ID

36471

Description

Efficacy Study of "Imaginative Distention", a Self Managed Tool to Cope With Fatigue,Insomnia and Stress in pw Insomnia and pw MS; ODM derived from: https://clinicaltrials.gov/show/NCT02290990

Link

https://clinicaltrials.gov/show/NCT02290990

Keywords

Versions (1)
  1. 5/16/19 5/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 16, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02290990

English

Eligibility Multiple Sclerosis NCT02290990

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
any gender, ethnicity
Description

Gender | Ethnicity

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0015031
aged 18-65 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ability to understand italian to be able to conduct the study
Description

Comprehension Italian language

Data type

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0022275
adherence to the study by written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
absence of serious internal medicine and psychiatric comorbidities
Description

Absence Comorbidity Serious Internal medicine | Absence Comorbidity Psychiatric Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0009488
UMLS CUI [1,3]
C0205404
UMLS CUI [1,4]
C0021782
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0009488
UMLS CUI [2,3]
C0205487
UMLS CUI [2,4]
C0205404
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
under 18 and above 65 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
lack of understanding italian to conduct of the studies
Description

Lacking Comprehension Italian language

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0233733
UMLS CUI [1,3]
C0022275
inability to provide informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
presence of severe internal medicine and psychiatric comorbidities
Description

Comorbidity Severe Internal medicine | Comorbidity Psychiatric Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0021782
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205487
UMLS CUI [2,3]
C0205082
specific criteria for inclusion:
Description

Inclusion criteria Specific

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205369
pw ms:
Description

Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0026769
diagnosis according to the criteria of polman, 2011: relapsing remitting or progressive (primary and secondary)
Description

Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive

Data type

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2]
C0751964
UMLS CUI [3]
C0751965
or in no specific drug therapy for the disease and symptomatic
Description

Absence Pharmacotherapy Specific Disease | Multiple Sclerosis Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C0205369
UMLS CUI [1,4]
C0012634
UMLS CUI [2,1]
C0026769
UMLS CUI [2,2]
C0231220
pw insomnia:
Description

Sleeplessness

Data type

boolean

Alias
UMLS CUI [1]
C0917801
diagnosis of psychophysiological insomnia according to dsm iv
Description

Psychophysiologic insomnia

Data type

boolean

Alias
UMLS CUI [1]
C1960036
or in no specific drug therapy for the disease and symptomatic
Description

Absence Pharmacotherapy Specific Disease | Insomnia Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C0205369
UMLS CUI [1,4]
C0012634
UMLS CUI [2,1]
C0917801
UMLS CUI [2,2]
C0231220
healthy professionals:
Description

Professionals Healthy

Data type

boolean

Alias
UMLS CUI [1,1]
C0679924
UMLS CUI [1,2]
C3898900
healthy personnel operating within the niguarda hospital
Description

Hospital Personnel Healthy

Data type

boolean

Alias
UMLS CUI [1,1]
C0031228
UMLS CUI [1,2]
C3898900
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Similar models

Eligibility Multiple Sclerosis NCT02290990

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Ethnicity
Item
any gender, ethnicity
boolean
C0079399 (UMLS CUI [1])
C0015031 (UMLS CUI [2])
Age
Item
aged 18-65 years
boolean
C0001779 (UMLS CUI [1])
Comprehension Italian language
Item
ability to understand italian to be able to conduct the study
boolean
C0233733 (UMLS CUI [1,1])
C0022275 (UMLS CUI [1,2])
Informed Consent
Item
adherence to the study by written informed consent
boolean
C0021430 (UMLS CUI [1])
Absence Comorbidity Serious Internal medicine | Absence Comorbidity Psychiatric Serious
Item
absence of serious internal medicine and psychiatric comorbidities
boolean
C0332197 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0021782 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0009488 (UMLS CUI [2,2])
C0205487 (UMLS CUI [2,3])
C0205404 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Age
Item
under 18 and above 65 years
boolean
C0001779 (UMLS CUI [1])
Lacking Comprehension Italian language
Item
lack of understanding italian to conduct of the studies
boolean
C0332268 (UMLS CUI [1,1])
C0233733 (UMLS CUI [1,2])
C0022275 (UMLS CUI [1,3])
Informed Consent Unable
Item
inability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Comorbidity Severe Internal medicine | Comorbidity Psychiatric Severe
Item
presence of severe internal medicine and psychiatric comorbidities
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0021782 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0205487 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
Inclusion criteria Specific
Item
specific criteria for inclusion:
boolean
C1512693 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Multiple Sclerosis
Item
pw ms:
boolean
C0026769 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive
Item
diagnosis according to the criteria of polman, 2011: relapsing remitting or progressive (primary and secondary)
boolean
C0751967 (UMLS CUI [1])
C0751964 (UMLS CUI [2])
C0751965 (UMLS CUI [3])
Absence Pharmacotherapy Specific Disease | Multiple Sclerosis Symptomatic
Item
or in no specific drug therapy for the disease and symptomatic
boolean
C0332197 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
C0026769 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Sleeplessness
Item
pw insomnia:
boolean
C0917801 (UMLS CUI [1])
Psychophysiologic insomnia
Item
diagnosis of psychophysiological insomnia according to dsm iv
boolean
C1960036 (UMLS CUI [1])
Absence Pharmacotherapy Specific Disease | Insomnia Symptomatic
Item
or in no specific drug therapy for the disease and symptomatic
boolean
C0332197 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
C0917801 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Professionals Healthy
Item
healthy professionals:
boolean
C0679924 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
Hospital Personnel Healthy
Item
healthy personnel operating within the niguarda hospital
boolean
C0031228 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
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