ID

15786

Beschreibung

Principal Investigator: Luisa Klotz Collaborator: Novartis Information provided by (Responsible Party):University Hospital Muenster -Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya (ToFingo2) Purpose A trial in patients with relapsing remitting multiple sclerosis (RRMS) Main objectives: •To evaluate changes in the reconstitution of immune surveillance over time upon switching from natalizumab to fingolimod assessed by a change in the expression of CD49d. •To evaluate changes in the migratory capacity of immune cells/peripheral blood mononuclear cells (PBMCs) upon switching from natalizumab to fingolimod in an in-vitro model of the blood-brain-barrier (BBB). •To evaluate changes in paraclinical disease activity over time upon switching from natalizumab to fingolimod assessed by MRI (changes in Gd+, T2w lesions and DTI). •To evaluate changes in T1w / FLAIR lesions upon switching from natalizumab to fingolimod. For further Information please visit https://clinicaltrials.gov/ct2/show/NCT02325440

Link

https://clinicaltrials.gov/ct2/show/NCT02325440

Stichworte

Versionen (3)
  1. 01.06.16 01.06.16 -
  2. 03.06.16 03.06.16 -
  3. 13.06.16 13.06.16 -
Hochgeladen am

13. Juni 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

ToFingo Screening V1 Physical examination NCT02325440

Deutsch Englisch

ToFingo Screening V1 Physical examination NCT02325440

1 Formulare  
Study administration
Beschreibung

Study administration

Data entry for this CRF completed
Beschreibung

Data entry for this CRF completed

Datentyp

boolean

Alias
UMLS CUI [1]
C3899518
Assessment Date
Beschreibung

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Current patient (ID)
Beschreibung

Current patient (ID)

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Physical examination
Beschreibung

Physical examination

Alias
UMLS CUI-1
C0031809
Head and neck: Result
Beschreibung

Head and neck: Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0460004
Head and neck: Comment
Beschreibung

Head and neck: Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0460004
UMLS CUI [1,2]
C0947611
Lung: Result
Beschreibung

Lung: Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024109
Lung: Comment
Beschreibung

Lung: Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0024109
UMLS CUI [1,2]
C0947611
Skin: Result
Beschreibung

Skin: Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1123023
Skin: Comment
Beschreibung

Skin: Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C1123023
UMLS CUI [1,2]
C0947611
Heart: Result
Beschreibung

Heart: Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0018787
Heart: Comment
Beschreibung

Heart: Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0018787
UMLS CUI [1,2]
C0947611
Abdomen: Result
Beschreibung

Abdomen: Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
Abdomen: Comment
Beschreibung

Abdomen: Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0000726
UMLS CUI [1,2]
C0947611
General appearance: Result
Beschreibung

General appearance: Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1148438
General appearance: Comment
Beschreibung

General appearance: Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C1148438
UMLS CUI [1,2]
C0947611
Vitalzeichen
Beschreibung

Vitalzeichen

Alias
UMLS CUI-1
C0518766
Body Height
Beschreibung

Body Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body weight
Beschreibung

Body weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Sitting pulse rate
Beschreibung

Sitting pulse rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0277814
bpm
Oral temperature
Beschreibung

Oral temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0442027
°C
Blutdruck syst.
Beschreibung

systolic blood pressure

Datentyp

integer

Maßeinheiten
  • /minute
Alias
UMLS CUI [1]
C0871470
/minute
Diastolic blood pressure
Beschreibung

Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • /minute
Alias
UMLS CUI [1]
C0428883
/minute
Neurological examination
Beschreibung

Neurological examination

Alias
UMLS CUI-1
C0027853
Neurological abnormality other than MS
Beschreibung

Neurological abnormality other than MS

Datentyp

text

Alias
UMLS CUI [1]
C0027765
Neurological examination result
Beschreibung

Neurological examination result

Datentyp

text

Alias
UMLS CUI [1]
C0027853
Neurological examination comment
Beschreibung

Neurological examination comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0947611
EDSS Score
Beschreibung

EDSS Score

Datentyp

float

Alias
UMLS CUI [1]
C0451246
MS relapses
Beschreibung

MS relapses

Alias
UMLS CUI-1
C0856120
MS exacerbations since last visit
Beschreibung

MS exacerbations since last visit

Datentyp

integer

Alias
UMLS CUI [1,1]
C0581392
UMLS CUI [1,2]
C2047944
Steroid therapy used for recent MS relapses
Beschreibung

Steroid therapy used for recent MS relapses

Datentyp

text

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0856120
Laboratory (Blood chemistry/Heamatology)
Beschreibung

Laboratory (Blood chemistry/Heamatology)

Alias
UMLS CUI-1
C0022877
ALT-level (GPT)
Beschreibung

ALT-level (GPT)

Datentyp

float

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
AST-level (GOT)
Beschreibung

AST-level (GOT)

Datentyp

float

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
HbA1C
Beschreibung

HbA1C

Datentyp

float

Maßeinheiten
  • mmol/mol
Alias
UMLS CUI [1]
C0019018
mmol/mol
Alkaline phosphatase
Beschreibung

Alkaline phosphatase

Datentyp

float

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
GGT
Beschreibung

GGT

Datentyp

float

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0202035
U/L
Total Bilirubin
Beschreibung

Total Bilirubin

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
UMLS CUI [1]
C0201913
mg/dL
WBC
Beschreibung

WBC

Datentyp

float

Maßeinheiten
  • Tsd./uL
Alias
UMLS CUI [1]
C0023508
Tsd./uL
Lymphocytes
Beschreibung

Lymphocytes

Datentyp

float

Maßeinheiten
  • Tsd./uL
Alias
UMLS CUI [1]
C0200635
Tsd./uL
Zum Seitenanfang zurückkehren

Ähnliche Modelle

ToFingo Screening V1 Physical examination NCT02325440

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Data entry for this CRF completed
Item
boolean
C3899518 (UMLS CUI [1])
Assessment Date
Item
date
C0011008 (UMLS CUI [1])
Current patient (ID)
Item
text
C2348585 (UMLS CUI [1])
Item Group
C0031809 (UMLS CUI-1)
Head and neck: Result
Item
text
C0031809 (UMLS CUI [1,1])
C0460004 (UMLS CUI [1,2])
Head and neck: Comment
Item
text
C0460004 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Lung: Result
Item
text
C0031809 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
Lung: Comment
Item
text
C0024109 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Skin: Result
Item
text
C0031809 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])
Skin: Comment
Item
text
C1123023 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Heart: Result
Item
text
C0031809 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
Heart: Comment
Item
text
C0018787 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Abdomen: Result
Item
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Abdomen: Comment
Item
text
C0000726 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
General appearance: Result
Item
text
C0031809 (UMLS CUI [1,1])
C1148438 (UMLS CUI [1,2])
General appearance: Comment
Item
text
C1148438 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Vitalzeichen
C0518766 (UMLS CUI-1)
Body Height
Item
integer
C0005890 (UMLS CUI [1])
Body weight
Item
float
C0005910 (UMLS CUI [1])
Sitting pulse rate
Item
integer
C0018810 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Oral temperature
Item
float
C0005903 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
systolic blood pressure
Item
Blutdruck syst.
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
integer
C0428883 (UMLS CUI [1])
Item Group
C0027853 (UMLS CUI-1)
Neurological abnormality other than MS
Item
text
C0027765 (UMLS CUI [1])
Neurological examination result
Item
text
C0027853 (UMLS CUI [1])
Neurological examination comment
Item
text
C0027853 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
EDSS Score
Item
float
C0451246 (UMLS CUI [1])
Item Group
C0856120 (UMLS CUI-1)
MS exacerbations since last visit
Item
integer
C0581392 (UMLS CUI [1,1])
C2047944 (UMLS CUI [1,2])
Steroid therapy used for recent MS relapses
Item
text
C0149783 (UMLS CUI [1,1])
C0856120 (UMLS CUI [1,2])
Item Group
C0022877 (UMLS CUI-1)
ALT-level (GPT)
Item
float
C0201836 (UMLS CUI [1])
AST-level (GOT)
Item
float
C0201899 (UMLS CUI [1])
HbA1C
Item
float
C0019018 (UMLS CUI [1])
Alkaline phosphatase
Item
float
C0201850 (UMLS CUI [1])
GGT
Item
float
C0202035 (UMLS CUI [1])
Total Bilirubin
Item
float
C0201913 (UMLS CUI [1])
WBC
Item
float
C0023508 (UMLS CUI [1])
Lymphocytes
Item
float
C0200635 (UMLS CUI [1])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video