ID

5077

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT01066208

Link

http://clinicaltrials.gov/show/NCT01066208

Stichworte

Versionen (3)
  1. 07.12.13 07.12.13 - Martin Dugas
  2. 17.04.14 17.04.14 - Julian Varghese
  3. 27.09.21 27.09.21 -
Hochgeladen am

17. April 2014

DOI

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Lizenz

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Eligibility NCT01066208 Wegener's Granulomatosis

Deutsch Englisch

Eligibility

1 Formulare  
  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
Ability to give informed consent. If the patient is unable to give informed consent as a result of death or physical incapacity, then informed assent from next of kin.
Beschreibung

Ability to give informed consent. If the patient is unable to give informed consent as a result of death or physical incapacity, then informed assent from next of kin.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0021430
Inclusion Criteria for Classification criteria:
Beschreibung

Inclusion Criteria for Classification criteria:

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0008902
SNOMED CT 2011_0131
278201002
UMLS CUI 2011AA
CL414621
Presumed diagnosis of a primary systemic vasculitis.
Beschreibung

Presumed diagnosis of a primary systemic vasculitis.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0332148
SNOMED CT 2011_0131
2931005
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0343187
SNOMED CT 2011_0131
407530004
diagnostic criteria
Beschreibung

Inclusion criteria for diagnostic criteria:

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0679228
Suspected diagnosis of a primary systemic vasculitis
Beschreibung

Suspected diagnosis of a primary systemic vasculitis

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0750491
SNOMED CT 2011_0131
415684004
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0343187
SNOMED CT 2011_0131
407530004
Inclusion criteria for controls group for diagnostic criteria:
Beschreibung

Inclusion criteria for controls group for diagnostic criteria:

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0009932
UMLS CUI 2011AA
C0679228
Patients presenting to secondary care with one of the following clinical presentations:
Beschreibung

Patients presenting to secondary care with one of the following clinical presentations:

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0175668
SNOMED CT 2011_0131
2603003
UMLS CUI 2011AA
C1947933
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C2708283
LOINC Version 232
MTHU032358
Multi-system disease. Presentation of disease with at least 2 organs involved.
Beschreibung

Multi-system disease. Presentation of disease with at least 2 organs involved.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0439064
SNOMED CT 2011_0131
255204007
UMLS CUI 2011AA
C0449913
SNOMED CT 2011_0131
246333005
LOINC Version 232
MTHU025766
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0178784
LOINC Version 232
MTHU020170
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
Pulmonary-renal syndrome. Defined as haemoptysis / pulmonary haemorrhage with acute renal impairment.
Beschreibung

Pulmonary-renal syndrome. Defined as haemoptysis / pulmonary haemorrhage with acute renal impairment.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0403529
SNOMED CT 2011_0131
50581000
MedDRA 14.1
10018620
ICD-10-CM Version 2010
M31.0
ICD-9-CM Version 2011
446.21
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
C0151701
SNOMED CT 2011_0131
78144005
MedDRA 14.1
10037394
ICD-10-CM Version 2010
R04.89
UMLS CUI 2011AA
C0403446
SNOMED CT 2011_0131
236424009
Kidney Failure, Acute
Beschreibung

Acute renal failure

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0022660
SNOMED CT 2011_0131
14669001
MedDRA 14.1
10038436
ICD-10-CM Version 2010
N17
ICD-9-CM Version 2011
584
CTCAE 1105E
E12973
Acute respiratory distress
Beschreibung

Acute respiratory distress.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0748355
SNOMED CT 2011_0131
373895009
Chronic upper airways symptoms and signs.
Beschreibung

Chronic upper airways symptoms and signs.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0852126
MedDRA 14.1
10046313
Inflammatory polyarthritis
Beschreibung

Inflammatory polyarthritis.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0162323
SNOMED CT 2011_0131
417373000
MedDRA 14.1
10021994
ICD-10-CM Version 2010
M13.0
Fever of unknown origin
Beschreibung

Fever of unknown origin

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0015970
SNOMED CT 2011_0131
7520000
MedDRA 14.1
10016563
ICD-10-CM Version 2010
R50.9
Acute or chronic abdominal pain
Beschreibung

Acute or chronic abdominal pain

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0740577
SNOMED CT 2011_0131
116290004
UMLS CUI 2011AA
C0232491
SNOMED CT 2011_0131
111985007
MedDRA 14.1
10066568
Hypertensive disease, High Blood Pressure
Beschreibung

Hypertension

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0020538
SNOMED CT 2011_0131
38341003
MedDRA 14.1
10020772
LOINC Version 232
MTHU020789
ICD-10-CM Version 2010
I10
ICD-9-CM Version 2011
997.91
CTCAE 1105E
E13785
Referred to secondary care with suspicion of vasculitis but confirmed not to have vasculitis.
Beschreibung

Referred to secondary care with suspicion of vasculitis but confirmed not to have vasculitis.

Datentyp

boolean

Alias
UMLS CUI 2011AA
CL415200
UMLS CUI 2011AA
C0175668
SNOMED CT 2011_0131
2603003
UMLS CUI 2011AA
C1947933
UMLS CUI 2011AA
C0242114
UMLS CUI 2011AA
C0042384
SNOMED CT 2011_0131
31996006
MedDRA 14.1
10047115
CTCAE 1105E
E13837
UMLS CUI 2011AA
C0521094
SNOMED CT 2011_0131
76104008
New onset headache
Beschreibung

New onset headache

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205314
SNOMED CT 2011_0131
7147002
UMLS CUI 2011AA
C0332162
SNOMED CT 2011_0131
77374008
UMLS CUI 2011AA
C0018681
SNOMED CT 2011_0131
25064002
MedDRA 14.1
10019211
LOINC Version 232
MTHU020860
ICD-10-CM Version 2010
R51
ICD-9-CM Version 2011
784.0
CTCAE 1105E
E12678
Jaw or tongue pain
Beschreibung

Jaw or tongue pain

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0236000
SNOMED CT 2011_0131
274667000
MedDRA 14.1
10033433
ICD-10-CM Version 2010
R68.84
ICD-9-CM Version 2011
784.92
UMLS CUI 2011AA
C0017672
SNOMED CT 2011_0131
30731004
MedDRA 14.1
10043969
ICD-10-CM Version 2010
K14.6
ICD-9-CM Version 2011
529.6
Sudden visual loss
Beschreibung

Sudden visual loss

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0155002
SNOMED CT 2011_0131
15203004
MedDRA 14.1
10042441
ICD-10-CM Version 2010
H53.13
ICD-9-CM Version 2011
368.11
Limb claudication
Beschreibung

Limb claudication

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0023216
SNOMED CT 2011_0131
61685007
LOINC Version 232
MTHU011970
UMLS CUI 2011AA
C0311395
SNOMED CT 2011_0131
275520000
MedDRA 14.1
10009240
Aneurysm of aorta
Beschreibung

Aortic aneurysm >5cm

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0003486
SNOMED CT 2011_0131
67362008
MedDRA 14.1
10002882
ICD-10-CM Version 2010
I71.9
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
age < 18 Years
Beschreibung

Patients < 18 years of age.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Exclusion criteria for classification criteria:
Beschreibung

Exclusion criteria for classification criteria:

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0008902
SNOMED CT 2011_0131
278201002
UMLS CUI 2011AA
CL414621
Inability to provide informed consent.
Beschreibung

Inability to provide informed consent.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0021430
Hepatitis B or C
Beschreibung

Hepatitis B or C

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0019163
SNOMED CT 2011_0131
66071002
MedDRA 14.1
10019731
UMLS CUI 2011AA
C0019196
SNOMED CT 2011_0131
50711007
MedDRA 14.1
10019744
ICD-10-CM Version 2010
B19.20
ICD-9-CM Version 2011
070.7
Co-morbidities that explain the clinical symptoms and signs on which the diagnosis of vasculitis is made. E.g. infection, tumour, other inflammatory condition, etc.
Beschreibung

Co-morbidities that explain the clinical symptoms and signs on which the diagnosis of vasculitis is made. E.g. infection, tumour, other inflammatory condition, etc.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0009488
UMLS CUI 2011AA
C0681841
LOINC Version 232
MTHU013812
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0042384
SNOMED CT 2011_0131
31996006
MedDRA 14.1
10047115
CTCAE 1105E
E13837
UMLS CUI 2011AA
C0021311
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
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
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1290884
SNOMED CT 2011_0131
128139000
diagnostic criteria
Beschreibung

Exclusion Criteria for diagnostic criteria:

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0679228
Patient or next of kin unable or unwilling to provide informed consent or assent.
Beschreibung

Patient or next of kin unable or unwilling to provide informed consent or assent.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0021430
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Ähnliche Modelle

Eligibility

1 Formulare
  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)
Ability to give informed consent. If the patient is unable to give informed consent as a result of death or physical incapacity, then informed assent from next of kin.
Item
Ability to give informed consent. If the patient is unable to give informed consent as a result of death or physical incapacity, then informed assent from next of kin.
boolean
C0021430 (UMLS CUI 2011AA)
Inclusion Criteria for Classification criteria:
Item
Inclusion Criteria for Classification criteria:
boolean
C0008902 (UMLS CUI 2011AA)
278201002 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Presumed diagnosis of a primary systemic vasculitis.
Item
Presumed diagnosis of a primary systemic vasculitis.
boolean
C0332148 (UMLS CUI 2011AA)
2931005 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0343187 (UMLS CUI 2011AA)
407530004 (SNOMED CT 2011_0131)
Inclusion criteria for diagnostic criteria:
Item
diagnostic criteria
boolean
C0679228 (UMLS CUI 2011AA)
Suspected diagnosis of a primary systemic vasculitis
Item
Suspected diagnosis of a primary systemic vasculitis
boolean
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0343187 (UMLS CUI 2011AA)
407530004 (SNOMED CT 2011_0131)
Inclusion criteria for controls group for diagnostic criteria:
Item
Inclusion criteria for controls group for diagnostic criteria:
boolean
C0009932 (UMLS CUI 2011AA)
C0679228 (UMLS CUI 2011AA)
Patients presenting to secondary care with one of the following clinical presentations:
Item
Patients presenting to secondary care with one of the following clinical presentations:
boolean
C0175668 (UMLS CUI 2011AA)
2603003 (SNOMED CT 2011_0131)
C1947933 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C2708283 (UMLS CUI 2011AA)
MTHU032358 (LOINC Version 232)
Multi-system disease. Presentation of disease with at least 2 organs involved.
Item
Multi-system disease. Presentation of disease with at least 2 organs involved.
boolean
C0439064 (UMLS CUI 2011AA)
255204007 (SNOMED CT 2011_0131)
C0449913 (UMLS CUI 2011AA)
246333005 (SNOMED CT 2011_0131)
MTHU025766 (LOINC Version 232)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0178784 (UMLS CUI 2011AA)
MTHU020170 (LOINC Version 232)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
Pulmonary-renal syndrome. Defined as haemoptysis / pulmonary haemorrhage with acute renal impairment.
Item
Pulmonary-renal syndrome. Defined as haemoptysis / pulmonary haemorrhage with acute renal impairment.
boolean
C0403529 (UMLS CUI 2011AA)
50581000 (SNOMED CT 2011_0131)
10018620 (MedDRA 14.1)
M31.0 (ICD-10-CM Version 2010)
446.21 (ICD-9-CM Version 2011)
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)
C0151701 (UMLS CUI 2011AA)
78144005 (SNOMED CT 2011_0131)
10037394 (MedDRA 14.1)
R04.89 (ICD-10-CM Version 2010)
C0403446 (UMLS CUI 2011AA)
236424009 (SNOMED CT 2011_0131)
Acute renal failure
Item
Kidney Failure, Acute
boolean
C0022660 (UMLS CUI 2011AA)
14669001 (SNOMED CT 2011_0131)
10038436 (MedDRA 14.1)
N17 (ICD-10-CM Version 2010)
584 (ICD-9-CM Version 2011)
E12973 (CTCAE 1105E)
Acute respiratory distress.
Item
Acute respiratory distress
boolean
C0748355 (UMLS CUI 2011AA)
373895009 (SNOMED CT 2011_0131)
Chronic upper airways symptoms and signs.
Item
Chronic upper airways symptoms and signs.
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0852126 (UMLS CUI 2011AA)
10046313 (MedDRA 14.1)
Inflammatory polyarthritis.
Item
Inflammatory polyarthritis
boolean
C0162323 (UMLS CUI 2011AA)
417373000 (SNOMED CT 2011_0131)
10021994 (MedDRA 14.1)
M13.0 (ICD-10-CM Version 2010)
Fever of unknown origin
Item
Fever of unknown origin
boolean
C0015970 (UMLS CUI 2011AA)
7520000 (SNOMED CT 2011_0131)
10016563 (MedDRA 14.1)
R50.9 (ICD-10-CM Version 2010)
Acute or chronic abdominal pain
Item
Acute or chronic abdominal pain
boolean
C0740577 (UMLS CUI 2011AA)
116290004 (SNOMED CT 2011_0131)
C0232491 (UMLS CUI 2011AA)
111985007 (SNOMED CT 2011_0131)
10066568 (MedDRA 14.1)
Hypertension
Item
Hypertensive disease, High Blood Pressure
boolean
C0020538 (UMLS CUI 2011AA)
38341003 (SNOMED CT 2011_0131)
10020772 (MedDRA 14.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE 1105E)
Referred to secondary care with suspicion of vasculitis but confirmed not to have vasculitis.
Item
Referred to secondary care with suspicion of vasculitis but confirmed not to have vasculitis.
boolean
CL415200 (UMLS CUI 2011AA)
C0175668 (UMLS CUI 2011AA)
2603003 (SNOMED CT 2011_0131)
C1947933 (UMLS CUI 2011AA)
C0242114 (UMLS CUI 2011AA)
C0042384 (UMLS CUI 2011AA)
31996006 (SNOMED CT 2011_0131)
10047115 (MedDRA 14.1)
E13837 (CTCAE 1105E)
C0521094 (UMLS CUI 2011AA)
76104008 (SNOMED CT 2011_0131)
New onset headache
Item
New onset headache
boolean
C0205314 (UMLS CUI 2011AA)
7147002 (SNOMED CT 2011_0131)
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C0018681 (UMLS CUI 2011AA)
25064002 (SNOMED CT 2011_0131)
10019211 (MedDRA 14.1)
MTHU020860 (LOINC Version 232)
R51 (ICD-10-CM Version 2010)
784.0 (ICD-9-CM Version 2011)
E12678 (CTCAE 1105E)
Jaw or tongue pain
Item
Jaw or tongue pain
boolean
C0236000 (UMLS CUI 2011AA)
274667000 (SNOMED CT 2011_0131)
10033433 (MedDRA 14.1)
R68.84 (ICD-10-CM Version 2010)
784.92 (ICD-9-CM Version 2011)
C0017672 (UMLS CUI 2011AA)
30731004 (SNOMED CT 2011_0131)
10043969 (MedDRA 14.1)
K14.6 (ICD-10-CM Version 2010)
529.6 (ICD-9-CM Version 2011)
Sudden visual loss
Item
Sudden visual loss
boolean
C0155002 (UMLS CUI 2011AA)
15203004 (SNOMED CT 2011_0131)
10042441 (MedDRA 14.1)
H53.13 (ICD-10-CM Version 2010)
368.11 (ICD-9-CM Version 2011)
Limb claudication
Item
Limb claudication
boolean
C0023216 (UMLS CUI 2011AA)
61685007 (SNOMED CT 2011_0131)
MTHU011970 (LOINC Version 232)
C0311395 (UMLS CUI 2011AA)
275520000 (SNOMED CT 2011_0131)
10009240 (MedDRA 14.1)
Aortic aneurysm >5cm
Item
Aneurysm of aorta
boolean
C0003486 (UMLS CUI 2011AA)
67362008 (SNOMED CT 2011_0131)
10002882 (MedDRA 14.1)
I71.9 (ICD-10-CM Version 2010)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patients < 18 years of age.
Item
age < 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Exclusion criteria for classification criteria:
Item
Exclusion criteria for classification criteria:
boolean
C0008902 (UMLS CUI 2011AA)
278201002 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Inability to provide informed consent.
Item
Inability to provide informed consent.
boolean
C0021430 (UMLS CUI 2011AA)
Hepatitis B or C
Item
Hepatitis B or C
boolean
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
Co-morbidities that explain the clinical symptoms and signs on which the diagnosis of vasculitis is made. E.g. infection, tumour, other inflammatory condition, etc.
Item
Co-morbidities that explain the clinical symptoms and signs on which the diagnosis of vasculitis is made. E.g. infection, tumour, other inflammatory condition, etc.
boolean
C0009488 (UMLS CUI 2011AA)
C0681841 (UMLS CUI 2011AA)
MTHU013812 (LOINC Version 232)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0042384 (UMLS CUI 2011AA)
31996006 (SNOMED CT 2011_0131)
10047115 (MedDRA 14.1)
E13837 (CTCAE 1105E)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1290884 (UMLS CUI 2011AA)
128139000 (SNOMED CT 2011_0131)
Exclusion Criteria for diagnostic criteria:
Item
diagnostic criteria
boolean
C0679228 (UMLS CUI 2011AA)
Patient or next of kin unable or unwilling to provide informed consent or assent.
Item
Patient or next of kin unable or unwilling to provide informed consent or assent.
boolean
C0021430 (UMLS CUI 2011AA)
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