Kota Bandung

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 studying healthy infants in Indonesia to compare the immune response and safety of two vaccines Minhais 13-valent Pneumococcal Polysaccharide Conjugate Vaccine PCV13-DTTT, also called Pneuminvac and Pfizers 13-valent Pneumococcal Conjugate Vaccine PCV13, known as Prevenar 13. The study focuses on infants aged 6 to 8 weeks and aims to show that Pneuminvac produces immune responses that are not worse than Prevenar 13 after a booster dose, while also monitoring vaccine safety when given together with a hexavalent vaccine. About 500 infants will be randomly assigned to two groups one receiving Pneuminvac and the other receiving Prevenar 13. Both vaccines will be given at 2, 4, and 12 to 15 months of age. Additionally, all infants will receive the hexavalent vaccine at 2, 3, and 4 months of age. This design follows World Health Organization recommendations for infant vaccination schedules. Participants will attend scheduled visits for vaccinations and assessments, including blood tests to measure immune responses one month after the booster dose. Safety will be closely tracked by recording any side effects after each vaccine dose and serious adverse events up to six months after the booster. The study aims to evaluate the percentage of infants with protective antibody levels and compare immune responses between vaccines, with total participation lasting from enrollment until several months after the final vaccine dose.

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.

Skin rejuvenation aims to improve the signs of skin aging, which involve changes in the skins layers including reduced collagen leading to thinner skin, laxity, and wrinkles. This trial evaluates and compares two types of laser therapies, fractional CO laser and long-pulsed 1064-nm NdYAG laser, both used to stimulate collagen production and improve skin condition. The goal is to assess their effects on dermal thickness, skin elasticity, wrinkles, and overall aesthetic improvement in adults aged 30 to 59 with moderate skin aging.

This research aims to understand how a modified poco-poco exercise affects aging markers and frailty levels in elderly people living in the community. The study focuses on people aged 60 and older in Bandung, Indonesia, investigating changes in global DNA methylation, GDF15 levels, Lamin A COP levels, and the degree of frailty after exercise. Frailty is a common issue in older adults linked to worsening health, and this study explores whether exercise can influence key biological markers related to aging. Participants will engage in a multicomponent exercise program that includes flexibility, balance, aerobic, and muscle-strengthening activities incorporated into a modified poco-poco routine. This exercise will be performed three times a week for 12 weeks. The modified exercise adds muscle strengthening to the traditional poco-poco exercise to better address the needs of frail elderly individuals. Throughout the study, researchers will measure changes in the participants levels of global DNA methylation, GDF15, Lamin A COP, and frailty at the start and after 12 weeks. Participants will be regularly assessed to track these biological and physical changes. The study is sponsored by Universitas Padjadjaran and aims to help improve health strategies for the elderly community through physical activity.

This research aims to evaluate the effectiveness of adding External Counterpulsation ECP therapy to standard medical treatment for patients with stable angina pectoris who are waiting for coronary artery bypass grafting CABG surgery. The study addresses the longer waiting times for CABG in Indonesia, which may increase risks during this period. The goal is to assess whether ECP can relieve symptoms and improve heart function and quality of life in these patients. Participants will be randomly assigned to either the intervention group receiving ECP therapy or the control group receiving only medical treatment. ECP therapy involves 36 sessions, each lasting one hour, conducted five days a week with an initial pressure of 300mmHg. The control group will not receive this therapy. The study will compare changes in heart function and symptoms between the two groups. Participants will undergo assessments before and after the seven-week intervention period, including echocardiography, treadmill tests, and questionnaires measuring angina severity and quality of life. Additional tests may include nuclear myocardial perfusion imaging and blood tests for heart-related biomarkers. Researchers will monitor major adverse cardiac events over two years and perform safety oversight. The total study duration includes the seven-week intervention and long-term follow-up for safety and effectiveness.

Women who have experienced preeclampsia during pregnancy face a higher risk of heart disease later in life due to lasting damage to blood vessels. This trial evaluates whether a new treatment using mesenchymal stem cell-derived exosomes can help repair blood vessel damage in postpartum women with a history of preeclampsia. Preeclampsia causes high blood pressure and endothelial dysfunction, leading to serious long-term cardiovascular risks. Participants will receive either a single dose of exosome therapy or a placebo through an intravenous or intramuscular injection. The exosomes contain healing substances such as growth factors and microRNAs that may promote blood vessel repair. The study includes 80 women randomly assigned to receive either the treatment or placebo, with follow-up visits extending up to 24 months to monitor long-term effects. Women in the study will undergo blood tests, vital sign checks, and imaging to assess blood vessel function and health. Researchers will measure changes in endothelial function biomarkers, blood pressure, blood counts, and edema at baseline and one week after treatment. Safety and health will be closely monitored throughout the study period, including proteinuria and uterine artery function, to evaluate the treatments impact on vascular repair and cardiovascular risk reduction.

Researchers are evaluating the real-world effectiveness and safety of Nebilet4 nebivolol in adults with hypertension across seven Asian countries. This multinational, multicenter, observational, and prospective study aims to assess blood pressure changes, treatment adherence, quality of life, prescription patterns, and cardiovascular outcomes over up to three years. The study also compares Nebilet4 used alone versus in combination therapy and investigates the relationship between home and office blood pressure measurements. Participants include about 5,000 adults newly diagnosed with or having uncontrolled hypertension who have recently started Nebilet4 or been on it no more than two weeks. Patients are followed regularly for 12, 24, and 36 months, with blood pressure measured at each visit and home readings encouraged. The study collects data on medication dosing and frequency, adherence, and cardiovascular risk factors, while monitoring major adverse cardiac events such as heart attack, stroke, and cardiovascular death. During the study, participants complete questionnaires to assess quality of life and medication adherence every few months. Data are recorded through an electronic system ensuring consistency across sites. Researchers evaluate changes in systolic and diastolic blood pressure and the proportion achieving target blood pressure goals. Safety and any adverse events are documented, with follow-up visits extending up to three years to provide insights into the long-term management of hypertension with Nebilet4.

Neuromuscular blocking agents like rocuronium are often used during surgeries such as laparoscopic cholecystectomy to help with intubation and muscle relaxation. This research compares two drugs, sugammadex and neostigmine, used to reverse the muscle relaxation after surgery. The goal is to see if half-dose sugammadex leads to faster recovery times than neostigmine, which is commonly used but has a slower and less predictable recovery. Participants will receive either sugammadex at 1 mgkg or neostigmine at 60 mcgkg combined with atropine after their surgery when moderate neuromuscular blockade is detected. Both groups will undergo the same anesthetic protocol, and muscle recovery will be monitored with a device called an acceleromyography monitor. Extubation will occur once the muscle function reaches a specific recovery level. During the study, patients muscle recovery times and possible side effects like bradycardia and hypotension will be closely observed. Monitoring includes checking the Train of Four Ratio to ensure safe extubation. The main outcome measured is the recovery time within one hour after reversal drug administration, with additional assessments for spontaneous recovery and safety within a few hours after surgery.

Systemic Lupus Erythematosus SLE is an autoimmune disease that affects multiple body systems with a wide range of symptoms, from mild skin and joint problems to severe, life-threatening issues. Patients with SLE are more vulnerable to infections due to their weakened immune system and the use of steroids and immunosuppressants. Tuberculosis TB is a common and serious infection in SLE patients, especially in Asia-Pacific countries, and there is currently no guideline for using isoniazid INH to prevent TB in these patients. This study compares two groups of SLE patients with mild or remission disease activity one group receives isoniazid 5 mgkgday up to 300 mgday plus pyridoxine 10 mgday for nine months, while the other group receives a placebo. Both groups continue their usual SLE medications. Patients are screened to exclude active TB, liver problems, pregnancy, malignancy, or history of allergy to INH. The study includes regular monitoring of liver enzymes and disease activity over one year. Participants will have their liver function and SLE activity checked at 2 weeks, monthly for the first three months, then every three months until one year. Researchers will assess drug-induced hepatitis and lupus disease activity using specific lab tests and clinical scores. The goal is to evaluate the safety of INH in preventing TB in SLE patients by carefully tracking side effects and disease changes during the study period.