ID

44451

Beskrivning

Effects of Acthar on Recovery From Cognitive Relapses in MS; ODM derived from: https://clinicaltrials.gov/show/NCT02290444

Länk

https://clinicaltrials.gov/show/NCT02290444

Nyckelord

Versioner (1)
  1. 2021-09-23 2021-09-23 -
Rättsinnehavare

State University of New York at Buffalo

Uppladdad den

23 september 2021

DOI

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Licens

Creative Commons BY-NC 4.0
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Eligibility Multiple Sclerosis NCT02290444

Engelsk

Eligibility Multiple Sclerosis NCT02290444

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males/females between 18 and 65 years of age who are capable of understanding and complying with the protocol (ie. have completed at least a 9th grade education and are fluent english).
Beskrivning

Gender | Age | Compliance behavior

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C1321605
2. have a diagnosis of relapsing remitting ms (rrms) or early secondary progressive ms (spms) as per revised mcdonald's criteria.
Beskrivning

Relapsing remitting ms (rrms) | Secondary progressive ms (spms)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0751967
UMLS CUI [1,2]
C0679228
UMLS CUI [2,1]
C0751965
UMLS CUI [2,2]
C0679228
3. have an expanded disability severity scale (edss) of ≤ 7.0.
Beskrivning

Kurtzke multiple sclerosis rating scale

Datatyp

boolean

Alias
UMLS CUI [1]
C0451246
4. have had valid neuropsychological testing (np) within the past 4 years
Beskrivning

Valid neuropsychological testing (np)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027902
UMLS CUI [1,2]
C2349101
5. experiencing an acute cognitive relapse identified by a clinical care provider as a.) a cognitive symptom of recent origin developing over 48 hours, or b.) supratentorial gad enhancing lesions on mri with confirmed cognitive decline.
Beskrivning

Cognitive symptom of recent origin | Supratentorial gad enhancing lesions on mri with confirmed cognitive decline

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0338656
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C1333400
UMLS CUI [2,2]
C0441938
UMLS CUI [2,3]
C0234985
confirmation of cognitive decline will be obtained by administering the symbol digit modalities test (sdmt) as a screening procedure for the study and comparing it to scores obtained within 4 years (see inclusion criteria #4). participants qualify if a raw point change on the sdmt greater than or equal to-3 points is detected.
Beskrivning

Symbol digit modalities test (sdmt) at screening | Symbol digit modalities test (sdmt) in the past

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0814254
UMLS CUI [1,2]
C0220908
UMLS CUI [1,3]
C0814254
UMLS CUI [1,4]
C1444637
UMLS CUI [1,5]
C1707455
6. are capable of performing the requirements of neuropsychological (np) testing, including near visual acuity 20/70 or better with correction.
Beskrivning

Capable of neuropsychological (np) testing including near visual acuity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027902
UMLS CUI [1,2]
C0429541
UMLS CUI [1,3]
C0332257
7. have given written informed consent prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care.
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. are found to have evidence on mri of new lesions in the brainstem, spinal cord, or optic nerve.
Beskrivning

Evidence of new lesions in the brainstem, spinal cord, or optic nerve on mri

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C0006121
UMLS CUI [1,4]
C0024485
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0205314
UMLS CUI [2,3]
C0037925
UMLS CUI [2,4]
C0024485
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0205314
UMLS CUI [3,3]
C0029130
UMLS CUI [3,4]
C0024485
2. have clear new physical signs or symptoms that are referable to the cord, brainstem or optic nerve.
Beskrivning

New physical signs or symptoms that are referable to the cord, brainstem or optic nerve

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C0006121
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205314
UMLS CUI [2,3]
C0037925
UMLS CUI [3,1]
C0037088
UMLS CUI [3,2]
C0205314
UMLS CUI [3,3]
C0029130
3. have cognitive deficits/impairment caused by concomitant medication usage, or are attributable to another medical condition or significant neurological/psychological disease.
Beskrivning

Impaired cognition caused by concomitant medication usage | Significant comorbidity | Significant nervous system disorder | Significant mental disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0338656
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0678226
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0750502
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0750502
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0750502
4. have evidence of current major depression as determined by a positive beck depression inventory-fast screen (bdi-fs) and clinician interview.
Beskrivning

Current major depression as determined by a positive beck depression inventory-fast screen (bdi-fs) and clinician interview.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0521116
UMLS CUI [1,3]
C0451022
UMLS CUI [1,4]
C0021822
5. patients with changes to medications known to influence cognition (narcotics, stimulants, etc.) or disease modifying therapy within one month of study initiation (or within a time frame deemed high risk by treating physician) will be excluded.
Beskrivning

Recent changes to medications known to influence cognition | Recent changes to disease modifying therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0580105
UMLS CUI [1,2]
C0009240
UMLS CUI [1,3]
C4054723
UMLS CUI [1,4]
C0332185
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0392747
UMLS CUI [2,4]
C0332185
6. are taking any medication, or have any medical condition contraindicated with acthar.
Beskrivning

Concomitant agent contraindicated with acthar | Comorbidity contraindicated with acthar

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C0718234
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1301624
UMLS CUI [2,3]
C0718234
7. presence of current infections as determined by clinician interview.
Beskrivning

Communicable Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
8. are currently nursing, intentionally seeking pregnancy, or deemed at-risk for unplanned pregnancy.
Beskrivning

Breast Feeding | Planned pregnancy | Childbearing potential

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032992
UMLS CUI [3]
C3831118
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Similar models

Eligibility Multiple Sclerosis NCT02290444

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Compliance behavior
Item
1. males/females between 18 and 65 years of age who are capable of understanding and complying with the protocol (ie. have completed at least a 9th grade education and are fluent english).
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1321605 (UMLS CUI [3])
Relapsing remitting ms (rrms) | Secondary progressive ms (spms)
Item
2. have a diagnosis of relapsing remitting ms (rrms) or early secondary progressive ms (spms) as per revised mcdonald's criteria.
boolean
C0751967 (UMLS CUI [1,1])
C0679228 (UMLS CUI [1,2])
C0751965 (UMLS CUI [2,1])
C0679228 (UMLS CUI [2,2])
Kurtzke multiple sclerosis rating scale
Item
3. have an expanded disability severity scale (edss) of ≤ 7.0.
boolean
C0451246 (UMLS CUI [1])
Valid neuropsychological testing (np)
Item
4. have had valid neuropsychological testing (np) within the past 4 years
boolean
C0027902 (UMLS CUI [1,1])
C2349101 (UMLS CUI [1,2])
Cognitive symptom of recent origin | Supratentorial gad enhancing lesions on mri with confirmed cognitive decline
Item
5. experiencing an acute cognitive relapse identified by a clinical care provider as a.) a cognitive symptom of recent origin developing over 48 hours, or b.) supratentorial gad enhancing lesions on mri with confirmed cognitive decline.
boolean
C0338656 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1333400 (UMLS CUI [2,1])
C0441938 (UMLS CUI [2,2])
C0234985 (UMLS CUI [2,3])
Symbol digit modalities test (sdmt) at screening | Symbol digit modalities test (sdmt) in the past
Item
confirmation of cognitive decline will be obtained by administering the symbol digit modalities test (sdmt) as a screening procedure for the study and comparing it to scores obtained within 4 years (see inclusion criteria #4). participants qualify if a raw point change on the sdmt greater than or equal to-3 points is detected.
boolean
C0814254 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0814254 (UMLS CUI [1,3])
C1444637 (UMLS CUI [1,4])
C1707455 (UMLS CUI [1,5])
Capable of neuropsychological (np) testing including near visual acuity
Item
6. are capable of performing the requirements of neuropsychological (np) testing, including near visual acuity 20/70 or better with correction.
boolean
C0027902 (UMLS CUI [1,1])
C0429541 (UMLS CUI [1,2])
C0332257 (UMLS CUI [1,3])
Informed consent
Item
7. have given written informed consent prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Evidence of new lesions in the brainstem, spinal cord, or optic nerve on mri
Item
1. are found to have evidence on mri of new lesions in the brainstem, spinal cord, or optic nerve.
boolean
C0221198 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0006121 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,4])
C0221198 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C0037925 (UMLS CUI [2,3])
C0024485 (UMLS CUI [2,4])
C0221198 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])
C0029130 (UMLS CUI [3,3])
C0024485 (UMLS CUI [3,4])
New physical signs or symptoms that are referable to the cord, brainstem or optic nerve
Item
2. have clear new physical signs or symptoms that are referable to the cord, brainstem or optic nerve.
boolean
C0037088 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0006121 (UMLS CUI [1,3])
C0037088 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C0037925 (UMLS CUI [2,3])
C0037088 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])
C0029130 (UMLS CUI [3,3])
Impaired cognition caused by concomitant medication usage | Significant comorbidity | Significant nervous system disorder | Significant mental disorder
Item
3. have cognitive deficits/impairment caused by concomitant medication usage, or are attributable to another medical condition or significant neurological/psychological disease.
boolean
C0338656 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0004936 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
Current major depression as determined by a positive beck depression inventory-fast screen (bdi-fs) and clinician interview.
Item
4. have evidence of current major depression as determined by a positive beck depression inventory-fast screen (bdi-fs) and clinician interview.
boolean
C1269683 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0451022 (UMLS CUI [1,3])
C0021822 (UMLS CUI [1,4])
Recent changes to medications known to influence cognition | Recent changes to disease modifying therapy
Item
5. patients with changes to medications known to influence cognition (narcotics, stimulants, etc.) or disease modifying therapy within one month of study initiation (or within a time frame deemed high risk by treating physician) will be excluded.
boolean
C0580105 (UMLS CUI [1,1])
C0009240 (UMLS CUI [1,2])
C4054723 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,4])
C0087111 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0332185 (UMLS CUI [2,4])
Concomitant agent contraindicated with acthar | Comorbidity contraindicated with acthar
Item
6. are taking any medication, or have any medical condition contraindicated with acthar.
boolean
C2347852 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0718234 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C0718234 (UMLS CUI [2,3])
Communicable Diseases
Item
7. presence of current infections as determined by clinician interview.
boolean
C0009450 (UMLS CUI [1])
Breast Feeding | Planned pregnancy | Childbearing potential
Item
8. are currently nursing, intentionally seeking pregnancy, or deemed at-risk for unplanned pregnancy.
boolean
C0006147 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
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