Clinical trials

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purpose of this study is to develop a new tool that uses information collected before life-sustaining treatments are withdrawn to better predict whether a patient will die within the time needed for organ donation to be possible.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.

During a cesarean delivery (C-section), most patients are awake and receive spinal or epidural anesthesia to block pain from the lower body. Even when this anesthesia works well, many patients still feel sensations during surgery, such as pulling, pressure, tugging, or, in some cases, pain. In the past, studies have mostly focused on whether patients felt "pain," and have often relied on patients remembering their experience afterward or on the surgical team's judgment of how the patient was doing. These approaches can miss sensations that bother the patient but are not clearly described as pain, and they may not reflect what the patient actually wanted done at the time. This study takes a different approach. Instead of asking only about pain, the researchers will ask patients, in real time during their C-section, what they are feeling in their own words, and whether they would like the medical team to do something about it (such as giving medication). The main idea is that the patient's own request for help, rather than someone else's opinion about how severe a sensation is, should be what counts as a moment that matters. The main purpose of the study is to find out how often patients undergoing a planned C-section ask for medication in response to a sensation they feel during surgery. The researchers will ask each patient at six specific points during the operation whether they feel any sensation, how they would describe it, and whether they would like the team to act. Patients will also rate how strong each sensation is and point to where on the body they feel it. All decisions about care will remain entirely with the patient's own medical team; the research team only records what the patient reports and what care is given. The study is also designed to answer several related questions: * What words and descriptions do patients naturally use for the sensations they feel during a C-section? * How often are sensations that patients do not call "painful" still bothersome enough that the patient asks for medication? * How do patients' feelings and mental health change over the first six months after delivery, including symptoms of post-traumatic stress, depression, and birth-related distress? * Does a patient's anxiety before surgery affect what they feel during surgery or how likely they are to ask for help? The main question the study is trying to answer is: How often do patients undergoing a planned cesarean delivery ask for medication because of something they feel during the operation? The researchers' hypothesis is that this number will be higher than what earlier pain-focused studies have reported. Specifically, they expect that more than 11.5 percent of patients will ask for medication during surgery, which is greater than the rate of pain requiring extra medication found in a similar previous study. If correct, this would suggest that the true number of patients who experience moments during a C-section when they want help has been underestimated by traditional methods that focus only on pain. This is an observational study. It does not test a new drug or change how anesthesia or surgery is performed. Instead, it carefully observes and records patients' experiences in order to better understand what patients feel during a cesarean delivery, how often they want the team to act, and how these experiences relate to their recovery and emotional well-being afterward. The goal is to use this information to improve the comfort, care, and long-term well-being of patients having a C-section.

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.

The study consist of 3 interventional periods which will be completed by each consenting participant in a randomized, crossover fashion. The interventional periods will be separated by a minimum 1 week washout period. One of the interventions consists of 4 days of daily supplementation with the commercially available broccoli sprout extract capsules (BrocElite). Another intervention will consist of 4 days of daily supervised treadmill running. The exercise protocol consists of 4 minutes of high-intensity running running followed by a 3 minute recovery period, repeated for a total of 4 repetitions. The last intervention combines the above two and consists of 4 days of daily supplementation and daily supervised exercise training. Before and after each intervention, basic anthropometrics (weight, heart rate, and blood pressure) will be recorded, and a venous blood sample will be collected. Blood samples will be analyzed for metabolic and inflammatory markers. Participants will be asked to refrain from structured exercise, alcohol consumption, and broccoli consumption during each of the experimental periods. Before any testing, willing participants will provide informed consent, and fill out a few demographic, and lifestyle questionnaires. The study will be conducted at the University of British Columbia in Kelowna, BC, Canada.

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 Access my Breast Cancer Care application was developed by a multidisciplinary team with the intention of providing breast cancer patients with a centralized area to navigate their journey. Several of the research team members (Dr. Macadam, Dr. Isaac, Selena (CNS) and Pauline (CNS)) provided clinical expertise to ensure accuracy of clinical content. The application houses educational resources, a calendar, symptom tracker, customizable care pathway, community forum and a chat feature. The study will be designed as a randomized controlled trial (RCT) to measure the effect of the application on patient-centered outcomes of 1) satisfaction with care 2) reduction in adverse events, 3) usability. The investigators will conduct focus groups to understand the benefit of the app from the patient perspective.

Leucine is an essential amino acid, which serves a special purpose of signaling cell growth in muscle in addition to making up protein. Essential amino acids like leucine need to be eaten every day from our foods like meat, dairy, eggs, beans, and nuts, as they cannot be made by our bodies. The current recommendation for leucine in the diet of school-age children are based upon adult needs. This study will measure the leucine requirement in children aged 6-10 years old using an non-invasive technique with special diets, safe stable isotopes, and simple breath collections. Creating guidelines based on measured requirements for leucine in this age group is essential for supporting optimal growth in healthy children.

Respiratory syncytial virus (RSV) is the leading cause of hospitalization in young infants in Canada. While most babies recover, RSV can cause severe breathing problems and place major stress on families and the health system. Infants born to pregnant women and people with HIV, even if they do not acquire the virus, face higher risks of RSV illness. This is partly because HIV increases the chance of preterm birth and can reduce the amount of protective antibodies passed to the baby during pregnancy. Two new tools now exist to prevent RSV. One is a vaccine given in late pregnancy (RSVpreF), which boosts antibodies that cross the placenta and protect the baby at birth. The other is a long-lasting antibody (nirsevimab) given directly to infants after delivery. Both work well in the general population, but pregnant people living with HIV were excluded from the original studies. Health care providers therefore do not know if perinatal vaccination provides enough protection for these babies. This study will follow 20 pregnant women/people with HIV at BC Women's Hospital who receive the RSVpreF vaccine. Antibody levels will be measured before and after vaccination from the pregnant recipient, and in infant blood sample, to see how well protection is transferred to infants. We will also assess vaccine safety, birth outcomes, and parental views on RSV immunization. Findings will guide Canadian policies to ensure that all infants, including those exposed to HIV, have equitable access to RSV protection.

The goal of this clinical trial is to learn whether immersive virtual reality (VR) reduces pain and anxiety in children aged 6-12 years during routine dental procedures. The main questions it aims to answer are: * Does VR distraction reduce self-reported pain and anxiety during dental treatment compared to standard behaviour guidance? * Does VR distraction improve children's post-procedural experience and willingness to return for future dental visits? Researchers will compare children using a VR headset during dental treatment to children receiving standard behaviour guidance techniques. Participants will: * Attend one routine dental appointment * Be randomly assigned to wear a VR headset or receive standard care during their procedure * Complete brief questionnaires about pain and anxiety before and after treatment * Receive a follow-up phone call 24-72 hours after the appointment

To conduct a randomized control trial to determine the impact of 6-weeks of blood flow restriction training on immune cell function and bioenergetics in adults living with type 2 diabetes.

This prospective observational study will evaluate pain outcomes in patients with neuropathic dental pain (Atypical Odontalgia/Phantom Tooth Pain) who undergo directional deep brain stimulation (DBS). Participants will complete validated pain, disability, quality-of-life, and mood assessments before surgery and following DBS programming. Directional stimulation will be applied to different thalamic targets to determine whether specific stimulation settings are associated with greater pain relief. The study aims to characterize changes in pain and quality of life following DBS and to identify the stimulation target associated with the greatest reduction in neuropathic dental pain.

The goal of this clinical trial is to learn if a shared decision-making tool called SHARE-HF can help more people with heart failure receive guideline-recommended medications. The study includes adults with a type of heart failure called heart failure with reduced ejection fraction (HFrEF), who attend heart function clinics in British Columbia, Canada. The main question it aims to answer is: \- Does use of SHARE-HF during clinic visits lead to more participants receiving their recommended heart failure medications after 6 months? Researchers will compare clinics using the SHARE-HF tool to clinics providing usual care to see if the tool helps more participants get their recommended medications. Participants will use the SHARE-HF web-based tool with their clinician during regular clinic visits. The tool shows participants how their heart failure may affect their health over time, explains their medication options, and helps them and their clinician make treatment decisions together.

Respiratory Syncytial Virus (RSV) is a main global cause of respiratory illness and death in infants. Previous infant vaccine trials have failed to demonstrate protection. Moreover, RSV infection during early infancy, particularly in infants younger than 4 months of age, is associated with more severe disease, reduced immune protection, and an increased risk of developing childhood asthma. This study aim to investigate the immunological and long-term health effects of a first exposure to RSV early (\<4 months) versus late (\>6-9 months) in infancy.

This study is an observational multi-country cohort study that aims to build algorithms that can identify children between 5 and 16 years of age admitted for proven or suspected sepsis who are at risk of mortality after they are discharged in East Africa. In low- and middle-income countries, about 5% of children discharged after hospitalization for sepsis will die in the weeks after returning home. Doctors and parents are often unaware of this period of vulnerability and are poorly equipped to identify or handle this critical situation. This project builds on past work that developed and evaluated models and the Smart Discharges program to predict, during hospitalization, an individual child's risk of recurrent illness and mortality, as well as to provide additional post-discharge support to at-risk children. Participants will be enrolled from facilities once they are admitted, collecting clinical and social variables. They will then be followed until 6 months post-discharge to understand what happens to them after they return home. This data will be evaluated to identify which variables collected at facilities can be predictive of mortality and recurrent illness after discharge.

health problems, such as heart disease, diabetes, cognitive impairment, and dementia. After a person suffers a stroke, they often experience difficulties in getting a good night's sleep. Approximately half of stroke survivors have insomnia, or have trouble falling and/or staying asleep. Poor sleep quality among stroke survivors increases the risk of recurrent stroke by 3-fold and the risk of early death by 76%. Hence, stroke survivors need strategies to promote better sleep. Fortunately, evidence shows that sleep quality can be improved with exercise, even among those who struggle with insomnia. Whether exercise training can improve sleep quality in adults with chronic stroke (i.e., at least 12 months has passed since their stroke) and poor sleep quality is not known. In addition, it is unknown if improved sleep is associated with improved outcomes in those with chronic stroke. This study will specifically evaluate the effect of twice-weekly targeted exercise training on sleep quality over a 6-month period in persons with chronic stroke and poor sleep quality. This study will also evaluate the effect of exercise on the following outcomes: 1) sleep structure; 2) fatigue; 3) daytime sleepiness; 4) mood; 5) physical function and capacity; 6) thinking abilities; 7) heart health; and 8) quality of life. Finally, this study will examine how changes in sleep quality may be related to changes in these outcomes. Our proposed research is timely as the importance of sleep to recovery, health, and wellbeing post-stroke is increasingly recognized.

This study aims to test whether a short liquid-based diet, followed by a low-sulfur eating plan, is safe, manageable, and helpful for people with mild to moderate ulcerative colitis. Investigators want to see if this approach can improve gut health, lower inflammation, and reduce symptoms. Investigators will also test breath samples as an easy, non-invasive way to track gut bacteria activity and disease changes. Investigators believe this diet plan can reduce harmful gut bacteria that produce irritating sulfur compounds, leading to better gut health and measurable improvements that can be detected through breath testing.

This study aims to evaluate the feasibility, safety, and cost-effectiveness of opportunistic salpingectomy (OS-the removal of the fallopian tubes) at the time of laparoscopic cholecystectomy (the removal of the gallbladder) to prevent ovarian cancer. Ovarian cancer is the fifth leading cause of cancer-related mortality in females in Canada. OS can prevent the most common and lethal type of ovarian cancer, high-grade serous carcinoma (HGSC). OS during gynecologic surgery (hysterectomy or instead of tubal ligation) is safe and effective. However, rates of hysterectomies and tubal sterilization are decreasing. This research team aims to extend the prevention of ovarian cancer by expanding to offer OS during other surgeries in the abdomen, when patients are already undergoing a surgical procedure. This study will examine: 1) the feasibility of OS at the time of laparoscopic cholecystectomy; 2) the safety of OS at the time of laparoscopic cholecystectomy; 3) any health services consequences of offering OBS during laparoscopic cholecystectomy. The hypothesis is that OS at the time of laparoscopic cholecystectomy is a feasible, safe, and cost-effective primary prevention strategy for ovarian cancer. It is also hypothesized that there will be 10-20 minutes of additional operating room time for completing OS, and that integrating the identified partners and knowledge users, as well as adding relevant knowledge users as the project progresses, will affect the rapid mobilization of our findings.

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

Persistent memory symptoms after concussion are common, and likely perpetuated by unhelpful illness beliefs and coping behaviors. Results from a pilot study suggested that traditional cognitive rehabilitation and a novel cognitive-behavioral therapy (CBT) protocol were both associated with improvements in subjective memory functioning. The present study will more definitively compare the effectiveness of these interventions for improving subjective memory functioning after concussion.

Shoe-worn insoles (also known as orthotics) can provide symptomatic relief for people with knee osteoarthritis. However, given they act at the feet, and given that many people with knee osteoarthritis also report foot pain, it is important to assess the effects of these devices at both joints. We will conduct a multi-centre randomized pilot trial to determine feasibility and preliminary efficacy.

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.