Ra Anana

Researchers are evaluating the safety and effectiveness of NDV01 KIT, a combination of gemcitabine HCl and docetaxel, given directly into the bladder for patients with high-grade Non-Muscle Invasive Bladder Cancer NMIBC. This prospective, single-arm Phase 2 study aims to assess how well this treatment works and its safety profile, including measuring complete response rates and monitoring adverse events over 48 weeks. A pharmacokinetic sub-study will also examine systemic exposure to the drugs. Participants will receive NDV01 KIT through a catheter directly into the bladder. The treatment includes six biweekly instillations on Days 1, 14, 28, 42, 56, and 70, followed by a Primary Disease Evaluation around Day 100. Patients who achieve a complete response may continue with monthly maintenance treatments up to Month 12, with doses on Days 107, 140, 187, 220, 250, 287, 310, and 340. Those who do not reach complete response at evaluation will receive a second round of six biweekly treatments followed by maintenance per protocol. During the study, participants will undergo disease evaluations, blood draws for pharmacokinetic analysis, and regular monitoring for safety and treatment effects. Researchers will track complete response durability, event-free survival, incidence of cystectomy, and overall survival. The total duration of participation may extend through the treatment and maintenance phases, with assessments scheduled at defined intervals to monitor response and safety.

This research aims to prevent the long-term development of phantom limb pain PLP in adults who have recently undergone limb amputation. Most amputees experience PLP, which can be severe and last for years. The study focuses on how combined neuromodulatory treatments using mirror therapy MT and transcranial direct current stimulation tDCS applied during the early acute phase of PLP might prevent chronic pain and improve related symptoms like phantom sensations, negative feelings, and body awareness. Participants will be randomly assigned to one of three groups no intervention natural course, MT with sham tDCS, or MT with real tDCS. Both MT and tDCS are self-administered through 20 daily sessions excluding weekends over four weeks, lasting 20 minutes each. The first two sessions occur in a clinic to train participants and caregivers, after which treatments can be done at home or in the clinic. The tDCS device is specially designed for home use and supports double-blind administration. Throughout the study, participants will continue their usual rehabilitation care, including physical therapy and medication. Data on pain intensity and other clinical and behavioral measures will be collected at five time points, focusing on pain levels four weeks after completing the interventions. Researchers will also assess body ownership, anxiety, depression, pain qualities, frequency of pain episodes, and other sensations related to amputation. The study will run until March 2029 and involves careful monitoring to evaluate the effectiveness of these combined treatments in preventing chronic PLP.

Researchers are evaluating the prevention of venous thromboembolism VTE in patients with spinal cord injuries SCI during the acute and sub-acute phases. This study compares the use of Apixaban versus Enoxaparin, which is the usual prophylactic anticoagulant treatment. The purpose is to assess which treatment better prevents blood clots in this patient population, with monitoring of clot formation and bleeding risks. The study is sponsored by Loewenstein Hospital and involves randomized assignment to treatment groups without masking. Participants in the sub-acute phase of SCI rehabilitation will receive either Enoxaparin at a dose of 40 mg once daily or Apixaban at doses between 2.5 mg and 5 mg twice daily, determined by the treating physician. Treatment duration depends on injury severity 6 weeks for AIS grades C-D and 12 weeks for AIS grades A-B. The study includes two groups one receiving Apixaban and the other Enoxaparin, both administered as drug treatments during the specified periods. Throughout the study, participants will undergo evaluations every two weeks, including D-Dimer tests to detect blood clots and ultrasound Doppler scans at the beginning and end of treatment to assess VTE presence. Bleeding events will be recorded, and hematocrit levels monitored regularly. The primary outcome is the number of participants who develop VTE over two years, while secondary outcomes focus on bleeding events within 6 to 12 weeks. Participants remain under medical supervision for the studys duration, which started in September 2023 and is expected to end by February 2026.

This research aims to evaluate the impact of preventative drug therapy on pain regulation in patients with spinal cord injuries who have not yet developed central pain. The study focuses on patients arriving for rehabilitation within three months after spinal cord injury, either traumatic or non-traumatic, and seeks to understand how early intervention may influence the development of central pain. Participants are divided into two groups one group receives Pregabalin 75 mg twice daily for three months as a preventative treatment, while the control group does not receive any preventative medication. The study observes these patients over time to monitor the onset and progression of central pain. During the study, participants will be followed up for one year, with assessments including the McGill Pain Questionnaire at three months and evaluation of central pain development at one year. The study team will monitor participants pain symptoms and overall condition, ensuring adherence to the treatment plan and tracking outcomes related to pain regulation.

This research aims to assess the feasibility and user experience of using a robotic system to support upper body physical training for adults undergoing inpatient rehabilitation for lower limb orthopedic conditions. The study focuses on encouraging physical activity among these patients, who often have limited mobility and low activity levels during rehabilitation. It seeks to understand how acceptable and suitable this robotic training is, including tracking attendance, engagement, satisfaction, and any unexpected adverse events. Participants will take part in self-practice sessions with a robotic trainer three times a week for three weeks, each lasting about 30 minutes. The training involves the robot demonstrating upper body strengthening and flexibility exercises, such as lifting weights and using resistance bands, with verbal instructions and motivational feedback. A physical therapist will help select exercises suited to the participants abilities and goals, supervise sessions to ensure safety, and adjust the program as needed. Participants will log into the system using a unique number and provide feedback through questionnaires before and after the training period. During the study, participants will complete questionnaires about their experience and personal attributes before starting. Each training session begins with the robot introducing itself and guiding exercises while collecting data on performance. After exercising, participants rate their exertion using a scale displayed on the robot. The study will monitor attendance, time spent exercising, enjoyment, and overall user experience. A physical therapist will oversee all sessions to ensure proper exercise execution and adjust difficulty. The total involvement spans approximately three to four weeks of treatment.

Researchers are studying how a speaking valve affects breathing, swallowing, and vocal functions in patients who have a tracheostomy and disturbances of consciousness. The study focuses on participants who do not require mechanical ventilation and are in a state such as unresponsive wakefulness syndrome or minimally conscious state. This research aims to understand if using the speaking valve during respiratory therapy offers benefits in managing breathing and secretions. Participants are randomly assigned to one of two groups one group receives respiratory physical therapy treatments using the Shiley2 phonate speaking valve connected to their tracheostomy tube for at least 8 sessions over 2 weeks. The other group receives similar respiratory physical therapy without the speaking valve. The study compares these approaches to evaluate differences in breathing and vocal function. During the study, researchers measure changes in oxygen saturation and breathing rate over 15 minutes as primary outcomes. Secondary outcomes include swallowing rate, vocalization presence after 2 weeks, cough rate, and the percentage of patients weaned from the tracheostomy over approximately 6 months. The study involves ongoing assessments to monitor these outcomes and the participants respiratory function throughout the treatment period and follow-up.