ID

21485

Beschreibung

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

Stichworte

Versionen (1)
  1. 24.04.17 24.04.17 -
Hochgeladen am

24. April 2017

DOI

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Creative Commons BY 4.0
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Eligibility Neurotoxicity NCT00301080

Englisch

Eligibility Neurotoxicity NCT00301080

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

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

Peripheral neuropathic pain

Datentyp

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.
Beschreibung

Stable pain medication

Datentyp

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.
Beschreibung

Opioid Use

Datentyp

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.
Beschreibung

Peripheral neuropathic pain associated with chemotherapy

Datentyp

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
Beschreibung

Peripheral pain symptoms involving the feet

Datentyp

boolean

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

Breast Cancer

Datentyp

boolean

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

Language ability and informed consent

Datentyp

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.
Beschreibung

Chemotherapy not causing peripheral neuropathy

Datentyp

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
Beschreibung

ECOG Performance Status

Datentyp

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.
Beschreibung

Gabapentin or pregabalin or anti-convulsant treatment

Datentyp

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.
Beschreibung

Diabetes mellitus without neuropathy

Datentyp

boolean

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

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.
Beschreibung

Secondary cause of neuropathic pain

Datentyp

boolean

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

Major depression or severe anxiety

Datentyp

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.
Beschreibung

Gynaecological Status

Datentyp

boolean

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

Seizures

Datentyp

boolean

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

Antibiotic therapy for tuberculosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0749724
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Ähnliche Modelle

Eligibility Neurotoxicity NCT00301080

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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