ID

20957

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT00710801

Keywords

versioni (1)
  1. 31/03/17 31/03/17 -
Caricato su

31 marzo 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Hepatitis C Virus NCT00710801

Inglese

Eligibility Hepatitis C Virus NCT00710801

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

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

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

Tipo di dati

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
Descrizione

Informed Consent

Tipo di dati

boolean

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

Study Subject Participation Status Transplantation Status post

Tipo di dati

boolean

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

Allograft Biopsy Possible

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Exclusion Criteria

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

Organ Transplantation multiple | Organ Transplantation

Tipo di dati

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.
Descrizione

Liver Transplant Cadaver donor

Tipo di dati

boolean

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

Transplant ABO incompatibility

Tipo di dati

boolean

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

Creatinine measurement, serum

Tipo di dati

boolean

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

Recipient HIV Antibodies Seropositive

Tipo di dati

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.
Descrizione

Acute Liver Failure Causing Transplantation

Tipo di dati

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
Descrizione

Study Subject Participation Status | Investigational New Drugs

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

Patient Transplanted | Malignant neoplasm of liver | Lesion Quantity

Tipo di dati

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.
Descrizione

Comorbidity Severe | Medical condition Unstable Affecting Study Protocol

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

Drugs, Non-Prescription | Therapeutic procedure Illicit

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332266
Ritorna all'inizio della pagina

Similar models

Eligibility Hepatitis C Virus NCT00710801

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial