Bethune

Researchers are conducting a French multicenter retrospective study to describe the clinical, histological, and radiological features of rare primary liver cancers. The study aims to collect biological tumor and blood samples and evaluate the effectiveness of treatments used in clinical practice to determine the best therapeutic sequences. This research will serve as the foundation for future translational studies to identify new molecular, histological, circulating, and radiological tumor biomarkers useful for diagnosis, prognosis, and treatment guidance. This study involves collecting data from patients diagnosed with rare liver cancers such as hepatocholangiocarcinoma, fibrolamellar hepatocellular carcinoma, epithelioid hemangioendothelioma, and hepatic angiosarcoma since January 1, 2018. Both living patients who agree to participate and deceased patients are included. Biological samples and tumor blocks are collected for analysis. Treatments received by patients in routine practice are reviewed to assess their efficacy and help define optimal treatment sequences. Participants provide consent for biological studies if living, and their medical records and tumor characteristics are reviewed. Researchers will describe the clinical, histological, and radiological tumor features and monitor outcomes up to five years from diagnosis. This detailed data collection supports long-term evaluation of rare liver cancers and aids in developing future biomarkers and therapeutic strategies.

WAYFIND-R is a global registry focused on collecting high-quality real-world data from cancer patients diagnosed with solid tumors who have undergone next-generation sequencing (NGS) testing. The registry aims to support clinical and epidemiological research, generate evidence to better understand health outcomes and cancer care, and describe treatments and clinical courses for these patients. Participants must be adults diagnosed with any type of solid tumor at any disease stage and have had NGS testing within three months before enrollment. The study collects data without assigning specific treatments or interventions, instead tracking clinical characteristics and outcomes over time. During the study, researchers will gather information linking NGS results to treatments and patient outcomes, including overall survival for up to five years from enrollment. Participants provide informed consent, and data collected will help improve understanding of solid tumor cancers and their management in real-world settings.

Pancreatic cancer, mainly caused by adenocarcinoma in over 90% of cases, is a leading cause of cancer death in Western countries. Surgical removal is the only curative option but is suitable for only 10 to 15% of patients. Prevention and screening are challenging due to the lack of clear risk factors and diagnostic markers. This research aims to expand the BACAP biobank by adding fresh tumor tissue and genetic analyses to support future studies focused on developing new diagnostic tools, understanding tumor development, identifying therapeutic targets, and exploring chemotherapy response factors. The study involves collecting biological samples such as whole blood and micro-biopsies from pancreatic tissue of patients with pancreatic adenocarcinoma. These samples will enrich the existing BACAP prospective collection. This biobank aims to enable research that could improve diagnosis and treatment of pancreatic cancer. Participants will be patients with pancreatic mass syndrome confirmed by ultrasound endoscopy, abdominal scanner, or histological/cytological diagnosis of pancreatic adenocarcinoma. Researchers will monitor the collection of biological samples and clinical data over a 5-year period. The primary outcome measure is to enrich the prospective BACAP collection to support future research projects. Safety and eligibility are carefully assessed, including exclusion of non-adenocarcinoma tumors and pregnant or breastfeeding patients.

Researchers are evaluating the effectiveness of different antimicrobial treatments for infections caused by difficult-to-treat Pseudomonas aeruginosa bacteria. This infection is especially challenging for patients who are critically ill or have weakened immune systems. The study focuses on comparing new beta-lactam/beta-lactamase inhibitor combinations, cefiderocol, and older drugs like aminoglycosides and colistin in real-life clinical settings across multiple hospital centers in France. Participants will receive intravenous antimicrobial therapy tailored to treat their difficult-to-treat P. aeruginosa infection. The study observes the use of new and older antimicrobial drugs to assess their clinical efficacy. Patient data and bacterial samples will be collected and analyzed centrally to better understand drug resistance mechanisms and treatment outcomes. Participants will be monitored for clinical cure shortly after completing therapy and on Day 7 ± 2 days. Researchers will collect clinical information through electronic case-report forms and send bacterial isolates to a national center for detailed testing. Outcomes include cure rates, resistance development, adverse events, and mortality rates, with follow-up during hospitalization and up to 28 days after treatment. The study aims to provide valuable real-world data on treating these challenging infections.

This research focuses on patients without a functioning spleen, known as asplenic patients, which can result from surgical removal due to trauma, cancer, auto-immune diseases, or diagnostic purposes, as well as from treatments like radiotherapy or splenic artery embolization. These patients face increased risks of infections caused by encapsulated bacteria, cancer, and thromboembolic diseases. The study aims to assess the complications that occur in French asplenic patients and to introduce new diagnostic tools for better follow-up and management. The study observes different groups of asplenic patients including those who underwent splenectomy, splenic artery embolization, or radiotherapy. It seeks to understand how splenic function and immunity change over time in these patients, recognizing that infectious risks may vary among these groups. The research emphasizes the limitations of current tools that assess splenic function and aims to implement new methods to accurately evaluate residual splenic function. Participants will be followed over time to monitor infectious and non-infectious complications. The study includes assessments of complication risk factors over a period of three years. Researchers will collect data on patient health outcomes to better estimate the incidence of complications and improve understanding of these risks. This longitudinal follow-up helps in advancing care for asplenic patients through improved diagnostic and management strategies.

Researchers are studying adults with community-acquired pneumonia who need oxygen therapy due to acute respiratory failure meeting acute respiratory distress syndrome (ARDS) criteria. This condition often leads to tracheal intubation and poor outcomes. Previous studies showed that prone positioning reduces mortality in invasively ventilated ARDS patients and improves oxygenation in non-intubated patients with viral pneumonia, including COVID-19 cases. This trial focuses on patients with non-COVID community-acquired pneumonia using nasal high flow therapy, aiming to see if awake prone positioning can reduce the need for intubation and related treatments like sedation and muscle relaxation. Participants will be encouraged to spend as much time as possible in the prone position, ideally 4 to 8 hours per session, with a goal of up to 16 hours or more within each 24-hour period, depending on their tolerance. This intervention is compared to usual care without prone positioning. The study excludes patients with recent COVID-19 infection or those requiring immediate intubation. During the study, researchers will monitor patients for up to 28 days after randomization, focusing on whether they require intubation. Participants will be admitted to an intensive care or intermediate care unit, and their oxygen levels will be closely assessed using the PaO2/FiO2 ratio or equivalent SpO2/FiO2 measurements. Consent and social security affiliation are required. Safety and effectiveness of awake prone positioning in reducing intubation needs will be evaluated throughout the study period.

Chronic use of nitrous oxide can cause toxicity leading to neurological problems such as combined sclerosis of the spinal cord. This can result in difficulties walking or sensations like numbness and tingling, which may improve or worsen to the point of requiring a wheelchair. Recently, cases of blood clots have also been linked to nitrous oxide use. Blood or urine tests for nitrous oxide are not commonly done because the gas leaves the body quickly, so other markers like vitamin B12 and homocysteine levels are studied instead, though no official monitoring guidelines currently exist. The exact biological processes causing these health problems are still not well understood. The study involves collecting blood samples from participants for biological analysis to better understand markers related to nitrous oxide use. Participants include current or former recreational nitrous oxide users, both with and without clinical signs or biological effects from use. Blood samples are preserved for testing as part of routine care within the study framework. Participants will be monitored with blood tests to measure markers linked to nitrous oxide consumption over about one year. The main outcome measured is the change in blood markers related to nitrous oxide use during this period. The study requires participants to consent and be socially insured, and it excludes pregnant or breastfeeding women and those who have not used nitrous oxide recently or are unwilling to complete the study.

Researchers are evaluating the effects of caffeine on cognitive decline in people with Alzheimer's disease at the beginning to moderate stages. This phase 3 trial aims to compare the impact of caffeine treatment versus placebo on cognition over 30 weeks. Alzheimer’s disease is a complex condition with no current cure, and caffeine's properties may offer symptomatic benefits, although high doses could cause anxiety and insomnia, especially in this vulnerable group. Participants will undergo a 6-week caffeine diet before starting treatment. Then, caffeine or placebo capsules will be given with a titration phase of 3 weeks increasing the dose by 100mg every stage until reaching a target of 400mg daily in two doses, maintained for 27 weeks. After treatment, doses will be gradually decreased following the same schedule. During the study, participants will be monitored for changes in cognitive function measured by neuropsychological tests at 30 weeks after randomization. Caregivers will be involved, and participants’ clinical status, safety, and adherence to a low caffeine diet will be assessed. The total participation duration includes the caffeine diet, titration, treatment, and dose reduction phases.

Researchers are evaluating the effectiveness of cotrimoxazole compared to the best standard antibiotic treatment for ventilator-associated pneumonia (VAP) caused by Enterobacteriaceae in adult patients admitted to intensive care units (ICU). This is a multicenter, randomized, non-inferiority Phase 3 trial aiming to show that cotrimoxazole is not worse than standard care in terms of patient survival 28 days after treatment begins. Participants must have a confirmed diagnosis of VAP with bacteria susceptible to cotrimoxazole. Patients are randomly assigned to receive either cotrimoxazole or the best standard antibiotic therapy, which may include beta-lactam or fluoroquinolone antibiotics. Treatment lasts for seven days, starting with an initial appropriate empiric antibiotic therapy. The dosing and administration of antibiotics are tailored according to current ICU guidelines. The trial is open-label due to variable antibiotic regimens in the control group. During the study, patients are closely monitored daily until death, ICU discharge, or 28 days after inclusion. Assessments include vital status, antibiotic use, new infections, and Clostridium difficile infections. Clinical signs and chest X-rays are reviewed on day 7 to evaluate cure. Weekly screenings for multidrug-resistant bacteria are performed until ICU discharge. The vital status is also checked at day 90, with follow-up contact for patients discharged before this time. An independent committee reviews the clinical and radiological outcomes without knowing the treatment assignments.

Researchers are evaluating the effects of early intravenous high-dose vitamin C combined with vitamin B1 in patients admitted to intensive care after an out-of-hospital cardiac arrest (OHCA) who develop post-cardiac arrest shock. This shock involves heart and blood circulation failure and can lead to multiple organ failure and early death in up to 35% of patients. The study is a phase II multicenter randomized controlled trial designed to assess if vitamin C and vitamin B1 can improve outcomes compared to standard care following OHCA. Participants are randomly assigned to one of two groups. The experimental group receives standard care plus intravenous high-dose vitamin C at 200 mg/kg per day, given as 50 mg/kg every 6 hours for 3 days, starting within one hour after randomization. They also receive intravenous thiamine (vitamin B1) 200 mg twice daily for 3 days. The control group receives standard care according to guidelines, with no high-dose vitamin C during the first 3 days. From day 4, standard vitamin C and thiamine supplementation at lower doses are allowed. During the 28-day participation, patients are monitored for recovery from the shock, including the need for blood pressure support medications (vasopressors). The primary outcome is the cumulative rate of weaning off vasopressors by day 3 after cardiac arrest. Researchers will also assess safety and recovery progress. The study plans to enroll 234 patients over 24 months, with follow-up lasting 28 days after enrollment.