ID

38120

Description

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

Lien

https://clinicaltrials.gov/show/NCT01784042

Mots-clés

Versions (1)
  1. 19/09/2019 19/09/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

19 septembre 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01784042

Anglais

Eligibility Breast Cancer NCT01784042

1 Formulaires  
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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

Contraceptives, Oral | Hormone replacement therapy

Type de données

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

Type de données

boolean

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

Tobacco use

Type de données

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

Type de données

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

Type de données

boolean

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

Cerebrovascular accident | Cardiovascular event

Type de données

boolean

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

Eating Disorders

Type de données

boolean

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

Gastrointestinal Disease Major | Impairment Absorption

Type de données

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

Type de données

boolean

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

Diet drugs | Diet drugs Planned

Type de données

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

Type de données

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

Type de données

boolean

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

Tamoxifen | Raloxifene

Type de données

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2]
C0244404
Retour au début de la page

Similar models

Eligibility Breast Cancer NCT01784042

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

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