JMIR Research Protocols最新文献

Background: Despite advances in surgical resection, radiotherapy, and chemotherapy, the prognosis of recurrent malignant gliomas (rMG) remains poor, with limited efficacy of conventional treatments due to the blood-brain barrier (BBB) hindering drug delivery to the tumor site. Studies have demonstrated that albumin-bound paclitaxel (ABX), while potent in vitro, is restricted in its intravenous use due to BBB limitations. To overcome this, specific-mode electrical stimulation (SMES) has shown promise in transiently opening the BBB, enhancing the accumulation of ABX in glioma tumors. Therefore, this protocol designs a single-center, single-arm, prospective phase II clinical trial aiming to evaluate the safety and clinical efficacy of SMES combined with ABX (SMES+ABX) for treating rMG.

Objective: This study primarily evaluates the safety of SMES+ABX therapy in treating patients with rMG and assesses whether it can improve the 4-month progression-free survival (4m-PFS) rate, while providing data support for future large-scale clinical trials.

Methods: In this study, 20 eligible patients will receive intravenous ABX (135-175 mg/m²) per 21-day cycle for 6 cycles, combined with SMES for BBB modulation. A Simon 2-stage design will be employed, with the primary end point being the 4m-PFS. Secondary end points include adverse events, disease control rate, objective response rate, duration of disease control, duration of response, Neurological Assessment in Neuro-Oncology score, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, progression-free survival, and overall survival.

Results: The results will determine the 4m-PFS rate, overall safety profile, secondary efficacy outcomes, and patient-reported quality of life measures. The data will be analyzed upon trial completion. Patient enrollment is scheduled to begin in May 2025. The treatment and primary efficacy assessment phases are anticipated to be completed by January 2027 (allowing for staggered enrollment and a 4-month treatment period for the last enrolled patient). The final survival follow-up for all patients is anticipated to be completed by January 2028 (ie, 1 year after the last patient completes treatment). Data management is currently ongoing, and formal statistical analyses have not yet been performed.

Conclusions: This study aims to evaluate the efficacy and safety of SMES combined with ABX in the treatment of rMG. If successful, the combination could offer a promising therapeutic strategy for this challenging patient population.

Background: Treatment options for knee osteoarthritis (KOA) remain limited. Although previous studies suggest that acupuncture can alleviate pain and functional impairment associated with KOA, there is significant variation in acupoint selection across studies and a lack of objective criteria to guide this choice. Infrared thermography (IRT) is recognized as a reliable method for identifying inflammatory regions in KOA. Our previous research revealed abnormal skin temperature at specific acupoints and surrounding areas in the lower limbs of patients with KOA, indicating potential treatment targets. However, there is still insufficient evidence to support their clinical application.

Objective: This pilot trial aims to assess the feasibility of conducting large-scale studies in the future and to provide preliminary evidence of the effects of acupuncture applied at IRT-guided thermal-sensitized acupoints (TAs) for the treatment of KOA.

Methods: This will be a randomized, controlled pilot trial with participant blinding. A total of 60 patients with KOA will be randomly allocated in a 1:1 ratio to either the TA group or the conventional acupoint group. Both groups will receive 3 acupuncture sessions per week for 4 weeks. In the TA group, acupoint selection will be based on points with abnormal skin temperature identified by IRT using real-time surface projection technology. In the conventional acupoint group, acupoint selection will follow the established prescription validated in previous studies. The primary outcome will be feasibility, assessed using a traffic light system to evaluate recruitment, retention, intervention completion, and completion of other outcome measures. Secondary outcomes will include the visual analog scale for pain, the Western Ontario and McMaster Universities Osteoarthritis Index function subscale, the credibility and expectancy questionnaire, skin temperature, and safety.

Results: The study has been approved by the ethics committee of the Third Affiliated Hospital of Beijing University of Chinese Medicine (BZYSY-2024KYKTPJ-44) and registered in the International Traditional Medicine Clinical Trial Registry. The first participant was enrolled on February 25, 2025, and a total of 30 participants had been enrolled by January 1, 2026. All enrollment and follow-up are expected to be completed by June 2026.

Conclusions: The findings of this study will provide evidence on the feasibility and preliminary clinical effects to support the future adoption of acupuncture prescriptions based on TAs for the treatment of KOA.

Trial registration: International Traditional Medicine Clinical Trial Registry ITMCTR2025000019; https://itmctr.ccebtcm.org.cn/mgt/project/view/-5870917416012215224.

International registered report identifier (irrid): DERR1-10.2196/81837.

Background: For long-term longevity and proper function, endodontically treated teeth must be restored appropriately. Fiber posts luted with dual-cure resin cement are frequently used because of their improved biomechanical and adhesive properties. However, achieving a strong binding between the fiber post and root canal dentin is difficult due to the physical constraints of the root canal and the presence of a smear layer. Bond strength may be increased by post space irrigation with solutions, such as 5% calcium hypochlorite, 17% ethylenediaminetetraacetic acid (EDTA), and saline, that have been activated using sonic or ultrasonic techniques. This study compares the effects of several activation techniques on the push-out bond strength of fiber posts luted with dual-cure resin cement.

Objective: This study aims to evaluate how the push-out bond strength of dual-cure resin-cemented fiber posts in excised human mandibular single-rooted premolars is affected by the sonic and ultrasonic activation of 3 post space irrigants: 5% calcium hypochlorite, 17% EDTA, and saline.

Methods: A total of 120 single-rooted mandibular premolars will be used in this in vitro investigation. A standardized procedure will be used to decoronate, instrument, and obturate the teeth. One of the 3 solutions, activated either sonically or ultrasonically, will be used to prepare and irrigate post spaces. Dual-cure resin cement will then be used to lute the fiber posts. Using a universal testing machine, push-out bond strength will be measured. The Tukey post hoc test and ANOVA will be used for statistical analysis of the data.

Results: Ethics approval for this study was obtained from the institutional ethics committee of Datta Meghe Institute of Higher Education and Research. The study is self-funded. Sample collection of extracted human mandibular premolars began in June 2025, and 68 specimens have been collected as of submission. Specimen preparation is ongoing, with data collection projected to be completed by October 2025. Data analysis is scheduled for November 2025, and results are expected to be published in early 2026. It is anticipated that irrigant type and activation method will influence push-out bond strength, with 17% EDTA and 5% calcium hypochlorite, particularly under ultrasonic activation, potentially yielding higher values than saline.

Conclusions: On the basis of previous literature, we expect that EDTA and calcium hypochlorite with ultrasonic activation may exhibit higher push-out bond strength.

International registered report identifier (irrid): DERR1-10.2196/76907.

Background: Health care systems are increasingly challenged by demographic shifts, rising chronic illnesses, human resource constraints, and growing efficiency demands. Improving both occupational safety and health (OSH) and patient safety (PS) management has been identified as a pivotal strategy to address these challenges. However, there is a paucity of evidence-based methods that support systematic and integrated OSH and PS. In response, the Systematic and Integrated Occupational Safety and Health and Patient Safety Management Systems (SIOHPS) intervention was developed, guided by the Safer Culture Framework and the Medical Research Council (MRC) framework for complex interventions.

Objective: This paper outlines the study protocol for a process evaluation embedded in the SIOHPS trial.

Methods: The process evaluation will use a convergent parallel mixed methods design. The SIOHPS trial is conducted in 13 Swedish hospital settings. Guided by the Consolidated Framework for Implementation Research (CFIR), quantitative and qualitative data will be collected before, during, and after the trial through questionnaires, telephone interviews, focus group interviews (FGIs), observations, the SIOHPS digital tool, and other relevant documentation. In line with the convergent parallel mixed methods study design, the quantitative and qualitative data will be analyzed in a stepwise manner, initially independently from each other, followed by iterative triangulation.

Results: Funding began in January 2023. The development phase was completed in early 2024, and the evaluation phase started in June 2024, with completion planned in early February 2026. Quantitative data collection for two of three clusters (baseline, 4- and 8-month follow-up) is complete, and data cleaning is underway. All qualitative data collected to date have been transcribed. Final data collection for cluster III, including the 8-month survey and FGIs, is scheduled for the end of January and early February 2026. Data analysis will begin in early 2026, with results to be disseminated through publications and conference presentations later in 2026.

Conclusions: The process evaluation will integrate quantitative and qualitative data sources to elucidate the mechanisms through which the SIOHPS intervention influences safety culture, health care worker (HCW) health, PS, and quality of care. This comprehensive approach unpacks the "black box" of the implementation process, which will provide an in-depth nuanced picture of the intervention's effectiveness and valuable insights into scalability and transferability across diverse health care contexts.

Trial registration: ClinicalTrials.gov NCT06398860; https://clinicaltrials.gov/study/NCT06398860.

International registered report identifier (irrid): DERR1-10.2196/89185.