Murcia

Researchers are evaluating whether a structured training program for intensive care unit (ICU) staff can reduce health problems known as post-intensive care syndrome (PICS) in adults after an ICU stay. PICS includes new or worsening physical, cognitive, and emotional difficulties that affect daily life, independence, memory, mood, and quality of life. The study also compares training on the standard ABCDEF care bundle with an expanded A-Z care bundle to see if the broader approach offers additional benefits in preventing PICS. The study involves a structured educational program for ICU teams, delivered through online courses, face-to-face sessions, checklists, pocket guides, and visual reminders. Two groups are trained: one on the classic ABCDEF bundle and another on the expanded A-Z bundle, which adds care aspects like nutrition, sleep, infection prevention, safety, discharge planning, and psychological support. At least 75% of staff in each ICU complete the training. After training, ICUs continue usual care while applying the trained care bundles and documenting adherence. Participants are adults who have stayed in the ICU for at least 48 hours and survived hospital discharge. They will be followed up at 1, 3, 6, and 12 months after discharge through tests and questionnaires about physical health, cognition, mood, and quality of life. The main measure is the presence of PICS three months after discharge. The study also monitors adherence to care practices and compares outcomes before and after training, as well as between the two training groups.

Researchers are evaluating the MammoWave device, which uses low-power microwaves instead of X-rays for breast cancer screening, in a large population of 10,000 women undergoing regular breast cancer screening programs. The study aims to confirm that MammoWave can achieve sensitivity greater than 75% and specificity greater than 90% in detecting breast cancer. This investigation is part of the MammoScreen project and involves multiple centers in Europe. Women participating in the study will first undergo a brief visit to check eligibility and review medical history. They will then have the MammoWave exam on both breasts, which includes an 8-minute data acquisition phase while lying prone on the device's bed, followed by data processing using specialized microwave imaging algorithms. The device will generate microwave images and classification results indicating the presence or absence of suspicious breast lesions. Participants will continue with their conventional breast screening examinations, such as mammograms, which serve as the reference standard for comparison. The study will monitor MammoWave's sensitivity and specificity during the procedure. Women aged 45 to 74 with average breast cancer risk and no symptoms are eligible, and the study excludes those with breast prostheses, prior breast cancer, certain genetic risks, pregnancy, or breast sizes too large for the device. The overall participation involves coordinating MammoWave testing with routine screening appointments and consenting to study procedures.

Researchers are evaluating a new multi-component score called the Readiness for EXtubation score (REXs) to predict when ICU patients on invasive mechanical ventilation are ready for extubation. Extubation readiness is determined through clinical criteria including improvement in underlying conditions, hemodynamic stability, and adequate respiratory effort. The study addresses the challenge of safely removing patients from mechanical ventilation by improving prediction of extubation success, defined as not needing invasive support within 48 hours after tube removal. The study involves screening ICU patients on invasive mechanical ventilation daily to collect various clinical data including ventilation parameters, blood gases, respiratory muscle strength, cough ability, sedation levels, heart rate, hemoglobin, and nutrition status. These data will be anonymously recorded in an electronic case report form. The REXs score will be developed and analyzed based on these parameters to predict extubation readiness. The target enrollment is about 470 patients to account for a 10% dropout rate. Participants will be monitored throughout the weaning process with assessments such as spontaneous breathing trials, arterial blood gas measurements, ventilator settings, and sedation scores. The primary outcome is extubation failure within 48 hours after extubation. Statistical analyses will evaluate associations between clinical variables and extubation outcomes, and the REXs score's predictive ability will be examined. Data collection, monitoring, and safety evaluations will occur during patients' ICU stay until hospital discharge or death.

Researchers are investigating IDP-121, a new drug designed to target the cMyc protein, in patients with relapsed or refractory blood cancers including multiple myeloma, diffuse large B-cell lymphoma, high-grade B-cell lymphoma with double or triple hit rearrangements, and chronic lymphocytic leukemia. This Phase 1/2 open-label, multicenter study aims first to find the maximum tolerated dose and recommended Phase 2 dose of IDP-121 and then to evaluate its overall response and survival outcomes in patients treated at that dose. The study has two parts: Phase 1 is a dose-escalation phase using a 3+3 design starting at a low dose and increasing after safety reviews. Patients receive treatment in 28-day cycles with adjustments based on observed toxicities. Phase 2 is an expansion phase where additional patients receive the recommended dose for up to 12 cycles or until treatment discontinuation due to progression or toxicity. Dose adjustments and schedules may be explored based on emerging data throughout the study. Participants will be closely monitored throughout their treatment cycles with assessments including safety, pharmacokinetics, and efficacy evaluations. Researchers will measure outcomes like response rates, duration of response, progression-free survival, and overall survival over a 12-month period. Safety follow-up and detailed data reviews will guide treatment continuation and dose decisions to ensure patient safety and study goals are met.

This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC/TAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG/3TC). The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing formulation for further evaluations.

Researchers are evaluating the efficacy and safety of UGN-104, a new formulation of UGN-101 (known as JELMYTO), for treating patients with low-grade upper tract urothelial cancer (LG-UTUC). This Phase 3, single-arm, multicenter study focuses on patients with LG-UTUC in the upper urinary tract. The study aims to measure the complete response rate about 3 months after the first treatment instillation. Participants will receive UGN-104 once weekly for 6 weeks, totaling 6 doses. UGN-104 is a drug combining mitomycin with a sterile hydrogel that changes from liquid to gel when warmed, helping deliver the medication directly to the upper urinary tract. Patients who achieve a complete response with no detectable disease at the primary disease evaluation visit may enter a follow-up period, where they can receive monthly maintenance doses of UGN-104 for up to 11 months. Patients will be monitored every 3 months during follow-up for up to 12 months or until disease progression, recurrence, or death. Throughout the study, patients undergo evaluations including urine cytology, visual inspections with ureteroscopy, and biopsies if needed. Response determination is centrally reviewed using laboratory and histopathology assessments. Safety and disease status will be closely monitored during treatment and follow-up visits to assess treatment effect and patient well-being.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are investigating treatments for patients with hormone receptor-positive (HR-positive), HER2-negative early-stage breast cancer who are at higher risk of relapse after surgery within the last five years. This phase II, open-label study uses a biomarker-driven approach to monitor minimal residual disease (MRD) by analyzing circulating tumor DNA (ctDNA) in blood samples. The study includes a pre-screening phase, a molecular follow-up phase with ctDNA surveillance, and an interventional treatment phase, aiming to identify patients at molecular relapse and evaluate whether early treatment can improve outcomes. Participants first enter a ctDNA surveillance phase where tumor tissue and blood samples are collected to create individualized mutation panels. Blood is tested every three months during the first year and every six months thereafter. If ctDNA is detected, patients may enter one of four treatment arms: standard treatment followed by change, giredestrant alone, giredestrant combined with abemaciclib, or giredestrant combined with inavolisib. LHRH agonists are given as appropriate for men and premenopausal women. Treatment dosing and schedules are defined, including special dosing for certain kidney function levels. The study allows arm expansions based on ctDNA response criteria. Throughout the study, patients undergo regular ctDNA assessments to monitor treatment response. Safety and disease progression are tracked with scans and clinical evaluations. After treatment, a follow-up period collects survival and new therapy information every three months until study end. The primary outcome is measuring a decrease or clearance of baseline ctDNA three months after starting treatment. Total enrollment includes 976 patients for surveillance, with 40 allocated to treatment arms initially, and potential expansion based on results.

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.

The target population for inclusion in this study is breast cancer patients recently diagnosed (from January 2016) with unresectable locally advanced or metastatic disease (either after a recurrence or as first diagnosis). No treatment regimen will be protocol specified. This is an observational study in which clinical decisions concerning the optimum management strategy for a particular patient are taken independently of and/or prior to, any decision by the physician to invite a patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study. Patients enrolled on the study are free to withdraw their informed consent for the use and disclosure of health information at any time and when asked, patients are not obliged to provide a reason. Patients may request discontinuation from the study at any time. The date and the reason for withdrawal or discontinuation from the study must be recorded in the electronic case report form (eCRF). An attempt will be made to determine the date of discontinuation and final status (i. e. withdrawal of consent, loss to follow-up, death) of any patient who discontinues from the study. However, the treating clinician is encouraged to follow the patient as long as possible, until patient death or through study end. The Sponsor has the right to terminate the study at any time. The Sponsor will notify the investigator if the study is placed on hold or if the Sponsor decides to discontinue the study.