ID

37924

Beskrivning

Evaluation of Homeopathic Treatment for Hot Flashes in Non Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01246427

Länk

https://clinicaltrials.gov/show/NCT01246427

Nyckelord

Versioner (1)
  1. 2019-08-30 2019-08-30 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

30 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01246427

Engelsk

Eligibility Breast Cancer NCT01246427

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patient aged ≥ 18 years
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
women with histologically proven non metastatic breast cancer
Beskrivning

Gender | Breast Carcinoma nonmetastatic

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C1518409
ecog ps ≤ 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
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...))
Beskrivning

Hormone Therapy Adjuvant | Aromatase Inhibitors | Tamoxifen | Ovarian suppression | Luteinizing Hormone-releasing Hormone Agonist | Ovariectomy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1522673
UMLS CUI [2]
C0593802
UMLS CUI [3]
C0039286
UMLS CUI [4]
C0677922
UMLS CUI [5]
C1518041
UMLS CUI [6]
C0029936
patient complaining of hot flashes with moderate to severe intensity, affecting quality of life, for at least 1 month before inclusion
Beskrivning

Hot flushes Moderate intensity | Hot flushes With intensity Severe | Hot flushes Affecting Quality of life

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600142
UMLS CUI [1,2]
C4081855
UMLS CUI [2,1]
C0600142
UMLS CUI [2,2]
C0522510
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C0600142
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0034380
patient agreement not to start another hot flash treatment during the study (allopathic treatment, e vitamin, dietary supplement, phytotherapy, acupuncture...)
Beskrivning

Absence Treatment Other Hot flushes | Biomedicine Treatment Absent | Vitamin E Absent | Dietary Supplements Absent | Phytotherapy Absent | Acupuncture Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0600142
UMLS CUI [2,1]
C1879848
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0042874
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0242295
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0242388
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0394664
UMLS CUI [6,2]
C0332197
patient able to understand, read and write french
Beskrivning

Comprehension French language | Able to read French language | Able to write French language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0376246
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376246
UMLS CUI [3,1]
C0584993
UMLS CUI [3,2]
C0376246
mandatory affiliation with a health insurance system
Beskrivning

Affiliation mandatory Health Insurance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1510825
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021682
signed, written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
ongoing chemotherapy or radiotherapy, or treatment planned to begin during the study
Beskrivning

Chemotherapy | Therapeutic radiology procedure | Chemotherapy Planned | Therapeutic radiology procedure Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C1301732
patient with a condition known to induce hot flashes such as hyperthyroidism, diabetes, adrenal tumor, enteric carcinoid tumor, mastocytosis...
Beskrivning

Condition Inducing Hot flushes | Hyperthyroidism | Diabetes Mellitus | Adrenal Gland Neoplasms | Small Intestinal Carcinoid Tumor | Mastocytosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205263
UMLS CUI [1,3]
C0600142
UMLS CUI [2]
C0020550
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0001624
UMLS CUI [5]
C0349536
UMLS CUI [6]
C0024899
patient with severe renal failure, severe hepatic failure, or cardiovascular disease
Beskrivning

Kidney Failure Severe | Liver Failure Severe | Cardiovascular Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0085605
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0007222
patient with one of the following contraindications:
Beskrivning

Medical contraindication Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1265611
known hypersensitivity to one of the components of the study drug
Beskrivning

Hypersensitivity Investigational New Drug Component

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1705248
galactose, fructose intolerance
Beskrivning

Fructose and Galactose Intolerance

Datatyp

boolean

Alias
UMLS CUI [1]
C1856686
lapp lactase deficiency, isomaltase invertase deficiency
Beskrivning

Lapps Lactase Deficiency | Isomaltase Deficiency | Invertase Deficiency

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0337904
UMLS CUI [1,2]
C0083183
UMLS CUI [1,3]
C0011155
UMLS CUI [2,1]
C0028941
UMLS CUI [2,2]
C0011155
UMLS CUI [3]
C1291487
glucose or galactose malabsorption syndrome
Beskrivning

Impaired glucose tolerance | Galactose malabsorption

Datatyp

boolean

Alias
UMLS CUI [1]
C0271650
UMLS CUI [2]
C1397928
follow up impossible because of social, familial, geographical or psychological reasons
Beskrivning

Follow-up Unsuccessful | Etiology Social factor | Etiology Factor Familial | Etiology Geographic Factors | Etiology Psychological Factors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1272705
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0337460
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C1521761
UMLS CUI [3,3]
C0241888
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0017444
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C0033898
patient suspected of poor compliance with protocol or treatment
Beskrivning

Protocol Compliance Poor Suspected | Treatment Compliance Poor Suspected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0542537
UMLS CUI [1,3]
C0750491
UMLS CUI [2,1]
C4319828
UMLS CUI [2,2]
C0542537
UMLS CUI [2,3]
C0750491
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
Beskrivning

Study Subject Participation Status | Biomedical Research Indication Same | Investigational New Drugs Indication Same

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0005540
UMLS CUI [2,2]
C3146298
UMLS CUI [2,3]
C0445247
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C3146298
UMLS CUI [3,3]
C0445247
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Similar models

Eligibility Breast Cancer NCT01246427

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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