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  • Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions

    Scalpel, electrocautery, and PEAK PlasmaBlade (PPB) have all been shown to be safe techniques for surgical incision, but no study has proven the superiority for cosmesis for PPB incision when compared to conventional electrocautery or scalpel. The investigators propose a double blind prospective randomized controlled study of consecutive patients scheduled for total mastectomy +/- axilla staging without immediate breast reconstruction to evaluate the cosmetic scar result from the use of scalpel, standard electrocautery or PEAK PlasmaBlade. Scar cosmesis will be evaluated postoperatively at two-to-four weeks, six months, and twelve months by two independent observers blinded to the equipment used, and patient reported outcomes will be reported using the validated SCAR-Q questionnaire.

    Phase

    N/A

    Span

    56 weeks

    Sponsor

    University of British Columbia

    Vancouver, British Columbia

    Recruiting

  • Sequential Multiple Assignment Randomized Trial for Bipolar Depression

    This is a comparative effectiveness study to address the critical questions of how best to treat people with bipolar disorder who have a major depressive episode: how to get them well, provide second-line treatment when they don't initially get well, and keep them well after they get well. This is a multisite Sequential Multiple Assignment Randomized Trial (SMART) comparative effectiveness design. Investigators will recruit 2726 participants who have BD with a current major depressive episode. In Stage 1, investigators will compare four treatment arms, including three FDA approved monotherapies and the most widely used, but understudied, treatment for BD major depressive episode (i.e., a non-FDA approved combination of an antipsychotic and antidepressant). In Stage 2, participants who do not remit will be re-randomized to treatments not used in Stage 1. Investigators will follow all participants for a total of 52 weeks. This study will be conducted in two phases, a feasibility phase and a full study phase. In the feasibility phase, investigators will recruit at 8 of the 19 study sites based on readiness and interest, to ensure the efficacy of the study design before launching the full study phase. Feasibility Aim 1: To ensure that 8 of the 19 selected sites can recruit, randomize, and retain participants. During the feasibility phase, the selected sites will recruit 133 participants, administer baseline assessments, randomize the participants (at baseline and again at 6-weeks for non-remitters), and conduct follow-up assessments at the end of Stage 1 (6-weeks) and the end of Stage 2 (12-weeks) and end of study (52 weeks or end of feasibility phase, whichever is sooner) and all other scheduled visits. Feasibility Aim 2: To refine and finalize all study standard operating procedures for the full-scale study. After Aim 1 is complete, any changes in standard operating procedures will be made as needed to be implemented in the full study phase. Full Scale Study Full-Scale Study Aim 1: To compare the effectiveness, tolerability, and safety of the four treatments for BD major depressive episodes. Hypothesis 1a: There will be significant differences across the Stage 1 treatments in the proportion of remitters at week 6 (primary endpoint, effectiveness) and in the average adverse event burden and suicidal ideation/behavior at week 6 (secondary endpoints, tolerability and safety). Hypothesis 1b: Among non-remitters of a given Stage 1 treatment (i.e., participants who do not remit by week 6), there will be significant differences across the three remaining Stage 2 treatments in the proportion of remitters at week 12 (primary endpoint, effectiveness) and the average side effect burden and suicidal ideation/behavior at week 12 (secondary endpoints, tolerability and safety). Full-Scale Study Aim 2: To characterize the effectiveness, tolerability, and safety of the 12 adaptive interventions for BD major depressive episodes embedded within the SMART design. Hypothesis 2: On average, there will be significant differences across the 12 embedded adaptive interventions in the proportion of remitters at week 12 (primary endpoint, effectiveness) and in the average side effect burden and suicidal ideation/behavior at week 12 (secondary endpoints, tolerability and safety). Full-Scale Study Aim 3: To determine individual-level characteristics that predict heterogeneity of treatment effect (HTE) across the 12 adaptive interventions for BD major depressive episodes embedded within the SMART design. Hypothesis 3a: Individual-level characteristics and symptoms assessed at baseline as well as symptom changes and side effect profiles at week 6 will predict HTE at weeks 12 and 52. Hypothesis 3b: Investigators hypothesize that an optimal personalized adaptive intervention will perform significantly better than the best aggregate embedded adaptive intervention identified in Aim 2 in terms of the proportion of remitters at week 12 (primary endpoint, effectiveness) and the side effect burden and suicidal ideation/behavior at week 12 (secondary endpoints, tolerability and safety).

    Phase

    4

    Span

    283 weeks

    Sponsor

    Massachusetts General Hospital

    Vancouver, British Columbia

    Recruiting

  • Autologous Hair Follicle Derived Secretome as Adjunct to Aesthetic Procedures

    This non-interventional, observation study is to collect real-world data on the use of an autologous, hair follicle derived secretome topical cosmetic product following various medical aesthetic procedures.

    Phase

    N/A

    Span

    25 weeks

    Sponsor

    Acorn Biolabs Inc.

    Vancouver, British Columbia

    Recruiting

  • Bupivacaine and Epinephrine Injection Study

    Phase

    2/3

    Span

    37 weeks

    Sponsor

    Amin Javer

    Vancouver, British Columbia

    Recruiting

  • Predicting IBD Treatment Outcomes With Gut Microbiome Analysis

    Inflammatory bowel disease (IBD) is a chronic and relapsing inflammatory condition affecting the gastrointestinal (GI) tract. The study aims to evaluate microbiome profiles (bacteriome, and mycobiome) across three different sample types (fecal, intestinal washings, and intestinal epithelial biopsies) in a cohort of adult patients with Crohn's disease (CD) living in British Columbia, Canada, and investigate whether a microbial signature may predict response to IBD therapy. Aims: 1. Determine microbiome signatures, across different sample types, in quiescent and active disease for patients with CD living in BC, Canada. 2. Evaluate whether fecal, mucosal, and/or intestinal epithelial biopsy microbiome signatures can predict response to therapy. Methods Study Design: Phase 1: A cross-sectional pilot study to evaluate the microbiome in patients with IBD (with active and quiescent disease) and in non-IBD controls. Primary Outcome: Compare results of microbial analyses (including bacteriome and mycobiome) across three different sample types: intestinal washings and intestinal epithelial biopsy specimens taken during colonoscopy, as well as fecal samples. Secondary Outcomes: Investigate correlations between the microbial analyses across different sample types and disease activity in CD. Compare the difference in microbial analyses within each sample type between active and quiescent CD as well as non-IBD patients. Investigate if fecal microbiome composition and function 2 weeks after bowel preparation is comparable to pre-bowel preparation fecal microbiome in a subset of patients with CD. Phase 2: A longitudinal observational study with a 12-month follow-up. Primary Outcome: Identify if there are any microbial signatures that predict response to therapy in patients with active disease requiring escalated therapy, assessed clinically and biochemically after induction (12-16 weeks) and at 12 months (+/- 3 months). Secondary Outcomes: Compare the sensitivity and specificity of microbial analyses from each sample type in predicting response to therapy.

    Phase

    N/A

    Span

    87 weeks

    Sponsor

    University of British Columbia

    Vancouver, British Columbia

    Recruiting

    Healthy Volunteers

  • Prednisone for CRPS in Distal Radius Fracture

    Purpose: Distal radius fractures are the most prevalent adult fracture, accounting for 17.5% of all fractures. Complex regional pain syndrome (CRPS) is a common complication that can occur in this population, with a reported incidence of up to 32%. CRPS can lead to permanent disability and is costly to the patient and to the healthcare system, with an estimated cumulative outpatient and pain prescription cost of $42,026 over 8 years after diagnosis. In addition, amidst the opioid epidemic, the risk of increased opioid use in patients with CRPS prompts the need to find viable treatment strategies. While there have been various proposed treatment modalities, evidence from randomized studies is lacking. Several small studies (retrospective and prospective case series) have shown potential efficacy of glucocorticoids for the treatment of CRPS. To our knowledge, there are no randomized controlled trials that evaluate treatment of CRPS in distal radius fractures with glucocorticoids. The purpose of this pilot study is to evaluate a short course of oral prednisone as potential treatment for patients identified as developing early signs of CRPS after sustaining a distal radius fracture that was treated operatively. We will examine feasibility metrics including patient recruitment rate, adherence to allocation and protocol, withdrawal from study, and follow-through, in order to inform design of a definitive clinical trial. We will also assess the resolution of CRPS, post-operative opioid use, and any adverse events in patients who sustain a distal radius fracture after receiving prednisone vs placebo for 2 weeks post-operatively, with 6 months follow up post injury. Hypothesis: We hypothesize that the proposed pilot trial will demonstrate feasibility of a future definitive trial. In addition, we hypothesize that there will be higher rates of CRPS resolution, lower amounts of opioid consumption, and no increased adverse effects, and better clinical outcomes in patients who receive prednisone treatment compared to those who received placebo. However, formal hypothesis testing will not be performed for this pilot trial. Justification: Developing CRPS after sustaining a distal radius fracture can lead to devastating outcomes, including permanent disability, opioid dependency, and the inability to return to work. In addition, diagnosing CRPS can be a prolonged process due to the range of vague symptoms on presentation, which can lead to delay in treatment and worsening of outcomes. Patients with CRPS may require more follow-up and referrals, which further burdens the healthcare system. The pathogenesis of CRPS is complex and not fully known; evidence suggests nervous system sensitisation, autonomic dysfunction, and inflammatory changes. There are numerous treatment options for CRPS, though little high-quality evidence supports their efficacy. These include but are not limited to oral anti-depressants, parenteral lidocaine and corticosteroids, surgical treatment with compressed nerve release, counselling, and occupational and physical therapy. Vitamin C has been proposed as effective prophylaxis for CRPS in distal radius fractures but data have been conflicting, with the most recent randomized controlled trial (RCT) in 2014 by Ekrol et al. showing no difference in functional outcomes or rate of CRPS in patients with distal radius fractures given Vitamin C versus placebo. Given the prevalence of distal radius fractures in adults, a relatively high CRPS incidence in this population, and no established efficacious treatment options, more research is needed to determine evidence-based and effective treatment options for this destructive condition. Studies have identified that using glucocorticoids can potentially be effective and safe for treating patients with CRPS, possibly due to the anti-inflammatory properties of glucocorticoids. One retrospective study of patients undergoing surgery for terrible triad elbow (complex elbow fracture dislocation) injuries demonstrated improved elbow range of motion for patients receiving intraoperative dexamethasone and 6-day oral course of methylprednisolone compared to patients who did not, with no increased postoperative infection. Furthermore, the anti-inflammatory nature of glucocorticoids deserves investigation for its potential to decrease opioid consumption after distal radius surgery. A variety of doses and duration of glucocorticoids have been used in studies to manage CRPS, with a recent review article by Kwak et al showing starting doses between 30 mg to 100 mg of prednisolone. Although glucocorticoids are known to be associated with adverse effects, most are only seen with long term therapy. In addition, studies have shown that a short-course of glucocorticoids (less than 3 to 4 weeks), irrespective of dose, do not require a tapering regimen and is not associated with increased risk of adrenal insufficiency. While osteoporosis and fracture non-union are known adverse events of long-term glucocorticoid use, this has not been demonstrated in literature for short-term use. Moreover, given the risk of non-union in distal radius fractures is exceedingly rare (0.2%), this calls for less concern for using glucocorticoids in this population. Therefore, evaluating prednisone, a relatively cheap, accessible, and safe oral medication when used for a short duration, as an anti-inflammatory and potential early treatment agent for CRPS in distal radius fractures in this pilot study may have implications for the complication profile and functional outcome for this common fracture. Research Design: This will be a pilot double-blind randomized control trial in patients who sustain a distal radius fracture treated operatively with a volar locked plate and identified as at risk of developing CRPS. Follow up will be 6 months, involving 4 study visits that correspond to standard post-operative clinic visits. Statistical Analysis: A power analysis assuming incidence of 20% CRPS and absolute risk reduction (ARR) of 10% with prophylaxis yielded a sample size of 199 patients per arm, with 80% power and significance level (α) of 0.05 (performed using online sample size calculator at clincalc.com/stats/samplesize.aspx). Incidence and ARR were estimated based on previous RCTs assessing Vitamin C as prophylaxis for CRPS in distal radius fractures. We aim to recruit 10% for this pilot study, with 20 per arm (placebo vs prednisone), for a total of 40 patients. The CONSORT guidelines for reporting of randomized pilot and feasibility trial will be followed for the analysis and reporting of results. An intention-to-treat analysis will be utilized. Primary Outcomes: Descriptive statistics, reported as count and percentage, will be used to summarize the feasibility outcomes (95% CI). Table 2 presents the traffic lights criteria for each outcome of the pilot study. Green indicates feasible, red indicates not feasible, and yellow indicates likely feasible but will require adjustments to the protocol. (please see attached protocol) Secondary and Tertiary Outcomes: Chi-square (or Fisher's Exact) test will be used to compare the proportion of CRPS between groups. Either Mann-Whitney U test or two-sample t test will be used for the other quantitative outcomes depending on the variable distribution. Multivariable regression analysis will be conducted to test for associations between the intervention and each outcome, controlling for differences in patient characteristics. All P values will be 2-sided and statistical significance will be set at P < 0.05. For this pilot trial, formal hypothesis testing will not be performed as it is underpowered.

    Phase

    N/A

    Span

    95 weeks

    Sponsor

    University of British Columbia

    Vancouver, British Columbia

    Recruiting

    Healthy Volunteers

  • An Innovative Master Platform for Clinical Trials in Mood Disorders

    The ENABLE platform offers to the Canadian neuroscience community (1) standardized data collection methods with deep clinical and neurobiological phenotyping of individuals across the spectrum of mood disorder symptoms; (2) a recruitment pool for efficient launch of clinical trials; and (3) an open source of clinical and neurobiological data for discovery analyses and/or grant applications. The assessments have been categorized into a tiered system, where participants must consent to complete tier 1 items in order to be enrolled in the platform. Tier 2 items will be optional measures, the absence of these measures will not compromise the inclusion in the platform. A separate written informed consent to be contacted regarding participation in future clinical trials associate with the ENABLE platform will also be offered. At tier 1, individuals complete clinical assessments (clinician administered and self-report) and during their tier 2, they provide blood, undergo neuroimaging procedures (MRI and EEG); and are given an actigraphy device to wear for two weeks.

    Phase

    N/A

    Span

    128 weeks

    Sponsor

    St. Joseph's Healthcare Hamilton

    Vancouver, British Columbia

    Recruiting

    Healthy Volunteers

  • Outpatient and Intermittent Dosing of Elranatamab in Relapsed/Refractory Multiple Myeloma

    This is a multi-centre, single arm, phase II study of single agent elranatamab in patients with relapsed and/or refractory multiple myeloma (MM) who have previously received at least three classes of therapeutic agents and are refractory to the last line of treatment. Potential study participants must have documented evidence of refractory or progressive disease during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry. Study participants will receive SC administration of elranatamab until disease progression, unacceptable toxicity or death. The primary short term outcome is hospitalization rate within the first 2 weeks of Cycle 1 of treatment; the primary long term outcome is rate of grade 3+ infections within the first 24 months of treatment. Study participants will be followed for survival for 36 months from the date of enrollment. A total of 40 study participants will be enrolled across approximately 5 Canadian clinical trial sites.

    Phase

    2

    Span

    197 weeks

    Sponsor

    Ontario Clinical Oncology Group (OCOG)

    Vancouver, British Columbia

    Recruiting

  • Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

    The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin. The study will be conducted at approximately 700 sites in approximately 40 countries globally.

    Phase

    3

    Span

    165 weeks

    Sponsor

    AstraZeneca

    Vancouver, British Columbia

    Recruiting

  • End Tidal Carbon Dioxide Concentration and Depth of Anesthesia in Children

    Purpose: Carbon dioxide (CO2) is a major end-product of metabolism and can have marked effects on central nervous system function. It can also be easily manipulated during general anesthesia via controlled ventilation. High levels of carbon dioxide (hypercapnia) are associated with sedation and have been shown to produce selective suppression of thermal and ischaemic pain in animals and humans. This effect was attenuated by dexamethasone and naloxone, indicating that stress pathways and endogenous opioids may be implicated. Hypercapnia during anesthesia may have additional benefits, including reduced levels of wound infection due to improved tissue oxygenation reduced incidence of postoperative nausea and vomiting and reduced recovery time from volatile anesthetic. It is a known phenomenon for high levels of CO2 to be associated with reduced levels of consciousness in humans, known as CO2 narcosis. A 1927 paper described narcosis of animals when breathing 30-40% CO2 in oxygen, with prompt recovery upon removal. The authors described a 'sharp sour taste' and associated hypertension when the same solution was administered to humans. However, few studies investigate the impact of carbon dioxide on anesthetic requirements. An animal study from 1967 demonstrated that very high levels of CO2 (>95 mmHg) offset halothane requirements in dogs. Most recently, increased carbon dioxide levels during surgery (40 - 45 mmHg) were shown to reduce the Minimal Alveolar Concentration to Blunt Adrenergic Response (skin incision; MAC-BAR) of sevoflurane in adult patients undergoing gastric carcinoma resection. Total intravenous anesthesia (TIVA), an alternative to inhalational anesthesia, is a commonly used anesthetic technique in the investigator's institution. This is due to its many benefits, including reduced emergence delirium, reduced environmental impact and reduced post-operative nausea and vomiting. Administration can be guided by depth of anesthesia monitoring such as the Bispectral Index (BIS), which measures the patient's level of consciousness derived from electroencephalogram readings. BIS has been shown to help guide propofol dosing in children regardless of whether the TIVA technique was target controlled or a manual infusion regimen, and to correlate well with both modelled and measured propofol levels in children. The investigator's study aims to determine whether differing levels of CO2 affect the anesthetic depth in anesthetized children, as measured by BIS. Hypothesis: Hypercarbia is associated with a reduction in BIS readings, in anesthetized children. Justification: The impact of EtCO2 on BIS has not been studied in children. If discovered, a correlation between the two could significantly change anesthetic practice. It is straightforward to increase EtCO2 levels in anesthetized patients, and if this was found to reduce their anesthetic requirements it could enable lower rates of anesthetic drug administration. This would benefit the patient by exposing them to less medication and fewer associated side effects, as well as benefitting the hospital and wider environment by reducing cost and use of disposable equipment such as ampoules, packaging and syringes. Objectives: (1) To determine the effect of EtCO2 on the depth of anesthesia in children, as measured by BIS. (2) Patient movement as detected clinically by the surgical or anesthetic team. Research Design: The investigators plan to conduct a randomized, prospective, crossover trial. The within-subject design allows patients to act as their own controls. The order in which the EtCO2 levels are tested will be randomized between patients using sealed envelopes. The anesthesiologist in the room will be blinded to the BIS reading but will be informed by a research assistant if it reads persistently high (>60) for over one minute. Statistical analysis: Physiological data will be collected in real-time using purpose-built software. Patient demographics and characteristics will be collected by a research assistant. Time-series plots of BIS and EtCO2 for each participant will be made in R (R Foundation for Statistical Computing, Vienna, Austria). Generalized estimating equations (GEE), using the geepack package, will be applied to estimate the effect of changes in target EtCO2 on serial BIS measurements during the anesthesia maintenance phase. Each participant will be considered their own data cluster to provide an appropriate grouping structure for the analysis. An independent correlation structure will be applied, and a robust (sandwich) estimator method will be used to obtain standard errors.

    Phase

    N/A

    Span

    132 weeks

    Sponsor

    University of British Columbia

    Vancouver, British Columbia

    Recruiting

    Healthy Volunteers

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