ID

24659

Descrizione

A Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose Naltrexone; ODM derived from: https://clinicaltrials.gov/show/NCT00501696

collegamento

https://clinicaltrials.gov/show/NCT00501696

Keywords

  1. 12/08/17 12/08/17 -
Caricato su

12 agosto 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0

Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Multiple Sclerosis NCT00501696

Eligibility Multiple Sclerosis NCT00501696

Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinically definite ms by current international criteria
Descrizione

Multiple Sclerosis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0026769
between 18 and 75 years of age
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
willingness to not change or start disease modifying or symptomatic therapies of ms during the trial
Descrizione

Disease Modification Therapeutic procedure Multiple Sclerosis | Therapeutic procedure Symptomatic Multiple Sclerosis | Therapeutic procedure Specified unchanged | Therapeutic procedure Specified Absent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3840684
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0026769
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C0026769
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0205369
UMLS CUI [3,3]
C0442739
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0205369
UMLS CUI [4,3]
C0332197
the patient should be able to understand english
Descrizione

Comprehension English Language

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0376245
the patients should read, understand and sign the study informed consent form prior to any participation in the study
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
patients currently on a disease modifying therapy should be on this medication for at least 3 months and not anticipate changing or discontinuing this medication during the 17 week study
Descrizione

Disease Modification Therapeutic procedure | Pharmaceutical Preparations unchanged | Pharmaceutical Preparations Discontinuation Absent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3840684
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0442739
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C0332197
patients not currently on a disease modifying therapy
Descrizione

Disease Modification Therapeutic procedure Absent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3840684
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0332197
for women of childbearing potential, willingness to use a barrier method of contraception during the trial
Descrizione

Childbearing Potential Barrier Contraception

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0004764
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
start of a disease modifying therapy within 3 months of entry in the trial
Descrizione

Disease Modification Therapeutic procedure Started

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3840684
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C1272689
planned start of dmt during the clinical trial
Descrizione

Disease Modification Therapeutic procedure Planned

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3840684
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C1301732
pregnancy
Descrizione

Pregnancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
current chronic opioid agonists use, i.e. any narcotic medication including hydroxycode and codeine-containing preparations
Descrizione

Opioid Agonist chronic | Narcotics | Pharmaceutical Preparations Containing Codeine

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1883695
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0027415
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0332256
UMLS CUI [3,3]
C0009214
patients under 18 years of age
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
patients older than 75 years prior to the start of therapy
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
patients who are currently on both interferon and glatiramer acetate
Descrizione

Interferon | glatiramer acetate

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3652465
UMLS CUI [2]
C0289884
patients who are currently taking ldn
Descrizione

Naltrexone Low dose

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0027360
UMLS CUI [1,2]
C0445550
patients who are currently taking immunosuppressive medications e.g. cyclophosphamide, mitoxantrone, azathioprine, methotrexate, mycophenolate mofetil, natalizumab, rituximab, alemtuzumab or other immune suppressants
Descrizione

Immunosuppressive Agents | Cyclophosphamide | Mitoxantrone | Azathioprine | Methotrexate | mycophenolate mofetil | natalizumab | rituximab | alemtuzumab

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0010583
UMLS CUI [3]
C0026259
UMLS CUI [4]
C0004482
UMLS CUI [5]
C0025677
UMLS CUI [6]
C0209368
UMLS CUI [7]
C1172734
UMLS CUI [8]
C0393022
UMLS CUI [9]
C0383429
participation in other clinical treatment trials in ms
Descrizione

Study Subject Participation Status | Multiple Sclerosis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0026769
the patients who cannot comprehend msqli54 instructions and
Descrizione

Multiple Sclerosis Quality of Life-54 Instrument Questionnaire Comprehension Unable

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3826975
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582

Similar models

Eligibility Multiple Sclerosis NCT00501696

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis
Item
clinically definite ms by current international criteria
boolean
C0026769 (UMLS CUI [1])
Age
Item
between 18 and 75 years of age
boolean
C0001779 (UMLS CUI [1])
Disease Modification Therapeutic procedure Multiple Sclerosis | Therapeutic procedure Symptomatic Multiple Sclerosis | Therapeutic procedure Specified unchanged | Therapeutic procedure Specified Absent
Item
willingness to not change or start disease modifying or symptomatic therapies of ms during the trial
boolean
C0012634 (UMLS CUI [1,1])
C3840684 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0026769 (UMLS CUI [1,4])
C0087111 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0026769 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0205369 (UMLS CUI [3,2])
C0442739 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0205369 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Comprehension English Language
Item
the patient should be able to understand english
boolean
C0233733 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Informed Consent
Item
the patients should read, understand and sign the study informed consent form prior to any participation in the study
boolean
C0021430 (UMLS CUI [1])
Disease Modification Therapeutic procedure | Pharmaceutical Preparations unchanged | Pharmaceutical Preparations Discontinuation Absent
Item
patients currently on a disease modifying therapy should be on this medication for at least 3 months and not anticipate changing or discontinuing this medication during the 17 week study
boolean
C0012634 (UMLS CUI [1,1])
C3840684 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Disease Modification Therapeutic procedure Absent
Item
patients not currently on a disease modifying therapy
boolean
C0012634 (UMLS CUI [1,1])
C3840684 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Childbearing Potential Barrier Contraception
Item
for women of childbearing potential, willingness to use a barrier method of contraception during the trial
boolean
C3831118 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Disease Modification Therapeutic procedure Started
Item
start of a disease modifying therapy within 3 months of entry in the trial
boolean
C0012634 (UMLS CUI [1,1])
C3840684 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1272689 (UMLS CUI [1,4])
Disease Modification Therapeutic procedure Planned
Item
planned start of dmt during the clinical trial
boolean
C0012634 (UMLS CUI [1,1])
C3840684 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Opioid Agonist chronic | Narcotics | Pharmaceutical Preparations Containing Codeine
Item
current chronic opioid agonists use, i.e. any narcotic medication including hydroxycode and codeine-containing preparations
boolean
C1883695 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0027415 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0009214 (UMLS CUI [3,3])
Age
Item
patients under 18 years of age
boolean
C0001779 (UMLS CUI [1])
Age
Item
patients older than 75 years prior to the start of therapy
boolean
C0001779 (UMLS CUI [1])
Interferon | glatiramer acetate
Item
patients who are currently on both interferon and glatiramer acetate
boolean
C3652465 (UMLS CUI [1])
C0289884 (UMLS CUI [2])
Naltrexone Low dose
Item
patients who are currently taking ldn
boolean
C0027360 (UMLS CUI [1,1])
C0445550 (UMLS CUI [1,2])
Immunosuppressive Agents | Cyclophosphamide | Mitoxantrone | Azathioprine | Methotrexate | mycophenolate mofetil | natalizumab | rituximab | alemtuzumab
Item
patients who are currently taking immunosuppressive medications e.g. cyclophosphamide, mitoxantrone, azathioprine, methotrexate, mycophenolate mofetil, natalizumab, rituximab, alemtuzumab or other immune suppressants
boolean
C0021081 (UMLS CUI [1])
C0010583 (UMLS CUI [2])
C0026259 (UMLS CUI [3])
C0004482 (UMLS CUI [4])
C0025677 (UMLS CUI [5])
C0209368 (UMLS CUI [6])
C1172734 (UMLS CUI [7])
C0393022 (UMLS CUI [8])
C0383429 (UMLS CUI [9])
Study Subject Participation Status | Multiple Sclerosis
Item
participation in other clinical treatment trials in ms
boolean
C2348568 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
Multiple Sclerosis Quality of Life-54 Instrument Questionnaire Comprehension Unable
Item
the patients who cannot comprehend msqli54 instructions and
boolean
C3826975 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial