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
Eligibility
- StudyEvent: Eligibility
Description
Ausschlusskriterien
Description
ExclusionCriterion_1
Data type
boolean
Alias
- UMLS CUI
- C0038901
- SNOMED CT 2010_0731
- 373353005
- UMLS CUI
- C0743733
- MDR
- 10057105
Description
ExclusionCriterion_2
Data type
boolean
Alias
- UMLS CUI
- C0017601
- CTCAE
- E10392
- ICD10CM
- H40-H42
- ICD9CM
- 365
- LNC
- MTHU020819
- MDR
- 10018304
- SNOMED CT 2010_0731
- 23986001
Description
ExclusionCriterion_3
Data type
boolean
Alias
- UMLS CUI
- C0007222
- ICD9CM
- 429.2
- MDR
- 10007649
- SNOMED CT 2010_0731
- 49601007
Description
ExclusionCriterion_4
Data type
boolean
Alias
- UMLS CUI
- C0679637
Description
ExclusionCriterion_5
Data type
boolean
Alias
- UMLS CUI
- C0151746
- MDR
- 10038451
- SNOMED CT 2010_0731
- 39539005
- UMLS CUI
- C0086565
- MDR
- 10019670
- SNOMED CT 2010_0731
- 75183008
- UMLS CUI
- C0006826
- ICD10CM
- C00-C96
- ICD9CM
- 199
- LNC
- MTHU010328
- MDR
- 10028997
- SNOMED CT 2010_0731
- 363346000
- UMLS CUI
- C0392920
- MDR
- 10061758
- SNOMED CT 2010_0731
- 367336001
- UMLS CUI
- C1522449
- MDR
- 10037794
- SNOMED CT 2010_0731
- 108290001
Description
Medizinische Konzepte
Description
Age
Data type
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 424144002
- LNC
- MTHU010047
Description
Healthy Subject
Data type
string
Alias
- UMLS CUI
- C1708335
Description
Diabetes Mellitus
Data type
string
Alias
- UMLS CUI
- C0011849
- ICD10CM
- E08-E13
- ICD9CM
- 250
- LNC
- MTHU020781
- MDR
- 10012602
- SNOMED CT 2010_0731
- 73211009
Description
Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn
Data type
string
Alias
- UMLS CUI
- C0366781
- LNC
- 4548-4
Description
Diabetic Retinopathy
Data type
string
Alias
- UMLS CUI
- C0011884
- ICD9CM
- 362.0
- MDR
- 10012689
- SNOMED CT 2010_0731
- 4855003
Description
Macular retinal edema
Data type
string
Alias
- UMLS CUI
- C0271051
- MDR
- 10025415
- SNOMED CT 2010_0731
- 37231002
Description
Ophthalmologic Surgical Procedures
Data type
string
Alias
- UMLS CUI
- C0038901
- SNOMED CT 2010_0731
- 373353005
Description
Eye laser surgery
Data type
string
Alias
- UMLS CUI
- C0743733
- MDR
- 10057105
Description
Glaucoma
Data type
string
Alias
- UMLS CUI
- C0017601
- CTCAE
- E10392
- ICD10CM
- H40-H42
- ICD9CM
- 365
- LNC
- MTHU020819
- MDR
- 10018304
- SNOMED CT 2010_0731
- 23986001
Description
Cardiovascular Diseases
Data type
string
Alias
- UMLS CUI
- C0007222
- ICD9CM
- 429.2
- MDR
- 10007649
- SNOMED CT 2010_0731
- 49601007
Description
major surgery
Data type
string
Alias
- UMLS CUI
- C0679637
Description
Abnormal renal function
Data type
string
Alias
- UMLS CUI
- C0151746
- MDR
- 10038451
- SNOMED CT 2010_0731
- 39539005
Description
Liver Dysfunction
Data type
string
Alias
- UMLS CUI
- C0086565
- MDR
- 10019670
- SNOMED CT 2010_0731
- 75183008
Description
Malignant Neoplasms
Data type
string
Alias
- UMLS CUI
- C0006826
- ICD10CM
- C00-C96
- ICD9CM
- 199
- LNC
- MTHU010328
- MDR
- 10028997
- SNOMED CT 2010_0731
- 363346000
Description
Chemotherapy Regimen
Data type
string
Alias
- UMLS CUI
- C0392920
- MDR
- 10061758
- SNOMED CT 2010_0731
- 367336001
Description
Therapeutic radiology procedure
Data type
string
Alias
- UMLS CUI
- C1522449
- MDR
- 10037794
- SNOMED CT 2010_0731
- 108290001
Similar models
Eligibility
- StudyEvent: Eligibility
E08-E13 (ICD10CM)
250 (ICD9CM)
MTHU020781 (LNC)
10012602 (MDR)
73211009 (SNOMED CT 2010_0731)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
4548-4 (LNC)
362.0 (ICD9CM)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)
10025415 (MDR)
37231002 (SNOMED CT 2010_0731)
373353005 (SNOMED CT 2010_0731)
C0743733 (UMLS CUI)
10057105 (MDR)
E10392 (CTCAE)
H40-H42 (ICD10CM)
365 (ICD9CM)
MTHU020819 (LNC)
10018304 (MDR)
23986001 (SNOMED CT 2010_0731)
429.2 (ICD9CM)
10007649 (MDR)
49601007 (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)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
E08-E13 (ICD10CM)
250 (ICD9CM)
MTHU020781 (LNC)
10012602 (MDR)
73211009 (SNOMED CT 2010_0731)
4548-4 (LNC)
362.0 (ICD9CM)
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373353005 (SNOMED CT 2010_0731)
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E10392 (CTCAE)
H40-H42 (ICD10CM)
365 (ICD9CM)
MTHU020819 (LNC)
10018304 (MDR)
23986001 (SNOMED CT 2010_0731)
429.2 (ICD9CM)
10007649 (MDR)
49601007 (SNOMED CT 2010_0731)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
C00-C96 (ICD10CM)
199 (ICD9CM)
MTHU010328 (LNC)
10028997 (MDR)
363346000 (SNOMED CT 2010_0731)
10061758 (MDR)
367336001 (SNOMED CT 2010_0731)
10037794 (MDR)
108290001 (SNOMED CT 2010_0731)
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