ID

43296

Description

ODM derived from http://clinicaltrials.gov/show/NCT01194154

Link

http://clinicaltrials.gov/show/NCT01194154

Keywords

Versions (2)
  1. 3/19/13 3/19/13 - Martin Dugas
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00006497 NCT01194154 Kidney Disease, Chronic

German English

Eligibility

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

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Adult (person)
Description

Adult patients, 18 years of age

Data type

boolean

Alias
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
For diabetic patients: Type 2 diabetes mellitus with HbA1c >7% or anti-diabetic treatment
Description

For diabetic patients: Type 2 diabetes mellitus with HbA1c >7% or anti-diabetic treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0241863
MedDRA 14.1
10012641
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
For renal allograft recipients: Status between 6 months and 10 years post transplantation
Description

For renal allograft recipients: Status between 6 months and 10 years post transplantation

Data type

boolean

Alias
UMLS CUI 2011AA
C0022646
SNOMED CT 2011_0131
64033007
LOINC Version 232
MTHU002935
UMLS CUI 2011AA
C0040739
UMLS CUI 2011AA
C1709854
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0040732
SNOMED CT 2011_0131
77465005
MedDRA 14.1
10057677
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0205456
SNOMED CT 2011_0131
3445001
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
Chronic kidney disease stage III
Description

Chronic kidney disease stage III

Data type

boolean

Alias
UMLS CUI 2011AA
C2316787
SNOMED CT 2011_0131
433144002
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Urinary albumine-to-creatinine ratio between >100 and <1000 mg/g creatinine
Description

Urinary albumine-to-creatinine ratio between >100 and <1000 mg/g creatinine

Data type

boolean

Alias
UMLS CUI 2011AA
C0455271
SNOMED CT 2011_0131
271075006
MedDRA 14.1
10053542
UMLS CUI 2011AA
C0010294
SNOMED CT 2011_0131
15373003
MedDRA 14.1
10011358
LOINC Version 232
38483-4
Exclusion Criteria
Description

Exclusion Criteria

Hemoglobin Measurement
Description

Hb-level <1 or 14 g/dL

Data type

boolean

Alias
UMLS CUI 2011AA
C0518015
MedDRA 14.1
10018876
Initiation of angiotensin converting enzyme inhibitor, angiotensin 2 receptor blocker or aliskiren treatment less than 3 months before enrolment
Description

Initiation of angiotensin converting enzyme inhibitor, angiotensin 2 receptor blocker or aliskiren treatment less than 3 months before enrolment

Data type

boolean

Alias
UMLS CUI 2011AA
C1704686
UMLS CUI 2011AA
C0003015
SNOMED CT 2011_0131
372733002
UMLS CUI 2011AA
C0521942
SNOMED CT 2011_0131
96308008
UMLS CUI 2011AA
C0915224
SNOMED CT 2011_0131
427002003
UMLS CUI 2011AA
C0039798
Iron deficiency
Description

Iron deficiency

Data type

boolean

Alias
UMLS CUI 2011AA
C0240066
SNOMED CT 2011_0131
35240004
MedDRA 14.1
10022970
ICD-10-CM Version 2010
E61.1
Hemoglobin A1c (HbA1c)
Description

HbA1c >9%

Data type

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
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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 at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Adult patients, 18 years of age
Item
Adult (person)
boolean
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
For diabetic patients: Type 2 diabetes mellitus with HbA1c >7% or anti-diabetic treatment
Item
For diabetic patients: Type 2 diabetes mellitus with HbA1c >7% or anti-diabetic treatment
boolean
C0241863 (UMLS CUI 2011AA)
10012641 (MedDRA 14.1)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
For renal allograft recipients: Status between 6 months and 10 years post transplantation
Item
For renal allograft recipients: Status between 6 months and 10 years post transplantation
boolean
C0022646 (UMLS CUI 2011AA)
64033007 (SNOMED CT 2011_0131)
MTHU002935 (LOINC Version 232)
C0040739 (UMLS CUI 2011AA)
C1709854 (UMLS CUI 2011AA)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0205456 (UMLS CUI 2011AA)
3445001 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Chronic kidney disease stage III
Item
Chronic kidney disease stage III
boolean
C2316787 (UMLS CUI 2011AA)
433144002 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Urinary albumine-to-creatinine ratio between >100 and <1000 mg/g creatinine
Item
Urinary albumine-to-creatinine ratio between >100 and <1000 mg/g creatinine
boolean
C0455271 (UMLS CUI 2011AA)
271075006 (SNOMED CT 2011_0131)
10053542 (MedDRA 14.1)
C0010294 (UMLS CUI 2011AA)
15373003 (SNOMED CT 2011_0131)
10011358 (MedDRA 14.1)
38483-4 (LOINC Version 232)
Item Group
Exclusion Criteria
Hb-level <1 or 14 g/dL
Item
Hemoglobin Measurement
boolean
C0518015 (UMLS CUI 2011AA)
10018876 (MedDRA 14.1)
Initiation of angiotensin converting enzyme inhibitor, angiotensin 2 receptor blocker or aliskiren treatment less than 3 months before enrolment
Item
Initiation of angiotensin converting enzyme inhibitor, angiotensin 2 receptor blocker or aliskiren treatment less than 3 months before enrolment
boolean
C1704686 (UMLS CUI 2011AA)
C0003015 (UMLS CUI 2011AA)
372733002 (SNOMED CT 2011_0131)
C0521942 (UMLS CUI 2011AA)
96308008 (SNOMED CT 2011_0131)
C0915224 (UMLS CUI 2011AA)
427002003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Iron deficiency
Item
Iron deficiency
boolean
C0240066 (UMLS CUI 2011AA)
35240004 (SNOMED CT 2011_0131)
10022970 (MedDRA 14.1)
E61.1 (ICD-10-CM Version 2010)
HbA1c >9%
Item
Hemoglobin A1c (HbA1c)
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
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