ID

27419

Beschrijving

N-AcetylCysteine vs. Placebo to Prevent Neurotoxicity Induced by Platinum Containing Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00637624

Link

https://clinicaltrials.gov/show/NCT00637624

Trefwoorden

  1. 14-11-17 14-11-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

14 november 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

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Eligibility Carcinoma, Non-Small-Cell Lung NCT00637624

Eligibility Carcinoma, Non-Small-Cell Lung NCT00637624

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnose is histologically or cytologically proven (nsclc,sclc), malignant mesothelioma (histologically)
Beschrijving

Non-Small Cell Lung Carcinoma | Small cell carcinoma of lung | Malignant mesothelioma

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C0149925
UMLS CUI [3]
C0345967
at least 4 cycles of cisplatin are planned
Beschrijving

Chemotherapy cycle Quantity Planned | Cisplatin

Datatype

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1301732
UMLS CUI [2]
C0008838
adequate renal function (creatinine clearance as calculated by cockroft-gault method > 60 ml/min)
Beschrijving

Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C2711451
karnofsky performance score > 60 %
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
patient must be able to comply with study measurements i.e. hospital visits for emg and qol assessments
Beschrijving

Protocol Compliance | Electromyography | Quality of life Assessment

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0013839
UMLS CUI [3,1]
C0034380
UMLS CUI [3,2]
C1516048
age ≥ 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with pre-existing neuropathy
Beschrijving

Neuropathy Pre-existing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C2347662
patients not willing to stop earlier prescribed nac
Beschrijving

NAC Discontinue Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001047
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0558080
patients not willing to stop vitamins e and a above daily advisory dosage
Beschrijving

Vitamin E Dosage Discontinue Unwilling | Vitamin A Dosage Discontinue Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042874
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1444662
UMLS CUI [1,4]
C0558080
UMLS CUI [2,1]
C0042839
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1444662
UMLS CUI [2,4]
C0558080
uncontrolled metastasis in the central or peripheral nervous system
Beschrijving

CNS metastases Uncontrolled | Metastases to peripheral nervous system Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0948131
UMLS CUI [2,2]
C0205318

Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT00637624

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | Small cell carcinoma of lung | Malignant mesothelioma
Item
diagnose is histologically or cytologically proven (nsclc,sclc), malignant mesothelioma (histologically)
boolean
C0007131 (UMLS CUI [1])
C0149925 (UMLS CUI [2])
C0345967 (UMLS CUI [3])
Chemotherapy cycle Quantity Planned | Cisplatin
Item
at least 4 cycles of cisplatin are planned
boolean
C1302181 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0008838 (UMLS CUI [2])
Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
adequate renal function (creatinine clearance as calculated by cockroft-gault method > 60 ml/min)
boolean
C0232804 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Karnofsky Performance Status
Item
karnofsky performance score > 60 %
boolean
C0206065 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance | Electromyography | Quality of life Assessment
Item
patient must be able to comply with study measurements i.e. hospital visits for emg and qol assessments
boolean
C0525058 (UMLS CUI [1])
C0013839 (UMLS CUI [2])
C0034380 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neuropathy Pre-existing
Item
patients with pre-existing neuropathy
boolean
C0442874 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
NAC Discontinue Unwilling
Item
patients not willing to stop earlier prescribed nac
boolean
C0001047 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Vitamin E Dosage Discontinue Unwilling | Vitamin A Dosage Discontinue Unwilling
Item
patients not willing to stop vitamins e and a above daily advisory dosage
boolean
C0042874 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C0558080 (UMLS CUI [1,4])
C0042839 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
CNS metastases Uncontrolled | Metastases to peripheral nervous system Uncontrolled
Item
uncontrolled metastasis in the central or peripheral nervous system
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0948131 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])

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