ID

43566

Description

The Role of Serotonin in Hot Flashes After Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00228943

Link

https://clinicaltrials.gov/show/NCT00228943

Keywords

Versions (2)
  1. 1/10/17 1/10/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00228943

English

Eligibility Breast Cancer NCT00228943

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
at least 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
willing and able to provide informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
reporting daily hot flashes
Description

Hot flashes Daily

Data type

boolean

Alias
UMLS CUI [1,1]
C0600142
UMLS CUI [1,2]
C0332173
able to read, write, and speak english
Description

Able to read English Language | Able to write English Language | Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0564215
UMLS CUI [3,2]
C0376245
postmenopausal to limit sample variability (> 12 months amenorrhea)
Description

Postmenopausal state | Sample Variability Limitation | Amenorrhea Duration

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0370003
UMLS CUI [2,2]
C2827666
UMLS CUI [2,3]
C0449295
UMLS CUI [3,1]
C0002453
UMLS CUI [3,2]
C0449238
greater then 1 month but < 5 years post-treatment (surgery, radiation, chemotherapy) for non-metastatic breast cancer.
Description

Duration post treatment | Operative Surgical Procedure Breast Carcinoma nonmetastatic | Therapeutic radiology procedure Breast Carcinoma nonmetastatic | Chemotherapy Breast Carcinoma nonmetastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C2709088
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0678222
UMLS CUI [2,3]
C1518409
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0678222
UMLS CUI [3,3]
C1518409
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0678222
UMLS CUI [4,3]
C1518409
these criteria allow inclusion of women successfully treated for recurrent breast cancer since there is no known reason to exclude them. menopausal status is assessed using self-reports due to problems in reliably measuring follicle-stimulating hormone levels and estradiol in tamoxifen users.
Description

Gender | Breast cancer recurrent Treated Successful | Menopausal Status | Follicle stimulating hormone measurement | Estradiol measurement | Tamoxifen

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0278493
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C1272703
UMLS CUI [3]
C3829127
UMLS CUI [4]
C0202022
UMLS CUI [5]
C0337434
UMLS CUI [6]
C0039286
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
exclusion criteria are current depression, history of migraines or hepatitis, abnormal chemistry profile (e.g., sodium, potassium, glucose), or a positive urine drug screen for illegal substances.
Description

Depressive disorder | Migraine Disorders | Hepatitis | Chemistry abnormal | Serum sodium abnormal | Serum potassium abnormal | Blood glucose abnormal | Urine drug screen positive Illicit Substance

Data type

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2]
C0149931
UMLS CUI [3]
C0019158
UMLS CUI [4]
C0740327
UMLS CUI [5]
C0858176
UMLS CUI [6]
C0858156
UMLS CUI [7]
C0580546
UMLS CUI [8,1]
C0743300
UMLS CUI [8,2]
C2697662
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Similar models

Eligibility Breast Cancer NCT00228943

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
willing and able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Hot flashes Daily
Item
reporting daily hot flashes
boolean
C0600142 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
Able to read English Language | Able to write English Language | Able to speak English Language
Item
able to read, write, and speak english
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0564215 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
Postmenopausal state | Sample Variability Limitation | Amenorrhea Duration
Item
postmenopausal to limit sample variability (> 12 months amenorrhea)
boolean
C0232970 (UMLS CUI [1])
C0370003 (UMLS CUI [2,1])
C2827666 (UMLS CUI [2,2])
C0449295 (UMLS CUI [2,3])
C0002453 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
Duration post treatment | Operative Surgical Procedure Breast Carcinoma nonmetastatic | Therapeutic radiology procedure Breast Carcinoma nonmetastatic | Chemotherapy Breast Carcinoma nonmetastatic
Item
greater then 1 month but < 5 years post-treatment (surgery, radiation, chemotherapy) for non-metastatic breast cancer.
boolean
C0449238 (UMLS CUI [1,1])
C2709088 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1518409 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C1518409 (UMLS CUI [3,3])
C0392920 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
C1518409 (UMLS CUI [4,3])
Gender | Breast cancer recurrent Treated Successful | Menopausal Status | Follicle stimulating hormone measurement | Estradiol measurement | Tamoxifen
Item
these criteria allow inclusion of women successfully treated for recurrent breast cancer since there is no known reason to exclude them. menopausal status is assessed using self-reports due to problems in reliably measuring follicle-stimulating hormone levels and estradiol in tamoxifen users.
boolean
C0079399 (UMLS CUI [1])
C0278493 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C1272703 (UMLS CUI [2,3])
C3829127 (UMLS CUI [3])
C0202022 (UMLS CUI [4])
C0337434 (UMLS CUI [5])
C0039286 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Depressive disorder | Migraine Disorders | Hepatitis | Chemistry abnormal | Serum sodium abnormal | Serum potassium abnormal | Blood glucose abnormal | Urine drug screen positive Illicit Substance
Item
exclusion criteria are current depression, history of migraines or hepatitis, abnormal chemistry profile (e.g., sodium, potassium, glucose), or a positive urine drug screen for illegal substances.
boolean
C0011581 (UMLS CUI [1])
C0149931 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
C0740327 (UMLS CUI [4])
C0858176 (UMLS CUI [5])
C0858156 (UMLS CUI [6])
C0580546 (UMLS CUI [7])
C0743300 (UMLS CUI [8,1])
C2697662 (UMLS CUI [8,2])
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