Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
Age
Item
Alter 18 bis 60 Jahre
boolean
Patients with end stage kidney disease who will undergo renal transplantation. Patients receiving a kidney transplant with compatible ABO blood type.
Item
Patients having end stage kidney disease who will undergo primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible AB0 blood type can be included.
boolean
Item Group
Ausschlusskriterien
high immunological risk
Item
Patient has a high immunological risk
boolean
Cold ischemia time >30 hours
Item
Cold ischemia time greater than 30 hours
boolean
liver disease
Item
Patient has significant liver disease
boolean
severe hyper-cholesterolaemia
Item
Patient has severe hyper-cholesterolaemia
boolean
allergy or intolerance to study medication
Item
Patient is allergic or intolerant to study medication
boolean
corticosteroids
Item
Patient requires ongoing dosing with corticosteroids.
boolean
Patient or donor is HIV positive
Item
Patient or donor is known to be HIV positive
boolean
malignancy or history of malignancy
Item
Patient with malignancy or history of malignancy
boolean
Item Group
Medizinische Konzepte
Age
Item
Alter
string
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnose
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
End stage kidney disease
Item
terminale Niereninsuffizienz
string
C1261469 (UMLS CUI)
46177005 (SNOMED CT 2010_0731)
585.6 (ICD-9-CM Version 2011)
Kidney Transplantation
Item
Renal transplant
string
C0022671 (UMLS CUI)
70536003 (SNOMED CT 2010_0731)
10038533 (MedDRA 13.1)
55.6 (ICD-9-CM Version 2011)
retransplantation
Item
retransplantation
string
C0597409 (UMLS CUI)
Transplanted kidney
Item
Nierentransplantat
string
C1261317 (UMLS CUI)
70948008 (SNOMED CT 2010_0731)
MTHU017667 (LOINC Version 232)
Living Donors
Item
Live donor
string
C0348050 (UMLS CUI)
105456007 (SNOMED CT 2010_0731)
Donor
Item
Donor person
string
C0013018 (UMLS CUI)
HLA Antigens
Item
humanes Leukozytenantigen, HLA
string
C0019721 (UMLS CUI)
47038001 (SNOMED CT 2010_0731)
MTHU018438 (LOINC Version 232)
ABO blood group system
Item
ABO Blutgruppensystem
string
C0000778 (UMLS CUI)
63915006 (SNOMED CT 2010_0731)
MTHU004899 (LOINC Version 232)
Immunological Risk Factors
Item
Immunological Risk Factors
string
CL365957 (UMLS CUI)
Cold Ischemia Time
Item
Cold Ischemic Time
string
C1563922 (UMLS CUI)
MTHU020173 (LOINC Version 232)
Liver disorder
Item
Lebererkrankung
string
C0023895 (UMLS CUI)
235856003 (SNOMED CT 2010_0731)
10024670 (MedDRA 13.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
Hypercholesterolemia
Item
Hypercholesterinämie
string
C0020443 (UMLS CUI)
13644009 (SNOMED CT 2010_0731)
10020603 (MedDRA 13.1)
E12127 (CTCAE Version 4.03)
Drug intolerance
Item
Drug intolerance
string
C0277585 (UMLS CUI)
59037007 (SNOMED CT 2010_0731)
10061822 (MedDRA 13.1)
DINT (HL7 V3 02-34)
Corticosteroids
Item
Corticosteroide
string
C0001617 (UMLS CUI)
79440004 (SNOMED CT 2010_0731)
continue
Item
fortlaufend
string
C0750536 (UMLS CUI)
HIV positive
Item
HIV-positiv
string
C0019699 (UMLS CUI)
165816005 (SNOMED CT 2010_0731)
10020188 (MedDRA 13.1)
Z21 (ICD-10-CM Version 2010)
Cancer
Item
Krebs
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)

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