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 they leave the hospital. PICS includes new or worsened physical, thinking, or emotional difficulties following serious illness, which can affect daily life, independence, memory, mood, and overall quality of life. This multicenter study compares patients treated before and after ICU staff training, focusing on whether the training reduces PICS three months after hospital discharge. The study also compares standard training on the ABCDEF care bundle with an expanded A-Z bundle that includes additional care elements like nutrition, sleep, infection prevention, safety, and psychological support. The study involves a cluster-randomized design where entire ICUs are assigned to receive training on either the standard ABCDEF bundle or the expanded A-Z bundle. The training program for ICU staff includes a month-long online course with educational materials, checklists, pocket guides, and visual reminders, plus face-to-face sessions to reinforce learning. After training, ICUs continue usual care while researchers track how often the trained care practices are followed during patients ICU stays, up to 21 days or until discharge or death. Follow-up visits for patients occur at 1, 3, 6, and 12 months after hospital discharge. Participants are adults who stay in the ICU for at least 48 hours and leave the hospital alive. They will undergo tests and questionnaires on physical health, memory, mood, and quality of life during follow-up visits. Data collection includes ICU care details and patient outcomes, monitored using electronic forms with quality checks. The main outcome measured is the number of participants who develop PICS three months after discharge. Secondary outcomes include adherence to care bundles, incidence of delirium, and quality of life assessments at various timepoints. The study runs until 2028 and maintains ethical and data protection standards throughout.

Researchers are evaluating MammoWave, a device that uses low-power microwaves instead of X-rays, for early breast cancer detection in women aged 45 to 74. This prospective, multicenter clinical investigation aims to confirm that MammoWave achieves sensitivity greater than 75% and specificity greater than 90% for breast cancer detection among 10,000 volunteers undergoing regular screening programs. The study compares MammoWave results with conventional breast examination methods including mammograms and other radiological or histological tests. Participants will undergo both the standard breast screening exams and the MammoWave exam. The MammoWave exam involves lying prone on a bed while the device collects microwave data from both breasts over about 8 minutes. Data processing uses a special imaging algorithm to produce microwave images and classification results indicating suspicious or non-suspicious findings. The study device contains the same hardware as a CE-marked version but uses updated software. During the study, participants will have conventional breast exams along with the MammoWave exam. Researchers will evaluate MammoWaves sensitivity and specificity during the procedure and analyze detection rates, recall rates, and positive predictive values at baseline. Volunteers will also complete satisfaction questionnaires. The study will monitor breast cancer detection by histological type, size, and breast density. The trial is expected to run until December 2026.

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 to be extubated. The process of liberation from mechanical ventilation involves weaning, readiness assessment, and extubation, with success defined as not needing invasive support within 48 hours. This study focuses on developing and analyzing REXs to help clinicians assess extubation readiness more accurately in critically ill patients. The study involves daily screening of ICU patients undergoing weaning from invasive mechanical ventilation. Data collected include clinical parameters such as arterial blood gases, ventilation settings, sedation and agitation scores, heart rate, hemoglobin levels, nutritional status, and cough strength, among others. Clinicians will anonymously enter data into an electronic case report form to develop and evaluate the REXs score. Patients prepared for extubation will have their readiness assessed using this score. Participants will be monitored during their ICU stay, with data collected on extubation success or failure at 24, 48, and 72 hours after extubation. Researchers will also track length of ICU and hospital stays and mortality outcomes. The study uses routine clinical data, with anonymization to protect patient confidentiality. Statistical methods will analyze associations between clinical factors and extubation outcomes to validate the REXs scores predictive ability. The total study duration extends until the end of 2026.

Researchers are evaluating IDP-121, a new drug targeting the cMyc protein, in patients with relapsed or refractory blood cancers including multiple myeloma, diffuse large B-cell lymphoma, high-grade B-cell lymphomas, and chronic lymphocytic leukemia. This open-label, multicenter Phase 12 study aims first to find the highest safe dose and recommended dose for further study, then to assess how well patients respond to the drug and how long those responses last. In the Phase 1 dose-escalation phase, patients receive IDP-121 by 4-hour intravenous infusion twice weekly on specific days within 28-day cycles. Doses start low and increase based on safety and tolerance, with monitoring for dose-limiting toxicities during the first treatment cycle. Once the recommended Phase 2 dose is identified, additional patients enter the expansion phase to further assess safety and effectiveness, receiving treatment for up to 12 cycles or until progression or unacceptable side effects. Participants will undergo regular monitoring including blood tests, heart function assessments, and evaluations of their disease status throughout treatment. Researchers will measure outcomes such as overall response rate, duration of response, and progression-free survival. The study allows treatment to continue up to one year, with careful tracking of safety and disease progression, aiming to gather comprehensive data on IDP-121s impact in these blood cancers.

Researchers are evaluating a new medication called VH4524184 for treating adults with HIV-1 who have never received treatment before. This Phase 2b study compares two doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide FTCTAF, against a standard HIV treatment combining dolutegravir and lamivudine DTG3TC. The goal is to collect long-term data on the antiviral activity of VH4524184 and to understand the best dosing for future studies. Participants are assigned to one of several groups one group receives a low dose of VH4524184 plus FTCTAF daily for 12 months, another group receives a high dose of VH4524184 plus FTCTAF daily for 12 months, and a third group takes DTG and 3TC daily for 24 months. After 12 months, those on VH4524184 may continue with a selected dose combined with FTCTAF daily until month 24. All medications are taken orally. During the study, participants attend scheduled visits for assessments including blood tests to measure HIV-1 RNA levels, CD4 T-cell counts, and drug concentrations. Researchers monitor the percentage of participants achieving viral suppression at 12 months and maintain it through 24 months. Safety is closely observed through tracking adverse events until roughly month 36. The total participation time may span up to 36 months to evaluate the long-term effects and safety of the treatments.

Researchers are studying UGN-104, a new formulation of UGN-101 also known as JELMYTO, to evaluate its effectiveness and safety in treating patients with low-grade upper tract urothelial cancer LG-UTUC. This phase 3, single-arm study focuses on patients with this specific type of cancer affecting the upper urinary tract, aiming to assess how well the treatment works and its safety profile. Participants will receive UGN-104 once a week for six weeks, with each dose administered directly into the upper urinary tract via a ureteral catheter or nephrostomy tube. The dose consists of 4 mg mitomycin per 1 mL sterile hydrogel. After the initial treatment period, patients who have no detectable disease at the primary disease evaluation visit about three months after the first dose may enter a follow-up phase where they could receive monthly maintenance doses for up to 11 months, depending on the investigators decision. During the study, participants will have evaluations every three months to check for disease response or recurrence. These assessments include urine cytology, visual inspection via ureteroscopy, and biopsies if needed. Researchers will monitor the complete response rate at three months as the primary outcome and track the duration of response, durable complete response rate, and any treatment-related side effects for up to 15 months. The total participation time varies depending on response and disease status.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the effectiveness, safety, and tolerability of camizestrant combined with ribociclib in patients with advanced ER-positive, HER2-negative breast cancer who have not received any prior systemic treatment for their advanced disease. This Phase IIIb global, multicenter, single-arm study aims to provide insight into this combination therapy as a first-line treatment option. Participants will receive daily oral tablets of camizestrant 75 mg and ribociclib 600 mg at standard doses continuously until they choose to stop treatment or it is discontinued for any reason. Approximately 150 participants will be enrolled and treated within this trial. During the study, participants will be monitored for treatment effectiveness using time to next treatment, time to discontinuation, and progression-free survival over a two-year period. Safety will be assessed by tracking adverse events, including any severe toxicities within the first six months. Participants will undergo regular assessments related to organ function and performance status throughout the treatment period, which may last until discontinuation.

Researchers are studying treatments for patients with hormone receptor-positive HR-positive and HER2-negative early-stage breast cancer who are at higher risk of relapse after surgery. This phase II, open-label study focuses on using a biomarker called circulating tumor DNA ctDNA to monitor minimal residual disease. The goal is to identify patients at molecular relapse and evaluate whether treatment at this stage can improve outcomes. The study involves multiple centers and is designed to test different treatment options based on ctDNA results. The study has three phases pre-screening, molecular follow-up ctDNA surveillance, and treatment. After giving consent, about 976 eligible patients will enter the ctDNA surveillance phase where tumor tissue and blood samples are collected to create a personalized mutation panel. Blood samples will be analyzed every three months during the first year and every six months thereafter to detect ctDNA. When ctDNA positivity is confirmed, up to 40 patients will be assigned sequentially to one of four treatment arms continuing standard endocrine therapy ET, giredestrant alone, giredestrant with abemaciclib, or giredestrant with inavolisib. Treatments are taken orally in cycles lasting 28 days and may continue up to five years or until disease recurrence or unacceptable side effects. Male and premenopausal participants receive additional hormone therapy LHRH agonist as needed. Participants will undergo regular blood sample collections during surveillance and treatment to monitor ctDNA levels and correlate changes with treatment response. Safety and side effects will be tracked throughout the treatment phase, which can last up to five years. After stopping treatment, patients enter a follow-up period where survival and new cancer therapies are recorded every three months. The primary outcome is measuring a decrease or clearance of ctDNA three months after starting treatment. Secondary outcomes include various ctDNA changes over time and treatment-related adverse events. Additional treatment arms may be added based on ongoing results.

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.