Lugano

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 with early symptoms of Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. This Phase III clinical trial focuses on those who show evidence of Alzheimer's pathology and have a recent history of cognitive decline. The study aims to measure changes in cognitive function over 72 weeks. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The trial is designed as a double-blind, placebo-controlled study, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 72 weeks, during which participants will undergo various assessments to monitor their cognitive status and safety. During the study, participants will complete clinical tests including cognitive assessments and imaging such as MRI, PET scans, or cerebrospinal fluid analysis to confirm Alzheimer's pathology. A study partner will assist participants as needed. Researchers will track changes from the start of the study through week 72 using tools like the Clinical Dementia Rating. Safety monitoring and adherence to study procedures will also be closely observed throughout the trial.

Researchers are evaluating the effects of pelacarsen (TQJ230), given as a monthly injection under the skin, in people with mild to moderate calcific aortic valve stenosis. This study aims to see if pelacarsen can safely slow the progression of this heart valve condition compared to a placebo. The trial is a phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers. Participants will receive either pelacarsen 80 mg or a matching placebo once a month. Before starting the treatment, they must have elevated lipoprotein(a) levels and be optimally treated for existing cardiovascular risk factors. The study focuses on those aged 50 to under 80 years with mild or moderate calcific aortic valve stenosis. During the 36 months of participation, researchers will monitor changes in peak aortic jet velocity and aortic valve calcium score to assess disease progression. Safety, tolerability, and the impact of the treatment will be evaluated. Participants will undergo regular assessments, including laboratory tests and clinical evaluations, to track heart valve condition and overall health throughout the study.

Researchers are evaluating the LeMaitre TufTex Over-the-Wire (OTW) Embolectomy Catheter in patients undergoing surgical treatment to remove arterial emboli and thrombi. This post-market clinical study aims to confirm the device's performance in effectively clearing blockages and monitor its safety to ensure a favorable benefit-risk balance. The study is prospective, single-arm, multicenter, and involves 112 participants across approximately four sites in three countries, with a total duration of 56 months including start-up, enrollment, follow-up, and closure periods. Participants will receive treatment using the TufTex OTW Embolectomy Catheter, which is designed for emboli and thrombi removal. The device can also be used for catheter placement over a guidewire, vessel occlusion, and fluid infusion or aspiration during the surgical procedure. The study includes one month of follow-up after the index procedure to assess outcomes. During the study, participants will be monitored for technical success defined as less than 30% residual stenosis one month after the procedure and safety outcomes during the procedure and follow-up. Data collection will focus on confirming the device's effectiveness and identifying any emerging risks. The total participation time for each subject is one month, with the overall recruitment period lasting 48 months.

Researchers are evaluating the LeMaitre4 TufTex Single Lumen Embolectomy Catheter in patients undergoing surgery to remove arterial emboli and thrombi. This post-market clinical study aims to confirm the device's performance and safety by collecting clinical data and identifying any emerging risks to ensure a favorable benefit-risk ratio. The study is sponsored by LeMaitre4 Vascular, Inc. and will take place at multiple sites in Europe involving approximately 112 patients. The study involves using the LeMaitre4 TufTex Single Lumen Embolectomy Catheter during surgical treatment to remove arterial emboli or thrombi. The catheter is designed specifically for this purpose. As a single-arm study, all participants will receive treatment using this device, with no comparator group. The focus is on procedures involving arterial or venous emboli and/or thrombi where thrombolytic therapy has failed or is contraindicated. Participants will be monitored during the procedure and for one month afterward to assess safety outcomes, including serious device- or procedure-related events. Researchers will also measure technical success, defined as achieving less than 30% residual narrowing (stenosis) one month post-procedure. The study includes obtaining informed consent, diagnosis confirmation, and follow-up assessments to evaluate both safety and performance over this timeframe.

Researchers are conducting a global study to understand the impact of moderate to severe alopecia areata (AA), non-segmental vitiligo (NSV), and hidradenitis suppurativa (HS) on adolescents and adults. This study aims to assess the burden these conditions place on patients' quality of life and daily functioning in a large real-world population. The study involves participants diagnosed by a physician with one of the three conditions: AA, NSV, or HS. There are no interventional treatments or medications being tested in this study, as it is observational in nature. Data collection focuses on patient-reported outcomes and measures that evaluate disease severity and its effects. Participants will complete various questionnaires and assessments related to their condition, such as the Alopecia Areata Symptom Impact Scale (AASIS) for AA, the Severity of Alopecia Tool (SALT) for scalp hair loss in AA, the Facial Vitiligo Area Scoring Index (F-VASI) and Vitiligo Quality of Life Score (VitiQoL) for vitiligo, and the Dermatology Life Quality Index (DLQI) and International Hidradenitis Suppurativa Severity Scoring System (IHS4) for HS. These tools help researchers understand how symptoms affect quality of life and disease severity. The study collects information up to the day of the study visit.

Malignant cerebral infarction can cause dangerous brain swelling that increases pressure inside the skull. The usual treatment involves removing part of the skull (decompressive hemicraniectomy or DCE) to relieve pressure, followed by a second surgery months later to replace the bone flap or use a substitute (cranioplasty or CP). This study is exploring whether a new approach using a specially molded space-expanding shield implanted during the initial surgery can protect the brain and avoid the risks linked to the two-step process, such as brain exposure and bone resorption. Participants will be divided into two groups: one receiving the standard DCE followed by CP about 90 days later, and the other receiving DCE plus implantation of the space-expanding shield in a single surgery. The shield is designed to allow brain swelling while providing protection, potentially eliminating the need for a second operation. The cranioplasty in the control group may use either the patient's original bone flap or a synthetic PMME bone flap. Patients will be monitored through examinations at 1 to 7 days, 6 weeks, 3 months, and 6 months after surgery. The main outcome measured is the modified Ranking Scale score at 6 months, which evaluates patients’ recovery and function. The study aims to assess whether the shield offers a viable alternative to the traditional two-step surgical approach, with follow-up lasting six months for each participant.

Researchers are evaluating efruxifermin (EFX) in adults aged 18 to 80 who have compensated cirrhosis caused by nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of EFX in improving liver health and delaying disease progression in this population. The study focuses on subjects with advanced liver fibrosis (stage 4) but without liver decompensation. Participants are randomly assigned to receive either efruxifermin or a placebo, both administered by subcutaneous injection. The study includes two cohorts: Cohort 1 requires biopsy confirmation of liver fibrosis and specific metabolic features, while Cohort 2 allows biopsy or non-invasive diagnosis. Treatment and observation continue over an extended period to evaluate changes in liver fibrosis and clinical events. During the study, researchers will monitor the time until significant clinical events such as disease progression or liver decompensation occur, with a follow-up of up to five years. For Cohort 1, the proportion of participants showing improvement in fibrosis without worsening steatohepatitis will be assessed at 96 weeks. Participants will undergo regular evaluations including clinical assessments and laboratory tests to track liver function and safety throughout the study period.

Researchers are evaluating the safety and tolerability of TAK-861 in people with narcolepsy type 1 (NT1) who have already been exposed to TAK-861 in earlier studies. The study also aims to observe improvements in symptoms such as excessive daytime sleepiness and the frequency of cataplexy episodes. This long-term extension trial continues from previous phase 2 and phase 3 trials and includes participants who completed those earlier studies. All participants in this trial will receive TAK-861 tablets. Those who were previously given a placebo in parent trials will be randomly assigned to a dose of TAK-861. The study plans to enroll up to 500 participants worldwide and will last approximately 5 years, or until the study is stopped or the drug is approved and launched. Participants will visit clinics multiple times, with some visits possibly done at home, and will have a follow-up check 4 weeks after their last dose. During the study, participants will be monitored for treatment-emergent adverse events from the time they consent until 4 weeks after their final dose, covering up to about 5 years. Researchers will assess safety and tolerability regularly through these visits and follow-ups. The focus is on identifying any side effects and understanding the long-term effects of TAK-861 in people with NT1.

Researchers are evaluating the effects of different steroid administration methods on patients with knee osteoarthritis undergoing Total Knee Arthroplasty (TKA). This phase 4 study compares perioperative intravenous (IV) dexamethasone, perioperative intra-articular (IA) dexamethasone, and a control group receiving standard anesthesia without steroids. The main goal is to understand which treatment offers better pain relief and overall benefits after surgery. The study involves 159 patients divided into three groups: one receives 9mg of dexamethasone intravenously, another receives the same dose intra-articularly, and the third group receives no steroid supplementation. All treatments are given around the time of surgery. Researchers will compare these groups for differences in post-operative pain, function, medication use, knee movement, inflammation, time to mobilization, hospital stay length, and patient satisfaction. Safety monitoring will focus on steroid-related side effects, like blood sugar issues and infections. Participants will be followed for up to 12 years, including 2 years of enrollment and 10 years of follow-up. Primary data analysis will occur after the 1-year follow-up. During the study, patients will be assessed for pain at rest during the first 3 days after surgery using a numeric rating scale. Researchers will also monitor complications and collect data on various recovery outcomes to evaluate the long-term effects of the steroid treatments compared to no steroid use.

Researchers are evaluating the safety and effectiveness of two different post-operative weight-bearing approaches after a modified Lapidus arthrodesis surgery for hallux valgus, which may include additional procedures like Akin or Weil/Hohmann surgery fusions. This randomized controlled trial compares immediate full weight-bearing to partial weight-bearing (10-15 kg) as a new method for rehabilitation following foot surgery. Participants will be randomly assigned to either a group that performs partial weight-bearing or one that performs complete weight-bearing right after surgery. Both groups will wear a VACOPASO shoe for 6 weeks during their recovery. The surgical procedure follows standard clinical practice for hallux valgus treatment, and post-operative care includes wearing the specialized shoe regardless of the weight-bearing level. Throughout the study, patients will undergo standard X-ray assessments at 6, 12, and 24 weeks to evaluate bone healing, hardware fixation, and implant stability. Pain levels will be tracked using a Visual Analogue Scale (VAS), while quality of life and subjective functional recovery will be measured with the American Orthopedic Foot and Ankle Score (AOFAS) and the Olerud and Molander Ankle Score (OMAS) respectively. The main outcome focuses on patient-reported function at 6 weeks. The total monitoring period extends up to 24 weeks post-surgery.