Sungai Buloh

Researchers are evaluating the safety and effects of different doses of a new medicine called NNC0519-0130 on kidney function in adults with chronic kidney disease, some of whom may also have type 2 diabetes, and who are living with overweight or obesity. The study compares NNC0519-0130 with semaglutide, an existing medicine, and a placebo, which is a "dummy" treatment. This is a Phase 2 proof-of-concept and dose-finding study aimed at understanding how these treatments may reduce kidney damage. Participants will be randomly assigned to one of three groups receiving either NNC0519-0130, semaglutide, or placebo. All treatments are given by subcutaneous injection once weekly. The study treatment phase lasts up to 36 weeks, with assessments at weeks 12, 24, and 36 to monitor changes in kidney damage by measuring the urinary albumin-to-creatinine ratio. The overall study duration can be up to 43 weeks. During the study, participants will be regularly monitored through laboratory tests and clinical evaluations to assess kidney function and safety. Researchers will measure changes from the start of the study in the urinary albumin-to-creatinine ratio at multiple time points. Participants will also need to have stable doses of certain blood pressure medications before joining. Safety and treatment effects will be assessed throughout the study period.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the efficacy of claseprubart (DNTH103) compared to placebo in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) in this Phase 3 study. The goal is to assess how well claseprubart works in treating this condition, which involves nerve inflammation leading to muscle weakness and sensory problems. The study consists of multiple periods: Part A is an open-label phase lasting up to 13 weeks where all participants receive claseprubart. Those who respond move to Part B, a randomized, double-blind, placebo-controlled phase lasting up to 52 weeks, where participants receive either claseprubart or placebo by infusion or injection. After Part B, eligible participants may join an optional open-label extension for up to 104 weeks. A safety follow-up period of 40 weeks follows the treatment phases. Participants will undergo various assessments including neurological evaluations and disease activity scoring. Researchers will monitor the time from the first dose to disease relapse as the main outcome. Additional safety and efficacy measures will be tracked throughout all study periods. Total participation may last over two years including extension and follow-up phases.

Researchers are evaluating the safety, effectiveness, and how the body processes VX-01 as an oral treatment for people with moderate to severe Non-Proliferative Diabetic Retinopathy (NPDR) without clinically significant diabetic macular edema (CI-DME). This Phase 2, multi-center study compares VX-01 to a placebo over 52 weeks, aiming to see if daily doses can improve the condition in adults with Type 1 or Type 2 diabetes. Participants will be randomly assigned to receive either VX-01 tablets (150 mg twice daily) or matching placebo tablets twice daily for one year. The study groups are balanced based on the presence of proliferative diabetic retinopathy and blood sugar control levels. After the 52-week treatment period, there is a 12-week follow-up phase where all participants continue to be monitored without the study drug. During the study, participants will have regular eye exams, including imaging and visual acuity tests, and blood tests to monitor safety and treatment effects. Researchers will track adherence to medication and evaluate outcomes such as vision changes and diabetic retinopathy progression. Safety and tolerability will also be closely observed throughout the treatment and follow-up periods, with total participation lasting about 64 weeks.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Dementia is increasingly common in Malaysia, placing significant demands on family members who serve as caregivers. Many of these caregivers face challenges such as limited knowledge about dementia, negative attitudes, and difficulties in caregiving practices, which can cause stress and reduce the quality of care. This study aims to evaluate the effectiveness of the DemensiaKITA mobile health application in improving caregivers' knowledge, attitudes, and practices (KAP), as well as in reducing their caregiving burden. The study involves a non-randomized controlled trial with dementia caregivers from Kuala Lumpur and Selangor. Participants in the intervention group will use the DemensiaKITA app, which offers educational modules, attitude-shaping messages, practical caregiving tips, and self-monitoring tools, regularly throughout the study. The control group will continue their usual caregiving routines and community support without access to the app. Both groups will be followed over a set period to compare outcomes. Participants will undergo assessments before and after the intervention using validated questionnaires, including tools that measure caregiving knowledge, attitudes, practices, and burden levels. Researchers will track changes in these areas at baseline, one month, and three months after starting the intervention. This study will help determine whether a mobile health application can effectively support dementia caregivers in Malaysia and potentially guide broader use in similar communities.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating the effectiveness of three different oral health education methods—traditional lectures, mobile health via WhatsApp, and a Metaverse platform—among secondary school students aged 15 to 16 in Malaysia. The study focuses on improving oral health knowledge, attitudes, and practices using immersive technology compared to conventional and mobile approaches. This research is designed as a quasi-experimental study involving adolescents enrolled in semi-government co-educational schools. Participants will be divided into three groups, each receiving one of the three education interventions simultaneously at the same time and place. Conventional education will be delivered by trained dentists, mobile health education will be provided through WhatsApp messages, and the Metaverse-based education will be accessed via computer using the Meta-OHE platform. The study is expected to take place from May 1, 2024, to December 31, 2024. Throughout the study, participants' oral health knowledge, attitudes, and practices will be assessed before and immediately after the interventions. Data collection will include questionnaires and other evaluations to measure changes in oral health status. The study involves minimal risk, and participants can skip any questions they find uncomfortable. The total participation duration spans approximately six months, covering all educational sessions and assessments.

Researchers are conducting an open-label, single arm, multicenter extension study to assess the long-term safety and tolerability of inclisiran in participants with heterozygous or homozygous familial hypercholesterolemia (HeFH or HoFH). The study includes participants who have previously completed the pediatric ORION-16, ORION-13, ORION-20, or ORION-19 studies. This phase 3 trial aims to provide continued access to inclisiran treatment while monitoring for safety over an extended period. Participants will receive inclisiran as a solution for injection during the study. This extension study allows those who benefited from inclisiran in the previous ORION studies to continue treatment under close observation. The study is designed to monitor participants over a long-term period to evaluate any treatment-related adverse effects and overall tolerability. During the study, researchers will track treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) from the first day until the end of the study visit, which may last up to 1080 days. Participants will undergo regular assessments to ensure safety and tolerability, with data collected to support the long-term use of inclisiran in this population.

This research aims to speed up the evaluation of different antibiotic treatments and strategies for serious multidrug-resistant Gram-negative bacterial infections, focusing on bloodstream infections, ventilator-associated pneumonia, and hospital-acquired pneumonia caused by carbapenem-resistant Gram-negative bacteria (CR-GNB). The study uses a platform trial design with adaptive methods to efficiently assess various treatment options and improve survival rates in affected patients. The trial includes multiple antibiotic regimens tailored to specific resistant bacteria, such as combinations involving Colistin/Polymyxin B, Sulbactam, Tigecycline, Eravacycline, Meropenem, Ceftazidime-avibactam, Fosfomycin, Aztreonam, Cefiderocol, and others. These treatments differ based on the bacterial species and geographic location, including sites in China, Malaysia, Thailand, Singapore, Europe, and Australia. Participants will be monitored for clinical outcomes 28 days after randomization to assess the effect of these interventions on all-cause mortality. The study involves evaluating infection signs, bacterial cultures, and antibiotic suitability within 96 hours of sample collection. Safety and effectiveness will be tracked through routine clinical assessments and laboratory testing during the treatment period.