ID

39120

Descrição

Anti-proliferative Effects of Vitamin D and Melatonin in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01965522

Link

https://clinicaltrials.gov/show/NCT01965522

Palavras-chave

  1. 02/12/2019 02/12/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

2 de dezembro de 2019

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Early Stage Breast Cancer NCT01965522

Eligibility Early Stage Breast Cancer NCT01965522

Inclusion Criteria
Descrição

Inclusion Criteria

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

Gender | Invasive carcinoma of breast | Ductal Breast Carcinoma | Breast cancer, lobular | Invasive Mixed Breast Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0853879
UMLS CUI [3]
C1527349
UMLS CUI [4]
C3549742
UMLS CUI [5]
C1517577
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 locally advanced or metastatic breast cancer
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C0205187
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C0205187
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 within 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
Descrição

Multivitamin preparation | Multivitamin preparation Discontinue Unwilling

Tipo de dados

boolean

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

Hyperparathyroid disorders | Disorder calcium

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0852179
UMLS CUI [2]
C0302590
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)
Descrição

Kidney Failure | Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0201976
hypercalcemia (serum calcium > 2.6 mmol/l)
Descrição

Hypercalcemia | Serum calcium measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020437
UMLS CUI [2]
C0728876
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 product
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 Early Stage Breast Cancer NCT01965522

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Invasive carcinoma of breast | Ductal Breast Carcinoma | Breast cancer, lobular | Invasive Mixed Breast Carcinoma
Item
woman with histologically confirmed invasive breast cancer (ductal, lobular, or mixed)
boolean
C0079399 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
C1527349 (UMLS CUI [3])
C3549742 (UMLS CUI [4])
C1517577 (UMLS CUI [5])
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])
Locally advanced breast cancer Inoperable | Secondary malignant neoplasm of female breast Inoperable
Item
inoperable locally advanced or metastatic breast cancer
boolean
C3495949 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2,1])
C0205187 (UMLS CUI [2,2])
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 within 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 | Multivitamin preparation Discontinue Unwilling
Item
currently taking a multivitamin and not willing to discontinue for the duration of the study
boolean
C0301532 (UMLS CUI [1])
C0301532 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Hyperparathyroid disorders | Disorder calcium
Item
hyperparathyroid disease or other calcium disturbance in the past five years
boolean
C0852179 (UMLS CUI [1])
C0302590 (UMLS CUI [2])
Kidney Calculi
Item
active renal stones in the last six months
boolean
C0022650 (UMLS CUI [1])
Kidney Failure | Creatinine measurement, serum
Item
renal failure (creatinine > 190 mmol/l)
boolean
C0035078 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Hypercalcemia | Serum calcium measurement
Item
hypercalcemia (serum calcium > 2.6 mmol/l)
boolean
C0020437 (UMLS CUI [1])
C0728876 (UMLS CUI [2])
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 product
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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