Mataro

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating LY3537021, a drug given by injection, to see how well it controls nausea and vomiting caused by chemotherapy in adults with cancer. This Phase 2 study compares LY3537021 to a placebo while participants also receive standard anti-nausea treatments. The study aims to understand the safety and effectiveness of LY3537021 during the period 24 to 120 hours after chemotherapy starts. Participants will receive chemotherapy drugs such as cisplatin or anthracycline with cyclophosphamide through an intravenous line. They will be randomly assigned to get either LY3537021 or a placebo, both given by subcutaneous injection, along with standard antiemetic therapies including medications taken by mouth, IV, or skin patches. The treatment period lasts through the chemotherapy cycle. During the study, participants will be monitored for their response to the anti-nausea treatment, particularly looking at how many achieve complete control of nausea and vomiting in the delayed phase after chemotherapy. Researchers will also track safety and any side effects. The entire participation may take about two months, covering all study parts until completion.

Researchers are evaluating two treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study focuses on comparing axillary radiotherapy (ART) without lymphadenectomy to axillary lymph node dissection (ALND) to see which approach lowers the risk of lymphedema while monitoring cancer recurrence and overall survival. The trial includes patients treated with either neoadjuvant chemotherapy or hormone therapy and aims to assess quality of life alongside clinical outcomes. This is a prospective, randomized, open-label, multicenter study involving about 820 patients divided evenly between chemotherapy and hormone therapy groups. Participants will receive either ART targeting axillary levels I and II plus level III, supraclavicular, and possibly the internal mammary chain, or undergo ALND followed by radiotherapy to level III, supraclavicular, and possibly the internal mammary chain. A pilot phase with the first 200 patients has been completed, and an interim analysis will be conducted on this group. During the study, researchers will track disease-free survival over up to five years from diagnosis, noting any recurrence or death. Patients will undergo imaging assessments such as ultrasound or MRI to evaluate axillary response after treatment. Quality of life and side effects like lymphedema will also be measured. Follow-up will include monitoring overall survival and recurrence, ensuring comprehensive evaluation of both treatment safety and effectiveness.

Researchers are collecting detailed information about patients with venous thromboembolism (VTE), which includes blood clots in veins such as deep-vein thrombosis and pulmonary embolism. The project aims to improve doctors' understanding of VTE, especially in patients often excluded from clinical trials, like pregnant women, elderly individuals, cancer patients, and those with other complex health issues. The goal is to reduce deaths, clot recurrence, bleeding problems, and artery-related events by sharing this knowledge widely. The study involves gathering extensive data on each patient's health status, treatments, and outcomes during the first three months of therapy. This registry is available online to help doctors quickly find information on patients with similar medical profiles and make informed decisions about managing high-risk individuals. There are no specific interventions being tested; instead, the focus is on collecting real-world patient data. Participants provide informed consent and are followed for at least three years to monitor for new clot events and complications. Researchers track recurrences of VTE, bleeding episodes, and deaths, aiming to create tools that predict which patients are most at risk for problems. This ongoing data collection supports improving care and guiding treatment decisions for diverse patient groups over time.

Researchers are evaluating the effects of micronized creatine monohydrate supplementation on muscle mass, strength, and functional capacity in older adults who have undergone total knee replacement surgery. This randomized, double-blind, placebo-controlled trial aims to assess the efficacy and safety of creatine supplementation during the usual rehabilitation program to improve outcomes related to sarcopenia, frailty, physical performance, and recovery after surgery. Participants will receive daily creatine monohydrate supplementation for 12 weeks starting at hospital discharge. The first week involves a loading dose of 20g per day divided into four doses to improve digestive tolerance, followed by a maintenance dose of 5g per day for the next 11 weeks taken with food. The control group will follow the same rehabilitation program but receive a placebo with identical appearance and dosing schedule. Throughout the study, muscle mass, muscle strength, prevalence of sarcopenia, functional capacity, physical and aerobic performance, walking speed, and adverse health events will be assessed at baseline, 3 months, and 6 months follow-up. This monitoring aims to measure the impact of creatine supplementation on recovery and overall physical function after knee arthroplasty.

This research aims to evaluate the effectiveness and safety of a mobile app called B·RIGHT designed to help people with borderline personality disorder manage emotional crises. The study compares two groups of patients: one receiving standard treatment and the other receiving standard treatment plus access to the mobile app. The trial includes 80 participants diagnosed with borderline personality disorder, ranging in age from 18 to 60 years. Participants in the study are divided into two groups. One group receives treatment as usual, which includes weekly group psychotherapy and individual psychotherapy sessions every two weeks. The second group receives the same usual treatment alongside the use of the B·RIGHT mobile app, which serves as a medical device for crisis intervention. This setup allows researchers to compare outcomes between standard care and care supplemented with the app. Throughout the 9-month study period, researchers monitor the number of psychiatric emergencies and hospitalizations among participants, as well as their level of smartphone addiction. The study involves ongoing assessments to observe how well the app helps manage emotional crises and to ensure its safety. Participants are followed closely to gather data on these key outcomes and to evaluate the app's impact in real-life settings.

Researchers are evaluating the effectiveness and safety of home-based transcranial direct current stimulation (tDCS) compared to tDCS treatment administered in a healthcare center for people with major depression. This study aims to explore the effects of an accelerated home-tDCS protocol. The main goal is to measure changes in depression symptoms using the Montgomery-5berg Depression Rating Scale (MADRS) at the end of the treatment periods. The trial includes three groups receiving tDCS: an accelerated home protocol with daily sessions over 3 weeks (starting with three sessions per day in week 1 and reducing to one session per day in week 3), a conventional home protocol with one session daily from Monday to Friday for 9 weeks, and a conventional in-person protocol at medical facilities with the same 9-week schedule. Each session lasts 20 minutes, and the tDCS applies a small electrical current to specific brain areas via electrodes. Participants will commit to the study team for supervision and safety monitoring while performing the interventions. Researchers will assess depression using the MADRS at the end of treatment (3 weeks for accelerated home-tDCS and 9 weeks for the other groups). Safety and adherence will be closely monitored throughout the study, which includes adults aged 18 to 65 diagnosed with major depression. The study also records whether participants are receiving pharmacological treatment during participation.

Researchers are evaluating the effectiveness of the ROB-Bitrack System, a 4-arm open and portable robotic platform, along with its ElectroSurgical Endoscopic (ESE) and Non-ElectroSurgical Endoscopic (NESE) instruments in urologic procedures. This multicenter, single-arm, open-label, non-randomized study focuses on adult patients aged 18 to 90 scheduled for robot-assisted laparoscopic surgeries including Radical or simple nephrectomy, Partial nephrectomy, and Radical prostatectomy. The study aims to confirm whether the operative time using the ROB-Bitrack System is equal to or shorter than the current state of the art in minimally invasive robotic surgery, regardless of user experience or site. Data will be collected up to 30 days post-surgery. The interventions include surgical procedures such as complete removal of the kidney (Radical Nephrectomy), partial removal of the kidney (Partial Nephrectomy), and complete removal of the prostate gland (Radical Prostatectomy). Additional procedures like Lysis of abdominal adhesions may be performed during these surgeries depending on the patient's condition and surgeon's criteria, and Lymphadenectomy (removal of lymph nodes) may be done after prostatectomy. The ROB-Bitrack System and its instruments assist surgeons during these laparoscopic procedures to improve control and precision. Participants will have scheduled visits including screening, baseline, the surgical procedure, discharge, and follow-ups at 14 and 30 days after surgery. Researchers will measure operative time during the procedure using the ROB-Bitrack System and monitor patients for 30 days after surgery to assess safety and effectiveness. The study is planned to enroll 50 patients over 11 months with total duration of 12 months including follow-up. Data collection includes surgical timing and post-operative recovery assessments.

Researchers are evaluating how inflammatory bowel disease (IBD) activity affects frailty in patients aged 60 years and older. This observational, multicenter, prospective, and longitudinal study also aims to understand how frailty influences the risk of hospitalization and death in this population. The study seeks to determine if frailty and its related complications can be reversed with proactive treatment and which frailty index best predicts these risks in patients with active IBD. At the start of the study, four clinical frailty indices will be calculated along with clinical information about IBD, including diagnosis, disease characteristics, treatments, and comorbidities. Patients will be followed for 12 months with three visits at 3, 6, and 12 months. During these visits, frailty, comorbidities, disease activity, changes in medical treatments, adverse effects, hospitalizations, and mortality will be reassessed to monitor progress and outcomes. Participants will have detailed assessments including frailty scales and clinical data collection at the beginning and during follow-up visits. Researchers will track hospitalizations and mortality over the year-long period. This monitoring will help evaluate the impact of both IBD activity and frailty on patient health outcomes in a real-world setting.

Researchers are working to improve personalized medicine for patients with rare hereditary anemia disorders (RHADs) by developing an integrative diagnostic approach. This approach combines deep genetic and phenotypic analyses to better understand conditions such as sickle cell disease, thalassemia, congenital dyserythropoietic anemia, and other related anemia disorders. The study aims to evaluate new biomarkers and genetic modifiers to provide valuable information on disease severity and patient prognosis. The study involves analyzing genetic modifiers through extensive sequencing and performing detailed phenotyping of blood samples. This includes examining red blood cell morphology, membrane stability, enzyme levels, and rheological properties using advanced technologies like LoRRca ektacytometry and microfluidic devices. These methods will be integrated into an innovative algorithm to better characterize patients and model disease progression, aiding in the development of novel diagnostic tools. Participants will undergo various blood tests and genetic analyses to collect data on their condition. Researchers will correlate these findings with clinical information and treatment history to assess the prognostic value of the new biomarkers over an average of two years. The results aim to inform clinical practice guidelines for managing rare anemia disorders, with support from European hematology organizations to ensure broad dissemination and application.