ID

43514

Descrição

ODM derived from http://clinicaltrials.gov/show/NCT00980135

Link

http://clinicaltrials.gov/show/NCT00980135

Palavras-chave

Versões (2)
  1. 25/07/2013 25/07/2013 - Martin Dugas
  2. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility NCT00980135 Atopic Dermatitis

Alemão Inglês

Eligibility

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Descrição

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter 18 bis 65 Jahre
Descrição

age 18 Years to 65 Years

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Male or female Caucasians aged between 18 and 65 years
Descrição

Male or female Caucasians aged between 18 and 65 years

Tipo de dados

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
C0007457
SNOMED CT 2011_0131
14045001
Patients with mild AD presenting a scoring AD (SCORAD) rating between 3-25
Descrição

Patients with mild AD presenting a scoring AD (SCORAD) rating between 3-25

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C2945599
SNOMED CT 2011_0131
255604002
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
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
UMLS CUI 2011AA
C0871208
Skin type I - IV according to Fitzpatrick
Descrição

Skin type I - IV according to Fitzpatrick

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C2700185
UMLS CUI 2011AA
C2700186
UMLS CUI 2011AA
C2700187
UMLS CUI 2011AA
C2700188
Acute AD symptoms on each assessment areas (local SCORAD >/=3 and <= 12)
Descrição

Acute AD symptoms on each assessment areas (local SCORAD >/=3 and <= 12)

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0011615
SNOMED CT 2011_0131
24079001
MedDRA 14.1
10012438
ICD-10-CM Version 2010
L20.9
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
UMLS CUI 2011AA
CL415116
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
Acute symptom of pruritus at Baseline
Descrição

Acute symptom of pruritus at Baseline

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
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
C1442488
Ausschlusskriterien
Descrição

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Any other skin disease at the test area that would interfere the clinical assessment in the opinion of the investigator
Descrição

Any other skin disease at the test area that would interfere the clinical assessment in the opinion of the investigator

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0037274
SNOMED CT 2011_0131
95320005
MedDRA 14.1
10048768, 10040831
LOINC Version 232
MTHU031899
UMLS CUI 2011AA
C0392366
SNOMED CT 2011_0131
272393004
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment
Descrição

Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0027960
SNOMED CT 2011_0131
400010006
MedDRA 14.1
10027806
ICD-10-CM Version 2010
D22
UMLS CUI 2011AA
C0221258
UMLS CUI 2011AA
C0442821
SNOMED CT 2011_0131
260404005
UMLS CUI 2011AA
C0031911
SNOMED CT 2011_0131
51083003
MedDRA 14.1
10035018
LOINC Version 232
MTHU015062
UMLS CUI 2011AA
C2004491
SNOMED CT 2011_0131
12402003
ICD-10-CM Version 2010
L90.5
UMLS CUI 2011AA
C0392366
SNOMED CT 2011_0131
272393004
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
Regular intake of antiphlogistic drugs (for example, NSAIDs)
Descrição

Regular intake of antiphlogistic drugs (for example, NSAIDs)

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205272
SNOMED CT 2011_0131
17854005
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0003209
SNOMED CT 2011_0131
330901000
UMLS CUI 2011AA
C0003211
SNOMED CT 2011_0131
16403005, 372665008
Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas)
Descrição

Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas)

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0814606
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1522168
SNOMED CT 2011_0131
6064005
HL7 V3 2006_05
TOPICAL
UMLS CUI 2011AA
C0003232
SNOMED CT 2011_0131
255631004
UMLS CUI 2011AA
C0003308
SNOMED CT 2011_0131
373219008
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UV-therapy or the use of solarium within 30 days before screening as well as during the trial
Descrição

UV-therapy or the use of solarium within 30 days before screening as well as during the trial

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0041626
SNOMED CT 2011_0131
363695005
MedDRA 14.1
10046850
ICD-9-CM Version 2011
99.82
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0183827
Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial
Descrição

Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1523987
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0011615
SNOMED CT 2011_0131
24079001
MedDRA 14.1
10012438
ICD-10-CM Version 2010
L20.9
UMLS CUI 2011AA
C0394664
SNOMED CT 2011_0131
44868003
MedDRA 14.1
10000646
UMLS CUI 2011AA
C0282567
UMLS CUI 2011AA
C0684199
SNOMED CT 2011_0131
182968001
MedDRA 14.1
10020363
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Similar models

Eligibility

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age 18 Years to 65 Years
Item
Alter 18 bis 65 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Male or female Caucasians aged between 18 and 65 years
Item
Male or female Caucasians aged between 18 and 65 years
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)
C0007457 (UMLS CUI 2011AA)
14045001 (SNOMED CT 2011_0131)
Patients with mild AD presenting a scoring AD (SCORAD) rating between 3-25
Item
Patients with mild AD presenting a scoring AD (SCORAD) rating between 3-25
boolean
C2945599 (UMLS CUI 2011AA)
255604002 (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)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
C0871208 (UMLS CUI 2011AA)
Skin type I - IV according to Fitzpatrick
Item
Skin type I - IV according to Fitzpatrick
boolean
C2700185 (UMLS CUI 2011AA)
C2700186 (UMLS CUI 2011AA)
C2700187 (UMLS CUI 2011AA)
C2700188 (UMLS CUI 2011AA)
Acute AD symptoms on each assessment areas (local SCORAD >/=3 and <= 12)
Item
Acute AD symptoms on each assessment areas (local SCORAD >/=3 and <= 12)
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C1516048 (UMLS CUI 2011AA)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
CL415116 (UMLS CUI 2011AA)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
Acute symptom of pruritus at Baseline
Item
Acute symptom of pruritus at Baseline
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
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)
C1442488 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Any other skin disease at the test area that would interfere the clinical assessment in the opinion of the investigator
Item
Any other skin disease at the test area that would interfere the clinical assessment in the opinion of the investigator
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0037274 (UMLS CUI 2011AA)
95320005 (SNOMED CT 2011_0131)
10048768, 10040831 (MedDRA 14.1)
MTHU031899 (LOINC Version 232)
C0392366 (UMLS CUI 2011AA)
272393004 (SNOMED CT 2011_0131)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment
Item
Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment
boolean
C0027960 (UMLS CUI 2011AA)
400010006 (SNOMED CT 2011_0131)
10027806 (MedDRA 14.1)
D22 (ICD-10-CM Version 2010)
C0221258 (UMLS CUI 2011AA)
C0442821 (UMLS CUI 2011AA)
260404005 (SNOMED CT 2011_0131)
C0031911 (UMLS CUI 2011AA)
51083003 (SNOMED CT 2011_0131)
10035018 (MedDRA 14.1)
MTHU015062 (LOINC Version 232)
C2004491 (UMLS CUI 2011AA)
12402003 (SNOMED CT 2011_0131)
L90.5 (ICD-10-CM Version 2010)
C0392366 (UMLS CUI 2011AA)
272393004 (SNOMED CT 2011_0131)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
Regular intake of antiphlogistic drugs (for example, NSAIDs)
Item
Regular intake of antiphlogistic drugs (for example, NSAIDs)
boolean
C0205272 (UMLS CUI 2011AA)
17854005 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0003209 (UMLS CUI 2011AA)
330901000 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
16403005, 372665008 (SNOMED CT 2011_0131)
Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas)
Item
Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas)
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0039798 (UMLS CUI 2011AA)
C0814606 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1522168 (UMLS CUI 2011AA)
6064005 (SNOMED CT 2011_0131)
TOPICAL (HL7 V3 2006_05)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0003308 (UMLS CUI 2011AA)
373219008 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
UV-therapy or the use of solarium within 30 days before screening as well as during the trial
Item
UV-therapy or the use of solarium within 30 days before screening as well as during the trial
boolean
C0041626 (UMLS CUI 2011AA)
363695005 (SNOMED CT 2011_0131)
10046850 (MedDRA 14.1)
99.82 (ICD-9-CM Version 2011)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0183827 (UMLS CUI 2011AA)
Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial
Item
Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial
boolean
C1523987 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
C0394664 (UMLS CUI 2011AA)
44868003 (SNOMED CT 2011_0131)
10000646 (MedDRA 14.1)
C0282567 (UMLS CUI 2011AA)
C0684199 (UMLS CUI 2011AA)
182968001 (SNOMED CT 2011_0131)
10020363 (MedDRA 14.1)
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