Clinical Research Directory

Effects of Carbon Fiber Insoles on CMJ and Sprint Performance

This study evaluates the effects of VKTRY carbon fiber insoles on vertical jump and sprint performance in moderately active men. Participants will perform tests with and without insoles, assessing both objective performance and subjective perception using a Likert-type scale.

Evaluation of 7-day vs 1-day Packaging of Small Quantity Lipid-based Nutrition Supplementation (SQ-LNS)

Small Quantity Lipid-based Nutrient Supplements (SQ-LNS), are fortified, lipid-based nutritional supplements that were specifically designed for children 6-24 months to prevent malnutrition. Recent research has shown reductions in mortality, severe wasting, severe stunting, iron deficiency anemia, and developmental delays. SQ-LNS is currently available in individual daily dose packets of 20g. Healthy children age 6-24 months receive 1 packet per day (1dp), and are typically given a 1- or 2- month supply at a time (30-60 packets). Recently, Nutriset Développement has developed a new packaging design for SQ-LNS that reduces the cost by over 15% overall, through production efficiency with 40% less packaging, and improved transportation efficiency by 20%. This new packaging is a 140g packet that will allow 20g to be dispensed daily for 7 days (7dp). The packaging has a chamber that will allow for accurate 10g dosing (either twice daily, or twice at once). Users of the packaging will also be able to close the spout to minimize risk of microbiological contamination. Edesia Nutrition is working with Nutriset to conduct field testing of this new packaging for SQ-LNS, and this mixed-methods study in North Shoa Zone, Amhara Region, Ethiopia, will help inform recommendations for the future use of the package. The study seeks to determine (1) the acceptability of integrating SQ-LNS distribution into the malnutrition program; (2) whether adherence to the 2 different package types differs, and if there are differences in usage; (3) and how the packages perform over time, their perceived safety and functionality, and how they are stored. Educational and communication tools will be developed and pre-tested as part of this study, and will become part of the final deliverable package to Edesia Nutrition, in addition to final recommendations on the product packaging, findings about how the packages are used, and behavior change and nutrition education strategies. The primary outcome of the quantitative evaluation will be adherence, calculated as the number of delivered doses of SQ-LNS divided by the number of expected doses per week (7). Adherence will be measured via weekly self-report via caregiver interview and counts of return of used and unused packages during weekly home visits. The percentage of children who receive a dose during structured observation periods will be calculated. Each adherence outcome will be analyzed separately.

Effectiveness of an AI-Enabled Mobile Intervention on Lifestyle Behaviors and Maternal-Infant Health

The goal of this pragmatic randomized controlled trial is to evaluate the effectiveness of an AI-enabled mobile health management application ("Better Pregnancy" app), grounded in the Theory of Planned Behavior, in preventing gestational diabetes mellitus (GDM) among pregnant women at high risk of GDM, and to assess its impact on maternal and infant health outcomes. Study Population: Eligible participants are pregnant women aged 18-49 years, with a singleton pregnancy, gestational age \<12 weeks at enrollment, and at least one GDM risk factor (age ≥35 years, pre-pregnancy BMI ≥24 kg/m², family history of diabetes, previous history of GDM, prior delivery of a macrosomic infant \[birth weight ≥4000 g\], or polycystic ovary syndrome). Participants must have no heart, liver, or kidney diseases, use an Android smartphone, and provide written informed consent. The main questions it aims to answer are: Can the AI-driven mobile lifestyle intervention reduce the incidence of GDM in high-risk pregnant women? Does the intervention improve lifestyle behaviors (diet, physical activity, sleep) and glycemic control (measured by continuous glucose monitoring) in participants? What is the adherence, acceptability, and cost-effectiveness of this intervention in real-world clinical settings? Comparison: Researchers will compare two groups of pregnant women: the intervention group (receiving the AI-enabled "Better Pregnancy" app plus routine antenatal care) and the control group (receiving routine antenatal care alone). Participants will: Enroll in the first trimester (\<12 weeks of gestation) and complete a baseline lifestyle and health status questionnaire In the intervention group: watch 7 cognitive-attitudinal videos within the first week, then complete 12 weeks of AI-driven personalized intervention (daily check-ins, receiving tailored recommendations on diet, physical activity, sleep, etc.) During the intervention period, participants in the intervention group will wear a continuous glucose monitoring device for 7 days to assess the impact of the intervention on glycemic fluctuations Complete the first follow-up lifestyle and health status assessment after the intervention (approximately in the second trimester) Undergo an oral glucose tolerance test during the second trimester (24-28 weeks) Complete the second follow-up lifestyle and health status assessment in the third trimester (≥28 weeks) Complete the third follow-up lifestyle and health status assessment at 42 days postpartum, along with collection of delivery outcomes and infant health information A subset of participants may voluntarily provide blood and stool samples for mechanistic studies

Enhancing Oral Cancer Awareness

To evaluate the impact of AI-powered chatbot interactions versus traditional educational handouts on increasing participants' knowledge of oral cancer and its prevention

Intraoperative Application of Cold Atmospheric Plasma to Prevent Postoperative Wound Complications in the Inguinal Region of High-risk Patients With Peripheral Arterial Occlusive Disease

The goal of this clinical trial is to learn if postoperative wound complications in the inguinal region of high-risk patients with peripheral arterial occlusive disease can be prevented by the intraoperative application of cold atmospheric plasma. The main questions it aims to answer are: Does the intraoperative application of cold atmospheric plasma reduce the need for surgical revision of inguinal wounds due to wound healing complications within 3 months postoperatively? Does the intraoperative application of cold atmospheric plasma reduce wound healing complications not requiring revision within 3 months postoperatively? Researchers will compare the application of cold atmospheric plasma to a placebo (a deactivated look-alike device). Participants will: Undergo surgical treatment with femoral artery access due to their peripheral arterial occlusive disease, in accordance with the respective vascular surgery department standard of care. Receive a single application of cold atmospheric plasma or, respectively, placebo in the area of their inguinal access wound during surgery (after subcutaneous closure and prior to skin closure). Be regularly assessed for wound healing during the first postoperative 14 days as part of routine clinical care and undergo a final evaluation at 3 months. They will also be surveyed regarding their quality of life.

The Use of the Functional Movement Screen™ in Preventing Injuries in Amateur Rugby Players

Rugby is a team contact sport that demands unparalleled physical engagement. This practice, which combines random running patterns with changes in speed and direction, also involves frequent contact situations with other players. These phases of the game account for 48% to 80% of total injuries. Injury prevention is an integral part of the physical therapist's expertise and plays a crucial role in reducing the occurrence of musculoskeletal injuries and mitigating their devastating consequences. The implementation of a risk prevention tool is particularly relevant for a population prone to injuries. However, the practicality of such a tool must be considered, as adherence to an injury prevention program depends on the "perceived usefulness, intensity, and time investment of the program". One tool appears to meet these criteria: the Functional Movement Screen™ (FMS™). This tool is designed to "evaluate an individual's functional movement patterns" and, according to its authors, can serve as "a crucial tool" for returning to sports after an injury or a period of inactivity. Given the high incidence of injuries in rugby players, calculating the injury incidence in this population and correlating it with FMS™ scores could provide valuable insights. For this prospective study, forty amateur rugby players from various clubs in Normandy competing at the Federal 3 level will be recruited using a recruitment letter and a call for volunteers. Each participant will perform two FMS™ (7 movements), at the beginning of the competitive season and at the end of the competitive season. The test will last 30 minutes per player. The initial interview will last 20 minutes. There will also be a follow-up of the players throughout the season to collect all injuries sustained by participants in the intervention. The main expected outcome is a significant correlation (p \< 0.05) between the FMS™ score and injury incidence. This correlation may then indicate a good predictive capacity of the FMS™, allowing it to be considered a predictive tool for injury risk. To evaluate the correlation between two variables (injury incidence sustained by the player and the FMS™ score), the Spearman correlation coefficient will be used. This coefficient, if its value approaches -1 or 1, will indicate a good correlation between the player's injury incidence and their FMS™ score. Conversely, if the coefficient approaches 0, the correlation will be considered poor. In a second phase, it is expected that a competitive season will directly affect the FMS™ score, highlighting the difficulty for an amateur player to maintain their physical capacities throughout an entire season.

The REMINDER4Care Program for Older Adults Supported by Residential and Daycare Facilities

Dementia incidence is rising, posing a public health challenge, but 45% of cases can be prevented by addressing modifiable risk factors. Multidomain trials show that lifestyle changes can improve cognitive function and reduce dementia risk (like the FINGER trial). The REMINDER program, a Portuguese-based dementia risk reduction protocol, was developed for community-dwelling older adults aged 55 and above. However, older adults in Residential and Daycare Facilities (RDF) have distinct needs that demand program adaptation to ensure its relevance and effectiveness. In addition, more studies are needed to evaluate the impact of multidomain interventions with older adults in RDF. To address these challenges, the REMINDER4Care program was developed as a tailored, multidomain intervention to reduce dementia risk. It emphasizes social and cognitive engagement and advances its adaptation and evaluation in Residential and Daycare Facilities (RDF). To assess efficacy, the investigators will perform a Randomized Controlled Trial.

The Swedish Hockey League Hand and Wrist Injury Tracking Trial

This study, titled Hand and Wrist Injuries in Professional Hockey Players in Sweden: A Nationwide Observational Cohort Study from the Swedish Hockey League (SHL-HITT), aims to deliver a comprehensive national overview of hand and wrist injuries among professional hockey players. These injuries are relatively common-accounting for approximately 16% of all hockey-related injuries-and can range from minor issues to severe conditions that jeopardize player performance and careers due to prolonged absences or lasting impairment. Despite their significance, there is limited detailed knowledge regarding the specific patterns, mechanisms, and consequences of hand and wrist injuries at the elite level. Utilizing data from a nationwide injury registry, this observational cohort study will cover three full SHL seasons: 2022/23, 2023/24, and 2024/25. The dataset is expected to include approximately 2,300 games, encompassing both regular season and playoff matches. The study will examine injury characteristics such as type (e.g., fractures, soft tissue damage), player position, in-game timing, and additional contextual factors. Statistical analyses will be conducted to identify trends, correlations, and potential risk profiles among different player groups or positions. The findings are expected to support the development of enhanced protective equipment and targeted prevention strategies, ultimately contributing to reduced injury incidence and improved athlete health and career sustainability. The study timeline includes preparation in late 2024, with data collection already ongoing and ethical approval obtained. The analysis will begin following the publication of the study protocol, and we aim for final publication of results in the second half of 2025.

Primary HPV-based Cervical Cancer Screening Algorithms in Botswana

Primary high-risk human papillomavirus (HPV) testing has become first line screening for cervical cancer in high-income countries. The feasibility of this approach in low- and middle-income countries (LMICs) is less clear, as is the role of HPV testing among women living with human immunodeficiency virus (HIV). The proposed study seeks to evaluate the accuracy of cervical cancer screening algorithms using primary HPV testing followed by various forms of visual evaluation, including visual inspection with acetic acid (VIA), colposcopy and HPV genotype restriction for the detection of high-grade cervical dysplasia, using histology as the gold standard. We will validate the AmpFire Assay for HPV self-sampling in our setting. We will evaluate optimal screening intervals in women living with HIV (WLHIV) in an HPV-based cervical cancer screening program and compare triage strategies for positive HPV results at WHO recommended screening intervals for WLHIV. We also seek to understand in-depth the attitudes, acceptability and preferences regarding cervical cancer screening, HPV testing, and self-sampling, for women in Botswana through interviews of a sub-set of women recruited for the cervical cancer screening study. Finally, we will analyze the cost of two-stage cervical cancer screening algorithms using high-risk HPV testing in Botswana.

Evaluation of Clinical Decision Support in Opioid Tapering

The 2022 Center for Disease Control and Prevention (CDC) clinical practice guideline for prescribing opioids for pain recommends that when tapering a patient's opioid dose, doses should be decreased at a slow rate to reduce the risk of withdrawal symptoms, overdose, and to promote tolerance of the tapering. This project will evaluate a clinical decision support (CDS) tool in the form of a clinical care pathway that gives providers information, recommendations, and educational material on strategies for opioid tapering. Primary care providers will be randomized at the clinic location to a control arm or intervention arm. The control arm will have the clinical care pathway available, but will not be reminded of the pathway when tapering a patient. The intervention arm will receive a nudge when prescribing a tapering opioid strategy to a patient to use the clinical care pathway. The rate of opioid tapering in line with CDC guidelines will be examined as well as long-term patient outcomes of opioid overdose or poisoning using existing patient health records. The study period will be approximately 18 months.

Study to Evaluate the Safety and Feasibility of Diamyd® in Individuals at Risk for Type 1 Diabetes

A 2-arm randomized Phase II Open Label Study to evaluate the safety and feasibility of intralymphatic administration of Diamyd® (Diamyd) also known as retogatein in individuals at risk of Type 1 diabetes carrying the HLA DR3-DQ2 haplotype.

Children in the Operating Room: Kids That go Thru Operating Room Will be Given a Connected Health Toothbrush, Kids Anticavity Toothpaste and Behavioral Health Intervention to Reduce Claim Costs

The objective of this study is to demonstrate that compliance and brushing adherence as a treatment to providers, insurance company and State Health Departments that can help improve oral health of children who have already been treated for caries in the Operating Room. This would include reactions such as how easy and enjoyable the use of the toothbrush and app seemed to be for their child and how useful the caregiver found the connected toothbrush to be.

Enhancing an Existing Prevention Strategy to Reduce Intentional Firearm Injuries Among High-risk Youth (Phase 1)

Over the past three decades, substantial resources have been devoted to developing youth violence prevention (YVP) programs. These programs have demonstrated positive effects on reducing aggression and related behaviors, firearm-specific risk factors were largely overlooked due to historical barriers to firearm research. This omission is concerning, as firearms are now the leading cause of injury and death among U.S. youth. Existing YVP strategies such as Emerging Leaders address general violence risk but do not directly target firearm-related risks or suicide prevention. There remains a critical gap in prevention strategies that integrate firearm-specific content while leveraging established program infrastructure.

Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section

This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in cesarean section (CS).

Psychological and Lifestyle Factors That Predict Adherence of Multi-domain Interventions for Promoting Brain Health

Ageing is associated with a rising burden of neurological disorders, particularly dementia, which are now the leading cause of disability worldwide. Many dementia cases could potentially be prevented by modifying lifestyle factors such as physical inactivity, unhealthy diet, poor sleep, low social engagement and psychological distress. The Barcelona Brain Health Initiative (BBHI), a longitudinal cohort of more than 6,000 adults aged 40-75 years, has shown substantial inter-individual variability in lifestyle and psychological profiles and has identified subgroups at higher risk for poorer brain health. ToBrainHealth is an 8-week, three-arm controlled intervention nested within BBHI. It evaluates different levels of personalisation and support to optimise healthy lifestyle behaviours using the ToBrainHealth platform, a digital platform that delivers recommendations, collects self-reported behaviours and integrates data from wearable activity trackers. A total of 120 BBHI volunteers classified as moderate- or high-risk based on previous lifestyle and psychological questionnaires will be selected (40 per arm). Allocation to study arms will be pseudo-randomised, stratified by age, sex, and lifestyle and psychological profiles. The three groups are: (1) a control group receiving only generic, non-personalised education about healthy lifestyles and regular online questionnaires, without use of ToBrainHealth platform tailoring; (2) a digital personalised intervention group using ToBrainHealth platform to deliver tailored lifestyle recommendations, adaptive intervention strategies and remote asynchronous supervision, supported by data from questionnaires and wearables; and (3) a digital personalised intervention plus intensive health-coaching group, which receives the same ToBrainHealth platform-based programme plus structured, proactive support and supervision by health professionals to enhance motivation and adherence. The primary outcome is adherence to the lifestyle intervention, operationalised as the percentage of recommended activities and goals achieved during the 8-week programme, based on platform's logs, questionnaires and wearable data. The study will test whether lifestyle and psychological profile increases adherence compared with generic education, and whether adding intensive coaching provides additional benefit (expected gradient: coaching \> digital only \> control). Secondary outcomes include the clinical impact of the intervention on brain-health-related measures. All participants will undergo pre- and post-intervention assessments including a brief medical evaluation (vital signs and anthropometrics), a digital neuropsychological battery, and questionnaires on motivation, lifestyle and psychosocial variables. These data will be analysed together with existing BBHI longitudinal information to explore changes in cognitive performance, health status and psychological wellbeing, and to characterise patterns and predictors of adherence across intervention arms. The trial will also assess feasibility and acceptability of ToBrainHealth platform as a remote monitoring and coaching tool for brain-health promotion. Results are expected to generate new knowledge on the role of psychological and lifestyle profiles in adherence, and to inform scalable, technology-supported, personalised interventions aimed at preserving brain health and reducing the long-term risk of cognitive decline in community-dwelling adults.

Virtual Assistant for Exercise Adherence in Older ADULTS

This study will evaluate the effectiveness of a virtual assistant-guided exercise program to improve adherence in older adults. In a nonrandomized controlled clinical trial, the experimental group will complete a 12-week, home-based program (60-minute sessions, 3 times per week) supported by a virtual assistant (BOT). The control group will comprise community-dwelling older adults already engaged in the municipal program Enguera se saludable, which delivers an in-person exercise program of comparable frequency and duration. The primary outcome is exercise adherence, defined as the proportion of prescribed sessions completed. Secondary outcomes include muscle strength, balance, functional capacity, health-related quality of life, and the user experience and usability of the virtual assistant.

Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease

The primary objective of this study is to evaluate whether a management strategy based on coronary computed tomography angiography (CCTA) for patients with non-obstructive coronary artery disease can improve the LDL-C target achievement rate compared to a traditional management strategy without follow-up CCTA, thereby reducing the incidence of major adverse cardiovascular and cerebrovascular events over a 3 years period, including all-cause mortality, myocardial infarction, ischemia driven revascularation and stroke.

Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT

This study was a prospective, multicenter, randomized controlled clinical study planned to recruit 266 hematological patients with allogeneic hematopoietic stem cell transplantation (allo-HSCT), who were randomly divided into two groups according to gender, type of transplantation, and type of primary disease. The control group was treated conventionally, and the experimental group increased moxibustion of Zhongji, Guanyuan and Qihai for 30 min qd starting on the first day after HSCT was performed until the 14th day after transplantation. Urine routine tests were performed at the time of admission, +1d, and +14d, and urine BK virus, JC virus, and adenovirus were tested at four time points, namely, +1d, +14 days, onset of hematuria symptoms, and remission of HC, respectively; routine urine tests were performed once every 7 days for all patients within 100days. For patients with Hemorrhagic cystitis (HC), daily severity grading, pain scoring, cystitis symptom scoring, use of antispasmodic and analgesic medications, and major TCM evidence were recorded with the aim of evaluating the efficacy of moxibustion in the prevention of HC in this patient population.

Prevention of Recurrence of Herpes Simplex in Autoimmune Rheumatic Diseases

The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate the effectiveness and safety of oral suppressive therapy with acyclovir in preventing herpes simplex virus (HSV) reactivation in patients with autoimmune rheumatic diseases (ARDs) who have a history of recurrent HS episodes. The main questions this study aims to answer are: Does continuous oral acyclovir reduce the frequency of HSV reactivation in ARD patients compared to placebo? What is the safety profile of prolonged acyclovir use in this population? What are the main risk factors (clinical and treatment-related) associated with HSV reactivation in immunosuppressed patients. Participants will: Be randomly assigned (1:1) to receive oral acyclovir (400 mg BID) or placebo for 12 months; Be followed for a total of 24 months, with regular clinical evaluations (every 3 months) and laboratory monitoring (every 3 months); Be assessed for HSV recurrence based on clinical symptoms, detection of HSV DNA by polymerase chain reaction (PCR) in mucocutaneous swabs in doubtful cases, and standardized reporting forms; Undergo disease activity assessments and adverse event monitoring at regular intervals. The study includes adult and pediatric patients with confirmed diagnoses of one of the following ARDs: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), dermatomyositis/polymyositis (DM/PM), systemic sclerosis (SSc), systemic vasculitis, primary Sjögren's syndrome, Mixed connective tissue disease (MCTD), Chronic recurrent multifocal osteomyelitis (CRMO), Sarcoidosis and Behçet's Syndrome. All participants must have a documented history of recurrent HSV (oral and/or genital) before inclusion.

Adding Aprepitant to a Multimodal Strategy for the Prevention of Postoperative Nausea and Vomiting in High-risk Outpatient Surgical Patients

Postoperative nausea and vomiting (PONV) are a frequent and debilitating complications after surgery, affecting up to 80% of patients at high risk in the absence of prophylaxis. Despite the rigorous application of the recommendations from the American Society of Anesthesiologists (ASA) at CHUM, a recent local study reveals a prevalence of 25% PONV at home after outpatient surgery. However, the therapeutic options at home remain limited. This study aims to evaluate if the addition of 40 mg aprepitant to a multimodal strategy for preventing PONV improves clinical outcomes in high-risk patients undergoing outpatient surgery.

Hybrid Delivery to Increase Access and Sustainability: Evaluating ezParent Implementation

The goal of this study is to evaluate the effects of the hybrid ezParent program (e.g., web-based training program plus synchronous group sessions) on parent and child outcomes in a community setting serving parents of children 2-5 years old. Parent participants will complete surveys at baseline, and 10 and 24-weeks post baseline.

Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the Primary Prevention of Endometrial Cancer

To develop an educational tool to help patients and healthcare professionals make informed decisions about endometrial cancer and available prevention options for it (such as the use of a levonorgestrel-releasing intrauterine system \[LNG-IUS\]).

Active Pauses for Musculoskeletal Disorder Prevention in Workers

The goal of this clinical trial is to learn if short exercise breaks at work can prevent muscle and joint pain in workers. The main questions it aims to answer are: Do strength exercises help workers move better and feel less pain? Are strength exercises better than stretching exercises for worker health? Researchers will compare a strength exercise program to a mobility (stretching) program to see which one works better to improve physical health and work ability. Participants will: Perform short exercise breaks (5 minutes) at their workplace every day for 8 weeks. Attend one supervised session per week to learn the exercises. Complete simple physical tests (like standing up from a chair) and answer surveys about their health at the start and end of the study.

Enhancing Mental and Physical Health of Women Veterans

Women Veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 20 VA facilities from 4 regions.