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ID

4942

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00628745

Link

http://clinicaltrials.gov/show/NCT00628745

Stichworte

  1. 09.12.13 09.12.13 - Martin Dugas
  2. 15.04.14 15.04.14 - Julian Varghese
Hochgeladen am

15. April 2014

DOI

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Creative Commons BY 4.0

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    Eligibility NCT00628745 Transthyretin Mutations

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425202
    age at least 18 Years
    Beschreibung

    age at least 18 Years

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Written informed consent.
    Beschreibung

    Written informed consent.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0021430
    HL7 V3 2006_05
    WRITTEN
    UMLS CUI 2011AA
    C0021430
    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).
    Beschreibung

    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).

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    C0017431
    UMLS CUI 2011AA
    C0032923
    SNOMED CT 2011_0131
    37959007
    LOINC Version 232
    MTHU004200
    UMLS CUI 2011AA
    C0026882
    SNOMED CT 2011_0131
    55446002
    UMLS CUI 2011AA
    C0032923
    SNOMED CT 2011_0131
    37959007
    LOINC Version 232
    MTHU004200
    UMLS CUI 2011AA
    C0332281
    SNOMED CT 2011_0131
    47429007
    UMLS CUI 2011AA
    C0002726
    SNOMED CT 2011_0131
    17602002
    MedDRA 14.1
    10002022
    LOINC Version 232
    E85
    ICD-10-CM Version 2010
    277.3
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0032923
    SNOMED CT 2011_0131
    37959007
    LOINC Version 232
    MTHU004200
    UMLS CUI 2011AA
    C0206247
    SNOMED CT 2011_0131
    193187004
    UMLS CUI 2011AA
    C0268407
    SNOMED CT 2011_0131
    16573007
    MedDRA 14.1
    10007509
    UMLS CUI 2011AA
    C0678926
    UMLS CUI 2011AA
    CL411823
    SNOMED CT 2011_0131
    85898001
    MedDRA 14.1
    10007636
    ICD-10-CM Version 2010
    I42.9
    ICD-9-CM Version 2011
    425
    Beschreibung

    Confirmation of wild-type ATTR-CM will be determined by one of the following set of criteria (A or B):

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    C0678926
    UMLS CUI 2011AA
    C0032923
    SNOMED CT 2011_0131
    37959007
    LOINC Version 232
    MTHU004200
    UMLS CUI 2011AA
    C0268407
    SNOMED CT 2011_0131
    16573007
    MedDRA 14.1
    10007509
    UMLS CUI 2011AA
    C0521095
    SNOMED CT 2011_0131
    436000
    UMLS CUI 2011AA
    C0332282
    SNOMED CT 2011_0131
    255260001
    UMLS CUI 2011AA
    C1705195
    UMLS CUI 2011AA
    CL414621
    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
    Beschreibung

    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

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0150312
    SNOMED CT 2011_0131
    52101004
    UMLS CUI 2011AA
    C0002716
    UMLS CUI 2011AA
    C1272575
    SNOMED CT 2011_0131
    386108004
    UMLS CUI 2011AA
    C0005558
    SNOMED CT 2011_0131
    86273004
    MedDRA 14.1
    10004720
    LOINC Version 232
    MTHU028106
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    C0032923
    SNOMED CT 2011_0131
    37959007
    LOINC Version 232
    MTHU004200
    UMLS CUI 2011AA
    C0002716
    UMLS CUI 2011AA
    C0020986
    UMLS CUI 2011AA
    C0017431
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0026882
    SNOMED CT 2011_0131
    55446002
    UMLS CUI 2011AA
    C1421224
    UMLS CUI 2011AA
    C0678926
    UMLS CUI 2011AA
    C0002085
    SNOMED CT 2011_0131
    9109004
    UMLS CUI 2011AA
    C0679560
    SNOMED CT 2011_0131
    405824009
    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.
    Beschreibung

    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.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0332120
    SNOMED CT 2011_0131
    18669006
    UMLS CUI 2011AA
    C1522601
    UMLS CUI 2011AA
    C1314939
    SNOMED CT 2011_0131
    248448006
    UMLS CUI 2011AA
    C2243117
    UMLS CUI 2011AA
    C1704788
    UMLS CUI 2011AA
    C0444504
    SNOMED CT 2011_0131
    255586005
    UMLS CUI 2011AA
    C0504053
    UMLS CUI 2011AA
    C1280412
    SNOMED CT 2011_0131
    246703001
    LOINC Version 232
    MTHU002984
    UMLS CUI 2011AA
    C0150312
    SNOMED CT 2011_0131
    52101004
    UMLS CUI 2011AA
    C0002716
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C1522601
    UMLS CUI 2011AA
    C0040300
    SNOMED CT 2011_0131
    85756007
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    C0032923
    SNOMED CT 2011_0131
    37959007
    LOINC Version 232
    MTHU004200
    UMLS CUI 2011AA
    C0002716
    UMLS CUI 2011AA
    C0021044
    SNOMED CT 2011_0131
    117617002
    MedDRA 14.1
    10059656
    UMLS CUI 2011AA
    C0017431
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0026882
    SNOMED CT 2011_0131
    55446002
    UMLS CUI 2011AA
    C1421224
    UMLS CUI 2011AA
    C0678926
    UMLS CUI 2011AA
    C0002085
    SNOMED CT 2011_0131
    9109004
    UMLS CUI 2011AA
    C0679560
    SNOMED CT 2011_0131
    405824009
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425201
    Patient has primary or secondary amyloidosis.
    Beschreibung

    Patient has primary or secondary amyloidosis.

    Datentyp

    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

    Ähnliche Modelle

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Inclusion Criteria
    CL425202 (UMLS CUI 2011AA)
    age at least 18 Years
    Item
    age at least 18 Years
    boolean
    C0001779 (UMLS CUI 2011AA)
    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)
    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)
    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)
    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)
    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)
    Item Group
    Exclusion Criteria
    CL425201 (UMLS CUI 2011AA)
    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)

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