ID

37672

Description

Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01975363

Link

https://clinicaltrials.gov/show/NCT01975363

Keywords

Versions (1)
  1. 8/15/19 8/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 15, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atypical Ductal Breast Hyperplasia NCT01975363

English

Eligibility Atypical Ductal Breast Hyperplasia NCT01975363

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
increased risk for breast cancer based on family history, personal history
Description

Risk Increased Breast Carcinoma | Etiology Family history | Etiology Medical History

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0205217
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0241889
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0262926
normal mammogram, clinical breast examination in the past 12 months
Description

Mammogram normal Examination of breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0740311
UMLS CUI [1,2]
C0199850
>1 year from pregnancy, lactation or chemotherapy
Description

Pregnancy In the past | Breast Feeding In the past | Chemotherapy In the past

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1444637
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C1444637
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1444637
body mass index (bmi) between 30 - 40
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent malignancy or metastatic malignancy of any kind
Description

Cancer Other | Neoplasm Metastasis Type Any

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332307
UMLS CUI [2,3]
C1552551
ongoing chemotherapy, radiation therapy, or other cancer-related treatment
Description

Chemotherapy | Therapeutic radiology procedure | Cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0920425
history of a bleeding tendency or current use of coumadin or other anticoagulants
Description

Bleeding tendency | Coumadin | Anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0699129
UMLS CUI [3]
C0003280
current or previous history of liver, gastrointestinal, hematopoietic, cardiac or renal disease, viral, bacterial, atypical or fungal infections of any organ system and human immunodeficiency virus (hiv) infection
Description

Liver disease | Gastrointestinal Disease | Hematological Disease | Heart Disease | Kidney Disease | Virus Diseases | Bacterial Infections | Communicable Diseases Atypical | Mycoses | HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0018939
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0042769
UMLS CUI [7]
C0004623
UMLS CUI [8,1]
C0009450
UMLS CUI [8,2]
C0205182
UMLS CUI [9]
C0026946
UMLS CUI [10]
C0019693
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
concurrent use of hormonal contraception or hormone replacement therapy
Description

Hormonal contraception | Hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1]
C2985296
UMLS CUI [2]
C0282402
concurrent use of immunosuppressant medications
Description

Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0021081
concurrent use of antacids, hydrogen (h2) antagonists, proton-pump inhibitors, or medications known to inhibit or induce hepatic enzyme cytochrome p450 (cyp) 3a4
Description

Antacids | Hydrogen antagonists | Proton Pump Inhibitors | CYP3A4 Inhibitors | CYP3A4 Inducers

Data type

boolean

Alias
UMLS CUI [1]
C0003138
UMLS CUI [2,1]
C0020275
UMLS CUI [2,2]
C0243076
UMLS CUI [3]
C0358591
UMLS CUI [4]
C3850053
UMLS CUI [5]
C3850041
barriers to fine needle aspiration sampling of breast adipose, including breast implants, history of radiation to both breasts, bilateral mastectomies, and/or insufficient breast adipose tissue for adequate fine needle aspiration (fna) sampling
Description

Barriers to Fine needle aspiration Adipose tissue of breast | Breast implant | Radiotherapy to breast Both | Bilateral mastectomy | Adipose tissue of breast Insufficient Fine needle aspiration

Data type

boolean

Alias
UMLS CUI [1,1]
C4296486
UMLS CUI [1,2]
C1510483
UMLS CUI [1,3]
C1305788
UMLS CUI [2]
C0178391
UMLS CUI [3,1]
C0948310
UMLS CUI [3,2]
C1706086
UMLS CUI [4]
C0191877
UMLS CUI [5,1]
C1305788
UMLS CUI [5,2]
C0231180
UMLS CUI [5,3]
C1510483
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation that would limit compliance with study requirements
Description

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Hypertensive disease | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

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]
C0020538
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
UMLS CUI [8,1]
C0748872
UMLS CUI [8,2]
C0439801
UMLS CUI [8,3]
C0525058
chronic use of any herbal or dietary supplement containing curcumin or curcuminoids within the 3 months prior to entry on the study or any other supplements that might interact with nec
Description

Herbal Supplements Curcumin chronic | Dietary Supplements Curcumin chronic | Herbal Supplements Curcuminoid chronic | Dietary Supplements Curcuminoid chronic | Supplements Interaction Nanoemulsion Curcumin

Data type

boolean

Alias
UMLS CUI [1,1]
C1504473
UMLS CUI [1,2]
C0010467
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C0010467
UMLS CUI [2,3]
C0205191
UMLS CUI [3,1]
C1504473
UMLS CUI [3,2]
C4086228
UMLS CUI [3,3]
C0205191
UMLS CUI [4,1]
C0242295
UMLS CUI [4,2]
C4086228
UMLS CUI [4,3]
C0205191
UMLS CUI [5,1]
C0242295
UMLS CUI [5,2]
C0687133
UMLS CUI [5,3]
C1881958
UMLS CUI [5,4]
C0010467
known sensitivity or allergy to turmeric spices or curry
Description

Hypersensitivity Turmeric extract | Hypersensitivity Curry

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0077524
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0453254
dietary intake of large amounts of curry, turmeric spices or black pepper on a regular basis
Description

Dietary intake Large amount Curry | Dietary intake Large amount Turmeric extract | Dietary intake Large amount Black Pepper

Data type

boolean

Alias
UMLS CUI [1,1]
C1286104
UMLS CUI [1,2]
C3869890
UMLS CUI [1,3]
C0453254
UMLS CUI [2,1]
C1286104
UMLS CUI [2,2]
C3869890
UMLS CUI [2,3]
C0077524
UMLS CUI [3,1]
C1286104
UMLS CUI [3,2]
C3869890
UMLS CUI [3,3]
C0162750
subjects on a standing regimen of full dose aspirin (>= 325 mg/day), non-steroidal anti-inflammatory drug (nsaid)s or nsaid-containing products
Description

Aspirin Dose Full U/day | NSAIDs | Pharmaceutical Preparations Containing NSAIDs

Data type

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0443225
UMLS CUI [1,4]
C0456683
UMLS CUI [2]
C0003211
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0332256
UMLS CUI [3,3]
C0003211
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Similar models

Eligibility Atypical Ductal Breast Hyperplasia NCT01975363

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Risk Increased Breast Carcinoma | Etiology Family history | Etiology Medical History
Item
increased risk for breast cancer based on family history, personal history
boolean
C0035647 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
Mammogram normal Examination of breast
Item
normal mammogram, clinical breast examination in the past 12 months
boolean
C0740311 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
Pregnancy In the past | Breast Feeding In the past | Chemotherapy In the past
Item
>1 year from pregnancy, lactation or chemotherapy
boolean
C0032961 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C1444637 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C1444637 (UMLS CUI [3,2])
Body mass index
Item
body mass index (bmi) between 30 - 40
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Neoplasm Metastasis Type Any
Item
concurrent malignancy or metastatic malignancy of any kind
boolean
C1707251 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
Chemotherapy | Therapeutic radiology procedure | Cancer treatment
Item
ongoing chemotherapy, radiation therapy, or other cancer-related treatment
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0920425 (UMLS CUI [3])
Bleeding tendency | Coumadin | Anticoagulants
Item
history of a bleeding tendency or current use of coumadin or other anticoagulants
boolean
C1458140 (UMLS CUI [1])
C0699129 (UMLS CUI [2])
C0003280 (UMLS CUI [3])
Liver disease | Gastrointestinal Disease | Hematological Disease | Heart Disease | Kidney Disease | Virus Diseases | Bacterial Infections | Communicable Diseases Atypical | Mycoses | HIV Infection
Item
current or previous history of liver, gastrointestinal, hematopoietic, cardiac or renal disease, viral, bacterial, atypical or fungal infections of any organ system and human immunodeficiency virus (hiv) infection
boolean
C0023895 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0018939 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0042769 (UMLS CUI [6])
C0004623 (UMLS CUI [7])
C0009450 (UMLS CUI [8,1])
C0205182 (UMLS CUI [8,2])
C0026946 (UMLS CUI [9])
C0019693 (UMLS CUI [10])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hormonal contraception | Hormone replacement therapy
Item
concurrent use of hormonal contraception or hormone replacement therapy
boolean
C2985296 (UMLS CUI [1])
C0282402 (UMLS CUI [2])
Immunosuppressive Agents
Item
concurrent use of immunosuppressant medications
boolean
C0021081 (UMLS CUI [1])
Antacids | Hydrogen antagonists | Proton Pump Inhibitors | CYP3A4 Inhibitors | CYP3A4 Inducers
Item
concurrent use of antacids, hydrogen (h2) antagonists, proton-pump inhibitors, or medications known to inhibit or induce hepatic enzyme cytochrome p450 (cyp) 3a4
boolean
C0003138 (UMLS CUI [1])
C0020275 (UMLS CUI [2,1])
C0243076 (UMLS CUI [2,2])
C0358591 (UMLS CUI [3])
C3850053 (UMLS CUI [4])
C3850041 (UMLS CUI [5])
Barriers to Fine needle aspiration Adipose tissue of breast | Breast implant | Radiotherapy to breast Both | Bilateral mastectomy | Adipose tissue of breast Insufficient Fine needle aspiration
Item
barriers to fine needle aspiration sampling of breast adipose, including breast implants, history of radiation to both breasts, bilateral mastectomies, and/or insufficient breast adipose tissue for adequate fine needle aspiration (fna) sampling
boolean
C4296486 (UMLS CUI [1,1])
C1510483 (UMLS CUI [1,2])
C1305788 (UMLS CUI [1,3])
C0178391 (UMLS CUI [2])
C0948310 (UMLS CUI [3,1])
C1706086 (UMLS CUI [3,2])
C0191877 (UMLS CUI [4])
C1305788 (UMLS CUI [5,1])
C0231180 (UMLS CUI [5,2])
C1510483 (UMLS CUI [5,3])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Hypertensive disease | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation 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])
C0020538 (UMLS CUI [6])
C0004936 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
Herbal Supplements Curcumin chronic | Dietary Supplements Curcumin chronic | Herbal Supplements Curcuminoid chronic | Dietary Supplements Curcuminoid chronic | Supplements Interaction Nanoemulsion Curcumin
Item
chronic use of any herbal or dietary supplement containing curcumin or curcuminoids within the 3 months prior to entry on the study or any other supplements that might interact with nec
boolean
C1504473 (UMLS CUI [1,1])
C0010467 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0242295 (UMLS CUI [2,1])
C0010467 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C1504473 (UMLS CUI [3,1])
C4086228 (UMLS CUI [3,2])
C0205191 (UMLS CUI [3,3])
C0242295 (UMLS CUI [4,1])
C4086228 (UMLS CUI [4,2])
C0205191 (UMLS CUI [4,3])
C0242295 (UMLS CUI [5,1])
C0687133 (UMLS CUI [5,2])
C1881958 (UMLS CUI [5,3])
C0010467 (UMLS CUI [5,4])
Hypersensitivity Turmeric extract | Hypersensitivity Curry
Item
known sensitivity or allergy to turmeric spices or curry
boolean
C0020517 (UMLS CUI [1,1])
C0077524 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0453254 (UMLS CUI [2,2])
Dietary intake Large amount Curry | Dietary intake Large amount Turmeric extract | Dietary intake Large amount Black Pepper
Item
dietary intake of large amounts of curry, turmeric spices or black pepper on a regular basis
boolean
C1286104 (UMLS CUI [1,1])
C3869890 (UMLS CUI [1,2])
C0453254 (UMLS CUI [1,3])
C1286104 (UMLS CUI [2,1])
C3869890 (UMLS CUI [2,2])
C0077524 (UMLS CUI [2,3])
C1286104 (UMLS CUI [3,1])
C3869890 (UMLS CUI [3,2])
C0162750 (UMLS CUI [3,3])
Aspirin Dose Full U/day | NSAIDs | Pharmaceutical Preparations Containing NSAIDs
Item
subjects on a standing regimen of full dose aspirin (>= 325 mg/day), non-steroidal anti-inflammatory drug (nsaid)s or nsaid-containing products
boolean
C0004057 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0443225 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0003211 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0003211 (UMLS CUI [3,3])
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