ID
44222
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 (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 -
Hochgeladen am
20. September 2021
DOI
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Lizenz
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
Beschreibung
Patient demographics
Beschreibung
Date of birth
Datentyp
integer
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Weight
Datentyp
integer
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Temperatur
Datentyp
integer
Maßeinheiten
- °C
Alias
- UMLS CUI [1]
- C0039476
Beschreibung
Blood pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- 1/sec
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Gender
Datentyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Ethnic Group
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
Medical history of serious illness, accidents, surgeries
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0010340
- UMLS CUI [2]
- C0000924
- UMLS CUI [3]
- C0543467
Beschreibung
Does the patient suffer from allergies?
Datentyp
integer
Alias
- UMLS CUI [1]
- C0489531
Beschreibung
Patient has suffered from chronic sinusitis since:
Datentyp
integer
Alias
- UMLS CUI [1]
- C0149516
Beschreibung
Inclusion criteria
Beschreibung
Initial examination including Ear, Nose and Throat Examination
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2729337
- UMLS CUI [2]
- C0278350
Beschreibung
Patient age
Datentyp
boolean
Beschreibung
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
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0149516
Beschreibung
Sinusitis Symptom Score total >= 5 and nasal obstruction score total >=2
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3533163
- UMLS CUI [1,2]
- C0037199
- UMLS CUI [2,1]
- C1299570
- UMLS CUI [2,2]
- C0037199
Beschreibung
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
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0037199
- UMLS CUI [1,2]
- C1634617
Beschreibung
Patient in good general condition without clinically significant disease which could affect study goal or study methods or which might impair patient´s safety.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1142435
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1740754
Beschreibung
Patient on prior medication: Observe wash out times prior to begin of study
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826257
Beschreibung
Written informed consent based on patient information by physician
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
Footer module
Beschreibung
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Patient who do not fulfill all inclusion criteria
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2827031
Beschreibung
Patient without contraception, pregnant/ breast-feeding
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0700589
- UMLS CUI [2]
- C0549206
- UMLS CUI [3]
- C0006147
Beschreibung
Patient has undergone nasal operation within the last 6 months
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0188970
Beschreibung
Patient with significant ECG changes
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0855329
Beschreibung
Patient with clinically relevant changes of vital bodily function
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0277803
Beschreibung
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
Datentyp
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
Beschreibung
Patient on systemic steroid therapy < 4 weeks prior to begin of study
Datentyp
boolean
Alias
- UMLS CUI [1]
- C4039704
Beschreibung
Patient on inhalable or intranasal steroid therapy < 2 weeks prior to begin of study
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3539185
Beschreibung
Drug intolerance to pharmaceutical ingredients of study medication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0277585
Beschreibung
Acute exacerbation of sinusitis or acute nasal infection < 2 weeks prior to begin of examination that required antibiotic therapy.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0235874
- UMLS CUI [1,2]
- C0037199
- UMLS CUI [1,3]
- C0338237
Beschreibung
Body Temperature > 38.5 °C at start of trial
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
White blood cell count exceeding > 150 % of upper limit
Datentyp
integer
Alias
- UMLS CUI [1]
- C0580531
Beschreibung
Acute Upper Respiratory Infection within last two weeks
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264222
Beschreibung
Patient on antibiotic therapy after increase of symptoms during medication phase.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0338237
Beschreibung
Person participating in trial or their relatives
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0008976
Beschreibung
In case one of the above mentioned questions is answered “YES” the patient may not be included into the study.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0680251
Beschreibung
Physical Examination
Beschreibung
Physical Examination
Datentyp
integer
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
Examination of nose
Datentyp
integer
Alias
- UMLS CUI [1]
- C0558826
Beschreibung
Anatomic, Congenital , Surgery-induced changes
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0302142
- UMLS CUI [2]
- C0000768
Beschreibung
Nasal Polyps
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0027430
Beschreibung
Endoscopy
Datentyp
integer
Alias
- UMLS CUI [1]
- C0014245
Beschreibung
Endoscopy findings: Assessment scale: 0=no finding; 1=minor; 2=major
Datentyp
integer
Alias
- UMLS CUI [1]
- C0438280
Beschreibung
Lund-MacKay (LM) CT scoring scale
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0040405
- UMLS CUI [1,2]
- C0036449
Beschreibung
Medication
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Please liste all "As Needed" medication
Datentyp
integer
Alias
- UMLS CUI [1]
- C3176065
Beschreibung
Pleae list all non-drug therapies the patient has sofar undergone or will undergo during this trial.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0677097
Beschreibung
Signature
Datentyp
integer
Alias
- UMLS CUI [1]
- C1519316
Beschreibung
Laboratory
Beschreibung
Blood test
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018941
Beschreibung
Rhinosinusitis Disability Index (RSBI)
Beschreibung
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.
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
Ähnliche Modelle
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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