ID

24659

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00501696

Palabras clave

Versiones (1)
  1. 12/8/17 12/8/17 -
Subido en

12 de agosto de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Multiple Sclerosis NCT00501696

Inglés

Eligibility Multiple Sclerosis NCT00501696

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Multiple Sclerosis

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

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

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

Tipo de datos

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
Descripción

Comprehension English Language

Tipo de datos

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
Descripción

Informed Consent

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Disease Modification Therapeutic procedure Absent

Tipo de datos

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
Descripción

Childbearing Potential Barrier Contraception

Tipo de datos

boolean

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

Exclusion Criteria

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

Disease Modification Therapeutic procedure Started

Tipo de datos

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
Descripción

Disease Modification Therapeutic procedure Planned

Tipo de datos

boolean

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

Pregnancy

Tipo de datos

boolean

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

Opioid Agonist chronic | Narcotics | Pharmaceutical Preparations Containing Codeine

Tipo de datos

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
Descripción

Age

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

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

Interferon | glatiramer acetate

Tipo de datos

boolean

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

Naltrexone Low dose

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Study Subject Participation Status | Multiple Sclerosis

Tipo de datos

boolean

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

Multiple Sclerosis Quality of Life-54 Instrument Questionnaire Comprehension Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3826975
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
Volver a la parte superior de la página

Similar models

Eligibility Multiple Sclerosis NCT00501696

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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