ID

35730

Beskrivning

Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02036372

Länk

https://clinicaltrials.gov/show/NCT02036372

Nyckelord

Versioner (1)
  1. 2019-03-19 2019-03-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus Type II NCT02036372

Engelsk

Eligibility Diabetes Mellitus Type II NCT02036372

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
known diabetes mellitus type ii for > 3 months
Beskrivning

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
aged 18-75 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
scheduled for elective non-cardiac surgery
Beskrivning

Elective Surgical Procedure Scheduled | Exception Cardiac Surgery procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0206058
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018821
daily insulin dosage of < 1 iu/kg body weight
Beskrivning

Insulin Daily Dose IU/kg body weight

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0560608
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
oral corticosteroid use
Beskrivning

Corticosteroid use Oral

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0239126
UMLS CUI [1,2]
C1527415
planned for day-care (ambulant) surgery
Beskrivning

Ambulatory Surgical Procedure Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002428
UMLS CUI [1,2]
C1301732
planned icu stay post-operatively
Beskrivning

ICU Stay Postoperative Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021708
UMLS CUI [1,2]
C3489408
UMLS CUI [1,3]
C0032790
UMLS CUI [1,4]
C1301732
planned bowel surgery
Beskrivning

Operation on intestine Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0192573
UMLS CUI [1,2]
C1301732
history of chronic pancreatitis or idiopathic acute pancreatitis
Beskrivning

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0341461
impaired liver function, defined as alanine aminotransferase (alat) ≥ 2.5 times upper normal limit
Beskrivning

Liver Dysfunction | Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
impaired renal function defined as serum-creatinine ≥ 133 μmol/l for males and ≥ 115
Beskrivning

Renal Insufficiency | Creatinine measurement, serum | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
μmol/l for females
Beskrivning

ID.13

Datatyp

boolean

females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
known or suspected allergy to trial product(s) or related products
Beskrivning

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Products Related | Hypersensitivity Suspected Products Related

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1514468
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C1514468
UMLS CUI [4,4]
C0439849
any condition that the local investigator feels would interfere with trial participation or the evaluation of results
Beskrivning

Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C0683954
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Similar models

Eligibility Diabetes Mellitus Type II NCT02036372

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
known diabetes mellitus type ii for > 3 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age
Item
aged 18-75 years
boolean
C0001779 (UMLS CUI [1])
Elective Surgical Procedure Scheduled | Exception Cardiac Surgery procedure
Item
scheduled for elective non-cardiac surgery
boolean
C0206058 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0018821 (UMLS CUI [2,2])
Insulin Daily Dose IU/kg body weight
Item
daily insulin dosage of < 1 iu/kg body weight
boolean
C0021641 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0560608 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Corticosteroid use Oral
Item
oral corticosteroid use
boolean
C0239126 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Ambulatory Surgical Procedure Planned
Item
planned for day-care (ambulant) surgery
boolean
C0002428 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
ICU Stay Postoperative Planned
Item
planned icu stay post-operatively
boolean
C0021708 (UMLS CUI [1,1])
C3489408 (UMLS CUI [1,2])
C0032790 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Operation on intestine Planned
Item
planned bowel surgery
boolean
C0192573 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alanine aminotransferase (alat) ≥ 2.5 times upper normal limit
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Renal Insufficiency | Creatinine measurement, serum | Gender
Item
impaired renal function defined as serum-creatinine ≥ 133 μmol/l for males and ≥ 115
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
ID.13
Item
μmol/l for females
boolean
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent
Item
females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Products Related | Hypersensitivity Suspected Products Related
Item
known or suspected allergy to trial product(s) or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C1514468 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C1514468 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results
Item
any condition that the local investigator feels would interfere with trial participation or the evaluation of results
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
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