ID

17300

Beschrijving

Efficacy and Safety of Insulin Detemir in Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00595374

Link

https://clinicaltrials.gov/show/NCT00595374

Trefwoorden

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

5 september 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Diabetes NCT00595374

Eligibility Diabetes NCT00595374

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00595374
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
duration of type 1 diabetes for at least 12 months
Beschrijving

Insulin-Dependent Diabetes Mellitus disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
bmi below 35 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
hba1c between 7.0-12.0%
Beschrijving

Glycosylated hemoglobin A

Datatype

boolean

Alias
UMLS CUI [1]
C0019018
current treatment with preprandial short acting insulin and insulin nph once or twice daily for at least 6 months
Beschrijving

Short-Acting Insulin ante cibus U/day | insulin isophane U/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0356365
UMLS CUI [1,2]
C1550738
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C0021658
UMLS CUI [2,2]
C0456683
fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the investigator
Beschrijving

Childbearing Potential Contraceptive methods | Risk of Pregnancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C4048193
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to trial product or related products
Beschrijving

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0439849
UMLS CUI [2,4]
C0013230
previous participation in this trial
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
receipt of any investigational products within the last 2 months prior to this trial
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
drug or alcohol dependence
Beschrijving

Substance Dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0038580
pregnancy, breast-feeding or intention of becoming pregnant
Beschrijving

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992

Similar models

Eligibility Diabetes NCT00595374

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00595374
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus disease length
Item
duration of type 1 diabetes for at least 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Body mass index
Item
bmi below 35 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c between 7.0-12.0%
boolean
C0019018 (UMLS CUI [1])
Short-Acting Insulin ante cibus U/day | insulin isophane U/day
Item
current treatment with preprandial short acting insulin and insulin nph once or twice daily for at least 6 months
boolean
C0356365 (UMLS CUI [1,1])
C1550738 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0021658 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods | Risk of Pregnancy
Item
fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the investigator
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C4048193 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related Investigational New Drugs
Item
known or suspected allergy to trial product or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
Study Subject Participation Status
Item
previous participation in this trial
boolean
C2348568 (UMLS CUI [1])
Investigational New Drugs
Item
receipt of any investigational products within the last 2 months prior to this trial
boolean
C0013230 (UMLS CUI [1])
Substance Dependence
Item
drug or alcohol dependence
boolean
C0038580 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnancy, breast-feeding or intention of becoming pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])

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