Neuchatel

This research aims to evaluate how the medicine nerandomilast affects lung fibrosis in adults with systemic autoimmune rheumatic diseases who have lung fibrosis. The study includes adults 18 years and older who have not shown improvement in lung function after standard immunosuppressant treatment. Participants have interstitial lung disease related to rheumatic diseases such as rheumatoid arthritis, systemic sclerosis, idiopathic inflammatory myopathy, Sjgrens disease, or mixed connective tissue disease. Participants are randomly divided into two groups one group receives nerandomilast tablets and the other receives placebo tablets that look identical but contain no medicine. Tablets are taken twice daily for at least 26 weeks and up to 1 year. Participants continue their usual immunosuppressant treatments during the study. Participants stay in the study for about 7.5 to 13 months and visit the study site 9 to 10 times. During visits, lung function tests and chest imaging are performed, and participants complete questionnaires about symptoms and quality of life. Researchers compare results between the groups to assess the effects of nerandomilast while monitoring health and any side effects throughout the study.

Researchers are evaluating an innovative walking exercise program called arm-in-arm gait training to help older adults at risk of falling improve their walking abilities. The trial focuses on healthy aging by testing whether walking while synchronizing steps with a younger partner can reduce fall risk, improve gait quality, balance, mood, and well-being. This is a randomized controlled trial comparing this approach to standard walking without step synchronization. Participants will be randomly assigned to one of two groups. One group will walk side-by-side without physical contact, choosing a comfortable pace, while the other group will walk arm-in-arm synchronizing their steps. Each training session lasts 30 minutes and is done three times a week for four weeks. Sessions may take place indoors to avoid bad weather. Gait quality assessments occur weekly during training and once more at week 7 after training ends. Participants will undergo evaluations including walking tests using sensors, functional assessments, and questionnaires measuring mood and physical activity. Falls will be tracked through online questionnaires every three months for 18 months after enrollment. The main outcome measured is walking speed at week 4, with additional measures of gait features, balance, mood, and fall frequency monitored throughout the study and follow-up period. The study also explores participant perceptions of the training.

Researchers are investigating whether tailored axillary surgery TAS combined with axillary radiotherapy ART is better than the current standard treatment, axillary lymph node dissection ALND, for patients with clinically node-positive breast cancer undergoing upfront surgery. The study aims to see if TAS plus ART improves arm-related quality of life and reduces the occurrence of lymphedema two years after treatment. This question arises because ALND, although standard, can cause significant side effects, and TAS selectively targets affected lymph nodes with potentially less harm. Participants will be randomly assigned to one of two groups one receiving ALND, which involves removing lymphatic tissue within the axilla, and the other receiving TAS with ART, where surgery removes sentinel and suspicious lymph nodes followed by targeted axillary radiotherapy. All participants will also receive breast or chest wall irradiation after breast-conserving surgery. The study compares these approaches to assess their impact on arm health and quality of life. During the trial, participants will be followed for at least two years to assess changes in arm-related quality of life and monitor for lymphedema. Researchers will collect quality of life questionnaires and clinical evaluations over this period. The study is sponsored by University Hospital Basel and aims to complete primary outcome assessments by the end of 2029, with overall study completion planned for 2037.

This research aims to explore whether profiling telomeres and other biological aging markers can reveal underlying causes of persistent infertility in women who have undergone treatment but remain unable to conceive. The study focuses on women aged 25 to 42 years with unexplained infertility despite proper management of known reproductive issues and repeated assisted reproductive technology ART attempts. It seeks to understand if these molecular aging indicators can define a biological aging pattern related to infertility and whether personalized integrative treatments can improve pregnancy outcomes. Participants receive baseline reproductive evaluations and blood tests to assess telomere length and aging hallmarks at the cellular level. The intervention includes a personalized integrative approach combining Traditional Chinese Medicine TCM herbal formulas and targeted nutritional supplements aimed at restoring cellular aging markers. This preconception phase lasts between 4 and 12 weeks, after which women attempt conception naturally or with ART such as intrauterine insemination IUI or in vitro fertilization IVF, while continuing integrative support. Throughout the study, participants undergo ongoing assessments of reproductive health, molecular aging markers, and pregnancy outcomes for up to 12 months. Researchers monitor changes in telomere length, the proportion of critically short telomeres, ovarian reserve markers, and overall safety and tolerability of the intervention. The main outcome is clinical pregnancy rate per conception attempt, with secondary measures evaluating molecular and reproductive changes related to the integrative therapy.

Researchers are investigating the best approach to treat low-risk patients with isolated subsegmental pulmonary embolism SSPE, a type of blood clot in small lung arteries. The study aims to determine whether monitoring patients without anticoagulation is as safe and effective as giving anticoagulant medication. This is important because many patients currently receive anticoagulants that carry a risk of bleeding, but it is unclear if all patients with isolated SSPE need this treatment. Patients in the trial are randomly assigned to one of two groups. One group receives the anticoagulant drug rivaroxaban, starting with 15 mg twice daily for 21 days, then 20 mg once daily for a total of 90 days. The other group receives a placebo matching the same schedule. The trial compares clinical surveillance without anticoagulation to anticoagulation treatment to assess safety and effectiveness. Participants will be followed for 90 days after randomization to monitor for recurrent venous thromboembolism, significant bleeding events, and overall survival. Researchers will track these outcomes through clinical assessments and safety monitoring. This study is designed to evaluate if careful monitoring alone is a safe alternative to anticoagulation in selected patients with isolated SSPE, potentially reducing bleeding risks from treatment.

This research aims to determine whether performing an extended pelvic lymph node dissection ePLND during radical prostatectomy benefits men with high-risk prostate cancer. The study investigates if ePLND improves cancer staging and removes undetectable cancer cells that standard imaging techniques like PSMA-PET might miss, potentially leading to better treatment outcomes. The trial is a multicenter, randomized phase III study sponsored by University Hospital, Basel, Switzerland. Participants will be randomly assigned to one of two groups radical prostatectomy with extended pelvic lymph node dissection or radical prostatectomy without the extended lymph node dissection. Extended PLND involves removing more lymph nodes than the standard procedure, aiming for better detection of cancer spread. The study compares outcomes between these two approaches, while considering surgery time and complication risks, which may be slightly higher with ePLND. During the study, participants will be monitored over a long-term period of up to 10 to 15 years. Researchers will measure prostate-specific antigen PSA persistence about 3 months after surgery and track biochemical recurrence-free survival within 24 months. Secondary measures include time to recurrence, metastasis, survival rates, complications, adverse events related to ePLND, and patient-reported outcomes. This comprehensive follow-up includes assessments during surgery, postoperatively, and over many years to evaluate the overall impact of the surgical approaches.

Critically ill patients in the Intensive Care Unit ICU often face acute pain, anxiety, and long-term challenges including post-intensive care syndrome PICS, which affects mental, physical, and cognitive health for up to a year after discharge. This trial is evaluating whether hypnosis sessions at ICU discharge and on days 7 and 14 after discharge can improve patient well-being at 28 days and reduce symptoms of PICS at three months. The study compares patients receiving standard post-discharge care with those receiving the same care plus hypnosis sessions. Participants in the hypnosis group will receive three hypnosis sessions one on the day of ICU discharge, a second seven days after discharge, and a third on day 14 if they remain hospitalized. These sessions are conducted by trained professionals using a standardized protocol focused on relaxation, reconnecting with the body, and creating a sense of safety and well-being. The control group will receive standard post-discharge care including mobilization, nutrition, pain control, and family support without hypnosis. During the study, researchers will assess well-being at 28 days using scales like ESAS and EQ-5D-5L. Secondary measures include anxiety, depression, PTSD, quality of life, and patient impressions of change at three months. Immediate well-being after hypnosis sessions will also be evaluated. The trial involves randomized assignment and single masking, with assessments at ICU discharge, day 7, day 14, day 28, and three months, to monitor the effects and safety of the hypnosis intervention.

Researchers are investigating the impact of the Culture Care program on the mobility of patients after thoracic or abdominal surgery. Sedentary behavior after surgery can negatively affect recovery and increase hospital stays and complications. This study aims to compare patient mobility before and after implementing the Culture Care program, which offers an innovative hospital environment enriched with art and culture to encourage early mobilization. The Culture Care program modernizes the hospital environment by adding interactive art displays, musical content, and audio podcasts accessible via bone-conduction headphones. Patients hospitalized after surgery will either experience the standard hospital environment or the enhanced Culture Care environment, while both groups receive standard care including early mobilization prescribed by physicians. Healthcare workers readiness to encourage patient mobility will also be assessed before and after the program implementation. Participants will wear an accelerometer for the first five postoperative days to track movement and complete questionnaires on psychological well-being, physical recovery, and mobility perception. Healthcare workers will complete surveys on their readiness to stimulate mobility. The study will measure daily time spent out of bed, steps taken, physical activity levels, recovery quality, psychological well-being, complications, and length of hospital stay, with additional qualitative interviews to gather experiences during the Culture Care program.

Researchers are evaluating the safety and functional outcomes of intravenous thrombolysis IVT in adult patients who have recently taken direct oral anticoagulants DOACs and experienced an acute ischemic stroke. This international, prospective observational registry aims to understand whether IVT can be safely administered to these patients and if it improves recovery. The study involves collecting data from about 2800 participants across multiple stroke centers and comparing three groups based on recent DOAC intake and IVT treatment status. Participants are divided into three groups those who have taken DOACs recently and receive IVT, those who have taken DOACs recently but do not receive IVT, and patients without recent DOAC intake who receive IVT. The study collects detailed information about the timing, dose, and type of IVT drugs used Tenecteplase and Alteplase, as well as any complications that occur. The follow-up period lasts 90 days after the stroke event. During the study, researchers will monitor participants for symptomatic intracerebral hemorrhage within 36 hours after IVT and assess functional outcomes at 90 days using the modified Rankin Scale. Secondary evaluations include stroke severity, stroke volume, mortality, major bleeding, and other adverse events within specified timeframes. Data collection involves clinical assessments and imaging to understand stroke progression and treatment effects. Participants are observed for an average of two years for related study outcomes.

Researchers are evaluating a personalized approach to reduce the size of the elective clinical target volume CTV in radiotherapy for patients with oropharyngeal squamous cell carcinoma SCC of all stages. This study aims to reduce treatment-related toxicity by tailoring radiation volumes based on individual risk factors and disease progression, using a model-based de-escalation strategy. The goal is to assess the feasibility and safety of this approach by monitoring out-of-field nodal recurrences. The treatment involves a personalized reduction of the elective nodal irradiation volume guided by a statistical model of lymphatic tumor progression developed from a large dataset of patients. This model estimates the probability of occult lymph node metastases based on clinical information such as tumor stage and lymph node involvement. The reduced radiation volumes are carefully reviewed by investigators to ensure consistency with clinical judgment and data. The study focuses on primary radiotherapy or chemoradiotherapy with elective lymph node irradiation. Participants will be monitored for up to two years after completing radiotherapy to track nodal recurrence outside the treated areas. Assessments include imaging scans like FDG-PET or MRI before treatment, physical exams, and evaluations of treatment toxicity and quality of life at various time points up to 24 months post-treatment. The study measures both early and late toxicities, loco-regional control, progression-free survival, overall survival, and quality of life related to head and neck symptoms to determine the safety and impact of this personalized radiation approach.