Clinical Research Directory

Future School of Comprehensive Well-Being

Good physical, mental and social health, particularly in childhood and early adolescence, are powerful predictors of positive life trajectories. Contrary to this, problems in these domains expose individuals to negative developmental trajectories. Schools are ideal settings to address these issues due to their incisiveness and long-term impact. However, school-based well-being interventions are not designed to be ingrained in basic pedagogical processes of school, this is, learning, teaching and studying. In this study the effects of a school-based pedagogically ingrained comprehensive well-being trial will be studied, involving curriculum embedded socio-pedagogical activities, designed to cultivate simultaneously learning and their mental, social and physical well-being. In the Future School of Comprehensive Well-Being (SchoolWell) Comprehensive wellbeing pedagogy intervention for primary and lower secondary school students: rationale and study protocol for the SchoolWell cluster randomized controlled trial -study the investigators use a cluster randomized hybrid type 1 effectiveness-implementation design. SchoolWell involves 10 Finnish speaking Teacher Training Schools including both primary and secondary schools. Randomization occurs at the school level. The intervention is a multicomponent implementation strategy that has been co-designed by SchoolWell research team and case schools' teachers. All 5th and 8th graders (aged 11-12 years and 14-15 years), from the control and intervention schools are eligible for the study. Total of 1440 students (560 5th and 880 8th graders) will be recruited for the study (n=717 students from intervention schools and n=723 students from control schools). Data is collected from Grade 5 and 8 students representing schools randomized to experimental (n=5) and control condition (n=5). The control group in Year 1 remains on the waitlist until the start of Year 2, when the second cohort of the experiment (low support condition) for these schools begins. The purpose of the low support condition is to examine whether intervention effects can be achieved with less support than in the high support condition, where researchers are more actively involved. Schools allocated to the intervention group deliver weekly SchoolWell activities over the full school year as part of the regular curriculum. The activities include socio-pedagogical activities, these are modes of teaching, learning and studying, promoting student mental, social and physical well-being as well as learning aligned with regular curriculum goals. Intervention schools have access to six implementation support strategies in addition to the training received as usual delivery to build knowledge and skills. Implementation and effectiveness outcomes are assessed using weekly online surveys, interviews at baseline T0 (8/2024), T1 (11/2024), T2 (4/2025) and at 19-month follow-up (T3; 4/2026) and four dialogues with teachers. Semi-structured interviews with teachers and support staff will be used to examine which implementation strategies worked for whom and under what conditions. The primary outcome is study engagement. Secondary outcomes include measures on learning, mental, social and physical well-being. Economic and process evaluations will also be conducted to determine cost-effectiveness, program acceptability, implementation, adaptability, and sustainability in schools. SchoolWell draws on the Consolidated Standards of Reporting Trials (CONSORT) and the Standards for Reporting Implementation Studies (StaRI) in evaluating the SchoolWell intervention. Also, the Consolidated Framework for Implementation Research (CFIR) is used to guide support strategies. The CFIR provides constructs that have been associated with effective implementation (intervention, outer settings, inner settings, individuals, implementation process). Subsequently, the Proctor's framework is followed to evaluate the implementation process. The framework stands for acceptability (treatment is agreeable or satisfactory), adoption (intention to employ an innovation or evidence-based practice), appropriateness (fit of the innovation to address a particular issue or problem), cost (cost impact of an implementation effort), feasibility (extent to which a new treatment can be successfully carried out in given setting), fidelity (extent how intervention is delivered as intended), penetration (number of providers who deliver treatment), and sustainability (extent to which a newly implemented treatment is maintained). Hypotheses are: H1. SchoolWell 1 intervention will have a positive effect on student-level outcomes (8- and 19-month post-tests). H2. The multidisciplinary intervention enhances both learning and mental, physical, and social well-being.

Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents

Generation Victoria (GenV) is a longitudinal, population-based study of Victorian children and their parents that will bring together data on a wide range of conditions ,exposures and outcomes. GenV blends study-collected, study-enhanced and linked data. It will be multi-purpose, supporting observational, interventional, health services and policy research within the same cohort. It is designed to address physical, mental and social issues experienced during childhood, as well as the antecedents of a wide range of diseases of ageing. It seeks to generate translatable evidence (prediction, prevention, treatments, services) to improve future wellbeing and reduce the future disease burden of children and adults. The GenV Cohort 2020s is open to all children born over a two-year period, and their parents, residing in the state of Victoria Australia. The GenV Cohort 2020s is preceded by an Advance Cohort of children born between 5 Dec 2020 and 3 October 2021, and their parents. This comprises all families recruited at GenV's Vanguard hospital (Joan Kirner Women's and Children's) and at birthing hospitals throughout Victoria as GenV scaled up to commence recruiting for the GenV Cohort 2020s. The Advance Cohort have ongoing and full participation in GenV for their lifetime unless they withdraw but may have less complete data and biosamples.

Human Learning of New Structured Information Across Time and Sleep

Acting adaptively requires quickly picking up on structure in the environment and storing the acquired knowledge for effective future use. Dominant theories of the hippocampus have focused on its ability to encode individual snapshots of experience, but the investigators and others have found evidence that it is also crucial for finding structure across experiences. The mechanisms of this essential form of learning have not been established. The investigators have developed a neural network model of the hippocampus instantiating the theory that one of its subfields can quickly encode structure using distributed representations, a powerful form of representation in which populations of neurons become responsive to multiple related features of the environment. The first aim of this project is to test predictions of this model using high resolution functional magnetic resonance imaging (fMRI) in paradigms requiring integration of information across experiences. The results will clarify fundamental mechanisms of how humans learn novel structure, adjudicating between existing models of this process, and informing further model development. There are also competing theories as to the eventual fate of new hippocampal representations. One view posits that during sleep, the hippocampus replays recent information to build longer-term distributed representations in neocortex. Another view claims that memories are directly and independently formed and consolidated within the hippocampus and neocortex. The second aim of this project is to test between these theories. The investigators will assess changes in hippocampal and cortical representations over time by re-scanning participants and tracking changes in memory at a one-week delay. Any observed changes in the brain and behavior across time, however, may be due to generic effects of time or to active processing during sleep. The third aim is thus to assess the specific causal contributions of sleep to the consolidation of structured information. The investigators will use real-time sleep electroencephalography to play sound cues to bias memory reactivation. The investigators expect that this work will clarify the anatomical substrates and, critically, the nature of the representations that support encoding and consolidation of novel structure in the environment.

Brain Stimulation Paired With Structured Language Learning in Adults

This study investigates whether transcranial electrical stimulation (tES) delivered during structured language-learning sessions affects the rate and quality of second-language acquisition in adults. Adults who are learning or planning to learn a new language are randomly assigned in equal numbers to receive either active stimulation or sham (placebo) stimulation while completing structured language-learning content. Participants wear a non-invasive transcranial electrical stimulation headset that delivers a low-level electrical current through electrodes resting on the scalp, targeting cortical regions associated with language. Sessions typically last 20 to 30 minutes and may be completed at home or in person at a participating language program. Language proficiency is measured with a standardized assessment before and after the intervention period, with additional app-derived performance metrics and participant-reported measures collected throughout. A follow-up assessment may be conducted up to 12 months after the intervention ends to evaluate whether any observed effects persist. In this study the device is applied as a learning aid in healthy adults. It is not used to diagnose, treat, cure, or prevent any disease.

Effects of a Familiarization Protocol on Time to Exhaustion Performance

Familiarization is widely recommended before exercise performance testing to improve measurement consistency and reduce learning effects. However, practical constraints often limit researchers to a single-or no-familiarization session, raising the possibility that improvements observed following an intervention may partially reflect increased familiarity with the testing procedure rather than genuine physiological adaptations. This issue may be particularly relevant for time-to-exhaustion (TTE) protocols, which have been reported to exhibit greater between-session variability than self-paced endurance tests. This exploratory analysis examined the magnitude of the familiarization effect during treadmill TTE testing by comparing a familiarization trial with a subsequent experimental trial. Linear mixed-effects models will be used to evaluate changes in TTE performance while accounting for pre-exercise fatigue and recovery, and between-session agreement was assessed using intraclass correlation coefficients and Bland-Altman analysis.

Application of the AI Platform iLN Based on DeepSeek in the Teaching of Lupus Nephritis

Aim: To evaluate the application effect of the teaching platform iLN in the teaching of lupus nephritis, aiming to provide practical experience and evidence-based support for the implementation of generative AI technology in professional medical education. Method: Based on the DeepSeek large language model, the investigators developed "iLN" - an interactive teaching platform for lupus nephritis. This platform integrates the latest authoritative textbooks, clinical guidelines, pathological atlases, and real clinical cases, and includes seven core modules, such as "case interaction", "knowledge teaching", and "AI question answering". The investigators conducted a randomized controlled trial (RCT) on 50 fourth-year undergraduate students from Nanjing University School of Medicine to evaluate the effectiveness of the iLN platform compared to traditional teaching methods. The teaching effect was evaluated through objective test scores and questionnaires about student satisfaction and platform usability.

Enhancing Letter-Speech Sound Learning and Reading Network Activation With Transcranial Electrical Stimulation

This study investigates the effects of transcranial electrical stimulation (tES) on the brain and its potential to enhance reading-related learning. Adult participants with a range of reading abilities will receive transcranial random noise stimulation (tRNS) while they perform an artificial orthography learning task. This task simulates letter-speech sound learning, an important first step during reading acquisition known to be impaired in individuals with developmental dyslexia. The effects of the intervention will be assessed using both behavioral measures and functional magnetic resonance imaging (fMRI).

Enhancing Mass Casualty Triage Through Virtual Reality Simulation

This interventional study aims to investigate whether Virtual Reality (VR) compared to traditional education and training, can enhance the correct triage abilities of nursing students in simulated mass casualty incidents (MCI). The primary research question seeks to answer if VR compared to Standard education supports students' ability to triage correctly in a simulated MCI situation. Additionally, this study aims to address the following secondary questions: Does VR compared to standard education have an effect on the time to triage in a simulated MCI situation? And, does VR compared to Standard education have an effect on theoretical knowledge retention concerning triage in MCI situations? In the interventional group, participants will utilize VR for MCI training and learning, while the control group will undergo standard education, including lectures and paper exercises. The researchers will compare the two groups of nursing students to assess whether VR yields better outcomes in MCI triage education.

Dual Orexin Antagonism and Emotion and Affective Processing Study

In this study, the investigators will examine the effects of blocking the orexin system on human behaviour and brain function using daridorexant, a medication that inhibits orexin activity. Orexin is a brain chemical involved in regulating sleep, emotion, motivation, and stress responses, which are often disrupted in mental health disorders. Healthy volunteers will be randomly assigned to receive a single dose of daridorexant or placebo in a double-blind design. Participants will then complete behavioural and cognitive tasks assessing emotional processing, aversive learning, and executive function. The study aims to clarify the role of orexin in emotional and cognitive processes relevant to conditions such as depression and anxiety.

Remediation Program Via a "Serious Game" for the Cognitive Functions of Multiple Sclerosis Patients

The main goal of this study is to assess the effectiveness of a cognitive remediation program based on a "serious game" on the information processing speed evolution and the process of learning via episodic memory in multiple sclerosis patients.

Interactive Virtual Occupational Safety Training Designed for Home Healthcare Workers

Overview. The investigators will collect preliminary data on the extent to which the knowledge gained from the enhanced HH-VSTS transfers to a real-world environment. Following abbreviated use of the enhanced HH-VSTS, participants will perform a walk-through of a realistic environment to assess their learning.

Integrated Learning Support System Based on Immersive Simulated Training for Nursing Students

This study aims to evaluate the effectiveness of an Integrated Learning Support System (ILSS) in preparing undergraduate nursing students for immersive simulated training in managing drug-induced nephrotoxicity. The study hypothesizes that the ILSS, which accommodates different learning styles, will be more effective in reducing stress and anxiety compared to the standard learning model (SLM). The research will involve a parallel randomized controlled trial with 96 students from two Brazilian institutions. The students will be divided into control and experimental groups, with the latter using the ILSS in addition to SLM during preparation. The study will assess outcomes such as knowledge acquisition, skill development, and stress reduction using various instruments, including the Lasater Clinical Judgment Rubric and DASS-21. The study's findings aim to validate the ILSS as a tool to enhance learning outcomes and reduce stress and anxiety, thereby promoting better professional development and patient safety in nursing practice.

Work Package 3 Education for ICU Clinicians in Basic Palliative Care

The EPIC project aims at sustainably improving palliative care for seriously ill patients and their families in ICUs. To this aim, an interdisciplinary consortium is working together to provide a new practical palliative care model using telemedicine. The project is the first European intervention study on palliative care in the ICU using a systems- based approach with proactive patient identification, checklist and blended learning designed to meet the specific needs of ICU staff. EPIC's vision is to contribute to a change in awareness from a narrow focus on prolonging life to a more holistic approach to care. The development of blended learning for intensive care staff is the task of Work Package (WP) 3. The aim is to improve the attitude, understanding and self-confidence of ICU staff. Blended learning is to be developed and implemented for this purpose. The aim is to teach the basics of palliative care on a cognitive, affective and psychomotor level. Due to the international character of the project, it is to be developed in English with subtitles in the local languages. In addition a workshop with patient and family advisors will be conducted.