ID
13818
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
Versions (1)
- 3/8/16 3/8/16 -
Uploaded on
March 8, 2016
DOI
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License
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
Description
Examination
Description
Temperature
Data type
integer
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Blood pressure
Data type
integer
Alias
- UMLS CUI [1]
- C0005823
Description
Heart rate
Data type
integer
Measurement units
- 1/sec
Alias
- UMLS CUI [1]
- C0018810
Description
Examination of nose
Data type
integer
Alias
- UMLS CUI [1]
- C0558826
Description
Anatomical / congenital/ operation induced changes?
Data type
integer
Alias
- UMLS CUI [1]
- C0000768
- UMLS CUI [2]
- C3826377
Description
If yes, please specify type of Antibiotics
Data type
integer
Alias
- UMLS CUI [1]
- C0003232
Description
Endoscopy
Data type
integer
Alias
- UMLS CUI [1]
- C0014245
Description
Endoscopy findings
Data type
integer
Alias
- UMLS CUI [1,1]
- C0014245
- UMLS CUI [1,2]
- C0243095
Description
Urine pregnancy test
Data type
integer
Alias
- UMLS CUI [1]
- C0430056
Description
Please state final weight
Data type
integer
Description
Diary collected?
Data type
boolean
Alias
- UMLS CUI [1]
- C0376660
Description
Medication
Description
Adverse event
Description
Did an adverse event occur?
Data type
integer
Alias
- UMLS CUI [1]
- C0877248
Description
Is this a serious adverse event ?
Data type
integer
Alias
- UMLS CUI [1]
- C1519255
Description
Adverse event form
Data type
integer
Alias
- UMLS CUI [1]
- C0877248
Description
Rhinosinusitis Disability Index (RSBI)
Description
(RSBI) Rhinosinusitis Disability Index (RSBI)
Data type
integer
Alias
- UMLS CUI [1,1]
- C0948780
- UMLS CUI [1,2]
- C3826998
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
Description
Laboratory
Description
Blood test
Data type
integer
Alias
- UMLS CUI [1]
- C0018941
Description
Urinalysis
Data type
integer
Alias
- UMLS CUI [1]
- C0042014
Description
Overall assessment of the treatment
Description
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.
Data type
integer
Alias
- UMLS CUI [1]
- C1515410
Description
Assessment of treatment satisfaction
Description
Please indicate one number to each question. How would you rate your satisfaction with the treatment that you have received for your chronic sinusitis?
Data type
integer
Alias
- UMLS CUI [1]
- C3476649
Description
Please indicate one number to each question.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0149516
- UMLS CUI [1,2]
- C0013175
Description
Please indicate one number to each question.
Data type
integer
Alias
- UMLS CUI [1]
- C0584671
Description
Final report
Description
This form is also to be completed at premature study discontinuation.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0008976
Description
End of study date and time
Data type
integer
Alias
- UMLS CUI [1]
- C2983670
- UMLS CUI [2]
- C3698632
Description
Study terminated by
Data type
integer
Alias
- UMLS CUI [1]
- C2348570
Description
I hereby confirm, that all data in this report have been checked and that they are accurate and substantially true. Signature and date
Data type
integer
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0683954
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