Informationen:
Fehler:
ID
15690
Beschreibung
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
Stichworte
Versionen (1)
- 08.06.16 08.06.16 -
Hochgeladen am
8. Juni 2016
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01579734
Eligibility Breast Cancer NCT01579734
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Breast Cancer NCT01579734
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])