ID

13067

Beskrivning

Prospective,multicentric,double blind and placebo-controlled Phase III clinical trial to determine efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in patients with allergic rhinoconjunctivits caused by grass or rye pollen. EudraCT-Nr. 2008-000513-29 Study-code:CLU-2008-001 Sponsor: ROXALL Medizin GmbH Carl-Petersen-Straße 4 20535 Hamburg Phone:040-8972520 Fax:040-89725223 Project coordinator: Dr.Jenny Uhlig ROXALL Medizin GmbH Head of clinical investigation: Prof.Dr.med.Ludger Klimek An den Quellen 10 65183 Wiesbaden Phone:0611-8904381 Fax:0611-3082360 Monitoring,data management and statistical evaluation: IMSIE- Institut for medical statistics,computer sciences and epidemiology University hospital Cologne Lindenburger Allee 42 50931 Cologne Phone:0221-4783456 Fax:0221-4783465

Nyckelord

  1. 2016-01-14 2016-01-14 -
Uppladdad den

14 januari 2016

DOI

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Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis 1.0

Case report form Visit 1

Inclusion criteria
Beskrivning

Inclusion criteria

Male or female between 18 and 75 years of age
Beskrivning

Age and gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
Allergic rhinitis or rhinoconjunctivitis with or without controlled seasonal asthma due to allergen-exposure
Beskrivning

Allergic rhinitis or rhinoconjunctivitis

Datatyp

boolean

Alias
UMLS CUI [1]
C2607914
UMLS CUI [2]
C0861154
Sensitization to grass and/or rye pollen
Beskrivning

Sensitization

Datatyp

boolean

Alias
UMLS CUI [1]
C3662483
The majority of symptoms is experienced during grass pollen season
Beskrivning

Seasonal Symptoms

Datatyp

boolean

Alias
UMLS CUI [1]
C2039344
Positive scratch test for grass pollen with minimum diameter of rash 3mm
Beskrivning

positive Scratch Test

Datatyp

boolean

Alias
UMLS CUI [1]
C0857598
Planned treatment for allergies and/or asthma with at least one of the following substances
Beskrivning

Allergy treatment

Datatyp

text

Alias
UMLS CUI [1]
C1262684
total symptom score of equal to or higher than 8 during previous pollen season
Beskrivning

Allergy symptom score

Datatyp

boolean

Alias
UMLS CUI [1]
C3533163
Patient is willing and able to keep track of symptoms and antiallergic medication with a patient diary
Beskrivning

Compliance behavior using a patient diary

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C3890583
Signed informed consent
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
All laboratory results are within normal range or to be considered not relevant
Beskrivning

Normal blood chemistry

Datatyp

boolean

Alias
UMLS CUI [1]
C0438257
Exclusion criteria
Beskrivning

Exclusion criteria

Participation in any other clinical trial at the same time
Beskrivning

Study subject participation status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
Hyposensitization with grass or rye pollen extract within 3 years prior to enrollment
Beskrivning

hyposensitization

Datatyp

boolean

Alias
UMLS CUI [1]
C0178702
Predominantly perennial allergic rhinitis
Beskrivning

perennial rhinitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0035457
Poorly or not controlled Asthma (GINA Guidelines 2007)
Beskrivning

Asthma

Datatyp

boolean

Alias
UMLS CUI [1]
C0004096
Inflammation or Infection of targeted organs
Beskrivning

Inflammation or Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0021368
UMLS CUI [2]
C3714514
Irreversible secondary changes to the targeted organ like emphysema or bronchiectasis (FEV < 70 percent of predicted value)
Beskrivning

Emphysema or bronchiectasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0034067
UMLS CUI [2]
C0006267
Active tuberculosis
Beskrivning

Tuberculosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0041296
Autoimmune diseases
Beskrivning

Autoimmune diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
Severe chronic inflammatory diseases
Beskrivning

Chronic inflammatory diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C1290886
Malignancies
Beskrivning

Malignancies

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
Alcohol abuse
Beskrivning

Substance use disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
Prior or continuing treatment with psychotropic drugs or tranquilizer
Beskrivning

psychotropic drugs or tranquilizer

Datatyp

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2]
C0020592
Prior or continuing treatment with Anti-IgE Antibodies
Beskrivning

Anti-IgE Antibodies

Datatyp

boolean

Alias
UMLS CUI [1]
C0051978
Treatment with adrenergic beta receptor antagonists (including locally applied eye drops) or other contraindicated drugs
Beskrivning

Concomitant agent

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
Any contraindication to the use of Adrenaline
Beskrivning

i.e: severe acute coronary heart disease, severe hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1301624
Women of childbearing potential, pregnancy or breastfeeding
Beskrivning

Pregnancy or breastfeeding,childbearing potential

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
Female of childbearing potential, not using safe contraceptive measures
Beskrivning

Contraceptive measures

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
Ability to understand directions or protocol limited due to comorbidity or language barrier
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
Suspected poor compliance or other contraindications to enrollment to the discretion of the investigator
Beskrivning

Compliance behavior

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
Dependency from the sponsor or the clinical investigator
Beskrivning

i.e :co-workers of the sponsor or the clinical research centre, family members,...

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347796
UMLS CUI [1,2]
C3244310
Medical History and documentation of first Dose of trial substance
Beskrivning

Medical History and documentation of first Dose of trial substance

Date of visit 1
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Date of informed consent
Beskrivning

Date of informed consent

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Please give Patient ID composed of Study site Nr and Patient Nr
Beskrivning

Patient Identification

Datatyp

integer

Alias
UMLS CUI [1]
C1269815
Patient date of birth
Beskrivning

Birth date

Datatyp

date

Måttenheter
  • DD.MM.YYYY
Alias
UMLS CUI [1]
C0421451
DD.MM.YYYY
Patient gender
Beskrivning

Gender

Datatyp

integer

Alias
UMLS CUI [1]
C0079399
Please state the patient´s ethnicity
Beskrivning

Ethnicity

Datatyp

text

Alias
UMLS CUI [1]
C0015031
Please specify other ethnicity
Beskrivning

Ethnicity

Datatyp

text

Alias
UMLS CUI [1]
C0015031
Female of childbearing potential, using safe contraceptive measures
Beskrivning

not using safe contraception will result in exclusion from the trial

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
Was a pregnancy test performed?
Beskrivning

Pregnancy test

Datatyp

boolean

Alias
UMLS CUI [1]
C0032976
Please specify the date of the pregnancy test
Beskrivning

Date of pregnancy test

Datatyp

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Result of pregnancy test
Beskrivning

Pregnancy test

Datatyp

text

Alias
UMLS CUI [1]
C0032976
Blood pressure (BP)
Beskrivning

Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Body height
Beskrivning

Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Edema
Beskrivning

Otorhinolaryngologic examination

Datatyp

text

Alias
UMLS CUI [1]
C0545486
secretion
Beskrivning

Otorhinolaryngologic examination

Datatyp

text

Alias
UMLS CUI [1]
C0545486
Redness
Beskrivning

Otorhinolaryngologic examination

Datatyp

text

Alias
UMLS CUI [1]
C0545486
Sensitization against grass pollen
Beskrivning

Allergologic medical history

Datatyp

boolean

Alias
UMLS CUI [1]
C0262926
Sensitization against rye pollen
Beskrivning

Allergologic medical history

Datatyp

boolean

Alias
UMLS CUI [1]
C0262926
Sensitization against other allergen,please specify
Beskrivning

Allergologic medical history

Datatyp

text

Alias
UMLS CUI [1]
C0262926
Clinical symptoms of Rhinits
Beskrivning

Rhinitis

Datatyp

text

Alias
UMLS CUI [1]
C0035455
Symptoms of Rhinitis are mainly:
Beskrivning

Rhinitis

Datatyp

text

Alias
UMLS CUI [1]
C0035455
Year Rhinitis occurred for the first time
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Clinical symptoms of rhinoconjunctivitis present?
Beskrivning

Allergic Rhinoconjunctivitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0861154
Year rhinoconjunctivitis occurred for the first time
Beskrivning

Allergic rhinoconjunctivitis

Datatyp

date

Alias
UMLS CUI [1]
C0861154
Has the patient been diagnosed with allergic asthma?
Beskrivning

Allergic asthma

Datatyp

boolean

Alias
UMLS CUI [1]
C0155877
Please state the year allergic asthma has been diagnosed
Beskrivning

Allergic Asthma

Datatyp

date

Alias
UMLS CUI [1]
C0155877
Asthma symptoms are mainly
Beskrivning

Allergic asthma

Datatyp

text

Alias
UMLS CUI [1]
C0155877
Symptoms are
Beskrivning

Allergic asthma

Datatyp

text

Alias
UMLS CUI [1]
C0155877
Please specify planned antiallergic treatment
Beskrivning

Antiallergic drugs

Datatyp

text

Alias
UMLS CUI [1]
C0282555
Please specify prior illnesses,vaccinations and antibiotic treatment of the past 10 years
Beskrivning

retrospective assessment

Datatyp

text

Alias
UMLS CUI [1]
C1514923
UMLS CUI [2]
C0220825
Are there any comorbidities?
Beskrivning

Comorbidities

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
Comorbidities
Beskrivning

Comorbidities

Datatyp

text

Alias
UMLS CUI [1]
C0009488
Please specify other comorbidities
Beskrivning

Comorbidities

Datatyp

text

Alias
UMLS CUI [1]
C0009488
Does the patient use any other medication?
Beskrivning

Concomitant agent

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
Does the patient use any of the above mentioned medications?
Beskrivning

contraindicated drugs include: antihistamins,decongestives (oral and nasal drops),steroids,any drug treatment to nose or eyes,asthma treatment other than inhalative beta-2-antagonists,Antileukotriene,beta-antagonists even if applied locally,ACE inhibitor drugs,Anti-IgE Antibodies,Tranquilizer,psychotropic drugs

Datatyp

text

Alias
UMLS CUI [1]
C2347852
Please specify any other concomitant agent
Beskrivning

Concomitant Agent

Datatyp

text

Alias
UMLS CUI [1]
C2347852
Examination of cardiovascular system
Beskrivning

physical examination

Datatyp

text

Alias
UMLS CUI [1]
C0031809
Please specify findings during examination of the cardiovascular system
Beskrivning

Cardiovascular system

Datatyp

text

Alias
UMLS CUI [1]
C0007226
Respiratory system
Beskrivning

Physical examination

Datatyp

text

Alias
UMLS CUI [1]
C0031809
Please specify findings during examination of the respiratory system
Beskrivning

Respiratory system

Datatyp

text

Alias
UMLS CUI [1]
C0035237
Gastrointestinal system
Beskrivning

Physical examination

Datatyp

text

Alias
UMLS CUI [1]
C0031809
Please specify findings during examination of the gastrointestinal system
Beskrivning

Gastrointestinal system

Datatyp

text

Alias
UMLS CUI [1]
C0012240
Examination of the eyes
Beskrivning

Physical examination

Datatyp

text

Alias
UMLS CUI [1]
C0031809
Please specify findings during examination of the eyes
Beskrivning

eyes

Datatyp

text

Alias
UMLS CUI [1]
C0015392
Physical examination of the nose
Beskrivning

Physical examination

Datatyp

text

Alias
UMLS CUI [1]
C0031809
Please specify findings during examination of the nose
Beskrivning

Nose

Datatyp

text

Alias
UMLS CUI [1]
C0028429
Physical examination of the ears
Beskrivning

Physical examination

Datatyp

text

Alias
UMLS CUI [1]
C0031809
Please specify findings during examination of the ears
Beskrivning

Ears

Datatyp

text

Alias
UMLS CUI [1]
C0013443
Physical examination of the throat
Beskrivning

Physical examination

Datatyp

text

Alias
UMLS CUI [1]
C0031809
Please specify findings during examination of the throat
Beskrivning

Throat

Datatyp

text

Alias
UMLS CUI [1]
C0031354
Examination of the endocrine system
Beskrivning

Physical examination

Datatyp

text

Alias
UMLS CUI [1]
C0031809
Please specify findings during testing of the endocrine system
Beskrivning

Endocrine system

Datatyp

text

Alias
UMLS CUI [1]
C0014130
Examination of the musculoskeletal system
Beskrivning

Physical examination

Datatyp

text

Alias
UMLS CUI [1]
C0031809
Please specify findings during examination of the musculoskeletal system
Beskrivning

Musculoskeletal system

Datatyp

text

Alias
UMLS CUI [1]
C0026860
Examination of the central nervous system
Beskrivning

Physical examination

Datatyp

text

Alias
UMLS CUI [1]
C0031809
Please specify findings during the examination of the central nervous system
Beskrivning

central nervous system

Datatyp

text

Alias
UMLS CUI [1]
C3714787
Examination of the genitourinary tract
Beskrivning

Physical examination

Datatyp

text

Alias
UMLS CUI [1]
C0031809
Please specify findings during examination of the genitourinary tract
Beskrivning

genitourinary tract

Datatyp

text

Alias
UMLS CUI [1]
C0042066
Examination of the lymphatic system
Beskrivning

Physical examination

Datatyp

text

Alias
UMLS CUI [1]
C0031809
Please specify findings during examination of the lymphatic system
Beskrivning

lymphatic system

Datatyp

text

Alias
UMLS CUI [1]
C0024235
Please specify any other finding during the physical examination
Beskrivning

Physical examination

Datatyp

text

Alias
UMLS CUI [1]
C0031809

Similar models

Case report form Visit 1

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion criteria
Age and gender
Item
Male or female between 18 and 75 years of age
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Allergic rhinitis or rhinoconjunctivitis
Item
Allergic rhinitis or rhinoconjunctivitis with or without controlled seasonal asthma due to allergen-exposure
boolean
C2607914 (UMLS CUI [1])
C0861154 (UMLS CUI [2])
Sensitization
Item
Sensitization to grass and/or rye pollen
boolean
C3662483 (UMLS CUI [1])
Seasonal Symptoms
Item
The majority of symptoms is experienced during grass pollen season
boolean
C2039344 (UMLS CUI [1])
positive Scratch Test
Item
Positive scratch test for grass pollen with minimum diameter of rash 3mm
boolean
C0857598 (UMLS CUI [1])
Item
Planned treatment for allergies and/or asthma with at least one of the following substances
text
C1262684 (UMLS CUI [1])
Code List
Planned treatment for allergies and/or asthma with at least one of the following substances
CL Item
local cromoglycate (eye,nose) (1)
CL Item
oral antihistamine (2)
CL Item
nasal steroid (3)
CL Item
oral leukotriene antagonist (4)
Allergy symptom score
Item
total symptom score of equal to or higher than 8 during previous pollen season
boolean
C3533163 (UMLS CUI [1])
Compliance behavior using a patient diary
Item
Patient is willing and able to keep track of symptoms and antiallergic medication with a patient diary
boolean
C1321605 (UMLS CUI [1])
C3890583 (UMLS CUI [2])
Informed consent
Item
Signed informed consent
boolean
C0021430 (UMLS CUI [1])
Normal blood chemistry
Item
All laboratory results are within normal range or to be considered not relevant
boolean
C0438257 (UMLS CUI [1])
Item Group
Exclusion criteria
Study subject participation status
Item
Participation in any other clinical trial at the same time
boolean
C2348568 (UMLS CUI [1])
hyposensitization
Item
Hyposensitization with grass or rye pollen extract within 3 years prior to enrollment
boolean
C0178702 (UMLS CUI [1])
perennial rhinitis
Item
Predominantly perennial allergic rhinitis
boolean
C0035457 (UMLS CUI [1])
Asthma
Item
Poorly or not controlled Asthma (GINA Guidelines 2007)
boolean
C0004096 (UMLS CUI [1])
Inflammation or Infection
Item
Inflammation or Infection of targeted organs
boolean
C0021368 (UMLS CUI [1])
C3714514 (UMLS CUI [2])
Emphysema or bronchiectasis
Item
Irreversible secondary changes to the targeted organ like emphysema or bronchiectasis (FEV < 70 percent of predicted value)
boolean
C0034067 (UMLS CUI [1])
C0006267 (UMLS CUI [2])
Tuberculosis
Item
Active tuberculosis
boolean
C0041296 (UMLS CUI [1])
Autoimmune diseases
Item
Autoimmune diseases
boolean
C0004364 (UMLS CUI [1])
Chronic inflammatory diseases
Item
Severe chronic inflammatory diseases
boolean
C1290886 (UMLS CUI [1])
Malignancies
Item
Malignancies
boolean
C0006826 (UMLS CUI [1])
Substance use disorder
Item
Alcohol abuse
boolean
C0038586 (UMLS CUI [1])
psychotropic drugs or tranquilizer
Item
Prior or continuing treatment with psychotropic drugs or tranquilizer
boolean
C0033978 (UMLS CUI [1])
C0020592 (UMLS CUI [2])
Anti-IgE Antibodies
Item
Prior or continuing treatment with Anti-IgE Antibodies
boolean
C0051978 (UMLS CUI [1])
Concomitant agent
Item
Treatment with adrenergic beta receptor antagonists (including locally applied eye drops) or other contraindicated drugs
boolean
C2347852 (UMLS CUI [1])
Contraindication
Item
Any contraindication to the use of Adrenaline
boolean
C1301624 (UMLS CUI [1])
Pregnancy or breastfeeding,childbearing potential
Item
Women of childbearing potential, pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Contraceptive measures
Item
Female of childbearing potential, not using safe contraceptive measures
boolean
C0700589 (UMLS CUI [1])
Informed consent
Item
Ability to understand directions or protocol limited due to comorbidity or language barrier
boolean
C0021430 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
Compliance behavior
Item
Suspected poor compliance or other contraindications to enrollment to the discretion of the investigator
boolean
C1321605 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
Dependency from investigator or sponsor
Item
Dependency from the sponsor or the clinical investigator
boolean
C2347796 (UMLS CUI [1,1])
C3244310 (UMLS CUI [1,2])
Item Group
Medical History and documentation of first Dose of trial substance
Date
Item
Date of visit 1
date
C0011008 (UMLS CUI [1])
Date of informed consent
Item
Date of informed consent
date
C0011008 (UMLS CUI [1])
Patient Identification
Item
Please give Patient ID composed of Study site Nr and Patient Nr
integer
C1269815 (UMLS CUI [1])
Birth date
Item
Patient date of birth
date
C0421451 (UMLS CUI [1])
Item
Patient gender
integer
C0079399 (UMLS CUI [1])
Code List
Patient gender
CL Item
male (1)
CL Item
female (2)
Item
Please state the patient´s ethnicity
text
C0015031 (UMLS CUI [1])
Code List
Please state the patient´s ethnicity
CL Item
caucasian (1)
CL Item
asian (2)
CL Item
negroid (3)
CL Item
other (4)
Ethnicity
Item
Please specify other ethnicity
text
C0015031 (UMLS CUI [1])
Contraceptive measures
Item
Female of childbearing potential, using safe contraceptive measures
boolean
C0700589 (UMLS CUI [1])
Pregnancy test
Item
Was a pregnancy test performed?
boolean
C0032976 (UMLS CUI [1])
Date of pregnancy test
Item
Please specify the date of the pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result of pregnancy test
text
C0032976 (UMLS CUI [1])
Code List
Result of pregnancy test
CL Item
positive-> exclusion from trial (1)
CL Item
negative->safe contraception throughout the trial (2)
Blood Pressure
Item
Blood pressure (BP)
integer
C0005823 (UMLS CUI [1])
Height
Item
Body height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item
Edema
text
C0545486 (UMLS CUI [1])
CL Item
none (0)
CL Item
little (1)
CL Item
severe (2)
Item
secretion
text
C0545486 (UMLS CUI [1])
CL Item
none (0)
CL Item
clear fluid (1)
CL Item
congested/mucous (2)
Item
Redness
text
C0545486 (UMLS CUI [1])
CL Item
none (0)
CL Item
little (1)
CL Item
severe (2)
Allergologic medical history
Item
Sensitization against grass pollen
boolean
C0262926 (UMLS CUI [1])
Allergologic medical history
Item
Sensitization against rye pollen
boolean
C0262926 (UMLS CUI [1])
Allergologic medical history
Item
Sensitization against other allergen,please specify
text
C0262926 (UMLS CUI [1])
Item
Clinical symptoms of Rhinits
text
C0035455 (UMLS CUI [1])
Code List
Clinical symptoms of Rhinits
CL Item
yes (1)
CL Item
No-> exclusion from trial (2)
Item
Symptoms of Rhinitis are mainly:
text
C0035455 (UMLS CUI [1])
Code List
Symptoms of Rhinitis are mainly:
CL Item
seasonal (1)
CL Item
perennial-> exclusion from trial (2)
Start Date
Item
Year Rhinitis occurred for the first time
date
C0011008 (UMLS CUI [1])
Allergic Rhinoconjunctivitis
Item
Clinical symptoms of rhinoconjunctivitis present?
boolean
C0861154 (UMLS CUI [1])
Allergic rhinoconjunctivitis
Item
Year rhinoconjunctivitis occurred for the first time
date
C0861154 (UMLS CUI [1])
Allergic asthma
Item
Has the patient been diagnosed with allergic asthma?
boolean
C0155877 (UMLS CUI [1])
Allergic Asthma
Item
Please state the year allergic asthma has been diagnosed
date
C0155877 (UMLS CUI [1])
Item
Asthma symptoms are mainly
text
C0155877 (UMLS CUI [1])
Code List
Asthma symptoms are mainly
CL Item
seasonal (1)
CL Item
perennial -> exclusion from trial (2)
Item
Symptoms are
text
C0155877 (UMLS CUI [1])
Code List
Symptoms are
CL Item
controlled (1)
CL Item
partially controlled ->exclusion from trial (2)
CL Item
uncontrolled -> exclusion from trial (3)
Item
Please specify planned antiallergic treatment
text
C0282555 (UMLS CUI [1])
Code List
Please specify planned antiallergic treatment
CL Item
local cromoglycat (1)
CL Item
oral antihistamine (2)
CL Item
nasal steroid (3)
retrospective assessment
Item
Please specify prior illnesses,vaccinations and antibiotic treatment of the past 10 years
text
C1514923 (UMLS CUI [1])
C0220825 (UMLS CUI [2])
Comorbidities
Item
Are there any comorbidities?
boolean
C0009488 (UMLS CUI [1])
Item
Comorbidities
text
C0009488 (UMLS CUI [1])
Code List
Comorbidities
CL Item
active tuberculosis -> exclusion (1)
CL Item
autoimmune diseases -> exclusion (2)
CL Item
severe chronic inflammatory diseases -> exclusion (3)
CL Item
malignancies -> exclusion (4)
CL Item
irreversible secondary changes to the targeted organ -> exclusion (5)
CL Item
severe hypertension -> exclusion (6)
CL Item
other (7)
Comorbidities
Item
Please specify other comorbidities
text
C0009488 (UMLS CUI [1])
Concomitant agent
Item
Does the patient use any other medication?
boolean
C2347852 (UMLS CUI [1])
Item
Does the patient use any of the above mentioned medications?
text
C2347852 (UMLS CUI [1])
Code List
Does the patient use any of the above mentioned medications?
CL Item
yes -> exclusion (1)
CL Item
no (2)
Concomitant Agent
Item
Please specify any other concomitant agent
text
C2347852 (UMLS CUI [1])
Item
Examination of cardiovascular system
text
C0031809 (UMLS CUI [1])
Code List
Examination of cardiovascular system
CL Item
normal (1)
CL Item
abnormal (2)
Cardiovascular system
Item
Please specify findings during examination of the cardiovascular system
text
C0007226 (UMLS CUI [1])
Item
Respiratory system
text
C0031809 (UMLS CUI [1])
Code List
Respiratory system
CL Item
Normal (1)
CL Item
Abnormal (2)
Respiratory system
Item
Please specify findings during examination of the respiratory system
text
C0035237 (UMLS CUI [1])
Item
Gastrointestinal system
text
C0031809 (UMLS CUI [1])
Code List
Gastrointestinal system
CL Item
normal (1)
CL Item
abnormal (2)
Gastrointestinal system
Item
Please specify findings during examination of the gastrointestinal system
text
C0012240 (UMLS CUI [1])
Item
Examination of the eyes
text
C0031809 (UMLS CUI [1])
Code List
Examination of the eyes
CL Item
Normal (1)
CL Item
Abnormal (2)
eyes
Item
Please specify findings during examination of the eyes
text
C0015392 (UMLS CUI [1])
Item
Physical examination of the nose
text
C0031809 (UMLS CUI [1])
Code List
Physical examination of the nose
CL Item
Normal (1)
CL Item
Abnormal (2)
Nose
Item
Please specify findings during examination of the nose
text
C0028429 (UMLS CUI [1])
Item
Physical examination of the ears
text
C0031809 (UMLS CUI [1])
Code List
Physical examination of the ears
CL Item
Normal (1)
CL Item
Abnormal (2)
Ears
Item
Please specify findings during examination of the ears
text
C0013443 (UMLS CUI [1])
Item
Physical examination of the throat
text
C0031809 (UMLS CUI [1])
Code List
Physical examination of the throat
CL Item
Normal (1)
CL Item
Abnormal (2)
Throat
Item
Please specify findings during examination of the throat
text
C0031354 (UMLS CUI [1])
Item
Examination of the endocrine system
text
C0031809 (UMLS CUI [1])
Code List
Examination of the endocrine system
CL Item
Normal (1)
CL Item
Abnormal (2)
Endocrine system
Item
Please specify findings during testing of the endocrine system
text
C0014130 (UMLS CUI [1])
Item
Examination of the musculoskeletal system
text
C0031809 (UMLS CUI [1])
Code List
Examination of the musculoskeletal system
CL Item
Normal (1)
CL Item
Abnormal (2)
Musculoskeletal system
Item
Please specify findings during examination of the musculoskeletal system
text
C0026860 (UMLS CUI [1])
Item
Examination of the central nervous system
text
C0031809 (UMLS CUI [1])
Code List
Examination of the central nervous system
CL Item
Normal (1)
CL Item
Abnormal (2)
central nervous system
Item
Please specify findings during the examination of the central nervous system
text
C3714787 (UMLS CUI [1])
Item
Examination of the genitourinary tract
text
C0031809 (UMLS CUI [1])
Code List
Examination of the genitourinary tract
CL Item
Normal (1)
CL Item
Abnormal (2)
genitourinary tract
Item
Please specify findings during examination of the genitourinary tract
text
C0042066 (UMLS CUI [1])
Item
Examination of the lymphatic system
text
C0031809 (UMLS CUI [1])
Code List
Examination of the lymphatic system
CL Item
Normal (1)
CL Item
Abnormal (2)
lymphatic system
Item
Please specify findings during examination of the lymphatic system
text
C0024235 (UMLS CUI [1])
Physical examination
Item
Please specify any other finding during the physical examination
text
C0031809 (UMLS CUI [1])

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