ID

30930

Beskrivning

The Effects of Erythropoietin on Clinical Disability and Brain Pathology in Patients With Progressive Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT01144117

Länk

https://clinicaltrials.gov/show/NCT01144117

Nyckelord

Versioner (1)
  1. 2018-07-03 2018-07-03 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

3 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis (Primary or Secondary Progressive Phase). NCT01144117

Engelsk

Eligibility Multiple Sclerosis (Primary or Secondary Progressive Phase). NCT01144117

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age between 19 and 60 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
primary progressive ms or secondary progressive ms without relapses during the last one year
Beskrivning

Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Relapses Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0751964
UMLS CUI [2]
C0751965
UMLS CUI [3,1]
C0035020
UMLS CUI [3,2]
C0332197
duration of the disease of at least 2 years clinical disability progression should have been observed in the 2 years prior to screening as per clinical judgment of the investigator. in addition, progression must be documented by an increase in the edss score of at least 0.5 points at any time during the 2 years prior to screening; or progression of 1 point in the pyramidal, cerebellar, brain stem , visual or sensory functional system during the last 2 years. should documented edss scores not be available, a written summary of the clinical evidence of disability progression in the previous 2 years must be submitted (for example walking distance or hand function).
Beskrivning

Disease length | Disability Progressive | Disease Progression EDSS | Disease Progression Pyramidal system | Disease Progression System Cerebellar | Disease Progression Brain Stem | Disease Progression Visual system | Disease Progression Sensory system function | Walking distance reduced | Hand function disability

Datatyp

boolean

Alias
UMLS CUI [1]
C0872146
UMLS CUI [2,1]
C0231170
UMLS CUI [2,2]
C0205329
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0451246
UMLS CUI [4,1]
C0242656
UMLS CUI [4,2]
C0228060
UMLS CUI [5,1]
C0242656
UMLS CUI [5,2]
C0449913
UMLS CUI [5,3]
C0007765
UMLS CUI [6,1]
C0242656
UMLS CUI [6,2]
C0006121
UMLS CUI [7,1]
C0242656
UMLS CUI [7,2]
C3536733
UMLS CUI [8,1]
C0242656
UMLS CUI [8,2]
C0036658
UMLS CUI [9]
C0424550
UMLS CUI [10]
C0556293
edss (expanded disability status scale) 4.0-6.5
Beskrivning

EDSS

Datatyp

boolean

Alias
UMLS CUI [1]
C0451246
mri fulfilling the barkhof criteria for ms
Beskrivning

MRI Criteria Fulfill | Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
UMLS CUI [2]
C0026769
written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or period of breastfeeding or missing adequate contraceptive protection
Beskrivning

Pregnancy | Breast Feeding Period | Contraceptive methods Missing

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C1948053
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C1705492
treatment with steroids in the last 30 days
Beskrivning

Steroid therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0149783
treatment with interferons, glatiramer acetate or ivig in the last1 month prior to enrolment
Beskrivning

Interferons | glatiramer acetate | Immunoglobulins, Intravenous

Datatyp

boolean

Alias
UMLS CUI [1]
C0021747
UMLS CUI [2]
C0289884
UMLS CUI [3]
C0085297
treatment with azathioprin, mitoxantrone or any other immuno-suppressive in the 6 months prior to enrolment
Beskrivning

Azathioprine | Mitoxantrone | Immunosuppressive Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0004482
UMLS CUI [2]
C0026259
UMLS CUI [3]
C0021081
cardiac insufficiency (nyha iii/iv), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, instable or advanced ischemic heart disease (ccs iii or iv), malignant hypertension (systolic > 180, diastolic > 110)
Beskrivning

Heart insuffiency New York Heart Association Classification | Cardiomyopathy | Cardiac Arrhythmia Treatment required for | Myocardial Ischemia Unstable CCS Class | Myocardial Ischemia Advanced CCS Class | Malignant Hypertension | Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392173
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0878544
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0332121
UMLS CUI [4,1]
C0151744
UMLS CUI [4,2]
C0443343
UMLS CUI [4,3]
C1879987
UMLS CUI [5,1]
C0151744
UMLS CUI [5,2]
C0205179
UMLS CUI [5,3]
C1879987
UMLS CUI [6]
C0020540
UMLS CUI [7]
C0871470
UMLS CUI [8]
C0428883
history of any haematological disorder
Beskrivning

Hematological Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0018939
history of renal insufficiency
Beskrivning

Renal Insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
any medical psychiatric or other circumstances which impede or restrict the subjects participation in the study in the manner intended
Beskrivning

Mental condition Interferes with Study Subject Participation Status | Condition Interferes with Study Subject Participation Status | Mental condition Study Subject Participation Status Limited | Condition Study Subject Participation Status Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0439801
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C0439801
contraindication for contrast enhanced mri (e.g. pace maker, aortic clip or any metal implant)
Beskrivning

Medical contraindication MRI with contrast | Artificial cardiac pacemaker | Clip Aortic | Metallic implant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0202671
UMLS CUI [2]
C0030163
UMLS CUI [3,1]
C0175722
UMLS CUI [3,2]
C0003483
UMLS CUI [4]
C3693688
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Similar models

Eligibility Multiple Sclerosis (Primary or Secondary Progressive Phase). NCT01144117

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age between 19 and 60 years
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Relapses Absent
Item
primary progressive ms or secondary progressive ms without relapses during the last one year
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0035020 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Disease length | Disability Progressive | Disease Progression EDSS | Disease Progression Pyramidal system | Disease Progression System Cerebellar | Disease Progression Brain Stem | Disease Progression Visual system | Disease Progression Sensory system function | Walking distance reduced | Hand function disability
Item
duration of the disease of at least 2 years clinical disability progression should have been observed in the 2 years prior to screening as per clinical judgment of the investigator. in addition, progression must be documented by an increase in the edss score of at least 0.5 points at any time during the 2 years prior to screening; or progression of 1 point in the pyramidal, cerebellar, brain stem , visual or sensory functional system during the last 2 years. should documented edss scores not be available, a written summary of the clinical evidence of disability progression in the previous 2 years must be submitted (for example walking distance or hand function).
boolean
C0872146 (UMLS CUI [1])
C0231170 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3,1])
C0451246 (UMLS CUI [3,2])
C0242656 (UMLS CUI [4,1])
C0228060 (UMLS CUI [4,2])
C0242656 (UMLS CUI [5,1])
C0449913 (UMLS CUI [5,2])
C0007765 (UMLS CUI [5,3])
C0242656 (UMLS CUI [6,1])
C0006121 (UMLS CUI [6,2])
C0242656 (UMLS CUI [7,1])
C3536733 (UMLS CUI [7,2])
C0242656 (UMLS CUI [8,1])
C0036658 (UMLS CUI [8,2])
C0424550 (UMLS CUI [9])
C0556293 (UMLS CUI [10])
EDSS
Item
edss (expanded disability status scale) 4.0-6.5
boolean
C0451246 (UMLS CUI [1])
MRI Criteria Fulfill | Multiple Sclerosis
Item
mri fulfilling the barkhof criteria for ms
boolean
C0024485 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0026769 (UMLS CUI [2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding Period | Contraceptive methods Missing
Item
pregnancy or period of breastfeeding or missing adequate contraceptive protection
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3,1])
C1705492 (UMLS CUI [3,2])
Steroid therapy
Item
treatment with steroids in the last 30 days
boolean
C0149783 (UMLS CUI [1])
Interferons | glatiramer acetate | Immunoglobulins, Intravenous
Item
treatment with interferons, glatiramer acetate or ivig in the last1 month prior to enrolment
boolean
C0021747 (UMLS CUI [1])
C0289884 (UMLS CUI [2])
C0085297 (UMLS CUI [3])
Azathioprine | Mitoxantrone | Immunosuppressive Agents
Item
treatment with azathioprin, mitoxantrone or any other immuno-suppressive in the 6 months prior to enrolment
boolean
C0004482 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
Heart insuffiency New York Heart Association Classification | Cardiomyopathy | Cardiac Arrhythmia Treatment required for | Myocardial Ischemia Unstable CCS Class | Myocardial Ischemia Advanced CCS Class | Malignant Hypertension | Systolic Pressure | Diastolic blood pressure
Item
cardiac insufficiency (nyha iii/iv), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, instable or advanced ischemic heart disease (ccs iii or iv), malignant hypertension (systolic > 180, diastolic > 110)
boolean
C0392173 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0878544 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C0151744 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C1879987 (UMLS CUI [4,3])
C0151744 (UMLS CUI [5,1])
C0205179 (UMLS CUI [5,2])
C1879987 (UMLS CUI [5,3])
C0020540 (UMLS CUI [6])
C0871470 (UMLS CUI [7])
C0428883 (UMLS CUI [8])
Hematological Disease
Item
history of any haematological disorder
boolean
C0018939 (UMLS CUI [1])
Renal Insufficiency
Item
history of renal insufficiency
boolean
C1565489 (UMLS CUI [1])
Mental condition Interferes with Study Subject Participation Status | Condition Interferes with Study Subject Participation Status | Mental condition Study Subject Participation Status Limited | Condition Study Subject Participation Status Limited
Item
any medical psychiatric or other circumstances which impede or restrict the subjects participation in the study in the manner intended
boolean
C3840291 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
Medical contraindication MRI with contrast | Artificial cardiac pacemaker | Clip Aortic | Metallic implant
Item
contraindication for contrast enhanced mri (e.g. pace maker, aortic clip or any metal implant)
boolean
C1301624 (UMLS CUI [1,1])
C0202671 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C0175722 (UMLS CUI [3,1])
C0003483 (UMLS CUI [3,2])
C3693688 (UMLS CUI [4])
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