ID
13818
Beschrijving
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
Trefwoorden
Versies (1)
- 08-03-16 08-03-16 -
Geüploaded op
8 maart 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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Visit 6 - Clinical Trial on the Efficacy and Safety BID Mometasone Furoate Nasal Spray (MFNS) in the Treatment of Chronic Sinusitis
Visit 6
- StudyEvent: ODM
Beschrijving
Examination
Beschrijving
Temperature
Datatype
integer
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Blood pressure
Datatype
integer
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- 1/sec
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Examination of nose
Datatype
integer
Alias
- UMLS CUI [1]
- C0558826
Beschrijving
Anatomical / congenital/ operation induced changes?
Datatype
integer
Alias
- UMLS CUI [1]
- C0000768
- UMLS CUI [2]
- C3826377
Beschrijving
If yes, please specify type of Antibiotics
Datatype
integer
Alias
- UMLS CUI [1]
- C0003232
Beschrijving
Endoscopy
Datatype
integer
Alias
- UMLS CUI [1]
- C0014245
Beschrijving
Endoscopy findings
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0014245
- UMLS CUI [1,2]
- C0243095
Beschrijving
Urine pregnancy test
Datatype
integer
Alias
- UMLS CUI [1]
- C0430056
Beschrijving
Please state final weight
Datatype
integer
Beschrijving
Diary collected?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0376660
Beschrijving
Medication
Beschrijving
Adverse event
Beschrijving
Did an adverse event occur?
Datatype
integer
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Is this a serious adverse event ?
Datatype
integer
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Adverse event form
Datatype
integer
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Rhinosinusitis Disability Index (RSBI)
Beschrijving
(RSBI) Rhinosinusitis Disability Index (RSBI)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0948780
- UMLS CUI [1,2]
- C3826998
Beschrijving
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
Alias
- UMLS CUI [1]
- C0681116
Beschrijving
Laboratory
Beschrijving
Blood test
Datatype
integer
Alias
- UMLS CUI [1]
- C0018941
Beschrijving
Urinalysis
Datatype
integer
Alias
- UMLS CUI [1]
- C0042014
Beschrijving
Overall assessment of the treatment
Beschrijving
Please indicate your impression on the efficacy of the trial medication and adverse events that may have occurred. Please take the severity of the disease into account please also take results of previous treatments into consideration.
Datatype
integer
Alias
- UMLS CUI [1]
- C1515410
Beschrijving
Assessment of treatment satisfaction
Beschrijving
Please indicate one number to each question. How would you rate your satisfaction with the treatment that you have received for your chronic sinusitis?
Datatype
integer
Alias
- UMLS CUI [1]
- C3476649
Beschrijving
Please indicate one number to each question.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0149516
- UMLS CUI [1,2]
- C0013175
Beschrijving
Please indicate one number to each question.
Datatype
integer
Alias
- UMLS CUI [1]
- C0584671
Beschrijving
Final report
Beschrijving
This form is also to be completed at premature study discontinuation.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0008976
Beschrijving
End of study date and time
Datatype
integer
Alias
- UMLS CUI [1]
- C2983670
- UMLS CUI [2]
- C3698632
Beschrijving
Study terminated by
Datatype
integer
Alias
- UMLS CUI [1]
- C2348570
Beschrijving
I hereby confirm, that all data in this report have been checked and that they are accurate and substantially true. Signature and date
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0683954
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Visit 6
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C3826998 (UMLS CUI [1,2])
C0013175 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
C3698632 (UMLS CUI [2])
C0683954 (UMLS CUI [1,2])