Kingston

Preterm birth before 37 weeks' gestation is common and linked to many health challenges, especially when it occurs before 29 weeks. At this early stage, infants often face breathing difficulties due to immature lungs, sometimes requiring resuscitation. This study aims to compare two oxygen concentrations, 30% and 60%, used during resuscitation of very preterm infants to determine which leads to better survival and neurodevelopmental outcomes by about two years of age. The study uses a cluster randomized crossover design, where hospitals alternate between using 30% and 60% oxygen to resuscitate infants born between 23 and 28 weeks gestation. Infants receive the assigned oxygen concentration for the first 5 minutes after birth, with adjustments made based on oxygen saturation levels to maintain safe ranges. The intervention lasts 10 minutes, including initial resuscitation and oxygen titration to stabilize the infant. Participants will be closely monitored during their hospital stay and followed up at 24 months corrected age to assess survival and major neurodevelopmental outcomes. Data collected will include oxygen saturation, heart rate during resuscitation, and longer-term health measures. The study's results aim to guide safer oxygen use in resuscitating extremely preterm infants worldwide.

Researchers are evaluating the feasibility of a culturally adapted psychosocial intervention called the Thinking Healthy Program (THP) delivered via a mobile app to support the mental well-being of Chinese immigrant pregnant women in Canada. This pilot study focuses on women who are at least 22 weeks pregnant, over 18 years old, speak Mandarin, and belong to the East Asian community. The study aims to determine if the Chinese version of THP is acceptable and usable, and how well processes like recruitment, retention, and adherence work for a future larger trial. It also seeks preliminary evidence on the program's effect on depression. Participants will use an Android-based mobile app containing three modules of the adapted THP, which incorporates culturally tailored cognitive behavioral therapy and behavioral activation through information and activities. The intervention duration is about three weeks. A subset of participants may be invited to share their experience in individual telephone interviews. The study recruits about 50 women through social media, professional networks, and community organizations serving East Asian immigrants. Participants will complete questionnaires at baseline, 3-4 weeks after starting the intervention, and 6-8 weeks postpartum, covering mental health measures like depression severity, anxiety, stress, resilience, social support, and the mother-infant relationship. Researchers will assess app usability, acceptability, recruitment success, retention through study completion (around 12 months), and adherence to the intervention. Data will help inform future studies and improve support for perinatal mental health in this population.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

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 conducting two related studies called RADICAL PC1 and RADICAL PC2 focused on men diagnosed with prostate cancer. RADICAL PC1 follows men within one year of their prostate cancer diagnosis or who have recently started androgen deprivation therapy (ADT). The goal is to understand factors linked to developing cardiovascular disease in these men, especially related to ADT. RADICAL PC2 is a randomized controlled trial within RADICAL PC1 that tests a systematic approach to improving heart health and lifestyle risk factors in this population. The treatments studied include behavioral advice on healthy nutrition, exercise including strength and resistance training, and smoking cessation support if needed. Drug treatments include prescriptions of low to moderate dose statins and ACE inhibitors or angiotensin receptor blockers for controlling blood pressure above 130 mmHg. The intervention targets men newly diagnosed or recently starting ADT, and treatment is personalized based on cardiovascular risk. Participants engage in assessments to monitor heart-related outcomes such as death, heart attacks, strokes, heart failure, or arterial revascularization over 3 to 5 years. The study tracks cardiovascular health and lifestyle factors throughout this period to evaluate the effectiveness of the interventions. Safety and progress are closely monitored to understand impacts on long-term outcomes in men with prostate cancer undergoing ADT.

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 research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are evaluating the safety and effectiveness of brenipatide compared to placebo for people with opioid use disorder. This study focuses on participants who are also using buprenorphine, with or without naloxone, as part of their treatment. The trial includes two parts, each with separate groups of participants, to better understand how brenipatide works alongside current therapies in early recovery from opioid use disorder. The study has two parts: Part A involves a double-blind treatment phase followed by an open-label extension, while Part B offers an open-label treatment only. Brenipatide and placebo are given as subcutaneous injections, and buprenorphine is administered either sublingually or buccally. Participants will be enrolled in only one part of the study, with treatment durations potentially lasting up to 144 weeks in Part A and 116 weeks in Part B, depending on enrollment timing and study progress. Participants will regularly attend study visits where they will be assessed through urine drug screens and self-reports to measure abstinence from opioid use. They will also maintain study diaries and complete questionnaires to track adherence and effects. The main outcomes measured include the percentage of weeks participants remain abstinent from opioids between weeks 13 and 24, verified by negative drug tests and no self-reported opioid use. Safety and long-term effectiveness will be monitored throughout the study duration.

Researchers are evaluating the safety, how the body processes the drug, and the effectiveness of calderasib alone or combined with other treatments in adults with advanced solid tumors that have a specific KRAS G12C mutation. This is a Phase 1, open-label, multicenter study focusing on participants with this genetic mutation in their tumors, aiming to understand how calderasib works alone and with other drugs. Participants receive calderasib as an oral dose, and some may also receive other medications such as pembrolizumab through intravenous infusion, or drugs like carboplatin, pemetrexed, cetuximab, oxaliplatin, leucovorin, and 5-fluorouracil according to standard guidelines. The treatments may be given alone or in combination depending on the study arm, with dosing schedules following label instructions or protocol specifications. During the study, participants will be closely monitored for any dose-limiting toxicities and adverse events, including reasons for stopping treatment. Researchers will assess these effects for up to about 21 days for dose-limiting toxicities and up to 56 months for adverse events and treatment discontinuation. The study involves regular evaluations to track safety, tolerability, and how well the treatment works over time.