Information:
Fel:
ID
13693
Beskrivning
Effect of NPH Insulin, Insulin Detemir and Insulin Glargine on GH-IGF-IGFBP Axis; ODM derived from: https://clinicaltrials.gov/show/NCT01461616
Länk
https://clinicaltrials.gov/show/NCT01461616
Nyckelord
Versioner (1)
- 2016-02-28 2016-02-28 -
Uppladdad den
28 februari 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT01461616
Eligibility Diabetes Mellitus, Type 1 NCT01461616
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 1 NCT01461616
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
informed consent
Item
1. informed consent obtained before any trial-related activities.
boolean
C0021430 (UMLS CUI [1])
diabetes mellitus type 1
Item
2. diagnosis of diabetes mellitus according to who criteria; history and clinical course consistent with type 1 diabetes mellitus.
boolean
C0011849 (UMLS CUI [1,1])
C0441729 (UMLS CUI [1,2])
C0441729 (UMLS CUI [1,2])
continuous subcutaneous insulin infusion
Item
3. diagnosed with diabetes for more than 6 years and using continuous subcutaneous insulin infusion (csii) at least 6 months at time of inclusion.
boolean
C0393124 (UMLS CUI [1])
Dosage insulin
Item
4. total daily insulin dose between 0.4 and 1.4 units/kg (both values included)
boolean
C0178602 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0021641 (UMLS CUI [1,2])
hba1c
Item
5. hba1c between 6% and 9% (both values included).
boolean
C0019018 (UMLS CUI [1])
age
Item
6. age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
bmi
Item
7. bmi between 18.5 and 28 kg /m2 (including both values).
boolean
C1305855 (UMLS CUI [1])
hypersensitivity study drugs
Item
1. known or suspected allergy to trial product(s) or related products.
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
hypoglycaemic episode
Item
2. recurrent major hypoglycaemic episodes.
boolean
C0745153 (UMLS CUI [1])
unstable angina pectoris; nyha classification
Item
3. heart: unstable angina pectoris, ami < 12 months or heart insufficiency classified according to nyha iii-iv
boolean
C0002965 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
C1275491 (UMLS CUI [2])
blood pressure; uncontrolled hypertension
Item
4. blood pressure: severe uncontrolled hypertension with bp > 180/110 mmhg, sitting
boolean
C0005823 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C1868885 (UMLS CUI [2])
Liver Dysfunction; serum alanine aminotransferase measurement
Item
5. liver: impaired hepatic function corresponding to serum-alat or basic phosphatase > 2 x upper reference limit of the local laboratory.
boolean
C0086565 (UMLS CUI [1])
C1883008 (UMLS CUI [2])
C1883008 (UMLS CUI [2])
renal dysfunction; serum-creatinine
Item
6. kidneys: impaired renal function corresponding to serum-creatinin > 150 μmol/l according to the local laboratory.
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0201976 (UMLS CUI [2])
Compliance behavior Limited Comorbidity
Item
7. any disease judged by the investigator to affect the trial.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Contraception status; hysterectomy
Item
8. pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures - adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.
boolean
C0420837 (UMLS CUI [1])
C0020699 (UMLS CUI [2])
C0020699 (UMLS CUI [2])