ID

43515

Description

ODM derived from http://clinicaltrials.gov/show/NCT00980629

Link

http://clinicaltrials.gov/show/NCT00980629

Keywords

Versions (3)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00980629 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 65 Years
Description

age 18 Years to 65 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Male or female patients (aged 18-65 years) with a diagnosis of AD.
Description

Male or female patients (aged 18-65 years) with a diagnosis of AD.

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
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0011615
SNOMED CT 2011_0131
24079001
MedDRA 14.1
10012438
ICD-10-CM Version 2010
L20.9
Female patients of child bearing potential must be using a medically acceptable form of contraception.
Description

Female patients of child bearing potential must be using a medically acceptable form of contraception.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Patients who are able and willing to give signed informed consent.
Description

Patients who are able and willing to give signed informed consent.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Patients who have pruritus exceed the reference range.
Description

Patients who have pruritus exceed the reference range.

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
CL384738
UMLS CUI 2011AA
CL415192
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Patients who have a history of allergy to hydrocortisone.
Description

Patients who have a history of allergy to hydrocortisone.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0020268
SNOMED CT 2011_0131
396458002
LOINC Version 232
MTHU035101
Patients who have a history of relevant drug hypersensitivity.
Description

Patients who have a history of relevant drug hypersensitivity.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0013182
LOINC Version 232
MTHU002637
Patients who have a history of contact dermatitis induced by a topical steroid.
Description

Patients who have a history of contact dermatitis induced by a topical steroid.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0011616
SNOMED CT 2011_0131
40275004
MedDRA 14.1
10012442
ICD-10-CM Version 2010
L25.9
UMLS CUI 2011AA
C0205263
SNOMED CT 2011_0131
16404004
UMLS CUI 2011AA
C1522168
SNOMED CT 2011_0131
6064005
HL7 V3 2006_05
TOPICAL
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
Patients who are taking, and who are unwilling not to take, any medications or therapy prohibited by the protocol for the complete duration of the study.
Description

Patients who are taking, and who are unwilling not to take, any medications or therapy prohibited by the protocol for the complete duration of the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C2348563
UMLS CUI 2011AA
C1554075
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0039798
Malignant Neoplasms
Description

Patients who have a history or presence of any cancer.

Data type

boolean

Alias
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Patients who have any renal or liver insufficiency, or clinically significant cardiac, renal or hepatic disease.
Description

Patients who have any renal or liver insufficiency, or clinically significant cardiac, renal or hepatic disease.

Data type

boolean

Alias
UMLS CUI 2011AA
C1565489
MedDRA 14.1
10038474
UMLS CUI 2011AA
C1306571
SNOMED CT 2011_0131
59927004
MedDRA 14.1
10056542
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
Patients who, in the opinion of the investigator, are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
Description

Patients who, in the opinion of the investigator, are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1302261
SNOMED CT 2011_0131
399223003
UMLS CUI 2011AA
C0521095
SNOMED CT 2011_0131
436000
UMLS CUI 2011AA
C0262926
SNOMED CT 2011_0131
417662000
LOINC Version 232
MTHU027722
UMLS CUI 2011AA
C0031809
SNOMED CT 2011_0131
5880005
MedDRA 14.1
10034986
LOINC Version 232
MTHU028014
ICD-9-CM Version 2011
89.7
UMLS CUI 2011AA
C0036043
UMLS CUI 2011AA
C0022885
SNOMED CT 2011_0131
15220000
MedDRA 14.1
10059938
Patients who have pruritus associated with conditions other than AD.
Description

Patients who have pruritus associated with conditions other than AD.

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
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0011615
SNOMED CT 2011_0131
24079001
MedDRA 14.1
10012438
ICD-10-CM Version 2010
L20.9
Patients who have pruritus only on the face and head.
Description

Patients who have pruritus only on the face and head.

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
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0015450
SNOMED CT 2011_0131
89545001
LOINC Version 232
MTHU003030
UMLS CUI 2011AA
C0018670
SNOMED CT 2011_0131
69536005
LOINC Version 232
MTHU001435
Patients who, in the opinion of the investigator, have clinically relevant history or presence of any disease, or surgical history other than AD which is likely to affect the conduct of the study.
Description

Patients who, in the opinion of the investigator, have clinically relevant history or presence of any disease, or surgical history other than AD which is likely to affect the conduct of the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0455610
SNOMED CT 2011_0131
161615003
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
C0681872
Patients who have used M5161(active ingredient of M516102).
Description

Patients who have used M5161(active ingredient of M516102).

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0439861
SNOMED CT 2011_0131
105590001
UMLS CUI 2011AA
C1372955
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
Patients who cannot communicate reliably with the investigator.
Description

Patients who cannot communicate reliably with the investigator.

Data type

boolean

Alias
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C1272703
SNOMED CT 2011_0131
385669000
UMLS CUI 2011AA
C0009452
SNOMED CT 2011_0131
263536004
LOINC Version 232
MTHU021752
UMLS CUI 2011AA
CL102947
Patients who are pregnant or lactating.
Description

Patients who are pregnant or lactating.

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
Patients who have used any IMP and/or participated in any clinical trial within 3 months.
Description

Patients who have used any IMP and/or participated in any clinical trial within 3 months.

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0162537
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
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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 65 Years
Item
age 18 Years to 65 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Male or female patients (aged 18-65 years) with a diagnosis of AD.
Item
Male or female patients (aged 18-65 years) with a diagnosis of AD.
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)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
Female patients of child bearing potential must be using a medically acceptable form of contraception.
Item
Female patients of child bearing potential must be using a medically acceptable form of contraception.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Patients who are able and willing to give signed informed consent.
Item
Patients who are able and willing to give signed informed consent.
boolean
C0021430 (UMLS CUI 2011AA)
Patients who have pruritus exceed the reference range.
Item
Patients who have pruritus exceed the reference range.
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)
CL384738 (UMLS CUI 2011AA)
CL415192 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patients who have a history of allergy to hydrocortisone.
Item
Patients who have a history of allergy to hydrocortisone.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0020268 (UMLS CUI 2011AA)
396458002 (SNOMED CT 2011_0131)
MTHU035101 (LOINC Version 232)
Patients who have a history of relevant drug hypersensitivity.
Item
Patients who have a history of relevant drug hypersensitivity.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0013182 (UMLS CUI 2011AA)
MTHU002637 (LOINC Version 232)
Patients who have a history of contact dermatitis induced by a topical steroid.
Item
Patients who have a history of contact dermatitis induced by a topical steroid.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0011616 (UMLS CUI 2011AA)
40275004 (SNOMED CT 2011_0131)
10012442 (MedDRA 14.1)
L25.9 (ICD-10-CM Version 2010)
C0205263 (UMLS CUI 2011AA)
16404004 (SNOMED CT 2011_0131)
C1522168 (UMLS CUI 2011AA)
6064005 (SNOMED CT 2011_0131)
TOPICAL (HL7 V3 2006_05)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
Patients who are taking, and who are unwilling not to take, any medications or therapy prohibited by the protocol for the complete duration of the study.
Item
Patients who are taking, and who are unwilling not to take, any medications or therapy prohibited by the protocol for the complete duration of the study.
boolean
C2348563 (UMLS CUI 2011AA)
C1554075 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Patients who have a history or presence of any cancer.
Item
Malignant Neoplasms
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Patients who have any renal or liver insufficiency, or clinically significant cardiac, renal or hepatic disease.
Item
Patients who have any renal or liver insufficiency, or clinically significant cardiac, renal or hepatic disease.
boolean
C1565489 (UMLS CUI 2011AA)
10038474 (MedDRA 14.1)
C1306571 (UMLS CUI 2011AA)
59927004 (SNOMED CT 2011_0131)
10056542 (MedDRA 14.1)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
Patients who, in the opinion of the investigator, are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
Item
Patients who, in the opinion of the investigator, are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
boolean
C1518422 (UMLS CUI 2011AA)
C1302261 (UMLS CUI 2011AA)
399223003 (SNOMED CT 2011_0131)
C0521095 (UMLS CUI 2011AA)
436000 (SNOMED CT 2011_0131)
C0262926 (UMLS CUI 2011AA)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0031809 (UMLS CUI 2011AA)
5880005 (SNOMED CT 2011_0131)
10034986 (MedDRA 14.1)
MTHU028014 (LOINC Version 232)
89.7 (ICD-9-CM Version 2011)
C0036043 (UMLS CUI 2011AA)
C0022885 (UMLS CUI 2011AA)
15220000 (SNOMED CT 2011_0131)
10059938 (MedDRA 14.1)
Patients who have pruritus associated with conditions other than AD.
Item
Patients who have pruritus associated with conditions other than AD.
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)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
CL411789 (UMLS CUI 2011AA)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
Patients who have pruritus only on the face and head.
Item
Patients who have pruritus only on the face and head.
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)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0015450 (UMLS CUI 2011AA)
89545001 (SNOMED CT 2011_0131)
MTHU003030 (LOINC Version 232)
C0018670 (UMLS CUI 2011AA)
69536005 (SNOMED CT 2011_0131)
MTHU001435 (LOINC Version 232)
Patients who, in the opinion of the investigator, have clinically relevant history or presence of any disease, or surgical history other than AD which is likely to affect the conduct of the study.
Item
Patients who, in the opinion of the investigator, have clinically relevant history or presence of any disease, or surgical history other than AD which is likely to affect the conduct of the study.
boolean
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0455610 (UMLS CUI 2011AA)
161615003 (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)
C0681872 (UMLS CUI 2011AA)
Patients who have used M5161(active ingredient of M516102).
Item
Patients who have used M5161(active ingredient of M516102).
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0439861 (UMLS CUI 2011AA)
105590001 (SNOMED CT 2011_0131)
C1372955 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Patients who cannot communicate reliably with the investigator.
Item
Patients who cannot communicate reliably with the investigator.
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C1272703 (UMLS CUI 2011AA)
385669000 (SNOMED CT 2011_0131)
C0009452 (UMLS CUI 2011AA)
263536004 (SNOMED CT 2011_0131)
MTHU021752 (LOINC Version 232)
CL102947 (UMLS CUI 2011AA)
Patients who are pregnant or lactating.
Item
Patients who are pregnant or lactating.
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
Patients who have used any IMP and/or participated in any clinical trial within 3 months.
Item
Patients who have used any IMP and/or participated in any clinical trial within 3 months.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0162537 (UMLS CUI 2011AA)
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)
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