ID

21485

Beschrijving

D-cycloserine in the Management of Chemotherapy-Induced Peripheral Neuropathic Pain; ODM derived from: https://clinicaltrials.gov/show/NCT00301080

Link

https://clinicaltrials.gov/show/NCT00301080

Trefwoorden

Versies (1)
  1. 24-04-17 24-04-17 -
Geüploaded op

24 april 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Neurotoxicity NCT00301080

Engels

Eligibility Neurotoxicity NCT00301080

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients will be at least 18 years of age.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients will be experiencing moderate to severe peripheral neuropathic pain
Beschrijving

Peripheral neuropathic pain

Datatype

boolean

Alias
UMLS CUI [1]
C0458960
patients may be on chronic adjuvant pain medications such as antidepressants but must be on stable doses for at least one week prior to admission.
Beschrijving

Stable pain medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C0205360
patients may be taking concurrent opioids but they must be willing to allow us to monitor their opioid use while on the trial.
Beschrijving

Opioid Use

Datatype

boolean

Alias
UMLS CUI [1]
C0240602
patients must have chronic peripheral neuropathic pain will be defined as pain of 3 or more months duration which began in association with chemotherapy.
Beschrijving

Peripheral neuropathic pain associated with chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0458960
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0392920
patient's will have bilateral peripheral neuropathic pain symptoms primarily involving the feet
Beschrijving

Peripheral pain symptoms involving the feet

Datatype

boolean

Alias
UMLS CUI [1,1]
C0458960
UMLS CUI [1,2]
C0016504
patients must have breast cancer (any stage)
Beschrijving

Breast Cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
patients must be able to read and speak english and provide informed consent.
Beschrijving

Language ability and informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C1145677
UMLS CUI [2]
C0021430
patients may be receiving chemotherapy as long as the agents are not known to cause a peripheral neuropathy.
Beschrijving

Chemotherapy not causing peripheral neuropathy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C1518422
UMLS CUI [1,4]
C0031117
patients must have an ecog performance status < 3 and be able to attend the physician study visits
Beschrijving

ECOG Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
patients must not concurrently use gabapentin or pregabalin or must be willing to wean off their anti-convulsant medications prior to starting the trial.
Beschrijving

Gabapentin or pregabalin or anti-convulsant treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0060926
UMLS CUI [2]
C0657912
UMLS CUI [3]
C0003299
patients may have diabetes mellitus (type 1 or 2) as long as there is no preexisting neuropathy.
Beschrijving

Diabetes mellitus without neuropathy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011882
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will not have secondary cause of neuropathic pain including: hiv/aids,traumatic injury, or a personal history of non chemotherapy-induced neuropathy.
Beschrijving

Secondary cause of neuropathic pain

Datatype

boolean

Alias
UMLS CUI [1,1]
C3714625
UMLS CUI [1,2]
C0175668
patients will not have a history of major depression or severe anxiety.
Beschrijving

Major depression or severe anxiety

Datatype

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0231403
women of childbearing age will agree to take measures to prevent pregnancy and will not breast-feed while on the study medication. women who are currently pregnant will not be invited to participate in this study.
Beschrijving

Gynaecological Status

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients will not have a history of seizures.
Beschrijving

Seizures

Datatype

boolean

Alias
UMLS CUI [1]
C0036572
patients cannot be currently receiving antibiotic therapy for tuberculosis (e.g. isoniazid).
Beschrijving

Antibiotic therapy for tuberculosis

Datatype

boolean

Alias
UMLS CUI [1]
C0749724
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Similar models

Eligibility Neurotoxicity NCT00301080

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients will be at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Peripheral neuropathic pain
Item
patients will be experiencing moderate to severe peripheral neuropathic pain
boolean
C0458960 (UMLS CUI [1])
Stable pain medication
Item
patients may be on chronic adjuvant pain medications such as antidepressants but must be on stable doses for at least one week prior to admission.
boolean
C0002771 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Opioid Use
Item
patients may be taking concurrent opioids but they must be willing to allow us to monitor their opioid use while on the trial.
boolean
C0240602 (UMLS CUI [1])
Peripheral neuropathic pain associated with chemotherapy
Item
patients must have chronic peripheral neuropathic pain will be defined as pain of 3 or more months duration which began in association with chemotherapy.
boolean
C0458960 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Peripheral pain symptoms involving the feet
Item
patient's will have bilateral peripheral neuropathic pain symptoms primarily involving the feet
boolean
C0458960 (UMLS CUI [1,1])
C0016504 (UMLS CUI [1,2])
Breast Cancer
Item
patients must have breast cancer (any stage)
boolean
C0678222 (UMLS CUI [1])
Language ability and informed consent
Item
patients must be able to read and speak english and provide informed consent.
boolean
C1145677 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Chemotherapy not causing peripheral neuropathy
Item
patients may be receiving chemotherapy as long as the agents are not known to cause a peripheral neuropathy.
boolean
C0392920 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C1518422 (UMLS CUI [1,3])
C0031117 (UMLS CUI [1,4])
ECOG Performance Status
Item
patients must have an ecog performance status < 3 and be able to attend the physician study visits
boolean
C1520224 (UMLS CUI [1])
Gabapentin or pregabalin or anti-convulsant treatment
Item
patients must not concurrently use gabapentin or pregabalin or must be willing to wean off their anti-convulsant medications prior to starting the trial.
boolean
C0060926 (UMLS CUI [1])
C0657912 (UMLS CUI [2])
C0003299 (UMLS CUI [3])
Diabetes mellitus without neuropathy
Item
patients may have diabetes mellitus (type 1 or 2) as long as there is no preexisting neuropathy.
boolean
C0011849 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011882 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Secondary cause of neuropathic pain
Item
patients will not have secondary cause of neuropathic pain including: hiv/aids,traumatic injury, or a personal history of non chemotherapy-induced neuropathy.
boolean
C3714625 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
Major depression or severe anxiety
Item
patients will not have a history of major depression or severe anxiety.
boolean
C1269683 (UMLS CUI [1])
C0231403 (UMLS CUI [2])
Gynaecological Status
Item
women of childbearing age will agree to take measures to prevent pregnancy and will not breast-feed while on the study medication. women who are currently pregnant will not be invited to participate in this study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Seizures
Item
patients will not have a history of seizures.
boolean
C0036572 (UMLS CUI [1])
Antibiotic therapy for tuberculosis
Item
patients cannot be currently receiving antibiotic therapy for tuberculosis (e.g. isoniazid).
boolean
C0749724 (UMLS CUI [1])
Terug naar het begin van de pagina 

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