Viganello

Researchers are conducting a Phase III, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of androgen deprivation therapy (ADT) with or without darolutamide in men with newly diagnosed metastatic prostate cancer who have vulnerable functional ability. These patients have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 participants who meet specific frailty and disease criteria. Participants will be randomly assigned to one of two groups: the experimental group will receive ADT plus darolutamide 600 mg taken orally twice daily, and the control group will receive ADT plus a placebo taken orally twice daily. Treatment will continue until there is evidence of disease progression on radiographic scans or if the patient or investigator decides to stop treatment for reasons such as side effects or other health conditions. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, additional cancer treatments, and any ongoing or new side effects. During the study, patients will undergo assessments according to established prostate cancer clinical trial criteria to evaluate their response to treatment. Researchers will monitor the time until disease progression or death for up to 18 months as the main outcome. Safety and treatment effects will be tracked through scheduled visits, laboratory tests, and imaging. The long-term follow-up will help understand survival outcomes and the impact of subsequent treatments over many years.

This research evaluates anonymous, previously collected medical data to review the outcomes of different treatment methods for chronic pain. The study is a retrospective review involving multiple centers and independent patient groups to compare results across various subgroups. The study examines clinical outcomes related to the use of spinal cord stimulation, radiofrequency (RF), and other implantable device systems from Boston Scientific and other manufacturers. Multiple cohorts will be analyzed based on the type of treatment system used. Participants' medical charts will be reviewed to measure response rates through approximately two years of follow-up. The study focuses on clinical results documented in patient records without any new treatment or intervention administered during the study.

Researchers are evaluating treatment strategies for older and frail patients aged 70 and above with metastatic non-small cell lung cancer (NSCLC) who have PD-L1 expression less than 50%. This phase II trial compares the safety and effectiveness of reduced-dose chemotherapy combined with cemiplimab versus cemiplimab alone. The study addresses the challenge that standard full-dose chemotherapy often causes severe side effects in elderly or frail patients, aiming to find a better-tolerated treatment option that maintains cancer control. Participants are randomly assigned to receive either reduced-dose platinum-doublet chemotherapy with cemiplimab or cemiplimab monotherapy. Chemotherapy drugs include carboplatin at a lower dose (AUC 3), combined with pemetrexed and gemcitabine or paclitaxel, given intravenously on specific days. Cemiplimab is administered as an IV infusion every three weeks and continued for up to two years or until disease progression or unacceptable side effects. Patients who progress on monotherapy may switch to the combination treatment if suitable. Throughout the study, patients undergo regular imaging scans every 6 to 12 weeks to monitor tumor response and disease progression. Quality of life questionnaires and geriatric assessments, including hand-grip strength and mobility tests, are conducted at defined intervals. Researchers measure progression-free survival over one year and overall survival, along with side effects, patient-reported treatment acceptability, and overall treatment benefit. The total sample size is approximately 156 patients across multiple sites in Switzerland.

Researchers are conducting a global, multi-center, prospective post-market study to observe the long-term effectiveness of Boston Scientific neurostimulation systems in managing pain. The study aims to gather real-world clinical outcomes, economic value, and technical performance data of these commercially approved neurostimulation devices when used in routine clinical practice. The treatment involves an initial trial period using a Boston Scientific neurostimulation device for pain relief. Participants who experience a positive response during the trial may proceed to receive a permanent implant of the neurostimulation system. The therapy is tailored individually based on the investigator's judgment and standard care practices at each study site, following specific inclusion and exclusion criteria. Participants will be monitored throughout the trial and permanent implant phases to assess pain relief and overall treatment effectiveness. Assessments may include patient evaluations of pain and ability to complete study requirements. The study focuses on capturing comprehensive data to evaluate both clinical outcomes and device performance during regular use. Total participation duration depends on individual treatment progression from trial to permanent implant.