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