Noida

Researchers are evaluating Mim8, a new medicine designed to help people with haemophilia A, including those with or without inhibitors. Mim8 aims to prevent bleeding episodes by replacing the function of the missing clotting factor VIII. This long-term study will last up to 5.5 years, ending either when Mim8 is approved in the participants country or by June 2028, whichever comes first. The study includes participants who have been involved in earlier related studies or are new infants with severe haemophilia A. Participants will receive Mim8 as a preventive treatment through subcutaneous injections. Depending on their entry point, participants may use an enhanced cartridge or a DV3407 pen-injector device for administering Mim8. The treatment is given regularly over the study period, with participants potentially receiving up to 262 injections. In the event of bleeding, additional haemostatic medications may be used as agreed with the study doctor. Female participants who are pregnant, breastfeeding, or planning pregnancy during the study are not eligible. During the study, participants will be monitored for any side effects, including injection site reactions and the development of antibodies against Mim8. Researchers will also track bleeding episodes, Mim8 blood levels, and device handling for some participants. Participants and their representatives will complete diaries and questionnaires about their treatment and health. Safety will be carefully followed throughout the study, which may last several years depending on individual enrollment and study progress.

Researchers are evaluating the effects of etavopivat in adolescents and adults with sickle cell disease. This study aims to confirm whether etavopivat reduces the number of painful vaso-occlusive crises caused by blood vessel blockages. It also examines if the medicine helps reduce organ damage, improve exercise tolerance, and decrease fatigue. The study is a phase 3, randomized, double-blind, placebo-controlled trial lasting about two years. Participants will be randomly assigned to receive either oral etavopivat or a placebo. The treatment is given by mouth, and neither the participants nor the researchers know which treatment is given during the study to ensure impartial results. The primary treatment period is 52 weeks, during which the number of vaso-occlusive crises with medical contact will be measured. Secondary assessments include changes in hemoglobin levels, fatigue scores, walking distance, and other blood markers related to sickle cell disease. During the trial, participants will undergo regular evaluations including blood tests, walking tests, and fatigue assessments from baseline to week 52. Researchers will monitor the safety and effectiveness of etavopivat throughout the study. The total participation time is about two years, with ongoing follow-ups to observe the treatment effects and any side effects. All procedures aim to provide detailed information on how etavopivat affects sickle cell disease symptoms and patient well-being.

Researchers are evaluating the effectiveness of icotrokinra JNJ-77242113 compared to a placebo in adults with active psoriatic arthritis PsA, including those who have and have not previously used biologic treatments. The study aims to assess how well icotrokinra reduces the signs and symptoms of PsA, focusing on improvements measured by the American College of Rheumatology ACR 20 response at Week 16. Participants are randomly assigned to receive one of two doses of icotrokinra or a matching placebo. Those initially receiving placebo will switch to one of the icotrokinra doses at Week 16. Participants who continue without discontinuing the study drug are eligible to enter a long-term extension phase, where they keep receiving their assigned icotrokinra dose. The treatment period involves regular monitoring and assessment of psoriatic arthritis symptoms. Throughout the study, participants will undergo various assessments, including evaluations of joint swelling and tenderness, skin psoriasis severity, fatigue, physical function, and quality of life. Laboratory tests such as C-reactive protein levels will be measured to monitor inflammation. Researchers will track responses using validated scales like the Psoriatic Area and Severity Index PASI and Investigator Global Assessment IGA. The total duration includes treatment and follow-up visits up to Week 16, with options for extended treatment in the long-term extension phase.

This research evaluates the antibacterial effects of different disinfection methods during root canal treatment in patients with type 2 diabetes and apical periodontitis. The study is a randomized controlled clinical trial conducted over one year, aiming to detect Peptostreptococcus species in infected root canals. The trial compares the use of a 940 nm diode laser, apple cider vinegar, Gymnema Sylvestre, and combinations of these against standard saline irrigation in diabetic patients aged 25 to 60 years. Participants undergo standard root canal treatment with aseptic isolation and access cavity preparation. Working length is determined by electronic apex locator and radiography. Canals are instrumented and irrigated using 5% sodium hypochlorite and 17% EDTA. They are then randomly assigned to one of six groups receiving either saline, apple cider vinegar, diode laser, Gymnema Sylvestre solution, or combinations of diode laser with apple cider vinegar or Gymnema Sylvestre. Post-disinfection microbial samples are collected for PCR analysis. Patients are followed up at 7, 15, 30, 45, and 60 days after treatment. Clinical outcomes are assessed using periapical radiographs and the Periapical Index PAI. Pain intensity is measured by the Visual Analog Scale VAS. Microbial presence of Peptostreptococcus species is monitored over one year using PCR. The study also tracks pain levels and treatment effects through repeated assessments during the follow-up period.

Researchers are evaluating the safety and effectiveness of LY4268989 compared to a placebo in adults with moderately to severely active ulcerative colitis UC. The study focuses on participants with a diagnosis of UC for at least 3 months, confirmed by specific clinical and endoscopic criteria. This Phase 2 trial aims to better understand how LY4268989 may impact clinical remission and response in this patient group over a long-term period. Participants will receive either one of two doses of LY4268989 or a placebo, all administered orally. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to approximately 108 weeks, excluding the screening phase, allowing for assessment of the drug over an extended time. During the study, participants will undergo regular evaluations including clinical assessments using the Modified Mayo Score to measure remission and response at multiple time points, including weeks 10 and 52. Researchers will also monitor symptomatic response and measure plasma concentrations of LY4268989. Safety and effectiveness will be tracked through these clinical and laboratory tests to understand the drugs impact on UC over the study duration.

Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90% of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.

Researchers are evaluating the impact of a couples-based financial literacy and gender-transformative intervention on relationship strength, empathy, and mental health among married couples in rural and urban communities across Maharashtra, Andhra Pradesh, and Rajasthan, India. This sub-study is part of a larger randomized controlled trial called Disentangling and Preventing Economic Violence against Women ECOVI, aiming to understand how empowering couples financially and promoting equitable relationships can improve mental well-being. Married couples in intervention clusters attend six structured community-based sessions, each lasting 2.5 to 3 hours. These sessions combine financial literacy topics like budgeting and savings with gender-equity education focusing on communication, shared decision-making, and empathy. Sessions are held approximately every 2-4 weeks in groups of about fifteen couples, led by male and female facilitators. Between sessions, participants receive SMS reminders to reinforce key messages. Couples in control clusters continue with usual community resources but do not receive the structured program during the study period. Participants complete baseline assessments before the intervention and endline surveys about six months after completing the sessions, measuring changes in relationship strength, empathy, and mental health using standardized scales. The study also plans to explore whether improvements in relationship quality mediate mental health benefits. Total participation spans approximately 1.5 years from baseline to endline. The trial is randomized with no masking and includes follow-up via surveys and SMS engagement to monitor progress and outcomes.

Researchers are evaluating the safety and how the body processes the drug luspatercept in children and adolescents aged 6 to under 18 years with beta-thalassemia, a blood disorder. This Phase 2a study includes both transfusion-dependent and non-transfusion-dependent participants. The study aims to find the recommended dose and assess pharmacokinetics over up to one year, with additional measurements of red blood cell transfusion burden, hemoglobin levels, iron therapy use, and safety events. The study is divided into two parts. Part A involves adolescents aged 12 to under 18 years with dose escalation and expansion cohorts for both transfusion-dependent and non-transfusion-dependent groups. After one year of treatment in Part A transfusion-dependent participants, Part B will enroll younger children aged 6 to under 12 years for further dose escalation cohorts. Luspatercept is given at specified doses, and participants benefiting from treatment may continue for up to five years in a long-term treatment period. Those who stop treatment will be followed up for at least five years or until study end. Participants will attend scheduled visits for treatment administration and assessments, including blood tests, monitoring of transfusions, hemoglobin levels, iron therapy, and adverse events. Pregnancy testing and reproductive education are required for participants of childbearing potential. The study monitors pharmacokinetics and safety throughout treatment, with follow-up continuing after treatment ends. Total participation can last up to 5 years or more depending on treatment continuation or follow-up needs.