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ID

44222

Description

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. 3/8/16 3/8/16 -
  2. 3/8/16 3/8/16 -
  3. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

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
    Description

    Header module

    Visit number
    Description

    Visit Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1549755
    Patient Name
    Description

    Patient Name

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1299487
    Center #
    Description

    Center #

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0009469
    Date
    Description

    Date

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0011008
    Patient demographics
    Description

    Patient demographics

    Date of birth
    Description

    Date of birth

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0421451
    Height
    Description

    Height

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Description

    Weight

    Data type

    integer

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Temperatur
    Description

    Temperatur

    Data type

    integer

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0039476
    °C
    Blood pressure
    Description

    Blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • 1/sec
    Alias
    UMLS CUI [1]
    C0018810
    1/sec
    Gender
    Description

    Gender

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0079399
    Ethnicity
    Description

    Ethnic Group

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0015031
    Medical history of serious illness, accidents, surgeries
    Description

    Medical history of serious illness, accidents, surgeries

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0010340
    UMLS CUI [2]
    C0000924
    UMLS CUI [3]
    C0543467
    Does the patient suffer from allergies?
    Description

    Does the patient suffer from allergies?

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0489531
    Chronic sinusitis
    Description

    Patient has suffered from chronic sinusitis since:

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0149516
    Inclusion criteria
    Description

    Inclusion criteria

    Initial examination including Ear, Nose and Throat Examination
    Description

    Initial examination including Ear, Nose and Throat Examination

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2729337
    UMLS CUI [2]
    C0278350
    Patient age between 18-65
    Description

    Patient age

    Data type

    boolean

    Patient with chronic sinusitis
    Description

    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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0149516
    Sinusitis symptom score
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3533163
    UMLS CUI [1,2]
    C0037199
    UMLS CUI [2,1]
    C1299570
    UMLS CUI [2,2]
    C0037199
    Sinusitis diagnostics through coronary CT
    Description

    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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0037199
    UMLS CUI [1,2]
    C1634617
    Patient in good general condition
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1142435
    Patient with stable intermittent asthma
    Description

    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.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1740754
    Patient on prior medication
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826257
    Written informed consent
    Description

    Written informed consent based on patient information by physician

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Footer module
    Description

    Footer module

    no participation
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0680252
    Date and signature
    Description

    Date and signature by physician

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0807937
    Exclusion criteria
    Description

    Exclusion criteria

    Alias
    UMLS CUI-1
    C0680251
    Patient who do not fulfill all inclusion criteria
    Description

    Patient who do not fulfill all inclusion criteria

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2827031
    Patient without contraception, pregnant/ breast-feeding
    Description

    Patient without contraception, pregnant/ breast-feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    UMLS CUI [2]
    C0549206
    UMLS CUI [3]
    C0006147
    Patient has undergone nasal operation within the last 6 months
    Description

    Patient has undergone nasal operation within the last 6 months

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0188970
    Patient with significant ECG changes
    Description

    Patient with significant ECG changes

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0855329
    Patient with clinically relevant changes of vital bodily function
    Description

    Patient with clinically relevant changes of vital bodily function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0277803
    Patient with Wegener's granulomatosis and/ or several other diseases
    Description

    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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3495801
    UMLS CUI [2,1]
    C0010674
    UMLS CUI [2,2]
    C0027430
    UMLS CUI [3]
    C0340037
    UMLS CUI [4]
    C0008780
    UMLS CUI [5]
    C0017601
    UMLS CUI [6]
    C0007222
    UMLS CUI [7]
    C0024115
    UMLS CUI [8]
    C0022658
    UMLS CUI [9,1]
    C0023895
    UMLS CUI [9,2]
    C0025517
    UMLS CUI [9,3]
    C0018939
    UMLS CUI [9,4]
    C0027765
    UMLS CUI [10]
    C0021081
    UMLS CUI [11]
    C0008728
    Patient on systemic steroid therapy < 4 weeks prior to begin of study
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4039704
    Patient on inhalable or intranasal steroid therapy < 2 weeks prior to begin of study
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3539185
    Drug intolerance
    Description

    Drug intolerance to pharmaceutical ingredients of study medication

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0277585
    Acute exacerbation of sinusitis
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0235874
    UMLS CUI [1,2]
    C0037199
    UMLS CUI [1,3]
    C0338237
    Body Temperature
    Description

    Body Temperature > 38.5 °C at start of trial

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005903
    White blood cell count
    Description

    White blood cell count exceeding > 150 % of upper limit

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0580531
    Acute Upper Respiratory Infection
    Description

    Acute Upper Respiratory Infection within last two weeks

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0264222
    Patient on antibiotic therapy
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0338237
    Person participating in trial
    Description

    Person participating in trial or their relatives

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0008976
    Exclusion Criteria
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    Physical Examination
    Description

    Physical Examination

    Physical Examination
    Description

    Physical Examination

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0031809
    Examination of nose
    Description

    Examination of nose

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0558826
    Anatomic, Congenital , Surgery-induced changes
    Description

    Anatomic, Congenital , Surgery-induced changes

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0302142
    UMLS CUI [2]
    C0000768
    Nasal Polyps
    Description

    Nasal Polyps

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027430
    Endoscopy
    Description

    Endoscopy

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0014245
    Endoscopy findings
    Description

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

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0438280
    Lund-MacKay (LM) CT scoring scale
    Description

    Lund-MacKay (LM) CT scoring scale

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0040405
    UMLS CUI [1,2]
    C0036449
    Medication
    Description

    Medication

    Concomitant medications
    Description

    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.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2347852
    PRN Medicines
    Description

    Please liste all "As Needed" medication

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3176065
    Non-drug therapy
    Description

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

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0677097
    Signature
    Description

    Signature

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1519316
    Laboratory
    Description

    Laboratory

    Blood test
    Description

    Blood test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0018941
    Rhinosinusitis Disability Index (RSBI)
    Description

    Rhinosinusitis Disability Index (RSBI)

    Rhinosinusitis Disability Index (RSBI)
    Description

    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.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0948780
    UMLS CUI [1,2]
    C3826998
    Impairment due to chronic sinusitis
    Description

    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:

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0681116

    Similar models

    Visit 1 - Baseline Form

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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