ID

4274

Description

ODM derived from http://clinicaltrials.gov/show/NCT00740831

Link

http://clinicaltrials.gov/show/NCT00740831

Keywords

Versions (1)
  1. 12/6/13 12/6/13 - Martin Dugas
Uploaded on

December 6, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00740831 Uterine Myomas

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 50 Years
Description

age 18 Years to 50 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Be a pre-menopausal woman between 18 and 50 years inclusive.
Description

Be a pre-menopausal woman between 18 and 50 years inclusive.

Data type

boolean

Alias
UMLS CUI 2011AA
C0279752
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
Have excessive uterine bleeding due to myoma
Description

Have excessive uterine bleeding due to myoma

Data type

boolean

Alias
UMLS CUI 2011AA
C0442802
SNOMED CT 2011_0131
260378005
UMLS CUI 2011AA
C0042134
SNOMED CT 2011_0131
38280009
MedDRA 14.1
10046765
CTCAE 1105E
E13237
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0027086
SNOMED CT 2011_0131
66357004, 92237006
MedDRA 14.1
10061692
ICD-10-CM Version 2010
D21
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Have a myomatous uterus with at least one myoma of >= 3 cm diameter in size
Description

Have a myomatous uterus with at least one myoma of >= 3 cm diameter in size

Data type

boolean

Alias
UMLS CUI 2011AA
C0282606
SNOMED CT 2011_0131
115228006
MedDRA 14.1
10070956
UMLS CUI 2011AA
C0042149
SNOMED CT 2011_0131
35039007
LOINC Version 232
MTHU002943
UMLS CUI 2011AA
C0027086
SNOMED CT 2011_0131
66357004, 92237006
MedDRA 14.1
10061692
ICD-10-CM Version 2010
D21
UMLS CUI 2011AA
C1301886
SNOMED CT 2011_0131
81827009
LOINC Version 232
MTHU002654
UMLS CUI 2011AA
C0456389
SNOMED CT 2011_0131
246115007
LOINC Version 232
MTHU010347
Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
Description

Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.

Data type

boolean

Alias
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C0020699
SNOMED CT 2011_0131
236886002
MedDRA 14.1
10021151
UMLS CUI 2011AA
C0195309
SNOMED CT 2011_0131
42010004
MedDRA 14.1
10028634
If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
Description

If of childbearing potential the subject must be practicing a non-hormonal method of contraception.

Data type

boolean

Alias
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0458083
SNOMED CT 2011_0131
278994005
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Body mass index >= 18 and <= 40
Description

Have a Body Mass Index (BMI) >= 18 and <= 40.

Data type

boolean

Alias
UMLS CUI 2011AA
C1305855
SNOMED CT 2011_0131
140075008
MedDRA 14.1
10005894
LOINC Version 232
LP35925-4
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Has a history of or current uterine, cervical, ovarian or breast cancer.
Description

Has a history of or current uterine, cervical, ovarian or breast cancer.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0153567
SNOMED CT 2011_0131
371973000
MedDRA 14.1
10046766
ICD-10-CM Version 2010
C55
ICD-9-CM Version 2011
179
UMLS CUI 2011AA
C0302592
SNOMED CT 2011_0131
285432005
MedDRA 14.1
10008342
UMLS CUI 2011AA
C0919267
SNOMED CT 2011_0131
123843001
MedDRA 14.1
10061535
UMLS CUI 2011AA
C0678222
SNOMED CT 2011_0131
254838004
MedDRA 14.1
10006204
Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
Description

Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0349579
SNOMED CT 2011_0131
277158007
MedDRA 14.1
10063353
ICD-10-CM Version 2010
N85.02
ICD-9-CM Version 2011
621.33
UMLS CUI 2011AA
C0001418
SNOMED CT 2011_0131
35917007
MedDRA 14.1
10001141
Has a known severe coagulation disorder.
Description

Has a known severe coagulation disorder.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0005779
SNOMED CT 2011_0131
64779008
MedDRA 14.1
10009802
ICD-10-CM Version 2010
D68.9
Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
Description

Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0027086
SNOMED CT 2011_0131
66357004, 92237006
MedDRA 14.1
10061692
ICD-10-CM Version 2010
D21
UMLS CUI 2011AA
C0034833
SNOMED CT 2011_0131
61078009
LOINC Version 232
MTHU002145
UMLS CUI 2011AA
C1268855
SNOMED CT 2011_0131
395962005
Has a history of or known current osteoporosis.
Description

Has a history of or known current osteoporosis.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0029456
SNOMED CT 2011_0131
64859006
MedDRA 14.1
10031282
LOINC Version 232
MTHU020796
ICD-10-CM Version 2010
M81.0
ICD-9-CM Version 2011
733.00
CTCAE 1105E
E12508
Has abnormal hepatic function at study entry.
Description

Has abnormal hepatic function at study entry.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086565
SNOMED CT 2011_0131
75183008
MedDRA 14.1
10019670
UMLS CUI 2011AA
C2348558
Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
Description

Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0240802
SNOMED CT 2011_0131
250423000
MedDRA 14.1
10036575
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
Has a current (within twelve months) problem with alcohol or drug abuse.
Description

Has a current (within twelve months) problem with alcohol or drug abuse.

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0085762
SNOMED CT 2011_0131
15167005
MedDRA 14.1
10001584
LOINC Version 232
LP36309-0
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
UMLS CUI 2011AA
C0013146
SNOMED CT 2011_0131
26416006
MedDRA 14.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
Description

Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C2346570
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
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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 50 Years
Item
age 18 Years to 50 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Be a pre-menopausal woman between 18 and 50 years inclusive.
Item
Be a pre-menopausal woman between 18 and 50 years inclusive.
boolean
C0279752 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
Have excessive uterine bleeding due to myoma
Item
Have excessive uterine bleeding due to myoma
boolean
C0442802 (UMLS CUI 2011AA)
260378005 (SNOMED CT 2011_0131)
C0042134 (UMLS CUI 2011AA)
38280009 (SNOMED CT 2011_0131)
10046765 (MedDRA 14.1)
E13237 (CTCAE 1105E)
CL420107 (UMLS CUI 2011AA)
C0027086 (UMLS CUI 2011AA)
66357004, 92237006 (SNOMED CT 2011_0131)
10061692 (MedDRA 14.1)
D21 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Have a myomatous uterus with at least one myoma of >= 3 cm diameter in size
Item
Have a myomatous uterus with at least one myoma of >= 3 cm diameter in size
boolean
C0282606 (UMLS CUI 2011AA)
115228006 (SNOMED CT 2011_0131)
10070956 (MedDRA 14.1)
C0042149 (UMLS CUI 2011AA)
35039007 (SNOMED CT 2011_0131)
MTHU002943 (LOINC Version 232)
C0027086 (UMLS CUI 2011AA)
66357004, 92237006 (SNOMED CT 2011_0131)
10061692 (MedDRA 14.1)
D21 (ICD-10-CM Version 2010)
C1301886 (UMLS CUI 2011AA)
81827009 (SNOMED CT 2011_0131)
MTHU002654 (LOINC Version 232)
C0456389 (UMLS CUI 2011AA)
246115007 (SNOMED CT 2011_0131)
MTHU010347 (LOINC Version 232)
Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
Item
Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
boolean
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0020699 (UMLS CUI 2011AA)
236886002 (SNOMED CT 2011_0131)
10021151 (MedDRA 14.1)
C0195309 (UMLS CUI 2011AA)
42010004 (SNOMED CT 2011_0131)
10028634 (MedDRA 14.1)
If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
Item
If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
boolean
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0458083 (UMLS CUI 2011AA)
278994005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Have a Body Mass Index (BMI) >= 18 and <= 40.
Item
Body mass index >= 18 and <= 40
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Has a history of or current uterine, cervical, ovarian or breast cancer.
Item
Has a history of or current uterine, cervical, ovarian or breast cancer.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0153567 (UMLS CUI 2011AA)
371973000 (SNOMED CT 2011_0131)
10046766 (MedDRA 14.1)
C55 (ICD-10-CM Version 2010)
179 (ICD-9-CM Version 2011)
C0302592 (UMLS CUI 2011AA)
285432005 (SNOMED CT 2011_0131)
10008342 (MedDRA 14.1)
C0919267 (UMLS CUI 2011AA)
123843001 (SNOMED CT 2011_0131)
10061535 (MedDRA 14.1)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
Item
Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0349579 (UMLS CUI 2011AA)
277158007 (SNOMED CT 2011_0131)
10063353 (MedDRA 14.1)
N85.02 (ICD-10-CM Version 2010)
621.33 (ICD-9-CM Version 2011)
C0001418 (UMLS CUI 2011AA)
35917007 (SNOMED CT 2011_0131)
10001141 (MedDRA 14.1)
Has a known severe coagulation disorder.
Item
Has a known severe coagulation disorder.
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0005779 (UMLS CUI 2011AA)
64779008 (SNOMED CT 2011_0131)
10009802 (MedDRA 14.1)
D68.9 (ICD-10-CM Version 2010)
Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
Item
Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0027086 (UMLS CUI 2011AA)
66357004, 92237006 (SNOMED CT 2011_0131)
10061692 (MedDRA 14.1)
D21 (ICD-10-CM Version 2010)
C0034833 (UMLS CUI 2011AA)
61078009 (SNOMED CT 2011_0131)
MTHU002145 (LOINC Version 232)
C1268855 (UMLS CUI 2011AA)
395962005 (SNOMED CT 2011_0131)
Has a history of or known current osteoporosis.
Item
Has a history of or known current osteoporosis.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0029456 (UMLS CUI 2011AA)
64859006 (SNOMED CT 2011_0131)
10031282 (MedDRA 14.1)
MTHU020796 (LOINC Version 232)
M81.0 (ICD-10-CM Version 2010)
733.00 (ICD-9-CM Version 2011)
E12508 (CTCAE 1105E)
Has abnormal hepatic function at study entry.
Item
Has abnormal hepatic function at study entry.
boolean
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
C2348558 (UMLS CUI 2011AA)
Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
Item
Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
boolean
C0240802 (UMLS CUI 2011AA)
250423000 (SNOMED CT 2011_0131)
10036575 (MedDRA 14.1)
C1442488 (UMLS CUI 2011AA)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
Has a current (within twelve months) problem with alcohol or drug abuse.
Item
Has a current (within twelve months) problem with alcohol or drug abuse.
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
Item
Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
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