ID

3847

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT01396083

Link

http://clinicaltrials.gov/show/NCT01396083

Stichworte

Versionen (1)
  1. 17.04.13 17.04.13 - Martin Dugas
Hochgeladen am

17. April 2013

DOI

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Eligibility NCT01396083 Visual Impairment

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

age at least 18 Years
Beschreibung

age at least 18 Years

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patients diagnosed with visual impairment due to macular edema following CRVO
Beschreibung

Patients diagnosed with visual impairment due to macular edema following CRVO

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0042798
SNOMED CT 2011_0131
397540003
MedDRA 14.1
10047571
ICD-10-CM Version 2010
H54.7
ICD-9-CM Version 2011
369.9
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0271051
SNOMED CT 2011_0131
37231002
MedDRA 14.1
10025415
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0154841
SNOMED CT 2011_0131
68478007
MedDRA 14.1
10007972
ICD-10-CM Version 2010
H34.81
ICD-9-CM Version 2011
362.35
Diagnosis of CRVO at maximum 6 months prior to Screening
Beschreibung

Diagnosis of CRVO at maximum 6 months prior to Screening

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0154841
SNOMED CT 2011_0131
68478007
MedDRA 14.1
10007972
ICD-10-CM Version 2010
H34.81
ICD-9-CM Version 2011
362.35
UMLS CUI 2011AA
C0806909
SNOMED CT 2011_0131
398303009
LOINC Version 232
MTHU008917
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
BCVA using ETDRS charts of 20/40 to 20/400 in the study eye
Beschreibung

BCVA using ETDRS charts of 20/40 to 20/400 in the study eye

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1690532
SNOMED CT 2011_0131
419775003
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C1275992
SNOMED CT 2011_0131
400914004
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Exclusion Criteria
Beschreibung

Exclusion Criteria

Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs
Beschreibung

Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205412
SNOMED CT 2011_0131
71978007
UMLS CUI 2011AA
C2963144
SNOMED CT 2011_0131
263707001
UMLS CUI 2011AA
C1299003
UMLS CUI 2011AA
C0522503
SNOMED CT 2011_0131
300828005
UMLS CUI 2011AA
C0439861
SNOMED CT 2011_0131
105590001
UMLS CUI 2011AA
C1383072
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0200189
SNOMED CT 2011_0131
20067007
ICD-9-CM Version 2011
95.11
Central retinal thickness (CRT) < 250 microm in the study eye
Beschreibung

Central retinal thickness (CRT) < 250 microm in the study eye

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205099
SNOMED CT 2011_0131
26216008
UMLS CUI 2011AA
CL414117
UMLS CUI 2011AA
C1280412
SNOMED CT 2011_0131
246703001
LOINC Version 232
MTHU002984
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Prior episode of RVO in the study eye
Beschreibung

Prior episode of RVO in the study eye

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0332189
SNOMED CT 2011_0131
272128006
UMLS CUI 2011AA
C0035328
SNOMED CT 2011_0131
46085004
MedDRA 14.1
10038907
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Active formation of new vessels in the study eye
Beschreibung

Active formation of new vessels in the study eye

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0302600
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline
Beschreibung

Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
UMLS CUI 2011AA
C0078058
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
IOP >= 30mmHg or uncontrolled glaucoma. Patients may be re-screened after 1 month if they have undergone glaucoma treatment
Beschreibung

IOP >= 30mmHg or uncontrolled glaucoma. Patients may be re-screened after 1 month if they have undergone glaucoma treatment

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0021888
SNOMED CT 2011_0131
41633001
LOINC Version 232
MTHU034775
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0017601
SNOMED CT 2011_0131
23986001
MedDRA 14.1
10018304
LOINC Version 232
MTHU020819
ICD-10-CM Version 2010
H40-H42
ICD-9-CM Version 2011
365
CTCAE 1105E
E10392
Improvement of > 10 letters on BCVA between Screening and Baseline
Beschreibung

Improvement of > 10 letters on BCVA between Screening and Baseline

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2986411
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205456
SNOMED CT 2011_0131
3445001
UMLS CUI 2011AA
C0439102
SNOMED CT 2011_0131
272074007
UMLS CUI 2011AA
C1690532
SNOMED CT 2011_0131
419775003
UMLS CUI 2011AA
CL426201
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1442488
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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
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients diagnosed with visual impairment due to macular edema following CRVO
Item
Patients diagnosed with visual impairment due to macular edema following CRVO
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0042798 (UMLS CUI 2011AA)
397540003 (SNOMED CT 2011_0131)
10047571 (MedDRA 14.1)
H54.7 (ICD-10-CM Version 2010)
369.9 (ICD-9-CM Version 2011)
CL420107 (UMLS CUI 2011AA)
C0271051 (UMLS CUI 2011AA)
37231002 (SNOMED CT 2011_0131)
10025415 (MedDRA 14.1)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0154841 (UMLS CUI 2011AA)
68478007 (SNOMED CT 2011_0131)
10007972 (MedDRA 14.1)
H34.81 (ICD-10-CM Version 2010)
362.35 (ICD-9-CM Version 2011)
Diagnosis of CRVO at maximum 6 months prior to Screening
Item
Diagnosis of CRVO at maximum 6 months prior to Screening
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0154841 (UMLS CUI 2011AA)
68478007 (SNOMED CT 2011_0131)
10007972 (MedDRA 14.1)
H34.81 (ICD-10-CM Version 2010)
362.35 (ICD-9-CM Version 2011)
C0806909 (UMLS CUI 2011AA)
398303009 (SNOMED CT 2011_0131)
MTHU008917 (LOINC Version 232)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
BCVA using ETDRS charts of 20/40 to 20/400 in the study eye
Item
BCVA using ETDRS charts of 20/40 to 20/400 in the study eye
boolean
C1690532 (UMLS CUI 2011AA)
419775003 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C1275992 (UMLS CUI 2011AA)
400914004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Item Group
Exclusion Criteria
Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs
Item
Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs
boolean
C0205412 (UMLS CUI 2011AA)
71978007 (SNOMED CT 2011_0131)
C2963144 (UMLS CUI 2011AA)
263707001 (SNOMED CT 2011_0131)
C1299003 (UMLS CUI 2011AA)
C0522503 (UMLS CUI 2011AA)
300828005 (SNOMED CT 2011_0131)
C0439861 (UMLS CUI 2011AA)
105590001 (SNOMED CT 2011_0131)
C1383072 (UMLS CUI 2011AA)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0200189 (UMLS CUI 2011AA)
20067007 (SNOMED CT 2011_0131)
95.11 (ICD-9-CM Version 2011)
Central retinal thickness (CRT) < 250 microm in the study eye
Item
Central retinal thickness (CRT) < 250 microm in the study eye
boolean
C0205099 (UMLS CUI 2011AA)
26216008 (SNOMED CT 2011_0131)
CL414117 (UMLS CUI 2011AA)
C1280412 (UMLS CUI 2011AA)
246703001 (SNOMED CT 2011_0131)
MTHU002984 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Prior episode of RVO in the study eye
Item
Prior episode of RVO in the study eye
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0332189 (UMLS CUI 2011AA)
272128006 (SNOMED CT 2011_0131)
C0035328 (UMLS CUI 2011AA)
46085004 (SNOMED CT 2011_0131)
10038907 (MedDRA 14.1)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Active formation of new vessels in the study eye
Item
Active formation of new vessels in the study eye
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0302600 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline
Item
Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline
boolean
C0039798 (UMLS CUI 2011AA)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C0078058 (UMLS CUI 2011AA)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
IOP >= 30mmHg or uncontrolled glaucoma. Patients may be re-screened after 1 month if they have undergone glaucoma treatment
Item
IOP >= 30mmHg or uncontrolled glaucoma. Patients may be re-screened after 1 month if they have undergone glaucoma treatment
boolean
C0021888 (UMLS CUI 2011AA)
41633001 (SNOMED CT 2011_0131)
MTHU034775 (LOINC Version 232)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0017601 (UMLS CUI 2011AA)
23986001 (SNOMED CT 2011_0131)
10018304 (MedDRA 14.1)
MTHU020819 (LOINC Version 232)
H40-H42 (ICD-10-CM Version 2010)
365 (ICD-9-CM Version 2011)
E10392 (CTCAE 1105E)
Improvement of > 10 letters on BCVA between Screening and Baseline
Item
Improvement of > 10 letters on BCVA between Screening and Baseline
boolean
C2986411 (UMLS CUI 2011AA)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205456 (UMLS CUI 2011AA)
3445001 (SNOMED CT 2011_0131)
C0439102 (UMLS CUI 2011AA)
272074007 (SNOMED CT 2011_0131)
C1690532 (UMLS CUI 2011AA)
419775003 (SNOMED CT 2011_0131)
CL426201 (UMLS CUI 2011AA)
C1409616 (UMLS CUI 2011AA)
C1442488 (UMLS CUI 2011AA)
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