Eligibility Breast Cancer NCT01579734

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal women candidates to hrt for control of menopausal symptoms or prevention of postmenopausal disorders. women currently undergoing hrt for any duration; (women off hrt for 1 year or longer are considered de novo users);
Beskrivning

postmenopausal women

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
negative bilateral mammography (within the last 6 months);
Beskrivning

negative bilateral mammography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0203027
UMLS CUI [1,2]
C0205160
written informed consent.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any type of malignancy, with the exclusion of cin and non-melanoma skin cancer;
Beskrivning

malignancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
active proliferative disorders of the endometrium such as atypical hyperplasia, history of active endometriosis, unresected polyps, symptomatic myomata;
Beskrivning

proliferative disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
alterations of metabolic, liver, renal and cardiac grade 2 function (nci criteria grade 2 or higher);
Beskrivning

alterations of function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0277785
UMLS CUI [1,2]
C0311400
UMLS CUI [2]
C0086565
UMLS CUI [3]
C3279454
UMLS CUI [4]
C3277906
any type of retinal disorders, severe cataract and glaucoma;
Beskrivning

retinal disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0035309
presence of significant risk factors for venous events, including immobilization within the last 3 months for longer than 2 weeks following surgery or trauma, history of estrogen-associated and "sine causa" superficial phlebitis, deep venous thrombophlebitis or other significant vte (pulmonary embolism, stroke, etc.);
Beskrivning

risk factors for venous events

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1869080
use of tamoxifen, raloxifene or other serms within the last 4 weeks;
Beskrivning

use of tamoxifen

Datatyp

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2]
C0244404
anticoagulant therapy in progress (heparin or dicoumarol);
Beskrivning

anticoagulant therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0019134
UMLS CUI [2]
C0005640
active infections;
Beskrivning

active infections

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
severe psychiatric disorders or inability to comply to the protocol procedures; any other factor that at the investigator's discretion contraindicates the use of either tamoxifen or hrt.
Beskrivning

inability to comply to the protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0004936

Similar models

Eligibility Breast Cancer NCT01579734

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
postmenopausal women
Item
postmenopausal women candidates to hrt for control of menopausal symptoms or prevention of postmenopausal disorders. women currently undergoing hrt for any duration; (women off hrt for 1 year or longer are considered de novo users);
boolean
C0232970 (UMLS CUI [1])
negative bilateral mammography
Item
negative bilateral mammography (within the last 6 months);
boolean
C0203027 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
informed consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
malignancy
Item
any type of malignancy, with the exclusion of cin and non-melanoma skin cancer;
boolean
C0006826 (UMLS CUI [1])
proliferative disorders
Item
active proliferative disorders of the endometrium such as atypical hyperplasia, history of active endometriosis, unresected polyps, symptomatic myomata;
boolean
C0009488 (UMLS CUI [1])
alterations of function
Item
alterations of metabolic, liver, renal and cardiac grade 2 function (nci criteria grade 2 or higher);
boolean
C0277785 (UMLS CUI [1,1])
C0311400 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2])
C3279454 (UMLS CUI [3])
C3277906 (UMLS CUI [4])
retinal disorders
Item
any type of retinal disorders, severe cataract and glaucoma;
boolean
C0035309 (UMLS CUI [1])
risk factors for venous events
Item
presence of significant risk factors for venous events, including immobilization within the last 3 months for longer than 2 weeks following surgery or trauma, history of estrogen-associated and "sine causa" superficial phlebitis, deep venous thrombophlebitis or other significant vte (pulmonary embolism, stroke, etc.);
boolean
C0035648 (UMLS CUI [1,1])
C1869080 (UMLS CUI [1,2])
use of tamoxifen
Item
use of tamoxifen, raloxifene or other serms within the last 4 weeks;
boolean
C0039286 (UMLS CUI [1])
C0244404 (UMLS CUI [2])
anticoagulant therapy
Item
anticoagulant therapy in progress (heparin or dicoumarol);
boolean
C0019134 (UMLS CUI [1])
C0005640 (UMLS CUI [2])
active infections
Item
active infections;
boolean
C0009450 (UMLS CUI [1])
inability to comply to the protocol
Item
severe psychiatric disorders or inability to comply to the protocol procedures; any other factor that at the investigator's discretion contraindicates the use of either tamoxifen or hrt.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])