Beziers

Philadelphia-negative myeloproliferative neoplasms MPNs such as Polycythemia Vera, Essential Thrombocythemia, and Prefibrotic Myelofibrosis are chronic blood cancers caused by mutations affecting blood cell growth. These diseases carry a high risk of blood clots, which can cause serious complications and death. Current treatments include low-dose aspirin, but blood clots still occur in some patients despite therapy. This trial aims to study whether direct oral anticoagulants DOACs, which have shown benefits in other cancer patients, might help prevent blood clots in MPN patients with a specific mutation called JAK2V617F. Participants will be randomly assigned to receive either a direct oral anticoagulanteither Apixaban 2.5 mg twice daily or Rivaroxaban 10 mg once dailyor low-dose aspirin 100 mg once daily. The choice of DOAC is up to the investigator. The treatments will be given to high-risk patients for up to 24 months to compare their effects on clot prevention. Throughout the study, participants will be closely monitored for any thrombotic or bleeding events. During the trial, researchers will track the time until any arterial or venous blood clots occur, as well as any major or clinically relevant bleeding events. They will also evaluate survival, adherence to therapy, quality of life, and healthcare costs related to these treatments. Participants will have regular follow-ups over 24 months, including assessments for heart rhythm problems and safety monitoring. This comprehensive approach aims to better understand the benefits and risks of DOACs compared to aspirin in preventing clots in MPN patients.

Researchers are investigating treatments for acute myeloid leukemia AML, a blood cancer where myeloid cells grow uncontrollably. This study focuses on patients newly diagnosed with de novo AML who have intermediate or adverse genetic risk. It aims to compare the effects of a new drug combination, CPX-351, against standard intensive chemotherapy, especially in patients with certain genetic mutations linked to worse outcomes with current treatments. Participants will be randomly assigned to receive either CPX-351 or the standard chemotherapy regimen known as 73, which includes cytarabine and idarubicin. CPX-351 is given intravenously on specific days for induction and consolidation phases, while the standard chemotherapy follows a different schedule. The study will monitor how well these treatments reduce leukemia cells, using detailed genetic and flow cytometry tests, and explore biomarkers like P-gp activity. During the trial, participants will undergo bone marrow and blood tests to measure minimal residual disease MRD after treatment. Researchers will track remission rates, survival outcomes, side effects, quality of life, and changes in genetic markers for up to several years. Patients must be able to attend regular visits and blood sampling sessions throughout the study to support these evaluations.

Researchers are evaluating the medicine pelacarsen TQJ230 compared to a placebo in adults with atherosclerotic cardiovascular disease ASCVD who have high levels of lipoproteina and are already receiving inclisiran treatment to lower their LDL cholesterol. This study is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial with a parallel group design to assess the efficacy, safety, and tolerability of pelacarsen. Participants will be randomly assigned to receive either pelacarsen injections once a month for 12 months or placebo injections once a month for 6 months, followed by pelacarsen injections for the remaining 6 months during an open-label phase. All participants also receive background inclisiran treatment consisting of two initial loading doses three months apart, followed by doses every six months as per approved guidelines. During the study, participants will have regular visits and assessments including laboratory tests to measure lipoproteina levels and monitor safety. Researchers will track changes in lipoproteina concentration at baseline and six months, along with adverse events and treatment tolerability over up to 16 months. The trial aims to understand how pelacarsen affects lipoproteina levels and overall safety when combined with inclisiran in this patient group.

Researchers are studying a new way to give immunotherapy as maintenance treatment for patients with metastatic non-squamous lung cancer. This phase III clinical trial compares a pulse dosing schedule with a conventional dosing schedule to see if the less frequent pulse dosing is not worse than the standard treatment. The study focuses on pembrolizumab alone or combined with pemetrexed as the maintenance therapy after initial chemotherapy and immunotherapy induction. Participants are randomly assigned to one of two groups. In the Pulse arm, pembrolizumab 200 mg is given every 6 weeks, and pemetrexed 500 mgm is given every 3 weeks if there is no contraindication. In the Control arm, pembrolizumab is given either 200 mg every 3 weeks or 400 mg every 6 weeks, plus pemetrexed 500 mgm every 3 weeks when appropriate. This treatment is given after patients have completed 3 or 4 cycles of induction therapy with pembrolizumab plus platinum and pemetrexed. During the study, participants will be monitored for overall survival over 6 years, along with progression-free survival, response duration, quality of life using several questionnaires, treatment tolerance, and economic factors. Researchers will also perform population pharmacokinetic analyses and study the drugs effect on immune cells. Patients will undergo regular assessments including clinical evaluations and laboratory tests to track treatment effects and safety throughout the study period.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.

Heart failure remains a significant health concern due to high rates of rehospitalization, mortality, and related costs. Researchers are evaluating whether monitoring the biomarker soluble suppression of tumorigenicity 2 sST2 can help guide medical management in patients with acute heart failure to reduce hospital readmissions. This study is a multicenter, blinded, randomized controlled trial involving 710 patients followed over 24 months to assess the impact of sST2-guided therapy on health outcomes and costs. Participants are randomly assigned to one of two groups usual care where sST2 levels are not disclosed, or an intervention group where sST2 levels are monitored and used to guide therapy at hospital discharge and during follow-up visits at 6, 12, 18, and 24 months. The study compares the cost-utility ratio as the primary outcome, with secondary outcomes including cost-efficacy, hospitalizations for heart failure, and cardiac remodeling markers. Throughout the trial, patients undergo evaluations at 6, 12, 18, and 24 months to monitor health status and biomarker levels. Researchers measure quality-adjusted life years, hospitalization rates, and economic outcomes. Safety and treatment effects are assessed over the two-year follow-up period to determine the potential benefits of using sST2 biomarker-guided therapy in managing acute heart failure.

Fever is a common reason for children aged 3 months to 15 years to visit healthcare providers. It can be hard to tell if the fever is caused by a viral or bacterial infection just by examining the child, which sometimes requires additional tests like measuring C-reactive protein CRP. This study looks at using a capillary medical device to measure CRP directly in primary care to help reduce unnecessary referrals to emergency rooms and labs, improving care for febrile children and easing healthcare system burdens. The study compares two groups one using capillary CRP measurement with the ACTIM-CRP device and a control group without this intervention. Children are randomly assigned to these groups during their primary care visit when they have a fever that meets specific duration and severity conditions. The study runs from September 2025 to June 2027 and focuses on referral rates and other outcomes related to care pathways for febrile children. Participants will be involved in the study during their initial consultation and followed up for up to seven days to monitor referrals, antibiotic prescriptions, satisfaction of both general practitioners and parents, fever duration, and cost impacts. Data on complementary tests and healthcare usage will also be collected to understand the effects of using capillary CRP testing in primary care. The study aims to improve the efficiency and quality of care for children with fever.

Disorders of blood sugar control are common in patients hospitalized for acute coronary syndrome ACS, with abnormal glucose levels found in about half of cases. High blood sugar is a major factor affecting outcomes after ACS, regardless of diabetes status. This research aims to evaluate the predictive value of various glucose measurements taken by a continuous glucose monitor over two weeks in patients with ACS. Participants will have the Freestyle Libre Pro iQ sensor applied upon admission to the cardiac intensive care unit. This device continuously and non-invasively measures interstitial glucose levels for up to 14 days. If necessary, a replacement sensor will be placed during hospitalization. The study focuses on the glucose data collected by this sensor and how it relates to cardiovascular events over one year. During the study, participants will be monitored using the sensor while receiving standard ACS care. Researchers will track cardiovascular events for 12 months and diabetes status at 2 and 12 months. The study collects detailed glucose variability data to assess its ability to predict major cardiovascular outcomes. Participation involves wearing the sensor during hospitalization and follow-up assessments over a year to evaluate health outcomes.

Young women, especially those between 15 and 25 years old, are at risk of psychiatric disorders, which can cause serious disability and high healthcare costs. The perinatal period, including pregnancy, is a time of increased psychological vulnerability when psychiatric disorders may develop or worsen but often go undiagnosed and untreated. This study aims to measure how common psychiatric disorders are during pregnancy at the time of the second-trimester ultrasound using a standardized clinical assessment called the MINI. The study involves pregnant adult women attending their scheduled second-trimester ultrasound, regardless of their pregnancy history or context. Participants will undergo psychiatric consultations that include the MINI test, evaluation of suicidal behavior, and collection of medical and obstetrical history. They will also complete self-administered psychiatric questionnaires such as the Edinburgh Postnatal Depression Scale and others. Optionally, blood samples will be collected to support biological research. Participants will be assessed at two points during the second-trimester ultrasound and again at two months postpartum. These evaluations include standardized psychiatric interviews, questionnaires on medication adherence and treatment beliefs, and scales measuring mother-infant bonding. The study aims to better understand the prevalence and characteristics of psychiatric disorders during pregnancy and postpartum, improve screening tools, and gather biological samples for future research. The total duration of participation spans from mid-pregnancy to two months after delivery.

This research aims to observe patients in France with HER2-negative early breast cancer who are treated with olaparib, a medication chosen by their doctors. The study focuses on understanding how often patients complete the full course of olaparib treatment and gathers information on related genetic factors and medical history. It is a national, multicenter, prospective observational study without experimental treatment assignment. Participants in this study receive adjuvant olaparib treatment as part of their usual care under their physicians discretion. The study does not assign treatments but follows patients who start olaparib, tracking their treatment progress for up to 18 months after inclusion. There are no additional interventions or placebo groups. Throughout the study, researchers collect data on treatment completion rates, types of BRCA mutations, variant types, medical history, and the time until olaparib treatment stops. Participation involves observational follow-up, with no extra treatment visits beyond routine care. The overall participation lasts 18 months after a patients enrollment, focusing on real-world treatment experiences and outcomes.