ID

25421

Description

Do Sulphonylureas Preserve Cortical Function During Hypoglycaemia?; ODM derived from: https://clinicaltrials.gov/show/NCT00472875

Lien

https://clinicaltrials.gov/show/NCT00472875

Mots-clés

Versions (1)
  1. 03/09/2017 03/09/2017 -
Téléchargé le

3 septembre 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT00472875

Anglais

Eligibility Type 1 Diabetes Mellitus NCT00472875

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-75
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
type 1 diabetes (who definition) of at least 5 years duration
Description

Insulin-Dependent Diabetes Mellitus disease length

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
history of impaired awareness of hypoglycaemia (capillary glucose readings < 3.5mmol/l without symptoms on > 3 occasions in the past 3 months (those with intact symptoms will be unlikely to show an improvement and would not really benefit from taking any medication intended just to increase symptoms)
Description

Loss of hypoglycemic warning | Capillary blood glucose measurement Quantity | Symptoms Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0342317
UMLS CUI [2,1]
C0457578
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy
Description

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
severe systemic illness
Description

Systemic disease Severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
active malignancy
Description

Malignant Neoplasms

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
severe complications of diabetes such as severe visual impairment, severe renal impairment, severe symptomatic autonomic neuropathy
Description

Complications of Diabetes Mellitus Severe | Severe visual impairment | Renal Insufficiency Severe | Autonomic neuropathy Symptomatic Severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1301509
UMLS CUI [3,1]
C1565489
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0259749
UMLS CUI [4,2]
C0231220
UMLS CUI [4,3]
C0205082
untreated ischemic heart disease, recent stroke
Description

Myocardial Ischemia untreated | Cerebrovascular accident

Type de données

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0038454
lactose intolerance ( the placebo will contain lactose)
Description

Lactose Intolerance | Placebo Containing Lactose

Type de données

boolean

Alias
UMLS CUI [1]
C0022951
UMLS CUI [2,1]
C1696465
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0022949
very poor diabetes control (hba1c > 10%) liver disease ( increase in alt / ast > 3x uln)
Description

Diabetes mellitus poor control Very | Glycosylated hemoglobin A | Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased

Type de données

boolean

Alias
UMLS CUI [1,1]
C0860161
UMLS CUI [1,2]
C0442824
UMLS CUI [2]
C0019018
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0151905
UMLS CUI [5]
C0151904
chronic kidney disease stage 4 or 5 ( egfr < 30ml/min)
Description

Chronic Kidney Disease Stage | Estimated Glomerular Filtration Rate

Type de données

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C2074731
UMLS CUI [2]
C3811844
severe untreated thyroid or adrenal insufficiency ( must be treated and on stable doses for at least 6 weeks)
Description

Hypothyroidism Severe untreated | Adrenal gland hypofunction Severe untreated

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020676
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332155
UMLS CUI [2,1]
C0001623
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332155
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Similar models

Eligibility Type 1 Diabetes Mellitus NCT00472875

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-75
boolean
C0001779 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus disease length
Item
type 1 diabetes (who definition) of at least 5 years duration
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Loss of hypoglycemic warning | Capillary blood glucose measurement Quantity | Symptoms Absent
Item
history of impaired awareness of hypoglycaemia (capillary glucose readings < 3.5mmol/l without symptoms on > 3 occasions in the past 3 months (those with intact symptoms will be unlikely to show an improvement and would not really benefit from taking any medication intended just to increase symptoms)
boolean
C0342317 (UMLS CUI [1])
C0457578 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Systemic disease Severe
Item
severe systemic illness
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Malignant Neoplasms
Item
active malignancy
boolean
C0006826 (UMLS CUI [1])
Complications of Diabetes Mellitus Severe | Severe visual impairment | Renal Insufficiency Severe | Autonomic neuropathy Symptomatic Severe
Item
severe complications of diabetes such as severe visual impairment, severe renal impairment, severe symptomatic autonomic neuropathy
boolean
C0342257 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1301509 (UMLS CUI [2])
C1565489 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0259749 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
Myocardial Ischemia untreated | Cerebrovascular accident
Item
untreated ischemic heart disease, recent stroke
boolean
C0151744 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2])
Lactose Intolerance | Placebo Containing Lactose
Item
lactose intolerance ( the placebo will contain lactose)
boolean
C0022951 (UMLS CUI [1])
C1696465 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0022949 (UMLS CUI [2,3])
Diabetes mellitus poor control Very | Glycosylated hemoglobin A | Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
very poor diabetes control (hba1c > 10%) liver disease ( increase in alt / ast > 3x uln)
boolean
C0860161 (UMLS CUI [1,1])
C0442824 (UMLS CUI [1,2])
C0019018 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0151904 (UMLS CUI [5])
Chronic Kidney Disease Stage | Estimated Glomerular Filtration Rate
Item
chronic kidney disease stage 4 or 5 ( egfr < 30ml/min)
boolean
C1561643 (UMLS CUI [1,1])
C2074731 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
Hypothyroidism Severe untreated | Adrenal gland hypofunction Severe untreated
Item
severe untreated thyroid or adrenal insufficiency ( must be treated and on stable doses for at least 6 weeks)
boolean
C0020676 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0001623 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
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