Clinical trials

The primary objectives of this present study are to examine whether a continuous interscalene block of a total duration of 48 hours reduces the incidence of rebound pain comparatively to single-shot interscalene block, through the evaluation of the NRS scores at rest and on movement in the postoperative period at 24, 48, 72 and 96 hours as well as the total opioid consumption in the same timeframe for patients undergoing total shoulder arthroplasty. Rebound pain has been defined in some studies as the "the transition from well-controlled pain (numerical rating scale \[NRS\] ≤3) while the block is working to severe pain (NRS ≥7) within 24 h of block performance."

Background \& Rationale: One in ten Canadian youth have migraine, a disabling neurological disease that is more common in females and characterized by moderate-severe disabling headaches. Migraine attacks occur in a cycle that begins with a prodromal phase, followed by aura, a pain phase (headache), and finally a postdrome phase when the pain is resolved but other symptoms persist. The prodrome is recognized by \~90% of all youth with migraine, occurs up to 24 hours before headache onset, and consists of a variety of symptoms including, but not limited to, food cravings, fatigue, yawning, mood changes, and sensory hypersensitivity (e.g., light sensitivity). Prodromal symptoms are disabling and frequently graded as moderate to severe. All acute migraine treatments for youth have been studied for use in the pain phase, with the greatest treatment success early in this phase. Unfortunately, only \~1/3 of youth achieve pain freedom within two hours. Recently, a groundbreaking trial found that treatment during the prodrome could prevent the pain phase, although prodromal treatment does not exist for youth. In considering the most innovative, safe, and patient-centered prodromal intervention, remote electrical neuromodulation (REN) is the obvious choice. The investigator's engagement with 175 youth with migraine and their caregivers shows that REN is preferred when pill-based interventions are ineffective or impractical. REN has none of the limitations of pill-based prodromal treatment. The REN device is wearable, battery-operated, worn on the upper arm, and controlled wirelessly by a smartphone application. REN electrically stimulates sensory nerves in the arm below their perceived pain thresholds, but above their depolarization thresholds, to induce a conditioned pain modulation response in the brain to modulate incoming migraine pain signals. Clinical trial and observational studies in youth with migraine have shown REN's safety and efficacy for home-based treatment during the pain phase and led the FDA to clear its use in youth \>8 years. In the adolescent trial, 71% of participants had pain relief at two hours, there were no serious adverse events (AE), and only one device-related AE (transient arm pain) occurred. Also, emerging data show that adults with migraine in the prodrome phase display pain facilitation due to a deficit in pain modulation. Thus, REN's mechanism of action is likely to be more effective during the prodrome vs. the pain phase as it can "turn on" deficient pain modulatory areas earlier when they are most impaired. Research Question \& Objectives: The investigators aim to determine the feasibility of implementing REN treatment during the prodrome to prevent migraine pain in youth with migraine, and hypothesize that: 1. trial design will be feasible 2. REN will be feasible for prodromal treatment, with \>80% of participants using their assigned device to treat a qualifying prodrome. The following feasibility and acceptability outcomes will be measured: 1. proportion of eligible youth that are enrolled into the screening period, subsequently randomized, and treat a qualifying prodrome with REN. 2. recruitment rate, retention, and withdrawals. 3. participant feedback. All secondary outcomes will be reported descriptively, and adverse events will be recorded and reported. Methods: This study will be a pilot randomized, single centre, double-blind, parallel group, sham-controlled trial comparing active to sham REN for the prevention of headache within 24 hours of treating prodromal symptoms in youth with migraine. Participants will be recruited from headache and neurology clinics at the Alberta Children's Hospital. Eligible and consenting participants will complete an intake visit and enter a 60-day screening period where they will complete electronic daily diaries to determine prodrome or headache occurrence and features. Participants with 3-28 qualifying prodromes during screening, where \>75% are followed by a headache within 6 hours, will be randomized 1:1 to treat one qualifying prodrome with active or sham REN over a 60-day treatment period. Participants will be trained on device use and will be instructed to not use any co-interventions during the qualifying prodrome; if headache onsets after the prodrome, participants will be instructed to use their typical acute treatment. During the treated prodrome, a survey will determine the presence, type, and number of prodromal symptoms. Surveys at 2, 24, and 48 hours post-treatment will record the presence or absence of headache, its characteristics, and AEs. The randomization sequence will be prepared by a biostatistician and will follow randomly ordered blocks of four and six, with variable block sizes. Only research pharmacists will have access to this sequence to prepare consecutively numbered blinded and matched study kits. These kits will contain a restricted mobile phone with only the REN software application pre-installed.

Patch testing remains the gold standard in the diagnosis of allergic contact dermatitis. Patches used in testing consist of a wide spectrum of allergens, with variability in the stability of products over time. Due to limited allergen stability, careful storage and preparation is needed to prevent product degradation over time. Expiration dates are provided by manufacturers to ensure stability and reactivity, while minimizing the risk of product degradation contributing to inaccurate testing results. Preparation of patch series can be time intensive and procurement of allergens comes with an associated economic burden. Expired allergens are not routinely used in patch testing, however many clinics have expired allergens accessible. There is paucity of evidence comparing the reactivity of expired vs non-expired patch series. If expired allergens remain effective, this could result in significant cost-savings and accessibility implications for dermatology practice.

The primary goals of this phase 2 clinical trial are to determine the feasibility, safety, and tolerability of oral Fecal Microbiota Transplantation (FMT) in adolescents (aged 13-17) with Attention-Deficit/Hyperactivity Disorder (ADHD).

The goal of the PARTUM trial is to determine if taking low-dose aspirin daily for 6 weeks after delivery is similar (non-inferior) to usual care low-molecular-weight heparin injections to prevent venous thromboembolism (VTE: blood clots in the legs or lungs) for postpartum individuals with VTE risk factors.

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.

Study Design and Duration: This domain will be conducted as part of ACT-GLOBAL platform trial and will have the nested domain name of REACT. It has a prospective, randomised, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design of up to 1,500 subjects with Acute Ischemic Stroke (AIS) who undergo EVT. Randomisation will be stratified by country/ region, and the IA thrombolytic agent (tenecteplase or alteplase). Minimal sufficient balance algorithm will operate within each stratum to preserve balance on key covariates while maintaining allocation randomness. Participants will be followed for 90 days (or until death, if prior to 90 days). The end of the trial is defined as the date that all participants have completed their Day 90 assessment. Primary outcome data will be determined by simplified, structured method of assessment using the modified Rankin scale (mRS), conducted through centralized telephone interviews or online media performed by central trial personnel blinded to treatment assignment and received. Domain Interventions: The intervention group will receive a single dose of local intraarterial thrombolysis using either tenecteplase (at a dose of 0.0625mg/kg; maximum dose of 6.25mg) or alteplase (0.225 mg/kg; maximum dose, 20mg) at the end of EVT procedure plus standard of care while the control group will receive standard of care alone. The selection of the thrombolytic agent will be determined according to local availability. The dose of intraarterial thrombolysis will be increased if the above dose meets prespecified posterior probabilities at the first or second interims. In all eligible patients: 1. Local intra-arterial thrombolysis using either tenecteplase at a dose of 0.0625mg/kg "maximum dose of 6.25mg" or alteplase "0.225 mg/kg; maximum dose, 20mg\* 2. No intra-arterial thrombolysis. * The dose of IA thrombolysis may be doubled to 0.125 mg/kg tenecteplase or 0.45 mg/kg alteplase if this dose shows futility at pre-specified interims Randomization will be stratified by country/ region, the IA thrombolytic agent used (tenecteplase or alteplase). IA thrombolysis will be administered as a one-time treatment.

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.

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.

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.

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.