ID

29040

Description

A Study to Assess the Safety of Single Doses of GSK189075 in Subjects With Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00575159

Link

https://clinicaltrials.gov/show/NCT00575159

Keywords

Versions (1)
  1. 2/21/18 2/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT00575159

English

Eligibility Diabetes Mellitus, Type 1 NCT00575159

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult male/female, 18 to 55 years old
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
diagnosis of type 1 diabetes mellitus for at least 6 months; and using a continuous insulin pump
Description

Insulin-Dependent Diabetes Mellitus Disease length | Insulin pump Use of

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C1140609
UMLS CUI [2,2]
C1524063
willing and able to follow all study-related instructions provided by the site staff.
Description

Protocol Compliance Willing | Protocol Compliance Able

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0085732
willing to provide signed informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or a nursing female.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
have a past or current disease such as heart, liver, kidney, blood, brain, or other disease.
Description

Heart Diseases | Liver diseases | Kidney Diseases | Hematological Disease | Brain Diseases | Disease Other

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0006111
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0205394
have hiv or hepatitis, or have alcohol or drugs in your system at the screening visit.
Description

HIV Infection | Hepatitis | Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019158
UMLS CUI [3]
C0038586
have a history of alcohol abuse or have an eating disorder
Description

Alcohol abuse | Eating Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0013473
have been in another research study in the last month or have taken certain medications in the 1 week before study drug would be taken.
Description

Study Subject Participation Status | Pharmaceutical Preparations Specific

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0205369
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00575159

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult male/female, 18 to 55 years old
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Insulin-Dependent Diabetes Mellitus Disease length | Insulin pump Use of
Item
diagnosis of type 1 diabetes mellitus for at least 6 months; and using a continuous insulin pump
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C1140609 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
Protocol Compliance Willing | Protocol Compliance Able
Item
willing and able to follow all study-related instructions provided by the site staff.
boolean
C0525058 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
Informed Consent
Item
willing to provide signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or a nursing female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart Diseases | Liver diseases | Kidney Diseases | Hematological Disease | Brain Diseases | Disease Other
Item
have a past or current disease such as heart, liver, kidney, blood, brain, or other disease.
boolean
C0018799 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0006111 (UMLS CUI [5])
C0012634 (UMLS CUI [6,1])
C0205394 (UMLS CUI [6,2])
HIV Infection | Hepatitis | Substance Use Disorders
Item
have hiv or hepatitis, or have alcohol or drugs in your system at the screening visit.
boolean
C0019693 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
Alcohol abuse | Eating Disorders
Item
have a history of alcohol abuse or have an eating disorder
boolean
C0085762 (UMLS CUI [1])
C0013473 (UMLS CUI [2])
Study Subject Participation Status | Pharmaceutical Preparations Specific
Item
have been in another research study in the last month or have taken certain medications in the 1 week before study drug would be taken.
boolean
C2348568 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
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