Oxidative Stress

Researchers are studying the long-term effects of reducing household air pollution (HAP) from biomass fuel use on heart, lung, and immune health among women and children in semi-rural Bangladesh. The study evaluates whether a mobile phone-based behavioral change communication (mHealth BCC) intervention can increase the adoption and exclusive use of cleaner cooking fuel, Liquid Petroleum Gas (LPG). This research also investigates how lowering pollution exposure might influence immune responses to vaccines and subclinical cardiovascular and pulmonary changes. The study is a large household-level randomized controlled trial comparing two groups: one receiving the mHealth BCC intervention encouraging exclusive LPG use and a control group receiving no such intervention. Researchers will monitor personal and area levels of air pollutants like PM2.5 and black carbon before and after intervention, alongside detailed assessments including spirometry, chest X-rays, high-resolution CT scans, blood pressure, EKG, metabolic markers such as HbA1c and lipid profiles, and immune cell function. The intervention messages are delivered via mobile phone with frequency tailored to participant responses. Participants will be followed over two years with repeated measurements to assess pollutant exposure and health effects. Evaluations include lung function tests, imaging, cardiovascular markers, metabolic blood tests, and immune function assays. The study aims to provide insights into the health benefits of sustained LPG use and improved air quality. Total participation spans pre-intervention assessments through two years of follow-up, with ongoing monitoring of pollution exposure and health outcomes.

Researchers are conducting a phase I clinical trial to explore a new type of cancer vaccine called the polyphenol whole tumor cell vaccine for patients with advanced malignant solid tumors. These tumors include cancers originating in epithelial, mesenchymal, or nervous tissues. The study aims to find the effective dose, assess safety and tolerability, and ultimately provide new treatment options to help control the disease long-term. This vaccine is based on previous promising research that showed enhanced immune responses and tumor suppression in animal models. The trial involves administering the polyphenol whole tumor cell vaccine at different dose levels to small groups of patients using a "3+3" dose escalation design. Patients receive five doses of basal immunization on days 0, 14, 28, 42, and 56, followed by individualized treatments of one dose per month for four months, depending on tumor assessment. The vaccine includes tumor cells coated with plant polyphenols and uses bacterial lipopolysaccharide as an adjuvant to stimulate the immune system against multiple tumor antigens. Participants will be closely monitored throughout the study for safety and side effects from the first dose until 14 days after the last vaccination. Researchers will also evaluate tumor response, progression-free survival, and overall survival over about one year. The study includes thorough assessments of organ function, blood tests, and tumor measurements. The trial is expected to last until the end of 2026 and aims to provide important information on the vaccine's safety and preliminary anti-tumor activity in patients with advanced solid tumors.

Researchers are conducting a randomized, single-blind, multi-center, placebo-controlled Phase 2a trial to study BX-001N in preventing acute kidney injury related to cardiac surgery and subsequent major adverse kidney events. The study aims to evaluate the efficacy and safety of BX-001N in approximately 40 adult participants undergoing cardiac surgery involving total circulatory arrest. Participants will be randomly assigned to one of three groups: two experimental groups receiving either low or high doses of BX-001N intravenously once daily for three days, and a placebo group receiving matching placebo injections on the same schedule. Hospitalization occurs from one day before surgery through Day 7, with the investigational product administered during this period. Participants will have follow-up visits up to Day 90 to assess safety and efficacy. Assessments include monitoring kidney injury biomarkers such as NGAL, serum creatinine, eGFR, and other related markers from baseline through specified days. Researchers will also track major adverse renal events and kidney function changes. Safety and treatment adherence will be closely monitored throughout the study.

This research investigates whether consuming apple cider vinegar affects post-meal oxidative stress in adults with obesity. The study focuses on changes in plasma malondialdehyde (MDA), a marker of lipid peroxidation linked to oxidative damage and cardiometabolic risk. Researchers aim to provide evidence on the acute effects of apple cider vinegar on postprandial lipid peroxidation, which has not been extensively studied before. Participants will be randomly assigned to one of two groups: an intervention group that receives a single dose of 15 mL apple cider vinegar diluted in 250 mL water before a standardized meal, and a control group that receives only 250 mL water. After beverage consumption, participants eat a standardized meal. The study includes a one-week run-in period with diet education and lifestyle restrictions to reduce factors affecting oxidative stress. During the study visit, participants fast overnight and provide blood samples before and three hours after the meal to measure plasma MDA levels. The primary outcome is the change in postprandial plasma MDA concentration. Compliance with meal and beverage intake is monitored, and non-compliant participants will be excluded from per-protocol analysis. The total study duration includes pre-intervention education and a single intervention visit.

This research aims to evaluate the potential of transferring mitochondria from a woman's own adipose stem cells to her oocytes during intracytoplasmic sperm injection (ICSI) to improve embryo development and increase the success rate for women who have experienced multiple failed IVF attempts. Embryo quality is crucial for successful assisted reproductive technologies, and factors such as age and genetics can affect this. Since oocytes depend heavily on mitochondria for energy, boosting mitochondrial content may enhance embryo quality in patients with repeated IVF failures. In this study, mature sibling oocytes will be randomly divided into two groups. One group will undergo conventional ICSI, while the other group will receive mitochondria transplanted from adipose-derived stem cells together with ICSI (called Mito-ICSI). Viable blastocysts from both groups will be biopsied for genetic testing to check for chromosome abnormalities. This randomized, double-blind study compares the outcomes of these two approaches. Participants will provide adipose tissue samples through subcutaneous liposuction and consent to have all embryos frozen and biopsied for genetic testing. Researchers will monitor embryo development rates up to 8 weeks after the procedure and track pregnancy outcomes, such as clinical pregnancy rates, live births, and complications, over up to 24 months. The study involves close monitoring and assessments to evaluate the effects of the mitochondrial transfer on embryo quality and pregnancy success.

Researchers are exploring new treatments to improve outcomes for patients with ST-segment elevation myocardial infarction (STEMI), a serious type of heart attack. Despite effective invasive strategies like primary percutaneous coronary intervention (PCI), many patients still face high mortality and disability. This research focuses on studying transcutaneous vagus nerve stimulation (TENS) as a potential way to protect the heart, reduce injury caused by restoring blood flow, and improve heart function after a heart attack. The study compares two groups: one receiving active TENS applied to the tragus of the left ear, and the other receiving sham TENS applied to the earlobe. The stimulation starts upon admission to PCI, continues during the procedure, and lasts for 30 minutes afterward. This noninvasive device-based treatment aims to evaluate whether vagus nerve stimulation can reduce heart damage and improve clinical outcomes in patients undergoing primary PCI for STEMI. Participants will be monitored for safety and effectiveness through hospital and 30-day mortality rates, as well as non-lethal cardiac events up to 14 days after treatment. The study uses randomization and quadruple masking to ensure reliable results. Throughout the study, patients will receive assessments including clinical evaluations and follow-up to observe changes in heart function and overall health during and after the intervention. The total study period spans from admission through one month post-treatment.

Climate change involves rising global temperatures, melting glaciers, and warmer oceans, leading to increased greenhouse gases like nitrogen and carbon dioxide that harm air and water quality. These changes contribute to extreme weather events such as heat waves, floods, and hurricanes. This research focuses on understanding how climate change and air pollution affect individuals with chronic lung diseases including COPD, asthma, bronchiectasis, and interstitial lung disease. The study aims to assess patients' awareness of climate change, heat waves, air pollution, and how these factors interact with their physical activity, anxiety, and depression levels.

Fibromyalgia is a common chronic pain disorder that causes widespread muscle pain along with symptoms like fatigue, sleep problems, cognitive issues, and anxiety or depression. This study evaluates fibromyalgia and related symptoms using tailored questionnaires and explores the biological role of a specific lipid, LPC16:0, which previous research suggests may be involved in fibromyalgia pain and could serve as a diagnostic biomarker. Adults with fibromyalgia meeting standard criteria and healthy adults without pain are enrolled over five years. Patients receive conventional treatments such as Pregabalin and Imipramine and undergo clinical follow-ups. The study uses questionnaires to assess pain, soreness, anxiety, depression, sleep quality, and stress at 2 and 4 weeks, alongside metabolomic and lipidomic tests at 3, 6, 9, and 12 months to investigate biological changes. Participants will attend interviews and complete multiple questionnaires to track symptom changes over time. Researchers will monitor biological markers in blood samples and assess questionnaire results to understand fibromyalgia's pathophysiology better. The study runs through June 2027, aiming to validate the clinical significance of LPC16:0 as a biomarker for fibromyalgia.

This trial investigates whether taking a nutritional supplement daily for two months can improve skin health measures in women aged 45 to 65 years. It is a national, single-center, double-blind, randomized pilot study designed to compare a food supplement against a placebo, with safety overseen by the sponsor. The study focuses on skin aging and hair and skin condition in healthy adult women with normal to dry skin. Participants will receive either a powder food supplement or a matching placebo to dissolve in water, taken once daily for 56 days. The placebo resembles the active supplement in taste and appearance, both provided as orange-flavored instant drinks in sachets. The study includes visits at the start, after 28 days, and after 56 days of supplementation to monitor progress. Throughout the trial, participants will keep a diary to record skin status and any side effects. Researchers will assess skin physiological parameters at baseline, day 28, and day 56. They will also evaluate subject satisfaction, skin and hair quality, and monitor any adverse events during the full study period to understand the supplement's effects and tolerability.

Researchers are evaluating a new treatment approach for children, adolescents, and young adults newly diagnosed with classical Hodgkin lymphoma (cHL). This study aims to improve early complete response rates while maintaining high 4-year event-free survival across all risk groups. The trial explores replacing certain drugs in the previous standard chemotherapy regimen with Brentuximab vedotin to reduce the need for radiation therapy and lower long-term side effects. The trial uses a modified chemotherapy regimen called Bv-AEPC, where Brentuximab vedotin replaces vincristine and bleomycin. Patients are grouped by risk level (low, intermediate, high). Those in the intermediate and high-risk groups who do not achieve complete metabolic remission early will receive more intensive treatment with additional drugs and potentially a PD-1 antibody, along with stem cell transplant or radiation if needed. Treatment plans adapt based on PET/CT scan results to improve outcomes and minimize toxicity. Participants will undergo early and late assessments using PET/CT scans to measure metabolic response. Researchers will monitor event-free survival, overall survival, and response rates over five years. The study involves regular follow-ups to evaluate treatment effects, with the goal of reducing radiation exposure and improving long-term health. Children and young adults will receive comprehensive care and monitoring throughout the trial period, which starts with enrollment at age 2 through 35 years and continues with several years of outcome assessment.