Bethune

This research aims to describe the clinical, histological, and radiological features of rare primary liver cancers. It focuses on collecting tumor and blood samples to better understand these cancers and to evaluate how well treatments used in real-world practice work, with the goal of identifying the best treatment sequences. The study serves as a foundation for future research to find new molecular and imaging biomarkers that could improve diagnosis and prognosis. The study is observational and retrospective, meaning it reviews past cases from multiple centers in France. It collects biological samples and clinical data from patients diagnosed with rare primary liver cancers after January 2018. The study evaluates treatments patients have received in clinical practice without assigning any new treatments or interventions. Participants data, including clinical characteristics, tumor biology, and imaging, will be reviewed for up to five years from diagnosis. Researchers will measure outcomes such as recurrence-free survival for patients without metastases, progression-free survival for those with metastases, and overall survival. The study includes both living patients who consent to participate and deceased patients, aiming to gather comprehensive information to support future translational studies.

Pancreatic cancer is a leading cause of cancer death in Western countries, with over 90% of cases caused by adenocarcinoma. Surgical removal of the tumor is currently the only curative treatment but is possible in only 10 to 15% of cases. This research aims to enhance understanding and treatment of pancreatic adenocarcinoma by enriching an existing biobank with fresh tumor tissue and genetic analysis to support future studies on diagnostic tools, tumor development, therapeutic targets, and chemotherapy response.

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.

This research focuses on patients without a functioning spleen, a condition known as asplenia, which can be congenital or acquired through surgery, radiotherapy, or splenic artery embolization. The study aims to assess the risk factors for complications such as infections, cancer, and blood clots in French patients with asplenia. Researchers want to better understand how the immune system and splenic function change over time in these patients. Participants include adults aged 18 and older who have asplenia due to splenectomy, embolization, or radiotherapy. The study is observational and follows patients prospectively over time to monitor complications. It seeks to implement new diagnostic tools to evaluate residual splenic function and improve patient management. The study distinguishes three groups based on the cause of asplenia to examine differences in infection risks. During the study, participants will be followed longitudinally for at least three years to assess complication risk factors. Researchers will use new and existing tools to monitor splenic function and immune status. The main measurement is the incidence of infectious and non-infectious complications. This long-term follow-up aims to provide detailed data on risks faced by asplenic patients to guide better care.

Researchers are studying patients with community-acquired pneumonia who need oxygen therapy due to acute respiratory distress and low blood oxygen levels. This research aims to see if placing patients in a prone position lying face down while they receive nasal high flow oxygen can reduce the need for intubation and improve outcomes. The study particularly excludes patients with COVID-19 and focuses on non-COVID pneumonia cases. Participants will be randomly assigned to one of two groups. One group will be encouraged and assisted to lie in the prone position for at least 8 hours per day in multiple sessions, aiming for up to 16 hours if tolerated. The other group will receive usual care with nasal high flow oxygen therapy but no prone positioning. Both groups will have oxygen levels monitored and care adjusted to maintain target oxygen saturation. During the study, patients will be observed for intubation rates within 28 days, comfort levels during prone positioning, oxygenation changes, time to escalation of breathing support, and overall outcomes including mortality up to 90 days. Safety measures like skin and infection monitoring will also be recorded. Quality of life will be assessed at 90 days and 5 years, with nursing workload tracked within the first day after randomization.

Researchers are studying the biological effects and monitoring methods of chronic nitrous oxide abuse, which can cause neurological problems such as combined sclerosis of the spinal cord. Patients may experience walking difficulties, abnormal sensations, and in severe cases may require a wheelchair. There have also been reports of thrombosis linked to nitrous oxide use. Traditional tests measuring nitrous oxide levels in blood or urine are not reliable due to the gass short half-life, so other markers like vitamin B12 and homocysteine are being evaluated. The underlying causes of these clinical effects are not yet fully understood. The study observes two groups of nitrous oxide users those hospitalized with clinical symptoms assessed by neurological evaluation using the Peripheral Neuropathy Disability score or thrombotic events, and those without clinical symptoms seen during routine medical consultations. Participants undergo blood collections for biological analysis, with samples preserved for further study. This is an observational study without experimental treatment. Participants will have blood tests at the start and at intervals up to six months to measure markers related to nitrous oxide use and clinical outcomes. Researchers will also assess nitrous oxide consumption through self-reporting and estimation, alongside the severity of related clinical signs. The main outcome is the change in blood markers over about one year. The study includes people aged 14 to 65 who currently or formerly use nitrous oxide and have social insurance coverage.

Researchers are evaluating the effects of caffeine on cognitive decline in people with Alzheimers disease at early to moderate stages, characterized by a Mini-Mental State Examination MMSE score between 16 and 24. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to study the 30-week impact of caffeine treatment on cognition. The study addresses the potential benefits and risks of caffeine, considering its complex effects on the central nervous system, including possible anxiety and insomnia at high doses, which may be more pronounced in Alzheimers patients. Participants begin with a 3-week dose escalation period, followed by a 27-week treatment phase. The caffeine group receives capsules starting at 100 mg, titrated up by 100 mg increments to a target dose of 400 mg per day divided into two doses, while the placebo group undergoes a similar regimen with placebo capsules. After the treatment period, caffeine is tapered off using the same negative titration. Both groups follow a low caffeine diet before and during the study. During the study, participants undergo regular assessments of cognitive function using the Neuropsychological Test Battery NTB scores at 30 weeks and six weeks after treatment ends to observe any lasting effects. Additional evaluations include MMSE scores, attention tests, sleepiness scales, daily living activities, quality of life, caregiver burden, clinical global impression, and safety monitoring of heart rate and blood pressure. Blood samples will measure caffeine and its derivatives. The study involves caregivers living with the patient and lasts for at least 36 weeks from randomization.

Researchers are evaluating the effectiveness of cotrimoxazole compared to standard antibiotic therapy for treating ventilator-associated pneumonia VAP caused by Enterobacteriaceae in adult patients in intensive care units ICU. This multicenter randomized trial aims to determine if cotrimoxazole is not inferior to the best standard care in terms of survival 28 days after treatment begins. Patients with confirmed VAP and susceptibility to cotrimoxazole are included, with specific attention to those with or without septic shock and COVID-19 pneumonia. Participants are randomly assigned to receive either cotrimoxazole or standard antibiotic treatment, such as beta-lactams or fluoroquinolones, for a total of 7 days including initial empiric treatment. The antibiotic dosing and administration are adjusted based on current ICU recommendations. The treatment period can last up to 28 days or until death or ICU discharge if earlier. The study is not blinded due to variable therapies in the control group. During the study, patients are monitored daily until death, ICU discharge, or day 28 for vital signs, antibiotic use, new infections, and Clostridium difficile infection. Clinical and radiological evaluations occur at day 7, and weekly screening for multidrug-resistant bacteria is performed. Survival status is followed up to 90 days through phone or hospital interview. An independent committee reviews clinical and radiological outcomes without knowledge of treatment assignment to ensure unbiased assessment.

Researchers are investigating the use of high-dose intravenous vitamin C combined with thiamine vitamin B1 to manage post-cardiac arrest shock in patients admitted to intensive care units after out-of-hospital cardiac arrest. This condition often leads to cardiac and circulatory failure, causing multi-organ failure and early death in a significant portion of patients. The study is a phase II, multicenter, randomized controlled trial comparing standard care with the addition of high-dose vitamin C and thiamine to assess potential benefits on shock recovery and neurological outcomes. Participants are randomly assigned to one of two groups the control group receiving standard post-cardiac arrest care according to international guidelines, and the experimental group receiving standard care plus high-dose intravenous vitamin C at 50 mgkg every 6 hours for 3 days, starting within an hour after randomization, along with intravenous thiamine 200 mg twice daily for 3 days. From day 4 onwards, standard vitamin C supplementation up to 1000 mg daily and thiamine are allowed in both groups. During the 28-day participation period, patients will be closely monitored for recovery from shock, neurological function, and organ failure. Assessments include measuring the time to stop vasopressors by day 3, survival rates related to shock by day 7, neurological status at day 28, maximum vasopressor doses within 3 days, changes in organ failure scores, and arterial lactate levels. Safety and effectiveness data will be collected throughout to evaluate the impact of the vitamin C and thiamine treatment alongside standard care.

This research aims to understand how clinical frailty affects adults aged 18 to 65 admitted to intensive care for septic shock. It focuses on whether patients classified as frail or severely frail using the Clinical Frailty Scale CFS face higher risks of death, longer hospital stays, increased readmission rates, and poorer quality of life. The study seeks to improve predictions and care decisions for critically ill younger patients with sepsis. The study observes patients admitted for suspected or confirmed type 3 sepsis who require vasopressor support to maintain blood pressure and have elevated lactate levels. There are no experimental treatments or interventions instead, this observational study collects data on patients frailty scores and their health outcomes over time. Participants will be closely monitored for 28 and 90 days after admission to evaluate mortality risk, length of hospital stay, use of invasive therapies, and readmission rates. Researchers will also assess changes in frailty and quality of life at 90 days. This detailed follow-up helps clarify the impact of frailty on recovery and survival, aiding better care planning and communication with patients and families.