ID
5131
Beschreibung
ODM derived from http://clinicaltrials.gov/show/NCT01335477
Link
http://clinicaltrials.gov/show/NCT01335477
Stichworte
Versionen (3)
- 21.03.13 21.03.13 - Martin Dugas
- 19.04.14 19.04.14 - Julian Varghese
- 20.09.21 20.09.21 -
Hochgeladen am
19. April 2014
DOI
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Lizenz
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Eligibility NCT01335477 Pulmonary Fibrosis
Eligibility
- StudyEvent: Eligibility
Beschreibung
Exclusion Criteria
Beschreibung
Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit of Normal (ULN)
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0004002
- SNOMED CT 2011_0131
- 26091008
- LOINC Version 232
- MTHU004883
- UMLS CUI 2011AA
- C0001899
- SNOMED CT 2011_0131
- 56935002
- LOINC Version 232
- MTHU006766
- UMLS CUI 2011AA
- C1519815
Beschreibung
Bilirubin > 1.5 x ULN
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1278039
- SNOMED CT 2011_0131
- 79706000
- LOINC Version 232
- 1975-2
Beschreibung
Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7)
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C2347946
- UMLS CUI 2011AA
- C0001883
- SNOMED CT 2011_0131
- 79688008
- MedDRA 14.1
- 10001539
- UMLS CUI 2011AA
- C3166210
- LOINC Version 232
- MTHU037641
- UMLS CUI 2011AA
- C3166211
- LOINC Version 232
- MTHU037642
Beschreibung
Patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation)
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0332148
- SNOMED CT 2011_0131
- 2931005
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0024128
- SNOMED CT 2011_0131
- 88039007
- MedDRA 14.1
- 10025127
- ICD-9-CM Version 2011
- 33.5
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Beschreibung
Myocardial infarction within 6 months
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0027051
- SNOMED CT 2011_0131
- 22298006
- MedDRA 14.1
- 10028596
- LOINC Version 232
- MTHU035551
- ICD-10-CM Version 2010
- I21-I22
- ICD-9-CM Version 2011
- 410
- CTCAE 1105E
- E10152
- UMLS CUI 2011AA
- C0332285
- SNOMED CT 2011_0131
- 18720000
- UMLS CUI 2011AA
- C0205452
- SNOMED CT 2011_0131
- 68244004
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
Beschreibung
Unstable angina within 1 month
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0002965
- SNOMED CT 2011_0131
- 4557003
- MedDRA 14.1
- 10002388
- ICD-10-CM Version 2010
- I20.0
- ICD-9-CM Version 2011
- 411.1
- UMLS CUI 2011AA
- C0332285
- SNOMED CT 2011_0131
- 18720000
- UMLS CUI 2011AA
- C0205447
- SNOMED CT 2011_0131
- 38112003
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
Beschreibung
Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months);
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1458140
- SNOMED CT 2011_0131
- 248250000
- MedDRA 14.1
- 10005134
- UMLS CUI 2011AA
- C0314657
- SNOMED CT 2011_0131
- 47708004
- UMLS CUI 2011AA
- C0016017
- SNOMED CT 2011_0131
- 385538006
- UMLS CUI 2011AA
- C0443225
- SNOMED CT 2011_0131
- 261015003
- UMLS CUI 2011AA
- C0178602
- SNOMED CT 2011_0131
- 260911001
- UMLS CUI 2011AA
- C0741135
- UMLS CUI 2011AA
- C0444956
- SNOMED CT 2011_0131
- 261829003
- UMLS CUI 2011AA
- C1096021
- MedDRA 14.1
- 10053460
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C1560581
- CTCAE 1105E
- MTHU116769
- UMLS CUI 2011AA
- C0019079
- SNOMED CT 2011_0131
- 66857006
- MedDRA 14.1
- 10018964
- ICD-10-CM Version 2010
- R04.2
- ICD-9-CM Version 2011
- 786.3
- UMLS CUI 2011AA
- C0018965
- SNOMED CT 2011_0131
- 34436003
- MedDRA 14.1
- 10018867
- ICD-10-CM Version 2010
- R31
- ICD-9-CM Version 2011
- 599.7
- CTCAE 1105E
- E13000
- UMLS CUI 2011AA
- C0017181
- SNOMED CT 2011_0131
- 74474003
- MedDRA 14.1
- 10017955
- ICD-10-CM Version 2010
- K92.2
- ICD-9-CM Version 2011
- 578
- UMLS CUI 2011AA
- C0041582
- SNOMED CT 2011_0131
- 10045285
- MedDRA 14.1
- 10045285
- LOINC Version 232
- MTHU022920
- UMLS CUI 2011AA
- C0332677
- SNOMED CT 2011_0131
- 2734008
- UMLS CUI 2011AA
- C0679637
Beschreibung
Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months;
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C2749785
- UMLS CUI 2011AA
- C0314657
- SNOMED CT 2011_0131
- 47708004
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0040053
- SNOMED CT 2011_0131
- 439127006
- MedDRA 14.1
- 10043607
- UMLS CUI 2011AA
- C0038454
- SNOMED CT 2011_0131
- 230690007
- MedDRA 14.1
- 10042244
- ICD-10-CM Version 2010
- I63.9
- CTCAE 1105E
- E12826
- UMLS CUI 2011AA
- C0007787
- SNOMED CT 2011_0131
- 266257000
- MedDRA 14.1
- 10044390
- LOINC Version 232
- MTHU020810
- ICD-10-CM Version 2010
- G45.9
- ICD-9-CM Version 2011
- 435.9
- CTCAE 1105E
- E12834
Beschreibung
International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by > 50% of institutional ULN)
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- CL415281
- UMLS CUI 2011AA
- C2673577
- UMLS CUI 2011AA
- C0030605
- SNOMED CT 2011_0131
- 42525009
- MedDRA 14.1
- 10000630
- UMLS CUI 2011AA
- C1519815
Beschreibung
N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0699252
- SNOMED CT 2011_0131
- 77731008
- UMLS CUI 2011AA
- C0032952
- SNOMED CT 2011_0131
- 116602009
- LOINC Version 232
- MTHU003245
- UMLS CUI 2011AA
- CL415123
Beschreibung
Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0298067
- SNOMED CT 2011_0131
- 438240001
- UMLS CUI 2011AA
- C0004482
- SNOMED CT 2011_0131
- 372574004
- LOINC Version 232
- MTHU006794
- UMLS CUI 2011AA
- C0010583
- SNOMED CT 2011_0131
- 387420009
- LOINC Version 232
- MTHU029970
- UMLS CUI 2011AA
- C0010592
- SNOMED CT 2011_0131
- 387467008
- LOINC Version 232
- MTHU005140
Ähnliche Modelle
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
516.31 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C1513491 (UMLS CUI 2011AA)
RECENT (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0037459 (UMLS CUI 2011AA)
C0220845 (UMLS CUI 2011AA)
C1512457 (UMLS CUI 2011AA)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0189485 (UMLS CUI 2011AA)
78603008 (SNOMED CT 2011_0131)
10004794 (MedDRA 14.1)
C0449774 (UMLS CUI 2011AA)
272135003 (SNOMED CT 2011_0131)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C3161101 (UMLS CUI 2011AA)
516.31 (ICD-9-CM Version 2011)
C0205202 (UMLS CUI 2011AA)
33714007 (SNOMED CT 2011_0131)
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C0001883 (UMLS CUI 2011AA)
79688008 (SNOMED CT 2011_0131)
10001539 (MedDRA 14.1)
C3166210 (UMLS CUI 2011AA)
MTHU037641 (LOINC Version 232)
C3166211 (UMLS CUI 2011AA)
MTHU037642 (LOINC Version 232)
2931005 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0024128 (UMLS CUI 2011AA)
88039007 (SNOMED CT 2011_0131)
10025127 (MedDRA 14.1)
33.5 (ICD-9-CM Version 2011)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
248250000 (SNOMED CT 2011_0131)
10005134 (MedDRA 14.1)
C0314657 (UMLS CUI 2011AA)
47708004 (SNOMED CT 2011_0131)
C0016017 (UMLS CUI 2011AA)
385538006 (SNOMED CT 2011_0131)
C0443225 (UMLS CUI 2011AA)
261015003 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0741135 (UMLS CUI 2011AA)
C0444956 (UMLS CUI 2011AA)
261829003 (SNOMED CT 2011_0131)
C1096021 (UMLS CUI 2011AA)
10053460 (MedDRA 14.1)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1560581 (UMLS CUI 2011AA)
MTHU116769 (CTCAE 1105E)
C0019079 (UMLS CUI 2011AA)
66857006 (SNOMED CT 2011_0131)
10018964 (MedDRA 14.1)
R04.2 (ICD-10-CM Version 2010)
786.3 (ICD-9-CM Version 2011)
C0018965 (UMLS CUI 2011AA)
34436003 (SNOMED CT 2011_0131)
10018867 (MedDRA 14.1)
R31 (ICD-10-CM Version 2010)
599.7 (ICD-9-CM Version 2011)
E13000 (CTCAE 1105E)
C0017181 (UMLS CUI 2011AA)
74474003 (SNOMED CT 2011_0131)
10017955 (MedDRA 14.1)
K92.2 (ICD-10-CM Version 2010)
578 (ICD-9-CM Version 2011)
C0041582 (UMLS CUI 2011AA)
10045285 (SNOMED CT 2011_0131)
10045285 (MedDRA 14.1)
MTHU022920 (LOINC Version 232)
C0332677 (UMLS CUI 2011AA)
2734008 (SNOMED CT 2011_0131)
C0679637 (UMLS CUI 2011AA)
C0314657 (UMLS CUI 2011AA)
47708004 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0040053 (UMLS CUI 2011AA)
439127006 (SNOMED CT 2011_0131)
10043607 (MedDRA 14.1)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0007787 (UMLS CUI 2011AA)
266257000 (SNOMED CT 2011_0131)
10044390 (MedDRA 14.1)
MTHU020810 (LOINC Version 232)
G45.9 (ICD-10-CM Version 2010)
435.9 (ICD-9-CM Version 2011)
E12834 (CTCAE 1105E)
C2673577 (UMLS CUI 2011AA)
C0030605 (UMLS CUI 2011AA)
42525009 (SNOMED CT 2011_0131)
10000630 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
77731008 (SNOMED CT 2011_0131)
C0032952 (UMLS CUI 2011AA)
116602009 (SNOMED CT 2011_0131)
MTHU003245 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
438240001 (SNOMED CT 2011_0131)
C0004482 (UMLS CUI 2011AA)
372574004 (SNOMED CT 2011_0131)
MTHU006794 (LOINC Version 232)
C0010583 (UMLS CUI 2011AA)
387420009 (SNOMED CT 2011_0131)
MTHU029970 (LOINC Version 232)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)