Thunder Bay

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are conducting a Phase III, randomized, open-label multicenter study to evaluate the effectiveness and safety of giredestrant compared with fulvestrant. Both drugs are combined with the investigators choice of a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib in participants with estrogen receptor-positive ER, HER2-negative advanced breast cancer who have become resistant to prior adjuvant endocrine therapy. Participants will be randomly assigned to one of two groups one group will receive giredestrant 30 mg orally daily on Days 1-28 of each 28-day cycle, while the other will receive fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and Day 1 of subsequent 28-day cycles. Both groups will also receive a CDK46 inhibitor chosen by the investigator, with dosing schedules depending on the specific inhibitor selected. Preperimenopausal women and men will receive a luteinizing hormone-releasing hormone LHRH agonist during treatment. Participants will be assessed for progression-free survival over up to 5 years, with additional measures including overall survival, response rates, duration of response, clinical benefit, and quality of life. Safety will be monitored through adverse event reporting, vital signs, and laboratory tests during treatment and up to 28 days after the last dose. The study is led by Hoffmann-La Roche and aims to provide detailed information on the treatments effects in this patient population.

Researchers are studying Canadian cancer patients who have rare genetic changes in their tumors, such as alterations in genes like ALK, EGFR, ROS1, BRAF, and KRAS G12C. These rare molecular alterations can affect how the cancer responds to certain targeted drugs called tyrosine kinase inhibitors TKIs. The study aims to better understand the natural history of these cancers and compare treatment outcomes, including side effects and patient-reported experiences, across different therapies. The study observes cancer patients who have received or are currently receiving TKIs or other targeted therapies. It includes three groups living patients with confirmed rare molecular alterations, deceased patients with such alterations, and a comparator group of cancer patients without these rare changes. Patient-reported outcomes are collected through surveys at baseline and every three months, especially when treatments change. Participants provide molecular testing reports and complete quality of life questionnaires regularly for up to 10 years. Researchers track progression-free survival or overall survival, the development of brain metastases, and economic impacts related to treatment. The study collects data from medical records and patient surveys to understand treatment patterns, effectiveness, and quality of life in the real-world Canadian context.

This research focuses on improving clinical trial enrollment for patients living with cancer in Canada. It evaluates the Clinical Trials Navigator CTN program, which was initially piloted in Windsor, Ontario, and aims to help patients, families, and healthcare providers find and enter meaningful clinical trials across Canada. The study addresses the common barrier of limited trial availability at patients local cancer centers, especially in rural and smaller community hospitals where enrollment rates are lowest. The study uses a stepped wedge, cluster randomized controlled trial design to roll out the CTN program sequentially to twenty cancer centers over 12 months. The CTN program includes expert navigators who perform thorough searches for available trials, a publicly accessible referral process, continuous quality improvement, and knowledge sharing. Two groups are compared standard care processes for trial enrollment and the CTN program-assisted enrollment process. Participants include patients receiving treatment for breast cancer and healthcare professionals at participating centers. Data collection involves monthly physician surveys to track patient referrals and enrollments in trials outside their home centers, as well as structured interviews with stakeholders before and after CTN program implementation. The study measures referral rates to clinical trials, enrollment rates, stakeholder attitudes, barriers to referral and enrollment, and the CTN programs scalability. The entire study lasts 12 months with no follow-up beyond this period.

Researchers are evaluating the effectiveness of different doses of epinephrine in adults who experience out-of-hospital cardiac arrest OHCA due to ventricular fibrillation VF or pulseless ventricular tachycardia VT. This randomized controlled trial compares a low cumulative dose of epinephrine to the standard dose during resuscitation efforts, aiming to understand which dosing strategy better supports survival to hospital discharge. Eligible patients are randomly assigned to receive either a low dose up to 2 mg total or a standard dose up to 6 mg total of epinephrine. Paramedics start cardiopulmonary resuscitation CPR and defibrillation according to usual protocols, then administer epinephrine doses every 3 to 5 minutes until return of spontaneous circulation ROSC or resuscitation is stopped. Additional treatments like antiarrhythmics, magnesium, beta blockers, or intubation may be given as needed. This trial is conducted at multiple centers and follows patients using hospital records and telephone interviews. Participants are closely monitored throughout resuscitation and hospital care. Outcome measures include survival to hospital discharge, return of spontaneous circulation, survival to emergency department arrival, and long-term health status evaluated up to five years. Researchers also track hospital and critical care stays, recurrent cardiac arrests, and rehospitalizations. The study provides important data on how epinephrine dosing affects outcomes in emergency cardiac arrest situations.

Researchers are evaluating how alcohol consumption affects physiological responses and perception during conditions similar to indoor extreme heat events. This study focuses on younger and older adults and aims to understand sex- and age-specific changes caused by alcohol intake in heat, building on recent findings that acute alcohol consumption does not negatively affect thermoregulation, hydration, or fluid balance markers compared to control fluids. Participants will be randomly assigned to consume either a placebo non-alcoholic beverage or an alcoholic beverage. Females will receive 0.75 b1 0.1 grams of ethanol per kilogram of body weight, while males will receive 1.0 b1 0.1 grams per kilogram. After consumption, they will rest in a climate-controlled room set at 40b0C and 30% relative humidity for 120 minutes, with the total study time lasting 180 minutes. During the study, heart rate, skin temperature, core temperature, blood pressure, heart rate variability, arrhythmia presence, skin blood flow, sweat loss, urine output, postural sway, and thermal sensation and comfort will be measured at baseline and every 30 minutes up to 120 minutes after drinking. Blood alcohol concentration and subjective alcohol effects will also be assessed over this period. These measures will help understand how alcohol impacts the bodys responses during heat exposure under controlled conditions.

This research aims to evaluate the harms and benefits of endocrine therapy in patients aged 70 years or older with lower-risk stage 1 hormone receptor-positive HR breast cancer. The current standard care includes breast-conserving surgery followed by radiotherapy and at least 5 years of endocrine therapy. However, in older patients, the benefit of endocrine therapy may be reduced due to higher risks of death from other causes and the presence of other health conditions that could affect quality of life and functional status. Participants will be randomly assigned to one of two groups either omission of endocrine therapy or administration of endocrine therapy for at least 5 years. Prior to this, they must have received standard local treatment, including breast-conserving surgery followed by radiotherapy or total mastectomy. The study is multicenter and randomized to assess the balance of benefits and harms associated with endocrine therapy in this older population. Throughout the study, participants will be followed for up to 5 years. Researchers will assess a hierarchical composite endpoint including overall survival, invasive disease-free survival, metastatic disease-free survival, and quality of life. Additional evaluations will include breast cancer-specific survival, treatment side effects, changes in geriatric health domains, adherence to endocrine therapy, and patient-reported symptoms such as hot flashes and joint pain. Quality of life questionnaires and belief assessments about therapy will be collected at multiple time points to monitor impact and treatment experiences.

Indigenous youth aged 18 to 25 in Northwestern Ontario who need mental health support often face longer wait times than non-Indigenous youth, which can worsen symptoms and increase risks like suicide or hospitalization. This research evaluates the JoyPop mobile mental health app designed to help improve emotion regulation for these transitional-aged youth while they wait for mental health services. The study is a randomized controlled trial comparing the apps impact to usual wait-list monitoring practices. Participants are randomly assigned to one of two groups. One group will use the JoyPop app for four weeks alongside usual wait-list monitoring, which includes regular check-in phone calls. The other group will receive usual wait-list monitoring alone for four weeks before being offered access to the app. The JoyPop app encourages usage at least twice daily but does not require specific usage rules. Throughout the study, emotion regulation will be measured before, during, and after the four-week period using a standardized scale. Additional assessments include mental health symptoms, treatment readiness, and economic impacts. Participants may attend virtual or in-person orientation sessions, and those without iOS devices will receive refurbished iPhones with the app. The study concludes by reviewing changes in emotion regulation and related outcomes, with the entire participation lasting at least four weeks.

Indigenous youth aged 12 to 17 in Northwestern Ontario who need mental health support often face longer waits than their non-Indigenous peers and youth in urban areas. These delays can worsen symptoms, increase distress, and raise risks for severe outcomes like suicide and hospitalization. Researchers, in partnership with Dilico Anishinabek Family Care, are studying the JoyPop mobile mental health app to help improve emotion regulation, a common challenge in youth with mental health issues, while they wait for services. The study is a two-arm randomized controlled trial comparing the JoyPop app plus usual wait-list monitoring to usual wait-list monitoring alone. Participants in the JoyPop group will use the app at least twice daily for four weeks, alongside regular phone check-ins. Those in the usual practice group will be monitored by phone and offered the app after four weeks. The trial will assess changes in emotion regulation and other mental health symptoms during this period. Participants will complete assessments at the start, after two weeks, and after four weeks, including questionnaires measuring emotion regulation, psychological distress, depression, anxiety, stress, and treatment readiness. Researchers will monitor app usage, mental health changes, and health service use. The total participation time is four weeks of app use and monitoring during the wait for mental health services, with data collected virtually or in person.