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Otitis clinical trials

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NCT ID: NCT06023550 Not yet recruiting - Sinusitis Clinical Trials

Complicated Infections in Otorhinolaryngology

ENT_infect
Start date: August 2024
Phase:
Study type: Observational [Patient Registry]

This observational study aims to learn more about complicated infections treated by otorhinolaryngologists. The main questions to answer are: - What is the management of complicated sinonasal infections in Ljubljana, Slovenia, - What is the management of complicated ear and temporal bone infections in Ljubljana, Slovenia, - What is the management of complicated neck soft tissue infections in Ljubljana, Slovenia, - What is the management of complicated laryngeal infections in Ljubljana, Slovenia Participants will receive standard treatment according to the established evidence-based clinical practice.

NCT ID: NCT05994768 Completed - Clinical trials for Malignant Otitis Externa

18F-FDG Tomography and Labeled Leukocyte Scintigraphy

OEN
Start date: December 18, 2020
Phase:
Study type: Observational

The study will aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled leukocyte scintigraphy in patients with a malignant otitis externa.

NCT ID: NCT05915078 Recruiting - Otitis Media Clinical Trials

Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry

Start date: June 15, 2023
Phase:
Study type: Observational [Patient Registry]

This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure (tympanostomy) using the Tula® System. The Registry will include up to 20 centers in the US and up to 200 patients for the initial evaluation. The FDA-approved Tula System includes the Tula Iontophoresis System (IPS) with TYMBION™ otic anesthetic for local anesthesia of the ear drum and the Tula Tube Delivery System (TDS) for ear tube placement. Clinical research established the safety, efficacy and tolerability of this system for in-office procedures in the pediatric population. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 6 months following extrusion or removal of their tube(s).

NCT ID: NCT05804123 Recruiting - Clinical trials for Upper Respiratory Tract Infections

LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media

Start date: October 28, 2021
Phase: N/A
Study type: Interventional

Acute respiratory tract infections (ARTIs), such as acute rhinosinusitis (ARS) and acute otitis media (AOM), are common worldwide and caused by viruses or bacteria entering the body through the mouth and nose. AOM frequently occurs in young children and is caused by bacterial reflux into the middle ear. ARS is a relatively common ARTIs and can occur at many ages. To accurately diagnose disease, careful clinical examination and accurate clinical judgment are required, as making a reasonable treatment regimen with the decision to use antibiotics. Probiotics have long been known to have beneficial effects on the digestive system. Not only limited to the gastrointestinal tract but probiotics are also known for their role in reducing infections in the respiratory system. Recently, the investigators have successfully conducted a clinical trial of nasal-spray Bacillus spore probiotics in children infected with respiratory syncytial virus (RSV), and the data show that the probiotics can rapidly and effectively relieve symptoms of RSV-induced ARTIs while exhibiting strong impacts in reducing viral load and inflammation. Here, the investigators conducted a study that directly spraying probiotics into the nose can effectively support to treatment of both ARS and AOM. The aim of the study about to evaluate the safety and effectiveness of nasal-spraying probiotics containing spores of Bacillus subtilis and Bacillus clausii in the supportive treatment of patients with ARS and AOM. Study Population: sample size is 120. Description of Sites: the study is carried out at Thai Binh Medical University Hospital and Thai Binh Children's Hospital. Description of Study Intervention: 120 eligible patients are divided into 2 groups (n=60/group) including the ARS group and the ARS accompanied by the AOM (ARS & AOM) group. 60 patients in each of the above groups were randomly assigned to two subgroups (n=30/subgroup): Patients in the Control-ARS and Control-ARS & AOM subgroups received the routine treatment and three times per day nasal-spraying 0.9% NaCl physiological saline. In contrast, the patients in the Navax-ARS and Navax-ARS & AOM subgroups received three times per day nasal-spraying LiveSpo Navax® in addition to the same standard of care treatment. The standard treatment regimen is 3-7 days, depending on the severity of the disease when the patient arrives for the exam and the progression of the disease during the treatment period. Study duration: 18 months

NCT ID: NCT05799404 Not yet recruiting - Otitis Media Clinical Trials

Stapes Footplate Thickness Measured With UHR-CT

Start date: April 28, 2023
Phase:
Study type: Observational

The aim of this study is to compare the thickness of the stapes footplate measured with ultra high resolution CT in control patients, otosclerosis patients and chronic otitis media patients.

NCT ID: NCT05741333 Recruiting - Otitis Media Clinical Trials

In-Office Clinical Study of the Solo+ TTD

VENTY
Start date: March 30, 2023
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.

NCT ID: NCT05657717 Completed - Clinical trials for Chronic Suppurative Otitis Media

Safety Profile of Applied 100% Manuka Honey in Tympanoplasty

Start date: July 13, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Throughout history, honey has been recognized for its healing properties. The use of honey for its medicinal properties dates back to 2200 BCE. The purpose of this clinical trial is to learn about the otological safety of 100% Medical grade Manuka Honey given to tympanoplasty patients The main question it aims to answer is: Can 100% Medical Grade Manuka Honey given at the time of Tympanoplasty otologically safe? Participants in the intervention group will receive a wound dressing of 100% medical grade Manuka honey after reconstructive surgery of the tympanic membrane. Researchers will compare the intervention group to the control group assess otological safety.

NCT ID: NCT05651633 Recruiting - Pain Clinical Trials

Analgesic Ear Drops for Children With Acute Otitis Media

OPTIMA
Start date: October 6, 2021
Phase: Phase 3
Study type: Interventional

This trial aims to investigate whether analgesic ear drops added to usual care provide superior ear pain relief over usual care alone in children presenting to primary care with AOM. Children will be randomly allocated (ratio 1:1) to either 1) lidocaine hydrochloride 5mg/g ear drops (Otalgan) 1-2 drops up to six times daily for a maximum of 7 days in addition to usual care (oral analgesics, with/without antibiotics) or 2) usual care. Parents will complete a symptom diary for 4 weeks as well as generic and disease-specific quality of life questionnaires at baseline and 4 weeks. The primary outcome is the parent-reported ear pain score (0-10) over the first 3 days. NOTE: At the time of publication of the study protocol paper, the investigators were unable to make any amendments to the trial registration record in the Netherlands Trial Register (NTR) (NL9500; date of registration: 28 May 2021). The addition of a data sharing plan was required to adhere to the International Committee of Medical Journal Editors (ICMJE) guidelines. The investigators therefore re-registered the trial in ClinicalTrials.gov. This second registration is for modification purposes only and the NTR record (NL9500) should be regarded as the primary trial registration.

NCT ID: NCT05641285 Active, not recruiting - Otitis Media Clinical Trials

Diagnostic Utility of Otosight Middle Ear Scope

Start date: February 21, 2023
Phase:
Study type: Observational

Evaluate clinic workflow impact of OtoSight use for patients seen in the pediatric otolaryngology clinic.

NCT ID: NCT05608993 Not yet recruiting - Acute Otitis Media Clinical Trials

RELAX: Reducing Length of Antibiotics for Children With Ear Infections

RELAX
Start date: April 2024
Phase: N/A
Study type: Interventional

The overarching goal of this study is to evaluate the effectiveness and implementation outcomes of two low-cost interventions of different intensities to increase prescribing of recommended short antibiotic durations for acute otitis media (AOM) for children 2 years of age and older. A multi-center cluster randomized controlled trial using a hybrid type 2 implementation effectiveness design will be used to evaluate interventions. The High-Intensity intervention will include clinician education, individualized clinician audit and feedback with peer comparison, and electronic health record (EHR) changes of prescription fields, whereas the Low-Intensity intervention will include clinician education and EHR changes. In total, 46 community-based clinics and/or urgent care centers across two distinct geographic regions in the United States will be randomized to one of the two interventions. The Practical Robust Implementation and Sustainability Model (PRISM) will be used to guide implementation and the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework will be used to evaluate outcomes. A mixed-methods approach will be used in the pre-implementation and evaluation phases and will utilize quantitative analyses, semi-structured interviews, focus groups, surveys, and cost analyses. National stakeholders at the American Academy of Pediatrics and the Centers for Disease Control and Prevention will assist with dissemination of findings and scaling of interventions.