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Actively Recruiting

Spontaneous intracerebral hemorrhage (ICH) is a severe type of stroke accounting for 10-15% of all strokes but causing about half of stroke-related deaths and disabilities. Many patients with ICH have decreased consciousness when admitted, yet intensive care and neurosurgical treatments are not common. Prior studies in low- and middle-income countries showed that a treatment package including early intensive blood pressure lowering and managing fever and high blood sugar improved outcomes. The I-CATCHER study aims to test a similar structured Care Bundle approach in Sweden, Australia, and other high-income countries to improve treatment and prognosis for patients with spontaneous ICH. This study compares a Care Bundle involving early intensive blood pressure control, reversal of oral anticoagulation within 30 minutes, fever management, blood sugar control, and timely referrals to intensive care or neurosurgery against standard care. The Care Bundle targets specific blood pressure levels depending on initial readings and aims to avoid do-not-resuscitate orders or withdrawal of care for 48 hours. Repeat brain imaging is done as needed. Hospitals are randomized in batches over three phases lasting 18 months each: usual care, randomized evaluation, and post-implementation follow-up, with the entire study rolling out over 2.5 years. Participants are adults aged 18 or older with spontaneous ICH confirmed by imaging and admitted within 24 hours of symptom onset. Patient information, treatments, and outcomes are recorded, including functional status measured by the Utility Weighted modified Rankin Scale at 180 days. The study collects data on various treatments, monitoring, and complications to assess if the Care Bundle improves recovery. Safety and sustainability of the Care Bundle are evaluated through continued hospital participation and follow-up.

Age: 18Years +All GendersPhase 4
52 locations
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Actively Recruiting

Researchers are evaluating whether remote video exercise-based cardiac rehabilitation (exCR) can increase participation in rehabilitation sessions after a myocardial infarction (heart attack), compared to traditional center-based exCR. The study is designed as a national multicenter registry-based cluster randomized crossover clinical trial, preceded by a feasibility and safety study conducted during the COVID-19 pandemic. Patients diagnosed with type 1 myocardial infarction and aged 18 to 79 years are included, with long-term follow-up planned at 1 and 3 years after the cardiac event. The study involves two phases: first, a feasibility study offering remote exCR at participating sites until the pandemic peak subsides, ending in August 2022; second, a randomized trial where cardiac rehabilitation centers are assigned to provide either remote exCR, usual center-based exCR, or a combination based on patient preference at intervention sites, while control sites offer only center-based exCR. The exercise program is standardized, requiring at least 24 supervised sessions over 3 to 4 months, each session including aerobic exercise and strength training at specified intensity levels. Success is defined as attending at least 75% of sessions within four months. Participants will be monitored through their attendance and adherence to the exercise sessions. Researchers will assess the average number of exCR sessions completed over 3 to 4 months. Additional evaluations include safety monitoring and long-term follow-up at 1 and 3 years to observe outcomes after the initial cardiac event. The study also considers patient access to internet for remote participation and evaluates exercise test results to ensure safety during rehabilitation.

Age: 18Years - 79YearsAll GendersPhase Not Applicable
26 locations
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Actively Recruiting

This research aims to evaluate the effectiveness of adding a sinus tarsi implant (STI) to medial displacement calcaneal osteotomy (MDCO) surgery in adults with mobile adult acquired flatfoot deformity (AAFD) stage II. AAFD is a complex foot deformity causing pain and difficulty walking, involving misalignment in three planes. While MDCO corrects the deformity in one plane, the STI is studied as an internal splint to better support soft tissues and improve foot correction, appearance, and long-term function. This is a phase 4, multicenter randomized controlled trial involving 130 patients aged 16 to 75 years. Participants will be randomly assigned to receive either MDCO with the sinus tarsi implant or MDCO alone. The surgical procedures include tendon transfers, ligament repairs, and other possible osteotomies as needed. Surgery is performed by experienced orthopedic specialists across nine centers in Sweden. After surgery, patients will wear a cast with weight-bearing restrictions depending on additional procedures performed. The study includes a thorough screening process, randomization, and follow-up visits scheduled at 4-5 months, 1 year, and 2 years postoperatively. Throughout the study, patients will complete questionnaires assessing foot and ankle function, quality of life, pain, and satisfaction with surgery at multiple time points. Clinical examinations by blinded physiotherapists or nurses will measure physical function and perform radiographic imaging to assess foot alignment changes, focusing on Meary's angle. Safety is monitored continuously, and any adverse events are recorded. The total participation duration includes preoperative assessments and two years of postoperative follow-up.

Age: 16Years - 75YearsAll GendersPhase 4
10 locations
S

Actively Recruiting

Researchers are evaluating the effectiveness of a CE-marked wearable system called Stroke Alarm, designed to detect the onset of a stroke with unilateral arm weakness within 3 hours. This multicenter, prospective observational study includes 500 patients at elevated risk of stroke due to recent transient ischemic attack (TIA), stroke without lasting arm weakness, or atrial fibrillation. The study compares results with a matched control group from the Swedish national stroke registry and aims for at least 60% sensitivity and 80% specificity in detecting strokes. Participants who qualify and consent receive Stroke Alarm bracelets to wear continuously for three months. The device includes sensor bracelets connected to a smartphone app that alerts selected contacts if it detects signs of stroke-related arm weakness. Users set up the device with help from study nurses and activate alarm recipients who can respond to alerts. The device continuously monitors arm movement and issues alarms through vibration, smartphone notifications, and SMS messages based on the user's response or lack thereof. During the study, participants are monitored at the start and followed up after three months, with additional data collected from national registries. Assessments include reviewing hospital records for stroke events and tracking device alerts. The primary outcome is the time from stroke onset to alarm by the device. The study also monitors false alarms and user interaction with the device to evaluate its performance and safety over the study period.

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

The menisci in the knee joint are made of cartilage and connective tissue, helping to stabilize the joint and distribute weight. This protects the knee from osteoarthritis, a common joint condition often called "joint wear." Meniscal surgeries are common worldwide, and recent advances have shifted treatment from removing damaged parts to preserving the meniscus. However, it is still unclear how soon surgery must be done to save the meniscus, with factors like age, other injuries, and surgical method playing a role. More research is needed to guide treatment and reduce the risk of early knee osteoarthritis after meniscus injuries. In this study, patients with a displaced bucket-handle meniscal tear will receive either meniscus suture (repair) or partial meniscectomy (removal of part of the meniscus). The study compares these two surgical approaches to see which leads to better outcomes over a 10-year period. The injury involves a large meniscus tear causing joint locking and knee extension problems. Treatment aims to preserve the meniscus whenever possible, but if the tear is too old or damaged, removal may be necessary. Participants will be followed for up to 10 years to monitor if re-operation is needed. Researchers will assess healing success, knee function, and long-term outcomes like osteoarthritis development. The study will include examinations, imaging, and evaluations over this time to understand which surgical approach better preserves knee health and reduces further surgeries.

Age: 15Years +All Genders
2 locations
Clinical trials in Hässleholm | DecenTrialz