ID

38209

Description

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

Link

https://clinicaltrials.gov/show/NCT02288806

Keywords

Versions (1)
  1. 9/27/19 9/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02288806

English

Eligibility Breast Cancer NCT02288806

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

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

Data type

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
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 or locally advanced or metastatic breast cancer
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205187
UMLS CUI [2]
C3495949
UMLS CUI [3]
C0346993
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 in 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 (i.e., until definitive surgery)
Description

Multivitamin preparation Discontinue Unwilling

Data type

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
Description

Hyperparathyroid disorders | Calcium Disturbance

Data type

boolean

Alias
UMLS CUI [1]
C0852179
UMLS CUI [2,1]
C0006675
UMLS CUI [2,2]
C2699787
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 in females and >200 mmol/l in males)
Description

Kidney Failure | Creatinine measurement, serum | Gender

Data type

boolean

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

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
participation in another clinical trial where the patient receives any other investigational agent
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 Breast Cancer NCT02288806

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