
43116000 (SNOMED CT 2011_0131)
10014184 (MedDRA 14.1)
L30.9 (ICD-10-CM Version 2010)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
C0439793 (UMLS CUI 2011AA)
246112005 (SNOMED CT 2011_0131)
C0918012 (UMLS CUI 2011AA)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Pregnant or breastfeeding women. Women of child-bearing potential or men who are not willing to follow the restrictions in inclusion criteria 3 and 4, respectively, are not allowed in the study.
Item
Pregnant or breastfeeding women. Women of child-bearing potential or men who are not willing to follow the restrictions in inclusion criteria 3 and 4, respectively, are not allowed in the study.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
CL425202 (UMLS CUI 2011AA)
Any systemic immunosuppressive treatment and/or phototherapy within 4 weeks prior to the first dosing.
Item
Any systemic immunosuppressive treatment and/or phototherapy within 4 weeks prior to the first dosing.
boolean
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
C0031765 (UMLS CUI 2011AA)
31394004 (SNOMED CT 2011_0131)
10063925 (MedDRA 14.1)
Any topical or oral treatment for atopic dermatitis within 2 weeks prior to the first dosing. Use of any topical or systemic treatment for atopic dermatitis (with the exception of emollients prescribed by the Investigator) will not be allowed during the study period.
Item
Any topical or oral treatment for atopic dermatitis within 2 weeks prior to the first dosing. Use of any topical or systemic treatment for atopic dermatitis (with the exception of emollients prescribed by the Investigator) will not be allowed during the study period.
boolean
C0150349 (UMLS CUI 2011AA)
386439008 (SNOMED CT 2011_0131)
C1515119 (UMLS CUI 2011AA)
C1273553 (UMLS CUI 2011AA)
394899003 (SNOMED CT 2011_0131)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0013983 (UMLS CUI 2011AA)
373380003 (SNOMED CT 2011_0131)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
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