Beziers

Researchers are studying Philadelphia-negative myeloproliferative neoplasms (MPN), which include Polycythemia Vera (PV), essential thrombocythemia (ET), and prefibrotic myelofibrosis (PreMF). These chronic blood cancers involve specific mutations like JAK2V617F and carry a high risk of blood clots that can cause serious health problems. Current treatments include low-dose aspirin to reduce arterial clots, but patients still face risks of thrombosis and bleeding. This trial explores whether direct oral anticoagulants (DOACs), such as Apixaban or Rivaroxaban, might better prevent these clotting events in patients with the JAK2V617F mutation. Participants will be randomly assigned to receive either a DOAC (Apixaban 2.5 mg twice daily or Rivaroxaban 10 mg once daily) or low-dose aspirin (100 mg once daily). The study focuses on high-risk MPN patients with JAK2V617F mutation and will compare the effectiveness and safety of DOACs versus aspirin for preventing blood clots. Treatment will continue with close monitoring throughout the study. During the study, researchers will track the time until any arterial or venous blood clots occur over a 24-month follow-up period. Participants will undergo regular assessments to monitor clotting events, bleeding risks, and overall health. The trial aims to gather detailed information on how well these treatments prevent thrombosis and their safety profiles, helping to guide future care for patients with these blood disorders.

This research investigates acute myeloid leukemia (AML), a blood cancer marked by the rapid growth of abnormal myeloid cells. The trial focuses on patients newly diagnosed with de novo AML who have intermediate or adverse-risk genetic profiles. It explores the effectiveness of CPX-351 compared to standard intensive chemotherapy, particularly in patients with secondary-type AML mutations, which are linked to poorer outcomes with conventional treatments. Participants are randomly assigned to receive either CPX-351 or intensive chemotherapy. CPX-351 is given as induction therapy with doses on days 1, 3, and 5, followed by consolidation therapy on days 1 and 3. The intensive chemotherapy group receives cytarabine and idarubicin with specific dosing schedules for induction and consolidation phases. The study examines these treatments in phase II, aiming to assess remission rates and molecular responses. During the study, patients undergo bone marrow sampling to measure minimal residual disease using a specialized flow cytometry method after the first induction phase. Researchers monitor remission depth, treatment response, and safety throughout the treatment. Patients must be available for regular assessments, blood tests, and clinical management at the study center. The trial tracks outcomes like deep remission rates and explores biomarkers related to treatment response over the study period.

The trial investigates the impact of personalized medical information delivered through a secure internet platform on preoperative anxiety in women undergoing breast cancer surgery. Breast cancer patients often experience high anxiety before surgery, which can affect anesthesia use and postoperative pain management. Visual tools like videos may help reduce anxiety, especially for patients with varying levels of education or language skills. This study evaluates whether unlimited access to this video-based platform can lower anxiety levels before surgery. Participants in the experimental group will receive standard oral and written preoperative information plus access to the EDOP internet platform. This secure platform includes an explanatory video about breast surgery and practical information on the surgery and recovery, accessible at any time during follow-up. The study is a multicenter, prospective, randomized, single-blind trial, with nursing staff blinded to group assignments. During the study, patients will complete self-questionnaires on anxiety, satisfaction, and understanding before surgery, the morning of surgery, at discharge, and six weeks postoperatively. Researchers will measure anxiety levels on the morning of surgery as the primary outcome. Secondary outcomes include changes in anxiety, medication use after surgery, and patient interactions with other medical resources. The study also monitors platform usage and satisfaction in the experimental group. Participation requires a follow-up lasting at least six weeks after surgery.

Researchers are investigating the effects of pelacarsen (TQJ230) compared to a placebo in adults with atherosclerotic cardiovascular disease (ASCVD) who have high levels of lipoprotein(a) (Lp(a)) and are also receiving inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C). The study is designed as a Phase 3 randomized, double-blind, placebo-controlled, multicenter trial with a parallel group structure, followed by an open-label treatment period. The aim is to assess the efficacy, safety, and tolerability of pelacarsen in this population. Participants will receive pelacarsen or placebo as a solution for subcutaneous injection using prefilled syringes. All participants will be given background treatment with inclisiran, starting with two loading doses spaced three months apart during the run-in period. Afterward, inclisiran will be administered every six months at Month 5 and Month 11. Following the double-blind phase, an open-label treatment period will continue, allowing further evaluation of the treatments. Throughout the study, participants will undergo assessments including measurement of lipoprotein(a) levels, with the primary outcome focusing on change in log-transformed Lp(a) concentration from baseline to six months. Laboratory tests will monitor LDL-C and other relevant markers. Safety and tolerability will be tracked continually, and standard care for cardiovascular risk factors such as hypertension and diabetes will be maintained. The study includes adults aged 18 to 80 years with established ASCVD and elevated lipid levels, ensuring ongoing monitoring and evaluation of treatment effects.

Researchers are evaluating a new way to give immunotherapy for adults with metastatic non-squamous lung cancer. This phase III randomized study compares a longer interval between pembrolizumab infusions as maintenance treatment against the usual schedule. Both groups may receive pembrolizumab alone or combined with pemetrexed, depending on eligibility and absence of contraindications. In the experimental Pulse arm, patients receive pembrolizumab 200 mg every 6 weeks plus pemetrexed 500 mg/m² every 3 weeks if appropriate. In the Control arm, patients get pembrolizumab either 200 mg every 3 weeks or 400 mg every 6 weeks, also with pemetrexed 500 mg/m² every 3 weeks when suitable. This study tests whether the longer dosing interval is not worse than the standard approach for maintenance therapy. Participants undergo regular evaluations including scans and clinical assessments to measure overall survival over 6 years. Eligibility checks include lung cancer diagnosis, prior induction therapy, and health status. Safety monitoring and follow-up continue throughout the study to track treatment effects and patient well-being.

Researchers are evaluating the effects of maridebart cafraglutide, given alongside standard care, in reducing heart failure events such as hospitalizations, urgent visits, cardiovascular deaths, and improving symptoms in people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This is a global phase 3, multicenter trial with a two-part design including a double-blind period followed by an open-label extension. The first part will end once around 850 key events have been recorded. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study includes an initial randomized, double-blind phase and a later open-label extension where all participants may receive the active treatment. The trial is designed to monitor participants over time to assess the safety and effects of the treatment compared to placebo. During the trial, participants will undergo assessments including monitoring for cardiovascular events, heart failure symptoms, and laboratory tests such as NT-proBNP levels. Researchers will track time until the first occurrence of cardiovascular death or heart failure events over approximately 35 months. Safety evaluations, adherence to treatment, and ongoing health status will be followed throughout the study period.

Heart failure is a serious health condition with high rates of hospital readmission, death, and treatment costs. Researchers are evaluating whether monitoring a biomarker called soluble suppression of tumorigenicity 2 (sST2) can help guide treatment to reduce hospital readmissions and improve patient management. This multicenter, prospective randomized controlled trial aims to study the medical and economic benefits of using sST2 levels to adapt therapy for patients with acute heart failure. The trial will include 710 patients from 10 centers over 12 months, with follow-up lasting 24 months. Participants are randomly assigned to either a usual care group where sST2 levels are not known or an intervention group where sST2 levels are measured at discharge and at 6, 12, 18, and 24 months to guide treatment decisions. This biomarker-guided therapy is compared to standard care to assess its impact on health outcomes and costs. During the study, patients will have external evaluations at 6, 12, 18, and 24 months. Researchers will measure quality-adjusted life years (QALYs) as the main outcome, along with cost-effectiveness, hospital readmission rates at 1 month and 2 years, and changes in heart structure through collagen biomarkers. This detailed monitoring aims to understand if sST2-guided treatment improves patient health and reduces healthcare costs over two years.

Researchers are evaluating the use of a capillary medical device to measure C-reactive protein (CRP) in children with fever aged between 0.25 months and 15 years. Fever is a common reason for outpatient visits among children, and distinguishing between viral and bacterial infections can be challenging. Since current CRP test results take several hours and cause delays in treatment, this study aims to assess whether rapid CRP measurement in primary care can reduce unnecessary referrals to emergency laboratories and ease overcrowding in emergency rooms and clinics. The study involves using the ACTIM-CRP device for semi-quantitative measurement of capillary CRP levels in febrile children during primary care visits. Children with fever meeting specific criteria related to fever duration and concern for bacterial infection are included. The intervention is designed to streamline the care pathway for these children by providing faster test results directly in primary care settings. Participants will be monitored for referral rates to facilities equipped for emergency laboratory testing on Day 1 and Day 7 after the initial consultation. The study also tracks treatment decisions and the impact on healthcare utilization. Parents and children will be informed about the study, and consent will be obtained. The overall goal is to improve fever management in children and reduce unnecessary emergency visits, benefiting both families and healthcare systems.

Disorders of blood sugar control are common in patients hospitalized for acute coronary syndrome (ACS), with abnormal blood sugar seen in about half of cases. High blood sugar during admission is a strong predictor of major cardiovascular events both shortly after and long term, regardless of whether the patient has diabetes. This trial investigates whether continuous glucose measurements taken with the Freestyle Libre Pro iQ sensor over two weeks can better predict cardiovascular events at 12 months after ACS. The study uses the Freestyle Libre Pro iQ, a professional sensor that continuously and non-invasively measures glucose levels under the skin for up to 14 days. Patients admitted to cardiac intensive care with ACS will have the sensor applied upon admission for the duration of their hospital stay. If the sensor is removed or defective before discharge, a replacement will be applied. For hospital stays longer than 14 days, a second sensor will be placed. Participants will be monitored for cardiovascular events over 12 months following their ACS. Researchers will collect detailed glucose data and analyze various glycemic parameters to understand their predictive value for cardiovascular outcomes. The study includes assessments during hospitalization and follow-up to track major cardiovascular events and glycemic variability using the continuous glucose measurements.

Young women aged 18 and over who are pregnant represent a group at risk for psychiatric disorders, which often begin between ages 15 and 25 and can cause significant disability and healthcare costs. The perinatal period increases psychological vulnerability, raising the risk of new or worsening psychiatric conditions that are frequently under-diagnosed and under-treated. This prospective multicenter study aims to determine how common psychiatric disorders are during pregnancy, specifically at the time of the second-trimester ultrasound, using a standardized clinical assessment called the Mini International Neuropsychiatric Interview (MINI). Participants will undergo a psychiatric consultation that includes the MINI test to assess psychiatric disorders, collection of medical, obstetrical, and family history, and evaluation of suicidal behavior with the Columbia-Suicide Severity Rating Scale. They will also complete multiple self-administered psychiatric questionnaires assessing topics such as depression, attachment, eating disorders, post-traumatic stress, and medication adherence. Additionally, an optional blood sample will be taken for biological research purposes. Throughout the study, women will participate in standardized psychiatric evaluations and complete self-questionnaires at the second-trimester ultrasound visit and again two months after giving birth. Researchers will measure the prevalence of psychiatric disorders during pregnancy and collect detailed psychiatric and biological data to improve understanding and future diagnosis. The study will also monitor safety and collect information on life events and social factors influencing mental health during this critical period.