Coslada

Researchers are evaluating the safety, feasibility, and initial effectiveness of expanded allogeneic mesenchymal stem cells derived from adipose tissue HC106 for treating urinary incontinence in women over 50 years old. This is a phase I, controlled trial aiming to gather proof of concept and preliminary data on this treatment for female urinary incontinence, specifically stress or mixed urinary incontinence with a predominance of effort-related leakage. The trial includes two groups one receiving a single dose of 40 million HC016 stem cells injected near the urinary sphincter, and a control group receiving a placebo saline solution injection. The cell or placebo injection is done under anesthesia and guided by cystoscopy to target specific points in the sphincter. The treatment involves one injection session, and the study follows participants to evaluate safety and effects. Participants will undergo assessments including a PAD-test, flowmetry, and quality of life questionnaires SF-12 and ICQ-SF at 3 and 6 months after treatment. Safety is monitored closely, especially for any complications within 7 days post-treatment. The total participation includes initial treatment and follow-up visits over at least 6 months to assess treatment impact and patient well-being.

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 effect of 12 months of continuous positive airway pressure CPAP treatment combined with conventional pharmacological therapy on lipid profiles in patients with dyslipidemia and moderate to severe obstructive sleep apnea OSA. This phase IV randomized, open-label, parallel clinical trial aims to explore improvements in blood lipid levels, serum uric acid, insulin resistance, cardiovascular risk, glycemic control, inflammation markers, and quality of life in this patient group aged 35 to 80 years. Participants will be randomly assigned to one of two groups one receiving standard hygienic-dietary advice and promotion of daily physical activity, and the other receiving the same plus CPAP therapy. CPAP treatment starts with an empirical pressure of 8 cmH2O and is adjusted within three weeks via automatic titration to a pressure corresponding to the 95th percentile. Patients in both groups will be encouraged to walk 10,000 steps daily, monitored with pedometers and step logs. During the 12-month study, patients will undergo assessments including blood tests for cholesterol, triglycerides, glucose, inflammatory and oxidative stress markers, and hormones related to appetite. Questionnaires on sleepiness, quality of life, and physical activity will also be completed. CPAP compliance, adverse events, and cardiovascular events will be monitored to evaluate safety and treatment effects over the study period ending in January 2028.

Researchers are examining the use of dexamethasone in adults with acute hypoxemic respiratory failure AHRF, including acute respiratory distress syndrome ARDS, caused by infections such as COVID-19. This condition leads to severe lung inflammation requiring mechanical ventilation and has high mortality rates. The effectiveness of corticosteroids like dexamethasone in treating AHRF and ARDS remains uncertain, prompting this study to compare different dosing strategies to better understand their impact on patient outcomes. The trial is a randomized, controlled, open-label study conducted across multiple centers in Spain. Participants who are mechanically ventilated with confirmed infection-related AHRF will be assigned to receive either a low dose of dexamethasone 6 mg daily for 10 days or a higher dose 20 mg daily for 5 days, followed by 10 mg daily for 5 days. The study compares these two dosing regimens to determine which may better reduce mortality and improve ventilator-free days. During the trial, participants will be closely monitored in intensive care units, with primary outcomes measured by mortality at 60 days and secondary outcomes by the number of days free from mechanical ventilation within 28 days. Researchers will gather data on lung function, infection status, and overall health. Participants progress will be followed to assess the safety and effects of the dexamethasone doses over the study period.