Clinical Research Directory

Extending the Reach of Evidence-based Practices to Support Student's Attention and Behavior Through Technology

The purpose of this study is to integrate digital health (dHealth) technology into the Collaborative Life Skills Program (CLS), an established, school-based behavioral intervention for students with ADHD, to make the program accessible to schools that serve students from low-socioeconomic (SES) backgrounds. Existing evidence-based interventions for students with ADHD are often inaccessible in schools with limited resources to support implementation. By adapting CLS to include a dHealth tool-CLS-D-investigators aim to improve the feasibility of intervention implementation in schools with limited resources and mitigate disparities in access to evidence-based interventions among students with ADHD who are from low-SES backgrounds.

Disrupted Connections: The Impact of Acute Stress on Memory Integration

The goal of this study is to better understand how stress impacts people's ability to learn across their experiences and link new information to what they already know. The investigators will compare performance on a memory task between stressed and non-stressed participants. This memory task requires people to integrate knowledge across learning experiences (think: having to "connect the dots", draw inferences, and generalize your knowledge to new situations and scenarios). Cortisol, the brain's primary stress hormone, will be measured at multiple points throughout the study to measure stress levels. The investigators hypothesize that: 1. Stress will disrupt performance on the memory task by interfering with memory processes that enable linking of related memories. 2. Higher cortisol levels, which reflect a greater stress response, will relate to greater deficits in memory performance across participants. This research has broad implications for understanding how stress impacts the ability to learn and retain new information, particularly in high-stress environments like schools and workplaces. Additionally, this work may provide insights into the cognitive difficulties experienced by individuals with psychiatric disorders, where stress can worsen memory and learning challenges.

Using Ecological Momentary Data to Inform a Web Intervention for Romantic Partners Concerned About Their Loved Ones' Drinking

Aim 1. Couples (N=50 dyads) with a Concerned Partner (CP) and a Drinking Partner (DP) will independently complete baseline and follow-up surveys and a 21-day EMA with three daily reports on their communication and DP's drinking. Aim 2. Iteratively develop a four-session web based intervention and evaluate the WBI's feasibility and acceptability with 15 CPs. Aim 3. Perform a pilot randomized controlled trial (RCT) comparing WBI to psychoeducation control in 110 couples.

Exercise and Protein Efficiency in T2D

In this randomized controlled trial, 30 older adults (aged\> 65 years; 15 with T2D, 15 controls) will participate in a 12-week progressive exercise training program. They will undergo pre- and post-testing that includes body composition measures; oral glucose tolerance testing; cardiovascular fitness and muscle performance testing; dietary protein efficiency assessed using the indicator amino acid oxidation (IAAO) method; and a gut microbiota trial. The dietary protein efficiency trial will include repeated ingestion of crystallized amino acids (drink) containing stable isotopes, urine samples, and breath samples. The gut microbiome trial will consist of a single ingestion of a Mediterranean-based modeled meal enriched with 13C-phenylalanine (in the drink) and repeated blood draws. Participants will also be asked to give a fecal sample after the gut microbiome trial.

Foot Strengthening to Improve Balance and Gait in Older Adults

The goal of this clinical trial is to learn whether different foot-strengthening strategies can improve foot strength, balance, walking ability, and fall-related outcomes in middle-aged and older adults (ages 45-85 years). The main questions it aims to answer are: * Does foot strength change from baseline after an 8-week foot-strengthening intervention? * Do balance, gait, and physical function improve following different foot-strengthening approaches? Researchers will compare minimalist footwear use, a foot exercise program, a foot-strengthening device (ToePro), and no intervention to see if these interventions lead to greater improvements in foot strength, balance, gait, and fall-related outcomes than no intervention. Participants will: * Complete baseline and post-intervention laboratory testing of foot strength, balance, physical function, and walking gait * Perform foot strengthening exercises or wear minimalist footwear (if applicable) five days/week for eight weeks * Complete daily logs to record intervention compliance

Hip Abduction and Adduction During Neurodynamic Stretching

Neurodynamic mobilization techniques are widely applied in rehabilitation and physiotherapy to enhance the mobility and function of peripheral nerves. Two main approaches are distinguished : Nerve tensioning and nerve flossing. They both involve proximal and distal joint movements to induce greater neural sliding while avoiding excessive tensile stress. However, contradictory findings following neurodynamic stretching highlighted the current lack of consensus regarding the position that should be used. Moreover, neurodynamic techniques are of interest for patients, it appeared it could also be applied in healthy individuals and more particularly in athletes. Accordingly, the primary objective of the present study was to determine the immediate effect of two hip positions (adduction vs. abduction) during neurodynamic flossing techniques on the sciatic nerve and hamstring tissues using the shear wave elastography (SWE, a form of ultrasonography).

Vision and Proprioception Evaluation With Robotics After Stroke

Stroke is highly prevalent in Canada and can lead to profound upper limb impairments in motor and sensory function, as well and vision. Clinical assessments for these functions often lack sensitivity making detecting impairments and tracking their recovery after stroke difficult. It is known that sensory function and vision interact to inform motor behaviours, yet how each of these modalities might contribute to motor impairments and subsequent recovery after stroke is undetermined. Using robotics to assess neurologic function after a stroke can be very beneficial, as they can measure on the scale of millimetres and milliseconds which can more easily detect subtle deficits in a persons function. Compared to current clinical tools, robotics offer greater objectivity and reliability, as they do not rely on the examiners clinical experience and/or impression. The use of robotics not only offers a more precise measurement, but robotics assessments can be completed in a relatively short amount of time, in comparison to some of the current clinical assessment tools, which can take along time to complete. In addition to robotics, collecting neuroimaging (MRI/CT) will allow us to relate our robotic and eye-tracking measures to neuroanatomical information about the person's stroke. With this data, we will assess how the brain changes post-stroke in relation to the recovery of motor, sensory and visual functions. This research will: 1) examine the relationship between visual and proprioceptive impairment on motor and eye movement behaviour over time after stroke, and 2) identify neuroanatomical correlates of visual, proprioceptive and sensory integrative dysfunction that impact motor recovery after stroke and examine the ability of regional damage and network disruption to predict recovery. Objectives: 1. Determine the impact of visual field loss and visual neglect in stroke survivors with impaired movement over the first 6 months post-stroke. 2. Identify the impact of Proprioceptive Impairment and Sensory Integration Impairment on recovery post-stroke using robotics and eye tracking. 3. Understand the impact of damage to neuroanatomic structures involved in vision, proprioception and sensory integration on motor recovery using MRI after stroke. The VIPERS study is recruiting both stroke and control participants. Stroke participants are recruited within the first 28 days post-stroke and are assessed longitudinally across the first 6-months post-stroke (four study timepoints). Control participants just complete a single session.

Inducing Self-Dehumanization to Examine Oxytocin and Suicide Risk

The goal of this experiment is to further determine if self-dehumanization is a novel risk factor for suicide. This study will induce self-dehumanization using a novel experimental self-dehumanized future condition (i.e., a futuristic paradigm that likens the individual to a machine) and compare this group to a control group to analyze the pathway between higher perceptions of self-dehumanization, suicidal ideation, and changes in oxytocin concentrations. It is hypothesized that participants randomly assigned to the self-dehumanized mechanistic future condition will exhibit temporary increases in suicidal ideation (which will be thoroughly assessed, intervened upon following the induction) and decreases in oxytocin concentrations as compared to the control condition, which will not display significant changes. Further, we will explore if the magnitude of the oxytocin response will partially mediate the change in suicidal ideation.

Determining Paediatric Usual Values for Hormones Dosages by LC-MS/MS

Liquid chromatography coupled with mass spectrometry (LC-MS/MS) is now the method of choice for steroid hormone analysis, as it enables analyses to be carried out on small-volume samples on a wider range of hormones, with improved specificity compared with immunoassays. Hormone assays currently face a twofold problem: on the one hand, immunoassays are highly dependent on the synthesis of antibody kits manufactured by companies with immunotechnology expertise; on the other hand, these immunoassays may require the use of radioactive products for quantification, generating considerable risks for both staff and environment. There are international recommendations from expert societies (World Anti-Doping Agency, Endocrine society) to develop new, more reliable assay methods, such as LC-MS/MS, and to phase out immuno- and radioassay techniques. However, changing measurement methods requires the development of reference values to maintain and optimize the management of patients. The aim of this project is therefore to establish usual values in a paediatric population, through collaboration between the clinical departments of the APHP and the METOMICS laboratory, which has mastered the technology.

Adapting An Evidence-Based Intervention To Improve HIV Testing And PrEP Uptake In Vietnam

Young men who have sex with men are experiencing an ongoing HIV epidemic in Vietnam, with an HIV prevalence of 12%. However, HIV testing and pre-exposure prophylaxis (PrEP) use among young men who have sex with men remain low. To improve HIV testing and PrEP use, mobile health (mHealth) interventions hold great promise to reach young men who have sex with men in low- and middle-income countries. HealthMindr, an evidence-based mHealth intervention developed in the United States for men who have sex with men, is an ideal option for adaptation for young men who have sex with men in Vietnam. The specific aims are to (1) Adapt the HealthMindr app to improve HIV testing and PrEP uptake among young men who have sex with men in Vietnam; (2) Examine acceptability, feasibility and preliminary effectiveness of the adapted app among young men who have sex with men in Vietnam and (3) Explore barriers and facilitators of implementing the adapted app among young men who have sex with men in Vietnam. In Aim 1, theater testing will be conducted through focus group discussions with young men who have sex with men and key other stakeholders, including health officials, clinic staff and community-based organizations. Theater testing data will be used to refine the app for beta testing. During beta testing, a small group of young men who have sex with men will use the app for 30 days, then complete an online survey and an exit interview to rate the app's usability, provide their perspectives of the app and report any other areas for improvement. App analytics will also be collected to understand whether and how the app is used. In Aim 2, the adapted app with be tested among young men who have sex with men through a randomized controlled design. Young men who have sex with men will be randomized into the intervention or control arm (1:1 ratio). The intervention arm will have full access to the app for 3 months, while the control group will receive standard-of-care HIV services. Key app features include HIV test planning, risk and PrEP eligibility assessment, ordering of free condoms and HIV test kits, information about PrEP, and PrEP provider and HIV testing locations. HIV testing and PrEP use will be assessed at baseline and 3 months and compared between groups. A mixed methods approach will be used to evaluate app acceptability and feasibility. Quantitative data on acceptability and feasibility will be collected through the 3-month online survey, while qualitative data will be collected through in-depth interviews with a subset of young men who have sex with men in the intervention arm and other key stakeholders. In Aim 3, through the same qualitative study as Aim 2, factors that influence the implementation of the app will be explored. Determinants from seven domains will be identified: condition, technology, value proposition, adopter system, health organization, wider system and embedding/adaption over time. Only when mHealth interventions are both effective and adopted can they maximize their potential to reduce HIV incidence among target populations. This proposal will generate data for designing a full-scale hybrid type 1 effectiveness-implementation trial to test the adapted app and identify implementation strategies to address the barriers of app implementation in low and middle-income countries.

Copper to Zinc Ratio in End Stage Renal Disease Patients Outcome

The goal of this observational clinical trial is to Study the impact of copper to zinc ratio on the outcome of ESRD patients

Effectiveness of AI Chatbots in Improving Students' General Wellbeing

The goal of this randomised controlled trial is to evaluate the effectiveness of an AI mental health chatbot in promoting emotional wellbeing and perceived empathy among university students in Singapore with mild or subclinical symptoms of anxiety and depression. The main questions it aims to answer are: Can the chatbot provide emotional validation and be perceived as empathic? Does the chatbot reduce symptoms of anxiety and depression and improve wellbeing more than an inactive control condition? Researchers will compare students who engage in four sessions with the chatbot to students who complete four neutral writing tasks to assess differences in emotional wellbeing, empathy, and resilience. Participants will: Complete baseline wellbeing assessments Be randomised to: Four 20-minute chatbot sessions providing personalised support using cognitive-behavioural and compassion-focused techniques (intervention group), or Four 20-minute neutral writing sessions unrelated to mental health (control group) Complete post-session and follow-up wellbeing questionnaires All sessions are conducted virtually over Zoom. Participants are full-time students at the National University of Singapore, aged 21 and above. The study aims to inform future development of AI tools for emotional support in non-clinical settings.

Reducing Disparities in Access to Evidence-Based Services for Attention Deficit Hyperactivity Disorder (ADHD) Through Technology

This project aims to develop an adaptation of the Collaborative Life Skills Program (CLS) that will be supported by mHealth technology. CLS is an evidence-based intervention for 2nd-5th grade children with ADHD that is delivered in schools through coordinated efforts among school mental health providers, teachers, and parents. School mental health providers are trained to coordinate evidence-based teacher- (i.e., Daily Behavioral Report Card) and parent-mediated (i.e., Behavioral Parent Training) behavioral interventions, and lead child social and organizational skills training groups. The adapted intervention, which integrates mHealth technology (CLS-M), will improve the usability, feasibility, and acceptability of CLS in schools with limited resources serving children from low-socioeconomic status (SES) and ethnic/racial minority (ERM) backgrounds, reducing disparities in access to evidence-based ADHD interventions in these populations. Barriers to service use in schools where low-SES and ERM families are most likely to receive services include logistical constraints (e.g., time, transportation, childcare, work schedules), perceptual barriers (e.g., cultural mistrust, stigma, perceived efficacy), and insufficient resources (e.g., staff, time, consultation support). Building on prior research, the investigators will develop and test a fully functional web-based mHealth application to support CLS-M that includes an integrated user portal for school mental health providers, teachers, and parents. The application will also include separate interfaces that support key features to facilitate each person's role in CLS implementation at school or at home, such as access to shared information about child assessments, goals, and automatically generated graphs of child Daily Behavioral Report Card performance. Messaging features will facilitate communication among school mental health providers, parents, and teachers, and calendar features that integrate with third- party calendar applications (e.g., Google Calendar) will facilitate scheduling, meeting tracking, and sharing links to third-party videoconferencing applications (e.g., Zoom). Based on stakeholder feedback from school administrators, school mental health providers, teachers, and parents, the investigators will work with mobile application developers to design a fully functional web-based mHealth application prototype to support the CLS-M protocol. the investigators will then test and refine the prototype through a series of individual usability tests and an open feasibility trial. the investigators will also collect formative data from stakeholders in rural schools in Imperial County to inform future research on adapting CLS-M for low-SES and ERM families served in this setting. Finally, the investigators will conduct a Hybrid Type I cluster randomized trial in 24 schools in a large urban school district, to evaluate whether CLS-M results in acceptable implementation outcomes and improved child outcomes in comparison to usual school services. The specific aims are to 1) Develop CLS-M and test its usability, feasibility, and acceptability among key stakeholders; 2) Collect formative data to inform future CLS-M adaptations for families living in rural settings; and 3) Evaluate CLS-M implementation and impact on child outcomes relative to typical school services.

Effect of Exercise and Heat Stress on Acute Cardiometabolic Adaptations in Healthy Young Adults

Life in space is completely void of physical and environmental stress. It is well known that living things need regular physical stress (e.g. exercise) to remain strong, functional and healthy. More and more research is showing that regular environmental stress, for example heat and hypoxia, can further improve physical health. Astronauts aboard the international space station (ISS) exercise for 1-2 hours every day to avoid physical deconditioning that would otherwise cause them to age rapidly in space. Although physical exercise is very effective in remedying this deconditioning, today's astronauts still have physiological changes that indicate accelerated aging. This is a cause for concern given NASA's priority to travel to mars within the next decade; a mission that will require at least double the duration in space for our astronauts. The investigators think that the complete absence of environmental stress, i.e., heat, may be contributing to the accelerated aging that occurs during spaceflight. Our study will assess the health effects of adding heat stress to exercise that could be performed in space by astronauts. The goal is to inform best practice for astronauts to avoid physical deconditioning during long-duration spaceflight. This information will also be relevant to life on earth as spaceflight is a model of inactivity here on earth. Therefore, the potential benefits of adding heat stress will likely translate to life in space and on earth.

Integrated Phenotyping of the Gut-plAtelet-Liver AXIS in the Progression of Chronic Liver Disease (iGAL-AXIS)

Objective of the study Our working hypothesis is that platelets activated by gut-derived metabolites dock in the liver of NAFLD patients and amplify the inflammatory state by releasing pro-inflammatory cytokines/chemokines, which in turn recruit and activate leukocytes in the liver sinusoids. Combined stimuli from leukocytes and platelets would then lead to metabolic reprogramming of hepatocytes, progression to NASH and eventually cirrhosis. To test this hypothesis, the investigators propose 2 objectives. Primary objective: To identify platelet features that correlate with liver disease progression. Secondary objective: To study the mechanistic relationship between gut dysbiosis, metabolome composition, inflammation, and platelet activation in chronic liver disease.