Zielona Gora

Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are evaluating VENT-03 to see if it can treat adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). The study also aims to learn about the safety of VENT-03 and how the body processes it. Participants will be compared to those receiving a placebo to determine if VENT-03 affects disease activity and severity, as well as to monitor any side effects. Participants will take either VENT-03 tablets or placebo tablets for 4 weeks in a double-blind phase. After this, all participants will switch to taking VENT-03 for an additional 8 weeks in an open-label extension. The study involves monthly clinic visits for checkups and tests throughout the treatment periods. During the study, researchers will assess the effect of VENT-03 on the interferon gene signature in the skin from baseline to the end of the double-blind treatment (up to Day 28). Participants will have regular evaluations including clinical assessments and safety monitoring to track how the treatment affects their condition and to watch for any side effects or adverse events over the total duration of 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 treatments for people with newly diagnosed multiple myeloma who are not candidates for or do not plan to have autologous stem cell transplant as initial therapy. The study compares the effectiveness of two new combination treatments: teclistamab with daratumumab and lenalidomide (Tec-DR), and talquetamab with daratumumab and lenalidomide (Tal-DR), against the standard treatment of daratumumab, lenalidomide, and dexamethasone (DRd). This is a Phase 3 randomized study designed to assess which treatment better controls the disease. Teclistamab, talquetamab, and daratumumab are given as subcutaneous injections, while lenalidomide is taken orally. Dexamethasone can be given either orally or by intravenous injection. Participants receive one of the three treatment combinations as assigned by the study. The treatments are administered regularly over the study period, with close monitoring and follow-up to evaluate outcomes. The study includes up to 9 years of follow-up to track disease progression and survival. Participants will undergo regular assessments including monitoring for disease progression and treatment response. Key measures include progression-free survival from the time of randomization and the presence of minimal residual disease-negative complete response at 12 months. Safety and tolerability are also tracked throughout the study. Total participation time includes treatment and extended observation to assess long-term outcomes and side effects.

Researchers are evaluating the effects of intravenous ferric carboxymaltose (FCM) compared to placebo in patients who recently experienced an acute myocardial infarction (AMI) and have iron deficiency. This phase 4, multicenter, randomized, double-blind, placebo-controlled trial aims to assess whether FCM impacts mortality, heart failure events, serum NT-proBNP levels, and quality of life over a follow-up period of up to 36 months. The study specifically looks at the number and timing of heart failure events, changes in heart failure biomarkers, and quality of life using the EQ-5D questionnaire.

Researchers are conducting an international multicenter prospective cohort study to gather information on breast reconstruction techniques using pre-pectoral implants after mastectomy due to breast cancer. The study aims to assess surgical, aesthetic, and oncological outcomes, as well as the quality of life of patients undergoing this type of breast reconstruction. This observational study does not change the usual care patients receive and poses no additional risks to participants. The study will enroll 1,236 female patients who have undergone therapeutic mastectomy and will receive pre-pectoral implant-based breast reconstruction, with or without mesh, and may include expanders. The focus is to evaluate how the pre-pectoral approach is used and to analyze the results related to different surgical techniques and the use of postmastectomy radiation therapy. Participants will be followed to measure outcomes including implant loss three months after surgery. Data collected will include surgical and aesthetic results, oncological outcomes, and quality of life aspects. The study seeks to provide valuable information to help guide future decisions about breast reconstruction methods using the pre-pectoral technique.

Researchers are collecting detailed imaging and clinical data from patients with atrial fibrillation or atrial flutter who need transoesophageal echocardiography before catheter ablation or cardioversion. The study aims to develop artificial intelligence models that can predict the presence of left atrial appendage thrombus (LAT), a blood clot that increases stroke risk in these patients. This observational registry will gather multimodal imaging data to help improve diagnosis and treatment decisions for patients undergoing these heart procedures. Participants undergo transoesophageal echocardiography along with transthoracic echocardiography and possibly other imaging tests like cardiac CT and MRI, if available. Data are collected both retrospectively and prospectively from multiple centers. The study includes clinical information, echocardiographic images, and optional tests such as electrocardiograms and electroanatomical maps. The goal is to create high-quality datasets that enable AI-based models to analyze imaging and clinical data for predicting LAT and guiding therapy. During the study, participants' imaging tests, clinical data, and follow-up information are recorded to assess heart function and the presence of LAT. Researchers analyze these data to validate AI models that automatically interpret echocardiographic images and predict thrombus risk. The main outcome is detecting LAT presence one day after transoesophageal echocardiography. The study helps build a comprehensive database to support future diagnostic and therapeutic improvements for patients with atrial fibrillation undergoing catheter ablation or cardioversion.

Researchers are evaluating the use of the PERCUTEK Tycheseal21 stent-graft system for repairing abdominal aortic aneurysms (AAA) in a real-world setting across multiple centers in Italy and Poland. This observational registry study aims to collect detailed patient, procedural, and outcome data to assess the technical success, safety, and mid-term performance of this tri-modular endograft system. The study focuses on patients with infrarenal AAA, a condition where the abdominal aorta is abnormally enlarged and at risk of rupture, which can be life-threatening without timely treatment. The PERCUTEK Tycheseal21 system consists of a main body and two iliac limb components designed for precise placement and adaptability to challenging anatomical features such as varying neck diameters and angles. The device is delivered through a low-profile system and includes features to enhance visibility and durability. Throughout the study, participants will receive endovascular repair using this device, with data collected on procedure details and device performance. Follow-up assessments occur at discharge, 1 month, 12 months, and 24 months after implantation to monitor outcomes. Participants will undergo regular evaluations including imaging studies such as Doppler ultrasound and angio CT to monitor for complications like endoleaks, aneurysm sac changes, stent-graft migration, occlusion, or rupture. The study measures technical success defined by correct device deployment without immediate complications and tracks freedom from adverse events over 12 months. Data are entered into standardized forms and monitored for quality. The total enrollment is expected to be 120-200 patients over 18 months, with follow-up continuing up to 24 months post-implantation.

Researchers are evaluating the effectiveness, safety, pharmacokinetics, and pharmacodynamics of RVU120 in adults with intermediate or high-risk primary or secondary myelofibrosis. This study includes patients who have been previously treated, are ineligible for, or had a suboptimal response to Janus kinase (JAK) inhibitor therapy. It is an open-label Phase 2 clinical trial assessing RVU120 alone or combined with ruxolitinib. Participants receive RVU120, a selective inhibitor of CDK8 and CDK19, either by itself or alongside ruxolitinib, a JAK1 and JAK2 kinase inhibitor. The study schedule includes a screening period of up to 28 days, followed by repeated 21-day treatment cycles. After treatment ends, participants have an end-of-treatment visit at 30 days and are followed for one year with assessments every three months. During the study, participants undergo evaluations of their response to treatment, including monitoring of symptoms and spleen size. Researchers also assess drug activity and safety over 12 months. The total study duration depends on the number of treatment cycles each participant receives. Participants can withdraw at any time, and their organ function and disease status are regularly checked to ensure safety and study goals are met.

Researchers are evaluating the safety, tolerability, effectiveness, and how the body processes and responds to a combination of two drugs, RVU120 and venetoclax, in adults with acute myeloid leukemia (AML) who have relapsed or did not respond to previous treatment with venetoclax and a hypomethylating agent. This study includes three parts: the first focuses on finding safe doses, the second tests these doses for safety and effectiveness, and the third confirms these findings in a larger group. In Part 1, participants receive increasing oral doses of RVU120 every other day and venetoclax daily in 21-day cycles to determine recommended doses based on safety and drug behavior. Part 2 evaluates whether these doses meet targeted response goals, and if successful, Part 3 enrolls more patients to further assess the combination's safety and effectiveness at the selected doses. Participants undergo regular assessments including physical exams, blood tests, and monitoring of heart and liver function to track safety and treatment effects. Researchers measure outcomes such as recommended doses over about 12 months and rates of complete remission or remission with incomplete blood recovery over approximately 36 months. Participants must be able to provide informed consent and complete study procedures during their involvement.