Informações:
Falhas:
ID
13133
Descrição
The HOME Trial: Hyperinsulinaemia: the Outcome of Its Metabolic Effects, a Randomized Controlled Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00375388
Link
https://clinicaltrials.gov/show/NCT00375388
Palavras-chave
Versões (1)
- 19/01/2016 19/01/2016 -
Titular dos direitos
CC BY-NC 3.0
Transferido a
19 de janeiro de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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Eligibility Type 2 Diabetes Mellitus NCT00375388
Eligibility Type 2 Diabetes Mellitus NCT00375388
- StudyEvent: Eligibility
Similar models
Eligibility Type 2 Diabetes Mellitus NCT00375388
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
patients of both sexes (women after menopause, women of child-bearing age after sterilization or if practicing reliable contraception)
Item
patients of both sexes (women after menopause, women of child-bearing age after sterilization or if practicing reliable contraception)
boolean
C0700589 (UMLS CUI [1])
diabetes mellitus type 2
Item
type 2 dm requiring insulin therapy after failure of maximal oral antidiabetic treatment (glycosylated hb > 7.5%) and need for exogenous insulin. (no concomitant use of oral antidiabetic agents)
boolean
C0011849 (UMLS CUI [1])
ambulatory
Item
being ambulatory
boolean
C0002423 (UMLS CUI [1])
age
Item
age: 30 to 80 years
boolean
C0001779 (UMLS CUI [1])
islet antibodies
Item
proven absence of islet antibodies, if qi < 28 kg/m2
boolean
C0063900 (UMLS CUI [1])
insulin
Item
insulin therapy 4 times daily (21), or insulin therapy 2 times daily using insulin ‘mixtures’ (rapidly and slowly acting)
boolean
C0021641 (UMLS CUI [1])
diet
Item
standard dietary prescription by the dietician
boolean
C0012155 (UMLS CUI [1])
ketoacidosis
Item
absence of keto-acidosis
boolean
C0011880 (UMLS CUI [1])
informed consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
NYHA
Item
congestive heart failure, nyha-classes iii or iv
boolean
C1275491 (UMLS CUI [1])
heart failure, myocardial infarction
Item
cardiac failure and/or myocardial infarction in the last four months before enrolment
boolean
C0018801 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0027051 (UMLS CUI [2])
severe organic / systemic disease
Item
other severe organic / systemic disease
boolean
C0009488 (UMLS CUI [1])
lactic acidosis
Item
metformin-induced lactic-acidosis
boolean
C0001125 (UMLS CUI [1])
intolerance to metformin hydrochloride
Item
intolerance to metformin hydrochloride
boolean
C0020517 (UMLS CUI [1,1])
C0770893 (UMLS CUI [1,2])
C0770893 (UMLS CUI [1,2])
renal disorder
Item
renal disease or renal dysfunction
boolean
C0022658 (UMLS CUI [1])
hypoxia
Item
hypoxic states
boolean
C0242184 (UMLS CUI [1])
hepatic dysfunction
Item
severe hepatic dysfunction
boolean
C0086565 (UMLS CUI [1])
alcohol intake
Item
excessive alcohol intake, acute or chronic
boolean
C0001948 (UMLS CUI [1])
metabolic acidosis
Item
acute or chronic metabolic acidosis
boolean
C0220981 (UMLS CUI [1])