ID

35580

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02443402

Stichworte

Versionen (1)
  1. 10.03.19 10.03.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

10. März 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02443402

Englisch

Eligibility Coronary Artery Disease NCT02443402

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age | Cardiac Surgery procedures

Datentyp

boolean

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

History of diabetes mellitus Absent

Datentyp

boolean

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

Medical History Hyperglycemia Absent

Datentyp

boolean

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

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Gastrointestinal obstruction | Paralytic Ileus | Suction gastrointestinal Expected

Datentyp

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
Beschreibung

Pancreatic Disease | Gall Bladder Disease

Datentyp

boolean

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

Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Injectable

Datentyp

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
Beschreibung

Mental condition | Comprehension Study Protocol Unable

Datentyp

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
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

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

Eligibility Coronary Artery Disease NCT02443402

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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