ID

38209

Descrição

Melatonin and Vitamin D in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02288806

Link

https://clinicaltrials.gov/show/NCT02288806

Palavras-chave

  1. 27/09/2019 27/09/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 de setembro de 2019

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT02288806

Eligibility Breast Cancer NCT02288806

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed invasive breast cancer (ductal, lobular, or mixed)
Descrição

Invasive Ductal Breast Carcinoma | Invasive Lobular Breast Carcinoma | Invasive carcinoma of breast Mixed

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1134719
UMLS CUI [2]
C0279565
UMLS CUI [3,1]
C0853879
UMLS CUI [3,2]
C0205430
planned to undergo definitive surgery, either lumpectomy or mastectomy in 3 or more weeks
Descrição

Operative Surgical Procedure Definitive Planned | Segmental Mastectomy | Mastectomy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0443196
UMLS CUI [1,3]
C1301732
UMLS CUI [2]
C0024885
UMLS CUI [3]
C0024881
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
less than 18 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
stage iiib or iv disease
Descrição

Disease TNM Breast tumor staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
inoperable or locally advanced or metastatic breast cancer
Descrição

Breast Carcinoma Inoperable | Locally advanced breast cancer | Secondary malignant neoplasm of female breast

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205187
UMLS CUI [2]
C3495949
UMLS CUI [3]
C0346993
neoadjuvant chemotherapy is intended
Descrição

Neoadjuvant Chemotherapy intended

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [1,3]
C1283828
currently taking vitamin d supplements
Descrição

Vitamin D supplement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3541352
currently taking melatonin supplements
Descrição

Melatonin Supplements

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025219
UMLS CUI [1,2]
C0242295
previously taking vitamin d or melatonin supplements in the last 3 months
Descrição

Vitamin D supplement Previous | Melatonin Supplements Previous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3541352
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0025219
UMLS CUI [2,2]
C0242295
UMLS CUI [2,3]
C0205156
currently taking a multivitamin and not willing to discontinue for the duration of the study (i.e., until definitive surgery)
Descrição

Multivitamin preparation Discontinue Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0301532
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0558080
hyperparathyroid disease or other calcium disturbances in the past five years
Descrição

Hyperparathyroid disorders | Calcium Disturbance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0852179
UMLS CUI [2,1]
C0006675
UMLS CUI [2,2]
C2699787
active renal stones in the last six months
Descrição

Kidney Calculi

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022650
renal failure (creatinine >190 mmol/l in females and >200 mmol/l in males)
Descrição

Kidney Failure | Creatinine measurement, serum | Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
known pregnancy
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
participation in another clinical trial where the patient receives any other investigational agent
Descrição

Study Subject Participation Status | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
unwilling or unable to provide informed consent
Descrição

Informed Consent Unwilling | Informed Consent Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582

Similar models

Eligibility Breast Cancer NCT02288806

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Invasive Ductal Breast Carcinoma | Invasive Lobular Breast Carcinoma | Invasive carcinoma of breast Mixed
Item
histologically confirmed invasive breast cancer (ductal, lobular, or mixed)
boolean
C1134719 (UMLS CUI [1])
C0279565 (UMLS CUI [2])
C0853879 (UMLS CUI [3,1])
C0205430 (UMLS CUI [3,2])
Operative Surgical Procedure Definitive Planned | Segmental Mastectomy | Mastectomy
Item
planned to undergo definitive surgery, either lumpectomy or mastectomy in 3 or more weeks
boolean
C0543467 (UMLS CUI [1,1])
C0443196 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0024885 (UMLS CUI [2])
C0024881 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Age
Item
less than 18 years of age
boolean
C0001779 (UMLS CUI [1])
Disease TNM Breast tumor staging
Item
stage iiib or iv disease
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Breast Carcinoma Inoperable | Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
inoperable or locally advanced or metastatic breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C3495949 (UMLS CUI [2])
C0346993 (UMLS CUI [3])
Neoadjuvant Chemotherapy intended
Item
neoadjuvant chemotherapy is intended
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C1283828 (UMLS CUI [1,3])
Vitamin D supplement
Item
currently taking vitamin d supplements
boolean
C3541352 (UMLS CUI [1])
Melatonin Supplements
Item
currently taking melatonin supplements
boolean
C0025219 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
Vitamin D supplement Previous | Melatonin Supplements Previous
Item
previously taking vitamin d or melatonin supplements in the last 3 months
boolean
C3541352 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0025219 (UMLS CUI [2,1])
C0242295 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
Multivitamin preparation Discontinue Unwilling
Item
currently taking a multivitamin and not willing to discontinue for the duration of the study (i.e., until definitive surgery)
boolean
C0301532 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Hyperparathyroid disorders | Calcium Disturbance
Item
hyperparathyroid disease or other calcium disturbances in the past five years
boolean
C0852179 (UMLS CUI [1])
C0006675 (UMLS CUI [2,1])
C2699787 (UMLS CUI [2,2])
Kidney Calculi
Item
active renal stones in the last six months
boolean
C0022650 (UMLS CUI [1])
Kidney Failure | Creatinine measurement, serum | Gender
Item
renal failure (creatinine >190 mmol/l in females and >200 mmol/l in males)
boolean
C0035078 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Pregnancy
Item
known pregnancy
boolean
C0032961 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
participation in another clinical trial where the patient receives any other investigational agent
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Informed Consent Unwilling | Informed Consent Unable
Item
unwilling or unable to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])

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