ID
13818
Beskrivning
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
Nyckelord
Versioner (1)
- 2016-03-08 2016-03-08 -
Uppladdad den
8 mars 2016
DOI
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Licens
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
Beskrivning
Examination
Beskrivning
Temperature
Datatyp
integer
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Blood pressure
Datatyp
integer
Alias
- UMLS CUI [1]
- C0005823
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- 1/sec
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Examination of nose
Datatyp
integer
Alias
- UMLS CUI [1]
- C0558826
Beskrivning
Anatomical / congenital/ operation induced changes?
Datatyp
integer
Alias
- UMLS CUI [1]
- C0000768
- UMLS CUI [2]
- C3826377
Beskrivning
If yes, please specify type of Antibiotics
Datatyp
integer
Alias
- UMLS CUI [1]
- C0003232
Beskrivning
Endoscopy
Datatyp
integer
Alias
- UMLS CUI [1]
- C0014245
Beskrivning
Endoscopy findings
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0014245
- UMLS CUI [1,2]
- C0243095
Beskrivning
Urine pregnancy test
Datatyp
integer
Alias
- UMLS CUI [1]
- C0430056
Beskrivning
Please state final weight
Datatyp
integer
Beskrivning
Diary collected?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0376660
Beskrivning
Medication
Beskrivning
Adverse event
Beskrivning
Did an adverse event occur?
Datatyp
integer
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Is this a serious adverse event ?
Datatyp
integer
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Adverse event form
Datatyp
integer
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Rhinosinusitis Disability Index (RSBI)
Beskrivning
(RSBI) Rhinosinusitis Disability Index (RSBI)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0948780
- UMLS CUI [1,2]
- C3826998
Beskrivning
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:
Datatyp
integer
Alias
- UMLS CUI [1]
- C0681116
Beskrivning
Laboratory
Beskrivning
Blood test
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018941
Beskrivning
Urinalysis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0042014
Beskrivning
Overall assessment of the treatment
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C1515410
Beskrivning
Assessment of treatment satisfaction
Beskrivning
Please indicate one number to each question. How would you rate your satisfaction with the treatment that you have received for your chronic sinusitis?
Datatyp
integer
Alias
- UMLS CUI [1]
- C3476649
Beskrivning
Please indicate one number to each question.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0149516
- UMLS CUI [1,2]
- C0013175
Beskrivning
Please indicate one number to each question.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0584671
Beskrivning
Final report
Beskrivning
This form is also to be completed at premature study discontinuation.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0008976
Beskrivning
End of study date and time
Datatyp
integer
Alias
- UMLS CUI [1]
- C2983670
- UMLS CUI [2]
- C3698632
Beskrivning
Study terminated by
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348570
Beskrivning
I hereby confirm, that all data in this report have been checked and that they are accurate and substantially true. Signature and date
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0683954
Similar models
Visit 6
- StudyEvent: ODM
C3826377 (UMLS CUI [2])
C0243095 (UMLS CUI [1,2])
C3826998 (UMLS CUI [1,2])
C0013175 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
C3698632 (UMLS CUI [2])
C0683954 (UMLS CUI [1,2])