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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Spontaneous intracerebral hemorrhage ICH is a serious type of stroke with high death and disability rates. Researchers are investigating whether a structured treatment package called a Care Bundle can improve the 3-month outcomes for patients with acute ICH compared to standard care. The study is an international, multicenter, parallel, cluster-randomized clinical trial focusing on implementing this Care Bundle in high-income countries, building on results from previous trials mostly done in low- and middle-income countries. The Care Bundle includes early intensive blood pressure lowering, treatment of fever and high blood sugar, rapid reversal of oral anticoagulation, and timely referrals to intensive care or neurosurgery when needed. Hospitals are randomized in batches through three phases usual care, randomized evaluation of the Care Bundle versus usual care, and a post-implementation follow-up where all hospitals apply the Care Bundle. Each batch lasts 18 months, with 6 months per phase, and the overall study rollout spans 2.5 years. Participants are adults aged 18 or older diagnosed with spontaneous ICH confirmed by imaging within 24 hours of symptom onset. During the study, patient management details and outcomes will be closely monitored, including brain imaging, blood pressure, glucose levels, and functional status. The primary outcome is functional recovery measured by a utility-weighted modified Rankin Scale score at 180 days. Secondary outcomes include disability, death, and health-related quality of life. The study also collects data on treatments and care decisions to evaluate the Care Bundles effectiveness and sustainability.
Actively Recruiting
Researchers are evaluating surgical treatments for adult acquired flatfoot deformity AAFD, a condition causing foot pain and changes in walking. This trial compares the standard medial displacement calcaneal osteotomy MDCO alone with MDCO combined with a sinus tarsi implant STI, which may provide better correction by supporting soft tissues and improving foot alignment. The study is a randomized controlled trial involving patients aged 16 to 75 with mobile AAFD stage II who have not improved after physiotherapy. Participants will be randomly assigned to receive either MDCO with STI or MDCO without STI. Both groups may also receive additional procedures like Strayers gastrocnemius recession, flexor digitorum longus tendon transfer, spring ligament repair, and possibly a Cotton osteotomy if needed. Surgery will be performed by experienced foot and ankle surgeons at multiple orthopedic centers. Postoperative care includes casting and weight-bearing instructions tailored to the procedures performed. Patients will be assessed before surgery and at 4-5 months, 1 year, and 2 years after surgery through clinical exams, questionnaires measuring foot function and quality of life SEFAS and EQ-5D, and weight-bearing foot X-rays to measure angles like Mearys angle. Researchers will also evaluate pain, satisfaction, heel-rise endurance, sick-leave duration, and complications. Follow-up involves blinded examiners and radiologists to ensure unbiased assessments, with patients encouraged to complete all visits and questionnaires over the two-year period.
Actively Recruiting
Researchers are evaluating the effectiveness of the CE-marked wearable device called Stroke Alarm to detect the start of a stroke with unilateral arm weakness within three hours of onset. This multicenter, prospective observational trial includes a single group using the device and compares results to a matched control group from a Swedish national stroke registry. The study aims to achieve at least 60% sensitivity and 80% specificity in identifying strokes using clinical diagnosis as the standard. Participants who meet eligibility criteria will receive the Stroke Alarm, which consists of sensor bracelets worn continuously for three months. The device pairs with a smartphone app that alerts chosen alarm recipients via SMS if stroke symptoms are detected. The study involves baseline data collection at enrollment, follow-up at three months, and additional data from national registry sources. Participants will use the device during normal daily activities and can add multiple alarm recipients who will be notified if the device detects signs of stroke. During the study, researchers will monitor device alarms, timing of stroke onset detection, hospital arrival times, and any treatments or complications related to the device. Participants are assessed at enrollment and after three months, with data collected from electronic records and national registries. The total study involvement is three months of device use with follow-up and data review to evaluate how well the device detects stroke events and triggers alarms for timely intervention.
Actively Recruiting
Researchers are studying how different surgical treatments for displaced bucket-handle meniscal tears in the knee compare in terms of outcomes. These injuries affect the menisci, which are important for knee stability and preventing osteoarthritis, a common joint disease. The study focuses on understanding the timing and success of meniscus-preserving surgery versus partial removal, aiming to reduce long-term knee problems and the need for repeat operations. The study observes patients who have a displaced bucket-handle meniscal injury treated either with meniscus suture surgery to repair the tear or with partial meniscectomy to remove the damaged part. The research monitors these treatments over a long period, up to 10 years, to assess the need for reoperation and the development of knee osteoarthritis. The study includes patients aged 15 years and older with specific injury characteristics confirmed by MRI. Participants will be followed to evaluate outcomes such as the rate of reoperation between 2 and 10 years after surgery, knee function and symptoms using the Knee Injury and Osteoarthritis Outcome Score from 6 months to 10 years, and the presence of osteoarthritis in the knee after 10 years. The study is observational, meaning it collects and analyzes data without assigning treatments. This long-term follow-up helps understand the healing and potential risks related to these surgical approaches.