ID

35580

Description

Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT02443402

Lien

https://clinicaltrials.gov/show/NCT02443402

Mots-clés

  1. 10/03/2019 10/03/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

10 mars 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Coronary Artery Disease NCT02443402

Eligibility Coronary Artery Disease NCT02443402

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females between the ages of 18 and 80 years undergoing, cardiac surgery
Description

Age | Cardiac Surgery procedures

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0018821
no previous history of diabetes
Description

History of diabetes mellitus Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0455488
UMLS CUI [1,2]
C0332197
no previous history of hyperglycemia
Description

Medical History Hyperglycemia Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0020456
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with hyperglycemia (blood glucose > 125 mg/dl); or glycated hemoglobin (hba1c) > 6.5%; or previous treatment with oral antidiabetic agents or insulin
Description

Hyperglycemia | Blood glucose measurement | Hemoglobin A1c measurement | Antidiabetics Oral | Insulin

Type de données

boolean

Alias
UMLS CUI [1]
C0020456
UMLS CUI [2]
C0392201
UMLS CUI [3]
C0474680
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1527415
UMLS CUI [5]
C0021641
severely impaired renal function (serum creatinine ≥3.0 mg/dl or gfr < 30 ml/min) or clinically significant hepatic failure
Description

Renal Insufficiency Severe | Creatinine measurement, serum | Glomerular Filtration Rate | Liver Failure

Type de données

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0017654
UMLS CUI [4]
C0085605
moribund patients and those at imminent risk of death (brain death or cardiac standstill)
Description

Moribund | At risk Death | At risk Brain Death | At risk Cardiac Arrest

Type de données

boolean

Alias
UMLS CUI [1]
C0424547
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0011065
UMLS CUI [3,1]
C1444641
UMLS CUI [3,2]
C0006110
UMLS CUI [4,1]
C1444641
UMLS CUI [4,2]
C0018790
subjects with gastrointestinal (gi) obstruction or adynamic ileus or those expected to require gi suction
Description

Gastrointestinal obstruction | Paralytic Ileus | Suction gastrointestinal Expected

Type de données

boolean

Alias
UMLS CUI [1]
C0236124
UMLS CUI [2]
C0030446
UMLS CUI [3,1]
C0038638
UMLS CUI [3,2]
C0521362
UMLS CUI [3,3]
C1517001
patients with clinically relevant pancreatic or gallbladder disease
Description

Pancreatic Disease | Gall Bladder Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0030286
UMLS CUI [2]
C0016977
treatment with oral or injectable corticosteroid
Description

Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Injectable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0086466
mental condition rendering the subject unable to understand the scope, and consequences of the study
Description

Mental condition | Comprehension Study Protocol Unable

Type de données

boolean

Alias
UMLS CUI [1]
C3840291
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C1299582
female subjects who are pregnant or breast feeding at time of enrollment into the study
Description

Pregnancy | Breast Feeding

Type de données

boolean

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

Similar models

Eligibility Coronary Artery Disease NCT02443402

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age | Cardiac Surgery procedures
Item
males or females between the ages of 18 and 80 years undergoing, cardiac surgery
boolean
C0001779 (UMLS CUI [1])
C0018821 (UMLS CUI [2])
History of diabetes mellitus Absent
Item
no previous history of diabetes
boolean
C0455488 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Medical History Hyperglycemia Absent
Item
no previous history of hyperglycemia
boolean
C0262926 (UMLS CUI [1,1])
C0020456 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hyperglycemia | Blood glucose measurement | Hemoglobin A1c measurement | Antidiabetics Oral | Insulin
Item
patients with hyperglycemia (blood glucose > 125 mg/dl); or glycated hemoglobin (hba1c) > 6.5%; or previous treatment with oral antidiabetic agents or insulin
boolean
C0020456 (UMLS CUI [1])
C0392201 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0021641 (UMLS CUI [5])
Renal Insufficiency Severe | Creatinine measurement, serum | Glomerular Filtration Rate | Liver Failure
Item
severely impaired renal function (serum creatinine ≥3.0 mg/dl or gfr < 30 ml/min) or clinically significant hepatic failure
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
C0017654 (UMLS CUI [3])
C0085605 (UMLS CUI [4])
Moribund | At risk Death | At risk Brain Death | At risk Cardiac Arrest
Item
moribund patients and those at imminent risk of death (brain death or cardiac standstill)
boolean
C0424547 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0011065 (UMLS CUI [2,2])
C1444641 (UMLS CUI [3,1])
C0006110 (UMLS CUI [3,2])
C1444641 (UMLS CUI [4,1])
C0018790 (UMLS CUI [4,2])
Gastrointestinal obstruction | Paralytic Ileus | Suction gastrointestinal Expected
Item
subjects with gastrointestinal (gi) obstruction or adynamic ileus or those expected to require gi suction
boolean
C0236124 (UMLS CUI [1])
C0030446 (UMLS CUI [2])
C0038638 (UMLS CUI [3,1])
C0521362 (UMLS CUI [3,2])
C1517001 (UMLS CUI [3,3])
Pancreatic Disease | Gall Bladder Disease
Item
patients with clinically relevant pancreatic or gallbladder disease
boolean
C0030286 (UMLS CUI [1])
C0016977 (UMLS CUI [2])
Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Injectable
Item
treatment with oral or injectable corticosteroid
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C0086466 (UMLS CUI [2,2])
Mental condition | Comprehension Study Protocol Unable
Item
mental condition rendering the subject unable to understand the scope, and consequences of the study
boolean
C3840291 (UMLS CUI [1])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
female subjects who are pregnant or breast feeding at time of enrollment into the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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