Clinical Research Directory

A Study on the Efficacy and Safety of Telitacicept in the Treatment of Children Ocular Myasthenia Gravis

Under conventional treatment regimens, pediatric ocular myasthenia gravis (OMG) is prone to relapse and is associated with corticosteroid-related adverse effects, indicating an unmet clinical need. In May 2025, the targeted B-cell biologic agent Telitacicept was approved for use in adult patients with acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (GMG) and subsequently initiated in national multicenter clinical trials for adult OMG. Our center published a retrospective study in the Chinese Journal of Evidence-Based Pediatrics in August 2025, which was the first report both domestically and internationally on the efficacy and safety of Telitacicept in four pediatric OMG patients. This study plans to conduct a prospective, multicenter, open-label, single-arm clinical trial aimed at evaluating the effectiveness and safety of Telitacicept in pediatric OMG.

Hospital at Home Versus Inpatient Care: Costs and Effectiveness

Background and Objectives Hospital at Home (HaH) delivers hospital-level treatment to acutely ill patients in their own homes, including daily medical and nursing visits, infusions, physiotherapy, and diagnostics. It bridges inpatient and outpatient care, working closely with hospitals, office-based physicians, home care services (Spitex), and therapy providers. There are two main pathways: Admission Avoidance: stable patients requiring hospitalization are admitted directly to HaH instead of an inpatient ward. Early Supported Discharge: patients treated in hospital are discharged earlier than usual and transferred to HaH. Evidence International studies show HaH to be safe and effective. Reviews report comparable mortality and rehospitalization, shorter hospital stays, and cost advantages. Admission avoidance is linked to trends toward lower mortality and costs. Research showed similar mortality but fewer rehospitalizations, longer treatment duration, and reduced risks of institutionalization, depression, and anxiety. HaH patients were older, with reduced daily living activities, yet care costs were on average USD 5,054 lower than inpatient care. In Switzerland, the mean hospital stay in 2019 was 8 days (acute somatic: 5.2; psychiatry: 33.5). Study Hypotheses HaH can be delivered at equal or lower cost than regular hospitalization. HaH care is safe, with few complications, and yields high patient satisfaction. Study Objective To demonstrate that hospital-equivalent home treatment of acutely ill patients is effective, appropriate, cost-efficient (according to Swiss WZW criteria), safe, and associated with high satisfaction and low complication rates compared with inpatient care. Endpoints Primary: Costs - HaH vs. inpatient care at Hirslanden Clinic, using REKOLE® cost accounting. Secondary: Mortality, therapy type, monitoring, diagnostics, rehospitalization, complications, satisfaction, patient-reported outcomes, length of stay, referrals to nursing homes, follow-up after discharge, ED visits, rehabilitation referrals, and home care type.

Evaluation of the Effectiveness of Virtual Reality Headsets With Hypnotic Scenarios for Hygiene Care in Patients With Alzheimer's Disease or Related Disorders With Behavioral Disturbances

A device combining a virtual reality (VR) headset with hypnotic scenarios may represent an effective tool to reduce anxiety and opposition during hygiene care in patients with neurocognitive disorders presenting with behavioral and psychological symptoms. The primary objective of this project is to assess the feasibility and effectiveness of VR headsets with hypnotic scenarios compared with standard care in patients with ADRD presenting behavioral disturbances during hygiene care.

Pharmacogenomics-Supported Psychotropic Prescribing Trial

Investigate the feasibility and utility of implementing pharmacogenetic testing for adults (aged 18 and older) seeking care for mental illness in Manitoba.

Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults

The aim of this clinical trial is to evaluate the effectiveness and user satisfaction of remote fine-tuning of hearing aids compared to traditional face-to-face adjustments. The main questions aims to answer: \- Are hearing aid outcomes (self-reported and objective) similar when using remote fine-tuning compared to face-to-face adjustments? Researchers will compare remote fine-tuning (using a smartphone app) to traditional face-to-face fine-tuning sessions in a clinical setting. Participants will: * Be randomized to either the remote fine-tuning group (intervention group) or the face-to-face adjustment group (control group). * Attend five scheduled consultations over a 3-month period, including baseline measurements, hearing aid fittings, and follow-up visits. Participants in the remote fine-tuning group will: \- Set up and use a hearing aid manufacturer's smartphone app to complete fine-tuning sessions from home. Participants in the face-to-face group will: \- Visit the clinic for in-person fine-tuning appointments. Data will be collected through questionnaires (e.g., SSQ-12, IOI-HA, and COSI) and objective measures such as the Speech Intelligibility Index (SII) and speech comprehension in noise (DS-FF). Additional qualitative data will be gathered from interviews with participants in the remote fine-tuning group.

Cultural Adaptation of a Web-Based App (myPlan Thailand) to Empower and Support Friends and Family of Intimate Partner Violence Survivors

This research will support and empower friends/family (F/F) of intimate partner violence (IPV) survivors in Thailand, where IPV is critical and common, and survivors first and foremost seek help for abuse from their F/F. myPlan app (www.myPlanapp.org) is a free mobile evidence-based intervention app to prevent IPV. The app was first developed in the United States (US) and has been disseminated to high-income countries (e.g., New Zealand, Canada, Australia) and lowincome (Kenya). One new hope for improving survivors' psychological and well-being is adapting and introducing the myPlan app for the concerned friends/family who support survivors in Thailand. Therefore, the propose of this longitudinal research study, Cultural Adaptation of a Web-Based App (myPlan Thailand) to Empower and Support Friends/Family of Intimate Partner Violence Survivors in Thailand, will have two consecutive phases with three aims: 1) To tailor the myPlan app content for concerned F/F members of Thai IPV survivors, 2) To integrate the adapted myPlan app content for concerned F/F members of Thai IPV survivors, 3) To test the feasibility and acceptability of the adapted myPlan app with concerned F/F members of Thai IPV survivors. Phase 1 (Year 1-2) will achieve aim 1-2 to tailor the myPlan app with Thai survivors and friends/family. The investigators will review current content and conduct in-depth interviews with survivors and concerned F/F members on social norms associated with IPV, informal support systems and the role/responsibility in helping survivors, safety strategies used by concerned F/F members and negative consequences for both survivor and F/F member providing support. Moreover, in phase 1, the adapted content will be pilot tested with concerned F/F members of survivors by using cognitive techniques and theater-testing methodology. Phase 2 (Year 3-4) will achieve aim 3 to test the feasibility and acceptability of the adapted myPlan app with F/F. The investigators will conduct a two-group RCT design with concerned F/F member randomized to receive a) the myPlan app for F/F member, or b) standard usual-care safety planning information. Primary outcomes for F/F members include change in knowledge and attitudes towards IPV and F/F empowerment to plan and take safety support survivor. Secondary outcomes will examine change in F/F' distress, frustration and consequences for supporting the survivor. This phase will also collect feasibility and acceptability data to informed a planned R01 submission in Year 3 of the study. The K43 application outlines a four-year plan to support a candidate who is a nursing instructor with 15 years of work in diverse projects, settings, and disciplines; which positions her for a successful career as an independent researcher in research field of intimate partner violence. The career development plan provides a sequence of carefully selected training and mentoring experiences, including coursework to increase research capacity, leadership skills, mentored research leading to a R01 proposal, peer reviewed publications, and professional networking, that will catapult this research to the next level of research achievement. The team will be a collaboration between the Boromarajonani College of Nursing Khon Kaen (BCNKK), Khon Kaen One Stop Crisis Center (OSCC), Johns Hopkins University (JHU), Notre Dame of Maryland University (NDM), and Auckland University of Technology (AUT), New Zealand.

Educational Intervention and Adherence

quasi-experimental, parallel study, with the objective of evaluating the effectiveness of an educational nursing intervention supported by ICTs, for the improvement of therapeutic adherence in people undergoing hemodialysis treatment in a renal unit in Barranquilla (Colombia)

Lenvatinib for Advanced Bone and Soft Tissue Sarcoma

A total of 60 patients with metastatic/surgically unresectable bone and soft tissue sarcomas who had previously received multi-target TKI therapy and failed were enrolled to evaluate the efficacy and safety.