ID

12805

Description

Therapeutic Interventions For Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL); ODM derived from: https://clinicaltrials.gov/show/NCT01506453

Link

https://clinicaltrials.gov/show/NCT01506453

Keywords

  1. 12/21/15 12/21/15 -
Uploaded on

December 21, 2015

DOI

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License

Creative Commons BY 4.0

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Eligibility Acute Lymphoblastic Leukemia NCT01506453

Eligibility Acute Lymphoblastic Leukemia NCT01506453

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant is enrolled on total xvi
Description

total xvi protocol

Data type

boolean

Alias
UMLS CUI [1]
C0949634
participant is 1 year of age or older
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
participant has symptoms of np/pn with onset no more than 7 days after one of the following vincristine doses: protocol week 1, week 2 (induction), week 7 (reinduction i), or week 17 (reinduction ii).
Description

neuropathic pain

Data type

boolean

Alias
UMLS CUI [1]
C0458960
patient is expected to receive 2 doses of vincristine in weekly intervals as outlined by the total xvi protocol while on study drug (i.e. no known dosage reductions or planned missed doses).
Description

treatment protocol

Data type

boolean

Alias
UMLS CUI [1]
C0949634
participant is able and willing to take oral medications.
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous participation in this study
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
participant is receiving gabapentin for another indication at the time of diagnosis of np/pn or has received gabapentin previously.
Description

participant is receiving gabapentin for another indication

Data type

boolean

Alias
UMLS CUI [1]
C0060926
UMLS CUI [2]
C0087111
pregnancy. female participants of childbearing potential must have documented negative urine or serum pregnancy test result not older than 7 days. male patients with reproductive potential will be counseled not to procreate during the study.
Description

pregnancy test negative , Contraception

Data type

boolean

Alias
UMLS CUI [1]
C0427780
UMLS CUI [2]
C0700589
impaired renal function: decreased egfr (<60ml/min/1.73m^2 as estimated by the revised schwartz equation)
Description

impaired renal function

Data type

boolean

Alias
UMLS CUI [1]
C0151746
participant has allergy or other contraindication for either morphine or gabapentin therapy.
Description

participant has allergy or other contraindication for either morphine or gabapentin therapy

Data type

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C0026549
UMLS CUI [3]
C0060926
inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430

Similar models

Eligibility Acute Lymphoblastic Leukemia NCT01506453

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
total xvi protocol
Item
participant is enrolled on total xvi
boolean
C0949634 (UMLS CUI [1])
age
Item
participant is 1 year of age or older
boolean
C0001779 (UMLS CUI [1])
neuropathic pain
Item
participant has symptoms of np/pn with onset no more than 7 days after one of the following vincristine doses: protocol week 1, week 2 (induction), week 7 (reinduction i), or week 17 (reinduction ii).
boolean
C0458960 (UMLS CUI [1])
treatment protocol
Item
patient is expected to receive 2 doses of vincristine in weekly intervals as outlined by the total xvi protocol while on study drug (i.e. no known dosage reductions or planned missed doses).
boolean
C0949634 (UMLS CUI [1])
compliance
Item
participant is able and willing to take oral medications.
boolean
C1321605 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
study subject participation status
Item
previous participation in this study
boolean
C2348568 (UMLS CUI [1])
participant is receiving gabapentin for another indication
Item
participant is receiving gabapentin for another indication at the time of diagnosis of np/pn or has received gabapentin previously.
boolean
C0060926 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
pregnancy test negative , Contraception
Item
pregnancy. female participants of childbearing potential must have documented negative urine or serum pregnancy test result not older than 7 days. male patients with reproductive potential will be counseled not to procreate during the study.
boolean
C0427780 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
impaired renal function
Item
impaired renal function: decreased egfr (<60ml/min/1.73m^2 as estimated by the revised schwartz equation)
boolean
C0151746 (UMLS CUI [1])
participant has allergy or other contraindication for either morphine or gabapentin therapy
Item
participant has allergy or other contraindication for either morphine or gabapentin therapy.
boolean
C0020517 (UMLS CUI [1])
C0026549 (UMLS CUI [2])
C0060926 (UMLS CUI [3])
informed consent
Item
inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
boolean
C0021430 (UMLS CUI [1])

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