Puchong

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating intismeran autogene combined with pembrolizumab compared to placebo plus pembrolizumab as an additional treatment after surgery for participants with certain stages of non-small cell lung cancer NSCLC. The study focuses on participants with margin-negative, completely resected Stage II, IIIA, or IIIB with nodal involvement NSCLC. The main question is whether the combination including intismeran autogene improves disease-free survival compared to pembrolizumab with placebo. Participants are randomly assigned to two groups. One group receives 1 mg of intismeran autogene by intramuscular injection every 3 weeks for nine doses plus 400 mg of pembrolizumab by intravenous infusion every 6 weeks for up to nine doses. The other group receives a placebo injection on the same schedule plus pembrolizumab on the same infusion schedule. Treatment continues until disease recurrence, unacceptable side effects, or approximately one year, whichever comes first. During the study, participants are monitored through regular assessments up to about 78 months for disease-free survival and up to 12 years for overall survival and other health outcomes. Quality of life questionnaires and adverse event monitoring are conducted at baseline and throughout the study. The research team tracks lung cancer-specific survival and distant metastasis-free survival, as well as changes in symptoms like coughing and chest pain. Safety is closely observed throughout treatment and follow-up periods.

This research aims to evaluate the effectiveness of a structured lifestyle intervention to induce remission of Type 2 Diabetes Mellitus T2DM among Malaysian adults. It also assesses the feasibility of implementing this approach within Malaysian primary and specialist care settings and examines the economic impact through cost-effectiveness analysis from a societal perspective. The study compares intensive lifestyle intervention to usual clinical care, hypothesizing higher diabetes remission rates, greater weight loss, better blood sugar control, and improved cost-effectiveness for those receiving the intervention. The trial uses a randomized, wait-list-controlled design with two phases. In the first phase, participants are randomly assigned to either an immediate intervention group or a wait-list control group. The intervention group undergoes a total diet replacement TDR phase for 8 to 12 weeks with a low-calorie diet, followed by a food reintroduction phase lasting 12 to 16 weeks, and then a 24-week weight maintenance phase. The wait-list control group receives usual care for 24 weeks before crossing over to the intervention. Medical management includes careful medication withdrawal and reintroduction protocols to manage blood pressure and blood sugar levels. Participants attend face-to-face or virtual appointments and phone calls with dietitians throughout the study. They complete food records and consumption logs to monitor adherence. The study measures diabetes remission rates at 6 months as the primary outcome, with secondary outcomes including remission maintenance at 12 months, weight loss, insulin resistance, and pancreatic function. Safety is monitored through regular checks of blood pressure, symptoms, and blood glucose levels, with adverse events reported promptly. The total participation period includes initial intervention and follow-up phases lasting up to 12 months.