ID
13818
Descripción
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
Palabras clave
Versiones (1)
- 8/3/16 8/3/16 -
Subido en
8 de marzo de 2016
DOI
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Licencia
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
Descripción
Examination
Descripción
Temperature
Tipo de datos
integer
Unidades de medida
- °C
Alias
- UMLS CUI [1]
- C0005903
Descripción
Blood pressure
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0005823
Descripción
Heart rate
Tipo de datos
integer
Unidades de medida
- 1/sec
Alias
- UMLS CUI [1]
- C0018810
Descripción
Examination of nose
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0558826
Descripción
Anatomical / congenital/ operation induced changes?
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0000768
- UMLS CUI [2]
- C3826377
Descripción
If yes, please specify type of Antibiotics
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0003232
Descripción
Endoscopy
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0014245
Descripción
Endoscopy findings
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0014245
- UMLS CUI [1,2]
- C0243095
Descripción
Urine pregnancy test
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0430056
Descripción
Please state final weight
Tipo de datos
integer
Descripción
Diary collected?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0376660
Descripción
Medication
Descripción
Adverse event
Descripción
Did an adverse event occur?
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0877248
Descripción
Is this a serious adverse event ?
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1519255
Descripción
Adverse event form
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0877248
Descripción
Rhinosinusitis Disability Index (RSBI)
Descripción
(RSBI) Rhinosinusitis Disability Index (RSBI)
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0948780
- UMLS CUI [1,2]
- C3826998
Descripción
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:
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0681116
Descripción
Laboratory
Descripción
Blood test
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0018941
Descripción
Urinalysis
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0042014
Descripción
Overall assessment of the treatment
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1515410
Descripción
Assessment of treatment satisfaction
Descripción
Please indicate one number to each question. How would you rate your satisfaction with the treatment that you have received for your chronic sinusitis?
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C3476649
Descripción
Please indicate one number to each question.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0149516
- UMLS CUI [1,2]
- C0013175
Descripción
Please indicate one number to each question.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0584671
Descripción
Final report
Descripción
This form is also to be completed at premature study discontinuation.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0008976
Descripción
End of study date and time
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2983670
- UMLS CUI [2]
- C3698632
Descripción
Study terminated by
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2348570
Descripción
I hereby confirm, that all data in this report have been checked and that they are accurate and substantially true. Signature and date
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0683954
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