Informações:
Falhas:
ID
14315
Descrição
Steroid Withdrawal in Pediatric Renal Transplant Recipients Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF); ODM derived from: https://clinicaltrials.gov/show/NCT00309218
Link
https://clinicaltrials.gov/show/NCT00309218
Palavras-chave
Versões (1)
- 10/04/2016 10/04/2016 -
Transferido a
10 de abril de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Kidney Diseases NCT00309218
Eligibility Kidney Diseases NCT00309218
- StudyEvent: Eligibility
Similar models
Eligibility Kidney Diseases NCT00309218
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
age < 18.0 years
boolean
C0001779 (UMLS CUI [1])
Bone age
Item
bone age of boys < 15 years, of girls < 13 years
boolean
C0429620 (UMLS CUI [1])
Kidney transplantation and transplant function
Item
patients 12-24 months after renal transplantation with stable transplant function
boolean
C0022671 (UMLS CUI [1])
C2170323 (UMLS CUI [2])
C2170323 (UMLS CUI [2])
Kidney transplant
Item
first or second kidney transplant, living or cadaver kidney donation
boolean
C0022671 (UMLS CUI [1])
Cyclosporine, MMF, daily steroids
Item
triple immunosuppression with cyclosporine (cya), mmf, and daily steroids at study entry
boolean
C0010592 (UMLS CUI [1])
C0627079 (UMLS CUI [2])
C0038317 (UMLS CUI [3])
C0627079 (UMLS CUI [2])
C0038317 (UMLS CUI [3])
Informed consent
Item
patients and parents, respectively, have given their written consent after enlightenment (informed consent)
boolean
C0021430 (UMLS CUI [1])
Rejection
Item
irreversible rejection of former transplant within 6 months
boolean
C0018129 (UMLS CUI [1])
Lymphocytotoxic antibodies
Item
highly reactive (> 80%) lymphocytotoxic antibodies within 12 months prior to transplantation
boolean
C0024284 (UMLS CUI [1])
Steroid-resistant rejection
Item
anamnestically steroid-resistant rejection of current transplant
boolean
C0018129 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])
C0038317 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])
Acute rejection
Item
more than 2 acute rejection reactions prior to study entry (i.e., in the first 12-24 months after kidney transplantation) or 1 acute rejection reaction during the last 6 months before study entry
boolean
C0403588 (UMLS CUI [1])
Glomerular filtration rate: Schwartz formula
Item
glomerular filtration rate (gfr) < 40 ml/min/1.73 m² (schwartz formula) at study entry
boolean
C1980037 (UMLS CUI [1])
Acute rejection and serum creatinine
Item
acute rejection reaction or unstable transplant function (increase of serum creatinine > 20%) during the last 6 months before study entry or histologically confirmed chronic rejection reaction
boolean
C0403588 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0201976 (UMLS CUI [2])
Compliance
Item
suspected insufficient medication compliance
boolean
C1321605 (UMLS CUI [1])
Immunosuppression differs from study protocol
Item
patients receiving a basic immunosuppression other than that prescribed in this protocol
boolean
C0021079 (UMLS CUI [1,1])
C0443127 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0443127 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Growth hormone therapy
Item
simultaneous therapy with growth hormone after renal transplantation
boolean
C0744483 (UMLS CUI [1])