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ID

44222

Descrizione

This study evaluates the effectiveness and safety of MFNS in improving the Treatment of Chronic Sinusitis. ODM derived from:"Randomized Double-blind Clinical Trial on the Efficacy and Safety of 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) or Placebo in the Treatment of Chronic Sinusitis". Leader of the clinical trial: Prof. Dr. med. Karl Hörmann Direktor der Hals-Nasen-Ohren-Klinik / Clinic Director Ear, Nose and Throat Clinic Medical Faculty Mannheim Heidelberg University at the University Medical Centre Mannheim Theodor-Kutzer-Ufer 1-3 68167 Mannheim

Keywords

  1. 08/03/16 08/03/16 -
  2. 08/03/16 08/03/16 -
  3. 13/04/21 13/04/21 - Dr. rer. medic Philipp Neuhaus
  4. 20/09/21 20/09/21 -
Caricato su

20 settembre 2021

DOI

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Licenza

Creative Commons BY-NC 3.0

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    Visit 1 - Baseline Form Clinical Trial on the Efficacy and Safety BID Mometasone Furoate Nasal Spray (MFNS) in the Treatment of Chronic Sinusitis

    Visit 1 - Baseline Form

    Header module
    Descrizione

    Header module

    Visit number
    Descrizione

    Visit Number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1549755 (Visit Number)
    Patient Name
    Descrizione

    Patient Name

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1299487 (Patient name)
    SNOMED
    371484003
    Center #
    Descrizione

    Center #

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0009469 (Community Health Centers)
    Date
    Descrizione

    Date

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Patient demographics
    Descrizione

    Patient demographics

    Date of birth
    Descrizione

    Date of birth

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0421451 (Patient date of birth)
    SNOMED
    184099003
    LOINC
    LP57552-9
    Height
    Descrizione

    Height

    Tipo di dati

    integer

    Unità di misura
    • cm
    Alias
    UMLS CUI [1]
    C0005890 (Body Height)
    SNOMED
    50373000
    cm
    Weight
    Descrizione

    Weight

    Tipo di dati

    integer

    Unità di misura
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Temperatur
    Descrizione

    Temperatur

    Tipo di dati

    integer

    Unità di misura
    • °C
    Alias
    UMLS CUI [1]
    C0039476 (Temperature)
    SNOMED
    703421000
    LOINC
    MTHU009008
    °C
    Blood pressure
    Descrizione

    Blood pressure

    Tipo di dati

    integer

    Unità di misura
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    Heart rate
    Descrizione

    Heart rate

    Tipo di dati

    integer

    Unità di misura
    • 1/sec
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    1/sec
    Gender
    Descrizione

    Gender

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    Ethnicity
    Descrizione

    Ethnic Group

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0015031 (Ethnic group)
    SNOMED
    398089004
    LOINC
    LP36231-6
    Medical history of serious illness, accidents, surgeries
    Descrizione

    Medical history of serious illness, accidents, surgeries

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0010340 (Critical Illness)
    UMLS CUI [2]
    C0000924 (Accidents)
    LOINC
    MTHU021177
    UMLS CUI [3]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    Does the patient suffer from allergies?
    Descrizione

    Does the patient suffer from allergies?

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0489531 (History of allergies)
    Chronic sinusitis
    Descrizione

    Patient has suffered from chronic sinusitis since:

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0149516 (Chronic sinusitis)
    SNOMED
    40055000
    Inclusion criteria
    Descrizione

    Inclusion criteria

    Initial examination including Ear, Nose and Throat Examination
    Descrizione

    Initial examination including Ear, Nose and Throat Examination

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2729337 (undefined)
    UMLS CUI [2]
    C0278350 (ENT examination)
    SNOMED
    113028003
    Patient age between 18-65
    Descrizione

    Patient age

    Tipo di dati

    boolean

    Patient with chronic sinusitis
    Descrizione

    Patient with chronic sinusitis for more than 8 weeks or with more than 4 periods during at least 10 days/year (nasal obstruction and unspecific headache, rhinorrhea, post-nasal-drip, facial pain, facial pressure

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0149516 (Chronic sinusitis)
    SNOMED
    40055000
    Sinusitis symptom score
    Descrizione

    Sinusitis Symptom Score total >= 5 and nasal obstruction score total >=2

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3533163 (Total symptom score)
    LOINC
    LP157096-1
    UMLS CUI [1,2]
    C0037199 (Sinusitis)
    SNOMED
    36971009
    UMLS CUI [2,1]
    C1299570 (Nasal sinus obstruction)
    SNOMED
    371126007
    UMLS CUI [2,2]
    C0037199 (Sinusitis)
    SNOMED
    36971009
    Sinusitis diagnostics through coronary CT
    Descrizione

    Sinusitis diagnostics via coronary CT not older than 6 month. Sinusitis diagnosis and scale: osteo-meatal complex score= 2 on at least one side, total score < 10

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0037199 (Sinusitis)
    SNOMED
    36971009
    UMLS CUI [1,2]
    C1634617 (CT angiography of coronary arteries)
    Patient in good general condition
    Descrizione

    Patient in good general condition without clinically significant disease which could affect study goal or study methods or which might impair patient´s safety.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1142435 (General physical condition)
    LOINC
    LP172762-9
    Patient with stable intermittent asthma
    Descrizione

    Patient with stable intermittent asthma: No medication at all or no medication with Beta-2 adrenergic receptor antagonists and without systemic, intranasal or inhaled corticosteroids medication.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1740754 (Intermittent asthma)
    SNOMED
    427603009
    Patient on prior medication
    Descrizione

    Patient on prior medication: Observe wash out times prior to begin of study

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2826257 (Prior Medication Usage)
    Written informed consent
    Descrizione

    Written informed consent based on patient information by physician

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Footer module
    Descrizione

    Footer module

    no participation
    Descrizione

    In case one of the above mentioned questions is answered “NO” the patient may not be included into the study.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0680252 (inclusion and exclusion)
    Date and signature
    Descrizione

    Date and signature by physician

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0807937 (Signature date)
    LOINC
    MTHU008294
    Exclusion criteria
    Descrizione

    Exclusion criteria

    Alias
    UMLS CUI-1
    C0680251 (Exclusion Criteria)
    Patient who do not fulfill all inclusion criteria
    Descrizione

    Patient who do not fulfill all inclusion criteria

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2827031 (Trial Inclusion Exclusion Criteria Rule)
    Patient without contraception, pregnant/ breast-feeding
    Descrizione

    Patient without contraception, pregnant/ breast-feeding

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [2]
    C0549206 (Patient currently pregnant)
    SNOMED
    77386006
    LOINC
    LA14670-6
    UMLS CUI [3]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    Patient has undergone nasal operation within the last 6 months
    Descrizione

    Patient has undergone nasal operation within the last 6 months

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0188970 (Operation on nose)
    SNOMED
    88733004
    Patient with significant ECG changes
    Descrizione

    Patient with significant ECG changes

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0855329 (Electrocardiogram change)
    Patient with clinically relevant changes of vital bodily function
    Descrizione

    Patient with clinically relevant changes of vital bodily function

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0277803 (Normal vital signs)
    SNOMED
    72970002
    Patient with Wegener's granulomatosis and/ or several other diseases
    Descrizione

    Patient with Wegener's granulomatosis, Cystic fibrosis, Nasal polyp, Young syndrome, Primary ciliary dyskinesia, Glaucoma, cardiovascular, pulmonary, renal, hepatic, metabolic, hematological or neurological disease, that may impair with the therapy, patient on immunosuppressive agents or with Churg–Strauss syndrome

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C3495801 (Granulomatosis with polyangiitis)
    SNOMED
    195353004
    UMLS CUI [2,1]
    C0010674 (Cystic Fibrosis)
    SNOMED
    190905008
    UMLS CUI [2,2]
    C0027430 (Nasal Polyps)
    SNOMED
    736500007
    UMLS CUI [3]
    C0340037 (Young Syndrome)
    SNOMED
    233666007
    UMLS CUI [4]
    C0008780 (Ciliary Motility Disorders)
    SNOMED
    86204009
    UMLS CUI [5]
    C0017601 (Glaucoma)
    SNOMED
    23986001
    LOINC
    LP74892-8
    UMLS CUI [6]
    C0007222 (Cardiovascular Diseases)
    SNOMED
    49601007
    UMLS CUI [7]
    C0024115 (Lung diseases)
    SNOMED
    19829001
    UMLS CUI [8]
    C0022658 (Kidney Diseases)
    SNOMED
    90708001
    UMLS CUI [9,1]
    C0023895 (Liver diseases)
    SNOMED
    235856003
    LOINC
    LA17774-3
    UMLS CUI [9,2]
    C0025517 (Metabolic Diseases)
    SNOMED
    30390004
    UMLS CUI [9,3]
    C0018939 (Hematological Disease)
    SNOMED
    34093004
    UMLS CUI [9,4]
    C0027765 (nervous system disorder)
    SNOMED
    118940003
    LOINC
    LA10590-0
    UMLS CUI [10]
    C0021081 (Immunosuppressive Agents)
    SNOMED
    69431002
    UMLS CUI [11]
    C0008728 (Eosinophilic granulomatosis with polyangiitis)
    SNOMED
    82275008
    Patient on systemic steroid therapy < 4 weeks prior to begin of study
    Descrizione

    Patient on systemic steroid therapy < 4 weeks prior to begin of study

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C4039704 (History of systemic steroid therapy)
    SNOMED
    134671000119104
    Patient on inhalable or intranasal steroid therapy < 2 weeks prior to begin of study
    Descrizione

    Patient on inhalable or intranasal steroid therapy < 2 weeks prior to begin of study

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C3539185 (Corticosteroid nasal preparations for topical use)
    Drug intolerance
    Descrizione

    Drug intolerance to pharmaceutical ingredients of study medication

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0277585 (Intolerance to drug)
    SNOMED
    59037007
    Acute exacerbation of sinusitis
    Descrizione

    Acute exacerbation of sinusitis or acute nasal infection < 2 weeks prior to begin of examination that required antibiotic therapy.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0235874 (Disease Exacerbation)
    UMLS CUI [1,2]
    C0037199 (Sinusitis)
    SNOMED
    36971009
    UMLS CUI [1,3]
    C0338237 (Antibiotic therapy)
    SNOMED
    281789004
    Body Temperature
    Descrizione

    Body Temperature > 38.5 °C at start of trial

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0005903 (Body Temperature)
    SNOMED
    722490005
    LOINC
    LP36617-6
    White blood cell count
    Descrizione

    White blood cell count exceeding > 150 % of upper limit

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0580531 (White blood cell count abnormal)
    SNOMED
    165509000
    Acute Upper Respiratory Infection
    Descrizione

    Acute Upper Respiratory Infection within last two weeks

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0264222 (Acute upper respiratory infection)
    SNOMED
    54398005
    Patient on antibiotic therapy
    Descrizione

    Patient on antibiotic therapy after increase of symptoms during medication phase.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0338237 (Antibiotic therapy)
    SNOMED
    281789004
    Person participating in trial
    Descrizione

    Person participating in trial or their relatives

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    Exclusion Criteria
    Descrizione

    In case one of the above mentioned questions is answered “YES” the patient may not be included into the study.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0680251 (Exclusion Criteria)
    Physical Examination
    Descrizione

    Physical Examination

    Physical Examination
    Descrizione

    Physical Examination

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Examination of nose
    Descrizione

    Examination of nose

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0558826 (Examination of nose)
    SNOMED
    274794006
    Anatomic, Congenital , Surgery-induced changes
    Descrizione

    Anatomic, Congenital , Surgery-induced changes

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0302142 (Deformity)
    SNOMED
    6081001
    LOINC
    LA18225-5
    UMLS CUI [2]
    C0000768 (Congenital Abnormality)
    SNOMED
    276654001
    Nasal Polyps
    Descrizione

    Nasal Polyps

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0027430 (Nasal Polyps)
    SNOMED
    736500007
    Endoscopy
    Descrizione

    Endoscopy

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0014245 (Endoscopy (procedure))
    SNOMED
    423827005
    LOINC
    LP6254-9
    Endoscopy findings
    Descrizione

    Endoscopy findings: Assessment scale: 0=no finding; 1=minor; 2=major

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0438280 (Endoscopy finding)
    SNOMED
    271936004
    Lund-MacKay (LM) CT scoring scale
    Descrizione

    Lund-MacKay (LM) CT scoring scale

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0040405 (X-Ray Computed Tomography)
    SNOMED
    77477000
    LOINC
    LP6207-7
    UMLS CUI [1,2]
    C0036449 (Scoring Methods)
    Medication
    Descrizione

    Medication

    Concomitant medications
    Descrizione

    Please list all drugs that the patient is taking at the start of this trial or that he will be taking during this trial. Please also note change of dosage. Please observe excluded drugs under the exclusion criteria section of this form.

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    PRN Medicines
    Descrizione

    Please liste all "As Needed" medication

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C3176065 (PRN medicine:Find:Pt:Medication.current:Ord:PhenX)
    LOINC
    66426-8
    Non-drug therapy
    Descrizione

    Pleae list all non-drug therapies the patient has sofar undergone or will undergo during this trial.

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0677097 (Identify non-drug therapy alternatives)
    Signature
    Descrizione

    Signature

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1519316 (Signature)
    LOINC
    LP248948-4
    Laboratory
    Descrizione

    Laboratory

    Blood test
    Descrizione

    Blood test

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0018941 (Hematologic Tests)
    SNOMED
    252275004
    Rhinosinusitis Disability Index (RSBI)
    Descrizione

    Rhinosinusitis Disability Index (RSBI)

    Rhinosinusitis Disability Index (RSBI)
    Descrizione

    The Rhinosinusitis Disability Index (RSDI) is a measure of sinus-related disability. It is a standardized, statistically validated, disease-specific tool and used to investigate the disability suffered patients with rhinologic diagnosis.

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0948780 (Rhinosinusitis)
    SNOMED
    897656009
    UMLS CUI [1,2]
    C3826998 (Health Assessment Questionnaire Disability Index With Pain Visual Analog Scale Questionnaire)
    LOINC
    LP186229-3
    Impairment due to chronic sinusitis
    Descrizione

    The following questions refer to the effects of chronic sinusitis on your ability to work and your daily activities. Please check the following boxes: 1. Are you currently employed? If no, please continue with question No. 6. The next questions refer to the last 7 days, today excluded: 2. How many hours of work did you miss in the last 7 days due to problems or discomfort resulting from your chronic sinusitis? 3. How many hours of work did you miss in the last 7 days due to other reasons such as holidays or because of participating at this trial? 4. How many hours did you work in the last 7 days in total? If you insert 0 hours, please skip the next question and continue with question 6. 5. How did the chronic sinusitis affect your performance at work in the last 7 days? Please take into consideration those days when the amount and type of work you could accomplish was reduced. Also consider those days when you accomplished less than you had planned to and you did not work as diligently as usual. If the chronic sinusitis had only a minor effect on your work please mark a low number. Mark a high number if you experienced a more severe impairment: 6. How did the chronic sinusitis affect your regular daily activities that are not work related in the last 7 days? Regular activities refer to house and garden work, shopping, education, sport etc.. Please consider the type and amount of your daily activities you could not do. Also consider those days when you accomplished less than you had planned to. If the chronic sinusitis had only a minor effect on your work please mark a low number. Mark a high number if you experienced a more severe impairment:

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0681116 (Impaired work performance)

    Similar models

    Visit 1 - Baseline Form

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Header module
    Visit Number
    Item
    Visit number
    integer
    C1549755 (UMLS CUI [1])
    Patient Name
    Item
    Patient Name
    integer
    C1299487 (UMLS CUI [1])
    Center #
    Item
    Center #
    integer
    C0009469 (UMLS CUI [1])
    Date
    Item
    Date
    integer
    C0011008 (UMLS CUI [1])
    Item Group
    Patient demographics
    Date of birth
    Item
    Date of birth
    integer
    C0421451 (UMLS CUI [1])
    Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Weight
    Item
    Weight
    integer
    C0005910 (UMLS CUI [1])
    Temperatur
    Item
    Temperatur
    integer
    C0039476 (UMLS CUI [1])
    Item
    Blood pressure
    integer
    C0005823 (UMLS CUI [1])
    Code List
    Blood pressure
    CL Item
    Systolic (1)
    C0871470 (UMLS CUI-1)
    CL Item
    Diastolic (2)
    C0428883 (UMLS CUI-1)
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Item
    Gender
    integer
    C0079399 (UMLS CUI [1])
    Code List
    Gender
    CL Item
    male (1)
    C1706180 (UMLS CUI-1)
    CL Item
    female (2)
    C0086287 (UMLS CUI-1)
    Item
    Ethnicity
    integer
    C0015031 (UMLS CUI [1])
    Code List
    Ethnicity
    CL Item
    Caucasian (1)
    CL Item
    Black (2)
    CL Item
    Oriental/Asian (3)
    CL Item
    Other (4)
    Medical history of serious illness, accidents, surgeries
    Item
    Medical history of serious illness, accidents, surgeries
    boolean
    C0010340 (UMLS CUI [1])
    C0000924 (UMLS CUI [2])
    C0543467 (UMLS CUI [3])
    Item
    Does the patient suffer from allergies?
    integer
    C0489531 (UMLS CUI [1])
    Code List
    Does the patient suffer from allergies?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    If yes, please specify (3)
    Item
    Chronic sinusitis
    integer
    C0149516 (UMLS CUI [1])
    Code List
    Chronic sinusitis
    CL Item
    Symptoms persit for more than 8 weeks (1)
    CL Item
    Patient has had at east 4 episodes with more than 10 symptom days/ year (2)
    CL Item
    What kind of pretreatment has been applied? (3)
    Item Group
    Inclusion criteria
    Initial examination including Ear, Nose and Throat Examination
    Item
    Initial examination including Ear, Nose and Throat Examination
    boolean
    C2729337 (UMLS CUI [1])
    C0278350 (UMLS CUI [2])
    Patient age between 18-65
    Item
    Patient age between 18-65
    boolean
    Patient with chronic sinusitis
    Item
    Patient with chronic sinusitis
    boolean
    C0149516 (UMLS CUI [1])
    Sinusitis symptom score
    Item
    Sinusitis symptom score
    boolean
    C3533163 (UMLS CUI [1,1])
    C0037199 (UMLS CUI [1,2])
    C1299570 (UMLS CUI [2,1])
    C0037199 (UMLS CUI [2,2])
    Sinusitis diagnostics through coronary CT
    Item
    Sinusitis diagnostics through coronary CT
    boolean
    C0037199 (UMLS CUI [1,1])
    C1634617 (UMLS CUI [1,2])
    Patient in good general condition
    Item
    Patient in good general condition
    boolean
    C1142435 (UMLS CUI [1])
    Patient with stable intermittent asthma
    Item
    Patient with stable intermittent asthma
    boolean
    C1740754 (UMLS CUI [1])
    Patient on prior medication
    Item
    Patient on prior medication
    boolean
    C2826257 (UMLS CUI [1])
    Written informed consent
    Item
    Written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    Footer module
    no participation
    Item
    no participation
    boolean
    C0680252 (UMLS CUI [1])
    Date and signature
    Item
    Date and signature
    integer
    C0807937 (UMLS CUI [1])
    Item Group
    Exclusion criteria
    C0680251 (UMLS CUI-1)
    Patient who do not fulfill all inclusion criteria
    Item
    Patient who do not fulfill all inclusion criteria
    boolean
    C2827031 (UMLS CUI [1])
    Patient without contraception, pregnant/ breast-feeding
    Item
    Patient without contraception, pregnant/ breast-feeding
    boolean
    C0700589 (UMLS CUI [1])
    C0549206 (UMLS CUI [2])
    C0006147 (UMLS CUI [3])
    Patient has undergone nasal operation within the last 6 months
    Item
    Patient has undergone nasal operation within the last 6 months
    boolean
    C0188970 (UMLS CUI [1])
    Patient with significant ECG changes
    Item
    Patient with significant ECG changes
    boolean
    C0855329 (UMLS CUI [1])
    Patient with clinically relevant changes of vital bodily function
    Item
    Patient with clinically relevant changes of vital bodily function
    boolean
    C0277803 (UMLS CUI [1])
    Patient with Wegener's granulomatosis
    Item
    Patient with Wegener's granulomatosis and/ or several other diseases
    boolean
    C3495801 (UMLS CUI [1])
    C0010674 (UMLS CUI [2,1])
    C0027430 (UMLS CUI [2,2])
    C0340037 (UMLS CUI [3])
    C0008780 (UMLS CUI [4])
    C0017601 (UMLS CUI [5])
    C0007222 (UMLS CUI [6])
    C0024115 (UMLS CUI [7])
    C0022658 (UMLS CUI [8])
    C0023895 (UMLS CUI [9,1])
    C0025517 (UMLS CUI [9,2])
    C0018939 (UMLS CUI [9,3])
    C0027765 (UMLS CUI [9,4])
    C0021081 (UMLS CUI [10])
    C0008728 (UMLS CUI [11])
    Patient on systemic steroid therapy < 4 weeks prior to begin of study
    Item
    Patient on systemic steroid therapy < 4 weeks prior to begin of study
    boolean
    C4039704 (UMLS CUI [1])
    Patient on inhalable or intranasal steroid therapy < 2 weeks prior to begin of study
    Item
    Patient on inhalable or intranasal steroid therapy < 2 weeks prior to begin of study
    boolean
    C3539185 (UMLS CUI [1])
    Drug intolerance
    Item
    Drug intolerance
    boolean
    C0277585 (UMLS CUI [1])
    Acute exacerbation of sinusitis
    Item
    Acute exacerbation of sinusitis
    boolean
    C0235874 (UMLS CUI [1,1])
    C0037199 (UMLS CUI [1,2])
    C0338237 (UMLS CUI [1,3])
    Body Temperature
    Item
    Body Temperature
    boolean
    C0005903 (UMLS CUI [1])
    White blood cell count
    Item
    White blood cell count
    integer
    C0580531 (UMLS CUI [1])
    Acute Upper Respiratory Infection
    Item
    Acute Upper Respiratory Infection
    boolean
    C0264222 (UMLS CUI [1])
    Patient on antibiotic therapy
    Item
    Patient on antibiotic therapy
    boolean
    C0338237 (UMLS CUI [1])
    Person participating in trial
    Item
    Person participating in trial
    boolean
    C0008976 (UMLS CUI [1])
    Exclusion Criteria
    Item
    Exclusion Criteria
    boolean
    C0680251 (UMLS CUI [1])
    Item Group
    Physical Examination
    Item
    Physical Examination
    integer
    C0031809 (UMLS CUI [1])
    Code List
    Physical Examination
    CL Item
    Done (1)
    CL Item
    Not done (2)
    CL Item
    Findings (3)
    C0243095 (UMLS CUI-1)
    Item
    Examination of nose
    integer
    C0558826 (UMLS CUI [1])
    Code List
    Examination of nose
    CL Item
    Done (1)
    CL Item
    Note done (2)
    CL Item
    Findings (3)
    Anatomic, Congenital , Surgery-induced changes
    Item
    Anatomic, Congenital , Surgery-induced changes
    boolean
    C0302142 (UMLS CUI [1])
    C0000768 (UMLS CUI [2])
    Nasal Polyps
    Item
    Nasal Polyps
    boolean
    C0027430 (UMLS CUI [1])
    Item
    Endoscopy
    integer
    C0014245 (UMLS CUI [1])
    Code List
    Endoscopy
    CL Item
    Done (1)
    CL Item
    Note done (2)
    CL Item
    Findings (3)
    Item
    Endoscopy findings
    integer
    C0438280 (UMLS CUI [1])
    Code List
    Endoscopy findings
    CL Item
    Edema (1)
    C0013604 (UMLS CUI-1)
    CL Item
    Post-nasal drip (2)
    C0032781 (UMLS CUI-1)
    CL Item
    Irritation (3)
    C0441723 (UMLS CUI-1)
    CL Item
    Ulceration (4)
    C3887532 (UMLS CUI-1)
    Item
    Lund-MacKay (LM) CT scoring scale
    integer
    C0040405 (UMLS CUI [1,1])
    C0036449 (UMLS CUI [1,2])
    Code List
    Lund-MacKay (LM) CT scoring scale
    CL Item
    Maxillary Sinus (1)
    C0024957 (UMLS CUI-1)
    CL Item
    Frontal Sinus  (2)
    C0016734 (UMLS CUI-1)
    CL Item
    Sphenoidal sinus  (3)
    C0037885 (UMLS CUI-1)
    CL Item
    Ethmoidal sinus  (4)
    C0015028 (UMLS CUI-1)
    CL Item
    osteo-meatal complex (5)
    Item Group
    Medication
    Item
    Concomitant medications
    integer
    C2347852 (UMLS CUI [1])
    Code List
    Concomitant medications
    CL Item
    Drug, please put generic name (1)
    C0592502 (UMLS CUI-1)
    CL Item
    Dosage (2)
    C0178602 (UMLS CUI-1)
    CL Item
    Start of medication (3)
    C0451613 (UMLS CUI-1)
    CL Item
    End of medication (4)
    C2826744 (UMLS CUI-1)
    CL Item
    Indication (5)
    C3146298 (UMLS CUI-1)
    Item
    PRN Medicines
    integer
    C3176065 (UMLS CUI [1])
    Code List
    PRN Medicines
    CL Item
    Drug (1)
    C0013227 (UMLS CUI-1)
    CL Item
    Dosage (2)
    C0178602 (UMLS CUI-1)
    CL Item
    Date (3)
    C0011008 (UMLS CUI-1)
    CL Item
    Indication (4)
    C3146298 (UMLS CUI-1)
    Item
    Non-drug therapy
    integer
    C0677097 (UMLS CUI [1])
    Code List
    Non-drug therapy
    CL Item
    Typ of treatment (1)
    CL Item
    Start (2)
    C0808070 (UMLS CUI-1)
    CL Item
    End (3)
    C0806020 (UMLS CUI-1)
    CL Item
    Indication (4)
    C3146298 (UMLS CUI-1)
    Signature
    Item
    Signature
    integer
    C1519316 (UMLS CUI [1])
    Item Group
    Laboratory
    Item
    Blood test
    integer
    C0018941 (UMLS CUI [1])
    Code List
    Blood test
    CL Item
    Sodium (1)
    C0337443 (UMLS CUI-1)
    CL Item
    Potassium (2)
    C0202194 (UMLS CUI-1)
    CL Item
    Glucose  (3)
    C0202042 (UMLS CUI-1)
    CL Item
    Alanine transaminase (4)
    C1557189 (UMLS CUI-1)
    CL Item
    Aspartate transaminase  (5)
    C0004002 (UMLS CUI-1)
    CL Item
    Bilirubin (6)
    C1278039 (UMLS CUI-1)
    CL Item
    Creatinine (7)
    C0201976 (UMLS CUI-1)
    CL Item
    Phosphate (HPO42−) (8)
    C0523826 (UMLS CUI-1)
    CL Item
    CRP (9)
    C0201657 (UMLS CUI-1)
    CL Item
    Chorionic Gonadotropin (bHCG) (10)
    C0106132 (UMLS CUI-1)
    CL Item
    Erythrocyte sedimentation rate (11)
    C0492504 (UMLS CUI-1)
    CL Item
    Urea (12)
    C0041942 (UMLS CUI-1)
    Item Group
    Rhinosinusitis Disability Index (RSBI)
    Item
    Rhinosinusitis Disability Index (RSBI)
    integer
    C0948780 (UMLS CUI [1,1])
    C3826998 (UMLS CUI [1,2])
    Code List
    Rhinosinusitis Disability Index (RSBI)
    CL Item
    Physical (11 items) (1)
    CL Item
    1. The pain or pressure in my face makes it difficult for me to concentrate (2)
    CL Item
    2. The pain in my eyes makes it difficult for me to read (3)
    CL Item
    3. I have difficulty stooping over to lift objects because of face pressure (4)
    CL Item
    4. Because of my problem I have difficulty with strenuous yard work and housework (5)
    CL Item
    5. Straining increases or worsens my problem (6)
    CL Item
    6. I am inconvenienced by my chronic runny nose (7)
    CL Item
    7. Food does not taste good because of my change in smell (8)
    CL Item
    8. My frequent sniffing is irritating to my friends and family (9)
    CL Item
    9. Because of my problem I don’t sleep well (10)
    CL Item
    10. I have difficulty with exertion due to my nasal obstruction (11)
    CL Item
    11. My sexual activity is affected by my problem (12)
    CL Item
    Functional (9 items) (13)
    CL Item
    1. Because of my problem I feel handicapped (14)
    CL Item
    2. Because of my problem I feel restricted in performance of my routine daily activities (15)
    CL Item
    3. Because of my problem I restrict my recreational activities (16)
    CL Item
    4. Because of my problem I feel frustrated (17)
    CL Item
    5. Because of my problem I feel fatigued (18)
    CL Item
    6. Because of my problem I avoid traveling (19)
    CL Item
    7. Because of my problem I miss work or social activities (20)
    CL Item
    8. My outlook on the world is affected by my problem (21)
    CL Item
    9. Because of my problem I find it difficult to focus my attention away from my problem and on other things (22)
    CL Item
    Emotional (10 items) (23)
    CL Item
    1. Because of my problem I feel stressed in relationships with friends and family (24)
    CL Item
    2. Because of my problem I feel confused (25)
    CL Item
    3. Because of my problem I have difficulty paying attention (26)
    CL Item
    4. Because of my problem I avoid being around people (27)
    CL Item
    5. Because of my problem I am frequently angry (28)
    CL Item
    6. Because of my problem I do not like to socialize (29)
    CL Item
    7. Because of my problem I frequently feel tense (30)
    CL Item
    8. Because of my problem I frequently feel irritable (31)
    CL Item
    9. Because of my problem I am depressed (32)
    CL Item
    10. My problem places stress on my relationships with members of my family or friends (33)
    Impairment due to chronic sinusitis
    Item
    Impairment due to chronic sinusitis
    integer
    C0681116 (UMLS CUI [1])

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