ID

44606

Description

ODM derived from http://clinicaltrials.gov/show/NCT01042977

Link

http://clinicaltrials.gov/show/NCT01042977

Keywords

Versions (3)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01042977 Type 2 Diabetes Mellitus

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 45 Years
Description

age at least 45 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Type 2 diabetes mellitus.
Description

Type 2 diabetes mellitus.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011860
Disease affecting entire cardiovascular system
Description

Cardiovascular disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
Uninterrupted anti-diabetic treatment for at least 8 weeks before enrolment
Description

Uninterrupted anti-diabetic treatment for at least 8 weeks before enrolment

Data type

boolean

Alias
UMLS CUI 2011AA
C0549178
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Patients with type 1 diabetes or diabetes insipidus
Description

Patients with type 1 diabetes or diabetes insipidus

Data type

boolean

Alias
UMLS CUI 2011AA
C0011854
SNOMED CT 2011_0131
46635009
MedDRA 14.1
10067584
LOINC Version 232
MTHU020217
ICD-10-CM Version 2010
E10
UMLS CUI 2011AA
C0011848
SNOMED CT 2011_0131
15771004
MedDRA 14.1
10012599
ICD-10-CM Version 2010
E23.2
ICD-9-CM Version 2011
253.5
Patients with >= 3 oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
Description

Patients with >= 3 oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes

Data type

boolean

Alias
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0359086
SNOMED CT 2011_0131
346597008
LOINC Version 232
MTHU003326
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
UMLS CUI 2011AA
C0860161
MedDRA 14.1
10012619
Any clinically significant illness, which would compromise the patient's safety and their participation in the study
Description

Any clinically significant illness, which would compromise the patient's safety and their participation in the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0221423
SNOMED CT 2011_0131
39104002
MedDRA 14.1
10040658
ICD-10-CM Version 2010
R69
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C1113679
UMLS CUI 2011AA
C2348568
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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
CL425202 (UMLS CUI 2011AA)
age at least 45 Years
Item
age at least 45 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Type 2 diabetes mellitus.
Item
Type 2 diabetes mellitus.
boolean
C0011860 (UMLS CUI 2011AA)
Cardiovascular disease
Item
Disease affecting entire cardiovascular system
boolean
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
Uninterrupted anti-diabetic treatment for at least 8 weeks before enrolment
Item
Uninterrupted anti-diabetic treatment for at least 8 weeks before enrolment
boolean
C0549178 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205454 (UMLS CUI 2011AA)
7319005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patients with type 1 diabetes or diabetes insipidus
Item
Patients with type 1 diabetes or diabetes insipidus
boolean
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
C0011848 (UMLS CUI 2011AA)
15771004 (SNOMED CT 2011_0131)
10012599 (MedDRA 14.1)
E23.2 (ICD-10-CM Version 2010)
253.5 (ICD-9-CM Version 2011)
Patients with >= 3 oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
Item
Patients with >= 3 oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
boolean
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0359086 (UMLS CUI 2011AA)
346597008 (SNOMED CT 2011_0131)
MTHU003326 (LOINC Version 232)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C0860161 (UMLS CUI 2011AA)
10012619 (MedDRA 14.1)
Any clinically significant illness, which would compromise the patient's safety and their participation in the study
Item
Any clinically significant illness, which would compromise the patient's safety and their participation in the study
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C1113679 (UMLS CUI 2011AA)
C2348568 (UMLS CUI 2011AA)
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