ID
5065
Beschreibung
ODM derived from http://clinicaltrials.gov/show/NCT01011205
Link
http://clinicaltrials.gov/show/NCT01011205
Stichworte
Versionen (3)
- 07.12.13 07.12.13 - Martin Dugas
- 17.04.14 17.04.14 - Julian Varghese
- 27.09.21 27.09.21 -
Hochgeladen am
17. April 2014
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY 4.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Eligibility NCT01011205 Liver Transplantation
Eligibility
- StudyEvent: Eligibility
Beschreibung
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Beschreibung
Receiving a multi-organ transplant or having previous received an organ transplant (including liver re-transplantation)
Datentyp
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
Beschreibung
Receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
Datentyp
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
Beschreibung
Receiving ABO incompatible graft or a graft from a non heart beating donor
Datentyp
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
Beschreibung
Ongoing dosing with systemic corticosteroids
Datentyp
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
Beschreibung
Subjects with systemic infection requiring treatment except viral hepatitis
Datentyp
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
Beschreibung
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:
Datentyp
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
Beschreibung
< 3 nodes
Datentyp
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
Beschreibung
no node larger than 5 cm
Datentyp
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
Beschreibung
no metastases
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0445092
- SNOMED CT 2011_0131
- 261985008
Beschreibung
no vascular tumoral invasion
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1264755
- SNOMED CT 2011_0131
- 127494000
Beschreibung
Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
Datentyp
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
Beschreibung
Subject or donor known to be HIV positive
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0019699
Beschreibung
Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
Datentyp
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
Beschreibung
Pregnant woman or breast-feeding mother
Datentyp
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
Beschreibung
Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C2348568
Beschreibung
Unlikely to comply with the Visits scheduled in the protocol
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0750558
- UMLS CUI 2011AA
- C0525058
- UMLS CUI 2011AA
- C1554196
- HL7 V3 2006_05
- ENC
- UMLS CUI 2011AA
- C0086960
Beschreibung
Any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator
Datentyp
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
Beschreibung
Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C1554075
- HL7 V3 2006_05
- NP
- UMLS CUI 2011AA
- C1707479
Beschreibung
Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator
Datentyp
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
Ähnliche Modelle
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
174425003 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
CL370605 (UMLS CUI 2011AA)
C0522536 (UMLS CUI 2011AA)
C0023911 (UMLS CUI 2011AA)
18027006 (SNOMED CT 2011_0131)
10024714 (MedDRA 14.1)
50.5 (ICD-9-CM Version 2011)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
C0430057 (UMLS CUI 2011AA)
167254001 (SNOMED CT 2011_0131)
10036577 (MedDRA 14.1)
C1516879 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0439064 (UMLS CUI 2011AA)
255204007 (SNOMED CT 2011_0131)
C0029216 (UMLS CUI 2011AA)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0029216 (UMLS CUI 2011AA)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
C0023884 (UMLS CUI 2011AA)
10200004 (SNOMED CT 2011_0131)
MTHU002039 (LOINC Version 232)
C0597409 (UMLS CUI 2011AA)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0332835 (UMLS CUI 2011AA)
24486003 (SNOMED CT 2011_0131)
C0336562 (UMLS CUI 2011AA)
3319006 (SNOMED CT 2011_0131)
C0007634 (UMLS CUI 2011AA)
118957004 (SNOMED CT 2011_0131)
MTHU001933 (LOINC Version 232)
C0449913 (UMLS CUI 2011AA)
246333005 (SNOMED CT 2011_0131)
MTHU025766 (LOINC Version 232)
C0860218 (UMLS CUI 2011AA)
10000206 (MedDRA 14.1)
C0332835 (UMLS CUI 2011AA)
24486003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0027045 (UMLS CUI 2011AA)
CL414920 (UMLS CUI 2011AA)
CL421051 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
91302008 (SNOMED CT 2011_0131)
10040047 (MedDRA 14.1)
995.91 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0042721 (UMLS CUI 2011AA)
3738000 (SNOMED CT 2011_0131)
10019799 (MedDRA 14.1)
MTHU020837 (LOINC Version 232)
B19 (ICD-10-CM Version 2010)
070 (ICD-9-CM Version 2011)
E11410 (CTCAE 1105E)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205314 (UMLS CUI 2011AA)
7147002 (SNOMED CT 2011_0131)
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
CL415147 (UMLS CUI 2011AA)
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)
LT (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0745761 (UMLS CUI 2011AA)
428187007 (SNOMED CT 2011_0131)
10049578 (MedDRA 14.1)
260413007 (SNOMED CT 2011_0131)
C0745761 (UMLS CUI 2011AA)
428187007 (SNOMED CT 2011_0131)
10049578 (MedDRA 14.1)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0475210 (UMLS CUI 2011AA)
258672001 (SNOMED CT 2011_0131)
261985008 (SNOMED CT 2011_0131)
127494000 (SNOMED CT 2011_0131)
19032002 (SNOMED CT 2011_0131)
CL415222 (UMLS CUI 2011AA)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1443924 (UMLS CUI 2011AA)
409587002 (SNOMED CT 2011_0131)
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)
C0024523 (UMLS CUI 2011AA)
155841000 (SNOMED CT 2011_0131)
K90.4 (ICD-10-CM Version 2010)
C0030920 (UMLS CUI 2011AA)
13200003 (SNOMED CT 2011_0131)
10034341 (MedDRA 14.1)
K27 (ICD-10-CM Version 2010)
533 (ICD-9-CM Version 2011)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1744706 (UMLS CUI 2011AA)
C0085149 (UMLS CUI 2011AA)
386975001 (SNOMED CT 2011_0131)
MTHU001849 (LOINC Version 232)
C0003240 (UMLS CUI 2011AA)
372480009 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0676831 (UMLS CUI 2011AA)
386978004 (SNOMED CT 2011_0131)
C0209368 (UMLS CUI 2011AA)
386976000 (SNOMED CT 2011_0131)
C1514468 (UMLS CUI 2011AA)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
10036586 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0026591 (UMLS CUI 2011AA)
72705000 (SNOMED CT 2011_0131)
MTHU035602 (LOINC Version 232)
MTH (HL7 V3 2006_05)
C0525058 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0086960 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0681832 (UMLS CUI 2011AA)
C1554075 (UMLS CUI 2011AA)
NP (HL7 V3 2006_05)
C1707479 (UMLS CUI 2011AA)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
C0004936 (UMLS CUI 2011AA)
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)