ID

39025

Description

Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy; ODM derived from: https://clinicaltrials.gov/show/NCT01746563

Link

https://clinicaltrials.gov/show/NCT01746563

Keywords

Versions (1)
  1. 11/21/19 11/21/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 21, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetic Retinopathy NCT01746563

English

Eligibility Diabetic Retinopathy NCT01746563

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
naive proliferative diabetic retinopathy eyes.
Description

Proliferative diabetic retinopathy | Therapy naive Eyes

Data type

boolean

Alias
UMLS CUI [1]
C0154830
UMLS CUI [2,1]
C0919936
UMLS CUI [2,2]
C0015392
best corrected-visual acuity at baseline > 20/320 in the study eye
Description

Best corrected visual acuity Clinical Trial Eye

Data type

boolean

Alias
UMLS CUI [1,1]
C1690532
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0015392
patients with and without diabetic macular edema
Description

Diabetic macular edema | Diabetic macular edema Absent

Data type

boolean

Alias
UMLS CUI [1]
C0730285
UMLS CUI [2,1]
C0730285
UMLS CUI [2,2]
C0332197
type ii diabetic subjects as defined by the world health organization aged ≥ 18 years.
Description

Non-Insulin-Dependent Diabetes Mellitus WHO classification | Age

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C4267671
UMLS CUI [2]
C0001779
women must be using effective contraception
Description

Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
ability to provide written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
indication of panretinal photocoagulation in both eyes
Description

Indication Panretinal photocoagulation Both eyes

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0730064
UMLS CUI [1,3]
C0229118
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
vitreous hemorrhage or pre-retinal hemorrhage
Description

Vitreous Hemorrhage | Preretinal hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0042909
UMLS CUI [2]
C4316879
eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months
Description

Eyes Panretinal photocoagulation Previous | Eyes Focal photocoagulation | Eyes Grid photocoagulation

Data type

boolean

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0730064
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C0015392
UMLS CUI [2,2]
C1302105
UMLS CUI [3,1]
C0015392
UMLS CUI [3,2]
C1302035
atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
Description

Atrophy Involving Center of macula | Scarring Involving Center of macula | Fibrosis Involving Center of macula | Hard exudates Involving Center of macula

Data type

boolean

Alias
UMLS CUI [1,1]
C0333641
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0016622
UMLS CUI [2,1]
C0008767
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0016622
UMLS CUI [3,1]
C0016059
UMLS CUI [3,2]
C1314939
UMLS CUI [3,3]
C0016622
UMLS CUI [4,1]
C0423410
UMLS CUI [4,2]
C1314939
UMLS CUI [4,3]
C0016622
cataract
Description

Cataract

Data type

boolean

Alias
UMLS CUI [1]
C0086543
any intraocular surgery within 6 months before trial enrollment
Description

Operative Surgical Procedure Intraocular

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C3282905
previous vitrectomy.
Description

Vitrectomy

Data type

boolean

Alias
UMLS CUI [1]
C0042903
any of the following underlying systemic diseases:
Description

Systemic disease Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205369
history or evidence of severe cardiac disease or previous thrombus-embolic event
Description

Heart Disease Severe | Thromboembolism

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0040038
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Similar models

Eligibility Diabetic Retinopathy NCT01746563

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Proliferative diabetic retinopathy | Therapy naive Eyes
Item
naive proliferative diabetic retinopathy eyes.
boolean
C0154830 (UMLS CUI [1])
C0919936 (UMLS CUI [2,1])
C0015392 (UMLS CUI [2,2])
Best corrected visual acuity Clinical Trial Eye
Item
best corrected-visual acuity at baseline > 20/320 in the study eye
boolean
C1690532 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,3])
Diabetic macular edema | Diabetic macular edema Absent
Item
patients with and without diabetic macular edema
boolean
C0730285 (UMLS CUI [1])
C0730285 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Non-Insulin-Dependent Diabetes Mellitus WHO classification | Age
Item
type ii diabetic subjects as defined by the world health organization aged ≥ 18 years.
boolean
C0011860 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Gender Contraceptive methods
Item
women must be using effective contraception
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
ability to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Indication Panretinal photocoagulation Both eyes
Item
indication of panretinal photocoagulation in both eyes
boolean
C3146298 (UMLS CUI [1,1])
C0730064 (UMLS CUI [1,2])
C0229118 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Vitreous Hemorrhage | Preretinal hemorrhage
Item
vitreous hemorrhage or pre-retinal hemorrhage
boolean
C0042909 (UMLS CUI [1])
C4316879 (UMLS CUI [2])
Eyes Panretinal photocoagulation Previous | Eyes Focal photocoagulation | Eyes Grid photocoagulation
Item
eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months
boolean
C0015392 (UMLS CUI [1,1])
C0730064 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0015392 (UMLS CUI [2,1])
C1302105 (UMLS CUI [2,2])
C0015392 (UMLS CUI [3,1])
C1302035 (UMLS CUI [3,2])
Atrophy Involving Center of macula | Scarring Involving Center of macula | Fibrosis Involving Center of macula | Hard exudates Involving Center of macula
Item
atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
boolean
C0333641 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0016622 (UMLS CUI [1,3])
C0008767 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0016622 (UMLS CUI [2,3])
C0016059 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0016622 (UMLS CUI [3,3])
C0423410 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C0016622 (UMLS CUI [4,3])
Cataract
Item
cataract
boolean
C0086543 (UMLS CUI [1])
Operative Surgical Procedure Intraocular
Item
any intraocular surgery within 6 months before trial enrollment
boolean
C0543467 (UMLS CUI [1,1])
C3282905 (UMLS CUI [1,2])
Vitrectomy
Item
previous vitrectomy.
boolean
C0042903 (UMLS CUI [1])
Systemic disease Specified
Item
any of the following underlying systemic diseases:
boolean
C0442893 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Heart Disease Severe | Thromboembolism
Item
history or evidence of severe cardiac disease or previous thrombus-embolic event
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0040038 (UMLS CUI [2])
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