Sant Joan Despi

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating MB12, a proposed pembrolizumab biosimilar, compared to Keytruda in combination with pemetrexed-platinum chemotherapy as the first treatment for patients with advanced metastatic non-squamous non-small cell lung cancer NSCLC. This randomized, double-blind, multicenter study aims to compare the pharmacokinetics, efficacy, safety, and immune response of MB12 and Keytruda in this patient population. Participants will be assigned to one of three groups MB12 with pemetrexed and carboplatin or cisplatin, European Union-sourced Keytruda with the same chemotherapy, or US-sourced Keytruda with the same chemotherapy. MB12 and Keytruda are given intravenously at 200mg every three weeks on Day 1. Pemetrexed is given at 500 mgm2 IV every three weeks on Day 1, while carboplatin or cisplatin is administered every three weeks for four cycles. During the study, participants will be monitored from Week 1 to Week 52 for drug levels in the body, treatment effectiveness, safety, and immune response. Key assessments include measuring pharmacokinetic bioequivalence and efficacy equivalence within the first 24 weeks, along with longer-term safety and immune monitoring. The study is led by mAbxience Research S.L. and is expected to continue until September 2027.

Researchers are investigating the relationship between chronic non-cancer pain and chronic insomnia, two conditions that often occur together and negatively impact quality of life. Chronic pain lasts more than three months and affects about 17% of adults in Spain, while chronic insomnia involves persistent trouble with sleep at least three times a week for three months or more. This study aims to estimate how common chronic insomnia is among adults suffering from chronic non-cancer pain, addressing an important gap in current knowledge. The study involves adult patients with chronic non-cancer pain who are receiving usual care from pain specialists or within dedicated pain units in outpatient settings. Participants will be observed to determine the prevalence of chronic insomnia and related factors, without any experimental treatments or interventions. All data collection will occur during a baseline visit. Participants will attend a baseline visit where they will be assessed for the presence of chronic insomnia, pain intensity, sleep quality, anxiety, depression, mood, well-being, functional capacity, and use of sleep-related medications. Researchers will collect these measurements to understand the overlap of insomnia and chronic pain and their impact on patients. The study will provide important information to help develop better integrated treatments for managing pain and sleep problems together.

Researchers are evaluating whether adding Hyperthermic Intraperitoneal Chemotherapy HIPEC with Mitomycin C after complete surgical removal of peritoneal metastases in patients with colon cancer affects the chance of cancer returning in the abdomen. This phase IV clinical trial addresses uncertainties from prior research by focusing on the time patients remain free from peritoneal recurrence rather than overall survival. It excludes rectal cancers and patients with extensive peritoneal disease or incomplete surgery to better understand HIPECs role in this setting. Participants are randomly assigned to one of two groups one receiving complete cytoreductive surgery plus HIPEC with Mitomycin C delivered at 35 mgm2 in a heated peritoneal dialysis solution for 90 minutes with dose fractionation, and the other receiving surgery alone without HIPEC. The study corrects previous trial shortcomings by increasing HIPEC infusion time and limiting patient selection based on cancer spread and surgery completeness. During the trial, participants will be monitored for peritoneal recurrence over three years, with assessments including imaging and disease-free survival measures. Researchers will also track postoperative complications within 90 days after surgery and evaluate quality of life at multiple points before surgery, after chemotherapy, and at one and two years. The trial aims to provide detailed information on recurrence patterns, survival, and patient well-being over three years following treatment.

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 presence of remaining fluid buildup, known as residual congestion, in patients hospitalized for acute heart failure. The study aims to assess this condition at the time of hospital discharge using multiple methods and compare how well each method predicts patient outcomes. Artificial intelligence will also be used to develop a new predictive model that may improve on standard approaches. The study involves measuring residual congestion through clinical signs such as orthopnea, jugular venous distension, and leg swelling imaging tests including non-invasive heart pressure measurements, lung ultrasound, and venous excess ultrasound scores and laboratory tests of various blood markers like NT-proBNP, hemoglobin, and others. All assessments are made at discharge to gather comprehensive data on fluid overload. Participants will be monitored for up to six months after leaving the hospital. During this time, researchers will track worsening heart failure, cardiovascular death, other heart failure events, and overall survival. The study includes regular evaluations of clinical signs, imaging, and laboratory tests to understand which evaluation methods best predict patient outcomes and to support the development of the new AI-based prognostic tool.

Researchers are evaluating two imaging methods, laparoscopic ultrasound LUS and fluorescence cholangiography with indocyanine green ICG, to identify biliary anatomy during technically challenging laparoscopic gallbladder removal surgery. This multicenter, prospective, interventional clinical trial aims to compare the success of these techniques in detecting critical junctions of bile ducts, which is important for patient safety during surgery. Participants will undergo both imaging tests during their gallbladder surgery in a set order first LUS, then fluorescence cholangiography before the key surgical dissection. This allows direct comparison of the two methods within the same procedure. The study focuses on patients who have anticipated surgical difficulty due to conditions like acute cholecystitis, prior abdominal surgeries, or obesity. During the study, researchers will monitor how clearly each imaging method identifies important bile duct junctions, how long it takes to visualize these structures, total surgery time, and any complications during or after surgery. The study also involves tracking patient outcomes intraoperatively and postoperatively to assess safety and effectiveness. Participation begins with surgery and includes follow-up for these measures.

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.

Crohns disease CD often leads to stenosis, a common complication that increases risks like repeated surgery and short bowel syndrome. This study focuses on patients with new de novo stenosis less than 10 cm in length, seeking to compare the effectiveness, complications, quality of life impact, and costs of surgical versus endoscopic treatments. There is currently no clear scientific evidence guiding the best treatment choice for these patients. The study compares two endoscopic treatmentsendoscopic balloon dilation EBD and self-expanding metal stents SEMSagainst surgical resection for managing de novo stenosis in CD. Participants in the endoscopic groups receive either pneumatic balloon dilations up to twice with intervals or placement of fully coated metal stents for four weeks. Surgical resection is also evaluated, with all procedures including post-procedural monitoring in a Short Stay Unit and sedation as appropriate. Participants will be followed for one year, during which their quality of life, clinical recurrence, and complications will be assessed. Evaluations include endoscopic and radiological tests to confirm stenosis and ongoing monitoring of symptoms. The study also considers treatment costs and long-term efficacy. The overall aim is to better understand which treatment approach offers the best balance of safety, effectiveness, quality of life, and cost for patients with CD-related stenosis.