Search Bar & Filters
Found 54 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety and effectiveness of different doses of Corabotase also called IPN10200 for treating adults with upper limb spasticity. This study aims to understand how Corabotase affects the body and to determine which doses provide the best balance of safety and benefit. The trial involves adult participants aged 18 to 70 years who have spastic hemiparesis following stroke or traumatic brain injury and meet other specific health criteria. The study includes several groups receiving different doses of Corabotase, Dysport, or placebo as single injections into various upper limb muscles. Participants are assigned randomly to groups, with some in dose-escalation cohorts and others in fixed-dose groups. The injections are given once, and doses are carefully adjusted to assess safety and response. The trial uses a double-blind design, meaning neither participants nor researchers know who receives which treatment. Participants will be monitored over nine months with regular assessments including physical exams, vital signs, lab tests, and evaluations of muscle spasticity using the Modified Ashworth Scale. Researchers will track any side effects, antibody development, and changes in muscle tone and disability. Patient and physician impressions of treatment effects and pain levels will also be recorded. This long-term follow-up helps researchers understand how the treatments work and their safety over time.
Actively Recruiting
Researchers are evaluating how the body processes nusinersen, a drug used for spinal muscular atrophy SMA, when it is delivered through an investigational implantable device called the ThecaFlex DRx System versus the standard lumbar puncture method. This Phase 1, open-label study aims to understand the drugs concentration in the blood after dosing with each delivery method. Participants in the PIERRE study, who have SMA, may join this PIERRE-PK study to help answer these questions. Participants will receive a 12 milligram dose of nusinersen by lumbar puncture first, followed by implantation of the ThecaFlex DRx System. After the device is implanted, participants will receive the same 12 milligram dose of nusinersen through the device. Blood samples will be collected before and after each dose to measure drug levels, with a final sample taken 24 hours after dosing. The study treatments and device implantation are part of the PIERRE and PIERRE-PK studies combined. The study involves a screening period of up to 30 days, which may overlap with the PIERRE study screening. Each participants involvement in the PIERRE-PK study lasts about five months, overlapping with their first five months in the PIERRE study. Researchers will monitor blood samples for the highest drug concentration and overall exposure during the first 24 hours after dosing to understand how nusinersen behaves in the body with each delivery method.
Actively Recruiting
Researchers are investigating a new drug called BAY 3389934 to find a better way to treat people with sepsis-induced coagulopathy, a serious condition where an active immune response causes uncontrolled blood clotting, damaging blood vessels and organs. This early-phase study aims to learn about the safety, appropriate dose, and effects of BAY 3389934 in patients receiving treatment for this condition in intensive care units. The research is focused on monitoring medical problems, called adverse events, that occur during and after treatment. Participants will receive BAY 3389934 as a continuous intravenous infusion for up to 96 hours. They will be divided into two groups the first group will receive a low starting dose, and their response will be closely monitored to adjust the dose if needed. If there are no serious side effects, the second group will receive a higher dose. This dose escalation approach helps determine the best dose for future studies. During the approximately 28-day study, participants will have blood and urine samples taken, physical exams, vital signs checked, and heart health monitored with electrocardiograms. Researchers will track the number and severity of any treatment-emergent adverse events within about four days after starting the infusion. They will also measure blood clotting times over the first six days to assess effects on coagulation. The study is designed to carefully observe safety and drug effects while patients receive intensive care.
Actively Recruiting
Researchers are evaluating the use of Mobile Stroke Units MSUs, specialized ambulances equipped with CT scanners, for prehospital initiation of intravenous thrombolysis IVT in patients with acute ischemic stroke. This trial compares MSU deployment to standard care and aims to assess both clinical outcomes and cost-utility, particularly focusing on time to treatment and functional recovery at 3 months. The study involves 450 patients in France with confirmed acute ischemic stroke within 6 hours of symptom onset, followed for 3 months. Participants are randomly assigned to either receive care from the MSU plus a conventional ambulance or from a conventional ambulance alone. The MSU group benefits from on-site CT imaging including intracranial CT angiography, enabling earlier IVT and better triage for mechanical thrombectomy eligibility. The trial is open-label but includes blinded assessment of outcomes. Recruitment occurs over 3 years, with follow-up assessments at 3 months after treatment. During the study, researchers collect data on treatment timing, clinical outcomes including the Modified Rankin Scale at 3 months, and health economics. They track the incremental cost-utility ratio over 3 months and project it over a lifetime horizon. Safety monitoring includes recording deaths within 7 and 90 days, symptomatic intracranial hemorrhage, and other relevant events. Participants provide informed consent after randomization, and outcomes related to IVT and mechanical thrombectomy use and timing are closely evaluated.
Actively Recruiting
Researchers are evaluating different antimicrobial therapies for infections caused by difficult-to-treat Pseudomonas aeruginosa, a type of bacteria resistant to many common antibiotics. This study focuses on comparing new beta-lactambeta-lactamase inhibitor combinations, cefiderocol, and older treatments like aminoglycosides and colistin to understand their effectiveness in real-life settings for patients facing these challenging infections. The study is a prospective, multicenter cohort involving patients who require intravenous antibiotic treatment for their P. aeruginosa infections. Participating patients will receive one of the available antimicrobial options, and their bacterial samples will be analyzed centrally to assess susceptibility and resistance mechanisms. The study collects clinical data throughout treatment and monitors outcomes such as cure rates, resistance development, adverse events, and mortality. Participants will be followed until hospital discharge and up to 28 days after treatment completion. Researchers will track clinical cures, microbiological eradication, adverse events, emergence of resistance, and acquisition of other multidrug-resistant bacteria. Data collection includes electronic case reports and laboratory testing on bacterial isolates. The total participation duration varies according to hospital stay and follow-up schedules, with rigorous monitoring of safety and treatment outcomes.
Actively Recruiting
Neurological disabilities resulting from traumatic spinal cord injuries can cause challenges in movement, bladder, and sexual functions. This trial investigates the use of epidural electrical stimulation EESS combined with locomotor training to restore these functions in adults with incomplete spinal cord injuries. Previous studies in animals and humans have shown promising improvements using this approach, but detailed clinical validation is needed. Participants will undergo two treatment sequences in a crossover design. One sequence involves 40 working days of stimulation combined with automated rehabilitation two 45-minute sessions daily, followed by a 30-day washout, then 40 working days of automated rehabilitation alone. The other sequence reverses this order. This approach aims to compare the effects of adding stimulation to rehabilitation in improving motor and autonomic functions. Throughout the study, participants will be monitored for their ability to move over a distance of 5 meters, as well as improvements in bladder and sexual function. Assessments will include evaluations of spinal neuronal excitability, quality of life, and safety monitoring for adverse events. The study spans several months, including treatment periods, washout phases, and follow-up assessments to capture lasting effects and tolerance.
Actively Recruiting
Researchers are studying acute bronchiolitis, a common lung infection in children under two years old caused mainly by the respiratory syncytial virus RSV. The study aims to understand why it is difficult to predict how severe the infection will become by looking at the role of the microbiota gut, oral, and nasal bacteria and the immune response to RSV in affected children. This observational study includes infants under 12 months old with bronchiolitis during the RSV season. The study involves collecting samples from 80 infants with different severities of bronchiolitis, including hospitalized, non-hospitalized, and those in intensive care. Researchers will take oral, nasal, and stool samples to study the microbiota and will collect capillary or venous blood samples to analyze immune responses. These samples help identify bacterial imbalances and immune markers during infection. Participants will provide these samples once during their illness. Researchers will measure dysbiosis, immune system markers like cytokines and chemokines, viral genetics, RSV antibodies, and bacterial load. The study team monitors these factors to better understand infection severity and immune response. The study runs from December 2024 through April 2026, and participation involves only sample collection with no treatment interventions.
Actively Recruiting
This research aims to understand the barriers to physical activity faced by people with cognitive, neuromotor, or sensory impairments as they age. It explores how these challenges evolve over time and examines the short- and long-term effects of medical and social treatments designed to reduce these barriers. The study focuses on patients seen in a Physical Medicine and Rehabilitation Department and their participation in competitive sports despite disabilities. The study includes patients who visit the Parasport Health Unit at a university hospital. Researchers collect data from medical records and clinical examinations, including radiological, biological, and physiological tests. The care provided to these patients follows standard procedures for their specific impairments. Data collection spans about one year and looks at how treatments, therapies, and devices like orthoses or prostheses help overcome barriers to physical activity. Participants will be followed during their regular medical visits, and information about their health, physical activity levels, and use of assistive devices will be gathered. Researchers will monitor changes in barriers to physical activity, physical fitness test results, and the progression of any related health conditions. The study aims to provide a detailed picture of factors affecting physical activity in this population over time, with an average follow-up period of one year.
Actively Recruiting
Infantile spasms are sudden, brief epileptic seizures characterized by rapid, repeated body contractions in flexion or extension, sometimes with eye movements. This condition is serious because delayed diagnosis and treatment can lead to cognitive decline. Diagnosing infantile spasms typically requires video-EEG, but this method is costly and not always accessible. To improve early detection, researchers are developing an automated system that analyzes simple smartphone or webcam videos using computer vision and learning models to identify spasms. The study aims to train this automated system by using a database of videos linked with electrophysiological data from pediatric neurophysiology labs. These videos have confirmed spasms based on expert analysis and video-EEG. The goal is for the system to reach over 95% sensitivity and specificity, allowing it to be used by healthcare professionals and families for early seizure detection and monitoring. This approach could facilitate faster referral and treatment, especially where access to specialized diagnostic tools is limited. Participants in this observational study include children up to 3 years old who have undergone video-EEG and have recorded spasms or other epilepsy types. Researchers will analyze existing video and EEG data to teach the system to distinguish spasms from other seizures. The primary outcome is achieving automated detection accuracy above 95% for spasms within two years. The study uses retrospective data from multiple hospitals and plans to publish results in a peer-reviewed journal.
Actively Recruiting
Researchers are investigating the use of the oXiris hemofiltration membrane in critically ill patients with vasoplegic shock, a condition where blood pressure is dangerously low due to an inappropriate response to infection. This observational pilot study aims to understand how blood purification with the oXiris membrane affects hemodynamics and the clearance of vasoactive metabolites, including angiotensin peptides, which may play a role in vascular tone regulation. Prior clinical data suggest that this treatment may reduce the need for vasopressors in both pediatric and adult patients. The study involves using the oXiris membrane hemofiltration with the Prismaflex system and specific dialysis solutions. Anticoagulation is managed with heparin, citrate, or none depending on bleeding risk. The treatment volume is capped at 35 mlkgh. Blood samples will be collected before treatment, at 24 hours, and at 72 hours to measure angiotensin peptides and related enzymes using advanced laboratory techniques. The samples are analyzed both immediately and after incubation to assess metabolite concentrations. Participants will be monitored for 90 days to track mortality and clinical progress. Data collected from medical records and lab tests will be entered into a database for analysis. The main outcome is a 50% reduction in the vaso-inotropic score within 24 hours after starting treatment. Additional outcomes include changes in vaso-inotropic scores over 72 hours, levels of angiotensins and regulatory enzymes, markers of endothelial function and immune response, and hemodynamic responses. This comprehensive monitoring aims to clarify the biological effects of oXiris treatment in vasoplegic shock.
1-10 of 54
1