ID
43295
Description
ODM derived from http://clinicaltrials.gov/show/NCT01190839
Lien
http://clinicaltrials.gov/show/NCT01190839
Mots-clés
Versions (2)
- 19/03/2013 19/03/2013 - Martin Dugas
- 20/09/2021 20/09/2021 -
Téléchargé le
20 septembre 2021
DOI
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Licence
Creative Commons BY 4.0
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Eligibility NCT01190839 Crohn's Disease
Eligibility
- StudyEvent: Eligibility
Description
Ausschlusskriterien
Description
Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening
Type de données
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0205275
- SNOMED CT 2011_0131
- 44104002
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C1610637
- MedDRA 14.1
- 10064904
- UMLS CUI 2011AA
- C0019655
- SNOMED CT 2011_0131
- 12962009
- MedDRA 14.1
- 10020141
- ICD-10-CM Version 2010
- B39.9
- ICD-9-CM Version 2011
- 115.90
- UMLS CUI 2011AA
- C0262426
Description
Have a chest radiograph within 3 months prior to the first infusion of study agent that shows a clinically significant abnormality, such as a malignancy or infection, or any abnormalities suggestive of TB
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0436503
- SNOMED CT 2011_0131
- 168734001
- MedDRA 14.1
- 10008499
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- UMLS CUI 2011AA
- C1704258
- UMLS CUI 2011AA
- C0038659
- UMLS CUI 2011AA
- C0041296
- SNOMED CT 2011_0131
- 56717001
- MedDRA 14.1
- 10044755
- LOINC Version 232
- MTHU020835
- ICD-10-CM Version 2010
- A15-A19
- ICD-9-CM Version 2011
- 010-018.99
Description
Have macroscopically active CD which was not resected at the time of surgery
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0439806
- SNOMED CT 2011_0131
- 255344003
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0010346
- SNOMED CT 2011_0131
- 34000006
- MedDRA 14.1
- 10011401
- ICD-10-CM Version 2010
- K50.9
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C1521996
Description
Do not meet the criteria for being at an increased risk of postoperative recurrence of active CD as outlined in the inclusion criteria
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0332197
- SNOMED CT 2011_0131
- 2667000
- UMLS CUI 2011AA
- C0332167
- SNOMED CT 2011_0131
- 15508007
- UMLS CUI 2011AA
- C0241311
- UMLS CUI 2011AA
- C2825055
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0010346
- SNOMED CT 2011_0131
- 34000006
- MedDRA 14.1
- 10011401
- ICD-10-CM Version 2010
- K50.9
Description
Have evidence of an active infection at the time of randomization or have had a serious infection not related to CD (e.g., hepatitis, pneumonia, or pyelonephritis), within 6 months prior to screening
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0205404
- SNOMED CT 2011_0131
- 42745003
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- UMLS CUI 2011AA
- CL414700
- UMLS CUI 2011AA
- C0010346
- SNOMED CT 2011_0131
- 34000006
- MedDRA 14.1
- 10011401
- ICD-10-CM Version 2010
- K50.9
- UMLS CUI 2011AA
- C0019158
- SNOMED CT 2011_0131
- 29001004
- MedDRA 14.1
- 10019717
- UMLS CUI 2011AA
- C0032285
- SNOMED CT 2011_0131
- 233604007
- MedDRA 14.1
- 10035664
- LOINC Version 232
- MTHU020831
- ICD-10-CM Version 2010
- J18.9
- CTCAE 1105E
- E13502
- UMLS CUI 2011AA
- C0034186
- SNOMED CT 2011_0131
- 45816000
- MedDRA 14.1
- 10037596
- ICD-10-CM Version 2010
- N16
- ICD-9-CM Version 2011
- 590.80
- CTCAE 1105E
- E11431
Description
Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0029118
- SNOMED CT 2011_0131
- 61274003
- MedDRA 14.1
- 10030901
- UMLS CUI 2011AA
- C0019360
- SNOMED CT 2011_0131
- 4740000
- MedDRA 14.1
- 10019974
- ICD-10-CM Version 2010
- B02
- ICD-9-CM Version 2011
- 53
- UMLS CUI 2011AA
- C0010825
- SNOMED CT 2011_0131
- 407444007
- MedDRA 14.1
- 10009701
- LOINC Version 232
- MTHU033986
- UMLS CUI 2011AA
- C0032276
- UMLS CUI 2011AA
- C0004030
- SNOMED CT 2011_0131
- 65553006
- MedDRA 14.1
- 10003488
- ICD-10-CM Version 2010
- B44
- ICD-9-CM Version 2011
- 117.3
- UMLS CUI 2011AA
- C0019655
- SNOMED CT 2011_0131
- 12962009
- MedDRA 14.1
- 10020141
- ICD-10-CM Version 2010
- B39.9
- ICD-9-CM Version 2011
- 115.90
- UMLS CUI 2011AA
- C0026912
- SNOMED CT 2011_0131
- 243368001
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0041296
- SNOMED CT 2011_0131
- 56717001
- MedDRA 14.1
- 10044755
- LOINC Version 232
- MTHU020835
- ICD-10-CM Version 2010
- A15-A19
- ICD-9-CM Version 2011
- 010-018.99
Description
Have any known malignancy or history of malignancy within the 5-year period prior to screening (with the exception of squamous or basal cell carcinoma of the skin that has been completely excised without evidence of recurrence)
Type de données
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
- UMLS CUI 2011AA
- C2735088
- LOINC Version 232
- MTHU034770
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- 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
- UMLS CUI 2011AA
- C0205197
- SNOMED CT 2011_0131
- 255594003
- UMLS CUI 2011AA
- C0728940
- SNOMED CT 2011_0131
- 65801008
Description
Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C0221099
- SNOMED CT 2011_0131
- 260379002
- UMLS CUI 2011AA
- C0018684
- SNOMED CT 2011_0131
- 263775005
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
- UMLS CUI 2011AA
- CL414898
- UMLS CUI 2011AA
- C1321605
- SNOMED CT 2011_0131
- 405078008
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C1514873
Similar models
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
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55561003 (SNOMED CT 2011_0131)
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34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1444662 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
C0666743 (UMLS CUI 2011AA)
386891004 (SNOMED CT 2011_0131)
MTHU018219 (LOINC Version 232)
CL414906 (UMLS CUI 2011AA)
C0919936 (UMLS CUI 2011AA)
10051259 (MedDRA 14.1)
C0220908 (UMLS CUI 2011AA)
20135006 (SNOMED CT 2011_0131)
C0019169 (UMLS CUI 2011AA)
81665004 (SNOMED CT 2011_0131)
C0451071 (UMLS CUI 2011AA)
273364009 (SNOMED CT 2011_0131)
88323005 (SNOMED CT 2011_0131)
C0005768 (UMLS CUI 2011AA)
C0023884 (UMLS CUI 2011AA)
10200004 (SNOMED CT 2011_0131)
MTHU002039 (LOINC Version 232)
C0022885 (UMLS CUI 2011AA)
15220000 (SNOMED CT 2011_0131)
10059938 (MedDRA 14.1)
C1522609 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205275 (UMLS CUI 2011AA)
44104002 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1610637 (UMLS CUI 2011AA)
10064904 (MedDRA 14.1)
C0019655 (UMLS CUI 2011AA)
12962009 (SNOMED CT 2011_0131)
10020141 (MedDRA 14.1)
B39.9 (ICD-10-CM Version 2010)
115.90 (ICD-9-CM Version 2011)
C0262426 (UMLS CUI 2011AA)
168734001 (SNOMED CT 2011_0131)
10008499 (MedDRA 14.1)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1704258 (UMLS CUI 2011AA)
C0038659 (UMLS CUI 2011AA)
C0041296 (UMLS CUI 2011AA)
56717001 (SNOMED CT 2011_0131)
10044755 (MedDRA 14.1)
MTHU020835 (LOINC Version 232)
A15-A19 (ICD-10-CM Version 2010)
010-018.99 (ICD-9-CM Version 2011)
255344003 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C1518422 (UMLS CUI 2011AA)
C1521996 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0241311 (UMLS CUI 2011AA)
C2825055 (UMLS CUI 2011AA)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
55561003 (SNOMED CT 2011_0131)
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
CL414700 (UMLS CUI 2011AA)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0019158 (UMLS CUI 2011AA)
29001004 (SNOMED CT 2011_0131)
10019717 (MedDRA 14.1)
C0032285 (UMLS CUI 2011AA)
233604007 (SNOMED CT 2011_0131)
10035664 (MedDRA 14.1)
MTHU020831 (LOINC Version 232)
J18.9 (ICD-10-CM Version 2010)
E13502 (CTCAE 1105E)
C0034186 (UMLS CUI 2011AA)
45816000 (SNOMED CT 2011_0131)
10037596 (MedDRA 14.1)
N16 (ICD-10-CM Version 2010)
590.80 (ICD-9-CM Version 2011)
E11431 (CTCAE 1105E)
61274003 (SNOMED CT 2011_0131)
10030901 (MedDRA 14.1)
C0019360 (UMLS CUI 2011AA)
4740000 (SNOMED CT 2011_0131)
10019974 (MedDRA 14.1)
B02 (ICD-10-CM Version 2010)
53 (ICD-9-CM Version 2011)
C0010825 (UMLS CUI 2011AA)
407444007 (SNOMED CT 2011_0131)
10009701 (MedDRA 14.1)
MTHU033986 (LOINC Version 232)
C0032276 (UMLS CUI 2011AA)
C0004030 (UMLS CUI 2011AA)
65553006 (SNOMED CT 2011_0131)
10003488 (MedDRA 14.1)
B44 (ICD-10-CM Version 2010)
117.3 (ICD-9-CM Version 2011)
C0019655 (UMLS CUI 2011AA)
12962009 (SNOMED CT 2011_0131)
10020141 (MedDRA 14.1)
B39.9 (ICD-10-CM Version 2010)
115.90 (ICD-9-CM Version 2011)
C0026912 (UMLS CUI 2011AA)
243368001 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0041296 (UMLS CUI 2011AA)
56717001 (SNOMED CT 2011_0131)
10044755 (MedDRA 14.1)
MTHU020835 (LOINC Version 232)
A15-A19 (ICD-10-CM Version 2010)
010-018.99 (ICD-9-CM Version 2011)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
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)
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0018684 (UMLS CUI 2011AA)
263775005 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
CL414898 (UMLS CUI 2011AA)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)