Tourcoing

Researchers are evaluating a new approach for adults with moderate to severe ulcerative colitis who need treatment with adalimumab. This Phase IV randomized trial compares standard care with a treat-to-target strategy that includes telemonitoring and patient education. The study aims to assess the impact of using home fecal calprotectin tests and e-monitoring combined with education on disease control by week 48. All participants will initially receive adalimumab with doses starting at 1608040 mg every other week until week 14, then 40 mg every other week until week 26. Dosage may be adjusted up to 80 mg every other week or 40 mg every week based on patient or investigator choice. In addition, patients may receive azathioprine or methotrexate alongside adalimumab until week 38. The study groups differ by follow-up method one group receives standard care with doctor visits every three months, while the other group has e-monitoring, home fecal calprotectin testing, and therapy education. Participants will be involved for about 144 weeks and complete regular assessments including endoscopic exams, clinical evaluations, quality of life surveys, and treatment adherence questionnaires. The study measures success primarily by endoscopic remission at week 48 and also tracks clinical remission, healing rates, patient satisfaction, hospitalizations, colectomies, and safety. Monitoring includes frequent e-monitoring questionnaires and fecal calprotectin testing at home. The trial also evaluates medication compliance and economic outcomes related to treatment.

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.

Researchers are evaluating four different isotonic and hypertonic seawater-based nasal sprays in real-life settings for their effectiveness, safety, usage, tolerance, and user satisfaction. The study focuses on infants, children, adults, and pregnant or breastfeeding women who have acute or chronic sinonasal conditions such as upper respiratory tract infections, allergic rhinitis, chronic rhinosinusitis, bronchiolitis, COVID-19, and post-surgery nasal issues. The investigation aims to understand how these devices perform when used as intended across various patient groups. Participants will use one of four CE-marked nasal spray devices according to their specific indications and target populations. The sprays include Respimer Hygiene-Prevention for babies, kids, and adults, Respimer Decongestion for babies from two months old and older, and Phytosun arms Hypertonic nasal wash for children six years and older and adults. Usage instructions vary by product, ranging from 1 to 6 sprays per nostril daily, with different frequencies for treatment and prevention purposes. The study period covers up to three months to assess both short-term and longer-term effects. During the study, participants or their parents will complete online questionnaires and follow healthcare providers advice on nasal wash techniques. Researchers will monitor nasal symptom changes, including intensity and frequency, improvement in nasal breathing, quality of life, and satisfaction with the sprays. Effectiveness will be evaluated from day 0 to day 5 for acute conditions and up to day 14 for chronic issues, extending to three months for seasonal symptom management. Safety, tolerance, and usage patterns will also be recorded throughout the study.

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.

This research aims to determine the best way to prevent stroke and systemic embolism in adults with non-valvular atrial fibrillation AF who have previously experienced an intracerebral haemorrhage ICH. Oral anticoagulant drugs have shown benefits in preventing stroke in AF patients, but these drugs were not tested in patients with prior ICH. This trial addresses the uncertainty about whether patients with AF and past ICH should use oral anticoagulants, undergo left atrial appendage closure LAAC, or avoid anticoagulation. Participants are randomly assigned to one of three groups treatment with the oral anticoagulant Apixaban 5 mg twice daily, treatment with LAAC devices chosen by local teams, or usual care with avoidance of anticoagulation and LAAC, which may include antiplatelet drugs or no antithrombotic treatment. The trial follows patients for 24 months to compare the net clinical benefit, including both major ischaemic and haemorrhagic events. During the study, participants undergo assessments including brain imaging, clinical evaluations using the Modified Rankin Scale and EQ-5D quality of life measures, and monitoring for adverse events. The primary outcome is a composite of major cardiovascular or cerebrovascular ischaemic or haemorrhagic events over 24 months. Secondary outcomes include individual event components, death, and complications related to endovascular treatment. The study is designed to help guide clinical decisions on the safest and most effective stroke prevention strategy for this patient group.

This research aims to describe HIV prevention practices in over 23 HIV sites across France, including overseas locations. It focuses on various aspects such as HIV screening, sexually transmitted infections STI screening, hepatitis screening, and the use of post-exposure prophylaxis PEP and pre-exposure prophylaxis PrEP. The study is observational and seeks to collect detailed information about HIV prevention measures in these diverse settings. Participants in this cohort study are observed based on their attendance for HIV prevention services including HIV, hepatitis, and STI screenings, as well as their use of PEP or PrEP. The study does not involve investigational treatments but follows participants over time to gather data on these prevention practices according to French national guidelines. During the study, researchers will track the number of people enrolled for HIV prevention over about one year, as well as proportions using PrEP and PEP and undergoing hepatitis and STI screenings. They will also monitor the incidence of sexually transmitted infections and hepatitis. Participants will provide informed consent and their progress will be observed without altering their usual care or treatment.

This clinical trial studies adults living with HIV who have controlled viral loads but previously developed the M184VI mutation, which causes resistance to lamivudine 3TC. Researchers aim to evaluate how well the combination of Doravirine, Lamivudine, and Tenofovir Disproxyl Fumarate DOR3TCTDF maintains viral suppression 24 weeks after switching to this regimen, with follow-up continuing to 48 weeks. The study also investigates changes in metabolism, weight, and HIV-DNA mutations over time. Participants will switch from their current antiretroviral treatment to a single pill combining Doravirine 100 mg, Lamivudine 300 mg, and Tenofovir disoproxil fumarate 245 mg Delstrigo, taken once daily for 48 weeks. This is a single-arm, open-label phase 2 trial, so all participants receive this combination without placebo comparison. During the study, participants will have their HIV-RNA levels carefully monitored at 24 and 48 weeks after the switch. Researchers will assess viral suppression, metabolic and weight changes, and mutation patterns. The trial includes regular visits and evaluations over the 48-week treatment period to track the effects and safety of switching to DOR3TCTDF.

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.

Charcot foot is a complication of diabetes that causes progressive damage to bones, soft tissues, and tendons in the ankle and foot, often leading to joint dislocation. This condition is not well understood by patients and caregivers, and its non-specific symptoms often result in delayed or missed diagnosis. Researchers are studying a group of patients with chronic Charcot foot in France to assess how quality of life changes over two years and to identify factors that predict worse outcomes among these patients. Participants in this observational study will complete questionnaires including the SF-36, FAAM-F, PHQ-9, PHQ-2, and a simplified EPICES score to evaluate quality of life, foot and ankle function, depression, and social precarity. These assessments will be conducted at the start, after 12 months, and after 24 months. In addition, X-rays will be used to track changes in foot bone and joint deformities. The study will also monitor diabetes complications, medical treatments for Charcot foot, presence of wounds or infections, amputations, hospitalizations, and depression symptoms over the two-year period. Participants will be asked to fill out questionnaires at these three time points and undergo foot X-rays and clinical evaluations to track their condition. Researchers will evaluate results from these questionnaires and imaging studies to understand how quality of life evolves and what factors contribute to outcomes. The study includes a comprehensive assessment of diabetic complications, foot deformities, and mental health. Participants will be followed for two years to gather this detailed information and help improve understanding of chronic Charcot foot.

Researchers are investigating the role of rifampicin in treating prosthetic joint infections caused by Cutibacterium acnes, which is involved in nearly 40% of shoulder prosthetic joint infections and is a leading cause of late-onset infections after hip and knee prosthesis. The study focuses on the challenges posed by biofilm-associated bacteria in these infections, which have slower growth and may be less responsive to antibiotics. Rifampicin is known for its activity against biofilm-related staphylococcal infections and is being evaluated for its effect on C. acnes infections. Participants receive either amoxicillin or moxifloxacin alone or combined with rifampicin for 12 weeks as antibiotic treatment during surgical revision of infected knee, hip, or shoulder prostheses. The study uses a randomized, parallel design comparing the antibiotic backbone alone versus the combination with rifampicin. Treatment choice between amoxicillin and moxifloxacin is at the investigators discretion. Rifampicin use is being assessed for its impact on treatment outcomes. Throughout the study, participants are monitored for treatment failure and adverse events related to rifampicin up to 24 months after completing antibiotics. The main outcome is the rate of infection management failure 24 months post-treatment. Researchers also track probable failures and failures at 12 months. Safety assessments focus on adverse events during rifampicin therapy. The total study duration includes treatment and long-term follow-up to evaluate both effectiveness and safety.