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Researchers are monitoring the use of the Virtue4 Male Sling System in men with stress urinary incontinence following prostate surgery. This observational study aims to collect medical data on the devices effectiveness and safety over 12 and 36 months after implantation. The study is conducted in multiple centers across Europe and focuses on real-world use by experienced urologists. The Virtue4 Male Sling is an implantable device made of polypropylene mesh designed to support the urethra and help manage urinary incontinence caused by intrinsic sphincter deficiency. This study involves men who have already received the sling during routine clinical care. Follow-up includes visits at baseline before implantation, between 1 and 3 months post-operation, and at 12 months, with additional annual questionnaires sent out at 24 and 36 months. Participants will undergo routine clinical assessments, including questionnaires about their urinary symptoms and quality of life, pad weight testing, uroflowmetry, and measurement of urine remaining after voiding at several points during the study. Researchers will monitor patient-reported improvement and any adverse events at 12 months. The study extends to 36 months with ongoing questionnaires to track long-term outcomes and satisfaction. Participation involves regular clinical visits and mailed surveys over three years.

Researchers are conducting a Phase III international trial to study the effects and safety of androgen deprivation therapy ADT with or without darolutamide in men newly diagnosed with metastatic prostate cancer who have vulnerable functional abilities. This study specifically includes patients who have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The goal is to evaluate how these treatments impact disease progression and patient health over time. Participants will be randomly assigned to one of two groups one receiving ADT plus darolutamide 600 mg taken orally twice daily, and the other receiving ADT plus a placebo taken with the same schedule. Treatment will continue until imaging shows disease progression or until the patient or doctor decides to stop for reasons such as side effects or other health issues. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, further treatments, and any ongoing or new side effects. During the study, participants will undergo regular assessments including imaging scans to check for cancer progression, blood tests, evaluations of urinary symptoms, and quality of life questionnaires. Researchers will track outcomes like progression-free survival, overall survival, symptom changes, and adverse events. Monitoring visits will occur periodically both during treatment and follow-up to gather comprehensive data on health status and treatment effects.

Chemotherapy-induced peripheral neuropathy CIPN is a common side effect experienced by cancer patients after chemotherapy, causing symptoms such as numbness, pain, and sensory changes typically in the hands and feet. Neuropathic pain is a major feature of CIPN and can significantly reduce quality of life by contributing to psychological distress, risk of falls, cognitive difficulties, and sleep problems. There are currently no proven preventive treatments for CIPN, and drug options for neuropathic pain relief remain limited. This trial aims to evaluate the effectiveness, feasibility, and safety of laser photobiomodulation PBM as a treatment for neuropathic pain in CIPN patients. Participants will receive photobiomodulation therapy using an ATP38 device that delivers laser light at specific wavelengths to the hands andor feet. The treatment consists of two sessions per week for four weeks, totaling eight sessions. Each session lasts 13 minutes, with laser light applied in a counterbalanced order between feet and hands. Certified clinicians will administer the therapy while patients are seated and wear protective glasses. A control group will receive sham therapy mimicking the procedure without active laser light, with an option to receive real treatment after the study. During the study, participants will be assessed for neuropathic pain and other related symptoms at baseline, throughout treatment, and up to 12 weeks after treatment completion, with additional follow-up up to 6 months. Evaluations include pain intensity, quality of life, sleep disorders, neurocognitive function, and emotional distress. Researchers will also monitor treatment adherence and safety. The total duration of participation spans from the start of treatment through extended follow-up visits to track pain evolution and potential benefits of photobiomodulation therapy.

Researchers are evaluating the medical benefit of spa therapy on skin and soft tissue fibrosis that occurs as a late reaction at least 6 months after radiotherapy for breast cancer or Upper Aerodigestive Tract UADT cancer. This randomized, controlled, multicenter trial aims to assess improvements in quality of life related to dermatological sequelae of fibrosis. The study focuses on patients with severe late reactions and compares immediate versus delayed spa treatment. The intervention being studied is a dermatologically oriented thermal cure that includes sedative and muscle-relaxing baths, decongestant sprays, and high-pressure thread-like showers using thermal water. Educational workshops on relaxation, sophrology, and hygiene are also part of the therapy. Participants are randomly assigned to receive spa treatment either immediately within 6 weeks of inclusion or after a 6-month delay, allowing comparison of outcomes between early and late treatment groups. Participants will be involved for at least 6 months, during which they will self-assess their dermatological quality of life using the DLQI score and undergo evaluations of generic and cancer-specific quality of life. Additional assessments include self-reported sequelae, radiological examinations of lesions, thickness, and volume, as well as monitoring of treatment and medical consultations. Adverse events and long-term quality of life benefits up to 12 months will be recorded to understand the therapys impact and safety.

This research aims to observe how the Maestro Platform is used in real-world laparoscopic surgeries. The study focuses on monitoring the safety and performance of this surgical assistance device, evaluating its impact during procedures. The research is sponsored by Moon Surgical and includes adult patients undergoing laparoscopic surgery. Participants will have laparoscopic surgeries performed using the Maestro Platform, which assists by positioning and holding the surgical scope and retractor as guided by the surgeon. Standard surgical techniques and equipment are used alongside the device. Surgeons can switch back to manual minimally invasive surgery or convert to open surgery if needed during the procedure. During the study, researchers will track adverse events related to the device or procedure, procedure completion without device failure, and various procedure details such as duration, recovery time, and surgeon satisfaction. Measurements include monitoring complications, pain after surgery, device preparation time, and human resource use. Participants are followed for 30 days to assess safety and recovery outcomes.

Researchers are evaluating the effectiveness of maintenance treatments using niraparib alone versus niraparib combined with bevacizumab in women newly diagnosed with advanced stage IIIA, IIIB, or IIIC high-grade epithelial ovarian cancer who have no visible disease remaining after initial surgery and chemotherapy. This phase II, randomized, open-label multicenter trial aims to compare these approaches following frontline surgery and adjuvant platinum-based chemotherapy with or without bevacizumab. Patients are stratified by BRCA status, cancer stage, and prior hyperthermic intraperitoneal chemotherapy. The study treatments include two groups one receiving carboplatin and paclitaxel chemotherapy over five cycles followed by daily oral niraparib for two years, and the other receiving the same chemotherapy plus bevacizumab for five cycles, then maintenance with both bevacizumab every three weeks for 15 months and daily niraparib for two years. Bevacizumab is administered intravenously starting with the second chemotherapy cycle. The trial investigates the impact of these regimens on progression-free survival and other long-term outcomes. Participants will undergo regular assessments including imaging scans between surgery and chemotherapy to confirm no disease, laboratory tests to monitor organ and bone marrow function, and physical exams during treatment. Researchers will track progression-free survival up to 24 months and other outcomes such as time to subsequent treatments, long-term overall survival, and treatment safety over up to five years. The study involves a total participation period that includes treatment and follow-up evaluations.

Squamous cell carcinoma of the anus is a rare but increasingly common cancer, often linked to human papillomavirus HPV. For early-stage tumors, combined radiotherapy and chemotherapy with 5FU and mitomycin-C provide good outcomes, but advanced tumors have a poor prognosis with a high relapse rate. Researchers are studying a new approach combining induction chemotherapy with docetaxel, cisplatin, and 5FU mDCF followed by standard chemoradiotherapy to improve treatment results for locally advanced anal cancer T3-4 or N1. This is a randomized phase 3 trial comparing this new strategy to the current standard treatment. The study includes two groups one receives the usual chemoradiotherapy, which involves 33 radiotherapy sessions over 6.5 weeks combined with mitomycin-C and capecitabine chemotherapy taken on radiotherapy days. The other group starts with 4 cycles of mDCF chemotherapy given every two weeks before receiving the same chemoradiotherapy as the control group. Radiotherapy uses intensity-modulated external irradiation with a targeted boost to the tumor and involved lymph nodes. Participants will be followed after treatment with check-ups at 8 weeks, then every 4 months for two years, and every 6 months in the third year. Follow-up includes clinical exams and imaging scans CT and MRI. The main measure of success is disease-related event-free survival two years after treatment. Other outcomes include overall survival, colostomy-free survival, treatment side effects, tumor response, and quality of life. The total study duration for each participant may extend over several years including this follow-up period.

Researchers are investigating treatments for castration-resistant prostate cancer CRPC that has spread to a limited number of sites, called oligometastatic CRPC. This trial compares the effectiveness of combining stereotactic body radiation therapy SBRT with the hormone therapy drug darolutamide against darolutamide alone. The study aims to see if this combination can better control cancer growth in men whose cancer continues despite hormone therapy and is detected using advanced PET scans. Participants will be randomly assigned to one of two groups one receiving darolutamide plus SBRT, and the other receiving darolutamide alone. Both groups will continue with androgen deprivation therapy ADT throughout the study. Darolutamide is taken orally twice daily for up to five years, while SBRT is given as a precise radiation treatment over one week. The study is international, open-label, and will last up to 60 months, including treatment and follow-up. During the trial, participants will have regular hospital visits for medical exams and tests to monitor their health and treatment effects. These include tumor assessments, blood tests, and questionnaires about pain and quality of life. The main outcome measured is radiographic progression-free survival, tracking the time until cancer progression or death. Secondary measures include overall survival, treatment safety, biochemical response, and quality of life assessments over the five-year period.

Researchers are studying the effects of acetylsalicylic acid and atorvastatin on overall survival in patients with castrate-resistant prostate cancer CRPC who are starting first-line treatment. This international, open, phase III trial uses a 2x2 factorial randomized design to evaluate these drugs in addition to the standard care for CRPC. The study aims to understand whether adding these medications can improve survival outcomes for this patient group. Participants are randomly assigned to one of four groups standard of care alone, standard of care plus acetylsalicylic acid 100 mg daily, standard of care plus atorvastatin 80 mg daily, or standard of care plus both acetylsalicylic acid and atorvastatin. These treatments are taken daily alongside the usual care for their cancer. The trial monitors patients over up to 15 years to assess the long-term impact on survival. During the study, participants will be regularly evaluated for overall survival, which is calculated from the date of randomization until death. Researchers will also monitor patients for safety and adherence to the treatments. The trial includes detailed eligibility screening, performance status assessments, and laboratory tests to ensure patients meet the criteria to participate safely. The long follow-up period allows for comprehensive observation of treatment effects and patient outcomes.

Researchers are evaluating a new chemotherapy dosing approach in women with poor prognostic ovarian cancers who have unfavorable primary chemosensitivity and incomplete debulking surgery. This phase III trial compares a salvage weekly dose-dense chemotherapy regimen to continuing the standard chemotherapy regimen, aiming to confirm if adjusting the dose and schedule improves outcomes. The study is pragmatic and open-label, reflecting routine clinical practice in a real-world patient population. Participants are randomly assigned to one of two groups an experimental arm receiving a intensified chemotherapy schedule with carboplatin and paclitaxel given weekly in 3-week cycles for three cycles, optionally combined with daily subcutaneous GCSF injections or a standard arm continuing the same 3-weekly carboplatin-paclitaxel regimen used during initial treatment, with optional GCSF support. Randomization accounts for factors like bevacizumab use, BRCA mutation status, and KELIM score subgroup. The treatment period focuses on this chemotherapy phase. During the trial, participants will be monitored for surgery outcomes, overall and progression-free survival, tumor response, and adverse events. Assessments include clinical evaluations and imaging based on RECIST criteria, with follow-up extending up to five years for survival analysis. Researchers will also evaluate the impact of additional treatments like PARP inhibitors and bevacizumab on patient outcomes. The total study duration covers treatment and long-term monitoring of efficacy and safety measures.