ID

42825

Description

ODM derived from http://clinicaltrials.gov/show/NCT00510406

Link

http://clinicaltrials.gov/show/NCT00510406

Keywords

Versions (2)
  1. 12/10/13 12/10/13 - 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 DRKS00004046 NCT00510406 Lower Urinary Tract Symptoms

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
male patients with LUTS associated with BPH diagnosed > 3 months
Description

male patients with LUTS associated with BPH diagnosed > 3 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0574785
SNOMED CT 2011_0131
307541003
MedDRA 14.1
10071289
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C1704272
SNOMED CT 2011_0131
266569009
MedDRA 14.1
10004446
ICD-10-CM Version 2010
N40
ICD-9-CM Version 2011
600.0
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
International prostate symptom score > 13
Description

IPSS score > 13

Data type

boolean

Alias
UMLS CUI 2011AA
C1998280
SNOMED CT 2011_0131
428433009
voiding and storage symptoms
Description

voiding and storage symptoms

Data type

boolean

Alias
UMLS CUI 2011AA
C0042034
SNOMED CT 2011_0131
28278009
UMLS CUI 2011AA
C0080274
SNOMED CT 2011_0131
267064002
MedDRA 14.1
10046555
LOINC Version 232
MTHU013460
ICD-10-CM Version 2010
R33.9
ICD-9-CM Version 2011
788.20
CTCAE 1105E
E13046
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
Maximal urinary flow rate
Description

maximum flow rate of > 4 mL/s and < 15 mL/s

Data type

boolean

Alias
UMLS CUI 2011AA
C0429784
SNOMED CT 2011_0131
251985005
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
post void residual volume > 200 mL
Description

post void residual volume > 200 mL

Data type

boolean

Alias
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0042034
SNOMED CT 2011_0131
28278009
UMLS CUI 2011AA
C1609982
SNOMED CT 2011_0131
65320000
UMLS CUI 2011AA
C2700258
symptomatic urinary tract infection
Description

symptomatic urinary tract infection

Data type

boolean

Alias
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C0042029
SNOMED CT 2011_0131
68566005
MedDRA 14.1
10046577
ICD-10-CM Version 2010
N39.0
ICD-9-CM Version 2011
599.0
CTCAE 1105E
E11614
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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)
male patients with LUTS associated with BPH diagnosed > 3 months
Item
male patients with LUTS associated with BPH diagnosed > 3 months
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0574785 (UMLS CUI 2011AA)
307541003 (SNOMED CT 2011_0131)
10071289 (MedDRA 14.1)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C1704272 (UMLS CUI 2011AA)
266569009 (SNOMED CT 2011_0131)
10004446 (MedDRA 14.1)
N40 (ICD-10-CM Version 2010)
600.0 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
IPSS score > 13
Item
International prostate symptom score > 13
boolean
C1998280 (UMLS CUI 2011AA)
428433009 (SNOMED CT 2011_0131)
voiding and storage symptoms
Item
voiding and storage symptoms
boolean
C0042034 (UMLS CUI 2011AA)
28278009 (SNOMED CT 2011_0131)
C0080274 (UMLS CUI 2011AA)
267064002 (SNOMED CT 2011_0131)
10046555 (MedDRA 14.1)
MTHU013460 (LOINC Version 232)
R33.9 (ICD-10-CM Version 2010)
788.20 (ICD-9-CM Version 2011)
E13046 (CTCAE 1105E)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
maximum flow rate of > 4 mL/s and < 15 mL/s
Item
Maximal urinary flow rate
boolean
C0429784 (UMLS CUI 2011AA)
251985005 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
post void residual volume > 200 mL
Item
post void residual volume > 200 mL
boolean
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0042034 (UMLS CUI 2011AA)
28278009 (SNOMED CT 2011_0131)
C1609982 (UMLS CUI 2011AA)
65320000 (SNOMED CT 2011_0131)
C2700258 (UMLS CUI 2011AA)
symptomatic urinary tract infection
Item
symptomatic urinary tract infection
boolean
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0042029 (UMLS CUI 2011AA)
68566005 (SNOMED CT 2011_0131)
10046577 (MedDRA 14.1)
N39.0 (ICD-10-CM Version 2010)
599.0 (ICD-9-CM Version 2011)
E11614 (CTCAE 1105E)
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