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ID

44504

Beschrijving

Radiofrequency Ablation Combined With Transcatheter Arterial Chemoembolization Versus Radiofrequency Ablation Alone for Recurrent Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01415063

Link

https://clinicaltrials.gov/show/NCT01415063

Trefwoorden

  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 NCT01415063

    Eligibility Hepatocellular Carcinoma NCT01415063

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. age 18 - 75 years;
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. distant recurrence of hcc after initial curative treatment (including initial rfa or hepatectomy);
    Beschrijving

    Recurrent Hepatocellular Carcinoma | Status post Curative treatment Initial | Radiofrequency ablation Initial | Hepatectomy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0861876
    UMLS CUI [2,1]
    C0231290
    UMLS CUI [2,2]
    C1273390
    UMLS CUI [2,3]
    C0205265
    UMLS CUI [3,1]
    C0850292
    UMLS CUI [3,2]
    C0205265
    UMLS CUI [4]
    C0019144
    3. no other treatment received except for the initial rfa or hepatectomy;
    Beschrijving

    Patient untreated | Exception Radiofrequency ablation Initial | Exception Hepatectomy

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C0332155
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0850292
    UMLS CUI [2,3]
    C0205265
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0019144
    4. single tumor less than 4cm in diameter;
    Beschrijving

    Single tumor Diameter

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1298180
    UMLS CUI [1,2]
    C1301886
    5. lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
    Beschrijving

    Lesion Visible Ultrasonography

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0205379
    UMLS CUI [1,3]
    C0041618
    6. no severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3;
    Beschrijving

    Blood Coagulation Disorders Severe Absent | Prothrombin Activity Measurement | Platelet Count measurement

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0005779
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C0332197
    UMLS CUI [2]
    C3274435
    UMLS CUI [3]
    C0032181
    7. eastern co-operative oncology group performance(ecog) status 0 -
    Beschrijving

    ECOG performance status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. the presence of vascular invasion or extrahepatic spread on imaging;
    Beschrijving

    Tumor Vascular Invasion Imaging | Spread Extrahepatic Imaging

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0521157
    UMLS CUI [1,2]
    C0011923
    UMLS CUI [2,1]
    C0332261
    UMLS CUI [2,2]
    C1517058
    UMLS CUI [2,3]
    C0011923
    2. a child-pugh class c liver cirrhosis or evidence of hepatic decompensation including ascites, severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic encephalopathy;
    Beschrijving

    Liver Cirrhosis Child-Pugh Classification | Hepatic decompensation | Ascites | Blood Coagulation Disorders Severe | Prothrombin Activity Measurement | Platelet Count measurement | Bleeding esophageal varices | Bleeding gastric varices | Hepatic Encephalopathy

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0023890
    UMLS CUI [1,2]
    C4050412
    UMLS CUI [2]
    C1394798
    UMLS CUI [3]
    C0003962
    UMLS CUI [4,1]
    C0005779
    UMLS CUI [4,2]
    C0205082
    UMLS CUI [5]
    C3274435
    UMLS CUI [6]
    C0032181
    UMLS CUI [7]
    C0155789
    UMLS CUI [8]
    C0267209
    UMLS CUI [9]
    C0019151
    3. an american society of anesthesiologists (asa) score ≥ 3
    Beschrijving

    ASA physical status class

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0578808

    Similar models

    Eligibility Hepatocellular Carcinoma NCT01415063

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    1. age 18 - 75 years;
    boolean
    C0001779 (UMLS CUI [1])
    Recurrent Hepatocellular Carcinoma | Status post Curative treatment Initial | Radiofrequency ablation Initial | Hepatectomy
    Item
    2. distant recurrence of hcc after initial curative treatment (including initial rfa or hepatectomy);
    boolean
    C0861876 (UMLS CUI [1])
    C0231290 (UMLS CUI [2,1])
    C1273390 (UMLS CUI [2,2])
    C0205265 (UMLS CUI [2,3])
    C0850292 (UMLS CUI [3,1])
    C0205265 (UMLS CUI [3,2])
    C0019144 (UMLS CUI [4])
    Patient untreated | Exception Radiofrequency ablation Initial | Exception Hepatectomy
    Item
    3. no other treatment received except for the initial rfa or hepatectomy;
    boolean
    C0030705 (UMLS CUI [1,1])
    C0332155 (UMLS CUI [1,2])
    C1705847 (UMLS CUI [2,1])
    C0850292 (UMLS CUI [2,2])
    C0205265 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C0019144 (UMLS CUI [3,2])
    Single tumor Diameter
    Item
    4. single tumor less than 4cm in diameter;
    boolean
    C1298180 (UMLS CUI [1,1])
    C1301886 (UMLS CUI [1,2])
    Lesion Visible Ultrasonography
    Item
    5. lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
    boolean
    C0221198 (UMLS CUI [1,1])
    C0205379 (UMLS CUI [1,2])
    C0041618 (UMLS CUI [1,3])
    Blood Coagulation Disorders Severe Absent | Prothrombin Activity Measurement | Platelet Count measurement
    Item
    6. no severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3;
    boolean
    C0005779 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0332197 (UMLS CUI [1,3])
    C3274435 (UMLS CUI [2])
    C0032181 (UMLS CUI [3])
    ECOG performance status
    Item
    7. eastern co-operative oncology group performance(ecog) status 0 -
    boolean
    C1520224 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Tumor Vascular Invasion Imaging | Spread Extrahepatic Imaging
    Item
    1. the presence of vascular invasion or extrahepatic spread on imaging;
    boolean
    C0521157 (UMLS CUI [1,1])
    C0011923 (UMLS CUI [1,2])
    C0332261 (UMLS CUI [2,1])
    C1517058 (UMLS CUI [2,2])
    C0011923 (UMLS CUI [2,3])
    Liver Cirrhosis Child-Pugh Classification | Hepatic decompensation | Ascites | Blood Coagulation Disorders Severe | Prothrombin Activity Measurement | Platelet Count measurement | Bleeding esophageal varices | Bleeding gastric varices | Hepatic Encephalopathy
    Item
    2. a child-pugh class c liver cirrhosis or evidence of hepatic decompensation including ascites, severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic encephalopathy;
    boolean
    C0023890 (UMLS CUI [1,1])
    C4050412 (UMLS CUI [1,2])
    C1394798 (UMLS CUI [2])
    C0003962 (UMLS CUI [3])
    C0005779 (UMLS CUI [4,1])
    C0205082 (UMLS CUI [4,2])
    C3274435 (UMLS CUI [5])
    C0032181 (UMLS CUI [6])
    C0155789 (UMLS CUI [7])
    C0267209 (UMLS CUI [8])
    C0019151 (UMLS CUI [9])
    ASA physical status class
    Item
    3. an american society of anesthesiologists (asa) score ≥ 3
    boolean
    C0578808 (UMLS CUI [1])

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