Thunder Bay

Researchers are studying a medicine called enlicitide to reduce low-density lipoprotein cholesterol (LDL-C) in adults with high cholesterol (hyperlipidemia). This trial aims to find out if taking enlicitide together with rosuvastatin, a standard cholesterol-lowering drug, works better than a placebo in lowering LDL-C levels. The study is a Phase 3 trial that is randomized, double-blind, and placebo-controlled to ensure accurate and unbiased results. Participants will receive oral tablets of enlicitide or placebo along with oral capsules of rosuvastatin or placebo. The study compares the effect of enlicitide plus rosuvastatin against placebo to evaluate their impact on LDL-C. The treatment period lasts 8 weeks, during which participants take their assigned medications as directed. During the study, researchers will measure the average percent change in LDL-C from the start of the trial to week 8. Participants will be monitored for safety and any side effects throughout the study. The total participation time includes screening, treatment, and follow-up assessments to evaluate the medicines' effects and safety in adults aged 18 to 64 with hyperlipidemia.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

Researchers are studying how well lebrikizumab works for adolescents and adults with moderate atopic dermatitis (eczema) who have a high level of itchiness and limited areas affected on the body. The study focuses on participants who have had eczema for at least one year and aims to measure improvements in skin condition and itch severity. This is a Phase 4, open-label, single-arm trial involving individuals aged 12 and older. Participants will receive lebrikizumab through subcutaneous injections. The treatment period lasts for 24 weeks (6 months), during which the medication is administered as per the study protocol. The entire participation, including screening and follow-up, spans approximately 38 weeks (9 and a half months). During the study, participants will undergo regular assessments including skin evaluations and itch severity ratings to track changes from baseline. Researchers will measure the percentage of participants achieving at least a 75% improvement in eczema severity or a 4-point reduction in itch intensity by week 16. Safety and adherence to treatment will also be monitored throughout the study duration.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are studying Canadian cancer patients who have rare genetic changes in their tumors. These changes include alterations in genes like ALK, EGFR, ROS1, BRAF, NTRK, and KRAS G12C, which may respond to targeted drugs called tyrosine kinase inhibitors (TKIs) or similar therapies. The study aims to compare the natural progress and treatment results, including side effects and patient experiences, of cancers with these rare molecular alterations. Participants in this study include those who have received or are receiving cancer treatments with TKIs or other molecularly targeted drugs. The study also collects patient-reported outcomes through surveys given at the start, every three months, and whenever treatment changes. This approach helps researchers observe real-world treatment patterns and outcomes in these rare cancer types. During the study, researchers review molecular testing reports to confirm gene alterations and follow participants' cancer care within Canada. They measure treatment effectiveness by tracking progression-free survival or overall survival for up to ten years. The study also evaluates quality of life, treatment side effects, and the use of biomarkers to better understand these rare cancer types and their management.

Researchers are evaluating the effectiveness of a low cumulative dose of epinephrine compared to a standard cumulative dose during resuscitation from ventricular fibrillation (VF) or ventricular tachycardia (VT) in adults experiencing out-of-hospital cardiac arrest (OHCA). This phase 4 randomized controlled trial aims to determine whether a lower total dose of epinephrine can improve survival to hospital discharge. The study addresses a critical treatment question for OHCA patients with these specific heart rhythms. Eligible adult OHCA patients treated by paramedics are randomly assigned to receive either a low cumulative dose of epinephrine (up to 2 mg total) or a standard cumulative dose (up to 6 mg total) in a 1:1 ratio. Paramedics begin cardiopulmonary resuscitation (CPR) and defibrillation according to standard protocols. After one shock and when possible, intravenous access is established, and epinephrine doses are administered every 3 to 5 minutes until return of spontaneous circulation (ROSC) or termination of resuscitation. Other necessary medications and interventions may be given as needed. Participants are followed up using health administrative databases and telephone interviews to monitor outcomes. The main outcome measured is survival to hospital discharge, tracked for up to five years. This study involves continuous monitoring during resuscitation and long-term follow-up to assess patient survival and response to different epinephrine dosing strategies.

Researchers are examining how alcohol consumption affects physiological responses and perceptions during indoor conditions similar to extreme heat events. This study focuses on younger and older adults to understand sex- and age-specific changes, addressing concerns about heat-related illnesses like heat exhaustion and heat stroke. The research responds to the reality that many adults use alcohol as a hydration strategy despite advice against it during heat waves. Participants consume either an alcoholic beverage or a placebo and then rest in a climate-controlled room set at 40°C with 30% relative humidity for 120 minutes, totaling 180 minutes including consumption. The study compares the effects of alcohol versus placebo on various physiological measures in these heat stress conditions. During the study, heart rate, skin temperature, core temperature, blood pressure, heart rate variability, arrhythmia presence, whole-body sweat loss, postural sway, skin blood flow, urine output, and thermal sensation and comfort are measured at baseline and every 30 minutes after drink consumption for up to 120 minutes. Researchers monitor participants closely to assess how alcohol impacts these responses during heat exposure.

Researchers are evaluating the impact of the JoyPop mobile mental health app for Indigenous transitional-aged youth (ages 18 to 25) in Northwestern Ontario who are waiting for mental health services. These youth often face longer wait times than non-Indigenous peers, which can worsen symptoms, increase distress, and raise risks of serious outcomes such as suicide and hospitalization. The study aims to support improved emotion regulation, a common challenge for youth with mental health difficulties, using a randomized controlled trial comparing the app to usual care while on the wait-list. Participants assigned to the intervention group will be asked to use the JoyPop app at least twice daily, though there are no strict requirements on which features to use or total usage time. The app was developed specifically to help with emotion regulation and is being tested for its effectiveness compared to usual practice without the app. The trial is conducted in partnership with Dilico Anishinabek Family Care and includes Indigenous youth who have access to an iOS device, with refurbished devices provided if needed. During the study, participants will complete the Difficulties in Emotion Regulation Scale - Short Form at baseline, after 2 weeks, and after 4 weeks to measure changes in overall emotion regulation and specific aspects such as impulse control, awareness, and clarity. The study also evaluates changes in mental health symptoms, treatment readiness, and collects youth feedback on the app's quality. The goal is to understand the app's broader impact while youth wait for mental health services and to assess its potential to reduce other health service use and costs.