Eligibility NCT00740831 Uterine Myomas

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

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age 18 Years to 50 Years
Item
Alter 18 bis 50 Jahre
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
BMI >= 18 und <= 40
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
Item Group
Ausschlusskriterien
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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