Kielce

This research aims to evaluate whether creating dedicated HIV teams in hospitals across ten European countries can increase HIV testing rates among patients showing signs of HIV-related conditions. The study uses a stepped-wedge design, where hospitals switch from routine care to the new intervention in sequence. This approach compares outcomes before and after the teams are in place, helping to understand the impact of the intervention across various locations and medical specialties. The intervention involves establishing local HIV teams led by specialists and supported by nurses and data experts. These teams identify patients needing HIV tests through electronic health records, provide feedback to doctors to encourage testing, offer education to healthcare staff about HIV, reduce stigma, and improve connections to prevention and care services. This program integrates smoothly into regular hospital routines and aims to close gaps in HIV diagnosis. Participants HIV testing rates will be monitored by reviewing records before and after the intervention. Researchers will also assess new HIV diagnoses, changes in testing patterns by country and specialty, and healthcare professionals knowledge and attitudes toward HIV. The study includes ongoing evaluation of how well the teams operate, resource use, and cost-effectiveness. Data collection extends up to several years to observe long-term effects, with continuous monitoring of care access and prevention services.

Researchers are investigating new treatments for metastatic cervical cancer, which is cancer that has spread beyond the cervix, the lower part of the uterus. This study evaluates the safety and effectiveness of the antibody drug conjugate sacituzumab tirumotecan sac-TMT combined with pembrolizumab and bevacizumab. The goal is to find out if these treatments, given together or with some variations, help patients live longer or delay cancer progression compared to standard care. The study has two parts. In Part 1, participants receive sac-TMT, pembrolizumab, and bevacizumab together to assess safety. In Part 2, all participants first get standard induction treatment with pembrolizumab, paclitaxel, and cisplatin or carboplatin, possibly with bevacizumab. Those whose cancer does not worsen then enter maintenance treatment, where they are randomly assigned to receive either pembrolizumab alone or sac-TMT plus pembrolizumab, with optional bevacizumab. Participants are involved for up to about 20 months during maintenance treatment after up to 4 months of induction. The study monitors safety by tracking side effects and treatment discontinuations. Effectiveness is measured by progression-free survival and overall survival up to several years. Quality of life and physical functioning are also assessed through questionnaires. Treatments and evaluations occur through regular intravenous infusions and periodic monitoring visits.

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 evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

Researchers are conducting a phase 2b, multicenter, randomized, double-blind, placebo-controlled study to evaluate camoteskimab in adults with moderate-to-severe atopic dermatitis. The study includes both treatment-naive participants and those who have had an inadequate response to previous biologic therapies, aiming to assess the effectiveness and safety of camoteskimab for this condition. The study has two parts. In Part 1, lasting 24 weeks, participants are randomly assigned to receive one of three doses of camoteskimab or a placebo, all given by subcutaneous injection. In Part 2, which is an extension period, all participants will receive camoteskimab. This design allows comparison of different doses and the placebo before all receive the active treatment. Participants will undergo regular assessments including evaluation of eczema severity, body surface area affected, and itch intensity using specific scales like the Eczema Area and Severity Index EASI and Peak Pruritus Numerical Rating Scale PP-NRS. Researchers will monitor changes from baseline over 24 weeks. Safety and adherence will be closely followed throughout the study, which is planned to continue until April 2028.

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus T2DM who are already being treated with insulin and other glucose-lowering medications. This Phase III study focuses on adults with T2DM who have had the condition for at least 90 days and meet certain health criteria. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are taken orally once daily. The study treatment period lasts up to 40 weeks, during which participants continue their background insulin and glucose-lowering medications. During the study, participants will have regular assessments to monitor changes in blood sugar control, including Hemoglobin A1c HbA1c, body weight, blood pressure, and insulin dose. Researchers will also track safety, side effects, and tolerability. The main outcome is the change in HbA1c from baseline to Week 40. Overall, participation involves visits for monitoring and evaluations over approximately 40 weeks.

Researchers are evaluating the efficacy, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

Researchers are studying an investigational drug called linvoseltamab in adults who have a moderate risk of developing multiple myeloma. This group 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 main goal is to understand how well linvoseltamab can eliminate abnormal plasma cells and laboratory signs associated with these conditions. Participants will receive linvoseltamab following a step-up dosing regimen to assess safety and tolerability before moving to one of four full dosing regimens. The study is divided into a safety run-in phase and an expansion phase where participants are assigned to different dose groups without randomization. Linvoseltamab is given according to the study protocol, with dosing schedules designed to monitor effects and side effects. During the study, participants will be closely monitored through regular safety observations over 35 days and longer-term assessments up to 5.5 years. Researchers will track adverse events, treatment responses including complete response rates, laboratory results, and the presence of antibodies against the drug. Blood levels of linvoseltamab are measured up to 9 months. This comprehensive monitoring will help understand the drugs impact and safety over time.

Researchers are evaluating the safety and effectiveness of UBT251, a medicine not yet available for prescription, in adults with type 2 diabetes. This study compares UBT251 with semaglutide, an already approved treatment, and their respective placebos. The goal is to see how well different doses of UBT251 lower blood sugar over time. Participants will be randomly assigned to receive either UBT251, UBT251 placebo, semaglutide, or semaglutide placebo. All treatments are given once weekly by injection under the skin. The study follows participants over several weeks, measuring effects at weeks 16, 28, and 40, focusing on blood sugar control and body weight changes. Throughout the study, participants will have regular assessments including blood tests to measure glycated hemoglobin HbA1c, insulin resistance, beta-cell function, fasting glucose, body measurements, blood pressure, cholesterol levels, and other health markers. Safety is monitored by tracking any adverse events, with total participation lasting up to 40 weeks of treatment plus additional safety follow-up.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.