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)
  1. 2013-12-09 2013-12-09 - Martin Dugas
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9 december 2013

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Eligibility NCT00133952 # Diabetes Mellitus

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Beskrivning

Inclusion criteria

No Healthy Volunteers
Beskrivning

Healthy Volunteers

Datatyp

boolean

Alias
UMLS CUI
C1708335
Type 1 or 2 diabetes
Beskrivning

InclusionCriterion_1

Datatyp

boolean

Alias
UMLS CUI
C0011849
ICD10CM
E08-E13
ICD9CM
250
LNC
MTHU020781
MDR
10012602
SNOMED CT 2010_0731
73211009
18 Years and older
Beskrivning

IclusionCriterion_2

Datatyp

boolean

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
424144002
LNC
MTHU010047
HbA1c less than or equal to 11%
Beskrivning

InclusionCriterion_3

Datatyp

boolean

Alias
UMLS CUI
C0366781
LNC
4548-4
Mild to very severe non-proliferative diabetic retinopathy in the study eye
Beskrivning

InclusionCriterion_4

Datatyp

boolean

Alias
UMLS CUI
C0011884
ICD9CM
362.0
MDR
10012689
SNOMED CT 2010_0731
4855003
Clinically significant macular edema in the study eye not within 100 microns of center of macula
Beskrivning

InclusionCriterion_5

Datatyp

boolean

Alias
UMLS CUI
C0271051
MDR
10025415
SNOMED CT 2010_0731
37231002
Exclusion criteria
Beskrivning

Exclusion criteria

Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye
Beskrivning

ExclusionCriterion_1

Datatyp

boolean

Alias
UMLS CUI
C0038901
SNOMED CT 2010_0731
373353005
UMLS CUI
C0743733
MDR
10057105
Glaucoma in the study eye
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
Unstable cardiovascular disease
Beskrivning

ExclusionCriterion_3

Datatyp

boolean

Alias
UMLS CUI
C0007222
ICD9CM
429.2
MDR
10007649
SNOMED CT 2010_0731
49601007
Major surgery within past 3 months
Beskrivning

ExclusionCriterion_4

Datatyp

boolean

Alias
UMLS CUI
C0679637
Significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy.
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
Medical Concepts
Beskrivning

Medical Concepts

Age
Beskrivning

Age

Datatyp

string

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

Healthy Subject

Datatyp

string

Alias
UMLS CUI
C1708335
Diabetes Mellitus
Beskrivning

Diabetes Mellitus

Datatyp

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
Beskrivning

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

Datatyp

string

Alias
UMLS CUI
C0366781
LNC
4548-4
Diabetic Retinopathy
Beskrivning

Diabetic Retinopathy

Datatyp

string

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

Macular retinal edema

Datatyp

string

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

Ophthalmologic Surgical Procedures

Datatyp

string

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

Eye laser surgery

Datatyp

string

Alias
UMLS CUI
C0743733
MDR
10057105
Glaucoma
Beskrivning

Glaucoma

Datatyp

string

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

Cardiovascular Diseases

Datatyp

string

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

major surgery

Datatyp

string

Alias
UMLS CUI
C0679637
Abnormal renal function
Beskrivning

Abnormal renal function

Datatyp

string

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

Liver Dysfunction

Datatyp

string

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

Malignant Neoplasms

Datatyp

string

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

Chemotherapy Regimen

Datatyp

string

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

Therapeutic radiology procedure

Datatyp

string

Alias
UMLS CUI
C1522449
MDR
10037794
SNOMED CT 2010_0731
108290001
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion criteria
Healthy Volunteers
Item
No Healthy Volunteers
boolean
C1708335 (UMLS CUI)
InclusionCriterion_1
Item
Type 1 or 2 diabetes
boolean
C0011849 (UMLS CUI)
E08-E13 (ICD10CM)
250 (ICD9CM)
MTHU020781 (LNC)
10012602 (MDR)
73211009 (SNOMED CT 2010_0731)
IclusionCriterion_2
Item
18 Years and older
boolean
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
InclusionCriterion_3
Item
HbA1c less than or equal to 11%
boolean
C0366781 (UMLS CUI)
4548-4 (LNC)
InclusionCriterion_4
Item
Mild to very severe non-proliferative diabetic retinopathy in the study eye
boolean
C0011884 (UMLS CUI)
362.0 (ICD9CM)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)
InclusionCriterion_5
Item
Clinically significant macular edema in the study eye not within 100 microns of center of macula
boolean
C0271051 (UMLS CUI)
10025415 (MDR)
37231002 (SNOMED CT 2010_0731)
Item Group
Exclusion criteria
ExclusionCriterion_1
Item
Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye
boolean
C0038901 (UMLS CUI)
373353005 (SNOMED CT 2010_0731)
C0743733 (UMLS CUI)
10057105 (MDR)
ExclusionCriterion_2
Item
Glaucoma in the study eye
boolean
C0017601 (UMLS CUI)
E10392 (CTCAE)
H40-H42 (ICD10CM)
365 (ICD9CM)
MTHU020819 (LNC)
10018304 (MDR)
23986001 (SNOMED CT 2010_0731)
ExclusionCriterion_3
Item
Unstable cardiovascular disease
boolean
C0007222 (UMLS CUI)
429.2 (ICD9CM)
10007649 (MDR)
49601007 (SNOMED CT 2010_0731)
ExclusionCriterion_4
Item
Major surgery within past 3 months
boolean
C0679637 (UMLS CUI)
ExclusionCriterion_5
Item
Significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy.
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
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Healthy Subject
Item
Healthy Subject
string
C1708335 (UMLS CUI)
Diabetes Mellitus
Item
Diabetes Mellitus
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
Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn
string
C0366781 (UMLS CUI)
4548-4 (LNC)
Diabetic Retinopathy
Item
Diabetic Retinopathy
string
C0011884 (UMLS CUI)
362.0 (ICD9CM)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)
Macular retinal edema
Item
Macular retinal edema
string
C0271051 (UMLS CUI)
10025415 (MDR)
37231002 (SNOMED CT 2010_0731)
Ophthalmologic Surgical Procedures
Item
Ophthalmologic Surgical Procedures
string
C0038901 (UMLS CUI)
373353005 (SNOMED CT 2010_0731)
Eye laser surgery
Item
Eye laser surgery
string
C0743733 (UMLS CUI)
10057105 (MDR)
Glaucoma
Item
Glaucoma
string
C0017601 (UMLS CUI)
E10392 (CTCAE)
H40-H42 (ICD10CM)
365 (ICD9CM)
MTHU020819 (LNC)
10018304 (MDR)
23986001 (SNOMED CT 2010_0731)
Cardiovascular Diseases
Item
Cardiovascular Diseases
string
C0007222 (UMLS CUI)
429.2 (ICD9CM)
10007649 (MDR)
49601007 (SNOMED CT 2010_0731)
major surgery
Item
major surgery
string
C0679637 (UMLS CUI)
Abnormal renal function
Item
Abnormal renal function
string
C0151746 (UMLS CUI)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
Liver Dysfunction
Item
Liver Dysfunction
string
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
Malignant Neoplasms
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
C00-C96 (ICD10CM)
199 (ICD9CM)
MTHU010328 (LNC)
10028997 (MDR)
363346000 (SNOMED CT 2010_0731)
Chemotherapy Regimen
Item
Chemotherapy Regimen
string
C0392920 (UMLS CUI)
10061758 (MDR)
367336001 (SNOMED CT 2010_0731)
Therapeutic radiology procedure
Item
Therapeutic radiology procedure
string
C1522449 (UMLS CUI)
10037794 (MDR)
108290001 (SNOMED CT 2010_0731)
Tillbaka till toppen 

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