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Rhinosinusitis Chronic clinical trials

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NCT ID: NCT06105346 Not yet recruiting - Long COVID Clinical Trials

Prevalence of ENT Diseseas

PrENT
Start date: December 1, 2023
Phase:
Study type: Observational [Patient Registry]

The aim of the present study will be to evaluate in conscripts at the military induction board the prevalence of rhinosinusitis, the prevalence of HPV vaccinations, the prevalence of hearing impairments and the prevalence of long-COVID symptoms and further, to evaluate different factors that influence on the one hand the prevalence (urban-bred, non-urban-bred) and on the other hand symptoms (ENT-surgeries in medical history). Further, we want to evaluate if there is a correlation between subjective symptoms and apparated-based diagnostic investigations. Therefore, questionnaires and data of medical examinations, aquired routinely at the military induction board, will be analysed.

NCT ID: NCT05923047 Not yet recruiting - Clinical trials for Rhinosinusitis Chronic

Mepolizumab and In-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.

MELYSA
Start date: September 1, 2023
Phase: Phase 4
Study type: Interventional

This randomized, controlled multicenter trial will recruit patients aged 18 to 70 7 years with recurrent nasal polyposis requiring surgery and indication for biologic treatment according to EPOS 2020 guideline. Patients in the Mepolizumab arms will receive 100 mg of subcutaneous mepolizumab every 4 weeks for a total of 12 doses in addition to daily topical corticosteroid treatment. All study procedures will be performed in five study visits and may take approximately 30 minutes. Clinical assessments include different questionnaires and nasal endoscopy. This trial includes three treatment arms. 1. Combined group (In-office nasal polypectomy group with mepolizumab): This group will undergone in-office nasal polypectomy and will receive Mepolizumab. 2. Medical group (mepolizumab): This group will receive Mepolizumab. 3. Surgical group (In-office nasal polypectomy): This group will undergone in-office nasal polypectomy. The main advantage is that it allows comparison of mepolizumab versus surgery and surgery/mepolizumab versus surgery + mepolizumab, providing more information on the most effective therapeutic approach. The presence of adverse effects will be assessed in each treatment arm.

NCT ID: NCT05836935 Not yet recruiting - Rhinosinusitis Clinical Trials

Role of Imaging in Complications of Sinusitis

Start date: May 2023
Phase: N/A
Study type: Interventional

This study aims to assess the diagnostic performance of CT and MRI in the diagnosis of complications of rhinosinusitis in comparison to clinical and operative findings.

NCT ID: NCT05639686 Recruiting - Clinical trials for Rhinosinusitis Chronic

TIVA vs TXA in Sinus Surgery to Evaluate Operative Blood Loss and Surgical Field Quality

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The goal of this interventional study is to compare the efficacy (surgical field quality and intra-operative blood loss) or cost of TIVA alone to general inhalational anesthetics with intravenous TXA in patient participants who are undergoing endoscopic sinus surgery. The main questions the study aims to answer are: - Is the surgical field quality better when using TIVA alone compared to general inhalational anesthetics with intravenous TXA? - Is one method more financially advantageous to the participant and the institution compared to the other method? Participants will be randomized into one of the two anesthesia cohorts prior to sinus surgery. One group will be given total intravenous anesthesia (TIVA) alone and the other will be given intravenous tranexamic acid (TXA) followed by general inhalational anesthesia. Researchers will compare the TIVA group to the TXA group to see if one group exhibits a better surgery field viewing quality through a subjective evaluation and measurement of blood loss and also which anesthesia regimen is most cost effective upon conducting a cost analysis.

NCT ID: NCT05450471 Recruiting - Clinical trials for Rhinosinusitis Chronic

Effectiveness of Endonasal Polymeric Implant for Chronic Rhinosinusitis

Start date: August 20, 2021
Phase: Phase 3
Study type: Interventional

Objective: The objective of this study is to evaluate a steroid-embedded Terpolymers polymer implant of L-lactide and trimethynele carbonate (TCM) at the level of disease control in patients with eosinophilic and central compartment chronic rhinosinusitis (CRS) after placement of the endonasal device, compared to a control group (placebo). The secondary objectives of this study are to assess comfort, perception of improvement and satisfaction, as well as adverse events. Methods: A randomized controlled trial will be carried out, with a blinded participant, therapist and evaluator. Patients over 18 years of age, with chronic rhinosinusitis (CRS) who have already undergone endoscopic sinus surgery (CENS), but who do not have the disease under control and, therefore, with an indication for a new CENS, will be selected. Participants will come from the otorhinolaryngology outpatient clinic of the academic and public service of the University of São Paulo - USP. Eligible patients will receive either the Terpolymers L-lactide and trimethynele carbonate (TCM) polymer implant placement or the placebo polymer. The primary outcome will be the control of the symptoms of chronic uncontrolled rhinosinusitis that will be evaluated through the NOSE Questionnaire, a nasal endoscopic evaluation based on the Lund-Kennedy criteria and the SNOT-22 Questionnaire. The sample size calculation was performed based on a difference between the intervention and placebo groups of 30% for cases that achieved disease control, resulting in a sample of 36 participants (18 in each group). Data will be analyzed using mixed linear models.

NCT ID: NCT05167552 Not yet recruiting - Allergic Rhinitis Clinical Trials

Treatment of Allergic Rhinitis and Chronic Polypous Rhinosinusitis With Olfactory Mucosa-derived Mesenchymal Stem Cells

Start date: March 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Treatment of patients with allergic rhinitis and chronic polypous rhinosinusitis with olfactory mucosa-derived mesenchymal stem cells

NCT ID: NCT05015530 Recruiting - Microbiome Clinical Trials

Impact of Symbiofilm On Nasal Microbiota

ISONAM
Start date: December 12, 2022
Phase:
Study type: Observational

Healsea® chronic is CE marked medical device indicated in adults for the treatment of nasal symptoms of chronic rhinosinusitis. This is an hypertonic seawater-based nasal spray supplemented with natural Symbiofilm® extract (0.2%) isolated from marine bacteria. In vitro, Symbiofilm® inhibits at early stage biofilm formation from bacteria found to be more prevalent and abundant in CRS patients (e.g. Staphylococcus aureus, Pseudomonas aeruginosa). This exploratory study is designed with aim to determine if the antibiofilm properties of Symbiofilm® may modify sino-nasal microbiota, impacting α and/ or β diversities.

NCT ID: NCT04703673 Completed - Bronchitis Clinical Trials

Sinolpan® Pharmacy Non-interventional Study - Quality of Live

Start date: January 8, 2021
Phase:
Study type: Observational

This non-interventional study investigates the Quality of Life of patients suffering from rhinosinusitis. Patients who seek advice in a pharmacy and choose to intake Sinolpan® or Sinolpan® forte or to use nasally applied α-sympathomimetics can participate in this anonymous patient survey.

NCT ID: NCT04420052 Withdrawn - Clinical trials for Rhinosinusitis Chronic

Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Chronic Rhinosinusitis (CRS) is a chronic condition with limited therapeutic options. Moreover, the pathophysiology is poorly understood. The aim of this study is to evaluate the efficacy of osteopathic manipulative treatment (OMT) in the course of this condition by applying several techniques supposed to be related to the autonomic nervous system. Our hypothesis is that these techniques could have beneficial effects on inflammation and head symptoms in CRS. Methods: A sample of 90 patients diagnosed by ENT specialist will be randomly assigned to the OMT group or the placebo group. The placebo procedure will consist in using light touch around the nose, on the throat and on the thorax. Treatment and placebo protocols are composed of two visits at day 0 and day 30. A general practitioner will determine the eligibility for the study. The outcomes include Peak Nasal Inspiratory Flow (PNIF) measured five times: at day 0, 30 (twice each, before and after treatment) and 180 (once). The two groups will be compared regarding short and long term evolution. The evolution of symptoms will be assessed by the Sino-nasal Outcome Test (SNOT-22) seven times: at day 0, 30, 60, 90, 120, 150 and 180. This outcome will be analyzed using mixed effect modelling A Qualitative study will be conducted in the two groups to understand the patients' experiences during care. This protocol has been approved by a french ethic committee (Comité de Protection des Personnes Sud Ouest et Outre-Mer II, 2020.04.09).

NCT ID: NCT03675022 Terminated - Sleep Apnea Clinical Trials

Effect of Dupilumab on Sleep Apnea in Patients With Rhinosinusitis

Start date: August 15, 2018
Phase: Early Phase 1
Study type: Interventional

Obstructive Sleep Apnea (OSA) is a common disorder with serious consequences that remains underrecognized, with >80% of OSA patients undiagnosed, and undertreated due to inadequate treatment options. The development of additional treatments for OSA, such as pharmacotherapy, are critically needed. The collaboration between Regeneron and Sanofi are funding this project. Regeneron will be providing the drug and the contract will be with Regeneron. Both companies are involved as it is a collaboration across the companies.