Nanaimo

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.

Researchers are investigating a treatment approach for patients hospitalized with community-acquired pneumonia (CAP), a condition with high rates of illness and death. This phase 3 trial compares therapeutic-dose heparin versus usual care pharmacological thromboprophylaxis to see if it improves patient outcomes. The study focuses on preventing complications caused by blood clots and inflammation that can worsen respiratory and organ function in CAP patients. Previous findings in COVID-19 pneumonia suggest heparin might reduce disease progression and mortality, but its effects in non-COVID-19 CAP are unknown. Participants will receive either therapeutic-dose heparin, preferably a low molecular weight heparin (LMWH) like enoxaparin, dalteparin, or tinzaparin, dosed by patient weight unless contraindicated. Intravenous unfractionated heparin (UFH) may be used instead, especially for those with kidney issues, with dosing adjusted to specific blood clotting targets. The trial is open-label and randomized, with adaptive rules to monitor progress. Usual care pharmacological thromboprophylaxis is the comparator. Treatment and monitoring occur during hospital admission, anticipated to last at least 72 hours after randomization. During the study, patients are assessed for survival at 30 days and monitored for complications related to CAP. Researchers collect clinical data including oxygen use, laboratory tests, and adverse events, tracking safety and effectiveness. The study excludes patients with active COVID-19, recent bleeding, contraindications to anticoagulation, or those receiving critical care interventions. Overall participation depends on hospital stay length and clinical status, with follow-up to evaluate the primary outcome of survival within a month.

Researchers are evaluating the long-term safety of two drugs, Deucravacitinib and Ustekinumab, in adults with moderate-to-severe plaque psoriasis. This Phase 3b/4 study focuses on participants who are candidates for phototherapy or systemic treatment and have specific cardiovascular risk factors such as smoking, hypertension, diabetes, obesity, or a family history of heart disease. Participants will receive either Deucravacitinib or Ustekinumab at specified doses on set days. This open-label, randomized study compares these treatments over an extended period to monitor their safety profiles, including cardiovascular health. Throughout the study, researchers will track major adverse cardiovascular events, including heart attacks, strokes, and related procedures, for up to five years. Participants will undergo regular assessments to monitor their psoriasis and cardiovascular status, ensuring comprehensive safety evaluation during the long-term treatment.

Chemotherapy-induced peripheral neuropathy (CIPN) is a painful and disabling condition affecting up to 70% of cancer patients who undergo chemotherapy. It causes nerve pain in a glove-and-stocking pattern, weakness, and other symptoms that impact quality of life, function, chemotherapy tolerance, and ability to return to work. Duloxetine is currently the only recommended medication for CIPN pain, but its benefits are modest. Methadone, an opioid with unique properties, may offer better pain control and less tolerance development over time, but it has not been studied for CIPN treatment. This study is a randomized double-blind controlled trial comparing methadone to duloxetine for painful CIPN treatment. Participants will be randomly assigned to receive either methadone 2 mg every 8 hours plus a duloxetine placebo once daily, or duloxetine 30 mg once daily plus a methadone placebo every 8 hours, with both treatments encapsulated to look identical. They will be followed weekly for 5 weeks in person or virtually. During these visits, questionnaires will be completed, adverse events reviewed, and doses adjusted weekly as tolerated to manage pain or until the study ends. Participants will answer brief questionnaires weekly over 5 weeks to assess pain levels and functional interference. The main measure is the reduction in average pain intensity using the Brief Pain Inventory-Short Form. Secondary outcomes include improvements in function and quality of life, patient global impression of change, and safety monitoring. This study aims to determine if methadone is an effective option for CIPN pain, potentially providing a new treatment for this challenging condition.

Researchers are evaluating new treatments for acute hypoxemic respiratory failure (AHRF), a serious condition affecting millions worldwide and often requiring mechanical ventilation or extracorporeal life support. This adaptive platform trial includes multiple domains that assess different therapies across a range of patient severity and investigational phases, from early mechanistic studies to full clinical trials. The study uses advanced statistical methods to efficiently test interventions focusing on mechanical ventilation, extracorporeal support, drugs, and medical devices. Participants may receive various interventions depending on the domain, including ultra-protective ventilation using VV-ECMO, lung-protective ventilation, driving pressure-limited ventilation, lung- and diaphragm-protective ventilation with sedation, corticosteroid treatments, fludrocortisone, nebulized furosemide, or inspiratory muscle training. Some domains also study ventilation strategies during extracorporeal life support or collect observational data. Treatments are delivered according to randomized assignments, sometimes involving specialized devices or adjusted ventilator settings. During the study, participants undergo assessments including physiological and biological measurements, monitoring of ventilation targets, adherence to protocols, and survival outcomes up to 60 days. Recruitment feasibility and barriers are tracked over years at multiple sites. The trial collects data on ventilator-free days, mortality, advanced respiratory support-free days, and protocol adherence. Safety and effectiveness are regularly evaluated through Bayesian adaptive analyses, with total enrollment periods ranging from months to years depending on the domain.