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Informações:
Falhas:
ID
25161
Descrição
Efficacy of Everolimus as Inhibitor of Fibrosis Progression in Liver Transplant Patients With Recurrence of Hepatitis C Viral Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00582738
Link
https://clinicaltrials.gov/show/NCT00582738
Palavras-chave
Versões (2)
- 28/08/2017 28/08/2017 -
- 28/08/2017 28/08/2017 -
Transferido a
28 de agosto de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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Eligibility Recurrent Hepatitis C NCT00582738
Eligibility Recurrent Hepatitis C NCT00582738
- StudyEvent: Eligibility
Similar models
Eligibility Recurrent Hepatitis C NCT00582738
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
male or female patients 18 - 65 years of age
boolean
C0001779 (UMLS CUI [1])
Recipient Cadaver donor | Recipient Living Donors
Item
recipients of deceased or living donors
boolean
C1709854 (UMLS CUI [1,1])
C0524354 (UMLS CUI [1,2])
C1709854 (UMLS CUI [2,1])
C0348050 (UMLS CUI [2,2])
C0524354 (UMLS CUI [1,2])
C1709854 (UMLS CUI [2,1])
C0348050 (UMLS CUI [2,2])
Transplantation of liver Primary
Item
patients who had undergone primary liver transplantation at least 6 months before enrolment
boolean
C0023911 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,2])
Hepatitis C recurrent | Liver Fibrosis Ishak Score | Liver Fibrosis Knodell Score
Item
recurrent hepatitis c viral infection and histologically confirmed liver fibrosis (stage i-iv in the ishak-knodell scale) obtained at baseline or within the previous 6 months to the date of enrolment
boolean
C2938989 (UMLS CUI [1])
C0239946 (UMLS CUI [2,1])
C2986945 (UMLS CUI [2,2])
C0239946 (UMLS CUI [3,1])
C3898641 (UMLS CUI [3,2])
C0239946 (UMLS CUI [2,1])
C2986945 (UMLS CUI [2,2])
C0239946 (UMLS CUI [3,1])
C3898641 (UMLS CUI [3,2])
Tacrolimus | cyclosporine microemulsion
Item
patients receiving tacrolimus or cyclosporine micro-emulsion with or without -
boolean
C0085149 (UMLS CUI [1])
C1577018 (UMLS CUI [2])
C1577018 (UMLS CUI [2])
Mycophenolic Acid | Steroids
Item
mycophenolic acid (mpa), with or without steroids.
boolean
C0026933 (UMLS CUI [1])
C0038317 (UMLS CUI [2])
C0038317 (UMLS CUI [2])
Rejection episode Absent
Item
absence of acute rejection episodes within the previous 6 months to the date of enrolment
boolean
C0877542 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
Allograft Biopsy | Medical contraindication Absent
Item
patient in whom an allograft biopsy will not be contraindicated
boolean
C0450127 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0005558 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Informed Consent | Study Subject Participation Status
Item
patient willing and capable of giving written informed consent for study participation and able to participate in the study for 24 months
boolean
C0021430 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C2348568 (UMLS CUI [2])
Liver carcinoma | Recurrence Absent
Item
patients with hepatocellular carcinoma (hcc) within the university california, san francisco (ucsf) criteria and no recurrence for at least 18 months after olt.
boolean
C2239176 (UMLS CUI [1])
C0034897 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0034897 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Recipient Organ Transplant multiple | Retransplantation
Item
recipients of multiple organ transplants or patients who have undergone retransplantation
boolean
C1709854 (UMLS CUI [1,1])
C0029216 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
C0597409 (UMLS CUI [2])
C0029216 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
C0597409 (UMLS CUI [2])
Complications biliary
Item
current biliary complications
boolean
C0009566 (UMLS CUI [1,1])
C0521378 (UMLS CUI [1,2])
C0521378 (UMLS CUI [1,2])
Substance Use Disorders
Item
history of drug or alcohol abuse within 1 year before enrolment
boolean
C0038586 (UMLS CUI [1])
Therapeutic procedure Against Hepatitis C virus
Item
patients treated with anti-hepatitis c virus treatment at the time of enrollment or within the previous month to the date of enrolment
boolean
C0087111 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
C0521124 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
HBV coinfection | HIV coinfection
Item
co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv)
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
C4062778 (UMLS CUI [2])
White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement
Item
patients with leukocyte count (wbc) < 3000/mm3, platelet count < 75000/mm3 or hemoglobin (hb) < 8 g/dl
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Proteinuria
Item
patients with proteinuria >1g/24 hours
boolean
C0033687 (UMLS CUI [1])
Severe Sepsis
Item
patient with a current severe systemic infection
boolean
C1719672 (UMLS CUI [1])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])