ID

4895

Description

ODM derived from http://clinicaltrials.gov/show/NCT00355849

Link

http://clinicaltrials.gov/show/NCT00355849

Keywords

Versions (2)
  1. 3/17/12 3/17/12 -
  2. 4/14/14 4/14/14 - Julian Varghese
Uploaded on

April 14, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00355849 Diabetes Mellitus, Type 2

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age >=18 Years
Description

age >=18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Diabetes Mellitus, Non-Insulin-Dependent
Description

type 2 diabetes mellitus

Data type

boolean

Alias
UMLS CUI 2011AA
C0011860
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
one or more oral antihyperglycemic medications
Description

one or more oral antihyperglycemic medications

Data type

boolean

Alias
UMLS CUI 1
C0013227
UMLS CUI 2
C0359086
SNOMED CT 2011_0131
346597008
LOINC Version 232
MTHU003326
once-daily insulin glargine
Description

once-daily insulin glargine

Data type

boolean

Alias
UMLS CUI 1
C0907402
SNOMED CT 1
411529005
UMLS CUI 3
C0556983
SNOMED CT 2
229797004
HbA1c greater than or equal to 7.5 and less than or equal to 10.5%
Description

HbA1c greater than or equal to 7.5 and less than or equal to 10.5%

Data type

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
Non-smoker
Description

Non-smoker

Data type

boolean

Alias
UMLS CUI 2011AA
C0337672
SNOMED CT 2011_0131
8392000
MedDRA 14.1
10029560
Exclusion Criteria
Description

Exclusion Criteria

taking a TZD dose greater than what is indicated
Description

taking a TZD dose greater than what is indicated

Data type

boolean

Alias
UMLS CUI 1
C1257987
SNOMED CT 1
109086001
UMLS CUI 2
C0178602
SNOMED CT 2
260911001
more than two episodes of severe hypoglycemia during the 6 months prior
Description

more than two episodes of severe hypoglycemia during the 6 months prior

Data type

boolean

Alias
UMLS CUI 1
C0020615
SNOMED CT 1
302866003
MedDRA 14.1
10020993
ICD-10-CM Version 2010
E16.2
ICD-9-CM Version 2011
251.2
CTCAE 1105E
E12322
UMLS CUI 2
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 3
C0332189
SNOMED CT 3
272128006
Have had a lower respiratory infection in the 3 months prior
Description

Have had a lower respiratory infection in the 3 months prior

Data type

boolean

Alias
UMLS CUI 2011AA
C0149725
SNOMED CT 2011_0131
50417007
MedDRA 14.1
10024968
systemic Steroid Therapy
Description

systemic glucocorticoid therapy

Data type

boolean

Alias
UMLS CUI 2011AA
CL383594
clinical signs or symptoms of liver disease, acute or chronic hepatitis
Description

clinical signs or symptoms of liver disease, acute or chronic hepatitis

Data type

boolean

Alias
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
history of renal transplantation
Description

history of renal transplantation

Data type

boolean

Alias
UMLS CUI 1
C0262926
SNOMED CT 1
417662000
LOINC Version 232
MTHU027722
UMLS CUI 2
C0022671
SNOMED CT 2
70536003
MedDRA 14.1
10038533
ICD-9-CM Version 2011
55.6
active or untreated malignancy
Description

Have an active or untreated malignancy

Data type

boolean

Alias
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Require more than 150 U/day of insulin glargine
Description

Require more than 150 U/day of insulin glargine

Data type

boolean

Alias
UMLS CUI 1
C0907402
SNOMED CT 1
411529005
UMLS CUI 2
C0178602
SNOMED CT 2
260911001
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age >=18 Years
Item
age >=18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
type 2 diabetes mellitus
Item
Diabetes Mellitus, Non-Insulin-Dependent
boolean
C0011860 (UMLS CUI 2011AA)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
one or more oral antihyperglycemic medications
Item
one or more oral antihyperglycemic medications
boolean
C0013227 (UMLS CUI 1)
C0359086 (UMLS CUI 2)
346597008 (SNOMED CT 2011_0131)
MTHU003326 (LOINC Version 232)
once-daily insulin glargine
Item
once-daily insulin glargine
boolean
C0907402 (UMLS CUI 1)
411529005 (SNOMED CT 1)
C0556983 (UMLS CUI 3)
229797004 (SNOMED CT 2)
HbA1c greater than or equal to 7.5 and less than or equal to 10.5%
Item
HbA1c greater than or equal to 7.5 and less than or equal to 10.5%
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
Non-smoker
Item
Non-smoker
boolean
C0337672 (UMLS CUI 2011AA)
8392000 (SNOMED CT 2011_0131)
10029560 (MedDRA 14.1)
Item Group
Exclusion Criteria
taking a TZD dose greater than what is indicated
Item
taking a TZD dose greater than what is indicated
boolean
C1257987 (UMLS CUI 1)
109086001 (SNOMED CT 1)
C0178602 (UMLS CUI 2)
260911001 (SNOMED CT 2)
more than two episodes of severe hypoglycemia during the 6 months prior
Item
more than two episodes of severe hypoglycemia during the 6 months prior
boolean
C0020615 (UMLS CUI 1)
302866003 (SNOMED CT 1)
10020993 (MedDRA 14.1)
E16.2 (ICD-10-CM Version 2010)
251.2 (ICD-9-CM Version 2011)
E12322 (CTCAE 1105E)
C0205082 (UMLS CUI 2)
24484000 (SNOMED CT 2011_0131)
C0332189 (UMLS CUI 3)
272128006 (SNOMED CT 3)
Have had a lower respiratory infection in the 3 months prior
Item
Have had a lower respiratory infection in the 3 months prior
boolean
C0149725 (UMLS CUI 2011AA)
50417007 (SNOMED CT 2011_0131)
10024968 (MedDRA 14.1)
systemic glucocorticoid therapy
Item
systemic Steroid Therapy
boolean
CL383594 (UMLS CUI 2011AA)
clinical signs or symptoms of liver disease, acute or chronic hepatitis
Item
clinical signs or symptoms of liver disease, acute or chronic hepatitis
boolean
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
history of renal transplantation
Item
history of renal transplantation
boolean
C0262926 (UMLS CUI 1)
417662000 (SNOMED CT 1)
MTHU027722 (LOINC Version 232)
C0022671 (UMLS CUI 2)
70536003 (SNOMED CT 2)
10038533 (MedDRA 14.1)
55.6 (ICD-9-CM Version 2011)
Have an active or untreated malignancy
Item
active or untreated malignancy
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Require more than 150 U/day of insulin glargine
Item
Require more than 150 U/day of insulin glargine
boolean
C0907402 (UMLS CUI 1)
411529005 (SNOMED CT 1)
C0178602 (UMLS CUI 2)
260911001 (SNOMED CT 2)
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