Gender | Age
Item
female patient aged ≥ 18 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender | Breast Carcinoma nonmetastatic
Item
women with histologically proven non metastatic breast cancer
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C1518409 (UMLS CUI [2,2])
ECOG performance status
Item
ecog ps ≤ 1
boolean
C1520224 (UMLS CUI [1])
Hormone Therapy Adjuvant | Aromatase Inhibitors | Tamoxifen | Ovarian suppression | Luteinizing Hormone-releasing Hormone Agonist | Ovariectomy
Item
patient receiving adjuvant hormonal therapy for at least 1 month (aromatase inhibitor or tamoxifen ± ovarian function suppression (luteinizing hormone releasing hormone agonist (lh-rh agonist), ovariectomy...))
boolean
C0279025 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C0593802 (UMLS CUI [2])
C0039286 (UMLS CUI [3])
C0677922 (UMLS CUI [4])
C1518041 (UMLS CUI [5])
C0029936 (UMLS CUI [6])
Hot flushes Moderate intensity | Hot flushes With intensity Severe | Hot flushes Affecting Quality of life
Item
patient complaining of hot flashes with moderate to severe intensity, affecting quality of life, for at least 1 month before inclusion
boolean
C0600142 (UMLS CUI [1,1])
C4081855 (UMLS CUI [1,2])
C0600142 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0600142 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0034380 (UMLS CUI [3,3])
Absence Treatment Other Hot flushes | Biomedicine Treatment Absent | Vitamin E Absent | Dietary Supplements Absent | Phytotherapy Absent | Acupuncture Absent
Item
patient agreement not to start another hot flash treatment during the study (allopathic treatment, e vitamin, dietary supplement, phytotherapy, acupuncture...)
boolean
C0332197 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0600142 (UMLS CUI [1,4])
C1879848 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0042874 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0242295 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0242388 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0394664 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Comprehension French language | Able to read French language | Able to write French language
Item
patient able to understand, read and write french
boolean
C0233733 (UMLS CUI [1,1])
C0376246 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376246 (UMLS CUI [2,2])
C0584993 (UMLS CUI [3,1])
C0376246 (UMLS CUI [3,2])
Affiliation mandatory Health Insurance
Item
mandatory affiliation with a health insurance system
boolean
C1510825 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021682 (UMLS CUI [1,3])
Informed Consent
Item
signed, written informed consent
boolean
C0021430 (UMLS CUI [1])
Chemotherapy | Therapeutic radiology procedure | Chemotherapy Planned | Therapeutic radiology procedure Planned
Item
ongoing chemotherapy or radiotherapy, or treatment planned to begin during the study
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Condition Inducing Hot flushes | Hyperthyroidism | Diabetes Mellitus | Adrenal Gland Neoplasms | Small Intestinal Carcinoid Tumor | Mastocytosis
Item
patient with a condition known to induce hot flashes such as hyperthyroidism, diabetes, adrenal tumor, enteric carcinoid tumor, mastocytosis...
boolean
C0348080 (UMLS CUI [1,1])
C0205263 (UMLS CUI [1,2])
C0600142 (UMLS CUI [1,3])
C0020550 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C0001624 (UMLS CUI [4])
C0349536 (UMLS CUI [5])
C0024899 (UMLS CUI [6])
Kidney Failure Severe | Liver Failure Severe | Cardiovascular Disease
Item
patient with severe renal failure, severe hepatic failure, or cardiovascular disease
boolean
C0035078 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0085605 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3])
Medical contraindication Quantity
Item
patient with one of the following contraindications:
boolean
C1301624 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drug Component
Item
known hypersensitivity to one of the components of the study drug
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Fructose and Galactose Intolerance
Item
galactose, fructose intolerance
boolean
C1856686 (UMLS CUI [1])
Lapps Lactase Deficiency | Isomaltase Deficiency | Invertase Deficiency
Item
lapp lactase deficiency, isomaltase invertase deficiency
boolean
C0337904 (UMLS CUI [1,1])
C0083183 (UMLS CUI [1,2])
C0011155 (UMLS CUI [1,3])
C0028941 (UMLS CUI [2,1])
C0011155 (UMLS CUI [2,2])
C1291487 (UMLS CUI [3])
Impaired glucose tolerance | Galactose malabsorption
Item
glucose or galactose malabsorption syndrome
boolean
C0271650 (UMLS CUI [1])
C1397928 (UMLS CUI [2])
Follow-up Unsuccessful | Etiology Social factor | Etiology Factor Familial | Etiology Geographic Factors | Etiology Psychological Factors
Item
follow up impossible because of social, familial, geographical or psychological reasons
boolean
C3274571 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0337460 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C1521761 (UMLS CUI [3,2])
C0241888 (UMLS CUI [3,3])
C0015127 (UMLS CUI [4,1])
C0017444 (UMLS CUI [4,2])
C0015127 (UMLS CUI [5,1])
C0033898 (UMLS CUI [5,2])
Protocol Compliance Poor Suspected | Treatment Compliance Poor Suspected
Item
patient suspected of poor compliance with protocol or treatment
boolean
C0525058 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0750491 (UMLS CUI [1,3])
C4319828 (UMLS CUI [2,1])
C0542537 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
Study Subject Participation Status | Biomedical Research Indication Same | Investigational New Drugs Indication Same
Item
participation in another biomedical research trial in the same indication, or administration of an experimental drug in the same indication in the 30 days before inclusion
boolean
C2348568 (UMLS CUI [1])
C0005540 (UMLS CUI [2,1])
C3146298 (UMLS CUI [2,2])
C0445247 (UMLS CUI [2,3])
C0013230 (UMLS CUI [3,1])
C3146298 (UMLS CUI [3,2])
C0445247 (UMLS CUI [3,3])