ID

39120

Description

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

Keywords

Versions (1)
  1. 12/2/19 12/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 2, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Early Stage Breast Cancer NCT01965522

English

Eligibility Early Stage Breast Cancer NCT01965522

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

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

Data type

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
Description

Operative Surgical Procedure Definitive Planned | Segmental Mastectomy | Mastectomy

Data type

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
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
less than 18 years of age
Description

Age

Data type

boolean

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

Disease TNM Breast tumor staging

Data type

boolean

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

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

Data type

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
Description

Neoadjuvant Chemotherapy intended

Data type

boolean

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

Vitamin D supplement

Data type

boolean

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

Melatonin Supplements

Data type

boolean

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

Vitamin D supplement Previous | Melatonin Supplements Previous

Data type

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
Description

Multivitamin preparation | Multivitamin preparation Discontinue Unwilling

Data type

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
Description

Hyperparathyroid disorders | Disorder calcium

Data type

boolean

Alias
UMLS CUI [1]
C0852179
UMLS CUI [2]
C0302590
active renal stones in the last six months
Description

Kidney Calculi

Data type

boolean

Alias
UMLS CUI [1]
C0022650
renal failure (creatinine > 190 mmol/l)
Description

Kidney Failure | Creatinine measurement, serum

Data type

boolean

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

Hypercalcemia | Serum calcium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0020437
UMLS CUI [2]
C0728876
known pregnancy
Description

Pregnancy

Data type

boolean

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

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

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

Informed Consent Unwilling | Informed Consent Unable

Data type

boolean

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

Eligibility Early Stage Breast Cancer NCT01965522

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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