Clinical Research Directory

Feasibility of the Reality PAWS Program for Children in Isolation

The goal of this clinical trial is to learn if a mixed reality program, Reality PAWS, delivered on a Meta Quest 3 VR headset, is a feasible intervention for pediatric patients in isolation. It will also evaluate the safety of the program and its effect on pain, anxiety, and loneliness. The main questions the study aims to answer are: What is the feasibility of utilizing Reality PAWS MR as a substitute for in-person dog therapy for children under isolation precautions? Are patients compliant with using Reality PAWS MR? What are the interventional outcomes of Reality PAWS MR? Participants will: Wear a Meta Quest 3 VR headset with the Reality PAWS program. Interact with the program. Answer surveys regarding demographics, anxiety, pain, loneliness, sickness, perceived exertion, and immersion in the program.

HELP Study - Towards High Throughput and Efficient Long-axial PET With Oral [18F]FDG

Typically, PET scans involve an IV injection of 18F-FDG that helps identify cancer. Patients are scanned 60 minutes after injecting 18F-FDG. This study aims to assess the feasibility of a different method of administration - oral ingestion (rather than IV) of 18F-FDG through delayed imaging to identify the optimal time for scanning after consuming the drug. The study will aim to recruit 15-24 individuals who will receive two PET scans - one using delayed oral 18F-FDG imaging and a second regular 18F-FDG. The analysis will focus on establishing a suitable protocol for this administration route while considering patient preference and image quality.

Music Therapy in Newly Diagnosed Glioblastoma After Chemoradiation Therapy (MELODY-GBM)

The Brain Cancer Program, in partnership with the Center for Music and Medicine at Johns Hopkins, will study whether music therapy is feasible in newly diagnosed GBM patients undergoing standard care.

Healthy Ageing: a Feasibility Study to Evaluate Digitally-enabled Ways to Support Healthy Ageing

The goal of this clinical trial is to learn if it is feasibility to conduct a trial of two digitally-enabled interventions that support older adults to adopt healthy behaviours. It will also learn about the safety of this digital intervention. The main questions it aims to answer are * How acceptable and feasible are the trial, intervention and control groups in assessing outcomes * What is the estimated effect of the interventions? Researchers will compare Smart devices with a bespoke 'Healthy Habits' application and three healthy habit coaching and data feedback modules, to a group with smart devices and standard off-the-shelf feedback application, to a control group that will receive an education leaflet to adopt healthy behaviours. Participants will: * Use sensors and the 'Healthy Habits' application for 3 months followed by standard application for 3 months, or sensors and standard application for 6 months, or control * Either home visit or in-centre visit once every 3 months for assessments and online health questionnaires * Complete daily diary of any healthcare use

Virtual Ward for Early Discharge in Patients Receiving Inpatient Care

This study evaluates the feasibility of providing hospital-level care at home for eligible patients through a Virtual Ward. Patients are discharged early from the hospital and monitored remotely using digital vital sign monitoring and anamnesis questionnaires. The primary aim is to determine if at least 30% of eligible patients can be safely and successfully transferred to the Virtual Ward under current Dutch healthcare conditions.

Evaluation of a Multi-Component Intervention to Support HIV Testing and Linkage to Services Among MSM in Peru

This study is testing a new program designed to improve access to HIV testing and help connect people with available treatment or prevention services, based on their test result. The version of the program being tested in this study was designed for men who have sex with men (MSM) in Lima, Peru. The program has two main parts: 1) offering HIV testing at venues where people go for sex (called "sex-on-premises venues" or SOPVs), and 2) a text messaging app that shares useful information about HIV treatment/prevention; users can also message back to get support from a healthcare worker. Before doing this study, the researchers worked with community members and healthcare providers in the area to make sure that the HIV testing approach and mobile app were designed in a way that would be engaging and meet their needs. Every Thursday, Friday, and Saturday night during recruitment, the researchers will go to SOPVs popular among the MSM community in Lima and invite people to take an HIV test. On each recruitment date, they will offer one of the following HIV testing options: 1. A rapid HIV test done on-site (participants will get their result right away) 2. An HIV self-testing kit to take home 3. A coupon for a free HIV test at a participating health center 4. Their choice of any one of the previous three options Only one of these options will be offered at a time, depending on the date. The specific HIV testing option offered on each date will be randomly assigned. All participants will receive the mobile app, which will send weekly messages with links to different types of online content (infographics, maps, videos) over the next 3 months. The specific sequence of messages and content will be different depending on the type of HIV test the person received and their HIV test result, once it is known. The study will measure two main outcomes related to the acceptability and feasibility of the program: * The number and percentage of people who accept the program when offered * The number and percentage of participants who continue to engage with the mobile app after 3 months The study will also measure: * overall satisfaction with the app (based on a questionnaire sent at 3 months) * the number and percentage of participants who completed any form of HIV testing after 3 months * the number and percentage of participants who started HIV treatment (out of those with a positive HIV test) * the number and percentage of participants who started HIV pre-exposure prophylaxis, or "PrEP" (out of those with a negative HIV test) All follow-up will be done remotely. Participants will have the app for 3 months. After 3 months, they will get a follow-up questionnaire asking about their experiences with the program. The researchers will keep tracking results related to the HIV treatment/prevention services that people receive for up to 6 months.

Feasibility of Adding a Plant-Based Protein Pudding to the Diet of Older Adults Who Attend a Medically Managed Fitness Facility

The goal of this a 12-week randomized controlled parallel arm feasibility trial is to evaluate the feasibility and acceptability of incorporating a plant-based protein pudding into the diets of older adults who attend a medically managed fitness facility. The primary participant population includes older adults, aged 60 years and above, who are generally healthy and engaged in structured fitness programs. The main questions it aims to answer are: Is a plant-based protein pudding acceptable and well-tolerated by older adults? Does regular consumption of the pudding support muscle health and overall well-being in this population? Participants will: Consume a plant-based protein pudding as one arm daily for 7 days per week (experimental) and the other will continue their current lifestyle (control). The experimental group will complete surveys or questionnaires to assess acceptability, taste, and ease of integration into daily meals. Undergo basic physical or health assessments (e.g., muscle function or strength evaluations) to evaluate potential effects.

Feasibility of Wireless Continuous Vital Sign Monitoring and Impact on Patients Undergoing Adult Spinal Surgery in a General Ward

The goal of this feasibility study is to explore the use of wireless continuous vital sign monitoring in an orthopaedic setting among orthopaedic nurses and patients undergoing adult spinal deformity surgery. In addition to the standard care National Early Warning Score the participants in this study will be monitored by CPC12S a wearable sensor that is worn on the chest using electrodes measuring electrocardiography single lead (ECG), Heart rate, respiratory rate, SpO2, blood pressure and temperature. Main hypotheses: The use of wireless continuous vital sign monitoring in daily clinical practice for patients undergoing ASD surgery is feasible in terms of increased acceptability among orthopeadic surgical nurses measured over 12 months with a response rate of at least 80% with an average score of ≥5 at the last measurement in each of the four dimensions of the USE questionnaire: Usefulness, ease of use, ease of learning and satisfaction. The following parameters will be evaluated: Primary outcome: 1. The feasibility in terms of acceptability of the concept of wCVSM among orthopedic surgical ward nurses. Secondary outcomes: 2. The feasibility in terms of acceptability of the concept of wCVSM in patients undergoing ASD surgery. 3. The technical fidelity of wCVSM, assessed by data collected of vital signs, display of alerts to staff nurses and response to the alerts. 4. The frequency of vital sign deviations in patients after ASD surgery using wCVSM compared to NEWS2. 5. Clinical outcomes of patients undergoing ASD surgery including surgical complications, reinterventions, ICU admissions, unplanned ward transfer, and admissions to another department.

Preserving Ability Through Virtual Exercise (PAVE)

Each day in the hospital leads to functional decline and loss of muscle mass, which older adults can find difficult or impossible to restore in the post-acute period. The overall objective of this proposed project is to explore the feasibility and preliminary efficacy of a virtual reality physical activity intervention at helping older adults engage in physical activity and maintain physical function and mental health during their hospital stay. As virtual reality technology becomes more affordable and ubiquitously available across the world, this study will demonstrate how this technology could be leveraged to maintain the function of older adults in the hospital.

Central Venous Catheter Placement With Thoracic Ultrasound and Intracavity ECG Positioning

The goal of this interventional study is to assess the feasibility of two bedside techniques for confirming central venous catheter (CVC) placement and detecting complications: * Intracavity ECG monitoring to confirm internal jugular vein CVC tip position. * Thoracic point-of-care ultrasound (POCUS) to rule out pneumothorax following CVC insertion. Participants who require an internal jugular CVC as part of their routine care and meet all inclusion and no exclusion criteria will be randomised to receive either: * Standard care, or * The intervention, consisting of intracavity ECG guidance and thoracic POCUS. The CVC will be inserted either on the left or right side of the neck. All participants will undergo a post-procedure chest X-ray regardless of study arm, to allow comparison of the intervention methods with standard care.

PURSUIT: A Technologically Augmented School-based Program to Improve Child Coping and Prevent Substance Use.

The study investigators aim to test an online support platform for Michigan youth aged 8-18 years enrolled in elementary, middle, or high school and their parent/caregiver. The online support platform will be hosted on the Computerized Intervention Authoring System (CIAS) 3.0 and will provide evidence-based cognitive behavioral coping skills for physical (pain) and mental (stress, mood) health symptoms, with additional substance use prevention content for youth aged 12 and older. Evaluations will occur at baseline and then a post assessment approximately 8 weeks later.

A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers

The goal of this clinical trial is to evaluate whether a home-based mHealth intervention can improve adherence to the 24-Hour Movement Guidelines in preschool-aged children (3-4 years old) who currently meet 0 or 1 of the guidelines for physical activity, sedentary behavior, and sleep. The main questions it aims to answer are: * Can the intervention increase the proportion of children meeting all three 24-Hour Movement Guidelines (physical activity, screen-time, and sleep)? * Is the intervention feasible for parents to implement, as measured by a parent feedback survey? Researchers will compare an intervention group to a waitlist control group to assess whether the intervention leads to increased guideline adherence. Parents and Participants: * Children will wear an accelerometer to track physical activity and sleep patterns. * Parents will use a mobile app that delivers weekly lessons and behavior-related goals to encourage healthy movement behaviors in their children. * Parents will complete questionnaires on their child's movement behaviors and development at baseline, 6 weeks, and 12 weeks. * Additionally, children will undergo motor skills assessments, and parents will provide feedback on cognitive development and behavioral changes.

Feasibility and Potential Efficacy of Herbs and Spices for Improving Dietary Quality in College Students: A Pilot Study

The goal of this single-arm feasibility, pilot study is to assess the feasibility, acceptability, and potential effectiveness of the Herbs and Spices Nutrition Education Program (HSNP-focusing on incorporating herbs and spices into the diet for adherence to the DGA's) for determining the scalability of implementing this intervention for a larger scale, more comprehensive study The main questions it aims to answer are: * What is the feasibility and acceptability of incorporating herbs and spices into the diet along with DGA-focused nutrition education through the HSNP in college students with poor dietary quality? * What are the preliminary effects of the HSNP on dietary intake/quality, cardiometabolic, and gut health in college students with poor dietary quality? * What are the barriers associated with HSNP implementation in college students with poor dietary quality? Participants will: * Be asked to come to the study site initially for a Screening Study Visit to confirm eligibility. * Be asked to come the clinical study site for a Pre-HSNP and Post-HSNP Study Visit (one week prior starting the HSNP and after week 6 of completing the HSNP) for assessments of cardiometabolic and gut health. * Be asked to come to the Nutrition Center for weeks 0 and 3 of the HSNP, where they will receive education on the Dietary Guidelines for Americans and the health benefits of herbs and spices, have a sensory evaluation of foods, be provided budget-friendly recipes and resources, and given take-home herbs, spices, and supporting materials * Be asked to complete 3-Day Food Records throughout the 6 week study period for assessment of dietary quality (4 total)

Behavioral Health Program for Short-Stay Nursing Facility Residents & Care Partners

The goal of this clinical trial is to test a behavioral health program (Interventions for Stressful Transitions in Later Life, InSTILL) for skilled nursing facility residents and their primary support person. The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful. The researchers will compare the InSTILL program to minimally enhanced usual care. Participants will be randomly assigned to receive either the InSTILL program or minimally enhanced usual care. Participants will complete assessments at three timepoints (all) and a brief-exit interview.

The Increasing Mindfulness Engagement Project

The goal of this clinical trial is to examine the feasibility and acceptability of different types of text messages and a integrated gaming app to increase engagement in a mindfulness mobile health application. 1. Does receiving text messages increase engagement in a mindfulness app? 2. Does an integrated gaming app increase engagement in a mindfulness app? Researchers will examine whether participants engage more in a mindfulness mobile health application if they receive text messages and if they engage in additional gaming app on their smartphone. Participants will: 1. Use a mindfulness and gaming mobile health application for 28-days. 2. Complete a pre-study survey, post-study survey, follow-up interview, and 3-month follow-up survey in addition to daily brief surveys.

ATTACH in Denmark: A Feasibility Randomized Controlled Trial

The goal of this feasibility randomized controlled pilot trial is to learn whether the trial can be done as planned, and to investigate if the 10-session parenting program "ATTACH(TM) increases mentalizing skills (the ability to reflect on thoughts and feelings) in parents of children between 0-5 years of age, who are receiving support for psychosocial problems in their municipal family treatment center. The main questions the trial aims to answer are: * How many eligible parents agree to participate in the random allocation to treatment? * How many parents allocated to receive "ATTACH(TM) will have completed the program 5 months after allocation (at least 7 out of 10 sessions)? * How many parents complete the data collection 5 months after allocation on the primary exploratory clinical outcome, i.e., parental mentalizing skills? * Do parents who received the ATTACH(TM) program show more increase in their mentalizing skills, compared to parents, who did not receive treatment with ATTACH(TM)? Researchers will compare ATTACH, added to Treatment as Usual, with Treatment as Usual without ATTACH in three municipal family treatment centers located in the Capital Region of Denmark. Participants will: 1. Take part in baseline data collection with a survey, video observation of parent-child interaction, and an interview assessing mentalizing skills. 2. Be randomly allocated to receive treatment in their local family center with or without ATTACH. 3. Take part in data collection 5 months after being allocated to either group, as well as participate in an interview about their experiences with the treatment they received. 4. After one year, the research group will follow up on the current treatment/support needs of the families, who were allocated to either group.

rTMS for Youth Inpatients With Depression

Youth aged 15-24 are likelier to have depression than all age groups in Canada. One-third of depressed youth do not respond to psychotherapy and/or antidepressant medications. A treatment called repetitive transcranial magnetic stimulation or rTMS has proven helpful in adolescents and young adults whose depressive symptoms have been difficult to treat with psychotherapy and/or antidepressants. Unfortunately, youth find rTMS difficult to access because it is not funded by the Ontario Health Insurance Plan, is typically only offered to adults, and the treatment schedule usually involves once-daily sessions, 5 days/week, for 4-6 weeks, which is associated with travel and opportunity costs e.g. missing school. This project looks at the feasibility of a new treatment pathway that allows youth with difficult-to-treat depression in hospital to receive rTMS twice-daily while engaging in on-unit schooling and therapeutic support. This "accelerated" way of providing rTMS is safe, has equal effectiveness to once-daily rTMS, and can shorten the time needed for treatment. This pathway is for youth already staying in hospital for difficult-to-treat depression or youth outside hospital who have difficult-to-treat depression that interferes with daily function to such a degree that they would benefit from staying in hospital. The investigators anticipate integrating rTMS and inpatient care for youth will be feasible, that it will be acceptable and accessible to youth and families, and there will be sufficient demand for this new treatment pathway. If successful, this project will inform care for youth with difficult-to-treat depression in Ontario and beyond.

Optimizing Patient-centred Outcomes Using Opioid Minimization Strategies: The OPUS Anesthesia Pilot Trial

Up to 40% of patients experience suboptimal recovery in the days following major surgery, limiting their return to functional independence. Few preventive interventions exist, but intravenous dexmedetomidine and lidocaine administered during general anesthesia represent simple strategies that may significantly impact recovery and other patient-centred outcomes after surgery. The goal of this pilot trial is to determine the feasibility of conducting a phase 3 pragmatic adaptive multicentre trial to evaluate the impact of dexmedetomidine and lidocaine administered during major non-cardiac surgery on patient-centred outcomes.

PROtective Ventilation With FLOW-Controlled Ventilation

The investigators want to investigate in patients undergoing robot-assisted laparoscopic surgery (a minimally invasive procedure) how applicable flow-controlled ventilation is, and whether it might also be safer than the current ventilation techniques, as well as its impact on potentially reducing the risk of lung-specific complications. Flow-controlled ventilation has already been tested in several studies on animals and humans and has proven to be a safe form of ventilation for patients undergoing surgery under general anesthesia. When patients undergo major surgery, general anesthesia is required and, as a result, mechanical ventilation of the lungs. Especially in long and complex surgeries, ventilation can become more difficult or lead to complications postoperatively. These patients may then experience shortness of breath, coughing, or require medication to improve lung function. In some cases, reintubation or additional mechanical ventilation may be necessary for support. Previous human studies have shown that flow-controlled ventilation is less stressful and, therefore, potentially safer for the lungs compared to traditional ventilation techniques, and that less supplemental oxygen is required. This effect and the safety of flow-controlled ventilation have been demonstrated in several studies. Therefore, in this study, the investigators aim to explore whether flow-controlled ventilation is potentially safer and easier to apply than traditional ventilation techniques and whether it can reduce the risk of lung-specific complications following robot-assisted surgeries, thereby improving the recovery process postoperatively.

CABGpreHAB - a Feasibility Study Protocol

Patients with ischemic heart disease (IHD) awaiting coronary artery bypass graft (CABG) surgery often face challenges like advanced age, frailty, comorbidities, and physical inactivity. These factors, combined with the physiological and psychological stress of surgery, can hinder postoperative recovery. Traditionally, strategies to improve surgical outcomes focus on the intra- and postoperative periods. However, the pre-surgery waiting period offers a "window of opportunity" for prehabilitation, which aims to enhance patients' functional capacity through exercise, nutrition, and psychological support. The CABGpreHAB feasibility study evaluates the feasibility of a home-based multimodal prehabilitation intervention for patients awaiting elective CABG surgery. This randomized pilot study compares the intervention plus usual care to usual care alone, assessing feasibility outcomes like recruitment, retention, attrition, fidelity, and adherence. The study aims to optimize a subsequent full-scale randomized controlled trial (RCT) and improve patient outcomes by leveraging the pre-surgery period for prehabilitation.

Digital Support Strategies for Caregiver Home Practice

This project is a pilot trial of the Engaging Families home practice smartphone application (or "app") as an add on to a family-based prevention program. Although there are many evidence-based preventive interventions delivered to caregivers to prevent youth substance use and mental illness and promote youth positive family and youth outcomes, the impact of these interventions is often limited by low home practice of intervention skills among caregivers. The Engaging Families home practice app is a digital behavior change intervention that was developed to support caregivers in practicing intervention skills at home. Researchers will ask participants if the app was acceptable and feasible for daily use at home. Researchers may also compare how often caregivers who use the study app do home practice of intervention skills compared with caregivers who do not receive the home practice app but are encouraged to use an app to help schedule their activities.

Feasibility Study of a Relapse Investigation Questionnaire Administered by an MS Care Coordinator Nurse in Patients With Multiple Sclerosis

This study aims to evaluate a questionnaire used by a specialized nurse to help manage relapses in people with multiple sclerosis (MS). The questionnaire is completed during a phone call when the patient reports new or worsening symptoms. It helps the nurse decide whether further tests or treatments are needed, based on a protocol developed with a neurologist. The goal is to improve how quickly and effectively patients receive care during a relapse. The study will include 10 adult patients with active forms of MS over a two-month period.

Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients

Post-operative delirium is a common complication following cardiac surgery and is associated with increased 1 year mortality. Currently there are no drug therapies to prevent delirium. Orexin is a neuromodulator thought to play an important role in disordered sleep, one of the instigators of delirium. Lembrorexant is an orexin antagonist, originally approved for sleep, that may also reduce the incidence of delirium. The Investigators propose a pilot study to determine the feasibility of a randomized controlled trial comparing Lembrorexant to placebo in patients following cardiac surgery in reducing the incidence of delirium, and improving sleep.

Evaluating an AI-Generated Health Podcast

This study aims to explore a new way of delivering health information using an AI-generated podcast. The podcast, created with Google NotebookLM, uses verified content from the American Academy of Periodontology website to provide easy-to-understand information on gum health and prevention. The goal is to determine whether this AI-generated podcast is a useful, engaging, and clear tool for educating the general public about health topics. Traditional health podcasts often feature expert interviews and can be lengthy, which sometimes limits their appeal and accessibility. By using AI to generate the podcast, investigator hope to offer a more standardized and concise presentation that avoids technical jargon. To evaluate the podcast, investigator developed a questionnaire based on the Questionnaire for Assessing Educational Podcasts (QAEP). This questionnaire was adapted to better suit a non-specialist audience and covers four key areas: how easy the podcast is to access and use, the design and structure of the podcast, the clarity and completeness of the content, and the podcast's value as a learning tool. Before using this questionnaire with the general public, investigator sent it to 10 experts in dentistry, public health, and communication for their review and feedback. Their input helped us make minor modifications to ensure the questionnaire is both clear and scientifically sound. After these revisions, investigator conducted a pilot study with 30 members of the general public who listened to the podcast and completed the questionnaire. This study will assess the feasibility and validity of using an AI-generated podcast as a health education tool. The results will help determine if this approach can effectively improve public understanding of health information and may guide the future design of digital health communication strategies.