ID

17302

Beschrijving

Efficacy and the Safety of Insulin Detemir in Subjects With Insulin Requiring Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00604344

Link

https://clinicaltrials.gov/show/NCT00604344

Trefwoorden

  1. 05-09-16 05-09-16 -
Geüploaded op

5 september 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Diabetes NCT00604344

Eligibility Diabetes NCT00604344

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00604344
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
duration of diabetes mellitus for at least 2 years
Beschrijving

Diabetes Mellitus disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0872146
current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart
Beschrijving

Basal insulin Bolus Therapeutic procedure | Insulin, Long-Acting | Insulins, intermediate-acting | Insulin Aspart

Datatype

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C1705509
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C0304870
UMLS CUI [3]
C3653576
UMLS CUI [4]
C1708521
hba1c below 11.0%
Beschrijving

Glycosylated hemoglobin A

Datatype

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
impaired renal function
Beschrijving

Renal Insufficiency

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
impaired hepatic function
Beschrijving

Hepatic Insufficiency

Datatype

boolean

Alias
UMLS CUI [1]
C1306571
serious heart diseases
Beschrijving

Heart Diseases Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
known hypoglycaemia unawareness or recurrent major hypoglycaemia
Beschrijving

Loss of hypoglycemic warning | Recurrent severe hypoglycemia

Datatype

boolean

Alias
UMLS CUI [1]
C0342317
UMLS CUI [2]
C0342316
proliferative retinopathy or maculopathy requiring acute treatment
Beschrijving

Proliferative retinopathy Requirement Therapeutic procedure | Disorder of macula of retina Proliferative Requirement Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0334094
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0087111
uncontrolled treated/untreated hypertension
Beschrijving

Uncontrolled hypertension treated | Uncontrolled hypertension untreated

Datatype

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0332155
current treatment with total insulin dose of more than 100 iu/day
Beschrijving

Insulin regime Dose Total IU/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439810
UMLS CUI [1,4]
C0439465
current treatment or expected at the screening to start treatment with systemic corticosteroids
Beschrijving

systemic steroids

Datatype

boolean

Alias
UMLS CUI [1]
C2825233

Similar models

Eligibility Diabetes NCT00604344

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00604344
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus disease length
Item
duration of diabetes mellitus for at least 2 years
boolean
C0011849 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin Bolus Therapeutic procedure | Insulin, Long-Acting | Insulins, intermediate-acting | Insulin Aspart
Item
current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart
boolean
C0650607 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0304870 (UMLS CUI [2])
C3653576 (UMLS CUI [3])
C1708521 (UMLS CUI [4])
Glycosylated hemoglobin A
Item
hba1c below 11.0%
boolean
C0019018 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
Hepatic Insufficiency
Item
impaired hepatic function
boolean
C1306571 (UMLS CUI [1])
Heart Diseases Serious
Item
serious heart diseases
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Loss of hypoglycemic warning | Recurrent severe hypoglycemia
Item
known hypoglycaemia unawareness or recurrent major hypoglycaemia
boolean
C0342317 (UMLS CUI [1])
C0342316 (UMLS CUI [2])
Proliferative retinopathy Requirement Therapeutic procedure | Disorder of macula of retina Proliferative Requirement Therapeutic procedure
Item
proliferative retinopathy or maculopathy requiring acute treatment
boolean
C0339467 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0730362 (UMLS CUI [2,1])
C0334094 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
Uncontrolled hypertension treated | Uncontrolled hypertension untreated
Item
uncontrolled treated/untreated hypertension
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Insulin regime Dose Total IU/day
Item
current treatment with total insulin dose of more than 100 iu/day
boolean
C0557978 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C0439465 (UMLS CUI [1,4])
systemic steroids
Item
current treatment or expected at the screening to start treatment with systemic corticosteroids
boolean
C2825233 (UMLS CUI [1])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial