ID

38120

Descrição

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

Palavras-chave

  1. 19/09/2019 19/09/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

19 de setembro de 2019

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT01784042

Eligibility Breast Cancer NCT01784042

Inclusion Criteria
Descrição

Inclusion Criteria

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

Risk Percentage Prediction Breast Carcinoma

Tipo de dados

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).
Descrição

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

Tipo de dados

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.
Descrição

Breast Carcinoma | BRCA1 gene mutation | BRCA2 gene mutation

Tipo de dados

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.
Descrição

Breast Density Percentage | Method 2-Dimensional

Tipo de dados

boolean

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

Exclusion Criteria

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

Weight loss Amount Timespan

Tipo de dados

boolean

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

Allergy to fish

Tipo de dados

boolean

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

Contraceptives, Oral | Hormone replacement therapy

Tipo de dados

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.
Descrição

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de dados

boolean

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

Tobacco use

Tipo de dados

boolean

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

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

Tipo de dados

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.
Descrição

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

Tipo de dados

boolean

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

Cerebrovascular accident | Cardiovascular event

Tipo de dados

boolean

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

Eating Disorders

Tipo de dados

boolean

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

Gastrointestinal Disease Major | Impairment Absorption

Tipo de dados

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.
Descrição

Bariatric Surgery

Tipo de dados

boolean

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

Diet drugs | Diet drugs Planned

Tipo de dados

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.
Descrição

Flaxseed Oil Supplements

Tipo de dados

boolean

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

Omega-3 Fatty Acids

Tipo de dados

boolean

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

Tamoxifen | Raloxifene

Tipo de dados

boolean

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

Similar models

Eligibility Breast Cancer NCT01784042

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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