Beersheba

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are studying adults with confirmed Primary Biliary Cholangitis (PBC) and cirrhosis, a scarring of the liver caused by damage to bile ducts. PBC is a slowly progressing disease that causes bile acid buildup and further liver damage, which can lead to cirrhosis. This study aims to evaluate if elafibranor, a daily medication, can prevent worsening clinical outcomes such as the need for liver transplant or death, compared to a placebo. It also looks at the safety of long-term elafibranor use and its effect on symptoms like itching and tiredness. Participants will take either an 80 mg tablet of elafibranor or a matching placebo once daily for up to 3.5 years in a double-blind setup, meaning neither the participants nor researchers know who receives which treatment. This long-term treatment period is designed to monitor the drug's impact over time. The study includes two groups: one receiving elafibranor and the other receiving placebo, with treatment lasting up to approximately 42 months. During the study, participants will be regularly assessed from the start until 4 weeks after treatment ends, with a maximum involvement of 3.5 years. Researchers will measure event-free survival, tracking if participants avoid clinical events indicating disease worsening. Safety monitoring will include tracking side effects and overall health, while symptom impact will be evaluated. Participants will provide informed consent and follow the study protocol throughout this extended observation period.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating the effects of pelacarsen (TQJ230), given as a monthly injection under the skin, in people with mild to moderate calcific aortic valve stenosis. This study aims to see if pelacarsen can safely slow the progression of this heart valve condition compared to a placebo. The trial is a phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers. Participants will receive either pelacarsen 80 mg or a matching placebo once a month. Before starting the treatment, they must have elevated lipoprotein(a) levels and be optimally treated for existing cardiovascular risk factors. The study focuses on those aged 50 to under 80 years with mild or moderate calcific aortic valve stenosis. During the 36 months of participation, researchers will monitor changes in peak aortic jet velocity and aortic valve calcium score to assess disease progression. Safety, tolerability, and the impact of the treatment will be evaluated. Participants will undergo regular assessments, including laboratory tests and clinical evaluations, to track heart valve condition and overall health throughout the study.

Researchers are evaluating faricimab in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) affecting at least one eye. The study, called FaReal, aims to assess the effectiveness, safety, clinical insights, and treatment patterns of faricimab in real-world routine clinical practice over a two-year follow-up period. It also seeks to describe and evaluate health economic aspects related to prior anti-VEGF treatments and current faricimab therapy. Faricimab will be given following local clinical practice and labeling guidelines. Patients must have started faricimab treatment at or within three months before signing consent and have received at least one dose in the study eye. The study does not specify fixed dosing schedules but observes real-world use over time. Participants will have data collected on visual acuity and central subfield thickness at baseline and throughout the study. The main outcome measure is the change in visual acuity from the start date to 12 months. Data on treatment safety, clinical practice insights, and health economic factors will also be gathered. The total follow-up period for patients is two years, allowing for long-term monitoring of treatment effects and safety.

Researchers are evaluating the safety and effectiveness of the xBar system as a monitoring tool for detecting post-operative anastomotic leaks in patients undergoing rectal or sigmoid resections with anastomosis. This pivotal, prospective, blinded, multi-center study plans to enroll about 190 eligible subjects having scheduled colorectal surgery without concomitant diversion. The clinical team will be blinded to the xBar system's leak detection results during the study. The xBar system is an investigational device consisting of a surgical drain with embedded electrodes connected to a small electronic device that records and relays data. This data is processed to detect complications early. During the index surgery, the xBar device will be placed according to standard institutional procedures, and data recording will continue for at least 3 days. The study evaluates safety and the device's ability to detect anastomotic leaks by comparing clinical diagnosis with the system's data retrospectively. Participants will be monitored for safety and performance outcomes for about 1 year. Researchers will assess the safety of the device, including the rate of severe leaks comparable to standard care. They will also measure successful placement of the device and evaluate the sensitivity and specificity of severe leak detection. Follow-up includes clinical monitoring and data collection throughout the study period to validate the xBar system's performance.

Researchers are evaluating the use of a smartphone application called COBMINDEX to reduce psychological stress, fatigue, and pain in patients with Crohn's disease. The study aims to improve patients' overall well-being, quality of life, disease-coping skills, and also to observe changes in their immunological profile and intestinal microbiome. This trial compares the effectiveness of learning and practicing the COBMINDEX intervention through a human therapist versus a digital therapist using the application. Two hundred patients with Crohn's disease will be randomly assigned to two groups: one group of 100 patients will learn and practice COBMINDEX with a human therapist, while the other 100 patients will use the COBMINDEX digital application for learning and practicing. The intervention consists of seven sessions teaching cognitive, behavioral, and mindfulness-based stress reduction techniques with daily self-exercises. During the first three months, progress is assessed, and the human therapist group has limited access to the app for daily exercises. The following nine months continue with app-based practice according to group permissions. Participants will be assessed daily for stress, pain, fatigue, and well-being, along with regular evaluations of their medical, psychological, and immunological status. The study will monitor adverse events and any medications taken throughout the 12-month period. The primary outcome measured is the effectiveness of the digital application compared to the human therapist over 12 months.

Researchers are evaluating how well the drug JNJ-79635322 works compared to an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody in adults with relapsed or refractory multiple myeloma. This phase 3 study includes participants who have received at least three prior treatments including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. The study aims to compare the effectiveness of these two treatments in this patient population. The study involves two treatment groups receiving either JNJ-79635322 or Teclistamab, both given as subcutaneous injections. Participants must have measurable disease and evidence of disease progression or lack of response to their most recent therapy. The study excludes those with certain infections, central nervous system involvement, allergies to the study drugs, recent major surgery, or recent live vaccine receipt. Participants will be monitored for overall response rate and progression-free survival for up to five years and four months. Throughout the study, performance status will be assessed, and participants will be regularly evaluated for safety and treatment response. The total duration of participation and follow-up allows for long-term evaluation of treatment effects and disease progression.

Researchers are evaluating the effectiveness and safety of risdiplam in young children under 2 years old diagnosed with spinal muscular atrophy (SMA) who have two copies of the SMN2 gene and have previously received gene therapy with onasemnogene abeparvovec but have experienced a plateau or decline in function. This is an open-label, single-arm, multicenter Phase IV study focusing on this specific pediatric population with SMA. The study aims to assess how risdiplam may impact motor development and overall function after gene therapy. Participants will receive risdiplam orally at doses adjusted according to their weight and age. The treatment is given during the study period, with the dose tailored to each child's characteristics. This study does not include a comparator group and monitors the participants over a treatment period of 72 weeks. The intervention involves continuous administration of risdiplam, and the study design allows observation of changes in motor function following prior gene therapy. During the study, children will be closely monitored through various assessments, including the Bayley Scales of Infant and Toddler Development to measure gross motor skills at baseline and after 72 weeks of treatment. Researchers will track changes in motor abilities, swallowing, respiratory function, and other developmental milestones. Safety evaluations and laboratory tests will be conducted throughout the study to ensure participant well-being. The total duration of participation includes treatment and follow-up visits over the 72-week period.