Lebanon

This research focuses on studying the effects and safety of alternating neoadjuvant chemotherapy for patients with borderline resectable pancreatic cancer. The study evaluates two chemotherapy treatments, modified FOLFIRINOX (mFOLFIRINOX) and gemcitabine plus nab-paclitaxel (GnP), both approved by the FDA for this condition. Researchers aim to see if alternating these treatments can improve how well the cancer responds, help remove tumors more effectively, and reduce the chance of cancer returning. Participants receive cycles of alternating chemotherapy: gemcitabine plus nab-paclitaxel is given on days 1, 8, and 15 during cycles 1 and 3, each lasting 28 days. Modified FOLFIRINOX is administered on days 1 and 15 during cycles 2 and 4, also lasting 28 days per cycle. This schedule alternates between the two chemotherapy regimens to assess their combined impact on the cancer. During the study, participants undergo evaluations including contrast-enhanced CT scans of the chest, abdomen, and pelvis before starting treatment. Researchers monitor participants' health and treatment response, focusing on one-year event-free survival. Safety assessments and performance status checks help ensure participants can tolerate the treatment. The study requires informed consent and follows specific guidelines for eligibility and ongoing monitoring throughout the trial.

Researchers are exploring the benefit of direct meetings between breast cancer patients and pathologists, where patients can review the pathology slides of their breast samples. This approach aims to improve patients' understanding and empowerment regarding their disease. While patient-pathologist communication has been limited historically, recent efforts seek to evaluate its usefulness to both patients and pathologists in a practical setting. Participants in the study will engage in a meeting with a pathologist to review their breast cancer pathology slides. The study involves completing questionnaires that measure patients' understanding of their diagnosis, their perceived benefit from the meeting, and levels of anxiety. These assessments occur before and after the visit, as well as following the meeting with the pathologist. During the study, participants will complete knowledge questionnaires and self-rating surveys about their experience and feelings related to their disease and the meeting. Researchers will evaluate changes in patients' knowledge and sense of empowerment within 1 to 2 weeks after the visit. The total time commitment includes the initial diagnosis and follow-up visits related to the study procedures.

Researchers are conducting an open-label, multi-center, non-randomized pivotal Phase 3 study to evaluate the effectiveness and safety of PET imaging using [18F]PI-2620 for detecting tau protein buildup in people with Alzheimer's disease and control subjects. The study compares PET imaging results during life with brain tissue analysis obtained after death through autopsy, aiming to improve diagnosis of tau-related brain changes. Participants will receive an intravenous injection of the radioligand [18F]PI-2620 at a dose of 185 MBq 20%. The PET imaging will be performed to visualize tau deposits in the brain. This study focuses on assessing the diagnostic accuracy of this imaging method by comparing it to post-mortem histopathology findings. Throughout the study, participants will undergo PET scans and assessments to determine the presence and extent of tau pathology. The primary outcome measure is the ability of visual assessment of [18F]PI-2620 PET images to correctly distinguish tau neurofibrillary pathology associated with Alzheimer's disease, confirmed at autopsy within about one year. Safety and tolerability during imaging procedures will also be monitored, with a total participation period depending on the timing of brain autopsy after death.

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

This research aims to collect long-term safety and effectiveness data for participants treated with ibrutinib, a medicine used for various blood cancers and conditions including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, and Chronic Graft Versus Host Disease. It also provides ongoing access to ibrutinib for participants who have completed previous ibrutinib studies, continue treatment, and benefit from it. This is an open-label Phase 3b study without formal hypothesis testing. Participants will continue their current ibrutinib dosing regimen from the prior study, taken orally once daily as capsules in doses of 560 mg, 420 mg, 280 mg, or 140 mg, around the same time each day. Treatment continues until the investigator decides the participant no longer benefits due to disease progression or side effects, the participant withdraws, alternative ibrutinib access becomes available, or the study ends. Participants not able to access ibrutinib elsewhere can keep receiving the single-agent ibrutinib until all transition or stop treatment, or until the study is stopped. During the study, safety is monitored throughout and summarized, and effectiveness may be analyzed together with previous study data. The main outcome measured is the number of participants experiencing any adverse events within 30 days after the last dose or until starting another cancer treatment. Participants will undergo assessments including pregnancy testing and investigator evaluations to ensure ongoing benefit and safety. The study duration depends on when participants stop treatment or transition to other access.

Researchers are evaluating BMS-986500 as a treatment for people with advanced solid tumors and those with advanced breast cancer previously treated with CDK4/6 inhibitors. This phase 1 study aims to assess BMS-986500 alone and in combination with other therapies, focusing on its safety and tolerability in these patient groups. Participants will receive BMS-986500 either by itself or combined with palbociclib and fulvestrant at specified doses on designated days. The study includes a group with advanced solid tumors and a subgroup with CCNE1-amplified ovarian cancer for specific evaluation. Treatment schedules and doses are defined according to the study protocol. During the study, researchers will monitor participants for dose-limiting toxicities, adverse events, serious adverse events, treatment-related events leading to discontinuation, and those resulting in death, all assessed up to 28 days after the last dose. Participants will undergo disease evaluations and performance status assessments to track treatment effects and safety throughout the study period.

Researchers are evaluating CPO301, an antibody drug conjugate, in adults with advanced or metastatic solid tumors. This Phase 1 study aims to determine the safe and tolerable dose of CPO301, assess how the body processes it, monitor for immune responses against the drug, and explore its preliminary effectiveness. The study focuses on patients who have progressed after prior treatments or are unable or unwilling to undergo standard therapies, including those with Non-Small Cell Lung Cancer (NSCLC) and other tumor types. The study is divided into two parts. Part A involves dose escalation using a modified 3+3 design to find the maximum tolerated dose or recommended Phase 2 dose by administering CPO301 intravenously every 3 weeks. Dose adjustments and additional dose groups may be added to find the optimal dose. In Part B, patients receive CPO301 at the determined safe dose, focusing on NSCLC patients with EGFR mutations and possibly other cancers sensitive to the drug, with treatment continuing until the doctor advises stopping. Participants will provide informed consent and undergo screening to confirm eligibility. They will attend regular study visits for treatment and monitoring, including imaging scans to measure tumor response. Safety and tolerability will be assessed throughout, with follow-up visits every 3 months for up to 2 years to track disease progression and long-term effects. The study aims to complete assessments over about one year, focusing on dosing and safety outcomes.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

This research aims to better understand the long-term safety risks of lonapegsomatropin in children with growth hormone deficiency who are treated with this medication in real-world settings. The study focuses on patients aged 1 to 18 years and is conducted in Europe and the USA. It is designed as a prospective, non-interventional, long-term safety study following the drug's approval for use. Participants continue their regular treatment with lonapegsomatropin without any additional interventions from the study. The study does not involve changes to their therapy but observes patients who are already receiving lonapegsomatropin. Eligible participants are pediatric patients clinically managed with this medication, and the study follows them over time to monitor safety outcomes. Throughout the study, researchers will track the occurrence of benign, malignant, and unspecified tumors as well as the development of type 2 diabetes mellitus over a period of five years. Participants provide informed consent and agree to follow-up requirements, which include regular monitoring and data collection to assess these outcomes. The study aims to provide important safety information about lonapegsomatropin in its post-marketing use.

Researchers are evaluating a new way to encourage exercise among breast cancer survivors who completed their main treatment within the last five years. This study aims to find out if at least half of the participants assigned to an exercise plan based on how exercise makes them feel will reach 90 minutes of moderate to vigorous activity by 12 weeks. It also compares satisfaction levels and study retention between participants receiving this affect-based exercise plan and those receiving a traditional effort-based plan. Participants will be assigned to one of two exercise plans: an affect-based prescription where they choose an exercise pace that feels good, or an effort-based prescription where they choose a challenging pace that limits conversation. Both groups will receive the same core exercise program, including education on exercise safety and strategies to overcome barriers. They will all get an exercise plan aiming to increase weekly exercise to at least 150 minutes, plus a smartwatch to help track their activity over the 12-week study period. During the study, participants will attend two meetings to support getting started with exercise. They will wear an activity monitor and complete brief surveys for 10 days at four different times: before starting, and then at 2, 6, and 12 weeks. The main outcomes measured are the average daily minutes of moderate to vigorous physical activity at each follow-up point. The researchers will also track participant satisfaction and how many stay enrolled through the study.