ID

15527

Beschreibung

Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Please document clinically significant findings as Adverse Events. Clinical Significance is defined as any variation in physical findings that has medical relevance and may result in an alteration in medical care. Safety Blood and Urine Examinations: Please document the results for Serum Creatinine, Platelets and TSH on CRF-Pages "Safety Laboratory Assessments". Part: Screening

Link

https://clinicaltrials.gov/ct2/show/NCT02419378

Stichworte

Versionen (3)
  1. 13.08.15 13.08.15 - Martin Dugas
  2. 21.05.16 21.05.16 -
  3. 02.06.16 02.06.16 -
Hochgeladen am

2. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Screening: Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

Englisch

Screening: Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

1 Formulare  
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Patient ID (derived)
Beschreibung

Patient ID (derived)

Datentyp

text

Alias
UMLS CUI [1]
C1269815
Vital Signs and Physical Examination: Date
Beschreibung

Vital Signs and Physical Examination: Date

Datentyp

date

Alias
UMLS CUI [1]
C2826644
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Respiratory Rate
Beschreibung

Respiratory Rate

Datentyp

integer

Maßeinheiten
  • /min
Alias
UMLS CUI [1]
C0231832
/min
Height
Beschreibung

Height

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Systolic blood pressure
Beschreibung

Systolic

Datentyp

integer

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

Diastolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Body weight
Beschreibung

Body weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Physical Examination: General Appearance
Beschreibung

Physical Examination: General Appearance

Datentyp

text

Alias
UMLS CUI [1,1]
C1148438
Physical Examination: General Appearance, Text
Beschreibung

Physical Examination: General Appearance, Text

Datentyp

text

Alias
UMLS CUI [1]
C1148438
Physical Examination: Skin
Beschreibung

Physical Examination: Skin

Datentyp

text

Alias
UMLS CUI [1]
C0437750
Physical Examination: Skin, Text
Beschreibung

Physical Examination: Skin, Text

Datentyp

text

Alias
UMLS CUI [1]
C0437750
Physical Examination: HEENT
Beschreibung

Physical Examination: HEENT

Datentyp

text

Alias
UMLS CUI [1]
C3494720
Physical Examination: HEENT, Text
Beschreibung

Physical Examination: HEENT, Text

Datentyp

text

Alias
UMLS CUI [1]
C3494720
Physical Examination: Lymph Nodes
Beschreibung

Lymph Nodes Status

Datentyp

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0449438
Physical Examination: Lymph Nodes, Text
Beschreibung

Physical Examination: Lymph Nodes, Text

Datentyp

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0449438
Physical Examination: Heart
Beschreibung

Heart rate, Auscultation of the heart

Datentyp

text

Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0018793
Physical Examination: Heart, Text
Beschreibung

Physical Examination: Heart, Text

Datentyp

text

Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0018793
Physical Examination: Lungs
Beschreibung

Physical Examination: Lungs

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024109
Physical Examination: Lungs, Text
Beschreibung

Physical Examination: Lungs, Text

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024109
Physical Examination: Abdomen
Beschreibung

Physical Examination: Abdomen

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
Physical Examination: Abdomen, Text
Beschreibung

Physical Examination: Abdomen, Text

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
Physical Examination: Extremeties/Joints
Beschreibung

Physical Examination: Extremeties/Joints

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278454
UMLS CUI [1,3]
C0022417
Physical Examination: Extremeties/Joints, Text
Beschreibung

Physical Examination: Extremeties/Joints, Text

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0022417
Physical Examination: Mental Status
Beschreibung

Physical Examination: Mental Status

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278060
Physical Examination: Mental Status, Text
Beschreibung

Physical Examination: Mental Status, Text

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278060
Initial Blood Pregnancy Test
Beschreibung

Blood Pregnancy Test

Datentyp

text

Alias
UMLS CUI [1]
C0850355
Initial Blood Pregnancy Test: Date
Beschreibung

Initial Blood Pregnancy Test: Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0850355
UMLS CUI [1,2]
C0011008
Initial Blood Pregnancy Test: Result
Beschreibung

Initial Blood Pregnancy Test: Result

Datentyp

text

Alias
UMLS CUI [1]
C0850355
Initial Blood Pregnancy Test: Reason
Beschreibung

Initial Blood Pregnancy Test: Reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0850355
UMLS CUI [1,2]
C0392360
Initial Blood Pregnancy Test: Reason, Text
Beschreibung

Initial Blood Pregnancy Test: Reason, Text

Datentyp

text

Alias
UMLS CUI [1,1]
C0850355
UMLS CUI [1,2]
C0392360
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Ähnliche Modelle

Screening: Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Patient ID
Item
Patient ID (derived)
text
C1269815 (UMLS CUI [1])
Vital Signs date
Item
Vital Signs and Physical Examination: Date
date
C2826644 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Respiratory Rate
Item
Respiratory Rate
integer
C0231832 (UMLS CUI [1])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Item
Physical Examination: General Appearance
text
C1148438 (UMLS CUI [1,1])
Physical Examination: General Appearance
Code List
Physical Examination: General Appearance
CL Item
yes (1)
CL Item
no (0)
General Appearance
Item
Physical Examination: General Appearance, Text
text
C1148438 (UMLS CUI [1])
Item
Physical Examination: Skin
text
C0437750 (UMLS CUI [1])
Physical Examination: Skin
Code List
Physical Examination: Skin
CL Item
yes (1)
CL Item
no (0)
Skin examination
Item
Physical Examination: Skin, Text
text
C0437750 (UMLS CUI [1])
Item
Physical Examination: HEENT
text
C3494720 (UMLS CUI [1])
Physical Examination: HEENT
Code List
Physical Examination: HEENT
CL Item
yes (1)
CL Item
no (0)
HEENT Examination
Item
Physical Examination: HEENT, Text
text
C3494720 (UMLS CUI [1])
Item
Physical Examination: Lymph Nodes
text
C0024204 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Physical Examination: Lymph Nodes
Code List
Physical Examination: Lymph Nodes
CL Item
yes (1)
CL Item
no (0)
Physical Examination: Lymph Nodes, Text
Item
Physical Examination: Lymph Nodes, Text
text
C0024204 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Item
Physical Examination: Heart
text
C0018810 (UMLS CUI [1,1])
C0018793 (UMLS CUI [1,2])
Physical Examination: Heart
Code List
Physical Examination: Heart
CL Item
yes (1)
CL Item
no (0)
Physical Examination: Heart, Text
Item
Physical Examination: Heart, Text
text
C0018810 (UMLS CUI [1,1])
C0018793 (UMLS CUI [1,2])
Item
Physical Examination: Lungs
text
C0031809 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
Physical Examination: Lungs
Code List
Physical Examination: Lungs
CL Item
yes (1)
CL Item
no (0)
Physical Examination: Lungs, Text
Item
Physical Examination: Lungs, Text
text
C0031809 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
Item
Physical Examination: Abdomen
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Physical Examination: Abdomen
Code List
Physical Examination: Abdomen
CL Item
yes (1)
CL Item
no (0)
Physical Examination: Abdomen, Text
Item
Physical Examination: Abdomen, Text
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Item
Physical Examination: Extremeties/Joints
text
C0031809 (UMLS CUI [1,1])
C0278454 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
Physical Examination: Extremeties/Joints
Code List
Physical Examination: Extremeties/Joints
CL Item
yes (1)
CL Item
no (0)
Physical Examination: Extremeties/Joints, Text
Item
Physical Examination: Extremeties/Joints, Text
text
C0031809 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
Item
Physical Examination: Mental Status
text
C0031809 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
Physical Examination: Mental Status
Code List
Physical Examination: Mental Status
CL Item
yes (1)
CL Item
no (0)
Physical Examination: Mental Status, Text
Item
Physical Examination: Mental Status, Text
text
C0031809 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
Item
Initial Blood Pregnancy Test
text
C0850355 (UMLS CUI [1])
Initial Blood Pregnancy Test
Code List
Initial Blood Pregnancy Test
CL Item
Test done (1)
CL Item
Test not done (0)
Initial Blood Pregnancy Test: Date
Item
Initial Blood Pregnancy Test: Date
date
C0850355 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Initial Blood Pregnancy Test: Result
text
C0850355 (UMLS CUI [1])
Initial Blood Pregnancy Test: Result
Code List
Initial Blood Pregnancy Test: Result
CL Item
negative (0)
CL Item
positive (1)
Item
Initial Blood Pregnancy Test: Reason
text
C0850355 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Initial Blood Pregnancy Test: Reason
Code List
Initial Blood Pregnancy Test: Reason
CL Item
no childbearing potential (0)
CL Item
other (9)
Initial Blood Pregnancy Test: Reason, Text
Item
Initial Blood Pregnancy Test: Reason, Text
text
C0850355 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
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