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13374
Beschreibung
Study part: Visit V0 Screening visit. Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.
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10. Februar 2016
DOI
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Visit V0 LAIS grass tablets by allergic rhinoconjunctivitis EudraCT-Nr.2012-004916-79
Visit V0 Screening visit
- StudyEvent: ODM
Ähnliche Modelle
Visit V0 Screening visit
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
age; Allergic rhinoconjunctivitis; Allergic asthma
Item
Female or male patients between 18 and 75 years with at least 2 years known, induced by grass pollen allergic rhinitis and / or allergic rhinoconjunctivitis with or without controlled allergic asthma
boolean
C0001779 (UMLS CUI [1])
C0861154 (UMLS CUI [2])
C0155877 (UMLS CUI [3])
C0861154 (UMLS CUI [2])
C0155877 (UMLS CUI [3])
sensitization; Perennial allergy
Item
Clinical sensitization to grass pollen. Patients with sensitization to perennial allergens such as dust mites, cats, dogs may be included where such sensitization during the analysis period are not clinically relevant.
boolean
C3662483 (UMLS CUI [1])
C2721639 (UMLS CUI [2])
C2721639 (UMLS CUI [2])
compliance behavior; patient diary
Item
Reliability and ability of the patient to fill out the patient diary for self-assessment of symptoms and taking the anti symptomatic medication selbsständig
boolean
C1321605 (UMLS CUI [1])
C3890583 (UMLS CUI [2])
C3890583 (UMLS CUI [2])
informed consent
Item
Signed and dated informed consent of the patient
boolean
C0021430 (UMLS CUI [1])
Study Subject Participation Status
Item
Simultaneous participation in other clinical trials
boolean
C2348568 (UMLS CUI [1])
immunotherapy; Grass pollen; allergen
Item
Previous immunotherapy with grass pollen allergen or cross-reacting allergen in the last 5 years
boolean
C0021083 (UMLS CUI [1])
C0440307 (UMLS CUI [2])
C0002092 (UMLS CUI [3])
C0440307 (UMLS CUI [2])
C0002092 (UMLS CUI [3])
immunotherapy; allergen
Item
Continuing immunotherapy for allergens
boolean
C0021083 (UMLS CUI [1])
C0002092 (UMLS CUI [2])
C0002092 (UMLS CUI [2])
investigator; relationship
Item
Patients who are in any sort of relationship or dependence on the sponsor and / or investigator
boolean
C0008961 (UMLS CUI [1])
C0439849 (UMLS CUI [2])
C0439849 (UMLS CUI [2])
compliance behavior limited
Item
Other reasons that according to the opinion of the investigator contraindicate an inclusion in the clinical trial (e.g, low reliability, inability of the patient to understand the study documents and instructions)
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,2])
contraception status
Item
An existing or planned pregnancy, lactation and / or lack of adequate contraception
boolean
C0420837 (UMLS CUI [1])
perennial allergic rhinitis
Item
Mostly perennial allergic rhinitis
boolean
C0035457 (UMLS CUI [1])
Perennial allergy Asthma
Item
Only partially controlled or non-controlled or predominantly perenniales Asthma
boolean
C2721639 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0004096 (UMLS CUI [1,2])
comorbidity; asthma; emphysem
Item
Chronic asthma or emphysema, in particular with an FEV1 <70% of the expected value
boolean
C0009488 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0034067 (UMLS CUI [3])
C0004096 (UMLS CUI [2])
C0034067 (UMLS CUI [3])
comorbidity; asthma; emphysem
Item
Chronic asthma or emphysema, in particular with an FEV1 <70% of the individual value
boolean
C0009488 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0034067 (UMLS CUI [3])
C0004096 (UMLS CUI [2])
C0034067 (UMLS CUI [3])
infection oral cavity
Item
Infections in the oral cavity with severe symptoms
boolean
C0009450 (UMLS CUI [1,1])
C0226896 (UMLS CUI [1,2])
C0226896 (UMLS CUI [1,2])
Intolerance galactose
Item
Patients with hereditary problems of galactose intolerance, lactase deficiency, glucose galactose malabsorption
boolean
C1744706 (UMLS CUI [1,1])
C0016945 (UMLS CUI [1,2])
C0016945 (UMLS CUI [1,2])
adenoid
Item
Patients with deformities of the nose and / or adenoids
boolean
C0001428 (UMLS CUI [1])
Active tuberculosis
Item
Active tuberculosis
boolean
C0151332 (UMLS CUI [1])
inflammatory disease
Item
General inflammatory / febrile and severe acute or chronic inflammatory diseases
boolean
C1290884 (UMLS CUI [1])
Immunodeficiencies
Item
Immunodeficiencies (for example, also induced by immunosuppressants)
boolean
C0596032 (UMLS CUI [1])
Autoimmune diseases
Item
Autoimmune diseases
boolean
C0004364 (UMLS CUI [1])
Autoimmune Diseases; internal disease
Item
By a doctor diagnosed internal diseases (for example, the liver, spleen, nervous system, the thyroid gland and rheumatic disorders), which are due to an autoimmune mechanism.
boolean
C0004364 (UMLS CUI [1])
C0679231 (UMLS CUI [2])
C0679231 (UMLS CUI [2])
Malignant tumors
Item
Malignant tumors
boolean
C0006826 (UMLS CUI [1])
Substance Use Disorder
Item
Alcohol abuse, drugs or medication abuse
boolean
C0038586 (UMLS CUI [1])
Contraindication epinephrine
Item
Contraindication to epinephrine (e.g. in acute or chronic myocardial ischemia symptomatology, severe hypertension)
boolean
C0522473 (UMLS CUI [1,1])
C0014563 (UMLS CUI [1,2])
C0014563 (UMLS CUI [1,2])
sedatives
Item
Completed or ongoing long-term treatment with sedatives, or psychoactive drugs
boolean
C0036557 (UMLS CUI [1])
Contraindicated drug
Item
Patients being treated with contraindicated Drug
boolean
C3845816 (UMLS CUI [1])
visit date
Item
Date of screening visit (= Day -28/ -3 of the study)
date
C1320303 (UMLS CUI [1])
consent date
Item
Date on which informed consent is signed
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
birth year
Item
Birth year
partialDate
C2826771 (UMLS CUI [1])
CL Item
male (1)
CL Item
female (2)
CL Item
caucasian (1)
CL Item
asian (2)
CL Item
negroid (3)
CL Item
other (4)
other
Item
If other, please mention
text
C0205394 (UMLS CUI [1])
visit date
Item
Date of next Visit V1 (3 to 28 days after V0)
date
C1320303 (UMLS CUI [1])
venipuncture date
Item
Date of venipuncture for total and specific IgE
date
C0600406 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
venipuncture date
Item
Date of venipuncture for safety laboratory
date
C0600406 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
no, then exclusion (1)
CL Item
yes, according to Supplement "Recognised methods of reliable contraception" (2)
CL Item
yes, other reasons for a safe contraception (3)
pregnancy test date
Item
Pregnancy test date
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
positive, exclusion (1)
CL Item
negative (2)
Weight
Item
Weight
float
C0005910 (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])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Examination (Rhinoscope)
C0582103 (UMLS CUI-1)
C0183044 (UMLS CUI-2)
C0183044 (UMLS CUI-2)
CL Item
no (1)
CL Item
slight (2)
CL Item
medium (3)
CL Item
strong (4)
CL Item
no (1)
CL Item
slight (2)
CL Item
medium (3)
CL Item
strong (4)
CL Item
no (1)
CL Item
slight (2)
CL Item
medium (3)
CL Item
strong (4)
grass pollen
Item
Grass pollen
boolean
C0440307 (UMLS CUI [1])
tree pollen
Item
Tree pollen
boolean
C3541399 (UMLS CUI [1])
Atopic dermatitis
Item
Atopic dermatitis
boolean
C0011615 (UMLS CUI [1])
weed pollen
Item
Weed pollen
boolean
C1328969 (UMLS CUI [1])
Food allergies
Item
Food allergies
boolean
C0016470 (UMLS CUI [1])
Food allergies
Item
If yes, which?
text
C0016470 (UMLS CUI [1])
allergy
Item
Other allergies
text
C0020517 (UMLS CUI [1])
allergic rhinitis; allergic rhinoconjunctivitis
Item
Allergic rhinitis/ allergic rhinoconjunctivitis
boolean
C2607914 (UMLS CUI [1])
C0861154 (UMLS CUI [2])
C0861154 (UMLS CUI [2])
Item
Allergic rhinitis/ allergic rhinoconjunctivitis
text
C2607914 (UMLS CUI [1])
C0861154 (UMLS CUI [2])
C0861154 (UMLS CUI [2])
Code List
Allergic rhinitis/ allergic rhinoconjunctivitis
CL Item
seasonal (1)
CL Item
predominantly perennial, then exclusion (2)
allergic rhinoconjunctivitis date
Item
Allergic rhinoconjunctivitis or allergic rhinitis since
date
C0861154 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Retrospective Rhinoconjunctivitis Total Symptom Score
C0449820 (UMLS CUI-1)
C0861155 (UMLS CUI-2)
C0861155 (UMLS CUI-2)
CL Item
no symptoms 0 (1)
CL Item
slight symptoms 1 (2)
CL Item
moderate symptoms 2 (3)
CL Item
strong symptoms 3 (4)
CL Item
no symptoms 0 (1)
CL Item
slight symptoms 1 (2)
CL Item
moderate symptoms 2 (3)
CL Item
strong symptoms 3 (4)
CL Item
no symptoms 0 (1)
CL Item
slight symptoms 1 (2)
CL Item
moderate symptoms 2 (3)
CL Item
strong symptoms 3 (4)
CL Item
no symptoms 0 (1)
CL Item
slight symptoms 1 (2)
CL Item
moderate symptoms 2 (3)
CL Item
strong symptoms 3 (4)
CL Item
no symptoms 0 (1)
CL Item
slight symptoms 1 (2)
CL Item
moderate symptoms 2 (3)
CL Item
strong symptoms 3 (4)
CL Item
no symptoms 0 (1)
CL Item
slight symptoms 1 (2)
CL Item
moderate symptoms 2 (3)
CL Item
strong symptoms 3 (4)
Summation
Item
Summation (when total RTSS score is < 8, exclusion of patient)
integer
C0234108 (UMLS CUI [1])
Concomitant medication
Item
Concomitant medication
boolean
C2347852 (UMLS CUI [1])
CL Item
contraindicated drugs (1)
CL Item
other medicines (2)
other
Item
If other, please mention
text
cardiovascular system
Item
Cardiovascular system
boolean
C0007226 (UMLS CUI [1])
respiratory
Item
Respiratory
boolean
C0035237 (UMLS CUI [1])
gastrointestinal tract
Item
Gastrointestinal Tract
boolean
C0017189 (UMLS CUI [1])
Eye
Item
Eye
boolean
C0015392 (UMLS CUI [1])
Nose
Item
Nose
boolean
C0028429 (UMLS CUI [1])
Ears
Item
Ears
boolean
C0013443 (UMLS CUI [1])
Neck
Item
Neck
boolean
C0027530 (UMLS CUI [1])
Skin
Item
Skin
boolean
C1123023 (UMLS CUI [1])
Skin
Item
Skin
boolean
C1123023 (UMLS CUI [1])
Endocrine system; lymphatic system
Item
Endocrine / lymphatic system
boolean
C0014130 (UMLS CUI [1])
C0024235 (UMLS CUI [2])
C0024235 (UMLS CUI [2])
muscle; skeleton
Item
Muscle/ Skeleton
boolean
C0026845 (UMLS CUI [1])
C0037253 (UMLS CUI [2])
C0037253 (UMLS CUI [2])
Nervous system
Item
Nervous system
boolean
C0027763 (UMLS CUI [1])
genitourinary
Item
Genitourinary
boolean
C0042066 (UMLS CUI [1])
Metabolic System
Item
Metabolic System
boolean
C0014136 (UMLS CUI [1])
CL Item
no (1)
CL Item
yes, please match with exclusion criteria and specify (2)
comorbidity
Item
Specification of comorbidity
text
C0009488 (UMLS CUI [1])
surgical procedures
Item
Retrospective registration of disease or surgical procedures on other organs within the last 10 years
text
C0543467 (UMLS CUI [1])
Specification
Item
If diagnosis, please describe
text
grass pollen
Item
Size of wheal for grass pollen mixture (> = 3 mm)
float
C0440307 (UMLS CUI [1])
histamine dihydrochloride
Item
Size of wheal for histamine dihydrochloride (positive control 10 mg/ml) (>=3 mm)
float
C0543456 (UMLS CUI [1])
Saline Solution
Item
Size of wheal for saline solution (< 2 mm)
float
C0036082 (UMLS CUI [1])
rye pollen
Item
Size of wheal for rye pollen
float
C0440328 (UMLS CUI [1])
hazel pollen
Item
Size of wheal for hazel pollen
float
C0440377 (UMLS CUI [1])
ambrosia pollen
Item
Size of wheal for ambrosia pollen
float
C3495104 (UMLS CUI [1])
Birch pollen
Item
Size of wheal for birch pollen
float
C4047367 (UMLS CUI [1])
mugwort pollen
Item
Size of wheal for mugwort pollen
float
C0440352 (UMLS CUI [1])
House dust mite
Item
Size of wheal for house dust mite
float
C3539110 (UMLS CUI [1])
cat hair
Item
Size of wheal for cat hair
float
C0440419 (UMLS CUI [1])
dog hair
Item
Size of wheal for dog hair
float
C0440417 (UMLS CUI [1])
Alternaria
Item
Size of wheal for alternaria
float
C0002343 (UMLS CUI [1])
Item Group
Spirometry or Peak expiratory flow measurement (For asthmatics)
C0037981 (UMLS CUI-1)
C0521299 (UMLS CUI-2)
C0521299 (UMLS CUI-2)
FEV1
Item
FEV1 (age-appropriate standard value)
float
C0748133 (UMLS CUI [1])
FEV1
Item
FEV1
float
C0748133 (UMLS CUI [1])
Ratio; FEV1; standard value
Item
FEV1/ Standard value (If FEV1 < 70% of age appropriate standard value, exclusion)
integer
C0456603 (UMLS CUI [1])
C0588029 (UMLS CUI [2])
C1442989 (UMLS CUI [3])
C0588029 (UMLS CUI [2])
C1442989 (UMLS CUI [3])
Peak expiratory flow measurement
Item
PEF 1
integer
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
PEF 2
integer
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
PEF 3
integer
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
Best PEF
integer
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
Optimum individual value PEF (If FEV1 < 70% of optimum individual value, exclusion)
integer
C0521299 (UMLS CUI [1])
Item
Conjunctival provocation test result 1
text
C0430565 (UMLS CUI [1])
CL Item
positive (1)
CL Item
negative (2)
Item
Conjunctival provocation test result 2 (to be carried out only when test 1 outcome is negative)
text
C0430565 (UMLS CUI [1])
Code List
Conjunctival provocation test result 2 (to be carried out only when test 1 outcome is negative)
CL Item
positive (1)
CL Item
negative (2)
Item
Conjunctival provocation test result 3 (to be carried out only when test 2 outcome is negative)
text
C0430565 (UMLS CUI [1])
Code List
Conjunctival provocation test result 3 (to be carried out only when test 2 outcome is negative)
CL Item
positive (1)
CL Item
negative (2)
Item
Allergen concentration at which the test outcome is positive
text
C1446561 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0002092 (UMLS CUI [1,2])
CL Item
100 SQ- E/ ml (1)
CL Item
1000 SQ-E/ ml (2)
CL Item
10000 SQ-E/ ml (3)
Conjunctival provocation testing
Item
The outcome for all tests is negative
boolean
Immunoglobulin E
Item
Total Immunoglobulin E
float
C0202086 (UMLS CUI [1])
Immunoglobulin G4
Item
Immunoglobulin IgG4
float
C0020860 (UMLS CUI [1])
Immunoglobulin; Grass pollen
Item
Grass (Phleum pratense) Phl p 1
float
C0021027 (UMLS CUI [1])
C0440307 (UMLS CUI [2])
C0440307 (UMLS CUI [2])
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Immunoglobulin; Grass pollen
Item
Grass (Phleum pratense) Phl p5b
float
C0021027 (UMLS CUI [1])
C0440307 (UMLS CUI [2])
C0440307 (UMLS CUI [2])
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Immunoglobulin; Grass pollen
Item
Grass (Phleum pratense) Phl p 7
float
C0021027 (UMLS CUI [1])
C0440307 (UMLS CUI [2])
C0440307 (UMLS CUI [2])
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Immunoglobulin; Grass pollen
Item
Grass (Phleum pratense) Phl p 12
float
C0021027 (UMLS CUI [1])
C0440307 (UMLS CUI [2])
C0440307 (UMLS CUI [2])
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Birch antigen
Item
Birch Bet v 1
float
C1527024 (UMLS CUI [1])
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Immunoglobulin Mugwort
Item
Mugwort Art v1
float
C0021027 (UMLS CUI [1,1])
C0348066 (UMLS CUI [1,2])
C0348066 (UMLS CUI [1,2])
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Immunoglobulin ambrosia
Item
Ambrosia Amb a1
float
C0021027 (UMLS CUI [1,1])
C0331432 (UMLS CUI [1,2])
C0331432 (UMLS CUI [1,2])
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Immunoglobulin Dermatophagoides pteronyssinus
Item
D. pteronyssinus Der p1
float
C0021027 (UMLS CUI [1,1])
C1122992 (UMLS CUI [1,2])
C1122992 (UMLS CUI [1,2])
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Immunoglobulin Dermatophagoides farinae
Item
D. farinae Der p2
float
C0021027 (UMLS CUI [1,1])
C0323677 (UMLS CUI [1,2])
C0323677 (UMLS CUI [1,2])
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Dog antigen
Item
Dog Can f1
float
C1443014 (UMLS CUI [1])
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Cat hair antigen
Item
Cat Fel d1
float
C1443200 (UMLS CUI [1])
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Immunoglobulin Alternaria
Item
Alternaria Alt a1
float
C0021027 (UMLS CUI [1,1])
C0002343 (UMLS CUI [1,2])
C0002343 (UMLS CUI [1,2])
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Erythrocyte
Item
Erythrocyte
float
C0014772 (UMLS CUI [1])
Thrombocyte
Item
Thrombocyte
float
C0005821 (UMLS CUI [1])
Leucocyte (total)
Item
Leucocyte (total)
float
C0023508 (UMLS CUI [1])
Hematocrit
Item
Hematocrit
float
C0518014 (UMLS CUI [1])
Bilirubin
Item
Bilirubin (total)
float
C1278039 (UMLS CUI [1])
Glutamate pyruvate transaminase
Item
SGPT- Serum Glutamate pyruvate transaminase
float
alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
SGOT- Aspartate aminotransferase measurement
float
C0201899 (UMLS CUI [1])
C reactive protein
Item
CRP C reactive protein
float
C0201657 (UMLS CUI [1])
Gamma-glutamyl transpeptidase
Item
Gamma-glutamyl transpeptidase
float
C1883012 (UMLS CUI [1])
allergy grass pollen
Item
the occurrence of the majority of the corresponding clinical symptoms during the grass pollen season
boolean
C0020517 (UMLS CUI [1,1])
C0440307 (UMLS CUI [1,2])
C0440307 (UMLS CUI [1,2])
sensitization
Item
Patients should not suffer from typical symptoms caused by co-allergens during the grass pollen season (for example, patients with sensitization to animal fur / - dandruff are not be exposed)
boolean
C3662483 (UMLS CUI [1])
skin prick test
Item
the positive skin prick test (wheal size> = 3 mm, negative control <2 mm)
boolean
C0430561 (UMLS CUI [1])
perennial allergy
Item
The results in the skin prick test for co-seasonal and most of the perennial co-allergenic are smaller than the skin prick test result for Grass pollen
boolean
C2721639 (UMLS CUI [1])
conjunctival Provocation test
Item
a positive reaction in the conjunctival Provocation test (CPT) with one of the three dilutions of grass allergy solution
boolean
C0430565 (UMLS CUI [1])
Score Rhinoconjunctivitis
Item
Retrospective Total symptom score (RRTSS) during the previous grass pollen season is greater than or equal to 8
boolean
C0449820 (UMLS CUI [1,1])
C0861155 (UMLS CUI [1,2])
C0861155 (UMLS CUI [1,2])
Antiallergic therapy
Item
Planned antiallergic or antiasthmatic treatment with the following medicines: local treatment with levocabastine (eye), loratadine (oral), beclomethasone (nasal) or inhaled corticosteroid with a long-acting beta-2 agonists
boolean
C1535925 (UMLS CUI [1])
immunoglobulin E
Item
Specific IgE reactivity to grass pollen: CAP RAST results for Phl p 1 or Phl p5b> = class 2 (0.70 kU / l) and CAP-RAST results for Phl p 1 or Phl p5b> CAP-RAST results for Phl p 7 or Phl p 12
boolean
C0202086 (UMLS CUI [1])
immunoglobulin E; Grass allergy
Item
The specific IgE values for predominantly perennial co- allergy (animal hair / - dandruff, dust mites) or for the predominantly co-seasonal allergen Alternaria must be less than the sIgE results for grass pollen allergens (Phl p 1 or Phl p5b). The difference must be at least a CAP RAAST class (> = 1).
boolean
C0202086 (UMLS CUI [1])
C1387134 (UMLS CUI [2])
C1387134 (UMLS CUI [2])