Lugano

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III trial aims to understand how trontinemab affects cognitive decline and disease progression in this population. Participants are randomly assigned to receive either intravenous trontinemab or a placebo in a parallel-group design. Treatment is administered by IV infusion, and the effects are compared over a period of 72 weeks. The study includes comprehensive safety and efficacy assessments throughout this period. During the 72 weeks of the study, participants will undergo various evaluations including cognitive tests such as the Clinical Dementia Rating-Sum of Boxes CDR-SB, Alzheimers Disease Assessment Scales, brain imaging with PET and MRI scans, and biomarker measurements in cerebrospinal fluid and blood. Safety monitoring includes tracking adverse events, infusion reactions, and antibody development. The study requires participants to have a study partner and to complete all study procedures over this time.

This trial studies adults aged 50 to under 80 with mild or moderate calcific aortic valve stenosis and elevated lipoproteina levels. Researchers are assessing the safety, tolerability, and ability of pelacarsen TQJ230 given once monthly by injection to slow the progression of this heart valve condition. The study compares pelacarsen to a placebo in a randomized, double-blind design. Participants receive either pelacarsen 80 mg or a matching placebo as a subcutaneous injection monthly. They continue treatment and monitoring for up to 36 months to observe changes in heart valve narrowing and calcium buildup. The study also tracks lipoproteina levels and clinical heart-related events during this period. Throughout the study, participants will have regular assessments including imaging to measure aortic valve function and calcium score, blood tests for lipoproteina, and monitoring for safety. The main outcomes analyzed after 36 months include changes in valve jet velocity and calcium score, alongside clinical events. Participants remain under medical care while being observed for any effects of the study drug or placebo.

This clinical investigation is a prospective, single-arm, multicenter post-market study designed to collect clinical data on the LeMaitre TufTex Over-the-Wire OTW Embolectomy Catheters. The study aims to confirm the devices performance in removing arterial emboli and thrombi, identify any emerging risks based on factual evidence, and ensure the continued acceptability of its benefit-to-risk ratio. The device is used for patients undergoing surgical treatment for emboli or thrombi removal, with the study sponsored by LeMaitre Vascular, Inc. The study involves using the LeMaitre TufTex OTW Embolectomy Catheter, which is intended for removing emboli and thrombi during embolectomy or thrombectomy. The catheter can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion, and aspiration. The investigation is planned to enroll 112 subjects across four sites in about three countries, with an enrollment period lasting 48 months. Each participant will be followed for one month after the procedure. The total study duration is approximately 56 months, including start-up, recruitment, follow-up, and closure phases. Participants will undergo surgical treatment using the catheter, and researchers will assess technical success defined as less than 30% residual stenosis one month after the procedure. Safety will be monitored during the procedure and follow-up. Additional outcomes measured include clinical success, revision rates, and vessel patency at one month post-procedure. The study includes monitoring for any adverse events to ensure safety and performance. Participation involves one month of follow-up after the surgical procedure to evaluate these outcomes.

This clinical trial evaluates the LeMaitre4 TufTex Single Lumen Embolectomy Catheter in patients undergoing surgery to remove arterial emboli and thrombi. The study aims to confirm the devices performance and safety, identify any new risks based on real patient data, and ensure the benefit-risk balance remains acceptable. Sponsored by LeMaitre4 Vascular, Inc., the study is conducted at several sites in Europe with a planned enrollment of 112 patients. Participants will receive treatment using the LeMaitre4 TufTex Single Lumen Embolectomy Catheter, a device featuring a latex balloon attached to a radiopaque shaft. The balloon helps remove emboli and thrombi by being withdrawn through an artery during surgery. This is a single-arm study, meaning all participants receive the device treatment without comparison groups. During the study, researchers will monitor safety outcomes such as device- or procedure-related serious events during and up to one month after the procedure. They will also assess technical success based on the amount of artery narrowing after one month. Additional evaluations include clinical success, revision rates, and artery openness over time. Participants will be followed for at least one month after treatment to track these outcomes and ensure safety.

Researchers are studying the impact and burden of three skin conditions moderate or severe alopecia areata, non-segmental vitiligo, and moderate to severe hidradenitis suppurativa. The study includes adolescents and adults and aims to understand how these conditions affect quality of life and daily functioning in a large global population. This is an observational study where participants with each condition will have a single visit for data collection following routine clinical practice. No experimental treatments are given instead, the study gathers information during this one visit to assess disease characteristics and impact. During the visit, participants will complete questionnaires and clinical assessments specific to their condition. These include tools measuring symptom impact, hair loss severity, skin depigmentation, and quality of life related to each disease. This helps researchers better understand the real-world burden of these conditions. Participation involves only this one visit, with no long-term follow-up or additional procedures.

This research aims to compare two surgical approaches for patients experiencing increased intracranial pressure caused by malignant stroke. It investigates whether using a single surgery with an individually molded space-expanding shield can be a viable alternative to the standard decompressive hemicraniectomy followed by a second surgery called cranioplasty. The study is planned as a randomized, controlled, multicenter trial to evaluate these methods in stroke patients aged 18 to under 70. Participants will be randomly assigned to one of two groups. The experimental group will receive decompressive hemicraniectomy with implantation of a space-expanding shield that allows brain swelling while providing protection in a single surgery. The control group will undergo the standard decompressive hemicraniectomy without the shield and later undergo cranioplasty about 90 days after the initial surgery. Follow-up examinations are scheduled at 1 to 7 days, 6 weeks, 3 months, and 6 months after surgery. During the study, participants will undergo evaluations including neurological assessments and imaging to monitor recovery and complications. Researchers will measure outcomes such as the modified Rankin Scale score at 6 months, number of additional surgeries for intracranial pressure control, infections, wound healing, syndrome of the trephined, survival, cosmetic satisfaction, and quality of life. The total duration of participation for each patient is 6 months, with safety and recovery closely monitored throughout.

Researchers are evaluating efruxifermin EFX in a phase 3, randomized, double-blind, placebo-controlled study involving adults with compensated cirrhosis caused by NASH Nonalcoholic Steatohepatitis or MASH Metabolic Dysfunction-Associated Steatohepatitis. This study aims to assess the safety and effectiveness of EFX in preventing significant clinical events such as disease progression and liver decompensation over a period of up to 5 years. Participants are randomly assigned to receive either efruxifermin 50 mg or a placebo, both given by subcutaneous injection. The study includes two cohorts one with biopsy-proven compensated cirrhosis and specific metabolic scores, and another with biopsy-proven or non-invasive diagnosis of compensated cirrhosis. The study treatment and monitoring extend up to 5 years, with evaluations at 96 weeks and long-term follow-up to track liver fibrosis, markers of liver injury, insulin sensitivity, glycemic control, body weight, and safety outcomes. During the trial, participants undergo regular assessments including laboratory tests, ECGs, ultrasounds, and vital sign monitoring. Researchers will measure changes in liver fibrosis, steatohepatitis resolution, and metabolic markers throughout the study. Safety and tolerability are closely tracked by documenting adverse events and exposure duration. The study duration allows for long-term observation of treatment effects and disease progression, with participant involvement lasting up to 5 years.

Researchers are evaluating the safety and tolerability of TAK-861 in people with narcolepsy type 1 NT1. This study focuses on participants who have already been exposed to TAK-861 doses in previous clinical trials. The goal is to monitor how TAK-861 affects symptoms such as excessive daytime sleepiness and cataplexy episodes over a long period. All participants in this trial will receive TAK-861 tablets. Those who previously received a placebo will be randomly assigned to one of the TAK-861 dose groups. The study is a long-term extension conducted worldwide and is expected to last approximately five years or until the product is approved or the study is stopped. Participants may switch doses as needed and will attend multiple clinic visits, some of which can be done at home. Throughout the trial, participants will be regularly assessed for safety by tracking any treatment-emergent adverse events. Researchers will also measure changes in sleep latency, sleepiness scores, and cataplexy rates compared to baseline data from earlier trials. Follow-up assessments will take place four weeks after the final dose to monitor ongoing effects and ensure participant safety.

Researchers are studying patients with knee osteoarthritis who are undergoing total knee arthroplasty TKA to compare three different steroid administration methods during surgery. This study aims to understand which methodintravenous steroid, intra-articular steroid, or no steroid supplementationprovides better outcomes in terms of pain relief and recovery. It is a randomized, double-blind trial designed to evaluate these approaches over a long period. The study involves three groups of patients receiving different treatments one group will receive 9 mg of intravenous dexamethasone during surgery, another will receive 9 mg of intra-articular dexamethasone, and the control group will receive the standard anesthesia protocol without steroids. Each group will consist of 53 patients, totaling 159 participants. The interventions are perioperative and occur at the time of surgery. Participants will be followed for up to 10 years with assessments including pain levels at rest in the first 3 days after surgery, knee function, pain intensity, opioid consumption, time to first mobilization, and length of hospital stay. Researchers will also monitor safety by recording steroid-related complications such as infections and hyperglycemia. The study will collect data at multiple points, including up to 10 years post-surgery, with primary data analysis planned after one year of follow-up.

Researchers are evaluating post-operative management approaches after a modified Lapidus arthrodesis surgery for hallux valgus, with or without additional surgeries such as Akin or WeilHohmann procedures. The study aims to compare the effectiveness and safety of immediate full weight-bearing versus partial weight-bearing 10-15 kg during rehabilitation. This randomized controlled trial explores a new rehabilitation method following foot surgery to improve recovery. Participants will be randomly assigned to one of two groups after surgery one group will follow partial weight-bearing with a specialized VACOPASO shoe and use crutches along with antithrombotic medication for 6 weeks, while the other group will have immediate complete weight-bearing with the same shoe and medication for the same period. The surgical operation follows standard clinical practices for hallux valgus correction. During the study, healing progress will be monitored through standard X-rays at 6, 12, and 24 weeks to check bone healing, hardware fixation, and fracture alignment. Pain will be measured using a Visual Analogue Scale at the day of surgery and at follow-up visits. Quality of life and functional recovery will be assessed through established foot and ankle scoring systems at multiple time points. The main outcome is the subjective functional recovery measured by the Olerud and Molander Ankle Score at 6 weeks post-surgery.