Clinical trials

This is a phase 1 clinical trial investigating the use of low-energy Transcranial Ultrasound Stimulation (TUS) to treat Tourette Syndrome (TS). Objectives and Background. TS is a neurodevelopmental condition marked by motor and vocal tics that often resist standard pharmacological or behavioral treatments. Current neuromodulation options like Deep Brain Stimulation (DBS) are invasive, while non-invasive methods like TMS lack the precision to reach deep brain structures. The study aims to: 1. Evaluate tolerability: Assess TUS safety in older adolescents and adults with TS. 2. Test efficacy: Compare TUS at the intralaminar thalamic nuclei (CM/Pf/Voi) and the supplementary motor area (SMA) against a sham treatment to see if it reduces tic frequency and severity. 3. Optimize protocols: Determine if dual-target or multiple-session stimulation is more effective than single-target or single-session protocols. TUS uses low energy, pulsed, focused ultrasound to induce transient neuromodulatory responses lasting up to 60 minutes. TUS can precisely target deep structures like the thalamus. Study Methods * Design: A phase 1, double-blind, crossover trial. * Participants: 20 individuals (ages 16+) with a diagnosis of TS and significant tic severity (YGTSS score \> 22 or sub-score \> 15). * Procedure: Participants receive four different modalities over four separate weeks, with 7-day washouts: * TUS of the CM/Pf/Voi only. * TUS of the SMA only. * Combined TUS of both targets. * Sham TUS. * Evaluation: The primary endpoint is the percent change on the Rush Video-Based Tic Rating Scale (RVBTRS). Secondary measures include the Yale Global Tic Severity Scale (YGTSS) and the Premonitory Urges for Tics Scale (PUTS). Because TUS requires extreme precision to hit deep brain targets, every participant undergoes a comprehensive imaging protocol using a 3T GE UHP scanner. * Mapping the Targets: We use Diffusion Tensor Imaging (DTI) and Tractography to locate the specific "wiring" of the individual's brain. This allows to find: * The CM/Pf/Voi (Centromedian-parafascicular complex) in the thalamus. * The SMA (Supplementary Motor Area) in the cortex. * Precision Imaging: High-resolution 1 mm-isotropic T1-weighted, T2-weighted, and Zero Echo Time (ZTE) images are used. ZTE is particularly important as it helps the BabelBrain software account for the thickness and density of the skull, which can deflect ultrasound waves. * Real-Time Tracking: During the actual stimulation, the team uses a Brainsight neuro-navigation system. This acts like a GPS, using the patient's MRI "map" to ensure the ultrasound transducer is perfectly aligned with the target. Innovation This is the first human study to apply TUS to TS patients. By targeting both deep and cortical regions independently or simultaneously, the researchers aim to modulate the "network-level" connectivity implicated in tic generation. Technical Ultrasound Parameters The study uses a custom 128-element phased-array transducer (Sonic Concepts H317) to deliver TUS. * Core Settings: * Frequency: 250 kHz. * Intensity: spatial-peak pulse-average intensity (ISPPA) of 10 W/cm2 * Targeting \& Safety: * BabelBrain Software: Calculates real-time acoustic simulations to correct for bone aberrations and ensure the Mechanical Index (MI) stays below 1.9 and thermal rise remains under 2°C. * Electronic Steering: Allows the focal spot to be moved without physically repositioning the device, enabling coverage of large areas like the SMA or deep structures like the CM/Pf/Voi complex. * Biological Protocols: * Inhibitory: pulse repetition frequency (PRF), 10% duty cycle, lasting 120 seconds. * Excitatory: "theta burst" PRF, 10% duty cycle, lasting 80 seconds. Clinical Assessment Criteria The trial employs three main scales to capture both objective tic data and subjective patient experiences: 1. Rush Video-Based Tic Rating Scale (RVBTRS): * The Primary Measure: This is the only validated tool that provides an objective assessment by analyzing 10-minute video recordings. * Method: Two blinded evaluators count tics and rate their severity across two views: a close-up (head/shoulders) and a full-body frontal view. * Focus: It specifically measures the patient's ability to actively inhibit tics during the recording. 2. Yale Global Tic Severity Scale (YGTSS): * The Gold Standard: A clinician-rated interview that assesses symptoms over the prior 7-10 days. * Scoring: It rates motor and phonic tics separately on five dimensions: number, frequency, intensity, complexity, and interference. * Baseline Requirement: To participate in the trial, patients must have a total tic severity score of at least 22 (or a sub-score of 15). 3. Premonitory Urges for Tics Scale (PUTS): * Self-Report: A 9-item questionnaire where patients rate the intensity of pre-tic sensations (like pressure, itchiness, or tension) on a scale of 1 to 4. * Interpretation: Scores range from 9 to 36; higher scores reflect more distressing urges.

The goal of this clinical trial is to assess whether microwave scans can depict the presence of implants in the breast in women with existing breast implants that were surgically placed at least 6 months ago. The main questions it aims to answer are: 1. Can a microwave imaging device effectively scan a breast containing implants? 2. Can the presence of implants be identified in a microwave scan? 3. Can the microwave scans of the left and right breasts be compared to assess whether similarity is observed?

The goal of this study is to measure the prevalence and risks of hyperglycemia in surgical patients with prediabetes. The main questions it aims to answer are: * What is the prevalence of hyperglycemia in surgical patients with prediabetes? * What is the relative risk of postoperative complications associated with hyperglycemia? To answer these questions, surgical patients with prediabetes will undergo universal glucose measurement in the perioperative period. Glucose data will be analyzed in conjunction with electronic health record (EHR) data describing patient outcomes.

This is a parallel arm randomized (1:1) controlled trial. Adolescents aged 12-17 years (n=228) who are starting or changing a selective serotonin reuptake inhibitor (SSRI) for depression and/or anxiety will be randomly allocated to receive 12-weeks of pharmacogenetic-guided antidepressant therapy (experimental intervention) or current prescribing guidelines/recommendations guided therapy (control intervention).

The purpose of this research study is to evaluate whether or not adding a Transversus Abdominis Plane Block (TAP block) improves pain control for patients having a cesarean section. A TAP block is a type of nerve block where at the end of the surgery an injection of a long acting local anesthetic is made into the abdominal wall. In studies in patient's having other abdominal surgeries this has reduced the amount of narcotics patients need for pain control. This may also led to patients being more active after surgery and maybe spending less time in hospital.

Background: After heart surgery, patients require temporary chest tubes - plastic drains placed inside the chest to prevent fluid building up around the heart and lungs. These tubes are often very painful and can limit breathing, coughing, and movement, which necessitates usage of painkiller medication (opioids and non-steroidal anti-inflammatory drugs (NSAIDs)) that have negative side effects and can prolong hospital recovery. Despite this common problem, routine care lacks simple, add-on strategies that directly numb pain at the chest tube sites rather than relying solely on whole-body painkiller medicine. Purpose: To determine whether injecting a long-acting numbing medicine (bupivacaine 0.5%) through chest tubes safely reduces pain and lowers opioid and NSAID use compared with placebo. Objective: With ethics approval, data access, and study procedures already in place before May, the specific objective for this studentship is to collect and analyze data to evaluate the short-term effect of bupivacaine versus placebo on: * Mean pain scores from initial recovery to chest tube removal * Total mean opioid and NSAID use Methods: This single-centre, 1:1 block randomized, double-blind, placebo-controlled trial will enroll 60 adults undergoing coronary artery bypass (procedure to bypass blocked blood vessels supplying heart muscle using healthy blood vessels) at the Foothills Medical Centre. Patients receive either 10 mL bupivacaine 0.5% or normal saline (saltwater placebo) through chest tubes by heart surgeons whenever pain hits ≥3/10 using the Numeric Rating Scale (0 = no pain; 10 = most intense pain), from initial recovery to chest tube removal. Standard pain care will continue for all patients. The study team will record pain scores, opioid and NSAID doses, and any side effects for each group. Interval pain reduction will be measured 30, 60, 120 and 240 minutes post injection. Mean pain reduction and total painkiller use will be compared between the two groups.

Post-operative atrial fibrillation is a common problem post cardiac surgery with rates exceeding 30%. Atrial fibrillation has multiple adverse effects on cardiac hemodynamics and can lead to hypotension, diminished end organ perfusion and lengthen the stay in ICU. Amiodarone is the medication of choice used for pharmacological cardioversion and can be used with vasoactive medications. Intravenous amiodarone is associated with hypotension and end organ perfusion requiring escalation in vasoactive support. Vernakalant is novel anti-arrhythmic agent approved in Canada for cardioversion of atrial fibrillation that primarily works on atrial channels and has no effect on contractility or vasodilation. Clinical trials have proved good efficacy of Vernakalant in conversion of paroxysmal atrial fibrillation however there is no comparison of Amiodarone to Vernakalant in post-operative cardiac surgery. We plan to perform a clinical trial comparing Vernakalant to amiodarone in post-cardiac surgery patients with a primary outcome of cardioversion at 90 minutes. Secondary outcomes will follow duration of vasoactive medications, days in ICU and economics.

The goal of this clinical trial is to determine how strengthening the hamstring muscles affects the knee joint in people living with hypermobility spectrum disorders (HSD) and hypermobile Ehlers-Danlos syndrome (hEDS). The main questions it aims to answer are: * Does hamstring strengthening reduce the looseness of the knee joint in HSD/hEDS? * Does hamstring strengthening improve clinical outcomes like pain in people living with HSD/hEDS? Participants will: * Attend two exercise classes per week for 12 weeks. * Visit the laboratory every 4-6 weeks for testing.

The purpose of this study is to determine the importance of the acute subjective experience induced by psilocybin (the primary component of "magic mushrooms") in facilitating positive outcomes. Participants in this study will be given psilocybin in combination with either a placebo or risperidone, an atypical antipsychotic that block the subjective effects of psilocybin.

The purpose of this study is to learn whether having Thyroid GuidePx® test results available before treatment may help patients with papillary thyroid cancer and doctors make better-informed treatment decisions.

This is a retrospective, observational study using routinely collected information collected by Alberta Health Services. The study will identify patients with chronic disease, defined by one or more of the following conditions; diabetes mellitus, heart failure, coronary artery disease, chronic kidney disease, or chronic lung disease. Adult residents of Alberta with a chronic disease of interest present upon hospital admission and who survive to hospital discharge will be included in the study cohort. The primary outcome will be the composite of hospital readmission or death within 30 days of discharge. Secondary outcomes will include components of the composite, length of stay, patient experiences related to their hospital to home transition of care, and processes of care. Multi-level interrupted time series analysis will be used to compare outcomes before versus after implementation of the Connect Care CIS.

The goal of this observational study is to generate a comprehensive, multi-dimensional dataset of health indicators collected from girls and women (aged 10 years and older) with and without ADHD across the lifespan. Participants will be asked to complete a detailed survey about hormonal and developmental life phases, ADHD status and symptoms, childhood experiences, health and well-being, and psychosocial outcomes.

The objective of this study is to determine if early high volume intravenous fluid administration (hyperhydration) may be effective in mitigating or preventing complications of shiga toxin-producing E. coli (STEC) infection in children and adolescents when compared with traditional approaches (conservative fluid management).

Current clinical guidelines, such as those from the Surviving Sepsis Campaign and ARDSNet, recommend short-term NMBA use for patients with moderate to severe ARDS who exhibit persistent ventilator dyssynchrony or high plateau pressures despite deep sedation . However, they do not provide clear recommendations regarding the mode of administration. As a result, clinicians are left to extrapolate from limited or indirect evidence, which may lead to practice variation, uncertainty, and suboptimal care. This pilot randomized controlled trial is designed to directly address this critical gap by comparing intermittent bolus administration versus continuous infusion of NMBAs in a pragmatic, real-world ICU setting. The study will assess feasibility metrics necessary to plan a definitive trial and generate preliminary clinical data on safety and effectiveness. By clarifying the comparative benefits and risks of each approach, the results may influence practice guidelines, reduce variation in care, and improve patient outcomes and reduce practice variation.patient outcomes, optimize resource use, and inform future guidelines on the management of moderate to severe ARDS.

The goal of this randomized controlled trial is to evaluate the efficacy of psilocybin administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce post-traumatic stress disorder (PTSD) symptom burden in adult (aged 18-65) survivors of intimate partner violence (IPV). This trail will test the following 2 aims: AIM 1 : To compare the efficacy of a therapeutic psilocybin dose at improving outcomes on the PCL-5 and CAPS-5 as compared to an active control psilocybin dose in IPV survivors with chronic PTSD. AIM 2: To evaluate the efficacy of psilocybin on quality of life, cognitive function, motor ability, depression, anxiety, and cognitive flexibility. Participants will be asked to: * Complete a 2 part screening process * Attend a baseline assessment * Complete a psychoeducation preparation session(s) * Attend psilocybin administration session (receive high dose \[25mg\] or low dose psilocybin \[1mg\]) * Complete 5-6 weekly sessions of ACT * Repeat outcome measures at 1-week, 4 weeks, 3 months (online questionnaires only), and 6 months post-psilocybin administration.

Many people with kidney disease also have heart disease. The procedures used to diagnose and treat heart disease (e.g., angiograms, angioplasty, or surgery) can improve symptoms and cardiovascular outcomes, but pose greater risks of kidney complications for people with chronic kidney disease. It's therefore important that patients with kidney disease and their health care providers understand the benefits versus risks of these procedures and use that information to make informed decisions regarding their health care. Prior research done with patients with kidney disease and their health care providers has led to the develop of a decision aid designed to help doctors provide personalized information on the benefits versus risks of having a heart procedure, as well as help patients communicate their own values and preferences to their doctor. This information is crucial for shared decision making, as previous research has shown that preferences and values vary for individual patients with kidney diseases, and should be incorporated into the decision-making process for heart disease management. The decision aid, called "My Heart Care and CKD", supports shared decision-making between patients with kidney disease and heart their care providers. This trial will implement and evaluate this decision aid within cardiovascular care in a pilot trial in Canada.

Method: Randomized Controlled Trial Study Duration: 3 Years Study Centre(s) University of Calgary and University of Alberta Objectives: To fill care gaps by implementing strategies to reduce length of hospital stay, readmission rates, and improve long-term outcomes after Acute Kidney Injury (AKI). Number of Participants: Three Hundred and fifty four (n=354) Diagnosis and Main Inclusion Criteria: Hospitalized adults with AKI at high risk of hospital readmission or death Study Intervention: Multi-component Digital Health Solutions, including: 1. Computerized Clinical Decision Support (CDS) and 2. Virtual Care Delivered through Hospital at Home (VC) Duration of administration: Determined by the Patient's clinical team Reference therapy: Usual Care Statistical Analyses: Descriptive Analysis, Regression

Investigators recently developed the APPROACH electronic patient reported outcome (ePROM) Survey and Clinician Report tools to collect individual results from online quality of life and health status surveys for patients with coronary heart disease, and report them back to their treating clinicians. This pilot interventional study uses a pre-post design to assess whether implementing the ePROM system into routine care is feasible and acceptable to patients and physicians, and to inform feasibility for a larger clinical trial. Specifically, the investigators aim to evaluate use of the ePROM Patient Survey and Clinician Report among eligible outpatients with known or suspected coronary artery disease and their cardiologists. Additionally, the investigators aim to determine if the use of the APPROACH ePROMs Clinician Report in routine medical encounters is acceptable (based on administrative burden, ease of use, and time required) to patients and clinicians, and supports effective communication for management of symptoms of coronary artery disease.

Attention-Deficit/Hyperactivity Disorder (ADHD) is characterized by poor attention, impulsivity, hyperactivity and emotional-motivational dysregulation. Here, we will test if theta burst repetitive transcranial magnetic stimulation (rTMS) can reduce the symptoms of ADHD.

The purpose of this study is to identify pharmacogenetic profiles associated with selective serotonin reuptake inhibitors (SSRI)-induced behavioral disinhibition in children with Major depressive disorder (MDD), anxiety disorders and/or obsessive-compulsive disorder (OCD) that could be used clinically to reduce the incidence of this adverse event and improve health outcomes.

Health education and self-management support are key facilitators of health behaviours. Moxie is a mixed media, self-management, education and support program for Albertans living with cardiovascular-related chronic conditions. Moxie is built upon our previous work within the ACCESS study (2015-21, n=4761), a RCT that previously tested the Moxie intervention in Alberta. Results demonstrated that MOXIE reduced the rate of hospitalizations (notably for hypertension, angina, hyper/hypoglycemia, heart failure decompensation, and acute kidney complications) by 34% in a population of low-income seniors living with cardiovascular-related chronic conditions. However, before Moxie can be effectively implemented province-wide, another trial is necessary to determine whether benefits can be observed in a larger cohort of patients with cardiovascular-related chronic conditions recruited immediately after hospital discharge (n=9000). Furthermore, the effectiveness of the two components of the ACCESS trial intervention will be assessed individually: (a) The Moxie Program, a tailored health and disease education component developed by a user-experience-centric design process incorporating patients, behavioural scientists, disease specialists, health system administrators and marketing/advertising professionals; and (b) the facilitated relay of clinical information to healthcare providers (letters). The trial is designed as a 2x2 factorial pragmatic, individual-level randomized pragmatic trial of these different interventions. This would yield the following groups: 1. Moxie SMES Program 2. Facilitated Relay 3. Moxie SMES Program and Facilitated Relay 4. True control Self-management education and support (SMES) intervention: This includes weekly physical mailers sent directly to patients' homes throughout the study containing information about chronic conditions, medication use, diet, physical activity, smoking cessation, and self-management/wellness principles. These messages will be refined by the social impact creative design partner and reviewed by clinicians and patients to ensure clinical safety and appropriate tone. Weekly mailers will encourage participants to enroll and consent to participate in the digital program by scanning a QR code or accessing a website where they will sign up for their own personalized Moxie mobile health app, complete a digital consent form and opt-in for electronic delivery of Moxie messages. Facilitated relay intervention: Participants allocated to this intervention will receive letters by mail, one addressed to them, one to their primary care provider, and one to their pharmacist. The letters will not be sent to their primary care provider directly; rather, they will be sent to patients who will be encouraged to take them to their primary care provider and pharmacist should they decide to do so. We hope this will empower patients to start discussions with their healthcare providers. This also supports patient autonomy by enabling patients to decide whether they want to take them to their provider or not. If for whatever reason they do not feel that this is going to be beneficial or of interest, they are not required to do so. The letter would contain a note to the patient's healthcare provider stating that their patient is at-risk of cardiovascular disease and that evidence has shown that the pharmacotherapy is effective in improving outcomes for patients similar to the participant. The primary outcome is readmission for cardiovascular-specific ambulatory care-sensitive conditions (ACSC) based on the most responsible diagnosis listed in CIHI Discharge Abstract Database-(DAD), using established algorithms within 12 months from randomization. This outcome includes all repeat admissions in the study period as recorded in the health record. This outcome is a count variable. We will calculate and compare each intervention arm's mean number and distribution of hospitalizations.

The goal of this pilot triple-blind randomized clinical trial is to determine the effectiveness of intra-muscular botulism injection for treatment of lower leg anterolateral chronic exertional compartment syndrome (CECS). Primary Research Question: What is the effectiveness of intra-muscular botulinum injection, compared to normal saline placebo, for reducing pain related to painful sport activity in patients with lower leg anterolateral chronic exertional compartment syndrome (CECS), over a 24-week period? Secondary outcomes will measure the time to initial onset and duration of pain during the painful sport activity, characterize the type of pain, foot paraesthesias, self-reported ankle instability, and ankle dorsiflexion and eversion muscle power. The Single Assessment Numeric Evaluation (SANE) score will provide a measure of overall leg function. Adult patients with a confirmed diagnosis of anterolateral CECS, as determined by post-exertional compartment pressure measurements, will be invited to participate in the study. Using concealed, consecutively-numbered randomization envelopes, participants will be randomly assigned to receive either the botulinum (treatment) or the normal saline (control) injection. Participants will answer a web-based outcome questionnaire at Baseline (prior to receiving the injection) and at 2, 4, 6, 8, 12, 16, 24-weeks follow-up. Participants will be asked to do their painful sport activity the day before completing the questionnaire. Ankle dorsiflexion and eversion muscle power will be manually measured by a physiatrist in clinic at 6, 16 and 24-week follow-up visits.

Autonomic nervous system imbalance causes postural tachycardia and related cardiac symptoms in Postural Orthostatic Tachycardia Syndrome (POTS). The impact of POTS is more far-reaching than postural tachycardia. Several systemic, autonomic symptoms along with neuro-cognitive dysfunction leading to poor quality of life contribute to significant disability in POTS. A combination of abnormal autonomic tone, abnormal cerebral blood flow regulation, and systemic inflammation may contribute to POTS symptoms. Auricular Vagal Neuromodulation Therapy (aVNT) has the potential for multisystem holistic benefit for patients with POTS: Autonomic neuromodulation by aVNT might address multiple aspects of POTS pathophysiology and improve POTS symptoms. It can reduce postural tachycardia by increasing the parasympathetic (PNS) and decreasing sympathetic (SNS) tone. In patients undergoing vagus nerve stimulation for various indications, an increase in PNS tone has been associated with improved middle cerebral artery velocity (MCAv) at rest and during cognitive stress. aVNT has been associated with improved cerebral blood flow and reduced infarct size in an experimental model of ischemic stroke, suggesting similar improvements in cerebral autoregulation in POTS. Vagus nerve stimulation has also been linked to improved cognitive function. The anti-inflammatory effect and improved endothelial function might improve cerebral blood flow regulation and cognitive function. The anti-inflammatory effects of aVNT may improve postural hemodynamics, reduce postural tachycardia, relieve other POTS symptoms, and improve quality of life (QoL). POTS is a complex multisystem disorder with debilitating symptoms that currently lack effective treatments. aVNT has the potential to recalibrate autonomic tone dysregulation, enhance MCAv, improve cognitive function, reduce inflammation, and ultimately improve symptoms and quality of life in POTS patients.

Many patients with postural orthostatic tachycardia syndrome (POTS) have decreased plasma volume. Current POTS guidelines recommend \~10 g of salt and 2-3 L of fluid per day. Despite this recommendation, there is no long term data evaluating the use of salt in POTS. This randomized, placebo-controlled cross-over trial will evaluate a high salt diet, compared to a normal salt diet over a period of 3 months. Participants will complete 3 in lab evaluations including autonomic function testing, tilt table testing, blood volume and urine sodium evaluation, plasma catecholamine measurements and and cytokine measurements.

Patients with Postural Orthostatic Tachycardia Syndrome (POTS) and Post-Acute Sequelae of COVID (PASC, or "Long COVID") experience cognitive dysfunction. The investigators will test the hypothesis that 999 mL of IV saline will improve cognitive function in patients with POTS and Long COVID compared to placebo (50 mL of saline).