ID

44370

Beschreibung

Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00901901

Link

https://clinicaltrials.gov/show/NCT00901901

Stichworte

Versionen (2)
  1. 18.08.18 18.08.18 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

see clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Creative Commons BY 4.0
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Eligibility Carcinoma, Hepatocellular NCT00901901

Englisch

Eligibility Carcinoma, Hepatocellular NCT00901901

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients > 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patients who have a life expectancy of at least 12 weeks
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
patients with histological or cytologically documented hcc
Beschreibung

Liver carcinoma; Histological finding | Liver carcinoma; Cytologic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0449575
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0205471
patients must have at least one tumor lesion that meets both of the following criteria:
Beschreibung

Neoplasms; Lesion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0221198
the lesion can be accurately measured in at least one dimension according to response evaluation criteria in solid tumors (recist)
Beschreibung

Neoplasms; Lesion; Measurement; Dimensions | Response Evaluation Criteria in Solid Tumors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0242485
UMLS CUI [1,4]
C0439534
UMLS CUI [2]
C1709926
the lesion has not been previously treated with local therapy
Beschreibung

Prior Therapy; Local Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1517925
patients who have an ecog ps (eastern cooperative oncology group performance status) of 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
cirrhotic status of child-pugh class a.
Beschreibung

Child-Pugh Classification; Cirrhotic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4050412
UMLS CUI [1,2]
C0439686
patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time.
Beschreibung

Informed Consent | Study Withdrawn

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C2348571
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of cardiac disease: congestive heart failure > new york heart association (nyha) class 2; active coronary artery disease (cad); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), or uncontrolled hypertension. myocardial infarction more than 6 months prior to study entry is permitted.
Beschreibung

Heart Diseases | Congestive heart failure | New York Heart Association Classification | Coronary Artery Disease | Cardiac Arrhythmia; Anti-Arrhythmia Agents; Adrenergic beta-1 Receptor Antagonists; Digoxin; Other | Uncontrolled hypertension | Myocardial Infarction; Before

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0018802
UMLS CUI [3]
C1275491
UMLS CUI [4]
C1956346
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0003195
UMLS CUI [5,3]
C0304516
UMLS CUI [5,4]
C0012265
UMLS CUI [5,5]
C0205394
UMLS CUI [6]
C1868885
UMLS CUI [7,1]
C0027051
UMLS CUI [7,2]
C0332152
abnormalities of the cornea based on history (e.g. dry eye syndrome, sogren's syndrome) including congenital abnormality (e.g. fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g. fluorescein, bengal-rose), and/or an abnormal corneal sensitivity test (schirmer test or similar tear production test).
Beschreibung

Abnormality of the cornea | Dry Eye Syndromes | Sjogren's Syndrome | Congenital Abnormality | Fuchs Endothelial Dystrophy | Slit lamp biomicroscopy (procedure) | Fluorescein | Rose Bengal | Schirmer's test abnormal | Sensitivity test; Cornea; Abnormality | Basic tear secretion test

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1855670
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C0013238
UMLS CUI [3]
C1527336
UMLS CUI [4]
C0000768
UMLS CUI [5]
C0016781
UMLS CUI [6,1]
C0419360
UMLS CUI [6,2]
C0013343
UMLS CUI [7]
C0060520
UMLS CUI [8]
C0035857
UMLS CUI [9]
C1141897
UMLS CUI [10,1]
C0497093
UMLS CUI [10,2]
C0010031
UMLS CUI [10,3]
C1704258
UMLS CUI [11]
C1301513
history of interstitial lung disease (ild).
Beschreibung

Lung Diseases, Interstitial

Datentyp

boolean

Alias
UMLS CUI [1]
C0206062
patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Beschreibung

Gastrointestinal Hemorrhage; Significant; Before

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017181
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0332152
previous treatment with yttrium-90 spheres
Beschreibung

previous therapy; Yttrium-90

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2114510
UMLS CUI [1,2]
C0303596
any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
Beschreibung

Patient's condition unstable | patient safety | Compliance behavior

Datentyp

boolean

Alias
UMLS CUI [1]
C0438114
UMLS CUI [2]
C1113679
UMLS CUI [3]
C1321605
uncontrolled ascites (defined as not easily controlled with diuretic treatment)
Beschreibung

ID.16

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0012798
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Ähnliche Modelle

Eligibility Carcinoma, Hepatocellular NCT00901901

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients > 18 years of age
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
patients who have a life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Liver carcinoma; Histological finding | Liver carcinoma; Cytologic
Item
patients with histological or cytologically documented hcc
boolean
C2239176 (UMLS CUI [1,1])
C0449575 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0205471 (UMLS CUI [2,2])
Neoplasms; Lesion
Item
patients must have at least one tumor lesion that meets both of the following criteria:
boolean
C0027651 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Neoplasms; Lesion; Measurement; Dimensions | Response Evaluation Criteria in Solid Tumors
Item
the lesion can be accurately measured in at least one dimension according to response evaluation criteria in solid tumors (recist)
boolean
C0027651 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C0439534 (UMLS CUI [1,4])
C1709926 (UMLS CUI [2])
Prior Therapy; Local Therapy
Item
the lesion has not been previously treated with local therapy
boolean
C1514463 (UMLS CUI [1,1])
C1517925 (UMLS CUI [1,2])
ECOG performance status
Item
patients who have an ecog ps (eastern cooperative oncology group performance status) of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Child-Pugh Classification; Cirrhotic
Item
cirrhotic status of child-pugh class a.
boolean
C4050412 (UMLS CUI [1,1])
C0439686 (UMLS CUI [1,2])
Informed Consent | Study Withdrawn
Item
patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time.
boolean
C0021430 (UMLS CUI [1])
C2348571 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Heart Diseases | Congestive heart failure | New York Heart Association Classification | Coronary Artery Disease | Cardiac Arrhythmia; Anti-Arrhythmia Agents; Adrenergic beta-1 Receptor Antagonists; Digoxin; Other | Uncontrolled hypertension | Myocardial Infarction; Before
Item
history of cardiac disease: congestive heart failure > new york heart association (nyha) class 2; active coronary artery disease (cad); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), or uncontrolled hypertension. myocardial infarction more than 6 months prior to study entry is permitted.
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C1275491 (UMLS CUI [3])
C1956346 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0003195 (UMLS CUI [5,2])
C0304516 (UMLS CUI [5,3])
C0012265 (UMLS CUI [5,4])
C0205394 (UMLS CUI [5,5])
C1868885 (UMLS CUI [6])
C0027051 (UMLS CUI [7,1])
C0332152 (UMLS CUI [7,2])
Abnormality of the cornea | Dry Eye Syndromes | Sjogren's Syndrome | Congenital Abnormality | Fuchs Endothelial Dystrophy | Slit lamp biomicroscopy (procedure) | Fluorescein | Rose Bengal | Schirmer's test abnormal | Sensitivity test; Cornea; Abnormality | Basic tear secretion test
Item
abnormalities of the cornea based on history (e.g. dry eye syndrome, sogren's syndrome) including congenital abnormality (e.g. fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g. fluorescein, bengal-rose), and/or an abnormal corneal sensitivity test (schirmer test or similar tear production test).
boolean
C1855670 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0013238 (UMLS CUI [2])
C1527336 (UMLS CUI [3])
C0000768 (UMLS CUI [4])
C0016781 (UMLS CUI [5])
C0419360 (UMLS CUI [6,1])
C0013343 (UMLS CUI [6,2])
C0060520 (UMLS CUI [7])
C0035857 (UMLS CUI [8])
C1141897 (UMLS CUI [9])
C0497093 (UMLS CUI [10,1])
C0010031 (UMLS CUI [10,2])
C1704258 (UMLS CUI [10,3])
C1301513 (UMLS CUI [11])
Lung Diseases, Interstitial
Item
history of interstitial lung disease (ild).
boolean
C0206062 (UMLS CUI [1])
Gastrointestinal Hemorrhage; Significant; Before
Item
patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
boolean
C0017181 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
previous therapy; Yttrium-90
Item
previous treatment with yttrium-90 spheres
boolean
C2114510 (UMLS CUI [1,1])
C0303596 (UMLS CUI [1,2])
Patient's condition unstable | patient safety | Compliance behavior
Item
any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
boolean
C0438114 (UMLS CUI [1])
C1113679 (UMLS CUI [2])
C1321605 (UMLS CUI [3])
ID.16
Item
uncontrolled ascites (defined as not easily controlled with diuretic treatment)
boolean
C0003962 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0012798 (UMLS CUI [2])
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