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ID
15690
Description
Phase III, Randomized, Double Blind Trial Low Dose Tamoxifen Versus Placebo in Hormone Replacement Therapy (HRT) Users; ODM derived from: https://clinicaltrials.gov/show/NCT01579734
Link
https://clinicaltrials.gov/show/NCT01579734
Keywords
Versions (1)
- 6/8/16 6/8/16 -
Uploaded on
June 8, 2016
DOI
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License
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01579734
Eligibility Breast Cancer NCT01579734
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT01579734
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
C0205160 (UMLS CUI [1,2])
informed consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
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])
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])
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])
C0244404 (UMLS CUI [2])
anticoagulant therapy
Item
anticoagulant therapy in progress (heparin or dicoumarol);
boolean
C0019134 (UMLS CUI [1])
C0005640 (UMLS CUI [2])
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])
C0439801 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])