ID

42143

Description

ODM derived from http://clinicaltrials.gov/show/NCT00356109

Link

http://clinicaltrials.gov/show/NCT00356109

Keywords

Versions (2)
  1. 4/14/14 4/14/14 - Julian Varghese
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on

April 13, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00356109 Diabetes Mellitus, Type 1

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
Type 1 diabetes for at least 24 months
Description

Type 1 diabetes for at least 24 months

Data type

boolean

Alias
UMLS CUI 1
C0011900
SNOMED CT 1
439401001
LOINC Version 1
MTHU008876
UMLS CUI 2
C0011854
SNOMED CT 2
46635009
MedDRA 14.1
10067584
LOINC Version 2
MTHU020217
ICD-10-CM Version 2010
E10
Have an HbA1c less than or equal to 11%
Description

Have an HbA1c less than or equal to 11%

Data type

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months
Description

Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0557978
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

Require a daily total insulin dosage greater than 150 U at screening
Description

Require a daily total insulin dosage greater than 150 U at screening

Data type

boolean

Alias
UMLS CUI 1
C0021641
SNOMED CT 1
67866001
LOINC Version 232
MTHU019392
UMLS CUI 2
C0178602
SNOMED CT 2
260911001
UMLS CUI 3
C1409616
Patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease
Description

Patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease

Data type

boolean

Alias
UMLS CUI 1
C0262926
SNOMED CT 1
417662000
LOINC Version 232
MTHU027722
UMLS CUI 2
C0024115
SNOMED CT 2
19829001
MedDRA 14.1
10025082
ICD-10-CM Version 2010
J98.4
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 lung transplantation and/or lung cancer
Description

History of lung transplantation and/or lung cancer

Data type

boolean

Alias
UMLS CUI 1
C0262926
SNOMED CT 1
417662000
LOINC Version 1
MTHU027722
UMLS CUI 2
C0024128
SNOMED CT 2
88039007
MedDRA 1
10025127
ICD-9-CM Version 2011
33.5
UMLS CUI 3
C0242379
SNOMED CT 3
363358000
MedDRA 2
10058467
ICD-10-CM Version 2010
C34.90
Diagnosed with pneumonia in the 3 months prior to screening
Description

Diagnosed with pneumonia in the 3 months prior to screening

Data type

boolean

Alias
UMLS CUI 1
C0262926
SNOMED CT 1
417662000
LOINC Version 1
MTHU027722
UMLS CUI 2
C0032285
SNOMED CT 2
233604007
MedDRA 1
10035664
LOINC Version 2
MTHU020831
ICD-10-CM Version 2010
J18.9
CTCAE 1105E
E13502
UMLS CUI 3
C1409616
UMLS CUI 4
C0449238
SNOMED CT 3
103335007
LOINC Version 3
MTHU001938
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

Active or untreated malignancy

Data type

boolean

Alias
UMLS CUI 1
C0006826
SNOMED CT 1
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
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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 1 diabetes for at least 24 months
Item
Type 1 diabetes for at least 24 months
boolean
C0011900 (UMLS CUI 1)
439401001 (SNOMED CT 1)
MTHU008876 (LOINC Version 1)
C0011854 (UMLS CUI 2)
46635009 (SNOMED CT 2)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 2)
E10 (ICD-10-CM Version 2010)
Have an HbA1c less than or equal to 11%
Item
Have an HbA1c less than or equal to 11%
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months
Item
Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months
boolean
C0557978 (UMLS CUI 2011AA)
Non-smoker
Item
Non-smoker
boolean
C0337672 (UMLS CUI 2011AA)
8392000 (SNOMED CT 2011_0131)
10029560 (MedDRA 14.1)
Item Group
Exclusion Criteria
Require a daily total insulin dosage greater than 150 U at screening
Item
Require a daily total insulin dosage greater than 150 U at screening
boolean
C0021641 (UMLS CUI 1)
67866001 (SNOMED CT 1)
MTHU019392 (LOINC Version 232)
C0178602 (UMLS CUI 2)
260911001 (SNOMED CT 2)
C1409616 (UMLS CUI 3 )
Patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease
Item
Patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease
boolean
C0262926 (UMLS CUI 1)
417662000 (SNOMED CT 1)
MTHU027722 (LOINC Version 232)
C0024115 (UMLS CUI 2)
19829001 (SNOMED CT 2)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
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 lung transplantation and/or lung cancer
Item
History of lung transplantation and/or lung cancer
boolean
C0262926 (UMLS CUI 1)
417662000 (SNOMED CT 1)
MTHU027722 (LOINC Version 1)
C0024128 (UMLS CUI 2)
88039007 (SNOMED CT 2)
10025127 (MedDRA 1)
33.5 (ICD-9-CM Version 2011)
C0242379 (UMLS CUI 3)
363358000 (SNOMED CT 3)
10058467 (MedDRA 2)
C34.90 (ICD-10-CM Version 2010)
Diagnosed with pneumonia in the 3 months prior to screening
Item
Diagnosed with pneumonia in the 3 months prior to screening
boolean
C0262926 (UMLS CUI 1)
417662000 (SNOMED CT 1)
MTHU027722 (LOINC Version 1)
C0032285 (UMLS CUI 2)
233604007 (SNOMED CT 2)
10035664 (MedDRA 1)
MTHU020831 (LOINC Version 2)
J18.9 (ICD-10-CM Version 2010)
E13502 (CTCAE 1105E)
C1409616 (UMLS CUI 3)
C0449238 (UMLS CUI 4)
103335007 (SNOMED CT 3)
MTHU001938 (LOINC Version 3)
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)
Active or untreated malignancy
Item
Active or untreated malignancy
boolean
C0006826 (UMLS CUI 1)
363346000 (SNOMED CT 1)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
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