ID
4459
Beschrijving
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.
Trefwoorden
Versies (1)
- 09-12-13 09-12-13 - Martin Dugas
Geüploaded op
9 december 2013
DOI
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Licentie
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00133952 # Diabetes Mellitus
Eligibility
- StudyEvent: Eligibility
Beschrijving
Ausschlusskriterien
Beschrijving
ExclusionCriterion_1
Datatype
boolean
Alias
- UMLS CUI
- C0038901
- SNOMED CT 2010_0731
- 373353005
- UMLS CUI
- C0743733
- MDR
- 10057105
Beschrijving
ExclusionCriterion_2
Datatype
boolean
Alias
- UMLS CUI
- C0017601
- CTCAE
- E10392
- ICD10CM
- H40-H42
- ICD9CM
- 365
- LNC
- MTHU020819
- MDR
- 10018304
- SNOMED CT 2010_0731
- 23986001
Beschrijving
ExclusionCriterion_3
Datatype
boolean
Alias
- UMLS CUI
- C0007222
- ICD9CM
- 429.2
- MDR
- 10007649
- SNOMED CT 2010_0731
- 49601007
Beschrijving
ExclusionCriterion_4
Datatype
boolean
Alias
- UMLS CUI
- C0679637
Beschrijving
ExclusionCriterion_5
Datatype
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
Beschrijving
Medizinische Konzepte
Beschrijving
Age
Datatype
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 424144002
- LNC
- MTHU010047
Beschrijving
Healthy Subject
Datatype
string
Alias
- UMLS CUI
- C1708335
Beschrijving
Diabetes Mellitus
Datatype
string
Alias
- UMLS CUI
- C0011849
- ICD10CM
- E08-E13
- ICD9CM
- 250
- LNC
- MTHU020781
- MDR
- 10012602
- SNOMED CT 2010_0731
- 73211009
Beschrijving
Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn
Datatype
string
Alias
- UMLS CUI
- C0366781
- LNC
- 4548-4
Beschrijving
Diabetic Retinopathy
Datatype
string
Alias
- UMLS CUI
- C0011884
- ICD9CM
- 362.0
- MDR
- 10012689
- SNOMED CT 2010_0731
- 4855003
Beschrijving
Macular retinal edema
Datatype
string
Alias
- UMLS CUI
- C0271051
- MDR
- 10025415
- SNOMED CT 2010_0731
- 37231002
Beschrijving
Ophthalmologic Surgical Procedures
Datatype
string
Alias
- UMLS CUI
- C0038901
- SNOMED CT 2010_0731
- 373353005
Beschrijving
Eye laser surgery
Datatype
string
Alias
- UMLS CUI
- C0743733
- MDR
- 10057105
Beschrijving
Glaucoma
Datatype
string
Alias
- UMLS CUI
- C0017601
- CTCAE
- E10392
- ICD10CM
- H40-H42
- ICD9CM
- 365
- LNC
- MTHU020819
- MDR
- 10018304
- SNOMED CT 2010_0731
- 23986001
Beschrijving
Cardiovascular Diseases
Datatype
string
Alias
- UMLS CUI
- C0007222
- ICD9CM
- 429.2
- MDR
- 10007649
- SNOMED CT 2010_0731
- 49601007
Beschrijving
major surgery
Datatype
string
Alias
- UMLS CUI
- C0679637
Beschrijving
Abnormal renal function
Datatype
string
Alias
- UMLS CUI
- C0151746
- MDR
- 10038451
- SNOMED CT 2010_0731
- 39539005
Beschrijving
Liver Dysfunction
Datatype
string
Alias
- UMLS CUI
- C0086565
- MDR
- 10019670
- SNOMED CT 2010_0731
- 75183008
Beschrijving
Malignant Neoplasms
Datatype
string
Alias
- UMLS CUI
- C0006826
- ICD10CM
- C00-C96
- ICD9CM
- 199
- LNC
- MTHU010328
- MDR
- 10028997
- SNOMED CT 2010_0731
- 363346000
Beschrijving
Chemotherapy Regimen
Datatype
string
Alias
- UMLS CUI
- C0392920
- MDR
- 10061758
- SNOMED CT 2010_0731
- 367336001
Beschrijving
Therapeutic radiology procedure
Datatype
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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