ID
43092
Beschrijving
ODM derived from http://clinicaltrials.gov/show/NCT01385657
Link
http://clinicaltrials.gov/show/NCT01385657
Trefwoorden
Versies (3)
- 17-04-13 17-04-13 - Martin Dugas
- 20-04-14 20-04-14 - Julian Varghese
- 20-09-21 20-09-21 -
Geüploaded op
20 september 2021
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility NCT01385657 Atopic Dermatitis
Eligibility
- StudyEvent: Eligibility
Beschrijving
Ausschlusskriterien
Beschrijving
Positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0149709
- SNOMED CT 2011_0131
- 165806002
- MedDRA 14.1
- 10019742
- UMLS CUI 2011AA
- C0281863
- MedDRA 14.1
- 10019747
- UMLS CUI 2011AA
- C1409616
Beschrijving
Treatment with an investigational drug within 8 weeks or within 5 half-lives, if known, whichever is longer, before the baseline visit
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0013230
Beschrijving
Treatment with leukotriene inhibitors within 4 weeks before the baseline visit
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0595726
- SNOMED CT 2011_0131
- 372517002
Beschrijving
Treatment with systemic corticosteroids within 4 weeks before the baseline visit
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205373
- SNOMED CT 2011_0131
- 31099001
- UMLS CUI 2011AA
- C0001617
- SNOMED CT 2011_0131
- 79440004
Beschrijving
Treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before the baseline visit
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0304604
- SNOMED CT 2011_0131
- 331645009
- UMLS CUI 2011AA
- C0085149
- SNOMED CT 2011_0131
- 386975001
- LOINC Version 232
- MTHU001849
- UMLS CUI 2011AA
- C1099414
- SNOMED CT 2011_0131
- 385580005
Beschrijving
Systemic treatment for AD with an immunosuppressive/immunomodulating substance within 4 weeks before the baseline visit
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1515119
- UMLS CUI 2011AA
- C0011615
- SNOMED CT 2011_0131
- 24079001
- MedDRA 14.1
- 10012438
- ICD-10-CM Version 2010
- L20.9
- UMLS CUI 2011AA
- C0021081
- SNOMED CT 2011_0131
- 372823004, 69431002
- UMLS CUI 2011AA
- C0005525
Beschrijving
Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, or antifungals within 4 weeks before the screening visit or superficial skin infections within 1 week before the screening visit
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0559681
- SNOMED CT 2011_0131
- 281791007
- UMLS CUI 2011AA
- C0559680
- SNOMED CT 2011_0131
- 281790008
- UMLS CUI 2011AA
- C0003451
- SNOMED CT 2011_0131
- 372701006
- UMLS CUI 2011AA
- C0003308
- SNOMED CT 2011_0131
- 373219008
- UMLS CUI 2011AA
- C0205124
- SNOMED CT 2011_0131
- 26283006
- UMLS CUI 2011AA
- C0037278
- SNOMED CT 2011_0131
- 108365000
- MedDRA 14.1
- 10040872
- CTCAE 1105E
- E11568
Beschrijving
Known history of human immunodeficiency virus (HIV) infection
Datatype
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0019693
- SNOMED CT 2011_0131
- 86406008
- MedDRA 14.1
- 10020161
- LOINC Version 232
- MTHU020829
- ICD-10-CM Version 2010
- B20
- ICD-9-CM Version 2011
- 042
Beschrijving
History of clinical parasite infection, other than treated trichomoniasis
Datatype
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0205210
- SNOMED CT 2011_0131
- 58147004
- UMLS CUI 2011AA
- C0747256
- SNOMED CT 2011_0131
- 17322007
- MedDRA 14.1
- 10021857
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- C0040921
- SNOMED CT 2011_0131
- 56335008
- MedDRA 14.1
- 10044620
- ICD-10-CM Version 2010
- A59
- ICD-9-CM Version 2011
- 131
Beschrijving
History of malignancy within 5 years before the baseline visit, with the following exceptions: patients with a history of completely treated carcinoma in situ of cervix, and non-metastatic squamous or basal cell carcinoma of the skin are allowed
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C2735088
- LOINC Version 232
- MTHU034770
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0580352
- SNOMED CT 2011_0131
- 182992009
- UMLS CUI 2011AA
- C0851140
- SNOMED CT 2011_0131
- 92564006
- MedDRA 14.1
- 10061809
- ICD-10-CM Version 2010
- D06.9
- ICD-9-CM Version 2011
- 233.1
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0036525
- SNOMED CT 2011_0131
- 77879006
- MedDRA 14.1
- 10027474
- UMLS CUI 2011AA
- C0553723
- SNOMED CT 2011_0131
- 254651007
- MedDRA 14.1
- 10041834
- UMLS CUI 2011AA
- C0007117
- SNOMED CT 2011_0131
- 1338007, 254701007
- MedDRA 14.1
- 10004146
Beschrijving
Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
- UMLS CUI 2011AA
- C0278060
- SNOMED CT 2011_0131
- 36456004
- LOINC Version 232
- MTHU001424
- CTCAE 1105E
- MTHU117157
- UMLS CUI 2011AA
- C1882509
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
- UMLS CUI 2011AA
- C0035647
- SNOMED CT 2011_0131
- 30207005
- HL7 V3 2006_05
- RSK
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C2348568
- UMLS CUI 2011AA
- C0459471
- SNOMED CT 2011_0131
- 280452008
- LOINC Version 232
- MTHU003869
- UMLS CUI 2011AA
- C0683954
Beschrijving
Pregnant or breast-feeding women
Datatype
boolean
Alias
- UMLS CUI 1
- C0549206
- MedDRA 1
- 10036586
- UMLS CUI 2
- C0006147
- MedDRA 2
- 10006247
Beschrijving
Unwilling to use adequate birth control, if of reproductive potential and sexually active
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0558080
- SNOMED CT 2011_0131
- 225465005
- UMLS CUI 2011AA
- C0700589
- SNOMED CT 2011_0131
- 146680009
- MedDRA 14.1
- 10010808
- UMLS CUI 2011AA
- C0750557
- UMLS CUI 2011AA
- C0035150
- UMLS CUI 2011AA
- C0237399
- UMLS CUI 2011AA
- C0241028
- SNOMED CT 2011_0131
- 228453005
- MedDRA 14.1
- 10066098
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Eligibility
- StudyEvent: Eligibility
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372517002 (SNOMED CT 2011_0131)
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24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0005525 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
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58147004 (SNOMED CT 2011_0131)
C0747256 (UMLS CUI 2011AA)
17322007 (SNOMED CT 2011_0131)
10021857 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C0040921 (UMLS CUI 2011AA)
56335008 (SNOMED CT 2011_0131)
10044620 (MedDRA 14.1)
A59 (ICD-10-CM Version 2010)
131 (ICD-9-CM Version 2011)
MTHU034770 (LOINC Version 232)
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92564006 (SNOMED CT 2011_0131)
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