ID

39086

Beskrivning

Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01622439

Länk

https://clinicaltrials.gov/show/NCT01622439

Nyckelord

Versioner (1)
  1. 2019-11-29 2019-11-29 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

29 november 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diffuse Large B-cell Lymphoma NCT01622439

Engelsk

Eligibility Diffuse Large B-cell Lymphoma NCT01622439

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-80 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed (according to the who classification) diffuse large b-cell lymphoma stage ii-iv
Beskrivning

Diffuse Large B-Cell Lymphoma WHO tumor classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C1301142
no previous treatment for lymphoma. corticosteroids for alleviation of lymphoma associated symptoms are allowed
Beskrivning

Prior Therapy Absent Lymphoma | Adrenal Cortex Hormones Mitigation Intent allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0024299
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1706602
UMLS CUI [2,3]
C0683607
who performance status 0-2
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
hiv negativity
Beskrivning

HIV negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0481430
seronegativity for hcv, hbsag, anti-hbc, or other active infection uncontrolled by treatment
Beskrivning

Hepatitis C virus Seronegative | Hepatitis B Surface Antigens Seronegative | Anti-HBc antibody Seronegative | Infection Uncontrolled Seronegative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220847
UMLS CUI [1,2]
C0521144
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0521144
UMLS CUI [3,1]
C0948759
UMLS CUI [3,2]
C0521144
UMLS CUI [4,1]
C3714514
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C0521144
absence of psychiatric illness or condition which could interfere with the subjects ability understand the requirements of the study
Beskrivning

Mental disorders Absent | Interference Comprehension Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C0162340
UMLS CUI [2,3]
C2348563
absence of neurological or neuropsychiatric disorder, interfering with the requirements of the study
Beskrivning

Nervous system disorder Absent | Neuropsychiatric syndrome Absent | Interference Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3203509
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C0525058
absence of hearing impairment > grade 2
Beskrivning

Absence Hearing impairment CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1384666
UMLS CUI [1,3]
C1516728
absence of porphyria
Beskrivning

Porphyria Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3463940
UMLS CUI [1,2]
C0332197
in females: absence of pregnancy and lactation
Beskrivning

Gender | Pregnancy Absent | Breast Feeding Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
all subjects must agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy
Beskrivning

Blood Donation Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0332197
all subjects must agree not to share study medication with another person, and to return all unused study drug to investigators
Beskrivning

Medication Sharing Absent | Investigational New Drugs Unused Return to Research Personnel

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0237876
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0445107
UMLS CUI [2,3]
C0332156
UMLS CUI [2,4]
C0035173
written informed concent according to ich/gcp and swedish regulations
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Diffuse Large B-cell Lymphoma NCT01622439

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-80 years
boolean
C0001779 (UMLS CUI [1])
Diffuse Large B-Cell Lymphoma WHO tumor classification
Item
histologically confirmed (according to the who classification) diffuse large b-cell lymphoma stage ii-iv
boolean
C0079744 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
Prior Therapy Absent Lymphoma | Adrenal Cortex Hormones Mitigation Intent allowed
Item
no previous treatment for lymphoma. corticosteroids for alleviation of lymphoma associated symptoms are allowed
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C1706602 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
WHO performance status scale
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
HIV negative
Item
hiv negativity
boolean
C0481430 (UMLS CUI [1])
Hepatitis C virus Seronegative | Hepatitis B Surface Antigens Seronegative | Anti-HBc antibody Seronegative | Infection Uncontrolled Seronegative
Item
seronegativity for hcv, hbsag, anti-hbc, or other active infection uncontrolled by treatment
boolean
C0220847 (UMLS CUI [1,1])
C0521144 (UMLS CUI [1,2])
C0019168 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
C0948759 (UMLS CUI [3,1])
C0521144 (UMLS CUI [3,2])
C3714514 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0521144 (UMLS CUI [4,3])
Mental disorders Absent | Interference Comprehension Study Protocol
Item
absence of psychiatric illness or condition which could interfere with the subjects ability understand the requirements of the study
boolean
C0004936 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0521102 (UMLS CUI [2,1])
C0162340 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
Nervous system disorder Absent | Neuropsychiatric syndrome Absent | Interference Protocol Compliance
Item
absence of neurological or neuropsychiatric disorder, interfering with the requirements of the study
boolean
C0027765 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3203509 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0521102 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
Absence Hearing impairment CTCAE Grades
Item
absence of hearing impairment > grade 2
boolean
C0332197 (UMLS CUI [1,1])
C1384666 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Porphyria Absent
Item
absence of porphyria
boolean
C3463940 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Gender | Pregnancy Absent | Breast Feeding Absent
Item
in females: absence of pregnancy and lactation
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Blood Donation Absent
Item
all subjects must agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy
boolean
C0005794 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Medication Sharing Absent | Investigational New Drugs Unused Return to Research Personnel
Item
all subjects must agree not to share study medication with another person, and to return all unused study drug to investigators
boolean
C0013227 (UMLS CUI [1,1])
C0237876 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2,1])
C0445107 (UMLS CUI [2,2])
C0332156 (UMLS CUI [2,3])
C0035173 (UMLS CUI [2,4])
Informed Consent
Item
written informed concent according to ich/gcp and swedish regulations
boolean
C0021430 (UMLS CUI [1])
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