ID

38120

Description

Dietary Energy Restriction and Omega-3 Fatty Acids on Mammary Tissue; ODM derived from: https://clinicaltrials.gov/show/NCT01784042

Link

https://clinicaltrials.gov/show/NCT01784042

Keywords

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

See clinicaltrials.gov

Uploaded on

September 19, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01784042

English

Eligibility Breast Cancer NCT01784042

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
five year predicted breast cancer risk of at least 1.66%.
Description

Risk Percentage Prediction Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0681842
UMLS CUI [1,4]
C0678222
prior breast biopsy showing atypical ductal or lobular hyperplasia or lobular carcinoma in situ or ductal carcinoma in situ (dcis).
Description

Atypical ductal hyperplasia Biopsy of breast | Atypical Lobular Breast Hyperplasia Biopsy of breast | Lobular carcinoma in situ of breast Biopsy of breast | DCIS Biopsy of breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0442834
UMLS CUI [1,2]
C0405352
UMLS CUI [2,1]
C1368920
UMLS CUI [2,2]
C0405352
UMLS CUI [3,1]
C0279563
UMLS CUI [3,2]
C0405352
UMLS CUI [4,1]
C0007124
UMLS CUI [4,2]
C0405352
known breast cancer-1 and -2 mutations.
Description

Breast Carcinoma | BRCA1 gene mutation | BRCA2 gene mutation

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C1511022
UMLS CUI [3]
C1511024
breast density >50% as assessed by the conventional two-dimensional method.
Description

Breast Density Percentage | Method 2-Dimensional

Data type

boolean

Alias
UMLS CUI [1,1]
C1659543
UMLS CUI [1,2]
C0439165
UMLS CUI [2,1]
C0025663
UMLS CUI [2,2]
C1705052
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
weight loss of 10 pounds in past six months.
Description

Weight loss Amount Timespan

Data type

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0872291
history of fish allergy.
Description

Allergy to fish

Data type

boolean

Alias
UMLS CUI [1]
C0856904
oral contraceptives or hormone replacement therapy in the past 6 months.
Description

Contraceptives, Oral | Hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1]
C0009905
UMLS CUI [2]
C0282402
pregnancy or lactation in the last 12 months or planning to become pregnant in the next 12 months.
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
current smoking.
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
diagnosis of cancer except basal cell carcinoma of the skin or lobular carcinoma in situ or dcis.
Description

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Lobular carcinoma in situ of breast | Exception DCIS

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0279563
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007124
diagnosis of type 1 or type 2 diabetes based on standard criteria, irrespective of treatment.
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
recent stroke or cardiovascular event.
Description

Cerebrovascular accident | Cardiovascular event

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C1320716
history of eating disorders documented in medical records.
Description

Eating Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0013473
history of major gastrointestinal disease impairing absorption.
Description

Gastrointestinal Disease Major | Impairment Absorption

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0221099
UMLS CUI [2,2]
C0237442
history of bariatric surgery.
Description

Bariatric Surgery

Data type

boolean

Alias
UMLS CUI [1]
C1456587
recent, current or planned use of diet drugs as per patient history.
Description

Diet drugs | Diet drugs Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0012155
UMLS CUI [1,2]
C0013227
UMLS CUI [2,1]
C0012155
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C1301732
participants must not use flaxseed oil supplements during study participation.
Description

Flaxseed Oil Supplements

Data type

boolean

Alias
UMLS CUI [1,1]
C0023754
UMLS CUI [1,2]
C0242295
participants must not use omega-3 preparations while participating on this trial.
Description

Omega-3 Fatty Acids

Data type

boolean

Alias
UMLS CUI [1]
C0015689
participants must not use tamoxifen or raloxifene during study participation.
Description

Tamoxifen | Raloxifene

Data type

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2]
C0244404
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Similar models

Eligibility Breast Cancer NCT01784042

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Risk Percentage Prediction Breast Carcinoma
Item
five year predicted breast cancer risk of at least 1.66%.
boolean
C0035647 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0681842 (UMLS CUI [1,3])
C0678222 (UMLS CUI [1,4])
Atypical ductal hyperplasia Biopsy of breast | Atypical Lobular Breast Hyperplasia Biopsy of breast | Lobular carcinoma in situ of breast Biopsy of breast | DCIS Biopsy of breast
Item
prior breast biopsy showing atypical ductal or lobular hyperplasia or lobular carcinoma in situ or ductal carcinoma in situ (dcis).
boolean
C0442834 (UMLS CUI [1,1])
C0405352 (UMLS CUI [1,2])
C1368920 (UMLS CUI [2,1])
C0405352 (UMLS CUI [2,2])
C0279563 (UMLS CUI [3,1])
C0405352 (UMLS CUI [3,2])
C0007124 (UMLS CUI [4,1])
C0405352 (UMLS CUI [4,2])
Breast Carcinoma | BRCA1 gene mutation | BRCA2 gene mutation
Item
known breast cancer-1 and -2 mutations.
boolean
C0678222 (UMLS CUI [1])
C1511022 (UMLS CUI [2])
C1511024 (UMLS CUI [3])
Breast Density Percentage | Method 2-Dimensional
Item
breast density >50% as assessed by the conventional two-dimensional method.
boolean
C1659543 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0025663 (UMLS CUI [2,1])
C1705052 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Weight loss Amount Timespan
Item
weight loss of 10 pounds in past six months.
boolean
C1262477 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Allergy to fish
Item
history of fish allergy.
boolean
C0856904 (UMLS CUI [1])
Contraceptives, Oral | Hormone replacement therapy
Item
oral contraceptives or hormone replacement therapy in the past 6 months.
boolean
C0009905 (UMLS CUI [1])
C0282402 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnancy or lactation in the last 12 months or planning to become pregnant in the next 12 months.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Tobacco use
Item
current smoking.
boolean
C0543414 (UMLS CUI [1])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Lobular carcinoma in situ of breast | Exception DCIS
Item
diagnosis of cancer except basal cell carcinoma of the skin or lobular carcinoma in situ or dcis.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0279563 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007124 (UMLS CUI [4,2])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosis of type 1 or type 2 diabetes based on standard criteria, irrespective of treatment.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Cerebrovascular accident | Cardiovascular event
Item
recent stroke or cardiovascular event.
boolean
C0038454 (UMLS CUI [1])
C1320716 (UMLS CUI [2])
Eating Disorders
Item
history of eating disorders documented in medical records.
boolean
C0013473 (UMLS CUI [1])
Gastrointestinal Disease Major | Impairment Absorption
Item
history of major gastrointestinal disease impairing absorption.
boolean
C0017178 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0221099 (UMLS CUI [2,1])
C0237442 (UMLS CUI [2,2])
Bariatric Surgery
Item
history of bariatric surgery.
boolean
C1456587 (UMLS CUI [1])
Diet drugs | Diet drugs Planned
Item
recent, current or planned use of diet drugs as per patient history.
boolean
C0012155 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0012155 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Flaxseed Oil Supplements
Item
participants must not use flaxseed oil supplements during study participation.
boolean
C0023754 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
Omega-3 Fatty Acids
Item
participants must not use omega-3 preparations while participating on this trial.
boolean
C0015689 (UMLS CUI [1])
Tamoxifen | Raloxifene
Item
participants must not use tamoxifen or raloxifene during study participation.
boolean
C0039286 (UMLS CUI [1])
C0244404 (UMLS CUI [2])
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