ID
44222
Beschrijving
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
Trefwoorden
Versies (4)
- 08-03-16 08-03-16 -
- 08-03-16 08-03-16 -
- 13-04-21 13-04-21 - Dr. rer. medic Philipp Neuhaus
- 20-09-21 20-09-21 -
Geüploaded op
20 september 2021
DOI
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Licentie
Creative Commons BY-NC 3.0
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Visit 1 - Baseline Form Clinical Trial on the Efficacy and Safety BID Mometasone Furoate Nasal Spray (MFNS) in the Treatment of Chronic Sinusitis
Visit 1 - Baseline Form
- StudyEvent: ODM
Beschrijving
Patient demographics
Beschrijving
Date of birth
Datatype
integer
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Weight
Datatype
integer
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Temperatur
Datatype
integer
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0039476
Beschrijving
Blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- 1/sec
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Gender
Datatype
integer
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Ethnic Group
Datatype
integer
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
Medical history of serious illness, accidents, surgeries
Datatype
boolean
Alias
- UMLS CUI [1]
- C0010340
- UMLS CUI [2]
- C0000924
- UMLS CUI [3]
- C0543467
Beschrijving
Does the patient suffer from allergies?
Datatype
integer
Alias
- UMLS CUI [1]
- C0489531
Beschrijving
Patient has suffered from chronic sinusitis since:
Datatype
integer
Alias
- UMLS CUI [1]
- C0149516
Beschrijving
Inclusion criteria
Beschrijving
Initial examination including Ear, Nose and Throat Examination
Datatype
boolean
Alias
- UMLS CUI [1]
- C2729337
- UMLS CUI [2]
- C0278350
Beschrijving
Patient age
Datatype
boolean
Beschrijving
Patient with chronic sinusitis for more than 8 weeks or with more than 4 periods during at least 10 days/year (nasal obstruction and unspecific headache, rhinorrhea, post-nasal-drip, facial pain, facial pressure
Datatype
boolean
Alias
- UMLS CUI [1]
- C0149516
Beschrijving
Sinusitis Symptom Score total >= 5 and nasal obstruction score total >=2
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3533163
- UMLS CUI [1,2]
- C0037199
- UMLS CUI [2,1]
- C1299570
- UMLS CUI [2,2]
- C0037199
Beschrijving
Sinusitis diagnostics via coronary CT not older than 6 month. Sinusitis diagnosis and scale: osteo-meatal complex score= 2 on at least one side, total score < 10
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0037199
- UMLS CUI [1,2]
- C1634617
Beschrijving
Patient in good general condition without clinically significant disease which could affect study goal or study methods or which might impair patient´s safety.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1142435
Beschrijving
Patient with stable intermittent asthma: No medication at all or no medication with Beta-2 adrenergic receptor antagonists and without systemic, intranasal or inhaled corticosteroids medication.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1740754
Beschrijving
Patient on prior medication: Observe wash out times prior to begin of study
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826257
Beschrijving
Written informed consent based on patient information by physician
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
Footer module
Beschrijving
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Patient who do not fulfill all inclusion criteria
Datatype
boolean
Alias
- UMLS CUI [1]
- C2827031
Beschrijving
Patient without contraception, pregnant/ breast-feeding
Datatype
boolean
Alias
- UMLS CUI [1]
- C0700589
- UMLS CUI [2]
- C0549206
- UMLS CUI [3]
- C0006147
Beschrijving
Patient has undergone nasal operation within the last 6 months
Datatype
boolean
Alias
- UMLS CUI [1]
- C0188970
Beschrijving
Patient with significant ECG changes
Datatype
boolean
Alias
- UMLS CUI [1]
- C0855329
Beschrijving
Patient with clinically relevant changes of vital bodily function
Datatype
boolean
Alias
- UMLS CUI [1]
- C0277803
Beschrijving
Patient with Wegener's granulomatosis, Cystic fibrosis, Nasal polyp, Young syndrome, Primary ciliary dyskinesia, Glaucoma, cardiovascular, pulmonary, renal, hepatic, metabolic, hematological or neurological disease, that may impair with the therapy, patient on immunosuppressive agents or with Churg–Strauss syndrome
Datatype
boolean
Alias
- UMLS CUI [1]
- C3495801
- UMLS CUI [2,1]
- C0010674
- UMLS CUI [2,2]
- C0027430
- UMLS CUI [3]
- C0340037
- UMLS CUI [4]
- C0008780
- UMLS CUI [5]
- C0017601
- UMLS CUI [6]
- C0007222
- UMLS CUI [7]
- C0024115
- UMLS CUI [8]
- C0022658
- UMLS CUI [9,1]
- C0023895
- UMLS CUI [9,2]
- C0025517
- UMLS CUI [9,3]
- C0018939
- UMLS CUI [9,4]
- C0027765
- UMLS CUI [10]
- C0021081
- UMLS CUI [11]
- C0008728
Beschrijving
Patient on systemic steroid therapy < 4 weeks prior to begin of study
Datatype
boolean
Alias
- UMLS CUI [1]
- C4039704
Beschrijving
Patient on inhalable or intranasal steroid therapy < 2 weeks prior to begin of study
Datatype
boolean
Alias
- UMLS CUI [1]
- C3539185
Beschrijving
Drug intolerance to pharmaceutical ingredients of study medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C0277585
Beschrijving
Acute exacerbation of sinusitis or acute nasal infection < 2 weeks prior to begin of examination that required antibiotic therapy.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0235874
- UMLS CUI [1,2]
- C0037199
- UMLS CUI [1,3]
- C0338237
Beschrijving
Body Temperature > 38.5 °C at start of trial
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
White blood cell count exceeding > 150 % of upper limit
Datatype
integer
Alias
- UMLS CUI [1]
- C0580531
Beschrijving
Acute Upper Respiratory Infection within last two weeks
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264222
Beschrijving
Patient on antibiotic therapy after increase of symptoms during medication phase.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0338237
Beschrijving
Person participating in trial or their relatives
Datatype
boolean
Alias
- UMLS CUI [1]
- C0008976
Beschrijving
In case one of the above mentioned questions is answered “YES” the patient may not be included into the study.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0680251
Beschrijving
Physical Examination
Beschrijving
Physical Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Examination of nose
Datatype
integer
Alias
- UMLS CUI [1]
- C0558826
Beschrijving
Anatomic, Congenital , Surgery-induced changes
Datatype
boolean
Alias
- UMLS CUI [1]
- C0302142
- UMLS CUI [2]
- C0000768
Beschrijving
Nasal Polyps
Datatype
boolean
Alias
- UMLS CUI [1]
- C0027430
Beschrijving
Endoscopy
Datatype
integer
Alias
- UMLS CUI [1]
- C0014245
Beschrijving
Endoscopy findings: Assessment scale: 0=no finding; 1=minor; 2=major
Datatype
integer
Alias
- UMLS CUI [1]
- C0438280
Beschrijving
Lund-MacKay (LM) CT scoring scale
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0040405
- UMLS CUI [1,2]
- C0036449
Beschrijving
Medication
Beschrijving
Please list all drugs that the patient is taking at the start of this trial or that he will be taking during this trial. Please also note change of dosage. Please observe excluded drugs under the exclusion criteria section of this form.
Datatype
integer
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Please liste all "As Needed" medication
Datatype
integer
Alias
- UMLS CUI [1]
- C3176065
Beschrijving
Pleae list all non-drug therapies the patient has sofar undergone or will undergo during this trial.
Datatype
integer
Alias
- UMLS CUI [1]
- C0677097
Beschrijving
Signature
Datatype
integer
Alias
- UMLS CUI [1]
- C1519316
Beschrijving
Laboratory
Beschrijving
Blood test
Datatype
integer
Alias
- UMLS CUI [1]
- C0018941
Beschrijving
Rhinosinusitis Disability Index (RSBI)
Beschrijving
The Rhinosinusitis Disability Index (RSDI) is a measure of sinus-related disability. It is a standardized, statistically validated, disease-specific tool and used to investigate the disability suffered patients with rhinologic diagnosis.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0948780
- UMLS CUI [1,2]
- C3826998
Beschrijving
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:
Datatype
integer
Alias
- UMLS CUI [1]
- C0681116
Similar models
Visit 1 - Baseline Form
- StudyEvent: ODM
C0000924 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C0278350 (UMLS CUI [2])
C0037199 (UMLS CUI [1,2])
C1299570 (UMLS CUI [2,1])
C0037199 (UMLS CUI [2,2])
C1634617 (UMLS CUI [1,2])
C0549206 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0010674 (UMLS CUI [2,1])
C0027430 (UMLS CUI [2,2])
C0340037 (UMLS CUI [3])
C0008780 (UMLS CUI [4])
C0017601 (UMLS CUI [5])
C0007222 (UMLS CUI [6])
C0024115 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0023895 (UMLS CUI [9,1])
C0025517 (UMLS CUI [9,2])
C0018939 (UMLS CUI [9,3])
C0027765 (UMLS CUI [9,4])
C0021081 (UMLS CUI [10])
C0008728 (UMLS CUI [11])
C0037199 (UMLS CUI [1,2])
C0338237 (UMLS CUI [1,3])
C0000768 (UMLS CUI [2])
C0036449 (UMLS CUI [1,2])
C3826998 (UMLS CUI [1,2])
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