Frauenfeld

Researchers are evaluating the safety, performance, and clinical benefits of the Affixus Natural Nail System Humeral Nail and its surgical instrumentation in patients with proximal humeral fractures or humeral shaft fractures requiring surgery. This observational, prospective study with optional retrospective enrollment aims to analyze adverse events, fracture healing, and functional outcomes. The primary goal is to confirm bone union within 12 months after surgery, while secondary goals include assessing functional outcomes, quality of life, radiographic results, and adverse events including any re-operations. Participants will be treated with the Affixus Natural Nail System Humeral Nail designed for intramedullary fixation of humeral fractures. The study will track patients who have already received or are scheduled to receive this implant. Treatment involves surgical intervention using the implant system and its instrumentation. Patients will be followed according to the study protocol to monitor healing and recovery outcomes. During the study, participants will undergo assessments including monitoring for adverse events, evaluation of fracture or osteotomy healing, and functional outcome measurements such as range of motion and standardized questionnaires. Quality of life will also be assessed using the EQ-5D-5L questionnaire. Follow-up will continue up to at least 12 months post-surgery to capture bone union and other clinical endpoints. Safety data will be collected throughout the study to evaluate any complications or re-operations.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are evaluating treatments for patients with clinically node positive breast cancer who undergo upfront surgery. The study aims to compare tailored axillary surgery (TAS) combined with axillary radiotherapy (ART) against the standard axillary lymph node dissection (ALND) to see which approach results in better arm-related quality of life and fewer cases of lymphedema two years after treatment. This trial addresses the concern that ALND, while standard, can cause significant harm and morbidity, and seeks to determine if TAS plus ART can reduce this burden. Participants are randomly assigned to receive either ALND, which involves surgical removal of lymphatic tissue in the armpit area, or the combination of TAS and ART. TAS targets positive lymph nodes more selectively than ALND and removes fewer nodes, while ART involves radiation treatment to the axillary region. The trial is conducted in the upfront surgery setting, with prior clipping of the most suspicious axillary lymph node to aid in treatment precision. During the study, participants will complete quality of life questionnaires and be closely monitored for the development of lymphedema over two years following randomization. The main outcomes measured are changes in arm-related quality of life and the occurrence of lymphedema. Safety and treatment effects will be tracked through regular follow-up visits, with the overall goal of improving patient well-being and reducing treatment-related side effects.

This research investigates the best approach for treating low-risk patients with isolated subsegmental pulmonary embolism (SSPE), a condition where small blood clots block tiny arteries in the lungs. The study aims to clarify whether SSPE truly requires anticoagulant treatment or if careful monitoring without medication is a safe option. Currently, many patients receive anticoagulants, which can increase bleeding risk, but some evidence suggests that avoiding these drugs might be safe in selected patients without other complications. Participants are randomly assigned to receive either the anticoagulant drug rivaroxaban or a placebo, allowing comparison between clinical surveillance without anticoagulation and standard anticoagulation treatment. This phase 4, multicenter trial evaluates outcomes over a 90-day period following randomization. During the study, researchers monitor participants for recurrent venous thromboembolism and assess safety outcomes related to bleeding. Participants provide informed consent and are followed closely to observe any clots returning or adverse events. The total follow-up is at least 90 days to determine the efficacy and safety of withholding anticoagulation in this specific patient group.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

Researchers are evaluating the effectiveness of first-line treatments for women with HER2-expressing, mismatch repair proficient (pMMR), primary advanced or recurrent endometrial cancer. This Phase III study compares two experimental combinations—trastuzumab deruxtecan (T-DXd) plus rilvegostomig and T-DXd plus pembrolizumab—against standard chemotherapy with carboplatin, paclitaxel, and pembrolizumab. The main goal is to measure progression-free survival, which is the length of time participants live without their cancer worsening, assessed up to about 45 months. Participants will be randomly assigned to one of three groups: Arm A receives trastuzumab deruxtecan combined with rilvegostomig, Arm B receives trastuzumab deruxtecan combined with pembrolizumab, and Arm C receives the standard chemotherapy combination with pembrolizumab. All treatments are given by intravenous infusion. The study is open-label and sponsor-blinded, meaning that participants and investigators know the treatments but the sponsor’s assessment is blinded. Throughout the study, participants will undergo regular assessments including tumor evaluations to monitor cancer progression. Researchers will track progression-free survival as the primary outcome measure. Safety and organ function will be monitored with tests such as left ventricular ejection fraction measurements and blood tests. The total study duration includes treatment and follow-up until progression or death, with evaluations conducted for up to approximately 45 months.

Researchers are evaluating the PTSD-iMPACT questionnaire, a new tool designed to measure the impact of post-traumatic stress disorder (PTSD) related functional impairment in children and adolescents aged 3 to 18 years. This study aims to validate the questionnaire's reliability and validity in both clinical and non-clinical populations in Switzerland and Germany. The need for this tool arises because PTSD and its symptoms often disrupt key areas of young people's lives, such as social interactions, schooling, and daily activities, but no widely accepted instrument currently exists to specifically assess these impairments. The study involves three versions of the PTSD-iMPACT questionnaire: self-report for children and adolescents aged 7 to 18, and caregiver-report for children aged 3 to 6 and 7 to 18. Participants complete the questionnaires either digitally or on paper, with some receiving assistance via phone or video calls for younger children. Data collection occurs in clinical settings, such as hospitals and mental health centers, and non-clinical settings like schools and kindergartens. Participants in clinical groups complete the questionnaire twice, two weeks apart, to assess test-retest reliability, while non-clinical participants complete it once. After data analysis, the final questionnaire and a user manual will be made freely available to support routine care. Participants and caregivers provide information through surveys covering PTSD symptoms, emotional and behavioral problems, quality of life, and functional impairment. The study tracks psychometric properties including internal consistency, validity, and factor structure of the questionnaire. Safety monitoring includes offering contact information for mental health support and ensuring voluntary participation with confidentiality. The total time commitment for clinical participants is about 40 minutes for the first assessment and 15 minutes for the follow-up. The study's design and procedures aim to produce a reliable, clinically useful tool to improve care for trauma-exposed children and adolescents.

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.

Urethral pain syndrome (UPS) causes persistent or recurring urethral or pelvic pain without clear infection or other obvious causes. This study aims to evaluate the effect of intraurethral and vaginal laser therapy on UPS symptoms in women, testing the hypothesis that laser treatment can significantly reduce urethral pressure pain. UPS is difficult to treat due to unclear causes, making new treatment options important for those affected. Participants will receive laser therapy using the FotonaSmooth Erbium:YAG device applied inside the urethra and vagina. This pilot study explores the safety and effectiveness of this laser treatment specifically for UPS. Laser treatments have shown benefits for other related conditions like stress urinary incontinence and genitourinary syndrome of menopause, but this is the first study to evaluate intraurethral and vaginal laser use for UPS. Women enrolled will be monitored over five months, with researchers assessing reductions in urethral pain symptoms. Evaluations include measuring urethral pressure pain upon palpation and tracking symptom improvement. Safety and tolerability will also be observed, with participants completing questionnaires and follow-up visits during the study period to record outcomes and monitor progress.

Researchers are evaluating the use of vacuum-assisted biopsy (VAB) as a less invasive method to detect residual tumor tissue in breast cancer patients who have undergone neoadjuvant chemotherapy (NAC). NAC is commonly used to shrink tumors before surgery and can lead to complete pathologic remission in over half of aggressive breast cancer types. However, current imaging methods like ultrasound, mammography, and MRI are not reliable enough to confirm if the tumor has been fully eliminated, so surgery remains necessary to assess or remove any remaining disease. In this trial, patients who show a radiological complete or near-complete response after NAC will undergo VAB guided by ultrasound or mammography immediately before their scheduled breast surgery. This biopsy procedure aims to collect tissue samples from the former tumor site to better detect any residual cancer cells. The accuracy of this biopsy will then be compared to the standard surgical tissue analysis to evaluate if VAB can serve as a reliable pre- or intra-operative tool. Participants will be involved in diagnostic imaging and biopsy procedures shortly before their routine breast surgery. Researchers will assess the sensitivity of the VAB in detecting residual tumor tissue within six weeks after patient registration. The study includes monitoring of biopsy results against surgical pathology findings to determine VAB's diagnostic value. Participants must meet specific eligibility criteria and will be followed closely during the trial to ensure safety and accurate data collection.