ID

14314

Beskrivning

Oxaliplatin in Cancer Patients With Impaired Kidney Function; ODM derived from: https://clinicaltrials.gov/show/NCT00001835

Länk

https://clinicaltrials.gov/show/NCT00001835

Nyckelord

Versioner (1)
  1. 2016-04-10 2016-04-10 -
Uppladdad den

10 april 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Kidney Disease NCT00001835

Engelsk

Eligibility Kidney Disease NCT00001835

1 Formulär  
Criteria
Beskrivning

Criteria

patients with prior chemotherapy, radiation therapy, hormonal therapy and immunotherapy are allowed with the exception that patients cannot have had prior treatment with oxaliplatin.
Beskrivning

Prior treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0021083
UMLS CUI [5,1]
C0332300
UMLS CUI [5,2]
C0069717
patients greater than or equal to 18 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patients must have an ecog performance status less than or equal to 2 (karnofsky greater than or equal to 60 percent) and a life expectancy of at least 3 months.
Beskrivning

Performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
UMLS CUI [3]
C0023671
patients must have adequate organ and marrow function which includes:
Beskrivning

Organ and marrow function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0542341
leukocytes must be greater than or equal to 3,000/microliter.
Beskrivning

Leukocytes count

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count must be greater than or equal to 1,500/microliter.
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet count must be greater than or equal to 100,000/microliter.
Beskrivning

Platelet count

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin within normal institutional limits.
Beskrivning

Total bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C0201913
ast (sgot)/alt(sgpt) less than or equal to 1.5 times the upper limit of normal.
Beskrivning

Ast (sgot)/alt(sgpt)

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
patients with no evidence of clinically significant neuropathy.
Beskrivning

Neuropathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0442874
women of child-bearing potential and men must agree to use adequate contraception.
Beskrivning

Contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
patients must have the ability to understand and the willingness to sign a written informed consent document.
Beskrivning

Written informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study, or within 6 weeks of prior platinum therapy will be excluded.
Beskrivning

Prior treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C2266918
UMLS CUI [4]
C2348558
patients undergoing therapy with other investigational agents will be excluded.
Beskrivning

Investigational agents

Datatyp

boolean

Alias
UMLS CUI [1]
C1875319
patients with known brain metastases will be excluded.
Beskrivning

Brain metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
patients with a history of an allergy to platinum compounds will be excluded.
Beskrivning

Allergy to platinum compounds

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2266854
patients with uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia will be excluded.
Beskrivning

Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
women must not be pregnant or nursing.
Beskrivning

Gynaecological status

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients must not be hiv-positive or receiving anti-retroviral therapy (haart).
Beskrivning

HIV and anti-retroviral therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0887947
patients actively receiving renal dialysis treatments while on the study will be excluded.
Beskrivning

Renal dialysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0011946
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Similar models

Eligibility Kidney Disease NCT00001835

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Prior treatment
Item
patients with prior chemotherapy, radiation therapy, hormonal therapy and immunotherapy are allowed with the exception that patients cannot have had prior treatment with oxaliplatin.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0332300 (UMLS CUI [5,1])
C0069717 (UMLS CUI [5,2])
Age
Item
patients greater than or equal to 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Performance status
Item
patients must have an ecog performance status less than or equal to 2 (karnofsky greater than or equal to 60 percent) and a life expectancy of at least 3 months.
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
Organ and marrow function
Item
patients must have adequate organ and marrow function which includes:
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0542341 (UMLS CUI [2,2])
Leukocytes count
Item
leukocytes must be greater than or equal to 3,000/microliter.
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count must be greater than or equal to 1,500/microliter.
boolean
C0948762 (UMLS CUI [1])
Platelet count
Item
platelet count must be greater than or equal to 100,000/microliter.
boolean
C0032181 (UMLS CUI [1])
Total bilirubin
Item
total bilirubin within normal institutional limits.
boolean
C0201913 (UMLS CUI [1])
Ast (sgot)/alt(sgpt)
Item
ast (sgot)/alt(sgpt) less than or equal to 1.5 times the upper limit of normal.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Neuropathy
Item
patients with no evidence of clinically significant neuropathy.
boolean
C0442874 (UMLS CUI [1])
Contraception
Item
women of child-bearing potential and men must agree to use adequate contraception.
boolean
C0700589 (UMLS CUI [1])
Written informed consent
Item
patients must have the ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Prior treatment
Item
patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study, or within 6 weeks of prior platinum therapy will be excluded.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C2266918 (UMLS CUI [3])
C2348558 (UMLS CUI [4])
Investigational agents
Item
patients undergoing therapy with other investigational agents will be excluded.
boolean
C1875319 (UMLS CUI [1])
Brain metastases
Item
patients with known brain metastases will be excluded.
boolean
C0220650 (UMLS CUI [1])
Allergy to platinum compounds
Item
patients with a history of an allergy to platinum compounds will be excluded.
boolean
C0020517 (UMLS CUI [1,1])
C2266854 (UMLS CUI [1,2])
Comorbidity
Item
patients with uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia will be excluded.
boolean
C0009488 (UMLS CUI [1])
Gynaecological status
Item
women must not be pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV and anti-retroviral therapy
Item
patients must not be hiv-positive or receiving anti-retroviral therapy (haart).
boolean
C0019699 (UMLS CUI [1])
C0887947 (UMLS CUI [2])
Renal dialysis
Item
patients actively receiving renal dialysis treatments while on the study will be excluded.
boolean
C0011946 (UMLS CUI [1])
Tillbaka till toppen 

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