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.

Mots-clés

Versions (1)
  1. 09/12/2013 09/12/2013 - Martin Dugas
Téléchargé le

9 décembre 2013

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00133952 # Diabetes Mellitus

Allemand Anglais

Eligibility

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Description

Einschlusskriterien

Healthy Volunteers
Description

Healthy Volunteers

Type de données

boolean

Alias
UMLS CUI
C1708335
InclusionCriterion_1
Description

InclusionCriterion_1

Type de données

boolean

Alias
UMLS CUI
C0011849
ICD10CM
E08-E13
ICD9CM
250
LNC
MTHU020781
MDR
10012602
SNOMED CT 2010_0731
73211009
IclusionCriterion_2
Description

IclusionCriterion_2

Type de données

boolean

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
424144002
LNC
MTHU010047
InclusionCriterion_3
Description

InclusionCriterion_3

Type de données

boolean

Alias
UMLS CUI
C0366781
LNC
4548-4
InclusionCriterion_4
Description

InclusionCriterion_4

Type de données

boolean

Alias
UMLS CUI
C0011884
ICD9CM
362.0
MDR
10012689
SNOMED CT 2010_0731
4855003
InclusionCriterion_5
Description

InclusionCriterion_5

Type de données

boolean

Alias
UMLS CUI
C0271051
MDR
10025415
SNOMED CT 2010_0731
37231002
Ausschlusskriterien
Description

Ausschlusskriterien

ExclusionCriterion_1
Description

ExclusionCriterion_1

Type de données

boolean

Alias
UMLS CUI
C0038901
SNOMED CT 2010_0731
373353005
UMLS CUI
C0743733
MDR
10057105
ExclusionCriterion_2
Description

ExclusionCriterion_2

Type de données

boolean

Alias
UMLS CUI
C0017601
CTCAE
E10392
ICD10CM
H40-H42
ICD9CM
365
LNC
MTHU020819
MDR
10018304
SNOMED CT 2010_0731
23986001
ExclusionCriterion_3
Description

ExclusionCriterion_3

Type de données

boolean

Alias
UMLS CUI
C0007222
ICD9CM
429.2
MDR
10007649
SNOMED CT 2010_0731
49601007
ExclusionCriterion_4
Description

ExclusionCriterion_4

Type de données

boolean

Alias
UMLS CUI
C0679637
ExclusionCriterion_5
Description

ExclusionCriterion_5

Type de données

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
Medizinische Konzepte
Description

Medizinische Konzepte

Age
Description

Age

Type de données

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
424144002
LNC
MTHU010047
Healthy Subject
Description

Healthy Subject

Type de données

string

Alias
UMLS CUI
C1708335
Diabetes Mellitus
Description

Diabetes Mellitus

Type de données

string

Alias
UMLS CUI
C0011849
ICD10CM
E08-E13
ICD9CM
250
LNC
MTHU020781
MDR
10012602
SNOMED CT 2010_0731
73211009
Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn
Description

Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn

Type de données

string

Alias
UMLS CUI
C0366781
LNC
4548-4
Diabetic Retinopathy
Description

Diabetic Retinopathy

Type de données

string

Alias
UMLS CUI
C0011884
ICD9CM
362.0
MDR
10012689
SNOMED CT 2010_0731
4855003
Macular retinal edema
Description

Macular retinal edema

Type de données

string

Alias
UMLS CUI
C0271051
MDR
10025415
SNOMED CT 2010_0731
37231002
Ophthalmologic Surgical Procedures
Description

Ophthalmologic Surgical Procedures

Type de données

string

Alias
UMLS CUI
C0038901
SNOMED CT 2010_0731
373353005
Eye laser surgery
Description

Eye laser surgery

Type de données

string

Alias
UMLS CUI
C0743733
MDR
10057105
Glaucoma
Description

Glaucoma

Type de données

string

Alias
UMLS CUI
C0017601
CTCAE
E10392
ICD10CM
H40-H42
ICD9CM
365
LNC
MTHU020819
MDR
10018304
SNOMED CT 2010_0731
23986001
Cardiovascular Diseases
Description

Cardiovascular Diseases

Type de données

string

Alias
UMLS CUI
C0007222
ICD9CM
429.2
MDR
10007649
SNOMED CT 2010_0731
49601007
major surgery
Description

major surgery

Type de données

string

Alias
UMLS CUI
C0679637
Abnormal renal function
Description

Abnormal renal function

Type de données

string

Alias
UMLS CUI
C0151746
MDR
10038451
SNOMED CT 2010_0731
39539005
Liver Dysfunction
Description

Liver Dysfunction

Type de données

string

Alias
UMLS CUI
C0086565
MDR
10019670
SNOMED CT 2010_0731
75183008
Malignant Neoplasms
Description

Malignant Neoplasms

Type de données

string

Alias
UMLS CUI
C0006826
ICD10CM
C00-C96
ICD9CM
199
LNC
MTHU010328
MDR
10028997
SNOMED CT 2010_0731
363346000
Chemotherapy Regimen
Description

Chemotherapy Regimen

Type de données

string

Alias
UMLS CUI
C0392920
MDR
10061758
SNOMED CT 2010_0731
367336001
Therapeutic radiology procedure
Description

Therapeutic radiology procedure

Type de données

string

Alias
UMLS CUI
C1522449
MDR
10037794
SNOMED CT 2010_0731
108290001
Retour au début de la page

Similar models

Eligibility

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Einschlusskriterien
Healthy Volunteers
Item
boolean
C1708335 (UMLS CUI)
InclusionCriterion_1
Item
boolean
C0011849 (UMLS CUI)
E08-E13 (ICD10CM)
250 (ICD9CM)
MTHU020781 (LNC)
10012602 (MDR)
73211009 (SNOMED CT 2010_0731)
IclusionCriterion_2
Item
boolean
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
InclusionCriterion_3
Item
boolean
C0366781 (UMLS CUI)
4548-4 (LNC)
InclusionCriterion_4
Item
boolean
C0011884 (UMLS CUI)
362.0 (ICD9CM)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)
InclusionCriterion_5
Item
boolean
C0271051 (UMLS CUI)
10025415 (MDR)
37231002 (SNOMED CT 2010_0731)
Item Group
Ausschlusskriterien
ExclusionCriterion_1
Item
boolean
C0038901 (UMLS CUI)
373353005 (SNOMED CT 2010_0731)
C0743733 (UMLS CUI)
10057105 (MDR)
ExclusionCriterion_2
Item
boolean
C0017601 (UMLS CUI)
E10392 (CTCAE)
H40-H42 (ICD10CM)
365 (ICD9CM)
MTHU020819 (LNC)
10018304 (MDR)
23986001 (SNOMED CT 2010_0731)
ExclusionCriterion_3
Item
boolean
C0007222 (UMLS CUI)
429.2 (ICD9CM)
10007649 (MDR)
49601007 (SNOMED CT 2010_0731)
ExclusionCriterion_4
Item
boolean
C0679637 (UMLS CUI)
ExclusionCriterion_5
Item
boolean
C0151746 (UMLS CUI)
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)
Item Group
Medizinische Konzepte
Age
Item
string
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Healthy Subject
Item
string
C1708335 (UMLS CUI)
Diabetes Mellitus
Item
string
C0011849 (UMLS CUI)
E08-E13 (ICD10CM)
250 (ICD9CM)
MTHU020781 (LNC)
10012602 (MDR)
73211009 (SNOMED CT 2010_0731)
Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn
Item
string
C0366781 (UMLS CUI)
4548-4 (LNC)
Diabetic Retinopathy
Item
string
C0011884 (UMLS CUI)
362.0 (ICD9CM)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)
Macular retinal edema
Item
string
C0271051 (UMLS CUI)
10025415 (MDR)
37231002 (SNOMED CT 2010_0731)
Ophthalmologic Surgical Procedures
Item
string
C0038901 (UMLS CUI)
373353005 (SNOMED CT 2010_0731)
Eye laser surgery
Item
string
C0743733 (UMLS CUI)
10057105 (MDR)
Glaucoma
Item
string
C0017601 (UMLS CUI)
E10392 (CTCAE)
H40-H42 (ICD10CM)
365 (ICD9CM)
MTHU020819 (LNC)
10018304 (MDR)
23986001 (SNOMED CT 2010_0731)
Cardiovascular Diseases
Item
string
C0007222 (UMLS CUI)
429.2 (ICD9CM)
10007649 (MDR)
49601007 (SNOMED CT 2010_0731)
major surgery
Item
string
C0679637 (UMLS CUI)
Abnormal renal function
Item
string
C0151746 (UMLS CUI)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
Liver Dysfunction
Item
string
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
Malignant Neoplasms
Item
string
C0006826 (UMLS CUI)
C00-C96 (ICD10CM)
199 (ICD9CM)
MTHU010328 (LNC)
10028997 (MDR)
363346000 (SNOMED CT 2010_0731)
Chemotherapy Regimen
Item
string
C0392920 (UMLS CUI)
10061758 (MDR)
367336001 (SNOMED CT 2010_0731)
Therapeutic radiology procedure
Item
string
C1522449 (UMLS CUI)
10037794 (MDR)
108290001 (SNOMED CT 2010_0731)
Retour au début de la page 

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