Inglés

Eligibility Type 2 Diabetes Mellitus NCT00375388

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients of both sexes (women after menopause, women of child-bearing age after sterilization or if practicing reliable contraception)
Descripción

patients of both sexes (women after menopause, women of child-bearing age after sterilization or if practicing reliable contraception)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
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)
Descripción

diabetes mellitus type 2

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011849
being ambulatory
Descripción

ambulatory

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002423
age: 30 to 80 years
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
proven absence of islet antibodies, if qi < 28 kg/m2
Descripción

islet antibodies

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0063900
insulin therapy 4 times daily (21), or insulin therapy 2 times daily using insulin ‘mixtures’ (rapidly and slowly acting)
Descripción

insulin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021641
standard dietary prescription by the dietician
Descripción

diet

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012155
absence of keto-acidosis
Descripción

ketoacidosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011880
informed consent
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
congestive heart failure, nyha-classes iii or iv
Descripción

NYHA

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1275491
cardiac failure and/or myocardial infarction in the last four months before enrolment
Descripción

heart failure, myocardial infarction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0027051
other severe organic / systemic disease
Descripción

severe organic / systemic disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
metformin-induced lactic-acidosis
Descripción

lactic acidosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001125
intolerance to metformin hydrochloride
Descripción

intolerance to metformin hydrochloride

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0770893
renal disease or renal dysfunction
Descripción

renal disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022658
hypoxic states
Descripción

hypoxia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242184
severe hepatic dysfunction
Descripción

hepatic dysfunction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
excessive alcohol intake, acute or chronic
Descripción

alcohol intake

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001948
acute or chronic metabolic acidosis
Descripción

metabolic acidosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220981
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00375388

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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