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])
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])