ID

27187

Description

Limonene Study in Women With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01046929

Link

https://clinicaltrials.gov/show/NCT01046929

Keywords

Versions (1)
  1. 11/3/17 11/3/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 3, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01046929

English

Eligibility Breast Cancer NCT01046929

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women who are 18 years of age or older
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
women electing to undergo excision surgery for early stage breast cancer
Description

Gender | Excision elective Early-Stage Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0728940
UMLS CUI [2,2]
C0439608
UMLS CUI [2,3]
C2986665
a minimum of 2 weeks from enrollment to definitive surgery
Description

Enrollment Operative Surgical Procedures Definitive

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0443196
underwent core needle biopsy for breast cancer diagnosis
Description

Core needle biopsy Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1318309
UMLS CUI [1,2]
C0678222
no clinical evidence of metastatic breast cancer
Description

Secondary malignant neoplasm of female breast Evidence Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0332268
ecog performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
participants must have normal organ and marrow function
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
women of child-bearing potential must agree to use adequate contraception
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
ability to understand and the willingness to sign a written informed consent document
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent chemotherapy or radiation therapy
Description

Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
use of selective estrogen receptor modifiers or aromatase inhibitors within the past 3 months or concurrently
Description

Selective Estrogen Receptor Modulators | Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0732611
UMLS CUI [2]
C0593802
history of other malignancies within the past 5 years excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment
Description

Cancer Other | Exception Skin carcinoma | Exception Organ removal Therapeutic procedure only

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1408858
UMLS CUI [3,3]
C0087111
UMLS CUI [3,4]
C0205171
participated in another clinical intervention trial within the past 3 months
Description

Study Subject Participation Status | Intervention

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0184661
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Description

Comorbidity Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0525058
UMLS CUI [6,3]
C0439801
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0525058
UMLS CUI [7,3]
C0439801
pregnant or breast-feeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
use of dietary supplement that contains large amounts of d-limonene (such as heartburn free with roh10 and coq with d-limonene) within the past 3 months
Description

Dietary Supplements | d-limonene | Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C0242295
UMLS CUI [2]
C0950252
UMLS CUI [3]
C3846158
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Similar models

Eligibility Breast Cancer NCT01046929

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women who are 18 years of age or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender | Excision elective Early-Stage Breast Carcinoma
Item
women electing to undergo excision surgery for early stage breast cancer
boolean
C0079399 (UMLS CUI [1])
C0728940 (UMLS CUI [2,1])
C0439608 (UMLS CUI [2,2])
C2986665 (UMLS CUI [2,3])
Enrollment Operative Surgical Procedures Definitive
Item
a minimum of 2 weeks from enrollment to definitive surgery
boolean
C1516879 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0443196 (UMLS CUI [1,3])
Core needle biopsy Breast Carcinoma
Item
underwent core needle biopsy for breast cancer diagnosis
boolean
C1318309 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Secondary malignant neoplasm of female breast Evidence Lacking
Item
no clinical evidence of metastatic breast cancer
boolean
C0346993 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
participants must have normal organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods
Item
women of child-bearing potential must agree to use adequate contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure
Item
concurrent chemotherapy or radiation therapy
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Selective Estrogen Receptor Modulators | Aromatase Inhibitors
Item
use of selective estrogen receptor modifiers or aromatase inhibitors within the past 3 months or concurrently
boolean
C0732611 (UMLS CUI [1])
C0593802 (UMLS CUI [2])
Cancer Other | Exception Skin carcinoma | Exception Organ removal Therapeutic procedure only
Item
history of other malignancies within the past 5 years excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1408858 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0205171 (UMLS CUI [3,4])
Study Subject Participation Status | Intervention
Item
participated in another clinical intervention trial within the past 3 months
boolean
C2348568 (UMLS CUI [1])
C0184661 (UMLS CUI [2])
Comorbidity Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0525058 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0525058 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Dietary Supplements | d-limonene | Other Coding
Item
use of dietary supplement that contains large amounts of d-limonene (such as heartburn free with roh10 and coq with d-limonene) within the past 3 months
boolean
C0242295 (UMLS CUI [1])
C0950252 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
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