Kota Bandung

Researchers are evaluating the immune response and safety of Minhai's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-DT/TT) compared to Pfizer's 13-valent Pneumococcal Conjugate Vaccine (PCV13) in healthy infants in Indonesia. The study aims to show that the immune response from the new PCV13-DT/TT vaccine is not worse than that from PCV13 when given alongside Hexavalent vaccines at specific infant ages. This phase 3 clinical trial includes infants vaccinated at 2, 4, and between 12 to 15 months of age to assess these outcomes. About 500 infants aged 6 to 8 weeks will be randomly assigned to two groups: one receiving the study PCV13 vaccine and the other receiving Pfizer's Prevenar13 vaccine. Both groups will receive their respective vaccines at 2, 4, and 12 to 15 months of age. Meanwhile, the Hexavalent vaccine will be administered at 2, 3, and 4 months of age. This schedule follows WHO recommendations for infant vaccination. Participants will be monitored through scheduled visits, vaccination plans, and laboratory tests to assess immune responses and safety. The main outcome measured is the percentage of infants with protective antibody levels 30 days after the booster dose. Researchers will also track any side effects and overall safety during the study. Participation will include informed consent from parents or guardians and follow-up throughout the vaccination period.

Researchers are evaluating whether the medicine tenecteplase helps adults recover from an acute ischemic stroke when given more than 4.5 hours after they were last seen well. This study focuses on people who had a stroke caused by a clot blocking blood flow in the brain and who have imaging showing brain tissue that can still be saved. Participants should not be planning to receive a procedure to remove the clot and must have a pre-stroke disability level of 0 or 1 on the modified Rankin Scale. Participants are randomly placed into two groups. One group receives a single injection of tenecteplase into a vein, while the other group receives standard medical care. The study includes adults aged 18 and over who had an acute stroke or woke up with stroke symptoms more than 4.5 hours ago. Imaging with MRI or CT is used to confirm eligibility. The study lasts about three months, starting with a hospital stay of about one week. During the study, participants have seven clinical examinations or visits to monitor their recovery and health. The last two visits may be done from home to allow remote assessments. Researchers use the modified Rankin Scale to measure disability or dependence in daily activities at 90 days after treatment. They also monitor for any side effects or health changes to compare the effects of tenecteplase against standard care.

Researchers are evaluating the effectiveness of two laser treatments, fractional CO2 laser and long-pulsed 1064-nm Nd:YAG laser, for improving signs of skin aging. Skin aging involves complex changes like thinning of the dermis and increased wrinkles, influenced by internal and external factors. Both lasers aim to stimulate collagen production and improve skin appearance, but no prior studies have directly compared their effects on dermal thickness, skin elasticity, wrinkles, and overall aesthetic improvement. The study uses a split-face design where one side of the face receives fractional CO2 laser treatment and the other side receives long-pulsed Nd:YAG laser treatment. Each laser is applied in three sessions spaced one month apart. The fractional CO2 laser creates small ablative zones to promote dermal remodeling, while the Nd:YAG laser provides non-ablative heating to encourage collagen remodeling and enhance skin texture and elasticity. Participants will be assessed from enrollment through 20 weeks of treatment, with measurements of dermal thickness, skin elasticity, wrinkle appearance, and global aesthetic improvement. Researchers will monitor changes over this period to compare the effects of the two laser therapies. The study includes careful follow-up and evaluations to determine which laser may provide better skin rejuvenation outcomes.

Toxoplasma gondii infects over one third of the global population, and cerebral toxoplasmosis is a common and deadly infection in people with HIV. This trial evaluates the use of adjunctive dexamethasone, a steroid, to reduce brain swelling and mortality in patients with cerebral toxoplasmosis. The study is a Phase 2 randomized controlled trial aiming to clarify the best dose and duration of steroid use, as current evidence is limited and conflicting regarding its benefits and safety. Participants will be randomly assigned to receive either intravenous dexamethasone 20 mg daily for 7 days or a placebo of normal saline for the same period. Dexamethasone is chosen for its strong anti-inflammatory and anti-edema effects, long half-life, and practical daily use. The study compares these two treatments to assess the impact on patient outcomes. During the study, participants will be monitored for mortality up to 90 days, along with clinical signs and symptoms of cerebral toxoplasmosis. Safety and effectiveness will be carefully evaluated to determine if dexamethasone reduces death rates without causing harm. The total follow-up period includes 90 days after treatment to assess longer-term outcomes.

Researchers are evaluating the effects of a modified poco-poco exercise on frailty and aging markers in elderly people living in Bandung. The study focuses on changes in global DNA methylation, growth deficiency factor (GDF15), lamin A cyclic osteo progenitor (COP), and frailty levels over 12 weeks. Frailty is common among the elderly population in West Java, affecting about 25.2% of Indonesians, and is linked to worsening health through aging mechanisms represented by these biomarkers. Participants will engage in a multicomponent exercise program including flexibility, aerobic, balance, and strengthening exercises based on the modified poco-poco routine. This exercise is performed three times a week for 12 weeks. The modified version adds muscle strengthening to better meet the needs of frail elderly individuals compared to the traditional poco-poco exercise. During the study, participants will be assessed for changes in biomarkers and frailty from baseline to 12 weeks. Researchers will measure global DNA methylation, GDF15, lamin A COP levels, and frailty stages at the start and end of the study. Participants' adherence to the exercise sessions will be monitored, and safety will be observed throughout the 12-week period.

Researchers are evaluating External Counterpulsation (ECP) therapy for patients with stable angina pectoris who are waiting for coronary artery bypass grafting (CABG) in Indonesia. Because the wait time for CABG is often longer than international guidelines recommend, patients remain at risk for chest pain and complications despite optimal medical therapy. This study aims to assess whether adding ECP to medical therapy improves heart function, exercise capacity, and clinical outcomes compared to medical therapy alone. Participants in the experimental group will receive ECP therapy consisting of 36 sessions, each lasting one hour per day, five days a week, at an initial pressure of 300mmHg. The control group will continue with medical therapy only without ECP. The study will measure changes in heart function using echocardiography and treadmill tests, as well as clinical scores related to angina severity and quality of life. Throughout the study, participants will be evaluated at the start and after seven weeks of intervention. Researchers will assess heart strain, ejection fraction, exercise tolerance, angina symptoms, and quality of life using standard questionnaires. Additional tests may include myocardial perfusion scans and blood biomarkers. Safety and data quality will be monitored by independent committees to ensure trustworthy results.

Women who have experienced preeclampsia during pregnancy face a higher risk of developing heart disease later in life due to lasting damage to their blood vessels. Preeclampsia is a serious condition causing high blood pressure and blood vessel injury during pregnancy. This research evaluates a new treatment using mesenchymal stem cell-derived exosomes, tiny particles containing healing substances, to help repair blood vessel damage in postpartum women who had preeclampsia. Participants will be randomly assigned to receive either a single intravenous or intramuscular dose of these exosomes, which contain therapeutic microRNAs like miR-126-3p that promote blood vessel repair, or a placebo saline solution. The treatment is given within the first or second week after giving birth. The study includes 80 women and represents a phase 1 and 2 clinical trial exploring this innovative regenerative therapy. During the study, participants will undergo blood tests and various health checks to monitor blood vessel function and other clinical markers. Follow-up visits occur one week after treatment to assess changes in endothelial function using biomarkers such as miR-126-3p. Safety monitoring and extended observation over 24 months will evaluate the long-term effects of the therapy on cardiovascular health in these women.

The HYIMPACT study is a large, observational research project across seven Asian countries designed to understand how Nebilet (nebivolol) works in people with high blood pressure, also called hypertension. It focuses on how Nebilet affects blood pressure control over time, treatment adherence, quality of life, prescription habits, and heart-related outcomes. The study includes about 5,000 adults with newly diagnosed or uncontrolled hypertension, some of whom may have other heart-related conditions. Participants will either start Nebilet treatment or have been on it for no more than two weeks before joining. They will be observed regularly for up to three years, with blood pressure measurements taken at baseline, 12, 24, and 36 months. The study also compares Nebilet used alone versus in combination with other treatments, and examines the relationship between blood pressure readings taken at home and in the clinic. Throughout the study, patients will have their blood pressure monitored, complete questionnaires about medication adherence and quality of life, and provide health information including cardiovascular risk factors and lab test results when available. Researchers will track major heart events like heart attacks and strokes, and record any side effects. Data will be collected electronically to ensure quality and consistency, helping to provide real-world insights about Nebilet's role in managing hypertension over time.

Researchers are comparing the recovery times of two reversal drugs, half-dose sugammadex and neostigmine, used to counteract muscle relaxation from rocuronium during surgery. Neuromuscular blocking agents like rocuronium are commonly used in surgeries such as laparoscopic cholecystectomy to help with intubation and patient safety. Sugammadex works directly to inactivate rocuronium and may offer faster and more predictable recovery compared to neostigmine, which acts indirectly and can have variable effects. This study aims to evaluate whether half-dose sugammadex leads to quicker recovery times after moderate neuromuscular blockade. Participants will receive either intravenous sugammadex at 1 mg/kg or intravenous neostigmine at 60 mcg/kg with atropine at the end of surgery once a specific level of muscle relaxation is observed. The sugammadex is given when a Train-of-Four Count of 2 is reached, as is the neostigmine and atropine combination. The study focuses on patients undergoing laparoscopic gallbladder removal under general anesthesia who have been treated with rocuronium as a muscle relaxant. During the study, researchers will closely monitor recovery time, defined as the time taken for muscle function to return after the reversal drug is given. The main outcome is the recovery time within one hour after administration. Participants will be assessed for safety and recovery progress following the surgery and reversal treatment. This trial will provide information on the effectiveness and timing of half-dose sugammadex compared to usual-dose neostigmine in this surgical context.

Systemic Lupus Erythematosus (SLE) is a complex autoimmune disease that can affect multiple organs and varies from mild to severe forms. Patients with SLE are more vulnerable to infections due to their weakened immune system and treatments involving steroids and immunosuppressants. Tuberculosis (TB) is a common and serious infection among SLE patients, especially in Asia-Pacific regions where TB rates are high. While isoniazid (INH) prophylaxis is recommended for HIV patients to prevent TB, there is no established guideline for its use in SLE patients due to limited safety data. This study compares two groups of female SLE patients aged 18 to 55 who have mild or remission disease activity. One group receives daily isoniazid 300 mg combined with pyridoxine 10 mg for nine months, while the other group receives a placebo called Saccharum Lactis. Both groups continue their usual SLE treatments. The study includes initial screening to exclude active TB, liver problems, pregnancy, malignancy, or allergy to isoniazid. Monitoring of liver enzymes and lupus disease activity occurs at two weeks, monthly for three months, and then every three months up to one year. Participants will undergo regular evaluations including physical exams, blood tests for liver function, and assessments of lupus activity using the SLEDAI score. The main goals are to measure any liver toxicity caused by isoniazid and changes in lupus disease activity over 12 months. The study aims to determine the safety of isoniazid preventive therapy in SLE patients to help guide future TB prevention strategies. The trial is conducted at Dr. Hasan Sadikin Hospital in Bandung from August 2022 to December 2024.