Saint Genis Laval

Researchers are evaluating the effectiveness and safety of combining sonrotoclax with either obinutuzumab or rituximab compared to venetoclax plus rituximab in adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma CLLSLL. This Phase 3 randomized study aims to understand which combination offers better progression-free survival and treatment outcomes in patients who have undergone prior therapies. The study has four treatment groups sonrotoclax combined with obinutuzumab, sonrotoclax combined with rituximab, sonrotoclax plus obinutuzumab with treatment guided by minimal residual disease evaluation, and venetoclax combined with rituximab. Sonrotoclax and venetoclax are given orally, while obinutuzumab and rituximab are administered intravenously. Participants receive these treatments according to their assigned group as part of this clinical research. Participants will be monitored for progression-free survival, overall survival, response rates, and minimal residual disease status over several months up to several years. Safety assessments include tracking treatment-emergent adverse events. Quality of life and symptom burden will be evaluated using questionnaires. The study involves regular visits for treatment administration and assessments, with follow-up extending up to 84 months to observe long-term outcomes.

Researchers are evaluating the combination of sonrotoclax plus zanubrutinib compared with zanubrutinib plus placebo in adults with relapsed or refractory mantle cell lymphoma MCL. This Phase 3 randomized, double-blind study aims to compare how well these treatments work and assess their safety in this patient population. The study is sponsored by BeOne Medicines and focuses on patients who have previously received 1 to 5 prior systemic therapies including anti-CD20 monoclonal antibody or chemoimmunotherapy. Participants will receive either sonrotoclax plus zanubrutinib or placebo plus zanubrutinib, both administered orally. The study has two groups one receiving the combination of sonrotoclax and zanubrutinib, and the other receiving zanubrutinib with placebo. Treatment continues as per protocol, and the study includes detailed assessments of response and safety over time. During the study, participants will be monitored for progression-free survival as the primary outcome, assessed by an independent review committee over approximately 41 months. Secondary outcomes include overall survival, response rates, duration of response, health-related quality of life, and adverse events up to around 58 months. Regular evaluations will be conducted to assess disease status, quality of life, and safety throughout the trial, which is planned to complete by 2032.

Stroke often causes significant motor disability, especially hemiplegia, with many patients retaining movement difficulties six months after the event. Access to intensive rehabilitation after hospital discharge is often limited due to mobility, geography, and insurance issues. Telerehabilitation using digital tools offers a way to provide interactive, accessible therapy at home, with effectiveness comparable to in-person rehabilitation. This trial aims to evaluate a 12-week home-based telerehabilitation program using the MindMotion GO device, providing extra therapy alongside standard care for stroke patients in sub-acute and chronic stages. Participants will use the MindMotion GO device at home for at least 300 minutes of active therapy weekly during the 12-week program. They will have one weekly live session with a physical or occupational therapist either in clinic or remotely by videoconference, combined with independent sessions guided by a personalized schedule set by a remote therapist. The study compares two groups one starting telerehabilitation immediately after discharge alongside standard care, and another receiving standard care first, then starting telerehabilitation after 12 weeks. Patients may continue the telerehabilitation beyond 12 weeks if they choose. Throughout the study, researchers will monitor participants progress using the Goal Attainment Scale at several timepoints up to 44 weeks. Assessments will include therapy adherence, motor function improvements, and the feasibility of the home-based program. Patients will transition smoothly from hospital to home rehabilitation without extending hospitalization or increasing in-person visits. The total study duration for participants may extend up to 44 weeks to evaluate both short- and longer-term effects.

Researchers are evaluating the impact of using a lightweight robotic lower limb exoskeleton called Keeogo on the quality of life of patients with multiple sclerosis who have walking difficulties. This study includes patients with a specific level of disability who live at home and use walking aids. The trial is designed as a multicenter, controlled, randomized, cross-over, open-label clinical investigation to compare the effects of the exoskeleton use with regular physical activity advice. Participants are assigned randomly to one of two groups one group uses the Keeogo exoskeleton at home for eight weeks after a five-day training program to learn how to use the device, followed by an eight-week wash-out period and then an eight-week control phase with recommended physical activity. The other group starts with the control phase, then the wash-out period, and finally the experimental phase using Keeogo. After both phases, there is a three-month follow-up period. During the study, participants will be assessed multiple times to measure changes in quality of life using a specific questionnaire for multiple sclerosis, walking and balance performance with and without the exoskeleton, muscle spasticity, fatigue, anxiety, depression, and daily walking distance. Satisfaction with the device and sense of self-efficacy will also be evaluated. Assessments occur at screening, after each phase, and during follow-up visits to monitor participant progress and safety over the study duration.

Researchers are investigating whether adding local vibration sessions to the dorsiflexor muscles of the affected leg can improve neuromotor recovery in patients who are in the subacute phase after a stroke. This study compares two groups of stroke patients one receiving vibration therapy alongside standard rehabilitation and the other receiving sham vibration with standard rehabilitation. The main goal is to see if this vibration program can help patients walk faster. The treatment involves 40 sessions over 8 weeks during hospitalization, with five sessions per week. One group receives actual vibration therapy at a frequency of 100Hz on the dorsiflexor muscles, while the other group receives sham vibration without effective stimulation. Both groups also continue with the usual rehabilitation program for stroke recovery. Participants will undergo various assessments including walking speed measured by a 10-meter walk test at 2 months, and other walking performance tests over several months. Additional evaluations include motor function, spasticity, autonomy in walking, muscle strength, and neuromuscular fatigue using tools like electromyograms and gait analysis. These tests occur at different timepoints up to 4 months to monitor recovery and treatment effects.

Researchers are evaluating the impact of an individual peer support intervention for patients recovering from a stroke as they return home. The study aims to see if personalized support from trained patient-partners can improve quality of life and empower patients during the discharge period compared to usual care. This pilot study considers the challenges patients and families face with shortened hospital stays and the need for emotional and social support at home. Participants in the intervention group will receive peer support from trained peers for six months after discharge, with the frequency and number of contacts tailored to each patients needs. This support includes meetings before discharge and ongoing follow-up through face-to-face, virtual, or phone contact, focusing on helping patients manage their situation and connect with health and social resources. The control group will receive standard care and be contacted for data collection six months after returning home. Throughout the study, patients will be assessed on various measures including feasibility, quality of life, anxiety and depression, patient activation, disability, adherence to care, assistance received at home, satisfaction, and caregiver burden and satisfaction. Data collection will occur over a six-month period after discharge. This approach aims to understand how peer support affects both patients and their caregivers during recovery at home.

This research focuses on adults who have experienced a stroke resulting in hemiparesis and spastic foot conditions such as equinovarus and toe claw due to muscle spasticity. The study compares two treatments tibial nerve selective neurotomy STN and botulinum toxin A BoNT-A injections. It aims to determine which treatment better reduces calf muscle spasticity and improves personal goals related to balance, walking, self-care, and quality of life for patients with post-stroke spastic foot. Participants are randomly assigned to one of two groups. The STN group will undergo surgery within three months after enrollment, targeting specific muscles defined before randomization. The procedure lasts about 90 minutes and requires a pre-anaesthetic evaluation. The BoNT group will receive botulinum toxin injections guided by electromyography, electrical stimulation, or ultrasound. Physicians may choose between two approved botulinum toxin formulations and determine the dosage and targeted muscles based on clinical guidelines and experience. Treatments are spaced at least three months apart. Throughout the 14-month study, participants will be assessed for progress toward personal goals using the Goal Attainment Scaling. Researchers will also evaluate functional outcomes, spasticity severity, ankle motion, pain levels, walking speed and distance, use of antispastic medication, adverse events, and patient satisfaction. These assessments aim to provide a comprehensive understanding of the impact of each treatment on spastic foot symptoms and daily living activities after stroke.

Researchers are evaluating the EXOPULSE Suit, a medical device designed to stimulate multiple muscle groups to help relax tense and spastic muscles, in people with Multiple Sclerosis MS. The study aims to confirm whether this device can improve walking ability compared to a sham version. This research is important for individuals with MS who experience reduced mobility and may not be able to use drug treatments like Fampridine due to side effects or other reasons. The EXOPULSE Suit is a wearable device with 50 electrodes that stimulate up to 43 major muscle groups. Participants will use the suit for one hour every other day at home. The study uses a randomized crossover design where participants first use the active suit for 4 weeks, then have a 4-week washout period, followed by 4 weeks using the sham suit, or vice versa. The sham suit provides stimulation only during the first minute, then turns off. During the study, participants will be assessed through various tests including walking scales, timed walk tests, and fatigue and pain questionnaires over 28-day periods. Researchers will monitor walking ability and muscle spasticity, among other outcomes. Participants must attend all medical visits and will be monitored throughout the study, which starts in March 2026 and continues until March 2027.

This research focuses on adults with bilateral traumatic amputation of both forearms, a rare condition that greatly affects independence and quality of life. The study evaluates two approaches bilateral hand and forearm allografts transplants and the use of prosthetic forehands. It aims to compare these options in terms of costs, quality of life, usefulness, satisfaction, autonomy, and social integration. The study builds on previous work that demonstrated the feasibility and functional benefits of bilateral hand grafts, despite the need for immunosuppressive treatment and potential medical complications. Participants receive either a bilateral allograft of the hands and forearms or prosthetic forehands. The transplant group must meet specific medical and psychological criteria, including a minimum of three months since amputation and no recent cancer history. The prosthetic group uses prosthetic devices for limb replacement. This non-randomized study conducted by Hospices Civils de Lyon compares these two treatment approaches over a 36-month period. During the study, researchers will monitor treatment costs over 36 months as the primary outcome. Participants will be assessed for quality of life, autonomy, satisfaction, and social integration. Medical evaluations include psychological assessments, kidney function, heart function, and blood pressure control for the transplant group. The study runs until October 2031, and participants will be regularly evaluated to understand the long-term impact and benefits of each treatment option.

Researchers are evaluating recombinant human plasma gelsolin rhu-pGSN combined with standard care for adults with moderate-to-severe Acute Respiratory Distress Syndrome ARDS caused by pneumonia or other infections. This Phase 2 study aims to assess the safety and effectiveness of rhu-pGSN in patients who develop acute hypoxemic respiratory failure within seven days of infection and require mechanical or noninvasive ventilation or high-flow oxygen support. Potential participants are screened within 24 hours of ARDS diagnosis to confirm eligibility based on oxygenation levels and infection status. Participants are randomly assigned to receive either rhu-pGSN or a saline placebo alongside standard care. Treatment consists of a single loading dose of 24 mgkg rhu-pGSN followed by five daily doses of 12 mgkg, delivered intravenously through a filter. The study drug or placebo is administered within 48 hours of moderate-to-severe ARDS diagnosis. The study includes detailed assessments such as medical history, imaging, blood tests, cultures, and pregnancy tests when applicable. Safety is monitored by an independent board with periodic reviews. During the study, participants undergo regular evaluations including blood sampling for immune response and biomarker analysis, imaging tests, and cultures as needed. The primary outcome is all-cause mortality at 28 days, with additional assessments of survival, ventilator use, ICU and hospital stay lengths, and adverse events up to 60 days. Follow-up visits occur at 14 and 28 days after discharge, including telephone checks at 60 days. The total participation duration varies depending on individual progress and clinical status.