Patients
Item
patients:
boolean
C0030705 (UMLS CUI [1])
Age | Chronic haemodialysis
Item
male or female, age equal to or above 18 years undergoing chronic haemodialysis
boolean
C0001779 (UMLS CUI [1])
C1740835 (UMLS CUI [2])
Hemodialysis Stable Adequate
Item
stable and adequate haemodialysis treatment three months prior to enrolment
boolean
C0019004 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
Healthy Volunteers
Item
healthy subjects:
boolean
C1708335 (UMLS CUI [1])
Matching Individual Group as study subject | Gender | Age
Item
matching an individual of the patient group by: gender and age (± 5 years)
boolean
C1708943 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0681860 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Matching Individual Group as study subject | Body Weight Post Dialysis
Item
matching an individual of the patient group by weight (after dialysis, ±10%)
boolean
C1708943 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0681860 (UMLS CUI [1,3])
C0005910 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0011946 (UMLS CUI [2,3])
Creatinine clearance measurement
Item
creatinine clearance above 80 ml/min
boolean
C0373595 (UMLS CUI [1])
Overall Well Being Age Adequate
Item
subjects must be in good health in accordance with their age as determined by a medical
boolean
C3813622 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
Medical History | Physical Examination | Vital signs | Electrocardiography | Hematology procedure | Clinical Chemistry Test
Item
history, physical examination, vital signs, ecg (electrocardiogram), routine haematology and clinical chemistry
boolean
C0262926 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
C0518766 (UMLS CUI [3])
C1623258 (UMLS CUI [4])
C0200627 (UMLS CUI [5])
C0525044 (UMLS CUI [6])
cuprophane membranes
Item
use of cuprophane membranes
boolean
C0056591 (UMLS CUI [1,1])
C0025255 (UMLS CUI [1,2])
Malignant Neoplasm
Item
active malignant disease
boolean
C0006826 (UMLS CUI [1])
Diabetes Mellitus
Item
diabetes
boolean
C0011849 (UMLS CUI [1])
Critical Illness | Support respiratory Patient need for | Support circulatory Patient need for
Item
critical illness as defined by the need of respiratory or circulatory support
boolean
C0010340 (UMLS CUI [1])
C1521721 (UMLS CUI [2,1])
C0521346 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
C1521721 (UMLS CUI [3,1])
C0005775 (UMLS CUI [3,2])
C0686904 (UMLS CUI [3,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs
Item
known or suspected allergy to the trial product
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Gender Fertile Pregnancy
Item
pregnancy, breast feeding, the intention of becoming pregnant or fertile women judged to be
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0015895 (UMLS CUI [4,2])
C0032961 (UMLS CUI [4,3])
Contraceptive methods Inadequate
Item
using inadequate contraceptive measures
boolean
C0700589 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
Blood Pressure Pre-dialysis
Item
blood pressure (pre-dialysis) above 180/110
boolean
C0005823 (UMLS CUI [1,1])
C1264634 (UMLS CUI [1,2])
Steroids chronic | Prednisolone Dose U/day | Prednisolone Equivalent
Item
chronic treatment with steroids in doses above 10 mg/day prednisolone (or equivalent)
boolean
C0038317 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0032950 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0032950 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
Immunosuppressive Agents
Item
treated with immunosuppressive agents
boolean
C0021081 (UMLS CUI [1])