Batu Caves

Researchers are evaluating the effectiveness of Saruparib (AZD5305) compared to placebo when added to a standard radiation therapy (RT) and androgen deprivation therapy (ADT) regimen in men with high-risk and very high-risk localized or locally advanced prostate cancer who have a BRCA gene mutation. This phase III study aims to assess whether Saruparib can improve metastasis-free survival in this population. About 700 adult male participants will be randomly assigned to receive either Saruparib or placebo along with ADT. There are two groups: Cohort A includes 400 participants with newly diagnosed high-risk or very high-risk prostate cancer treated with primary RT or with high-risk biochemical recurrence after radical prostatectomy receiving salvage RT. Cohort B includes 300 participants with very high-risk locally advanced prostate cancer receiving primary RT combined with ADT and abiraterone. Saruparib and placebo will be given orally, and standard ADT and abiraterone with prednisone/prednisolone will be administered as per the regimen. Participants will be followed for up to about 93 months to monitor metastasis-free survival and overall safety. Assessments include imaging scans like CT, MRI, bone scans, and PSMA-PET to confirm disease status. The study also monitors organ function, performance status, and treatment adherence. An independent committee will review safety and efficacy data throughout the trial to ensure participant well-being and study integrity.

Researchers are evaluating the effectiveness of icotrokinra (JNJ-77242113) compared to a placebo in adults with active psoriatic arthritis (PsA). This study includes both participants who have previously used biologic treatments and those who have not. The goal is to assess how well the drug reduces the signs and symptoms of PsA by the 16th week of treatment. This is a Phase 3, multicenter, randomized, double-blind clinical trial designed to provide reliable evidence on the drug's impact on this condition. Participants will receive either icotrokinra or a placebo. The treatments will be administered according to the study protocol, but specific dosing details are not provided. Participants will be monitored over 16 weeks to evaluate their response to the treatment, focusing on the American College of Rheumatology (ACR) 20 response, which measures improvement in disease activity. The study compares the active drug against placebo to determine its efficacy and safety in this patient group. During the study, participants will undergo assessments to monitor their psoriatic arthritis symptoms, including joint swelling and tenderness, as well as blood tests to measure inflammation markers like C-reactive protein. Female participants who can become pregnant will have pregnancy tests before and during the study to ensure safety. Researchers will collect data on disease activity and safety throughout the study period to understand the treatment's effects. Total participation time and additional follow-up details are not specified.

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 an early switch from intravenous (IV) to oral antibiotic treatment for patients with uncomplicated Staphylococcus aureus bloodstream infection (bacteraemia). This phase 3, multicenter, randomized, open-label trial compares the safety and effectiveness of early oral antibiotic therapy against the standard minimum 14-day course of IV antibiotics in patients considered low-risk for complications. The study involves 290 patients from 12 Malaysian tertiary hospitals who have received 3 to 7 days of IV antibiotics. Participants are randomly assigned to either continue standard IV antibiotic treatment or switch early to oral antibiotics, including options like trimethoprim-sulfamethoxazole, clindamycin, cephalexin, or linezolid. The choice of antibiotic depends on bacterial susceptibility and patient factors. The treatment phase lasts 7 to 11 days, followed by a 90-day follow-up period with scheduled phone or inpatient visits. During the approximately 12-week study, patients undergo screening and enrollment, receive open-label antibiotic treatment, and are monitored at days 7-11, 30, and 90 after randomization. Researchers assess outcomes such as the rate of relapse of Staphylococcus aureus bacteraemia within 90 days. Patient condition reviews and standard clinical assessments are conducted to ensure safety and measure treatment effectiveness.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Researchers are evaluating whether the medicine BI 764198 can help adults and adolescents with specific kidney diseases, including secondary focal segmental glomerulosclerosis, treatment-resistant primary minimal change disease, Alport Syndrome, and treatment-resistant primary membranous nephropathy. This Phase II study aims to assess the safety, tolerability, and effectiveness of BI 764198 compared to a placebo in these proteinuric kidney diseases. Participants are randomly assigned to one of two groups: one group takes BI 764198 tablets once daily, while the other takes placebo tablets that look like the medicine but contain no active drug. All participants continue their usual kidney disease treatments during the 20-week treatment period. After treatment, there is a follow-up period, and overall, participants are involved in the study for about seven months. During the study, participants visit the study site six times and have three phone calls with the study team. Doctors regularly collect urine and blood samples to monitor protein levels and kidney function. Researchers compare these results between the two groups to determine if BI 764198 affects kidney disease markers. Participants' health and any side effects are also closely monitored throughout the study.