ID

44451

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02290444

Stichworte

Versionen (1)
  1. 23.09.21 23.09.21 -
Rechteinhaber

State University of New York at Buffalo

Hochgeladen am

23. September 2021

DOI

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Creative Commons BY-NC 4.0
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Eligibility Multiple Sclerosis NCT02290444

Englisch

Eligibility Multiple Sclerosis NCT02290444

1 Formulare  
Inclusion Criteria
Beschreibung

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).
Beschreibung

Gender | Age | Compliance behavior

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Kurtzke multiple sclerosis rating scale

Datentyp

boolean

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

Valid neuropsychological testing (np)

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Capable of neuropsychological (np) testing including near visual acuity

Datentyp

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.
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Concomitant agent contraindicated with acthar | Comorbidity contraindicated with acthar

Datentyp

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.
Beschreibung

Communicable Diseases

Datentyp

boolean

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

Breast Feeding | Planned pregnancy | Childbearing potential

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032992
UMLS CUI [3]
C3831118
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Ähnliche Modelle

Eligibility Multiple Sclerosis NCT02290444

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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