Clinical trials

During exercise, working muscles require more oxygen. The heart meets this demand in two ways: by beating faster (heart rate) and by pumping more blood with each beat (stroke volume). Heart rate increases steadily with exercise intensity until exhaustion, but the amount of blood pumped with each beat tends to plateau at moderate intensities. Why the amount of blood pumped with each beat becomes limited before heart rate, however, is not well understood. Studying these mechanisms is difficult because most drugs that lower heart rate also affect how strongly the heart pumps, making it hard to separate the two effects. One medication that can help with this is ivabradine, which is used to treat people with heart disease who have high resting heart rates. It slows the heart rate without changing how strongly the heart pumps. This study will investigate whether ivabradine lowers heart rate during exercise in healthy younger and older adults, and whether a higher dose lowers heart rate more. The results will help us better understand how heart rate influences the heart's ability to supply oxygen to the body during exercise, and what limits the ability to exercise as people age. Participants will: * Attend three visits at SportsCardiologyBC in Vancouver * Complete a cycling exercise test at each visit to measure heart rate and how hard they can exercise * Take ivabradine (a heart-rate-lowering medication) before the exercise test at Visits 2 and 3 (a lower dose at Visit 2 and a higher dose at Visit 3) * Be monitored for side effects including slow heart rate, visual symptoms, and headache.

This study will compare mitochondrial function and leg blood flow during exercise in healthy endurance-trained females and males aged 19-35.

Shared decision-making (SDM) is the accepted ethical and legal standard for informed consent, but it is not known how it operates in anesthesia consent for cesarean delivery. Neuraxial anesthesia is recommended for most cesarean deliveries, and many anesthesiologists therefore present it as the only primary option, with general anesthesia (GA) available only as a rescue. Others present GA as a genuine alternative the patient can choose. This study will observe the existing variation in practice and will not change care. A trained observer will attend the pre-operative anesthesia consent encounter for women having an elective cesarean delivery at BC Women's Hospital and record which options were presented, using the observer-rated OPTION-5 instrument. Written research consent and a questionnaire follow 24-48 hours after delivery, and include the 9-item Shared Decision Making Questionnaire (SDM-Q-9). The primary aim is to compare patient-perceived SDM (SDM-Q-9) between consultations in which GA was offered as a genuine primary option and those in which it was not. This study hypothesizes that the SDM-Q-9 score will be higher when GA was offered as a primary option. Secondary aims are to describe observed SDM, decisional conflict, provider-level variation, and women's preference to be offered a choice in a future cesarean. The findings will inform a planned interventional trial of a standardized consent model.

This pilot study will examine how a single 25 mg dose of psilocybin affects nicotine craving in people with nicotine dependence. Following psilocybin administration, participants will complete repeated brain imaging (MRI) sessions that mimic the design and procedures of the SCANS (H24-02776) study they previously completed. This will allow us to compare craving and related brain activity before and after psilocybin. We will also explore changes in nicotine use, thoughts about nicotine, motivation to quit, and mental health symptoms. Findings will help inform the design of larger future studies of psilocybin for substance use.

Perimenopause is now considered a possible risk factor for dementia and may contribute to the fact that 2/3 of those living with Alzheimer's disease are females. Indeed, research studies show that middle-aged females demonstrate significant declines in their thinking abilities and detrimental changes in their brains as they go through perimenopause. Thus, perimenopausal females need strategies to bolster their brain health. The World Health Organization strongly recommends physical activity interventions to reduce the risk of decline in thinking abilities. However, whether exercise can improve thinking abilities and brain health in perimenopausal females has not been examined. Our research aims to address this important knowledge gap in female brain health. We will study the effects of a 6-month resistance exercise training (e.g., lifting free weights, exercise with weight machine) program on thinking abilities in 50 physically inactive perimenopausal females, aged 40 to 55 years, who are experiencing difficulties with their thinking abilities. In addition to measuring thinking abilities, we will determine if exercise benefits muscle health, heart health, sleep quality, psychological well-being, menopausal symptoms, and quality of life. We will also explore how resistance exercise training improves thinking abilities as such information can lead to new discoveries and therapies for brain health in females.

Cerebral palsy can make it difficult for children and adolescents to participate consistently in enjoyable physical activity. This study will examine whether a small humanoid robot called NAO can deliver a short, story-based active-play session that encourages movement and participation. Children and adolescents with cerebral palsy will complete one session at BC Children's Hospital. The study will assess whether the intervention is practical to deliver, acceptable to children and caregivers, and safe to use. Participants and caregivers will also provide feedback about their experience. The findings will be used to refine the intervention and plan a future larger trial.

This is a multi-centre, open-label RCT at four Emergency Departments (EDs) in British Columbia and Alberta. The purpose of the current study is to compare the effectiveness of buprenorphine/naloxone microdosing and standard dosing take-home induction regimens at enabling patients to successfully complete the induction regimen, and at retaining patients on opioid agonist therapy. We will randomize our enrolled patients to receive take-home microdosing or standard dosing packages of buprenorphine/naloxone. For the microdosing arm, patients immediately start taking low doses that increase to effective levels without requiring them to go into withdrawal. We hypothesize that ED patients provided buprenorphine/naloxone microdosing packages will be more likely to successfully complete the induction period compare to patients provided standard dosing packages. We furthermore hypothesize that those provided microdosing will be more likely to be retained in opioid agonist therapy, and will experience lower overdose, mortality, and healthcare utilization subsequent to their ED visit.

Prospective, single center study designed to assess blood biomarkers for classifying injury severity and predict neurologic recovery in traumatic spinal cord injured (SCI) patients. Study will also establish the accuracy of point to care devices for SCI blood biomarkers and support the biospecimen collection for the International Spinal Cord Injury Biobank (ISCIB).

This observational study will use intestinal ultrasound images to help develop computer programs that may make it easier to assess bowel inflammation. The study will include adults who are healthy or who are having an intestinal ultrasound as part of care for inflammatory bowel disease, such as Crohn disease or ulcerative colitis. Researchers want to find out whether a computer program can measure bowel wall thickness from ultrasound images as accurately as experienced ultrasound clinicians. They will also explore whether the program can identify other changes in the bowel. Participants will have an intestinal ultrasound as part of their usual care. People who agree to take part will allow the research team to use de-identified ultrasound images and a small amount of related health information. No medication, experimental treatment, or additional ultrasound procedure will be given for this study. The computer program will not be used to make decisions about a participant's care, and participants will not receive individual results from the program.

Cognitive impairment is common in Parkinson's disease. A recent study demonstrated 40% of people with PD suffer from mild cognitive impairment and \> 80% of patients develop dementia after a disease duration of 20 years. Cognitive impairment significantly impairs quality of life and has limited treatment options. While the pathophysiology of cognitive symptoms in PD is multifactorial, one contributing factor is dysfunction in subthalamic-cortical loops. The subthalamic nucleus (STN) receives input from distributed regions of the cortex, forming partially segregated parallel networks with sensorimotor regions, associative (cognitive) cortical regions, and limbic cortical regions. These subthalamic-cortical networks are thought to play a domain general role in inhibitory control, which is a fundamental mechanism underlying flexible behavior across motor, cognitive, and affective domains. Information processing in these subthalamic-cortical networks is expressed through oscillatory activity within distinct frequency bands. For example, communication between the STN and prefrontal regions involved in executive function is thought to occur through coherence in the theta (4-8 Hz) frequency band. As a result of these observations, stimulation of the STN at a theta frequency has been investigated as a method of modulating cognitive processes. Theta stimulation of the STN has been shown to enhance coherence in subthalamic-cortical networks, facilitating information processing and modulating behavior. For example, a recent study demonstrated that theta stimulation of the STN improved working memory performance in PD subjects, while no effect was seen for other frequency bands. The authors performed a post-hoc analysis and found that the effect may be mediated by connectivity between the stimulated STN region and the right dorsolateral prefrontal cortex (DLPFC). While these studies have demonstrated proof of principle, they are limited by small sample sizes and post-hoc analyses assessing the relationship between stimulation location and outcomes. Further research is needed to directly test the hypothesis that theta stimulation of the STN can improve executive control in PD patients by modulating associative STN circuitry.

The goal of this clinical trial is to optimize treatment strategies for patients with p53-mutant oral epithelial dysplasia (OED) and early-stage oral squamous cell carcinoma (OSCC). The main question it aims to answer is what the most optimal treatment is at each diagnostic stage. It is hypothesized that lesions with p53-abnormal low-grade dysplasia (LGD) without surgical intervention will progress to high-grade dysplasia (HGD) or SCC in 4 years. It is also predicted that a clear p53 and severe/CIS excision margins in patients with p53-abnormal HGD will reduce the progression to invasive SCC, compared to clear severe/CIS margins, within 4 years. Finally, it is thought that patients with p53-abnormal cT1N0 and DOI\<4mm receiving an END will have improved disease free and overall survival. This research will elucidate whether or not these hypotheses are correct. Participants in each diagnostic cohort will be assigned to one of two different treatment options, listed below: Cohort 1: A) No intervention, observation only B) Surgical excision with clear margins Cohort 2: A) Surgical excision with clear severe/CIS margins B) Surgical excision with clear severe/CIS and p53 margins Cohort 3: A) Surgical excision and elective neck dissection (END) B) Surgical excision and close follow-up, only salvage ND if development of nodal disease

The Problem: The proposed trial will address the problem of how to effectively prevent subsequent falls in community-dwelling cognitively frail older adults with a history of falls. Primary Question: In community-dwelling older adults with cognitive frailty and a history of falls, can a home-based exercise program with behavioural change techniques significantly reduce falls vs. health education (i.e., control; CON)?

Virtual Surgical Planning (VSP), where 3D modeling is used to create 3D-printed surgical guides, has been shown to improve outcomes for patients who undergo mandibular reconstruction surgery, usually due to invasion of cancer from the oral cavity to the jaw. This trial will directly compare the outcomes of patients who receive VSP versus patients who receive the current standard of care, which is Free-Hand Surgery (FHS). They will be randomized into either treatment at a 1:1 ratio and bony union rates will be compared between 12-month postoperative CT scans for each treatment group. Secondary objectives include comparing other short and long-term complication rates, reconstruction accuracy, quality of life, and functional outcomes of VSP and FHS. An economic analysis of VSP will also be performed.

The goal of this clinical trial is to learn whether radioguided surgery can help surgeons find and remove lymph nodes containing prostate cancer in men whose cancer has returned in a small number of lymph nodes after previous prostate cancer treatment. It will also learn about the safety of this approach, changes in prostate-specific antigen (PSA), quality of life, and longer-term cancer outcomes. The main questions the study aims to answer are: Does radioguided surgery increase the proportion of removed lymph nodes that are found to contain prostate cancer compared with standard surgery? How well do the lymph nodes identified on imaging scans match the cancer found when the removed lymph nodes are examined in the laboratory? Does radioguided surgery lead to a greater decrease in PSA after surgery? What side effects or surgical complications occur? How does each type of surgery affect quality of life, the need for additional cancer treatment, and the risk of the cancer spreading? Researchers will compare radioguided salvage lymph node surgery with standard salvage lymph node surgery. Salvage lymph node surgery is an operation to remove lymph nodes after prostate cancer has returned. Participants will: Be randomly assigned to one of two treatment groups. Have surgery to remove lymph nodes suspected of containing prostate cancer. If assigned to the radioguided group, receive a radioactive PSMA-targeting tracer called 99mTc-MIP-1404, undergo a SPECT/CT scan, and have surgery the following day. During surgery, the surgeon will use a handheld detector to locate lymph nodes that have taken up the tracer. If assigned to the standard-surgery group, have surgery planned using a standard PSMA-PET/CT scan, without the handheld radioguidance procedure. Have PSA blood tests, assessments for complications, and quality-of-life questionnaires after surgery. Be followed for cancer outcomes for up to two years.

The goal of this study is to find out if self-collected vaginal swabs can be used to detect early signs of uterine cancer or related conditions in people with Lynch syndrome (LS) who still have their uterus. The study also tests if people with LS are willing and able to collect these samples themselves and whether they find the process acceptable. The main questions this study asks are: * Will people with LS take part in self-collection of vaginal samples, and do they find it acceptable? * Can vaginal DNA mutations predict cancer risk or match results from other genetic or biopsy testing? * Can a cancer risk model used in the general population also help identify risk in people with LS? Participants will: * Answer a health questionnaire about lifestyle and symptoms * Collect their own vaginal swabs and measure their vaginal pH at home using a self-collection kit * Complete short surveys around the time of self-collection and at the end of the study

The goal of this randomized controlled trial is to investigate the effectiveness of a health-coaching intervention to improve physical activity in older adults with limited mobility when compared to a control, health education group.

Communication impairment is common among critically ill patients who are mechanically ventilated, have tracheostomies, or have neurological injuries such as spinal cord injury. In acute care settings, inability to communicate contributes to patient distress, impairs symptom assessment, and may delay care. Although a range of communication supports exist, many are difficult to use in patients with severe weakness, limited endurance, or fluctuating cognition. More advanced assistive communication systems, including eye-tracking and brain-computer interface platforms, have shown promise in chronic neurological populations but have not been well adapted to the practical realities of acute care. This study will use a sequential exploratory mixed-methods design to better understand communication barriers in acute care from the perspective of frontline healthcare providers. In the qualitative phase, semi-structured interviews will be conducted with nurses and speech-language pathologists working with patients who have spinal cord injury, tracheostomy, or other causes of impaired verbal communication in ICU and related acute care settings. Findings from these interviews will inform development of a structured survey to be distributed to a broader group of nurses and speech-language pathologists. Qualitative and quantitative findings will then be integrated to identify priority communication needs, limitations of current strategies, and practical requirements for future assistive communication tools. Findings will inform development of clinically relevant communication solutions for acute care environments.

This study aims to test a new treatment called hyperbaric oxygen therapy (HBOT) for a severe type of inflammatory bowel disease called perianal Crohn's disease (PCD). PCD causes painful perianal infections and chronic drainage from fistula tracts, and current treatments are only moderately effective and may not be suitable for all patients. HBOT is a safe and commonly used treatment for chronic non-healing wounds and other conditions. Previous studies have suggested that HBOT may help heal fistulas in PCD patients, but these studies were small and lacked controls.

The aim of this study is to test the hypothesis that low-frequency rTMS (LFR) works as well as the established intermittent thetaburst rTMS (iTBS) treatment for treatment resistant depression (TRD).

Choose to Move (CTM) is a 3-month, choice-based health-promoting program for low active older adults being scaled-up across British Columbia (BC), Canada. Recently, the investigators adapted CTM for the \>14000 people in BC who are on surgical waitlists for total knee replacement or total hip replacement (TKR/THR) for osteoarthritis (OA). The primary goals of this observational study are to describe how the adapted program, Choose to Move Replacement Ready (CTM-RR), is implemented in BC and determine if the adapted program improves health outcomes in people with hip and/or knee osteoarthritis who are on surgical waitlists for TKR/THR. The investigators will also evaluate whether any health benefits achieved by CTM-RR participants are maintained three months after they finish the program and also during the remaining time that they wait for their TKR/THR surgery. The investigators will work with referral partners from hospitals and orthopaedic clinics in BC to recruit participants into CTM-RR. Participants who enrol in CTM-RR will answer online survey questions about the program and about their physical activity, mobility, pain, function, quality of life, willingness to undergo surgery, overall perception of their joint condition, psychosocial health, self-efficacy, social isolation, loneliness, and sedentary time. CTM-RR activity coaches will also answer online survey questions about the program. CTM-RR participants, activity coaches, and referral partners will also participate in interviews about the program.

The purpose of this study is to develop a new tool that uses information collected before life-sustaining treatments are withdrawn to better predict whether a patient will die within the time needed for organ donation to be possible. The tool created should help improve planning for organ donation and provide families and healthcare teams with more accurate information.

The objective of this study is to see if providing an appropriate therapy based on the genomic testing of prostate tumour tissue will result in an improved clinical response. Each participant will be treated with 8 weeks of a luteinizing hormone-releasing hormone agonist (LHRHa) plus apalutamide (APA) while genome sequence characterization is being done. Participants with biopsy specimens deemed unevaluable for genomic testing will remain on LHRHa plus APA for an additional 16 weeks. Participants with evaluable tissue will be assigned to one of the open-label sub-studies on the basis of genomic profiling results. Within each group, they will be randomized to a specific treatment arm either LHRHa plus APA alone or adding abiraterone acetate and prednisone, docetaxel or niraparib. The study will evaluate the response rate and outcomes after radical prostatectomy in each arm of the trial.

Perioperative neurocognitive disorders are common after surgery and pre-existing cognitive impairment is an important risk factor. Current guidelines recommend identifying cognitive impairment before surgery; however, screening remains inconsistent, particularly when preoperative assessments are performed remotely. This prospective observational diagnostic validation study aims to determine whether a modified Mini-Cog cognitive screening tool administered by telephone can reliably identify cognitive impairment in patients aged 65 years and older undergoing preoperative assessment. Telephone-based modified Mini-Cog results will be compared with standard in-person Mini-Cog assessments to evaluate agreement and feasibility. This study may improve access to preoperative cognitive screening and support optimization of surgical care for older adults.

Vaginismus, a condition characterized by involuntary tightening of the pelvic floor muscles due to strong fear of vaginal insertion, impact ≥6% of the female population and can make vaginal intercourse and medical exams difficult. This project explores virtual reality exposure (VRE) as a new treatment approach. Building on our two previous studies showing that VRE is feasible and effective in helping patients to gradually face feared sexual encounters in a virtual environment, we aim to implement our VRE protocol at the BC Centre for Vulvar Health (BCCVH). We will assess barriers/facilitators to implementation, clinician uptake, and patients' outcomes and engagement.

Small Steps for Big Changes (SSBC) is a diet and exercise counselling program that significantly reduces the risk of developing Type 2 Diabetes (T2D). In partnership with YMCAs in Canada spanning 8 provinces, the aim of this study is to scale-up program delivery and evaluate the implementation and effectiveness of SSBC. To evaluate implementation, the number of staff trained/patients enrolled, attendance, sessions delivered as planned, delivery costs, and number of sites continuing to deliver the program will be examined. To evaluate program effectiveness, changes in patient health (e.g., T2D status, blood glucose, weight, exercise, diet) will be measured over 2 years following program completion.