Clinical trials

Background: While third-generation EGFR tyrosine kinase inhibitors (TKI) like aumolertinib have significantly improved outcomes for patients with advanced lung adenocarcinoma, those harboring the L858R mutation still experience inferior prognosis compared to those with exon 19 deletions. Recent evidence suggests that combining TKIs with chemotherapy improves progression-free survival (PFS), but universal application of this combination exposes all patients to cytotoxic toxicity, even those who might thrive on TKI monotherapy alone. Circulating cell-free DNA (cfDNA) and minimal residual disease monitoring offer a dynamic window to identify which patients truly require treatment intensification. Objectives: The primary objective is to evaluate the predictive value of early molecular response by determining the association between the change in EGFR mutant allele fraction in cfDNA after a 6-week aumolertinib lead-in induction phase (T1) and a 4-cycle combination chemotherapy (T2) with clinical PFS. Secondary objectives include assessing overall response rates (ORR), disease control rate (DCR), safety, and the dynamics of EGFR mutant allele fraction and circulating immune cell profiles. Study Design: This is a prospective, single-arm, multicenter, phase II clinical trial enrolling 50 evaluable patients. The study utilizes a three-phase treatment framework: * Induction Phase: Aumolertinib monotherapy (110 mg/day) once daily for 6 weeks. * Consolidation Phase: Combination of aumolertinib (110 mg/day) once daily with pemetrexed (500 mg/m²) and carboplatin (AUC 5) once every three weeks for 4 cycles. * Maintenance Phase: Aumolertinib monotherapy once daily until disease progression. Endpoints: The primary efficacy endpoint is Progression-Free Survival (PFS). Molecular efficacy will be measured via the Molecular Clearance Rate (MCR) and Molecular Response Rate (MRR) at baseline (T0), post-induction (T1), and post-chemotherapy (T2). Safety will be graded according to CTCAE v5.0. Conclusion and Significance: This trial aims to establish a molecularly driven framework for personalized lung cancer management, seeking to maximize efficacy for high-risk patients while providing the foundation to spare molecular responders from unnecessary chemotherapy in the future. The results will serve as the base for the design of future confirmatory phase III trials.

Parkinson's disease (PD) is a progressive neurological disorder characterized by both motor and non-motor symptoms due to the degeneration of dopamine-producing neurons. There is currently no cure. Menthol, a natural compound that activates TRPM8 receptors, has shown neuroprotective and motor function benefits in preclinical PD models. In mice, distal limb immersion in menthol improved dopamine neuron survival and motor performance. Similar menthol-based interventions improved outcomes in a stroke model and a clinical trial with stroke patients. This study investigates whether topical menthol can offer therapeutic benefits for individuals with PD.

This study aims to find out which method of spontaneous breathing trial (SBT) better helps overweight and obese ICU patients prepare for extubation, which is the removal of the breathing tube. The two methods being compared are pressure support ventilation (PSV) and the T-piece. Participants are adults with a body mass index (BMI) of 25 or higher who have been on a breathing machine (invasive mechanical ventilation) for more than 24 hours. Before removing the breathing tube, participants will be randomly assigned to receive either a PSV or a T-piece trial for 1 hour. After that, doctors will decide if they are ready for extubation. The main question this study wants to answer is: Which method leads to a higher rate of successful extubation-defined as not needing to be reintubated within 72 hours?

Over half of cancer patients experience cancer-related pain. Despite advances in pain management with opioids, many patients continue to suffer from chronic cancer pain. The underlying mechanisms of cancer-related pain remain poorly understood, but they may be linked to brain neuroplasticity. As a result, some researchers suggest that targeting the motor cortex in cancer patients could improve pain management. However, few studies have investigated the effectiveness of remodeling neuroplasticity with repetitive transcranial magnetic stimulation (rTMS) to reduce cancer-related pain. To validate the use of rTMS in cancer-related pain, we plan to conduct a randomized controlled trial involving 30 cancer pain patients. Participants will be randomly assigned to receive either rTMS or sham rTMS treatment. Functional magnetic resonance imaging (fMRI) and pain index assessments will be conducted before and after the treatment to evaluate the outcomes.

This is a prospective, randomized, two-arm, phase II study. The purpose of this study is: * To evaluate and compare the efficacy and safety of magnetic resonance-guided focused ultrasound (MRgFUS) and radiofrequency ablation (RFA) for treatment of facet-joint osteoarthritis low back pain. * Determining the effect of the MRgFUS System and RFA for improving functional disabilities and in reducing pain resulting from facet-joint osteoarthritis low back pain. Efficacy will be determined by the level of pain relief (as measured by the Numerical Rating Scale, NRS), decrease in analgesics/opiate, improved quality of life (as measured by the Oswestry Disability Questionnaire, ODQ, and core outcome measures index questionnaire, COMI), pain interference with function (as measured by the Brief Pain Inventory-Interference scale, BPI-QoL), general health status (as measured by the EQ5D), physical exam, X-ray and MRI studies from baseline up to 12-Months post- MRgFUS and radiofrequency treatment. * Evaluate incidence and severity of adverse events associated with the MRgFUS system and RFA used for the treatment of pain resulting from facet-joint osteoarthritis low back pain.

Pain is a major complaint in hemodialysis (HD) patients. Concentrations of parathyroid hormone (PTH) \>250 pg/ml are associated with chronic pain. Visual Analogue Scale (VAS) score which is used to assess the pain severity is positively related to PTH levels. This study is aimed to assess the effects of multiple mega dosages vitamin D supplementations in HD patients with chronic pain. It's a single-center, parallel, double-blind randomized control trial that administrations of 576,000 IU once a week of vitamin D3 for 4 weeks or placebo are for 120 eligible subjects. VAS and laboratory tests including serum concentrations of 25(OH)D, calcium, phosphorus, PTH and C-reactive protein will be evaluated.