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Sinusitis clinical trials

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NCT ID: NCT06313281 Completed - Clinical trials for Meningitis and Sinusitis in Transnasal Surgery

Effectiveness of Preoperative Antiseptic Preparation in Transnasal Skull Base Surgery

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Objective: Transnasal skull-base surgery is a complex and invasive procedure that involves the use of preoperative antiseptic preparations. However, evidence supporting their use in preventing postoperative infectious complications is limited. The aim of this study is to assess the efficacy of preoperative antiseptic techniques in reducing postoperative infectious complications within 30 days of surgery. Methods: A multicenter, prospective, randomized, single-blind, three-arm trial was conducted from February 2019 to October 2021. Participants were randomized to either of three antiseptic preparation techniques: external 0.9%NaCl nasal preparation, external 0.05% chlorhexidine gluconate, or intranasal irrigation with 80 mg of gentamicin added to 1000 ml of 0.9%NaCl plus external nasal preparation with chlorhexidine gluconate 0.05%. A total of 130 adults with skull-base pathologies were randomized, 12 were excluded before randomization for failure to meet inclusion criteria (n=9) or refusal to participate (n=3). The investigators excluded patients with evidence of infection adjacent to the surgical site, allergies to preparation methods, those who underwent craniotomy during the same admission, and pediatric patients.

NCT ID: NCT06016335 Completed - Hearing Loss Clinical Trials

MRI-based Synthetic CT Images of the Head and Neck

Start date: September 22, 2022
Phase: N/A
Study type: Interventional

In case of surgical procedures in the head and neck region, MRI in combination with CT of the bone is often the standard modality to visualise bony landmarks for planning, navigation and risk assessment. An important downside of a CT scan is the associated radiation exposure, especially in children. An additional downside is the sedation or general anaesthesia needed for both the MRI and CT scan session in very young children. These downsides could be removed if the CT scan can be substituted by an MRI sequence that can provide the same information as CT. This project aims to determine the feasibility of recreating CT like images of the craniofacial bones from MRI images using machine learning techniques.

NCT ID: NCT05999955 Completed - Rhinitis Clinical Trials

Safety and Efficacy of DSM 32444 Postbiotic in the Treatment of Acute Rhinosinusitis

Start date: December 29, 2022
Phase: N/A
Study type: Interventional

Rhinitis is a type of upper respiratory infection with a common nasal pathology especially in Southeast Asia, which is characterized by the presence of one or more of the following symptoms: itchy nose, sneezing, runny nose, and nasal congestion. Other symptoms occasionally experienced include headache, excessive pain reaction, cough, fever. Rhinitis can be idiopathic or due to a variety of causes, including allergens, medications, endocrine/metabolic, infectious, inflammatory, and abnormal nasal structures. The treatment of acute rhinosinusitis and allergic rhinitis in hospitals is currently carried out according to the general professional guidance of the Vietnam Ministry of Health. Most patients are prescribed corticosteroids, antihistamines, and antibiotics for immediate decongestion and anti-inflammatory effects. Current concerns about antimicrobial resistance (AMR) as well as side effects of corticosteroids and antihistamines have led to an urgent need for a naturebased next generation therapeutic approach that is safe, effective and helps in addressing the issues of AMR. The goal of this interventional study is to evaluate the safety and efficacy of postbiotic nasal spray using inert bioparticles of Bacillus subtilis DSM32444 in treatment of acute rhinosinusitis; and to compare the efficacy against Neomycin/Dexamethasone//Xylometazoline administered as a nasal spray as an adjunct to Amoxicillin/Clavulanate standard treatment in patients with acute rhinosinusitis. Patients with acute rhinosinusitis who give consent to participate in the study will be randomly assigned in a 1:1 ratio to one of two groups using postbiotic of Bacillus subtilis DSM32444 nasal spray ("Sperovid") or Neomycin/ Dexamethasone nasal spray for a period of 10 days. Investigators will compare whether the nasal spray using postbiotic Bacillus subtilis DSM32444 has similar efficacy as compared to Neomycin/Dexamethasone/Xylometazoline nasal spray as an adjuvant therapy along with the standard Amoxicillin/Clavulanate regimen in patients with acute rhinosinusitis based on time to improvement of rhinosinusitis symptoms.

NCT ID: NCT05984004 Completed - Rhino Sinusitis Clinical Trials

Safety Evaluation of Intranasal Use of DSM 32444 Postbiotic in Humans

Start date: September 26, 2022
Phase: N/A
Study type: Interventional

Rhinitis is a type of upper respiratory infection with a common nasal pathology especially in Southeast Asia, which is characterized by the presence of one or more of the following symptoms: itchy nose, sneezing, runny nose, and nasal congestion. The treatment of acute rhinosinusitis and allergic rhinitis in hospitals is currently carried out according to the general professional guidance of the Vietnam Ministry of Health. A common treatment regime for patients with rhinosinusitis in Vietnam includes a combination of steroids and antibiotics (Neomycin/Dexamethasone/ Xylometazoline) administered as a nasal spray, in adjunct with Amoxicillin/clavulanate 875/125 mg taken orally every 12- hours. The duration of treatment for patients is about 10 days depending on the severity of the disease. During the treatment period, a change in the systemic antibiotic regimen is necessary if the observations after 3 to 5 days of treatment do not show signs of a satisfactory response. Current concerns about antimicrobial resistance (AMR) as well as side effects of corticosteroids and antihistamines have led to an urgent need for a naturebased next generation therapeutic approach that is safe, effective and helps in addressing the issues of AMR. There have been multiple research studies supporting the efficacy of bacterialbased approaches in the prevention of viral respiratory infections, and that have potential for treatment. For use in the respiratory tract, it is necessary to have a completely sterile product to ensure safety in the long-term and there is a need for safety assessment of products both in animal models and human studies. This phase of the study aims to evaluate the safety in humans of a nasal spray using a postbiotic preparation of Bacillus subtilis DSM32444 and that is a sterile inert bioparticle.

NCT ID: NCT05931744 Completed - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis

Start date: May 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

To investigate the usage of budesonide as an agent in the injection of Type 2 chronic rhinosinusitis with nasal polyps

NCT ID: NCT05865613 Completed - Fatigue Clinical Trials

Effect of Electromagnetic Therapy on Patients With Chronic Rhinosinusitis.

Start date: December 15, 2021
Phase: N/A
Study type: Interventional

This study aimed to evaluate the efficacy of Pulsed electromagnetic field (PEMF) for Chronic sinusitis in a randomized, double-blind, placebo-controlled trial.

NCT ID: NCT05861817 Completed - Fatigue Clinical Trials

Effect of Low Level Laser Therapy in Patients With Chronic Rhinosinusitis.

Sinusitis
Start date: January 18, 2022
Phase: N/A
Study type: Interventional

This study aimed to evaluate the efficacy of low-level laser therapy (LLLT) for Chronic sinusitis in a randomized, double-blind, placebo-controlled trial.

NCT ID: NCT05639959 Completed - Clinical trials for Acute Rhinosinusitis

Efficacy and Safety of New Mometasone Furoate Nasal Spray Formulation in Acute Rhinosinusitis Patients: A Randomized Clinical Trial

Start date: September 10, 2022
Phase:
Study type: Observational [Patient Registry]

Seasonal and perennial allergic rhinitis, acute rhino sinusitis, and nasal polyposis are examples of common inflammatory disorders of the airway that significantly reduce patient health and quality of life. Intranasal corticosteroids are advised as part of treatment plans for each of these illnesses since they help to reduce inflammation and thus symptoms. Objective In order to assess the effectiveness and safety of a new nano formulation of Mometasone furoate nano-nasal spray (FM-NNS) for the treatment of allergic rhinitis. Mometasone Furoate Nano-nasal spray (FM-NNS) was compared with commercial available nasal spray named as MFNS.

NCT ID: NCT05494164 Completed - Clinical trials for Chronic Rhinosinusitis

Nigella Sativa for Selected Outcomes in Chronic Rhinosinusitis

Start date: August 7, 2022
Phase: N/A
Study type: Interventional

the study is intended to test the effect of Nigella sativa nasal oil drops on selected outcomes among patients with chronic rhinosinusitis using prospective clinical trial design. To achieve the aim of the current trial the following research hypotheses are postulated: H1. The total severity of symptoms mean scores of patients with CRS who will use Nigella sativa nasal oil drops will be different from the total severity of symptoms mean scores of a control group. H2. The total sleep quality mean scores of patients with CRS who will use Nigella sativa nasal oil drops will be different from the total sleep quality mean scores of a control group. H3. The total patient satisfaction mean scores of patients with CRS who will use Nigella sativa nasal oil drops will be different from the total patient satisfaction mean scores of a control group.

NCT ID: NCT05442606 Completed - Rhinosinusitis Clinical Trials

Physiotherapy Protocol in Treating Chronic Rhinosinusitis

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This study aims to investigate the effect of adding of integrated physiotherapy program to the conservative medical therapy on quality of life and pressure pain threshold (PPT) in chronic rhinosinusitis patients. Patients in this study will be randomly assigned into 2 groups. Group A (control group) will receive conservative medical treatment only which prescribed by Ear, Nose and Throat (ENT) specialist, while group B (experimental group) will receive the conservative medical treatment prescribed by ENT specialist in addition to physiotherapy program. Quality of Life (QoL) will be evaluated by Rhinosinusitis Disability Index (RSDI) and PPT will be evaluated by digital algometer at the baseline and immediately after the end of tenth session of treatment for both groups.