Cork

Preterm birth before 37 weeks' gestation is common and linked to many health challenges, especially when it occurs before 29 weeks. At this early stage, infants often face breathing difficulties due to immature lungs, sometimes requiring resuscitation. This study aims to compare two oxygen concentrations, 30% and 60%, used during resuscitation of very preterm infants to determine which leads to better survival and neurodevelopmental outcomes by about two years of age. The study uses a cluster randomized crossover design, where hospitals alternate between using 30% and 60% oxygen to resuscitate infants born between 23 and 28 weeks gestation. Infants receive the assigned oxygen concentration for the first 5 minutes after birth, with adjustments made based on oxygen saturation levels to maintain safe ranges. The intervention lasts 10 minutes, including initial resuscitation and oxygen titration to stabilize the infant. Participants will be closely monitored during their hospital stay and followed up at 24 months corrected age to assess survival and major neurodevelopmental outcomes. Data collected will include oxygen saturation, heart rate during resuscitation, and longer-term health measures. The study's results aim to guide safer oxygen use in resuscitating extremely preterm infants worldwide.

Researchers are evaluating whether an investigational drug called OHB-607 can prevent Bronchopulmonary Dysplasia (BPD), a common chronic lung disease, in extremely premature infants. The study compares infants receiving OHB-607 alongside standard neonatal care to those receiving standard care alone to reduce the burden of this lung condition. This is a Phase 2b, multicenter, randomized, open-label study focused on safety and clinical efficacy. Participants will receive an intravenous infusion of OHB-607 from birth until reaching a postmenstrual age (PMA) of 29 weeks and 6 days. The study includes two arms: one group receives the investigational drug plus standard care, while the other group receives only standard neonatal care. The treatment period ends at 29 weeks plus 6 days PMA, after which infants are monitored. Throughout the study, researchers will track the incidence of severe BPD or death up to 36 weeks PMA, whichever occurs first. Assessments will include clinical evaluations and monitoring for safety and any side effects. The study also involves long-term follow-up to observe the infants' health outcomes beyond the treatment period. Participation involves consent from parents and collection of birth and medical history information.

Researchers are studying advanced renal cell carcinoma (RCC) that has returned after prior adjuvant therapy. The trial aims to find out if treatment with belzutifan and zanzalintinib helps patients live longer and delays disease progression compared to treatment with cabozantinib. This is a Phase 3 randomized study focusing on participants with recurrent advanced RCC who have previously received anti-PD-1/L1 therapy. Participants are randomly assigned to receive one of two oral drug regimens: either belzutifan combined with zanzalintinib, both taken once daily, or cabozantinib alone, also taken once daily. The study compares these treatments to assess their effects on disease control and overall survival. During the study, participants will be monitored for progression-free survival and overall survival for up to approximately 73 months. Researchers will evaluate how well the cancer responds to treatment and track any changes in health status over time. Safety and effectiveness of the treatments will be closely followed throughout the study period.

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Vitamin D deficiency is a common problem worldwide, caused by limited sun exposure and low vitamin D levels in food. In Ireland, the northern location and weather reduce UVB light needed for skin to make vitamin D, so people rely on vitamin D in their diet to avoid deficiency. This study tests if eating vitamin D-fortified bread as part of a healthy diet with other fortified foods can prevent low vitamin D levels during winter in Irish families. In this randomized controlled dietary study, 390 participants from households including children, teens, and adults will be assigned to one of two groups. The treatment group will receive bread fortified with more than 20 micrograms of vitamin D3 daily and advice to eat other fortified foods. The control group will get identical bread without vitamin D and the same dietary advice. The study aims to see if increased vitamin D intake from food can keep vitamin D levels above deficiency thresholds during winter. Participants will follow their assigned diet for 8 weeks and attend study appointments. Researchers will measure vitamin D levels in the blood after 8 weeks to evaluate the effect of the fortified bread. Participants must be in good health and willing to consume the provided bread and follow the diet. The study also monitors safety and adherence throughout the intervention period.

Researchers are evaluating the safety and early effectiveness of IAM1363, a new drug, in adults with advanced cancers that have changes in the HER2 gene. This Phase 1/1b open-label study includes patients with various HER2-related tumors, including those with brain metastases. The trial aims to find the best dose and understand how IAM1363 works alone and combined with other cancer treatments. The study has four parts: Part 1 tests increasing doses of IAM1363 alone to find the maximum tolerated dose or recommended Phase 2 dose. Part 2 further optimizes the dose and evaluates safety and preliminary effectiveness. Part 3 expands to specific tumor groups to assess IAM1363 at the chosen dose. Part 4 involves four groups receiving IAM1363 combined with other anti-cancer drugs such as capecitabine with trastuzumab, zanidatamab, T-Dxd, pembrolizumab, and sometimes carboplatin and pemetrexed. Participants will be closely monitored through imaging scans to measure tumors, lab tests to check blood, liver and kidney function, heart function assessments, and electrocardiograms to detect any heart rhythm changes. Researchers will track side effects, dose changes, and how the drug moves through the body. The study duration may last up to about 46 months to fully assess treatment response and safety.

Psychosis, including affective and non-affective types, is treated with antipsychotic medications that are effective but often cause significant weight gain and metabolic problems such as increased blood sugar and fat levels. These side effects can lead to other health issues like obesity, diabetes, and heart disease, and may reduce medication adherence and quality of life. Researchers are exploring if a probiotic, Bifidobacterium longum APC1472, can help reduce these side effects in people taking antipsychotic drugs by targeting gut bacteria involved in metabolism and appetite regulation. Participants will receive either a capsule containing Bifidobacterium longum APC1472 or a maltodextrin placebo. The study will assess changes in weight and glucose levels over 4, 8, 12 weeks, with an additional follow-up at 18 weeks to monitor any lasting effects after stopping the treatment. The probiotic is being tested as an added supplement to standard antipsychotic treatment to see if it can prevent or lessen weight gain and metabolic disturbances. During the study, participants will provide blood, saliva, and stool samples for analysis, and their weight and glucose levels will be regularly checked. Researchers will monitor safety and adherence throughout the study. The goal is to find supportive treatments that improve health outcomes, medication adherence, and quality of life for individuals with psychosis receiving antipsychotic medications.

Researchers are evaluating an investigational drug called linvoseltamab in adults at moderate risk of developing multiple myeloma. This includes patients with precancerous conditions known as High-Risk Monoclonal Gammopathy of Undetermined Significance (HR-MGUS) and Non-High-Risk Smoldering Multiple Myeloma (NHR-SMM). The study aims to understand how well linvoseltamab can eliminate abnormal plasma cells and improve laboratory signs related to these conditions. It is a Phase 2 dose-ranging and interception study focused on these specific patient groups. Participants receive linvoseltamab as directed by the study protocol. The treatment schedule and dosing details are determined per protocol to assess the drug's effects and safety. The study does not mention comparator groups, focusing solely on evaluating linvoseltamab. The study includes a safety observation period lasting 35 days to monitor adverse events and a long-term follow-up of up to 5.5 years to assess the achievement of complete response. During the study, participants are regularly monitored for side effects and treatment-emergent adverse events. Researchers measure how often these events occur and their severity during the 35-day safety period. They also evaluate whether participants achieve a complete response, as determined by the investigator, over up to 5.5 years. Blood tests and laboratory evaluations are conducted to track drug levels and immune responses, including antibody formation against linvoseltamab. The study involves ongoing safety and effectiveness assessments throughout the participation period.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the effectiveness, safety, and tolerability of a combination treatment including adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to a placebo combined with pembrolizumab and platinum-doublet chemotherapy. This study focuses on adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The trial is a randomized, double-blind, phase 3 study designed to provide insights into treatment options for this specific lung cancer type. Participants receive either adagrasib plus pembrolizumab alongside platinum-doublet chemotherapy drugs such as carboplatin or cisplatin and pemetrexed, or they receive a placebo plus pembrolizumab and the same chemotherapy regimen. The dosages and schedules of these drugs are specified and administered on predetermined days. The trial compares these two treatment groups to understand better the impact of adding adagrasib to the existing pembrolizumab and chemotherapy treatment. Throughout the study, participants are closely monitored for progression-free survival and overall survival, assessed up to seven years using standardized criteria for tumor response. Regular imaging scans such as CT or MRI are used to measure disease status. Safety and tolerability are also evaluated during the study, with ongoing assessments to track adverse effects and treatment response. The total duration of follow-up allows for long-term observation of treatment outcomes and participant health.