ID

13199

Beschreibung

EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00006436

Link

https://clinicaltrials.gov/show/NCT00006436

Stichworte

Versionen (1)
  1. 23.01.16 23.01.16 -
Hochgeladen am

23. Januar 2016

DOI

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Creative Commons BY 4.0
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Eligibility Lymphoma, AIDS-related NCT00006436

Englisch

Eligibility Lymphoma, AIDS-related NCT00006436

1 Formulare  
Criteria
Beschreibung

Criteria

aggressive cd20 positive diffuse large b-cell lymphoma confirmed by laboratory of pathology, nci.
Beschreibung

pathology

Datentyp

boolean

Alias
UMLS CUI [1]
C0030664
UMLS CUI [2]
C0054946
UMLS CUI [3]
C0079744
UMLS CUI [4]
C1332225
hiv + serology.
Beschreibung

hiv

Datentyp

boolean

Alias
UMLS CUI [1]
C0019682
all stages (i-iv) of disease.
Beschreibung

disease stage

Datentyp

boolean

Alias
UMLS CUI [1]
C0699749
ecog performance status 0-4
Beschreibung

ecog

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
nhl previously untreated with cytotoxic chemotherapy.
Beschreibung

chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0024305
age greater than or equal to 18 years
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than or equal to 50 ml/min
Beschreibung

creatinine

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
bilirubin less than 2.0 mg/dl, or total bilirubin less than or equal to 4.5 mg/dl with direct fraction less than or equal to 0.3 mg/dl in patients for whom these abnormalities are felt to be due to protease inhibitor therapy
Beschreibung

bilirubin

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
ast and alt less than or equal to 3x uln (ast and alt less than or equal to 6x uln for patients on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation)
Beschreibung

ast, alt

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
anc greater than or equal to 1000/mm(3)
Beschreibung

anc

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet greater than or equal to 75,000/mm(3) (unless impairment due to itp)
Beschreibung

platelet count

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
ability of patient to provide informed consent.
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous rituximab
Beschreibung

rituximab

Datentyp

boolean

Alias
UMLS CUI [1]
C0393022
pregnancy or nursing.
Beschreibung

pregnancy, lactation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
doxorubicin, etoposide, vincristine and cyclophosphamide are teratogenic and may be excreted in milk.
Beschreibung

doxorubicin, etoposide, vincristine and cyclophosphamide

Datentyp

boolean

Alias
UMLS CUI [1]
C0013089
UMLS CUI [2]
C0015133
UMLS CUI [3]
C0042679
UMLS CUI [4]
C0010583
antiretroviral therapy is indicated during pregnancy and nursing.
Beschreibung

antiretroviral therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1963724
current clinical heart failure or symptomatic ischemic heart disease.
Beschreibung

heart disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
serious underlying medical condition or infection other than hiv that would contraindicate sc-epoch-r.
Beschreibung

comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
severe aids-related wasting
Beschreibung

aids-related wasting

Datentyp

boolean

Alias
UMLS CUI [1]
C0343755
sever intractable diarrhea
Beschreibung

diarrhea

Datentyp

boolean

Alias
UMLS CUI [1]
C0011991
active inadequately treated opportunistic infection of the cns
Beschreibung

opportunistic infection cns

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007684
UMLS CUI [1,2]
C0029118
concurrent anti-retroviral therapy during epoch therapy.
Beschreibung

antiretroviral therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1963724
primary cns lymphoma.
Beschreibung

primary cns lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0280803
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Ähnliche Modelle

Eligibility Lymphoma, AIDS-related NCT00006436

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
pathology
Item
aggressive cd20 positive diffuse large b-cell lymphoma confirmed by laboratory of pathology, nci.
boolean
C0030664 (UMLS CUI [1])
C0054946 (UMLS CUI [2])
C0079744 (UMLS CUI [3])
C1332225 (UMLS CUI [4])
hiv
Item
hiv + serology.
boolean
C0019682 (UMLS CUI [1])
disease stage
Item
all stages (i-iv) of disease.
boolean
C0699749 (UMLS CUI [1])
ecog
Item
ecog performance status 0-4
boolean
C1520224 (UMLS CUI [1])
chemotherapy
Item
nhl previously untreated with cytotoxic chemotherapy.
boolean
C0392920 (UMLS CUI [1])
C0024305 (UMLS CUI [2])
age
Item
age greater than or equal to 18 years
boolean
C0001779 (UMLS CUI [1])
creatinine
Item
creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than or equal to 50 ml/min
boolean
C0201976 (UMLS CUI [1])
bilirubin
Item
bilirubin less than 2.0 mg/dl, or total bilirubin less than or equal to 4.5 mg/dl with direct fraction less than or equal to 0.3 mg/dl in patients for whom these abnormalities are felt to be due to protease inhibitor therapy
boolean
C1278039 (UMLS CUI [1])
ast, alt
Item
ast and alt less than or equal to 3x uln (ast and alt less than or equal to 6x uln for patients on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
anc
Item
anc greater than or equal to 1000/mm(3)
boolean
C0948762 (UMLS CUI [1])
platelet count
Item
platelet greater than or equal to 75,000/mm(3) (unless impairment due to itp)
boolean
C0032181 (UMLS CUI [1])
informed consent
Item
ability of patient to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
rituximab
Item
previous rituximab
boolean
C0393022 (UMLS CUI [1])
pregnancy, lactation
Item
pregnancy or nursing.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
doxorubicin, etoposide, vincristine and cyclophosphamide
Item
doxorubicin, etoposide, vincristine and cyclophosphamide are teratogenic and may be excreted in milk.
boolean
C0013089 (UMLS CUI [1])
C0015133 (UMLS CUI [2])
C0042679 (UMLS CUI [3])
C0010583 (UMLS CUI [4])
antiretroviral therapy
Item
antiretroviral therapy is indicated during pregnancy and nursing.
boolean
C1963724 (UMLS CUI [1])
heart disease
Item
current clinical heart failure or symptomatic ischemic heart disease.
boolean
C0018799 (UMLS CUI [1])
comorbidity
Item
serious underlying medical condition or infection other than hiv that would contraindicate sc-epoch-r.
boolean
C0009488 (UMLS CUI [1])
aids-related wasting
Item
severe aids-related wasting
boolean
C0343755 (UMLS CUI [1])
diarrhea
Item
sever intractable diarrhea
boolean
C0011991 (UMLS CUI [1])
opportunistic infection cns
Item
active inadequately treated opportunistic infection of the cns
boolean
C0007684 (UMLS CUI [1,1])
C0029118 (UMLS CUI [1,2])
antiretroviral therapy
Item
concurrent anti-retroviral therapy during epoch therapy.
boolean
C1963724 (UMLS CUI [1])
primary cns lymphoma
Item
primary cns lymphoma.
boolean
C0280803 (UMLS CUI [1])
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