ID

29261

Beskrivning

Evaluation of Retinal Changes in Systemic Darbepoetin Alpha Treatment in Patients With Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00704652

Länk

https://clinicaltrials.gov/show/NCT00704652

Nyckelord

Versioner (1)
  1. 2018-03-13 2018-03-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 mars 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetic Retinopathy NCT00704652

Engelsk

Eligibility Diabetic Retinopathy NCT00704652

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
group a:
Beskrivning

Group A

Datatyp

boolean

Alias
UMLS CUI [1]
C0441835
males and females aged 18 to 80 yrs
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
diabetes mellitus type 1 or 2
Beskrivning

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
haemoglobin level above the treatment threshold level (as described in the drug description)
Beskrivning

Hemoglobin increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0549448
receiving no darbepoetin alfa treatment
Beskrivning

Darbepoetin alfa Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0937950
UMLS CUI [1,2]
C0332197
best corrected visual acuity (bcva) better than 20/200
Beskrivning

Best corrected visual acuity

Datatyp

boolean

Alias
UMLS CUI [1]
C1690532
no clinically significant macular edema (csme) or csme already treated with laser photocoagulation.
Beskrivning

Macular edema Absent | Laser photocoagulation Macular edema Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0271051
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0441510
UMLS CUI [2,2]
C0271051
UMLS CUI [2,3]
C0332197
group b:
Beskrivning

Group B

Datatyp

boolean

Alias
UMLS CUI [1]
C0441836
males and females aged 18 to 80 yrs
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
diabetes mellitus type 1 or2
Beskrivning

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
anaemia (due to renal failure), haemoglobin level under the treatment threshold level before the initialisation of the therapy (as described in the drug label)
Beskrivning

Anemia Due to Kidney Failure | Hemoglobin measurement Below threshold level

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002871
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0035078
UMLS CUI [2,1]
C0518015
UMLS CUI [2,2]
C0443151
starting to receive darbepoetin alfa treatment (darbepoetin alfa, aranesp, amgen)
Beskrivning

darbepoetin alfa | Aranesp

Datatyp

boolean

Alias
UMLS CUI [1]
C0937950
UMLS CUI [2]
C1134440
bcva better than 20/200
Beskrivning

Best corrected visual acuity

Datatyp

boolean

Alias
UMLS CUI [1]
C1690532
no clinically significant macular edema (csme) or csme already treated with laser photocoagulation.
Beskrivning

Macular edema Absent | Laser photocoagulation Macular edema Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0271051
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0441510
UMLS CUI [2,2]
C0271051
UMLS CUI [2,3]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of retinal disease other than dr
Beskrivning

Retinal Disease | Exception Diabetic Retinopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0035309
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011884
history of intraocular surgery, including laser treatment in the past 4 month
Beskrivning

Operative Surgical Procedures Intraocular | Laser Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C3282905
UMLS CUI [2]
C1955835
a major change in the insulin treatment of the patient in the past 4 month or during the follow up period.
Beskrivning

Insulin regime Major change

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C3845593
inability to communicate in german or english
Beskrivning

Lacking Able to communicate German language | Lacking Able to communicate English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2364293
UMLS CUI [1,3]
C0017477
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2364293
UMLS CUI [2,3]
C0376245
dementia; inability to follow commands
Beskrivning

Dementia | Instructions Compliance behavior Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2,1]
C2051542
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C1299582
epilepsy
Beskrivning

Epilepsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0014544
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Similar models

Eligibility Diabetic Retinopathy NCT00704652

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Group A
Item
group a:
boolean
C0441835 (UMLS CUI [1])
Age
Item
males and females aged 18 to 80 yrs
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
diabetes mellitus type 1 or 2
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Hemoglobin increased
Item
haemoglobin level above the treatment threshold level (as described in the drug description)
boolean
C0549448 (UMLS CUI [1])
Darbepoetin alfa Absent
Item
receiving no darbepoetin alfa treatment
boolean
C0937950 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Best corrected visual acuity
Item
best corrected visual acuity (bcva) better than 20/200
boolean
C1690532 (UMLS CUI [1])
Macular edema Absent | Laser photocoagulation Macular edema Absent
Item
no clinically significant macular edema (csme) or csme already treated with laser photocoagulation.
boolean
C0271051 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0441510 (UMLS CUI [2,1])
C0271051 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Group B
Item
group b:
boolean
C0441836 (UMLS CUI [1])
Age
Item
males and females aged 18 to 80 yrs
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
diabetes mellitus type 1 or2
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Anemia Due to Kidney Failure | Hemoglobin measurement Below threshold level
Item
anaemia (due to renal failure), haemoglobin level under the treatment threshold level before the initialisation of the therapy (as described in the drug label)
boolean
C0002871 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0035078 (UMLS CUI [1,3])
C0518015 (UMLS CUI [2,1])
C0443151 (UMLS CUI [2,2])
darbepoetin alfa | Aranesp
Item
starting to receive darbepoetin alfa treatment (darbepoetin alfa, aranesp, amgen)
boolean
C0937950 (UMLS CUI [1])
C1134440 (UMLS CUI [2])
Best corrected visual acuity
Item
bcva better than 20/200
boolean
C1690532 (UMLS CUI [1])
Macular edema Absent | Laser photocoagulation Macular edema Absent
Item
no clinically significant macular edema (csme) or csme already treated with laser photocoagulation.
boolean
C0271051 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0441510 (UMLS CUI [2,1])
C0271051 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Retinal Disease | Exception Diabetic Retinopathy
Item
history of retinal disease other than dr
boolean
C0035309 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0011884 (UMLS CUI [2,2])
Operative Surgical Procedures Intraocular | Laser Therapy
Item
history of intraocular surgery, including laser treatment in the past 4 month
boolean
C0543467 (UMLS CUI [1,1])
C3282905 (UMLS CUI [1,2])
C1955835 (UMLS CUI [2])
Insulin regime Major change
Item
a major change in the insulin treatment of the patient in the past 4 month or during the follow up period.
boolean
C0557978 (UMLS CUI [1,1])
C3845593 (UMLS CUI [1,2])
Lacking Able to communicate German language | Lacking Able to communicate English Language
Item
inability to communicate in german or english
boolean
C0332268 (UMLS CUI [1,1])
C2364293 (UMLS CUI [1,2])
C0017477 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C2364293 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
Dementia | Instructions Compliance behavior Unable
Item
dementia; inability to follow commands
boolean
C0497327 (UMLS CUI [1])
C2051542 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Epilepsy
Item
epilepsy
boolean
C0014544 (UMLS CUI [1])
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