Neuchatel

This trial studies adults aged 18 years and older with lung fibrosis caused by systemic autoimmune rheumatic diseases who have not shown lung function improvement after standard immunosuppressant treatment. It evaluates how the medicine nerandomilast affects lung disease associated with these conditions. The study is a phase 3, double-blind, randomized, placebo-controlled trial designed to test nerandomilast's safety and efficacy over at least 26 weeks. Participants are randomly assigned to receive either nerandomilast tablets or placebo tablets twice daily for a period of at least 26 weeks and up to 1 year. Alongside this, participants continue their ongoing immunosuppressant treatments for their rheumatic disease. The study involves two groups receiving either the active drug or placebo to compare outcomes between them. During the 7.5 to 13 months of participation, individuals visit the study site about 9 to 10 times for lung function tests, chest imaging at select visits, and to complete questionnaires about symptoms and quality of life. Researchers monitor changes in lung disease using high-resolution CT scans and assess safety by recording any side effects. The main outcome is the change in lung fibrosis score after 26 weeks of treatment.

Researchers are evaluating an arm-in-arm walking program designed for older adults at risk of falling. This randomized controlled trial aims to assess whether walking in sync with a younger partner improves gait quality, reduces fall risk, and enhances mood and well-being compared to normal walking without synchronization. The study focuses on healthy aging and the role of physical activity in preventing falls among seniors. The intervention consists of four weeks of 30-minute arm-in-arm synchronized gait training, done three times a week. Participants are randomly assigned to either the arm-in-arm synchronized walking group or a control group walking side-by-side without physical contact or step synchronization. The younger partners are aged between 18 and 40 years and walk alongside the older participants. This approach uses rhythmic external cues through physical synchronization to potentially improve walking safety and enjoyment. Participants will be monitored through six gait assessments using sensors on the lower back and foot at baseline, weekly during training, and at a follow-up three weeks after the intervention ends. Functional tests and questionnaires will evaluate physical abilities and mood. Falls will be tracked via an online questionnaire every three months for 18 months post-inclusion. The main outcome measured is walking speed after 4 weeks of training, with additional evaluations of gait quality, balance, fall risk, physical activity level, and participant perceptions of the intervention.

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 whether profiling telomeres and other biological aging markers can uncover hidden causes of persistent infertility in women who remain infertile despite treatment and assisted reproductive technologies (ART). The focus is on women aged 25 to 42 years with post-treatment unexplained infertility, aiming to see if a personalized treatment guided by these aging biomarkers can improve the chances of pregnancy. The study addresses a gap in current infertility diagnostics by exploring molecular signs of reproductive aging that are not detected through standard hormonal or structural assessments. Participants receive a baseline evaluation including blood tests to analyze telomere length and distribution, revealing cellular aging patterns. They then undergo a 4 to 12-week tailored integrative treatment combining Traditional Chinese Medicine herbal formulas and targeted nutritional supplements designed to restore telomere health, support mitochondrial function, and reduce cellular aging effects. After this preconception phase, participants try to conceive naturally or with standard ART methods like intrauterine insemination or in vitro fertilization, continuing integrative therapy to maintain cellular health. Throughout the study, researchers monitor reproductive outcomes including clinical pregnancy rates over up to 12 months from the start of conception attempts. They also assess changes in biological aging markers, ovarian reserve, menstrual characteristics, and treatment safety. The goal is to correlate improvements in molecular signs of aging with better fertility results, providing new insights into treating women with unexplained infertility that has not responded to previous therapies.

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.

Prostate cancer is a common cancer in men and a leading cause of cancer deaths in Europe. For men with localized prostate cancer who have a life expectancy over 10 years, radical prostatectomy is the standard treatment to improve survival. This research evaluates whether removing more lymph nodes in the pelvis, called extended pelvic lymph node dissection (ePLND), during surgery offers additional benefit by better staging the cancer and possibly removing hidden cancer cells, compared to not removing these lymph nodes. The study focuses on men with high-risk prostate cancer and negative PSMA-PET scans for metastasis. The study compares two groups of men undergoing radical prostatectomy: one group will receive extended pelvic lymph node dissection along with surgery, and the other group will have surgery without lymph node removal. Extended lymph node removal involves taking out more nodes to improve detection of cancer spread, but it may increase surgery time and complications slightly. The study is a multicenter, randomized Phase III trial. Participants will be monitored through prostate-specific antigen (PSA) tests three months after surgery to check for cancer persistence and followed for up to 24 months to observe biochemical recurrence-free survival. Researchers will assess cancer staging, treatment outcomes, and safety. The study includes regular evaluations and close follow-up to understand if extended lymph node removal improves long-term outcomes for men with high-risk prostate cancer.

Critically ill patients who have been in the Intensive Care Unit (ICU) often face serious challenges including pain, anxiety, and a decreased quality of life after discharge. Up to 40% of these patients develop post-intensive care syndrome (PICS), which can cause ongoing mental, physical, and cognitive problems for up to a year. Current standard care focuses on pain management, mobilization, nutrition, and family support, but there are no specific treatments proven to improve long-term well-being or prevent PICS. This research aims to evaluate whether hypnosis sessions can improve well-being at 28 days after ICU discharge and reduce PICS symptoms at three months. Participants will receive hypnosis sessions tailored to their needs, including relaxation, reassociation techniques, and creating a safe mental space. The sessions are given at ICU discharge, then again seven days later, and a third session at day 14 if the patient is still hospitalized. These hypnosis interventions will be compared to standard care alone to assess their effect on patient well-being. The study does not specify a control group receiving a placebo but compares hypnosis plus standard care to standard care only. During the study, researchers will measure well-being at 28 days after ICU discharge using scales like ESAS and EQ-5D-5L. Secondary outcomes at three months include anxiety, depression, post-traumatic stress disorder, quality of life, and patient impression of change using validated questionnaires. The study includes assessments before and after hypnosis sessions to evaluate immediate effects. Participants are monitored closely to ensure safety and track changes in mental and physical health over time.

Sedentary behavior after surgery can slow down recovery and increase complications, hospital stay length, and healthcare costs. This research explores the impact of the Culture Care program, an innovative hospital experience including art and culture, on patient mobility after thoracic or abdominal surgery. The study compares mobility between patients before and after implementing this program to see if it encourages more movement during recovery. The Culture Care program transforms the hospital environment by displaying interactive art posters along hallways, accessible through QR codes linked to music and audio podcasts via bone-conduction headphones. This program is offered to patients, their families, caregivers, and healthcare workers, aiming to create a stimulating atmosphere that may reduce sedentary behavior during hospitalization. Participants will wear accelerometers for the first five days after surgery to track movement and complete questionnaires about their well-being, recovery, and mobility perception. Healthcare workers will also complete surveys about their readiness to encourage patient mobility. The study includes interviews with patients and staff to understand their experiences. Primary outcomes measured are daily time spent out of bed and daily step counts from postoperative day 1 to day 3.

Researchers are evaluating the safety and effectiveness of intravenous thrombolysis (IVT) in adults who have suffered an acute ischemic stroke and have recently taken direct oral anticoagulants (DOACs). This international, prospective observational registry, called DO-IT, aims to understand whether IVT improves functional outcomes without increasing the risk of symptomatic intracerebral hemorrhage (sICH) in this patient group. The study will collect data from 2800 participants at several high-volume stroke centers worldwide and follow them for 90 days after their stroke event. Participants are divided into three groups: those who received IVT after recent DOAC intake (DOAC+IVT), those with recent DOAC intake who did not receive IVT (DOAC), and anonymized patients without DOAC use who received IVT. The study tracks detailed information on the timing, dose, and type of IVT given, including drugs like Tenecteplase and Alteplase, as well as any complications that occur during treatment. During the study, patients are monitored closely with functional outcome assessments up to 90 days after the stroke. The primary outcomes include the number of participants experiencing symptomatic intracerebral hemorrhage within 36 hours after IVT and the proportion achieving a good functional outcome (measured by the modified Rankin Scale 0-2) at 90 days or return to baseline. This comprehensive follow-up helps researchers determine the safety and potential benefits of IVT in stroke patients with recent DOAC use.

Researchers are evaluating the impact of a brief Consultation-Liaison (CL) psychiatry intervention in primary care settings in French-speaking Switzerland. This study focuses on patients who present with mental health problems such as psychiatric symptoms, psychosomatic disorders, depression, and anxiety. The trial aims to assess whether integrating CL-psychiatric care into primary care improves mental health symptoms, quality of life, and the doctor-patient relationship, compared to usual treatment practices. This pilot study will determine the feasibility of a larger, mixed-method randomized controlled trial. The intervention involves a brief CL psychiatric consultation delivered over about two months in three phases: a referral from the patient's primary care physician (PCP) to a CL psychiatrist, 1 to 4 psychiatric sessions conducted at the PCP's practice, and a joint feedback session with the PCP, patient, and psychiatrist. The control group receives treatment as usual (TAU) from their PCP, which may include supportive care, referrals, medications, or other standard therapies. The study is conducted in three private primary care group practices across two regions. Participants will complete baseline questionnaires and follow-up assessments at 3, 6, and 12 months to evaluate psychiatric symptoms, quality of life, and healthcare complexity. A subset of patients, PCPs, and psychiatrists will also participate in interviews to explore their experiences and the collaboration process. The study measures outcomes using standardized tools and monitors progress and safety over a one-year follow-up period, with a total expected participation of 30 individuals in this pilot phase.