Douai

Researchers are investigating treatments for adults with moderate to severe ulcerative colitis who have not responded well to steroids or other therapies. This Phase IV, randomized, open-label, multicenter trial aims to compare standard care with a treat-to-target approach using telemonitoring and patient education for those starting adalimumab (Humira4). The study will assess if home fecal calprotectin testing combined with e-monitoring and education improves patient outcomes by week 48. All participants will begin treatment with adalimumab at doses of 160 mg, then 80 mg, and 40 mg every other week until week 14, followed by 40 mg every other week until week 26. Based on patient and doctor preference, doses can be adjusted up to 80 mg every other week for two months and continued with azathioprine or methotrexate until week 38. Patients will also receive patient education sessions at weeks 0, 2, 14, 26, and 38, along with regular e-monitoring throughout the study. Participants will be followed for a total of 144 weeks across 20 sites in France. The main outcome is endoscopic remission at week 48, measured by an endoscopic Mayo score of 0. Additional assessments include clinical remission, steroid-free remission, healing rates, quality of life, patient satisfaction, safety, pharmacokinetics, hospitalizations, treatment adherence, and economic impact. Patients will report stool frequency, bleeding, and injection details via e-monitoring at multiple time points. This comprehensive monitoring aims to evaluate treatment effectiveness and patient engagement over time.

Researchers are evaluating whether using fungal biomarkers can help doctors stop antifungal treatment earlier in critically ill patients suspected of invasive Candida infections. The study aims to compare this biomarker-based approach to the usual care strategy, assessing if early discontinuation can safely reduce unnecessary antifungal use without increasing mortality by day 28. This is a randomized controlled open-label study involving patients who need empirical antifungal therapy for the first time in the ICU. Participants are divided into two groups. The intervention group will have their antifungal treatment duration guided by blood tests measuring (1,3)-Beta-D-glucan and mannan levels at the start of treatment and on day 3, with recommendations to stop treatment early if biomarker results allow. The control group will receive routine care based on international guidelines, typically involving 14 days of treatment if no proven infection occurs and the patient improves, or shorter durations in other cases. During the study, researchers will monitor when antifungal treatment is stopped, particularly noting if treatment ends before day 7 after it begins. They will also track patient outcomes up to day 28 to ensure safety. Participants must provide informed consent and are expected to stay in the ICU for at least 6 days after starting treatment. The main outcome measured is the percentage of patients who stop antifungal therapy early according to the study protocols.

Drug Hypersensitivity Syndrome, also known as DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms), is a severe and potentially life-threatening allergic reaction to medication that can cause serious organ damage. The exact causes and mechanisms of DRESS are not fully understood, especially regarding the role of eosinophils, a type of white blood cell involved in the immune response. This research aims to evaluate the activation of eosinophils in patients with DRESS compared to those with drug-induced rashes without or with eosinophilia and healthy individuals, to better understand the disease's underlying processes. The study will assess the activation status of circulating and skin-associated eosinophils in adults diagnosed with DRESS and in two comparison groups with drug-induced maculopapular exanthema, one with eosinophilia and one without. Participants will be grouped based on specific clinical criteria including rash timing, fever, organ involvement, and blood eosinophil levels. The study will not involve experimental treatments but will focus on measuring immune cell activation to identify different disease subtypes and potential therapeutic targets. Participants will undergo blood sampling to evaluate eosinophil activation using flow cytometry. Researchers will collect data on clinical symptoms and immune responses to explore links between eosinophil behavior and organ damage. The primary outcome is the activation status of circulating eosinophils at the start of the study. The study excludes individuals with other causes of eosinophilia, recent immunomodulatory treatments, pregnant or breastfeeding women, and those unable to provide the required blood samples. The participation period and follow-up details are not specified.

Researchers are evaluating how well the Clinical Global Impression Scale (CGI) score, assessed immediately after a traumatic event, can predict the later development of post-traumatic stress disorder (PTSD). PTSD is a condition that can occur after experiencing or witnessing a sudden, severe trauma and involves distressing symptoms like intrusive memories, avoidance, mood changes, and heightened alertness. This study focuses on patients who have experienced psychotrauma to understand if early CGI scores can help identify those at high risk for PTSD, enabling earlier intervention and care. The study involves an initial inclusion visit where participants undergo psychiatric assessment and complete questionnaires including the CGI and Peritraumatic Distress Inventory (PDI). Follow-up occurs at 1 month and 6 months through phone calls, where researchers assess PTSD symptoms using the PTSD Checklist Scale (PCL-5) and screen for related psychiatric conditions such as major depressive episodes and substance use disorders using the Mini International Neuropsychiatric Interview (MINI). The goal is to find a CGI score threshold that predicts PTSD risk, facilitating systematic telephone follow-ups for patients with high acute stress scores. Participants will provide socio-demographic information and complete standardized assessments during the study. Researchers will monitor symptoms remotely by phone and evaluate the psychometric properties of the CGI in predicting PTSD. The study aims to improve early detection of PTSD and guide patients toward specialized psychological care. Total participation includes the initial assessment and two follow-up calls over six months, with safety and symptom monitoring throughout this period.

Researchers are evaluating lumateperone as an additional treatment for adults aged 18 to 65 with major depressive disorder (MDD) who have not responded adequately to current antidepressant therapy. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the effectiveness and safety of lumateperone in patients diagnosed according to the DSM-5 criteria, including those with psychotic features. Participants must have moderate to severe depression and an ongoing major depressive episode lasting between 12 weeks and 18 months. Participants will be randomly assigned to receive either lumateperone 42 mg capsules or matching placebo capsules once daily during a six-week double-blind treatment period. Before treatment, there is a screening period of up to two weeks to confirm eligibility. After the treatment phase, there is a one-week safety follow-up visit to monitor participants after completing the study medication. Throughout the study, patients will be assessed using depression rating scales including the Montgomery-Asberg Depression Rating Scale (MADRS). Other evaluations include psychiatric interviews, symptom questionnaires, and safety monitoring for suicidal thoughts or behaviors. The study tracks changes in depression severity and safety outcomes from screening through treatment and follow-up, totaling approximately nine weeks of participation.

This research aims to evaluate the long-term safety, tolerability, and effectiveness of NMRA-335140 in adults with major depressive disorder (MDD). It involves participants who completed earlier Phase 3 studies of NMRA-335140 for MDD and met specific eligibility and consent requirements. The study provides an opportunity to extend treatment and monitor outcomes over a longer period. Participants will receive NMRA-335140 at a dose of 80 mg taken orally once daily for a 52-week treatment period. This open-label extension allows continued assessment beyond the initial parent studies, focusing on sustained safety and effectiveness of the medication. Throughout the 52 weeks, researchers will monitor participants for treatment emergent adverse events and use validated clinical scales to assess safety and tolerability. The study's total duration for participants is up to 54 weeks, including safety assessments. Data collected will help understand the long-term effects of NMRA-335140 in managing MDD.