Neuilly Sur Seine

This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.

Researchers are evaluating the efficacy and safety of induction therapy with Afimkibart (also called RO7790121) in people aged 16 to 80 years who have moderately to severely active Crohn's disease. This Phase III, multicenter, double-blind, placebo-controlled study focuses on how well Afimkibart works compared to placebo in improving symptoms and healing the intestine. Participants will receive Afimkibart either as an intravenous (IV) infusion or a subcutaneous (SC) injection. The study includes a placebo group receiving a matching IV infusion. Treatment is given during the induction phase to assess the initial response. During the study, participants will be monitored for clinical remission using the Crohn's Disease Activity Index and for endoscopic response at 12 weeks. Researchers will assess safety, effectiveness, and any side effects throughout the study. Participants will undergo evaluations including symptom tracking and medical tests to measure treatment outcomes.

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

This research aims to understand brain-heart interactions in patients who are comatose after cardiac arrest. Despite progress in care after return of spontaneous circulation (ROSC), many survivors suffer brain damage ranging from mild cognitive issues to a vegetative state. Current methods to predict patient outcomes are limited, so this study seeks new markers related to how the brain and heart interact, which may help predict recovery or severity of brain injury in these patients. The study is an ancillary part of the HEAVENwARd trial and includes patients admitted to intensive care after cardiac arrest who remain comatose with a Glasgow score below 8. All eligible patients have routine EEG recordings with an ECG lead to monitor synchronous brain and heart activity. The study will assess the presence and prognostic value of abnormal bilateral brain-heart interactions in this group. Participants are monitored through EEG and ECG recordings taken during routine care. Researchers will evaluate heart-brain coupling to see if it relates to the severity of brain injury and neurological outcomes at day 28. The study focuses on measuring brain-heart interactions as a marker for consciousness and cognitive processing in comatose patients after cardiac arrest, helping to improve prognostic evaluations and potentially guide future treatments.

Researchers are evaluating early brain damage assessment scores in adult patients admitted to intensive care after cardiac arrest. Despite successful return of spontaneous circulation, outcomes remain poor and survival rates vary widely depending on arrest circumstances and post-resuscitation care. The study aims to compare different scoring systems to identify the best way to predict patient outcomes and guide treatment decisions in the critical early period after cardiac arrest. The study involves calculating early prognosis scores at the time of intensive care unit admission using clinical and biological data. These scores will be compared to determine which system most accurately predicts brain damage and patient prognosis following cardiac arrest. Participants will be assessed upon intensive care admission, typically within about three hours after cardiac arrest, using the cerebral admission hospital prognosis (CAHP) score and other scoring models. Data from clinical evaluations and biological tests will be collected to calculate these scores. Researchers will use these measures to determine the area under the curve for each scoring system to evaluate their predictive accuracy for patient outcomes.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

Researchers are evaluating the effectiveness and safety of obefazimod compared to a placebo in adults with moderately to severely active Crohn's Disease who have not responded well or are intolerant to conventional or advanced treatments. The study is a Phase 2b trial and includes three treatment phases: a 12-week Induction Phase, a 40-week Maintenance Phase, and a 48-week Extension Phase. The main goals are to assess how well obefazimod controls disease activity and its safety over these periods. Participants will receive either obefazimod or a matching placebo once daily, preferably in the morning with food. The trial includes an initial 12-week treatment to induce response, followed by a 40-week maintenance period to sustain results. Those who complete these phases may enter a 48-week Extension Phase to further evaluate the long-term safety and tolerability of obefazimod compared to placebo. During the study, participants will undergo regular assessments including clinical evaluations of disease activity using the Crohn's Disease Activity Index and endoscopic scoring at various time points up to week 52. Safety is monitored throughout, especially during the Extension Phase with checks for adverse events, blood tests, and other laboratory evaluations at scheduled visits. Overall, participation may last over a year, with careful monitoring of treatment effects and safety.

Researchers are evaluating the impact of a remote monitoring digital tool called MedicWise on patients with active Inflammatory Bowel Disease (IBD), including Crohn Disease and Ulcerative Colitis. The study aims to determine whether tight remote monitoring can improve disease control and increase the time patients spend in remission over 12 months. Secondary goals include assessing the effect on IBD-related disability and understanding how this tool influences the organization of care teams managing IBD patients. Previous studies showed mixed results for telemonitoring in IBD, highlighting the need for more standardized and technologically advanced solutions like MedicWise. The trial involves two groups where both receive the MedicWise application, which automatically collects biological and healthcare data, reducing the need for patient input. In the active telemonitoring group, alerts based on fixed thresholds notify care teams about patient status, while the control group receives standard care without active alert monitoring. Data are collected at enrollment and every three months up to one year. The response to alerts is managed internally by each center's healthcare professionals. Randomization is stratified by center and disease type. Participants will engage with the study over a 12-month period, using the MedicWise app to provide data remotely. Researchers will monitor the percentage of time patients spend in symptomatic remission during this period. Patient health status will be regularly evaluated, and the study also considers the organization and response of care teams to telemonitoring alerts. The study includes safety and efficacy monitoring throughout the follow-up.

Researchers are evaluating the use of a noninvasive liquid biopsy method to detect and measure circulating tumor cells (CTCs) in women with breast cancer. This study aims to track changes in the number of CTCs during breast cancer follow-up using ScreenCell technology. Identifying and studying these cells could provide valuable information about the cancer's stage and molecular features throughout the follow-up period. The study uses the DM/DIV ScreenCell device, which is applied to blood samples taken from participants rather than directly to the participants themselves. The study includes women with metastatic breast cancer, non-metastatic invasive breast cancer who have not yet received treatment, and healthy volunteers without cancer. The main focus is to observe how CTC levels evolve from enrollment to nine months of follow-up. Participants will provide blood samples at scheduled times during the follow-up period, which lasts nine months. Researchers will analyze the circulating tumor cells in these samples to understand their kinetics over time. The study will monitor safety and ensure participant consent throughout. The total participation duration corresponds to the follow-up period of nine months, during which data on CTC evolution will be collected and evaluated.

Researchers are studying gynecological conditions including endometriosis, adenomyosis, ovarian cysts, fibroids, and various gynecologic cancers such as ovarian, cervical, and uterine cancer. This international, multicenter, observational study aims to find a diagnostic signature for these gynecological diseases by analyzing the coding and non-coding RNA present in saliva samples from symptomatic and asymptomatic female patients. The study does not change the usual care, treatment, or diagnostic procedures for participants. The study collects saliva samples from women scheduled for surgery or biopsy for suspected or diagnosed gynecologic pathologies, as well as from asymptomatic women undergoing cervical cancer screening. Participants are managed according to local medical recommendations without modification. The intervention consists solely of collecting saliva samples for RNA analysis, with no treatment or medication administered as part of the study. Participants will provide informed consent and be followed for about one year. Researchers will evaluate the diagnostic accuracy of salivary RNA by measuring the area under the curve (AUC) of the receiver operating curve (ROC). Participants continue their usual medical care and undergo necessary examinations and follow-up as per their healthcare providers. The study includes monitoring of safety and adherence to study procedures but does not involve any changes to treatment or additional interventions beyond saliva collection.