ID

20957

Beschrijving

Assessment of Biomarkers for Recurrent HCV Infection Post-liver Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT00710801

Link

https://clinicaltrials.gov/show/NCT00710801

Trefwoorden

Versies (1)
  1. 31-03-17 31-03-17 -
Geüploaded op

31 maart 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatitis C Virus NCT00710801

Engels

Eligibility Hepatitis C Virus NCT00710801

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
about to undergo a primary liver transplant (including living donor, split liver) and are hcv positive.
Beschrijving

Transplantation of liver Primary | Living Donor | Liver Split | Hepatitis C virus test positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023911
UMLS CUI [1,2]
C0205225
UMLS CUI [2]
C0348050
UMLS CUI [3,1]
C0023884
UMLS CUI [3,2]
C1534709
UMLS CUI [4]
C2748185
willing and capable of giving written consent for study participation
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
expected to be capable of study participation for full 24 months post-transplantation.
Beschrijving

Study Subject Participation Status Transplantation Status post

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0040732
UMLS CUI [1,3]
C0231290
allograft biopsies will be possible
Beschrijving

Allograft Biopsy Possible

Datatype

boolean

Alias
UMLS CUI [1,1]
C0450127
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C0332149
expected use of calcineurin inhibitor (neoral or tacrolimus) as primary immunosuppression an immunosuppressive regimen consisting of a calcineurin inhibitor (neoral or tacrolimus) in combination with simulect and mycophenolate sodium
Beschrijving

Calcineurin inhibitor | Neoral | Tacrolimus | Therapeutic immunosuppression Primary | Simulect | mycophenolate sodium

Datatype

boolean

Alias
UMLS CUI [1]
C1562036
UMLS CUI [2]
C0699605
UMLS CUI [3]
C0085149
UMLS CUI [4,1]
C0021079
UMLS CUI [4,2]
C0205225
UMLS CUI [5]
C0723325
UMLS CUI [6]
C1337395
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
this is a multi-organ transplant or if the patient has previously been transplanted with any other organ.
Beschrijving

Organ Transplantation multiple | Organ Transplantation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C0439064
UMLS CUI [2]
C0029216
this is a liver transplant from a non-heart beating donor.
Beschrijving

Liver Transplant Cadaver donor

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023911
UMLS CUI [1,2]
C0524354
this is an abo incompatible transplant.
Beschrijving

Transplant ABO incompatibility

Datatype

boolean

Alias
UMLS CUI [1,1]
C3841811
UMLS CUI [1,2]
C0860218
patients with serum creatinine level > 250 umol/l.
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
the recipient is seropositive for human immunodeficiency virus (hiv) antibodies.
Beschrijving

Recipient HIV Antibodies Seropositive

Datatype

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0019683
UMLS CUI [1,3]
C0521143
fulminant liver failure is the reason for transplant.
Beschrijving

Acute Liver Failure Causing Transplantation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162557
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0040732
patient is participating in other clinical trial involving exploratory drug
Beschrijving

Study Subject Participation Status | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
there is a known malignancy, or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin, or hepatocellular carcinoma less than 5 cm meeting milan criteria for transplantation5.
Beschrijving

Malignant Neoplasms | Basal cell carcinoma Treated Successful | Squamous cell carcinoma of skin Treated Successful | Liver carcinoma Size

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C1272703
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C1272703
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C0456389
the patient is being transplanted for hepatic malignancy with greater than 5 known lesions.
Beschrijving

Patient Transplanted | Malignant neoplasm of liver | Lesion Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0700106
UMLS CUI [2]
C0345904
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1265611
severe coexisting disease is present or if any unstable medical condition is present which could affect the study objectives.
Beschrijving

Comorbidity Severe | Medical condition Unstable Affecting Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C2348563
a female transplant candidate is pregnant, lactating or of childbearing potential and not practicing an acceptable method of contraception.
Beschrijving

Gender | Indication Transplantation | Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Inadequate

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0040732
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0006147
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0700589
UMLS CUI [5,3]
C0205412
an unlicensed drug or therapy has been administered within one month prior to study entry or if such therapy is to be instituted post-transplantation.
Beschrijving

Drugs, Non-Prescription | Therapeutic procedure Illicit

Datatype

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332266
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Similar models

Eligibility Hepatitis C Virus NCT00710801

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Transplantation of liver Primary | Living Donor | Liver Split | Hepatitis C virus test positive
Item
about to undergo a primary liver transplant (including living donor, split liver) and are hcv positive.
boolean
C0023911 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0348050 (UMLS CUI [2])
C0023884 (UMLS CUI [3,1])
C1534709 (UMLS CUI [3,2])
C2748185 (UMLS CUI [4])
Informed Consent
Item
willing and capable of giving written consent for study participation
boolean
C0021430 (UMLS CUI [1])
Study Subject Participation Status Transplantation Status post
Item
expected to be capable of study participation for full 24 months post-transplantation.
boolean
C2348568 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
C0231290 (UMLS CUI [1,3])
Allograft Biopsy Possible
Item
allograft biopsies will be possible
boolean
C0450127 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,3])
Calcineurin inhibitor | Neoral | Tacrolimus | Therapeutic immunosuppression Primary | Simulect | mycophenolate sodium
Item
expected use of calcineurin inhibitor (neoral or tacrolimus) as primary immunosuppression an immunosuppressive regimen consisting of a calcineurin inhibitor (neoral or tacrolimus) in combination with simulect and mycophenolate sodium
boolean
C1562036 (UMLS CUI [1])
C0699605 (UMLS CUI [2])
C0085149 (UMLS CUI [3])
C0021079 (UMLS CUI [4,1])
C0205225 (UMLS CUI [4,2])
C0723325 (UMLS CUI [5])
C1337395 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Organ Transplantation multiple | Organ Transplantation
Item
this is a multi-organ transplant or if the patient has previously been transplanted with any other organ.
boolean
C0029216 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0029216 (UMLS CUI [2])
Liver Transplant Cadaver donor
Item
this is a liver transplant from a non-heart beating donor.
boolean
C0023911 (UMLS CUI [1,1])
C0524354 (UMLS CUI [1,2])
Transplant ABO incompatibility
Item
this is an abo incompatible transplant.
boolean
C3841811 (UMLS CUI [1,1])
C0860218 (UMLS CUI [1,2])
Creatinine measurement, serum
Item
patients with serum creatinine level > 250 umol/l.
boolean
C0201976 (UMLS CUI [1])
Recipient HIV Antibodies Seropositive
Item
the recipient is seropositive for human immunodeficiency virus (hiv) antibodies.
boolean
C1709854 (UMLS CUI [1,1])
C0019683 (UMLS CUI [1,2])
C0521143 (UMLS CUI [1,3])
Acute Liver Failure Causing Transplantation
Item
fulminant liver failure is the reason for transplant.
boolean
C0162557 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
patient is participating in other clinical trial involving exploratory drug
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Malignant Neoplasms | Basal cell carcinoma Treated Successful | Squamous cell carcinoma of skin Treated Successful | Liver carcinoma Size
Item
there is a known malignancy, or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin, or hepatocellular carcinoma less than 5 cm meeting milan criteria for transplantation5.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C1272703 (UMLS CUI [2,3])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C1272703 (UMLS CUI [3,3])
C2239176 (UMLS CUI [4,1])
C0456389 (UMLS CUI [4,2])
Patient Transplanted | Malignant neoplasm of liver | Lesion Quantity
Item
the patient is being transplanted for hepatic malignancy with greater than 5 known lesions.
boolean
C0030705 (UMLS CUI [1,1])
C0700106 (UMLS CUI [1,2])
C0345904 (UMLS CUI [2])
C0221198 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Comorbidity Severe | Medical condition Unstable Affecting Study Protocol
Item
severe coexisting disease is present or if any unstable medical condition is present which could affect the study objectives.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
Gender | Indication Transplantation | Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Inadequate
Item
a female transplant candidate is pregnant, lactating or of childbearing potential and not practicing an acceptable method of contraception.
boolean
C0079399 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0040732 (UMLS CUI [2,2])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0205412 (UMLS CUI [5,3])
Drugs, Non-Prescription | Therapeutic procedure Illicit
Item
an unlicensed drug or therapy has been administered within one month prior to study entry or if such therapy is to be instituted post-transplantation.
boolean
C0013231 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0332266 (UMLS CUI [2,2])
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