ID

17137

Description

Clinical Effects of Pulsatile Insulin Delivery on Cognitive Function- Phase 1; ODM derived from: https://clinicaltrials.gov/show/NCT00228865

Link

https://clinicaltrials.gov/show/NCT00228865

Keywords

  1. 8/26/16 8/26/16 -
Uploaded on

August 26, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus NCT00228865

Eligibility Diabetes Mellitus NCT00228865

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
inclusion criteria:
Description

ID.1

Data type

boolean

diagnosed with type 1 or type 2 diabetes mellitus.
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
self reporting or diagnosed with memory changes
Description

Memory changes | Patient Self-Report

Data type

boolean

Alias
UMLS CUI [1]
C1822023
UMLS CUI [2]
C0681906
taking oral agents and/or insulin for diabetic control
Description

oral medication Diabetes control | Insulin Diabetes control

Data type

boolean

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C0011847
UMLS CUI [1,3]
C0243148
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0011847
UMLS CUI [2,3]
C0243148
under endocrinologist's supervision for diabetes management
Description

Endocrinologist Supervision Diabetes mellitus management

Data type

boolean

Alias
UMLS CUI [1,1]
C0259863
UMLS CUI [1,2]
C0038842
UMLS CUI [1,3]
C0948092
endocrinologist must assess and approve patient for participation in this study
Description

Study Subject Participation Status Assessment Endocrinologist

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0259863
ability to swallow without difficulty
Description

Able to swallow well

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0205170
ability to commit to the weekly time requirements associated with the study
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
other causes of cognitive impairment not related to diabetes
Description

Impaired cognition Causes | Diabetes

Data type

boolean

Alias
UMLS CUI [1,1]
C0338656
UMLS CUI [1,2]
C0015127
UMLS CUI [2]
C0011847
inability to take cognitive testing
Description

Testing Cognitive Completion Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0039593
UMLS CUI [1,2]
C1516691
UMLS CUI [1,3]
C0205197
UMLS CUI [1,4]
C1299582
lack of intravenous access
Description

Lack Access Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0444454
UMLS CUI [1,2]
C0348016
UMLS CUI [1,3]
C0332268
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
alcohol abuse, drug addiction or the use of illegal drugs
Description

Alcohol abuse | Drug Dependence | Illicit drug use

Data type

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C1510472
UMLS CUI [3]
C0281875
positive hiv
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
inability to breathe into machine for respiratory quotients
Description

Respiratory quotient measurement Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0199508
UMLS CUI [1,2]
C1272705

Similar models

Eligibility Diabetes Mellitus NCT00228865

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
inclusion criteria:
boolean
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed with type 1 or type 2 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Memory changes | Patient Self-Report
Item
self reporting or diagnosed with memory changes
boolean
C1822023 (UMLS CUI [1])
C0681906 (UMLS CUI [2])
oral medication Diabetes control | Insulin Diabetes control
Item
taking oral agents and/or insulin for diabetic control
boolean
C0175795 (UMLS CUI [1,1])
C0011847 (UMLS CUI [1,2])
C0243148 (UMLS CUI [1,3])
C0021641 (UMLS CUI [2,1])
C0011847 (UMLS CUI [2,2])
C0243148 (UMLS CUI [2,3])
Endocrinologist Supervision Diabetes mellitus management
Item
under endocrinologist's supervision for diabetes management
boolean
C0259863 (UMLS CUI [1,1])
C0038842 (UMLS CUI [1,2])
C0948092 (UMLS CUI [1,3])
Study Subject Participation Status Assessment Endocrinologist
Item
endocrinologist must assess and approve patient for participation in this study
boolean
C2348568 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0259863 (UMLS CUI [1,3])
Able to swallow well
Item
ability to swallow without difficulty
boolean
C2712086 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
Protocol Compliance
Item
ability to commit to the weekly time requirements associated with the study
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Impaired cognition Causes | Diabetes
Item
other causes of cognitive impairment not related to diabetes
boolean
C0338656 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0011847 (UMLS CUI [2])
Testing Cognitive Completion Unable
Item
inability to take cognitive testing
boolean
C0039593 (UMLS CUI [1,1])
C1516691 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Lack Access Intravenous
Item
lack of intravenous access
boolean
C0444454 (UMLS CUI [1,1])
C0348016 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Alcohol abuse | Drug Dependence | Illicit drug use
Item
alcohol abuse, drug addiction or the use of illegal drugs
boolean
C0085762 (UMLS CUI [1])
C1510472 (UMLS CUI [2])
C0281875 (UMLS CUI [3])
HIV Seropositivity
Item
positive hiv
boolean
C0019699 (UMLS CUI [1])
Respiratory quotient measurement Unsuccessful
Item
inability to breathe into machine for respiratory quotients
boolean
C0199508 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])

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