Mataro

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.

Researchers are evaluating KT-621, an oral drug, for its safety and effectiveness in treating adults with uncontrolled moderate to severe eosinophilic asthma. This Phase 2b randomized, double-blind, placebo-controlled trial aims to understand how KT-621 affects lung function and asthma control compared to a placebo. The study is sponsored by Kymera Therapeutics, Inc. and seeks to provide detailed information on KT-621s behavior in the body and its tolerability. Participants will be randomly assigned to one of four groups receiving different doses of KT-621 or a matching placebo. The treatment period lasts 12 weeks, during which participants take the study drug orally. The trial includes regular assessments to monitor lung function, asthma symptoms, and quality of life, with additional follow-up extending to 16 weeks to evaluate safety and drug levels in the blood. Throughout the study, participants will attend scheduled visits for lung function tests, questionnaires about asthma control and quality of life, and blood sampling to measure drug concentration and monitor safety. Researchers will track changes in lung function from the start through Week 12 and observe any adverse events up to Week 16. Participants are expected to comply with all study visits, treatments, and procedures, including keeping an electronic diary to record relevant health information.

This trial is focused on adults with cancer who are receiving chemotherapy and experience nausea and vomiting as side effects. Researchers are studying a drug called LY3537021 to see how well it controls these symptoms and to evaluate its safety. The study is a Phase 2, double-blind, placebo-controlled trial designed to better understand the treatment options for chemotherapy-induced nausea and vomiting in this population. Participants are randomly assigned to receive either LY3537021 or a placebo, both given as a subcutaneous injection before chemotherapy. All participants also receive standard anti-nausea treatments, which may be taken orally, intravenously, or through skin patches. The chemotherapy drugs involved include cisplatin or an anthracycline and cyclophosphamide combination. The study treatment is given prior to chemotherapy, and the trial lasts about two months per participant. During the study, participants will be monitored for nausea and vomiting from the time of their chemotherapy infusion through up to five days afterward. Researchers will collect data on symptom control, the need for rescue medications, and drug levels in the body. Participants will complete diaries to track nausea severity. Safety and response to treatment are carefully observed. The study aims to measure how many participants have a complete response to nausea and vomiting during the delayed phase after chemotherapy.

Researchers are evaluating two different treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study aims to compare axillary radiotherapy ART with axillary lymph node dissection ALND to see which approach results in less risk of lymphedema and how each affects recurrence and overall survival. This trial is a prospective, randomized, open-label, parallel-assigned, multicenter study involving 820 patients over 5 years, including those treated with chemotherapy and hormone therapy. Participants are randomly assigned to one of two groups. One group receives axillary radiotherapy targeting levels I and II plus level III and supraclavicular areas, with or without the internal mammary chain, but without lymphadenectomy. The other group undergoes axillary lymph node dissection along with radiotherapy to level III and supraclavicular areas, with or without the internal mammary chain. The study includes a pilot phase with the first 200 patients and plans interim analysis to assess progress. During the trial, participants will be monitored for disease-free survival, overall survival, and the incidence of lymphedema for up to 5 years, with lymphedema tracked for up to 3 years after surgery. Researchers will evaluate outcomes related to recurrence and quality of life. The study involves regular assessments including imaging to evaluate axillary response and follow-up visits to monitor health and side effects. Participants are followed closely to understand the long-term impact of the treatments.

Researchers are studying the use of ribociclib, a CDK46 inhibitor, in women with early hormone receptor-positive HR and HER2-negative breast cancer who are at intermediate risk of cancer recurrence. The study aims to see if patients can avoid chemotherapy, which has significant side effects, by using ribociclib along with hormone therapy after surgery. This phase III trial builds on the NATALEE study, which showed that ribociclib added to hormone therapy improved survival free of invasive disease in similar patients. Participants will be randomly assigned to one of two groups one receiving ribociclib plus endocrine hormone therapy, and the other receiving chemotherapy followed by ribociclib and endocrine therapy. Ribociclib treatment lasts for three years, and chemotherapy is given before starting ribociclib and hormone treatment. The trial aims to compare the outcomes of chemotherapy de-escalation versus standard treatment in this patient group. During the study, participants will attend scheduled visits for treatment and monitoring, including laboratory tests, heart monitoring with ECG, and questionnaires about their quality of life. Researchers will track invasive breast cancer-free survival and other outcomes such as overall survival and treatment side effects for up to 12 years. Safety and quality of life assessments will continue during and after treatment to evaluate the long-term effects and benefits of the treatment approaches.

The registry focuses on patients with venous thromboembolism VTE, including those often excluded from typical clinical trials such as pregnant women, elderly patients, and those with serious health conditions. It aims to improve medical knowledge and patient care by collecting detailed data on these patients clinical status and treatment outcomes. The project also seeks to develop predictive scores to identify patients at higher risk of complications from thromboembolic disease. This observational registry collects extensive information on patients diagnosed with VTE, including details on coexisting conditions, antithrombotic treatment type, dose, and duration, as well as outcomes during the first three months of therapy. It captures data on VTE recurrences, bleeding complications, and deaths, providing insights into real-world treatment and patient management. Participants provide informed consent and are followed for at least three months to monitor clinical outcomes. The registry supports physicians by giving access to data on patients with similar profiles to help manage complex cases. The main outcomes measured include VTE events and complications over a three-year period, supporting ongoing improvements in patient care and risk assessment.

Researchers are evaluating the effects of micronized creatine monohydrate supplementation on muscle mass, strength, sarcopenia, frailty, functional capacity, and physical performance in older adults who have undergone total knee arthroplasty. This randomized, double-blind, placebo-controlled trial aims to assess the efficacy and safety of creatine supplementation alongside a usual rehabilitation program. The study is led by Consorci Sanitari del Maresme and focuses on adults aged 65 and older. Participants will be randomly assigned to one of two groups an intervention group receiving creatine monohydrate and a control group receiving a placebo. Both groups will start supplementation at hospital discharge with a loading dose of 20g per day for 1 week, divided into four intakes to aid digestion. This will be followed by a maintenance dose of 5g per day for 11 weeks, taken with food to improve absorption. Both groups will follow the same rehabilitation program. During the study, researchers will assess muscle mass, muscle strength, sarcopenia prevalence, functional capacity, physical performance, aerobic capacity, walking speed, and adverse health events at baseline, 3 months, and 6 months follow-up. They will also monitor frailty status and arthroscopy complications. Participants will be involved in regular evaluations over the 6-month period to track changes and safety outcomes related to the supplementation.

Researchers are evaluating the effectiveness and safety of a mobile app called B3RIGHT designed to help people with borderline personality disorder manage emotional crises. This pragmatic randomized controlled trial includes 80 patients, comparing standard treatment alone to standard treatment combined with the mobile app. The study aims to better understand how this technology may assist in crisis management for individuals with this condition. Participants will be divided into two groups one receiving treatment as usual, which includes weekly group psychotherapy and bimonthly individual psychotherapy, and the other receiving the same treatment plus access to the B3RIGHT mobile app for crisis intervention. The study is conducted in an outpatient setting. Participants are randomly assigned to either group to fairly assess the apps impact when added to standard care. During the 9-month study period, researchers will monitor the number of psychiatric emergencies and hospitalizations as primary outcomes. They will also assess smartphone addiction levels. Participants will be regularly evaluated to track their progress and the safety of using the app alongside their usual therapy. The total participation duration covers the treatment and follow-up needed to capture these outcomes.

Researchers are evaluating the safety and effectiveness of home-based transcranial direct current stimulation tDCS for treating major depression. This randomized controlled trial compares home tDCS with tDCS delivered in a healthcare center and explores the impact of an accelerated home tDCS schedule. The main measure of success is the change in depression severity at the end of treatment, assessed by the Montgomery-sberg Depression Rating Scale MADRS. The study has three treatment groups an accelerated home tDCS protocol applied over 3 weeks with 42 sessions, a conventional home tDCS protocol over 9 weeks with 42 sessions, and conventional ambulatory tDCS in a medical facility over 9 weeks with 42 sessions. Each session uses a weak direct current of 2 mA applied to specific brain areas for 20 minutes. The accelerated home group receives multiple daily sessions initially, reducing frequency over three weeks, while the other groups have daily sessions Monday to Friday for nine weeks. Participants will be monitored closely during the study through regular assessments including depression rating scales at several time points, such as after 2 weeks, at the end of treatment, and during follow-up months later. Safety and treatment adherence will be supervised, and secondary measures include anxiety and global impression scores. The total participation period varies by group but includes treatment and follow-up visits extending up to 21 weeks. This study is sponsored by Ionclinics & Deionic SL.

Researchers are studying how inflammatory bowel disease IBD activity affects frailty in patients aged 60 years and older. This observational, multicenter, prospective, and longitudinal study aims to understand if frailty and related risks like hospitalization and mortality can be reversed with proactive treatment in frail patients with active IBD. The study also evaluates which frailty index best predicts complications in this population. At the start, four clinical frailty indices will be calculated for each participant, alongside recording clinical variables related to IBD and other health conditions. Patients will be followed through three visits at 3, 6, and 12 months, during which frailty, disease activity, treatment changes, adverse effects, hospitalizations, and mortality will be reassessed to track progress and outcomes. Participants will be involved in these visits where various assessments will be done, including measuring frailty and comorbidities and reviewing their IBD activity and treatments. The main outcomes include assessing the impact of IBD activity on frailty and how frailty affects hospitalization and mortality risk over a 12-month period. The study is led by the Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa and runs until May 2027.