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Researchers are conducting a long-term extension study to evaluate the safety, tolerability, and effectiveness of ORX750 in adults aged 18 to 65 years who have narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia. This study follows participants who completed a previous ORX750 clinical trial and focuses on providing ongoing information about the treatment over an extended period. Participants will receive oral ORX750 in an open-label format, grouped by their specific diagnosis narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia. The study does not involve randomization or blinding, allowing all participants to know they are receiving the study drug. The treatment and monitoring periods include assessments up to about 70 days for safety and roughly 63 days for measures of drug concentration and wakefulness. During the study, participants will undergo frequent evaluations including monitoring for adverse events, laboratory tests, vital signs, ECGs, and assessments for suicidal thoughts or behaviors. They will also complete tests measuring wakefulness and sleepiness levels. This ongoing observation aims to ensure the treatments safety and to understand its effects over time, with participant involvement lasting through the entire study period.

Researchers are evaluating NEU-411 in adults aged 40 to 80 years who have early Parkinsons Disease PD with elevated activity in the LRRK2 pathway, identified through a genetic test. This Phase 2 study aims to assess the safety and effectiveness of NEU-411, a selective brain-penetrant inhibitor of LRRK2, compared to placebo in participants with LRRK2-driven PD. Participants will be randomly assigned to receive either NEU-411 at 30 mg once daily or a matching placebo for a 52-week treatment period. After this phase, participants may join an open-label extension to receive NEU-411 treatment for an additional 26 weeks. The study evaluates treatment effects on PD symptoms and adverse events. During the study, participants will undergo assessments including the Roche digital biomarker score using a Parkinsons Disease application and the Movement Disorder Societys Unified Parkinsons Disease Rating Scale. Safety monitoring includes tracking treatment-emergent and serious adverse events, with a follow-up visit scheduled within two weeks after treatment ends. Total study participation may extend up to 78 weeks including the extension phase.

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 the optimal doses of the drug E2086 compared to placebo in adults with narcolepsy, a condition characterized by excessive daytime sleepiness EDS. The study focuses on reducing EDS as measured by the Mean Sleep Latency MSL using the first four maintenance of wakefulness tests MWTs. This Phase 2 trial includes participants diagnosed with either narcolepsy type 1 NT1 or type 2 NT2 within the last 10 years. Participants will be randomly assigned to receive either E2086 or a matching placebo tablet taken orally once daily for four weeks at low, middle, and high doses. Each dosing period is separated by a washout period of at least seven days, with a total treatment duration of approximately 14 weeks. This design allows comparison of the effects of different doses of E2086 on narcolepsy symptoms. During the study, participants will undergo assessments to measure changes in sleep latency, cataplexy episodes, and sleepiness scales. Additional safety evaluations include monitoring for adverse events, laboratory tests, vital signs, ECG parameters, and suicidality assessments. Blood samples will be collected to analyze drug concentration levels. The study involves regular monitoring up to Day 113 and aims to assess both efficacy and safety over the course of treatment and follow-up.

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.

This research aims to compare two surgical techniques, anterior and posterior white line advancement, for correcting primary aponeurotic ptosis in adults. The study seeks to determine if the anterior approach improves eyelid position, measured by Marginal Reflex Distance 1 MRD1, better at 6 months than the posterior approach. It also evaluates differences in eyelid symmetry, contour, vision, and patient satisfaction between the two methods. Participants will be randomly assigned to one of two groups one receiving the anterior approach involving a skin crease incision to access and advance the levator aponeurosis, and the other receiving the posterior approach, which uses a conjunctival incision without a skin cut. Both surgeries involve advancing the white line to the anterior tarsus using sutures. The study includes follow-up visits at 7 days, 2 months, and 6 months after surgery. During these visits, researchers will measure eyelid position and symmetry, evaluate eyelid contour using both software and masked evaluators, and test vision and tear film stability. Patients will also complete surveys on dry eye symptoms, scar quality, satisfaction, and psychosocial function. Surgical time and complications will be monitored. All images and data will be securely stored, and outcome assessors will be blinded to the group assignments for certain evaluations.

Researchers are studying the use of ribociclib, a CDK46 inhibitor, in women with early hormone receptor-positive HR and HER2-negative breast cancer who are at intermediate risk of cancer recurrence. The study aims to see if patients can avoid chemotherapy, which has significant side effects, by using ribociclib along with hormone therapy after surgery. This phase III trial builds on the NATALEE study, which showed that ribociclib added to hormone therapy improved survival free of invasive disease in similar patients. Participants will be randomly assigned to one of two groups one receiving ribociclib plus endocrine hormone therapy, and the other receiving chemotherapy followed by ribociclib and endocrine therapy. Ribociclib treatment lasts for three years, and chemotherapy is given before starting ribociclib and hormone treatment. The trial aims to compare the outcomes of chemotherapy de-escalation versus standard treatment in this patient group. During the study, participants will attend scheduled visits for treatment and monitoring, including laboratory tests, heart monitoring with ECG, and questionnaires about their quality of life. Researchers will track invasive breast cancer-free survival and other outcomes such as overall survival and treatment side effects for up to 12 years. Safety and quality of life assessments will continue during and after treatment to evaluate the long-term effects and benefits of the treatment approaches.

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 effectiveness of a remote monitoring software called Caaring in cancer patients undergoing outpatient oral cancer treatment. The study aims to see if using this self-management platform helps patients manage their illness better and reduces the number of in-person and telephone visits with specialized medical and nursing staff. This is a randomized, multicenter clinical trial comparing two groups of patients over 12 weeks. One group will use the Caaring app on their smartphones to report data and complete questionnaires related to their treatment and health. This group will also receive educational and prevention recommendations about cancer. The other group will receive routine medical follow-up visits without the remote monitoring app. Both groups will be observed for 12 weeks following their inclusion in the study. Participants will be monitored through the app or routine visits, with researchers collecting information on treatment adherence, completion of data, use of health resources, and patient satisfaction with the software. The main outcome is the percentage of adherence to prescribed treatment over 12 weeks. Secondary outcomes include data completion rates, changes in health resource use, and patient satisfaction. The study involves regular assessments and questionnaires, with a total participation duration of 12 weeks.

Researchers are evaluating the added value of staged bilateral Exablate thalamotomy in patients with Essential Tremor who have previously undergone unilateral Exablate thalamotomy. This post-market, randomized, controlled, and blinded multicenter trial aims to compare the effects of bilateral treatment against continued unilateral treatment combined with local standard medical care. The study focuses on tremor reduction, functional abilities, quality of life, adverse events, and patient perceptions of treatment outcomes. Participants in the treatment group will receive staged bilateral Exablate thalamotomy, while those in the control group will continue with their existing unilateral treatment alongside local standard medical care. The primary goal is to assess tremor improvement at 6 months, measured by the Treated Upper Limb Clinical Rating Scale for Tremor CRST. Safety will also be evaluated by tracking adverse events related to the treatment during this period. Throughout the study, participants will undergo assessments of tremor severity using various clinical rating scales and quality of life questionnaires at 6 and 12 months. Safety monitoring will include recording any adverse events related to the treatment. Participants will be expected to complete required evaluations and remain in the study for at least 6 months, allowing researchers to gather comprehensive data on the treatments impact and safety.