Solothurn

Atrial fibrillation is the most common heart rhythm problem worldwide and increases the risk of heart failure, stroke, and death. Researchers expect its prevalence to rise, especially in people over 65 years old, with about one in three developing atrial fibrillation. Electrocardioversion is a procedure that restores normal heart rhythm but often results in the arrhythmia returning within a short time. This trial aims to study whether inflammation plays a role in this recurrence and if treating it can reduce the return of atrial fibrillation after electrocardioversion. The trial compares two groups one receives a daily oral dose of 0.5 mg Colchicine for three months, taken in the morning without a loading dose, alongside their usual treatments. The other group receives a matched placebo. This is a randomized, triple-blind Phase 3 study evaluating the effect of low-dose Colchicine on preventing atrial fibrillation recurrence after electrocardioversion. Participants will be monitored for recurrence of atrial fibrillation over six months following electrocardioversion. Researchers will assess the number of arrhythmia recurrences at one, three, and six months, the time to any repeat electrocardioversion, use of antiarrhythmic drugs, and hospitalizations. Safety and overall wellbeing will also be followed during this period, with the main outcome focused on arrhythmia recurrence within six months.

Researchers are evaluating elacestrant compared to standard endocrine therapy in patients with estrogen receptor-positive ER and human epidermal growth factor receptor 2-negative HER2- breast cancer who have a relapse detected by circulating tumor DNA ctDNA. This international, multi-center, randomized, open-label phase III trial focuses on patients without distant metastasis who show ctDNA positivity during screening. The study aims to assess whether elacestrant can improve outcomes over the current standard endocrine treatments. The study consists of two phases. First, during the ctDNA screening phase, patients on standard adjuvant endocrine therapy will have plasma samples collected every six months for about 5.7 years to detect ctDNA. Patients who test positive will undergo imaging to confirm no distant metastasis and then be randomized 11 to either continue their current endocrine therapy or receive elacestrant 400 mg orally once daily. Treatment duration depends on prior endocrine therapy length, lasting between 2 to 6 years. Intensive follow-up with ctDNA testing and imaging occurs for up to 3 years after randomization. Participants will be monitored closely with blood tests for ctDNA at weeks 4, 16, and every 16 weeks thereafter, along with yearly mammograms, bone scans, and CT scans every 16 weeks to detect metastases or recurrences. Safety, quality of life, and overall survival are assessed throughout, with follow-up continuing until three years after the last patient enrolls. The primary outcome measured is distant metastasis-free survival at 6.25 years after the first randomization.

Researchers are evaluating the impact of core muscle training on the occurrence of incisional hernia, chronic postsurgical pain CPSP, and sarcopenia after abdominal surgery. The study addresses the common practice of limiting core muscle activity post-surgery to prevent hernias, despite no evidence supporting this approach. The trial will explore whether physical restriction or specific core muscle exercises before and after surgery influence the incidence of incisional hernias and the development of CPSP and sarcopenia. Participants will be randomly assigned to one of two groups. The control group will receive standard physiotherapy, which includes early mobilization and exercises to prevent complications, while limiting core muscle activity and weight bearing based on pain. The intervention group will perform four specific core muscle exercises daily during hospitalization under physiotherapist supervision and continue at home for two months, alongside standard physiotherapy. Follow-up visits will occur at two, twelve, and twenty-four months post-surgery. During the study, participants will undergo clinical examinations and ultrasound scans to detect incisional hernias, assessments of chronic postsurgical pain and its treatment, and evaluations of muscle mass using CT scans. Researchers will also monitor exercise activity, hospital stay length, readmission and re-operation rates, and the incidence of sarcopenia. The study period includes regular follow-ups for up to two years to track these outcomes and evaluate the effects of postoperative rehabilitation.

Researchers are evaluating the addition of niraparib to anti-PD-L1 antibody maintenance treatment in patients with SLFN11-positive extensive-disease small cell lung cancer ED-SCLC that has not progressed after standard first-line chemo-immunotherapy. This international, multicenter, single-arm phase II trial aims to assess the clinical effectiveness of this combined treatment approach. The treatment involves giving niraparib orally at a dose of 200 mg once daily, which may be increased to 300 mg daily for patients with body weight 77 kg or higher and platelet counts of at least 150 gL, continuing until disease progression. This is combined with ongoing anti-PD-L1 antibody maintenance therapy following initial chemo-immunotherapy. The trial includes a screening phase for SLFN11 expression in tumor tissue and treatment continues as long as patients meet criteria and tolerate therapy. Participants will be closely monitored with tumor assessments following RECIST v1.1 criteria, tracking progression-free survival at 3 months as the primary outcome. Secondary outcomes include longer-term progression-free survival, overall survival, disease control rate, and adverse events according to CTCAE version 5.0. The total observation period extends approximately 25 to 30 months after the first patient enrollment. Safety and treatment adherence are also evaluated throughout this period.

Researchers are evaluating how pharmacist-guided pre-emptive pharmacogenetic testing can influence the selection and dosing of antidepressant medication for patients diagnosed with moderate to severe depression. The study compares this approach with standard antidepressant treatment where medication decisions are made without genetic testing support. This randomized clinical trial aims to assess the effectiveness and tolerability of antidepressants, with 95 patients planned for each treatment group, all hospitalized and closely monitored during their treatment period. The study involves three groups an intervention group receiving antidepressant therapy guided by pharmacogenetic testing and clinical pharmacist recommendations a standard care group where doctors choose antidepressants based on clinical judgment alone and an observational group for patients who do not require medication adjustments after the first hospitalization week. Pharmacogenetic testing includes genotyping and interpretation using the Stratipharm service to personalize antidepressant selection and dosing. Participants remain hospitalized for at least five weeks, allowing thorough monitoring of treatment response. During the study, participants undergo assessments including their response to antidepressant therapy at 28 days, time to response, remission rates, and changes in depression severity via the HAM-D17 scale. Additional measures include patient self-ratings of depression, side effect evaluations, and tracking of any adverse events related to medication. The study continues monitoring participants until they leave the clinic, with follow-up lasting up to three months to capture time until discharge and longer-term outcomes.

Researchers are evaluating zirconia dental implants as an alternative to traditional titanium implants, which dominate the market due to their long history, low cost, and proven designs. Zirconia implants offer potential benefits such as improved aesthetics, especially in front teeth, suitability for patients with titanium allergies, and appeal to those preferring metal-free dental care. This observational registry study aims to collect long-term clinical data on the performance of Z-Systems zirconia dental implants without selecting patients, reflecting routine clinical use. The study observes two types of zirconia dental implants Z5-BL and Z5-TL. Data are collected from patients who have received up to five implants from these product groups. This registry captures information during routine dental care, focusing on how these implants perform over time in everyday clinical practice. No experimental treatments or comparisons are made, as this is a post-market follow-up tracking the use of these devices. Participants will be monitored regularly after implant surgery, with check-ups at 3 months, 6 months, and then yearly up to 5 years after the final prosthesis is placed. Researchers will assess outcomes such as absence of pain, infection, and implant mobility 12 months after loading the prosthesis. They will also track device-related adverse events and patient satisfaction throughout follow-up visits to understand the implants safety and clinical performance over time.

Researchers are studying primary and acquired resistance mechanisms to standard treatments targeting BRAF V600E mutations in metastatic colorectal cancer. This observational study focuses on patients receiving combined therapy with BRAF inhibitor encorafenib, anti-EGFR antibody cetuximab, and chemotherapy. Resistance to this combination often develops, limiting treatment options, so the study aims to uncover genetic and non-genetic reasons behind this resistance to help develop better future therapies. Participants will receive standard-of-care treatment with encorafenib, cetuximab, and possibly chemotherapy. Before starting treatment and at the time of disease progression, researchers will collect tumor tissue, blood, and stool samples. These samples will be used to study molecular changes and the microbiome, and to create patient-derived organoids for laboratory testing. Blood samples will be collected regularly during treatment to analyze circulating tumor DNA over time. Throughout the study, participants will be followed longitudinally with sample collections before treatment and at progression, continuing for up to around 24 months. Researchers will measure molecular alterations linked to resistance, compare tissue and liquid biopsy findings, characterize gut microbiome changes, and track tumor DNA dynamics. The studys findings aim to improve understanding of resistance and support personalized treatment approaches for metastatic colorectal cancer.

Researchers are collecting detailed information about people with cerebral palsy CP in Switzerland through the Swiss-CP-Reg, a national patient registry started in 2017. This registry gathers data on diagnosis, symptoms, treatments, and follow-up care for children, adolescents, and adults with CP. The goal is to better understand CPs prevalence, risk factors, clinical profiles, and needs, ultimately aiming to improve treatment and quality of life. The registry involves multiple Swiss clinics and medical practices and invites all people diagnosed with CP who were born, treated, or live in Switzerland to participate. Data collected include medical records, questionnaires for patients and families, and links to routine statistics and medical registries. Follow-up data are gathered regularly at diagnosis, ages 5, 10, 15, and at the transition to adult care around age 18. The registry also supports clinical research and international collaboration to enhance knowledge exchange and therapeutic approaches. Participants provide informed consent and are followed over time with regular updates on their medical status, motor function, comorbidities, treatments, and quality of life. The registry collects comprehensive information such as birth history, diagnosis details, therapies, surgeries, and socio-economic factors. Data collection includes questionnaires on health, education, and social participation. The study continually analyzes and publishes findings to support better care for people with CP in Switzerland.

Gastroentero-pancreatic neuroendocrine tumours GEP-NETs are rare cancers arising from the neuroendocrine cells in the gastrointestinal tract and pancreas. These tumours share common clinical features but their cell biology and mechanisms are not well understood, limiting targeted treatments. The SwissNET registry is designed to collect detailed information to better understand GEP-NETs and improve management strategies in Switzerland. This study collects data prospectively from patients diagnosed with neuroendocrine tumours confirmed by tissue analysis, regardless of the tumours original location. Data entry is anonymized and gathered from hospitals and general practitioners across Switzerland. A study nurse visits contributing centers to review patient files, and a review board addresses conflicting information. The registry monitors treatment approaches including surgery, medical therapy, and peptide-receptor radionuclide therapy. Participants provide informed consent for their data to be included. Researchers regularly evaluate patient outcomes such as tumour-related mortality and hospitalisation rates every five years. The registry also tracks the incidence of GEP-NETs in Switzerland and the effects of different treatments over time. This ongoing data collection aims to improve understanding and guide future care for patients with neuroendocrine tumours.

Researchers are conducting a post-marketing surveillance study to evaluate the SMS femoral stem prosthesis used in patients with severely painful or disabling hip conditions such as osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head. The study focuses on observing the performance and safety of this device over a long period to understand its survivorship and patient outcomes. Participants receive the SMS femoral stem as part of their primary total hip replacement surgery. This is an observational study where the devices clinical and radiographic performance will be tracked at multiple intervals including 3, 5, 7, and 10 years. Additional evaluations include bone remodeling, stem migration, patient satisfaction, quality of life, and monitoring of adverse events up to 10 years after implantation. During the study, participants will undergo regular assessments such as radiographic imaging, clinical evaluations, and questionnaires about their satisfaction and quality of life from 6 months through 10 years. Researchers will closely monitor the devices survivorship, bone remodeling patterns, and any complications to gather long-term safety and effectiveness data. The total participation duration can extend up to 10 years, allowing comprehensive long-term follow-up.