ID
44517
Beschrijving
Study part: Screening Visite/ Run-In- Phase (Visite 1/ Woche -4). TMP001 in Relapsing-remitting Multiple Sclerosis: A Multicentre Open, Baseline-controlled Phase IIa Clinical Trial.
Trefwoorden
Versies (2)
- 19-11-17 19-11-17 -
- 27-09-21 27-09-21 -
Houder van rechten
SocraMetrics
Geüploaded op
27 september 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Screening Visite/ Run-In- Phase (Visite 1/ Woche -4) TMP001 Multiple Sclerosis NCT02686788
Screening Visite/ Run-In- Phase (Visite 1/ Woche -4)
- StudyEvent: ODM
Beschrijving
Demographische Daten
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Age
Datatype
integer
Maateenheden
- Jahre
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
Gender
Datatype
integer
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Height
Datatype
float
Maateenheden
- m
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Ethnicity
Datatype
text
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
Gebärfähigkeit
Alias
- UMLS CUI-1
- C3831118
Beschrijving
Messung der Vitalparameter und der Körpertemperatur
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-3
- C0005903
Beschrijving
Systolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Pulse
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
Body temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Krankengeschichte und Begleiterkrankungen
Alias
- UMLS CUI-1
- C0009488
Beschrijving
Date of diagnosis Multiple Sclerosis, Acute Relapsing
Datatype
date
Alias
- UMLS CUI [1,1]
- C2316983
- UMLS CUI [1,2]
- C0393664
Beschrijving
medical history; Comorbidity
Datatype
text
Alias
- UMLS CUI [1]
- C0262926
- UMLS CUI [2]
- C0009488
Beschrijving
Concomitant medication
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Körperliche Untersuchung
Alias
- UMLS CUI-1
- C0031809
Beschrijving
General physical condition
Datatype
text
Alias
- UMLS CUI [1]
- C1142435
Beschrijving
Specification
Datatype
text
Alias
- UMLS CUI [1]
- C2348235
Beschrijving
Relevance
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschrijving
Skin
Datatype
text
Alias
- UMLS CUI [1]
- C1123023
Beschrijving
Specification
Datatype
text
Alias
- UMLS CUI [1]
- C2348235
Beschrijving
Relevance
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschrijving
Eye
Datatype
text
Alias
- UMLS CUI [1]
- C0015392
Beschrijving
Specification
Datatype
text
Alias
- UMLS CUI [1]
- C2348235
Beschrijving
Relevance
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschrijving
Ear
Datatype
text
Alias
- UMLS CUI [1]
- C0013443
Beschrijving
Specification
Datatype
text
Alias
- UMLS CUI [1]
- C2348235
Beschrijving
Relevance
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschrijving
Nose
Datatype
text
Alias
- UMLS CUI [1]
- C0028429
Beschrijving
Specification
Datatype
text
Alias
- UMLS CUI [1]
- C2348235
Beschrijving
Relevance
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschrijving
Throat
Datatype
text
Alias
- UMLS CUI [1]
- C0031354
Beschrijving
Specification
Datatype
text
Alias
- UMLS CUI [1]
- C2348235
Beschrijving
Relevance
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschrijving
Heart; Lungs
Datatype
text
Alias
- UMLS CUI [1]
- C0018787
- UMLS CUI [2]
- C0024109
Beschrijving
Specification
Datatype
text
Alias
- UMLS CUI [1]
- C2348235
Beschrijving
Relevance
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschrijving
Abdomen
Datatype
text
Alias
- UMLS CUI [1]
- C0000726
Beschrijving
Specification
Datatype
text
Alias
- UMLS CUI [1]
- C2348235
Beschrijving
Relevance
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschrijving
lymph nodes
Datatype
text
Alias
- UMLS CUI [1]
- C0024204
Beschrijving
Specification
Datatype
text
Alias
- UMLS CUI [1]
- C2348235
Beschrijving
Relevance
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschrijving
extremities
Datatype
text
Alias
- UMLS CUI [1]
- C0278454
Beschrijving
Specification
Datatype
text
Alias
- UMLS CUI [1]
- C2348235
Beschrijving
Relevance
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347946
Beschrijving
Urinanalyse
Alias
- UMLS CUI-1
- C0042014
Beschrijving
Urine pH
Datatype
text
Alias
- UMLS CUI [1]
- C0042044
Beschrijving
Leukocytes
Datatype
text
Alias
- UMLS CUI [1]
- C0023516
Beschrijving
assessment
Datatype
text
Alias
- UMLS CUI [1]
- C1516048
Beschrijving
Urine nitrite
Datatype
text
Alias
- UMLS CUI [1]
- C0580333
Beschrijving
assessment
Datatype
text
Alias
- UMLS CUI [1]
- C1516048
Beschrijving
Urine protein
Datatype
text
Alias
- UMLS CUI [1]
- C0262923
Beschrijving
assessment
Datatype
text
Alias
- UMLS CUI [1]
- C1516048
Beschrijving
Urine glucose
Datatype
text
Alias
- UMLS CUI [1]
- C0004076
Beschrijving
assessment
Datatype
text
Alias
- UMLS CUI [1]
- C1516048
Beschrijving
Urine ketone
Datatype
text
Alias
- UMLS CUI [1]
- C0555179
Beschrijving
assessment
Datatype
text
Alias
- UMLS CUI [1]
- C1516048
Beschrijving
Urobilinogen
Datatype
text
Alias
- UMLS CUI [1]
- C0042052
Beschrijving
assessment
Datatype
text
Alias
- UMLS CUI [1]
- C1516048
Beschrijving
Urine Bilirubin
Datatype
text
Alias
- UMLS CUI [1]
- C0042040
Beschrijving
assessment
Datatype
text
Alias
- UMLS CUI [1]
- C1516048
Beschrijving
Urine erythrocytes
Datatype
text
Alias
- UMLS CUI [1]
- C2188659
Beschrijving
assessment
Datatype
text
Alias
- UMLS CUI [1]
- C1516048
Beschrijving
Urine pregnancy test
Datatype
text
Alias
- UMLS CUI [1]
- C0430056
Beschrijving
Lokale Laboruntersuchungen (Klinische Chemie, Hämatologie, Gerinnung, Serologie)
Alias
- UMLS CUI-1
- C0022877
Beschrijving
date blood sampling
Datatype
date
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0005834
Beschrijving
Laboratory result
Datatype
boolean
Alias
- UMLS CUI [1]
- C0587081
Beschrijving
Laboratory result; Medical history
Datatype
boolean
Alias
- UMLS CUI [1]
- C0587081
- UMLS CUI [2]
- C0262926
Beschrijving
Blutprobe zum Versand an Zentrallabor Frankfurt
Alias
- UMLS CUI-1
- C0005834
Beschrijving
Neurologische Scores (Funktionelle Systeme und Expanded Disability Status Skala nach Kurtzke)
Alias
- UMLS CUI-1
- C3887783
Beschrijving
Pyramidal Tracts; Paralysed
Datatype
integer
Alias
- UMLS CUI [1]
- C0034229
- UMLS CUI [2]
- C0522224
Beschrijving
Cerebellum; Cerebellar Ataxia
Datatype
integer
Alias
- UMLS CUI [1]
- C0007765
- UMLS CUI [2]
- C0007758
Beschrijving
Brain Stem; Speech Disorders; Deglutition Disorders
Datatype
integer
Alias
- UMLS CUI [1]
- C0006121
- UMLS CUI [2]
- C0037822
- UMLS CUI [3]
- C0011168
Beschrijving
Sensory; Hypesthesia
Datatype
integer
Alias
- UMLS CUI [1]
- C0445254
- UMLS CUI [2]
- C0020580
Beschrijving
Urinary Bladder; Urinary Incontinence; Rectum
Datatype
integer
Alias
- UMLS CUI [1]
- C0005682
- UMLS CUI [2]
- C0042024
- UMLS CUI [3]
- C0034896
Beschrijving
visual acuity; Scotoma
Datatype
integer
Alias
- UMLS CUI [1]
- C0042812
- UMLS CUI [2]
- C0036454
Beschrijving
Cerebral hemisphere structure; Behavioral change; Dementia
Datatype
integer
Alias
- UMLS CUI [1]
- C0228174
- UMLS CUI [2]
- C0542299
- UMLS CUI [3]
- C0497327
Beschrijving
Expanded Disability Status Scale
Datatype
integer
Alias
- UMLS CUI [1]
- C0451246
Beschrijving
date MRT
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0024485
Beschrijving
Einschlusskriterien
Alias
- UMLS CUI-1
- C1512693
Beschrijving
age
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
Relapsing-Remitting Multiple Sclerosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0751967
Beschrijving
MS relapse
Datatype
boolean
Alias
- UMLS CUI [1]
- C0856120
Beschrijving
Enhancing Lesion MRI
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3830314
- UMLS CUI [1,2]
- C0024485
Beschrijving
EDSS
Datatype
boolean
Alias
- UMLS CUI [1]
- C0451246
Beschrijving
childbearing potential; contraception
Datatype
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0700589
Beschrijving
informed consent
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
Protocol Compliance
Datatype
boolean
Alias
- UMLS CUI [1]
- C0525058
Beschrijving
Auschlusskriterien
Alias
- UMLS CUI-1
- C0680251
Beschrijving
immunodeficiency syndrome
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021051
Beschrijving
infection active; pneumonia
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3714514
- UMLS CUI [1,2]
- C0205177
- UMLS CUI [2]
- C0032285
Beschrijving
neuromyelitis optica; Clinically isolated syndrome; secondary progressive multiple sclerosis; primary progressive multiple sclerosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0027873
- UMLS CUI [2]
- C2921627
- UMLS CUI [3]
- C0751965
- UMLS CUI [4]
- C0751964
Beschrijving
Substance abuse disorders
Datatype
boolean
Alias
- UMLS CUI [1]
- C0038586
Beschrijving
MS relapse; corticosteroid treatment
Datatype
boolean
Alias
- UMLS CUI [1]
- C0856120
- UMLS CUI [2]
- C0149783
Beschrijving
Therapy Interferon-beta glatiramer acetate teriflunomide dimethyl fumarate fingolimod
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0015980
- UMLS CUI [1,3]
- C0289884
- UMLS CUI [1,4]
- C1718383
- UMLS CUI [1,5]
- C0058218
- UMLS CUI [1,6]
- C1699926
Beschrijving
Therapeutic immunosuppression azathioprine methotrexate
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021079
- UMLS CUI [1,2]
- C0004482
- UMLS CUI [1,3]
- C0025677
Beschrijving
Therapy alemtuzumab; body irradiation; bone marrow transplantation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0383429
- UMLS CUI [2]
- C0043162
- UMLS CUI [3]
- C0005961
Beschrijving
investigational drug; placebo
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013230
- UMLS CUI [2]
- C0032042
Beschrijving
Pregnancy; lactating
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Beschrijving
Study subject participation status
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschrijving
comorbidity malignancy
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0006826
Beschrijving
contraindication MRI
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C0024485
Beschrijving
Hypersensitivity contrast agent
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0009924
Beschrijving
Study Subject Participation Status
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschrijving
White blood count
Datatype
boolean
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
Lymphocytes
Datatype
boolean
Alias
- UMLS CUI [1]
- C0200635
Beschrijving
renal insufficiency stage
Datatype
boolean
Alias
- UMLS CUI [1]
- C1565489
Beschrijving
hypersensitivity study medication
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0304229
Beschrijving
hypersensitivity NSAlDs
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0003211
Beschrijving
peptic ulcer disease; gastrointestinal bleeding
Datatype
boolean
Alias
- UMLS CUI [1]
- C0030920
- UMLS CUI [2]
- C0017181
Beschrijving
Renal disorder; Hepatic disorder; metabolic disorder
Datatype
boolean
Alias
- UMLS CUI [1]
- C0022658
- UMLS CUI [2]
- C0023895
- UMLS CUI [3]
- C0025517
Beschrijving
myocardial infarction; ischemic stroke; heart failure
Datatype
boolean
Alias
- UMLS CUI [1]
- C0027051
- UMLS CUI [2]
- C0948008
- UMLS CUI [3]
- C0018801
Beschrijving
thrombophilia; Blood Coagulation Disorders
Datatype
boolean
Alias
- UMLS CUI [1]
- C0398623
- UMLS CUI [2]
- C0005779
Beschrijving
STUDIENEINSCHLUSS
Alias
- UMLS CUI-1
- C1512693
Beschrijving
inclusion; exclusion criteria
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1512693
- UMLS CUI [1,2]
- C0680251
Beschrijving
date inclusion
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1512693
Beschrijving
documentation complete
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0920316
- UMLS CUI [1,2]
- C0205197
Beschrijving
date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Investigator Signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Similar models
Screening Visite/ Run-In- Phase (Visite 1/ Woche -4)
- StudyEvent: ODM
C1710477 (UMLS CUI [1,2])
C0005903 (UMLS CUI-3)
C0393664 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2])
C0005834 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C0522224 (UMLS CUI [2])
C0007758 (UMLS CUI [2])
C0037822 (UMLS CUI [2])
C0011168 (UMLS CUI [3])
C0020580 (UMLS CUI [2])
C0042024 (UMLS CUI [2])
C0034896 (UMLS CUI [3])
C0036454 (UMLS CUI [2])
C0542299 (UMLS CUI [2])
C0497327 (UMLS CUI [3])
C0024485 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2])
C0205177 (UMLS CUI [1,2])
C0032285 (UMLS CUI [2])
C2921627 (UMLS CUI [2])
C0751965 (UMLS CUI [3])
C0751964 (UMLS CUI [4])
C0149783 (UMLS CUI [2])
C0015980 (UMLS CUI [1,2])
C0289884 (UMLS CUI [1,3])
C1718383 (UMLS CUI [1,4])
C0058218 (UMLS CUI [1,5])
C1699926 (UMLS CUI [1,6])
C0004482 (UMLS CUI [1,2])
C0025677 (UMLS CUI [1,3])
C0383429 (UMLS CUI [1,2])
C0043162 (UMLS CUI [2])
C0005961 (UMLS CUI [3])
C0032042 (UMLS CUI [2])
C0006147 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,2])
C0009924 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0003211 (UMLS CUI [1,2])
C0017181 (UMLS CUI [2])
C0023895 (UMLS CUI [2])
C0025517 (UMLS CUI [3])
C0948008 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0005779 (UMLS CUI [2])
C0680251 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])