ID

12500

Description

Dietary Bioflavonoid Supplementation for the Prevention of Neoplasia Recurrence; ODM derived from: https://clinicaltrials.gov/show/NCT00609310

Link

https://clinicaltrials.gov/show/NCT00609310

Keywords

  1. 8/30/15 8/30/15 -
  2. 11/24/15 11/24/15 - Julian Varghese
Uploaded on

November 24, 2015

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 Colorectal Cancer NCT00609310

Eligibility Colorectal Cancer NCT00609310

Inclusion Criteria
Description

Inclusion Criteria

patient who had a recent surgical resection of colorectal cancer with pathologically proven stage 2 or stage 3 (without adjuvant chemotherapy or after completion of adjuvant chemotherapy) according to uicc. the time interval for recruitment should be within 3-12 month after surgery.
Description

time interval; chemotherapy; colorectal; resection; adjuvant; surgery; n stage; cancer

Data type

boolean

Alias
UMLS CUI [1]
C0009402
male or female
Description

gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
caucasian
Description

caucasian

Data type

boolean

Alias
UMLS CUI [1]
C0007457
50 to 75 years old
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
broca-index: between -20 and +25%
Description

broca index

Data type

boolean

Alias
UMLS CUI [1]
C0003550
who are willing and capable to confirm written consent to enrolment after ample information has been provided
Description

written consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
who are in a stable condition that it can be expected that no changes in relevant medical conditions will occur during the study
Description

medical condition; conditions; study

Data type

boolean

Alias
UMLS CUI [1]
C0348080
Exclusion Criteria
Description

Exclusion Criteria

subjects with any major relevant clinical abnormality (as based on extensive medical history, physi-cal examination, vital signs)
Description

medical history; vital signs; examination; extensive; clinical

Data type

boolean

Alias
UMLS CUI [1]
C1704258
subjects with active cancer
Description

active cancer

Data type

boolean

Alias
UMLS CUI [1]
C0006826
subjects with any major clinically relevant laboratory abnormality.
Description

laboratory

Data type

boolean

Alias
UMLS CUI [1]
C0022877
subjects who participated in another trial with any investigational substance within the last 4 weeks
Description

substance; last

Data type

boolean

Alias
UMLS CUI [1]
C0008976
subjects who are known or suspected to be (social) drug dependent, incl. those drinking more than moderately and who are not willing to abstain from alcohol abuse during the active study phase
Description

drug dependent; alcohol abuse; moderately; suspected; active; phase; study; from

Data type

boolean

Alias
UMLS CUI [1]
C0221628
subjects who adhere to a extreme diet or lifestyle that might interfere with the investigation
Description

investigation; diet

Data type

boolean

Alias
UMLS CUI [1]
C0012155
subjects who are known or suspected not to comply with the study directives and/or who are known or suspected not to be reliable or trustworthy
Description

suspected; study

Data type

boolean

Alias
UMLS CUI [1]
C0680927
subjects who are known or suspected not to be capable of understanding and evaluating the in-formation that is given to them as part of the formal information policy (informed consent), in par-ticular regarding the risks and discomfort to which they would agree to be exposed
Description

informed consent; suspected; agree; part

Data type

boolean

Alias
UMLS CUI [1]
C0021430

Similar models

Eligibility Colorectal Cancer NCT00609310

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
time interval; chemotherapy; colorectal; resection; adjuvant; surgery; n stage; cancer
Item
patient who had a recent surgical resection of colorectal cancer with pathologically proven stage 2 or stage 3 (without adjuvant chemotherapy or after completion of adjuvant chemotherapy) according to uicc. the time interval for recruitment should be within 3-12 month after surgery.
boolean
C0009402 (UMLS CUI [1])
gender
Item
male or female
boolean
C0079399 (UMLS CUI [1])
caucasian
Item
caucasian
boolean
C0007457 (UMLS CUI [1])
age
Item
50 to 75 years old
boolean
C0001779 (UMLS CUI [1])
broca index
Item
broca-index: between -20 and +25%
boolean
C0003550 (UMLS CUI [1])
written consent
Item
who are willing and capable to confirm written consent to enrolment after ample information has been provided
boolean
C0021430 (UMLS CUI [1])
medical condition; conditions; study
Item
who are in a stable condition that it can be expected that no changes in relevant medical conditions will occur during the study
boolean
C0348080 (UMLS CUI [1])
medical history; vital signs; examination; extensive; clinical
Item
subjects with any major relevant clinical abnormality (as based on extensive medical history, physi-cal examination, vital signs)
boolean
C1704258 (UMLS CUI [1])
active cancer
Item
subjects with active cancer
boolean
C0006826 (UMLS CUI [1])
laboratory
Item
subjects with any major clinically relevant laboratory abnormality.
boolean
C0022877 (UMLS CUI [1])
substance; last
Item
subjects who participated in another trial with any investigational substance within the last 4 weeks
boolean
C0008976 (UMLS CUI [1])
drug dependent; alcohol abuse; moderately; suspected; active; phase; study; from
Item
subjects who are known or suspected to be (social) drug dependent, incl. those drinking more than moderately and who are not willing to abstain from alcohol abuse during the active study phase
boolean
C0221628 (UMLS CUI [1])
investigation; diet
Item
subjects who adhere to a extreme diet or lifestyle that might interfere with the investigation
boolean
C0012155 (UMLS CUI [1])
suspected; study
Item
subjects who are known or suspected not to comply with the study directives and/or who are known or suspected not to be reliable or trustworthy
boolean
C0680927 (UMLS CUI [1])
informed consent; suspected; agree; part
Item
subjects who are known or suspected not to be capable of understanding and evaluating the in-formation that is given to them as part of the formal information policy (informed consent), in par-ticular regarding the risks and discomfort to which they would agree to be exposed
boolean
C0021430 (UMLS CUI [1])

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