Orsay

This research aims to evaluate antibiotic treatments for acute pyelonephritis AP in children aged 1 month to 3 years. It compares a shorter intravenous IV antibiotic course of 3 days alone to a longer treatment consisting of 3 days IV followed by 7 days of oral antibiotics. The goal is to see if the shorter IV treatment is as effective in curing AP and preventing recurrence and renal scarring, while reducing the risk of antibiotic resistance and preserving gut microbiota diversity. Participants are randomly assigned to one of two groups. The experimental group receives only 3 days of IV antibiotics with ceftriaxone andor amikacin, after which treatment is stopped. The control group receives the usual care of 3 days IV antibiotics followed by 7 days of oral antibiotics, either cotrimoxazole or cefixime. The study includes collection of fecal or rectal swabs and blood tests to assess microbiota and resistance. Treatment effectiveness and safety are compared between groups. During the study, children are monitored for fever, symptoms, and urine cultures to confirm infection clearance. Researchers measure recurrence of febrile urinary tract infections within 28 days after treatment ends and follow clinical cure at 10 or 17 days depending on the group. Additional assessments include monitoring recurrence at 90 days, antimicrobial resistance in gut bacteria, and intestinal microbiota diversity over about a month. Participation lasts through treatment and follow-up visits up to several weeks.

Researchers are evaluating the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis SPMS. This is a Phase III, randomized, double-blind, placebo-controlled, multi-center study involving approximately 1275 participants. The study aims to provide important data on remibrutinibs effect on disability progression in SPMS and includes both a Core Part and an Extension Part for further assessment. Participants are randomly assigned to receive either remibrutinib or a matching placebo as oral film-coated tablets during the Core Part. The Core Part includes double-blind treatment, followed by an Extension Part where all participants receive open-label remibrutinib tablets. Treatment is taken orally, and the study is event-driven, continuing until required endpoints are met. During the study, participants undergo regular assessments of disability progression using the Expanded Disability Status Scale EDSS, Timed 25-Foot Walk, 9-Hole Peg Test, and Symbol Digit Modalities Test, among others. Brain imaging and safety monitoring for adverse events are performed throughout up to approximately five years. Researchers track changes in brain lesions and atrophy, and follow participants for safety and treatment effects over time.

This research aims to evaluate the consistency of liver stiffness measurement LSM results obtained using a new Single Probe SP FibroScan device compared to the standard reference probes M and XL in adults with chronic liver diseases. This international, prospective, interventional study includes 309 adult patients from sites in Hong Kong and France. The goal is to assess how well the new single probe performs across various liver disease causes. Participants will undergo FibroScan examinations using different probe setups depending on their group assignment. Early patients 001-050 will have three tests with different single probes followed by a standard examination, with the best single probe selected for subsequent patients. Later groups will receive one or two single probe examinations and one or two standard reference probe exams. The study includes evaluations of test repeatability and patient comfort. During the study, participants will have liver stiffness and controlled attenuation parameter CAP measurements recorded using both the single probe and reference probes. Researchers will compare measurement differences, successful examination rates, and patient comfort scores. The main outcome is the difference in LSM values on the same day. The total study duration extends from November 2025 to May 2027, with primary measurements taken at the initial examination visit.

Researchers are conducting a European, prospective, interventional clinical study at two sites in France to develop a new method for measuring liver stiffness using FibroScan. The study will include 153 adult patients who have liver disease, suspected chronic liver disease, or consequences of chronic liver disease from any cause. The goal is to improve the accuracy and reliability of liver stiffness measurements. Participants will undergo examinations using a Research FibroScan device and a Reference FibroScan device. Different groups of patients will have various sequences of these exams to compare the new measurement method with the current standard. The study will assess liver stiffness measurements and related parameters over a 24-month period. During the study, participants will have multiple FibroScan examinations at the same measurement points with the same probes. Researchers will measure outcomes such as reduced variability in liver stiffness readings and compare different measurement biases between the devices. The study involves monitoring and collecting data over two years to evaluate the new methods performance and reliability.

Major depressive disorder is a leading cause of disability worldwide, with current treatments like antidepressants often taking 2 to 6 weeks to show effects. This delay can lead to hospitalization for severe major depressive episodes MDE. Researchers are evaluating the early effects of intravenous ketamine, alongside standard venlafaxine treatment, in patients hospitalized with severe unipolar depression to potentially improve early treatment response and reduce risks such as suicidal ideation and long hospital stays. Participants in this study will receive either three doses of intravenous ketamine or placebo on days 1, 4, and 7, in addition to their usual venlafaxine treatment. The study compares ketamine to placebo as an add-on therapy to venlafaxine during this early treatment phase. The study is randomized and quadruple-blinded to assess the efficacy and safety of ketamine in this setting. During the study, participants will be closely monitored for depressive symptoms using tools like the Hamilton Depression Rating Scale HDRS, Beck Depression Inventory BDI, and Clinical Global Impression CGI at multiple time points up to 42 days. Safety parameters such as blood pressure, heart rate, respiratory rate, and side effects like nausea and dissociation will also be tracked. Additional assessments include hospitalization duration, suicidal ideation, anxiolytic use, biomarkers, and PET imaging in a subset of patients. The total follow-up period extends to 42 days after treatment initiation.

Researchers are studying early psychosis, including schizophrenia, focusing on young people aged 15 to 30 who are at ultra-high risk or have had a first episode of psychosis. The study explores how cognitive deficits and biological factors like inflammation and oxidative stress contribute to the disorder, aiming to improve functional recovery by using a combined personalized care approach. This approach includes cognitive training and neuroprotective strategies tailored to each persons needs and biological profile. The study compares several treatment groups, including standard treatment as usual TAU featuring psycho-education and cognitive behavioral therapy, TAU combined with cognitive training via digital applications and virtual reality for those with higher deficits, TAU combined with personalized neuroprotective supplements such as Vitamin B12, folinic acid, Omega 3, and N-acetyl-cysteine, and TAU combined with both cognitive training and neuroprotective strategies. Supplements and cognitive training are provided over 12 weeks, with digital and virtual reality tools designed to be accessible and engaging. Participants will be assessed multiple times at baseline, then at 3 to 4 months and again at 6 to 8 months after starting interventions. Evaluations include global functioning, cognitive abilities, motivation, quality of life, medication adherence, and biological markers. Researchers will also monitor the acceptability and satisfaction with the e-health application used for cognitive training. The studys primary outcome is improvement in global functioning measured 3 to 4 months after starting treatment, with ongoing follow-up for up to four years to assess longer-term effects and cost-effectiveness.

Researchers are evaluating a new technique called 3D magnetic resonance spirometry to measure lung function in healthy people and patients with respiratory diseases like asthma, COPD, and bilateral lung transplants. This method aims to provide detailed local maps of lung ventilation and mechanics, improving diagnosis beyond traditional spirometry, which only measures global lung function. The study compares results from 3D spirometry with standard spirometry to assess their agreement in four groups healthy volunteers, asthma patients, COPD patients, and lung transplant patients with or without bronchiolitis obliterans syndrome BOS. Participants will undergo several tests, including standard spirometry performed in sitting and lying positions with various breathing types, and dynamic lung MRI scans in prone and supine positions before and after a bronchodilator salbutamol reversibility test. The salbutamol is given via inhalation at a total dose of 400 micrograms. These procedures aim to map lung function regionally and evaluate responses to treatment. During the study, participants will be assessed through lung function tests, MRI scans, and reversibility testing. Researchers will measure lung volumes and airflow differences between lung regions and assess correlations between spontaneous and forced breathing volumes. The study includes monitoring breathing patterns and evaluating lung mechanical behavior. Participants need to remain still during MRI scans and provide informed consent. The total study duration and follow-up details are not specified.

Researchers are studying mechanisms of neuronal resilience in patients with Alzheimers disease who have early onset symptoms before 65 years old, as well as in those with a focal form called posterior cortical atrophy PCA. These patients show different cognitive and brain damage patterns despite having similar pathological features like amyloid and tau protein deposits. The study aims to understand why some patients show resistance to brain degeneration through brain network reorganization and resilience, which is important for improving disease management and future treatments. The study includes three groups 15 patients with early-onset Alzheimers disease AD-Y, 15 patients with PCA, and 15 healthy control participants. All participants will undergo a combined PETMRI scan session lasting about 3 hours. This imaging includes a 30-minute PET scan with an injected tracer and various MRI sequences to assess brain structure, function, and pathology simultaneously. The study is non-randomized and observational in terms of group assignment. During the study, participants will have brain imaging to highlight resilient neural networks and quantify brain impairment related to Alzheimers disease within three months. Researchers will also analyze cerebrospinal fluid to correlate tau protein levels with brain lesions and develop models linking brain structural changes to functional alterations. The study monitors participants closely for safety and aims to clarify brain mechanisms underlying resilience to neurodegeneration, which could guide future therapies.

Researchers are investigating the best treatment to prevent stroke recurrence in patients aged 60 to 80 years who have a patent foramen ovale PFO with a large shunt or associated atrial septal aneurysm ASA, and have had a recent unexplained ischemic stroke. This trial aims to compare PFO closure plus antiplatelet therapy against antiplatelet therapy alone, and to evaluate oral anticoagulant therapy versus antiplatelet therapy. Prior studies showed benefits of PFO closure in patients up to 60 years old, but the best approach in older patients remains unclear. Participants are randomly assigned to one of three groups antiplatelet therapy alone aspirin or clopidogrel, oral anticoagulant therapy apixaban, dabigatran, or rivaroxaban, or PFO closure followed by dual antiplatelet therapy for 3 months then single antiplatelet therapy. The study is designed as a randomized controlled trial with single blinding and includes long-term follow-up to assess stroke recurrence and other outcomes. During the study, participants will be monitored for up to 8 years to track time to recurrent strokes, disabling strokes, and other cardiovascular events. Quality of life will be assessed every 6 months. Safety measures include monitoring for bleeding events and procedure-related complications. Researchers will also evaluate device implantation success and incidence of atrial fibrillation. The trial includes regular assessments to ensure participant safety and study adherence.

Researchers are studying advanced cancer of the stomach and the gastro-esophageal junction, a serious disease with low survival rates. The trial focuses on patients whose cancer has progressed after two or three prior treatments. The study aims to evaluate whether combining the oral drug trifluridinetipiracil with the anti-angiogenic drug fruquintinib can improve survival compared to trifluridinetipiracil alone. This international Phase III trial builds on recent advances in immunotherapy and targeted therapies for this cancer type. Participants are randomly assigned to one of two groups. One group receives trifluridinetipiracil alone in 28-day cycles, taking the drug by mouth twice daily on Days 1 to 5 and Days 8 to 12 with rest days in between, repeated every 4 weeks. The other group receives the same trifluridinetipiracil schedule plus fruquintinib by mouth once daily for 21 days each cycle. Treatment continues until the cancer progresses, unacceptable side effects occur, or the participant chooses to stop. During the study, participants undergo regular assessments to monitor overall survival up to 18 months after starting treatment. Researchers will also measure progression-free survival during this period. Patients will have tumor evaluations, laboratory tests, and monitoring for treatment side effects. Participants must meet specific health criteria and agree to biological studies. The study provides close follow-up to evaluate the effects of the treatments over time.