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Filter by:Chronic rhinosinusitis (CRS) is a condition of persistent sinonasal mucosal inflammation which affects 11.9% of the US population. Mepolizumab is newly approved to treat chronic rhinosinusitis with nasal polyps (CRSwNP, the spaces inside nose and head are swollen and inflamed) and acts booking interleukin-5 (IL-5) a protein implicated in the inflammatory process. We aim to use Single-cell RNA sequencing (RNA-Seq, a method of genetically 'barcoding' cells to allow gene expression to be profiled at the level of individual cells) to study the effects of IL-5 blockade on the generation and maintenance of nasal adaptive immune responses, in CRS subjects.
As the 3rd generation, EGFR TKI has become a standard treatment option for the 1st line therapy in EGFR mutated patients, the necessity for evaluating resistant mechanism to determine the matched subsequent therapeutic option has been highlighted. From the 1st line Osimertinib treatment, the heterogenous resistance mechanism has been observed showing most commonly by MET amplification (7-15%) followed by additional on-target EGFR mutation (6-10%), BRAF, PI3KCA, KRAS, HER2 mutation (13-14%) and still 40 to 50% remain unknown for the mechanism. (A. Leonetti et al.British Journal of Cancer(2019)) Based on the observation showing the MET amplification as the most common resistance mechanism to the 3rd generation EGFR TKI treatment, the "TATTON" study, a multi-arm, phase IB trial, demonstrated early clinical data of Osimertinib in combined with savolitinib. Among the patients, c-MET amplified patients who were previously treated with 3rd generation EGFR TKI, a combination of Osimertinib and savolitinib, showed an objective response rate of 33% and median PFS of 5.5 months. (G. Oxnard et al. Annals of Oncology(2020)) The clinical efficacy of Osimertinib with savolitinib in MET overexpressed or amplification patients are reported from the global phase II, "SAVANNAH" study. The preliminary results from the SAVANNAH trial showed that Osimertinib plus savolitinib demonstrated an objective response rate of 49% in patients with a high level of MET overexpression and/or amplification, defined as IHC90+ and/or FISH 10+, whose disease progressed on treatment with Osimertinib. The highest ORR was observed in patients with a high level of MET who were not treated with prior chemotherapy (52%). In patients whose tumors did not show a high level of MET, the ORR was 9% (MJ Ahn, WCLC, 2022). There are ongoing global Phase III SAFFRON study to validate the outcome from SAVANNAH study. It has been reported that around 62% of tumor in Osimertinib progressed sample has MET overexpression and/or amplification, and more than one-third (34%) met the defined high MET level cut-off. As Lazertinib is about to be approved as the treatment option for the treatment naïve EGFR mutated NSCLC, it is also becoming important to develop a further treatment plan based on the MET amplification status. In this study, the investigators designed a phase II study based on the MET amplification status to evaluate the clinical efficacy of Lazertinib + tepotinib.
to study pulmonary function tests in children with ESRD on regular HD and its correlation with dialysis duration and other various risk factors
This is a prospective, multicentric, comparative, randomised-controlled study to evaluate the safety and efficacy of the Facet Fixation implant. The main objective is to evaluate the effectiveness of spinal decompression associated with FFX® implants compared to spinal decompression alone in treating lumbar spinal stenosis after 2 years of treatment.
The overall study objectives outlined in this study are to derive 129Xe MRI pulmonary vascular biomarker signatures that differentiate common subtypes of PAH and to determine the ability of 129Xe MRI to longitudinally monitor disease progression and response to therapy in PAH, with the aid of additional assessments, such as labs, echocardiography, and six-minute walk distance (6MWD).
The primary aim of our study is to leverage lung ultrasound to assess and identify postoperative pulmonary complications following shoulder arthroscopic surgery and the implications of the used irrigation fluid.the investigators will further investigate the impact of intraoperative fluid management strategies on these Postoperative pulmonary complications and their effects on hemodynamics. By harnessing the potential of lung ultrasound in this context, we aspire to enhance both the diagnostic capabilities and overall safety of shoulder arthroscopic surgery, ultimately improving patient outcomes.
The purpose of this pilot feasibility study is to test a pharmacist-facing clinical decision support tool designed to increase adherence to guideline-directed medical therapy and evaluate the tool using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) evaluation framework.
The study is a non-randomized, two-part, open label, prospective single-site, single arm, safety and performance study. The study is designed to collect acute and long-term clinical data and user reported outcome data from using the PreSens-Catheter and PACER Software during cardiac catheterization and Cardiac Resynchronization Therapy (CRT) device implantation procedures. Subjects with indication for arterial catheterization and CRT will be included.
The enrolled head and neck squamous cell carcinoma patients in this study received high-dose multiday chemotherapy with cisplatin and synchronous radiation therapy, which had a high risk of nausea and vomiting. On the first and third days, they took Netopitam Palonosetron capsules and dexamethasone to reduce the incidence of acute vomiting. The aim of this study is to evaluate the antiemetic effect of Netopitam Palonosetron capsules and to explore the effectiveness of using Netopitam Palonosetron capsules again for antiemetic treatment during the study period when breakthrough vomiting occurs.
The ClearSkin module, Er: Glass 1540nm, is largely used in the treatment of acne vulgaris and acne scars. The non-ablative ER:Glass 1540 nm laser deeply penetrates the skin, causing thermal damage to the sebaceous glands, destroying P. acnes bacteria and reducing sebum production, while leaving the epidermis intact. The integrated vacuum mechanism extracts accumulated sebaceous material from the pores, while contact cooling protects the skin, reducing pain and allowing for safer and more effective treatment of the sebaceous glands within the dermis. Based on this background, the investigators have considered a pilot study aimed at assessing the efficacy and safety of the ClearSkin Module in treating subjects with facial acne scars.