ID
5065
Beschrijving
ODM derived from http://clinicaltrials.gov/show/NCT01011205
Link
http://clinicaltrials.gov/show/NCT01011205
Trefwoorden
Versies (3)
- 07-12-13 07-12-13 - Martin Dugas
- 17-04-14 17-04-14 - Julian Varghese
- 27-09-21 27-09-21 -
Geüploaded op
17 april 2014
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
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Eligibility NCT01011205 Liver Transplantation
Eligibility
- StudyEvent: Eligibility
Beschrijving
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Beschrijving
Receiving a multi-organ transplant or having previous received an organ transplant (including liver re-transplantation)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0439064
- SNOMED CT 2011_0131
- 255204007
- UMLS CUI 2011AA
- C0029216
- MedDRA 14.1
- 10061890
- LOINC Version 232
- MTHU000173
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- C0029216
- MedDRA 14.1
- 10061890
- LOINC Version 232
- MTHU000173
- UMLS CUI 2011AA
- C0023884
- SNOMED CT 2011_0131
- 10200004
- LOINC Version 232
- MTHU002039
- UMLS CUI 2011AA
- C0597409
Beschrijving
Receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C1524062
- LOINC Version 232
- MTHU013802
- UMLS CUI 2011AA
- C0332835
- SNOMED CT 2011_0131
- 24486003
- UMLS CUI 2011AA
- C0336562
- SNOMED CT 2011_0131
- 3319006
- UMLS CUI 2011AA
- C0007634
- SNOMED CT 2011_0131
- 118957004
- LOINC Version 232
- MTHU001933
- UMLS CUI 2011AA
- C0449913
- SNOMED CT 2011_0131
- 246333005
- LOINC Version 232
- MTHU025766
Beschrijving
Receiving ABO incompatible graft or a graft from a non heart beating donor
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0860218
- MedDRA 14.1
- 10000206
- UMLS CUI 2011AA
- C0332835
- SNOMED CT 2011_0131
- 24486003
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0027045
- UMLS CUI 2011AA
- CL414920
Beschrijving
Ongoing dosing with systemic corticosteroids
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0750536
- UMLS CUI 2011AA
- CL421051
- UMLS CUI 2011AA
- C0205373
- SNOMED CT 2011_0131
- 31099001
- UMLS CUI 2011AA
- C0001617
- SNOMED CT 2011_0131
- 79440004
Beschrijving
Subjects with systemic infection requiring treatment except viral hepatitis
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0243026
- SNOMED CT 2011_0131
- 91302008
- MedDRA 14.1
- 10040047
- ICD-9-CM Version 2011
- 995.91
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0042721
- SNOMED CT 2011_0131
- 3738000
- MedDRA 14.1
- 10019799
- LOINC Version 232
- MTHU020837
- ICD-10-CM Version 2010
- B19
- ICD-9-CM Version 2011
- 070
- CTCAE 1105E
- E11410
Beschrijving
Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully. However, subjects with primary liver carcinoma can be included if they meet the following criteria:
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0011900
- SNOMED CT 2011_0131
- 439401001
- LOINC Version 232
- MTHU008876
- UMLS CUI 2011AA
- C0205314
- SNOMED CT 2011_0131
- 7147002
- UMLS CUI 2011AA
- C0332162
- SNOMED CT 2011_0131
- 77374008
- 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
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0040732
- SNOMED CT 2011_0131
- 77465005
- MedDRA 14.1
- 10057677
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0007117
- SNOMED CT 2011_0131
- 1338007
- MedDRA 14.1
- 10004146
- UMLS CUI 2011AA
- C0553723
- SNOMED CT 2011_0131
- 254651007
- MedDRA 14.1
- 10041834
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- C1272703
- SNOMED CT 2011_0131
- 385669000
- UMLS CUI 2011AA
- CL425202
- UMLS CUI 2011AA
- C0220630
- UMLS CUI 2011AA
- C0750557
- UMLS CUI 2011AA
- C1550543
- HL7 V3 2006_05
- FLFS
- UMLS CUI 2011AA
- C0332282
- SNOMED CT 2011_0131
- 255260001
- UMLS CUI 2011AA
- CL414621
Beschrijving
< 3 nodes
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0439092
- SNOMED CT 2011_0131
- 276139006
- HL7 V3 2006_05
- LT
- UMLS CUI 2011AA
- C0205449
- SNOMED CT 2011_0131
- 421291004
- UMLS CUI 2011AA
- C0745761
- SNOMED CT 2011_0131
- 428187007
- MedDRA 14.1
- 10049578
Beschrijving
no node larger than 5 cm
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0549184
- SNOMED CT 2011_0131
- 260413007
- UMLS CUI 2011AA
- C0745761
- SNOMED CT 2011_0131
- 428187007
- MedDRA 14.1
- 10049578
- UMLS CUI 2011AA
- C0439093
- SNOMED CT 2011_0131
- 276140008
- HL7 V3 2006_05
- GT
- UMLS CUI 2011AA
- C0205451
- SNOMED CT 2011_0131
- 34001005
- UMLS CUI 2011AA
- C0475210
- SNOMED CT 2011_0131
- 258672001
Beschrijving
no metastases
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0445092
- SNOMED CT 2011_0131
- 261985008
Beschrijving
no vascular tumoral invasion
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1264755
- SNOMED CT 2011_0131
- 127494000
Beschrijving
Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- CL415222
- UMLS CUI 2011AA
- C0021311
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- UMLS CUI 2011AA
- C1443924
- SNOMED CT 2011_0131
- 409587002
- UMLS CUI 2011AA
- C0042963
- SNOMED CT 2011_0131
- 249497008
- MedDRA 14.1
- 10047700
- LOINC Version 232
- MTHU013530
- ICD-10-CM Version 2010
- R11.1
- CTCAE 1105E
- E11068
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C1268997
- SNOMED CT 2011_0131
- 181244000
- UMLS CUI 2011AA
- C0024523
- SNOMED CT 2011_0131
- 155841000
- ICD-10-CM Version 2010
- K90.4
- UMLS CUI 2011AA
- C0030920
- SNOMED CT 2011_0131
- 13200003
- MedDRA 14.1
- 10034341
- ICD-10-CM Version 2010
- K27
- ICD-9-CM Version 2011
- 533
Beschrijving
Subject or donor known to be HIV positive
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0019699
Beschrijving
Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 257550005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C1744706
- UMLS CUI 2011AA
- C0085149
- SNOMED CT 2011_0131
- 386975001
- LOINC Version 232
- MTHU001849
- UMLS CUI 2011AA
- C0003240
- SNOMED CT 2011_0131
- 372480009
- UMLS CUI 2011AA
- C0001617
- SNOMED CT 2011_0131
- 79440004
- UMLS CUI 2011AA
- C0676831
- SNOMED CT 2011_0131
- 386978004
- UMLS CUI 2011AA
- C0209368
- SNOMED CT 2011_0131
- 386976000
- UMLS CUI 2011AA
- C1514468
- UMLS CUI 2011AA
- C0015237
- SNOMED CT 2011_0131
- 360215002
Beschrijving
Pregnant woman or breast-feeding mother
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
- UMLS CUI 2011AA
- C0026591
- SNOMED CT 2011_0131
- 72705000
- LOINC Version 232
- MTHU035602
- HL7 V3 2006_05
- MTH
Beschrijving
Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C2348568
Beschrijving
Unlikely to comply with the Visits scheduled in the protocol
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0750558
- UMLS CUI 2011AA
- C0525058
- UMLS CUI 2011AA
- C1554196
- HL7 V3 2006_05
- ENC
- UMLS CUI 2011AA
- C0086960
Beschrijving
Any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0443343
- SNOMED CT 2011_0131
- 263922001
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0681832
Beschrijving
Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C1554075
- HL7 V3 2006_05
- NP
- UMLS CUI 2011AA
- C1707479
Beschrijving
Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0740858
- SNOMED CT 2011_0131
- 66214007
- MedDRA 14.1
- 10066169
- LOINC Version 232
- MTHU019364
- UMLS CUI 2011AA
- C0004936
- SNOMED CT 2011_0131
- 74732009
- MedDRA 14.1
- 10037174
- ICD-10-CM Version 2010
- F99
- ICD-9-CM Version 2011
- 290-319.99
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C1522701
- UMLS CUI 2011AA
- C0009452
- SNOMED CT 2011_0131
- 263536004
- LOINC Version 232
- MTHU021752
- UMLS CUI 2011AA
- CL102947
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995.91 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
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C0042721 (UMLS CUI 2011AA)
3738000 (SNOMED CT 2011_0131)
10019799 (MedDRA 14.1)
MTHU020837 (LOINC Version 232)
B19 (ICD-10-CM Version 2010)
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E11410 (CTCAE 1105E)
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C0007117 (UMLS CUI 2011AA)
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C1272703 (UMLS CUI 2011AA)
385669000 (SNOMED CT 2011_0131)
CL425202 (UMLS CUI 2011AA)
C0220630 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
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421291004 (SNOMED CT 2011_0131)
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10049578 (MedDRA 14.1)
260413007 (SNOMED CT 2011_0131)
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428187007 (SNOMED CT 2011_0131)
10049578 (MedDRA 14.1)
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276140008 (SNOMED CT 2011_0131)
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C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
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C0042963 (UMLS CUI 2011AA)
249497008 (SNOMED CT 2011_0131)
10047700 (MedDRA 14.1)
MTHU013530 (LOINC Version 232)
R11.1 (ICD-10-CM Version 2010)
E11068 (CTCAE 1105E)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1268997 (UMLS CUI 2011AA)
181244000 (SNOMED CT 2011_0131)
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K90.4 (ICD-10-CM Version 2010)
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13200003 (SNOMED CT 2011_0131)
10034341 (MedDRA 14.1)
K27 (ICD-10-CM Version 2010)
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66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
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74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1522701 (UMLS CUI 2011AA)
C0009452 (UMLS CUI 2011AA)
263536004 (SNOMED CT 2011_0131)
MTHU021752 (LOINC Version 232)
CL102947 (UMLS CUI 2011AA)