ID

36898

Description

Molecular Effects of a Multi-carotenoids (MCS) New Agent on Prostate Cancer Chemoprevention; ODM derived from: https://clinicaltrials.gov/show/NCT02426216

Link

https://clinicaltrials.gov/show/NCT02426216

Keywords

Versions (1)
  1. 6/19/19 6/19/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 19, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02426216

English

Eligibility Prostate Cancer NCT02426216

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject of mcs-8 study inclusion criteria of mcs-8 study
Description

Inclusion criteria Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
1. high-risk subjects of prostate cancer.
Description

High risk of Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0600139
2. male subject with age from 50 to 75 years old.
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
3. no active urinary tract infection (uti) or bacterial prostatitis.
Description

Urinary tract infection Absent | Bacterial prostatitis Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0042029
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0748023
UMLS CUI [2,2]
C0332197
4. subject is able to understand and willing to comply with the study procedures and has signed the informed consent form (icf).
Description

Protocol Compliance | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
exclusion criteria of mcs-8 study
Description

Exclusion Criteria Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
1. subjects' elevated psa is deemed by the investigators solely to inflammation or infection of the prostate.
Description

Raised prostate specific antigen Due to Prostatitis | Raised prostate specific antigen Due to Prostate infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0033581
UMLS CUI [2,1]
C0178415
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0240811
2. subjects who are or will be taking long-term hormonal agents that may affect the normal physiology of sex hormone function.
Description

Pharmaceutical Preparations Hormonal Long-term | Affecting Sex hormone function

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0458083
UMLS CUI [1,3]
C0443252
UMLS CUI [2,1]
C0392760
UMLS CUI [2,2]
C0036884
UMLS CUI [2,3]
C0031843
3. subjects with a psa > 10.0 ng/ml.
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
4. subjects with a history of prostate cancer.
Description

Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0600139
5. subjects are currently taking or planning to take oral bile acid sequestrants.
Description

Bile acid sequestrants Oral | Bile acid sequestrants Oral Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C2917337
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C2917337
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C1301732
6. subjects have malabsorption conditions.
Description

Malabsorption Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0024523
7. subject participated in another investigational agent study in the past 30 days or is planning to do so during the study period.
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
8. subjects are considered ineligible for the study as judged by the investigator.
Description

Study Subject Participation Status Ineligible

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512714
9. other malignancies except non-melanoma skin cancer.
Description

Cancer Other | Exception Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
2. subject is eligible for mcs-8 study but did not sign up for the mcs-8 study.
Description

Study Subject Eligible Clinical Trial Specified | Enrollment Absent Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205369
UMLS CUI [2,1]
C1516879
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0008976
UMLS CUI [2,4]
C0205369
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject is not able to understand and willing to comply with the study procedures and has not signed the informed consent form (icf).
Description

Study Protocol Comprehension Unable | Protocol Compliance Unwilling | Informed Consent Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0332197
note: (mcs-8-twn-ii clinicaltrials.gov nct02042807)
Description

Identification Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0205396
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
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Similar models

Eligibility Prostate Cancer NCT02426216

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Clinical Trial Specified
Item
1. subject of mcs-8 study inclusion criteria of mcs-8 study
boolean
C1512693 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
High risk of Prostate carcinoma
Item
1. high-risk subjects of prostate cancer.
boolean
C0332167 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Gender | Age
Item
2. male subject with age from 50 to 75 years old.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Urinary tract infection Absent | Bacterial prostatitis Absent
Item
3. no active urinary tract infection (uti) or bacterial prostatitis.
boolean
C0042029 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0748023 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Protocol Compliance | Informed Consent
Item
4. subject is able to understand and willing to comply with the study procedures and has signed the informed consent form (icf).
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Exclusion Criteria Clinical Trial Specified
Item
exclusion criteria of mcs-8 study
boolean
C0680251 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Raised prostate specific antigen Due to Prostatitis | Raised prostate specific antigen Due to Prostate infection
Item
1. subjects' elevated psa is deemed by the investigators solely to inflammation or infection of the prostate.
boolean
C0178415 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0033581 (UMLS CUI [1,3])
C0178415 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0240811 (UMLS CUI [2,3])
Pharmaceutical Preparations Hormonal Long-term | Affecting Sex hormone function
Item
2. subjects who are or will be taking long-term hormonal agents that may affect the normal physiology of sex hormone function.
boolean
C0013227 (UMLS CUI [1,1])
C0458083 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
C0392760 (UMLS CUI [2,1])
C0036884 (UMLS CUI [2,2])
C0031843 (UMLS CUI [2,3])
Prostate specific antigen measurement
Item
3. subjects with a psa > 10.0 ng/ml.
boolean
C0201544 (UMLS CUI [1])
Prostate carcinoma
Item
4. subjects with a history of prostate cancer.
boolean
C0600139 (UMLS CUI [1])
Bile acid sequestrants Oral | Bile acid sequestrants Oral Planned
Item
5. subjects are currently taking or planning to take oral bile acid sequestrants.
boolean
C2917337 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C2917337 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Malabsorption Syndrome
Item
6. subjects have malabsorption conditions.
boolean
C0024523 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
7. subject participated in another investigational agent study in the past 30 days or is planning to do so during the study period.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Study Subject Participation Status Ineligible
Item
8. subjects are considered ineligible for the study as judged by the investigator.
boolean
C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
Cancer Other | Exception Skin carcinoma
Item
9. other malignancies except non-melanoma skin cancer.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Study Subject Eligible Clinical Trial Specified | Enrollment Absent Clinical Trial Specified
Item
2. subject is eligible for mcs-8 study but did not sign up for the mcs-8 study.
boolean
C0681850 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
C1516879 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0205369 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Study Protocol Comprehension Unable | Protocol Compliance Unwilling | Informed Consent Absent
Item
subject is not able to understand and willing to comply with the study procedures and has not signed the informed consent form (icf).
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Identification Clinical Trial Specified
Item
note: (mcs-8-twn-ii clinicaltrials.gov nct02042807)
boolean
C0205396 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
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