Roubaix

Researchers are conducting a prospective, multicenter cohort study to follow children with idiopathic nephrotic syndrome INS, a rare kidney disease. The study aims to collect data on pediatric patients treated by pediatric nephrologists in France and its overseas territories to better understand the diseases characteristics and support future clinical trials. The study involves regularly recording medical, biological, psychological, and social data through routine clinical follow-ups, hospitalizations, and consultations. Additionally, annual telephone interviews will be conducted for patients in remission. Quality of life, treatment adherence, and treatment impact questionnaires will also be collected. A biobank is established to collect blood, urine, hair, and nail samples at the disease onset before immunosuppressive treatment begins. Participants will be followed from disease onset until age 18 or transfer to adult nephrology care. Data is collected via a secure website, medically validated and entered by clinical research staff. The main outcome is the number of cases included and their characteristics over two years. Participation involves routine care visits, interviews, and questionnaires, with continued monitoring planned through the study period ending in 2048.

Researchers are evaluating the real-world effectiveness of deucravacitinib in adults diagnosed with moderate-to-severe plaque psoriasis. This observational study aims to understand how this treatment works outside of controlled clinical trials, focusing on health outcomes important to patients and doctors. It is sponsored by Bristol-Myers Squibb and conducted in France. Participants in this study have started treatment with deucravacitinib as prescribed by their doctors. The study observes these patients over time without altering their treatment plans. There are no placebo or comparison groups since this is an observational study that follows patients initiating deucravacitinib treatment. During the study, doctors will assess skin condition using the Physicians Global Assessment and measure quality of life with the Dermatology Life Quality Index at baseline and several points up to 24 months. Patients will also report symptoms like itch, skin pain, and fatigue using visual scales. Researchers will track how long patients remain on treatment and reasons for stopping. The study involves regular follow-ups at months 1, 4, 12, 18 optional, and 24 to gather this information.

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 studying the biological effects and monitoring methods of chronic nitrous oxide abuse, which can cause neurological problems such as combined sclerosis of the spinal cord. Patients may experience walking difficulties, abnormal sensations, and in severe cases may require a wheelchair. There have also been reports of thrombosis linked to nitrous oxide use. Traditional tests measuring nitrous oxide levels in blood or urine are not reliable due to the gass short half-life, so other markers like vitamin B12 and homocysteine are being evaluated. The underlying causes of these clinical effects are not yet fully understood. The study observes two groups of nitrous oxide users those hospitalized with clinical symptoms assessed by neurological evaluation using the Peripheral Neuropathy Disability score or thrombotic events, and those without clinical symptoms seen during routine medical consultations. Participants undergo blood collections for biological analysis, with samples preserved for further study. This is an observational study without experimental treatment. Participants will have blood tests at the start and at intervals up to six months to measure markers related to nitrous oxide use and clinical outcomes. Researchers will also assess nitrous oxide consumption through self-reporting and estimation, alongside the severity of related clinical signs. The main outcome is the change in blood markers over about one year. The study includes people aged 14 to 65 who currently or formerly use nitrous oxide and have social insurance coverage.

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 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 evaluating the safety of the SECURIDRAP4 SELFIA4 bedding system in adults with disorientation, cognitive impairment, or behavior disorders. This interventional, multicenter, prospective, and non-comparative clinical investigation takes place in nursing homes and hospitals in France. It was initiated following the market withdrawal of the first version of the product and is conducted to confirm the safety of the second version as recommended by the ASNM. Participants will use the SECURIDRAP4 SELFIA4 restraint system for 15 consecutive nights as part of their usual care. An independent assessor will monitor the proper use of the bedding system during this period to ensure compliance with safety conditions. The study focuses on adverse events linked to the product, user errors, patient bedridden status, healthcare team satisfaction, and the learning curve for proper use. During the 15-night follow-up, patients will be closely observed, and data on adverse events and user-related safety issues will be collected. Healthcare teams will provide feedback on time savings, comfort, well-being, and respect for patient dignity. The study tracks the rate of patients remaining bedridden each night and monitors the staffs ability to learn the proper use of the SECURIDRAP4 SELFIA4 system. The total participation duration is 15 nights with minimal risks and constraints.

Chronic kidney disease CKD is a significant global health concern, with hypertension being the leading risk factor for death, cardiovascular problems, and progression to end-stage kidney disease in these patients. Lowering blood pressure is known to reduce these risks, but the best second-line treatment after initial therapy with ACE inhibitors or angiotensin receptor blockers ARBs is unclear. This study aims to compare a diuretic-based blood pressure lowering approach to usual care in patients with moderate to severe CKD and uncontrolled hypertension. Participants are assigned to one of two groups one group receives blood pressure management guided by a diuretic-based algorithm, while the other group follows the usual care provided by their clinicians, which may include pharmacological or non-pharmacological therapies. The study is a randomized, open-label, phase 3 trial using a parallel design. Treatment adjustments are made according to the assigned strategy, and the study will continue for up to 36 months to observe outcomes. During the study, participants will be monitored for kidney function decline, cardiovascular events, all-cause mortality, and blood pressure control. Researchers will assess changes in kidney filtration rate, proteinuria, diuretic use, and quality of life over time. Regular evaluations will include blood pressure measurements and other clinical assessments to track the effectiveness of the treatment strategies. The total participation time can last up to three years, with ongoing monitoring of health outcomes throughout this period.

This research aims to collect long-term safety and effectiveness information on commercially available Corin hip arthroplasty devices. It focuses on patients who have had hip replacement surgery using Corin implants, including those with primary, secondary, or post-traumatic osteoarthrosis, femur head necrosis, congenital dislocations, and revision surgeries. The study supports post-market surveillance and clinical evaluations of these devices. Participants are patients with hip implants from Corin. The study observes their outcomes over many years, starting during surgery and continuing up to 20 years after. Key evaluations include clinical performance, safety, radiological positioning and bone integration of the implants, as well as patient quality of life and satisfaction at various intervals. During the study, participants will undergo assessments at multiple time points including 3 months, 2.5 years, and up to 20 years after surgery. Researchers will collect data on implant outcomes, patient well-being, and implant safety. The main measure is the long-term outcome at 10 years, with additional follow-ups at 15 and 20 years to monitor ongoing performance and safety. The total duration of participation can extend up to 30 years from the start date.

Drug Hypersensitivity Syndrome, also known as DRESS Drug Reaction with Eosinophilia and Systemic Symptoms, is a serious and potentially life-threatening drug allergy that can cause severe organ damage. This research focuses on understanding the role and activation of eosinophils, a type of white blood cell involved in this condition, as well as investigating the immune mechanisms behind the eosinophilia seen in DRESS patients. The study aims to compare eosinophil activation and immune cell involvement between patients with DRESS, those with drug-induced maculopapular exanthema MPE with or without eosinophilia, and healthy individuals.