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ID
4459
Description
The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurence of sustained moderate visual loss (SMVL) in patients with clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the patient's last 6 months of study participation. The SMVL data from this study will be combined with the SMVL data from Study B7A-MC-MBDL for the purpose of comparing ruboxistaurin to placebo.
Keywords
Versions (1)
- 12/9/13 12/9/13 - Martin Dugas
Uploaded on
December 9, 2013
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00133952 # Diabetes Mellitus
Similar models
Eligibility
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Healthy Volunteers
Item
boolean
C1708335 (UMLS CUI)
InclusionCriterion_1
Item
boolean
C0011849 (UMLS CUI)
E08-E13 (ICD10CM)
250 (ICD9CM)
MTHU020781 (LNC)
10012602 (MDR)
73211009 (SNOMED CT 2010_0731)
E08-E13 (ICD10CM)
250 (ICD9CM)
MTHU020781 (LNC)
10012602 (MDR)
73211009 (SNOMED CT 2010_0731)
IclusionCriterion_2
Item
boolean
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
InclusionCriterion_3
Item
boolean
C0366781 (UMLS CUI)
4548-4 (LNC)
4548-4 (LNC)
InclusionCriterion_4
Item
boolean
C0011884 (UMLS CUI)
362.0 (ICD9CM)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)
362.0 (ICD9CM)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)
InclusionCriterion_5
Item
boolean
C0271051 (UMLS CUI)
10025415 (MDR)
37231002 (SNOMED CT 2010_0731)
10025415 (MDR)
37231002 (SNOMED CT 2010_0731)
ExclusionCriterion_1
Item
boolean
C0038901 (UMLS CUI)
373353005 (SNOMED CT 2010_0731)
C0743733 (UMLS CUI)
10057105 (MDR)
373353005 (SNOMED CT 2010_0731)
C0743733 (UMLS CUI)
10057105 (MDR)
ExclusionCriterion_2
Item
boolean
C0017601 (UMLS CUI)
E10392 (CTCAE)
H40-H42 (ICD10CM)
365 (ICD9CM)
MTHU020819 (LNC)
10018304 (MDR)
23986001 (SNOMED CT 2010_0731)
E10392 (CTCAE)
H40-H42 (ICD10CM)
365 (ICD9CM)
MTHU020819 (LNC)
10018304 (MDR)
23986001 (SNOMED CT 2010_0731)
ExclusionCriterion_3
Item
boolean
C0007222 (UMLS CUI)
429.2 (ICD9CM)
10007649 (MDR)
49601007 (SNOMED CT 2010_0731)
429.2 (ICD9CM)
10007649 (MDR)
49601007 (SNOMED CT 2010_0731)
ExclusionCriterion_4
Item
boolean
C0679637 (UMLS CUI)
ExclusionCriterion_5
Item
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)
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)
Age
Item
string
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Healthy Subject
Item
string
C1708335 (UMLS CUI)
Diabetes Mellitus
Item
string
C0011849 (UMLS CUI)
E08-E13 (ICD10CM)
250 (ICD9CM)
MTHU020781 (LNC)
10012602 (MDR)
73211009 (SNOMED CT 2010_0731)
E08-E13 (ICD10CM)
250 (ICD9CM)
MTHU020781 (LNC)
10012602 (MDR)
73211009 (SNOMED CT 2010_0731)
Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn
Item
string
C0366781 (UMLS CUI)
4548-4 (LNC)
4548-4 (LNC)
Diabetic Retinopathy
Item
string
C0011884 (UMLS CUI)
362.0 (ICD9CM)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)
362.0 (ICD9CM)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)
Macular retinal edema
Item
string
C0271051 (UMLS CUI)
10025415 (MDR)
37231002 (SNOMED CT 2010_0731)
10025415 (MDR)
37231002 (SNOMED CT 2010_0731)
Ophthalmologic Surgical Procedures
Item
string
C0038901 (UMLS CUI)
373353005 (SNOMED CT 2010_0731)
373353005 (SNOMED CT 2010_0731)
Eye laser surgery
Item
string
C0743733 (UMLS CUI)
10057105 (MDR)
10057105 (MDR)
Glaucoma
Item
string
C0017601 (UMLS CUI)
E10392 (CTCAE)
H40-H42 (ICD10CM)
365 (ICD9CM)
MTHU020819 (LNC)
10018304 (MDR)
23986001 (SNOMED CT 2010_0731)
E10392 (CTCAE)
H40-H42 (ICD10CM)
365 (ICD9CM)
MTHU020819 (LNC)
10018304 (MDR)
23986001 (SNOMED CT 2010_0731)
Cardiovascular Diseases
Item
string
C0007222 (UMLS CUI)
429.2 (ICD9CM)
10007649 (MDR)
49601007 (SNOMED CT 2010_0731)
429.2 (ICD9CM)
10007649 (MDR)
49601007 (SNOMED CT 2010_0731)
major surgery
Item
string
C0679637 (UMLS CUI)
Abnormal renal function
Item
string
C0151746 (UMLS CUI)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
Liver Dysfunction
Item
string
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
Malignant Neoplasms
Item
string
C0006826 (UMLS CUI)
C00-C96 (ICD10CM)
199 (ICD9CM)
MTHU010328 (LNC)
10028997 (MDR)
363346000 (SNOMED CT 2010_0731)
C00-C96 (ICD10CM)
199 (ICD9CM)
MTHU010328 (LNC)
10028997 (MDR)
363346000 (SNOMED CT 2010_0731)
Chemotherapy Regimen
Item
string
C0392920 (UMLS CUI)
10061758 (MDR)
367336001 (SNOMED CT 2010_0731)
10061758 (MDR)
367336001 (SNOMED CT 2010_0731)
Therapeutic radiology procedure
Item
string
C1522449 (UMLS CUI)
10037794 (MDR)
108290001 (SNOMED CT 2010_0731)
10037794 (MDR)
108290001 (SNOMED CT 2010_0731)