ID

43371

Description

ODM derived from http://clinicaltrials.gov/show/NCT00525512

Link

http://clinicaltrials.gov/show/NCT00525512

Keywords

  1. 12/10/13 12/10/13 - Martin Dugas
  2. 4/14/14 4/14/14 - Julian Varghese
  3. 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 NCT00525512 Pulmonary Disease, Chronic Obstructive

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 40 Years
Description

age at least 40 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
All patients must sign an informed consent
Description

All patients must sign an informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Diagnosis of COPD with specific spirometric criteria (determined at study visits)
Description

Diagnosis of COPD with specific spirometric criteria (determined at study visits)

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0024117
SNOMED CT 2011_0131
13645005
MedDRA 14.1
10009033
ICD-10-CM Version 2010
J44.9
ICD-9-CM Version 2011
496
UMLS CUI 2011AA
C1552740
UMLS CUI 2011AA
C0037981
SNOMED CT 2011_0131
127783003
MedDRA 14.1
10041629
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
Age >= 40 years
Description

Age >= 40 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Medical Research Council Dyspnea Scale >= 2
Description

Medical Research Council Dyspnoea score >= 2

Data type

boolean

Alias
UMLS CUI 2011AA
C1513061
Current or ex-smoker with a >= 10 pack-year smoking history
Description

Current or ex-smoker with a >= 10 pack-year smoking history

Data type

boolean

Alias
UMLS CUI 2011AA
C0337664
SNOMED CT 2011_0131
77176002
MedDRA 14.1
10048880
UMLS CUI 2011AA
C0337671
SNOMED CT 2011_0131
8517006
MedDRA 14.1
10015572
UMLS CUI 2011AA
C1277691
SNOMED CT 2011_0131
315609007
UMLS CUI 2011AA
C1519384
Ability to exercise on treadmill
Description

Ability to exercise on treadmill

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0015259
SNOMED CT 2011_0131
256235009
MedDRA 14.1
10015634
UMLS CUI 2011AA
C0184069
SNOMED CT 2011_0131
1211003
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
Description

Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment

Data type

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0024117
SNOMED CT 2011_0131
13645005
MedDRA 14.1
10009033
ICD-10-CM Version 2010
J44.9
ICD-9-CM Version 2011
496
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1610642
SNOMED CT 2011_0131
440181000
UMLS CUI 2011AA
C0600260
MedDRA 14.1
10025081
UMLS CUI 2011AA
C0039991
SNOMED CT 2011_0131
177765008
MedDRA 14.1
10043491
ICD-9-CM Version 2011
34.01
UMLS CUI 2011AA
C0396565
SNOMED CT 2011_0131
119746007
UMLS CUI 2011AA
C1869044
MedDRA 14.1
20000042
UMLS CUI 2011AA
C0010674
SNOMED CT 2011_0131
190905008
MedDRA 14.1
10011762
LOINC Version 232
MTHU021607
ICD-10-CM Version 2010
E84
ICD-9-CM Version 2011
277.0
UMLS CUI 2011AA
C2709248
SNOMED CT 2011_0131
264164005
LOINC Version 232
MTHU031874
UMLS CUI 2011AA
C0040038
SNOMED CT 2011_0131
371039008
MedDRA 14.1
10043566
ICD-9-CM Version 2011
453.9
CTCAE 1105E
E13825
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0006267
SNOMED CT 2011_0131
12295008
MedDRA 14.1
10006445
ICD-10-CM Version 2010
J47.9
ICD-9-CM Version 2011
494
UMLS CUI 2011AA
C0151332
SNOMED CT 2011_0131
427099000
MedDRA 14.1
10071157
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C1881878
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C1565489
SNOMED CT 2011_0131
236423003
MedDRA 14.1
10062237
Clinical history of asthma
Description

Clinical history of asthma

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0004096
SNOMED CT 2011_0131
195967001
MedDRA 14.1
10003553
LOINC Version 232
MTHU020815
ICD-10-CM Version 2010
J45
ICD-9-CM Version 2011
493
Use of supplemental oxygen therapy
Description

Use of supplemental oxygen therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C2348609
UMLS CUI 2011AA
CL426373
Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
Description

Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)

Data type

boolean

Alias
UMLS CUI 2011AA
C0035243
SNOMED CT 2011_0131
275498002
MedDRA 14.1
10062352
LOINC Version 232
MTHU026191
UMLS CUI 2011AA
C0740304
MedDRA 14.1
10010953
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
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C1710661
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1512346
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C2004454
Recent history (<= 12 months) of myocardial infarction
Description

Recent history (<= 12 months) of myocardial infarction

Data type

boolean

Alias
UMLS CUI 2011AA
C0332185
SNOMED CT 2011_0131
6493001
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
Unstable or life-threatening cardiac arrhythmia
Description

Unstable or life-threatening cardiac arrhythmia

Data type

boolean

Alias
UMLS CUI 2011AA
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C1610642
SNOMED CT 2011_0131
440181000
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
Malignancy treated with radiation therapy or chemotherapy in the last 5 years
Description

Malignancy treated with radiation therapy or chemotherapy in the last 5 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0332293
SNOMED CT 2011_0131
28995006
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
Pregnant or nursing women
Description

Pregnant or nursing women

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Known hypersensitivity to anticholinergic drugs or any component of the study medications
Description

Known hypersensitivity to anticholinergic drugs or any component of the study medications

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0570982
SNOMED CT 2011_0131
294065003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013182
LOINC Version 232
MTHU002637
Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
Description

Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C2709248
SNOMED CT 2011_0131
264164005
LOINC Version 232
MTHU031874
UMLS CUI 2011AA
C1522601
UMLS CUI 2011AA
C0034991
SNOMED CT 2011_0131
52052004
MedDRA 14.1
10057374
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
Estimated life expectancy < 2 years
Description

Estimated life expectancy < 2 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
SNOMED CT 2011_0131
414135002
Symptomatic prostatic hyperplasia or bladder neck obstruction
Description

Symptomatic prostatic hyperplasia or bladder neck obstruction

Data type

boolean

Alias
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C2937421
SNOMED CT 2011_0131
433234005
MedDRA 14.1
10020728
ICD-10-CM Version 2010
N40
ICD-9-CM Version 2011
600
UMLS CUI 2011AA
C0005694
SNOMED CT 2011_0131
399072004
MedDRA 14.1
10005060
ICD-10-CM Version 2010
N32.0
ICD-9-CM Version 2011
596.0
Known narrow-angle glaucoma
Description

Known narrow-angle glaucoma

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0017605
SNOMED CT 2011_0131
392291006
MedDRA 14.1
10002500
Any condition that is contraindicated for exercise
Description

Any condition that is contraindicated for exercise

Data type

boolean

Alias
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C1444657
SNOMED CT 2011_0131
410536001
UMLS CUI 2011AA
C0015259
SNOMED CT 2011_0131
256235009
MedDRA 14.1
10015634
Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing
Description

Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing

Data type

boolean

Alias
UMLS CUI 2011AA
C0026857
SNOMED CT 2011_0131
928000
MedDRA 14.1
10048592
UMLS CUI 2011AA
C0026848
SNOMED CT 2011_0131
129565002
MedDRA 14.1
10028641
ICD-10-CM Version 2010
G72.9
ICD-9-CM Version 2011
359.9
UMLS CUI 2011AA
C0442874
SNOMED CT 2011_0131
386033004
MedDRA 14.1
10029328
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0205272
SNOMED CT 2011_0131
17854005
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0001701
SNOMED CT 2011_0131
229072005
UMLS CUI 2011AA
C0015259
SNOMED CT 2011_0131
256235009
MedDRA 14.1
10015634
UMLS CUI 2011AA
C0039593
Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space
Description

Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space

Data type

boolean

Alias
UMLS CUI 2011AA
C1305855
SNOMED CT 2011_0131
140075008
MedDRA 14.1
10005894
LOINC Version 232
LP35925-4
UMLS CUI 2011AA
C0745732
UMLS CUI 2011AA
CL381565

Similar models

Eligibility

  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 40 Years
Item
age at least 40 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
All patients must sign an informed consent
Item
All patients must sign an informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Diagnosis of COPD with specific spirometric criteria (determined at study visits)
Item
Diagnosis of COPD with specific spirometric criteria (determined at study visits)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0024117 (UMLS CUI 2011AA)
13645005 (SNOMED CT 2011_0131)
10009033 (MedDRA 14.1)
J44.9 (ICD-10-CM Version 2010)
496 (ICD-9-CM Version 2011)
C1552740 (UMLS CUI 2011AA)
C0037981 (UMLS CUI 2011AA)
127783003 (SNOMED CT 2011_0131)
10041629 (MedDRA 14.1)
CL414621 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Age >= 40 years
Item
Age >= 40 years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Medical Research Council Dyspnoea score >= 2
Item
Medical Research Council Dyspnea Scale >= 2
boolean
C1513061 (UMLS CUI 2011AA)
Current or ex-smoker with a >= 10 pack-year smoking history
Item
Current or ex-smoker with a >= 10 pack-year smoking history
boolean
C0337664 (UMLS CUI 2011AA)
77176002 (SNOMED CT 2011_0131)
10048880 (MedDRA 14.1)
C0337671 (UMLS CUI 2011AA)
8517006 (SNOMED CT 2011_0131)
10015572 (MedDRA 14.1)
C1277691 (UMLS CUI 2011AA)
315609007 (SNOMED CT 2011_0131)
C1519384 (UMLS CUI 2011AA)
Ability to exercise on treadmill
Item
Ability to exercise on treadmill
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C0184069 (UMLS CUI 2011AA)
1211003 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
Item
Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0024117 (UMLS CUI 2011AA)
13645005 (SNOMED CT 2011_0131)
10009033 (MedDRA 14.1)
J44.9 (ICD-10-CM Version 2010)
496 (ICD-9-CM Version 2011)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1610642 (UMLS CUI 2011AA)
440181000 (SNOMED CT 2011_0131)
C0600260 (UMLS CUI 2011AA)
10025081 (MedDRA 14.1)
C0039991 (UMLS CUI 2011AA)
177765008 (SNOMED CT 2011_0131)
10043491 (MedDRA 14.1)
34.01 (ICD-9-CM Version 2011)
C0396565 (UMLS CUI 2011AA)
119746007 (SNOMED CT 2011_0131)
C1869044 (UMLS CUI 2011AA)
20000042 (MedDRA 14.1)
C0010674 (UMLS CUI 2011AA)
190905008 (SNOMED CT 2011_0131)
10011762 (MedDRA 14.1)
MTHU021607 (LOINC Version 232)
E84 (ICD-10-CM Version 2010)
277.0 (ICD-9-CM Version 2011)
C2709248 (UMLS CUI 2011AA)
264164005 (SNOMED CT 2011_0131)
MTHU031874 (LOINC Version 232)
C0040038 (UMLS CUI 2011AA)
371039008 (SNOMED CT 2011_0131)
10043566 (MedDRA 14.1)
453.9 (ICD-9-CM Version 2011)
E13825 (CTCAE 1105E)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0006267 (UMLS CUI 2011AA)
12295008 (SNOMED CT 2011_0131)
10006445 (MedDRA 14.1)
J47.9 (ICD-10-CM Version 2010)
494 (ICD-9-CM Version 2011)
C0151332 (UMLS CUI 2011AA)
427099000 (SNOMED CT 2011_0131)
10071157 (MedDRA 14.1)
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C1881878 (UMLS CUI 2011AA)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1565489 (UMLS CUI 2011AA)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
Clinical history of asthma
Item
Clinical history of asthma
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0004096 (UMLS CUI 2011AA)
195967001 (SNOMED CT 2011_0131)
10003553 (MedDRA 14.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
Use of supplemental oxygen therapy
Item
Use of supplemental oxygen therapy
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C2348609 (UMLS CUI 2011AA)
CL426373 (UMLS CUI 2011AA)
Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
Item
Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
boolean
C0035243 (UMLS CUI 2011AA)
275498002 (SNOMED CT 2011_0131)
10062352 (MedDRA 14.1)
MTHU026191 (LOINC Version 232)
C0740304 (UMLS CUI 2011AA)
10010953 (MedDRA 14.1)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C1710661 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1512346 (UMLS CUI 2011AA)
C0034656 (UMLS CUI 2011AA)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C2004454 (UMLS CUI 2011AA)
Recent history (<= 12 months) of myocardial infarction
Item
Recent history (<= 12 months) of myocardial infarction
boolean
C0332185 (UMLS CUI 2011AA)
6493001 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Unstable or life-threatening cardiac arrhythmia
Item
Unstable or life-threatening cardiac arrhythmia
boolean
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C1610642 (UMLS CUI 2011AA)
440181000 (SNOMED CT 2011_0131)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
Malignancy treated with radiation therapy or chemotherapy in the last 5 years
Item
Malignancy treated with radiation therapy or chemotherapy in the last 5 years
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0332293 (UMLS CUI 2011AA)
28995006 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Pregnant or nursing women
Item
Pregnant or nursing women
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Known hypersensitivity to anticholinergic drugs or any component of the study medications
Item
Known hypersensitivity to anticholinergic drugs or any component of the study medications
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0570982 (UMLS CUI 2011AA)
294065003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013182 (UMLS CUI 2011AA)
MTHU002637 (LOINC Version 232)
Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
Item
Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C2709248 (UMLS CUI 2011AA)
264164005 (SNOMED CT 2011_0131)
MTHU031874 (LOINC Version 232)
C1522601 (UMLS CUI 2011AA)
C0034991 (UMLS CUI 2011AA)
52052004 (SNOMED CT 2011_0131)
10057374 (MedDRA 14.1)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Estimated life expectancy < 2 years
Item
Estimated life expectancy < 2 years
boolean
C0023671 (UMLS CUI 2011AA)
414135002 (SNOMED CT 2011_0131)
Symptomatic prostatic hyperplasia or bladder neck obstruction
Item
Symptomatic prostatic hyperplasia or bladder neck obstruction
boolean
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C2937421 (UMLS CUI 2011AA)
433234005 (SNOMED CT 2011_0131)
10020728 (MedDRA 14.1)
N40 (ICD-10-CM Version 2010)
600 (ICD-9-CM Version 2011)
C0005694 (UMLS CUI 2011AA)
399072004 (SNOMED CT 2011_0131)
10005060 (MedDRA 14.1)
N32.0 (ICD-10-CM Version 2010)
596.0 (ICD-9-CM Version 2011)
Known narrow-angle glaucoma
Item
Known narrow-angle glaucoma
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0017605 (UMLS CUI 2011AA)
392291006 (SNOMED CT 2011_0131)
10002500 (MedDRA 14.1)
Any condition that is contraindicated for exercise
Item
Any condition that is contraindicated for exercise
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1444657 (UMLS CUI 2011AA)
410536001 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing
Item
Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing
boolean
C0026857 (UMLS CUI 2011AA)
928000 (SNOMED CT 2011_0131)
10048592 (MedDRA 14.1)
C0026848 (UMLS CUI 2011AA)
129565002 (SNOMED CT 2011_0131)
10028641 (MedDRA 14.1)
G72.9 (ICD-10-CM Version 2010)
359.9 (ICD-9-CM Version 2011)
C0442874 (UMLS CUI 2011AA)
386033004 (SNOMED CT 2011_0131)
10029328 (MedDRA 14.1)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0205272 (UMLS CUI 2011AA)
17854005 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0001701 (UMLS CUI 2011AA)
229072005 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C0039593 (UMLS CUI 2011AA)
Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space
Item
Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
C0745732 (UMLS CUI 2011AA)
CL381565 (UMLS CUI 2011AA)

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