Clinical Research Directory

Exploration of Potential Biomarkers of Polyphenol Intake From a Supplement Derived From Artichoke By-products Rich in Hydroxycinnamic Acids (ARTI-UP ADME)

The bioavailability study analyzes the absorption, distribution, metabolism, and excretion (ADME) processes of the polyphenols under study (HCAs). To achieve the planned objectives, blood and urine samples will be collected before and at different time intervals following the intake of the study supplement, which will consist of capsules made from dehydrated artichoke by-products rich in HCAs. To determine the bioavailability of the active compounds, volunteers will be asked to follow a diet low in polyphenols/plant-based foods for 48 hours prior to the supplement intake and up to 48 hours after product consumption . Blood and urine samples will be collected before intake and during the following 48 hours. Subsequently, the samples will be analyzed using high-performance liquid chromatography coupled with mass spectrometry (HPLC-MS) to identify and quantify the bioactive compounds of interest and their metabolites. The results of the ADME trial will allow for the identification of plasma and urinary metabolites, the characterization of intake markers, and the determination of inter-individual differences in metabolic profiles.

A Study to Assess the Bioavailability and Adhesion of Selegiline TDS in Healthy Subjects

The purpose of this research study is to compare the bioavailability and adhesion of a generic Selegiline transdermal system (TDS) against the marketed comparator (EMSAM®) in healthy volunteers. Systemic and local safety and tolerability will be also observed and evaluated.

Psychological Impact of an 80-km Ultra-Endurance Race

Ultra-endurance races (ultra-marathons) take place under extreme environmental conditions, over long distances, involving prolonged physical activity and multiple psychological and physiological challenges. These extreme conditions expose runners to a wide range of emotions-both pleasant and unpleasant-that can influence their performance, fatigue, and perception of exertion. Emotional intelligence and emotional regulation appear to be key determinants of emotional trajectories and performance in these contexts. Previous research shows that high levels of emotional intelligence and adaptive emotional regulation strategies are associated with functional emotional trajectories and better performance, whereas maladaptive strategies are linked to dysfunctional emotional trajectories and reduced performance. Furthermore, defense mechanisms constitute a complementary approach to emotional self-regulation. They can be adaptive or maladaptive and influence how runners cope with emotions and psychological stressors during competition. Longitudinal studies conducted to date have primarily explored post-race emotional trajectories in relation to emotional intelligence, without examining the impact of defense mechanisms on emotional dynamics during the race. Furthermore, few studies have examined the mediating role of emotional intensity between emotional regulation and perceived performance, and even fewer have adopted an approach that integrates physiological indicators such as heart rate or heart rate variability. Thus, this study lies at the intersection of sports psychology, emotion, and physiology, and aims to fill these gaps by exploring: 1. the influence of defense mechanisms on emotional dynamics and physical and mental fatigue during an ultra-endurance race, and 2. the mediating role of emotional intensity on the relationship between emotional regulation and perceived performance. The objective of this study is to examine how certain psychological mechanisms used to cope with difficult situations influence the evolution of emotions experienced by participants during and after an 80-kilometer ultra-endurance race.

Location- and Frequency-Dependent Effects of Thalamic Temporal Interference Stimulation During Sleep

This study is to find out whether a type of non-invasive electrical brain stimulation called temporal interference transcranial electrical stimulation (TI-TES) can temporarily change brain activity during sleep, especially sleep spindles (brain rhythms in the \~8-16 Hz range). Up to 24 healthy participants in Dane County, Wisconsin will be enrolled for 3 overnight study visits. Participants can expect to be on study for approximately 5 weeks, depending on scheduling availability.

Evaluation of MTX-439 in Healthy Adults and Adults With Diabetic Kidney Disease

This is a phase 1 randomized, double-blind, single ascending dose (SAD) and multiple ascending dose (MAD) study to assess the safety, tolerability, and Pharmacokinetics (PK) of single and multiple ascending doses of MTX-439 administered in healthy adults and adults with diabetic kidney disease (DKD)

Ginkgo Active App-Based Exercise Training

The purpose of this study is to investigate the effectiveness and usability of a Gingko app based exercise training in middle and older aged adults. The main question it aims to answer is if the personalized Gingko app-based exercise is more effective in improving overall physical function than self-guided training with the NIA exercise booklet.

EVASTRESS Healthy Subjects

The goal of this observational study is to learn the feasibility of using a mobile application "Stressometer" to measure perceived stresss levels several times per day. The study will also explore if the stress scores collected with the application are similar to results from standard questionnaires about stress, anxiety, and depression. The main questions it aims to answer are: Can participants regularly report their stress four times a day for two weeks using the mobile application? Do participants find the application easy and acceptable to use? Are stress scores collected with the application related to scores from validated questionnaires on stress, anxiety, and depression? Participants will: Use the Stressometer mobile application to rate their stress level four times per day for 14 days Complete questionnaires about stress, anxiety, and depression at the beginning and/or end of the study Provide feedback on how easy and acceptable the application is to use Researchers will use this information to understand whether this mobile tool is practical for measuring stress in daily life and whether it provides results similar to established psychological questionnaires.

Metabolome and Gut Microbiome Changes During Smoking Cessation in Long-term Drug Therapy in a Therapeutic Community

Theoretical Framework: Cigarette smoking is the leading preventable cause of death worldwide, with nicotine dependence notably common among individuals with Substance Use Disorders (SUD). Smoking exacerbates both physical and mental health issues, further complicating the treatment of SUD. Current therapeutic approaches for SUD often prove inadequate, indicating a need for new strategies. Recent advancements in metabolomics and gut microbiome research have provided valuable insights into the biological mechanisms underlying addiction. Objectives: This study aims to investigate the therapeutic potential of smoking cessation for individuals with SUD, using a six-week intervention within a therapeutic community. The research specifically explores the psychobehavioral, metabolic, and gut microbiome domains. It is hypothesized that smoking cessation will improve emotional regulation, self-efficacy, and reduce substance craving, mediated by changes in metabolic and microbiome profiles linked to brain reward systems. Methods: A randomized controlled trial (N=150) will be conducted, examining outcomes such as clinical relapse rates, microbial and metabolic markers, particularly in choline and folate metabolism. Participants with SUD (n=100) will undergo a six-week smoking cessation intervention, with pre- and post-assessments, compared to a control group receiving treatment as usual. Metabolomic and microbiome analyses will be conducted using blood and stool samples, alongside psychological assessments via questionnaires. Assessments on a behavioural level will take place at a 3-months follow-up. A cross-sectional, non-interventional healthy control group (n=50) will be examined at a single timepoint with an anologous panel of psychological variables, blood and stool to ascertain differences between smokers with SUD and healthy controls.

A Single Centre, Open-label, 2-period Fixed-sequence, Phase I Clinical Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Polymyxin B in Healthy Volunteers

This is an open-label, fixed sequence Phase I clinical study to evaluate the effect of multiple doses of BV100 on the PK of polymyxin B in healthy participants (HPs).

Impact of Abdominal Muscle-Induced Fatigue on Hip Muscle Performance and Functional Balance in Healthy Adults

The study is based on the theory that the abdominal muscles contribute to transverse and frontal plane torques that complement hip abductor torque, as both muscle groups act in the same counterclockwise direction within the proposed biomechanical model. Through their role in trunk and pelvic stabilization, the abdominal muscles help optimize the mechanical environment in which the hip abductors operate, potentially enhancing their effective torque production during functional tasks. This shared torque direction suggests a functional interdependence between core and hip musculature, whereby deficits or fatigue in the abdominal muscles may compromise hip abductor performance and load distribution at the hip joint. Clinically, this relationship supports the integration of abdominal muscle assessment and targeted core rehabilitation into the evaluation and management of hip-related injuries, with the potential to improve movement control, reduce injury risk, and enhance treatment outcomes. A quasi-experimental, within-subject study conducted at the Isokinetic Laboratory, Faculty of Physical Therapy, Cairo University, to examine the effect of abdominal muscle-induced fatigue on hip muscle strength, endurance, and functional balance. Seventy healthy male college students aged 20-25 years will be assessed before and after an isokinetic abdominal fatigue protocol using an isokinetic dynamometer. Outcome measures include isokinetic hip muscle strength and endurance, as well as balance assessed by the Single Leg Stance Test and Star Excursion Balance Test. The study procedure consists of participant preparation, baseline assessment, abdominal muscle fatigue induction, and immediate post-fatigue reassessment. Sample size was determined using G\*Power to ensure adequate statistical power, and data will be analyzed using one-way within-subject MANOVA with significance set at p \< 0.05. This study holds critical importance for advancing both biomechanical theory and clinical practice by directly investigating a key, yet under-quantified, link in the human kinetic chain: the specific impact of abdominal muscle fatigue on hip muscle performance and functional balance. By employing instrumented (Isokinetic dynamometer, star excursion balance test and single leg stance test)., pre- and post-fatigue measurements in a healthy non-athletic population, it will generate novel empirical evidence clarifying how core endurance directly influences proximal stability and distal function. Clinically, the outcomes promise to transform assessment and rehabilitation paradigms-shifting focus from isolated hip treatment toward integrated core-hip strategies-ultimately informing more effective injury prevention programs, optimizing movement efficiency, and enhancing rehabilitation outcomes for both athletic and general populations.

A Phase 1 Study of KHN707 Tablets in Healthy Participants

This is a single-center, randomized, double-blind, placebo-controlled study . The objective is to evaluate the safety , tolerability and PK profile of KHN707 tablets in Chinese healthy participants.

Effect of Transcranial Random Noise Stimulation on the Performance in Language Tasks

Language is an essential part of daily life, enabling us to communicate, understand others, read, and learn. Certain brain injuries can disrupt these abilities, and current treatments do not always lead to a full recovery. To improve future therapeutic approaches, it is necessary to better understand how the brain processes language and how its activity can be modulated. This study aims to evaluate the effects of a non-invasive brain stimulation technique called transcranial random noise stimulation. This method involves applying a very weak electrical current to the scalp to modulate the activity of brain regions involved in language. It is commonly used in research and is considered safe when administered in accordance with current guidelines. Healthy adult volunteers will participate in this study. Each participant will take part in two sessions spaced about a week apart. During one session, active stimulation will be used, and during the other, placebo stimulation will be used. Placebo stimulation resembles the actual stimulation but has no active effect. Neither the participants nor the researchers will know which type of stimulation is being used during each session. During the sessions, participants will perform various language tasks, and their brain activity will be recorded using an electroencephalogram (EEG), a painless method. This study does not provide any direct benefit to participants. The risks are low and limited to temporary sensations, such as a tingling sensation on the scalp. The results will provide a better understanding of how the brain processes language and could eventually contribute to the development of new rehabilitation approaches.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

This study is the first-in-human (FIH) study of BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants, followed by a Part E to evaluate the safety and tolerability of BGB-45035 in adults with autoimmune dermatological diseases like atopic dermatitis (AD) and prurigo nodularis (PN). An additional biomarker cohort will be evaluated in Part F. Study details include: * The study duration will be up to 24 months. * The treatment duration will be up to 14 days for Parts A-D, up to 12 weeks for Part E, and up to 3 weeks for Part F. * Safety follow-up 30 days after last dose of study drug.

A Clinical Trial to Test the Safety, Tolerability, and How the Body Processes CPV-104 in Healthy People and Patients With C3-Glomerulopathy

This study is the first time the new medicine CPV-104 is being tested in people. CPV-104 is designed to regulate the complement system, which can be overactive in diseases such as C3 glomerulopathy (C3G), an ultra-rare kidney disorder. The study includes healthy adults and adult patients with C3G to assess safety, tolerability, how the body processes the medicine, and whether the immune system reacts to it. The study is divided in two part; in Part 1 (SAD), healthy volunteers receive one IV dose of CPV-104 or a placebo while in Part 2 (MAD) patients with C3G receive four weekly IV doses of CPV-104 (no placebo). Participants will have close monitoring, including side-effect checks, blood and urine tests, ECGs, vital signs, and blood samples to measure drug levels and antibodies. For those with C3G, researchers will also observe kidney function, although the main goal is safety, not testing effectiveness. A Safety Review Committee will regularly review results to ensure it is safe to continue to the next dose or study group.

Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of PORT-77 Administered to Healthy Adult Participants

A First-in-Human 2-part, randomized, double-blind, placebo-controlled, single ascending dose, multiple ascending dose, and food effect, investigation of the administration of PORT-77 in healthy adult participants.

Evaluate Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 After Single Subcutaneous Injection in Healthy Chinese Volunteers

The goal of this study is to evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 after Single Subcutaneous Injection in Healthy Chinese Volunteers

Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN2230 in Healthy Participants

The primary objective of this study is to evaluate the safety and tolerability of single subcutaneous (SC) doses of ALXN2230 in healthy participants.

Effect of Magnesium Supplementation on Sleep Quality and Cognitive Function in Saudi Adults

The goal of this clinical trial was to evaluate whether magnesium citrate supplementation improved sleep quality and cognitive function in healthy Saudi adults. It also assessed the effects of magnesium on selected blood markers. The main questions it aimed to answer were: Did magnesium supplementation improve sleep quality? Did magnesium supplementation improve cognitive function? Researchers compared participants who received magnesium citrate to a control group that did not receive any intervention to evaluate its effects. Participants: Took magnesium citrate (400 mg daily) for 90 days (two capsules: one in the afternoon and one 1-2 hours before bedtime) Visited Umm Al-Qura University twice (before and after the intervention) for: Sleep quality assessment Cognitive function assessment Blood sample collection to measure serum magnesium and HbA1c The control group did not receive any supplementation during the study period.

A Study to Evaluate the Bioequivalence of DA-5230 Compared to DA-5230-R

A study to evaluate the bioequivalence of DA-5230 compared to DA-5230-R

Safety and Efficacy of a Prebiotic Blend in Healthy Humans

The GRASP Trial is a 30-day, randomized, double-blind, placebo-controlled study (Protocol No.: GW-2025-02) designed to evaluate the safety and tolerability of a novel multi-fiber prebiotic blend in healthy adult volunteers (age 18-60, normal BMI). Participants will be randomized (1:1:1) to receive either a low dose (1 dose/day), a high dose (2 doses/day), or an identical placebo powder for 30 days. The primary objective is to evaluate safety and tolerability, measured by the incidence and severity of gastrointestinal adverse events (AEs) and discontinuations. Secondary objectives include assessing the fiber blend's impact on gastrointestinal symptoms (measured by the Gastrointestinal Symptom Rating Scale or GSRS score), beneficial gut microbiome composition (specifically SCFA-producing bacteria like Bifidobacterium spp.), and gut barrier function/inflammation (via markers like LBP, zonulin, hs-CRP, and IL-6). Exploratory objectives will examine effects on sleep and activity patterns using a wearable tracker, as well as quality of life (SF-36) and stress (PSS). The trial includes assessments at baseline (Day 0) and end-of-treatment (Day 28 ± 2), including the collection of blood, urine, and stool samples for comprehensive analysis.

Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1

Evaluate \[18F\]GATT-44 (aka \[18F\]GAT44), to characterize its pharmacokinetic, metabolic, and in vivo binding profile, and assess the reproducibility of kinetic and binding parameters. Assess specific binding levels of \[18F\]GATT-44 by conducting a test-block study in humans. Estimate human dosimetry of \[18F\]GATT-44 by performing whole-body imaging studies.

Kimchi and Gut Health

The goal of this study is to learn about the effects of eating kimchi on the gut health of healthy adults in the USA. The investigators will be researching the changes in the gut microbiome, biomarkers of gut health and cardiometabolic health after consuming fermented and unfermented cabbage. The main questions it aims to answer are: Does eating kimchi (fermented cabbage) result in enrichment of lactic acid bacteria in the stools of participants? Does eating kimchi result in metabolic changes in the gut microbiome, biomarkers of gut and cardiometabolic health of participants? Researchers will compare a group of participants eating fermented cabbage (kimchi) daily to a group of participants eating non-fermented cabbage daily. Participants will: Eat kimchi or cabbage daily for 3 weeks. Visit the study site for brief visits up to 5 times. Have blood drawn and provide a fecal sample 2 times - at beginning and end of the 3 week study. Keep occasional records of food intake and questionnaires about any gastrointestinal symptoms that participants may have.

RIG 101 Trial in Healthy Adults and Adults With Asthma

Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy

Turkish Validity and Reliability Study of PRevention of Toxic Chemicals in the Environment for Children Tool

The aim of this study is to conduct a Turkish validity and reliability study of the "Prevention of Toxic Chemicals in the Environment for Children Tool," developed to examine the knowledge and attitudes of parents and prospective parents regarding the effects of toxic chemicals in the environment on children's development.