ID

44655

Description

ODM derived from http://clinicaltrials.gov/show/NCT01157871

Link

http://clinicaltrials.gov/show/NCT01157871

Keywords

Versions (3)
  1. 12/6/13 12/6/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01157871 Peripheral Arterial Occlusive Disease

German English

Eligibility

1 forms  
  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
History of typical intermittent claudication lasting for at least 3 months, showing no improvement and consistent with treadmill test findings
Description

History of typical intermittent claudication lasting for at least 3 months, showing no improvement and consistent with treadmill test findings

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0021775
SNOMED CT 2011_0131
63491006
MedDRA 14.1
10022562
ICD-10-CM Version 2010
I73.9
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0087110
MedDRA 14.1
10044555
UMLS CUI 2011AA
C0243095
Objective evidence of Peripheral Arterial Occlusive Disease. After 10 minutes of rest, either by Ankle brachial index measure (ABI) <0.8 or Systolic ankle pressure (AP) < 50 mmHg or Systolic toe pressure <50 mmHg
Description

Objective evidence of Peripheral Arterial Occlusive Disease. After 10 minutes of rest, either by Ankle brachial index measure (ABI) <0.8 or Systolic ankle pressure (AP) < 50 mmHg or Systolic toe pressure <50 mmHg

Data type

boolean

Alias
UMLS CUI 2011AA
C1306889
SNOMED CT 2011_0131
399957001
MedDRA 14.1
10062585
UMLS CUI 2011AA
C1328319
SNOMED CT 2011_0131
446841001
MedDRA 14.1
10062762
UMLS CUI 2011AA
C0871470
SNOMED CT 2011_0131
271649006
UMLS CUI 2011AA
C0003086
SNOMED CT 2011_0131
344001
UMLS CUI 2011AA
C0871470
SNOMED CT 2011_0131
271649006
UMLS CUI 2011AA
C0040357
SNOMED CT 2011_0131
29707007
LOINC Version 232
MTHU012113
Patent femoral inflow above the level of injections recently (<2 weeks) documented either with Doppler ultrasonography or Magnetic Resonance Angiography or Angiography
Description

Patent femoral inflow above the level of injections recently (<2 weeks) documented either with Doppler ultrasonography or Magnetic Resonance Angiography or Angiography

Data type

boolean

Alias
UMLS CUI 2011AA
C0175566
SNOMED CT 2011_0131
56116003
UMLS CUI 2011AA
C0015811
SNOMED CT 2011_0131
261080001
LOINC Version 232
MTHU011985
UMLS CUI 2011AA
C0678861
UMLS CUI 2011AA
CL384738
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
C1533685
SNOMED CT 2011_0131
59108006
MedDRA 14.1
10052995
UMLS CUI 2011AA
C0162481
UMLS CUI 2011AA
C0243032
SNOMED CT 2011_0131
241663008
MedDRA 14.1
10057784
UMLS CUI 2011AA
CL378222
SNOMED CT 2011_0131
77343006
MedDRA 14.1
10050062
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Evidence of other causes for leg pain other than intermittent claudication.
Description

Evidence of other causes for leg pain other than intermittent claudication.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
UMLS CUI 2011AA
C0023222
SNOMED CT 2011_0131
10601006
MedDRA 14.1
10024130
ICD-10-CM Version 2010
M79.669
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0021775
SNOMED CT 2011_0131
63491006
MedDRA 14.1
10022562
ICD-10-CM Version 2010
I73.9
Illnesses limiting subject exercise capacity (angina pectoris, heart failure, respiratory disease, orthopaedic disease, neurological disorders)
Description

Illnesses limiting subject exercise capacity (angina pectoris, heart failure, respiratory disease, orthopaedic disease, neurological disorders)

Data type

boolean

Alias
UMLS CUI 2011AA
C0221423
SNOMED CT 2011_0131
39104002
MedDRA 14.1
10040658
ICD-10-CM Version 2010
R69
UMLS CUI 2011AA
C0948372
MedDRA 14.1
10052325
UMLS CUI 2011AA
C0002962
SNOMED CT 2011_0131
194828000
MedDRA 14.1
10002383
ICD-10-CM Version 2010
I20
ICD-9-CM Version 2011
413
UMLS CUI 2011AA
C0018801
SNOMED CT 2011_0131
155374007
MedDRA 14.1
10019279
ICD-9-CM Version 2011
428
CTCAE 1105E
E10124
UMLS CUI 2011AA
C0035204
SNOMED CT 2011_0131
50043002
MedDRA 14.1
10038683
ICD-10-CM Version 2010
J98.9
ICD-9-CM Version 2011
519.9
UMLS CUI 2011AA
C0029355
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0027765
SNOMED CT 2011_0131
118940003
MedDRA 14.1
10029202
ICD-10-CM Version 2010
G98.8
ICD-9-CM Version 2011
349.9
Pain at rest
Description

Pain at rest

Data type

boolean

Alias
UMLS CUI 2011AA
C0234253
SNOMED CT 2011_0131
52598005
MedDRA 14.1
10059073
Thromboangiitis Obliterans
Description

Buerger's disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0040021
SNOMED CT 2011_0131
52403007
MedDRA 14.1
10006538
ICD-10-CM Version 2010
I73.1
ICD-9-CM Version 2011
443.1
Positive serology for HIV 1 or 2, positive serology hepatitis B or C.
Description

Positive serology for HIV 1 or 2, positive serology hepatitis B or C.

Data type

boolean

Alias
UMLS CUI 2011AA
C0242089
SNOMED CT 2011_0131
168276008
MedDRA 14.1
10050409
UMLS CUI 2011AA
C0019704
SNOMED CT 2011_0131
89293008
MedDRA 14.1
10020192
LOINC Version 232
MTHU009425
UMLS CUI 2011AA
C0019707
SNOMED CT 2011_0131
36115006
MedDRA 14.1
10020193
UMLS CUI 2011AA
C0019163
SNOMED CT 2011_0131
66071002
MedDRA 14.1
10019731
UMLS CUI 2011AA
C0019196
SNOMED CT 2011_0131
50711007
MedDRA 14.1
10019744
ICD-10-CM Version 2010
B19.20
ICD-9-CM Version 2011
070.7
Subjects with serum creatinine > 2 mg/dl (176 micromol/l) and subjects on dialysis.
Description

Subjects with serum creatinine > 2 mg/dl (176 micromol/l) and subjects on dialysis.

Data type

boolean

Alias
UMLS CUI 2011AA
C0700225
SNOMED CT 2011_0131
166717003
MedDRA 14.1
10021678
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0011946
SNOMED CT 2011_0131
108241001
MedDRA 14.1
10061105
Active proliferative retinopathy defined by the presence of new vessel formation and scarring.
Description

Active proliferative retinopathy defined by the presence of new vessel formation and scarring.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0339467
MedDRA 14.1
10038934
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0302600
UMLS CUI 2011AA
C0008767
SNOMED CT 2011_0131
48677004
MedDRA 14.1
10039589
Subjects who had a stroke or neurologic deficit presumed to be due to stroke within 3 months prior to the first administration of study treatment
Description

Subjects who had a stroke or neurologic deficit presumed to be due to stroke within 3 months prior to the first administration of study treatment

Data type

boolean

Alias
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
C0521654
SNOMED CT 2011_0131
264552009
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
Previous treatment with any angiogenic growth factor
Description

Previous treatment with any angiogenic growth factor

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0312818
SNOMED CT 2011_0131
18509003
Pregnant or breast feeding women or who disagree to practice a medically accepted method of birth control. Men and women who do not agree to use condoms as the only accepted protection barrier, for the entire study period
Description

Pregnant or breast feeding women or who disagree to practice a medically accepted method of birth control. Men and women who do not agree to use condoms as the only accepted protection barrier, for the entire study period

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
CL415046
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0025266
SNOMED CT 2011_0131
339947000
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
CL415046
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
Serious concomitant medical conditions not adequately controlled.
Description

Serious concomitant medical conditions not adequately controlled.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C0205412
SNOMED CT 2011_0131
71978007
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
Current alcohol or drug abuse
Description

Current alcohol or drug abuse

Data type

boolean

Alias
UMLS CUI 2011AA
C0237123
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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 40 Years
Item
age at least 40 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
History of typical intermittent claudication lasting for at least 3 months, showing no improvement and consistent with treadmill test findings
Item
History of typical intermittent claudication lasting for at least 3 months, showing no improvement and consistent with treadmill test findings
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0021775 (UMLS CUI 2011AA)
63491006 (SNOMED CT 2011_0131)
10022562 (MedDRA 14.1)
I73.9 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0087110 (UMLS CUI 2011AA)
10044555 (MedDRA 14.1)
C0243095 (UMLS CUI 2011AA)
Objective evidence of Peripheral Arterial Occlusive Disease. After 10 minutes of rest, either by Ankle brachial index measure (ABI) <0.8 or Systolic ankle pressure (AP) < 50 mmHg or Systolic toe pressure <50 mmHg
Item
Objective evidence of Peripheral Arterial Occlusive Disease. After 10 minutes of rest, either by Ankle brachial index measure (ABI) <0.8 or Systolic ankle pressure (AP) < 50 mmHg or Systolic toe pressure <50 mmHg
boolean
C1306889 (UMLS CUI 2011AA)
399957001 (SNOMED CT 2011_0131)
10062585 (MedDRA 14.1)
C1328319 (UMLS CUI 2011AA)
446841001 (SNOMED CT 2011_0131)
10062762 (MedDRA 14.1)
C0871470 (UMLS CUI 2011AA)
271649006 (SNOMED CT 2011_0131)
C0003086 (UMLS CUI 2011AA)
344001 (SNOMED CT 2011_0131)
C0871470 (UMLS CUI 2011AA)
271649006 (SNOMED CT 2011_0131)
C0040357 (UMLS CUI 2011AA)
29707007 (SNOMED CT 2011_0131)
MTHU012113 (LOINC Version 232)
Patent femoral inflow above the level of injections recently (<2 weeks) documented either with Doppler ultrasonography or Magnetic Resonance Angiography or Angiography
Item
Patent femoral inflow above the level of injections recently (<2 weeks) documented either with Doppler ultrasonography or Magnetic Resonance Angiography or Angiography
boolean
C0175566 (UMLS CUI 2011AA)
56116003 (SNOMED CT 2011_0131)
C0015811 (UMLS CUI 2011AA)
261080001 (SNOMED CT 2011_0131)
MTHU011985 (LOINC Version 232)
C0678861 (UMLS CUI 2011AA)
CL384738 (UMLS CUI 2011AA)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
C1533685 (UMLS CUI 2011AA)
59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
C0162481 (UMLS CUI 2011AA)
C0243032 (UMLS CUI 2011AA)
241663008 (SNOMED CT 2011_0131)
10057784 (MedDRA 14.1)
CL378222 (UMLS CUI 2011AA)
77343006 (SNOMED CT 2011_0131)
10050062 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Evidence of other causes for leg pain other than intermittent claudication.
Item
Evidence of other causes for leg pain other than intermittent claudication.
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C0023222 (UMLS CUI 2011AA)
10601006 (SNOMED CT 2011_0131)
10024130 (MedDRA 14.1)
M79.669 (ICD-10-CM Version 2010)
CL411789 (UMLS CUI 2011AA)
C0021775 (UMLS CUI 2011AA)
63491006 (SNOMED CT 2011_0131)
10022562 (MedDRA 14.1)
I73.9 (ICD-10-CM Version 2010)
Illnesses limiting subject exercise capacity (angina pectoris, heart failure, respiratory disease, orthopaedic disease, neurological disorders)
Item
Illnesses limiting subject exercise capacity (angina pectoris, heart failure, respiratory disease, orthopaedic disease, neurological disorders)
boolean
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
C0948372 (UMLS CUI 2011AA)
10052325 (MedDRA 14.1)
C0002962 (UMLS CUI 2011AA)
194828000 (SNOMED CT 2011_0131)
10002383 (MedDRA 14.1)
I20 (ICD-10-CM Version 2010)
413 (ICD-9-CM Version 2011)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C0035204 (UMLS CUI 2011AA)
50043002 (SNOMED CT 2011_0131)
10038683 (MedDRA 14.1)
J98.9 (ICD-10-CM Version 2010)
519.9 (ICD-9-CM Version 2011)
C0029355 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
Pain at rest
Item
Pain at rest
boolean
C0234253 (UMLS CUI 2011AA)
52598005 (SNOMED CT 2011_0131)
10059073 (MedDRA 14.1)
Buerger's disease
Item
Thromboangiitis Obliterans
boolean
C0040021 (UMLS CUI 2011AA)
52403007 (SNOMED CT 2011_0131)
10006538 (MedDRA 14.1)
I73.1 (ICD-10-CM Version 2010)
443.1 (ICD-9-CM Version 2011)
Positive serology for HIV 1 or 2, positive serology hepatitis B or C.
Item
Positive serology for HIV 1 or 2, positive serology hepatitis B or C.
boolean
C0242089 (UMLS CUI 2011AA)
168276008 (SNOMED CT 2011_0131)
10050409 (MedDRA 14.1)
C0019704 (UMLS CUI 2011AA)
89293008 (SNOMED CT 2011_0131)
10020192 (MedDRA 14.1)
MTHU009425 (LOINC Version 232)
C0019707 (UMLS CUI 2011AA)
36115006 (SNOMED CT 2011_0131)
10020193 (MedDRA 14.1)
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
Subjects with serum creatinine > 2 mg/dl (176 micromol/l) and subjects on dialysis.
Item
Subjects with serum creatinine > 2 mg/dl (176 micromol/l) and subjects on dialysis.
boolean
C0700225 (UMLS CUI 2011AA)
166717003 (SNOMED CT 2011_0131)
10021678 (MedDRA 14.1)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0011946 (UMLS CUI 2011AA)
108241001 (SNOMED CT 2011_0131)
10061105 (MedDRA 14.1)
Active proliferative retinopathy defined by the presence of new vessel formation and scarring.
Item
Active proliferative retinopathy defined by the presence of new vessel formation and scarring.
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0339467 (UMLS CUI 2011AA)
10038934 (MedDRA 14.1)
C1704788 (UMLS CUI 2011AA)
C0302600 (UMLS CUI 2011AA)
C0008767 (UMLS CUI 2011AA)
48677004 (SNOMED CT 2011_0131)
10039589 (MedDRA 14.1)
Subjects who had a stroke or neurologic deficit presumed to be due to stroke within 3 months prior to the first administration of study treatment
Item
Subjects who had a stroke or neurologic deficit presumed to be due to stroke within 3 months prior to the first administration of study treatment
boolean
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0521654 (UMLS CUI 2011AA)
264552009 (SNOMED CT 2011_0131)
CL420107 (UMLS CUI 2011AA)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
Previous treatment with any angiogenic growth factor
Item
Previous treatment with any angiogenic growth factor
boolean
C1514463 (UMLS CUI 2011AA)
C0312818 (UMLS CUI 2011AA)
18509003 (SNOMED CT 2011_0131)
Pregnant or breast feeding women or who disagree to practice a medically accepted method of birth control. Men and women who do not agree to use condoms as the only accepted protection barrier, for the entire study period
Item
Pregnant or breast feeding women or who disagree to practice a medically accepted method of birth control. Men and women who do not agree to use condoms as the only accepted protection barrier, for the entire study period
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
CL415046 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
CL415046 (UMLS CUI 2011AA)
C0677582 (UMLS CUI 2011AA)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
Serious concomitant medical conditions not adequately controlled.
Item
Serious concomitant medical conditions not adequately controlled.
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
CL415222 (UMLS CUI 2011AA)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0205412 (UMLS CUI 2011AA)
71978007 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
Current alcohol or drug abuse
Item
Current alcohol or drug abuse
boolean
C0237123 (UMLS CUI 2011AA)
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