Clinical Research Directory

Opioid-Free Versus Opioid-Based Anesthesia in Thyroid Surgery

This study will compare opioid-free anesthesia and opioid-based anesthesia in adult euthyroid patients undergoing elective thyroidectomy. Opioid-based anesthesia is commonly used during surgery, but opioids may be associated with adverse effects such as nausea, vomiting, respiratory depression, hyperalgesia, and increased postoperative opioid use. Opioid-free anesthesia uses non-opioid medications as part of a multimodal strategy to provide intraoperative analgesia. The main aim of this prospective randomized study is to evaluate whether opioid-free anesthesia changes the perioperative oxidative stress response compared with opioid-based anesthesia. Oxidative stress will be assessed using serum biomarkers, including native thiol, total thiol, disulfide, total antioxidant status, total oxidant status, and oxidative stress index. Eligible patients will be randomly assigned to receive either opioid-free anesthesia or fentanyl-based opioid anesthesia. Blood samples will be collected before anesthesia induction, 30 minutes after extubation, and 24 hours after surgery. The study will also compare postoperative pain scores, rescue analgesic requirement, postoperative nausea and vomiting, recovery characteristics, and intraoperative hemodynamic variables between the two anesthesia strategies.

Nicotinamide Riboside Supplementation for Treating Arterial Stiffness and Elevated Systolic Blood Pressure in Patients With Moderate to Severe CKD

Risk of cardiovascular diseases (CVD) is significantly elevated in patients with chronic kidney disease (CKD); however, this increased risk is only partially explained by traditional CV risk factors. Arterial dysfunction is an important nontraditional CV risk factor gaining increased recognition in the field of nephrology. This process is best represented, both physiologically and pathophysiologically, by increases in the gold standard measure of arterial stiffening, carotid to femoral artery pulse wave velocity (CFPWV), which reflects, in particular, increases in aortic stiffness. Aortic stiffening with CKD is mediated by structural and functional (increased vascular smooth muscle tone) changes in the arterial wall stimulated by oxidative stress and chronic low-grade inflammation. Caloric restriction (CR) is a promising strategy for prevention of CKD-associated arterial dysfunction and CVD. However, long-term adherence to chronic CR regimens with optimal nutrition is very difficult to achieve. Research has shown that boosting NAD+ bioavailability to stimulate SIRT-1, a "CR mimetic" approach, reduces CFPW and oxidative stress in old mice, and this lab recently took the first step in translating these findings in a study of adults with normal kidney function and elevated systolic blood pressure (SBP). The data found that supplementation with nicotinamide riboside, a natural, commercially available precursor of NAD+ and novel CR mimetic, increased NAD+ bioavailability and reduced CFPWV and SBP. A randomized, placebo-controlled, double-blind, single-site phase IIa clinical trial to assess the safety and efficacy of oral nicotinamide riboside (500 mg capsules 2x/day; NIAGEN®; ChromaDex Inc.) for 3 months vs. placebo for decreasing aortic stiffness and SBP in patients (35-80 years) with stage III and IV CKD is being proposed. It is hypothesized that treatment will reduce CFPWV and SBP, as related to increases in systemic NAD+ bioavailability and reductions in oxidative stress, and inflammation. Aim 1: To measure CFPWV (primary outcome) before/after nicotinamide riboside vs. placebo treatment; Aim 2: To measure casual and 24h-ambulatory SBP (secondary outcome) before and after treatment; Aim 3: To determine the safety and tolerability of treatment with nicotinamide riboside vs. placebo; Aim 4: To measure systemic NAD+ and NAD+-related metabolite concentrations, as well as circulating markers of oxidative stress, inflammation, and vasoconstriction factors before and after treatment.

The Effect of Training on Oxidative Stress in Patients With kneeOA.

A six week patient study that intends to prove that training helps improve the life of people with osteoatritis of the knee. It looks at pain and function in daily life and markers in the blood that show stress at a cell level.

New Zealand Blackcurrant and Recovery in Elite Taekwondo

This randomized, double-blind, placebo-controlled trial evaluated the effects of short-term supplementation with anthocyanin-rich New Zealand blackcurrant (NZBC) extract on exercise-induced muscle damage, oxidative stress, antioxidant status, inflammatory responses, and perceived muscle soreness in elite male taekwondo athletes. Thirty national-level male taekwondo athletes were enrolled and randomly assigned in a 1:1 ratio to receive either NZBC extract (CurraNZ®, UK; 600 mg/day providing approximately 210 mg anthocyanins) or a matched placebo for 7 days. Blood samples and muscle soreness ratings were collected at baseline, immediately after exercise, 24 hours after exercise, and after 7 days. The primary outcome was plasma creatine kinase (CK). Secondary outcomes included reactive oxygen species (ROS), total antioxidant capacity (TOAC), protein carbonyls, inflammatory cytokines (IL-6, TNF-α, and IL-10), and perceived muscle soreness assessed using a visual analog scale (VAS). The study was approved by the Biruni University Clinical Research Ethics Committee (No. 2015-KAEK-80-23-33; December 22, 2023). Written informed consent was obtained from all participants.

Impact of Electronic Cigarette Temperature and Solvent on Biomarkers

This project seeks to determine how e-cigarette (EC) physical design features, including those that allow the user to manipulate the quality and quantity of aerosols, affect exposure and toxicity from oxidants and other aerosol constituents.

Targeting Oxidative Stress to Prevent Vascular and Skeletal Muscle Dysfunction During Disuse

Prolonged periods of reduced activity are associated with decreased vascular function and muscle atrophy. Physical inactivity due to acute hospitalization is also associated with impaired recovery, hospital readmission, and increased mortality. Older adults are a particularly vulnerable population as functional (vascular and skeletal muscle mitochondrial dysfunction) and structural deficits (loss in muscle mass leading to a reduction in strength) are a consequence of the aging process. The combination of inactivity and aging poses an added health threat to these individuals by accelerating the negative impact on vascular and skeletal muscle function and dysfunction. The underlying factors leading to vascular and skeletal muscle dysfunction are unknown, but have been linked to increases in oxidative stress. Additionally, there is a lack of understanding of how vascular function is impacted by inactivity in humans and how these changes are related to skeletal muscle function. It is our goal to investigate the mechanisms that contribute to disuse muscle atrophy and vascular dysfunction in order to diminish their negative impact, and preserve vascular and skeletal muscle function across all the lifespan.

The Impact of 12-week Ashwagandha Supplementation Induced by Resistance Training on Strength, Levels of Neurotrophic and Stress Response Proteins, Oxidative and Psychological Stress, and Cognitive Function in Physically Active Male Adults

This clinical trial will study the effects of Ashwagandha (Withania somnifera), a natural plant extract, on physical and mental health in adult men. Ashwagandha is known for its potential to reduce stress, support hormonal balance and improve sleep and physical performance. The study will explore how taking Ashwagandha for 12 weeks, with resistance training, affects various health markers such as stress hormones, brain function, muscle strength, body composition, sleep quality, and cognitive abilities. Participants will be healthy, non-smoking men aged 25-40, with regular resistance training experience. They will be randomly assigned to one of two groups: (1) weight training + Ashwagandha, (2) weight training + placebo. The study is double-blinded, meaning neither participants nor researchers will know who is receiving Ashwagandha or placebo. Participants will: * Take Ashwagandha or a placebo every day for 12 weeks * Train in the gym three times a week Researchers will assess changes in blood markers (like cortisol, testosterone and BDNF - brain-derived neurotrophic factor), physical performance (muscle strength and endurance), sleep quality, stress perception and cognitive function before and after the 12-week period. The goal is to better understand how Ashwagandha works.

Wild Blueberries for Gut, Brain, and Heart Health in Adults With High Blood Pressure

The purpose of the study is to determine the effectiveness of wild blueberries on cardiovascular health, cognitive function, and gut microbiota composition in non-Hispanic Black and White adults with elevated blood pressure.

Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Prediabetes

The goal of this clinical trial is to determine the effectiveness of using a freeze-dried wild blueberry powder on cardiometabolic health, cognitive function, and gut microbiota composition in adult women with prediabetes.

Effect of Rosmarinus Officinalis Extract on Oxidative Stress and Inflammatory Biomarkers in Patients With Type 2 Diabetes (T2DM)

This randomized, placebo-controlled clinical trial evaluates the effects of a methanolic extract of Rosmarinus officinalis (rosemary) in patients with type 2 diabetes mellitus. Participants are randomly assigned to receive either methanolic rosemary extract or placebo in addition to their usual treatment and are followed for six months. A data cut-off at Month 3 is used for the analysis of metabolic, oxidative stress, and cytogenetic outcomes, while selected inflammatory and cardiovascular biomarkers continue to be assessed through Month 6. The study investigates the potential complementary effects of methanolic rosemary extract on metabolic control, oxidative stress, inflammation, genomic stability, and cardiovascular-related biomarkers in patients with type 2 diabetes mellitus.

Effect of Cordyceps Supplementation Timing on Physiological Responses and Aerobic Adaptation in Athletes

Athletes frequently perform high-intensity exercise to improve physical performance and aerobic capacity. However, such training can induce exercise-induced muscle damage, oxidative stress, and inflammatory responses that may delay recovery and compromise subsequent training adaptations. Optimizing recovery strategies is therefore essential to maintain performance, reduce injury risk, and support long-term athletic development. Cordyceps is a medicinal mushroom that contains several bioactive compounds, including cordycepin and polysaccharides, which have demonstrated antioxidant, anti-inflammatory, and immunomodulatory properties. Although previous studies have reported beneficial effects of Cordyceps supplementation on exercise performance and physiological function, limited evidence exists regarding the optimal timing of supplementation relative to exercise. This study aims to investigate the effects of different Cordyceps supplementation timing strategies on physiological responses and aerobic adaptation following acute and chronic exercise training. Participants will be assigned to receive Cordyceps supplementation before exercise, after exercise, or placebo. The study will evaluate biomarkers of inflammation (IL-6), oxidative stress (MDA), muscle damage (CK), aerobic capacity (VO2max), and neuromuscular performance assessed using countermovement jump (CMJ) testing. The findings of this study are expected to provide evidence-based recommendations regarding nutritional recovery strategies and supplementation timing to optimize recovery and training adaptation in athletes and physically active individuals.

Hyaluronic Acid as an Adjunct to Non-Surgical Periodontal Therapy in Smokers

The goal of this clinical trial is to evaluate whether hyaluronic acid (HA) improves periodontal healing in people with periodontal disease who smoke. Moreover, the effects of HA on biomolecules and bacteria levels will be assessed during the follow up period. The main questions it will answer are: Will periodontal sites treated with HA gel after non-surgical periodontal treatment (NSPT) lead to better outcomes in clinical parameters compared to the sites treated with NSPT only in smokers? Will adjunctive use of HA gel reduce oxidative stress markers and bacteria levels during follow-up? Researchers will compare periodontal sites receiving NSPT with adjunctive HA gel application to sites receiving NSPT alone to determine whether HA provides additional clinical, biochemical and microbiological benefits. Participants will: * first receive full-mouth NSPT then, randomization will be performed in selected jaw to determine the test sites. These two interproximal test sites will additionally receive HA gel application. * attend follow-up visits at 1, 3 and 6 months for clinical periodontal measurements and to provide gingival crevicular fluid samples (GCF) and subgingival samples. The GCF samples will be evaluated for Metallothionein (MT) and 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels and subgingival samples for periodontal pathogens.

Black Forest Cocoa Flavanol Supplementation and Health Trial

This randomized, double-blind, controlled clinical trial will evaluate the effects of daily cocoa flavanol supplementation on vascular and inflammatory biomarkers in healthy adult men aged 30 to 75 years. Participants will be randomized to receive either a cocoa flavanol supplement or a nutrient-matched low-flavanol control product for 4 to 8 weeks. The study will assess changes in inflammatory biomarkers, endothelial function, oxidative stress markers, vascular measurements, and circulating endothelial progenitor cell-related markers. Optional assessments include flow-mediated dilation and single-cell RNA sequencing of peripheral blood mononuclear cells to explore mechanistic biological responses to cocoa flavanol supplementation.

Effect of Dexmedetomidine on Microsurgery Reconstruction in Cancer Patient

This double-blinded randomized controlled trial aims to investigate the effect of intraoperative dexmedetomidine administration on early flap viability and microvascular integrity in cancer patients undergoing elective microvascular reconstructive surgery. The primary outcome is clinical flap viability within 48 hours postoperatively, assessed using a standardized scoring system based on flap color, temperature, capillary refill time, and tissue turgor. Secondary outcomes include the evaluation of biomarkers related to endothelial glycocalyx degradation (syndecan-1), oxidative stress (SOD-1), inflammation (IL-6, IL-10), thrombosis (PAI-1), and angiogenesis (VEGF), as well as microcirculatory assessment using Sidestream Dark Field (SDF) imaging. The study is designed to determine whether dexmedetomidine improves early surgical outcomes by modulating pathophysiological processes involved in microvascular flap success.

Vitamin D Status and Asthma Control, Pulmonary Function, and Oxidative Stress in Adults With Bronchial Asthma

Asthma is a chronic inflammatory airway disease associated with variable airflow limitation and persistent respiratory symptoms. Vitamin D has been proposed as a potential biomarker related to immune regulation, asthma control, pulmonary function, and oxidative stress balance. This prospective cross-sectional observational study aims to investigate the association between serum 25-hydroxyvitamin D \[25(OH)D\] concentrations, asthma control, pulmonary function parameters, and erythrocyte oxidative stress biomarkers among Egyptian adults with bronchial asthma. A total of 200 adult asthma patients will be recruited from Abbassia Chest Hospital, Cairo, Egypt. Participants will undergo clinical assessment, Asthma Control Test (ACT), post-bronchodilator spirometry, serum vitamin D measurement, and oxidative stress biomarker assessment including malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GPx), and reduced glutathione (GSH). Participants will be categorized according to serum 25(OH)D concentrations into vitamin D deficient, insufficient, and sufficient groups. No intervention or treatment assignment will be performed. 5\. Detailed Description

Role of NADPH Oxidase in Microvascular Dysfunction Following GDM

The purpose of this investigation is to examine NADPH oxidase as a source of reactive oxygen species contributing to aberrant microvascular function in otherwise healthy women with a history of GDM.

The Combined Effects of Cordyceps and Fartlek Training on Muscle Recovery and Bone Health in Soccer Players

Purpose of the Study:This study aims to evaluate the effectiveness of combining Cordyceps supplementation and fartlek training as a recovery and performance enhancement strategy for soccer players. Muscle injuries often occur when athletes train intensely without adequate recovery. Cordyceps contains bioactive compounds with anti-inflammatory and antioxidant properties, while Fartlek training is designed to improve cardiovascular endurance. This study analyses how this combination affects both the physiological recovery and physical performance of soccer players. Research Question: Does the combination of Cordyceps supplementation and Fartlek training effectively reduce muscle damage, decrease oxidative stress, promote bone metabolism, and improve cardiorespiratory fitness in soccer players? Methodology and Biomarkers: To answer this question, the study evaluates specific physiological indicators from the participants' blood samples and physical tests. Muscle damage and recovery are assessed through creatine kinase (CK), interleukin-6 (IL-6), and interleukin-10 (IL-10). Oxidative stress levels are monitored using superoxide dismutase (SOD) and malondialdehyde (MDA). Bone metabolism and health are measured via bone alkaline phosphatase (BALP) and osteocalcin (OST). Additionally, improvements in the athletes' aerobic capacity and overall physical performance are determined by measuring their maximal oxygen consumption (VO₂max).

Pumpkin Seed Oil as a Nutraceutical for Hemodialysis Patients

Patients with end-stage renal disease (ESRD) on maintenance hemodialysis experience chronic systemic inflammation, oxidative stress, and dyslipidemia, which together drive much of the excess cardiovascular morbidity and mortality seen in this population. Pumpkin seed oil is a nutraceutical rich in polyunsaturated fatty acids, phytosterols,and tocopherols, with documented antioxidant, anti-inflammatory, and antihyperlipidemic properties in preclinical and limited clinical studies. This study investigates the potential role of pumpkin seed oil as a nutraceutical on the clinical and biochemical outcomes of hemodialysis patients. It is a randomized, open-label, prospective interventional study in which daily oral supplementation with pumpkin seed oil (1000 mg once daily) for 3 months is evaluated against usual care. Eighty-five participants will be assigned to either an intervention group (n=45, pumpkin seed oil 1000 mg/day plus usual care) or a control group (n=40, usual care only). The biochemical outcomes assessed are changes in serum interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP), soluble vascular cell adhesion molecule-1 (sVCAM-1), lipid profile, malondialdehyde (MDA), and superoxide dismutase (SOD) from baseline to the end of the 3-month follow-up period. The study is being conducted at the Hemodialysis Center, Al-Karama Teaching Hospital, Iraq

Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease

The objective of this study is to evaluate oxidative stress and/or inflammation in patients with Gaucher disease type I using a series of biomarkers and correlate with measurements of currently used diagnostic biomarkers.

The Effects of Endotracheal Suctioning on Pain and Serum Markers

The goal of this experimental study is to understand if endotracheal tube (ETT) suctioning increases pain and causes stress on the body in intubated adult ICU patients. These patients are already on ventilators, which means they need suctioning to keep their airways clear, but this procedure may be uncomfortable and cause stress. The main questions this study aims to answer are: Does ETT suctioning raise pain levels as measured by the Critical-Care Pain Observation Tool (CPOT)? Does ETT suctioning increase certain chemicals in the blood (hypoxanthine, xanthine, and uric acid) that show stress and lack of oxygen in the body? Researchers will compare patients who have ETT suctioning (intervention group) with those who do not have suctioning during the study period (control group) to see if there are differences in pain and blood markers of stress. Participants will: Have pain measured before and after suctioning using the CPOT. Have blood samples taken from an existing line at three time points: 5 minutes before, 5 minutes after, and 30 minutes after suctioning. Provide demographic information (like age, gender, and diagnosis) from medical records. This research will help improve how pain is managed for ICU patients who cannot speak for themselves, potentially leading to better pain relief methods in the future.

The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes

The goal of this clinical trial is to test the effect of 12 weeks of 1.5 cups per day of fresh mango on glucose control, insulin resistance, lipids, inflammation, oxidation and body composition in individuals with prediabetes. The main questions it aims to answer are: * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on indicators of glycemic control including fasting glucose and HgbA1c? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on fasting blood insulin and insulin resistance (HOMA-IR)? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on lipids including LDL-cholesterol, total cholesterol, HDL-cholesterol and triglycerides? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on oxidative stress including oxidized LDL-cholesterol and 8-iso-PGF2-alpha? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on markers of inflammation including c-reactive protein, e-selectin, ICAM, VCAM, TNF-alpha and IL-beta? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on percent body fat, fat mass, and lean mass? Participants will be asked to: * Consume 1.5 cups of mango per day for 12 weeks, take a 4 to 8 week break, and then avoid consuming mangos for 12 weeks * Attend a prerandomization clinic prior to study * Attend three (3) clinics where blood will be drawn during weeks 0, and 12 of the first phase and last week of the second phase of the study * Attend eight (8) clinics where anthropometric measurements (height, weight, body composition) will be conducted and interaction with study clinicians will occur during weeks 0, 4, 8, 12 of each phase of the study * Complete questionnaires and surveys in person and remotely, including six (6) 24-hour dietary recalls. Researchers will compare the 12 weeks participants consume mango to the 12 weeks the participants are not consuming mango to see if there are differences in glycemic indicators, insulin resistance, lipids, inflammation, oxidation and body composition between the two time periods.

8-OHdG and Oxidative Stress in Febrile Seizures

This prospective case-control study investigates whether serum 8-hydroxy-2'-deoxyguanosine (8-OHdG), an established biomarker of reactive oxygen species-mediated DNA oxidation, is elevated in children with febrile seizures compared with healthy children, and whether it differs between simple and complex febrile seizure subtypes. Children presenting with a febrile seizure and age-matched healthy controls have serum 8-OHdG measured within 24 hours of seizure onset, alongside routine inflammatory markers (white-cell count, C-reactive protein) and haemoglobin. The primary aim is to determine whether acute oxidative DNA damage is detectable after febrile seizures and whether 8-OHdG levels distinguish simple from complex subtypes. The study is exploratory and hypothesis-generating; it is not designed to establish 8-OHdG as a clinically applicable diagnostic biomarker.

Evaluation of the Effect of Hyperuricemia on Alveolar Bone Loss

Periodontitis is a multifactorial disease characterized by chronic inflammation of the gum tissue and alveolar bone destruction, and is known to be associated with various systemic diseases. Hyperuricemia, on the other hand, is a metabolic condition characterized by increased serum uric acid levels and can affect inflammation, oxidative stress, and bone metabolism. In recent years, the relationship between hyperuricemia and periodontal diseases has been increasingly investigated, but the biological mechanisms of this relationship have not yet been fully elucidated. Therefore, this study aimed to determine whether there is a relationship between hyperuricemia and periodontitis and to reveal the possible pathophysiological mechanisms of this relationship, which are shaped by inflammation, oxidative stress, and bone metabolism. A total of 80 individuals aged 18-65 years will be included in this clinical observational study. The periodontal status of the participants will be assessed using clinical periodontal parameters such as probing pocket depth, clinical attachment loss, plaque index, gingival index, and bleeding on probing. Participants will be divided into four groups according to their periodontal status and the presence of hyperuricemia: individuals with periodontitis and hyperuricemia, individuals with periodontally healthy and hyperuricemia, individuals with periodontitis but without hyperuricemia, and individuals with periodontally healthy and without hyperuricemia. Gingival crevicular fluid and serum samples will be taken from the participants. In these samples, receptor-mediated nuclear factor kappa B ligand, osteoprotegerin, total antioxidant status, total oxidant status, oxidative stress index, interleukin-1 beta, interleukin-10, interleukin-18, and nucleotide-binding oligomerization domain-like receptor protein 3 levels will be analyzed. This study is considered unique because it examines the relationship between hyperuricemia and periodontitis by evaluating inflammation, oxidative stress, and bone metabolism parameters together.

Effects of Magnesium and Spinning Training on Echocardiographic, Inflammatory, and Aerobic Outcomes

Regular aerobic exercise may improve cardiorespiratory fitness while modulating systemic inflammation and oxidative stress. Spinning, as a structured indoor cycling modality, provides a practical aerobic exercise model with adjustable intensity and duration, but its effects on redox balance, inflammatory status, aerobic capacity, and cardiac functional parameters may vary according to individual recovery and nutritional status. Magnesium is an essential micronutrient involved in energy metabolism, muscle contraction-relaxation, ion regulation, and inflammatory and oxidative pathways; therefore, magnesium use may be relevant to exercise adaptation and recovery. This study aims to evaluate the associations of magnesium use and spinning training with oxidative stress, inflammation, aerobic capacity, and cardiac parameters. In this context, biochemical markers related to oxidative/antioxidant status and inflammation, aerobic performance indicators, and echocardiographic cardiac function parameters will be assessed together. The study is expected to provide real-world evidence on whether magnesium use in individuals participating in spinning training is associated with more favorable redox, inflammatory, aerobic, and cardiac profiles.