Solothurn

Atrial fibrillation is the most common heart rhythm disorder globally, increasing 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 can restore normal heart rhythm in atrial fibrillation patients, but around 60% experience a short-term return of the condition, showing current treatments are not fully effective. Inflammation is thought to play a key role in starting and maintaining atrial fibrillation, so this study aims to explore if targeting inflammation can reduce its recurrence after electrocardioversion. This clinical trial tests whether taking low-dose Colchicine, an anti-inflammatory drug, once daily for 90 days can lower the chance of atrial fibrillation returning following electrocardioversion. Participants receive either Colchicine 0.5 mg orally or a matching placebo, both given in the same manner. The study is a Phase 3 trial called COLECTRO-AF, comparing these two groups to evaluate the effect of Colchicine treatment on post-procedure outcomes. Participants will be monitored for up to six months after electrocardioversion to see if atrial fibrillation comes back. The main outcome measured is the number of recurrences within this period. Patients undergo ECGs and other assessments to confirm heart rhythm status and monitor safety. The study requires informed consent and careful follow-up to track treatment effects and any side effects. The overall goal is to find better ways to prevent atrial fibrillation from returning after treatment.

Researchers are investigating the use of 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 aims to determine if elacestrant offers a benefit over current endocrine treatments in this group of patients without distant metastases. The study includes a lengthy ctDNA screening phase to identify eligible participants and monitor their disease status over time. The study begins with a ctDNA screening phase, where patients receive standard adjuvant endocrine therapy such as tamoxifen, letrozole, anastrozole, or exemestane, and have blood collected every six months for ctDNA testing until about 5.7 years after enrollment ends. Those who test positive for ctDNA and show no distant metastasis on imaging will be randomized within four weeks to continue their current endocrine therapy or switch to elacestrant taken orally at 400 mg daily. Treatment duration varies based on prior endocrine therapy exposure, ranging from two to seven years. After treatment, further care is at the physician's discretion. Participants will have frequent follow-up visits with ctDNA testing at weeks 4 and 16 post-randomization and every 16 weeks thereafter for up to three years. Imaging studies including mammograms, bone scans, and CT scans will be conducted regularly to monitor for distant metastases or new cancers. The main outcome measured is distant metastasis-free survival, assessed up to 6.25 years following the first patient enrollment. The study ends when all patients complete their visits or discontinue for reasons such as withdrawal, loss to follow-up, or death, and data is fully analyzed and finalized.

Researchers are evaluating whether core muscle exercises immediately after abdominal surgery affect the chance of developing incisional hernias, a common complication. The study also looks at how these exercises impact chronic postsurgical pain (CPSP) and muscle loss (sarcopenia). Although current practice limits physical activity after surgery to prevent hernias, there is no clear evidence supporting this approach, and reduced activity may lead to other problems like pain and muscle weakness. Participants are divided into two groups: one receiving standard care with physical restrictions, and the other performing four specific core muscle exercises targeting the abdominal muscles daily from the first day after surgery until two months post-surgery. The study includes patients undergoing elective or emergency abdominal surgery through laparoscopic or open methods, with midline or transverse incisions. During follow-up visits at two, twelve, and twenty-four months after surgery, doctors will perform clinical exams and ultrasounds to check for incisional hernias. They will also assess chronic postsurgical pain and its treatment and evaluate muscle mass using CT scans. The main outcome measured is the incidence of incisional hernia 24 months after surgery.

Researchers are evaluating the addition of niraparib, a drug taken orally once daily, to anti-PD-L1 antibody maintenance treatment in patients with extensive-disease small cell lung cancer (ED-SCLC) who have SLFN11-positive tumors. This phase II, international, multicenter, single-arm trial aims to assess the clinical effectiveness of this combined treatment approach in patients whose cancer has not progressed after receiving standard first-line chemo-immunotherapy. Patients must have confirmed SLFN11 expression and have completed prior platinum-etoposide chemotherapy with anti-PD-L1 antibody treatment without disease progression. The treatment involves administering niraparib at 200 mg orally once daily, with a possible increase to 300 mg daily for patients weighing at least 77 kg and with sufficient platelet counts. Niraparib is added to ongoing anti-PD-L1 antibody maintenance therapy. Treatment continues until disease progression is observed. The study does not mention separate treatment periods beyond this maintenance phase. Participants will be monitored through investigator assessments for progression-free survival over 3 months following enrollment, using RECIST v1.1 criteria to evaluate tumor response. Eligibility screening includes testing for SLFN11 expression on tumor tissue. Safety and efficacy will be closely observed throughout the trial, with attention to patients' blood counts, organ function, and performance status. The study includes careful monitoring of side effects and adherence to treatment protocols throughout the trial duration.

Researchers are evaluating how effective and tolerable antidepressant treatments are when guided by pharmacist-led genetic testing compared to standard care in adults with depression. The study focuses on patients diagnosed with moderate or severe unipolar depressive episodes or recurrent depressive disorder. The purpose is to see if using genetic information to select and dose antidepressants improves treatment response during hospitalization. Participants are randomly assigned to one of two groups after the first week of hospitalization if the treating physician decides a medication change is needed. In the intervention group, clinical pharmacists perform genetic testing using the Stratipharm® service and provide personalized medication recommendations to the psychiatrist. The standard group receives antidepressant treatment selected and dosed by the physician without genetic testing. All drugs used are approved in Switzerland for depression treatment. If no change in medication is needed after the first week, patients enter an observational arm and continue monitoring. Patients remain hospitalized for at least five weeks and are monitored until discharge. Researchers assess treatment response at 4 weeks by measuring improvement in depression symptoms. Throughout the study, patients' medication history, co-medications, and progress are tracked. The study plans to enroll 95 patients each in the intervention and standard groups, evaluating how genetic-guided therapy affects antidepressant response and tolerability.

Researchers are investigating the use of zirconia dental implants as an alternative to the commonly used commercially pure titanium implants for patients with missing teeth. Zirconia implants are of interest due to their biocompatibility, aesthetic advantages, and appeal to patients seeking metal-free or bio-holistic dental treatments. This study aims to capture long-term clinical data on zirconia implants in real-world dental practice without selecting patients based on specific criteria. The study observes patients receiving either Z5-BL or Z5-TL zirconia dental implants. Data is collected on the use of these devices during routine clinical care, focusing on their performance and safety. This registry design allows comprehensive monitoring of implant outcomes over time without assigning treatments. Participants will be followed for at least 12 months after the final prosthesis is placed. Researchers will assess the absence of ongoing subjective complaints, lack of peri-implant infections, and implant stability (absence of mobility) at this time point. This follow-up helps evaluate the long-term success and safety of zirconia dental implants in everyday clinical use.

Researchers are gathering comprehensive information on cerebral palsy (CP), a chronic disorder affecting movement and posture caused by early brain injury or malformation. This national Swiss registry collects data on diagnosis, symptoms, treatments, and follow-up of children, adolescents, and adults with CP. The goal is to better understand CP's prevalence, risk factors, clinical profiles, and patient needs to improve care and quality of life. The registry was launched in 2017 in major Swiss pediatric clinics and is expanding to include all Swiss clinics and adults in the future. The Swiss Cerebral Palsy Registry collects detailed medical data at diagnosis (ages 0 to 5 years) and during follow-ups at ages 5, 10, 15, and at transition to adult care around age 18. Data include birth history, neonatal care, CP classification, motor functions, comorbidities, neuroimaging, treatments, therapies, surgeries, and socio-economic factors. Questionnaires gather information on quality of life, participation, medical care, and family needs. The registry also links to routine statistics and medical registries for broader health insights. Participants and their families provide consent and receive information about the registry during clinical visits. The study tracks changes over time in motor skills, cognition, behavior, health status, and treatments. Data collection continues throughout childhood and into adulthood, supporting national and international research collaborations. The registry aims to enhance knowledge exchange between clinicians, researchers, therapists, and health authorities to optimize CP treatment and outcomes in Switzerland.

Gastroentero-pancreatic neuroendocrine tumors (GEP-NETs) are rare tumors that arise from the neuroendocrine system in the gastrointestinal tract and pancreas. This registry study aims to better understand these tumors by collecting detailed clinical information from patients diagnosed with GEP-NETs in Switzerland. Since limited knowledge exists about the biology and treatment of these tumors, the study focuses on gathering data to improve understanding and management strategies. Patients with a confirmed diagnosis of neuroendocrine tumors from any location who agree to participate will have their information entered prospectively into a secure, anonymized database. Data collection involves visits from study nurses to healthcare centers, where patient files are reviewed and information is recorded. There are no specific treatments assigned by this registry; instead, it tracks various treatment approaches used in Switzerland. Participants contribute data that includes tumor types, treatments received, and outcomes such as mortality and hospitalization rates. The study reviews and evaluates this information regularly to identify patterns and assess patient outcomes over time. The main outcome measured is tumor-related mortality every five years, helping to monitor long-term effects. This registry allows for improved knowledge sharing across hospitals and practitioners in Switzerland to enhance care for patients with neuroendocrine tumors.

This research evaluates the Medacta SMS femoral stem prosthesis in patients with severely painful or disabling hip joints caused by conditions such as osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head. The study focuses on monitoring the device after it has been marketed to understand its long-term performance. It includes adults aged 18 to 75 who are scheduled for primary total hip replacement surgery. Participants receive the SMS femoral stem device as part of their hip replacement procedure. The study is conducted across multiple centers and countries to observe the use of this specific femoral stem component. There are no additional drug treatments or comparison groups specified; the focus is on the prosthesis itself. During the study, participants will be followed for an extended period, with the primary measurement being the survivorship of the femoral stem over 10 years. Researchers will monitor the device's performance and collect data through follow-ups and reviews to assess long-term outcomes and safety. The study aims to gather detailed information on how well the implant functions over time in real-world clinical practice.