Netanya

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who have agitation related to Alzheimer's Disease. This phase 3 study aims to better understand how these treatments impact agitation symptoms in this population by comparing them to a placebo group. Participants must have a confirmed Alzheimer's diagnosis and meet specific criteria for agitation severity to join the study. Participants will receive either the Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, or a placebo, each given at specified doses on designated days. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison of treatment effects. The treatment period lasts through Week 14, during which dosing schedules are closely followed. Throughout the study, participants will be regularly assessed using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) to measure changes in agitation levels from baseline to Week 14. Caregivers will provide reports on participant status and help ensure medication compliance. Safety and symptom changes will be carefully monitored to evaluate the treatments' effects during this period.

Researchers are investigating the safety and effectiveness of eloralintide compared to a placebo in adults with persistent obesity or overweight. This includes people with or without type 2 diabetes who are already on stable weekly incretin therapy. The study is a phase 3, randomized, double-blind trial focusing on this specific group to better understand treatment outcomes. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once a week. The study compares these two treatments over the course of the trial. Participants must continue their stable incretin therapy throughout the study period. The study lasts about 80 weeks in total. Researchers will monitor changes in body weight from the start of treatment to week 64 as the main outcome. Participants will have regular assessments to track their health, safety, and treatment effects during this time.

This trial focuses on people aged 55 to 90 who have agitation related to Alzheimer's Disease and previously finished one of two earlier studies. It aims to assess the long-term safety and effectiveness of a combination treatment using xanomeline tartrate/trospium chloride immediate release capsules (KarXT) and xanomeline enteric capsules (KarX-EC) in these participants. The study is a Phase 3 open-label extension, meaning all participants receive the treatment while researchers observe effects over time. Participants receive specified doses of KarXT and KarX-EC on set days as part of the treatment regimen. The study follows those who completed the earlier parent studies CN012-0023 or CN012-0024, continuing to monitor their response to the combined medication over an extended period. Throughout the study, researchers evaluate the number of participants who experience any treatment-emergent adverse events up to about 30 weeks. Caregiver involvement is required, with at least one caregiver having regular contact of about 10 hours per week or more. Safety and tolerability are closely monitored to understand the long-term impact of the treatment in managing agitation associated with Alzheimer's Disease.

This research aims to evaluate the safety of a treatment called ELGN-2112 compared to a placebo in two groups of preterm infants: those born before 26 weeks of gestational age and those with intra-uterine growth restriction (IUGR) born between 26 and 32 weeks of gestational age below the 3rd percentile. The study is a Phase 2, multi-center, double-blind, randomized trial designed to carefully monitor safety outcomes in these vulnerable infants. Participants will receive either ELGN-2112 or a placebo that contains the same inactive ingredients as the treatment drug. The study includes two arms and uses a parallel-group design. Treatment and monitoring will occur from five days after birth until 42 days of age. The study specifically targets infants born very prematurely or with significant growth restriction to assess how safe ELGN-2112 is in these populations. During the study period, infants will be closely observed while receiving the assigned treatment. Researchers will compare safety data between the ELGN-2112 and placebo groups over the course of 37 days of treatment exposure. The total participation includes treatment and follow-up to ensure thorough safety monitoring. The study involves infants from birth up to approximately 42 days of life, with careful evaluation of any adverse effects or safety concerns.

This research aims to assess the effects of ELGN-2112 on intestinal malabsorption in preterm infants, focusing on its safety and effectiveness. The study is a phase 3, multicenter, double-blind, randomized, placebo-controlled trial designed to compare ELGN-2112 to a placebo treatment in this vulnerable population. Participants will receive either ELGN-2112, a form of human insulin, or a placebo in two parallel groups. The study will monitor how long it takes for infants to achieve full enteral feeding, measured up to 28 days or until discharge from the hospital. The trial is carefully controlled and blinded to ensure unbiased results. Throughout the study, infants will be closely observed for their feeding progress and general health. Researchers will track the number of days required to reach full enteral feeding as the primary outcome. Safety and efficacy data will be collected to understand the impact of ELGN-2112 on intestinal absorption in preterm infants, with the total monitoring period lasting up to 28 days or until hospital discharge.

Researchers are studying adults aged 20 to 60 with Posttraumatic Stress Disorder (PTSD) to better understand how difficulties with attention, sensory processing, and emotional regulation relate to PTSD symptoms. This study also explores the effects of combining two medications, reboxetine and methylphenidate, which target brain pathways involved in attention, to see if they can improve these challenges in PTSD patients. The research includes a case-control design and a double-blind randomized controlled trial phase to evaluate these effects. Participants include 53 adults with PTSD and 53 healthy controls who first complete baseline assessments to create a profile of attentional and sensory function. Then, PTSD patients are randomized to receive either active treatment with reboxetine 4mg daily plus methylphenidate 10mg twice daily for one week after two weeks of reboxetine alone, or matched placebos, for a total treatment duration of three weeks. The study uses advanced brain imaging methods and questionnaires to measure attention and sensory processing. During the study, participants undergo neurophysiological testing with functional near-infrared spectroscopy or electroencephalography, as well as attention and sensory questionnaires and executive function assessments. PTSD symptoms are measured using clinician-administered scales before and after treatment. The study also collects information on daily functioning and quality of life. Safety and treatment effects are monitored throughout, with the primary outcome being changes in PTSD symptom severity after 26 days.

Low back pain is a frequent problem, especially among athletes who face intense physical stress. This research aims to evaluate how group hydrotherapy affects chronic low back pain and physical function in athletes. Hydrotherapy uses water properties like buoyancy and resistance to help perform exercises that might be difficult or painful on land. Participants with chronic low back pain will join a 6-week program led by a certified physiotherapist. The program includes hydrotherapy sessions and guidance for independent exercises. Exercises will involve reduced-weight activities at waist-to-neck depth, resistance training at various water depths, and the use of buoyancy and resistance devices. A control group will receive regular physical therapy treatments for comparison. Before and after the 6-week intervention, participants will complete assessments including a demographic questionnaire, back pain history, and body measurements. Function will be evaluated using the Oswestry questionnaire, pain intensity with a visual analog scale, hip range tests, forward flexion distance, and back alignment tests. At the end, a global rating scale will assess overall improvement. The primary outcome measured is the change in pain level over 8 weeks.

Researchers are studying the effects of training load and menstrual cycle phases on various health and performance measures in elite and non-elite female athletes. The study aims to improve understanding of how hormone changes during the menstrual cycle might influence physiological parameters, performance, injury rates, and psychological factors over a year. This longitudinal observational study will follow 200 premenopausal female athletes and track how training and menstrual phases relate to performance, blood markers, and intestinal microbiome. Participants will be tested at three distinct times during a year representing low, moderate, and high training loads. Elite athletes' testing times correspond to specific training phases, while non-elite athletes are assessed at three points aiming to reflect similar load variations. At each period, data collection includes questionnaires, blood draws during specific menstrual phases, stool sample collection, and physical performance tests such as VO2max, strength, flexibility, and jump power. Training load and wellness will be tracked through devices, diaries, and subjective scales. During the study, participants provide detailed menstrual records via an app and complete various questionnaires on health, nutrition, psychological state, and training wellness three times yearly. Blood tests analyze hormones and metabolites, while stool samples are collected for microbiome analysis. Performance tests and injury monitoring are conducted multiple times throughout the year. Researchers will monitor training load with wearable devices and diaries, and participants will record food intake to assess energy availability. The study aims to identify links between menstrual cycle phases, training load, and athlete health and performance.

Researchers are studying the long-term outcomes of children who experienced neonatal intraventricular hemorrhage (IVH) or intracranial hemorrhage (ICH), especially focusing on extremely preterm infants. While severe IVH (Grade III-IV) and other brain lesions have been linked to negative neurodevelopmental effects, the impact of lower-grade IVH and non-traumatic neonatal ICH on development is less understood. This study aims to retrospectively review medical records and follow-up data to better understand how these brain hemorrhages affect children's cognitive, motor, and functional development. The study will involve a retrospective chart review of newborns or premature babies with IVH or ICH who were discharged from Laniado Hospital's neonatal care unit or followed in the hospital's pediatric neurosurgical and neonatology clinics. Clinical and radiological data from hospital records and follow-up visits will be collected and anonymized. No additional tests will be performed specifically for the research. The primary focus is on determining how many children required surgery related to their brain hemorrhage, with additional assessment of their clinical and functional outcomes, including schooling and daily living activities. Participants' medical charts will be reviewed for clinical and imaging data, and follow-up information will be gathered as part of routine clinical care. Researchers will analyze outcomes in relation to the type of hemorrhage, gestational age, and birth weight. The primary outcome measured is the need for surgery related to neonatal hemorrhage over a 3-year period. Secondary outcomes include evaluating the children's functional abilities and developmental progress compared to their peers. This monitoring will help clarify the long-term effects of neonatal brain hemorrhages on children's health and development.

Researchers are investigating the best treatment for bloodstream infections caused by bacteria that produce extended-spectrum beta-lactamase (ESBL), making them resistant to certain antibiotics. This study focuses on patients with bacteremia due to cephalosporin-non-susceptible Enterobacteriaceae and aims to compare the effects of two antibiotic treatments. The study evaluates whether piperacillin-tazobactam is not worse than meropenem in treating these infections. Participants will receive one of two treatments: piperacillin/tazobactam at a dose of 4.5 grams four times a day or meropenem at 1 gram three times a day. This is a randomized controlled trial designed to assess the effectiveness of these drugs in managing bloodstream infections caused by resistant bacteria. Both community-acquired and hospital-acquired infections are included. During the study, researchers will monitor participants for important outcomes such as death from any cause within 30 days and treatment failure within 7 days after starting the assigned treatment. Participants will be assessed through blood cultures and clinical evaluations to determine how well the infection is controlled. Safety and treatment effectiveness will be closely followed throughout the study period to gather comprehensive data on these antibiotic therapies.