ID

4313

Description

ODM derived from http://clinicaltrials.gov/show/NCT01131585

Link

http://clinicaltrials.gov/show/NCT01131585

Keywords

Versions (1)
  1. 12/6/13 12/6/13 - Martin Dugas
Uploaded on

December 6, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01131585 Diabetic Macular Edema

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

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

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Reduced visual acuity
Description

Visual Acuity impairment

Data type

boolean

Alias
UMLS CUI 2011AA
C0234632
SNOMED CT 2011_0131
13164000
MedDRA 14.1
10047531
Macular Edema in at least one eye
Description

Macular Edema in at least one eye

Data type

boolean

Alias
UMLS CUI 2011AA
C0271051
SNOMED CT 2011_0131
37231002
MedDRA 14.1
10025415
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Type 1 or Type 2 Diabetes Mellitus
Description

Type 1 or Type 2 Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI 2011AA
C0011854
SNOMED CT 2011_0131
46635009
MedDRA 14.1
10067584
LOINC Version 232
MTHU020217
ICD-10-CM Version 2010
E10
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
Stable medication of diabetes in past 3 month
Description

Stable medication of diabetes in past 3 month

Data type

boolean

Alias
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Patients with uncontrolled systemic or ocular diseases
Description

Patients with uncontrolled systemic or ocular diseases

Data type

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0442893
SNOMED CT 2011_0131
56019007, 264578000
UMLS CUI 2011AA
C0015397
SNOMED CT 2011_0131
371405004
MedDRA 14.1
10015916
ICD-10-CM Version 2010
H44
ICD-9-CM Version 2011
379.90
Laser photocoagulation in the study eye for the last 3 months
Description

Laser photocoagulation in the study eye for the last 3 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0441510
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Any history of any intraocular surgery in the study eye within the past 3 months
Description

Any history of any intraocular surgery in the study eye within the past 3 months

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
CL429484
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Blood pressure (BP)
Description

Blood pressure > 160/100 mmHg

Data type

boolean

Alias
UMLS CUI 2011AA
C0005823
SNOMED CT 2011_0131
75367002
LOINC Version 232
MTHU008342
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
Visual Acuity impairment
Item
Reduced visual acuity
boolean
C0234632 (UMLS CUI 2011AA)
13164000 (SNOMED CT 2011_0131)
10047531 (MedDRA 14.1)
Macular Edema in at least one eye
Item
Macular Edema in at least one eye
boolean
C0271051 (UMLS CUI 2011AA)
37231002 (SNOMED CT 2011_0131)
10025415 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Type 1 or Type 2 Diabetes Mellitus
Item
Type 1 or Type 2 Diabetes Mellitus
boolean
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
Stable medication of diabetes in past 3 month
Item
Stable medication of diabetes in past 3 month
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0013227 (UMLS CUI 2011AA)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patients with uncontrolled systemic or ocular diseases
Item
Patients with uncontrolled systemic or ocular diseases
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0442893 (UMLS CUI 2011AA)
56019007, 264578000 (SNOMED CT 2011_0131)
C0015397 (UMLS CUI 2011AA)
371405004 (SNOMED CT 2011_0131)
10015916 (MedDRA 14.1)
H44 (ICD-10-CM Version 2010)
379.90 (ICD-9-CM Version 2011)
Laser photocoagulation in the study eye for the last 3 months
Item
Laser photocoagulation in the study eye for the last 3 months
boolean
C0441510 (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)
Any history of any intraocular surgery in the study eye within the past 3 months
Item
Any history of any intraocular surgery in the study eye within the past 3 months
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
CL429484 (UMLS CUI 2011AA)
C0038895 (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)
Blood pressure > 160/100 mmHg
Item
Blood pressure (BP)
boolean
C0005823 (UMLS CUI 2011AA)
75367002 (SNOMED CT 2011_0131)
MTHU008342 (LOINC Version 232)
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