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Actively Recruiting

Researchers are evaluating the effectiveness of a personalized, stepped, multidisciplinary intervention delivered through a virtual multimodal rehabilitation hub for adults undergoing colorectal cancer surgery. This study aims to reduce postoperative complications within 30 days after surgery compared to usual care. Secondary goals include assessing quality of life, days spent at home after surgery, quality of recovery, cost-effectiveness, and implementation outcomes. The trial is a pragmatic randomized Type I hybrid effectiveness-implementation study involving 564 participants across Australia. Participants will be randomly assigned to either the virtual multimodal hub intervention or usual care. The intervention includes preoperative and postoperative components such as exercise (aerobic, endurance, respiratory, muscle strength, education), nutrition support (screening, weight monitoring, dietetic counseling), psychological support (CBT skills, emotional validation, psycho-education), nursing care (risk management, pain, wound and bowel/stoma care, education), and fortnightly peer support groups moderated by social workers. Allied health workers provide personalized virtual sessions before and after surgery, lasting up to 12 months or until treatment goals are met. Participants without internet access may receive tablets to facilitate virtual participation. During the study, participants will undergo baseline assessments and be monitored for postoperative complications within 30 days. Data collection includes patient-reported outcomes, quality of life questionnaires, and days at home at various intervals post-surgery. Safety is overseen by an independent Data and Safety Monitoring Board, with adherence to Good Clinical Practice guidelines. The total study duration is approximately 60 months, with ongoing assessments and support provided through the virtual hub and usual care pathways.

Age: 18Years +All GendersPhase Not Applicable
31 locations
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Actively Recruiting

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.

Age: 18Years +All GendersPhase 3
408 locations
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the impact of scaling up finger-stick point-of-care testing for hepatitis C virus (HCV) to improve diagnosis and treatment rates. This observational cohort study focuses on people at risk of HCV infection, including those attending services like drug treatment clinics, needle and syringe programs, prisons, mental health services, and homelessness support. The study aims to address declining treatment uptake and challenges caused by COVID-19, contributing to national efforts to eliminate HCV by 2030. Participants will be offered finger-stick point-of-care testing for HCV antibodies, with results available within 1 to 20 minutes. If the antibody test is positive, a point-of-care HCV RNA test will be done to detect active infection. Those previously infected or treated will directly receive the HCV RNA test. No treatment is provided within the study, but participants with active infection will be connected to standard care services for clinical assessment and treatment initiation. Participants attend a single visit for testing and to complete a self-administered survey. The study will monitor the proportion of participants who start HCV treatment within 12 weeks after testing positive for HCV RNA. Researchers will also link survey data to health records to assess long-term impacts of expanded HCV testing and treatment. This approach aims to improve diagnosis rates and support efforts to reduce HCV-related health burdens.

Age: 18Years +All Genders
69 locations
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