Kfar Saba

Researchers are evaluating how well experienced intensive care unit ICU physicians and nurses can predict patient mortality within 28 days compared to three established scoring models APACHE 2, MPM 2, and MODS. This study aims to determine whether medical staff predictions are as accurate or better than these models, which are used to guide ICU admission and care management decisions. It also explores which factors most influence the predictions made by ICU staff. This research is a prospective observational study involving about 2,000 patients admitted to the ICU between 2025 and 2027. For each patient, mortality risk will be calculated using the three scoring systems, while three senior ICU physicians and one experienced ICU nurse independently estimate the risk based on their clinical judgment. The reasons behind the medical and nursing staffs mortality risk assessments will also be documented. Participants will be monitored during their ICU stay, with mortality predictions recorded and compared over a 28-day period. The study measures how accurately ICU staff and scoring systems predict mortality, helping to assess the reliability of clinical judgment versus model-based scores. The findings may inform future ICU care strategies and patient management. The study is sponsored by Meir Medical Center and does not involve any intervention or treatment changes for participants.

Researchers are evaluating new treatments for advanced renal cell carcinoma RCC, a type of kidney cancer. This study compares the effects of combining two targeted therapies, belzutifan and zanzalintinib, against belzutifan with a placebo. The goal is to see if the combination can help people live longer and prevent the cancer from getting worse after other treatments have failed. Participants will take 120 mg of belzutifan orally and either 60 mg of zanzalintinib or a matching placebo once daily for about 24 months. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active combination or placebo. Two groups are compared belzutifan plus zanzalintinib and belzutifan plus placebo. During the study, participants will be monitored for progression-free survival and overall survival, with assessments up to around 30 to 50 months. Researchers will also evaluate tumor response, duration of response, quality of life, and side effects. Safety and tolerability will be tracked throughout treatment and follow-up periods. The study is sponsored by Merck Sharp & Dohme LLC and aims to provide important information on treating advanced RCC.

Researchers are evaluating if combining the medicines calderasib and subcutaneous pembrolizumab can more effectively treat people with non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study aims to find out whether patients receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a Phase 3 clinical trial focusing on first-line treatment for advanced or metastatic nonsquamous NSCLC. Participants are assigned to one of two groups. One group receives subcutaneous pembrolizumab plus berahyaluronidase alfa every 6 weeks for up to 18 cycles about 2 years along with oral calderasib until treatment discontinuation criteria are met. The other group receives the same pembrolizumab and berahyaluronidase alfa regimen plus chemotherapy with pemetrexed and either carboplatin or cisplatin infusions during the early cycles. Treatment continues based on individual response and tolerability. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess progression-free survival, overall survival, response rates, and quality of life using questionnaires and symptom scores over several years. Safety will be monitored through adverse event reporting. The trial lasts up to about 7 years with ongoing evaluation of health outcomes and side effects to understand the impact of these treatment combinations.

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are studying MK-1084, a targeted therapy, to treat advanced or metastatic non-squamous non-small cell lung cancer NSCLC with a specific KRAS G12C mutation. The study aims to evaluate the safety and tolerability of MK-1084 when combined with other treatments, and to see how many participants experience tumor shrinkage or disappearance. This trial is part of a larger master protocol and includes participants who have previously received certain cancer therapies. Participants will receive MK-1084 combined with either patritumab deruxtecan HER3-DXd or sacituzumab tirumotecan Sac-TMT until treatment is stopped due to side effects, adverse events, or investigator decision. MK-1084 is taken orally, while the other drugs are given by intravenous infusion. The arm combining MK-1084 with cetuximab was discontinued per protocol amendment. Throughout the study, participants will undergo assessments to monitor dose-limiting toxicities, adverse events, and treatment response for up to approximately 63 months. Researchers will also evaluate progression-free survival and drug concentration levels in the blood. Safety and treatment effects will be closely tracked, and participants may receive rescue medications to manage symptoms like nausea. The total study duration extends to 2032, with primary outcome evaluation by 2029.

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are investigating new treatments for people with high-risk, localized non-small cell lung cancer NSCLC that has been completely removed by surgery. The study aims to find out if giving one or two specific treatments after surgery can help prevent the cancer from returning. This Phase 3 trial focuses on participants with Stage I NSCLC who have certain high-risk features. Participants are randomly assigned to one of three groups one group receives intismeran combined with pembrolizumab coformulated with berahyaluronidase alfa, another group receives intismeran alone, and a third group receives a placebo. Intismeran is given as an intramuscular injection, while pembrolizumab with berahyaluronidase alfa is administered subcutaneously. The trial compares disease-free survival among these groups over an extended period. Throughout the study, participants will be monitored regularly with health assessments and questionnaires to evaluate quality of life and physical functioning. Researchers will track how long participants remain free from cancer and observe any side effects or adverse events. The study may last up to several years, with ongoing safety and outcome evaluations to better understand the treatments impact.

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

Researchers are studying UGN-104, a new formulation of UGN-101 also known as JELMYTO, to evaluate its effectiveness and safety in treating patients with low-grade upper tract urothelial cancer LG-UTUC. This phase 3, single-arm study focuses on patients with this specific type of cancer affecting the upper urinary tract, aiming to assess how well the treatment works and its safety profile. Participants will receive UGN-104 once a week for six weeks, with each dose administered directly into the upper urinary tract via a ureteral catheter or nephrostomy tube. The dose consists of 4 mg mitomycin per 1 mL sterile hydrogel. After the initial treatment period, patients who have no detectable disease at the primary disease evaluation visit about three months after the first dose may enter a follow-up phase where they could receive monthly maintenance doses for up to 11 months, depending on the investigators decision. During the study, participants will have evaluations every three months to check for disease response or recurrence. These assessments include urine cytology, visual inspection via ureteroscopy, and biopsies if needed. Researchers will monitor the complete response rate at three months as the primary outcome and track the duration of response, durable complete response rate, and any treatment-related side effects for up to 15 months. The total participation time varies depending on response and disease status.

Researchers are evaluating AZD8965 in a Phase IIb trial to study its safety, tolerability, and effectiveness in treating Idiopathic Pulmonary Fibrosis IPF. The study compares three doses of AZD8965 to a placebo in participants with IPF, including those who are on stable doses of approved antifibrotic therapies such as nintedanib, pirfenidone, or nerandomilast, as well as those not taking antifibrotic treatment. The trial is randomized, placebo-controlled, double-blind, and parallel-group in design. Participants are assigned to one of four groups placebo, low dose AZD8965, medium dose AZD8965, or high dose AZD8965. The treatment lasts for 24 weeks, during which participants receive their assigned medication. The study includes approximately 360 participants across around 200 sites worldwide. Researchers aim to assess the clinical efficacy of AZD8965 by measuring changes in lung function and study the relationship between dose and outcomes. During the study, participants will undergo various assessments including lung function tests such as forced vital capacity FVC, monitoring for adverse events, and pharmacokinetic analyses of AZD8965. Safety and tolerability are monitored up to 25 weeks. Researchers will also track any serious adverse events and treatment discontinuations. The total participation time covers the 24-week treatment period with scheduled visits to assess the study outcomes and participant health.