ID

30948

Beschrijving

Trial of Ginkgo as a Treatment for Cognitive Problems in Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00841321

Link

https://clinicaltrials.gov/show/NCT00841321

Trefwoorden

Versies (1)
  1. 06-07-18 06-07-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

6 juli 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00841321

Engels

Eligibility Multiple Sclerosis NCT00841321

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
a diagnosis of multiple sclerosis by mcdonald's criteria
Beschrijving

Multiple Sclerosis

Datatype

boolean

Alias
UMLS CUI [1]
C0026769
age 18 to 65 years, inclusive
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
a score minus one standard deviation below the mean on one or more of the following tests: pasat, cowat, cvlt-ii, stroop
Beschrijving

Score One standard deviation below mean Paced Auditory Serial Addition Functional Test | Score One standard deviation below mean Controlled Oral Word Association Test | Score One standard deviation below mean California Verbal Learning Test - Second Edition | Score One standard deviation below mean Stroop Test

Datatype

boolean

Alias
UMLS CUI [1,1]
C0449820
UMLS CUI [1,2]
C1299388
UMLS CUI [1,3]
C3898036
UMLS CUI [2,1]
C0449820
UMLS CUI [2,2]
C1299388
UMLS CUI [2,3]
C3827022
UMLS CUI [3,1]
C0449820
UMLS CUI [3,2]
C1299388
UMLS CUI [3,3]
C3899729
UMLS CUI [4,1]
C0449820
UMLS CUI [4,2]
C1299388
UMLS CUI [4,3]
C2718024
edss 0 - 7.5, inclusive
Beschrijving

EDSS

Datatype

boolean

Alias
UMLS CUI [1]
C0451246
no ginkgo biloba in preceding 30 days
Beschrijving

Ginkgo biloba extract Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0772125
UMLS CUI [1,2]
C0332197
native english speaker
Beschrijving

English Language native speaker

Datatype

boolean

Alias
UMLS CUI [1,1]
C0376245
UMLS CUI [1,2]
C0814951
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
current substance abuse disorder, psychosis, or significant depression (score on the beck depression inventory ii (bdi -ii) greater than 28
Beschrijving

Substance Use Disorders | Psychotic Disorders | Depressive disorder Beck depression inventory

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0033975
UMLS CUI [3,1]
C0011581
UMLS CUI [3,2]
C0451022
any significant uncontrolled medical problem including diabetes requiring insulin
Beschrijving

Patient Problem Uncontrolled | Diabetes Mellitus Requirement Insulin

Datatype

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021641
relapse of multiple sclerosis within the 30 days before screening
Beschrijving

Multiple sclerosis relapse

Datatype

boolean

Alias
UMLS CUI [1]
C0856120
abnormalities of coagulation or current use of anticoagulants or antiplatelet agents
Beschrijving

Abnormality of coagulation | Anticoagulants | Antiplatelet Agents

Datatype

boolean

Alias
UMLS CUI [1]
C1846821
UMLS CUI [2]
C0003280
UMLS CUI [3]
C0085826
elective surgery planned for the study period or the following four weeks
Beschrijving

Elective Surgical Procedures Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0206058
UMLS CUI [1,2]
C1301732
epilepsy or history of seizures
Beschrijving

Epilepsy | Seizures

Datatype

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0036572
use of nifedipine, nicardipine, saint john's wort, papaverine, mono amine oxidase inhibitors
Beschrijving

Nifedipine | Nicardipine | ST. JOHN'S WORT EXTRACT | Papaverine | Monoamine Oxidase Inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C0028066
UMLS CUI [2]
C0028005
UMLS CUI [3]
C0813171
UMLS CUI [4]
C0030350
UMLS CUI [5]
C0026457
pregnancy or women not using a reliable form of contraception
Beschrijving

Pregnancy | Gender Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
corrected binocular visual acuity worse than 20/50 or more than one error on binocular color vision testing with the ishihara color plates or sustained nystagmus or diplopia on primary gaze
Beschrijving

Binocular Corrected visual acuity | Binocular Color vision examination | Ishihara chart tests Error Quantity | Nystagmus Sustained | Diplopia Primary gaze

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042794
UMLS CUI [1,2]
C1275680
UMLS CUI [2,1]
C0042794
UMLS CUI [2,2]
C0200159
UMLS CUI [3,1]
C0858377
UMLS CUI [3,2]
C0743559
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0028738
UMLS CUI [4,2]
C0443318
UMLS CUI [5,1]
C0012569
UMLS CUI [5,2]
C1443287
inability to complete the neuropsychological test battery at the screening visit
Beschrijving

Neuropsychological Tests Complete Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027902
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C1299582
history of alcohol abuse or illicit drug use in the prior six months
Beschrijving

Alcohol abuse | Illicit medication use

Datatype

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0281875
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Similar models

Eligibility Multiple Sclerosis NCT00841321

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis
Item
a diagnosis of multiple sclerosis by mcdonald's criteria
boolean
C0026769 (UMLS CUI [1])
Age
Item
age 18 to 65 years, inclusive
boolean
C0001779 (UMLS CUI [1])
Score One standard deviation below mean Paced Auditory Serial Addition Functional Test | Score One standard deviation below mean Controlled Oral Word Association Test | Score One standard deviation below mean California Verbal Learning Test - Second Edition | Score One standard deviation below mean Stroop Test
Item
a score minus one standard deviation below the mean on one or more of the following tests: pasat, cowat, cvlt-ii, stroop
boolean
C0449820 (UMLS CUI [1,1])
C1299388 (UMLS CUI [1,2])
C3898036 (UMLS CUI [1,3])
C0449820 (UMLS CUI [2,1])
C1299388 (UMLS CUI [2,2])
C3827022 (UMLS CUI [2,3])
C0449820 (UMLS CUI [3,1])
C1299388 (UMLS CUI [3,2])
C3899729 (UMLS CUI [3,3])
C0449820 (UMLS CUI [4,1])
C1299388 (UMLS CUI [4,2])
C2718024 (UMLS CUI [4,3])
EDSS
Item
edss 0 - 7.5, inclusive
boolean
C0451246 (UMLS CUI [1])
Ginkgo biloba extract Absent
Item
no ginkgo biloba in preceding 30 days
boolean
C0772125 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
English Language native speaker
Item
native english speaker
boolean
C0376245 (UMLS CUI [1,1])
C0814951 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Substance Use Disorders | Psychotic Disorders | Depressive disorder Beck depression inventory
Item
current substance abuse disorder, psychosis, or significant depression (score on the beck depression inventory ii (bdi -ii) greater than 28
boolean
C0038586 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
C0011581 (UMLS CUI [3,1])
C0451022 (UMLS CUI [3,2])
Patient Problem Uncontrolled | Diabetes Mellitus Requirement Insulin
Item
any significant uncontrolled medical problem including diabetes requiring insulin
boolean
C1254481 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
Multiple sclerosis relapse
Item
relapse of multiple sclerosis within the 30 days before screening
boolean
C0856120 (UMLS CUI [1])
Abnormality of coagulation | Anticoagulants | Antiplatelet Agents
Item
abnormalities of coagulation or current use of anticoagulants or antiplatelet agents
boolean
C1846821 (UMLS CUI [1])
C0003280 (UMLS CUI [2])
C0085826 (UMLS CUI [3])
Elective Surgical Procedures Planned
Item
elective surgery planned for the study period or the following four weeks
boolean
C0206058 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Epilepsy | Seizures
Item
epilepsy or history of seizures
boolean
C0014544 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
Nifedipine | Nicardipine | ST. JOHN'S WORT EXTRACT | Papaverine | Monoamine Oxidase Inhibitors
Item
use of nifedipine, nicardipine, saint john's wort, papaverine, mono amine oxidase inhibitors
boolean
C0028066 (UMLS CUI [1])
C0028005 (UMLS CUI [2])
C0813171 (UMLS CUI [3])
C0030350 (UMLS CUI [4])
C0026457 (UMLS CUI [5])
Pregnancy | Gender Contraceptive methods Absent
Item
pregnancy or women not using a reliable form of contraception
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Binocular Corrected visual acuity | Binocular Color vision examination | Ishihara chart tests Error Quantity | Nystagmus Sustained | Diplopia Primary gaze
Item
corrected binocular visual acuity worse than 20/50 or more than one error on binocular color vision testing with the ishihara color plates or sustained nystagmus or diplopia on primary gaze
boolean
C0042794 (UMLS CUI [1,1])
C1275680 (UMLS CUI [1,2])
C0042794 (UMLS CUI [2,1])
C0200159 (UMLS CUI [2,2])
C0858377 (UMLS CUI [3,1])
C0743559 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0028738 (UMLS CUI [4,1])
C0443318 (UMLS CUI [4,2])
C0012569 (UMLS CUI [5,1])
C1443287 (UMLS CUI [5,2])
Neuropsychological Tests Complete Unable
Item
inability to complete the neuropsychological test battery at the screening visit
boolean
C0027902 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Alcohol abuse | Illicit medication use
Item
history of alcohol abuse or illicit drug use in the prior six months
boolean
C0085762 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
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