ID
4459
Beskrivning
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.
Nyckelord
Versioner (1)
- 2013-12-09 2013-12-09 - Martin Dugas
Uppladdad den
9 december 2013
DOI
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Licens
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00133952 # Diabetes Mellitus
Eligibility
- StudyEvent: Eligibility
Beskrivning
Ausschlusskriterien
Beskrivning
ExclusionCriterion_1
Datatyp
boolean
Alias
- UMLS CUI
- C0038901
- SNOMED CT 2010_0731
- 373353005
- UMLS CUI
- C0743733
- MDR
- 10057105
Beskrivning
ExclusionCriterion_2
Datatyp
boolean
Alias
- UMLS CUI
- C0017601
- CTCAE
- E10392
- ICD10CM
- H40-H42
- ICD9CM
- 365
- LNC
- MTHU020819
- MDR
- 10018304
- SNOMED CT 2010_0731
- 23986001
Beskrivning
ExclusionCriterion_3
Datatyp
boolean
Alias
- UMLS CUI
- C0007222
- ICD9CM
- 429.2
- MDR
- 10007649
- SNOMED CT 2010_0731
- 49601007
Beskrivning
ExclusionCriterion_4
Datatyp
boolean
Alias
- UMLS CUI
- C0679637
Beskrivning
ExclusionCriterion_5
Datatyp
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
Beskrivning
Medizinische Konzepte
Beskrivning
Age
Datatyp
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 424144002
- LNC
- MTHU010047
Beskrivning
Healthy Subject
Datatyp
string
Alias
- UMLS CUI
- C1708335
Beskrivning
Diabetes Mellitus
Datatyp
string
Alias
- UMLS CUI
- C0011849
- ICD10CM
- E08-E13
- ICD9CM
- 250
- LNC
- MTHU020781
- MDR
- 10012602
- SNOMED CT 2010_0731
- 73211009
Beskrivning
Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn
Datatyp
string
Alias
- UMLS CUI
- C0366781
- LNC
- 4548-4
Beskrivning
Diabetic Retinopathy
Datatyp
string
Alias
- UMLS CUI
- C0011884
- ICD9CM
- 362.0
- MDR
- 10012689
- SNOMED CT 2010_0731
- 4855003
Beskrivning
Macular retinal edema
Datatyp
string
Alias
- UMLS CUI
- C0271051
- MDR
- 10025415
- SNOMED CT 2010_0731
- 37231002
Beskrivning
Ophthalmologic Surgical Procedures
Datatyp
string
Alias
- UMLS CUI
- C0038901
- SNOMED CT 2010_0731
- 373353005
Beskrivning
Eye laser surgery
Datatyp
string
Alias
- UMLS CUI
- C0743733
- MDR
- 10057105
Beskrivning
Glaucoma
Datatyp
string
Alias
- UMLS CUI
- C0017601
- CTCAE
- E10392
- ICD10CM
- H40-H42
- ICD9CM
- 365
- LNC
- MTHU020819
- MDR
- 10018304
- SNOMED CT 2010_0731
- 23986001
Beskrivning
Cardiovascular Diseases
Datatyp
string
Alias
- UMLS CUI
- C0007222
- ICD9CM
- 429.2
- MDR
- 10007649
- SNOMED CT 2010_0731
- 49601007
Beskrivning
major surgery
Datatyp
string
Alias
- UMLS CUI
- C0679637
Beskrivning
Abnormal renal function
Datatyp
string
Alias
- UMLS CUI
- C0151746
- MDR
- 10038451
- SNOMED CT 2010_0731
- 39539005
Beskrivning
Liver Dysfunction
Datatyp
string
Alias
- UMLS CUI
- C0086565
- MDR
- 10019670
- SNOMED CT 2010_0731
- 75183008
Beskrivning
Malignant Neoplasms
Datatyp
string
Alias
- UMLS CUI
- C0006826
- ICD10CM
- C00-C96
- ICD9CM
- 199
- LNC
- MTHU010328
- MDR
- 10028997
- SNOMED CT 2010_0731
- 363346000
Beskrivning
Chemotherapy Regimen
Datatyp
string
Alias
- UMLS CUI
- C0392920
- MDR
- 10061758
- SNOMED CT 2010_0731
- 367336001
Beskrivning
Therapeutic radiology procedure
Datatyp
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)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)
10025415 (MDR)
37231002 (SNOMED CT 2010_0731)
373353005 (SNOMED CT 2010_0731)
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)
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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