ID

35730

Descripción

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

Link

https://clinicaltrials.gov/show/NCT02036372

Palabras clave

  1. 19/3/19 19/3/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

19 de marzo de 2019

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus Type II NCT02036372

Eligibility Diabetes Mellitus Type II NCT02036372

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent
Descripción

Informed Consent

Tipo de datos

boolean

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

Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

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

Elective Surgical Procedure Scheduled | Exception Cardiac Surgery procedure

Tipo de datos

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
Descripción

Insulin Daily Dose IU/kg body weight

Tipo de datos

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
oral corticosteroid use
Descripción

Corticosteroid use Oral

Tipo de datos

boolean

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

Ambulatory Surgical Procedure Planned

Tipo de datos

boolean

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

ICU Stay Postoperative Planned

Tipo de datos

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
Descripción

Operation on intestine Planned

Tipo de datos

boolean

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

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Tipo de datos

boolean

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

Liver Dysfunction | Alanine aminotransferase increased

Tipo de datos

boolean

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

Renal Insufficiency | Creatinine measurement, serum | Gender

Tipo de datos

boolean

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

ID.13

Tipo de datos

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)
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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

Similar models

Eligibility Diabetes Mellitus Type II NCT02036372

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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