ID

31672

Description

Synthetic Genistein (BONISTEIN™) in Patients Who Are Undergoing Surgery for Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00546039

Link

https://clinicaltrials.gov/show/NCT00546039

Keywords

  1. 9/19/18 9/19/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 19, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Prostatic Neoplasms NCT00546039

Eligibility Prostatic Neoplasms NCT00546039

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological proven prostate cancer clinical stage t1c or t2.
Description

Prostate carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C3258246
are to be treated by radical prostatectomy 3 to 6 weeks after consent.
Description

Radical prostatectomy Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0194810
UMLS CUI [1,2]
C1514873
have signed the informed consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have been on previous or concurrent hormonal therapy or chemotherapy.
Description

Hormone Therapy | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0392920
history of previous or other hormone dependent malignancies.
Description

Neoplasms, Hormone-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0027661
concomitant thyroid disease or are currently taking thyroid hormone replacement medication.
Description

Thyroid Disease | Thyroid hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1]
C0040128
UMLS CUI [2]
C2242640
on current high dose soy, micronutrient or herbal supplements.
Description

Soy High dose | Micronutrients High dose | Herbal Supplements High dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0037733
UMLS CUI [1,2]
C0444956
UMLS CUI [2,1]
C0282575
UMLS CUI [2,2]
C0444956
UMLS CUI [3,1]
C1504473
UMLS CUI [3,2]
C0444956
on soy or vegetarian nutrition or have any other extreme dietary habits.
Description

Soy | Vegetarian food | Dietary Habits Extreme

Data type

boolean

Alias
UMLS CUI [1]
C0037733
UMLS CUI [2]
C0453866
UMLS CUI [3,1]
C0086152
UMLS CUI [3,2]
C0205403
on oral anticoagulants.
Description

Oral anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0354604
history of liver or pancreas diseases.
Description

Liver diseases | Pancreatic Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0030286
history of hypersensitivity to genistein or soy containing products.
Description

Hypersensitivity Genistein | Hypersensitivity Soy product

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0061202
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1532456
have a malabsorption condition which might interfere with absorption of the investigational product.
Description

Malabsorption Interferes with Absorption Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C3714745
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0013230

Similar models

Eligibility Prostatic Neoplasms NCT00546039

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma TNM clinical staging
Item
histological proven prostate cancer clinical stage t1c or t2.
boolean
C0600139 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Radical prostatectomy Required
Item
are to be treated by radical prostatectomy 3 to 6 weeks after consent.
boolean
C0194810 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Informed Consent
Item
have signed the informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy | Chemotherapy
Item
have been on previous or concurrent hormonal therapy or chemotherapy.
boolean
C0279025 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Neoplasms, Hormone-Dependent
Item
history of previous or other hormone dependent malignancies.
boolean
C0027661 (UMLS CUI [1])
Thyroid Disease | Thyroid hormone replacement therapy
Item
concomitant thyroid disease or are currently taking thyroid hormone replacement medication.
boolean
C0040128 (UMLS CUI [1])
C2242640 (UMLS CUI [2])
Soy High dose | Micronutrients High dose | Herbal Supplements High dose
Item
on current high dose soy, micronutrient or herbal supplements.
boolean
C0037733 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0282575 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C1504473 (UMLS CUI [3,1])
C0444956 (UMLS CUI [3,2])
Soy | Vegetarian food | Dietary Habits Extreme
Item
on soy or vegetarian nutrition or have any other extreme dietary habits.
boolean
C0037733 (UMLS CUI [1])
C0453866 (UMLS CUI [2])
C0086152 (UMLS CUI [3,1])
C0205403 (UMLS CUI [3,2])
Oral anticoagulants
Item
on oral anticoagulants.
boolean
C0354604 (UMLS CUI [1])
Liver diseases | Pancreatic Diseases
Item
history of liver or pancreas diseases.
boolean
C0023895 (UMLS CUI [1])
C0030286 (UMLS CUI [2])
Hypersensitivity Genistein | Hypersensitivity Soy product
Item
history of hypersensitivity to genistein or soy containing products.
boolean
C0020517 (UMLS CUI [1,1])
C0061202 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1532456 (UMLS CUI [2,2])
Malabsorption Interferes with Absorption Investigational New Drugs
Item
have a malabsorption condition which might interfere with absorption of the investigational product.
boolean
C3714745 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial