ID

42666

Descripción

Dose Escalation Study for Primary Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00243841

Link

https://clinicaltrials.gov/show/NCT00243841

Palabras clave

Versiones (2)
  1. 23/7/16 23/7/16 -
  2. 17/9/21 17/9/21 -
Subido en

17 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Carcinoma, Hepatocellular NCT00243841

Inglés

Eligibility Carcinoma, Hepatocellular NCT00243841

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
evaluation by the surgery and/or liver transplant team has been performed and the patient is not considered a candidate for either "standard" therapy to target area (upper abdomen)
Descripción

Patient evaluation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679830
adequate liver function defined as:
Descripción

adequate liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
total bilirubin < 3mg/dl, albumin > 2.5 g/dl
Descripción

bilrubin, albumin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428441
UMLS CUI [2]
C0728877
normal pt/ptt unless on anticoagulants
Descripción

normal pt/ptt

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030605
mild elevation of liver enzymes acceptable (must be less than three times upper limit of normal)
Descripción

mild elevation of liver enzymes

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0235996
adequate renal function (creatinine < 1.8 mg/dl or creatinine clearance ≥ 50 ml/min)
Descripción

renal function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0600061
UMLS CUI [3]
C0812399
adequate bone marrow reserve:
Descripción

bone marrow reserve

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221130
anc count ≥ 1500 mm3
Descripción

anc count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
platelets ≥ 50,000/mm3
Descripción

platelets

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005821
hemoglobin > 9 g/dl
Descripción

hemoglobin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019046
note: lab values must be obtained within 2 weeks prior to being registered for protocol therapy.
Descripción

time of lab values

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022885
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
no history of systemic lupus erythematous, rheumatoid arthritis, systemic sclerosis or scleroderma
Descripción

systemic lupus erythematous, rheumatoid arthritis, systemic sclerosis or scleroderma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0036421
no chemotherapy within 14 days before radiotherapy (chemotherapy may cause transient hepatitis with hepatomegaly)
Descripción

chemotherapy before radiotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
no subsequent chemotherapy planned within 2 weeks of radiotherapy
Descripción

subsequent chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3846090
UMLS CUI [1,2]
C3665472
no active liver infection
Descripción

no active liver infection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1112211
UMLS CUI [1,2]
C2707252
no acute hepatitis. definition of active disease:
Descripción

no acute hepatitis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0744827
hepatitis a: acute hepatitis determined by presence of anti-hav-
Descripción

hepatitis a

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019159
UMLS CUI [1,2]
C0062524
hepatitis b:
Descripción

hepatitis b

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019163
1. hbsag (hb surface antigen): present in patients with acute and chronic hepatitis
Descripción

hbsag (hb surface antigen

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019168
2. hbv dna present in patients with active viral replication in amounts greater than 100,000 copies
Descripción

hbv dna

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3641250
UMLS CUI [1,2]
C0042774
3. hbeag is present in wild type hbv infection and suggests active replication
Descripción

hbeag

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019167
UMLS CUI [1,2]
C0042774
4. anti-hbs: antibody against hbsag appears after hbv infections and confers immunity
Descripción

anti-hbs antibodies

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201478
5. anti-hbc-igm: antibody against hbcag, fraction igm, present in acute infection and often could be detected during periods of high viral replication in chronic disease
Descripción

anti-hbc-igm

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4049590
UMLS CUI [1,2]
C0042774
6. anti-hbc-igg: is present in chronic disease
Descripción

anti-hbc-igg

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0312633
UMLS CUI [2]
C0008679
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Similar models

Eligibility Carcinoma, Hepatocellular NCT00243841

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Patient evaluation
Item
evaluation by the surgery and/or liver transplant team has been performed and the patient is not considered a candidate for either "standard" therapy to target area (upper abdomen)
boolean
C0679830 (UMLS CUI [1])
adequate liver function
Item
adequate liver function defined as:
boolean
C0232741 (UMLS CUI [1])
bilrubin, albumin
Item
total bilirubin < 3mg/dl, albumin > 2.5 g/dl
boolean
C0428441 (UMLS CUI [1])
C0728877 (UMLS CUI [2])
normal pt/ptt
Item
normal pt/ptt unless on anticoagulants
boolean
C0030605 (UMLS CUI [1])
mild elevation of liver enzymes
Item
mild elevation of liver enzymes acceptable (must be less than three times upper limit of normal)
boolean
C0235996 (UMLS CUI [1])
renal function
Item
adequate renal function (creatinine < 1.8 mg/dl or creatinine clearance ≥ 50 ml/min)
boolean
C0232804 (UMLS CUI [1])
C0600061 (UMLS CUI [2])
C0812399 (UMLS CUI [3])
bone marrow reserve
Item
adequate bone marrow reserve:
boolean
C0221130 (UMLS CUI [1])
anc count
Item
anc count ≥ 1500 mm3
boolean
C0948762 (UMLS CUI [1])
platelets
Item
platelets ≥ 50,000/mm3
boolean
C0005821 (UMLS CUI [1])
hemoglobin
Item
hemoglobin > 9 g/dl
boolean
C0019046 (UMLS CUI [1])
time of lab values
Item
note: lab values must be obtained within 2 weeks prior to being registered for protocol therapy.
boolean
C0022885 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
systemic lupus erythematous, rheumatoid arthritis, systemic sclerosis or scleroderma
Item
no history of systemic lupus erythematous, rheumatoid arthritis, systemic sclerosis or scleroderma
boolean
C0024141 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0036421 (UMLS CUI [3])
chemotherapy before radiotherapy
Item
no chemotherapy within 14 days before radiotherapy (chemotherapy may cause transient hepatitis with hepatomegaly)
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
subsequent chemotherapy
Item
no subsequent chemotherapy planned within 2 weeks of radiotherapy
boolean
C3846090 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
no active liver infection
Item
no active liver infection
boolean
C1112211 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
no acute hepatitis
Item
no acute hepatitis. definition of active disease:
boolean
C0744827 (UMLS CUI [1])
hepatitis a
Item
hepatitis a: acute hepatitis determined by presence of anti-hav-
boolean
C0019159 (UMLS CUI [1,1])
C0062524 (UMLS CUI [1,2])
hepatitis b
Item
hepatitis b:
boolean
C0019163 (UMLS CUI [1])
hbsag (hb surface antigen
Item
1. hbsag (hb surface antigen): present in patients with acute and chronic hepatitis
boolean
C0019168 (UMLS CUI [1])
hbv dna
Item
2. hbv dna present in patients with active viral replication in amounts greater than 100,000 copies
boolean
C3641250 (UMLS CUI [1,1])
C0042774 (UMLS CUI [1,2])
hbeag
Item
3. hbeag is present in wild type hbv infection and suggests active replication
boolean
C0019167 (UMLS CUI [1,1])
C0042774 (UMLS CUI [1,2])
anti-hbs antibodies
Item
4. anti-hbs: antibody against hbsag appears after hbv infections and confers immunity
boolean
C0201478 (UMLS CUI [1])
anti-hbc-igm
Item
5. anti-hbc-igm: antibody against hbcag, fraction igm, present in acute infection and often could be detected during periods of high viral replication in chronic disease
boolean
C4049590 (UMLS CUI [1,1])
C0042774 (UMLS CUI [1,2])
anti-hbc-igg
Item
6. anti-hbc-igg: is present in chronic disease
boolean
C0312633 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
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