ID

36466

Beschreibung

Aerobic Exercise and Flu-like Symptoms Following Interferon Beta 1a Injections in Patients With Multiple Sclerosis?; ODM derived from: https://clinicaltrials.gov/show/NCT02236624

Link

https://clinicaltrials.gov/show/NCT02236624

Stichworte

Versionen (1)
  1. 16.05.19 16.05.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

16. Mai 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02236624

Englisch

Eligibility Multiple Sclerosis NCT02236624

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
definite relapsing-remitting ms according to the mcdonald criteria
Beschreibung

Multiple Sclerosis, Relapsing-Remitting

Datentyp

boolean

Alias
UMLS CUI [1]
C0751967
treated with ifnß-1a (avonex®) for at least 6 months
Beschreibung

Interferon beta-1a | Avonex

Datentyp

boolean

Alias
UMLS CUI [1]
C0254119
UMLS CUI [2]
C0594372
frequent experiencing fls (muscle aches, chills, fatigue, fewer9) in the hours following ifnß-1a injection (self-reporting that this happens 75% or more of the times after injection).
Beschreibung

Influenza-like symptoms | Myalgia | Chills | Fatigue | Fever | Status post Interferon beta-1a Injection

Datentyp

boolean

Alias
UMLS CUI [1]
C0392171
UMLS CUI [2]
C0231528
UMLS CUI [3]
C0085593
UMLS CUI [4]
C0015672
UMLS CUI [5]
C0015967
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C4026102
female subjects of childbearing potential are required to practice effective contraception during the study and to continue contraception for 30 days after their last dose of study treatment.
Beschreibung

Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
expected to be able to complete the aerobic exercise intervention
Beschreibung

Aerobic Exercise Completion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001701
UMLS CUI [1,2]
C0205197
willingly to transport themselves to the exercise/testing facility
Beschreibung

Patient Transport Self Exercise Facility

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0150390
UMLS CUI [1,2]
C0036588
UMLS CUI [1,3]
C0015259
UMLS CUI [1,4]
C1547538
give informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
age above 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
have fls (i.e. muscle aches, chills, fatigue or fewer) or serious infection within a 24h period prior to the screening. patients having chronic fls or infection will, therefore, be excluded. this will be tested by patient interview and, if required, further examination
Beschreibung

Influenza-like symptoms Recent | Myalgia | Chills | Fatigue | Fever | Communicable Disease Serious Recent | Influenza-like symptoms chronic | Chronic infectious disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392171
UMLS CUI [1,2]
C0332185
UMLS CUI [2]
C0231528
UMLS CUI [3]
C0085593
UMLS CUI [4]
C0015672
UMLS CUI [5]
C0015967
UMLS CUI [6,1]
C0009450
UMLS CUI [6,2]
C0205404
UMLS CUI [6,3]
C0332185
UMLS CUI [7,1]
C0392171
UMLS CUI [7,2]
C0205191
UMLS CUI [8]
C0151317
have a known history or positive test result for hepatitis b, hepatitis c, or hiv
Beschreibung

Hepatitis B | Hepatitis C | HIV Infection | Hepatitis B test positive | Hepatitis C test positive | HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
UMLS CUI [4]
C1608966
UMLS CUI [5]
C1609517
UMLS CUI [6]
C0019699
use beta-blockers.
Beschreibung

Adrenergic beta-1 Receptor Antagonists

Datentyp

boolean

Alias
UMLS CUI [1]
C0304516
have clinically significant abnormality in laboratory or electrocardiogram measures, chronic fatigue syndrome or fibromyalgia, pre-malignant disease, or malignant disease
Beschreibung

Laboratory test result abnormal | ECG abnormal | Chronic Fatigue Syndrome | Fibromyalgia | Disease Premalignant | Malignant disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0522055
UMLS CUI [3]
C0015674
UMLS CUI [4]
C0016053
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C1514391
UMLS CUI [6]
C0442867
have had allergy shot or desensitization therapy within 1 month of day 1 (randomization) vaccination within 2 weeks of day 1.
Beschreibung

Allergy Shot | Desensitization therapy | Vaccination

Datentyp

boolean

Alias
UMLS CUI [1]
C1510857
UMLS CUI [2]
C0178702
UMLS CUI [3]
C0042196
stop taking ifnß-1a.
Beschreibung

Interferon beta-1a Discontinued

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0254119
UMLS CUI [1,2]
C1444662
are pregnant.
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
suffer from dementia, alcohol abuse or have a pacemaker.
Beschreibung

Dementia | Alcohol abuse | Artificial cardiac pacemaker

Datentyp

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0085762
UMLS CUI [3]
C0030163
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Ähnliche Modelle

Eligibility Multiple Sclerosis NCT02236624

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting
Item
definite relapsing-remitting ms according to the mcdonald criteria
boolean
C0751967 (UMLS CUI [1])
Interferon beta-1a | Avonex
Item
treated with ifnß-1a (avonex®) for at least 6 months
boolean
C0254119 (UMLS CUI [1])
C0594372 (UMLS CUI [2])
Influenza-like symptoms | Myalgia | Chills | Fatigue | Fever | Status post Interferon beta-1a Injection
Item
frequent experiencing fls (muscle aches, chills, fatigue, fewer9) in the hours following ifnß-1a injection (self-reporting that this happens 75% or more of the times after injection).
boolean
C0392171 (UMLS CUI [1])
C0231528 (UMLS CUI [2])
C0085593 (UMLS CUI [3])
C0015672 (UMLS CUI [4])
C0015967 (UMLS CUI [5])
C0231290 (UMLS CUI [6,1])
C4026102 (UMLS CUI [6,2])
Childbearing Potential Contraceptive methods
Item
female subjects of childbearing potential are required to practice effective contraception during the study and to continue contraception for 30 days after their last dose of study treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Aerobic Exercise Completion
Item
expected to be able to complete the aerobic exercise intervention
boolean
C0001701 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Patient Transport Self Exercise Facility
Item
willingly to transport themselves to the exercise/testing facility
boolean
C0150390 (UMLS CUI [1,1])
C0036588 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
C1547538 (UMLS CUI [1,4])
Informed Consent
Item
give informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
age above 18 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Influenza-like symptoms Recent | Myalgia | Chills | Fatigue | Fever | Communicable Disease Serious Recent | Influenza-like symptoms chronic | Chronic infectious disease
Item
have fls (i.e. muscle aches, chills, fatigue or fewer) or serious infection within a 24h period prior to the screening. patients having chronic fls or infection will, therefore, be excluded. this will be tested by patient interview and, if required, further examination
boolean
C0392171 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0231528 (UMLS CUI [2])
C0085593 (UMLS CUI [3])
C0015672 (UMLS CUI [4])
C0015967 (UMLS CUI [5])
C0009450 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C0332185 (UMLS CUI [6,3])
C0392171 (UMLS CUI [7,1])
C0205191 (UMLS CUI [7,2])
C0151317 (UMLS CUI [8])
Hepatitis B | Hepatitis C | HIV Infection | Hepatitis B test positive | Hepatitis C test positive | HIV Seropositivity
Item
have a known history or positive test result for hepatitis b, hepatitis c, or hiv
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C1608966 (UMLS CUI [4])
C1609517 (UMLS CUI [5])
C0019699 (UMLS CUI [6])
Adrenergic beta-1 Receptor Antagonists
Item
use beta-blockers.
boolean
C0304516 (UMLS CUI [1])
Laboratory test result abnormal | ECG abnormal | Chronic Fatigue Syndrome | Fibromyalgia | Disease Premalignant | Malignant disease
Item
have clinically significant abnormality in laboratory or electrocardiogram measures, chronic fatigue syndrome or fibromyalgia, pre-malignant disease, or malignant disease
boolean
C0438215 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
C0015674 (UMLS CUI [3])
C0016053 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C1514391 (UMLS CUI [5,2])
C0442867 (UMLS CUI [6])
Allergy Shot | Desensitization therapy | Vaccination
Item
have had allergy shot or desensitization therapy within 1 month of day 1 (randomization) vaccination within 2 weeks of day 1.
boolean
C1510857 (UMLS CUI [1])
C0178702 (UMLS CUI [2])
C0042196 (UMLS CUI [3])
Interferon beta-1a Discontinued
Item
stop taking ifnß-1a.
boolean
C0254119 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
Pregnancy
Item
are pregnant.
boolean
C0032961 (UMLS CUI [1])
Dementia | Alcohol abuse | Artificial cardiac pacemaker
Item
suffer from dementia, alcohol abuse or have a pacemaker.
boolean
C0497327 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
C0030163 (UMLS CUI [3])
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