ID

32665

Beschrijving

Autologous Adult Stem Cells to Patients With Type 1 Diabetes and a Successful Renal Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT00788827

Link

https://clinicaltrials.gov/show/NCT00788827

Trefwoorden

  1. 11-11-18 11-11-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 november 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Type 1 Diabetes NCT00788827

Eligibility Type 1 Diabetes NCT00788827

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients aged from 16 to 65 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patient with type i or type 2 diabetes mellitus plus:
Beschrijving

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
successful previous kidney transplant.
Beschrijving

Kidney Transplantation Successful

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C1272703
good kidney allograft function /no episodes of rejection for at least one year post-transplant
Beschrijving

Allograft kidney function Good | Graft rejection episode Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0564454
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0205170
UMLS CUI [2,1]
C0877542
UMLS CUI [2,2]
C0332197
not taking steroids as part of standard immuno-suppression
Beschrijving

Steroids Immunosuppression Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0021079
UMLS CUI [1,3]
C0332197
has a who performance score of less than 2
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
has a life expectancy of at least 3 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
ability to give written consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
women of childbearing potential may be included, but must use a reliable and appropriate contraceptive method
Beschrijving

Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients below the age of 16 or above the age of 65 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients with chronic pancreatitis and poor exocrine pancreatic function
Beschrijving

Pancreatitis, Chronic | Exocrine pancreatic function test abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C1262139
pregnant or lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with recent recurrent gi bleeding or spontaneous bacterial peritonitis
Beschrijving

Recurrent gastrointestinal bleeding | Spontaneous bacterial peritonitis

Datatype

boolean

Alias
UMLS CUI [1]
C0585174
UMLS CUI [2]
C0275551
patients with evidence of hiv or other life threatening infection
Beschrijving

HIV Infection | Life-threatening infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C1859430
patients unable to give written consent
Beschrijving

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
patients with a history of hypersensitivity to g-csf
Beschrijving

Hypersensitivity G-CSF

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0079459
patients who have been included in any other clinical trial within the previous month
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Type 1 Diabetes NCT00788827

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients aged from 16 to 65 years of age
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
patient with type i or type 2 diabetes mellitus plus:
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Kidney Transplantation Successful
Item
successful previous kidney transplant.
boolean
C0022671 (UMLS CUI [1,1])
C1272703 (UMLS CUI [1,2])
Allograft kidney function Good | Graft rejection episode Absent
Item
good kidney allograft function /no episodes of rejection for at least one year post-transplant
boolean
C0564454 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205170 (UMLS CUI [1,3])
C0877542 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Steroids Immunosuppression Absent
Item
not taking steroids as part of standard immuno-suppression
boolean
C0038317 (UMLS CUI [1,1])
C0021079 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
WHO performance status scale
Item
has a who performance score of less than 2
boolean
C1298650 (UMLS CUI [1])
Life Expectancy
Item
has a life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
ability to give written consent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential may be included, but must use a reliable and appropriate contraceptive method
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
patients below the age of 16 or above the age of 65 years
boolean
C0001779 (UMLS CUI [1])
Pancreatitis, Chronic | Exocrine pancreatic function test abnormal
Item
patients with chronic pancreatitis and poor exocrine pancreatic function
boolean
C0149521 (UMLS CUI [1])
C1262139 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Recurrent gastrointestinal bleeding | Spontaneous bacterial peritonitis
Item
patients with recent recurrent gi bleeding or spontaneous bacterial peritonitis
boolean
C0585174 (UMLS CUI [1])
C0275551 (UMLS CUI [2])
HIV Infection | Life-threatening infection
Item
patients with evidence of hiv or other life threatening infection
boolean
C0019693 (UMLS CUI [1])
C1859430 (UMLS CUI [2])
Informed Consent Unable
Item
patients unable to give written consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Hypersensitivity G-CSF
Item
patients with a history of hypersensitivity to g-csf
boolean
C0020517 (UMLS CUI [1,1])
C0079459 (UMLS CUI [1,2])
Study Subject Participation Status
Item
patients who have been included in any other clinical trial within the previous month
boolean
C2348568 (UMLS CUI [1])

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