Informed Consent | Informed Consent Parent | Informed Consent Guardian
Item
written informed consent obtained from patient or parents/ guardian.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
Age
Item
subject age >= 18
boolean
C0001779 (UMLS CUI [1])
Blood flow measurement | Dialysate Flow mL/min
Item
effective blood flow 350 ml/min and dialysate flow of 500 ml/min
boolean
C0005776 (UMLS CUI [1])
C0011947 (UMLS CUI [2,1])
C0806140 (UMLS CUI [2,2])
C0439445 (UMLS CUI [2,3])
Hemodialysis Duration
Item
on hemodialysis for a minimum of 3 months
boolean
C0019004 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Cimino shunt | GORE-TEX Shunt
Item
use of cimino- or gore-tex shunts
boolean
C1142577 (UMLS CUI [1])
C0018088 (UMLS CUI [2,1])
C0542331 (UMLS CUI [2,2])
Routine Dialysis
Item
routine dialysis-treatment for 240 min
boolean
C0205547 (UMLS CUI [1,1])
C0011946 (UMLS CUI [1,2])
Dialysis Stable
Item
documented dialysis adequacy parameter that has been stable for past 3 months
boolean
C0011946 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Dialysis Planned
Item
plan to dialyze at participating hemodialysis centre for at least 3-months duration.
boolean
C0011946 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Free of Clotting Unusual | Free of Access Problem
Item
free from any currently known unusual clotting or access problems
boolean
C0332296 (UMLS CUI [1,1])
C0005779 (UMLS CUI [1,2])
C2700116 (UMLS CUI [1,3])
C0332296 (UMLS CUI [2,1])
C0444454 (UMLS CUI [2,2])
C0033213 (UMLS CUI [2,3])
Hepatitis B surface antigen negative | Hepatitis B surface antibody positive
Item
hepatitis b surface antigen (hbsag) negative, documented within the past 90 days or hepatitis b surface antibody (anti-hbs) positive.
boolean
C0919711 (UMLS CUI [1])
C0149708 (UMLS CUI [2])
Hepatitis C antibody negative
Item
anti hepatitis c virus (anti-hcv) negative, documented within the past 90 days
boolean
C0853904 (UMLS CUI [1])
HIV antibody negative
Item
anti human immunodeficiency virus (anti hiv) negative, documented within the past 90 days
boolean
C1142096 (UMLS CUI [1])
Hematocrit level | Hemoglobin measurement
Item
hematocrit (hct) between 25 and 40% or haemoglobin (hb) not less than 8 g/dl, as documented 14 days prior to the first treatment
boolean
C0518014 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Intolerance Blood flow mL/min
Item
patients who are unable to tolerate an effective blood flow of 350 ml/min
boolean
C0231199 (UMLS CUI [1,1])
C0232338 (UMLS CUI [1,2])
C0439445 (UMLS CUI [1,3])
Dialysis catheter
Item
patients using catheter for dialysis
boolean
C0179747 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Hormonal contraception | Contraceptive implant | Contraceptive patch | Contraceptives, Oral, Hormonal | Barrier Contraception Double | Intrauterine Devices | Female Condoms | Vaginal Spermicides | Vaginal contraceptive diaphragm | Contraceptive Sponge | CERVICAL CAP FOR CONTRACEPTIVE USE
Item
pregnant or nursing woman. women of childbearing potential must agree to avoid pregnancy during the study period by use of hormonal contraception (implantable; patch; oral) and/ or double-barrier methods (any double combination of: iud; condom with spermicidal gel; diaphragm; sponge; cervical cap)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C2985296 (UMLS CUI [3,2])
C1657106 (UMLS CUI [4])
C2985284 (UMLS CUI [5])
C0009907 (UMLS CUI [6])
C0004764 (UMLS CUI [7,1])
C0205173 (UMLS CUI [7,2])
C0021900 (UMLS CUI [8])
C0221829 (UMLS CUI [9])
C0087145 (UMLS CUI [10])
C0042241 (UMLS CUI [11])
C0183461 (UMLS CUI [12])
C0493327 (UMLS CUI [13])
Absence Hemodialysis Center
Item
previous plan for extended absences from the participating hemodialysis centre
boolean
C0332197 (UMLS CUI [1,1])
C0019004 (UMLS CUI [1,2])
C1552416 (UMLS CUI [1,3])
Transplantation Expected | Living related donor
Item
expected to be transplanted (living related donor) within the maximum of 3 months for the study period
boolean
C0040732 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C3494891 (UMLS CUI [2])
Medical condition Interferes with Therapeutic procedure | Medical condition Interferes with Assessment | Medical condition Excludes Completion of clinical trial | Disability Interferes with Therapeutic procedure | Disability Interferes with Assessment | Disability Excludes Completion of clinical trial
Item
any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C0231170 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0231170 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1516048 (UMLS CUI [5,3])
C0231170 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C2732579 (UMLS CUI [6,3])