Eligibility Islet Transplantation in Diabetes Mellitus Type 1, NCT01817959

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StudyEvent: Eligibility
1. Eligibility Islet Transplantation in Diabetes Mellitus Type 1, NCT01817959

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

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])

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])

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Eligibility Islet Transplantation in Diabetes Mellitus Type 1, NCT01817959