ID

42760

Description

ODM derived from http://clinicaltrials.gov/show/NCT00786253

Link

http://clinicaltrials.gov/show/NCT00786253

Keywords

Versions (2)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00004098 NCT00786253 Erectile Dysfunction

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 64 Years
Description

age 18 Years to 64 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
male, male gender
Description

Males 18-64 years of age

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
Mild or mild to moderate ED (defined as >15 and <21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)
Description

Mild or mild to moderate ED (defined as >15 and <21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)

Data type

boolean

Alias
UMLS CUI 2011AA
C2945599
SNOMED CT 2011_0131
255604002
UMLS CUI 2011AA
C1299392
SNOMED CT 2011_0131
371923003
UMLS CUI 2011AA
C0242350
SNOMED CT 2011_0131
397803000
MedDRA 14.1
10061461
ICD-10-CM Version 2010
N52
ICD-9-CM Version 2011
302.72
CTCAE 1105E
E13088
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C2959680
SNOMED CT 2011_0131
445992001
History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease
Description

History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
UMLS CUI 2011AA
C0020538
SNOMED CT 2011_0131
38341003
MedDRA 14.1
10020772
LOINC Version 232
MTHU020789
ICD-10-CM Version 2010
I10
ICD-9-CM Version 2011
997.91
CTCAE 1105E
E13785
UMLS CUI 2011AA
C2315729
SNOMED CT 2011_0131
431545001
Stable, heterosexual relationship for > 6 months
Description

Stable, heterosexual relationship for > 6 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0556476
SNOMED CT 2011_0131
228471003
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Primary hypoactive sexual desire
Description

Primary hypoactive sexual desire

Data type

boolean

Alias
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0020594
SNOMED CT 2011_0131
270903007
MedDRA 14.1
10020933
ICD-10-CM Version 2010
F52.0
ICD-9-CM Version 2011
302.71
History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 months
Description

History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 months

Data type

boolean

Alias
UMLS CUI 2011AA
C1275835
SNOMED CT 2011_0131
399211009
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
UMLS CUI 2011AA
C2826244
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
Nitrate therapy.
Description

Nitrate therapy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0028125
SNOMED CT 2011_0131
89119000
LOINC Version 232
MTHU003455
UMLS CUI 2011AA
C0039798
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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 18 Years to 64 Years
Item
age 18 Years to 64 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Males 18-64 years of age
Item
male, male gender
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
Mild or mild to moderate ED (defined as >15 and <21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)
Item
Mild or mild to moderate ED (defined as >15 and <21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)
boolean
C2945599 (UMLS CUI 2011AA)
255604002 (SNOMED CT 2011_0131)
C1299392 (UMLS CUI 2011AA)
371923003 (SNOMED CT 2011_0131)
C0242350 (UMLS CUI 2011AA)
397803000 (SNOMED CT 2011_0131)
10061461 (MedDRA 14.1)
N52 (ICD-10-CM Version 2010)
302.72 (ICD-9-CM Version 2011)
E13088 (CTCAE 1105E)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C2959680 (UMLS CUI 2011AA)
445992001 (SNOMED CT 2011_0131)
History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease
Item
History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
C0020538 (UMLS CUI 2011AA)
38341003 (SNOMED CT 2011_0131)
10020772 (MedDRA 14.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE 1105E)
C2315729 (UMLS CUI 2011AA)
431545001 (SNOMED CT 2011_0131)
Stable, heterosexual relationship for > 6 months
Item
Stable, heterosexual relationship for > 6 months
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0556476 (UMLS CUI 2011AA)
228471003 (SNOMED CT 2011_0131)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Primary hypoactive sexual desire
Item
Primary hypoactive sexual desire
boolean
CL414904 (UMLS CUI 2011AA)
C0020594 (UMLS CUI 2011AA)
270903007 (SNOMED CT 2011_0131)
10020933 (MedDRA 14.1)
F52.0 (ICD-10-CM Version 2010)
302.71 (ICD-9-CM Version 2011)
History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 months
Item
History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 months
boolean
C1275835 (UMLS CUI 2011AA)
399211009 (SNOMED CT 2011_0131)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C2826244 (UMLS CUI 2011AA)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
Nitrate therapy.
Item
Nitrate therapy.
boolean
C0028125 (UMLS CUI 2011AA)
89119000 (SNOMED CT 2011_0131)
MTHU003455 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
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