Age
Item
ages 18-70 years, inclusive.
boolean
C0001779 (UMLS CUI [1])
Patients Eligible Islets of Langerhans Transplantation
Item
patients eligible for a pancreatic islet transplantation program
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0079646 (UMLS CUI [1,3])
Islets of Langerhans Transplantation intrahepatic Planned | Cadaver donor Brain Death
Item
planned intrahepatic islet transplantation alone from a non-living donor with brain death.
boolean
C0079646 (UMLS CUI [1,1])
C1512948 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0524354 (UMLS CUI [2,1])
C0006110 (UMLS CUI [2,2])
Protocol Compliance
Item
patients willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
patients who have given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
boolean
C0021430 (UMLS CUI [1])
Recipient Transplant Previous | Recipient Islets of Langerhans Transplantation Previous
Item
recipients of any previous transplant, including recipients of previous pancreatic islet transplantation.
boolean
C1709854 (UMLS CUI [1,1])
C0332835 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C1709854 (UMLS CUI [2,1])
C0079646 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
Recipient Islet cell transplant Cadaver donor
Item
recipients of islet from a non-heart beating donor.
boolean
C1709854 (UMLS CUI [1,1])
C0079646 (UMLS CUI [1,2])
C0524354 (UMLS CUI [1,3])
Status pre- Transplant | Requirement Insulin U/day
Item
pre-transplant average daily insulin requirement >1 iu/kg/day.
boolean
C0332152 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
Status pre- Transplant | Hemoglobin A1c measurement
Item
pre-transplant (the more recent value obtained within the 4 months prior to enrolment) hba1c >11%.
boolean
C0332152 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
Renal function Inadequate | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
patients with inadequate renal reserve as per calculated creatinine clearance (clcr) < 60 ml/min according to the cockcroft-gault formula (1976).
boolean
C0232804 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C2711451 (UMLS CUI [2])
Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin
Item
patients with hepatic dysfunction as defined by increased alt/ast > 3 x upper limit of normal (uln) and increased total bilirubin > 3mg/dl [>51.3 µmol/l]).
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
Medical condition Treated | Patient need for Systemic steroids chronic
Item
patients who receive treatment for a medical condition requiring chronic use of systemic steroids.
boolean
C3843040 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C2825233 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
Antidiabetics | Exception Insulin
Item
treatment with any anti-diabetic medication other than insulin within 4 weeks of transplant.
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
Investigational New Drugs | Antiinflammatory therapy | Anti-TNF-alpha therapy | Therapy Against Interleukin-1 | Therapy Rheumatoid Arthritis
Item
use of any investigational agent within 12 weeks of enrolment, including "anti-inflammatory" strategies (e.g. anti-tnfα, anti-il-1 ra).
boolean
C0013230 (UMLS CUI [1])
C1096024 (UMLS CUI [2])
C0281481 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0521124 (UMLS CUI [4,2])
C0021755 (UMLS CUI [4,3])
C0087111 (UMLS CUI [5,1])
C0003873 (UMLS CUI [5,2])
Hypersensitivity
Item
hypersensitivity to:
boolean
C0020517 (UMLS CUI [1])
Ibuprofen allergy | Allergy to nonsteroidal anti-inflammatory agents Quantity
Item
1. ibuprofen or to more than one non steroidal anti-inflammatory drug (nsaid).
boolean
C0020741 (UMLS CUI [1])
C0746949 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Allergy to sulfonamides | Sulfadimidine allergy | Hypersensitivity Sulfamethoxazole | Sulfasalazine allergy | Hypersensitivity Nimesulide | Hypersensitivity Celecoxib
Item
2. medications belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib.
boolean
C0038757 (UMLS CUI [1])
C0571486 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0038689 (UMLS CUI [3,2])
C0570587 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C0132515 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0538927 (UMLS CUI [6,2])
Pregnancy | Breast Feeding | Contraceptive methods Unwilling
Item
pregnant or breast-feeding women; unwillingness to use effective contraceptive measures (females and males).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Exclusion Criteria Additional Specific
Item
additional exclusion criteria specific for us centre.
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])