ID
43092
Beschreibung
ODM derived from http://clinicaltrials.gov/show/NCT01385657
Link
http://clinicaltrials.gov/show/NCT01385657
Stichworte
Versionen (3)
- 17.04.13 17.04.13 - Martin Dugas
- 20.04.14 20.04.14 - Julian Varghese
- 20.09.21 20.09.21 -
Hochgeladen am
20. September 2021
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility NCT01385657 Atopic Dermatitis
Eligibility
- StudyEvent: Eligibility
Beschreibung
Ausschlusskriterien
Beschreibung
Positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit
Datentyp
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
Beschreibung
Treatment with an investigational drug within 8 weeks or within 5 half-lives, if known, whichever is longer, before the baseline visit
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0013230
Beschreibung
Treatment with leukotriene inhibitors within 4 weeks before the baseline visit
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0595726
- SNOMED CT 2011_0131
- 372517002
Beschreibung
Treatment with systemic corticosteroids within 4 weeks before the baseline visit
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0205373
- SNOMED CT 2011_0131
- 31099001
- UMLS CUI 2011AA
- C0001617
- SNOMED CT 2011_0131
- 79440004
Beschreibung
Treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before the baseline visit
Datentyp
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
Beschreibung
Systemic treatment for AD with an immunosuppressive/immunomodulating substance within 4 weeks before the baseline visit
Datentyp
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
Beschreibung
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
Datentyp
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
Beschreibung
Known history of human immunodeficiency virus (HIV) infection
Datentyp
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
Beschreibung
History of clinical parasite infection, other than treated trichomoniasis
Datentyp
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
Beschreibung
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
Datentyp
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
Beschreibung
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
Datentyp
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
Beschreibung
Pregnant or breast-feeding women
Datentyp
boolean
Alias
- UMLS CUI 1
- C0549206
- MedDRA 1
- 10036586
- UMLS CUI 2
- C0006147
- MedDRA 2
- 10006247
Beschreibung
Unwilling to use adequate birth control, if of reproductive potential and sexually active
Datentyp
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
397669002 (SNOMED CT 2011_0131)
90734009 (SNOMED CT 2011_0131)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
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C0011900 (UMLS CUI 2011AA)
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246112005 (SNOMED CT 2011_0131)
C0918012 (UMLS CUI 2011AA)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
C0281858 (UMLS CUI 2011AA)
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246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
128178001 (SNOMED CT 2011_0131)
10050311 (MedDRA 14.1)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
392521001 (SNOMED CT 2011_0131)
C1320680 (UMLS CUI 2011AA)
405786003 (SNOMED CT 2011_0131)
C0304604 (UMLS CUI 2011AA)
331645009 (SNOMED CT 2011_0131)
C1562036 (UMLS CUI 2011AA)
416798007 (SNOMED CT 2011_0131)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
165806002 (SNOMED CT 2011_0131)
10019742 (MedDRA 14.1)
C0281863 (UMLS CUI 2011AA)
10019747 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
C0595726 (UMLS CUI 2011AA)
372517002 (SNOMED CT 2011_0131)
31099001 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0304604 (UMLS CUI 2011AA)
331645009 (SNOMED CT 2011_0131)
C0085149 (UMLS CUI 2011AA)
386975001 (SNOMED CT 2011_0131)
MTHU001849 (LOINC Version 232)
C1099414 (UMLS CUI 2011AA)
385580005 (SNOMED CT 2011_0131)
C0011615 (UMLS CUI 2011AA)
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)
C0559681 (UMLS CUI 2011AA)
281791007 (SNOMED CT 2011_0131)
C0559680 (UMLS CUI 2011AA)
281790008 (SNOMED CT 2011_0131)
C0003451 (UMLS CUI 2011AA)
372701006 (SNOMED CT 2011_0131)
C0003308 (UMLS CUI 2011AA)
373219008 (SNOMED CT 2011_0131)
C0205124 (UMLS CUI 2011AA)
26283006 (SNOMED CT 2011_0131)
C0037278 (UMLS CUI 2011AA)
108365000 (SNOMED CT 2011_0131)
10040872 (MedDRA 14.1)
E11568 (CTCAE 1105E)
392521001 (SNOMED CT 2011_0131)
C0019693 (UMLS CUI 2011AA)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
392521001 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
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)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0580352 (UMLS CUI 2011AA)
182992009 (SNOMED CT 2011_0131)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
C1518422 (UMLS CUI 2011AA)
C0036525 (UMLS CUI 2011AA)
77879006 (SNOMED CT 2011_0131)
10027474 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C0007117 (UMLS CUI 2011AA)
1338007, 254701007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
MEDCCAT (HL7 V3 2006_05)
C0278060 (UMLS CUI 2011AA)
36456004 (SNOMED CT 2011_0131)
MTHU001424 (LOINC Version 232)
MTHU117157 (CTCAE 1105E)
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C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C2348568 (UMLS CUI 2011AA)
C0459471 (UMLS CUI 2011AA)
280452008 (SNOMED CT 2011_0131)
MTHU003869 (LOINC Version 232)
C0683954 (UMLS CUI 2011AA)
10036586 (MedDRA 1)
C0006147 (UMLS CUI 2)
10006247 (MedDRA 2)
225465005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
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C0237399 (UMLS CUI 2011AA)
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