ID
13818
Beschreibung
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
Stichworte
Versionen (1)
- 08.03.16 08.03.16 -
Hochgeladen am
8. März 2016
DOI
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Lizenz
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
Beschreibung
Examination
Beschreibung
Temperature
Datentyp
integer
Maßeinheiten
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Blood pressure
Datentyp
integer
Alias
- UMLS CUI [1]
- C0005823
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- 1/sec
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Examination of nose
Datentyp
integer
Alias
- UMLS CUI [1]
- C0558826
Beschreibung
Anatomical / congenital/ operation induced changes?
Datentyp
integer
Alias
- UMLS CUI [1]
- C0000768
- UMLS CUI [2]
- C3826377
Beschreibung
If yes, please specify type of Antibiotics
Datentyp
integer
Alias
- UMLS CUI [1]
- C0003232
Beschreibung
Endoscopy
Datentyp
integer
Alias
- UMLS CUI [1]
- C0014245
Beschreibung
Endoscopy findings
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0014245
- UMLS CUI [1,2]
- C0243095
Beschreibung
Urine pregnancy test
Datentyp
integer
Alias
- UMLS CUI [1]
- C0430056
Beschreibung
Please state final weight
Datentyp
integer
Beschreibung
Diary collected?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0376660
Beschreibung
Medication
Beschreibung
Adverse event
Beschreibung
Did an adverse event occur?
Datentyp
integer
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Is this a serious adverse event ?
Datentyp
integer
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Adverse event form
Datentyp
integer
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Rhinosinusitis Disability Index (RSBI)
Beschreibung
(RSBI) Rhinosinusitis Disability Index (RSBI)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0948780
- UMLS CUI [1,2]
- C3826998
Beschreibung
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:
Datentyp
integer
Alias
- UMLS CUI [1]
- C0681116
Beschreibung
Laboratory
Beschreibung
Blood test
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018941
Beschreibung
Urinalysis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0042014
Beschreibung
Overall assessment of the treatment
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1]
- C1515410
Beschreibung
Assessment of treatment satisfaction
Beschreibung
Please indicate one number to each question. How would you rate your satisfaction with the treatment that you have received for your chronic sinusitis?
Datentyp
integer
Alias
- UMLS CUI [1]
- C3476649
Beschreibung
Please indicate one number to each question.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0149516
- UMLS CUI [1,2]
- C0013175
Beschreibung
Please indicate one number to each question.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0584671
Beschreibung
Final report
Beschreibung
This form is also to be completed at premature study discontinuation.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0008976
Beschreibung
End of study date and time
Datentyp
integer
Alias
- UMLS CUI [1]
- C2983670
- UMLS CUI [2]
- C3698632
Beschreibung
Study terminated by
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348570
Beschreibung
I hereby confirm, that all data in this report have been checked and that they are accurate and substantially true. Signature and date
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0683954
Ähnliche Modelle
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])