Saint Quentin

Women who have experienced interpersonal violence often face a higher risk of developing post-traumatic stress disorder PTSD. In France, female victims can request a medico-legal examination at a clinical forensic medicine unit, which also offers initial psychological assessment. However, many women do not attend follow-up appointments. This research is a prospective, multicenter, open-label, randomized controlled trial aiming to evaluate the effectiveness of a case management algorithm that uses early phone contact to improve clinical outcomes after such consultations for female victims of violence. Participants are divided into two groups. The experimental group, called VIGITRAUMA, will receive a phone call three weeks after their consultation, with a second call if needed. If contact is not made after the second call, a postcard will be sent. The control group will receive the usual follow-up care without this additional phone contact. The study is conducted by the University Hospital, Lille. Participants will be assessed through phone calls at 3, 6, and 12 months after their consultation to monitor clinical outcomes. Researchers will measure PTSD symptom severity, general psychopathology, somatic symptoms, medical costs, judicial outcomes, suicidal thoughts, and suicide attempts. The study aims to track these outcomes over a full year to understand the impact of the case management algorithm compared to standard care.

Researchers are evaluating the efficacy and safety of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced Stage III, unresectable non-small cell lung cancer NSCLC whose disease has not progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

This research aims to observe the real-world use and effects of pegcetacoplan in adults diagnosed with Paroxysmal Nocturnal Hemoglobinuria PNH. As a new treatment with a unique mechanism of action, pegcetacoplans effectiveness and safety in routine medical practice are being studied to provide valuable information for patients, healthcare providers, and payers. The study will also gather data on blood transfusions and healthcare resource use before and after starting pegcetacoplan. Patients who have started pegcetacoplan treatment within the past 12 months or are prescribed the drug at enrollment will be included. Data collection includes retrospective information from up to 12 months before treatment start and prospective monitoring for approximately 36 months, with the total data period extending up to about 48 months. After stopping pegcetacoplan, patients remain in the study for 8 weeks to record any adverse events. Patients continue regular clinic visits, where data from each visit will be gathered. Participants will have data collected on various health measures such as hemoglobin levels, blood markers, transfusion needs, and patient and physician treatment satisfaction at regular intervals up to 36 months. Safety and adverse events will be monitored throughout. The main outcome measured is the change in hemoglobin level from treatment start to 6 months. This long-term observational study allows for comprehensive tracking of pegcetacoplans use and effects over time in usual care settings.

Researchers are evaluating the efficacy and safety of the combination of divarasib and pembrolizumab compared with pembrolizumab combined with pemetrexed and either carboplatin or cisplatin. This study focuses on adults with previously untreated, advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The goal is to assess these treatments as first-line options in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group will take divarasib orally once daily and receive pembrolizumab through an intravenous infusion every three weeks. The other group will receive pembrolizumab, pemetrexed, and either carboplatin or cisplatin via intravenous infusions every three weeks. Treatment continues with these schedules, following the study protocol for up to approximately five years of follow-up. During the study, participants will have regular assessments to monitor their health and response to treatment. These include imaging and clinical evaluations to measure progression-free survival and overall survival for up to five years. Researchers will also track quality of life, symptom changes, treatment side effects, and adverse events using questionnaires and patient-reported outcomes. Safety monitoring and detailed evaluations will help understand the effects of the treatments over the study duration.

Radiotherapy for breast cancer can cause arm lymphedema, which is swelling that may lead to long-term discomfort and affect quality of life. This clinical trial is designed to assess whether an artificial intelligence AI tool that predicts individual risk of arm lymphedema after radiotherapy can help patients and doctors make better treatment decisions. The trial includes women aged 18 or older with breast cancer needing regional lymph node radiotherapy after surgery, regardless of hormone receptor or tumor status. Participants will be randomly assigned to two groups. In the experimental group, patients and physicians will see the AI-predicted risk through a web app that explains risk factors and suggests measures like compression sleeves. In the control group, this risk information will not be shared. Both groups receive the same radiotherapy treatment they would normally have, with no changes to dose or technique. The AI tool is evaluated only for its impact on decision-making and outcomes. Throughout two years, participants will have regular check-ups to track treatment choices, side effects, shoulder movement, breast appearance, quality of life, and the accuracy of the AI tools predictions. Researchers will also monitor how well patients follow recommendations for using compression sleeves, as well as cancer recurrence and survival. Questionnaires and clinical exams will be conducted at baseline, during treatment, and at multiple follow-up points to gather detailed information.

Researchers are studying ways to reduce the duration of immunotherapy treatment in patients with advanced non-small cell lung cancer NSCLC who have their disease controlled after initial treatment. The study focuses on comparing a shorter immunotherapy maintenance period of 6 months to the usual 2 years to see if less treatment can still be effective. This phase II-III randomized study enrolls patients with stage IV NSCLC who have not received prior treatment for advanced disease. Participants will first receive a combination of chemotherapy and pembrolizumab for about 6 months, using specific chemotherapy drugs based on their cancer type. After this induction, patients showing disease control without severe side effects will be randomly assigned to one of two groups continuing pembrolizumab with or without pemetrexed for certain cancer types for up to 2 years or observation with or without pemetrexed. Researchers will monitor various factors including patient characteristics and tumor markers. During the study, participants will attend scheduled visits for treatment and monitoring, including imaging scans to measure tumor response and laboratory tests to check health status. Quality of life and survival will be tracked up to about 24 months after randomization. The study also collects data on side effects and progression-free survival to better understand the benefits and risks of shorter versus longer immunotherapy maintenance.

Researchers are evaluating the safety and effectiveness of DPX-Survivac combined with pembrolizumab, with and without low-dose cyclophosphamide CPA, in adults with relapsed or refractory diffuse large B-cell lymphoma DLBCL. This Phase 2b, randomized, open-label study aims to better understand how these treatments work in this group of patients who have had previous therapies. The study is sponsored by ImmunoVaccine Technologies, Inc. IMV Inc.. Participants will be randomly assigned to one of two groups one group receives DPX-Survivac, pembrolizumab, and intermittent low-dose CPA, while the other group receives DPX-Survivac and pembrolizumab without CPA. DPX-Survivac is given as two 0.5 mL doses three weeks apart on days 7 and 28, followed by up to twelve 0.1 mL doses every eight weeks. Pembrolizumab is administered intravenously at 200 mg on day 7 and then every three weeks. In the CPA group, subjects take 50 mg of oral CPA twice daily for 7 days followed by 7 days off, repeating this cycle throughout the treatment period. During the study, participants will undergo assessments to monitor tumor response and safety for about 24 months, with some measures extending up to 48 months. Researchers will evaluate objective response rates, adverse events, duration and time to response, progression-free survival, and disease control rates. Patient-reported outcomes will be collected using specific questionnaires. The study involves regular visits for treatment administration, tumor biopsies, and laboratory tests to track the participants health and treatment effects over time.

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 conducting a phase 3, open-label, randomized study in adults aged 18 to 69 with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation ASCT and high-dose chemotherapy. The trial aims to evaluate the effectiveness and safety of using elranatamab and lenalidomide as alternatives to standard chemotherapy in the consolidation phase, and to compare elranatamab alone with standard maintenance therapies. This study involves about 824 patients across approximately 70 sites and addresses important outcomes like minimal residual disease MRD negativity, progression-free survival, and overall survival. Participants receive standard induction therapy with four cycles of D-VRd daratumumab, bortezomib, lenalidomide, dexamethasone followed by either ASCT and D-VRd consolidation standard arm or elranatamab with lenalidomide consolidation experimental arm. After consolidation, patients enter a maintenance phase where they are re-randomized to receive either daratumumab plus lenalidomide or elranatamab monotherapy for about two years. Treatment adjustments depend on MRD status and disease progression during maintenance. Throughout the study, participants undergo regular assessments including disease evaluations and safety monitoring. Researchers measure MRD negativity rates, progression-free survival, overall survival, adverse events, and quality of life using validated questionnaires. The trial offers long-term follow-up, lasting up to around 10 years, to capture comprehensive data on treatment effects and patient well-being.

This research aims to describe how patients aged 18 years or older with moderate to severe atopic dermatitis AD are managed with systemic therapy. It focuses on patients eligible for or currently receiving systemic treatments, following their care under real-world conditions. The study involves French dermatologists experienced in AD management, whether practicing in hospitals or private offices. Treatment decisions are made independently by the physicians and not influenced by the study enrollment. Participants will receive systemic treatments for AD prescribed by their doctors as part of routine care, with no investigational drugs involved. Information will be collected during regular visits according to usual clinical practice. The study will follow patients for one year, tracking their treatments and management without altering standard care. During the year, patients will be assessed at baseline, 6 months, and 12 months. Researchers will collect data on previous and current treatments, treatment adherence, changes in disease severity, itch, sleep disturbance, skin pain, quality of life, psychological health, work absences, and hospitalizations related to AD. This comprehensive follow-up aims to better understand how systemic therapies are used and their impact on patients in everyday clinical settings.