ID
4459
Beschreibung
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.
Stichworte
Versionen (1)
- 09.12.13 09.12.13 - Martin Dugas
Hochgeladen am
9. Dezember 2013
DOI
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Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00133952 # Diabetes Mellitus
Eligibility
- StudyEvent: Eligibility
Beschreibung
Exclusion criteria
Beschreibung
ExclusionCriterion_1
Datentyp
boolean
Alias
- UMLS CUI
- C0038901
- SNOMED CT 2010_0731
- 373353005
- UMLS CUI
- C0743733
- MDR
- 10057105
Beschreibung
ExclusionCriterion_2
Datentyp
boolean
Alias
- UMLS CUI
- C0017601
- CTCAE
- E10392
- ICD10CM
- H40-H42
- ICD9CM
- 365
- LNC
- MTHU020819
- MDR
- 10018304
- SNOMED CT 2010_0731
- 23986001
Beschreibung
ExclusionCriterion_3
Datentyp
boolean
Alias
- UMLS CUI
- C0007222
- ICD9CM
- 429.2
- MDR
- 10007649
- SNOMED CT 2010_0731
- 49601007
Beschreibung
ExclusionCriterion_4
Datentyp
boolean
Alias
- UMLS CUI
- C0679637
Beschreibung
ExclusionCriterion_5
Datentyp
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
Beschreibung
Medical Concepts
Beschreibung
Age
Datentyp
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 424144002
- LNC
- MTHU010047
Beschreibung
Healthy Subject
Datentyp
string
Alias
- UMLS CUI
- C1708335
Beschreibung
Diabetes Mellitus
Datentyp
string
Alias
- UMLS CUI
- C0011849
- ICD10CM
- E08-E13
- ICD9CM
- 250
- LNC
- MTHU020781
- MDR
- 10012602
- SNOMED CT 2010_0731
- 73211009
Beschreibung
Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn
Datentyp
string
Alias
- UMLS CUI
- C0366781
- LNC
- 4548-4
Beschreibung
Diabetic Retinopathy
Datentyp
string
Alias
- UMLS CUI
- C0011884
- ICD9CM
- 362.0
- MDR
- 10012689
- SNOMED CT 2010_0731
- 4855003
Beschreibung
Macular retinal edema
Datentyp
string
Alias
- UMLS CUI
- C0271051
- MDR
- 10025415
- SNOMED CT 2010_0731
- 37231002
Beschreibung
Ophthalmologic Surgical Procedures
Datentyp
string
Alias
- UMLS CUI
- C0038901
- SNOMED CT 2010_0731
- 373353005
Beschreibung
Eye laser surgery
Datentyp
string
Alias
- UMLS CUI
- C0743733
- MDR
- 10057105
Beschreibung
Glaucoma
Datentyp
string
Alias
- UMLS CUI
- C0017601
- CTCAE
- E10392
- ICD10CM
- H40-H42
- ICD9CM
- 365
- LNC
- MTHU020819
- MDR
- 10018304
- SNOMED CT 2010_0731
- 23986001
Beschreibung
Cardiovascular Diseases
Datentyp
string
Alias
- UMLS CUI
- C0007222
- ICD9CM
- 429.2
- MDR
- 10007649
- SNOMED CT 2010_0731
- 49601007
Beschreibung
major surgery
Datentyp
string
Alias
- UMLS CUI
- C0679637
Beschreibung
Abnormal renal function
Datentyp
string
Alias
- UMLS CUI
- C0151746
- MDR
- 10038451
- SNOMED CT 2010_0731
- 39539005
Beschreibung
Liver Dysfunction
Datentyp
string
Alias
- UMLS CUI
- C0086565
- MDR
- 10019670
- SNOMED CT 2010_0731
- 75183008
Beschreibung
Malignant Neoplasms
Datentyp
string
Alias
- UMLS CUI
- C0006826
- ICD10CM
- C00-C96
- ICD9CM
- 199
- LNC
- MTHU010328
- MDR
- 10028997
- SNOMED CT 2010_0731
- 363346000
Beschreibung
Chemotherapy Regimen
Datentyp
string
Alias
- UMLS CUI
- C0392920
- MDR
- 10061758
- SNOMED CT 2010_0731
- 367336001
Beschreibung
Therapeutic radiology procedure
Datentyp
string
Alias
- UMLS CUI
- C1522449
- MDR
- 10037794
- SNOMED CT 2010_0731
- 108290001
Ähnliche Modelle
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)