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Researchers are evaluating the treatment of anemia in patients with chronic kidney disease CKD who are on hemodialysis. This Phase III, investigator-blinded, randomized, multicenter study compares two drugs, efepoetin alfa and darbepoetin alfa, to see how well they maintain hemoglobin levels in these patients. The study aims to maintain hemoglobin between 10.0 gdL and 12.0 gdL, which is important for managing anemia in CKD. Participants will be randomly assigned in a 21 ratio to receive either efepoetin alfa or darbepoetin alfa. Both drugs are given by intravenous injection, typically after dialysis sessions. Efepoetin alfa is administered weekly from Day 1 to Week 28, with possible interval changes to one or two weeks from Week 29 to Week 52 based on investigator judgment. The study consists of three periods screening up to 28 days, treatment about 52 weeks, and a 4-week follow-up with phone contacts up to Week 56 or the last visit. During the study, participants will undergo regular assessments including hemoglobin level monitoring to evaluate the mean change between Week 20 and Week 28. Safety and efficacy are closely observed, with dosages adjusted to maintain target hemoglobin levels. Follow-up will include phone contacts to monitor participants up to Week 56. The total participation duration is approximately one year, starting from screening through treatment and follow-up.

Researchers are evaluating the efficacy and safety of BGM0504 compared with semaglutide as additional treatment to metformin in adults with type 2 diabetes in Indonesia. This Phase 3 trial aims to assess how well these treatments control blood sugar levels and their safety profiles in patients who have stable diabetes but still need better blood sugar management. Participants will receive either 5 mg or 10 mg of BGM0504 or 1 mg of semaglutide, all given by weekly subcutaneous injections. The study is randomized and open label, meaning participants are randomly assigned to one of these three groups and both participants and researchers know which treatment is given. The treatment period lasts 24 weeks, during which these drugs will be added to the participants ongoing metformin therapy. During the study, participants will have their blood sugar control measured through hemoglobin A1c HbA1c changes from baseline to week 24, along with body weight and fasting serum glucose levels. Assessments will also be made at week 12 for some outcomes. The trial involves safety monitoring and evaluates the percentage of participants reaching specific HbA1c target levels. The full participation duration is 24 weeks, with regular follow-up and assessments throughout this period.

Researchers are evaluating the safety, immune response, and effectiveness of the V181 dengue vaccine in healthy children aged 2 to 17 years. This study aims to see if V181 can reduce the number of dengue infections caused by any of the four dengue virus types, regardless of whether participants have had dengue before. The trial is a phase 3, randomized, double-blind, placebo-controlled study sponsored by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive a single 0.5 mL dose of either the V181 vaccine or a placebo by subcutaneous injection on Day 1. About 3600 participants are included in the Reactogenicity and Immunogenicity Subset, which will be monitored for safety and immune response for 28 days after vaccination. A smaller group of about 620 participants from this subset will be followed for up to 5 years to assess long-term immune response using specific virus neutralization tests. During the study, participants will be monitored for adverse events, vaccine reactions, and dengue infections, including severity and hospitalization rates, up to 5 years after vaccination. Safety assessments include tracking medically attended and serious adverse events. Immune responses will be measured by antibody levels and seroconversion rates. Participants will have scheduled visits during the first month postvaccination and ongoing follow-ups for several years to evaluate the vaccines long-term effects and protective benefits.

This trial is for adults who have had an acute ischemic stroke caused by a blood clot blocking a brain vessel. It focuses on people whose stroke occurred or was discovered more than 4.5 hours ago, including those who woke up with stroke symptoms. The study aims to find out if the medicine tenecteplase helps recovery when given after this 4.5-hour window, compared to standard medical care. Tenecteplase is already used within 4.5 hours after stroke onset, but this study tests its effect when given later. Participants are randomly assigned to one of two groups one receives a single injection of tenecteplase into a vein, and the other receives the usual standard treatment. Both groups have an equal chance of receiving either treatment. The study lasts about three months, starting with approximately one week of hospital stay. During the study, participants have seven clinical examinations or visits, with the final two visits conducted remotely from home to allow for easier participation. Throughout the study, doctors regularly assess participants recovery using a scale that measures disability and dependence in daily activities. They also monitor overall health and record any side effects. The main outcome measured is the level of recovery 90 days after treatment, comparing the two groups. This includes neurological improvement, bleeding events, and survival over the study period.

The trial investigates pain management after mastectomy for breast cancer, focusing on comparing two regional analgesia techniques. It aims to evaluate the pain relief and quality of recovery between a combined Pectoral Nerve II PECS II and Superficial Parasternal Intercostal Plane PIP block versus the standard Thoracic Paravertebral Block TPVB. This study addresses risks related to TPVB and explores whether the combined blocks can provide effective pain control with fewer complications. Participants are randomly assigned to one of two groups following general anesthesia induction one receiving the combined ultrasound-guided PECS II and PIP blocks with specific doses of 0.25% Bupivacaine, and the other receiving the ultrasound-guided TPVB at thoracic levels T4 and T6. Both groups receive standardized general anesthesia and intraoperative monitoring. Postoperative pain management includes oral paracetamol, IV ketorolac, and IV Morphine via patient-controlled analgesia PCA. During the 24-hour postoperative period, participants have their pain levels assessed at rest and movement using the Numeric Rating Scale NRS at multiple time points. Researchers also measure total opioid use, time to first analgesic request, and quality of recovery using the QoR-15 questionnaire. Monitoring for complications related to nerve blocks, such as local anesthetic toxicity and pneumothorax, is conducted, ensuring comprehensive safety and efficacy evaluation throughout the study.

Researchers are studying ambulatory antibiotic treatments for neonates with all-risk asymptomatic congenital syphilis in a randomized, open-label phase II trial called CARES-1. The study aims to evaluate the pharmacokinetics and safety of different antibiotic options to improve treatment approaches for this vulnerable newborn population. Participants are randomly assigned to one of three treatment groups a 10-day course of oral Linezolid given twice daily at 10 mgkg, a 10-day course of oral Amoxicillin given twice daily at 50 mgkg, or a single intramuscular dose of Benzathine Penicillin G at 50,000 IUkg. These treatments are provided in an ambulatory setting to assess their effectiveness and tolerability in newborns. During the study, infants will be monitored from enrollment through day 10 for antibiotic levels in blood and cerebrospinal fluid, and adverse events will be tracked for up to 24 weeks. Clinical outcomes will be evaluated through week 24 to assess treatment impact. This includes measuring time above minimum inhibitory concentrations and AUCMIC ratios in serum and CSF. Safety and treatment effects will be closely observed throughout the study duration.

This research aims to gather more information on the safety, effectiveness, and performance of the DynamX Coronary Bioadaptor System in treating patients with ischemic heart disease caused by new native coronary artery lesions. It focuses on a real-world patient population with coronary artery disease to confirm how well this device works and its safety when used in routine medical care. All participants in the study will receive at least one implant of the DynamX Novolimus-eluting Coronary Bioadaptor System during a percutaneous coronary intervention PCI procedure. The device will be used following the products instructions in a commercial setting. This registry monitors the devices performance and outcomes over time without altering the usual care process. During the study, patients will be followed to assess clinical outcomes such as device success, procedural success, and various cardiovascular events including myocardial infarction, revascularization, stroke, and death. These outcomes will be tracked at hospital stay, 30 days, and 12 months after the procedure. The study also collects data on the duration of dual antiplatelet therapy DAPT and will monitor device safety and effectiveness throughout the follow-up period, which extends up to 12 months and beyond.

Endometriosis is a long-lasting condition affecting 10-15% of women of childbearing age, commonly causing pelvic pain. Researchers are evaluating the effects of the drug triptorelin, a treatment approved in Indonesia for endometriosis symptoms, to compare dosing intervals and their impact on pain and hormone levels. This study aims to assess whether extending the dose interval can reduce side effects and improve patient adherence while effectively managing symptoms. Participants will be divided into two groups receiving triptorelin over an 18-week period. The first group will receive three doses two before surgery at baseline and week 6, and one after surgery at week 12. The second group will receive a single dose after surgery at week 12. The study is open label and non-randomized, with visits every six weeks to monitor treatment effects. During the study, participants will have their pain levels measured using a visual analogue scale VAS at baseline, week 6, week 12 before surgery, and week 18. Blood tests will assess Anti Mullerian Hormone AMH and estradiol levels at baseline and week 12. Additionally, surgical evaluation will assess the condition of the uterus and cysts. This approach allows researchers to observe hormone changes, pain improvement, and physical condition related to endometriosis treatment over time.

Researchers are studying the protective effects of oral vitamin C on the corneal endothelial layer in patients with hard cataracts undergoing phacoemulsification, a type of cataract surgery. The trial aims to determine whether vitamin C, given before and after surgery, can reduce oxidative stress and corneal endothelial damage compared to no vitamin C. This study also examines changes in oxidative stress markers in the eyes aqueous humour and blood, and the relationship between these markers. Participants are randomly assigned to one of three groups taking vitamin C before and after surgery, taking vitamin C only before surgery followed by placebo after, or taking placebo before and after surgery. The vitamin C or placebo is taken as 500 mg orally three times daily, starting seven days before surgery and continuing for 28 days after surgery. The trial includes a 7-week follow-up period with regular checkups. During the study, participants will visit the ophthalmology clinic on days 1, 7, 28, and 42 after surgery for assessments. They will keep a logbook to track medication intake and any symptoms. Researchers will measure endothelial cell loss, oxidative stress markers in blood and aqueous humour, corneal thickness, eye cell grading, and visual acuity over six weeks. Safety and adherence to medication will be monitored throughout the trial.

Researchers are evaluating whether pharmacopuncture using Platelet-Rich Plasma PRP can effectively reduce chronic neck pain in patients with cervical myofascial syndrome related to the upper trapezius muscle. This study aims to compare the effects of PRP pharmacopuncture to a placebo normal saline and assess improvements in pain, function, and quality of life, while monitoring any adverse effects. Participants will be randomly assigned to one of two groups one receiving a single intramuscular injection of PRP at acupuncture points targeting the upper trapezius muscle, and the other receiving a single injection of normal saline as a placebo. Both treatments will be given only once during the study. After the intervention, participants will be evaluated at 2, 4, and 8 weeks to measure various outcomes including pain levels, neck function, stress, quality of life, cervical range of motion, and changes in muscle trigger points. Biomarker parameters will be assessed before treatment and at 4 weeks post-treatment. This comprehensive monitoring aims to capture the treatment effects and any potential side effects over an 8-week period.