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

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2016-03-08 by Johannes Osterloh

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    Patient demographics


    cm
    >= 0
  1. mmHg














    Physical Examination




















    Medication















    Laboratory








    There are 7 more items that can be looked at in the detailed view

    Rhinosinusitis Disability Index (RSBI)








    There are 28 more items that can be looked at in the detailed view

    S.0000

    Visit 1 - Baseline Form

    Header module

    Name: Header module
    Description: Header module

    Name Visit Number
    Question Visit number
    Datatype integer
    Aliases:  
    UMLS CUI [1] C1549755
    Name Patient Name
    Question Patient Name
    Datatype integer
    Aliases:  
    UMLS CUI [1] C1299487
    Name Center #
    Question Center #
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0009469
    Name Date
    Question Date
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0011008

    Patient demographics

    Name: Patient demographics
    Description: Patient demographics

    Name Date of birth
    Question Date of birth
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0421451
    Name Height
    Question Height
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0005890
    Measurement Units cm
    Range checks >= 0
    Name Weight
    Question Weight
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0005910
    Measurement Units kg
    Name Temperatur
    Question Temperatur
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0039476
    Measurement Units °C
    Name Blood pressure
    Question Blood pressure
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0005823
    Measurement Units mmHg
    Codelistitems  
      Systolic(1)
    UMLS CUI-1: C0871470
      Diastolic(2)
    UMLS CUI-1: C0428883
    Name Heart rate
    Question Heart rate
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0018810
    Measurement Units 1/sec
    Name Gender
    Question Gender
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0079399
    Codelistitems  
      male(1)
    UMLS CUI-1: C1706180
      female(2)
    UMLS CUI-1: C0015780
    Name Ethnic Group
    Question Ethnicity
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0015031
    Codelistitems  
      Caucasian(1)
      Black(2)
      Oriental/Asian(3)
      Other(4)
    Name Medical history of serious illness, accidents, surgeries
    Question Medical history of serious illness, accidents, surgeries
    Datatype boolean
    Aliases:  
    UMLS CUI [1] C0010340
    UMLS CUI [2] C0000924
    UMLS CUI [3] C0543467
    Name Does the patient suffer from allergies?
    Question Does the patient suffer from allergies?
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0489531
    Codelistitems  
      Yes(1)
      No(2)
      If yes, please specify(3)
    Name Chronic sinusitis
    Question Chronic sinusitis
    Description Patient has suffered from chronic sinusitis since:
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0149516
    Codelistitems  
      Symptoms persit for more than 8 weeks(1)
      Patient has had at east 4 episodes with more than 10 symptom days/ year(2)
      What kind of pretreatment has been applied?(3)

    Inclusion criteria

    Name: Inclusion criteria
    Description: Inclusion criteria

    Name Initial examination including Ear, Nose and Throat Examination
    Question Initial examination including Ear, Nose and Throat Examination
    Datatype boolean
    Aliases:  
    UMLS CUI [1] C2729337
    UMLS CUI [2] C0278350
    Name Patient age between 18-65
    Question Patient age between 18-65
    Description Patient age
    Datatype boolean
    Aliases:  
    Name Sinusitis symptom score
    Question Sinusitis symptom score
    Description Sinusitis Symptom Score total >= 5 and nasal obstruction score total >=2
    Datatype boolean
    Aliases:  
    UMLS CUI [1,1] C3533163
    UMLS CUI [1,2] C0037199
    UMLS CUI [2,1] C1299570
    UMLS CUI [2,2] C0037199

    Footer module

    Exclusion criteria

    Name: Exclusion criteria
    Description: Exclusion criteria

    Name Patient without contraception, pregnant/ breast-feeding
    Question Patient without contraception, pregnant/ breast-feeding
    Description Patient without contraception, pregnant/ breast-feeding
    Datatype boolean
    Aliases:  
    UMLS CUI [1] C0700589
    UMLS CUI [2] C0549206
    UMLS CUI [3] C0006147
    Name Patient with significant ECG changes
    Question Patient with significant ECG changes
    Description Patient with significant ECG changes
    Datatype boolean
    Aliases:  
    UMLS CUI [1] C0855329
    Name Patient with Wegener's granulomatosis
    Question 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
    Datatype boolean
    Aliases:  
    UMLS CUI [1] C3495801
    UMLS CUI [2,1] C0010674
    UMLS CUI [2,2] |C0027430
    UMLS CUI [3] C0340037
    UMLS CUI [4] C0008780
      ...
      There are 10 more alias. Click to show them.
    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
    Name Drug intolerance
    Question Drug intolerance
    Description Drug intolerance to pharmaceutical ingredients of study medication
    Datatype boolean
    Aliases:  
    UMLS CUI [1] C0277585
    Name Body Temperature
    Question Body Temperature
    Description Body Temperature > 38.5 °C at start of trial
    Datatype boolean
    Aliases:  
    UMLS CUI [1] C0005903
    Measurement Units °C
    Name White blood cell count
    Question White blood cell count
    Description White blood cell count exceeding > 150 % of upper limit
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0580531
    Name Person participating in trial
    Question Person participating in trial
    Description Person participating in trial or their relatives
    Datatype boolean
    Aliases:  
    UMLS CUI [1] C0008976

    Physical Examination

    Name: Physical Examination
    Description: Physical Examination

    Name Physical Examination
    Question Physical Examination
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0031809
    Codelistitems  
      Done(1)
      Not done(2)
      Findings(3)
    UMLS CUI-1: C0243095
    Name Examination of nose
    Question Examination of nose
    Description Examination of nose
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0558826
    Codelistitems  
      Done(1)
      Note done(2)
      Findings(3)
    Name Anatomic, Congenital , Surgery-induced changes
    Question Anatomic, Congenital , Surgery-induced changes
    Description Anatomic, Congenital , Surgery-induced changes
    Datatype boolean
    Aliases:  
    UMLS CUI [1] C0302142
    UMLS CUI [2] C0000768
    Name Nasal Polyps
    Question Nasal Polyps
    Description Nasal Polyps
    Datatype boolean
    Aliases:  
    UMLS CUI [1] C0027430
    Name Endoscopy
    Question Endoscopy
    Description Endoscopy
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0014245
    Codelistitems  
      Done(1)
      Note done(2)
      Findings(3)
    Name Endoscopy findings
    Question Endoscopy findings
    Description Endoscopy findings: Assessment scale: 0=no finding; 1=minor; 2=major
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0438280
    Codelistitems  
      Edema(1)
    UMLS CUI-1: C0013604
      Post-nasal drip(2)
    UMLS CUI-1: C0032781
      Irritation(3)
    UMLS CUI-1: C0441723
      Ulceration(4)
    UMLS CUI-1: C3887532
    Name Lund-MacKay (LM) CT scoring scale
    Question Lund-MacKay (LM) CT scoring scale
    Description Lund-MacKay (LM) CT scoring scale
    Datatype integer
    Aliases:  
    UMLS CUI [1,1] C0040405
    UMLS CUI [1,2] C0036449
    Codelistitems  
      Maxillary Sinus(1)
    UMLS CUI-1: C0024957
      Frontal Sinus (2)
    UMLS CUI-1: C0016734
      Sphenoidal sinus (3)
    UMLS CUI-1: C0037885
      Ethmoidal sinus (4)
    UMLS CUI-1: C2325945
      osteo-meatal complex(5)

    Medication

    Name: Medication
    Description: Medication

    Name Concomitant medications
    Question 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.
    Datatype integer
    Aliases:  
    UMLS CUI [1] C2347852
    Codelistitems  
      Drug, please put generic name(1)
    UMLS CUI-1: C0592502
      Dosage(2)
    UMLS CUI-1: C0178602
      Start of medication(3)
    UMLS CUI-1: C0451613
      End of medication(4)
    UMLS CUI-1: C2826744
      Indication(5)
    UMLS CUI-1: C3146298
    Name PRN Medicines
    Question PRN Medicines
    Description Please liste all "As Needed" medication
    Datatype integer
    Aliases:  
    UMLS CUI [1] C3176065
    Codelistitems  
      Drug(1)
    UMLS CUI-1: C0013227
      Dosage(2)
    UMLS CUI-1: C0178602
      Date(3)
    UMLS CUI-1: C0011008
      Indication(4)
    UMLS CUI-1: C3146298
    Name Non-drug therapy
    Question Non-drug therapy
    Description Pleae list all non-drug therapies the patient has sofar undergone or will undergo during this trial.
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0677097
    Codelistitems  
      Typ of treatment(1)
      Start(2)
    UMLS CUI-1: C0808070
      End(3)
    UMLS CUI-1: C0806020
      Indication(4)
    UMLS CUI-1: C3146298
    Name Signature
    Question Signature
    Datatype integer
    Aliases:  
    UMLS CUI [1] C1519316

    Laboratory

    Name: Laboratory
    Description: Laboratory

    Name Blood test
    Question Blood test
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0018941
    Codelistitems  
      Sodium(1)
    UMLS CUI-1: C0337443
      Chorionic Gonadotropin (bHCG)(10)
    UMLS CUI-1: C0106132
      Erythrocyte sedimentation rate(11)
    UMLS CUI-1: C0492504
      Urea(12)
    UMLS CUI-1: C0041942
      Potassium(2)
    UMLS CUI-1: C0202194
      ...
      There are 7 more items on this list. Click to show them.
      Glucose (3)
    UMLS CUI-1: C0202042
      Alanine transaminase(4)
    UMLS CUI-1: C1557189
      Aspartate transaminase (5)
    UMLS CUI-1: C0004002
      Bilirubin(6)
    UMLS CUI-1: C1278039
      Creatinine(7)
    UMLS CUI-1: C0201976
      Phosphate (HPO42−)(8)
    UMLS CUI-1: C0523826
      CRP(9)
    UMLS CUI-1: C0201657

    Rhinosinusitis Disability Index (RSBI)

    Name: Rhinosinusitis Disability Index (RSBI)
    Description: Rhinosinusitis Disability Index (RSBI)

    Name Rhinosinusitis Disability Index (RSBI)
    Question 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.
    Datatype integer
    Aliases:  
    UMLS CUI [1,1] C0948780
    UMLS CUI [1,2] C3826998
    Codelistitems  
      Physical (11 items)(1)
      9. Because of my problem I don’t sleep well(10)
      10. I have difficulty with exertion due to my nasal obstruction(11)
      11. My sexual activity is affected by my problem(12)
      Functional (9 items)(13)
      ...
      There are 28 more items on this list. Click to show them.
      1. Because of my problem I feel handicapped(14)
      2. Because of my problem I feel restricted in performance of my routine daily activities(15)
      3. Because of my problem I restrict my recreational activities(16)
      4. Because of my problem I feel frustrated(17)
      5. Because of my problem I feel fatigued(18)
      6. Because of my problem I avoid traveling(19)
      1. The pain or pressure in my face makes it difficult for me to concentrate(2)
      7. Because of my problem I miss work or social activities(20)
      8. My outlook on the world is affected by my problem(21)
      9. Because of my problem I find it difficult to focus my attention away from my problem and on other things(22)
      Emotional (10 items)(23)
      1. Because of my problem I feel stressed in relationships with friends and family(24)
      2. Because of my problem I feel confused(25)
      3. Because of my problem I have difficulty paying attention(26)
      4. Because of my problem I avoid being around people(27)
      5. Because of my problem I am frequently angry(28)
      6. Because of my problem I do not like to socialize(29)
      2. The pain in my eyes makes it difficult for me to read(3)
      7. Because of my problem I frequently feel tense(30)
      8. Because of my problem I frequently feel irritable(31)
      9. Because of my problem I am depressed(32)
      10. My problem places stress on my relationships with members of my family or friends(33)
      3. I have difficulty stooping over to lift objects because of face pressure(4)
      4. Because of my problem I have difficulty with strenuous yard work and housework(5)
      5. Straining increases or worsens my problem(6)
      6. I am inconvenienced by my chronic runny nose(7)
      7. Food does not taste good because of my change in smell(8)
      8. My frequent sniffing is irritating to my friends and family(9)
    Name Impairment due to chronic sinusitis
    Question 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:
    Datatype integer
    Aliases:  
    UMLS CUI [1] C0681116

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  2. You may not exercise any of the rights granted to You in Section 3 above in any manner that is primarily intended for or directed toward commercial advantage or private monetary compensation. The exchange of the Work for other copyrighted works by means of digital file-sharing or otherwise shall not be considered to be intended for or directed toward commercial advantage or private monetary compensation, provided there is no payment of any monetary compensation in connection with the exchange of copyrighted works.
  3. If You Distribute, or Publicly Perform the Work or any Adaptations or Collections, You must, unless a request has been made pursuant to Section 4(a), keep intact all copyright notices for the Work and provide, reasonable to the medium or means You are utilizing: (i) the name of the Original Author (or pseudonym, if applicable) if supplied, and/or if the Original Author and/or Licensor designate another party or parties (e.g., a sponsor institute, publishing entity, journal) for attribution ("Attribution Parties") in Licensor's copyright notice, terms of service or by other reasonable means, the name of such party or parties; (ii) the title of the Work if supplied; (iii) to the extent reasonably practicable, the URI, if any, that Licensor specifies to be associated with the Work, unless such URI does not refer to the copyright notice or licensing information for the Work; and, (iv) consistent with Section 3(b), in the case of an Adaptation, a credit identifying the use of the Work in the Adaptation (e.g., "French translation of the Work by Original Author," or "Screenplay based on original Work by Original Author"). The credit required by this Section 4(c) may be implemented in any reasonable manner; provided, however, that in the case of a Adaptation or Collection, at a minimum such credit will appear, if a credit for all contributing authors of the Adaptation or Collection appears, then as part of these credits and in a manner at least as prominent as the credits for the other contributing authors. For the avoidance of doubt, You may only use the credit required by this Section for the purpose of attribution in the manner set out above and, by exercising Your rights under this License, You may not implicitly or explicitly assert or imply any connection with, sponsorship or endorsement by the Original Author, Licensor and/or Attribution Parties, as appropriate, of You or Your use of the Work, without the separate, express prior written permission of the Original Author, Licensor and/or Attribution Parties.
  4. For the avoidance of doubt:

    1. Non-waivable Compulsory License Schemes. In those jurisdictions in which the right to collect royalties through any statutory or compulsory licensing scheme cannot be waived, the Licensor reserves the exclusive right to collect such royalties for any exercise by You of the rights granted under this License;
    2. Waivable Compulsory License Schemes. In those jurisdictions in which the right to collect royalties through any statutory or compulsory licensing scheme can be waived, the Licensor reserves the exclusive right to collect such royalties for any exercise by You of the rights granted under this License if Your exercise of such rights is for a purpose or use which is otherwise than noncommercial as permitted under Section 4(b) and otherwise waives the right to collect royalties through any statutory or compulsory licensing scheme; and,
    3. Voluntary License Schemes. The Licensor reserves the right to collect royalties, whether individually or, in the event that the Licensor is a member of a collecting society that administers voluntary licensing schemes, via that society, from any exercise by You of the rights granted under this License that is for a purpose or use which is otherwise than noncommercial as permitted under Section 4(c).
  5. Except as otherwise agreed in writing by the Licensor or as may be otherwise permitted by applicable law, if You Reproduce, Distribute or Publicly Perform the Work either by itself or as part of any Adaptations or Collections, You must not distort, mutilate, modify or take other derogatory action in relation to the Work which would be prejudicial to the Original Author's honor or reputation. Licensor agrees that in those jurisdictions (e.g. Japan), in which any exercise of the right granted in Section 3(b) of this License (the right to make Adaptations) would be deemed to be a distortion, mutilation, modification or other derogatory action prejudicial to the Original Author's honor and reputation, the Licensor will waive or not assert, as appropriate, this Section, to the fullest extent permitted by the applicable national law, to enable You to reasonably exercise Your right under Section 3(b) of this License (right to make Adaptations) but not otherwise.

5. Representations, Warranties and Disclaimer

UNLESS OTHERWISE MUTUALLY AGREED TO BY THE PARTIES IN WRITING, LICENSOR OFFERS THE WORK AS-IS AND MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND CONCERNING THE WORK, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF TITLE, MERCHANTIBILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, OR THE ABSENCE OF LATENT OR OTHER DEFECTS, ACCURACY, OR THE PRESENCE OF ABSENCE OF ERRORS, WHETHER OR NOT DISCOVERABLE. SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF IMPLIED WARRANTIES, SO SUCH EXCLUSION MAY NOT APPLY TO YOU.

6. Limitation on Liability. EXCEPT TO THE EXTENT REQUIRED BY APPLICABLE LAW, IN NO EVENT WILL LICENSOR BE LIABLE TO YOU ON ANY LEGAL THEORY FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR EXEMPLARY DAMAGES ARISING OUT OF THIS LICENSE OR THE USE OF THE WORK, EVEN IF LICENSOR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

7. Termination

  1. This License and the rights granted hereunder will terminate automatically upon any breach by You of the terms of this License. Individuals or entities who have received Adaptations or Collections from You under this License, however, will not have their licenses terminated provided such individuals or entities remain in full compliance with those licenses. Sections 1, 2, 5, 6, 7, and 8 will survive any termination of this License.
  2. Subject to the above terms and conditions, the license granted here is perpetual (for the duration of the applicable copyright in the Work). Notwithstanding the above, Licensor reserves the right to release the Work under different license terms or to stop distributing the Work at any time; provided, however that any such election will not serve to withdraw this License (or any other license that has been, or is required to be, granted under the terms of this License), and this License will continue in full force and effect unless terminated as stated above.

8. Miscellaneous

  1. Each time You Distribute or Publicly Perform the Work or a Collection, the Licensor offers to the recipient a license to the Work on the same terms and conditions as the license granted to You under this License.
  2. Each time You Distribute or Publicly Perform an Adaptation, Licensor offers to the recipient a license to the original Work on the same terms and conditions as the license granted to You under this License.
  3. If any provision of this License is invalid or unenforceable under applicable law, it shall not affect the validity or enforceability of the remainder of the terms of this License, and without further action by the parties to this agreement, such provision shall be reformed to the minimum extent necessary to make such provision valid and enforceable.
  4. No term or provision of this License shall be deemed waived and no breach consented to unless such waiver or consent shall be in writing and signed by the party to be charged with such waiver or consent.
  5. This License constitutes the entire agreement between the parties with respect to the Work licensed here. There are no understandings, agreements or representations with respect to the Work not specified here. Licensor shall not be bound by any additional provisions that may appear in any communication from You. This License may not be modified without the mutual written agreement of the Licensor and You.
  6. The rights granted under, and the subject matter referenced, in this License were drafted utilizing the terminology of the Berne Convention for the Protection of Literary and Artistic Works (as amended on September 28, 1979), the Rome Convention of 1961, the WIPO Copyright Treaty of 1996, the WIPO Performances and Phonograms Treaty of 1996 and the Universal Copyright Convention (as revised on July 24, 1971). These rights and subject matter take effect in the relevant jurisdiction in which the License terms are sought to be enforced according to the corresponding provisions of the implementation of those treaty provisions in the applicable national law. If the standard suite of rights granted under applicable copyright law includes additional rights not granted under this License, such additional rights are deemed to be included in the License; this License is not intended to restrict the license of any rights under applicable law.