Netanya

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who experience agitation related to Alzheimers Disease. This Phase 3 study aims to understand how these medications impact agitation symptoms in this population, using recognized criteria to confirm Alzheimers diagnosis and agitation severity. Participants will be randomly assigned to receive either the combination of KarXT and KarX-EC or a placebo. Dosing is specified for certain days, and the study includes a 14-week treatment period during which agitation and other symptoms will be closely monitored. The study design includes a quadruple-blind method to reduce bias. During the study, participants and their caregivers will attend regular visits where the researchers will assess changes in agitation using tools like the Cohen-Mansfield Agitation Inventory and Clinical Global Impressions-Severity scale. Safety will also be carefully monitored through various assessments including vital signs, lab tests, ECGs, and movement scales. Participant involvement extends up to 18 weeks to capture any adverse events and treatment effects.

Researchers are evaluating eloralintide, a drug given once weekly, in adults who have persistent obesity or are overweight, including those with or without type 2 diabetes. The study focuses on people who are already on stable incretin therapy, aiming to compare the effects and safety of eloralintide to a placebo over about 80 weeks. This phase 3 trial is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive one of four different doses of eloralintide or a placebo, all administered by subcutaneous injection. The treatment period involves weekly dosing, continuing through the study duration. The study uses a double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. The main goal is to measure changes in body weight from the start to week 64, along with other health indicators. Throughout the study, participants will undergo various assessments including measurements of waist circumference, blood pressure, fasting glucose, insulin levels, and inflammatory markers. They will also complete questionnaires about their quality of life and eating behaviors. Researchers will monitor medication use and drug levels in the body to understand how eloralintide behaves. The total participation time is about 80 weeks, with safety and efficacy evaluations at regular intervals.

This research aims to evaluate the long-term efficacy and safety of a combined formulation of xanomeline tartratetrospium chloride in an immediate release capsule KarXT and xanomeline enteric capsules KarX-EC for treating agitation in participants with Alzheimers Disease. The study focuses on individuals who have completed prior parent studies CN012-0023 or CN012-0024 and seeks to understand treatment effects over an extended period. Participants will receive specified doses of KarXT and KarX-EC on designated days as part of this single-group, non-randomized study. The treatment phase lasts up to approximately 30 weeks, during which the combined drugs are administered and monitored for safety and effectiveness related to agitation management in Alzheimers Disease. Throughout the study, participants will be monitored for treatment-emergent adverse events and other safety measures. Assessments include tracking adverse events, serious adverse events, changes in vital signs, laboratory evaluations, electrocardiograms, cognitive function tests like the Mini-mental State Examination and ADAS-Cog-13, as well as symptom severity scales. Caregiver involvement is required to provide support and facilitate study participation. The total study duration extends up to about 30 weeks with ongoing safety and efficacy evaluations.

Researchers are evaluating the safety of ELGN-2112 compared to a placebo in preterm infants born before 26 weeks of gestational age and in infants with intra-uterine growth restriction IUGR born between 26 and 32 weeks of gestational age. This phase 2 study aims to understand how ELGN-2112, a drug treatment, impacts these vulnerable infant groups in terms of safety. Participants will be randomly assigned to receive either ELGN-2112 or a placebo that contains the same inactive ingredients but no active drug. The study is double-blind, meaning neither the participants caregivers nor the researchers know who is receiving the drug or placebo. Treatment and monitoring will occur from five days after birth until 42 days. The study includes two groups preterm infants born less than 26 weeks GA and IUGR infants born between 26 and 32 weeks GA with very low birth weight. During the study, infants will be closely observed for safety outcomes over the 42-day treatment period. Researchers will measure and compare the safety of ELGN-2112 against placebo in these infant groups. The study lasts from shortly after birth through this 42-day period, with careful monitoring to track any effects of the treatment. Participants must be preterm infants fitting the specified gestational ages and birth weights to join the study.

Researchers are evaluating the effects of ELGN-2112, a human insulin rDNA, on intestinal malabsorption in preterm infants. The study is designed as a multi-center, double-blind, randomized, placebo-controlled phase 3 trial to assess both the safety and efficacy of ELGN-2112 in this vulnerable population. The trial includes two groups one receiving ELGN-2112 and the other receiving a placebo. Participants are preterm infants born between 26 and 32 weeks gestation, with birth weight of at least 500 grams, including singletons and twins. The study uses a quadruple masking approach to ensure unbiased results. Participants will be monitored to measure the number of days it takes to achieve full enteral feeding, either within 28 days or by hospital discharge. The study involves regular assessments to track feeding progress and safety, with the total duration extending until the primary outcome is reached. The study is sponsored by Elgan Pharma Ltd. and is planned to run until May 2029.

Researchers are studying adults aged 20 to 60 with Posttraumatic Stress Disorder PTSD to understand attentional, sensory, and emotional difficulties linked to the condition. The study evaluates how attention, emotional regulation, and sensory processing relate in PTSD patients, comparing them to healthy controls. It also investigates the effects of the drugs reboxetine and methylphenidate on these symptoms using a randomized, double-blind controlled trial. Participants with PTSD will be randomly assigned to receive either active treatment with reboxetine and methylphenidate or a placebo. Reboxetine is taken daily starting at 2 mg for three days, then increased to 4 mg for 26 days. On day 22, methylphenidate or placebo 10 mg is administered twice daily for four days under clinic observation. The placebo group follows the same medication schedule without active drugs. Throughout the study, participants undergo various assessments including brain activity measurements with functional near-infrared spectroscopy and electroencephalography, attention tests, sensory and executive function questionnaires, and quality of life surveys. The main outcome compares PTSD symptom changes before and after treatment using the Clinician-Administered PTSD Scale. Safety is monitored during medication dosing, with the study lasting approximately 26 days for each participant.

Low back pain is a common problem, especially in athletes who undergo intense physical stress. This research aims to study the effects of group hydrotherapy on chronic low back pain and how it impacts function in athletes. Hydrotherapy uses waters properties like buoyancy and resistance to help perform exercises that might be painful on land. This study is designed to evaluate these effects in a controlled setting. Participants will be randomly assigned to one of two groups one group will receive hydrotherapy alongside regular physical therapy, while the other group will receive only regular physical therapy. The hydrotherapy sessions will last for six weeks and will be led by a certified physiotherapist. Exercises include reduced-weight activities performed at waist-to-neck water depth, resistance exercises at various depths, and the use of buoyancy and resistance devices. Participants will also get guidance for independent exercises. Throughout the study, participants will complete various assessments before and after the intervention. These include questionnaires on demographics, back pain history, and function, as well as physical tests like hip range of motion, forward flexion distance, and back alignment. Pain levels will be measured using a visual analog scale, and a global rating scale will assess overall improvement. The primary outcome is the change in pain level over up to eight weeks, monitored under study conditions.

Researchers are studying the effects of training load and menstrual cycle phases on performance, health, and biological markers in elite and non-elite female athletes. This observational study aims to understand how hormone changes during the menstrual cycle influence physiological parameters, injury rates, and sport emotions. The goal is to identify periods of high training load and prevent over-training by tracking various health and performance indicators over one year. The study involves 200 premenopausal female athletes who will be followed for 12 months. Participants will be tested at three time points reflecting different training load phases low, moderate, and high. Tests include blood sampling during menstrual cycle phases, stool sample collection for microbiome analysis, performance tests like VO2max and strength measurements, and questionnaires about health, nutrition, and psychological state. Both elite and non-elite athletes will be included, with schedules adjusted to their training plans and menstrual status. Participants will attend sessions to complete physical tests, provide biological samples, and fill out questionnaires multiple times during the study year. Blood tests will be drawn fasting and in the morning, timed with menstrual cycle phases when possible. Training load will be monitored using diaries, devices like Garmin watches, and subjective ratings. Injury data will be recorded by medical professionals. Researchers will analyze stool microbiome, serum metabolites, physical performance, body composition, and psychological measures. This comprehensive monitoring aims to clarify how menstrual cycle phases and training load affect female athletes over time.

This research aims to understand the long-term effects of neonatal intraventricular hemorrhage IVH and intracranial hemorrhage ICH in premature infants. IVH is a common brain injury seen on ultrasound in extremely premature babies, with higher grades linked to worse developmental outcomes. However, the impact of lower-grade IVH and non-traumatic ICH on childrens cognitive, motor, and functional development is less clear and is the focus of this study. The study is a retrospective review of medical records and imaging from babies who had IVH or ICH during the newborn period and were cared for or followed at Laniado Hospital. Researchers will collect clinical and radiological data from hospital records and follow-up visits without adding extra tests. The study will analyze how many children required surgery related to their brain hemorrhage and assess their developmental progress, including schooling and daily living skills. Participants include children up to 3 years old who experienced neonatal brain hemorrhage. Researchers will review medical charts and imaging done during hospitalization and follow-up to evaluate outcomes. They will examine correlations between the type of hemorrhage, birth details like gestational age and weight, and long-term development. The study will track surgery needs by age 3 and functional outcomes such as school readiness and independence with daily activities by age 6.

Researchers are evaluating the best treatment for bloodstream infections caused by cephalosporin-resistant Enterobacteriaceae bacteria, specifically looking at whether piperacillin-tazobactam is as effective as meropenem. The study focuses on adults with blood infections due to E. coli or Klebsiella species that are resistant to certain antibiotics but susceptible to both study drugs. The trial aims to determine if piperacillin-tazobactam is not worse than meropenem in treating these infections. Participants are randomly assigned to receive either piperacillintazobactam at a dose of 4.5 grams four times a day or meropenem at 1 gram three times a day. Both treatments are given to treat the bloodstream infection during the study. The trial includes patients with both community and hospital-acquired infections and excludes those with certain severe conditions or prior infections not fully treated. During the study, participants are monitored for outcomes such as death within 30 days and treatment failure within 7 days after starting treatment. Additional assessments include mortality at 14 and 90 days, microbiological outcomes, infection relapses, hospital readmissions, antibiotic use, resistance development, and adverse events. The study collects detailed data over 90 days to evaluate the safety and impact of these antibiotic treatments.