Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion criteria
Healthy Volunteers
Item
No Healthy Volunteers
boolean
C1708335 (UMLS CUI)
InclusionCriterion_1
Item
Type 1 or 2 diabetes
boolean
C0011849 (UMLS CUI)
E08-E13 (ICD10CM)
250 (ICD9CM)
MTHU020781 (LNC)
10012602 (MDR)
73211009 (SNOMED CT 2010_0731)
IclusionCriterion_2
Item
18 Years and older
boolean
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
InclusionCriterion_3
Item
HbA1c less than or equal to 11%
boolean
C0366781 (UMLS CUI)
4548-4 (LNC)
InclusionCriterion_4
Item
Mild to very severe non-proliferative diabetic retinopathy in the study eye
boolean
C0011884 (UMLS CUI)
362.0 (ICD9CM)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)
InclusionCriterion_5
Item
Clinically significant macular edema in the study eye not within 100 microns of center of macula
boolean
C0271051 (UMLS CUI)
10025415 (MDR)
37231002 (SNOMED CT 2010_0731)
Item Group
Exclusion criteria
ExclusionCriterion_1
Item
Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye
boolean
C0038901 (UMLS CUI)
373353005 (SNOMED CT 2010_0731)
C0743733 (UMLS CUI)
10057105 (MDR)
ExclusionCriterion_2
Item
Glaucoma in the study eye
boolean
C0017601 (UMLS CUI)
E10392 (CTCAE)
H40-H42 (ICD10CM)
365 (ICD9CM)
MTHU020819 (LNC)
10018304 (MDR)
23986001 (SNOMED CT 2010_0731)
ExclusionCriterion_3
Item
Unstable cardiovascular disease
boolean
C0007222 (UMLS CUI)
429.2 (ICD9CM)
10007649 (MDR)
49601007 (SNOMED CT 2010_0731)
ExclusionCriterion_4
Item
Major surgery within past 3 months
boolean
C0679637 (UMLS CUI)
ExclusionCriterion_5
Item
Significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy.
boolean
C0151746 (UMLS CUI)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
C0006826 (UMLS CUI)
C00-C96 (ICD10CM)
199 (ICD9CM)
MTHU010328 (LNC)
10028997 (MDR)
363346000 (SNOMED CT 2010_0731)
C0392920 (UMLS CUI)
10061758 (MDR)
367336001 (SNOMED CT 2010_0731)
C1522449 (UMLS CUI)
10037794 (MDR)
108290001 (SNOMED CT 2010_0731)
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Healthy Subject
Item
Healthy Subject
string
C1708335 (UMLS CUI)
Diabetes Mellitus
Item
Diabetes Mellitus
string
C0011849 (UMLS CUI)
E08-E13 (ICD10CM)
250 (ICD9CM)
MTHU020781 (LNC)
10012602 (MDR)
73211009 (SNOMED CT 2010_0731)
Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn
Item
Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn
string
C0366781 (UMLS CUI)
4548-4 (LNC)
Diabetic Retinopathy
Item
Diabetic Retinopathy
string
C0011884 (UMLS CUI)
362.0 (ICD9CM)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)
Macular retinal edema
Item
Macular retinal edema
string
C0271051 (UMLS CUI)
10025415 (MDR)
37231002 (SNOMED CT 2010_0731)
Ophthalmologic Surgical Procedures
Item
Ophthalmologic Surgical Procedures
string
C0038901 (UMLS CUI)
373353005 (SNOMED CT 2010_0731)
Eye laser surgery
Item
Eye laser surgery
string
C0743733 (UMLS CUI)
10057105 (MDR)
Glaucoma
Item
Glaucoma
string
C0017601 (UMLS CUI)
E10392 (CTCAE)
H40-H42 (ICD10CM)
365 (ICD9CM)
MTHU020819 (LNC)
10018304 (MDR)
23986001 (SNOMED CT 2010_0731)
Cardiovascular Diseases
Item
Cardiovascular Diseases
string
C0007222 (UMLS CUI)
429.2 (ICD9CM)
10007649 (MDR)
49601007 (SNOMED CT 2010_0731)
major surgery
Item
major surgery
string
C0679637 (UMLS CUI)
Abnormal renal function
Item
Abnormal renal function
string
C0151746 (UMLS CUI)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
Liver Dysfunction
Item
Liver Dysfunction
string
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
Malignant Neoplasms
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
C00-C96 (ICD10CM)
199 (ICD9CM)
MTHU010328 (LNC)
10028997 (MDR)
363346000 (SNOMED CT 2010_0731)
Chemotherapy Regimen
Item
Chemotherapy Regimen
string
C0392920 (UMLS CUI)
10061758 (MDR)
367336001 (SNOMED CT 2010_0731)
Therapeutic radiology procedure
Item
Therapeutic radiology procedure
string
C1522449 (UMLS CUI)
10037794 (MDR)
108290001 (SNOMED CT 2010_0731)

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