Perigueux

Researchers are conducting a prospective, multicenter cohort study to follow children with idiopathic nephrotic syndrome INS, a rare kidney disease. The study aims to collect data on pediatric patients treated by pediatric nephrologists in France and its overseas territories to better understand the diseases characteristics and support future clinical trials. The study involves regularly recording medical, biological, psychological, and social data through routine clinical follow-ups, hospitalizations, and consultations. Additionally, annual telephone interviews will be conducted for patients in remission. Quality of life, treatment adherence, and treatment impact questionnaires will also be collected. A biobank is established to collect blood, urine, hair, and nail samples at the disease onset before immunosuppressive treatment begins. Participants will be followed from disease onset until age 18 or transfer to adult nephrology care. Data is collected via a secure website, medically validated and entered by clinical research staff. The main outcome is the number of cases included and their characteristics over two years. Participation involves routine care visits, interviews, and questionnaires, with continued monitoring planned through the study period ending in 2048.

Researchers are evaluating the real-world effectiveness of deucravacitinib in adults diagnosed with moderate-to-severe plaque psoriasis. This observational study aims to understand how this treatment works outside of controlled clinical trials, focusing on health outcomes important to patients and doctors. It is sponsored by Bristol-Myers Squibb and conducted in France. Participants in this study have started treatment with deucravacitinib as prescribed by their doctors. The study observes these patients over time without altering their treatment plans. There are no placebo or comparison groups since this is an observational study that follows patients initiating deucravacitinib treatment. During the study, doctors will assess skin condition using the Physicians Global Assessment and measure quality of life with the Dermatology Life Quality Index at baseline and several points up to 24 months. Patients will also report symptoms like itch, skin pain, and fatigue using visual scales. Researchers will track how long patients remain on treatment and reasons for stopping. The study involves regular follow-ups at months 1, 4, 12, 18 optional, and 24 to gather this information.

Researchers are evaluating two antibiotic treatments for community-acquired pneumonia CAP in patients aged 65 years or older who are hospitalized in non-intensive care unit ICU wards. The study aims to compare the clinical effectiveness and safety of amoxicillin alone versus amoxicillin combined with clavulanate. This trial addresses an important gap in evidence about the best antibiotic choice for older adults with CAP, as current broad-spectrum antibiotic use is debated due to possible side effects and antibiotic resistance concerns. Participants will be randomly assigned to receive either amoxicillin or amoxicillinclavulanate for 5 days. Both medications are approved for treating respiratory infections and can be given orally or intravenously. Amoxicillin is given as 500 mg capsules or 1 g IV every 8 hours, while amoxicillinclavulanate is given as tablets containing 500 mg amoxicillin with 62.5 mg clavulanate or IV vials with 1 g amoxicillin and 200 mg clavulanate every 8 hours. This open-label, non-inferiority trial will compare outcomes at 30 days after treatment begins. During the study, participants will be monitored for clinical responses, cure rates, antibiotic treatment duration, hospital stay length, mortality, and adverse events related to antibiotics. Researchers will also track pneumonia recurrence, ICU transfers, and compliance with treatment. Follow-up assessments include clinical evaluations and laboratory tests up to 30 days after hospital admission. The study will provide important data to guide antibiotic use in older adults with CAP.

Researchers are evaluating different antimicrobial therapies for infections caused by difficult-to-treat Pseudomonas aeruginosa, a type of bacteria resistant to many common antibiotics. This study focuses on comparing new beta-lactambeta-lactamase inhibitor combinations, cefiderocol, and older treatments like aminoglycosides and colistin to understand their effectiveness in real-life settings for patients facing these challenging infections. The study is a prospective, multicenter cohort involving patients who require intravenous antibiotic treatment for their P. aeruginosa infections. Participating patients will receive one of the available antimicrobial options, and their bacterial samples will be analyzed centrally to assess susceptibility and resistance mechanisms. The study collects clinical data throughout treatment and monitors outcomes such as cure rates, resistance development, adverse events, and mortality. Participants will be followed until hospital discharge and up to 28 days after treatment completion. Researchers will track clinical cures, microbiological eradication, adverse events, emergence of resistance, and acquisition of other multidrug-resistant bacteria. Data collection includes electronic case reports and laboratory testing on bacterial isolates. The total participation duration varies according to hospital stay and follow-up schedules, with rigorous monitoring of safety and treatment outcomes.

Philadelphia-negative myeloproliferative neoplasms MPNs such as Polycythemia Vera, Essential Thrombocythemia, and Prefibrotic Myelofibrosis are chronic blood cancers caused by mutations affecting blood cell growth. These diseases carry a high risk of blood clots, which can cause serious complications and death. Current treatments include low-dose aspirin, but blood clots still occur in some patients despite therapy. This trial aims to study whether direct oral anticoagulants DOACs, which have shown benefits in other cancer patients, might help prevent blood clots in MPN patients with a specific mutation called JAK2V617F. Participants will be randomly assigned to receive either a direct oral anticoagulanteither Apixaban 2.5 mg twice daily or Rivaroxaban 10 mg once dailyor low-dose aspirin 100 mg once daily. The choice of DOAC is up to the investigator. The treatments will be given to high-risk patients for up to 24 months to compare their effects on clot prevention. Throughout the study, participants will be closely monitored for any thrombotic or bleeding events. During the trial, researchers will track the time until any arterial or venous blood clots occur, as well as any major or clinically relevant bleeding events. They will also evaluate survival, adherence to therapy, quality of life, and healthcare costs related to these treatments. Participants will have regular follow-ups over 24 months, including assessments for heart rhythm problems and safety monitoring. This comprehensive approach aims to better understand the benefits and risks of DOACs compared to aspirin in preventing clots in MPN patients.

Researchers are investigating the immune response to pneumococcal vaccination strategies in adults treated for lymphoma and acute leukemia. The study compares the traditional two-step vaccination approach using a 13-valent conjugate vaccine PCV13 followed by a 23-valent polysaccharide vaccine PPV23 against a newer guideline recommending a single injection of PREVENAR20. These patients often have weakened immune systems due to chemotherapy, increasing their risk for pneumococcal invasive diseases, but the effectiveness of these vaccination strategies in this group is not well documented. The trial includes two groups one group of 80 patients received PCV13 followed by PPV23 at least two months later, and another group of 80 patients will receive a single PREVENAR20 injection. The study monitors immune responses at multiple points, including before vaccination, four weeks after each vaccine injection, and up to 14 months post-vaccination. Researchers measure specific antibodies and immune activity to evaluate how well each vaccination method prompts an immune response. Participants will undergo blood tests at several time points to measure pneumococcal antibody levels and immune activity. The study also assesses vaccine safety, looking for local or general reactions and any invasive pneumococcal infections. Researchers aim to identify factors that predict poor response to vaccination by comparing patient demographics, biological data, and treatments received. The total follow-up period extends to 14 months after vaccination to assess the durability of the immune response.

Researchers are studying men over 40 years old with benign prostatic hyperplasia BPH who need surgery to improve urinary symptoms. The trial compares two types of prostate surgery a conventional endoscopic resection and a newer partial surgery that aims to preserve ejaculation function. This study explores whether the partial surgery can maintain ejaculation without reducing the relief of urinary symptoms, which is important because ejaculatory dysfunction often lowers quality of life after surgery. Participants are randomly assigned to one of two surgical groups. One group undergoes conventional endoscopic resection of the prostate, while the other receives a partial endoscopic resection that preserves the apex area near the veru montanum. The study is single-blinded, meaning patients do not know which surgery they receive. The main focus is on symptom improvement measured by the International Prostatic Symptom Score IPSS six months after surgery. During the study, men will have evaluations at 1, 3, 6, 12, and 36 months after surgery. These assessments include urinary symptoms, ejaculation and overall sexual life, urinary flow rates, and any surgery-related complications. The trial tracks these outcomes to understand the benefits and effects of each surgical method over time. Patients are expected to comply with scheduled visits and provide informed consent before participating.

This research aims to compare the cost-effectiveness of focal high-intensity focused ultrasound F-HIFU treatment versus radical prostatectomy RP in men with favorable intermediate risk localized prostate cancer. The study focuses on patients with non-treated prostate cancer characterized by specific Gleason scores and tumor visibility on MRI, evaluating both treatments from a healthcare system perspective. It is a randomized, pragmatic clinical trial conducted across multiple centers, aiming to provide insights into cancer control and side effect profiles such as urinary, sexual, and digestive outcomes. Participants will be randomly assigned to receive either F-HIFU using the Focal-Oneae device under local or general anesthesia or undergo a radical prostatectomy performed via open, laparoscopic, or robot-assisted surgery under general anesthesia. Randomization is stratified by center and initially equal but later adjusted to a 21 ratio favoring F-HIFU. Treatment is followed by regular monitoring up to 48 months, with data collection enhanced using national health databases to assess costs, mortality, and cancer control without additional patient visits. During the study, men will undergo assessments including urinary and sexual function evaluations, quality of life questionnaires, and survival monitoring at multiple timepoints up to 48 months. The primary outcome focuses on the cost-utility ratio at 24 months, with secondary outcomes including survival rates, preserved life costs, and treatment-related quality of life. Participants are closely followed through clinical visits and data linkage, ensuring comprehensive evaluation of both treatment approaches over time.

Researchers are evaluating treatments for catheter-related bloodstream infections CR-BSIs caused by Staphylococcus aureus, a common and serious hospital infection. This study aims to demonstrate that a single intravenous dose of dalbavancin is not less effective than the standard 14-day antibiotic treatment following catheter removal. The research also looks at cure rates at different times, mortality within 90 days, time to clear blood infection, patient quality of life, hospital stay length, costs, and adverse events. Participants will receive either a single 1500 mg intravenous dose of dalbavancin or the standard antibiotic therapy recommended by national guidelines for 14 days, which may include an oral switch after at least 7 days of intravenous treatment. Dalbavancins long half-life allows effective treatment with one dose, potentially reducing hospital stays and catheter-related complications. In case of clinical worsening, additional antibiotics may be prescribed as needed. During the study, patients will be closely monitored with blood cultures, assessments of infection clearance, quality of life questionnaires, and evaluations of hospital stay duration and healthcare costs. Adverse events will be tracked until 90 days after treatment. The main measure of success is the cure rate at 30 days. Participation includes follow-up visits up to 90 days to assess outcomes and safety, with total involvement lasting about three months.

Researchers are evaluating the safety and effectiveness of DPX-Survivac combined with pembrolizumab, with and without low-dose cyclophosphamide CPA, in adults with relapsed or refractory diffuse large B-cell lymphoma DLBCL. This Phase 2b, randomized, open-label study aims to better understand how these treatments work in this group of patients who have had previous therapies. The study is sponsored by ImmunoVaccine Technologies, Inc. IMV Inc.. Participants will be randomly assigned to one of two groups one group receives DPX-Survivac, pembrolizumab, and intermittent low-dose CPA, while the other group receives DPX-Survivac and pembrolizumab without CPA. DPX-Survivac is given as two 0.5 mL doses three weeks apart on days 7 and 28, followed by up to twelve 0.1 mL doses every eight weeks. Pembrolizumab is administered intravenously at 200 mg on day 7 and then every three weeks. In the CPA group, subjects take 50 mg of oral CPA twice daily for 7 days followed by 7 days off, repeating this cycle throughout the treatment period. During the study, participants will undergo assessments to monitor tumor response and safety for about 24 months, with some measures extending up to 48 months. Researchers will evaluate objective response rates, adverse events, duration and time to response, progression-free survival, and disease control rates. Patient-reported outcomes will be collected using specific questionnaires. The study involves regular visits for treatment administration, tumor biopsies, and laboratory tests to track the participants health and treatment effects over time.