Saint Quentin

Research shows that women who experience interpersonal violence are at a higher risk of developing post-traumatic stress disorder (PTSD). In France, female victims can request a medico-legal examination in clinical forensic medicine units, which also offer initial psychological evaluations. However, many women do not attend follow-up appointments. This trial aims to evaluate the effectiveness of a case management algorithm using early phone contact compared to usual care on clinical outcomes after such consultations for female victims of violence. Participants in the intervention group, called VIGITRAUMA, will receive a phone call three weeks after their initial consultation, with the possibility of a second call. If contact is not made after the second call, a postcard will be sent. The control group will receive the standard follow-up care without additional phone contact. The study is a prospective, multicenter, open-label, randomized controlled clinical trial involving women victims of violence. Women enrolled will be evaluated via phone at 3 months, 6 months, and 12 months following their consultation to assess clinical outcomes related to PTSD and violence-related symptoms. The study monitors the effectiveness of early phone contact in improving these outcomes and reducing the risk of PTSD development among participants.

Researchers are evaluating the safety and effectiveness 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 worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are evaluating the safety and effectiveness of divarasib combined with pembrolizumab compared to pembrolizumab with pemetrexed and either carboplatin or cisplatin. The study focuses on adults with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation. This is a Phase III trial aiming to improve first-line treatment options for these patients. Participants will receive one of two treatment combinations. One group will take divarasib orally once daily along with pembrolizumab given through an intravenous infusion every three weeks. The other group will receive pembrolizumab with pemetrexed and either carboplatin or cisplatin, all administered by intravenous infusion every three weeks. Treatment schedules and dosages are carefully monitored during the study. Throughout the study, participants will be regularly assessed for progression-free survival and overall survival, with follow-up lasting up to approximately five years. Researchers will perform various evaluations including tumor measurements and safety monitoring. This long-term observation helps to understand the treatments' effects and safety over time, supporting informed decisions for future lung cancer therapies.

Researchers are investigating a new approach to immunotherapy duration for patients with metastatic non-small cell lung cancer (NSCLC). This phase II-III randomized trial focuses on patients with stage IV NSCLC who have not received prior treatment for advanced disease. The study aims to compare the standard two-year immunotherapy maintenance with a shorter six-month (27-week) treatment period in patients who achieve disease control after initial chemo-immunotherapy induction, addressing the need to optimize treatment duration while maintaining disease control. Participants will first receive a combination of chemotherapy and pembrolizumab as initial treatment: either paclitaxel-carboplatin for squamous cell carcinoma (SCC) patients or pemetrexed-platinum for non-SCC patients, along with pembrolizumab every three weeks. After six months, patients who show disease control without severe toxicity will be randomly assigned to either continue pembrolizumab (with or without pemetrexed for non-SCC) until disease progression or unacceptable toxicity or complete two years of treatment, or to observation (with or without pemetrexed for non-SCC). Throughout the study, participants will undergo regular assessments including imaging to measure tumor response according to RECIST 1.1 criteria. Researchers will monitor overall survival at 18 months in phase II and about 24 months after randomization in phase III. Additional evaluations include performance status, PD-L1 expression, and safety monitoring. The total participation duration includes the initial six-month induction followed by the randomized maintenance or observation phase, allowing comprehensive evaluation of long-term outcomes and treatment impact.

Researchers are evaluating the safety and effectiveness of DPX-Survivac combined with pembrolizumab, with or 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 compare these treatments in patients who have previously received at least two lines of systemic therapy but whose disease has progressed. Participants will be randomly assigned to one of two groups: one group will receive DPX-Survivac, pembrolizumab, and intermittent low-dose CPA; the other group will receive DPX-Survivac and pembrolizumab without CPA. DPX-Survivac is given as two subcutaneous injections three weeks apart followed by up to twelve smaller doses every eight weeks. Pembrolizumab is administered by intravenous infusion every three weeks. For those in the CPA group, oral CPA is taken twice daily in a cycle of seven days on and seven days off, continuing throughout treatment. During the study, participants will be monitored for treatment response over approximately 24 months, focusing on the objective response rate in each group. Evaluations include tumor biopsies before and during treatment, laboratory tests, and disease assessments. Safety will be closely observed, and participants must have a life expectancy greater than three months to join. The study plans to enroll up to 102 subjects, with regular follow-up to track treatment effects and side effects.

Researchers are evaluating the effects of caffeine on cognitive decline in people with Alzheimer's disease at the beginning to moderate stages. This phase 3 trial aims to compare the impact of caffeine treatment versus placebo on cognition over 30 weeks. Alzheimer’s disease is a complex condition with no current cure, and caffeine's properties may offer symptomatic benefits, although high doses could cause anxiety and insomnia, especially in this vulnerable group. Participants will undergo a 6-week caffeine diet before starting treatment. Then, caffeine or placebo capsules will be given with a titration phase of 3 weeks increasing the dose by 100mg every stage until reaching a target of 400mg daily in two doses, maintained for 27 weeks. After treatment, doses will be gradually decreased following the same schedule. During the study, participants will be monitored for changes in cognitive function measured by neuropsychological tests at 30 weeks after randomization. Caregivers will be involved, and participants’ clinical status, safety, and adherence to a low caffeine diet will be assessed. The total participation duration includes the caffeine diet, titration, treatment, and dose reduction phases.

Researchers are conducting a phase 3, multicenter, open-label, randomized study to evaluate new treatments for adults with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation (ASCT). The study aims to compare the effectiveness and safety of a combination of elranatamab and lenalidomide as a replacement for standard chemotherapy during the consolidation phase, and to assess elranatamab alone versus standard care during maintenance therapy. Participants will first receive standard induction therapy with four cycles of a drug combination called D-VRd. After this, they will be randomly assigned to either receive standard consolidation therapy involving high-dose chemotherapy and ASCT followed by D-VRd consolidation (Arm A), or elranatamab combined with lenalidomide for consolidation (Arm B). Upon completing consolidation, patients will be re-randomized to receive maintenance treatment with either lenalidomide alone (Arm C) or elranatamab alone (Arm D). During the study, participants will be monitored for treatment effects including minimal residual disease negativity at the end of consolidation, progression-free survival, and overall survival. The study involves various assessments including clinical evaluations, laboratory tests, and monitoring for disease progression or side effects. The entire treatment and follow-up period may last up to several years, allowing researchers to evaluate long-term outcomes and safety.

Researchers are conducting a French prospective observational study to understand how patients aged 18 years and older with moderate to severe atopic dermatitis (AD) are managed when eligible for or currently receiving systemic therapy. The study aims to describe treatment patterns, including previous and current therapies, and monitor drug survival and compliance over time. Experienced dermatologists in hospital and office settings will participate, ensuring treatment decisions reflect real-world clinical practice. Patients will be followed for one year under routine care, with systemic treatment decisions made solely by their physicians independent of study enrollment. The study does not involve specific interventions or changes in treatment but observes the use and management of systemic therapies for AD, including topical corticosteroid use and other systemic options. Participants will complete questionnaires and undergo assessments at baseline, six months, and twelve months. Researchers will collect data on previous and current treatments, therapeutic management of atopic comorbidities, drug survival changes, and treatment adherence. The study focuses on gathering real-life information on systemic therapy use and patient outcomes over the 12-month follow-up period.

Cancer patients often experience anxiety, nausea, and vomiting during chemotherapy, which can affect their quality of life. This research investigates the use of immersive virtual reality (VR) to help manage these symptoms in patients receiving their first line of chemotherapy. The study also measures the overall quality of life and satisfaction levels of both patients and nursing staff during treatment. The study is a controlled, randomized clinical trial with two groups: one group receives standard care with VR immersion using the Healthy Mind VR program during their first three chemotherapy sessions, while the other group receives standard care without VR. The trial includes a pre-inclusion visit 7 days before starting chemotherapy, treatment visits during three chemotherapy cycles, and follow-up visits at 3, 6, and 9 months after chemotherapy completion. Participants will complete quality of life questionnaires and satisfaction surveys, and anxiety, pain, depression, fatigue, nausea, and vomiting will be measured using various tools such as the QLQ-C30 questionnaire, Visual Analogue Scale, HAD score, and MASCC Antiemesis Tool. Patient and nurse satisfaction with chemotherapy procedures will also be assessed. Monitoring occurs at multiple points including before and after chemotherapy cycles and during follow-up visits up to 9 months post-treatment.

Bronchiectasis is a chronic lung condition where parts of the bronchial tubes become permanently widened, leading to mucus buildup, infections, and ongoing inflammation. Managing this disease often includes respiratory physiotherapy to help clear mucus. However, accessing this therapy regularly can be difficult due to time, location, and availability of trained professionals. Researchers are evaluating the long-term use of the SIMEOX device, which uses brief air pressure pulses to help loosen and move mucus, combined with remote physiotherapy, to improve the quality of life and reduce lung flare-ups in adults with non-cystic fibrosis bronchiectasis. The study compares two groups: one using the SIMEOX device daily at home along with remote physiotherapy sessions, and a control group receiving enhanced standard care plus remote physiotherapy. The remote physiotherapy is delivered monthly for the first three months and then every three months afterward. The study lasts on average 24 months, allowing assessment of the device's effects over the mid and long term. Participants will be monitored through quality of life questionnaires and tracking of pulmonary exacerbations during the study. Evaluations include respiratory assessments and ensuring participants can use the device and follow procedures. The main outcomes measured are changes in respiratory quality of life after six months and the annual rate of lung exacerbations over the full study period. Safety and treatment adherence will also be continuously reviewed throughout participation.