ID

40506

Description

Study to Assess Efficacy & Safety of Reparixin in Pancreatic Islet Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT01817959

Link

https://clinicaltrials.gov/show/NCT01817959

Keywords

Versions (1)
  1. 4/28/20 4/28/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 28, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Islet Transplantation in Diabetes Mellitus Type 1, NCT01817959

English

Eligibility Islet Transplantation in Diabetes Mellitus Type 1, NCT01817959

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ages 18-70 years, inclusive.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients eligible for a pancreatic islet transplantation program
Description

Patients Eligible Islets of Langerhans Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0079646
planned intrahepatic islet transplantation alone from a non-living donor with brain death.
Description

Islets of Langerhans Transplantation intrahepatic Planned | Cadaver donor Brain Death

Data type

boolean

Alias
UMLS CUI [1,1]
C0079646
UMLS CUI [1,2]
C1512948
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C0524354
UMLS CUI [2,2]
C0006110
patients willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
recipients of any previous transplant, including recipients of previous pancreatic islet transplantation.
Description

Recipient Transplant Previous | Recipient Islets of Langerhans Transplantation Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0332835
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C1709854
UMLS CUI [2,2]
C0079646
UMLS CUI [2,3]
C0205156
recipients of islet from a non-heart beating donor.
Description

Recipient Islet cell transplant Cadaver donor

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0079646
UMLS CUI [1,3]
C0524354
pre-transplant average daily insulin requirement >1 iu/kg/day.
Description

Status pre- Transplant | Requirement Insulin U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0332152
UMLS CUI [1,2]
C0040732
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0021641
UMLS CUI [2,3]
C0456683
pre-transplant (the more recent value obtained within the 4 months prior to enrolment) hba1c >11%.
Description

Status pre- Transplant | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0332152
UMLS CUI [1,2]
C0040732
UMLS CUI [2]
C0474680
patients with inadequate renal reserve as per calculated creatinine clearance (clcr) < 60 ml/min according to the cockcroft-gault formula (1976).
Description

Renal function Inadequate | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C2711451
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]).
Description

Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0741494
patients who receive treatment for a medical condition requiring chronic use of systemic steroids.
Description

Medical condition Treated | Patient need for Systemic steroids chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C2825233
UMLS CUI [2,3]
C0205191
treatment with any anti-diabetic medication other than insulin within 4 weeks of transplant.
Description

Antidiabetics | Exception Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021641
use of any investigational agent within 12 weeks of enrolment, including "anti-inflammatory" strategies (e.g. anti-tnfα, anti-il-1 ra).
Description

Investigational New Drugs | Antiinflammatory therapy | Anti-TNF-alpha therapy | Therapy Against Interleukin-1 | Therapy Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C1096024
UMLS CUI [3]
C0281481
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0521124
UMLS CUI [4,3]
C0021755
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0003873
hypersensitivity to:
Description

Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1]
C0020517
1. ibuprofen or to more than one non steroidal anti-inflammatory drug (nsaid).
Description

Ibuprofen allergy | Allergy to nonsteroidal anti-inflammatory agents Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0020741
UMLS CUI [2,1]
C0746949
UMLS CUI [2,2]
C1265611
2. medications belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib.
Description

Allergy to sulfonamides | Sulfadimidine allergy | Hypersensitivity Sulfamethoxazole | Sulfasalazine allergy | Hypersensitivity Nimesulide | Hypersensitivity Celecoxib

Data type

boolean

Alias
UMLS CUI [1]
C0038757
UMLS CUI [2]
C0571486
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0038689
UMLS CUI [4]
C0570587
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0132515
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0538927
pregnant or breast-feeding women; unwillingness to use effective contraceptive measures (females and males).
Description

Pregnancy | Breast Feeding | Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0558080
additional exclusion criteria specific for us centre.
Description

Exclusion Criteria Additional Specific

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0205369
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Similar models

Eligibility Islet Transplantation in Diabetes Mellitus Type 1, NCT01817959

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
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])
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