ID

13818

Descrizione

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

versioni (1)
  1. 08/03/16 08/03/16 -
Caricato su

8 marzo 2016

DOI

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Licenza

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

Inglese

Visit 6

1 moduli  
  1. StudyEvent: ODM
    1. Visit 6
Header module
Descrizione

Header module

Visit Number
Descrizione

Visit Number

Tipo di dati

integer

Alias
UMLS CUI [1]
C1549755
Patient Name
Descrizione

Patient Name

Tipo di dati

integer

Alias
UMLS CUI [1]
C1299487
Center #
Descrizione

Center #

Tipo di dati

integer

Alias
UMLS CUI [1]
C0009469
Date
Descrizione

Date

Tipo di dati

integer

Alias
UMLS CUI [1]
C0011008
Examination
Descrizione

Examination

Temperature
Descrizione

Temperature

Tipo di dati

integer

Unità di misura
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Blood pressure
Descrizione

Blood pressure

Tipo di dati

integer

Alias
UMLS CUI [1]
C0005823
Heart rate
Descrizione

Heart rate

Tipo di dati

integer

Unità di misura
  • 1/sec
Alias
UMLS CUI [1]
C0018810
1/sec
Examination of nose
Descrizione

Examination of nose

Tipo di dati

integer

Alias
UMLS CUI [1]
C0558826
Anatomical / congenital/ operation induced changes?
Descrizione

Anatomical / congenital/ operation induced changes?

Tipo di dati

integer

Alias
UMLS CUI [1]
C0000768
UMLS CUI [2]
C3826377
Were Antibiotics administered?
Descrizione

If yes, please specify type of Antibiotics

Tipo di dati

integer

Alias
UMLS CUI [1]
C0003232
Endoscopy
Descrizione

Endoscopy

Tipo di dati

integer

Alias
UMLS CUI [1]
C0014245
Endoscopy findings
Descrizione

Endoscopy findings

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0014245
UMLS CUI [1,2]
C0243095
Urine pregnancy test
Descrizione

Urine pregnancy test

Tipo di dati

integer

Alias
UMLS CUI [1]
C0430056
Medication collected?
Descrizione

Please state final weight

Tipo di dati

integer

Diary collected?
Descrizione

Diary collected?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0376660
Medication
Descrizione

Medication

Concomitant drug
Descrizione

Concomitant drug

Tipo di dati

integer

Alias
UMLS CUI [1]
C2347852
PRN medicine
Descrizione

PRN medicine

Tipo di dati

integer

Alias
UMLS CUI [1]
C3176065
Non-drug therapy
Descrizione

Non-drug therapy

Tipo di dati

integer

Alias
UMLS CUI [1]
C3661844
Adverse event
Descrizione

Adverse event

Did an adverse event occur?
Descrizione

Did an adverse event occur?

Tipo di dati

integer

Alias
UMLS CUI [1]
C0877248
Is this a serious adverse event ?
Descrizione

Is this a serious adverse event ?

Tipo di dati

integer

Alias
UMLS CUI [1]
C1519255
Adverse event form
Descrizione

Adverse event form

Tipo di dati

integer

Alias
UMLS CUI [1]
C0877248
Rhinosinusitis Disability Index (RSBI)
Descrizione

Rhinosinusitis Disability Index (RSBI)

(RSBI) Rhinosinusitis Disability Index (RSBI)
Descrizione

(RSBI) Rhinosinusitis Disability Index (RSBI)

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0948780
UMLS CUI [1,2]
C3826998
Impairment due to chronic sinusitis
Descrizione

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 di dati

integer

Alias
UMLS CUI [1]
C0681116
Laboratory
Descrizione

Laboratory

Blood test
Descrizione

Blood test

Tipo di dati

integer

Alias
UMLS CUI [1]
C0018941
Urinalysis
Descrizione

Urinalysis

Tipo di dati

integer

Alias
UMLS CUI [1]
C0042014
Overall assessment of the treatment
Descrizione

Overall assessment of the treatment

Overall therapy evaluation
Descrizione

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 di dati

integer

Alias
UMLS CUI [1]
C1515410
Assessment of treatment satisfaction
Descrizione

Assessment of treatment satisfaction

Treatment satisfaction
Descrizione

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 di dati

integer

Alias
UMLS CUI [1]
C3476649
Would you be willing to take this medication for the treatment of chronic sinusitis again?
Descrizione

Please indicate one number to each question.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0149516
UMLS CUI [1,2]
C0013175
Would you recommend this treatment of the chronic sinusitis to other patients?
Descrizione

Please indicate one number to each question.

Tipo di dati

integer

Alias
UMLS CUI [1]
C0584671
Final report
Descrizione

Final report

Reason for discontinuation of trial
Descrizione

This form is also to be completed at premature study discontinuation.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0008976
End of study date and time
Descrizione

End of study date and time

Tipo di dati

integer

Alias
UMLS CUI [1]
C2983670
UMLS CUI [2]
C3698632
Study terminated by
Descrizione

Study terminated by

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348570
Confirmation of study results
Descrizione

I hereby confirm, that all data in this report have been checked and that they are accurate and substantially true. Signature and date

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0683954
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Similar models

Visit 6

1 moduli
  1. StudyEvent: ODM
    1. Visit 6
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Header module
Visit Number
Item
Visit Number
integer
C1549755 (UMLS CUI [1])
Patient Name
Item
Patient Name
integer
C1299487 (UMLS CUI [1])
Center #
Item
Center #
integer
C0009469 (UMLS CUI [1])
Date
Item
Date
integer
C0011008 (UMLS CUI [1])
Item Group
Examination
Temperature
Item
Temperature
integer
C0005903 (UMLS CUI [1])
Item
Blood pressure
integer
C0005823 (UMLS CUI [1])
Blood pressure
Code List
Blood pressure
CL Item
Systolic (1)
C0871470 (UMLS CUI-1)
CL Item
Diastolic ( 2)
C0428883 (UMLS CUI-1)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item
Examination of nose
integer
C0558826 (UMLS CUI [1])
Examination of nose
Code List
Examination of nose
CL Item
Done (1)
CL Item
Note done (2)
CL Item
Finding (3)
C0243095 (UMLS CUI-1)
Anatomical / congenital/ operation induced changes?
Item
Anatomical / congenital/ operation induced changes?
integer
C0000768 (UMLS CUI [1])
C3826377 (UMLS CUI [2])
Were Antibiotics administered?
Item
Were Antibiotics administered?
integer
C0003232 (UMLS CUI [1])
Item
Endoscopy
integer
C0014245 (UMLS CUI [1])
Endoscopy
Code List
Endoscopy
CL Item
Done, please state date (1)
C0802603 (UMLS CUI-1)
CL Item
Not done (2)
C1272696 (UMLS CUI-1)
CL Item
Findings (3)
C0243095 (UMLS CUI-1)
Item
Endoscopy findings
integer
C0014245 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Endoscopy findings
Code List
Endoscopy findings
CL Item
edema (1)
C0013604 (UMLS CUI-1)
CL Item
flow of secretion (2)
C0036536 (UMLS CUI-1)
CL Item
irritation  (3)
C1706307 (UMLS CUI-1)
CL Item
ulceration (4)
C0041582 (UMLS CUI-1)
Item
Urine pregnancy test
integer
C0430056 (UMLS CUI [1])
Urine pregnancy test
Code List
Urine pregnancy test
CL Item
Result (1)
C2826772 (UMLS CUI-1)
CL Item
Not done (2)
C1272696 (UMLS CUI-1)
Medication collected?
Item
Medication collected?
integer
Diary collected?
Item
Diary collected?
boolean
C0376660 (UMLS CUI [1])
Item Group
Medication
Item
Concomitant drug
integer
C2347852 (UMLS CUI [1])
Concomitant drug
Code List
Concomitant drug
CL Item
Drug name (1)
C0013227 (UMLS CUI-1)
CL Item
Dosage (2)
C0178602 (UMLS CUI-1)
CL Item
Start of medication (3)
C0451613 (UMLS CUI-1)
CL Item
End of medication (4)
C2826659 (UMLS CUI-1)
CL Item
Indication (5)
C3146298 (UMLS CUI-1)
Item
PRN medicine
integer
C3176065 (UMLS CUI [1])
PRN medicine
Code List
PRN medicine
CL Item
Drug (1)
C0013227 (UMLS CUI-1)
CL Item
Dosage (2)
C0178602 (UMLS CUI-1)
CL Item
Date (3)
C0011008 (UMLS CUI-1)
CL Item
Indication (4)
C3146298 (UMLS CUI-1)
Item
Non-drug therapy
integer
C3661844 (UMLS CUI [1])
Non-drug therapy
Code List
Non-drug therapy
CL Item
Typ of treatment (1)
CL Item
Start (2)
C0808070 (UMLS CUI-1)
CL Item
End (3)
C0806020 (UMLS CUI-1)
CL Item
Indication (4)
C3146298 (UMLS CUI-1)
Item Group
Adverse event
Did an adverse event occur?
Item
Did an adverse event occur?
integer
C0877248 (UMLS CUI [1])
Is this a serious adverse event ?
Item
Is this a serious adverse event ?
integer
C1519255 (UMLS CUI [1])
Item
Adverse event form
integer
C0877248 (UMLS CUI [1])
Adverse event form
Code List
Adverse event form
CL Item
Description of adverse event icd (1)
C1632372 (UMLS CUI-1)
CL Item
Date and time of adverse event (2)
C2826793 (UMLS CUI-1)
CL Item
Previously in CRF documted (3)
CL Item
Progress (4)
C1335499 (UMLS CUI-1)
CL Item
Related to study drug? (5)
C0013175 (UMLS CUI-1)
Item Group
Rhinosinusitis Disability Index (RSBI)
Item
(RSBI) Rhinosinusitis Disability Index (RSBI)
integer
C0948780 (UMLS CUI [1,1])
C3826998 (UMLS CUI [1,2])
(RSBI) Rhinosinusitis Disability Index (RSBI)
Code List
(RSBI) Rhinosinusitis Disability Index (RSBI)
CL Item
Physical (11 items) (1)
CL Item
1. The pain or pressure in my face makes it difficult for me to concentrate (2)
CL Item
2. The pain in my eyes makes it difficult for me to read (3)
CL Item
3. I have difficulty stooping over to lift objects because of face pressure (4)
CL Item
4. Because of my problem I have difficulty with strenuous yard work and housework (5)
CL Item
5. Straining increases or worsens my problem (6)
CL Item
6. I am inconvenienced by my chronic runny nose (7)
CL Item
7. Food does not taste good because of my change in smell (8)
CL Item
8. My frequent sniffing is irritating to my friends and family (9)
CL Item
9. Because of my problem I don’t sleep well (10)
CL Item
10. I have difficulty with exertion due to my nasal obstruction (11)
CL Item
11. My sexual activity is affected by my problem (12)
CL Item
Functional (9 items) (13)
CL Item
1. Because of my problem I feel handicapped (14)
CL Item
2. Because of my problem I feel restricted in performance of my routine daily activities (15)
CL Item
3. Because of my problem I restrict my recreational activities (16)
CL Item
4. Because of my problem I feel frustrated (17)
CL Item
5. Because of my problem I feel fatigued (18)
CL Item
6. Because of my problem I avoid traveling (19)
CL Item
7. Because of my problem I miss work or social activities (20)
CL Item
8. My outlook on the world is affected by my problem (21)
CL Item
9. Because of my problem I find it difficult to focus my attention away from my problem and on other things (22)
CL Item
Emotional (10 items) (23)
CL Item
1. Because of my problem I feel stressed in relationships with friends and family (24)
CL Item
2. Because of my problem I feel confused (25)
CL Item
3. Because of my problem I have difficulty paying attention (26)
CL Item
4. Because of my problem I avoid being around people (27)
CL Item
5. Because of my problem I am frequently angry (28)
CL Item
6. Because of my problem I do not like to socialize (29)
CL Item
7. Because of my problem I frequently feel tense (30)
CL Item
8. Because of my problem I frequently feel irritable (31)
CL Item
9. Because of my problem I am depressed (32)
CL Item
10. My problem places stress on my relationships with members of my family or friends (33)
Impairment due to chronic sinusitis
Item
Impairment due to chronic sinusitis
integer
C0681116 (UMLS CUI [1])
Item Group
Laboratory
Item
Blood test
integer
C0018941 (UMLS CUI [1])
Blood test
Code List
Blood test
CL Item
Sodium (1)
C0337443 (UMLS CUI-1)
CL Item
Potassium (2)
C0202194 (UMLS CUI-1)
CL Item
Glucose  (3)
C0202042 (UMLS CUI-1)
CL Item
Alanine transaminase (4)
C1557189 (UMLS CUI-1)
CL Item
Aspartate transaminase  (5)
C0004002 (UMLS CUI-1)
CL Item
Bilirubin (6)
C1278039 (UMLS CUI-1)
CL Item
Creatinine (7)
C0201976 (UMLS CUI-1)
CL Item
Phosphate (HPO42−) (8)
C0523826 (UMLS CUI-1)
CL Item
CRP (9)
C0201657 (UMLS CUI-1)
CL Item
Chorionic Gonadotropin (bHCG) (10)
C0106132 (UMLS CUI-1)
CL Item
Erythrocyte sedimentation rate (11)
C0492504 (UMLS CUI-1)
CL Item
Urea (12)
C0041942 (UMLS CUI-1)
Item
Urinalysis
integer
C0042014 (UMLS CUI [1])
Urinalysis
Code List
Urinalysis
CL Item
Urine screening for blood  (1)
C0202514 (UMLS CUI-1)
CL Item
Urine leukocytes finding  (2)
C0555120 (UMLS CUI-1)
CL Item
Urine pregnancy test  (3)
C0430056 (UMLS CUI-1)
CL Item
Microscopic urinalysis  (4)
C0430397 (UMLS CUI-1)
Item Group
Overall assessment of the treatment
Item
Overall therapy evaluation
integer
C1515410 (UMLS CUI [1])
Overall therapy evaluation
Code List
Overall therapy evaluation
CL Item
Efficacy  (1)
C1280519 (UMLS CUI-1)
CL Item
Adverse events (2)
C0877248 (UMLS CUI-1)
Item Group
Assessment of treatment satisfaction
Item
Treatment satisfaction
integer
C3476649 (UMLS CUI [1])
Treatment satisfaction
Code List
Treatment satisfaction
CL Item
extremely satisfied (1)
CL Item
very satisfied (2)
CL Item
somewhat satisfied (3)
CL Item
somewhat unsatisfied (4)
CL Item
very unsatisfied (5)
CL Item
extremely unsatisfied (6)
Would you be willing to take this medication for the treatment of chronic sinusitis again?
Item
Would you be willing to take this medication for the treatment of chronic sinusitis again?
boolean
C0149516 (UMLS CUI [1,1])
C0013175 (UMLS CUI [1,2])
Item
Would you recommend this treatment of the chronic sinusitis to other patients?
integer
C0584671 (UMLS CUI [1])
Would you recommend this treatment of the chronic sinusitis to other patients?
Code List
Would you recommend this treatment of the chronic sinusitis to other patients?
CL Item
I would definitely recommend it (1)
CL Item
I would likely recommend it (2)
CL Item
I am not sure (3)
CL Item
I would likely not recommend it (4)
CL Item
I would definitely not recommend it (5)
Item Group
Final report
Item
Reason for discontinuation of trial
integer
C0457454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Reason for discontinuation of trial
Code List
Reason for discontinuation of trial
CL Item
study terminated as scheduled (1)
C2348570 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
serious study protocol deviation (3)
C2347845 (UMLS CUI-1)
CL Item
lack of efficacy (4)
C0235828 (UMLS CUI-1)
CL Item
reasons that are not linked to the study (5)
C2826295 (UMLS CUI-1)
CL Item
loss of contact (6)
C3203585 (UMLS CUI-1)
CL Item
other, please specify (7)
C0205394 (UMLS CUI-1)
End of study date and time
Item
End of study date and time
integer
C2983670 (UMLS CUI [1])
C3698632 (UMLS CUI [2])
Item
Study terminated by
integer
C2348570 (UMLS CUI [1])
Study terminated by
Code List
Study terminated by
CL Item
Patient (1)
C0030705 (UMLS CUI-1)
CL Item
Sponsor (2)
C2347796 (UMLS CUI-1)
CL Item
Study director (3)
C0025081 (UMLS CUI-1)
Confirmation of study results
Item
Confirmation of study results
integer
C0750484 (UMLS CUI [1,1])
C0683954 (UMLS CUI [1,2])
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