Eligibility Rhinosinusitis NCT02296814 DRKS00006877

1 Formulários

StudyEvent: ODM
1. Eligibility Rhinosinusitis NCT02296814 DRKS00006877

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

Inclusion Criteria

C1512693 (UMLS CUI-1)

Informed Consent

Item

1. Signed informed consent

boolean

C0021430 (UMLS CUI [1])

Outpatient, Age

Item

2. Male and female outpatients, aged ≥ 18 and ≤ 75 years

boolean

C0029921 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])

Rhinosinusitis

Item

3. Diagnosis of acute, uncomplicated (or recurrent acute) rhinosinusitis - characterized by Major Rhinosinusitis Symptom Score (MRSSinv) ≥ 8 and ≤ 15 points - individual score for facial pain/pressure (on bending) ≥ 1 (mild) and ≤ 2 (moderate) - with presence of symptoms ≤ 3 days prior to inclusion Out of the 5 main rhinosinusitis symptoms, at least 3 must be present. Among these, the presence of nasal congestion and facial pain / pressure (on bending) is mandatory.

boolean

C0948780 (UMLS CUI [1])

Contraceptive Methods

Item

4. Women of childbearing potential: willingness to use contraception methods

boolean

C0700589 (UMLS CUI [1])

Exclusion Criteria

Item Group

Exclusion Criteria

C0680251 (UMLS CUI-1)

Chronic rhinosinusitis

Item

Medical History: Diseases 1. Chronic rhinosinusitis (i.e. all forms and causes of persistent chronic rhinosinusitis)

boolean

C0149516 (UMLS CUI [1])

Nasal Polyps

Item

Medical History: Diseases 2. Polyposis nasi, recent history

boolean

C0027430 (UMLS CUI [1])

Maxilla Infection

Item

Medical History: Diseases 3. Infection of dental origin in the maxilla

boolean

C1400602 (UMLS CUI [1])

Cystic fibrosis

Item

Medical History: Diseases 4. Cystic fibrosis, recent history

boolean

C0010674 (UMLS CUI [1])

Deviated nasal septum

Item

Medical History: Diseases 5. Anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation / air flow

boolean

C0549397 (UMLS CUI [1])

Allergic Rhinitis

Item

Medical History: Diseases 6. Acute symptoms of a known allergic rhinitis

boolean

C2607914 (UMLS CUI [1])

Smoking Status

Item

Medical History: Diseases 7. History of smoking within the last two years prior to study enrolment or current smoking habits

boolean

C1519386 (UMLS CUI [1])

Asthma

Item

Medical History: Diseases 8. Patients with asthma

boolean

C0004096 (UMLS CUI [1])

Hypersensitivity to Study Drug

Item

Medical History: Diseases 9. Known hypersensitivity to study medication or excipients (asteraceae, lactose, allergy to bee venom, etc.)

boolean

C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])

Immune Deficiency

Item

Medical History: Diseases 10. Underlying diseases leading to a significant immune deficiency

boolean

C1855771 (UMLS CUI [1])

Bacterial Sinusitis

Item

Medical History: Diseases 11. Signs or symptoms of bacterial sinusitis requiring antibiotic treatment (e.g. fever >38.3°C, orbital complications, severe unilateral frontal headache or toothache)

boolean

C1262006 (UMLS CUI [1])

Comorbidity

Item

Medical History: Diseases 12. atients with progressive auto-immune diseases, tuberculosis, leukemia or leukemia-like diseases, multiple sclerosis, inflammatory diseases of the connective tissues, rheumatoid arthritis, Lupus erythematodes, HIV infection or other chronic viral diseases

boolean

C0009488 (UMLS CUI [1])

Thyroid Diseases

Item

Medical History: Diseases 13. Patients with untreated/unstable thyroid gland disorder (treatment should not include iodine supplementation)

boolean

C0040128 (UMLS CUI [1])

Gynaecological Status

Item

Medical History: Diseases 14. Pre-menopausal women (last menstruation ≤ 1 year prior to informed consent) who: - are nursing or pregnant, - or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, double barrier methods, sexual abstinence and vasectomised partner.

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])

Liver or Kidney Disease

Item

Medical History: Diseases 15. Severe diseases of liver or kidney

boolean

C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])

Neurological or Mental Disorder

Item

Medical History: Diseases 16. Severe somatopathic, neurological and / or psychiatric diseases

boolean

C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])

Malignant Neoplasms

Item

Medical History: Diseases 17. Patients with malignant growth processes or cancer treatment within the last two years prior to study inclusion.

boolean

C0006826 (UMLS CUI [1])

Substance Use Disorder

Item

Medical History: Diseases 18. History of alcohol or drug abuse

boolean

C0038586 (UMLS CUI [1])

Antibiotics, Corticosteroids

Item

Medical History: Medication 1. Treatment with systemic or nasal antibiotics or nasal or systemic corticosteroids within the last 4 weeks prior to study inclusion

boolean

C0003232 (UMLS CUI [1])
C0001617 (UMLS CUI [2])

Alternative medicine

Item

Medical History: Medication 2. Treatment with alternative medicine preparations (homeopathic and phytotherapeutical drugs) for treatment of common cold like symptoms or with immunomodulating properties (such as Echinacea), within the last 7 days prior to study inclusion

boolean

C0002346 (UMLS CUI [1])

Decongestants

Item

Medical History: Medication 3. Treatment with decongestant (α-sympathomimetics on the day of study inclusion within 5 hours prior to screening and during the study)

boolean

C0282374 (UMLS CUI [1])

Chronic Use of Decongestants

Item

Medical History: Medication 4. Chronic use of decongestant remedies

boolean

C0282374 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])

Immunosuppression

Item

Medical History: Medication 5. Treatment with immunosuppressive medication 8 weeks prior to study inclusion and during the study for any condition

boolean

C0021079 (UMLS CUI [1])

Antiviral Treatment

Item

Medical History: Medication 6. Systemic antiviral treatment such as aciclovir; zanamivir, or oseltamivir within 30 days prior to study inclusion

boolean

C2363964 (UMLS CUI [1])

Requiring Antibiotics

Item

Medical History: Medication 7. Patients requiring antibiotic treatment for any condition at study entry

boolean

C0003232 (UMLS CUI [1,1])
C0027552 (UMLS CUI [1,2])

Study Participation Status

Item

Medical History: General 1. Parallel participation in any other clinical study or participation in another study within less than 6 weeks prior to study inclusion, or previous participation in this same study

boolean

C2348568 (UMLS CUI [1])

Understanding Ability

Item

Medical History: General 2. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study

boolean

C0582778 (UMLS CUI [1])

Custody

Item

Medical History: General 3. Patients in custody by juridical or official order

boolean

C0680610 (UMLS CUI [1])

Language Ability

Item

Medical History: General 4. Patients who have difficulties in understanding the language (German) in which the patient information is given

boolean

C1145677 (UMLS CUI [1])

Relationship

Item

Medical History: General 5. Patients who are employees of a trial center, the CRO, the sponsor or its authorised representatives or are relatives either of the study site staff, the CRO staff; the sponsor staff or its authorised representatives

boolean

C0439849 (UMLS CUI [1])

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Eligibility Rhinosinusitis NCT02296814 DRKS00006877