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This research focuses on participants with narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. It is a long-term extension study following a previous trial, aiming to evaluate the long-term safety, tolerability, and effectiveness of the drug ORX750 in these conditions. The study is part of a Phase 2 clinical trial program specifically involving participants who completed the initial parent study. Participants will receive oral ORX750 during the long-term extension period. This open-label study continues treatment with ORX750, allowing researchers to observe its effects over an extended time without a placebo comparison. The study builds upon prior treatment to assess ongoing outcomes and safety. During the study, participants will be closely monitored for any treatment-emergent adverse events, serious adverse events, abnormal lab tests, changes in vital signs, abnormal ECG results, and any signs of suicidal thoughts or behavior up to day 70. The study requires participants to adhere to protocol requirements and will assess their continued safety and response to ORX750 throughout the treatment period.

Researchers are studying the effects of NEU-411 in men and women aged 40 to 80 years who have early Parkinson's Disease (PD) with increased activity in the LRRK2 pathway, identified through a genetic test. This Phase 2 trial aims to evaluate how well NEU-411 works and its safety in this specific group compared to a placebo. The study involves participants with clinically established or probable PD and focuses on those with LRRK2-driven PD. Participants will be randomly assigned to receive either NEU-411, a brain-penetrant oral drug that inhibits LRRK2 activity, or a matching placebo once daily for 52 weeks. After completing this treatment phase, participants will have a safety follow-up visit within two weeks. Those eligible may join an open-label extension to receive NEU-411 for an additional 26 weeks. During the study, researchers will monitor changes in a digital biomarker score using a Parkinson's Disease app from enrollment through 52 weeks, along with recording any treatment-emergent or serious adverse events until the study ends at 54 weeks. Assessments include genetic testing, clinical evaluations of PD status, safety monitoring, and tracking of side effects to understand the drug's effects and tolerability over time.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating the optimal doses of E2086, an oral tablet, compared to a matching placebo in adults with narcolepsy to reduce excessive daytime sleepiness. This phase 2 randomized, double-blind, placebo-controlled trial focuses on measuring sleepiness using the Mean Sleep Latency (MSL) from four maintenance of wakefulness tests (MWTs). Participants include adults diagnosed with narcolepsy type 1 or type 2, with specific clinical and diagnostic criteria based on the 2023 International Classification of Sleep Disorders. Participants receive either E2086 or placebo tablets during the study. The treatment period lasts four weeks, during which participants complete the MWTs to assess changes in sleep latency. The study monitors the effect of the drug on daytime sleepiness compared to placebo and evaluates safety and tolerability. During the trial, participants will undergo assessments including sleep diaries, clinical history reviews, and MWTs at baseline and week 4. Researchers will measure changes in mean sleep latency to evaluate treatment effect. Safety monitoring includes tracking adverse events and clinical observations throughout the study. The total participation time includes screening, treatment, and follow-up assessments as required by the protocol.

Researchers are evaluating the safety, feasibility, and initial effectiveness of using expanded allogeneic mesenchymal stem cells derived from adipose tissue (HC106) to treat urinary incontinence in women over 50 years old. This phase I controlled trial aims to provide proof of concept and preliminary efficacy data by comparing the stem cell treatment to a saline placebo control group. The study focuses on women diagnosed with genuine or mixed stress urinary incontinence who have not responded to or refused rehabilitative or surgical treatments. Participants are divided into two groups: one receiving a single dose of 40 million HC106 cells and the other receiving a placebo saline solution. The treatment involves anesthesia, identification of the urinary sphincter area through cystoscopy, and injection of the cell suspension or placebo at two specific points around the sphincter. The injection is shallow to create a visible wheal, and any remaining cells or materials are properly discarded following hospital waste procedures. Throughout the study, patients will be monitored for complications and safety within 7 days following treatment. Researchers will assess the proportion of patients experiencing any treatment-related complications. Participants must provide informed consent and undergo urine cultures to ensure no active infection at enrollment. The overall study duration and additional long-term follow-up details are not specified but safety and initial efficacy outcomes will be closely observed during the trial period.

Researchers are comparing two surgical methods, anterior and posterior white line advancement, to treat primary aponeurotic ptosis in adults. This trial aims to determine whether the anterior approach improves eyelid position, measured by Marginal Reflex Distance 1 (MRD1), more than the posterior approach at 6 months. The study also examines differences in eyelid symmetry, contour, vision, tear function, and patient satisfaction between the two techniques. Participants will be randomly assigned to receive either anterior or posterior white line advancement surgery. The anterior technique involves a skin crease incision and suturing the white line to the front of the tarsus, while the posterior technique uses a conjunctival incision without a skin cut to advance the white line. Both methods use absorbable sutures to reposition the eyelid structures and aim to improve eyelid height and contour. Participants will be evaluated before surgery and at 7 days, 2 months, and 6 months after the procedure. Assessments include eyelid position and symmetry measurements, vision and tear film tests such as TBUT and Schirmer's test, and patient surveys on dry eye symptoms, scar quality, satisfaction, and psychosocial function. Standardized photographs will document eyelid contour, and surgical time and complications will be recorded. The main outcome is the change in MRD1 from baseline to 6 months post-surgery, with ongoing monitoring for safety and patient-reported results.

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 effectiveness of remote monitoring for cancer patients who are receiving outpatient oral cancer treatment. This study aims to determine if using a self-management software platform called Caaring® can empower patients during their illness and reduce the number of in-person and telephone visits with specialized medical and nursing staff. The study is designed as a randomized trial with two groups to compare the outcomes. Participants are divided into two groups: one group will use the Caaring® software for remote monitoring, where they will confidentially enter data and complete questionnaires on their smartphones. This group will also receive educational and prevention recommendations related to cancer. The second group will be followed through their routine medical visits without remote monitoring for 12 weeks after enrollment. Participants will be involved for 12 weeks during which adherence to their prescribed cancer treatment will be measured. Researchers will collect data through the software and routine visits, assessing treatment adherence rates, and monitoring patient progress. The study also involves evaluating participants' technological skills to use the smartphone application and ensuring safety and routine follow-up throughout the study period.

This trial is a post-market, Phase IV, randomized, controlled, and blinded multicenter study focused on patients with Essential Tremor who have previously undergone unilateral Exablate thalamotomy. It aims to evaluate the added benefit of staged bilateral Exablate thalamotomy compared to patients continuing with their previous unilateral treatment combined with local standard medical care. The study measures how the bilateral procedure affects tremor reduction, functional impairment, quality of life, adverse events, and patients' overall perception of treatment. Participants assigned to the treatment group will receive staged bilateral Exablate thalamotomy, while those in the control group will continue with local standard medical treatment after their previous unilateral Exablate thalamotomy. The study observes the impact of these treatments over a period of 6 months, focusing on tremor severity and safety outcomes related to adverse events. Throughout the study, participants will undergo assessments including tremor evaluation using the Treated Upper Limb Clinical Rating Scale for Tremor (CRST) at 6 months. Other evaluations involve imaging scans such as CT and MRI before treatment, communication during procedures, and monitoring for adverse events. Participants must be able to complete all required assessments and remain in the study for at least 6 months to evaluate treatment effects and safety.

Researchers are comparing two types of blades used with videolaryngoscopes to see which is better for first-attempt tracheal intubation in patients admitted to intensive care units (ICU). This study focuses on critically ill patients who need intubation and aims to find out if the hyperangulated blade improves the success rate compared to the Macintosh blade, which is more similar to traditional laryngoscopy blades. The study is a prospective, multicenter, randomized trial designed to provide clarity on the best blade choice during ICU intubations. Participants will be randomly assigned to have their tracheal intubation performed using either a hyperangulated videolaryngoscope blade or a Macintosh videolaryngoscope blade during their first attempt. Both groups use videolaryngoscopy as the device for intubation, but differ in the blade type. The study evaluates the success of intubation on the first try using these different blades. During the study, researchers will monitor the intubation process to measure the percentage of successful first attempts. They will also track any complications or difficulties related to intubation. The study includes adult ICU patients from 18 to 90 years old who require intubation. Data on intubation success and related outcomes will help determine which blade offers better airway management in critically ill patients.