ID
5065
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT01011205
Link
http://clinicaltrials.gov/show/NCT01011205
Palabras clave
Versiones (3)
- 7/12/13 7/12/13 - Martin Dugas
- 17/4/14 17/4/14 - Julian Varghese
- 27/9/21 27/9/21 -
Subido en
17 de abril de 2014
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY 4.0
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Eligibility NCT01011205 Liver Transplantation
Eligibility
- StudyEvent: Eligibility
Descripción
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Descripción
Receiving a multi-organ transplant or having previous received an organ transplant (including liver re-transplantation)
Tipo de datos
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
Descripción
Receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
Tipo de datos
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
Descripción
Receiving ABO incompatible graft or a graft from a non heart beating donor
Tipo de datos
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
Descripción
Ongoing dosing with systemic corticosteroids
Tipo de datos
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
Descripción
Subjects with systemic infection requiring treatment except viral hepatitis
Tipo de datos
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
Descripción
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:
Tipo de datos
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
Descripción
< 3 nodes
Tipo de datos
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
Descripción
no node larger than 5 cm
Tipo de datos
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
Descripción
no metastases
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0445092
- SNOMED CT 2011_0131
- 261985008
Descripción
no vascular tumoral invasion
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1264755
- SNOMED CT 2011_0131
- 127494000
Descripción
Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
Tipo de datos
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
Descripción
Subject or donor known to be HIV positive
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0019699
Descripción
Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
Tipo de datos
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
Descripción
Pregnant woman or breast-feeding mother
Tipo de datos
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
Descripción
Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C2348568
Descripción
Unlikely to comply with the Visits scheduled in the protocol
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0750558
- UMLS CUI 2011AA
- C0525058
- UMLS CUI 2011AA
- C1554196
- HL7 V3 2006_05
- ENC
- UMLS CUI 2011AA
- C0086960
Descripción
Any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator
Tipo de datos
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
Descripción
Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C1554075
- HL7 V3 2006_05
- NP
- UMLS CUI 2011AA
- C1707479
Descripción
Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator
Tipo de datos
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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