Information:
Fel:
ID
4942
Beskrivning
ODM derived from http://clinicaltrials.gov/show/NCT00628745
Länk
http://clinicaltrials.gov/show/NCT00628745
Nyckelord
Versioner (2)
- 2013-12-09 2013-12-09 - Martin Dugas
- 2014-04-15 2014-04-15 - Julian Varghese
Uppladdad den
15 april 2014
DOI
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Licens
Creative Commons BY 4.0
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Eligibility NCT00628745 Transthyretin Mutations
Eligibility
- StudyEvent: Eligibility
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Beskrivning
Patient has primary or secondary amyloidosis.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0268381
- SNOMED CT 2011_0131
- 23132008
- MedDRA 14.1
- 10036673
- UMLS CUI 2011AA
- C0221014
- SNOMED CT 2011_0131
- 281034005
- MedDRA 14.1
- 10039811
- ICD-10-CM Version 2010
- E85.3
Similar models
Eligibility
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
397669002 (SNOMED CT 2011_0131)
Written informed consent.
Item
Written informed consent.
boolean
C0021430 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
Patient has confirmed: genotyped TTR mutation with or without a diagnosis of TTR-associated amyloidosis (e.g., ATTR-PN, ATTR-CM), or Wild-type TTR-associated amyloidosis with cardiomyopathy (wild-type ATTR-CM).
Item
Patient has confirmed: genotyped TTR mutation with or without a diagnosis of TTR-associated amyloidosis (e.g., ATTR-PN, ATTR-CM), or Wild-type TTR-associated amyloidosis with cardiomyopathy (wild-type ATTR-CM).
boolean
C0750484 (UMLS CUI 2011AA)
C0017431 (UMLS CUI 2011AA)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0026882 (UMLS CUI 2011AA)
55446002 (SNOMED CT 2011_0131)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0002726 (UMLS CUI 2011AA)
17602002 (SNOMED CT 2011_0131)
10002022 (MedDRA 14.1)
E85 (LOINC Version 232)
277.3 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0206247 (UMLS CUI 2011AA)
193187004 (SNOMED CT 2011_0131)
C0268407 (UMLS CUI 2011AA)
16573007 (SNOMED CT 2011_0131)
10007509 (MedDRA 14.1)
C0678926 (UMLS CUI 2011AA)
CL411823 (UMLS CUI 2011AA)
85898001 (SNOMED CT 2011_0131)
10007636 (MedDRA 14.1)
I42.9 (ICD-10-CM Version 2010)
425 (ICD-9-CM Version 2011)
C0017431 (UMLS CUI 2011AA)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0026882 (UMLS CUI 2011AA)
55446002 (SNOMED CT 2011_0131)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0002726 (UMLS CUI 2011AA)
17602002 (SNOMED CT 2011_0131)
10002022 (MedDRA 14.1)
E85 (LOINC Version 232)
277.3 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0206247 (UMLS CUI 2011AA)
193187004 (SNOMED CT 2011_0131)
C0268407 (UMLS CUI 2011AA)
16573007 (SNOMED CT 2011_0131)
10007509 (MedDRA 14.1)
C0678926 (UMLS CUI 2011AA)
CL411823 (UMLS CUI 2011AA)
85898001 (SNOMED CT 2011_0131)
10007636 (MedDRA 14.1)
I42.9 (ICD-10-CM Version 2010)
425 (ICD-9-CM Version 2011)
Confirmation of wild-type ATTR-CM will be determined by one of the following set of criteria (A or B):
Item
boolean
C0750484 (UMLS CUI 2011AA)
C0678926 (UMLS CUI 2011AA)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0268407 (UMLS CUI 2011AA)
16573007 (SNOMED CT 2011_0131)
10007509 (MedDRA 14.1)
C0521095 (UMLS CUI 2011AA)
436000 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C1705195 (UMLS CUI 2011AA)
CL414621 (UMLS CUI 2011AA)
C0678926 (UMLS CUI 2011AA)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0268407 (UMLS CUI 2011AA)
16573007 (SNOMED CT 2011_0131)
10007509 (MedDRA 14.1)
C0521095 (UMLS CUI 2011AA)
436000 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C1705195 (UMLS CUI 2011AA)
CL414621 (UMLS CUI 2011AA)
A. Presence of amyloid in cardiac biopsy tissue confirmed as TTR amyloid by immunohistochemistry and genotyped confirmation that patient does not possess a known mutation in TTR gene (i.e., is a carrier of wild-type allele only) via genetic testing
Item
A. Presence of amyloid in cardiac biopsy tissue confirmed as TTR amyloid by immunohistochemistry and genotyped confirmation that patient does not possess a known mutation in TTR gene (i.e., is a carrier of wild-type allele only) via genetic testing
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0002716 (UMLS CUI 2011AA)
C1272575 (UMLS CUI 2011AA)
386108004 (SNOMED CT 2011_0131)
C0005558 (UMLS CUI 2011AA)
86273004 (SNOMED CT 2011_0131)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
C0750484 (UMLS CUI 2011AA)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0002716 (UMLS CUI 2011AA)
C0020986 (UMLS CUI 2011AA)
C0017431 (UMLS CUI 2011AA)
C0750484 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0026882 (UMLS CUI 2011AA)
55446002 (SNOMED CT 2011_0131)
C1421224 (UMLS CUI 2011AA)
C0678926 (UMLS CUI 2011AA)
C0002085 (UMLS CUI 2011AA)
9109004 (SNOMED CT 2011_0131)
C0679560 (UMLS CUI 2011AA)
405824009 (SNOMED CT 2011_0131)
52101004 (SNOMED CT 2011_0131)
C0002716 (UMLS CUI 2011AA)
C1272575 (UMLS CUI 2011AA)
386108004 (SNOMED CT 2011_0131)
C0005558 (UMLS CUI 2011AA)
86273004 (SNOMED CT 2011_0131)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
C0750484 (UMLS CUI 2011AA)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0002716 (UMLS CUI 2011AA)
C0020986 (UMLS CUI 2011AA)
C0017431 (UMLS CUI 2011AA)
C0750484 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0026882 (UMLS CUI 2011AA)
55446002 (SNOMED CT 2011_0131)
C1421224 (UMLS CUI 2011AA)
C0678926 (UMLS CUI 2011AA)
C0002085 (UMLS CUI 2011AA)
9109004 (SNOMED CT 2011_0131)
C0679560 (UMLS CUI 2011AA)
405824009 (SNOMED CT 2011_0131)
B. Evidence of cardiac involvement by echocardiogram as defined by mean left ventricle wall thickness of > 12 mm, and presence of amyloid in non-cardiac tissue confirmed as TTR amyloid by immunohistochemistry, and genotyped confirmation that patient does not possess a known mutation in TTR gene (i.e., is a carrier of wild-type allele only) via genetic testing.
Item
B. Evidence of cardiac involvement by echocardiogram as defined by mean left ventricle wall thickness of > 12 mm, and presence of amyloid in non-cardiac tissue confirmed as TTR amyloid by immunohistochemistry, and genotyped confirmation that patient does not possess a known mutation in TTR gene (i.e., is a carrier of wild-type allele only) via genetic testing.
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C1522601 (UMLS CUI 2011AA)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C2243117 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
C0444504 (UMLS CUI 2011AA)
255586005 (SNOMED CT 2011_0131)
C0504053 (UMLS CUI 2011AA)
C1280412 (UMLS CUI 2011AA)
246703001 (SNOMED CT 2011_0131)
MTHU002984 (LOINC Version 232)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0002716 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1522601 (UMLS CUI 2011AA)
C0040300 (UMLS CUI 2011AA)
85756007 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0002716 (UMLS CUI 2011AA)
C0021044 (UMLS CUI 2011AA)
117617002 (SNOMED CT 2011_0131)
10059656 (MedDRA 14.1)
C0017431 (UMLS CUI 2011AA)
C0750484 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0026882 (UMLS CUI 2011AA)
55446002 (SNOMED CT 2011_0131)
C1421224 (UMLS CUI 2011AA)
C0678926 (UMLS CUI 2011AA)
C0002085 (UMLS CUI 2011AA)
9109004 (SNOMED CT 2011_0131)
C0679560 (UMLS CUI 2011AA)
405824009 (SNOMED CT 2011_0131)
18669006 (SNOMED CT 2011_0131)
C1522601 (UMLS CUI 2011AA)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C2243117 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
C0444504 (UMLS CUI 2011AA)
255586005 (SNOMED CT 2011_0131)
C0504053 (UMLS CUI 2011AA)
C1280412 (UMLS CUI 2011AA)
246703001 (SNOMED CT 2011_0131)
MTHU002984 (LOINC Version 232)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0002716 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1522601 (UMLS CUI 2011AA)
C0040300 (UMLS CUI 2011AA)
85756007 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0002716 (UMLS CUI 2011AA)
C0021044 (UMLS CUI 2011AA)
117617002 (SNOMED CT 2011_0131)
10059656 (MedDRA 14.1)
C0017431 (UMLS CUI 2011AA)
C0750484 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0026882 (UMLS CUI 2011AA)
55446002 (SNOMED CT 2011_0131)
C1421224 (UMLS CUI 2011AA)
C0678926 (UMLS CUI 2011AA)
C0002085 (UMLS CUI 2011AA)
9109004 (SNOMED CT 2011_0131)
C0679560 (UMLS CUI 2011AA)
405824009 (SNOMED CT 2011_0131)
Patient has primary or secondary amyloidosis.
Item
Patient has primary or secondary amyloidosis.
boolean
C0268381 (UMLS CUI 2011AA)
23132008 (SNOMED CT 2011_0131)
10036673 (MedDRA 14.1)
C0221014 (UMLS CUI 2011AA)
281034005 (SNOMED CT 2011_0131)
10039811 (MedDRA 14.1)
E85.3 (ICD-10-CM Version 2010)
23132008 (SNOMED CT 2011_0131)
10036673 (MedDRA 14.1)
C0221014 (UMLS CUI 2011AA)
281034005 (SNOMED CT 2011_0131)
10039811 (MedDRA 14.1)
E85.3 (ICD-10-CM Version 2010)
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