ID

44511

Beschrijving

Magnetic Resonance With Gadoxetic Acid for the Diagnosis of Hepatocellular Carcinoma in Patients With Liver Cirrhosis. Evaluation of Its Impact for the Non-invasive Diagnosis; ODM derived from: https://clinicaltrials.gov/show/NCT01575574

Link

https://clinicaltrials.gov/show/NCT01575574

Trefwoorden

Versies (2)
  1. 19-02-20 19-02-20 -
  2. 27-09-21 27-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

27 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01575574

Engels

Eligibility Hepatocellular Carcinoma NCT01575574

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
more than 18 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patient with diagnosis of liver cirrhosis child pugh a-b
Beschrijving

Liver Cirrhosis Child-Pugh Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C4050412
patients without previous hepatocellular carcinoma in whom ultrasound detects a suspicious hepatic lesion; solitary solid and well-defined nodule between 10 and 20mm
Beschrijving

Absence Liver carcinoma Previous | Lesion of liver Suspicious Ultrasonography | Nodule Solid Solitary | Nodule size

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C2239176
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C0577053
UMLS CUI [2,2]
C0750493
UMLS CUI [2,3]
C0041618
UMLS CUI [3,1]
C0028259
UMLS CUI [3,2]
C0205208
UMLS CUI [3,3]
C0205171
UMLS CUI [4]
C0449457
patients in whom diagnosis of hepatocellular carcinoma is a clinical need prior to treatment indication
Beschrijving

Liver carcinoma | Status pre- Treatment Indication

Datatype

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C3146298
patient that agree to participate signing informed consent form
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with poor liver function who would have undergone transplantation even without hepatocellular carcinoma diagnosis (child-pugh c)
Beschrijving

Liver Dysfunction Child-Pugh Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C4050412
patients with previous diagnosis of hepatocellular carcinoma
Beschrijving

Prior diagnosis Liver carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332132
UMLS CUI [1,2]
C2239176
patients with significant comorbidities that could prevent the optimum therapeutic decision in case of positive diagnosis of hepatocellular carcinoma
Beschrijving

Comorbidity Preventing Therapy Optimal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C2698651
patients with severe clotting alterations that contraindicate the fine-needle biopsy-patients with chronic kidney disease or glomerular filtration rate < 30 ml/min
Beschrijving

Alteration in clotting Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C4062962
UMLS CUI [1,2]
C0205082
patients with contraindications to perform magnetic resonance imaging (pacemaker, claustrophobia...)
Beschrijving

Medical contraindication Magnetic Resonance Imaging | Pacemakers | Claustrophobia

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0810633
UMLS CUI [3]
C0008909
known hypersensitivity to study drugs or excipients
Beschrijving

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipients

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
pregnancy or breastfeeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Hepatocellular Carcinoma NCT01575574

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
more than 18 years old
boolean
C0001779 (UMLS CUI [1])
Liver Cirrhosis Child-Pugh Classification
Item
patient with diagnosis of liver cirrhosis child pugh a-b
boolean
C0023890 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Absence Liver carcinoma Previous | Lesion of liver Suspicious Ultrasonography | Nodule Solid Solitary | Nodule size
Item
patients without previous hepatocellular carcinoma in whom ultrasound detects a suspicious hepatic lesion; solitary solid and well-defined nodule between 10 and 20mm
boolean
C0332197 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0577053 (UMLS CUI [2,1])
C0750493 (UMLS CUI [2,2])
C0041618 (UMLS CUI [2,3])
C0028259 (UMLS CUI [3,1])
C0205208 (UMLS CUI [3,2])
C0205171 (UMLS CUI [3,3])
C0449457 (UMLS CUI [4])
Liver carcinoma | Status pre- Treatment Indication
Item
patients in whom diagnosis of hepatocellular carcinoma is a clinical need prior to treatment indication
boolean
C2239176 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,3])
Informed Consent
Item
patient that agree to participate signing informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver Dysfunction Child-Pugh Classification
Item
patients with poor liver function who would have undergone transplantation even without hepatocellular carcinoma diagnosis (child-pugh c)
boolean
C0086565 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Prior diagnosis Liver carcinoma
Item
patients with previous diagnosis of hepatocellular carcinoma
boolean
C0332132 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
Comorbidity Preventing Therapy Optimal
Item
patients with significant comorbidities that could prevent the optimum therapeutic decision in case of positive diagnosis of hepatocellular carcinoma
boolean
C0009488 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C2698651 (UMLS CUI [1,4])
Alteration in clotting Severe
Item
patients with severe clotting alterations that contraindicate the fine-needle biopsy-patients with chronic kidney disease or glomerular filtration rate < 30 ml/min
boolean
C4062962 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Medical contraindication Magnetic Resonance Imaging | Pacemakers | Claustrophobia
Item
patients with contraindications to perform magnetic resonance imaging (pacemaker, claustrophobia...)
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0810633 (UMLS CUI [2])
C0008909 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipients
Item
known hypersensitivity to study drugs or excipients
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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